Pesticide Registry by Equivalence.
In relation to pesticide records by equivalence. In this regard, there are various pesticide registration strategies, which after the evaluation of exhaustive scientific data must demonstrate:
a) the efficacy of the product considering its purpose; and,
b) that its use does not generate unacceptable risks to human health, fauna or the environment.
These strategies can range from the most basic to the most comprehensive and as a consequence their complexity and requirements vary.
The Food and Agriculture Organization of the United Nations (“FAO” for its acronym in English), for its part, indicates that a registration by equivalence is a registration tool, which proceeds in the event of the existence of a pesticide that has not been registered, and that due to its similarities may be equivalent to another similar product already registered in the country.
In Mexico, the Federal Commission for the Prevention of Sanitary Risks (“COFEPRIS”), in charge of evaluating and authorizing pesticides, through our legislation and particularly the Regulation on Registries, Import and Export Authorizations and Export Certificates of Pesticides, Nutrients Plants and Hazardous Toxic Substances and Materials (“REGULATION”), has adopted as a strategy, among others, the granting of pesticide registrations by equivalence.
The REGULATION in subsection j) of section X and section XI of article 12 establishes the scenarios, options and requirements to request a registration by equivalence.
Returning, a record by equivalence can be given, when:
I. the special legislation -in this case the REGULATION- contemplates it;
II. there are two equivalent pesticides from different manufacturers;
III. have impurity and toxicological profiles, physical and chemical properties of similar technical materials; and,
IV. have similar levels of risk.
By virtue of the foregoing, Briffault Abogados, SC, is at your service to provide appropriate and timely advice, regarding requesting records by equivalence. As well as, for any abuse by the authority in charge of granting it.