Concise summary Chemical active substance(s): Active ... · Product code / Product name Part B – TemplateSection 3 – UK National Addendum Page 5 /23 for chemical PPP side effects,

DRAFT REGISTRATION REPORT

Part B

Section 3

Efficacy Data and Information

Concise summary

Product code: xxx

Product name(s): xxx

Chemical active substance(s):

Active substance 1, xxx g/L or g/kg




Northern/Central/Southern Zone/Interzonal

Zonal Rapporteur Member State: zRMS

NATIONAL ADDENDUM The UK

(authorization/extension of use/…)

Applicant: company name

Submission date: dd/mm/yyyy

MS Finalisation date: dd/mm/yyyy

Product code / Product name

Part B – Section 3 – UK National Addendum

Page 2 /23 Template for chemical PPP

Version history

When What




Table of Contents

3 Efficacy Data and Information (including Value Data) on the Plant

Protection Product (KCP 6) ........................................................................ 4

3.1 Summary and conclusions of Ctgb on Section 3: Efficacy (KCP 6) ............. 5

3.2 Efficacy data (KCP 6) .................................................................................... 7 3.2.1 Preliminary tests (KCP 6.1) ......................................................................... 13 3.2.2 Minimum effective dose tests (KCP 6.2) ..................................................... 14 3.2.3 Efficacy tests (KCP 6.2) .............................................................................. 14

3.3 Information on the occurrence or possible occurrence of the development

of resistance (KCP 6.3) ................................................................................ 15

3.4 Adverse effects on treated crops (KCP 6.4) ................................................. 16 3.4.1 Phytotoxicity to host crop (KCP 6.4.1) ........................................................ 16

3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2) .............. 16 3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3) .................... 17 3.4.4 Effects on transformation processes (KCP 6.4.4) ........................................ 17 3.4.5 Impact on treated plants or plant products to be used for propagation

(KCP 6.4.5) .................................................................................................. 17

3.5 Observations on other undesirable or unintended side-effects (KCP 6.5) ... 18 3.5.1 Impact on succeeding crops (KCP 6.5.1) ..................................................... 18

3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2) ..................... 18 3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3) ............. 18

3.6 Other/special studies .................................................................................... 19

3.7 List of test facilities including the corresponding certificates ..................... 20

Appendix 1 Lists of data considered in support of the evaluation ............................. 21




3 Efficacy Data and Information (including Value Data) on the

Plant Protection Product (KCP 6)

EU guidance SANCO 10055/20131 describes the principles and framework for zonal efficacy product

evaluations, including the differentiation between core zonal assessments, and individual Member State

(MS) National Addenda.

This document specifically addresses the requirements of a Part B, Section 3 (Efficacy Data and Infor-

mation) draft registration report (dRR) where a UK National addendum is required. It contains

guidance (under the relevant sections) 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. Or in

relation to those issues where there is no agreed EU/EPPO guidance and relies on any National re-

quirements (e.g. convenience tank mixtures; supporting IPM claims). One of the main objectives is to

highlight the general information that will assist HSE-CRD when acting as a concerned MS, authoris-

ing uses based on the zRMS core assessment (Article 33applications), and guidance on putting the core

zonal assessment into context for a UK authorisation. 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. References are also made to UK resistance management restrictions and label-

ling. (See 3.2 for further explanation).

(The information and examples provided in the template and guidance notes for the core Part B,

Section 3 are not repeated in this document. Only the information that could be helpful in the

preparation of a UK national addendum is provided).

Article 33 authorisations including UK-only uses

As part of a zonal application, National addenda may be used to support a specific use in one of the

individual concerned MS. Please refer to SANCO 10055/2013 regarding the appropriateness of rec-

ommending a specific use (crop and/or target/different dose) in an individual MS. (If the proposed use

were to represent the ‘worst case risk envelope’ in any area of the risk assessment it should be consid-

ered in the core). Any additional UK uses should be clearly highlighted and explained in the UK Na-

tional addendum, and supported by appropriate data.

