Decision

Guidance on the approach to handling applications for emergency authorisation of plant protection products

Updated 18 January 2024

Applies to England

This guidance note outlines the key elements involved in assessing and deciding on applications for emergency authorisation of plant protection products.

The note has been agreed between Defra, Scottish Government, Welsh Government, Department of Agriculture, Environment and Rural Affairs Northern Ireland and the Health and Safety Executive (HSE). It will also be shared with the UK Expert Committee on Pesticides (ECP).

The HSE, Defra and the Devolved Administrations will take into account the principles set out here when considering applications for emergency authorisation.

It is intended that this note should be the first step towards guidance for applicants and competent authorities. This will be developed with the HSE, the Devolved Administrations and the ECP.

Article 53 of retained Regulation 1107/2009

Under Article 53 of retained Regulation 1107/2009 ^{[footnote 1]}, in special circumstances the UK Government and the Devolved Administrations may each authorise the placing on the market of plant protection products for limited and controlled use "where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means".

Emergency authorisation cannot allow the placing on the market of plant protection products for a period exceeding 120 days.

The legislation specifies that all the following requirements are to be considered before an emergency authorisation can be granted:

1. authorisation may only be granted in 'special circumstances'
2. authorisation may only be granted where there is a 'danger'
3. authorisation must be necessary because of that 'danger'
4. authorisation must be necessary because that danger cannot be contained by any 'other reasonable means'
5. an emergency authorisation may authorise only 'limited and controlled' use of the plant protection product

Article 53 provides that emergency authorisation is "By way of derogation from Article 28". Article 28 requires products to be authorised according to the process for standard authorisation under Regulation 1107/2009.

Emergency authorisation is therefore a derogation from standard authorisation requirements, but the overall objectives of the legislation must nevertheless be borne in mind, including securing a high level of protection for human health, animal health and the environment, in the context of addressing the danger.

The legislation does not explain how the requirements for emergency authorisation should be dealt with and how decisions should be reached. This note outlines the key elements to be considered in assessing applications and taking decisions.

However, the question of whether the above requirements of Article 53 are satisfied is a matter of judgement to be determined on a case-by-case basis on the particular facts and circumstances of each case. Any examples given in this guidance note are used for illustrative purposes only.

The elements

Are there special circumstances?

Retained Regulation 1107/2009 states that special circumstances must exist for an emergency authorisation to be granted.

The term 'special circumstances' is not defined in the legislation, but the key question is likely to be that of whether there are exceptional circumstances which justify a departure from the standard approach to granting authorisations. The factors relevant to this consideration should be assessed on a case-by-case basis.

Where appropriate, in particular in cases of a repeat emergency authorisation application, the applicant should have a plan for establishing a longer-term solution to the danger.

This could include consideration of different approaches drawing from the integrated pest management toolbox (including, among other possibilities, particular cultivation techniques, crop rotations, enhanced plant hygiene measures, or breeding of resistant plant varieties). It may also include evidence that authorisation of the pesticide or an alternative is being progressed.

Is there a danger?

A danger may relate, for example, to plant production or ecosystems ^{[footnote 2]}

The nature and extent of the relevant danger should be clearly identified and described, including (as appropriate) the likelihood of it occurring and the magnitude of its potential impact.

For example, is there an existing or expected problem with pests, diseases or weeds that is either current or probable based on the available evidence, and what impact will that have on crops or the environment?

Different factors may be relevant in different situations. For crops, losses caused for example by yield or quality issues, or problems establishing the crop, may be important. In non-crop situations, protection of the environment may be relevant (for example, the need to control bracken in upland areas).

Does the emergency authorisation appear necessary to address the danger?

An emergency authorisation should constitute a proportionate means of addressing the identified danger. In assessing whether this is the case on the facts of each individual application, the decision-maker should:

• identify the nature and extent of any potential adverse effects (including any potential adverse effects on human and animal health or the environment) of the emergency authorisation, taking into account any measures or conditions to mitigate or reduce those effects
• identify the extent to which granting the emergency authorisation will address the identified danger
• consider whether the benefits of granting the authorisation (in terms of addressing the identified danger) outweigh the potential adverse effects (including any potential adverse effects on human and animal health or the environment).

