Change product authorisation - major changes

Do you apply for a major change in the product authorisation, such as:

  • amendment of uses
  • extension of uses
  • change in restriction sentences
  • change in the legal instructions for use – WG(GA)
  • major change in product composition

These major changes require an amendment of the existing authorisation (PPPR 1107/2009, art 33) and will be processed following the zonal procedure. Non-significant changes are evaluated at the national level. Changes in a derived authorisation follow the process of 'derived authorisation'.

In the central zone  it has been agreed the (d)RR for label extensions/amendments should be restricted to only those parts relevant to the application, both in case the existing authorisation has a RR (under 1107/2009) and for authorisations without a RR (under 91/414/EG). In the following table an overview is given for the RR per section:

dRR required for label extensions/amendments on authorisations:

Part C – Confidential information

not necessary since this covered by the original authorisation

Part A – Risk Management

should be submitted, covering:

  • only summaries of the risk assessment for the extension
  • gap table including only the extended uses (new uses)
  • new (complete) label text
  • copy of authorisation document for the extension

Part B1 – Identity, physical and chemical properties, other information

Should be submitted, covering:

  • EU gap table including only the extended uses
  • if the application rate (dilution) of the new uses is outside the range of the existing uses, relevant technical properties (e.g. foaming, suspensibility) should be re-evaluated, where appropriate
  • no further details needed, make reference to original RR

Part B2 -  Analytical Methods

Should only be submitted in case:

  • new analytical methods may need to be provided concerning the new uses (additional exposure scenarios or different crop groups)
  • no further details needed, make reference to original RR

Part B3 – Mammalian Toxicology

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation

Part B4 – Metabolism and Residues

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation. (Note: new Guidance Documents adopted after the original authorisation should be taken into account.)
  • residue trials and MRLs for the new uses
  • bridging studies, if necessary
  • summaries of studies submitted in connection to the new uses

Part B5 – Environmental Fate

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation (Note: new Guidance Documents adopted after the original authorisation should be taken into account. The latest model versions should be used.)
  • summaries of studies submitted in connection to the new uses

Part B6 - Ecotoxicology

Should be submitted, covering:

  • all aspects, either by a new risk assessment, or by a statement or data showing that the risk of the new uses is covered by the RR for the original authorisation (Note: new Guidance Documents adopted after the original authorisation should be taken into account.)
  • bridging studies, if necessary
  • summaries of studies submitted in connection to the new uses

Part B7 - Efficacy

Should be submitted, covering:

  • all aspects, either by a new data, or by a statement or data showing that the aspect is covered by the RR for the original authorisation (Note: new Guidance Documents adopted after the original authorisation should be taken into account.)
  • bridging studies, if necessary
  • summaries of studies submitted in connection to the new uses

Part B8 – Groundwater metabolites

Should only be submitted in case:

  • new uses give rise to assessment of relevant metabolites