Please note that the UK view is even data/information supporting uses intended for only one MS

should still usually form part of the core zonal consideration. This is because there will often be

relevant associated data in the core, whether it is on other targets and/or other crops, which strengthen

the supporting evidence both for effectiveness and crop safety. The zRMS should evaluate the data

even if a final conclusion is dependent on National cMS consideration. Circumstances where it may be

relevant to submit a UK National addenda could be based around a lower dose due to specific UK risk

assessment considerations; data protection related issues/bridging to a UK-specific product. If submit-

ting a UK National addendum for a specific use, applicants are strongly encouraged to cross-reference

to relevant parts of the core assessment. For example, various aspects of crop safety and unintended

1 Guidance document on the Efficacy composition of Core Dossier and National Addenda submitted to

support the authorization of plant protection products under Regulation (EC) No 1107/2009 of the EU

Parliament and Council on placing of plant protection products on the market.




side effects, and resistance management, may be appropriately addressed by information in the core.

This document is also relevant and may be used if applying for an Article 33 authorisation where the

UK is the only requested MS.

Article 40 Mutual Recognition Authorisations

This guideline may also be relevant for applications for a UK authorisation, based on Mutual Recogni-

tion of another MS authorisation. In particular, consideration should be given to the relevance of agro-

nomic conditions (including pest/crop) to the UK, UK resistance management, and any other UK spe-

cific requirements.

This is a working document, and will be revised over time as experience of zonal product assessments

develops. It will also reflect any longer term initiatives to harmonise approaches in some of the

specific areas discussed below, where there is currently no EU guidance.

Notes: Text shaded turquoise provides general information/support and should be deleted when the

document is finalized. Text highlighted in yellow should be changed as specified; it shows example

text. Explanation may be added and text that is not relevant may be removed. Text in black shows the

headers for each section. It also shows example text and can be changed if necessary.

Fields shaded in grey are reserved for HSE-CRD assessors and should not be filled in by the applicant.

3.1 Summary and conclusions of HSE-CRD on Section 3: Efficacy (KCP 6)

Abstract

HSE-CRD will provide the main conclusion on whether authorisation of the use is acceptable in the

UK, and briefly explaining the reasons for the conclusions (data missing, relevance of uses to the UK,

relevant UK restrictions and proposed warning).

NB proposed UK label warnings will usually appear in Part A




Table 3.1-1: Acceptability of intended uses for the Netherlands (and respective fall-back GAPs, if applicable)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Use-

No.

*

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F,

Fn,

Fnp

G,

Gn,

Gnp

or

I **

Pests or Group of

pests controlled

(additionally: develop-

mental stages of the pest or pest group)

Application Application rate PHI (days)

Remarks:

e.g. g safener/ synergist per ha,

other dose rate expression, dose

range (min-max)

Conclusion

(efficacy) Method /

Kind Timing /

Growth stage

of crop &

season

Max. number a) per use

b) per crop/

season

Min. interval between

applications

(days)

kg or L product / ha

a) max. rate per

appl. b) max. total

rate per crop/season

g or kg as/ha

a) max. rate per

appl. b) max. total

rate per crop/season

Water L/ha

min / max

Zonal uses (field or outdoor uses, certain types of protected crops)

1 NL

2 NL

Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms)

3 NL

4 NL

Minor uses according to Article 51 (field uses)

5 NL

6 NL

Minor uses according to Article 51 (interzonal uses)

7 NL

8 NL

* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1.

** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional

and non-professional greenhouse use, I: indoor application

Column 15: zRMS conclusion. A Acceptable

R Acceptable with further restriction

N Not acceptable / evaluation not possible

n.r. Not relevant for section 3




3.2 Efficacy data (KCP 6)

This national addendum has been prepared for the evaluation of <insert product code/name> for the

Netherlands. This national addendum should be read in conjunction with the core assessment part B, Sec-

tion 3 Efficacy.

While there is no requirement to automatically submit National Addenda there may be specific MS

issues relating to certain proposed uses, requiring at least some further explanation if not fully ad-

dressed in the core assessment. It is envisaged, however, that generally National addenda should only

contain a limited amount of data, in support of a specific individual use or uses in a particular MS (pro-

vided within the core ‘risk envelope’).

