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Processes and Procedures for the authorisation of PPP, October 2017, version 1.3

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Overview of the Processes and

Procedures for the Authorisation

of Plant Protection Products in

the UK under Regulation (EC) No

1107/2009


2

Table (i): Amendments to Version 1.2 (October 2017)

Amendment

References in Document

Following zonals where the UK is a cMS, and Mutual Recognitions (Article 40) have been removed

Under Application Sift, point 2) Detailed technical sift.

The ‘FZ/MR’ column has been removed from the table in Appendix 3.

All references deleted from the individual specialist sections in Appendix 4.

The specialist sections referred to general advice relating to common errors and omissions. For example, discrepancies in GAP tables and UK label; addressing EFSA data requirements. In order to simplify the sift criteria, and to maintain consistency through the document, these issues have been removed from individual sections, and are now highlighted in the general introduction.

Appendix 4 introduction and general information table (p 22-24) have provided further details.

Minor issues may be identified by specialists at the detailed technical sift. These are not considered reasons for rejecting the application, but may need addressing during the evaluation. It is recognised that it would be useful to highlight these and provide feedback at this stage.

An additional line at the beginning of each section may be used: ‘Additional points for consideration’. Specialists will highlight where appropriate any areas where additional information and/or explanation may be required during the course of the assessment. Some typical examples are given in some of the specialist sections

Using experience gained since the introduction of the detailed sift criteria, each specialist section has been critically reviewed. As a result, a number of criteria (15) have been re-assigned as ‘additional points for consideration’, rather than outright reasons to reject the application.

Amendments have been made in specialist sections, noting that certain points are now highlighted areas to address instead of reject criteria. These are clearly marked in each section.

Following on from feedback from applicants, where possible relevant links to CRD (or EU) guidance has been provided.

CRD links have been provided where possible under individual data points.

For completeness, an additional point ‘Further information’ has been added, reminding of the need to provide packaging details This is not a rejection point, but would be highlighted under ‘additional points’ if there is an omission.

Added alongside ‘analytical methods’ on p15 of Appendix 4.

Mammalian toxicology has now been separated for further clarity into dietary and non-dietary (operator exposure) sections

Appendix 4, (Mammalian Toxicology, p18, and Operator Exposure p21).


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Table of contents Introduction…………………………………………………………………………………..…4 Application streams……………………………………………………………………………4 Application form………………………………………….………………………..…………...5 The authorisation process……………………………………………..……………………...5 Fees………………………………………………………………………………………….….5 Draft Registration Reports…………………………………………………………………….6 Evaluation types………………………………………………………………………………..6 Appendix 1 (Timelines)……………………...…………………………………………….…..11 Appendix 2 (Flowcharts)……………………………………………………………………....12 Appendix 3 (Validation check criteria)……………………………………...……….…….…18 Appendix 4 (Detailed technical sift criteria)……………………………………………….…20


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Introduction

As explained in Regulatory Update 07/2016 (24 March 2016), HSE has been conducting a review of its regulatory procedures for the consideration of plant protection product applications under Regulation (EC) No 1107/2009. The key objective of the review is to improve the efficiency of the processes and procedures in order to increase the predictability in the delivery of regulatory decisions and ensure HSE fully recovers the costs of all work involved in the evaluation process. The new timelines introduced for processing applications will be in accordance with Regulation (EC) No 1107/2009. Following this review, this guidance document outlines the key changes to HSE’s processes for the authorisation of plant protection products, being introduced for applications submitted from 29 June 2016. A link to an FAQ on the new process can be found on the Applicant Guidance Contents Page. Application streams From the 29 June 2016 all applications for an authorisation of a plant protection product will be processed in accordance with the streams identified in Table 1. Table 1: New application streams to be implemented from 29 June 2016

Evaluation Type

Article Number of Regulation 1107/2009

Timeline Comment

Authorisation or amendment of an authorisation

33, 34, 51* and 54

12 months Timeline defined by legislation

Additional information request

33, 47 and 51* - A total of 6 months given for the provision of further information

Following zonal, mutual recognition and Low risk products

33, 40 and 47 120 days Timeline defined by legislation

Art 43 Renewals 43 and 51* 26 weeks Timeline defined by legislation/guidance

Parallel permit 52 45 days Timeline defined by legislation

Import Tolerance

Regulation (EC) No 396/2005

12 months No timeline in Regulation – align with timeline for other applications

Emergency situations in plant protection

53 As agreed with HSE

Once we have accepted an application as an emergency, we will contact the applicant to discuss

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1107

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/applicant-guide-contents.htm



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the date by which the authorisation is required and arrange a suitable processing target time for your application.

*Article 51 covers Extension of authorisations for minor uses

Whilst, in moving to the legislative deadlines, the timelines for some of the current streams have increased, HSE will endeavour to complete all applications as soon as possible, and for certain application types this is likely to be well within the legislative deadline. Applications of a purely administrative nature, for example, will be processed within 6 weeks. HSE will also still accept cases for urgent consideration of applications e.g. urgent extensions of authorisation for minor uses (EAMUs). Application forms

Revised application forms reflecting the new application streams are now available in: Applicant Guidance: What Should I include in an Application. There are two new applications forms; CRD8 should be completed for technical equivalence applications and CRD-R should be completed for Article 43 (renewal of authorisations). These should be used where possible for applications submitted from 29 June 2016 but must be used for all applications from 3 October 2016. Fees

Information on the fees HSE charge for individual application types is available in: Applicant

Guidance - Fees

Outline of the authorisation process

All applications submitted from 29 June 2016 and onwards will be processed in accordance

with the streams outlined in Table 1 which reflects the timelines defined in Regulation (EC)

No 1107/2009.

The process for the authorisation of a PPP involves the assessment and charging of an

application in stages.

The main stages in the authorisation process are:

1) Pre-submission meetings – Fee charged

2) Application sift

a. Validation check – Fee charged

b. Detailed technical sift – Fee charged

3) Evaluation stage – Fee charged

a. Initial evaluation

b. Requests for additional information

c. Commenting period (where applicable)

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/what-should-i-include-in-an-application.htm#application_forms

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/the-applicant-guide-applica-3.htm

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/the-applicant-guide-applica-3.htm


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4) UK regulatory decision

The process of considering and charging for an application in stages has a number of

advantages. Applications that do not meet the regulatory requirements, following a

preliminary assessment, will be identified early in the authorisation process and will not be

charged for an evaluation. The overall aim is to support the submission of applications that

meet the regulatory requirements in terms of the supporting documentation (including

appropriate summaries in the dRR) and the data requirements.

The process applies in full to applications for the authorisation or amendment of an

authorisation (Article 33 submissions of Regulation (EC) No 1107/2009). The details of how

the process will operate for these submissions are outlined below (see evaluation types).

The process outlined for Article 33 submissions will be implemented for other evaluation

types, although not all the stages in the process will be applicable to each evaluation type

(e.g. simpler applications would not involve a pre-submission meeting, administrative

applications would not be subjected to a detailed technical sift).

Outlined below are details of how HSE will process different evaluation types.

Draft Registration Reports

All applications (new product, amendment and renewal) for PPPs should be made in the form of a draft Registration Report (dRR). The dRR is split into 3 sections:

Part A – risk management Part B – data evaluation and risk assessment Part C – confidential information

Further Guidance on the use of dRR can be found in the folder 'Dossier and draft assessment report'

Evaluation types

1) Authorisation or amendment of an authorisation Article Numbers in Regulation (EC) No 1107/2009: 33, 34, 51, 53 and 54 The overall zonal and mutual recognition process under Regulation (EC) No 1107/2009 is outlined in the EU guidance document SANCO/13169/2010 rev.9. The information presented below outlines how the procedure will be operated in the UK. Pre-submission meetings (PSM) PSM are not a new concept and have been in operation for some time. PSM are voluntary as they are not required by the legislation. However, HSE encourage them for groups of applications and for complex applications to discuss the content and expectations of the application(s).

The meetings will be an opportunity for applicants and HSE to discuss all aspects of planned applications for authorisation. This might include matters such as potential scientific issues

https://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents_en


http://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/application_procedure/index_en.htm


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and addressing the data requirements; approaches to timelines from active substance approval to submission of the application for product authorisations. HSE will also be able to outline the standards that need to be met in the submissions. Applicants are asked to provide a draft initial agenda outlining the points they want to discuss, where necessary HSE will add to this agenda.

The meetings will involve the particular specialist areas identified as being relevant and required for the applications concerned. This may include not only those requested by the company, but others where HSE believe there is a need.

The length of the meeting will depend on the issues. The standard fee for a PSM is currently £5200 and covers the resource required for the specialists to prepare for the meeting, attend the meeting and post meeting follow up. Application sift The application sift consists of two stages: 1) Validation check When HSE receives the application, an initial assessment of the information will be made to determine if the submission is complete. The information checked at this stage is outlined in Appendix 3. A fee of £229 is charged for this step whether the application is accepted or not. If the submission is regarded as incomplete it will be rejected and the application closed. Any subsequent application will need to be submitted in full and will be allocated a new application (COP) number. Details of the reasons for rejection will be provided. For administrative applications, requiring no technical input, the detailed technical sift and evaluation stage are not applicable. Following the validation check applications requiring a technical input will be streamed appropriately to either directly entering the evaluation stage or to be considered by the detailed technical sift. The latter applies to the types of application listed below (see detailed technical sift). 2) Detailed technical sift If the application is accepted following the validation check it will undergo a detailed sift, where required, to ensure that the application is of sufficient quality to undergo a full evaluation. A fee of £1872 is charged for this step. Applications requiring a detailed technical sift are:

All zonal applications for new products

Voluntary work share zonal applications for re-registration

National assessments for new products and re-registration


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All requests for assessment of technical equivalence of new sources of active

substances

The detailed technical sift is necessary to ensure the product dossier supports the proposed uses and where necessary issues identified are communicated to applicants. Potential reasons for rejection at this stage include:

Poor application overview that does not clearly define how each area of the risk

assessment is being supported (e.g. new data, reference to previous evaluations,

data considered for the approval/renewal of the active).

Incorrect data access.

Inconsistent GAP within application.

Use of incorrect endpoints.

Use of incorrect Article.

The presence/absence of information prevents a regulatory decision being made.

Poor presentation of supporting information such that it is not possible to proceed

with the assessment.

The criteria applied in each specialist area for the detailed technical sift are outlined in

Appendix 4 and includes additional explanation. This has been provided to assist in

understanding what key information is required in each specialist area. Applications will be

assessed against these criteria, but the list is not exhaustive, and the product dossiers must

comply with the requirements of Regulation (EC) No 1107/2009.

If the application fails the detailed technical sift, it will be rejected and closed, with full details of the reasons for rejection being provided. There will be no opportunity at this point to provide the missing information to complete the original application; instead, a new application will be required. As for applications rejected at the validation step, any subsequent application must be submitted in full and a new application (COP) number will be allocated. Passing the detailed technical sift does not guarantee that an application will result in an authorisation. The detailed technical sift in most cases will be completed within 4 weeks of receiving the application at HSE’s weekly application sift. Evaluation stage

If the application is accepted at the detailed technical sift it will be charged the appropriate specialist module fees and the detailed evaluation will begin. After the initial evaluation, additional information may be required to complete the assessment. As outlined in Regulation (EC) No 1107/2009 and the EU guidance document the evaluating MS shall set a period for the applicant to supply the additional information, with the total time not exceeding 6 months. Within HSE the total time of 6 months will automatically be given to applicants when additional information is required. The total period will be split into two separate requests that in general will be divided into the following areas:


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1st Request – Chemistry, Toxicology, Residues and Fate and Behaviour 2nd Request – Operator Exposure, Ecotoxicology and Efficacy An applicant will have 3 months (13 weeks) to respond to each request. When additional information is requested the application is suspended for the time taken by the applicant to submit the requested information. No additional time is added to allow for additional evaluation. Commenting round As outlined in the EU guidance document SANCO/13169/2010 Rev 9 other MS can comment on the zonal RMS’ assessment. The aim is to start the commenting process by week 43.

Stage 4: Regulatory decision

The overall processing time from accepting the application until a regulatory decision is

delivered by HSE is specified in Regulation 1107/2009 as a maximum of 12 months.

Table 2 provides an outline of the important timings (milestones) during this 12 month

period.

