The Applicant Guide: Extensions of Use under Regulation (EC) 1107/2009

Authorised uses on plant protection product labels (‘on-label’/product authorisations) do not cover every pest/crop combination, particularly for minor uses. You may, therefore, not be able to control a pest using a current on-label/product authorisation. If economically damaging levels of pests occur in a crop where there is no on-label/product authorisation of a suitable plant protection product, then you have two possible options to control this pest:

1. Use the ‘Long Term Arrangements for Extension of Use’ (LTAEU) for non edible crops only ; or,
2. Apply for an ‘Extension of Use’.

Under Article 51 of Regulation (EC) 1107/2009 both authorisation holders and growers or grower organisations can apply for an extension of use. This is defined as an extension of authorisation for minor uses of existing authorised products. The extension can be given where the use is minor in nature, is in the public interest and all safety aspects of the risk assessment can be satisfied. When an extension of use is given it can appear on the product label in a separate section titled ‘Extension of Use’ and with 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 efficacy 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 Use Notice that can be obtained from CRD’s website.

The Long Term Arrangements for Extension of Use

The LTAEU are arrangements that allow for the extrapolation of the use of a plant protection product from crops on an authorised product label or extension of use to certain other listed crops without the requirement for an additional specific authorisation. This in effect allows the use of plant protection products on a specific ‘minor’ crop provided an authorisation exists for use of the same plant protection product on a specific ‘major’ crop. These arrangements now only apply to non-edible crops.

The LTAEU provides UK growers with access to potentially large numbers of plant protection uses whilst ensuring that risks to the operator, consumer and the environment are not increased. Full details of these arrangements can be found on our website.

You should note that these extrapolations are performed at your own risk and we will not be responsible for any commercial loss as a result of the use of a plant protection product under the LTAEU.

CRD has concluded that it is no longer possible to maintain the LTAEU in their current format and will be replacing the Arrangements during the next few years.

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Extensions of Use

Where a plant protection product (PPP) does not have an appropriate on-label authorisation, an extrapolation under the LTAEU is not possible, professional agricultural organisations, professional users/growers or their representative organisations, official or scientific bodies involved in agricultural activities or authorisation holders may apply for an extension of the authorised use of the PPP under Regulation (EC) 1107/2009.

The amount of data or information that you will need to provide in support of your application will depend on your request and the target processing time will also depend on the nature and urgency of your request.

For further information on processing targets and application streams for your application see the guidance on application streams and targets. Information on how applications are processed can be found in The Applicant Guide. All applications are subject to an evaluation fee and details of current fees can be found in the guidance on application fees. Please note that 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.

Extension of use applications are subject to the zonal authorisation procedure as set out in Articles 33 – 39 of Regulation (EC) 1107/2009 and CRD’s assessments will therefore be made available to other MSs in the same zone to allow for commenting. The commenting period for those applications accepted in the no data stream will be 2 weeks and for those in the data or data plus stream will be 6 weeks. This will not apply to admin applications or applications for an extension of use the same as already issued for a similar product.

You should also be aware that where action is taken to include an active substance in Annex I of Council Directive 91/414/EEC (e.g. following the EC Review or completion of evaluation for new active substances) or approve it under Regulation (EC) 1107/2009, we may need to take regulatory action on any extension of use for a product containing that active substance. Full details are given in the guidance on re-registration.

How do I apply for an Extension of Use?

For Extensions of Use for new uses

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

1. A covering letter explaining the reasons for the application. This should detail why the proposed extension of use will not increase the risks to the consumer, operator and environment compared to existing uses (see (d) below). The letter should also include a reasoned scientific case for ‘need’ (see (c) below) and ‘urgency’ if appropriate (see (f) below); and,
2. A fully completed application form CRD3 (see The Applicant Guide); and,
3. reasoned case to demonstrate the ‘need’ for the proposed use. The reasoned case should include:
   • Details of the nature of the problem which must include reference to a named pest. If you wish to control more than one pest then details of all pests should be included. You should also consider:
   • Is the problem occurring now? If the proposed extension of use is only a contingency measure for an anticipated problem, you should explain your reasons for applying for the extension of use now.
   • Is the problem established or is it a problem that has not been previously encountered? If the problem is established you should explain your reasons for applying for the extension of use now.
   • Details of the scale of the problem including the approximate size, severity and scope of the problem (including total and geographical area affected and the proportion of the crop affected/lost). Details of the potential for economic damage (i.e. cost) that will occur if an extension of use is not granted should also be provided.
   • An explanation as to why alternative means of control (both existing on-label authorisations and cultural methods) cannot be used. You should note that a justification for an extension of use based on the fact that the proposed product is cheaper than other products already approved for that use is not acceptable. You should also note that 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.
   • NOTE – for applications from authorisation holders this case for need must be supported by users/growers of the product for this use.