Using a National addendum to the core dRR can be very useful for the relevant concerned MS by

providing a 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 con-

sidered in the core zonal assessment significantly different to that already approved in the con-

cerned MS?). This is one of the commonest problems not properly considered or explained to

concerned MS. Using National addenda is particularly relevant in this context.

Applicants should 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 be-

low), local target pressure will determine the number and interval of applications in the treat-

ment 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. There-

fore 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 to the core as-

sessment and use this as the basis when drawing up UK specific recommendations.

How have the UK draft label uses and recommendations been derived from the zonal assess-

ment

Are there particular UK issues that should be reflected in the proposed UK labels

CRD experience to date is that the above issues are sometimes poorly addressed when making Article

33 following zonal applications to CRD as a concerned MS (or Article 40 applications). This can result

in requests for further clarification, and questions may be raised over the proposed draft label recom-

mendations.

For this reason CRD advise applicants to consider submitting a UK ‘National addendum’ (using this

dRR format). The intention is not for applicants to re-submit or re-evaluate data from the core assess-

ment. 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 applica-

tions, 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 rele-

vant to UK conditions.




UK PLANT PROTECTION PRODUCT LABELLING: Efficacy aspects

a) Relevance of proposed target species

A common problem is applicants do not consider the relevance of the proposed target species, and in-

stead 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. HSE-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 vegetable brassicas, as well as more special-

ised crops (e.g. apple/pear). Applicants’ are advised to consult these when drawing up UK labels and

also when determining if the pest is supported by an appropriate number of trials (i.e is the pest major

or minor in the UK).

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. The onus is

on the applicant to demonstrate that the proposed target species are found in the UK. It is accepted that

these instances may be sporadic, in either location or frequency over the seasons in the UK. But, to be

considered as pests, evidence is required that when the pests do occur, economic damage justifying

treatment with a plant protection product is warranted. In this regard, information provided by relevant

growers can be very helpful.

HSE-CRD operates a system of ‘qualified recommendations’ that can appear on a label, designed to

support claims for UK minor/sporadic pest species. This is in recognition of the costs of conducting

trials, and sometimes the impracticality of generating data on such species. This can also be a relevant

factor for crops not widely grown in the UK. The scheme is based on extrapolation from either limited

data (or no data) generated on relevant related crops/targets. Although it is anticipated that for zonal

authorisations, sufficient data may already be available from the core assessment (e.g generated in

areas outside the UK where the crop and/or pest is more widely distributed). Applicants should also

consult the EPPO Minor Use Extrapolation Tables, as relevant extrapolation possibilities may be speci-

fied there. If neither of these options is relevant, applicants may propose a ‘qualified recommenda-

tion’, with a reasoned case explaining how the use is being supported. These should appear on the UK

label under a heading ‘Qualified recommendation’, and a sentence noting that the relevant use (crop or

target) is based on limited effectiveness and/or crop safety data (as appropriate). For example, a quali-

fied recommendation on leeks in addition to other fully supported label disease claims, might be de-

scribed as:

‘Qualified recommendation on leeks: limited effectiveness data indicate some control of White tip

(Phytophthora porri) ( PHYTPO ). Conditions of use for leeks described in the ‘important infor-

mation’ box must be followed’.

(NB in this example because other diseases on leeks were fully supported, crop safety was established

and it is not necessary to indicate ‘limited crop safety’)

(Please note that there are some common European pest species that are statutory pests in the UK sub-

ject to specific plant health measures, or on the UK Plant Health Risk register but not yet established in

the UK. 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. Current

examples include Colorado beetle (Leptinotarsa decemlineata) and Western corn rootworm (Diabroti-

ca virgifera); Japenese leaf rust (Gymnosorangium asiaticum).




b) Claims of control

The UK also operates a system of differential claims for any particular target species, based on the

level and consistency of control. 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. This is reproduced below:

1.1.1. Insect Pests

In considering data submitted towards justification of claims of effectiveness against pests, a number of

factors will need to be taken into account when considering and interpreting the level of control

demonstrated. These include the time of assessment in relation to application, the duration of effective-

ness and the potential for re-invasion, and any recommendations for repeat applications.

