Changing your pesticide product formulation or manufacturing site

Formulation changes

A formulation change can be either significant (which may or may not be supported by data), or non-significant in nature.

Non-significant formulation changes

Non-significant formulation changes are those where there is no chemical change to the manufactured product. The following formulation changes are considered to be non-significant:

• Where a co-formulant is from an alternative source or has a new trade name. The co-formulant must be chemically equivalent and present in the same quantity as the co-formulant that it is replacing.
• For anionic surfactants/dispersants the cation may be exchanged.
• The addition of a marker substance to a plant protection product where it is less than 0.1% of the formulation and presents no toxicological or ecotoxicological concern. This must have been determined by HSE under a previous assessment. The marker must already be included in the authorised formulation of another plant protection product.

Further guidance on significant/non-significant formulation changes is available from the EC website:

• GD formulation change (europa.eu)
• How to notify HSE of a non-significant formulation change.

Significant formulation changes

Significant formulation changes that are supported by data usually result in new products (with new MAPP numbers), and you should follow the guidance for new products if the formulation change requires data. Significant changes where no data are required can be made to a product formulation (usually without the need to change the MAPP number).

You must:

• Fully explain your request in the covering letter
• Complete application form CRD1
• Submit any letters of access to third party data that are required
• Submit any previous relevant correspondence which must be, at a minimum, a copy of your product's authorisation. If the authorisation is unavailable, a reference (including COP number, date of issue and Notice of Authorisation Number) must be submitted
• Submit reasoned cases or data to address all areas of the risk assessment. This information may be provided in the format of an Application Overview and the areas you should particularly consider are mammalian toxicology, pesticide chemistry and efficacy although residues and ecotoxicology may be affected. You do not usually need to submit labels for a formulation change, although you should provide a justification for the classification for your product (and whether the formulation change will impact upon this). Introduction to classification and labelling
• All applications for PPPs should be made in the form of a dRR. Use the dRR templates to create your dRR.
• Submit Safety Data Sheets (SDS) for the co-formulants in your product. A reference should be provided for any SDS that have been previously submitted (including COP number and date submitted)

When making applications for a new formulation you should be aware of the restrictions on the use of unacceptable co-formulants (see guidance on Physical and Chemical Properties ).

How to submit your pesticide application.

Change to manufacturing site

If you change the site at which your formulation is manufactured, then you must inform us immediately - email: [email protected]

We will update our records and write to you to confirm the change.