Regulation
Directorate / DRAFT INFORMATION FOR APPLICANTS / 2016
1107/2009 Efficacy Assessments:UK Product Labelling and National Issues/Addenda –DRAFT
Background
EU guidance SANCO 10055/2013[1]outlinesthe framework for zonal efficacy product evaluations. In particular it describes what should be considered as part of the core zonal assessment, and what might be addressed in individual Member State (MS) National Addenda.
This information document provides specific information on the very limited number of UK-specific efficacy issues that may require specific supporting data, if not already sufficiently covered in the core zonal dossier. It should be read in conjunction with SANCO 10055/2013; however, the main purpose is to highlight the general information that will assist CRD when acting as a concerned MSauthorising uses based on the zRMS assessment. In doing so, it brings together into one document the various specific UK labelling requirements relating to efficacy that should be considered when drafting the UK label. This guideline will also be relevant for UK-only proposed uses, when considering both labelling and addressing specific UK conditions.
This isa working document in draft format only. It will be replaced in due course with a guidance document based on using the dRR format, but is provided here as a short term measure in the interim.
General Introduction: Putting the zonaluses into context for the UK as a concerned Member State (MS)
While there is no requirement to submit National Addenda there may be specific MS issues relating to certain proposed uses, requiring at least some further explanation if not fully addressed in the core assessment. It is envisaged, however, that generally National addenda should only contain a limited amount of data, in support ofa specific individual use or uses in a particular MS (provided within the core ‘risk envelope’).
Using a National addendum to the core dRRcan be very useful for the relevant concerned MS by providinga brief overview on how the proposed zonal uses specifically relate to those requested in the individual concerned MS. In particular applicants should consider:
- How do any proposed uses relate to relevant existing products (e.g. is the proposed dose considered in the core zonal assessment significantly different to that already approved in the concerned MS?). This is one of the commonest problems not properly considered or explained to concerned MS. Using National addenda is particularly relevant where this is the case.
- Is the proposed GAP relevant/typical of the individual MS conditions, and treatment regimes for the proposed target?
- How have any proposed National draft label uses and recommendations been derived from the zonal assessment
- Are there particular issues/MS concerns that should be reflected in requested uses/proposed labels
CRD experience to date is that the above issues are sometimes poorly addressed when making the following zonal application to CRD as a concerned MS. This can result in requests for further clarification, and questions may be raised over the proposed draft label recommendations.
For this reason CRD advises applicants to consider submitting a UK ‘National addendum’ (using the dRR format). The intention is not for applicants to re-submit or re-evaluate data from the core assessment. Instead the UK National addendum should include a brief overview putting the proposed UK uses in context, considering how they are derived from the core zonal assessment, and whether any adjustments are needed to reflect UK conditions. This might include the proposed number of applications, and any information on thresholds for treatment.
If, for a particular target species, there is a range of different doses proposed across the zone, then an explanation and justification of the proposed UK dose should be provided. The zonal data package, for common uses, should be representative of the range of conditions found within the proposed zone. It should not therefore be necessary to submit more data, but simply cross-reference to the relevant part of the core dossier, whether they were generated directly in the UK or in a region still considered relevant to UK conditions.
In summary, the UK national addendum should include:
- General introduction explaining how the proposed UK label is supported/ derived from the core assessment
- Highlight and justify any variations in pattern of use (within the core GAP, the data itself should be presented within the core assessment)
- Address any relevant issues discussed below
- Present any additional data for UK-ONLY uses (further guidance below).
UK Efficacy Labelling
In the UK a product label must be provided for all product authorisations. A common problem encountered is that applicants do not consider the relevance of the proposed target species and/or crop to the UK. Instead all the proposed zonal uses are included on the UK draft label. This can lead to time being spent on trying to clarify and determine relevant UK uses. CRD has produced several UK efficacy guidelines which give information on what are considered to be major/minor target species on some of the most important UK crops – cereals, oilseed rape and vegetablebrassicas, as well as more specialised crops (e.g. apple/pear). Applicants’ are advised to consult these when drawing up UK labels.
It is acknowledged that the pest spectra on a particular crop can change over time, as indeed can the commercialisation of new crops in the UK. There are instances, particularly for insect pests, where the prevalence of some existing species (or new species) is becoming more common in UK. However the onus is on the applicant to demonstrate that the proposed target species not only occur (however sporadic in either location or frequency over the seasons) in the UK, but that they actually cause economic damage warranting treatment. Evidence of economic importance can be provided by the relevant grower groups. CRD operates a system of qualified recommendations specifically designed to support claims on the product label for both minor crops and/or minor/sporadic pest species. This is in recognition of the costs of conducting trials and sometimes the impracticality of generating data on such species. The qualified recommendation scheme is based on extrapolation from a relevant related crop/target species (full details in Chapter 8 of ‘The Data requirements handbook’ which is available from the UK Government web archive section of ‘The National Archives’ website). (Please note that there are some common European pest species that, currently, are statutory pests in the UK subject to specific plant health measures. Such pest species are not permitted on UK product labels, but Plant Health will be informed on the potential availability of relevant authorisations, should control measures be required).
