EEC Working Documents
Working documents for guidance on the implementation of Council Directive 91/414/EEC
Those not on the CRD site are from the EC website working documents page
FOCUS: Forum for the Co-ordination of pesticide fate models and their Use
Guidance Documents
This earlier version has been retained only for calculation of spray drift surface water PECs for national UK approvals. Do not use for annex 1 of Directive 91/414/EEC listings aspect of submissions.
Modified Ecotoxicity Studies
The Environmental Panel of the Advisory Committee on Pesticides has recently considered modified ecotoxicity studies. These studies range from the inclusion of sediment in a standard fish toxicity study, to varying the exposure profile to increase realism. In considering these studies the Environmental Panel has proposed how these studies could be interpreted and hence used in regulatory risk assessment. It is recommended that Applicants should consult this paper if they are considering using modified toxicity studies to refine their risk assessment. It is also recommended that Applicants should consult the Ecotox Section of the Environment Branch (enviro@hse.gsi.gov.uk) to discuss design, interpretation and use of these studies.
Formulation Studies in Ecotoxicology
This guidance provides advice on the need for Ecotox. formulation studies and their use in risk assessment. Formal sections of the Dir. 91/414/EEC (Annex III requirements) and existing SANCO guidance documents are presented together with additional CRD guidance. Applicants are advised to read this document before deciding on a formulation testing strategy.
From 1st April 2012, CRD will expect all product applications for products with multiple active substances to contain the appropriate aquatic and /or combined bird and mammal risk assessments. For the majority of applications CRD do not require new data - a reasoned case is sufficient. See Regulatory Update 05/2012 for further information.
Guidance on environmental hazard and risk labelling for Plant Protection Products in the UK
This guidance on environmental hazard and risk labelling relates to how Plant Protection Products should be labelled under the Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP 3) and Annex V of Directive 91/414/EEC. Please also see below for brief guidance on CHIP 3.
A brief guide to CHIP 3 - Chemicals (Hazard Information and Packaging for Supply) Regulations
This guidance on CHIP 3 relates to aquatic hazard classification and associated safety phrases required by the Chemicals (Hazard Information and Packaging for Supply) Regulations (known as 'CHIP 3'). These UK regulations closely follow the European Commission's 'Labelling Guide' which forms Annex VI to the Dangerous Substances Directive 67/548/EEC and are also in line with Directive 1999/45/EC concerning the classification, packaging and labelling of dangerous preparations.
Applicants should note that new classification and labelling legislation (CHIP4) came into force on 6 April 2009. See HSE website pages on CHIP for further information. The above guidance on CHIP 3 will be updated in due course, otherwise it has not changed significantly and may still be followed.
Honeybee toxicity studies
Regulatory update 10/2010 highlights that some testing facilities have conducted acute oral and contact toxicity studies on honeybees that reference OECD 213 and 214, respectively, but that are not strictly in accordance with these protocols
Guidance on carrying out a bird and mammal risk assessment
Bird and mammal risk assessments should be conducted according to the new EFSA Guidance Document or SANCO 4145/2000/EEC. See Regulatory Update 43/2011 for information about which guidance document is appropriate.
It is appreciated that, whilst the guidance documents provide much useful information, additional information is sometimes required to assist the risk assessment process. A checklist has been developed to act as an aide to the risk assessment process the latest version (March 2006) is attached. (Please note that as more research becomes available, the attached document will be modified. Therefore, it is recommended that you ensure that you have the most up to date version).
Any enquiries/questions should be made to enviro@hse.gsi.gov.uk.
Checklist of issues to note when carrying out a Bird and Mammal Risk Assessment with SANCO 4145/2000/EEC (version 2)
De-husking of seeds by small mammals
During evaluation of seed treatment applications the risk assessment for small mammals frequently needs to be refined to determine whether the risk is acceptable. In such cases, applicants often use de-husking behaviour to mitigate the risk to mammals. In order to accept a quantitative refinement of de-husking robust support of the value used is required by CRD. Since there is very little robust information on de-husking behaviour in small mammals, CRD commissioned a new research project (PS2349), to investigate the role de-husking plays in reducing pesticide exposure to mammals and to develop a methodology to calculate rates of de-husking for different seed types. The Final Report has been published on the defra website and the implications of this research have been considered by CRD.