Table 1: Levels of pest control expected for effectiveness claims

Level of effectiveness Label claim appropriate

Consistent control commonly above 80% Control

Control, between 60 and 80% Useful level of control (moderate control

may also be used)

Lower levels of control e.g. 40-60%; lower

in exceptional cases.

Some control/reduction (in numbers or dam-

age)

For a claim for effectiveness below 80% to be supported authorisation, the level of control demonstrat-

ed for that pest must be considered beneficial for protection of the crop. For some pests particularly

those affecting the quality of the crop, higher levels of consistent control (i.e. above 85%) would need

to be demonstrated to support a claim of ‘full’ control. Examples of pests falling into this category are

pea moth and codling moth.

1.1.2. Diseases

Disease may be assessed as either severity or incidence. Measurement of disease incidence is particu-

larly useful when low levels of disease are present but may be of little value when infection is more

widespread, when severity is more likely to give a useful measurement of disease control. There is

normally no benefit in reporting both. Table 2 a)indicates the levels of control expected to be demon-

strated to support label claims for diseases and should be used where either severity or incidence are

recorded as a percentage or other linear scale.

Table 2a) ; Levels of disease control expected for effectiveness claims


80% and above Control

60-80% Partial/moderate/useful level of control

40-60% Reduction/some control

These criteria are not appropriate in cases where disease control is assessed as a score on a non-linear

scale. These scales are often relatively coarse with as few as four divisions. With such scales meaning-

ful levels of control can be difficult to determine unless disease pressure is relatively high. Table 2b)

indicates the levels of control expected to be demonstrated to support label claims for diseases where

measurements are made on a non-linear scale. In addition, statistical analysis of assessments on a non

linear scale is generally not appropriate. Even the calculation of means should be avoided. When re-

cording and assessing such results it may be better to assign letters rather than numbers to the steps on




the scale to avoid the temptation to analyse them numerically.

Table 2b); Levels of disease control expected for effectiveness claims when using a non-linear

scale


Consistently reduces disease to below 20-

25%, normally the lowest class.

Control

Reduces disease to<20-25% in the major-

ity of cases

Partial/moderate/useful level of control

Clear reduction in disease Reduction/some control

For some diseases, particularly those affecting the quality of the crop, higher levels of consistent con-

trol will need to be demonstrated. For a claim of control of seed borne pathogens (e.g. bunt, loose smut,

leaf stripe), a product needs to be 98% effective or better. For leaf stripe and loose smut, control in the

region of 85-95% would allow the claim for moderate control with the condition that seed cannot be

used for multiplication purposes.

In some cases an argument may also be made for higher claims than are justified by disease control

alone. For stem base diseases of cereals, for example, a claim of control may be appropriate even when

disease control is not consistently above 80%, if it can be shown that the treatment significantly reduc-

es lodging and/or disease levels are kept to a level where they have no significant effect on yield.

1.1.3. Weeds

In arable and horticultural field crops, the label claim supported by a certain level of weed control is as

follows:

Table 3; Levels of weed control expected for effectiveness claims

Label claim appropriate Level of effectiveness

Susceptible Consistent control of 85% and above (see below

†)

Moderately susceptible More variable control, mean 75-85%, but with

results often above 85%

Moderately resistant Variable control, Mean 60-75%, but some re-

sults above this level.

Resistant Poor control below the levels given above

† To ensure worthwhile levels of control of certain important weeds in field crops, all these categories

are raised with the susceptible rating being as follows: pernicious grass weeds where seed return must

be prevented, e.g. black-grass and wild-oats, 95% and above, cleavers 90% and above.

For perennial weeds, assessments of control levels in the year following treatment will be important in

determining the claim allowed.

c) Winter and Spring Crops

In January 2015 an important change was made to the qualifiers used to define spring and winter crops.

The qualifiers changed from being based on variety to being based on the time of year in which the

crop is planted. This change better reflected the environmental risk assessment and allowed growers

more flexibility to plant spring varieties in the autumn.