Table 2: Milestones in the zonal evaluation process

Time period (week) Milestone

0 - 4 Validation and detailed technical sift completed

5 – 30 Initial evaluation completed. Requests for additional information sent to the applicant. Application can be suspended for up to 6 months. The assessment will be re-started once a response has been received from the applicant.

30 - 43 Additional information submitted by the applicant is evaluated

43 - 52 Commenting round and preparation of final documentation

52 Regulatory decision delivered by UK

The time lines for the Article 33 zonal submission process are summarised in Appendix 1.

Application process flowcharts for the Article 33 zonal submission are outlined in Appendix

2.

2) Formulation comparisons and technical equivalence assessments Article Number in Regulation (EC) No 1107/2009: Article 33

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_mut-rec_en.pdf


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Applications for formulation comparisons and technical equivalence assessments will be processed under Article 33 of Regulation (EC) No 1107/2009. The process of considering two stage applications will be the same as they are now. These applications will be subjected to an application sift and a fee is charged for this step. Information on the application sift criteria checked for technical equivalence assessments can be seen in: Applicant Guide: Checklist for Applications.

3) Renewal of authorisation Article Numbers in Regulation (EC) No 1107/2009: 43 and 51

The general approach outlined above for Article 33 submission (Voluntary Pre-Submission Meeting, validation check, detailed technical sift, evaluation stage) will apply to Article 43 submissions. However, HSE recognises the shorter timelines for these submissions and the fact that requests for additional information are not included under Article 43 of Regulation (EC) No 1107/2009. Further information on the procedures for Article 43 submissions was outlined in guidance issued with Regulatory update 02/2016: Guidance on UK Procedures for product renewal applications (Article 43 of Regulation 1107/2009). 4) Import Tolerance applications Regulation (EC) No 396/2005 Information on applications for import tolerances can be seen in: The Applicant Guide: Maximum Residue Levels and Import Tolerances. 5) Low risk products Article Numbers in Regulation (EC) No 1107/2009: 47 For low risk products the general procedure outlined above are applicable. However, the processing time is 120 days. If additional information is required to complete the assessment then the applicant will have 6 months to provide such information. 6) Administrative application Article Numbers in Regulation (EC) No 1107/2009: 33 Administrative applications will be subject to the validation check but not the detailed technical sift. 7) Other evaluation types For information on adjuvants, Parallel trade permits, Extension of authorisations for minor uses please see the ‘FAQ’ which is available at the following link: Applicant Guidance Contents Page.

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/the-applicant-guide-common.htm

http://www.hse.gov.uk/pesticides/article-43.pdf

http://www.hse.gov.uk/pesticides/article-43.pdf

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/maximum-residue-levels.htm





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Appendix 1: Timeline for the authorisation process (Article 33 submissions)


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Appendix 2: Authorisation process flowcharts for Article 33 submissions

Voluntary Pre-submission meeting (PSM)


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Validation check

*The next stages are as follows:

Administrative applications – A regulatory decision is delivered

Applications subject to a detailed technical sift – The detailed technical sift is undertaken

Applications not currently considered in the detailed technical sift – A full evaluation is undertaken


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Detailed technical sift

This process is applicable to the following types of application:

All zonal applications for new products

Voluntary work share zonal applications for re-registration

National assessments for new products and re-registration


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Evaluation


16

Commenting


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Overall authorisation process

Request for HSE to

act as zRMS

submitted by the

applicant

Decision 1: Is the submission

complete?

Dossier is rejected and fee is charged. A

new submission will be required

No

Decision 2: Is the

product dossier suitable for

evaluation?

Application is rejected and fee is charged. A

new submission will be required

No

Decision 3: Is additional

information required?

Pre-submission

meeting arranged

and held

Product dossier

submitted

Application is

accepted and

dossier

enters the next

stage

Yes

Detailed

technical

sift

Invoice is raised

and dossier enters

next stage

Yes

Evaluation undertaken

Evaluation

completed

Commenting

undertaken where

required

Decision 4: Can an

authorisation be granted?

No

Refusal issued

No

Authorisation issued

Yes

Request for

additional

information sent

Additional

information

evaluated

Yes

Additional

information

submitted

Detailed technical sift

not required

Evaluation not required


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Appendix 3: Criteria for the validation check

Requirements New

product

Amendment

to

authorisation

Experi-

mental

permit

EAMU Admin Parallel Adjuvant Technical

equivalence

Article number(s) in Regulation (EC) No 1107/2009 33, 34 33, 34, 54 51, 53 33 52 58 38

Covering letter

http://www.hse.gov.uk/pesticides/topics/pesticide-

approvals/pesticides-registration/applicant-

guide/what-should-i-include-in-an-application.htm

Y Y Y Y Y Y Y Y

Application form – correct type for application


approvals/pesticides-registration/applicant-guide/what-

should-i-include-in-an-application.htm#application_forms

Y Y Y Y Y Y Y -

Draft Label




Y Y if changes

to use - - - Y -- -

Application overview


approvals/pesticides-registration/applicant-guide/what-

should-i-include-in-an-application.htm

Y Y Y

Y if

from

auth.

holder

- - - -

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/what-should-i-include-in-an-application.htm










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Requirements New

product

Amendment

to

authorisation

Experi-

mental

permit

EAMU Admin Parallel Adjuvant Technical

equivalence

Draft Registration Report




Y Y - - - - - -

Demonstration of data access (either unprotected data or

Letter of Access submitted) - - - - Y - - -

Current CHIP/CLP status – ‘parent’ product must have CLP

notification - - - - Y - - -

Full justification for EAMU applications -- - - Y - - - -

Photographs or scans of original container and label for

imported product - - - - - Y - -

Draft list entry - - -- - - - Y -





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Appendix 4: Criteria for the detailed technical sift

This appendix contains practical information explaining the criteria that will be applied by the HSE in the detailed technical sift. The HSE Project Manager will contact the applicant to address minor omissions or points of clarification, this may include an agreement to address minor issues during the course of the evaluation. Specialists may also highlight such issues and include as feedback during the detailed technical sift (examples are given in some of the sections below). Applications for an authorisation of a PPP must comply with Regulation (EC) No 1107/2009 and the data requirements outlined in Regulation (EC) No 544/2011 and Regulation (EC) No 545/2011 or Regulation (EC) No 283/2013 and Regulation (EC) No 284/2013. Therefore, applications in the detailed technical sift stage will be assessed in accordance with, but will not be limited to, the information outlined in this Appendix. A wealth of additional information on complying with the data requirements is available on the HSE website and the EU commission website (Procedure to apply for authorisation of a PPP - European Commission and Guidelines on Active Substances and Plant Protection Products - European Commission. It should be noted that separate dRR are required for amateur and professional products, as well as protected and field uses. There are a number of common issues to consider when submitting an application:

GAP - The correct critical zonal GAP should be identified and clearly presented with all relevant details: crop, crop growth stage, maximum single application rate, number of applications, and minimum interval between applications, application timing (including earliest and latest): individual target recommendations. The proposed UK GAP, draft label, and core zonal assessment should all correspond, or any deviations clearly explained and justified. Consideration should be given to the relevance of the core risk assessment and proposed requested crops/targets to the UK, with a UK addendum submitted where required (further guidance is given in each specialist section).

The application needs to clearly explain the basis for how the intended uses are supported. For example: new data, reference to the DAR, reference to other existing authorised uses, data access etc. Where previously submitted data are referred to, or data access to an existing authorised product for the UK, the relevant COP application number should be given along with full authorisation details.

Active substance data addressing data gaps identified in the European Food Safety Authority (EFSA) conclusions should be evaluated at the renewal of the active substance, UNLESS:

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1107

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:155:0001:0066:EN:PDF





http://www.hse.gov.uk/pesticides

http://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/application_procedure/index_en.htm




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o the data are provided by the applicant and relate to ‘an area member states shall pay particular attention to’ when assessing

applications for authorisation of plant protection products containing that active substance (as specified in the Implementing regulation, Column ‘specific provisions’, Part B), OR

o The data are necessary to support an authorisation (i.e. the authorisation could not be granted without an assessment of the data), as per paragraphs 4.1 and 4.2 of SANCO/10328/2004

The detailed technical sift will examine if data are required under either of these two circumstances, and identify these as relevant data gaps where appropriate.

Information on the criteria for the detailed technical sift is outlined for the following areas:

General Information

Identity of the Plant Protection Product

Physical and Chemical Properties

Efficacy Data and Information

Further Information on the Plant Protection Product

Analytical Methods

Mammalian Toxicology

Mammalian Toxicology: Operator Exposure

Metabolism and Residues

Environmental Fate

Ecotoxicology


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General Information

Requirements

The application has not been submitted using the required current draft Registration Report (dRR) format. The current dRR template can be found by

following this link: https://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents_en

Full formulation details 2.1 and 2.2 of the application form are required, see link for guidance: http://www.pesticides.gov.uk/Resources/CRD/Migrated-

Resources/Documents/D/DRH_v2_2_Chapter3_PhysChem.pdf

Reference has been made to the fact that further studies/trials reports will be available shortly. All the data to support the application must be present from

the outset and cannot be submitted later. Confirmation is required whether the application should continue based only on the submitted studies. [Where this

is the only identified issue at the sift, CRD will contact the applicant to avoid a rejection where possible]

The application has included draft reports/studies. CRD will only consider the application is complete and ready for acceptance once the final trials/study reports are submitted.

There are discrepancies in the proposed GAP (rates, earliest and latest timings, interval, uses/crops, growth stages, targets, method of application) between the draft label//application overview/ and dRR B0).These discrepancies must be clarified, confirming the correct GAP, noting that a new draft label may be required if changes are considered major.

The proposed formulation details differ from those currently approved in the UK [reference]. Clarification of the formulation details is required, including

whether a proposed change is intended. If necessary, revised details should be submitted.

It is stated that the application is to be supported by the use of data from a UK authorised reference product. Full authorisation details of any UK product must be provided (including the MAPP number, formulation composition where possible (outlined in Part C), material safety data sheets (MSDS) for all co-formulants in all referenced products). The details should include a comparison of the authorised uses/GAP, classification of components for the existing UK product and the requested uses/product, and make clear how the existing UK authorised product supports this application. Note, access to unprotected data can only be made by reference to one product; see link for guidance: http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/the-applicant-guide-the-pro.htm

The product contains a candidate for substitution, and an assessment of comparative assessment and substitution must be provided in line with CRD

guidance: http://www.hse.gov.uk/pesticides/resources/U/UK-Comp-Assess-Guidancev2.pdf

The application overview does not clearly outline how each area of the risk assessment is being supported for each of the intended uses. For example:

whether the data are new; reference to a previous assessment or existing uses(details required), evaluation in the DAR/RAR for the approval/renewal of the

active); extrapolation; or a combination of these approaches.


http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/D/DRH_v2_2_Chapter3_PhysChem.pdf

http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/D/DRH_v2_2_Chapter3_PhysChem.pdf

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/the-applicant-guide-the-pro.htm

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/the-applicant-guide-the-pro.htm

http://www.hse.gov.uk/pesticides/resources/U/UK-Comp-Assess-Guidancev2.pdf


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Identity of the Plant Protection Product

Additional points for consideration: Any identified issues requiring further clarification may be highlighted. These are not significant enough to warrant rejection but will need addressing during the course of the evaluation. Included in this are any individual data points with the comment: This is not a point of rejection, but the information must be submitted during the course of the assessment.

Data point What are the key issues for the detailed technical sift

1.3 Trade names and producer’s development code numbers for the preparations (KCP 1.3)

All code names used in the dRR and studies should be listed. This is not a point of rejection, but the information must be submitted during the course of the assessment.

1.4.2 Information on the active substance (KCP1.4.2)

The ISO name, CAS number, EINECS number, CIPAC number and a statement as to whether the active is present in the PPP as an ester, salt or anion or cation must be included. Where an active is present as a variant information on the amount of the active moiety and variant should be stated. Information on how the identity complies with the implementing regulation is required (e.g. the implementing regulation covers the acid moiety). The tolerance limits for the technical material and pure active in the PPP should be stated.

1.5 Type and code of the plant protection product (KCP 1.5)

The formulation type and the corresponding croplife international codes should be stated. This is not a point of rejection, but the information must be submitted during the course of the assessment.

1.6 Function (KCP 1.6)

The function of the PPP (e.g. herbicide, fungicide, insecticide) should be stated. This is not a point of rejection, but the information must be submitted during the course of the assessment.

