The Applicant Guide: extensions of authorisation for minor use under Regulation (EC) 1107/2009

Overview

Authorised uses on plant protection product labels ('on-label'/product authorisations) do not cover every pest and crop combination, particularly for minor uses.

If economically damaging levels of pests, weeds or diseases occur in a crop where there is no on-label/product authorisation of a suitable plant protection product, then you have a possible option to control this pest, weed or disease which is to apply for an extension of authorisation for minor use (EAMU) under Article 51 of Regulation (EC) 1107/2009.

Extensions of authorisation for minor use

Both authorisation holders and growers or grower organisations can apply for an EAMU. The extension can be given where it meets all the following:

When an EAMU is given it can appear on the product label in a separate section titled 'Extension of Use' after the main body of the 'Directions for Use', it does not appear in the biological use statement, nor in the Important Information area, and appears underneath the following text:

"This extension of the authorised use provides for the use of the [product name] in respect of crops and situations, other than those included on the product label [above]. No effectiveness or phytotoxicity data have been assessed and as such the 'extension of use', is at all times done at the user's choosing, and the commercial risk is entirely theirs."

The product authorisation holder can decline to put the extension of use on the product label, but it will be available as an Extension of Authorisation for Minor Use Notice from this website.

Note regarding parallel trade plant protection products (for Northern Ireland (NI) only):

Under Regulation 1107/2009 (NI), parallel trade plant protection products are only permitted to be used in accordance with the provisions of the authorisation of the reference product. This means that parallel trade products cannot be authorised in their own right for EAMUs but if an EAMU is issued for a NI reference product, then any parallel trade product of the named reference product in NI may also be used with that EAMU. The reference product is shown on the permit notice for parallel trade products.

Advice on fees and processing times

For further information on processing targets and application streams for your application read the guidance on application streams and targets.

Information on how applications are processed can be found in The Applicant Guide - how will my application be processed.

For information on when grouping of crops will be issued, go to the questions and answers in the next section.

All applications are subject to an evaluation fee and details of current fees can be found in the guidance on application fees. Applications from authorisation holders will be charged the full modular fees and applications from other parties such as grower organisations will be charged the standard 'flat' off-label fee.

Where action is taken on completion of evaluation for new active substances or approval of an existing active substance under Regulation (EC) 1107/2009, we may need to take regulatory action on any extension of authorisation for minor use for a product containing that active substance.

Full details are given in the guidance on renewals.

How authorisations will reflect crops and/or crop groups, and subsequent charging

Q1. How will applications for soft fruits be handled, which fruits will need a separate Notice of Authorisation, and how many off-label fees will be charged?

Applications for an extension of authorisation for minor use (EAMU) on soft fruits will result in a different Notice of Authorisation being issued for each crop group. For example if an application was submitted for an EAMU on strawberry, raspberry and blackcurrant, three  separate authorisations would be issued. This would be charged three separate fees, one for each risk assessment. Where the application covers similar species such as one crop grouping, for instance raspberry, tayberry, loganberry, and other Rubus species, only one Notice of Authorisation would be issued, as they are all in the same crop group. This application would be charged only one off-label fee.

Q2. If I apply for an extension of authorisation for minor use on lettuce, parsley, mint and baby leaf brassicas how many Notices of Authorisation will be issued and how many fees charged?

Only one Notice of Authorisation would be issued for these crops, as they are all based on the same lettuce residue trials data, resulting in one fee.

Q3. If I apply for an extension of authorisation for minor use on apple, pear, cherry and mirabelle how many Notices of Authorisation will be issued and how many fees charged?

Two Notices of Authorisation would be issued, one for apple and pear and one for cherry and mirabelle. This is because there is one consumer risk assessment for apple and pear and another one for cherry and mirabelle. As there are two risk assessments two fees will be charged.

Q4. If I apply for an extension of authorisation on the following crops, how many Notices of Authorisation will be issued and how many fees charged?

a. peas and beans

b. cabbage, Brussels sprouts and cauliflower

c. leek, bulb onion, garlic and shallot

Only one Notice of Authorisation would be required, if the rates and timings are the same for a, b and c and therefore only one fee would be charged for each of these crop groups.

If the rates and timings are different for pea and bean then two risk assessments will be necessary resulting in two Notices of Authorisation being issued and two fees being charged.

If the rates and timings are different for cabbage, Brussels sprout and cauliflower then three risk assessments will be required resulting in three Notices of Authorisation and three fees being charged.

