Pesticide Registration Toolkit
Submission of dossier.. Initial administrative actions Completeness check Dossier evaluation Registration decision Publication

Registration phase

The registration phase starts with the submission of the application for registration and supporting information by the applicant. Both the data requirements and the dossier format have to be established by the registration authority.

After receipt of the dossier by the registration authority, various initial administrative actions are taken, including the formal opening of a registration file, acknowledgement of receipt, reception of fees, and establishment of the exact dossier evaluation procedure. 

At this stage the establishment of data protection (confidential business information / exclusive use of registration data) is an important aspect.

The completeness check of the dossier allows the registration authority to verify whether all necessary information has been provided by the applicant. Missing information will generally be requested before the next step of actual evaluation of the dossier is initiated.

The technical and scientific evaluation of the dossier is the main step in the registration phase. The registration authority assesses the characteristics of the pesticide product submitted for registration and assesses its efficacy against the target pest(s), as well as the risks of  adverse effects on human and animal health and the environment.

On the basis of the evaluation of the dossier, the registration authority will take a decision on registration for use of the pesticide product in the country. This decision may include specific risk mitigation measures, such as restrictions and label statements.

After the registration decision has been taken, the registration authority proceeds with publication of the decision as well as of the product the details.

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

Registration phase – Submission of the dossier by the applicant [RP01-02-01]

The applicant should fulfill all technical and financial requirements as specified in the registration regulations of the country, and should submit the application for registration according to the format and conditions as defined by the registration authority. The registration authority may consider requesting an electronic dossier to facilitate storage and retrieval of the data.

Composition and format of the dossier

The registration authority of a country should specify clearly and comprehensively the types of data that are required for the registration of a pesticide. The format as well as the number of copies of the dossier that are required should be stated. These requirements should be made publicly available and any specific requirement should be made available from the registration authority upon written request.

The responsibility to generate or supply the data to support an application for registration of pesticides is with the applicant. Data provided in support of registration should reflect the conditions in the country or region where the pesticide is intended for use.

General outline of data requirements

Data required to support an application of a registration should cover all relevant aspects of  the product during its full life-cycle. They should include the identity and physical and  chemical properties of the active ingredient and formulated pesticide product, analytical  methods, human and environmental toxicity, proposed label and uses, safety data sheets,  efficacy for the intended application or use as well as residues resulting from their use, container management and waste product disposal. FAO and WHO assessments of pesticides should be included, when available.

Suggested data requirements for specific pesticide groups/types, intended uses, and various types of registration can be found through the Data Requirements and Testing Guidelines Tool. Testing guidelines that are available to generate such data can also be identified through this tool.

Registration by analogy

Considerably fewer data will be required for registration by analogy than for more comprehensive evaluation of the pesticide. Focus will be on the use details of the pesticide (e.g. Good Agricultural Practice (GAP) table), formulation specifications, basic toxicology of the formulation, and information on safety measures and precautions. The Data Requirements and Testing Guidelines Tool provides further details.

Tiered approach to data requirements

Increasingly, registration authorities apply tiered or step-wise approaches to evaluation and data requirements.

In a tiered approach, a more limited data set is required in a first submission by the applicant. If, on the basis of this limited data set, the assessment of efficacy, residues, and human and environmental risk show that the product is acceptable for registration, no further data need to be submitted. If, however, the limited data set does not allow for a conclusive assessment, additional data are requested from the applicant for the areas that need further evaluation (e.g. more specific toxicity studies, more precise exposure data, or larger-scale efficacy trials). This process of step-wise or tiered assessment may be repeated several times until a final decision on the registration is taken.

The advantages of tiered assessments and data requirements are that costs for the applicant are limited to the absolutely necessary, and that the registration authority only evaluates the data needed to come to a final decision. However, efficient communication between the applicant and registration authority is required for the approach to be effective and not delay the registration process.

Country-specific data requirements

Countries may require data that are not generally required in other registration schemes. This may particularly be the case if conditions of use are different in that specific country or region, where the pests, modes of application, or exposure due to climatic conditions are different.

Data quality

The data provided by the applicant should be of high quality and reliability and, whenever possible, be based on internationally recognized testing guidelines and methods, such as those published by FAO, WHO and the Organisation for Economic Co-operation and Development (OECD), among others.

