Instructions for completing the form 'applicant information to support the process of comparative assessment' for GB/NI

Form: applicant information to support the process of comparative assessment

Whilst this guidance sets out steps in the order most likely to be an efficient approach for most products, you may choose to start your consideration at any step.

Applicants should refer to European Plant Protection Organisation (EPPO) standard EPPO PP1 - PP1/271 – ‘Guidance on efficacy aspects of comparative assessment for further advice and guidance on the relevant efficacy related steps and approaches on how to address them.

If you conclude at any step that substitution would not be appropriate for the uses of your product, you do not need to complete any remaining steps.

Step 1

Is your product authorised for use only in the home garden?

This first step will be considered at the applications sift. Products authorised for use in home gardens will not be charged for a comparative assessment and this won’t be considered at evaluation even if a document is submitted.

Your information for comparative assessment of home garden products is to state ‘home garden use – significantly safer alternatives not available’.

A generic consideration of GB/NI requirements for home garden authorisation has concluded that significantly safer plant protection products are not likely to be available. This is because products cannot be authorised for home garden use in GB/NI if personal protective equipment (PPE) is required to mitigate risks to the user. Such products are used in small, localised areas so risks to people and the environment are low. Non-chemical alternatives have been considered and these non-chemical alternatives are options that a gardener can consider for the specific situation that needs treating, including as a part of a programme of integrated pest management.

More information on home garden alternatives.

Step 2

a) Is your proposed new or additional use, a minor use?

Minor uses are defined as:
'Use of a plant protection product on:

any crop other than a major crop (major crops are: Grassland, barley, forage maize, oats, wheat, dry harvested field beans, oilseed rape, sugar beet and potatoes (other than seed).
a major crop against a minor pest for which no practicable control measures are available'

More information on home garden alternatives

b) What are the potential consequences on minor uses if the uses considered for your product are lost?

Please include a list of the minor uses of your product. These may be label recommendations or Extension of Authorisation for Minor Uses (EAMU).

Search for EAMUs

If the additional uses are all minor uses, state 'minor use – further comparative assessment is not required', and you need not need to provide further information.

Otherwise, please explain the consequences on minor uses if the uses under consideration were to be replaced by a safer alternative. If there are many minor uses, you may wish to focus specifically on uses where there is likely to be sufficient chemical diversity to minimize the occurrence of resistance (see Steps 5 and 6). You might also have specific commercial information that may be of use in explaining the consequences on minor uses.

Step 3

What are the major uses of your product to be considered in a comparative assessment?

You need to consider all major uses at renewal, but only the proposed new or amended use in other applications.

Consideration of alternative control measures in a comparative assessment is required for major uses of the product. 'Use' can refer to the specific crop or crop/pest combinations and the level of control claimed. If it is clear that you can complete an assessment without listing all of the details of the individual uses of the product (levels of control for example), then this is acceptable.

Step 4

If you believe a comparative assessment is required, do you want to make use of the derogation in Article 50(3) for uses where it is necessary to acquire experience first through using that product in practice?

Examples where you may wish to use this derogation include a new use (a first use of an active substance on that crop or against that pest; significant advance in formulation type; introduction of a new active substance to a sector of agriculture).

You will need to make the case that there is a need to gain experience, but you do not need to provide any further information to support a comparative assessment.

An authorisation given under Article 50(3) can be granted once for a period not exceeding 5 years, following which a new application with a comparative assessment will be required to continue the authorisation.

Step 5

If the derogation is not applicable, what other options are available for the proposed uses to be assessed?

a) Non-chemical alternatives:

Defra has funded research into non-chemical alternatives available in the UK (PS2809). This research concluded that few, if any, non-chemical alternatives suitable to substitute for uses of plant protection products are available. Thus, you do not need to consider non-chemical alternatives further and appropriate reference to this publication will be sufficient.

These non-chemical alternatives are options that a grower can consider for the specific situation of the crop that needs treating, usually as a part of a programme of integrated pest management.

b) Other authorised plant protection products:

Relevant information on alternative plant protection products is available from a range of sources including specialist agronomic advisory databases and the British Crop Protection Council 'The UK Pesticide Guide' (also known as 'the green book'). Please list the alternative products, providing the information specified in the table. If there are many alternative products, it is unlikely to be necessary to consider them all. You may be able to select one or two products containing each of the possible alternative active substances as examples.

Information about the chemical mode of action of the active substances in your product and of the alternative active substances can be found in information published by the relevant resistance action committees and groups. The British Crop Protection Council 'The UK Pesticide Guide' ('the green book') includes this information.

Information on resistance and chemical modes of action can be found in guidance published by the UK Resistance Actions Groups here:

In addition, the Resistance Action Committees produce lists of modes of action

Step 6

Is the chemical diversity of the active substances in alternative products adequate to minimise the occurrence of resistance?