Other missing information not covered under general or specific data points

Any missing information/data that does not apply to any point raised above may also be raised in the detailed technical sift if the lack of the data/information means it is not possible to proceed with the assessment.

dRR Part C

1.1.3 Statement of purity (and detailed information on impurities) of the active substance(s) (KCP 1.2)

A clear reference is required to where the source of the active substance(s) used in the PPP was considered e.g. reference the DAR or reference the details of the technical equivalence report (MS and date).


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1.2.2 Composition of the plant protection product (KCP 1.4)

The amount of the pure and technical grade active ingredient (TGAI) in the PPP should be stated. Where an active is present as a variant information must be provided outlining at what stage in the manufacturing process the variant is produced i.e. the manufacture of the TGAI or manufacture of the PPP. The amount of the variant and the ‘acid moiety’ should be stated. Compliance with the identity established in the implementing regulation is required. Information on relevant impurities are required. Where data have been conducted on different formulations from the one for which an authorisation is being sought then the full composition details should also be given along with a case on why the data generated can be extrapolated to the PPP being supported for authorisation.

1.2.2 Information on co-formulants (KCP 1.4.3)

For each co-formulant a MSDS should be provided. The applicant should confirm that these represent the latest version. For each co-formulant the following information is required:

Trade name

IUPAC name

Chemical name

CAS number

Relevant EC numbers

Structure/formula

Function




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Physical and Chemical Properties



Classification properties: Explosive properties (KCP 2.2.1) Oxidizing properties (KCP 2.2.2) Flash point (KCP 2.3.1) Flammability (KCP 2.3.2) Self-heating (KCP 2.3.3)

The classification of the PPP must be in accordance with CLP (Regulation EC (No) 1272/2008).

The test methods applicable are outlined in the commission communication document (2013/C 95/02). Cases presented to address the classification properties must be robust. For the active it is acceptable to refer to data evaluated for the approval (provided data access is available) or make a case based on the chemical structure. For the co-formulants reference to the MSDS can be made. The CRD Guidance document for the generation of data on the physical, chemical and technical properties of plant protection products, including CLP and storage stability aspects, can be found here: http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/physical.htm

Viscosity (KCP 2.5.1) Surface tension (KCP 2.5.2)

Regulation (EC) No 284/2013:

For Liquid formulations the viscosity shall be determined at two shear rates and at 20°C and 40°C.

For liquid formulations the surface tension should be determined at the highest in use concentration. Regulation (EC) No 545/2011: The viscosity and surface tension is required for liquid formulations. In both cases; The aspiration hazard should be assessed where the hydrocarbon content of the PPP is ≥ 10 % - the dynamic viscosity should be determined at 40˚C for this assessment.

(Kinematic viscosity = Dynamic viscosity/density)

http://www.hse.gov.uk/pesticides/resources/P/Phys-Chem-Properties-and-Storage-Stability-Guidance-Document.pdf


http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/physical.htm



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Storage Stability after 14 days at 54º C (KCP 2.7.1) Stability after storage for other periods and/or temperatures (KCP 2.7.2) Minimum content after heat stability testing (KCP 2.7.3) Ambient temperature shelf life (KCP 2.7.5)

The active content should be determined prior to and after storage. Any decrease observed must be within acceptable criteria or the decrease adequately addressed including the fate of the active and a justification of an appropriate shelf life. Any relevant impurities that can form or increase on manufacture or storage of the PPP must be determined prior to and after storage. For any relevant impurities not determined a case to justify their non-determination must be given. It should be made clear what analytical methods have been used to determine the active content and any relevant impurities (cross reference details outlined in section 5 of the dRR). All relevant technical properties should be determined prior to and after storage. It should be made clear what packaging the formulation has been stored in for the stability and shelf life studies.

Technical properties (KCP 2.8.1 – 2.8.7)

All relevant properties for the PPP must be determined or a justification given for missing data. Please see the CRD Guidance document for details.

The applicant should clearly outline the maximum and minimum in use concentrations being supported for authorisation.

For technical properties which are concentration dependant (e.g. persistent foaming, suspensibility and emulsifiability), the concentration of the product tested for each technical property should relate to the recommended in use rates given on the label, even where other concentrations are indicated in the test method, so long as the concentration tested is within the scope of the method.

Where data have not been generated at the recommended minimum and maximum in use rates then a robust justification should be outlined.

For particle size, if > 1 % of particles has a diameter of < 50 µm then the impact on operators and the satisfactory application of the PPP through the application equipment must be addressed.




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Technical properties (KCP 2.8.1 – 2.8.7) (continued)

The following data should be generated in the ambient storage studies:

Storage of liquid PPP in containers of > 20L must have ambient storage conducted in a container of at least 20 L

Solid formulations sold in flexible packs must address the impact of stacking on the physical and chemical properties

The above requirements can be set as post authorisation data requirements if they are not addressed in the core assessment. The following data are required prior to an authorisation being possible for ready to use PPP in trigger sprayers:

Evidence must be provided that the preparation may be satisfactorily applied and that this is maintained on storage (e.g. demonstration that no nozzle blockage occurs on storage). This can be achieved by demonstrating that the quantity of spray dispensed is consistent for multiple spray actions and this is maintained at interim time periods and after storage.

Physical compatibility of tank mixes (KCP 2.9.1)

A compatibility assurance statement (CAS) will be required where tank mixes are included on the label or if any advice will be given to users. NB – For zonal submissions, additional data may be required by other MS to support any tank mix recommendations made on their respective labels.

Adhesion to seeds (KCP 2.10.1) Distribution to seed (KCP 2.10.2)

For seed treatments data on the adhesion and distribution to seeds must be provided. The types of seed tested

must be fully justified. The method of analysis used to determine the active on the seed should be stated and cross

reference to the validation data presented in section 5 of the dRR made.




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Efficacy Data and Information

Additional points for consideration: Any identified issues requiring further clarification may be highlighted. These are not significant enough to

warrant rejection but will need addressing during the course of the evaluation. Included in this are any individual data points with the comment: This

is not a point of rejection, but the information must be submitted during the course of the assessment. Examples could include:

All efficacy trials should be conducted in accordance with the principles of Good Experimental Practice (GEP) in line with EPPO PP 1/181. The GEP status of all trials should be indicated and the relevant Official Recognition (GEP) Certificates for that trial provided. (For UK organisations, reference to the relevant ORETO number is sufficient). Where, for non UK trials, the testing facilities is not certificated it must be confirmed that the facility is an official testing station.

Included in the Article 33 proposed UK uses are target pests that are not relevant/do not cause economic damage warranting control measures. To support use in the UK, additional justification and evidence with this application. The specific proposed targets are: [further details will be provided by the specialist, including intentions to refuse use]: [Please note, if this was to affect either all product uses, or one specific crop, more detailed discussions may be required]

Only commercially grown crops may be included on a UK authorisation for professional products. If it is not clear whether the crop is grown commercially in the UK, further evidence may be required.

General What are the key issues for the detailed technical sift

Format The dRR and Biological Assessment Dossier (BAD) should follow the dRR Part 3 (efficacy) format for data requirements and numbering. In most cases it would be expected that a BAD will be submitted, with an appropriate concise summary in the dRR, following the dRR template guidance. All data points should be addressed appropriately, including sufficient detail on methodology and summary tables in the BAD and dRR. If the BAD and dRR are absent, have significant omissions, or considered overall poor quality (rather than a specific issue with a data point as listed below), this may result in a rejection. (Exceptionally, if only a small number of trials is being summarised, it may be possible to submit just one document rather than producing two, provided all relevant information is present). The proposed uses in the relevant GAP tables, dRR and on the proposed UK label should be identical. Specific attention should be given to individual pest uses. In addition, any discrepancies/changes to existing UK uses should be identified and addressed.


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Reference products used in

Efficacy trials (Including:

preliminary, MED, efficacy

trials, crop safety etc.)

The BAD and/or dRR must include details of the authorised uses for the reference products used, to confirm their relevance in terms of whether the reference is authorised for that use, and at what rate. (A zRMS will only be able to confirm these details for their own MS authorised products). The details can either be provided via an authorised label, or relevant sections for the specific target(s). The labels/details of reference products from other MS should be translated into English.

Background and context The dRR (core and National) and BAD must provide the background information required to conduct an assessment. The details and requirements for Zonal applications are found in EPPO guideline PP1/278. Information should be provided in line with the dRR Part B3 template. These details include an introduction, description of the active substance(s) and the mode of action, description of the PPP and its currently registered/proposed uses.

Proposed Crops/situations and targets

The dRR Section 3 template (Table 3.2-4) includes a table where applicants should provide an indication on the

importance of the crop/situation and economic importance of the proposed pests in each of the requested MS.

(These details are usually provided in the BAD, but it is helpful to include these in the dRR itself, as this is often a

point raised by cMS during commenting). This information should be used by the applicant, and assists the zRMS,

when justifying both the location and number of trials submitted in support of the uses.


3.2.1 Preliminary Data (KCP 6.1)

This point should be covered in line with the draft Part B3 template. The data or information required for this section depends on how old or well-known an active substance it and how many active substances are within the product. If preliminary data are available it should be included with detailed descriptions (or cross-referenced if included under other data points). New active substances should submit relevant preliminary data.

For all co-formulated products, a justification of the combination of multiple active or safener/synergistic substances is required. This can include the rationale for combining the actives, evidence on the ratio of actives, resistance management information. (MED of the co-formulated product itself are addressed under 3.2.2)

3.2.2 Minimum Effective Dose (KCP 6.2)

Guidance is given in the draft Part B3 template and the EPPO standards, particularly PP 1/225. MED should be

addressed in at least one of the major uses. If no data/reduced data were produced against a specific target,

justification must be provided to support extrapolation to those targets. Consideration should be given to the

relevance of the targets on which MED has been based, to ensure the crop/use is relevant for the requested cMS.

Summary tables: Summary tables must contain sufficient detail for an evaluation to be conducted. Examples of

summary tables can be found in the Part B3 template. Examples of details that should be included are EPPO

climatic zone, target, number of trials, infestation in untreated control, BBCH stages, % control with the test (at

different rates for MED) % control with reference products etc. Infestations and % control should include a mean,

min and max value


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3.2.3 Efficacy tests (KCP 6.2)

This point should be covered in line with the draft Part B3 template and the EPPO standards. Details of trial methodology should be provided. All of the proposed crops/uses and targets should be considered with either data or a justification that data are not required. (For example, appropriate extrapolations with reference to the EPPO Minor Use Extrapolation tables). Data should usually be presented separately for each EPPO climatic zone. EPPO PP 1/226 provides guidance on the number of trials required.

Summary tables must contain sufficient detail for an evaluation to be conducted. Examples of summary tables can be found in the Part B3 template. Examples of details that should be included are EPPO climatic zone, target, number of trials, level of infestation in untreated control, BBCH stages, % control with the test and reference products etc. Infestations and % control should include a mean, min and max value.

3.3 Information on the occurrence or possible occurrence of the development of Resistance (KCP 6.3)

This point should be covered in line with the draft Part B3 template and the EPPO standards, in particular EPPO PP 1/213. A resistance risk analysis should be conducted and should consider amongst other details the active substance, its mode of action and any evidence of resistance or cross resistance. If considered necessary, a suitable resistance management strategy should be provided. Where the UK is a cMS, refer to UK Resistance Action Groups, and CRD specific guidance for specific strategies and any UK restrictions (see below under UK National Addenda).

3.4 Adverse Effects on treated crops (KCP 6.4)

3.4.1 Phytotoxicity to host crop (KCP 6.4.1)

This point should be covered in line with the draft Part B3 template and the EPPO standards, in particular EPPO PP 1/135. For Herbicides, phytotoxicity will need to be considered in specific weed free selectivity trials and the test product must be applied at both N and 2N. Details on trial methodology should be provided. All of the proposed crops/uses should be considered with either data or a justification that data are not required. Data should be presented separately for each EPPO climatic zone. EPPO PP 1/226 provides guidance on the number of trials required.

Summary tables: Summary tables must contain sufficient detail for an evaluation to be conducted. Examples of summary tables can be found in the Part B3 template. Examples of details that should be included are EPPO climatic zones, BBCH stages, number of trials with x% amount of damage for the test and reference products at both N and 2N (including maximum levels and the level of symptoms at the last assessment).

