A company wishing to market an adjuvant for use with a pesticide in the UK must apply for its inclusion on the ‘Official List’ of adjuvants. The ‘Official List’ provides details of the adjuvant products that may be used with pesticides and the conditions of use to which they are subject. Your documentation will therefore take the form of a ‘List Entry’ and will specify the identity of the adjuvant and the conditions that a user will need to comply with.
In this guidance, the ‘applicant’ has the same meaning as ‘approval holder’ has for pesticides.
What are the controls on adjuvants?
Our legal controls on adjuvants are limited to controlling the use of adjuvants with pesticides. Unlike with pesticides, we do not have controls on advertisement, sale, supply or storage of adjuvants, although other legislation will apply in these areas, such as the Health and Safety at Work Act 1974; the Control of Substances Hazardous to Health Regulations (COSH) 1999 and the ‘Chemicals (Hazard Information and Packaging for Supply) Regulations 2009’ (CHIP 4).
How do I include an adjuvant on the Official List?
If you wish to include an adjuvant on the Official List or to amend an existing List Entry then you will need to submit an application containing the appropriate information which will demonstrate the safety of the adjuvant for the proposed uses. The inclusion of your adjuvant on the Official List will be subject to the setting of certain conditions defined in the list entry.
What is an Effective Adjuvant Component?
An Effective Adjuvant Component (EAC) is the main active component of an adjuvant, akin to the active substance in a pesticide product.
What data requirements do I need to address for the inclusion of my adjuvant on the Official List?
We require appropriate data or information on the adjuvant’s identity, including its physical and chemical properties. For adjuvants intended for use in conjunction with pesticides on crops destined for human or animal consumption, we also need supporting residues data to demonstrate an acceptable risk to consumers. Residues data requirements that need to be addressed for the inclusion of adjuvant products on the Official List differ to the residues data requirements that need to be addressed for the approval of a pesticide product.
Unlike with pesticides, we do not consider data relating to storage stability of the adjuvant; acute toxicity or operator exposure (but CHIP 4 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 CHIP 4).
You will need to address all of the data requirements required to support a List Entry when submitting an application for the consideration of a new adjuvant never previously included on the Official List and prior to an Official List entry being issued.
Where an EAC has been previously considered in an Officially Listed adjuvant and where the you have access to the data used to support that Official Listing, you may be able to reference the previously submitted data rather than submit new data. You will need to ensure that you explain why the data you are referencing are relevant to your application.
There is no option for provisional listing of an adjuvant. A listing cannot be given subject to further confirmatory data requirements being set.
How may I address the data requirements?
As for pesticides, 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;. or submitting a reasoned case as to why the data requirement is not applicable to the proposed application. All studies must be in English and must be generated in line with relevant international test guidelines and the applicable requirements for Good Laboratory Practice (GLP) compliance or Official Recognition. Data supporting adjuvants are considered 'outwith' in terms of data protection, (i.e. protected indefinitely).
What should I include in an application for the inclusion of an adjuvant on the Official List?
Covering letter
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 e.g. 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 e.g. 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
You must complete an appropriate application form CRD4 (see The Applicant Guide) for every application you submit, with all forms fully completed.
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. This information should be included in the covering letter or as a separate Annex to the application form.
Letter of authorisation from an applicant for a third party to act on their behalf
If you are submitting the application on behalf of the applicant, a letter of authorisation from the applicant confirming this arrangement is required. A letter will be required for all types of applications. Suggested wording for this letter is detailed below:
‘We [company name] wish to apply for inclusion on the Official List of adjuvants the product [product name]. This application is for [give details]
We hereby authorise [company/person] to act on our behalf with regard to all matters relating to this application.’
........................ signed’
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). As an alternative you may provide a reference to the appropriate COP number(s) under which the current List Entry for your product was issued.
- Copies of the current List Entry for any other adjuvants referred to in your application e.g. for new adjuvants based on similarity to adjuvants that already have a List Entry. Alternatively, you may provide a reference to the appropriate COP numbers under which the relevant List 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 pesticides (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 approval. For this reason there is no requirement for you to submit draft labels with your application, particularly if you provide a draft List Entry. However, we may remove a product from the Official List if the marketed label or other literature do not comply with conditions in the List Entry or the relevant pesticide approval(s).
You may choose to submit draft labels as a means of explaining the proposed uses of the adjuvant, otherwise, the proposed uses should be specified in the form of a ‘draft List Entry’. We may provide advice on labelling relating to the use of the adjuvant in the covering letter accompanying the List Entry.
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.
What about CHIP 4?
Adjuvants are subject to classification and labelling under the Dangerous Preparations Directive, which is implemented by CHIP 4 in Great Britain. Advice on labelling with regard to CHIP 4 is available on the HSE's website. You should provide details of proposed classification and labelling when you submit your application.
How will my application be processed?
General information on where to submit applications, processing times and information set out during evaluations, please see the Applicant Guide
What stream will my application be placed into?
Adjuvant applications are placed in our usual streams (see the guidance document on application streams for further information). If the EAC in your adjuvant product has not previously been included on the Official List and is not present as a co-formulant in an approved pesticide product, your application will be considered via the ‘Major Change’ Stream. Where a new EAC is chemically similar to one used in an adjuvant already included on the Official List, your application will be processed via the ‘No-Data’ or ‘Data’ streams, depending on whether data are provided.
Some applications require no technical input, and can be considered via the Admin stream. Typically, these include applications for:
- Change in applicant or product name for an existing adjuvant.
- A new adjuvant identical to an existing adjuvant.
- An application for a change to an adjuvant which is identical to a change being considered for another adjuvant.
- An application for a new source of an EAC (already considered in another adjuvant).
How much will my application cost?
Adjuvant applications are free of charge.
What happens after my application is completed?
If your application is successful, we will inform you in the normal way (see The Applicant Guide for further information). An electronic copy of the List Entry will be included on the Adjuvant Database on our website and if your product is a new one, it will also be added to the Official List of adjuvants.
For any changes to existing products, the List Entries will be amended appropriately. If your application involved a major change to the product’s identity, we will produce a List Entry for both the ‘new’ product and the ‘old’ product. The latter will normally include a use-up period to allow existing stocks to pass safely through the supply chain.
If your application is unsuccessful we will send you a detailed letter explaining the reasons why your application has been refused and specifying what data requirements you need to address if you wish to make a further attempt to obtain inclusion on the Official List of Adjuvants of a product or new use of an existing product.
You can obtain the full Official List by emailing asg@hse.gsi.gov.uk.
Unique registration (ADJ) number
Upon issue of the first Official List Entry for your adjuvant product, your adjuvant will be assigned a unique adjuvant registration number, prefixed by ‘ADJ’. The number allocated will always remain with your adjuvant product, unless you subsequently make a major change to its identity or to its formulation. Our approach to ‘ADJ’ numbers is similar to MAPP or MAFF numbers for pesticide products. See the guidance document on registration numbers for details of when we may need to issue or change an ‘ADJ’ number.
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, e.g. a pesticide or its uses are withdrawn from the market, we will amend your List Entry to reflect the use-up period for the associated pesticide product or use.
What if I want to take my listed product or use off the market?
If you wish to withdraw a product or use for the the Official List, please follow the guidance on commercial withdrawals.