A clarification has been added to these qualifiers to highlight that application to spring varieties sown

in the winter (and vice versa) is likely to be at the growers own commercial risk. This is because crop

safety and effectiveness may not have been demonstrated on spring varieties sown in the winter (or




vice versa). The relevant phrase will be added to the label of professional products which have a specif-

ic authorisation for winter crops but not spring (or vice versa) (and which are not seed treatments),

where relevant data on all varieties is not provided.

For products authorised on winter crops:

“This product is authorised in winter sown crops. Growers choosing to apply this product to winter

sown spring varieties should note that crop safety has not been demonstrated in spring varieties. As a

result application of this product to winter sown spring varieties is done so at the growers own com-

mercial risk (and this also applies to unclassified varieties).”

For products authorised on spring crops:

“This product is authorised in spring sown crops. Growers choosing to apply this product to spring

sown winter varieties should note that crop safety has not been demonstrated in winter varieties. As a

result application of this product to spring sown winter varieties is done so at the growers own com-

mercial risk (and this also applies to unclassified varieties).”

(Full information on the UK Crops Definition List is available from the HSE website:

http://www.hse.gov.uk/pesticides/Crop-Definitions-List-Feb-2016-word-version-2.pdf)

d) Labelling of Molluscicide Products

In the UK traps baited with molluscicide pellets were historically used to assess the risk of damage in

cereals by estimating slug populations. The potential hazard to wildlife meant this practice was

stopped and has been replaced with non-toxic chicken layer's mash (commercial poultry food). A re-

search project calibrated the method using this bait to establish a threshold for winter wheat and estab-

lished a relationship between numbers trapped in cereal crops and stubble prior to drilling winter

oilseed rape.

The method and relevant thresholds are published on the Agriculture and Horticulture Development

Board (AHDB) website. The following label wording must appear on all professional molluscicide

products:

“For further information on slug trapping and damage risk assessment, please refer to AHDB Infor-

mation Sheet 02 ‘Integrated slug control – risk assessment and monitoring slug damage’, available on

the AHDB website’

In addition, there are further advisory paragraphs which applicants can choose to add:

a) For product labels that wish to include specific information on damage risk assess-

ments using bait trap methods in winter wheat and winter oilseed rape, the following,

or words of similar meaning, can be added.

“To establish the need for pellet application on winter wheat or winter oilseed rape,

monitor for slug activity. Where bait traps are used, use a foodstuff attractive to slugs

e.g. chicken layer's mash which has proven to be particularly effective. D0 NOT use

slug pellets as bait in traps since they are a potential hazard to wildlife and pets.”




b) For product labels that wish to include details of the actual method on their product

labels, appropriate suggested wording is as follows:

“Put slug traps out before cultivation, when the soil surface is visibly moist and the

weather mild (5-25°C). Traps consist of a cover about 25cm across, with a small heap (20ml

or 2 heaped teaspoonfuls) of chicken layers' mash (NOT slug pellets) beneath. In each field,

nine traps (13 in fields larger than 20ha) should be set out in a 'W' pattern. Also concentrate

on areas known to suffer damage. Leave traps overnight and examine early the following

morning.

FOR WINTER WHEAT, a catch of 4 or more slugs/trap indicates a possible risk, where soil

and weather conditions favour slug activity. FOR WINTER OILSEED RAPE a catch of 4 or

more slugs in standing cereals, or 1 or more in cereal stubble, if other conditions were met,

would also indicate possible risk of damage.”

Introduction

The introduction should include an explanation on why the National addendum is provided, and which

areas are being addressed within this addendum, with cross-reference where appropriate to the core

dossier.

Further details about the proposed uses (GAP) can be found in Part A, or in Appendix 1 of Part B Section

0 (all MS uses).

3.2.1 Preliminary tests (KCP 6.1)

Please refer to the core assessment Part B, Section 3.

This point is considered to be addressed usually in the core Section 3.