The UK also operates a system of differential claims for any particular target species, based on the level and consistency of control(full details are available in Chapter 8 of ‘The Data requirements handbook’ which is available from the UK Government web archive section of ‘The National Archives’ website). There is no need for any re-evaluation or re-presentation of data in the UK National addendum, but applicants should draft the UK label in accordance with this scheme. Where relevant, it may be helpful to point to the appropriate sections of the core zonal assessment to illustrate the levels of control obtained.
Applicants should also consider the relevance of the proposed GAP to UK conditions. As well as being aware of any UK statutory conditions imposed due to resistance management (see below), local target pressure will determine the number and interval of applications in the treatment programme in any one season. Broadly speaking, for many insect species in the UK there is a tendency not to complete as many generations in a season as elsewhere in Europe. Therefore the overall spray programme may involve fewer insecticide applications, and the treatment interval might be longer than in some other MS. Conversely, disease pressure in the UK tends to be high, reflected by a need for shorter, more frequent applications (particularly curative) or higher doses. For all of these aspects it should be possible to cross-reference tothe core assessment and use this as the basis when drawing up UK specific recommendations.
UK National Addendum Issues
The following are identified as UK specific issues related to the effectiveness/crop safety of the product under UK conditions, or UK specific approaches where currently no harmonised guidance is available. Please note that although these are areas which need consideration, this does not mean that specific additional data are always required. It may be possible to address these by specific reference to relevant data in the core dRR, but the applicant is expected to reflect on these issues and explain in a UK National addendum how these have been addressed. The format of National addenda can be a dRR, which discusses these issues under the relevant data point (there is no need to reproduce data from the original core assessment). In some specific cases, additional specific data may be required.
a)UK Resistance managementstrategies and statutory restrictions
For those targets considered to be a high resistance risk in the UK, and for which a resistance management strategy is required, applicants are expected to consider, and where necessary adapt, this strategy to UK conditions.
There is a range of available information, starting with the UK specific resistance action groups (RAGs), which give information on current resistance issues, as well as publishing various,specific guidance.This information may be found in the Advisory Groups section of CRDs website.
In addition, CRD have produced some additional specific guidance. Contained within these guidelines is information on UK specific labelling and, in some cases, statutory restrictions on the conditions of use. These restrictions are based around limiting the number of applications for a specific mode of action (MOA) groupon particulartargets , for example neonicotinoid insecticides, azole fungicides, andACCase/ALS inhibitor herbicides.
601: Insecticides/acaricides}
602: Herbicides } UK product Labelling and statutory restrictions
603: Fungicides }
606: Resistance risk analysis and use of resistance management strategies
611: Restriction on use of high risk herbicides
617: Re-registration of triazoles in cereals
Applicants must refer to the relevant UK advice and restrictions, and ensure these are complied with on their proposed UK labels.
b)Herbicides: Succeedingcrops, and ALS sequences
A detailed risk assessment covering succeeding crops (rotational and re-planting/crop failure) will have been included in the core zonal assessment. The core assessment should have covered an appropriate range of crops, and more than one typical crop rotation scenario (encompassing the worst case situation).
However, the applicant may need to consider further and, if necessary, adapt as appropriate to UK conditions. In particular, the sensitive indicator crop species and crop rotation scenarios (including planting intervals) must be relevant to the UK. For example, maize is not common in a UK crop rotation. Has the predominance of autumn sowing in the UK been covered in the core risk assessment? The applicant may need to consider further the need for specific UK risk mitigation and label warnings.
In addition to the above, the applicant must address the specific issue of the use of sequences or mixtures of ALS inhibiting herbicides. Such herbicides have been identified in the past as presenting a particular risk to succeeding crops when used under UK conditions and UK labels typically prohibit mixtures or sequences of herbicides containing ALS inhibitors. It may possible to remove this restriction, by submission of appropriate data.
Applicants should refer to Efficacy guideline 303 for full details.This restriction is distinct from those in place on resistance grounds as outlined in Efficacy guideline 611.
c)Molluscicides and seed treatments
For both these types of products, evidence of satisfactory flow and retention of pellet/seed integrity during application through representative commercial machinery is required. The applicant can argue on the relevance of the commercial machinery used in this assessment.
Molluscicides also have specific requirements to observe palatability and pellet integrity over the course of the trial. Furthermore, if specific label claims are made on the ‘shower proof’ or ‘rain proof’ properties of the pellets, these must be supported by data. Full details are given in Efficacy guideline 510, with updated methodology available in Regulatory Update 21/2013[2]. The methodologies are also described in EPPO 1/95(4) ‘Slugs’. Please also note the specific labelling requirements for molluscicide amateur products (Regulatory Update 03/2010(2)[3]). These assessments are shortly to be included in revised EPPO slug standards PP 1/95 and PP 1/96.
