Adjuvant listing: What should I include in an application?
You should submit a covering letter for each application. This is an important document since it helps us understand why you have submitted your application. The letter should detail:
- the purpose of the application for example to add an adjuvant to the Official List
- the context of the application in relation to any previous list entries
- brief details as to how you are supporting your application, for example the submission of reasoned scientific cases; the submission of new data. You may expand this information to provide details of how you are addressing each area of the assessment. This could take the form of an application overview.
You must submit an appropriate CRD 4 application form with every application. The forms should be fully completed.
Where you are applying for a new effective adjuvant component (EAC) or new source of EAC you must also submit information on the nomenclature of the EAC.
Information required on the EAC nomenclature.
Previous relevant correspondence
You must submit, or refer to, copies of any previous relevant correspondence relating to your application, so that the assessment manager can access or trace all supporting information. Relevant correspondence can consist of letters and emails and may include the following:
- reference to the current list entry for your product (refer to the appropriate COP number)
- reference to the current list entry(s) for other product(s) that you are referencing in support of your application (for example for new products based on similarity to products that are already listed; for applications for inclusion of a source of an effective adjuvant component already authorised in another product).
- copies of correspondence which clarifies data requirements (for example copies of correspondence on data requirements that must be addressed for your product.
- other advice we have provided you with that relates to your application
Letter of access
If you are not submitting (or referring to) your own data, you will need to provide a letter from the appropriate data owner which allows us to access to their data.
Letters are required to cover all the data used to support your adjuvant, not just the data submitted in support of a specific application. Further information on letters of access is provided.
Draft List Entry
The proposed uses for the adjuvant should ideally be submitted as a "draft List Entry". You can use the example list entry to help you. However, you may choose to submit draft labels as a means of explaining the proposed uses of the adjuvant.
You may submit a draft label with your application. Whilst we have no legal control over the marketing and advertisement of adjuvant products, we can provide advice on labelling relating to the use of the adjuvant in the covering letter accompanying the list entry.
It is your responsibility to ensure that any product literature is in accordance with both the conditions of use of the adjuvant as specified in the list entry and the pesticide authorisation.
A product can be removed from the official list if the marketed label or other literature does not comply with conditions in the list entry or the relevant plant protection product authorisation(s).
Guidance on the labelling of pesticide products is given in The Labelling Handbook. You may wish to use this guidance to help you produce a draft label for your adjuvant product.
Compatibility Assurance Statement
You must submit a Compatibility Assurance Statement (CAS) with all applications for new products, or new uses, or formulation changes. This certifies that data or other evidence are available to demonstrate that the adjuvant may be safely used in a tank mixture with the recommended plant protection products (as to be specified in the new list entry). An application must be submitted to amend the list entry if changes are made to the recommended uses. A template for this CAS is provided.
You may address the data requirements and residues data requirements for adjuvants 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
For all applications you must provide a summary of the submitted data and an assessment as to how these data support the proposed product and use(s). This summary can be in the format of an application overview.
A copy of all the data referenced in support of your application must be submitted (single paper copy, CD/Email or electronically).
Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008
Adjuvants are subject to the Regulation on Classification, Labelling and Packaging (CLP) of Substances and Mixtures (EC) 1272/2008. All adjuvants being placed on the market must be classified and labelled in line with CLP. Advice on labelling with regard to CLP is available on the HSE's website.
You should provide details of proposed classification and labelling when you submit your application.
Do I need to submit everything before my application is accepted?
We do not accept incomplete applications. The only exception to this is if a letter of access from a third party is to be submitted separately. This does not apply to applications processed via the Admin Stream, when all supporting information must have been submitted, including letters of access, before an application can be accepted.