3.2.2 Minimum effective dose tests (KCP 6.2)


In principle this should be addressed in the core assessment, however in some circumstances additional

information may be presented in the UK-National Addenda. In particular, applicants should consider

the relevance of the target pest and crop to the UK (i.e. major/minor?) and proposed UK GAP. If dose

ranging data in the core are not on a relevant to the UK, further data may need to be submitted in this

section.

Other circumstances may include dose expression in three dimensional crops, and if addressed in the

core in an expression not used in the UK-GAP, further justification and explanation must be provided.

This particularly applied in pome fruit, where EPPO PP 1/239(20 recommends using amount/ha leaf

wall area (LWA), but UK labels express as amount/ha (see 3.2.3).

3.2.3 Efficacy tests (KCP 6.2)


a) General

UK follows EPPO standards in relation to the zonal principles and numbers of trials, depending on

whether a major or minor pest and/or crop. Applicants should also refer to the relevant EPPO Minor

Use Extrapolation tables and associated EPPO1/257 ‘Efficacy and crop safety extrapolations for minor

uses’.

Where there are potential problems in supporting a UK authorisation, commonly, it is insufficient data

on target pests which are major in the UK, or the data are not typical of all conditions of the zone (i.e.

have not encompassed areas sufficiently challenging and representative of UK conditions). This tends

to apply to fungal pathogens, where UK disease pressures can be high within the Central zone, and

certain cereal diseases which are major in the UK but minor elsewhere; or weed species such as black-

grass (Alopecurus myosuroides) which is a major weed in the UK due to the heavy soil conditions (and

widespread resistance to a number of current herbicides). Applicants are also reminded that winter

sown cereals and winter sown oilseed rape predominates in the UK, which can impact on target pest

species, and should be reflected appropriately in the core data package.

As noted above, information is available in various UK efficacy guidelines on major/minor pest status

for some UK crops. Applicants should also refer to other relevant published guidance, such as Agricul-

ture and Horticulture Development Board (www.ahdb.org.uk), which a number of detailed guidelines

on cereals, OSR, and horticultural crops, and these include information on major UK pests. For insects

in particular, the AHDB ‘Encyclopaedia of pests and natural enemies in field crops’ is a comprehensive

guide and includes where available UK treatment thresholds.

3-D crops, including pome fruit

EPPO 1/239(2) 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

http://www.ahdb.org.uk/




convert, where relevant, to any Member State national method. In the UK, dose is expressed on prod-

uct labels as an amount/ha (sometimes % concentration is also included, but amount/ha is a require-

ment 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 1/239(2) 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 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 sea-

son 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 apples 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 rec-

ommend 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 AHDB Apple Best Practice

Guide, or PACE website

3.3 Information on the occurrence or possible occurrence of the development of

resistance (KCP 6.3)


For those targets considered to be a high resistance risk in the UK, and for which a resistance manage-

ment strategy is required, applicants are expected to consider, and where necessary adapt, the proposed

strategy in the core dossier to UK conditions. As part of this consideration should be given to pest

pressures, and relevance of the GAP (including number of applications as part of the required season

long treatment programme). There is a range of available information, starting with the UK Resistance

Action Groups (RAGs), which give information on current resistance issues, as well as publish various

specific guidance, see:

http://www.pesticides.gov.uk/guidance/industries/pesticides/advisory-groups/Resistance-Action-

Groups

http://www.pesticides.gov.uk/guidance/industries/pesticides/advisory-groups/Resistance-Action-Groups

http://www.pesticides.gov.uk/guidance/industries/pesticides/advisory-groups/Resistance-Action-Groups




In addition, CRD have produced specific guidance for each product type, within which is information

on UK specific label wording 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)

group on particular targets, for example neonicotinoid insecticides, azole fungicides, and ACCase/ALS

inhibitor herbicides.

Guideline

601: Insecticides/acaricides }

602: Herbicides } UK product Labelling and statutory restrictions

603: Fungicides }

606: Resistance risk analysis and use of resistance management strategies

607: Insecticide Mixtures

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.

