Requirements For Extensions of Authorisation for Minor Use (EAMU)s
Where a plant protection product (PPP) does not have an appropriate on-label authorisation, authorisation holders, growers or their representative organisations may apply for the authorisation of a PPP 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:
- fully explain your request in the covering letter of your application
- 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
- 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 Authorisation Number) must be submitted
- submit a reasoned case to demonstrate the ‘need’ of the proposed 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
- submit data and/or reasoned scientific cases to address the risks to consumers, operators, wildlife and the environment
- if you wish your application to be considered as a priority, submit a reasoned case to demonstrate the ‘urgency’ of the proposed EAMU. The reasoned case must include details of when the proposed EAMU is required and an estimation of the severity of the problem.
Extension of use: renewal
Once an active substance has been approved under Regulation 1107/2009 (GB/NI) (formerly inclusion in Annex I of Council Directive 91/414/EEC), we must re-evaluate PPPs and uses in accordance with Annex VI to the Directive 91/414 UK (the Uniform Principles) [now article 29(6) of Regulation 1107/2009 (GB/NI)], 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 renewal. You should refer to the UK guidance for Article 43 renewal of existing products for more details.