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

This point should be covered in line with the draft Part B3 template and the EPPO standards, in particular EPPO PP 1/135. For Herbicides, yield will need to be considered in specific weed free selectivity trials and the test product must be applied at both N and 2N. Details on trial methodology should be provided. All of the proposed crops/uses should be considered with either data or a justification that data are not required. Data should be presented separately for each EPPO climatic zone. EPPO PP 1/226 provides guidance on the number of trials required. There should be a consideration of the relationship between phytotoxicity and yield - it is useful to include the trials with significant phytotoxicity or yield reductions in a summary table to determine if there is a relationship.


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Summary tables: Summary tables must contain sufficient detail for an evaluation to be conducted. Examples of summary tables can be found in the Part B3 template. Examples of details that should be included are EPPO climatic zones, BBCH stages, number of trials, crop and variety, yield in untreated, yield at N and 2N as % of untreated for both test and reference products.

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

This point should be covered in line with the draft Part B3 template and the EPPO standards, in particular EPPO PP

1/135 which describes the appropriate quality assessments for a range of crops. The individual assessments

required for aspects of quality will be dependent on the proposed uses, and in particular the crops. Any tests should

be described and summarised in tabular form if appropriate.

EPPO PP 1/242 ‘Taint tests’ should be followed for relevant crops.. It should be noted that a case based only on

lack of residues at harvest may not acceptable because taint effects can arise from applications made at early

growth stages. In addition, in certain circumstances, taint tests may also be relevant for fresh produce. This is not

a point of rejection, but the information must be submitted during the course of the assessment.

3.4.4 Effects on transformation processes (KCP 6.4.4)

This point should be covered in line with the draft Part B3 template and the EPPO standards PP 1/243 on transformation process and (where relevant) PP 1/268 (unintentional effects on wine). It is particularly critical for major crops where transformation is a key process for the harvested crop portion, and it is considered a high risk situation. For example, a fungicide for use in cereals or vines.

3.4.5 Impact on treated plants or plant products or plant products to be used for propagation (KCP 6.4.5)

This point should be covered in line with the draft Part B3 template and the EPPO standards. In particular, Table 1 in EPPO PP 1/135 provides a decision scheme outlining when data are required to address this issue. This should be used to justify either data provided or a reasoned case that not required.

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

3.5.1 Impact on succeeding crops (KCP 6.5.1)

This point should be covered in line with the draft Part B3 template and the EPPO standards, in particular EPPO PP 1/207. A theoretical risk assessment should be conducted and if there is considered to be a potential for negative effects, field trials should be conducted. Data or a justification of its absence should be provided to support all of the following crops proposed on the label - or if no restrictions are proposed, data/ a justification should be provided to support this. Cultivation methods such as ploughing can be proposed to reduce the impact on following crops. Any tests should be described and summarised in tabular form. (NB - the UK has a specific requirement to address the use of sequences or mixtures of ALS inhibiting herbicides. For full details, refer to the UK National addenda guidance, link below).

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

This point should be covered in line with the draft Part B3 template and the EPPO standards, in particular EPPO PP 1/256. A theoretical risk assessment should be conducted and if there is considered to be a potential for negative effects, field trials should be conducted. Data or a justification of its absence should be provided to support the safety to adjacent crops. Any tests should be described and summarised in tabular form.


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Sufficient data (or justification for its absence) should be submitted to demonstrate that residues of the plant protection product do not remain in the application equipment after cleaning, and that there is no risk to subsequently treated crops. (See EPPO PP 1/292).

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

Consideration of this section is only usually required at a National level, for example when specific claims have been made on the National label (usually for an insecticide) e.g. ‘Compatable with IPM programmes’. Applicants may need to submit relevant National addendum. (If claims are made on the UK label, see UK section). Cross reference to the ecotoxicology section of the dRR should be sufficient, and/or details of any assessments made in the effectiveness trials. For a zonal core assessment (Article 33), this is not a point of rejection, but the information must be submitted during the course of the assessment.

3.6 Other/special studies (KCP 6.6)

The level of data or information required in this section will depend on the type of product/active substance. Many of these issues will relate to specific claims or wording on National labels, and should be addressed in National addenda. This section should refer to relevant EPPO standards, where available, or for UK uses any relevant UK specific guidelines. The types of issues may include biological compatibility, convenience tank mixes and sequences, proposed label, rainfastness claims, justification of water volumes and the impact of environmental conditions on the efficacy of the product.



dRR Part B: UK National Addendum1

Where the UK is a cMS, applicants should refer to CRD Efficacy guidance document: ‘Efficacy Assessments: UK Product labelling and National issues/addenda’, available at: http://www.hse.gov.uk/pesticides/resources/E/efficacy-national-addenda.pdf. It is drafted as a UK National Addendum dRR B3, with appropriate UK-specific information under the relevant associated data points. The guidance covers:

UK label scheme differentiating the expected efficacy of the product, based on the underlying data assessed in the regulatory trials.

Specific efficacy label phrases associated with certain product types and/or active substances.

The limited number of cases for specific product types or proposed uses, where UK specific issues may need addressing

Overview of UK Resistance Management

Deficiencies in relation to UK-specific issues will be addressed as further points of clarification and the application accepted (provided there is no core issues identified above) unless the request is for a UK-only authorisation, and the deficiencies are considered significant. For example: the relevance of the GAP and requested uses to the UK; requirement to consider statutory resistance management restrictions, discrepancies between requested GAP and relevant authorised product.

1 For general advice refer to EU SANCO 10055/2013 ‘Guidance document on the Efficacy composition of Core Dossier and national addenda submitted to support the authorization of plant

protection products under Regulation (CE) No 1107/2009 of the EU Parliament and Council on placing plant protection products on the market’

http://www.hse.gov.uk/pesticides/resources/E/efficacy-national-addenda.pdf


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UK Labelling Issues that may require further consideration of the label wording can include: the expression of the level of control, in relation to the underlying data; addition of specific UK label phrases relevant for a particular target or product type; UK resistance management. This is not a point of rejection, but the information must be submitted during the course of the assessment.

UK Resistance Management

Consideration should be given to the relevance of any zonal core resistance management strategy to UK conditions,

adapting as necessary. For example, UK current resistance status of relevant targets; availability of alternatives;

overall treatment programmes; cultural practices, specific resistance label phrases. Further general information on

UK-resistance management can be found from the UK-Resistance Action Groups (UK RAGs):

https://cereals.ahdb.org.uk/crop-management/stewardship/resistance-action-groups.aspx This is not a point of rejection, but the information must be submitted during the course of the assessment.

For certain active substances, there are statutory restrictions. For example, the total number of applications of any

product containing the relevant active substance on a crop. Full details on UK Resistance label phrases and

statutory restrictions are in CRD Efficacy guidelines: 601, 602, 603, 606, 611 and 617) at:

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/efficacy-guides.htm

Where the proposed UK GAP conflicts with these restrictions, an amended GAP will be required. If the application

involves the UK as a zRMS with other cMS, it will be clarified during the evaluation. However, if this occurs for a

UK-only authorisation, the application will be rejected and a revised GAP required.

UK-only proposed authorisations

For UK-only requested uses, further justification may be required for the relevance of the generated data to UK

conditions (agronomic, pest biology, environmental conditions etc.). Details are provided in EPPO PP 1/278, PP

1/241 and PP 1/269. The proposed GAP should also reflect UK circumstances, in terms of crop, pest and

agronomic practice. An explanation and comparison of proposed uses with any existing relevant UK authorisations

may also be relevant, and require further justification. Any proposed discrepancies must be explained.



https://cereals.ahdb.org.uk/crop-management/stewardship/resistance-action-groups.aspx

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/efficacy-guides.htm


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Further information on the plant protection product



4.1 Packaging and

compatibility with the

preparation

(KCP 4.4)

Full details of the proposed packaging should be outlined with a clear indication of the composition of the material in

contact with the PPP. Where several types of packaging are proposed then extrapolations between different

packaging is possible. Details are outlined in the CRD Guidance document for the generation of data on the

physical, chemical and technical properties of plant protection products, section 2.11, which can be found here:

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-

handbook/physical.htm NB: An authorisation in the UK on the basis of accelerated storage data only is possible,

and a data requirement for continued authorisation can be set to fully address the stability of the packaging.

This is not a point of rejection, but the information must be submitted during the course of the assessment.






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Analytical Methods Data point What are the key issues for the detailed technical sift

5.2.1.1 Determination of active substance and/or variant in the PPP (KCP 5.1.1)

The validation data must comply with the criteria set out in SANCO 3030/99 rev. 4 with any deviations being fully justified. The guidance document can be found here: Technical Material and Preparations - Analytical methods for Annex II (part A, Section 4) and Annex III (part A, Section 5) - 11 July 2000 If the validation data have been generated on a different formulation then full composition details must be outlined in part C of the dRR. A justification to extrapolate the validation data generated to the PPP for which authorisation is sought must be outlined.

5.2.1.2 Description of analytical methods for the determination of relevant impurities (KCP 5.1.1)

Validation data must comply with SANCO 3030/99 rev. 4 which can be found here: Technical Material and

Preparations - Analytical methods for Annex II (part A, Section 4) and Annex III (part A, Section 5) - 11 July 2000

Under Regulation (EC) No 284/2013: Monitoring methods are required for all relevant impurities regardless of whether they need to be included or not in the storage stability studies. Where a method is required for a relevant impurity then confirmation of identity is also a relevant validation parameter.

5.2.2 Methods for the determination of residues (pre-registration methods) (KCP 5.1.2)

Validation data must comply with SANCO 3029/99 rev. 4 which can be found here: Residues analytical methods - for pre-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) - 11 July 2000 Under Regulation (EC) No 545/2011:

A full description and analytical validation data are not required under regulation (EC) No 545/2011 for all pre-registration methods. However, some specific studies may require full details and validation data for the methods used to collect data. This includes (but is not limited to) the following examples: data to support seed loading; residue trials

Under Regulation (EC) No 284/2013: Full details and supporting validation data for all methods

† used to generate data in all areas of the risk assessment

must be provided. (†Currently it is the UK’s position that this requirement would only apply to new studies and not

studies already accepted for an authorisation. However, this issue is under discussion between MS).

5.3.2 Description of analytical methods for the determination of residues (post-authorisation monitoring methods)

Validation data must comply with SANCO 825//00 rev. 8.1 guidance which can be found here:Residues analytical methods - for post-registration control and monitoring - 17 March 2004 Clear details of the methods available to support each of the following matrices must be provided:

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_tech-mat-preps.pdf




https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_res_pre-reg-cont-monitor.pdf


https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_res_post-reg-cont-monitor.pdf

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_res_post-reg-cont-monitor.pdf


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(KCP 5.2)

Plants (should support all matrices for which an authorisation is being sought)

Products of animal origin

Soil

Water (drinking or ground water and surface water)

Air

Body fluids and tissues Where reference is made to the data assessed for approval/renewal then this must be clearly stated with brief details of the method available e.g.

HPLC-MS/MS methods regarded as fully validated for two ion transitions for high water crops and high acid crops with an LOQ of 0.01 mg/kg

HPLC-MS method validated for three ions on soil with an LOQ of 0.01 mg/kg with a data gap identified for further accuracy data.

Where a method is not required then this should be stated and a reason clearly outlined.




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Mammalian Toxicology



Discrepancy in proposals- The proposed details on the label, application overview, dRR Pt B and Pt A should be consistent in terms of classification, PPE and dilution rates. Discrepancies between existing authorised labels and draft labels should be identified and addressed.

Material safety data sheets (MSDS)

MSDS should be in English, in the CLP style and format, and have a print or release date confirming they are less than 2 years old. A clear statement that an older MSDS is still current is acceptable.

Classification Classification on the product label and dRR Pt A must be to CLP.

Vertebrate data Under Article 33/3(c) of Regulation 1107/2009, vertebrate studies should not have been performed with PPPs where alternative methods (e.g. calculation or in vitro) are available. If such studies are submitted they need to be justified. Justification might include, for example, ‘calculation cannot be performed as data are missing for skin sensitisation of some co-formulants’. For further information, refer to Regulatory Update 03/2017 on the HSE pesticides website: http://www.hse.gov.uk/pesticides/news/vertebrate-data-for-pesticide-author.htm and http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/vertebrate-testing.htm

Data point What are the key issues for the technical sift

6.1 Summary The proposal for classification and labelling needs to be consistent with the label, Pt A and the application overview.

6.2 Toxicological information on the active substances

This should include details of the classification of the active substances and the reference doses (AOEL specifically). These should be checked against MSDS in terms of classification and the EFSA conclusion or EU database: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=homepage&language=EN. In addition, confirm that the AOEL here is the one used in the exposure sections.