For each use considered, specify how many different modes of action are available. If there are four modes of action or fewer available, substitution will not be appropriate as the chemical diversity of the active substances is unlikely to be sufficient to minimise the occurrence of resistance. EPPO PP1 - PP1/271 guidance requires at least four modes of action to manage a high resistance risk. Whilst lower levels of resistance risk might be managed with fewer modes of action, the impact of the reregistration programme and of other legislation such as the Water Framework Directive can, in practice, further reduce the availability of alternatives.

Where more than four modes of action are available, please provide a further analysis of whether you consider the chemical diversity is sufficient to minimise the occurrence of resistance. For example, information about specific resistance problems for a particular use might mean additional concern is merited. This additional information will be considered by HSE in reaching a judgement as to whether substitution would be appropriate.

Step 7

Can the alternative controls be used with similar effect on the target pest and without significant economic and practical disadvantages to the user?

The claims for control that appear on GB/NI product labels have all been assessed against the specific requirements for product efficacy, and thus the label information will provide useful information as to whether alternatives give similar effect.

The EU guidance on comparative assessment defines significant disadvantages as 'quantifiable impairment of working practices or business activity leading to an inability to maintain sufficient control of the target organism'. Information that might provide useful evidence includes the need for and availability of specialist application equipment or techniques (for some alternative products where these would result in such a disadvantage), the availability of necessary infrastructure such as specialist storage facilities, restrictions on flexibility in the timing of treatments to respond to environmental and other conditions. Product labels often contain information about other aspects of the use of the products such as the application equipment recommended or required, the life stage of the pest that is controlled, and the pre-harvest intervals required following use. You might also hold specific commercial information useful in addressing this consideration that would support your case.

Step 8

Is there a possible significant difference in risk?

Annex IV of Regulation 1107/2009 indicates that a range of criteria are to be used to determine a significant difference in risk. These include:

the properties of the active substance and plant protection product
the possibility of exposure of different population subgroups directly or indirectly through food, water or the environment
the stringency of imposed restrictions on use and PPE prescribed

List the risk mitigation measures required for your product and for the alternative controls in the table.

Information on the properties of the plant protection product and risk mitigation measures such as PPE, buffer zones or restrictions on timing of applications may be included on the product labels and in product authorisations. Most companies provide information from their product labels on their websites and you can see a copy of most UK product authorisations in the pesticides register database.

More information on Pesticides databases.

Some differences in mitigation measures may simply reflect assessment under different guidance. The objective is to identify any significant differences that will be indicative that a more detailed consideration is required. More marginal differences will be ignored.

If there are many alternative products, it is unlikely to be necessary to consider them all. You may be able to select one or two products containing each of the possible alternative active substances to exemplify whether there are any significant differences in risk mitigation.

If the risk mitigation measures of the alternative products are significantly different, or there are other reasons to believe that there are significantly safer alternative products, HSE will undertake a more detailed comparative assessment.

Step 9

Do you have any other relevant information that will enable a comparison of risk?

This is your opportunity to provide any additional information that you consider significant in the comparative risk assessment of your product.

Example of completed UK draft Registration Report (dRR)

Applicant conclusion on Comparative assessment and substitution

[Product name] contains [Active substance] which is approved as a Candidate for Substitution because (use as appropriate):

low ADI, ARfD or AOEL
two of PBT
significant proportion of non-active isomers
classified Carcinogen 1A or 1B
classified as toxic for reproduction 1A or 1B
endocrine disruption
other reasons for concern

The conclusion of the comparative assessment is (use as appropriate):

suitable for substitution
not suitable for substitution

because:

specify your conclusion for each use assessed

Example text:

Bloggo contains wonderstuff, approved as a candidate for substitution because it is persistent and toxic (PT).
The conclusion of the comparative assessment is that it is not suitable for substitution because there is only one alternative mode of action available amongst alternative products for all of its uses and thus the chemical diversity remaining is not sufficient to minimise the occurrence of resistance.

The conclusion of the comparative assessment is that it is not suitable for substitution due to the presence of minor crops on the label which will be lost if a substitution is made.

The conclusion of the comparative assessment is that it is not suitable for substitution because, under the derogation, we require to gain experience with the product in practice due to the fact that this product is the first use of wonderstuff on [crop] in the UK.

Bloggo contains wonderstuff, approved as a candidate for substitution because it is persistent and toxic (PT).

The conclusion of the comparative assessment is that it is suitable for substitution because the product 'lovely' is a significantly safer alternative with no significant economic or practical disadvantages. Sufficient alternatives remain available to minimise the occurrence of resistance and there are no adverse consequences for minor use authorisations.