If the rates and timings are different between leek and onion then two risk assessments will be required, resulting in two fees and two Notices of Authorisation; one for leek and one for bulb onion, garlic and shallot.

Q5. Will previously issued Notices of Authorisation be retrospectively revised to separate authorisations for each crop group?

In general no, although where an existing authorisation has to be revised because a crop or the conditions of use are being changed for safety or maximum residue level (MRL) reasons then the new authorisations will have a Notice of Authorisation for each crop grouping. Where this is for review or MRL reasons no charge will be made.

Q6. How many Notices of Authorisation will be issued and fees charged when requesting an extension of authorisation for minor use for a new similar product on the basis of an existing EAMU, without any new data being submitted?

One Notice of Authorisation will be issued for each crop group on the original authorisation. As no new risk assessment will be required only one off-label fee will be charged, but additional admin fees will be charged for each additional notice to be issued. Applications for extensions of authorisation for minor use of new identical products based on an existing simple EAMU notice, with only one or two crops or crop groupings, will be considered via the admin stream. However, where the authorisation is complex, containing many crops or crop groups, then the application will be considered via the 52-week stream and charged an off-label fee. Where several EAMUs are requested for the new identical product then an admin fee will be charged for each notice of authorisation.

How do I apply for an extension of authorisation for minor use (EAMU)?

EAMU for new uses

You must submit the following information in support of an application for an EAMU:

  1. A covering letter explaining the reasons for the application. This must detail why the proposed use will not increase the risks to the consumer, non-dietary human exposure (operators, workers and bystanders), wildlife and environment compared to existing uses (go to 4. below). The letter must also include a reasoned scientific case for 'need' (go to 3. below) and 'urgency' if appropriate (go to 5. below)
  2. A fully completed application form CRD3 (see The Applicant Guide - what should I include in an application)
  3. A reasoned case to demonstrate the 'need' for the proposed use. The reasoned case must include:
    • Details of the nature of the problem which must include reference to named pest(s), weed or disease(s). You should also consider:
      • Is the problem occurring now? If the proposed extension of authorisation for minor use (EAMU) is only a contingency measure for an anticipated problem, you must explain your reasons for applying for the EAMU now.
      • Is the problem established or is it a problem that has not been previously encountered? If the problem is established you must explain your reasons for applying for the EAMU now.
    • Details of the scale of the problem including the approximate size, severity and scope of the problem (including total and geographical are affected and the proportion of the crop affected or lost). Details of the potential for economic damage (meaning cost) that will occur if an EAMU is not granted must also be provided.
    • An explanation as to why alternative means of control (both existing authorisations and cultural methods) cannot be used. A justification for an EAMU based on the fact that the proposed product is cheaper than other products already authorised for that use is not acceptable. Retailer preference for particular products not to be used or a requirement for a crop to be completely free of pests for cosmetic reasons are also not acceptable justifications.

For applications from authorisation holders this case for need must be supported by users of the product (this can also be grower or grower organisation) for each specific use requested; not from agronomists, marketing companies or distributors. For additional information, read Information required to support the 'need' for applications for extension of authorisation for minor use.

  1. All areas of the safety aspects of the risk assessment for the proposed use must be addressed using data and/or reasoned scientific cases. You must address the risks to non-dietary human exposure (operators, workers and bystanders), consumers (meaning residues), wildlife and the environment from the proposed use. Reasoned cases may include the extrapolation from relevant authorised on-label use to support the proposed use (for example where the authorised on-label use(s) reflect those proposed for the EAMU).

We strongly recommend that you provide a table comparing the rates of use, timings (including time of year of application), situation of use (indoor or outdoor), method of application and any other relevant information between the proposed extension of use and the authorised on-label use. If any of these factors differ then you must explain why this will not have an impact on non-dietary human exposure, consumer or environmental exposure.

We expect applicants who are authorisation holders to submit full risk assessments to support their EAMU request in the form of a detailed application overview and/or draft Registration Report and letter of access to 3rd party data.

If there is an immediate 'need' for the proposed use then you must submit a request for 'Urgent consideration'. We will process acceptable urgent requests within a quicker timescale than normal requests.