     Examples of such information have been provided; and

4. All areas of the safety aspects of the risk assessment for the proposed extension of use should be addressed using data and/or reasoned scientific cases. You should address the risks to operators, consumers (i.e. 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 extension of use (i.e. where the authorised on-label use(s) reflect those proposed for the extension of use).

   We would suggest 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 should explain why this will not have an impact on operator, consumer or environmental exposure.

   We expect applicants who are authorisation holders to submit full risk assessments to support their extension of use request.

5. A letter of access to 3^rd party data, for guidance on letters of access see – link.
   

   If there is an immediate ‘need’ for the proposed use then you will need to submit a request for ‘Emergency consideration’. We will process acceptable emergency requests within a quicker timescale to non-emergency requests. For this type of application you will also need to submit the following:

6. reasoned case to support the ‘urgency’ of your application and why it should be treated as a priority. This evidence should include the following:
   • When the proposed off-label use is required so that the pest can be controlled.
   • An estimation of the severity of the problem (including details of potential crop losses and economic damage) if the extension of use is not granted within the processing target time for an emergency request and why these losses would be significant.
   • Where the authorisation holder is submitting the application then the case for urgency must be supported by growers detailing the urgency of the need for the use for them.
     You should always carefully assess whether an application for an Emergency consideration meets the criteria for ‘urgency’. If there is not going to be an immediate failure and loss of the crop if the extension of use is not authorised quickly then the application should not be submitted for urgent consideration. This will help us to ensure that genuinely urgent cases are processed as quickly as possible.
   
   We will consider your case(s) for ‘need’ and ‘urgency’, consulting externally if we feel it is necessary. You should note that if your application satisfactorily demonstrates ‘need’ but not ‘urgency’ it will be dealt with as a non-emergency application in the relevant stream.

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For applications addressing data requirements for existing Extension of use authorisations

If your previous application was evaluated under COPR then you may have only received a provisional level of authorisation if further confirmatory data are required to support your Extension of use (i.e. for full authorisation under COPR to be granted).

The COPR authorisation will have specified two dates; the first date is the deadline by which any outstanding data need to be submitted to us and the second date is the date of expiry of the authorisation.

In support of an application to meet outstanding data requirements and upgrade your extension of use you must submit:

1. A covering letter explaining the reasons for the application; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A copy of the existing authorisation or a full reference (including the COP number) under which the off-label use was evaluated; and,
4. Data and/or reasoned scientific cases to address the outstanding data requirements; and,

5. A letter of access to 3^rd party data, for guidance on letters of access see – link
6. A full explanation if you wish to make any changes to the currently authorised conditions of use.

If you wish to apply for authorisation of an additional pest and/or crop for your extension of use you must ensure that you provide a full justification with regard to ‘need’ and address the risks to consumer, operators and the environment. If this information is not provided, the additional pest and/or crop will not be considered under your application.

To avoid your extension of use expiring without a replacement being issued you must ensure that you submit an application to address the outstanding data requirements in good time so that we have enough time to evaluate your application prior to the date of expiry. If your application is submitted after the data submission deadline we cannot guarantee that your application will be evaluated by the date of expiry.

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For applications for the authorisation of a new Extension of Use on the basis of a currently authorised Extension of Use

You may submit an application for authorisation of an extension of use on the basis of a currently authorised identical or similar Extension of Use without submitting a case for ‘need’. The case for ‘need’ would have already been considered when the original authorisation was granted and is therefore not required again. You will, however, have to detail the Extension of Use authorisation/s on which you wish to base your application. These must be for the same pest/disease/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 that they need to use it to control that specific pest on the crop listed on the original Extension of Use authorisation.

For products that are identical

If an Extension of Use is required for the same conditions of use (i.e. crop, rates, timings, pests) as authorised for an existing Extension of Use and the products are identical with regard to formulation type, description and quantity of active substance and co‑formulants you will need to submit:

1. A covering letter explaining the reasons for the application; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A copy of the existing authorisation or a full application reference (including the COP number) under which the extension of use was evaluated; and,
4. A letter of support from the user of the product, for applications from Authorisation Holders; and,
5. A letter of access to 3^rd party data, for guidance on letters of access see –link

These requests will be considered via the admin stream.

For products that are similar

If an Extension of Use is required for the same conditions of use (i.e. crop, rates, timings, pests) as approved for an existing extension of use 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; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A copy of the existing authorisation or a full reference (including the COP number) under which the authorisation was evaluated; and,
4. A letter of support from the user of the product, for applications from Authorisation Holders; and,
5. A letter of access to 3^rd party data, for guidance on letters of access see – link

We will consider whether the assessment performed for the original Extension of Use is applicable for your proposed Extension of Use. 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 authorised Extension of Use, we would generally not expect there to be an urgent need for a new extension of use for the same use.

For products that contain different active substances

If an extension of use is required for the same conditions of use (i.e. crop, rates, timings, pests) as approved for an existing extension of use where the products contain different active substances you will need to submit:

1. A covering letter explaining the reasons for the application; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A copy of the existing extension of use or a full reference (including the COP number) under which the extension of use was evaluated; and,
4. A letter of access to 3^rd party data, for guidance on letters of access see – link ; and,
5. A letter of support from the user of the product, for applications from Authorisation Holders; and,
6. A data and/or scientifically reasoned cases addressing all aspects of the safety risk assessment as detailed in How Do I Apply for an Extension of Use, d. above.

If the authorisation is required urgently then you will need to submit a case for ‘urgency’ as described in How Do I Apply for an Extension of Use, f. above.

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Extension of Use based on mutual recognition of a minor use authorisation in another MS [in accordance with Article 51 (7) of Regulation (EC) 1107/2009]

Where there is a minor use authorisation/extension of use in another MS you can apply for an extension of use in the UK. The product must be the same as that approved in the UK. The minor use authorisation must have been assessed to the requirements of Article 29 of Regulation (EC) 1107/2009, including the Uniform Principles. For further guidance on mutual recognition and the specialist guidance for such applications see the links below:

Mutual Recognition

Specialist guidance for mutual recognition

How do I apply for an Extension of Use based on mutual recognition of a minor use authorisation?

You must submit:

1. A covering letter clearly stating that you are seeking authorisation based on mutual recognition of a minor use authorisation in another MS; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A reasoned case for need (and urgency if appropriate) as set out in the section on applying for Extensions of Use for New Uses above; and,
4. A copy of the product label and authorisation document from the MS in which the use is authorised, with a translation of both into English; and,
5. A letter of access to 3^rd party data, for guidance on letters of access see – link
6. Confirmation from the authorisation holder that the formulations are identical; and,
7. Data and/or cases to address the UK specific requirements for mutual recognition applications as detailed in Mutual Recognition or Specialist guidance for mutual recognition.

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For Extension of Use based on mutual recognition of product authorisation [in accordance with Article 40(2) of Regulation (EC) 1107/2009]

Where there is a product authorisation for a use in another MS, growers can apply for an extension of use based on that authorisation if the use has not been approved in the UK and the authorisation holder gives their consent. If the authorisation holder refuses to give their consent CRD may still consider the application if it is in the public interest. Authorisation holders cannot apply for an extension of use on this basis. Authorisation holders must seek a product authorisation on the basis of mutual recognition under Article 40. The product must be the same as that authorised in the UK. The authorisation must have been assessed to the requirements of Article 29 of Regulation (EC) 1107/2009, including the Uniform Principles. For further guidance on mutual recognition and the specialist guidance for such applications see the links below:

Mutual Recognition

Specialist guidance for mutual recognition

How do I apply for an Extension of Use based on mutual recognition of a use on a product authorisation?

You must submit:

1. A covering letter clearly stating that you are seeking authorisation based on mutual recognition of a product authorisation in another MS; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A reasoned case for need (and urgency if appropriate) as set out in the section on applying for Extensions of Use for New Uses above; and,
4. A copy of the product label and authorisation document from the MS in which the use is authorised, with a translation of both into English; and,
5. A letter of access to 3^rd party data, for guidance on letters of access see –link
6. Confirmation from the authorisation holder that the formulations are identical and their consent to your application for this use; and,
7. Data and/or cases to address the UK specific requirements for mutual recognition applications as detailed in Mutual Recognition or Specialist guidance for mutual recognition

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For re-registration of minor use authorisations previously issued under the Recognition procedure under COPR

To reregister authorisations issued via this procedure, following Annex I inclusion/approval of the actives in the product, you need to submit a copy of the authorisation [SOLA] to the applications sift. We will check with the MS whether they have reregistered the use to the requirements of Article 29 of Regulation (EC) 1107/2009, including the Uniform Principles. If they have, we will accept your application as a mutual recognition application under Article 51 (7) or Article 40 of Regulation (EC) 1107/2009, as appropriate. For further details see the Mutual Recognition page of the Applicant Guide. If the MS has not reregistered the use to the requirements of Directive 91/414/EEC, we will require the underlying supporting residue trials data and will conduct a UK national assessment for consumers, operators and the environment.

What will I need to submit?

1. A covering letter clearly stating that you are seeking to re-register the off-label use based on mutual recognition of a product authorisation in another MS; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. A copy of the authorisation to be re-registered (optional); and,
4. A letter of access to 3^rd party data, for guidance on letters of access see –link.
5. Data and/or cases to address the UK specific requirements for mutual recognition applications as detailed in Mutual Recognition or Specialist guidance for mutual recognition

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For Extensions of Use 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 ‘revocation period’); or,
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 revoked because of other regulatory action. It is still legal to use the product on the crop during its revocation period; or,

3. We have revoked the use for regulatory reasons. It may still be legal to use the product on the crop during its revocation period.

You may confirm the authorisation status of a plant protection product/crop combination by contacting the CRD General Enquiries team (Communications Branch).

Where an authorised use has been commercially withdrawn you may apply for an extension of use for that use. Once the revocation period has ended, it will be illegal to use the plant protection product on that crop unless an extension of use has been issued. However, an extension of use will only be issued where there is no suitable alternative product authorisation available. For further information on revocation periods and commercial withdrawals see revocation of authorisation guidance and commercial withdrawal guidance.

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

1. The uses were withdrawn because of data that showed adverse effects to human health, animal health or the environment; or,
2. The uses were withdrawn at a data submission deadline, because of the failure of the authorisation holder to submit data to address outstanding data requirements, or following a review of the active substance. You may apply for an extension of use if you can submit the outstanding data.

   However, we will consider issuing an extension of use 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 extension of use should ideally be made within the revocation period of the use to ensure that the use can continue. If you do not submit your application in good time, we may not be able to issue an extension of use before the end of the revocation period. In support of your application you must submit:

1. A covering letter explaining the reasons for the application; and,
2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide); and,
3. Evidence of ‘need’; and,
4. A safety assessment; and,
5. A reference to where the notification of the revocation of the use was published; and,
6. A letter of access to 3^rd party data, for guidance on letters of access see –link

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

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For the re-registration of an Extension of Use following the inclusion of the active substance in the product in Annex I/Approval of the active substance in the product under Regulation (EC) 1107/2009.

For information on the re-registration of Extensions of Use see the 'Guidance on re‑registration'

For applications for an Extension of Use which require no technical input

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

1. Where changes to the commercially marketed product have resulted in a change in MAPP number (e.g. because of a change in product name or marketing company). In these cases the extension of use will need to be amended to take into account the new details.
2. Where authorisation of an extension of use is requested on the basis of a currently authorised extension of use for an identical product. The Admin Stream fee will be charged for each extension of use issued for the product.

In support of your application you should submit:

1. A covering letter explaining the reasons for the application; and,
2. A fully completed, signed and dated application form CRD3 (see (see The Applicant Guide); and,
3. A copy of the existing extension of use (if relevant); and,
4. A letter of support from the user of the product, for applications from Authorisation Holders; and,
5. A letter of access to 3^rd party data, for guidance on letters of access see –link

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

Any new data submitted will be protected for 10 years from the date of issue of the extension of use. The covering letter will detail the data submitted, whether it was used and data protection period applied. Where the authorisation holder applies for an extension of use and submits new data to support it those data will be protected for 10 years from date of issue 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.

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