Data should be generated in accordance with sound scientific and experimental procedures and follow the principles of good laboratory practice, whenever applicable. If requested by the registration authority, full reports should be submitted. Summaries should equally be of high quality, and fully reflect the findings of the studies. Applicants should ensure that proposed use patterns, label claims and directions, packages and technical literature truly reflect the outcome of scientific tests and assessments.

Registration phase – Initial administrative actions by the registration authority [RP01-02-02 ]

Initial administrative actions

Upon receipt of the application for registration, the registration authority should create a unique file for this application and ensure that all correspondence is properly filed and can be easily retrieved.

The registration authority should, upon receipt of the application for registration, send an acknowledgement of receipt to the applicant within a reasonable time frame. In case a fee is required for submission of the application for registration, verification of receipt of the fee should also be carried out as part of the completeness check.

Confidential data on pesticide products should be handled by authorized staff only. Such documents should be held in a secure location at all times. Measures against loss (fire, theft, damage by water, etc.) should be taken. A duplicate dossier should be stored safely in a physically different location.

Data protection and confidentiality

Pesticide registration authorities will receive many documents, materials and a wide range of data from companies wishing to register their products. Companies submitting such data for registration of a pesticide have an interest in ensuring that this information, which is costly to generate, and which may be used unfairly by competitors, is suitably protected. At the same time, good public policy and national legislation strive to reconcile competing interests, and, provide sufficient incentives for such data to be generated in the first place, ensuring that follow-on producers have reasonable opportunities to enter the market and providing for the possibility of making all or part of the data concerned accessible to the public.

More information on data protection and confidentiality of pesticide registration data is provided  here

Registration phase – Completeness check [RP01-02-03]

The registration authority should check, in a timely manner, whether the dossier is complete with respect to the requirements and specified criteria. The check should also include consideration of any request for waivers from the applicant.

Based on the completeness check, the registration authority should request the applicant to supply any missing or incomplete information in the dossier. If the gaps in data submitted are considered essential for their evaluation, the registration authority should inform the applicant that further processing of the application is postponed, pending the submission of these additional data.

Basic completeness check-lists can be generated using the Data Requirements and Testing Guidelines Tool. (Use the Print button, after having selected a set of specific data requirements)

Registration by analogy

Because the data required to be submitted for registration by analogy are limited and will basically consist of summaries, the completeness check will generally only take little time. However, the registration authority will still need to conduct this step in the process seriously, to ensure that the submitted summaries are reliable and complete.

Registration phase – Dossier evaluation [RP01-02-04]

Evaluation by experts

The registration dossier should be submitted to qualified experts in relevant fields including efficacy, human health and environmental effects for technical evaluation of the data. These experts could either be part of the office of the registration authority or experts from academia or research institutions. They should perform the evaluation, whenever possible, making use of internationally agreed methodologies and criteria. Care should be taken to ensure that these experts are indeed independent, that no conflict of interest is declared with respect to the data they are evaluating and that the dossier is treated confidentially.

Assessment of the submitted information

Dossier evaluation generally consists of the following elements:

  • Verification of authenticity: The registration authority should ensure that an applicant has the rights to submit the registration dossier and the data submitted are authentic.
  • Completeness check: The registration authority should ensure that data in the submitted dossier is complete and in conformity with the officially published data requirements for the intended use of the pesticide (see also the section on the Completeness check).
  • Waiving request: The registration authority should ensure that if there is a request for a waiver from certain data requirements, reasons given are acceptable based on the criteria set.
  • Assessment of data quality: The registration authority should ensure that the data submitted are of acceptable quality and that they comply with the standards required.
  • Assessment of registration status in other countries: The registration authority should ensure that the information is provided and includes information about restrictions.
  • Assessment of all technical data: The registration authority should ensure that the data support the registration for the intended use.
  • Risk assessment: The registration authority should ensure that the risks of using the pesticide according to the proposed label are acceptable.
  • Relevance of data: The registration authority should ensure that all data provided is relevant to the conditions under which the product will be used and to the crops and pests/diseases to which it will be applied.

If and when appropriate, the registration authority may also take note of expert opinion from other competent regulatory authorities when evaluating data.

Further guidance on the evaluation methods and procedures for different parts in the registration dossier can be found in the Assessment methods tool.

