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The Applicant Guide: Application Requirements For Extensions of Authorisation for Minor Use (EAMU)

Extensions of Authorisation for a Minor use (previously known as off-labels)

Where a plant protection product does not have an appropriate on-label approval/authorisation, or an extrapolation under the Long Term Arrangements for the Extension of Use is not possible, authorisation holders, growers or their representative organisations may apply for the authorisation of a plant protection product on a specific crop under an Extension of authorisation for a Minor Use.

There are a number of different types of Extensions of Use and you should see the guidance document for Extension of Use for further advice.

Extension of use application

For each type of EAMU , you must justify the need for the authorisation, and if you want it quickly you need to address the urgency of the application. Further advice is given in the Guidance on extensions of use, but in general you will need to:

  1. Fully explain your request in the covering letter of your application;
  2. Complete the CRD3 application form (see Applicant Guide: What should I Include in an Application ? for Application Forms). You must ensure that the form includes a name and date; and,
  3. Submit any previous relevant correspondence which must be, at a minimum, a copy of your product’s authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Approval/Authorisation Number) must be submitted; and,
  4. Submit a reasoned case to demonstrate the ‘need’ of the proposed Extension of use EAMU . The reasoned case must include details of the nature and scale of the problem and an explanation as to why alternative means of control are not adequate; and,
  5. Submit data and/or reasoned scientific cases to address the risks to consumers, operators, wildlife and the environment; and,
  6. If you wish for your application to be considered as a priority, submit a reasoned case to demonstrate the ‘urgency’ of the proposed EAMU. The reasoned case should include details of when the proposed EAMU is required and an estimation of the severity of the problem.

These types of applications can be accepted and evaluated during the transition between COPR and PPPR once the active substance has been approved under EC Regulation 1107/2009 (see Under what legislation will applications be considered? for further information).

Extension of Use: meeting a data submission deadline

EAMU s granted under COPR may be subject to the provision of data (usually residues trials) to support continuing authorisation. These data requirements (and the deadline) will have been specified when the SOLA/EAMU was first granted.

For this type of application you will need to:

  1. Fully explain your request in the covering letter of your application; and,
  2. Complete the CRD3 application form (see Applicant Guide: What should I Include in an Application ? for Application Forms). You must ensure that the form includes a name and is dated; and,
  3. Submit any previous relevant correspondence which must be, at a minimum, a copy of your product’s authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Approval/Authorisation Number) must be submitted; and,
  4. Submit a copy of the existing EAMU or a full reference (including the COP number and Notice of Approval/Authorisation Number) under which the EAMU was evaluated; and,
  5. Submit data and/or reasoned scientific cases to address the outstanding data requirements; and,
  6. Submit a full explanation if you make any changes to the currently approved conditions of use.

These types of applications can be accepted and evaluated during the transition between COPR and PPPR once the active substance has been included in Annex I of Directive 91/414/EEC (see Under what legislation will applications be considered?).

Extension of Use via Mutual Recognition

You can submit an application for a new EAMU on the basis of the ‘Mutual Recognition’ (MR) of a product approval/authorisation in another Member State (MS) provided that the proposed uses are considered minor in the UK. The MR process is a way of meeting the requirement for a consumer exposure risk assessment without the need to submit residues data. However, you will still need to address all other areas of the risk assessment.

In support of your application you must submit the following (see The Applicant Guide for further information):

  1. A covering letter that fully explains your request;
  2. A signed and completed application form (CRD3);
  3. A reasoned case to demonstrate the ‘need’ of the proposed EAMU. The reasoned case should include details of the nature and scale of the problem and an explanation as to why alternative means of control are not adequate;
  4. A reasoned case to demonstrate the ‘urgency’ of the proposed EAMU, if you wish for your application to be considered as a priority. The reasoned case should include details of when the proposed EAMU is required and an estimation of the severity of the problem;
  5. A copy of the authorisation issued for the product in the reference Member State with a translation into English;
  6. Detailed evidence that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the reference Member State are comparable with those in the UK. The evidence should consist of the application rate, timing, frequency, method of application, situation of use (ie protected or outdoors) and harvest interval (ie these factors for the proposed use must all be the same as that authorised for the UK product). This evidence should ideally be presented in a tabular format;
  7. Evidence that the UK product holds an extant authorisation and is identical to the product authorised in the reference Member State;
  8. Evidence that the use to be mutually recognised has been registered in full accordance of EC Regulation 1107/2009, including the Uniform Principles and using EU agreed endpoints.

Extension of Use: re-registration

Once an active substance has been approved under Regulation (EC) 1107/2009 (formerly inclusion in Annex I of Council Directive 91/414/EEC), Member States must re-evaluate plant protection products and uses in accordance with Annex VI to the Directive 91/414 EC (the Uniform Principles) [now article 29(6) of Regulation EC1107/2009], on the basis of dossiers satisfying the data requirements of Annex II (active substance related data) and Annex III (product related data). We refer to this process as re-registration. You should refer to the UK guidance for the re-registration for Extensions of Use for more details.

Further information

Updated 2016-11-07