Identity and physical and chemical properties of the active substance and plant protection product
Guidance for applicants on how to address the chemistry data requirements which apply under Regulation (EC) No 1107/2009.
Before you submit your application you can check it’s complete using the chemistry section of the applications checklist.
Active substance
For each source of an active substance a technical specification is required.
A 'source' refers to a technical material manufactured by a specific process in a particular location and is described by an individual technical specification and its supporting data package.
A number of sources may be authorised for an individual active substance based on different supporting data packages. In addition, a number of sources of an active substance may be authorised in a product.
All technical specifications must be supported by batch data and validated methods of analysis so that HSE can ensure the technical specification reflects the minimum level of the active substance and the maximum levels of impurities found in routine manufacturing.
The technical specification should contain the following:
- minimum content (g/kg) of the pure active substance
- the nature and maximum levels (g/kg) of all impurities, isomers or additives present at or greater than 1 g/kg of the total content of the active substance (ie those impurities deemed significant)
- the nature and maximum levels (g/kg) for toxicologically relevant impurities even if present at less than 1 g/kg
Changes to the technical specification
The technical specification is dependent on many factors, including the manufacturing location, manufacturing process, and scale of manufacture. If any of these factors change, then it is necessary to provide data to either support a revised specification or a reasoned case as to why data are not required.
If a specification is different to that which is authorised, an assessment of technical equivalence to the reference specification (usually that considered for approval of the active) is required.
Pesticide active substance source changes: technical equivalence
How we assess technical equivalence
Technical equivalence is determined in accordance with the Guidance document on the assessment of the equivalence of technical materials of substance regulated under Regulation (EC) No 1107/2009 (SANCO 10597/2003). The technical equivalence assessment is formalised in the completion of an equivalence report.
Plant protection product
The details of a product consist of the technical specification and the product 'recipe', this consists of:
- nominal target content of the pure active substance, with acceptable tolerance limits in line with Food and Agriculture Organisation of the UN (FAO) guidance Manual on the development and use of FAO and WHO specifications for chemical pesticides, 2022
- chemical name, trade name and/or CAS number, structure and quantity of all other components (the co-formulants) in the product (please note the unacceptable co-formulants register)
- The content of pure active substance and levels of co-formulants should be given in % w/w and either g/kg or g/L depending on the physical state of the product. The density of liquid products used to calculate the % w/w values should also be given.
Details of physical, chemical and technical properties data required to support the registration/authorisation of a plant protection product are available in the technical guidance on physical, and chemical technical properties.
For authorisations for seed treatments, read the guidance on the requirements to address chemistry assessments.