Pesticide Registration Toolkit
Archiving Notification of Rotterdam Convention Monitoring Extensions and changes Appeals and litigation

Post-registration phase

After a registration decision has been taken, various activities may need to be conducted. The order of activities is not as explicit as in the registration phase, and depends on the local legal provisions and administrative organization of the registration authority.

Proper archiving of the complete dossier and any accompanying documentation is an important action in the pesticide registration process.

If the country is Party to the Rotterdam Convention, and the registration authority has prohibited a pesticide, refused its registration, or severely restricted it, for health or environmental reasons, the Convention Secretariat will need to be notified of that decision.

Post-registration monitoring is an essential mechanism to measure the validity of any registration decision, in particular with respect to biological efficacy, human health effects, and environmental concentrations and impact.

The applicant may request the registration authority to perform administrative changes or extension(s) of the registered use(s) of an existing registration.

If the applicant or a third party does not agree with the registration decision of the registration authority, an appeals or litigation procedure may be initiated.

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

Post-registration phase – Archiving [RP01-03-01]

The registration authority should ensure that decisions made, including summaries, assessments, deliberations and conclusions of the Pesticides Registration Board, written communications (including e-mails) and data, are properly documented and stored for future reference. Adequate facilities should be provided to store such confidential information, which should be accessible to authorized personnel only.

Post-registration phase – Notification of the Rotterdam Convention [RP01-03-02]

For Parties to the Rotterdam Convention, the registration authority should inform the designated national authority (DNA) of the Convention (if it is not itself that authority) of any final regulatory action it has taken to prohibit or severely restrict the use of a pesticide in order to protect human health or the environment.

Such decisions are considered as a ban or a severe restriction under Article 2 of the Convention, that also covers a pesticide that has been refused approval for first-time use or has been withdrawn by industry either from the domestic market of from further consideration in the domestic approval process, where there is clear evidence that such action has been taken in order to protect human health and the environment. In line with Article 5 of the Convention, the DNA is required to notify the secretariat of such final regulatory actions within 90 days after the regulatory action has taken effect.

When a chemical is listed in Annex III of the Convention, it is subject to the prior informed consent, or PIC procedure. Under this procedure, Parties are required to inform the Secretariat whether or not they consent to the future import of these chemicals. Parties to the Convention are legally bound to respect these decisions. In line with article 10, a decision not to consent to future import should be accompanied by prohibition of (i) the import of the chemical from any source and (ii) domestic production of the chemical for domestic use. Prohibition of the import and domestic production of a chemical would warrant cancellation of its registration.

More information on the notification of final regulatory action as well as the operation of the PIC procedure can be found on the web site of the Rotterdam Convention.

Post-registration phase – Monitoring and evaluation [RP01-03-03]

Post-registration monitoring and evaluation provide a means of measuring the validity of predictions, based on registration data, regarding the efficacy, safety and environmental effects of a particular pesticide product. Post-registration monitoring and evaluation may reveal that a product is no longer effective as a result of the documented development of pesticide resistance to a level of field performance failure, that the product is of poor quality or that it has caused unacceptable risks to human health or the environment. Widespread abuse of the pesticide concerned or non-adherence to restrictions are factors that should also be taken into consideration.

The registration authority may make use of the findings of post-registration monitoring and evaluation to take the necessary corrective actions such as the amendment of recommendations on use and dosage, restriction on use or, if necessary, withdrawal of the registration of the product.

The Code of Conduct calls upon governments to periodically review the pesticides marketed in their country, their acceptable uses and their availability to each sector of the public, to conduct special reviews when indicated by scientific evidence and to carry out health surveillance programmes of those who are occupationally exposed to pesticides and investigate, as well as document, poisoning cases.

There should be provision for a mechanism for reporting adverse effects caused by pesticides as well as for collecting and analysing such data. Governments should collect and record data on the import, export, manufacture, formulation, quality, quantity and use of pesticides in order to assess the extent of any possible effects on human health or the environment and to follow trends in pesticide use for economic and other purposes. The development of track-and-trace systems of pesticides will facilitate such data collection, and should be encouraged whenever feasible.

Post-registration monitoring or evaluation may also consider other information sources such as publications regarding health or environmental problems related to the pesticides concerned in other countries, in particular when such data can be extrapolated to the local situation in an appropriate manner.

Post-registration phase – Extensions and changes [RP01-03-04]

Administrative arrangements for minor changes

Minor changes in the registration dossier, such as changes to company address or telephone number or in distributors, which do not affect the content of the registration decision, may be handled by a simple administrative arrangement, although they would have a consequence for the labelling of the product.

It is recommended that any minor changes made to the registration be reflected in the registration number, for example by adding a suffix at the end of the number. This will facilitate traceability of the product in relation to the originally registered product.

Administrative arrangements for major changes – label extension

Major changes in the registration, such as changes to the label or adding new uses (crops, pests or vectors), will require full or partial review of the data package submitted by the registrant and, where necessary, additional data will be requested and evaluated before approval of the request. Pesticide industry should provide such additional data to the registration authority to support new uses. If these additional label claims are approved by the authorities, they would then be included on the label.

Post-registration phase – Appeals and litigation [RP01-03-05]

Appeals procedure

If the registration of a pesticide is refused, or if restrictions apply, the applicant should be allowed to appeal against the decision. A formal appeals procedure should be included in the pesticide regulations, stipulating the full procedure, the conditions of appeal and time limits to all steps in the procedure. The registration authority should communicate this information to the applicant where applicable. However, the appeals procedure explicitly should not allow questioning of the validity of criteria.


Depending on the national legal system, an applicant may take its case to court if it is not satisfied with the outcome of the appeals procedure. Third parties, including public interest groups, depending on the national legal system, may also have the opportunity to contest in court the decision to register or not to register a pesticide. The pesticide board should therefore keep records of all its decisions and deliberations.