For this type of application you must also submit the following:

  1. Reasoned case to support the 'urgency' of your application and why it should be treated as a priority. This evidence must include the following:
    1. When (the date) the proposed EAMU is required so that the pest can be controlled.
    2. An estimation of the severity of the problem (including details of potential crop losses and economic damage) if the EAMU is not granted by the date that the use is urgently required, and why these losses would be significant.
    3. Where the authorisation holder is submitting the application then the case for urgency must be supported by growers of that crop(s) detailing the urgency of the need for the use for them.
    4. You must assess whether an application for an urgent consideration meets the criteria for 'urgency'. If there is not going to be an immediate failure and loss of the crop if the use is not authorised quickly, then the application should not be submitted for urgent consideration. If your application demonstrates 'need' but not 'urgency' it will be dealt with as a standard application in the relevant stream.

Applications for a new EAMU on the basis of a current EAMU

You may submit an application for an EAMU on the basis of a currently authorised identical or similar EAMU without submitting a case for 'need'. However, you must detail the EAMU notice of authorisation number/s on which you wish to base your application. These must be for the same pest, disease or weed to be controlled on the same crop as you now require. Applications from authorisation holders will need to be supported by the users of the product (regarding the need to use it to control that specific pest on the crop listed on the original authorisation.)

For products that are identical

If an EAMU is required for the same conditions of use (for example crop, rates, timings, pests) as authorised for an existing EAMU and the products are identical with regard to formulation type, description and quantity of active substance and co-formulants you must submit:

  1. A covering letter explaining the reasons for the application
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide - what should I include in an application)
  3. A copy of the existing authorisation or a full application reference (including the Notice of Authorisation number, COP number) under which the use was evaluated
  4. A letter of support from the user of the product, for applications from authorisation holders
  5. A letter of access to 3rd party data
  6. These requests will be considered via the admin stream

For products that are similar

If an EAMU is required for the same conditions of use (for example crop, rates, timings, pests) as authorised for an existing EAMU and the products contain the same active substance and are similar (but not identical) with regard to formulation type, description and quantities of active substance and co-formulants you will need to submit:

  1. A covering letter explaining the reasons for the application
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide - what should I include in an application)
  3. A copy of the existing authorisation or a full reference (including the Notice of Authorisation number, COP number) under which the authorisation was evaluated
  4. A letter of support from the user of the product, for applications from authorisation holders
  5. A letter of access to 3rd party data

We will consider whether the assessment performed for the original EAMU is applicable for your proposed EAMU. If the authorisation is required urgently then you will need to submit a case for 'urgency'. However, you should note that as there is already an EAMU for that crop, we would generally not expect there to be an urgent need for a new EAMU for the same use.

For products that contain different active substances

If an EAMU is required for the same conditions of use (for example crop, rates, timings, pests) as authorised for an existing EAMU where the products contain different active substances you will need to submit:

  1. A covering letter explaining the reasons for the application
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide - what should I include in an application)
  3. A copy of the existing extension of use or a full reference (including the Notice of Authorisation number, COP number) under which the extension of authorisation for minor use was evaluated
  4. A letter of access to 3rd party data
  5. A letter of support from the user of the product, for applications from authorisation holders
  6. Data and/or scientifically reasoned cases addressing all aspects of the safety risk assessment as detailed in EAMUs for new uses

If the authorisation is required urgently then you will need to submit a case for 'urgency' as described in EAMU for new uses Extensions of Authorisation.

EAMU based on recognition of a minor use authorisation in an EU MS (NI only)

Where there is a minor use authorisation or extension of use in another climatically and agronomical comparable EU MS you can apply for an extension of authorisation for minor use in Northern Ireland (NI) only. The product must be the same as that authorised in NI. The minor use authorisation must have been assessed to the requirements of Articles 8(4)(a) and (b), 29 and any guidance issued under Article 77 of Regulation 1107/2009 (NI), including the Uniform Principles. For further advice and the specialist guidance for such applications use the link below:

Authorisation under Article 40 of Regulation 1107/2009 (NI)

You must submit:

  1. A covering letter clearly stating that you are seeking authorisation in NI based on a minor use authorisation in an EU MS
  2. A fully completed, signed and dated application form CRD3 (go to The Applicant Guide - what should I include in an application)
  3. A reasoned case for need (and urgency if appropriate) as set out in the section on applying for EAMU for new uses Extensions of Authorisation
  4. A copy of the product label and authorisation document from the EU MS in which the use is authorised, with a translation of both into English
  5. A letter of access to 3rd party data
  6. Confirmation from the authorisation holder that the formulation and sources/technical specifications of the active substance(s) are identical to those in the NI authorised product
  7. Assessment report of the EU MS containing information on the evaluation and decision on the minor use authorisation.