The HSE will carry out the best possible assessment of the potential adverse effects, including the ways it is proposed to mitigate or reduce the potential harms, within the context of the available time and scientific information.

The decision-maker will consider whether the potential for harm, taking into account any potential mitigations, is outweighed by the benefit of addressing the danger.

Are there reasonable alternatives?

The decision-maker should consider whether there are alternatives (used either individually or in combination) that could acceptably address the identified danger with less potential adverse impact.

Reasonable alternatives may include other plant protection products (including biopesticides) and agronomic or management approaches, including integrated pest management.

In assessing whether alternatives are a reasonable means of dealing with the relevant danger, relevant factors might include, but are not limited to:

• efficacy, for example, the extent to which the alternatives would address the identified danger. Consideration of whether there is significant or widespread resistance to potential alternatives may be relevant here
• costs where available, for example, of the product, labour and equipment to apply the product
• the availability of alternative products as well as the timing for applying them to the relevant crop
• the potential benefits and adverse impacts of the use of the alternatives
• whether use of the alternatives could lead to increased reliance on other plant protection products in a manner that could increase resistance to those products

Is the use limited and controlled?

The decision-maker should consider whether the applicant has identified appropriate measures to ensure that, as far as reasonably practical, the product is only used to deal with the identified danger, and to mitigate its potential adverse impacts as far as reasonably possible.

The appropriate restrictions will depend on the particular circumstances of the application, the nature of the danger, and the potential adverse impacts of use of the product.

Relevant restrictions might include, but are not limited to:

• specifying the maximum geographical region or overall proportion of the crop on which the product can be used
• specifying the maximum number of applications
• specifying the dose rate of application
• limiting use to the proportion of the crop or area considered at highest risk
• identifying appropriate thresholds that must be met before the product can be used
• Limiting use to a particular 'window' of application (for example, by calendar month or crop growth stage, or pest life stage)

The decision-maker should also ensure that there are mechanisms to control the use of the product to ensure that relevant restrictions are complied with.

For example, would it be appropriate to require oversight of the use of the product through appropriate stewardship measures?

These might include, for example, communication plans for growers with directions on how a product should be used in certain circumstances and requirements for monitoring the use of the product. The decision-maker can, where they judge it appropriate, consider limits and controls not proposed in the original application.

The decision maker may, where appropriate, impose the types of conditions that are commonly imposed on standard authorisations under Article 31 of the standard procedure. Any authorisation will also usually include a condition providing that the emergency authorisation may be varied or withdrawn:

1. if the relevant product is not used in accordance with relevant restrictions; or
2. relevant new information about the relevant danger, or the effects of the relevant PPP, were to come to the decision's attention.

If the application is for a repeat of an emergency authorisation previously granted, does the applicant have evidence of success in limiting and controlling the product's use?

If limits and controls have been placed on previous emergency authorisations, what were the effects of those in addressing the danger?

Taking the decision

The process

The HSE will carry out an assessment against the elements outlined above and will, where appropriate, invite the UK Expert Committee on Pesticides(ECP) to offer independent advice on scientific issues raised by the application.

The ECP is not required to provide an overall conclusion or recommendation but provides scientific analysis taking into account the key criteria above (where relevant to their consideration).

When submitting an application, applicants should provide all relevant information to the decision-maker to enable them to make an informed decision in a timely manner.

The HSE or the decision-maker may request that the applicant provide further information in support of their application and may, where considered appropriate, rely on additional information considered pertinent to the assessment of the application.

The functions in respect of decision-making (for England) on emergency authorisations under Article 53 may be exercised by HSE on behalf of the Secretary of State under an Agency Agreement, or by the Secretary of State. The Devolved Administrations have similar arrangements.

Taking the final decision

The decision-maker may grant the emergency authorisation if they are satisfied that:

• there are special circumstances
• there is a danger
• the grant of the emergency authorisation is proportionate, in that the benefits of granting the authorisation to address the identified danger are considered to outweigh the potential adverse effects on human and animal health or the environment
• there are no other reasonable means available to address the danger
• use of the product will be limited and controlled

1. Retained Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC ↩

2. See recital 32 of the European Union's Regulation (EC) 1107/2009 as it was immediately prior to the end of the Transition Period. ↩