This website uses non-intrusive cookies to improve your user experience. You can visit our cookie privacy page for more information.

Summary of New Guidance

Three major guidance documents (covering the areas of derivation of soil DegT50 values (time for 50% of a substance to degrade), groundwater exposure assessments and emissions from protected crops), have recently been noted at the EU Standing Committee on Plants, Animals, Food and Feed. Guidance documents 1 and 2 have an implementation date of 1 May 2015.   Guidance document 3 has an implementation date of 1st December 2015.

General implementation in the UK

HSE's CRD 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. CRD will be applying the new guidance in the following ways:

The approaches outlined in the DegT50 and groundwater guidance documents should be implemented for all active substance submissions made from the 1st May 2015.

CRD 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. The same approach will apply to Koc values – we will continue to accept the Annex I agreed mean value, and not routinely expect Applicants to use the geometric mean as proposed in the new 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, CRD will apply the new crop interception values for submissions made from 1 May 2015. As far as possible CRD intends to make use of existing risk envelopes, however it is not acceptable to use the Risk Envelope from Annex I assessment for product authorisations where 'old' interception values have been used.

Due to concerns over how the protected crops guidance document should be implemented, Applicants are requested to contact CRD for further advice before making an application for a protected crop use.

Further details and additional information on how CRD intends to implement the changes can be found below.

Implementation of new EU guidance in Fate & Behaviour by CRD:

Three major guidance documents (covering the areas of derivation of soil DegT50 values, groundwater exposure assessments and emissions from protected crops), have been noted at the EU Standing Committee on Plants, Animals, Food and Feed, with an implementation date of 1 May 2015 (1st December 2015 for SANCO guidance document on assessing emissions from protected crops).

The main changes to assessment methods proposed by the documents are as follows:

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; Commission Guidance Document SANCO/12117/2014 – final.

Background summary:

The Plant Protection Products and their Residues (PPR) Panel of EFSA produced an opinion for evaluating laboratory and field dissipation studies to obtain degradation rate parameters (DegT50matrix values) of active substances of plant protection products and transformation products of these active substances in soil.

This subsequent EFSA Guidance Document, based on the opinion, provides guidance for users on how to obtain DegT50matrix values to be used in exposure assessment when performing risk assessments according to Regulation EC No 1107/2009 of the European Parliament and the Council (EC, 2009).

It replaces the EFSA PPR Panel (2010) opinion document as EU guidance.

The aims of this guidance are:

  1. To provide methods to derive the DegT50matrix from individual laboratory and field dissipation studies.
  2. To explain how to determine whether the databases of DegT50matrix values from laboratory and field studies can be treated as separate databases or whether they should be pooled.
  3. To provide guidance on selecting the appropriate input parameter for use in environmental exposure modelling.

Overall, the Guidance Document contains guidance covering a number of areas, principally the following topics:

2. Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU; Commission Guidance Document SANCO/13144/2010, version 3, 10 October 2014

See SANCO guidance document

See also EFSA guidance documents

Supported by additional information presented in the Generic Guidance for Tier 1 FOCUS Ground Water Assessments (version 2.2, May 2014)

Background summary:

The generic guidance for FOCUS groundwater assessments which gives guidance on the selection of pesticide input parameters has been updated to reflect the EFSA DegT50 guidance (2014) [and also the recommendations of the EFSA PPR scientific opinion (2013a)] and the original and new FOCUS groundwater reports. Version 2.2 of the 'Generic Guidance for Tier 1 FOCUS Ground Water Assessments' also has an implementation date of 1 May 2015.
Changes to the FOCUS groundwater guidance impact on the following main areas:

Use of updated crop interception values (see Tables 1.4 and 1.5 of the report)

3. Guidance Document on clustering and ranking of emissions of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments; Commission Guidance Document SANCO/12184/2014 – rev. 5.1 14 July 2015

See SANCO guidance document

See also EFSA guidance document

The Commission asked EFSA to prepare a guidance document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments. This EFSA Guidance Document forms an appendix to the Commission Guidance Documents. It provides guidance for users on how to assess these emissions when performing risk assessments according to Regulation EC no 1107/2009.

For any protected cropping system other than walk-in tunnels and greenhouses, the EFSA guidance recommends performing an exposure assessment as per the standard open field situation. For walk-in tunnels and greenhouses, the EFSA guidance differentiates between soil bound or soil less systems.

For soil bound systems; the EFSA guidance recommends use of the FOCUS surface water drainage scenarios for the purposes of estimating surface water exposure, with new example scenarios parameterised for greenhouses.

For soil less systems; the EFSA guidance recommends use of the newly developed Greenhouse Emission Model (GEM) as part of a tiered assessment scheme. This GEM model will be released shortly. There are also new example leaching scenarios for groundwater from walk-in tunnels and greenhouses, utilising the current FOCUS models.

Application of the new guidance by HSE's Chemicals Regulation Division (CRD)

CRD will apply this new guidance as follows:

CRD 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. The same approach will apply to Koc values – we will continue to accept the Annex I agreed mean value, and not routinely expect Applicants to use the geometric mean as proposed in the new guidance.

CRD do not expect changes in active substance and metabolite endpoints to occur routinely at the time of plant protection product registration, but at the time of Annex I renewal.

The new guidance should only be applied to Product submissions when the approaches set out in the guidance have been applied to the active substance level assessment (ie for new active substances and active substance renewals after the 1st May 2015). CRD consider that application of the new guidance will almost inevitably result in changes to the Annex I agreed endpoints for active substances and metabolites.

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, CRD will apply the new crop interception values for submissions made from 1 May 2015. CRD will make use of existing risk envelopes (existing worst case uses), however it is not acceptable to use the Risk Envelope from Annex I assessment for product authorisations where 'old' interception values have been used.

For products that go beyond existing risk envelopes (eg due to higher rates, different timings or crops etc.), the new crop interception values will need to be applied for applications received from the 1st May 2015.

For mixed active products, a combined risk assessment is required, with a suitable risk envelope product needed to support all individual actives in the proposed new product, to address the combined risk.

For products submitted after the 1st May 2015 requesting uses not covered by a satisfactory risk envelope, new environmental exposure assessments are required, that comply with the new guidance on interception values (see 2 above).

The need to perform FOCUS groundwater assessments using more than one model.
Leaching risk is considered low: Where it can be shown that on the basis of a single model that the leaching risk is very low for all substances (eg PECgw values <0.001μg/l) CRD will accept a reasoned case that the leaching risk is likely to be low and will not request additional modelling.

For Zonal authorisations, Where the crops of interest are defined for the Châteaudun MACRO scenario, CRD require simulations to be performed and presented in the core dossier. This will ensure that the previous UK specific requirement to conduct MACRO modelling are addressed in the core (note that this will not always be the case; where the crop is not present at Châteaudun but the substance has Koc >100 then modelling with a surrogate crop would be required to address the UK requirement).

For UK only authorisations, the requirement to conduct MACRO modelling for all substances with a Koc > 100ml/g remains. When modelling pH dependent behaviour, CRD support the recommendations to base modelling on a realistic worst case considering the pH of soil in the EU (rather than the previous FOCUS recommendation to base modelling on the specific pH of the individual FOCUS scenarios).

SANCO guidance document on assessing emissions from protected crops, There is uncertainty over the status of the new leaching and drainage scenarios, (which are described as being preliminary and with a recommendation that these should be developed over time). It is unclear how this new guidance impacts on interzonal evaluations under Article 33 (2b). Whilst this uncertainty remains, Applicants should contact CRD for further advice before making an application for a protected crop use.

Updated 2017-07-11