Registration by analogy

The evaluation of the pesticide when applying registration by analogy is much less complex as described above. It focusses on bridging the use conditions, potential exposure to the pesticide and indicative risks between the local situation where the pesticide is submitted for registration and a reference country. This is described in more detail on the registration by analogy pages.

Request for and assessment of additional data

If the registration authority should conclude that data submitted are incomplete or that the outcomes of certain studies require more detailed information, it should request the applicant to submit additional data to enable a more complete assessment to be made. Different scenarios may apply:

(a) the data set is incomplete to allow for an assessment and the registration process is suspended until receipt of the additional data required;

(b) the data set is complete for an assessment leading to a provisional registration under certain restrictive conditions for a limited period of time, such as provisional registration;

(c) the data is complete when compared to the requirements, but certain aspects require further study. The registration authority may decide to grant registration for a period that is long enough to allow for these additional studies to be carried out.

The registration authority should also specify a time period within which these data should be submitted as well as indicate that further processing of the application for registration is postponed until receipt of these data.

Use of existing evaluations of the same active ingredient and/or product

In case the applicant has the ownership of the data or can fully justify the right to use the data for his application for registration, elements of existing registrations can be used for new applications based on the same active ingredient. However, if the data were to be owned by a different owner and the applicant could not justify his right to use these data, the registration authority should not use the data and evaluation from the first registrant for approval of the product of the second applicant.

Preparation of summaries and conclusions

Reviewers should submit their conclusions to the registration authority within a reasonable and agreed time frame and provide a summary listing of the data and assessments that formed the basis of their conclusions.

Based on the evaluations and recommendations of the experts, the registration authority should prepare a comprehensive summary of all relevant data and the conclusions from the experts for consideration by the pesticide board if it is of the view that review of the data is complete and ready for a decision.

Registration phase – Registration decision and risk management [RP01-02-05]

The pesticide registration board will normally take the final decision on the registration of the pesticide, taking into account the review prepared by the registration authority, and possibly the outcome of the public review procedure.

The decision of the board may be provisional or full registration, with or without restrictions and/or conditions, or refusal. The board may also decide to suspend a decision and request further data or assessments to be provided.

Use of a pesticide is generally approved only for specific applications, e.g. for control of specific pest(s) on certain crops or specific applications for control of nuisance pests or vectors of diseases. These approved purposes should be incorporated in the registration decision.

Effectiveness of the product to control specific pests, and risk of residues on the crop concerned, are among the factors that play a role in decisions to limit approval to certain crop–pest combinations.

In cases of elevated human health or environmental risk, the use of certain pesticides may be severely restricted. Such severe restrictions may, for instance, specify that the product can be used only by licensed applicators for very specific purposes.

However, restricting the use of pesticides as a form of risk management is only effective if the restrictions are actually adhered to and are being enforced. The Code of Conduct therefore stipulates that prohibition of the importation, sale and purchase of highly toxic and hazardous products may be desirable if other control measures or good marketing practices are insufficient to ensure that the product can be handled with acceptable risk to the user.

In case the Board concludes that a registration may be granted, the registration authority should assign a unique registration number linked to the specific registration from the specific applicant. If the registration of a pesticide is refused, or if the use of pesticide is severely restricted, specific additional post-registration actions may need to be taken in order to protect human health or the environment.

The registration authority may publish its summary and proposed registration decision and invite third parties to provide comments. Care should be taken that any public review period

does not unreasonably delay the registration process.

Further guidance on decision making and risk management can be found in the Decision Making tool.

Registration phase – Publication and dissemination of the registration decision [RP01-02-06]

The registration authority should inform the applicant of the decision taken by the pesticide board. In cases where registration is granted, the registration authority should inform the applicant of all relevant conditions linked to the registration, including the labelling and marketing conditions and the registration number.

The registration authority should then take the necessary actions to publish the decision in the governmental or official gazette for the product to be legally registered. The information

contained in the gazette should include: name of registrant, registration number, trade name of product, active ingredient(s) as well as its concentration(s), formulation and usage. Only registrants of registered products should be allowed to import and/or manufacture the products for sale. The registration authority may also make this information available on the Internet.

The registration authority should also inform all key representatives of relevant governmental agencies and institutions, including enforcement agencies, customs departments, plant protection services or public health services as well as experts who participated in the evaluation of a positive decision. Enforcement agencies and experts may also receive information regarding refused applications.