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 eg to add an adjuvant to the Official List; and,
- The context of the application in relation to any previous List Entries; and,
- Brief details as to how you are supporting your application eg 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.
The application form
Where you are submitting an application for a new EAC you will also need to submit a document providing information on the nomenclature of the EAC.
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.
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.
Previous relevant correspondence
Relevant correspondence can consist of letters and emails and includes:
- The current List Entry for your adjuvant (if it has one) and any others referred to in your application. As an alternative you may provide a reference to the appropriate COP number(s) under which the current List Entry/Entries were issued.
- Copies of correspondence which clarifies data requirements.
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 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 the CAS is provided.
Do I need to submit a draft label
We have no legal control over the marketing and advertisement of adjuvant products.
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. However, we may provide advice on labelling relating to the use of the adjuvant in the covering letter accompanying the List Entry.
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).
What about 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) No. 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.