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Annex A Question and Answer for Extension of Authorisation for minor use

Question and Answer Sheet 1 - Issuing Notice of Authorisation Numbers (NANUMs) for Extensions of Authorisation for Minor Use (EAMUs)

Q1 What types of changes will require new (NANUMs) to be issued?

A1 Complex changes, or those which have a negative impact on the conditions of use will require new NANUMs. These situations will include:

Q2 What types of changes are considered to be ‘administrative’, and so will mean that the old NANUM can be retained?

A2 Simple changes which do not have a negative impact on the conditions of use will not require a change to the NANUMs. These situations include:

Q3 In the past, existing Notices of Authorisation for EAMUs have been changed by ‘amendment notice’ eg when MAPP number or marketing company changes. What happens to current EAMUs that have had an amendment Notice issued?

A3 Amendment Notices will not be issued for EAMUs. Instead, the system will generate a new authorisation reflecting the new product details and MAPP number. The new authorisation will be given a new NANUMs as appropriate, in line with situations outlined in Answer 1 above.

Q4 Will I be able to continue to use the ‘old’ authorisation when a new Notice of Authorisation number is not issued? Do I have to obtain a copy of the most recent version of a Notice of Authorisation?

A4 You will still be able to use the ‘old’ authorisation when a new NANUM is not issued. However, it is good practice to be aware of the most up to date version of that authorisation, and you should ensure that you are aware of any changes made. The new version of the authorisation will explain in the advisory information section that it is a revised version of the authorisation and what changes have been made.

Q5 How will I tell which is the most up-to-date authorisation when the Notice of Authorisation Number is not changed?

A5 You will be able to check for the most recent version by referring to the date of issue on the Authorisation. This will be revised with each version and you should use the version with the latest date of issue. Only the latest version will be available from the web site, so it will be easy to check this.

Question and Answer Sheet 2 - How authorisations will reflect crops and/or crop groups, and subsequent charging.

Q1 How will applications for soft fruits be handled, which fruits will need a separate Notice of Authorisation, and how many EAMU fees will be charged?

A1 Applications for an Authorisation for an Extension of use on soft fruits will result in a different Notice of Authorisation being issued for each crop group. For example if an application was submitted for minor use on strawberry, raspberry and blackcurrant, three separate authorisations would be issued. This would be charged three separate fees, one for each risk assessment. Where the application covers similar species ie one crop grouping such as raspberry, tayberry, loganberry, and other Rubus species, only one Notice of Authorisation would be issued, as they are all in the same crop group. This application would be charged only one EAMU fee. Crop groupings are based on the Crop Definitions list.

Q2 If I apply for an Extension of Authorisation for a Minor Use on lettuce, parsley, mint and baby leaf brassicas how many Notices of Authorisation will be issued and how many fees charged?

A2 Only one Notice of Authorisation would be issued for these crops, as they are all based on the same lettuce residue trials data, resulting in one fee.

Q3 If I apply for an Extension of Authorisation for a Minor Use on apple, pear, cherry and mirabelle, how many Notices of Authorisation will be issued and how many fees charged?

A3 Two Notices of Authorisation would be issued, one for apple and pear and one for cherry and mirabelle. This is because there is one consumer risk assessment for apple and pear and another one for cherry and mirabelle. As there are two risk assessments, two fees will be charged.

Q4 If I apply for an Extension of Authorisation for a Minor Use on the following crops, how many Notices of Authorisation will be issued and how many fees charged? a. peas and beans, b. cabbage, Brussels sprouts and cauliflower, or c. leek, bulb onion, garlic and shallot.

A4 Only one Notice of Authorisation would be required, if the rates and timings are the same for a) pea and bean, b) cabbage, Brussels sprout and cauliflower, and c) leek, bulb onion, shallot and garlic and therefore only one fee would be charged.

  1. If the rates and timings are different for pea and bean then two risk assessments will be necessary resulting in two Notices of Authorisation being issued, and two fees being charged.
  2. If the rates and timings are different for cabbage, Brussels sprout and cauliflower then three risk assessments will be required resulting in three Notices of Authorisation and three fees being charged.
  3. If the rates and timings are different between leek and onion then two risk assessments will be required, resulting in two fees and two Notices of Authorisation; one for leek and one for bulb onion, garlic and shallot.

Q5 Will current Notices of Authorisation be retrospectively revised to separate authorisations for each crop group?

A5 In general no, although where an existing authorisation has to be revised because a crop or the conditions of use are being changed for safety or MRL reasons, then the new authorisations will have a Notice of Authorisation for each crop grouping. Where this is for review or MRL{Maximum Residue Level}} reasons no charge will be made.

Q6 How many Notices of Authorisation will be issued and fees charged when requesting authorisation for a new similar product on the basis of an existing Extension of Authorisation for a Minor Use, without any new data being submitted?

A6 One Notice of Authorisation will be issued for each crop group in line with the original authorisation. As no new risk assessment will be required, only one EAMU fee will be charged. Applications for EAMUs of new identical products based on an existing simple EAMU Notice of Authorisation, with only one or two crops or crop groupings, will be considered via the admin stream. Where there is more than one minor use Notice of Authorisation an additional task fee will be charged for each additional notice.

Applications for EAMUs based on products that are similar but not identical will be considered in the no-data stream and charged the full EAMU fee. An Admin fee will be charged for the first additional Notice of Authorisation, with task fees being charged for each further additional notice.

Updated 2017-02-01