For seed treatments, relevant EPPO standards should be followed. It should be noted that claims of activity against unnamed seed/soil-borne pests are generally not allowed. In addition, UK labelling policy is to have only one recommended dose, which is based on the major, prevalent pest target (and on which dose justification is based).
d)Integrated Pest Management
Further specific data, beyond the core zonal assessment, is only required if specific positive claims are proposed on UK labels regarding compatibility of the product with Integrated Pest management.
Claims such as ‘IPM compatible’ are generally discouraged because such a broad based statement is difficult to support without an extensive data package (unless an argument can be made based on the mode of action e.g. a biopesticide). Instead claims relating to specific beneficial species (usually commercial species used in certain crops) are more easily supported by data, for example safe re-introduction periods or highlighting temporary adverse effects. Such claims can be supported in part by reference to relevant ecotoxicology data. However, further data would be required under more realistic conditions to consider e.g. affects of predators eating treated prey, affects of contact with pesticide residues on plants (either direct lethal affects or on fecundity). In situations where biological control is commonly practised (e.g. top fruit, glasshouse crops), if no information is provided on IPM compatibility, a label warning will be added ‘Safety to beneficial organisms used in IPM systems has not been established and cannot be assumed’.
e)Dose expression in orchards
EPPO standard PP 1/239 recommends leaf wall area (LWA) as an appropriate common dose expression method for orchard trials. It also emphasises the need to record all orchard structure parameters in order to then convert, where relevant, to any Member State national method. In the UK, dose is expressed on product labels as an amount/ha (sometimes % concentration is also included, but amount/ha is a requirement both for efficacy and other areas of the risk assessment). Therefore whilst the core dossier may express the dose applied in the effectiveness trials as LWA, this must be appropriately converted onto UK labels as amount product/ha.
EPPO standard PP 1/239 includes various conversion methods based on commonly used Member State dose expression methods. The relevant UK conversion from LWA into product/ha is based on a standard UK orchard structure of 3.5 m single row distance and 3 m high). It is assumed that the tree is in full foliage (a CAF factor of 1, unless a growth stage is specified that would exclude application at full canopy - for explanation see below). The conversion factor for a standard UK orchard (as described above) is there are 1.7 ha LWA per ha (ground).
Applicants should also be aware that typical UK practice is to use lower water volumes (100-300 l/ha) compared to other MS. The core data package should ideally include trials conducted at this lower range, since the package should be typical of the range of conditions. Alternatively, specific UK data using such water volumes may be included in the UK addenda.
It is recognised that growers use their experience to adjust the label recommended dose during the season in response to tree size and growth. UK funded research developed a common scheme: ‘Pesticide Adjustment to the Crop Environment (PACE) scheme’. The scheme provides a series of pictographs of typical apple trees of different canopy density to aid assessment of the ‘Crop Adjustment Factor’ (CAF) used to calculate the applied pesticide dose in a given orchard. The label should generally recommend the higher dose applicable to a full tree height in a typical UK orchard (e.g. 3-3.5 m) at full canopy density (CAF value of 1). (This is unless the label specifies a particular pre-blossom or early season recommendation). Ideally the tree height should also be specified on the label. In addition, the label should contain the following wording:
Where tree height and/or canopy density is reduced, the dose (and water volume) should be adjusted in accordance with an appropriate dose adjustment scheme. Consult your specialist advisor for further information. Further information on the PACE scheme is available from the AHDB, or see the AHDBleaflet (Orchard Spraying: Opportunities to reduce rates) available on the CRD website.
f)Apple and pear commercial varieties
The principle UK commercial apple varieties remain to be ‘Cox’ and ‘Bramley’ with ‘Conference’ being the predominant pear variety. All these varieties are prone to russetting and there have been historical cases of pesticides increasing these effects. It is important therefore that this aspect of crop quality is satisfactorily addressed for these UK varieties. Applicants may be able to refer to an appropriate range of tested varieties in the core zonal package. To do so, the UK national addendum should cross-reference to the appropriate part of the core dossier, and highlight those varieties tested that are also sensitive to russetting. Alternatively, specific data should be provided on the above named UK varieties. Where sufficient data/evidence of safety to the major UK varieties is not provided a label warning “Crop safety on ‘Cox’/‘Bramley’/‘Conference’ has not been established” may be required.
g)Formulation changes
EU Guidance SANCO 12638 provides broad principles on changes in chemical composition of a formulation. However, it has little specific advice on what constitutes either major or minor changes (for which data may/may not be required), and takes a more precautionary approach to changes in content. EPPO are currently developing guidance to address Efficacy aspects.
In the interim, the UK criteria for formulation changes can be applied to UK-only proposed formulation changes, where they are not already addressed in SANCO 12638. Applicants should refer to the ‘Formulation comparability’ under ‘Other efficacy guidelines’. (Further details can be found in Chapter 8 of the ‘Data Requirements Handbook’available from the ‘UK Government Web Archive’ section of ‘The National Archives’ website).