6.3 Toxicological evaluation of the PPP

If any vertebrate studies initiated after the entry into force of 1107/2009 have been submitted, a justification needs to be presented (see above in general section).

http://www.hse.gov.uk/pesticides/news/vertebrate-data-for-pesticide-author.htm

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/vertebrate-testing.htm


http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=homepage&language=EN


38

6.3 (continued) Copies of any cited study reports should be available. It is not acceptable to cross refer to submission with another application. The study summary conclusions should match those cited in this section; do not check the detail, just the conclusion. The tested material should be the same as that for which authorisation is sought (e.g. code numbers). If there are discrepancies there should be a case to explain the differences. If relying on read across from another product the composition of all products should be provided in the confidential section (Pt C) and a case on the impact of any differences is required. There is no need to evaluate the case at this stage but check to ensure it covers the basic information. Any comparisons should be against a tested formulation, not one where extrapolation has already taken place. If classifying by calculation full details in line with the CLP methodology need to be provided (normally found in Pt C).

6.4 Toxicological evaluation of groundwater metabolites

The evaluation should be in line with the SANCO guidance document (221/2000 Rev 10; 25/2/2003 http://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_metabolites-groundwtr.pdf The submitted data and/or cases need to be consistent with the levels reported. The location of the full relevance assessment should be provided. Study reports for any cited studies should be available. However, if they have been evaluated by another MS or at EFSA peer review these conclusions can be accepted providing suitable supporting documentation is provided.

6.5 Dermal absorption (KCP 7.3)

The dermal absorption consideration should have been performed in line with the EFSA guidance document (2012; http://www.efsa.europa.eu/en/efsajournal/pub/2665 ). Particular points to confirm are the inclusion of tape strips and standard deviations. Any read across from a related product needs to be explained and justified. Details of the composition of the comparison formulation need to be provided and the impact of any differences on dermal absorption explained in line with the EFSA guidance. If the comparison is with a formulation that already relies on extrapolation from a tested formulation, this is not acceptable unless the two formulations are identical in all respects. If citing the values agreed during EU peer review, the relationship to the formulation considered at EU review needs to be explained.

6.6.6 Combined exposure Where the PPP contains two or more actives the need to conduct combined risk assessments for operators, workers, residents and bystanders should be considered.

Other missing information for not covered under general or specific data points

Any missing information/data that does not apply to any point raised above should be raised here if the lack of the data/information means it is not possible to proceed with the assessment.

http://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_metabolites-groundwtr.pdf

http://www.efsa.europa.eu/en/efsajournal/pub/2665


39

dRR PART B UK National Addenda: Section 6. Mammalian Toxicology

Format The format of any dRR should be in line with the current dRR for Section B6. Only new data needs to be presented in full for detailed evaluation, following the dRR approach to only summarising previously evaluated data. The end-points from such studies should be clear.

6.6.6 Combined exposure Where the PPP contains two or more actives there must be a consideration of the need to conduct combined risk assessments for operators, workers, residents and bystanders. For renewal applications under Article 43, combined exposure does not need to be considered until all actives within the formulation have been renewed.


Skin sensitizers For products classified for skin sensitisation, containing potent skin sensitizers (classified Cat 1A) or those where water volumes are less than 100L per kg a case needs to be presented to confirm that the in use dilution does not present a risk of producing skin sensitisation in unprotected persons.


dRR Part A

2.4 Classification and labelling

Classification and labelling needs to be consistent within the application (e.g. Pt B6, label, Pt A, application overview). Any discrepancies need to be explained. Particular attention should be paid to products containing components that are skin sensitizers. A warning text (EUH208) is required when there is no formal classification for skin sensitisation.

3.5 Mammalian toxicology The results of this section need to be consistent with those in dRR B6.

dRR Part C

1.2 Composition of the PPP (KCP 1.4)

Details of the components present in the product and the amounts present must be presented. For products used as part of read across cases (e.g. classification or dermal absorption) full compositional details are also required. If such information is not available, an explanation must be provided.

1.3.1 Material safety data sheets (KCP 1.4.3)

This section should include MSDS for all co-formulants in the product that is the subject of the application and for any products that are being used in read across arguments. If such information is not available, an explanation must be provided. If not appended to Pt C a cross reference must be provided indicating where the MSDS can be found. MSDS should be in English, in the CLP style and format, and have a print or release date confirming they are less than 2 years old. A clear statement that an older MSDS is still current is acceptable. Where interchangeable co-formulants are listed, the classifications need to be the same or an explanation of any impact on classification of the product should be supplied.

1.3.2 Available toxicological data for each formulants

A brief summary of the classifications of all co-formulants should be provided. This must be consistent with the MSDS supplied. If classification is performed by calculation methods, full details of the calculations should be provided. If a co-formulant has a severe classification (e.g. cancer, mutagenicity, reproduction) which carries over to the product classification, an assessment needs to be provided to demonstrate risks are acceptable.


40

Mammalian Toxicology: (Non-dietary - Operator exposure)


Data point What are the key issues for the technical sift

6.6.2 Operator exposure

(KCP 7.2.1) Operator exposure must be estimated following the EFSA guidance:

https://www.efsa.europa.eu/en/efsajournal/pub/3874

For scenarios not included in the guidance the advice in the data requirements handbook should be followed:


handbook/operator-exposure.htm

Justification must be provided for any deviation from the default values in the guidance supported by submission of

data used to derive alternative values.

6.6.3 Measurement of

operator exposure Where specific data are referred to these should conform to the OECD Guidance Document GD(97)148:

http://www.oecd.org/officialdocuments/displaydocument/?cote=ocde/gd(97)148&doclanguage=en

and must include a case as to how these data are more relevant to the proposed use than the existing data

supporting the EFSA calculator. The following points should be addressed: GLP; analytical methods; and

representativeness of subjects, equipment; application method, applied material, and task duration should also be

demonstrated.

6.6.4 Worker exposure

(KCP 7.2.3)

Worker exposure must be estimated following the EFSA guidance:




handbook/worker-exposure.htm

Multiple applications, crop entry activities prior to harvest, and harvesting activities where workers may contact

treated surfaces must be addressed. Justification must be provided for any deviation from the default values in the

guidance supported by submission of data used to derive alternative values.


http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/operator-exposure.htm




http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/worker-exposure.htm



41

6.6.4.2 Refinement of

generic DFR value

(KCP 7.2)

The following points should be addressed: GLP; analytical methods; number of sites/samples; representativeness of

crop; growth stages; application method, applied material, and weather conditions.

The usual standard for studies is the US EPA Occupational and Residential Exposure Test Guidelines Series

875.2100: Foliar Residue Dissipation:

https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-875-occupational-and-residential-

exposure

Alternative approaches should be supported by justification.

6.6.4.3 Measurement of

worker exposure

Where specific data are referred to these should conform to the OECD Guidance Document GD(97)148:


The following points should be addressed: GLP; analytical methods; and representativeness of subjects, equipment;

application method, applied material, and task duration should also be demonstrated.

6.6.5 Bystander and

resident exposure

(KCP 7.2.2)

If an AAOEL is set then a bystander assessment is required in addition to a resident assessment. In other cases

the resident assessment protects bystanders. Bystander and resident exposure must be estimated following the

EFSA guidance: https://www.efsa.europa.eu/en/efsajournal/pub/3874



handbook/bystander-and-resident-exposure.htm




bystander and/or resident

exposure

Where specific data are referred to these should follow the principles of the OECD Guidance Document GD(97)148:


And must include a case as to how these data are more relevant than the existing data supporting the EFSA

calculator. The following points should be addressed: GLP; analytical methods; and representativeness of subjects,

equipment; application method, applied material, and task duration should also be demonstrated.

6.6.6 Combined exposure Where the PPP contains two or more actives, there must be a consideration of the need to conduct combined risk assessments for operators, workers, residents and bystanders.

https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-875-occupational-and-residential-exposure




http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/bystander-and-resident-exposure.htm




42



dRR PART B UK National Addenda: Section 6. Mammalian Toxicology – none dietary exposure

UK specific requirements Consideration should be given to the relevance of the core assessment to UK conditions. If this has not been

provided and UK National Addendum may be required. This may include instances where the proposed GAP is

different to existing uses already authorised in the UK. Where that is the case an appropriate explanation must be

provided. There is some UK specific exposure issues which may not have been addressed in the core assessment

(see below). If this is the case, a UK National Addendum may be required to address the issues.

6.6.2 Operator exposure

(KCP 7.2.1)

Operator exposure must be estimated following the EFSA guidance for applications submitted after 1st

January

2016: https://www.efsa.europa.eu/en/efsajournal/pub/3874



handbook/operator-exposure.htm



The exposure mitigation measures of drift reduction nozzles and an increased buffer strip as provided in the EFSA

Calculator are currently not accepted in the UK.

6.6.3 Measurement of

operator exposure Where specific data are referred to these should conform to the OECD Guidance Document GD(97)148:


And must include a case as to how these data are more relevant to the proposed use than the existing data



demonstrated.






43

6.6.4 Worker exposure

(KCP 7.2.3)

Worker exposure must be estimated following the EFSA guidance for applications submitted after 1st

January 2016:




handbook/worker-exposure.htm

Multiple applications, crop entry activities prior to harvest, and harvesting activities where workers may contact

treated surfaces must be addressed.



For protected crops the UK does not assume that long sleeved shirt and trousers are consistently worn therefore the

potential exposure TC value assuming no protection from clothing should be used to estimate exposure to re-entry

workers.

Where use of personal protection gloves are required to reduce exposure to re-entry workers, the UK assessment

must reflect Regulatory update 24/2014 ‘New arrangements for the use of personal protection gloves to reduce skin

exposure in re-entry work after application of plant protection products to crops’:

http://webarchive.nationalarchives.gov.uk/20151023155227/http://www.pesticides.gov.uk/guidance/industries/pestici

des/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/PPE-gloves-reg-up-2014.htm

Information should be provided to confirm that the use of splash resistant single use gloves is a feasible and

practical risk mitigation measure to protect all groups of re-entry workers entering treated crops; and there is a

reasonable expectation of compliance through employers and the self-employed understanding their duties, under

the ‘Health and Safety at Work Act’ and the ‘Control of Substances Hazardous to Health Regulations’.

6.6.4.2 Refinement of

generic DFR value

(KCP 7.2)

The following points should be addressed: GLP; analytical methods; number of sites/samples; representativeness of

crop; growth stages; application method, applied material, and weather conditions. The usual standard for studies

is the US EPA Occupational and Residential Exposure Test Guidelines Series 875.2100: Foliar Residue Dissipation:

https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-875-occupational-and-residential-

exposure. Alternative approaches should be supported by justification.




http://webarchive.nationalarchives.gov.uk/20151023155227/http:/www.pesticides.gov.uk/guidance/industries/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/PPE-gloves-reg-up-2014.htm

http://webarchive.nationalarchives.gov.uk/20151023155227/http:/www.pesticides.gov.uk/guidance/industries/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/PPE-gloves-reg-up-2014.htm




44


worker exposure

Where specific data are referred to these should conform to the OECD Guidance Document GD (97)148.


The following points should be addressed: GLP; analytical methods; and representativeness of subjects, equipment;

application method, applied material, and task duration should also be demonstrated.

6.6.5 Bystander and

resident exposure

(KCP 7.2.2)

If an AAOEL is set then a bystander assessment is required in addition to a resident assessment. In other cases

the resident assessment protects bystanders. Bystander and resident exposure must be estimated following the

EFSA guidance for applications submitted after 1st

January 2016:




handbook/bystander-and-resident-exposure.htm




bystander and/or resident

exposure

Where specific data are referred to these should follow the principles of the OECD Guidance Document GD(97)148:


and must include a case as to how these data are more relevant to the proposed use than the existing data



demonstrated.

6.6.6 Combined exposure Where the PPP contains two or more actives there should be a consideration of the need to conduct combined risk

assessments for operators, workers, residents and bystanders. For renewal applications under Article 43, combined

exposure does not need to be considered until all actives within the formulation have been renewed.


