Kit de Herramientas para el Registro de Plaguicidas

Legislation

Protection goal

Legislation will set out the protection goals. These are usually described in general terms and require a high level of protection (eg no harm or unintended effect to the environment). Some legislative frame-works refer to the protection goals as ‘safety criteria’.

Some legislative frameworks emphasise and elaborate on certain aspects of the protection goal (eg the scope including surface waters, ground water, soil and air and impact on biodiversity and ecosystems).

Matters to be taken into account in making a decision

The legislative criteria may set out a number of technical matters that the decision-maker must have regard to in determining whether the protection goal is met (ie that the risks to the environment are acceptable)

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Decision-making principles


A pesticide is registered if scientific evaluation of the submitted data deter-mines that the legislative criteria are met. Conditions may apply, as deemed necessary.

In the EU legislation also sets out uniform principals to be followed by individual decision-makers when evaluating and registering a pesticide.


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Groundwater

Setting of toxicological reference values and the use of assessment factors

Abbreviations:

Exposure assessment

Abbreviations:

Risk assessment and acceptability criteria

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Surface water

Hazard assessment and end-point selection

The assessment of the ecotoxicological and other relevant data in line with the matters to be taken into account as set out in legislation, forms the basis for the hazard assessment

Abbreviations:

Setting of toxicological reference values and the use of assessment factors

The toxicological reference values are derived by applying an assessment factor to the outcomes of the hazard assessment to account for potential differences in species sensitivity and, as relevant, specific protection goals.

Assessment factors can also be referred to as uncertainty factors or safety factors.

Abbreviations:

  • RAC - Regulatory Acceptable Concentration, a toxicological reference value derived by applying an assessment factor to the relevant end-point

Exposure assessment

The exposure assessment involves estimating concentration of the pesticide in surface water based on a specific water body scenario and taking into consideration the application rate(s), chemical properties and environmental fate properties, including the dissipation of the pesticide between applications.

Abbreviations:

Risk assessment and acceptability criteria

The risk assessment considers the outcomes of the hazard assessment as represented by the toxicological reference value in conjunction with the exposure expected when the product is used in accordance with the label instructions (including application equipment and methods, buffer zones and other risk mitigation methods).

The criteria for acceptable risk is where the estimated exposure is less than or equal to the relevant toxicological reference value. The criteria for acceptable risk is some-times expressed as the Risk Quotient being less than or equal to 1. It may also be expressed as 1 being the Level of Concern.

Abbreviations:

  • RQ - Risk Quotient
  • LOC - Level of Concern, the policy tool used to determine potential risk

 

 

Bees

Hazard assessment and end-point selection

The assessment of the ecotoxicological and other relevant data in line with the matters to be taken into account as set out in legislation, forms the basis for the hazard assessment

Abbreviations:

  • LC50/LD50 - concentration/dose required to kill half the members of a tested population after a specified test duration
  • NOAEL - No Observable Adverse Effect Level
  • NOEL - No Observable Effect level

Setting of toxicological reference values and the use of assessment factors

The toxicological reference values are derived by applying an assessment factor to the outcomes of the hazard assessment to account for potential differences in species sensitivity and, as relevant, specific protection goals.

Assessment factors can also be referred to as uncertainty factors or safety factors.

Abbreviations:

  • RAD - regulatory acceptable dose

Exposure assessment

The exposure assessment may use formula based on application rates or calculated using specifically developed modelling tools.

Abbreviations:

Risk assessment and acceptability criteria

The risk assessment considers the outcomes of the hazard assessment (where applicable represented by the toxicological reference value) in conjunction with the exposure expected when the product is used in accordance with the label instructions.

The criteria for acceptable risk may be expressed as the Risk Quotient, a Hazard Quotient or an Exposure Ratio. The Risk Quotient is expressed as the ratio: estimated exposure/the hazard end-point or, where applicable the ratio of the estimated exposure/toxicological reference value). The Hazard Quotient is expressed as the ratio: application rate/hazard end-point. The Exposure Ratio is expressed as the ratio: exposure/end-point.

The criteria for acceptable risk are based on the Risk Quotient, the Hazard Quotient or the Exposure Ratio (as applicable) being lower than a specified value (sometimes also referred as the Trigger Value or Level of Concern).

Abbreviations:

 

 

Soils

Hazard assessment and end-point selection

The assessment of the ecotoxicological and other relevant data in line with the matters to be taken into account as set out in legislation, forms the basis for the hazard assessment

Abbreviations:

  • EC10 - concentration that induces an effect to 10% of the test population
  • EC50 - concentration that induces an effect to 50% of the test population
  • LC50 - concentration that is lethal to 50% of the test population
  • NOEC - No Observable Effect Concentration

Setting of toxicological reference values and the use of assessment factors

The toxicological reference values are derived by applying an assessment factor to the outcomes of the hazard assessment to account for potential differences in species sensitivity and, as relevant, specific protection goals.

Assessment factors can also be referred to as uncertainty factors or safety factors.
Abbreviations:

  • RAC - Regulatory Acceptable Concentration, a toxicological reference value derived by applying an assessment factor to the relevant end-point

Exposure assessment

The exposure assessment involves estimating concentration of the pesticide in surface water based on a specific water body scenario and taking into consideration the application rate(s), chemical properties and environmental fate properties, including the dissipation of the pesticide between applications.

Abbreviations:

Risk assessment and acceptability criteria

The risk assessment considers the outcomes of the hazard assessment as represented by the toxicological reference value in conjunction with the exposure expected when the product is used in accordance with the label instructions (including application equipment and methods, buffer zones and other risk mitigation methods).

The criteria for acceptable risk is where the estimated exposure is less than or equal to the relevant toxicological reference value. The criteria for acceptable risk is sometimes expressed as the Risk Quotient being less than or equal to 1.

Abbreviations: