“The deadlines and steps may vary depending on the specific case and the complexity of the product in question…”
Romy Ursúa Monreal is a founding partner of IKAN Consultores, a lawyer at the Technological University of Mexico, and a specialist in the regulatory area of pesticides and of the plant nutrition sector.
Ursúa is head of the Crop Protection Commission of the Mexican Association of Sanitary Regulation Professionals and was coordinator of regulatory affairs for the Mexican Association of the Phytosanitary Industry.
AgriBrasilis – How does the pesticide registration process work in Mexico and which bodies are involved?
Romy Ursúa – In Mexico, the registration of pesticides is regulated by the Secretariat of Agriculture and Rural Development – Sader, by the Secretariat of the Environment and Natural Resources – Semarnat and by the Federal Commission for Protection against Sanitary Risks – Cofepris. These agencies are involved in issuing the Coordinated Sanitary Register (RSCO), after compliance with product safety and efficacy tests. The registration process is time-consuming, involving submitting detailed technical information and conducting rigorous assessments.
In the Initial Order stage, detailed information about the product is provided (composition, formulation, physical and chemical characteristics, mode of action). During Evaluation, studies and laboratory tests collect evidence on the safety and efficacy of the product. Subsequently, Cofepris issues a Technical Opinion, and when the requirements are met, the Registration and Certificate for the distribution and commercialization of the crop protection product are obtained.
AgriBrasilis – What are the stages of registering chemical and biological products?
Romy Ursúa – The deadlines and steps may vary depending on the specific case and the complexity of the product in question, but I will give you an overview of the registration process.
First, an import license must be requested to carry out an experimental sample. Then, the studies are compiled as established in the Plafest Regulation [regulation on registration, import and export authorizations for pesticides, plant nutrients and toxic substances], that also includes biological efficacy studies.
Once the requirements are met, the product’s dossier is assembled and an appointment is requested with Cofepris to include this product. After this process, you must wait for the registration to be granted.
The Plafest Regulation establishes that, once the request has been made and Sader and Semarnat have issued the technical opinion, Cofepris has a period of 80 days to issue a warning. Finally, Cofepris has a period of 40 days to issue the final resolution on the registration of the chemical or biological product.
AgriBrasilis – What documents and studies are needed to register these products?
Romy Ursúa – Data from the applicant, information on the active ingredients, on the composition of the product, intended use, mode of action and a variety of studies are required: acute and chronic toxicology; safety; effectiveness in controlling target and non-target pests; ecotoxicology to assess effects on non-target organisms and the environment; residues in food; and pesticide stability and compatibility, to name a few.
In addition, labeling information is provided, including usage instructions, safety precautions, warnings and a detailed package insert.
AgriBrasilis – How long does it take on average to register a product? And what about in the case of biological products?
Romy Ursúa – The legislation defines, for both cases, that registrations must be granted within nine months, but in reality, the wait period is, on average, up to three or four years.
AgriBrasilis – What is the cost of registering chemical and biological pesticides? Is there any cost after registration?
Romy Ursúa – The cost of pesticide registration in Mexico can vary depending on several factors, such as the type of pesticide, the category of use, the number of active ingredients and the complexity of the necessary studies.
In general, fees must be paid for steps such as application for registration, file analysis, evaluation and issuance of the registration certificate, among other expenses related to carrying out studies in specialized laboratories.
As of June 2023, costs range from US$ 1380 to US$ 5200, depending on the toxicological category. There are no further payments unless modifications or extension of registration are required.
AgriBrasilis – What criteria supported the prohibition of glyphosate? What is your opinion on this prohibition?
Romy Ursúa – The use of glyphosate in agriculture is supported by regulatory bodies in over 160 countries, that carry out rigorous scientific tests to determine its safety and effectiveness.
Although the ban on glyphosate has been controversial, several regulatory bodies have concluded that it can be used safely if used as directed on the label.
Decisions on banning glyphosate should be based on an objective and scientific assessment based on evaluation.
AgriBrasilis – What are the works carried out by Ikan Consultores?
Romy Ursúa – Ikan Consultores is a Mexican consultancy expert in agrochemical registrations. We advise on procedures for requests, registrations, modifications, extensions and health licenses before Cofepris.
We are committed to offering a personalized and quality service to help companies optimally establish themselves in the Mexican market.
We help promote appropriate legislation and represent companies on regulatory matters before working groups, conducting benchmarking, writing briefings and following up on relevant regulations and provisions.