Any missing information/data that does not apply to any point raised above should be raised here if the lack of the data/information means it is not

possible to proceed with the assessment.

dRR Part A

3.5 Mammalian toxicology The results of this section need to be consistent with those in dRR B6.







45

Metabolism and Residues



MRLs In Table 7.2-9 and 7.2.12 it is important to outline the MRLs required for the proposed GAP and products of animal

origin and the current MRLs in force. The implementing regulation that amends Regulation (EC) No 396/2005 with

the current MRLs should be stated. In addition, any future potential MRLs the applicant is aware of (e.g. in a

published article 12 RO) should also be stated.

New MRL required

As outlined on the HSE website and in regulatory update 20/2015 an applicant must clearly outline in the submission (cover letter, application overview) that a new MRL is required. The EFSA ER and MRL application form must also be completed and submitted in the application. EU procedural and technical guidance for MRLs is available at the following link:

http://ec.europa.eu/food/plant/pesticides/max_residue_levels/guidelines_en

Guidance documents for

residues

The data requirements applied in the residues assessment will be those that were applied to the relevant

approval/renewal of the active substance.

Information on the transitional arrangements for applying data requirements is outlined in the guidance document

SANTE/11509 /2013– rev. 5.2. This is available at the following link:

http://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents_en


The residues data applicable are those outlined in Regulation (EC) No 544/2011 – and this is referenced in the

subsequent sections.

The guidance relevant to the assessment are the Lundehn guidance available on the EU commission website:


NB – For any MRL assessment where a dietary burden calculation for livestock is required then the OECD

feeding tables must be applied.



http://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents_en



46

Guidance documents for

residues (Continued)


The residues data applicable are those outlined in Regulation (EC) No 283/2013 – and this is referenced in the

subsequent sections. The guidance relevant to the assessment are the OECD guidance which are available at the

following link:

http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-5-other-test-

guidelines_20745796


7.2.1 Stability of residues (KCA 6.1)

It must be clearly outlined how the available data support the proposed uses and all components of the residue definition:

The data must cover the crop matrices being supported.

For new residue trials the maximum length of storage for each crop should be stated so it is clear that these time periods are supported by the available data.

All components and analytes in the risk assessment and monitoring residue definitions as applicable must be addressed.

The analytical method(s) used should be satisfactorily validated in accordance with the SANCO 3029/99/rev.4 guidance, which can be found here, and a summary of the validated method included in section 5 of the dRR

7.2.2.1 Nature of residue in primary crops (KCA 6.2.1)

The available plant metabolism data must be suitability representative of the crop group, application method, rate and PHI for the proposed uses. The agreed residue definitions (for risk assessment and monitoring) should be stated. Any deviations from EU decisions should be stated and justified.

7.2.2.2 Nature of residue in rotational crops (KCA 6.6.1)

The data must cover the proposed uses, appropriate plant back intervals and the proposed application rates. The agreed residue definitions (for risk assessment and monitoring) should be stated. Any deviations from EU decisions should be stated and justified.

7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1)

The nature of the residue on processing must be assessed.

Under Regulation (EC) No 283/2013, these data are necessary when residues are found in the consumable part of

the crop (≥0.01 mg/kg).

Under Regulation (EC) No 544/2011, these data are usually necessary when residues are found > 0.1 mg/kg). A clear statement on the need for processing for each crop should be stated.

7.2.2.5 Nature of residues in livestock (KCA 6.2.2-6.2.5)

If relevant to the proposed uses and the resulting dietary burden of livestock then livestock metabolism data will be required. The agreed residue definitions (for risk assessment and monitoring) should be stated. Any deviations from EU decisions should be stated and justified.

http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-5-other-test-guidelines_20745796

http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-5-other-test-guidelines_20745796



47

Triggers for livestock data Regulation (EC) No 544/2011; Residues ≥0.1 mg/kg (DM) in the diet of livestock Regulation (EC) No 283/2013; >0.004 mg/kg bw/day (DM) in the diet of livestock

7.2.3 Magnitude of residues in plants (KCA 6.3)

Details of how the use is supported

It must be clear how each use is being supported. A summary of the trials data available to support each GAP should be given and the individual residue trial values, any conversion factors used (monitoring to risk assessment), STMR, HR and MRL required for the proposed GAP should be stated. In this summary the source of all parts should be clear whether trials are new data submitted or previously evaluated trials (DAR, EFSA Conclusion, existing UP assessment, new data (e.g. Smith et al., 2014)).

It must be clear how the trials data comply with the residue definitions for risk assessment and monitoring. Conversion factors used (monitoring to risk assessment and their derivation should be clearly stated). Any deviations must be clearly presented and fully justified

Use of overdose trials

Where overdosed trials have been used a justification for their use should be outlined.

If the proportionality principle has been applied sufficient information should be outlined to show how it has been applied and the residues obtained in the trials and the resulting residues at the N rate given. Note it is not applicable to use the proportionality principle when the PHI is a varying factor, and caution needs to be made with multiple applications. If there can be time dependent variations, use of the proportionality principle might not be appropriate.

Extrapolations

If extrapolations have been relied upon these should be clearly stated on a crop by crop basis. The use of different

formulation types should also be justified if the PHI is relatively short (up to 7 days).

Extrapolations must be in accordance with SANCO 7525/VI/95 –rev 10.3 , which can be found here:

Appendix D - comparability, extrapolation, group tolerances and data requirements

Air assisted applications

Where the proposed GAP is an all over spray (e.g. to pome fruits, stone fruits, fruiting vegetable) then the in use concentration of the spray solution for each trial, the water volumes and amount applied per hectare for each trial should be clearly outlined. An assessment as to how the data support the proposed in use concentrations should be made, also considering the water volumes recommended for use.

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_app-d.pdf


48

7.2.3 Magnitude of residues in plants (KCA 6.3) (Continued)

Data not relevant to the central zone

Uses not being supported in the central zone should be removed from the dRR unless they are required e.g. form part of the MRL assessment or data from the SEU required to complete the data set of trials.

Analytical methods

The analytical methods used in the new trials should be clearly indicated (using the company specific code for the analytical method) with the details and validation data outlined in section 5 (this part, section 5, can either include details of the new method and/or new validation data in full or reference to a previous UP assessment of the method and validation data for relevant crop matrices).

The procedural recoveries for all new trials should be summarised in the residues section.

Previous assessments

Where reference is made to a previous evaluation then this must have been conducted to uniform principles (UP) e.g. evaluation for the approval/renewal of the active or a previous product assessed to UP. Sufficient information must be given to allow an assessment of the trials data available to be easily made.

NB - It is not sufficient to refer to the MRL compilation dossier or the EFSA RO on the article 12 review – these evaluations are not necessarily conducted to uniform principles and data protection is not addressed in the MRL review.

7.2.4 Magnitude of residues in livestock: Dietary burden of livestock and livestock feeding studies (KCA 6.4.1-6.4.3)

The feeding tables used (OECD or SANCO) should be stated. (NB- where the data requirements outlined in EC Regulation 283/2013 were applicable to the active assessment then the OECD feeding tables must be used. The OECD feeding tables should also be applied where an article 10 MRL submission will be required and this includes uses on animal feed items. In other cases the SANCO feeding tables can be applied). Input values must be clearly defined (e.g. taken from the trials presented in the submission, the article 12 MRL review, a recent article 10 reasoned opinion and must take into account residues in rotational crops if relevant. Any processing factors used should be clearly outlined and justified. The maximum and median dietary burdens should be presented. The resulting residues (for risk assessment and MRLs) for products of animal origin must be clearly outlined.


49

(KCA 6.4.1-6.4.3) (Continued)

Triggers of livestock data Regulation (EC) No 544/2011; Residues ≥0.1 mg/kg (DM) in the diet of livestock and livestock metabolism data demonstrate that residues of ≥ 0.01 mg/kg may occur. Regulation (EC) No 283/2013; >0.004 mg/kg bw/day (DM) in the diet of livestock and livestock metabolism data demonstrate that residues of ≥ 0.01 mg/kg may occur.

7.2.5 Magnitude of residues in processed commodities (KCA 6.5.2 – 6.5.3)

Outline the need for processing data for each crop For each crop being supported it should be stated if processing data are required and if not the reason the magnitude of residues in processed commodities are not required. Where data are required it should be stated what data are available. The highest residue found in the consumed commodities arising from use at the GAP should be clear in this section for each of the intended uses.

Triggers for processing data Regulation (EC) No 544/2011: Residues > 0.1 mg/kg. Regulation (EC) No 283/2013: Residues ≥ 0.1 mg/kg. NB – under some circumstances magnitude of residue studies may be required even when residues are <0.1 mg/kg (e.g. pesticide has a high acute toxicity, the ADI is low, toxicological relevant metabolites formed on processing, the significance of the processed commodity in the diet) Deviations from the above ‘triggers’ should be explained taking account of the considerations in the data requirements regarding the circumstances for when data are required.

7.2.6 Magnitude of residues in representative succeeding crops (KCA 6.6.2)

Outline the need for rotational crop data Does the magnitude of residues in rotational crops need to be considered? If not, the reason should be outlined e.g. crop is not rotated, rotational crop metabolism study shows for the proposed application rates residues will be < 0.01 mg/kg.

Relevant crops and plant back periods Data should be available on a cereal, a root and tuber vegetable and a leafy crop for appropriate plant back periods (typically 30, 90 and 365 days).

It should be clearly outlined how the proposed application rates compare to the application rates investigated in the rotational crop studies. An estimate of the residues from the field studies for the N rate should be outlined.

Plateau concentration

If annual applications of persistent active substances result in higher plateau concentrations in soil than a single application, the plateau concentration shall be taken into account.


50

(KCA 6.6.2) (Continued)

NB - The draft OECD guidance on rotational crops proposes that the plateau concentration needs to be considered where the DT90 > 500 days and the DT50 > 150 days.

Positive residues in rotational crops If positive residues are obtained then the impact of these on the dietary burden of livestock, MRLs and consumer exposure must be addressed. Where relevant appropriate plant back intervals must be proposed. NB – plant back restrictions must be based on the available data. In addition, they cannot be used to negate the need to generate data (e.g. animal metabolism data).

7.2.8 Estimation of exposure through diet and other means (KCA 6.9)

For the UK, consumer intake assessments should be conducted using PRIMo and the UK specific models. Where the UK is the zRMS these assessments can be presented in the core assessment rather than in an addendum. These models can be found here:

* EFSA PRIMo model

* UK NESTI (Acute) model

* UK NEDI (Chronic) model

Input values must be clearly defined and must take into account residues in rotational crops if relevant.

Any processing factors used should be clearly outlined and justified.

Where the PPP contains two or more actives there must be a consideration of the need to conduct a combined risk assessment been made. (NB – if a combined risk assessment is required the dRR implies that only a combined acute assessment is required. For the UK a chronic combined risk assessment is also required).



dRR PART B UK National Addenda: Section 7. Metabolites and Residues

7.2.8 Estimation of exposure through diet and other means (KCA 6.9)

In the UK it is a requirement to present dietary intake assessments using the UK models (See links in 7.2.8 above).

The need to conduct a combined chronic and acute risk assessments is required where the PPP contains two or more actives. (NB – if a combined risk assessment is required the dRR implies that only a combined acute assessment is required. For the UK a chronic combined risk assessment is also required). The above assessments are required where the UK is the zRMS and there are proposed UK uses. Under these circumstances, the above assessments can be presented in the core assessment. This is not a point of rejection, but the information must be submitted during the course of the assessment.

https://www.efsa.europa.eu/sites/default/files/assets/calculationacutechronic_2.xls

http://www.hse.gov.uk/pesticides/resources/A/Acute_consumer_ver1_1.xls

http://www.hse.gov.uk/pesticides/resources/C/Chronic_consumer_ver1_1.xls


51

Environmental Fate




Providing appropriate input and output files for FOCUS gw / sw modelling, providing the files for the scenario/crop which generated the

highest PEC values. These files are required in order for the evaluation to be completed.

PECsoil formulation, or justify that the formulation is less toxic than the a.s.

PECsw formulation spray drift

Omission of output files


Unsupported uses The core dRR or UK National Addenda must encompass all of the uses specified in the GAP table and/or proposed label. Where a single use pattern has been selected to represent the risk envelope for multiple uses in a particular environmental compartment (e.g. soil, surface water, sediment, groundwater and air), this must be clearly explained in the dRR (see Risk envelope section below).


