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Technical equivalence in Mexico: how COFEPRIS compares your technical

If the active ingredient you manufacture is already registered in Mexico, you can register by equivalence: you show that your technical matches the reference profile and file far less data. The criteria are written in the regulation, and they are stricter on paper than many manufacturers expect.

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The two definitions that frame everything

The Mexican pesticide registration regulation defines an equivalent pesticide as a technical from a different manufacturer that is similar to a reference profile in its impurities, its toxicological profile, or both (article 2, section XLVIII).

The reference profile is the compilation of study results identifying relevant and non-relevant impurities and toxicological properties of a technical, used as the yardstick for equivalence (article 2, section XXXVI).

How the reference profile is chosen

Article 12 Bis sets the rules. First, there must be at least one current registration in Mexico of the active ingredient, as a technical or as a formulated product. No Mexican registration, no equivalence route.

Then COFEPRIS follows this order of priority:

  • 01Information offered by registrants who agree to have their product used as the reference profile.
  • 02FAO/WHO specifications, or those of other international organisations Mexico belongs to.
  • 03Reference profiles recognised by health authorities of other countries.
  • 04Profiles set under guidelines COFEPRIS publishes for that purpose.

Some reference-profile data are public by law: common and chemical name, minimum purity, isomeric composition, maximum content of relevant impurities, oral and dermal LD50 and inhalation LC50, eye and skin irritation, sensitisation result, and the date of publication (article 12 Bis, section III).

Two routes: chemical only, or chemical plus toxicology

Article 12, section XI, item (a) lets the applicant choose:

  • 01Chemical equivalence: you file the chemical information, the label and the hazard category. If COFEPRIS finds the technical is not chemically equivalent, you must then file the acute toxicology.
  • 02Chemical and toxicological equivalence: you file the chemical information and the acute toxicology (oral, dermal and inhalation, skin and eye irritation, sensitisation) together.

The chemical information is built around the five-batch analysis. We cover it in detail in the five-batch analysis guide.

The chemical criteria

Under article 12, section XI, item (f), your technical is chemically equivalent when:

  • 01Your guaranteed minimum active ingredient content is equal to or higher than the reference profile's.
  • 02The maximum level of each non-relevant impurity does not increase by more than 50% over the reference, or by more than 3 g/kg in absolute terms, whichever is the larger increase.
  • 03There are no new relevant impurities.
  • 04The maximum level of relevant impurities does not increase.
  • 05Any new impurity at 0.1% (1 g/kg) or above comes with technical evidence that it is not relevant, such as structure-activity studies or toxicological contribution analysis based on published literature.

The impurity thresholds match the FAO/WHO Tier 1 criteria (paragraph F.3). FAO/WHO Tier 1 also compares the bacterial mutagenicity profile, which the Mexican regulation does not list.

Hypothetical example: the reference profile allows a non-relevant impurity at up to 4 g/kg. A 50% increase gives 6 g/kg; a 3 g/kg increase gives 7 g/kg. The larger increase applies, so up to 7 g/kg is acceptable.

The toxicological criteria

Under item (g), the toxicological profile is equivalent when oral and dermal LD50 and inhalation LC50 do not differ from the reference by more than a factor of two (or a factor proportional to the dose spacing, where that is greater than two; a product up to ten times less toxic can also be considered equivalent), skin and eye irritation are equal or lower, and sensitisation does not change from negative to positive, provided the same guideline was used.

What changed in 2025 and 2026

The simplification notice published in the DOF on 22 October 2025 merged the equivalence procedures for technicals and formulated products into one: “Registration of technical and/or formulated chemical pesticides by equivalence” (procedure code COFEPRIS-06-011). The same notice cut the maximum resolution time from 120 to 80 business days, effective once the electronic platforms are running.

The amendment to the regulation published on 24 April 2026 created the category of “new agricultural chemical product” and a ten-year protection for its safety and efficacy data, counted from its first registration in Mexico (article 13 Bis). Within those ten years, using that information requires the express consent of its holder. If the product is covered by a patent in force in Mexico, the applicant files the IMPI patent title or a licence registered with IMPI.

Who files, if you have no company in Mexico

The applicant must operate an establishment in Mexico with a health notice (aviso de funcionamiento) or a health licence (article 10; since 2025 these data are entered in the application form), and the supplier's letter must name that applicant as the buyer of the product (article 11). If you manufacture in India or China and have no such entity, someone who has one has to hold the registration. Read how registration holding works before you hand that role to a distributor.

Frequently asked questions

Can I register by equivalence if the active ingredient is not registered in Mexico?

No. Article 12 Bis requires at least one current Mexican registration of the active ingredient, as a technical or a formulated product, before a reference profile can be set.

What impurity increase does COFEPRIS accept for equivalence?

For each non-relevant impurity, no more than 50% over the reference maximum or 3 g/kg in absolute terms, whichever is larger. Relevant impurities cannot increase and no new relevant impurities are allowed.

Do I always need acute toxicity studies?

Not always. Under the chemical-only route you file them only if COFEPRIS finds your technical is not chemically equivalent. Under the combined route you file them from the start.

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 DOF, 13 February 2014: articles 2 (sections XXXVI and XLVIII), 10, 11, 12 (section XI) and 12 Bis.
  • Simplification notice for COFEPRIS procedures (Acuerdo por el que se establecen acciones de simplificación…), DOF 22 October 2025, articles second, third and sixth; fifth transitory article.
  • Decree amending the pesticide registration regulation, DOF 24 April 2026 (article 2, section XXXII Bis; article 10; article 13 Bis).
  • FAO/WHO Manual on the development and use of FAO and WHO specifications for chemical pesticides, determination of equivalence (Tier 1).

Informational guide based on public regulations in force on the date shown. It does not replace a review of your dossier.

Related guides

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