Adjuvant listing: How to apply for inclusion on the Official List of Adjuvants
A company wishing to market an adjuvant for use with a plant protection product (PPP) in the UK must apply for its inclusion on the 'Official List of Adjuvants'. The application must contain information demonstrating the safety of the adjuvant for the proposed uses.
What data requirements do I need to address for the inclusion of my adjuvant on the official list?
You must provide appropriate data or information on:
- the adjuvant's identity, including its physical and chemical properties - adjuvant data requirements
- for adjuvants intended for use in conjunction with PPPs on crops destined for human or animal consumption, we also need supporting residues data to demonstrate an acceptable risk to consumers - residues data requirements for adjuvants
We do not currently consider data relating to storage stability of the adjuvant; acute toxicity or operator exposure (but Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008) applies to these aspects); its efficacy or crop safety; or its fate and behaviour in the environment and its effects on non-target species (also subject to CLP).
How may I address the data requirements?
You may address the data requirements by:
- submitting new data specific to the proposed EAC/formulation details/uses
- submitting published studies or other information from scientific journals or other sources
- referencing data that have already been evaluated by us in support of the same or another product
- submitting a letter of access authorising us to access third party data that have already been evaluated in support of the same or another product
- submitting a reasoned case as to why the data requirement is not applicable to the proposed application
All studies must be:
- in English
- generated in line with relevant international test guidelines and the applicable requirements for good laboratory practice (GLP) compliance or official recognition
How will my application be processed?
General information on where to submit applications, processing times and information sent out during evaluations is in the Applicant Guide how will my application be processed.
Adjuvant applications are placed in our usual processing streams (see the guidance document on application streams for further information):
- applications which require a technical assessment (for example a new formulation, a new source of EAC, supporting residues data) will be considered to the same timeframe as an application for the authorisation of a PPP.
- applications which do not require any technical input will be considered via the admin stream
How much will my application cost?
Currently applications for inclusion on the Official List of Adjuvants do not incur a fee.
How do I find out the target date and what might impact upon the processing time?
We will inform you of the target date for completion of your application once it has been accepted at the sift (except for admin applications where the short processing time makes this impractical).
For some applications we may need to seek further information from you. Any time spent seeking further information does not count towards our processing time of your application.
What happens after my application is completed?
If your application is successful, we will inform you in the normal way (see The Applicant Guide how will my application be processed for further information).
An electronic copy of the list entry will be included on the Adjuvant Database and new products will be added to the Official List of Adjuvants.
If your application involved a major change to the product's, we will produce a list entry for both the 'new' product and the 'old' product. There will normally be a use-up period for 'old' products.
If your application is unsuccessful, we will explain the reasons why your application has been refused and specify what data requirements you need to address to obtain inclusion on the Official List of Adjuvants.
What happens after a list entry has been included on the Official List of Adjuvants?
We carry out regular checks to ensure that list entries are up to date.
If revocation action is taken against a pesticide or its uses which will affect your list entry, we will amend your entry.
What if I want to take my listed product off the market?
If you wish to withdraw your product from the market for a commercial reason you should contact us so that your list entry can be formally withdrawn. We do not charge a fee for carrying out this procedure.
You should email the Applications Sift: [email protected] confirming:
- details of the product you wish to withdraw
- reasons for withdrawal
- the withdrawal period you require to allow for a use up period of existing stock (usually up to 2 years)
What if I want to remove a use from my listed product?
If you wish to withdraw a use from the list entry of your product you will need to apply for the commercial withdrawal of this use as a new list entry will need to be issued for the product.
In your application you must state why you wish the use to be withdrawn.