3.4 Adverse effects on treated crops (KCP 6.4)

3.4.1 Phytotoxicity to host crop (KCP 6.4.1)


It is anticipated that this should in most cases be satisfactorily addressed in the core assessment. In

certain circumstances specific UK data may be or at least further justification may be required for key

commercial varieties. This is where it is important to ensure a broad range of varieties have been test-

ed, to make a case that this would be relevant to UK specific varieties.

Again, extrapolation can be based on EPPO extrapolation tables, in conjunction with EPPO1/257 ‘Effi-

cacy and crop safety extrapolations for minor uses’.

3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2)


It is anticipated this will be addressed in the core assessment, unless a specific UK crop is requested.




3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3)


Apples and Pears

The principle UK commercial varieties remain ‘Cox’ and ‘Bramley’ (apple), and ‘Conference’ (pear).

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. Alter-

natively, specific data should be provided on the above named UK varieties. Where sufficient da-

ta/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.

Taint

For certain crop/product type uses, it is necessary to consider the possibility of taint. Full details on

when and how to address these issues are available in EPPO standard 242(1) ‘Taint tests’. It is ex-

pected that this aspect is covered in the core assessment, unless there are relevant crops specifically

requested for the UK.

Where taint has not been addressed for the relevant crops, the UK label will carry the warning as de-

scribed in 1/242(1), listing the specific crops where taint has not been addressed:

‘CONSULT PROCESSOR BEFORE USING ON [listed crops] FOR PROCESSING.’

3.4.4 Effects on transformation processes (KCP 6.4.4)


For certain crop/product type uses, it is necessary to consider the potential impact on (biological) trans-

formation processes. Full details on when and how to address these issues are available in EPPO

standard 1/243 (1) ‘Effects of plant protection products on transformation processes. It is expected

that this aspect is covered in the core assessment, unless there are relevant crops specifically requested

for the UK.

3.4.5 Impact on treated plants or plant products to be used for propagation (KCP

6.4.5)


It is not anticipated that a UK National addenda would be required for this point, unless exceptionally a

UK specific crop was considered (and where EPPO 1/135 requires further testing).




3.5 Observations on other undesirable or unintended side-effects (KCP 6.5)

3.5.1 Impact on succeeding crops (KCP 6.5.1)


Herbicides: Succeeding Crops, 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 situa-

tion).

However, the applicant may need to consider further, and if necessary, adapt as appropriate to UK con-

ditions. In particular, are the sensitive indicator crop species and crop rotation scenarios (including

planting intervals) 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 appli-

cant 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 mix-

tures of acetolactate synthase (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 is possible to re-

move 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 Guide-

line 611).

3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2)


It is not anticipated that a UK National addenda would be required for this point.

3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3)

Detailed studies on the potential adverse effects to beneficial organisms are summarised in part B, Section

9 Ecotoxicology.

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 com-

mercial 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 real-




istic conditions to consider e.g. effects of predators eating treated prey, effects 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’.

3.6 Other/special studies

a) Molluscicide pellets

The UK has specific requirements for molluscicide pellets, based on their long term use in the UK and

high slug pressures, related to quality aspects of the pellet to ensure there is not a significant breakdown

of pellet during application; or for the duration of control. There is also specific standardised method-

ology where UK labels include claims over the properties of pellet in relation to periods of rainfall.

Whilst these are requirement for the UK, with full details in Efficacy guideline 510, the methodologies

are also recommended in EPPO 1/95(4) ‘Slugs’

Observe palatability and pellet integrity over the course of the effectiveness trial.

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 if the product label makes specific statement on

the ‘shower proof’ or ‘rain proof’ properties of the pellets, these must be supported by data.

Please also note there are specific labelling requirements for molluscicide amateur products (Regulato-

ry Update 03/2010(2)2).

b) Seed treatments

It should be noted that claims of activity against unnamed seed/soil-borne pests are generally not al-

lowed. In addition, UK labelling policy is to have only one recommended dose, which is based on the

major pest target (and on which dose justification is based).