EAMU where the authorised use has been commercially withdrawn

The authorisation holder of a plant protection product may sometimes choose not to include an authorised on-label use on a plant protection product label, although this does not mean that the use itself is not authorised. This may be because:

  1. The authorisation holder has notified us of the commercial withdrawal of the use. However, it is still legal to use the product on the crop for a period of time after its withdrawal (the 'withdrawal period')
  2. The authorisation holder has withdrawn the use, or never included it on the product label, but we have not been informed. The use is therefore authorised until it is commercially withdrawn or withdrawn because of other regulatory action. It is still legal to use the product on the crop during its withdrawal period
  3. We have withdrawn the use for regulatory reasons. It may still be legal to use the product on the crop during its withdrawal period

You may confirm the authorisation status of a plant protection product/crop combination by contacting us.

Where an authorised on-label use has been commercially withdrawn, you may apply for an EAMU. However, an EAMU will only be issued where there is no suitable alternative product authorisation available. For further information on withdrawal periods and commercial withdrawals see withdrawal of authorisation guidance and commercial withdrawal guidance.

An EAMU will not be granted for a use that has been commercially withdrawn when:

However, we will consider issuing an EAMU where a use has been withdrawn because adverse data relating to the efficacy of the product have been received, or where efficacy data have not been submitted to support continuing authorisation.

Any application for an EAMU should ideally be made within the withdrawal period of the use to ensure that the use can continue. In support of your application you must submit:

  1. A covering letter explaining the reasons for the application
  2. A fully completed, signed and dated application form CRD3 (go to The Applicant Guide - what should I include in an application)
  3. Evidence of 'need'
  4. A safety assessment
  5. A reference to where the notification of the withdrawal of the use was published
  6. A letter of access to 3rd party data

The EAMU will come into force on the day after the end of the withdrawal period of the withdrawn use even if the authorisation is issued before the end of the withdrawal period. After the end of the withdrawal period the treatment of the crop under the EAMU will be entirely at the user's own commercial risk.

Renewal of an EAMU following the renewal of the active substance in the product under Regulation (EC) 1107/2009

Authorisation holders are encouraged to support an existing EAMU in their dossiers for the renewal of the product authorisation under Article 43 of Regulation (EC) 1107/2009. To do this they need to include the minor uses in their registration report and provide the necessary risk assessments.

If the authorisation holder does not support the EAMUs in their renewal submission then as a grower/grower organisation you can submit applications to renew them. Before doing so you should check with the authorisation holder whether they have supported the EAMU in their renewal application. Authorisation holders are requested to inform EAMU holders that the assessment is completed when HSE asks them to comment on the draft assessment. HSE undertakes to inform EAMU holders when the product renewal application is completed so you see can what uses were deemed acceptable before submitting your renewal application.
To support the renewal of an EAMU, you will need to submit:

  1.  A covering letter explaining the reasons for the application
  2. A fully completed, signed and dated application form CRD3 (go to The Applicant Guide - what should I include in an application); one for each crop/crop group
  3. A safety assessment
  4. A copy of the EAMU to be renewed (optional)
  5. A letter of access to 3rd party data

Please note: Once an active substance is renewed, then no new EAMUs based on the old end points and risk assessments can be considered. The only exception is where no risk assessment is required for the new EAMU because it is supported solely by extrapolation from existing authorised uses. If any risk assessment is required then the new EAMU cannot be considered until the product has been renewed.

Application for an EAMU which requires no technical input

If your application requires no technical input then it may be processed via the Admin Stream. These applications include those:

In support of your application you should submit:

  1. A covering letter explaining the reasons for the application
  2. A fully completed, signed and dated application form CRD3 (go to The Applicant Guide - what should I include in an application)
  3. A copy of the EAMU (if relevant)
  4. A letter of support from the user of the product, for applications from authorisation holders
  5. A letter of access to 3rd party data

Will any protection be applied to data I submit in support of an application for EAMU?

Any new data submitted will be protected for 10 years from the date of issue of the first authorisation of the product. The covering letter will detail the data submitted, whether it was used, and the data protection period applied. Where the authorisation holder applies for an EAMU and submits new data to support it those data will be protected for 10 years from date of issue of the first product authorisation and the data protection period for the original data package for the product will be extended by 3 months if the extension of use is issued within 5 years of the first authorisation of the product.

Further information

 
Updated 2021-08-09