Where the requirement comes from
Article 12, section XI, of the Mexican pesticide registration regulation sets out what a technical seeking registration as equivalent must file. Item b.3 asks for the final report of the analysis of the active ingredient and its impurities in at least five production batches. The regulation defines a batch as the quantity of material produced in a single operation (article 2, section XXV).
The same block of information is required when a registrant adds a new manufacturing site for the same technical (article 22, section IV, item b). The report is compared site against site.
This matches the FAO/WHO approach: manufacturing limits for impurities at or above 1 g/kg must be supported by data from at least five typical batches.
If you manufacture outside Mexico and have no company there, someone has to hold the registration: see how registration holding works.
The twelve elements the report must contain
Article 12, section XI, item b.3 lists them. You can present them in any order, but none can be left out.
- 01Start and end dates of the analysis.
- 02Name and address of the laboratory.
- 03Name and address of the study sponsor.
- 04The active ingredient and impurities analysed.
- 05Sample preparation for the active ingredient, by-products and isomers (where applicable) and impurities.
- 06Instrumental techniques, equipment and operating conditions.
- 07The internal standard used, by chemical name, if any.
- 08The fortification procedure, if fortified samples were used.
- 09Supporting evidence of quantification (chromatograms or spectra) identifying the active ingredient and each impurity.
- 10Results for the active ingredient and impurities in all five batches.
- 11The formula used to calculate concentrations.
- 12Method validation: specificity, precision and linearity for the active ingredient and impurities, plus limit of quantification for impurities.
The numbers that decide it
Item (e) of the same section sets two hard thresholds for the five-batch report:
- 01Mass balance of 98% or more.
- 02Unidentified or unaccounted-for fraction of 2% or less.
Impurities below 1 g/kg that are not relevant may be left out of the impurity profile. Relevant impurities must be declared and limited even below 0.1% (item b.2.3).
What travels with the report
The five-batch report does not stand alone. Item b.2 requires a manufacturing specification table (minimum active ingredient content, maximum level of each impurity at or above 0.1% or 1 g/kg, and maximum level of each relevant impurity), and item b.4 requires a summary of the manufacturing route: raw materials with chemical names and proportions, a general process description (batch or continuous, reactions and main unit operations) and an explanation of how each impurity forms, based on chemical theory.
Those limits are then compared with the reference profile using the criteria in item (f). We explain them in the technical equivalence guide.
Studies must follow internationally recognised guidelines and come from laboratories with a quality assurance system; Mexico accepts reports in Spanish or English (article 4).
Gaps that most often trigger a deficiency letter
- 01Specification limits that the five batches do not support, or whose basis (for example, highest value found, or mean plus 3 standard deviations) is not explained.
- 02Validation covering the active ingredient but not the impurities, or no limit of quantification for impurities.
- 03Chromatograms missing, unreadable or not labelled with the peaks being quantified.
- 04An impurity explained in the manufacturing route that never appears in the analysis, or the other way round.
- 05Mass balance reported without showing how it was calculated.
Every one of these is visible on paper before filing. We review the five-batch report against the reference profile before anything goes to COFEPRIS, and we do not file an incomplete dossier.
Frequently asked questions
How many batches does COFEPRIS require?
At least five production batches, under article 12, section XI, item b.3 of the Mexican pesticide registration regulation.
What mass balance does Mexico require in a five-batch analysis?
98% or more, with the unidentified or unaccounted-for fraction at 2% or less (article 12, section XI, item e).
Can the five-batch report be in English?
Yes. Article 4 of the regulation accepts studies written in Spanish or English. Other languages need a summary translated into Spanish by a certified translator.
Does the five-batch analysis have to be GLP?
Article 4 asks for a laboratory with a quality assurance system: one that applies international or national guidelines accepted by ISO, or its own good-practice guidelines. A study run under OECD GLP is generally taken to meet it, since GLP is an internationally recognised good-practice system.
Sources
- Mexican Pesticide Registration Regulation (Reglamento en Materia de Registros, Autorizaciones de Importación y Exportación y Certificados de Exportación de Plaguicidas, Nutrientes Vegetales y Sustancias y Materiales Tóxicos o Peligrosos), as amended in the Diario Oficial de la Federación (DOF), 13 February 2014: articles 2 (section XXV), 4, 12 (section XI) and 22 (section IV).
- FAO/WHO Manual on the development and use of FAO and WHO specifications for chemical pesticides, data requirements for technical materials (batch analysis of at least five typical batches).
Informational guide based on public regulations in force on the date shown. It does not replace a review of your dossier.
Related guides
