Risk assessment and data generation for pesticide applications

Formulation chemistry and toxicology

Which applications will require an assessment of formulation chemistry?

Formulation physico-chemical properties and storage stability are dependent upon the formulation constituents and the packaging of the product. This aspect should be addressed for the following applications:

new product with a formulation never previously authorised.
changes to the formulation of an authorised product.
changes to the packaging for an authorised product.
any other changes that may affect the physico-chemical properties of the formulation.

For details on how to support applications for the changes listed above see Physical and Chemical Properties.

How do I generate data on the toxicology of the active substance?

The toxicology evaluation will be performed in accordance with uniform principles. Data on formulated products should be provided in accordance with Commission Regulation (EC) 284/2013. Further information is available on the pesticide toxicology webpages.

Environmental exposure, ecotoxicology and efficacy

How do I generate data on environmental exposure?

Full details on the requirement and generation of data are given in the environmental fate guidance.

What data are used in the assessment of ecotoxicology?

Data and other information used to assess the risk to non-target organisms resulting from the use of the product as recommended on the label (eg small mammals, birds, aquatic life, non-target arthropods, honeybees, earthworms, soil microbial processes and non-target terrestrial plants).

Guidance on data requirements:

Guidance on the ecotoxicology data requirements for active substances are given on the European Commission website.
Further guidance is available on this website: Ecotoxicology guidance.

Arrangements are in place to ensure that tests involving vertebrates are not repeated unnecessarily. Full details of this procedure are given in Data protection: pesticide product authorisation.

Applications for which an ecotoxicology assessment is necessary

An assessment is necessary to address the risk from all new products, new uses of existing products (including for example, increase in application rates, change in time of application, new crops) and any changes to existing conditions of authorisation or other label claims/recommendation which may affect exposure of non-target organisms.

Examples of how these changes may increase exposure and risk to non-target organisms include:

Higher application rates may increase the risk to all areas of concern, (for example an increase in seed loading may increase the risk to birds, whereas an increase in the application rate of a spray may increase the risk to aquatic life).
Changes to recommended timings (meaning time of application or crop stage) may increase the risk to non-target organisms, (for example a change in the time of use to cover a change in season could increase the risk to non-target arthropods. Likewise, use on cereals at an earlier growth stage may result in an increased exposure of grazing birds).
Any other changes to the GAP which could result in an increased risk to non-target organisms should be considered further.
If a new product results from a change in the formulation of an existing product, then there may be an increase in the risk to non-target organisms.

How will the ecotoxicology assessment be carried out?

New uses never previously considered

If you are making an application for authorisation of new uses or products which have never previously been considered by HSE, you must include a risk assessment for non-target organisms such as small mammals, birds, aquatic life, honeybees and other non-target arthropods, earthworms, soil microbial processes and non-target terrestrial plants. The risk that a use poses should be assessed in line with Regulation (EC) 1107/2009 and associated guidance, such as the EFSA guidance for the risk assessment of birds and mammals (EFSA, 2009, 7(12)1438). Further information can be found in the Ecotoxicology section. Data used in the risk assessment with the application must be submitted.

Extrapolation of previous risk assessment

Where the proposed use involves an active substance previously authorised in another product for the same or similar uses, it may be possible to extrapolate data to the proposed use where there is access to the relevant data. You should address whether the rates and timings of the proposed use are within those already authorised for the same or a comparable use in an authorised formulation (preferably as a tabulated comparison). Any differences between the proposed and authorised uses should be addressed with data or a reasoned case. In addition, you should present reasoned cases explaining why extrapolation of data between different formulations is acceptable (advice on comparison of different formulations is given in the section 'Formulation changes' below).

Formulation changes

You should address the effect of formulation changes on both the hazard classification, with respect to aquatic life, and the risk to aquatic life and other non-target organisms. Depending on the nature of the change, new data or a reasoned case for extrapolation of previously evaluated active substance or product-related data should be submitted.

