skip to main content

Gaining Technical Equivalence for your sources of pesticide active substances

As part of the approval process for active substances under the plant protection products regulation (Regulation (EU) No. 1107/2009) a ‘reference’ technical specification is set for the source of active substance technical material considered for the approval. The ‘source’ of an active substance is defined by its manufacturing site, whilst its technical specification defines the minimum purity of the active substance and the limit of significant and (eco)toxicologically relevant impurities present in the technical material.
 
Where there is a change in the source of active substance intended to be used in plant protection products – for example, an alternative source is to be used or there is a change in the manufacturing process for the existing source – a technical equivalence assessment must first be performed. The purpose of this assessment is to establish if the level of hazard posed to health and the environment by the new / amended source is comparable to the reference source.
 

According to the European Commission guidance document on the assessment of equivalence of technical materials (SANCO/10597/2003 – rev. 10.1), the assessment follows a tiered approach involving:

 Tier I

  • Covers the identity of the active substance and associated analytical methods used.
  • Requires submission of 5-batch data on the chemical composition of the active substance technical material.
  • Requires submission of validation data for the analytical methods used to generate the 5-batch data.
  • The 5-batch data is used to propose a technical specification for the new active substance source.
  • A comparison of the technical specifications of the new source and the reference source is performed to determine equivalence.
  • Equivalence of the new source is established if: (i) it has a minimum purity not lower than the reference source, (ii) it contains no new impurities, (iii) the limits for (eco)toxicologically relevant impurities certified in the reference source are not exceeded, and (iv) the limits for non-relevant impurities certified in the reference source are not in exceedance of well-defined threshold values.

If equivalence cannot be established based upon the chemical comparison, then the assessment moves on to:

Tier II

  • Addresses the (eco)toxicological properties of the new source of the active substance technical material.
  • The assessment establishes if the new source presents an unacceptable hazard increase compared to the reference source due to: (i) any new impurities, (ii) increased levels of (eco)toxicologically relevant impurities, or (iii) increased levels of non-relevant impurities which exceed the acceptable limits.
  • If sufficient evidence can be provided to demonstrate that the new source presents no unacceptable increased hazards to health or the environment then equivalence can be concluded.

 

Enviresearch has expertise and experience in the preparation of technical equivalence dossiers in accordance with SANCO/10597/2003 – rev. 10.1. 

Our services include:

  • Review of 5-batch data for deriving technical specifications.
  • Review of method validation data to ensure regulatory compliance. Performing (Q)SAR analysis for prediction of (eco)toxicological properties of impurities.
  • Study monitoring of 5-batch (Tier I) and bacterial reverse mutation studies (Tier II).
  • Preparation of technical equivalence reports according the European Commission evaluation report template.
If you wish to discuss how we can support your technical equivalence applications in the EU, please contact our Regulatory Affairs Team Lead, Rachel Gill, at This email address is being protected from spambots. You need JavaScript enabled to view it..
 
 

 

sub field

   

sub crop

   

side soil

 

 

 


Contact

Enviresearch Ltd
34 Grainger Park Road
Newcastle upon Tyne NE4 8RY

Telephone: +44 (0)191 243 0687
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Further Information