All seed treatments must be labelled with the following precautionary general statement:

‘Sowing treated seed that has been stored for prolonged periods (beyond the season of treatment) may

adversely affect effectiveness and/or crop safety’

This does not preclude companies from choosing to support a specific label claim concerning the peri-

od of time treated seed may be stored before sowing. In such instances, data should be generated with

the storage period in any studies reflecting the length of time proposed on the label. These data follow

the requirements for seed treatments when not stored and are fully described under the relevant chemis-

try sections of the data requirements.

The data should cover the satisfactory retention of the chemical and physical properties of the seed

2 Regulatory Update 03/2010 ‘Changes to labelling and other requirements for home and garden pesticides (2)’




treatment product in its container, and demonstrating satisfactory loading of the product on the seed when treatment is made by commercial seed treatment machinery.

The suggested minimum retention of active ingredient(s) is 70 % of the initial target dose, and this is the level that would be usually expected after the claimed storage period. Alternatively, a case for satisfactory retention of active ingredient(s) may be made based on the biological effectiveness of the product. For example, effectiveness trials using treated seed that has been stored for the relevant time period before sowing.

Seed drill tests – Please note that for all treated seed (and pelleted formulations), evidence must

be provided to demonstrate the satisfactory flow of treated seed through the relevant seed drill mechanism(s) available commercially.

Comparison should be made with untreated and standard treated seed from the same batch.

c) Convenience tank mixtures

A convenience tank mix is the combination, by the user, of two or more pesticides in the same spray

tank to reduce the number of spray operations.

No efficacy data are required to support applications for convenience tank-mixes. Evidence of physical

and chemical compatibility continues to be required in line with EU guidance. (See Regulatory Update

22/2014 ‘Tank mixtures of plant protection products – Updated UK Requirements for full details).

NOTE – this does not change the requirements for positive recommendations (with other pesticides or

adjuvants), which still require supporting efficacy data; or for ALS herbicides (see Efficacy Guideline

303: Effects on Non-Target Crops of Highly Active Herbicides – including Mixtures and Sequences’;

or anticholinesterase products.

d) Formulation changes

EU Guidance SANCO 12638 provides broad principles on changes in chemical composition of a for-

mulation. However, it has little specific advice on what constitutes either major or minor changes (for

which efficacy 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, particularly in relation to

changes in surfactant systems.

In the interim, the UK criteria for formulation changes can be applied to UK-only proposed formulation

changes, where the proposed change is not already addressed in the EU document. Applicants should

refer to Efficacy Guideline ‘UK Guidance on Plant Protection Products formulation changes.

3.7 List of test facilities including the corresponding certificates


IF additional trials are submitted in the UK National addenda (further to those in the core assessment),

please provide appropriate details here. (NB – it is anticipated this will be an exception, and most data

should be presented in zonal core). For any trials conducted in the UK by a GEP facility, reference to

the relevant UK-ORETO number may be made instead of submitting the actual certificate.




Appendix 1 Lists of data considered in support of the evaluation

The following lists should include all product data considered in support of the evaluation, even if they may have been evaluated previously, e.g. in the EU peer re-

view of the active substance(s), and thus, are not summarised in this document in detail. New data evaluated for the active substance(s) should be included as well.

Please sort by data points and within one data point by names of authors

Tables considered not relevant can be deleted as appropriate.

MS to blacken authors of vertebrate studies in the version made available to third parties/public.

List of data submitted by the applicant and relied on

Data point Author(s) Year

Title

Company Report No.

Source (where different from company)

GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner

KCP XX Author YYYY Title

Company Report No

Source

GLP/non GLP/GEP/non GEP

Published/Unpublished

Y/N Owner




List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner


Company Report N

Source



Y/N Owner

The following tables are to be completed by MS

List of data submitted by the applicant and not relied on


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner


Company Report N

Source



Y/N Owner




List of data relied on not submitted by the applicant but necessary for evaluation


Title

Company Report No.


GLP or GEP status

Published or not

Vertebrate

study

Y/N

Owner


Company Report N

Source



Y/N Owner

Documents

Concise summary Chemical active substance(s): Active ... · Product code / Product name Part B – TemplateSection 3 – UK National Addendum Page 5 /23 for chemical PPP side effects,