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Registration Tools

A complete framework for regulatory assessment and decision-making

All eight sections from the presentation are available as clickable pages and summarized below.

Scientific regulatory assessment
01

Registration Strategies

Select an approach suited to available resources, evidence and the regulatory framework of the target country.

Open section02

Registration Process

From pre-registration through review, every step supports a structured assessment of the application.

Open section03

Data Requirements & Testing

Define the studies needed to demonstrate product efficacy and safety through internationally accepted protocols.

Open section04

Assessment Methods

Apply procedures and models suited to each scientific component of the dossier.

Open section05

Risk Mitigation

Define effective, practical and communicable measures to reduce health and environmental risks.

Open section06

Decision Making

Connect risks, values, alternatives and management measures to reach a regulatory decision.

Open section07

Registration Criteria

Verify that the product meets general protection goals and applicable scientific and legislative criteria.

Open section08

Assessment of Alternatives

Compare available options when a product is highly hazardous or its risks are difficult to manage.

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01

Registration Strategies

A registration strategy is the overall approach used to evaluate and authorize a plant protection product. Depending on available resources, expertise and data, it may range from a basic route to an exhaustive assessment.

Analogy

Compare the product with one already approved in a reference country.

Equivalence

Demonstrate that the product is equivalent to one already registered locally.

Resource rationalization

Share data, extrapolate results or conduct joint reviews with other countries.

Local evaluation

Conduct a complete assessment using locally generated data and evaluations.

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02

Registration Process

The registration process involves many steps, from initial preparation through the final decision. Specific steps may differ by country according to available human, scientific and financial resources.

1. Pre-registration

Optional pre-application meeting and experimental permit for research or field trials.

2. Registration

Dossier submission, administrative and completeness checks, technical and scientific evaluation, risk-management decision, registration number and publication.

3. Post-registration

Record archiving, field monitoring, Rotterdam Convention notification where relevant, label changes, appeals or litigation.

4. Review

Periodic re-registration or unscheduled review leading to renewal, amendment or cancellation.

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03

Data Requirements & Testing

Data requirements guide the safety and efficacy assessment of plant protection products using internationally accepted protocols. They are adapted to the product type, intended uses and registration category.

Safety

Toxicology, residues, environmental fate and behaviour, ecotoxicology and exposure.

Efficacy

Biological trials, selectivity, rates, uses, application timing and agronomic justification.

Standardization

Protocols, methods, acceptance criteria and reports organized in a standardized, transparent and scientifically rigorous manner.

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04

Assessment Methods

Assessment methods describe the procedures and models used to examine each dossier component. They may offer different levels of complexity so authorities can adapt the assessment to their technical resources and scientific capacity.

Identity and properties

Identity, composition and physical, chemical and technical properties of the product.

Uses and product information

Use details, classification, packaging, labelling and further information.

Analytical methods

Methods for formulation, residues and relevant matrices.

Human health and residues

Toxicology and exposure of operators, workers, residents and consumers.

Environment

Environmental fate and behaviour and effects on non-target species.

Efficacy and conclusions

Biological efficacy, selectivity and overall assessment conclusions.

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05

Risk Mitigation

Risk-mitigation measures are designed to reduce plant protection product risks to human health and the environment. Their effectiveness should be assessed under local conditions of use.

Local effectiveness

The measure should be demonstrated, or likely, to be effective under local conditions.

Practicality

It should be practicable for the product user without unnecessarily compromising efficacy.

Communication

It should be capable of being communicated clearly through labels, instructions or training.

Enforcement

It should have a reasonable possibility of enforcement where relevant.

Quantification

Where possible, its effectiveness should be estimated quantitatively for inclusion in the risk assessment.

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06

Decision Making

The objective of plant protection product registration is to demonstrate that the product is effective for its intended purposes and does not pose an unacceptable risk to human or animal health or the environment under the conditions of use in the country or region.

Framework

National PPP legislation, other environmental, health, trade and economic-development policies, and national protection goals.

Risks

Effects assessment, exposure assessment, acceptability criteria and risk characterization for health and the environment.

Values

Efficacy, sustainability and economic considerations.

Alternatives

Plant protection product and non-PPP alternatives.

Management options

Registration with or without mitigation, restricted or temporary registration, denial, emergency authorization, active-ingredient ban or cancellation of an existing registration.

Monitoring

Inspection, enforcement, surveys, monitoring and feedback from users, distributors and other stakeholders.

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07

Registration Criteria

Registration criteria translate general protection goals for human health, animal health and the environment into technical and scientific requirements applicable to the dossier.

Technical criteria

Ensure that the product meets the general protection goals established by national legislation.

Evidence-based approach

Align the dossier with statutory requirements that must be met before legal registration.

Legislative compliance

Bridge high-level legislative goals and the detailed technical principles applied during assessment.

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08

Assessment of Alternatives

Assessment of alternatives is particularly relevant when a product is, or may be, highly hazardous, or when its risks are difficult or impossible to manage under local conditions of use.

Categories

Cultural practices, physical methods, resistant varieties, biological control, biopesticides and other low-risk synthetic PPPs.

Principles

Start from the pest problem rather than replacing one product with another, consider all categories and avoid regrettable substitution.

Consultation

Conduct the analysis with farmers, researchers, extension officers, industry, finance providers and civil society.

Five steps

Assess current uses, identify priority crops and pests, identify alternatives, compare viable options and develop an implementation plan.

Decision independence

Alternative identification is participatory, but the registration or re-registration decision remains with the national authority under applicable legislation.

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