Decree amending the regulations on registration, import and export authorizations and export certificates for pesticides, plant nutrients and toxic or hazardous substances and materials April 2026
On April 24, 2026, the President of the United Mexican States published in the Official Gazette of the Federation (“DOF”) the “Decree reforming and adding various provisions to the Regulations on Registration, Import and Export Authorizations and Export Certificates for Pesticides, Plant Nutrients and Toxic or Hazardous Substances and Materials” (the “Decree”). This regulation, issued pursuant to the General Health Law, the General Law of Ecological Balance and Environmental Protection, and the Federal Plant Health Law, introduces significant modifications regarding sanitary registrations, data protection, and import and export requirements for agrochemical products. Its scope is of particular interest to companies in the agro-industrial and chemical sectors, and especially to those developing bioenergy or biofuel projects that involve the use, production, or marketing of pesticides and plant nutrients.
Fundamental aspects
- New regulatory category: The definition of “new agricultural chemical product” is incorporated.
- New documentary requirements: The requirements for obtaining registrations with COFEPRIS are updated, including a data protection mechanism for security and effectiveness.
- Data exclusivity for 10 years: Article 13 Bis is introduced, which establishes a 10-year protection on information regarding the safety and efficacy of new agricultural chemicals.
- Registration extension updated: The extension of the registrations will be valid for 10 years from the date of issuance.
- Implementation timeframe: The Ministry of Health has 180 calendar days to issue the necessary regulatory and administrative adjustments.
- Entry into force: The day after its publication in the DOF (April 25, 2026).
Key Points of the Decree
New definition: “New Agricultural Chemical Product”
The Decree adds section XXXII Bis to article 2 of the Regulations to define as “new agricultural chemical product” This category includes pesticides or plant nutrients containing an active ingredient that has not been used in any product previously registered under the Regulation. This category is the cornerstone of the new data protection mechanisms detailed below.
Update of Requirements for Obtaining Registrations
Article 10 of the Regulations is being amended to clarify and expand the documentation that interested parties must submit to COFEPRIS. Among the most important aspects of the new text are the following:
- Express consent of the data subject: When the applicant intends to use, in whole or in part, the safety and efficacy information of a new agricultural chemical product already registered, he must present the express consent of the holder of said information, provided that no more than 10 years have elapsed since the date of issue of the original registration.
- Patent accreditation: If the product has a valid patent in Mexico, the applicant must present the document issued by the Mexican Institute of Industrial Property that proves its ownership or, if applicable, the certificate of the exploitation license registered with the same Institute.
- Public databases: COFEPRIS will publish and update on its website the databases of granted registrations, as well as pending registration applications, at least every 30 calendar days from the start of its publication.
The documentation must be submitted classified into five sections: (i) administrative and identification information; (ii) identity, composition and analytical methods; (iii) toxicological information and label draft; (iv) ecotoxicological and environmental fate information; and (v) information on physical properties, maximum residue limits and biological effectiveness.
New Article 13 Bis: Data Protection, Security and Effectiveness
This is undoubtedly the most relevant provision of the Decree. The new Article 13 Bis It establishes that information concerning the safety and efficacy of a new agricultural chemical product—including physicochemical, toxicological, ecotoxicological and environmental fate data—shall enjoy protection for a period of 10 years counted from the date on which the first registration was granted in national territory.
During this period, the competent authority may not allow third parties, without the express consent of the holder, to obtain a registration to market the same or a similar product, whether based on this information or on the previously granted sanitary registration. This protection applies even when the original application was based on a marketing authorization granted abroad.
Registration Extension
Article 23 Bis 4 is amended to establish that the extension of registrations will have a validity of 10 years counted from its issuance, and which may be reviewed at any time by COFEPRIS, in accordance with the provisions of the General Health Law.
Transitional provisions and deadlines
The Decree establishes the following transitional provisions that all companies in the sector must take into account:
| Provision | Responsible and adaptable | Term |
| Entry into force of the Decree | April 25, 2026 (the day after publication in the Official Gazette of the Federation) | |
| Conclusion of matters in process under the previous rules | Interested parties / COFEPRIS | Until its conclusion in accordance with the provisions in force at the time of its presentation |
| Regulatory and administrative adjustments for implementation | Ministry of Health | 180 calendar days from the entry into force of the Decree |
| Expenditures under the Decree charged to the authorized budget | Spending officers | Without additional resources; charged to the existing regularizable budget. |
It is important to note that, until the Ministry of Health issues the aforementioned regulatory and administrative adjustments, the previous provisions will continue to apply in all matters that do not contradict this Decree, and the competent authority must directly apply the provisions of the latter in case of conflict.
Does your company operate in the agrochemical or agroindustrial sector?
En Santamarina + Steta We help you to:
- Evaluate the impact of the Decree on your current and pending health registrations.
- Design strategies for the protection of data security and effectiveness of your new products.
- Manage registration, import and export procedures with COFEPRIS.
- Advise you on complying with the new obligations during the transition period.
References: https://dof.gob.mx/nota_detalle.php?codigo=5785958&fecha=24/04/2026













