The Applicant Guide: Article 53/Emergency (120 day) Authorisation
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
Under certain circumstances it is possible for Member States to authorise the use of a plant protection product for a period not exceeding 120 days, for a limited and controlled use where such a measure is necessary because of a danger which cannot be contained by any other means as set out in Article 53 of Regulation (EC) 1107/2009.
When issuing such emergency authorisations the MS concerned must inform the other MSs and the Commission of the authorisation given, detailed information about the situation and any measures taken to ensure consumer safety. If necessary, the Commission will take a decision as to whether the MS can extend or repeat the emergency authorisation or not or whether the authorisation must be amended or withdrawn.
Applications for emergency authorisation cannot be made for plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC. Agreement from the Expert Committee on Pesticides (ECP) and the Defra (Department for Environment, Food and Rural Affairs) Minister would be required before authorisation could be agreed within the UK. Authorisation would be given for a maximum period of 120 days and as such it is a temporary solution to a pest problem for which a more permanent solution must be found.
What are the requirements for an emergency authorisation?
You need to submit all of the following
- The documentation detailed in The Applicant Guide;
- A full description of the pest or disease causing economic damage or issue relevant to public health
- Details of when the use is required and what would be the consequence if authorisation is not given by this date;
- The approximate scale and scope of the problem and the potential for economic damage;
- An explanation as to why alternative means of control (both existing on-label authorisations, extensions of use and cultural methods) cannot be used
- A reasoned case to demonstrate the 'need' for the proposed use for each crop/crop group (see the guidance document for extension of use)
- A reasoned case to support the 'urgency' of your application and why it should be treated as an emergency (see the guidance document for extension of use);
- Details of the location and area (eg hectarage) of the crop that will need to be treated and how the supply of the product and treatment of the crop will be controlled to ensure that it is limited;
- Details of any research work, proposals or progress towards a long term solution to the pest problem;
- Data or cases to address the risk assessment in order to minimise risks to consumers, operators and the environment.
Link to page giving further guidance on the information required.
Points 2 to 10 must be detailed in the application form CRD9 but further additional supporting information can be submitted as supplementary documents.
Where there is no existing information on the active substance e.g. where an active substance is new to the EU, then HSE will not progress an emergency application because of the volume of evaluation work required to meet the requirements of Article 53.
HSE recognises that many applicants do not always have access to the information and data supporting the authorised product being cited in the emergency application. Applicants should always seek advice and assistance from the authorisation holder and data owner in order to complete the section in the CRD9 form relating to the risk assessment.
Note: in rare circumstances, HSE may complete the risk assessment at the request of the applicant. HSE will charge accordingly for this extra work. We will not do this routinely but only in exceptional circumstances. These will be considered on a case by case basis.
Where the applicant is the authorisation holder rather than the user, then the case for need and urgency must be supported by growers of the crop(s) concerned and for each crop/crop group.
We will consider each application on its merits and the decision to accept an application for an emergency authorisation is made at our discretion.
HSE must charge fees to recover the full cost of processing emergency applications As for other types of applications, the modular fee charging system is now used.
At the validation stage we will check the completeness of the application and consider the justification for need and urgency, for which we will charge a sift and reasoned case fee. When accepted, we will also charge the relevant data or case fees as required, dependent on the information submitted.
For further details of the current fees, check the fees page.
Once we have accepted your application as an emergency, we will contact you to discuss the date by which the authorisation is required and arrange a suitable processing target time for your application.
All emergency authorisation applications accepted will be considered by the ECP and it will advise the Minister of their recommendation. The final decision on whether authorisation can be given will be made by the Minister.
Consultation with the ECP will be via a paper for the next scheduled ECP meeting. In exceptional circumstances, HSE may consult the ECP via correspondence if the nature of the danger means that consideration cannot be delayed until the next scheduled meeting. Applicants must provide evidence of the extreme urgency to support the need for the application to be considered outside an ECP meeting.
Note that due to the temporary nature of this derogation from the full requirements of Regulation (EC) 1107/2009 HSE will not normally consider more than three repeat requests for Article 53 emergency authorisation for the same product and use. Applications for repeat Article 53 emergency authorisations are by their nature not unexpected and can be planned therefore they must be submitted by the end of January of the year in which the use is required.