This tool outlines the criteria that are applied by key registration authorities around the world when making a decision to register, or refuse registration, of a pesticide. It provides summary information about how, and in what context, the criteria are applied to allow registration staff and decision-makers to understand the principles and processes followed in making a registration decision. It also refers to risk assessment models/methods which provide the framework for decision-making.

The tool focuses on the technical registration criteria. It does not cover the administrative or procedural matters relating to data, dossier requirements, completeness checks or public consultation processes. It does not cover either the application of regulatory risk management tools such as labeling or the powers to restrict or place conditions on the registration.

Criteria are in legislation while procedures and methods are in guidelines and manuals

Registration criteria are set by countries or regions in their legislation. Pesticide registration authorities make decisions on whether to register, or whether not to register, a pesticide in line with the criteria set out in legislation. The legislation will set out the criteria that must be met before a pesticide can be registered. If the criteria cannot be met then the pesticide cannot be registered. Some legislative frameworks also include specific criteria that, if met, prohibit registration.
 
The legislation will set out the high-order goals to be achieved when making a registration decision. The goals relate to the protection of human and animal health and the environment and are often referred to as ‘general protection goals’. Some legislative frameworks will set out detailed technical criteria and principles to be applied during evaluation and in decision-making, other legislative frameworks focus on high order principles. In each case a scientific evidence-based approach is applied.

Detailed risk assessment and risk management methodology or policies that guide the evaluation process and decision-making are generally described in operational guidelines and manuals. Guidelines and manuals can be reviewed and updated to ensure that the risk assessment processes and regulatory decision are in line with current scientific knowledge. The guidelines and manuals set out the framework and principles that should be followed and, unless specified by law, are not mandatory.  Thus decision-makers may use a different approach in a specific circumstance provided a valid scientific argument applies.

The summary information can provide a reference for countries that do not have criteria available or only have limited criteria available. However, countries or registration authorities should not rely on the summary information alone to interpret or locally implement criteria used by other registration authorities. More detailed research and understanding of the procedures and methods underlying the decision-making processes would be required before one country can properly interpret and potentially use the criteria of another country. Furthermore local/regional agricultural practices, pesticide use patterns and climatic conditions should be compared and contrasted and the assumptions and limitations of the methods and models used must be fully understood.

What does this tool on registration criteria include?

The focus of the tool is primarily on chemical pesticides and on risks for two key priority risk areas: human health and environment. For each risk area:

• An initial part focuses on summarising the criteria as set out in legislation.
• The subsequent parts cover sub-areas and, for each, summarise the risk assessment methodology and policies used in the evaluation process and in decision-making.
• Last, for each part, a final section includes remarks about whether the criteria and the policies used during evaluation and decision-making can be applied in other countries.

The areas on human health and environment currently includes a number of specific risks and associated criteria for a given number of countries/regions. Both the number of risk areas and of countries covered will be expanded over time.

Sections of this tool are closely related to information on data requirements and on assessment methods.