In many cases, minor changes to your product label will not impact upon the original safety and efficacy assessment, but we need to check that this is the case, and whether those changes need to be supported by data.
Changes where no application required
Some label changes do not require an application. These are detailed in the Labelling Handbook.
Adding undersown crops
It’s common agricultural practice for growers to undersow cereals with grass or clover as a secondary crop, providing grazing and increased biodiversity.
However, many herbicide, growth regulator, fungicide and insecticide products do not have label recommendations for use on undersown crops. Use of pesticides on a cereal crop undersown with grass or clover therefore technically breaches the conditions of authorisation.
To regularise the position, and in recognition of this common agricultural practice, we encourage authorisation holders to add undersown crops to their product labels, by applying for authorisation.
How to apply – for insecticides and fungicides
For insecticides and fungicides, you can apply for undersown crops of grass or clover to be added to authorised products for use on cereals by submitting:
- a covering letter fully explaining your request and detailing the requirements below
- completed application form CRD2
- letters of access to third party data
- any previous relevant correspondence for example a copy of the parent product authorisation, previous authorisation/trials permit/EAMU as appropriate or any written advice previously provided by HSE
You do not need to include revised draft labels in the application but you should include:
- evidence relating to consumer safety
- evidence of undersown crop safety
- on the application form, details of the:
- product name
- Ministerially Authorised Pesticide Product (MAPP) number
- active ingredient(s)
- type of product (such as fungicide or insecticide)
- a statement relating to consumer safety
- data or a case to support crop safety to the undersown crop
- on application form CRD1, details of the:
- product name(s)
- MAPP number(s)
- active ingredient(s)
- type of product, such as herbicide
Consumer safety
You must provide evidence to demonstrate that there will be no increased risk to consumers from the addition of undersown crops to the label, for the listed products applied as foliar treatments to cereals. This evidence could be based on the authorised use on the cereal crop, the known properties and behaviour of the active substance or a simple risk assessment.
Crop safety
You must provide evidence that you have considered the crop safety profile of the product and that it would not be expected to cause crop damage to the undersown ley.
How to apply – for herbicides and growth regulators
To add undersown crops to herbicide and growth regulator products, you must submit an application which requires technical consideration.
You do not need to include revised draft labels, but you should include:
It’s also possible to add a request for undersown crops to an application you’re submitting for another reason.
How authorisations will be amended
For successful applications, we will issue an amended authorisation, specifying undersown crops of grass or clover and allowing these uses to be added to the product label.
All other changes
For all other changes, submit application form CRD1 with the other documents and information required for your application.