The Applicant Guide: How Do I Make Changes To An Authorisation?
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
What types of changes will require an authorisation?
Changes to the product identity
If you wish to change the trade name, authorisation holder or marketing company of your product then you must submit an application. Assuming there are no other changes then your application can be processed as an Admin application (see the checklists on the requirements for different types of applications). We will issue a new MAPP number for your product if you request a change in trade name or marketing company so that we can differentiate between the two products.
Changes to the technical specification
If you wish to change the technical specification for the active substance(s) in your product you must submit an application unless the change is considered to be a minor one. Further guidance on making changes to technical specifications can be found in the guidance on technical specifications.
Changes to the formulation
If you wish to change the formulation recipe of your product then you must submit a full application. The target time for processing the application will depend on the date of submission of the application. The fee charged will depend upon the change required and whether supporting data are needed to support the change.
HSE also allows applicants to make non-significant changes to their authorised formulation (ie those in line with SANCO/12638/2011) via a simplified notification procedure. See What changes do not need the submission of an application?
Changes to the conditions of use and claims on the product label
If you wish to change any of the conditions that relate to the sale, supply, storage, use and advertisement of your product you must submit an application. These changes include:
- Changes to the authorised crops and/or situations.
- Changes to the authorised dose rates and/or the number of treatments.
- Changes to the latest time of application.
- Changes to the restrictions relating to operator protection, environmental protection or any other specified restrictions.
- Changes to the size, material or design of the product's packaging.
- Changes to the product's label that we need to consider (see The Labelling Handbook for further information).
- Changes to the product's label to add use on undersown crops (see Applications for addition of undersown crops to product labels).
What changes do not need the submission of an application?
Changes that can be made to your authorisation that do not require the issue of a new authorisation or the submission of an application are known as 'notifications'. The following changes can be made via the notification procedure:
Changes to the address of the authorisation holder or marketing company
If the address of the authorisation holder or marketing company of your product changes then you must inform us immediately. We will write to you to confirm the change and update our records, but we will not issue a new authorisation for your product.
Changes to the formulation manufacturing site
If you change the site at which your formulation is manufactured then you must inform us immediately. We will update our records and write to you to confirm the change.
Meeting requirements for further data that relate to the active substance
If you submit an application to meet a data requirement that relates to an active substance in your product, you do not need to submit an application for any other products which have the same data requirement. However, you must notify us of the other products which have this data requirement otherwise authorisation for these products may be withdrawn at the data submission deadline. However, if the data requirement is the only outstanding requirement for your product, you must submit an application so that if the data requirement is successfully met an appropriate authorisation can be issued.
Non-significant formulation change for a single co-formulant
You can notify a non-significant formulation change to a product using a notification form.
What is a non-significant formulation change?
Non-significant formulation changes are those where there is no chemical change to the manufactured product. The following formulation changes are considered to be non-significant:
- Where a co-formulant is from an alternative source or has a new trade name. The co-formulant must be chemically equivalent and present in the same quantity as the co-formulant that it is replacing.
- For anionic surfactants/dispersants the cation may be exchanged.
- The addition of a marker substance to a plant protection product where it is less than 0.1% of the formulation and presents no toxicological or ecotoxicological concern. This must have been determined by HSE under a previous assessment. The marker must already be included in the authorised formulation of another plant protection product.
Further Information on Notification process for non-significant changes to formulations.
Changes to the technical specifications of the active substance
If you wish to make a change to the technical specification of the active substance(s) authorised in your product, there are certain criteria under which an application is not required. Further information on making changes to technical specifications can be found in the guidance on technical specifications. If you make a change to your authorisation, your product's registration (MAFF/MAPP) number may change. See the guidance document on registration numbers for information on when this will happen.
- The contents page for The Applicant Guide
- Guidance documents for The Applicant Guide
- Do I need to submit an application?
- How will my application be processed?
- What should I include in an application?
- What happens once my application is completed?