Pesticide Registration Toolkit

Pre-registration phase

 

The responsible authority may invite the applicant to discuss the legal and other requirements prior to the submission of the application for registration. In some countries this has been formalized by requiring a pre-application meeting between the applicant and the registration authority.

Furthermore, before an application can be done for the registration of a pesticide product, the applicant may need to conduct certain local studies. In most cases, these studies are limited to biological efficacy trials and residue studies in local commodities, but in some cases other local studies will need to be carried out as part of the registration dossier. Since the pesticide may not yet be registered for use in the country, an experimental permit may need to be issued for the importation and use of the product.

Registration by analogy

Local efficacy trials or residue studies are generally not conducted in countries that apply registration by analogy. The registration authority will often not have the human resources to evaluate the results of such trials.

Click on the relevant arrow box in the chart for further information and options for each step.

 

Pre-registration phase – Pre-application meeting [RP01-01-01] 

It is often considered very effective to have a pre-application meeting between the applicant and the registration authority, during which the applicant can be informed about the exact registration procedures and data requirements.

Certain registration schemes may permit applicants to submit a pre-application dossier – a limited dossier that indicates the major issues that are relevant for the specific product – in order to obtain more specific guidance on whether the product can be registered and which data will be required. The responsible authority can at this stage inform the applicant that the product for which the registration is sought may not fulfil the criteria for registration, based on experience or on certain basic criteria (e.g. pesticides of certain toxicity class may not be permitted for a specific group of users in the country).

It is important to prepare a brief report of the pre-application meeting, and share this with the applicant, as a record of any decisions taken and recommendations made.

 

Pre-registration phase – Experimental permit [RP01-01-02]

Governments should have in place regulations for the importation of limited quantities of unregistered pesticides for the purposes of research, education or registration. Such regulations will enable the registration authority to issue an experimental permit to a party that wishes to import a limited quantity of pesticide for any of the above purposes.

The regulations should, among others, require applicants to provide basic information on the pesticide, such as the name of the active ingredient, common name or code name, type of pesticide, chemical group, percentage active ingredient, acute oral and dermal LD50, inhalation toxicity, environmental fate and toxicity. In addition, the applicants for an experimental permit should provide information on the purpose of the import, the quantity to be imported, and particulars on where, when and by whom the experiment(s) will be carried out.

The responsible authority should then evaluate the information and decide whether an experimental permit can be issued and, if so, the conditions attached to its issuance. The conditions of the permit may, among others, depend on the stage of development of the chemical. The permit will define the quantity of pesticide authorized for importation, any possible requirement to destroy the treated crops or commodities after the experiment, the location of the experiment, and the proposed date(s) of the experiment(s) to allow inspection by the responsible authority.

Registration by analogy

Although countries that apply registration by analogy will generally not require local studies to be conducted, it will be useful to have regulations that allows the issuance of experimental permits. As a country develops its pesticide registration system, such studies may be required in the near future.