Clarity of GAP 8.1. Critical GAP and overall conclusions

Applications must clearly state the GAP including the following information (where appropriate): crop types, earliest and latest growth stages, timings of application (month/season), number of applications, application rate (g a.s/ha), interval, application method, and crop interception. If the application method involves any additional information which could influence the exposure assessment, such as banded applications, or split doses, this must be clearly explained with the GAP table. Where the product is not intended for use on an annual basis this must be made clear in the GAP, label, and the dRR. Within each environmental compartment it must be clear what GAP has been used for the modelling, including all of the GAP specific inputs given above.

Risk envelope 8.7 / 8.8 / 8.9

Where the use of the risk envelope approach is proposed to simplify the environmental exposure assessment in any given compartment, the rationale for selecting the risk envelope GAP must be clearly explained. In order to use the risk envelope approach correctly, consideration is needed of multiple factors, including crop type, application rate, method and timing of application, crop interception, earliest and latest application timings, soil types and relevant FOCUS scenarios etc. For further guidance see:


52

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/risk-envelope-suitability.htm

Clarity of endpoints used in modelling and provision of example output: 8.7 / 8.8 /8.9.

Applicants should clearly show the inputs used for modelling in each compartment.

For FOCUS ground water and FOCUS surface water it is required to provide an example input and summary output

file from each FOCUS model used (PEARL, PELMO, MACRO, PRZM), ideally the files for the run which resulted in

the highest PEC would be provided.

The omission of the output files will not be considered as a reason for rejection, however the information should be provided to enable the evaluation to be completed.

Justification of new

endpoints:

8.7.1 / 8.8.1 / 8.9.1

EU agreed endpoints should be used, in line with EU review assessments and this should be clear in the report.

Where endpoints from a confirmatory data assessment that has been noted by the EU procedure are available, these must be used unless: it can be justified that existing assessments using previously agreed EU endpoints are protective of assessments using the new endpoints (e.g. if the confirmatory data process resulted in more favourable endpoints), AND an acceptable assessment with existing EU agreed endpoints has already been provided. The approach must be clarified, with a justification why it is acceptable.

Where any additional active substance and metabolite data are provided it must be demonstrated that these data

are essential to support the authorisation. In addition it is essential to demonstrate clearly how the new endpoints

have been derived. It must also be demonstrated there is a right to access of the data which generated new

endpoints.

As a standard approach new guidance relating to active substance and metabolite endpoints that was not in place

at the time of the approval of the substance should not be applied. For example, do not recalculate the DT50 values

using a Q10 of 2.58 when the Annex I listing was on the basis of a Q10 of 2.2.

However, the exception to this would be where it can be demonstrated that application of new guidance is essential to support the safe use for the proposed product. In such cases, adequate justification must be provided; and the presentation of a 1

st tier assessment with agreed endpoints and a 2

nd tier assessment applying the later guidance.

Where there are multiple potential endpoints for use for the parent (e.g. pH dependence for the DT50), the values to use when modelling the parent may differ from the value to use when modelling the metabolite. The approach and endpoints used in the EU assessment should be used, or any post approval assessment that modified this approach. If the approach departs from this, robust justification should be provided.

8.7 Predicted environmental Concentrations in soil (KCP 9.1.3)

PECsoil calculations should be provided for the GAP which results in the highest soil loading (justification for which GAP results in the highest soil loading should be shown). If GAP contains alternative applications such as banded applications the PECsoil should still be determined based on the full amount reaching the soil. The input parameters used for the calculations must be clearly shown.




53

PECsoil accumulation 8.7 Predicted environmental Concentrations in soil (KCP 9.1.3):

If soil DissT50 is > 365days for active substance or metabolite PECsoil accumulation values should be provided.

8.7.2.3 PECsoil of formulation

A PECsoil formulation is required either; where the product contains multiple active substances; or where there is only a single a.s. but the formulation is more toxic than the a.s. PECsoil formulations are not required if the applicant can demonstrate that the risk from formulation is addressed by the active substance(s). This will not be considered as a reason for rejection, however the information should be provided to enable the evaluation to be completed.

8.8 Predicted environmental Concentration in groundwater (KCP 9.2.4)

Simulations should be conducted for all crops included in the GAP, or for the critical GAP IF justification as to why it is the critical GAP is also provided. A justification must be provided for the application timings modelled, ensuring that they cover the worst case for both the parent active substance and the metabolites. Where new modelling is required, modelling for the appropriate GAPs using the latest models and versions of FOCUS PEARL and PELMO should be provided. MACRO is required for the crop is parameterized for scenario Châteaudun, unless the PECGW values calculated with FOCUS PEARL and FOCUS PELMO are far below the trigger of 0.1 µg/L (e.g. <0.001µg/L).

8.9 Predicted Environmental Concentration in surface water (KCP 9.2.5)

Modelling should be provided using FOCUS sw step-wise approach for the appropriate GAP(s) in order to generate PECsw values. The application timings modelled must be justified, ensuring that they address the worst case for both the parent active substance and the metabolites. Simulations should be conducted for all crops included in the GAP, unless a robust justification is provided that the GAPs modelled are protective of the GAPS which have not been modelled. If mitigation measures are needed to grant an authorisation of the plant protection product, Step 4 simulations are to be provided in the Core assessment

8.9.2.3 PECsw/sed of formulation

There is a requirement provide PECsw formulation EITHER where the product contains multiple active substances; OR where there is only a single active substance but the formulation is more toxic than the active substance. PECsw formulation spray drift should be determined using the Drift calculator in SWASH. This will not be considered as a reason for rejection, however the information should be provided to enable the evaluation to be completed.

8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

A justification must be provided if it is considered that exposure via air is not of concern. As a first tier this should be in line with the approach taken within the EU reviewed process.


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If the EFSA conclusion/EU peer review for the substance raised a specific issue with respect to exposure of the air, the implications for atmospheric exposure from the requested GAP must be taken into consideration.


Surrogate crops A clear justification must be provided for the choice of surrogate crop (e.g. for use in some FOCUS models, or for drift values, or for crop interception). The justification should include a description of the growth habit and size of both the crop in the GAP and the surrogate crop at the time of product application, so that it can be determined if the choice of surrogate crop was appropriate.

Broad crop categories A clear justification for the input parameters used in exposure assessments (e.g. crop interception) must be provided when the crop category is very broad e.g. ornamentals

Any missing information/data that does not apply to any point raised above may also be raised in the detailed technical sift if the lack of the

data/information means it is not possible to proceed with the assessment. [For example, EFSA data requirements to address an area Member

States shall pay particular attention to in the product assessment. Specialist to give details]

dRR PART B UK National Addenda: Section 8. Environmental Fate

Please refer to all points in the Core section above, except those relating to FOCUS surface water.

UK specific requirements UK specific assessments must be provided for:

PECsw/sed (for all applications)

PECgw for any substance with a KOC >100ml/g A UK addendum should be provided covering ALL aspects of the evaluation. Applicants can cross reference to a core evaluation for the same product for areas which are not UK specific (IF the GAP is modelled is protective of the UK GAP). Details of environmental fate and behaviour data requirements can be found at: http://www.pesticides.gov.uk/Resources/CRD/Migrated-

Resources/Documents/D/DRH_v2_2_Chapter6_EnvFate.pdf

and

http://www.pesticides.gov.uk/guidance/industries/pesticides/topics/publications/all-approval-holders-letters/aahl-2002/aahl-33-2002-checklist-for-environmental-assessment.htm.

UK specific GAP 8.1 Critical GAP and overall conclusions:

Where the UK GAP differs from the Core GAP it should be clear what GAP has been modelled in each environmental compartment in the UK addenda. The modelling must cover the GAP on the UK Label. Where a UK specific assessment is not provided, but refer to the core evaluation, this should be made clear in the UK addendum.

http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/D/DRH_v2_2_Chapter6_EnvFate.pdf

http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/D/DRH_v2_2_Chapter6_EnvFate.pdf

http://www.pesticides.gov.uk/guidance/industries/pesticides/topics/publications/all-approval-holders-letters/aahl-2002/aahl-33-2002-checklist-for-environmental-assessment.htm

http://www.pesticides.gov.uk/guidance/industries/pesticides/topics/publications/all-approval-holders-letters/aahl-2002/aahl-33-2002-checklist-for-environmental-assessment.htm


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8.7.1 / 8.8.1 / 8.9.1

Justification of new

endpoints:

See Core Section 8 above.

Note that in the UK water dissipation (DisT50) values should be utilised in surface water calculations and this should be clearly noted.

PECgw- UK specific requirement 8.8 Predicted Environmental Concentrations in groundwater (KCP 9.2.4)

If the active substance or any of its metabolites formed in soil have a Koc greater than 100 ml/g, FOCUS MACRO modelling using the Chateaudun scenario, in addition to the modelling provided in the core assessment, must be provided.

UK specific PECsw spray drift 8.9. Predicted Environmental Concentrations in surface water (KCP 9.2.5):

UK specific spray drift exposure assessment should be provided for the parent and for all ecotoxicologically relevant

metabolites formed in water. Where appropriate, model early and late PECsw spray drift.

The inputs used for modelling should be clearly shown (noting that water dissipation values can be used in UK assessments instead of DT50).

For products applied within permanent fully enclosed protected structures, the UK assessment should include

surface water spray drift assessment in line with the latest EFSA guidance.

8.9.2.3 PECsw/sed of formulation

A UK specific PECsw formulation spray drift is required, either where the product contains multiple active

substances; or where the formulation is more toxic than the single active substance.

The calculation should be based on one application of the formulation and should use the appropriate UK

calculators see: http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-

requirements-handbook/fate/active-substance-uk.htm

This will not be considered as a reason for rejection, however the information should be provided to enable

the evaluation to be completed.

PECsw Drift reduction technology (DRT) 8.9 Predicted Environmental Concentration in surface water (KCP 9.2.5)

Either DRT or standard spray drift calculations must be provided (and NOT both). Where both have been supplied but DRT is stipulated on the label, only the DRT assessment will be evaluated. If DRT is required on the label then the PECsw spray drift must be determined for DRT. Guidance on DRT can be

found at http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-

handbook/fate/uk-surface-water.htm

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_fate_efsa_protected-crops.pdf

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/active-substance-uk.htm


http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/uk-surface-water.htm

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/uk-surface-water.htm


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UK specific PECsw drainflow 8.9 Predicted Environmental Concentration in surface water (KCP 9.2.5):

If the crop in the GAP can be grown on drained soils (http://www.hse.gov.uk/pesticides/topics/pesticide-

approvals/pesticides-registration/data-requirements-handbook/fate/active-substance-uk.htm) then an assessment is

required of potential surface water exposure via drainflow.

Where a quantitative assessment is required, PECsw drainflow results for the parent and metabolites formed in both

soil and water (noting that the approach for each is different) is required. For further information and access to the

appropriate calculator see: http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-

requirements-handbook/fate/active-substance-uk.htm

The inputs used for modelling should be clearly shown.

When required to address the ecotoxicology assessment, applicants should provide PECsed drainflow values for parent and for all ecotoxicologically relevant metabolites formed in soil or water or sediment. When the GAP includes multiple applications the first tier approach is to assess total dose for both parent and metabolites.

Higher Tier Drainflow (HTDF) 8.9 Predicted Environmental Concentration in surface water (KCP 9.2.5):

If the PECsw drainflow fails at the first tier (in relation to the relevant ecotoxicology end points), a higher tier drainflow modelling (using either Webram or MACRO) will be required. It must be demonstrated that the correct aquatic organisms groups been considered in the HTDF modelling, and that the correct triggers/approaches have been used. In addition, if the product contains more than one active substance, assessment of the combined drainflow may be required Where possible the need for higher tier modelling will be identified during the detailed technical sift. Otherwise it will

be highlighted during the course of the environment/ecotoxicology assessments.


Protected use It must be clear what types of structures are being referred to when discussing protected crops. The exposure

assessment for fully enclosed permanent glasshouse structures differs greatly from that for polytunnels. Therefore

the protected environment must be clearly classified. For further information, refer to SANCO/12184/2014 – rev. 5 –

27 January 2015: (https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-

proc_guide_fate_efsa_protected-crops.pdf)

This guidance document explains 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.








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Further CRD guidance explaining the differences between ‘protected’ and ‘permanent protection with full enclosure’ is available at: http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-

handbook/crop-qual-per-protectio.htm

and (http://www.hse.gov.uk/pesticides/resources/C/Crop-defn.pdf) This guidance explains the differences between ‘protected’ and permanent protection with full enclosure.