For many formulation changes a reasoned case may be presented as a comparison between the active substance and co-formulant content of the formulations. Safety Data Sheets for the co-formulants or other information on their ecotoxicology should be used to address whether the change will affect the product hazard classification or the risk to non-target organisms resulting from use.

For major changes in formulation type, (for example from a liquid formulation to a granule), new data may be required to enable the risk to non-target organisms to be fully addressed.

For applications considered under Regulation 1107/2009 (as it applies in Great Britain and Northern Ireland) the formal requirements for Ecotoxicology formulation testing are laid out in Part A, Section 10, Annex to the Regulation 284/2013. UK specific formulation guidance is also available as outlined in the HSE formulation guidance. (PDF)

This HSE guidance provides advice on the need for ecotoxicology formulation studies and their use in risk assessment, along with how to consider the combined risk for relevant groups. Formal sections of the data requirements and existing guidance documents are presented together with additional guidance. Applicants are advised to read this document before deciding on a formulation testing strategy.

How do I generate data to address efficacy?

What data are used in the assessment of efficacy?

The efficacy evaluation ensures that when pesticides are used as recommended on the label, a consistent benefit is achieved. We use data and other information to assess effectiveness and crop safety of the formulation. This is dependent on the formulation itself, applied dose, timing and methods of application, dilution volumes and other recommendations specified in the 'DIRECTIONS FOR USE' section of the label. In addition to the need to demonstrate consistent control of the target organism, no unacceptable effects on yield and quality of the treated and non-target crops should be seen. Any risk of resistance to the pesticide developing in the target organism should be addressed.

Guidance on data requirements:

Details of efficacy data requirements are given on the European Commission website.
Extensive guidance is given in The Efficacy Guidelines.

Residues and consumer exposure

What data are used in the assessment of consumer exposure?

Guidance on the data required to address residues and consumer exposure can be found at the following links:

Which applications will require an assessment of consumer exposure?

New products, new uses of existing products and any changes to existing conditions of authorisation or other label claims/recommendation which may affect consumer exposure will require an assessment of consumer exposure. Examples of changes to existing authorisation that may increase exposure include:

Additional crop types. Changes from indoor to outdoor use or vice versa.
Increases to the maximum application rate, number of treatments or total dose.
Changes to the application timing or pre-harvest interval.
Changes in formulation type.

How will the assessment of consumer exposure be carried out?

Authorisation of new uses

You will need to address consumer exposure arising from the proposed use of the product. This can be done by either the submission of relevant metabolism/residues data or if not available, it may be possible to extrapolate residues data which support a similar use in another formulation (ie show that consumer exposure will be within that previously considered for another product).

Submission of new data

Where new data relating to crop residues have been submitted to support authorisation, the data should be summarised in the format of a draft Registration Report, to include an OECD dossier guidelines Tier I Summary, available at the OECD pesticides registration website.

Submission of reasoned cases

This section of the Application Overview should be used where consumer exposure is being addressed by extrapolation of a previous risk assessment or a reasoned case as to why the consumer risk assessment or a data requirement need not be addressed (ie new data are not submitted with a Tier 1 Summary).

Extrapolation of a previous risk assessment may be most clearly presented as a tabulated comparison between the relevant conditions of use of the approved and proposed formulations, ideally in the form shown below. This example assumes that the proposed product contains two active substances and residues data are to be extrapolated from two products each containing one of those active substances.

Example of a tabulated comparison for consumer exposure to active substances in crop protection products.
Parameter	Proposed product (containing active substances 'x' and 'y')	Approved product (containing active substance 'x')	Approved product (containing active substance 'y')
Crop
Maximum individual dose (g a.s./ha)
Latest time of application
Maximum number of treatments (per crop)
Maximum total dose (g a.s./ha/crop)

Where the formulations of the proposed and authorised products are different, you must explain why extrapolation of data between the formulations is acceptable.
Where the authorised conditions of either of the authorised products fall outside of those proposed such that the residues data are not relevant, you should address this with a reasoned case or data.

Details of extrapolations which are available between formulation and crop types can be found in the extrapolations guidance.