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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.

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: see LTAEU section below ; or,
  2. Apply for an 'Extension of Use' (EAMU) under Article 51 of Regulation (EC) 1107/2009: See EAMU section below

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.

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

You should also be aware that the LTAEU will be discontinued during the next few years.

Details of these arrangements can be found on the LTAEU page.

Extensions of Authorisation for Minor 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.

Note regarding Parallel trade plant protection products:

Under Regulation (EC) No 1107/2009, 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 extensions of authorisation for a minor use (EAMU), but if a reference product is authorised for an EAMU, then any parallel trade product of the named reference product may also be used with that EAMU. The reference product is now shown on the Notice of Authorisation for parallel trade products.

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.

For information on grouping of crops and when new Notice of Authorisation numbers will be issued see Annex A.

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.

Extension of use applications are subject to the zonal authorisation procedure in (EC) 1107/2009 and therefore assessments will be made available to other MSs in the same zone to allow for commenting. The commenting period can be 2- 6 weeks.

Where action is taken to include an active substance in Annex I of Council Directive 91/414/EEC (eg 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?

Subsections, with links to each are:

For Extensions of Use for new uses

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

We 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 must 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.

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

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

For applications addressing data requirements for existing Extension of use authorisations

If your previous application was evaluated under COPR (UK national legislation pre-Regulation (EC) 1107/2009then you may have only received a provisional level of authorisation if further confirmatory data are required to support your Extension of use (ie for full authorisation under COPR to be granted).

The COPR (UK national legislation pre-Regulation (EC) 1107/2009authorisation 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:

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.

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. We cannot guarantee that your application will be evaluated by the date of expiry if your application is submitted after the data submission deadline.

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 Use without submitting a case for 'need'. However, you must 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 ( 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 Extension of Use is required for the same conditions of use (ie 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 must submit:

For products that are similar

If an Extension of Use is required for the same conditions of use (ie crop, rates, timings, pests) as authorised 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:

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 (ie crop, rates, timings, pests) as authorised 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;
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide);
  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;
  4. A letter of access to 3rd party data, for guidance see letters-of-access; and,
  5. A letter of support from the user of the product, for applications from Authorisation Holders;
  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.

Extension of Use based on mutual recognition of a minor use authorisation in another Member State [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 authorised 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:

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 Member State;
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide);
  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;
  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;
  5. A letter of access to 3rd party data, for guidance see letters of access;
  6. Confirmation from the authorisation holder that the formulations are identical;
  7. Data and/or cases to address the UK specific requirements for mutual recognition applications as detailed in Mutual Recognition.

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 Member State, growers can apply for an extension of use based on that authorisation if the use has not been authorised 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:

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;
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide);
  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;
  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;
  5. A letter of access to 3rd 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;
  7. Data and/or cases to address the UK specific requirements for mutual recognition applications as detailed in Mutual Recognition.

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

(UK national legislation pre-Regulation (EC) 1107/2009

To re-register authorisations issued via this procedure, following Annex I inclusion/approval of the actives in the product, you must submit a copy of the authorisation Extension of authorisation for a Minor Use to the applications sift.
We will check with the MS whether they have re-registered 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 re-registered 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 extension of use based on mutual recognition of a product authorisation in another MS;
  2. A fully completed, signed and dated application form CRD3 (see The Applicant Guide );
  3. A copy of the authorisation to be re-registered (optional);
  4. A letter of access to 3rd party data, for guidance see letters of access.
  5. Data and/or cases to address the UK specific requirements for mutual recognition applications as detailed in Mutual Recognition

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 'withdrawal 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 withdrawn because of other regulatory action. It is still legal to use the product on the crop during its withdrawal period; or,
  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 use has been commercially withdrawn, you may apply for an extension of use. However, an extension of use 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 extension of use will not be granted for a use that has been commercially withdrawn when:

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 withdrawal period of the use to ensure that the use can continue. In support of your application you must submit:

The extension of use 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 extension of use will be entirely at the user's own commercial risk.

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:

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 (see (see The Applicant Guide);
  3. A copy of the existing extension of use (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, for guidance on letters of access see –link

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.

Further information

Updated 2017-01-06