Availability of treated seed on the soil surface after drilling
During evaluation of seed treatment applications, the risk assessments for birds and mammals often need to be refined to demonstrate whether the risk is acceptable. Prior to refinement, the risk is contextualised by estimating the area that would need to be foraged by a bird or mammal to obtain a lethal dose, using seed availability data. I.e. if an unfeasibly large foraging area is required for a relevant focal species to obtain a lethal dose, it may be possible to conclude that the risk is low. Conversely, if a lethal dose can be obtained from an area that is clearly small enough for a focal species to forage in a short period of time, this confirms a cause for concern. Since there are very limited UK-specific data available, CRD commissioned a research project (PS2334), to investigate seed availability on the soil surface after drilling for a range of arable crops. The Final Report has been published on the Defra website and the regulatory implications of this research have been considered by CRD.
Combined toxicity risk assessments for birds and mammals
Many plant protection products contain more than one active substance. Authorisation requires consideration of the product and hence the combined effects of any active substances within them. Active substances may have the same mode of action and/or cause the same toxic effects within test organisms. In such cases a combined assessment is required for acute and long-term effects on birds and mammals. See Regulatory Update 23/2011 for further information.
Use of new crop qualifier ‘Permanent protection with full enclosure’
Regulatory Update 25/2011announced and explained the use of a new crop qualifier ‘Permanent protection with full enclosure’ – which may be specified by CRD on Notices of Approval of certain plant protection products used in protected crop situations, together with the inclusion (where required) of three ‘Other specific restrictions’.
Worked example of a buffer zone assessment for spray drift for a horizontal boom sprayer in field crops
A worked example is provided showing how the aquatic buffer zones for crops on a product label are calculated under the interim extension of the LERAP scheme.A calculator is also available for producing the Predicted Environmental Concentration in surface water (PECsw) and this is also available on this website below.
Modelling Software
CRD is not responsible for the accuracy or use of any endpoints derived using the following
Predicted Environmental Concentration Calculator for spray drift in field crops
Calculator for producing the Predicted Environmental Concentration in surface water (PECsw) for spray drift for a horizontal boom sprayer in field crops.
Estimated Theoretical Exposure (ETE) Calculations
At the end of 2002, the Commission noted the EU Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (see SANCO/4145/2000). As part of this Guidance Document, there are several 'look-up' tables that are used to calculate the 'Estimated Theoretical Exposure' (ETE). CRD has produced a spreadsheet to aid the calculation of ETE (see footnote). It is strongly recommended that the guidance document is read prior to using this spreadsheet.
Proportion of different food types in the bird and mammal diet
PD, or the proportion of different food types in the bird and mammal diet, is one of the refinement steps discussed in the EU Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (see SANCO/4145/2000). Guidance is provided in SANCO 4145/2000 on how to refine PD, however to assist in this refinement step, CRD has produced a spreadsheet to aid the calculation of proportion of different food types in the bird and mammal diet. There is an instruction page linked to this spreadsheet and it is strongly recommended that this is read before using the spreadsheet. It is also strongly recommended that the guidance document is read prior to using this spreadsheet.
HardSPEC: Surface and Ground Water Exposure Model
A First-tier Model for Estimating Surface- and Ground-Water Exposure resulting from Herbicides applied to Hard Surfaces.
Release of new FOCUS Groundwater models and guidance
The assessment of risk of groundwater contamination by pesticides and their metabolites within the scope of EU pesticides authorisation legislation is performed using models and guidance developed by the FOCUS (‘Forum for the Co-ordination of Pesticide Fate Models and their Use’) initiative of the European Commission. The current models and associated report and guidance have been in place since 2000. However, an updated report, associated guidance and models were released on 11 April 2011. A Regulatory Update gives information on CRDs approach to the release of this new FOCUS Groundwater modelling tools and guidance.
Proceedings of a Workshop on Aged Sorption of Pesticides in Soil
The proceedings of a workshop on aged sorption of pesticides in soil held in York on 27th – 28th April 2010 are now available.
Research reports
- List of useful references for bird and mammal risk assessment
- Approaches and Tools for Higher Tier Assessment of Environmental Fate in the UK
Defra contract report PL0546 & PS2202 - Beulke S., Brown C.D. and Dubus, I.G. (1998). Evaluation of the use of preferential flow models to predict the movement of pesticides to water sources under UK conditions. Research report for MAFF project PL0516, Cranfield Centre for EcoChemistry, Silsoe, Beds, UK, 101 pp.
- Beulke S., Renaud F. and Brown C.D. (2002). Development of guidance on parameter estimation for the preferential flow model MACRO 4.2. Research report for Defra project PL0538, Cranfield Centre for EcoChemistry, Silsoe, Beds, UK, 67 pp.