An assessment based on the disposal of compost onto land following the use of compost for crops grown under protection should be provided.


http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/crop-qual-per-protectio.htm

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/crop-qual-per-protectio.htm

http://www.hse.gov.uk/pesticides/resources/C/Crop-defn.pdf


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Ecotoxicology




Justification for conducting vertebrate studies

UK label phrase for risk to non-target plants


Study reports and summaries

Is there a submitted study report and robust study summary for all data relied on? (a list of studies/papers relied on should be summarised in the appendix of Part B).

Formulation studies If the formulation studies submitted have not tested the product under assessment – has a case for comparability/extrapolation of the data to support this product been provided? (should be provided in the Part C, HSE formulation guidance, 2015 advises on extrapolation consideration)

Vertebrate Data Under Article33/3(c) of Regulation (EC) 1107/2009, vertebrate studies should not have been performed with PPPs where alternative methods are available. If such studies are submitted they need to be justified. For further information please refer to Regulatory Update 03/2017 on the HSE pesticides website. http://www.hse.gov.uk/pesticides/news/vertebrate-data-for-pesticide-author.htm and http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/vertebrate-testing.htm If justification is not provided this reason alone is not sufficient to reject the application, but should be noted in the ‘Additional points for consideration’ box above and relayed to the applicant to address during the evaluation.

GAP Has the correct critical zonal GAP been identified and clearly presented? (The GAP should include the crop, maximum single application rate in g a.s/ha, number of applications, minimum interval between applications, BBCH range)

http://www.hse.gov.uk/pesticides/resources/E/CRD-Formulation-Guidance-ecotox.pdf

http://www.hse.gov.uk/pesticides/news/vertebrate-data-for-pesticide-author.htm




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9.2 Effects on birds (KCP 10.1.1) 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

Have EU agreed endpoints been used in the risk assessment for the active substance(s)? If not has additional data been submitted to support a change in an agreed endpoint? (please note that further consideration of a study already evaluated and concluded on at Annex I is not acceptable)

Has the correct guidance document been used (currently EFSA, 2009)? (should be the current guidance document at the time of application submission)

Has an acute risk assessment been provided for the active substances(s) and proposed critical product GAP?

Has a long-term risk assessment been provided for the active substances(s) and proposed critical product GAP?

Has a drinking water assessment been provided for the active substances(s) and proposed critical product GAP?

Has a secondary poisoning assessment been provided for the active substances(s) using FOCUSsw PECs (if triggered)?

If there are >1 active substance, has a combined acute and reproductive risk assessment been provided? (Approaches for the core and UK assessments detailed in HSE formulation guidance, 2015).

If a higher tier assessment is required – are all refinements either supported by submitted data or have been previously agreed during the EU approval for the active substance(s)?

If a higher tier assessment is required – have focal species been proposed and justified? Is their relevance to the crop justified?

If a higher tier assessment is required – is residue decline proposed as a refinement? If so has the relevance of the trials for the central zone and proposed GAP been justified? (i.e. climate, agricultural landscape, tested GAP)

9.5 Effects on aquatic organisms (KCP 10.2)

Have EU agreed endpoints been used in the risk assessment for the active substance and the metabolites? If not have additional data been submitted to support a refinement of that endpoint? (Please note that further consideration of a study already evaluated and concluded on at Annex I is not acceptable).

For any new aquatic studies submitted do analytical results of the study support the expression of endpoints (i.e. nominal/initial measured/mean measured concentrations)?

Has the correct guidance document been used (i.e. EFSA 2013)? (should be the current guidance document at the time of application submission)

Have FOCUSsw values been used in the risk assessment for all uses?

Has the risk to all relevant aquatic organism groups and exposure timescales been assessed?

Related to the above: If relevant for the substance(s) and/or metabolites has the risk to sediment-dwellers been assessed considering exposure via sediment?

If multiple species data are relied on, is the method and Assessment Factor used in line with EFSA, 2013?

If endpoints from a mesocosm has been used, then has the endpoint and Assessment Factor used been justified (i.e. in line with what was agreed at Annex I or in line with EFSA, 2013).

If the product contains > 1 active substance: Has an assessment (or case) been provided for the risk from the formulated product (including the risk from exposure to combined active substances.)? Current HSE formulation guidance outlines the approaches to be taken in the core and UK national assessments.

9.6 Effects on bees (KCP 10.3.1)

Have EU agreed endpoints been used in the risk assessment for the active substance(s)? If not has additional data been submitted to support a change in an agreed endpoint? (please note that further consideration of a study

https://www.google.com/url?q=http://www.hse.gov.uk/pesticides/resources/E/CRD-Formulation-Guidance-ecotox.pdf&sa=U&ved=0ahUKEwjtreaU08nSAhUC1iwKHSwhD2QQFggEMAA&client=internal-uds-cse&usg=AFQjCNGtfjj1IziiBy931KuxG2RxoiI7lw




60

already evaluated and concluded on at Annex I is not acceptable)

Has the correct guidance document been used (currently SANCO, 2002 referencing EPPO scheme, 2002b)? (should be the current guidance document at the time of application submission)

Has an acute contact risk assessment been provided for the active(s), formulated product and proposed critical product GAP?

Has an acute oral risk assessment been provided for the active(s), formulated product and proposed critical product GAP?

If a higher tier assessment is required – are the study guidelines and the guidance document used for the assessment stated?

9.7 Effects on arthropods other than bees (KCP 10.3.2)

Has the correct guidance document been used (currently ESCORT II, 2001)? (should be the current guidance document at the time of application submission).

Is the proposed GAP for pre emergence of the crop or early post-emergence? If so PERsoil should be considered for the in-field risk assessment.

Has a first tier in-field and off-field risk assessment been provided using glass plate toxicity studies? (If glass plate studies and a HQ assessment have not been provided then it is assumed that the tier 1 assessment

for in-field would not demonstrate an acceptable risk and therefore extended laboratory studies would be required

for the 2 indicators species plus 2 additional species. If these extended studies have been provided then glass plate

studies are not required. If not then the assessment is not considered to be sufficient and a data gap would be

applicable.)

If a higher tier risk assessment is required for the in-field and/or off-field risk – has it been provided and is it in accordance with the methodology of ESCORT II?

If a higher tier MAF refinement using soil/foliar DT50 data for the substance has been provided- has this been justified? (By use in a previous HSE agreed assessment, EU approved assessment or justified by submitting new data?)

9.8 Effects on non-target soil meso-and macrofauna (KCP 10.4) 9.9 Effects on soil microbial activity (KCP 10.5)

Have EU agreed endpoints been used in the risk assessment for the active substance(s) and metabolites? If not has additional data been submitted to support a change in an agreed endpoint? (please note that further consideration of a study already evaluated and concluded on at Annex I is not acceptable)

Has the correct guidance document been used (currently SANCO, 2002)? (should be the current guidance document at the time of application submission)

For soil meso- and macrofauna studies: If the Log Pow of the active(s) is >2 and studies have been conducted in artificial soil, has the correction factor been applied to the endpoints? (this correction factor should be used regardless of the organic matter content of the soil)

Has a risk assessment been provided for all substances (active(s), metabolites and formulated product) and critical proposed GAP?

If >1 active substance in the product, has a consideration of the combined risk t been provided for these organism groups?


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If a higher tier risk assessment is required – are the refinements supported by new data or are they previously agreed? (e.g.EU-agreed for the active substance)

9.10 Effects on non-target terrestrial plants (KCP 10.6)

If there are EU agreed active endpoints, have these been used in the risk assessment for all uses?

Has the correct guidance document been used (currently SANCO, 2002)? (should be the current guidance document at the time of application submission)

If considered necessary, has a tier I assessment been conducted?

Has a tier II deterministic/probabilistic assessment been conducted (with at least 6 species)?

If a HC5 has been calculated- has it been demonstrated that the data belongs to the same sensitivity distribution? (via goodness of fit test results, visual inspection of the response curve)

If the risk is not resolved, has further assessment been provided to address this risk?


Any missing information/data that does not apply to any point raised above may also be raised in the detailed technical sift if the lack of the

data/information means it is not possible to proceed with the assessment. [For example, EFSA data requirements to address an area Member

States shall pay particular attention to in the product assessment. Specialist to give details]

dRR PART B UK National Addenda: Section 9. Ecotoxicology


Document provided Is there a separate UK addenda provided (for zonal, MR and following zonal applications), fully addressing all UK specific issues?

GAP Has the correct critical UK GAP been identified and clearly presented? (The GAP should include the crop, maximum single application rate in g a.s/ha, number of applications, minimum interval between applications, BBCH range)


9.2 Effects on birds (KCP 10.1.1) 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

Has a secondary poisoning assessment for fish eating birds/mammals been provided for the active substances(s) using UK PECsw values (if triggered)?

If there are >1 active substance, has a combined acute and reproductive risk assessment been provided? (approaches for the core and UK assessments detailed in HSE formulation guidance, 2015)

Have any higher tier refinements been considered further in regards to the UK GAP and specific national requirements (i.e. focal species relevance, residue decline trails relevant for the UK)

9.5 Effects on aquatic organisms (KCP 10.2) 9.5 Effects on aquatic organisms

Have UK-specific PECsw values for spray drift and drainflow been used in the risk assessment?

If relevant for the substance(s) and/or metabolites has the risk to sediment-dwellers been assessed considering UK-

modelled exposure via sediment?



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(KCP 10.2) (cont.)

Has a higher tier drainflow assessment been triggered for any of the actives in the formulated product? If so have

the number of exceedance events been considered for the aquatic organism group for which an acceptable risk has

not been demonstrated at first tier? Reference should be made to current HSE website guidance on higher tier

drainflow risk assessment. (For a risk to aquatic plants and algae being assessed via MACRO, a 10% overall

failure rate and 60% failure in any one scenario is considered to be acceptable (CRD Regulatory Update 09/2009,

10th March 2009, the risk to fish and aquatic invertebrates is assessed on a case-by-case basis)

Has any risk mitigation required for UK authorisation been clearly identified?

If multiple species data is relied on, is the method and Assessment Factor used in line with EFSA, 2013?

If endpoints from a mesocosm has been used, then has the endpoint and Assessment Factor used been justified (i.e. in line with what was agreed at Annex I or in line with EFSA, 2013).

Has an assessment (or case) been provided for the risk from the formulated product and critical UK GAP?

If the product contains > 1 active substance: Has an assessment (or case) been provided for the risk from the formulated product (including the risk from exposure to combined active substances.)? Current HSE formulation guidance outlines the approaches to be taken in the core and UK national assessments

9.7 Effects on arthropods other than bees (KCP 10.3.2)

Is any proposed mitigation for an off-field risk in line with current HSE guidance on risk mitigation? (i.e. 5m buffer zone for field crops)

9.10 Effects on non-target terrestrial plants (KCP 10.6)

If the risk is not resolved in the core assessment at the standard 1m/3m distance, has the UK label phrase been proposed? If this phrasing is not provided this reason alone is not sufficient to reject the application, but should be noted in the ‘Additional points for consideration’ box above and relayed to the applicant to address/consider during the evaluation.



dRR Part A

Classification Has environmental classification been conducted according to CLP?

Summary Is there are summary of the risk assessment for all non-target organism groups?

dRR Part C

Comparability of formulations

If formulation studies provided data have not tested the product under assessment – has a case for comparability/extrapolation of the data to support this product been provided in the part C? (HSE formulation guidance, 2015)

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/macro.htm

http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/macro.htm



https://www.google.com/url?q=http://www.hse.gov.uk/pesticides/resources/E/Ecotox_risk_mitigation_labelling-2015.pdf&sa=U&ved=0ahUKEwj2i8jD5snSAhWCKywKHVQ3DOUQFggEMAA&client=internal-uds-cse&usg=AFQjCNEv36tEQRSRAeUCqf8t-9e12ic2pA

https://www.google.com/url?q=http://www.hse.gov.uk/pesticides/resources/E/CRD-Formulation-Guidance-ecotox.pdf&sa=U&ved=0ahUKEwiZzbyb58nSAhXiJ5oKHQpGDboQFggEMAA&client=internal-uds-cse&usg=AFQjCNGtfjj1IziiBy931KuxG2RxoiI7lw

https://www.google.com/url?q=http://www.hse.gov.uk/pesticides/resources/E/CRD-Formulation-Guidance-ecotox.pdf&sa=U&ved=0ahUKEwiZzbyb58nSAhXiJ5oKHQpGDboQFggEMAA&client=internal-uds-cse&usg=AFQjCNGtfjj1IziiBy931KuxG2RxoiI7lw

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