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Guidance omzetting in bodem en uitspoeling naar grondwater

Guidances on derivation of soil and groundwater exposure

Two major guidance documents have been noted at the EU Standing Committee on Plants, Animals, Food and Feed recently. The guidances covering the areas of derivation of soil (DegT50 values) and groundwater exposure. Both have an implementation date of 1 May 2015 and can be found on the EU website under Technical guidance - Fate and behaviour.

  1. Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil.
    This Guidance Document (SANCO/12117/2014) covers a number of areas, principally relating to methods for deriving the DegT50matrix from individual laboratory and field dissipation studies and additional guidance on selecting the appropriate input parameters for use in environmental exposure modelling.
  2. Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU.
    This Guidance Document (SANCO/13144/2010) describes several higher tier options for groundwater assessments.

In addition, the Generic Guidance for Tier 1 FOCUS Ground Water Assessments (version 2.2, May 2014) has been updated to reflect the EFSA DegT50 guidance (2014) and also other EFSA PPR recommendations. Principal changes include the use of two FOCUS models for PECgw (Predicted Environmental Concentration in groundwater) simulations, use of geomean values for Kom, Koc and DegT50, recommendations relating to the use of pH dependent modelling, recommended default value of 0 for the Transpiration Stream Concentration Factor (TSCF) for all compounds and new FOCUS crop interception values for some crops.

How to use the guidance on derivation of soil and groundwater exposure

Ctgb has considered how to implement the proposed changes in regulatory submissions in a pragmatic and practical way that will not place an unnecessary burden on Applicants. Ctgb will be applying the new guidance in the following ways:

  1. The approaches outlined in the DegT50 guidance document should be implemented for all active substance submissions made from the 1st of May 2015. Dossiers for approval or renewal of active substances which are currently under evaluation but were officially submitted before May 1st 2015, can make use of the guidance but it is not mandatory.

    Ctgb will NOT require Applicants to update DT50soil values in line with the EFSA DegT50 guidance for plant protection product submissions. We request that Applicants continue to use Annex I agreed endpoints in line with the guidance document on the evaluation of new active substance data post approval (SANCO/10328/2004– rev 8) which states that new active substance data may only be used if this results in an end-point which leads to a more favourable risk assessment compared to the end-point listed in the LoEP and a safe use can only be demonstrated by using the new endpoint (provided that the studies are valid). The same approach will apply to Koc values – we will continue to accept the Annex I agreed values, and not routinely expect Applicants to use the geometric mean as proposed in the new guidance.

    When the active substance has been approved/renewed based on this guidance document, than automatically all submissions for product registration based on this substance will comply to this guidance.

    The other major change in this guidance is related to crop interception values for certain crops and growth stages; as the crop interception values relate to the use/GAP of the plant protection product and not to the properties of actives substances and/or metabolites, Ctgb will potentially apply the new crop interception values for submissions made from 1 May 2015. However, as far as possible Ctgb intends to make use of existing risk envelopes and will not actively change the crop interception values for product registrations made after May 1st 2015.
  2. The approaches outlined in the FOCUS Guidance Document Groundwater (2014) should be implemented for all active substance submissions made from the 1st May 2015. However, in the introduction of the document that was noted at the SCoPAFF-Legislation meeting, no detailed information was given on when applications for product registration and approval of active substances will need to comply to this guidance document. The document has been conceived as a working document and has been noted as such. This means it does not intend to produce legally binding effects by its nature.

    Dossiers for approval or renewal of active substances which are currently under evaluation but were officially submitted before May 1st 2015, can make use of the guidance but it is not mandatory. A large part of the guidance document concerns issues which will alter the existing agreed endpoints for the active substance and are therefore regarded as new active substance data. The guidance document on the evaluation of new active substance data post approval (SANCO/10328/2004– rev 8) states that new active substance data may only be used if this results in an end-point which leads to a more favourable risk assessment compared to the end-point listed in the LoEP and a safe use can only be demonstrated by using the new endpoint (provided that the studies are valid). The same approach will apply to TSCF values – we will continue to accept the Annex I agreed values, and not routinely expect Applicants to use the default TSCF value of zero as proposed in the new guidance.

    In short, for product registrations an applicant can use the guidance if it helps them. When the active substance has been approved/renewed based on this guidance document, than automatically all submissions for product registration based on this substance will comply to this guidance.