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Framework for the Assessment

of Plant Protection Products

Department of Pesticides and Biocides

Danish Environmental Protection Agency

May 2011

Revised February 2013

Revised April 2014

Revised May 2016

Revised May 2017

Version 1.5

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Danish Environmental Protection Agency

Strandgade 29, DK-1401 Copenhagen K, Denmark

Phone: +45 72544000

www.mst.dk

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Editing log - Framework for the Assessment of Plant Protection Products

Alf Aagaard, Pesticides and Gene technology, Danish EPA

Contact person

Date

2011-06-10

Ver-

sion

1.0

Issues changed

Revised framework for assessment of plant protec-

tion products published. Text on legal framework

still pending. The Framework for Human health on-

ly contains changes in the assessment practise, and

needs to be supplemented with existing practise.

Introduction has been updated with legal frame-

work and references to the data requirements pub-

lished in June 2011 has updated.

The framework for human health assessment has

been updated to encompass the entire risk assess-

ment of the mammalian toxicology.

Updated fate and ecotox:

- Assessment of persistency

- Specify GW assessment of metabolites

- Chronic bird and mammal risk assessment

in relation to autumn use

Updated Human health assessment

Bystanders and residents p. 13

The decision on the division of PPP’s into products

for either professionals or non-professional users

has been included into the Framework on Human

health assessment.

Modelling of leaching – model versions, refine-

ment due to crop rotation

Updated birds and mammals section

Buffer zones for nta and ntp has been linked to an-

nex 11 which has been updated for the terrestrial

environment

Non-professional use of product containing co-

formulant assessed as sensitiser

Estimation of exposure for non-professional users

For field studies non-normalised DT

values must

be used in the persistency assessment

PEC

soil

must be calculated in accordance with the

Northern Zone guidance

Input for SW modelling should follow FOCUS

guidance (the same as in the rest of EU)

The aquatic section has been updated in accordance

with NZ GD and the revised EFSA aquatic GD.

Main changes:



Use of RAC is accepted



Criteria developed for when and how

TWA can be used to refine exposure



Geometric mean can be applied in a

Weight of Evidence approach

The environmental data requirements have been re-

vised.

Harmonisation within the EU and/or Northern

Zone: 1) Estimation of operator, worker, bystander

and resident exposure using the EFSA calculator, 2)

no special safety factors for establishing AOEL

(e.g. cancer), 3) no special protection factors for

PPE, 4) cumulative risk assessment irrespective of

similar effects of active substances, 5) Seed treat-

Responsible Implementation

date

AAA

2011-06-10

2011-06-24

1.0

AAA

2011-06-24

2012-11-19

1.1

KRJBO

2013-08-01*

2013-02-18

1.2

LOUIS/AAA

2013-08-01*

2014-02-13

1.3

KREGR

2015-01-01*

2014-04-01

1.3

KRJBO

2015-06-01

2014-04-01

1.3

ANLGI

AAA

2015-01-01*

2015-06-01

2015-06-08

2015-08-05

1.4

KREGR

KRJBO

ANLGI

AAA

2016-05-01

2015-08-05

2016-01-29

1.4

AAA

MIKJA

2016-05-01

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ment as in NZ GD.

2016-05-04

1.4

Editorial corrections in ERA

AAA

2016-05-04

2017-05-03

1.5

Use of drift reducing equipment in human health

MIKJA/KRJB

2017-11-01

risk assessment. Use of gloves for workers and re-

entry as a risk mitigation measure, as well as wait-

ing periods for roof fogging application in green-

houses.

Clarification of buffer strips.

2016-08-31

1.5

Clarification concerning cumulative chronic Birds

AAA

Already in force

and Mammals risk assessment

2016-08-31

1.5

How to assess data on beneficial arthropods

SABLA

Already in force

2017-05-03

1.5

Update of fate and behaviour and toxicology con-

ANLGI

2017-05-03

cerning persistency and leaching of metabolites.

* New applications should at the latest follow the framework from this date. Applications are assessed according to the

framework from the date of publication on the DEPA’s webpage (25. February 2013 for version 1.2; 3. April 2014 for

version 1.3; 1. May 2016 for version 1.4 and 3. May 2017 for version 1.5).

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Contents

INTRODUCTION ............................................................................................................................................................ 7

URPOSE OF THIS DOCUMENT

........................................................................................................................................... 7

EGAL FRAMEWORK

.......................................................................................................................................................... 7

FRAMEWORK FOR THE HUMAN HEALTH RISK ASSESSMENT ..................................................................... 8

ACKGROUND

.................................................................................................................................................................... 8

LEGISLATIVE USER RESTRICTIONS ...................................................................................................................... 8

ENERAL APPROACH TO HUMAN HEALTH RISK ASSESSMENT

.......................................................................................... 8

HAZARD IDENTIFICATION – classification ............................................................................................................ 8

HAZARD CHARACTERISATION – setting of the AOEL and AAOEL ....................................................................... 9

EXPOSURE ASSESSMENT ........................................................................................................................................ 9

Dermal absorption .................................................................................................................................................... 10

Operators .................................................................................................................................................................. 10

Workers..................................................................................................................................................................... 10

Bystanders ................................................................................................................................................................ 10

Residents ................................................................................................................................................................... 10

Out-door treatment - fields, lawns, orchards ............................................................................................................ 11

In-door treatment - greenhouse ................................................................................................................................ 11

Seed treatment .......................................................................................................................................................... 11

RISK CHARACTERISATION ................................................................................................................................... 11

Out-door Treatment - fields, lawns, orchards........................................................................................................... 12

In-door treatment - greenhouse

........................................................................................................................... 14

RISK MANAGEMENT – Decision making ............................................................................................................... 15

METABOLITES OF NO CONCERN – Groundwater contamination ....................................................................... 15

FRAMEWORK FOR THE ENVIRONMENTAL ASSESSMENT ........................................................................... 16

ACKGROUND

................................................................................................................................................................... 16

ATE AND DISTRIBUTION

BEHAVIOR IN THE ENVIRONMENT

PERSISTENCE

MOBILITY AND BIOACCUMULATION

...... 17

FFECTS ON NON

TARGET ORGANISMS

AQUATIC AND TERRESTRIAL ORGANISMS

...................................................... 18

ENVIRONMENTAL RISK ASSESSMENT AND DECISIONS................................................................................ 19

ATE AND BEHAVIOUR

DISTRIBUTION IN THE ENVIRONMENT

....................................................................................... 19

Fate in air ................................................................................................................................................................. 20

Persistence in soil ..................................................................................................................................................... 20

Groundwater/Mobility .............................................................................................................................................. 21

Surface water ............................................................................................................................................................ 23

IOACCUMULATION

......................................................................................................................................................... 23

FFECTS ON NON

TARGET ORGANISMS AND RISK ASSESSMENT

. .................................................................................... 24

Aquatic organisms .................................................................................................................................................... 26

For cumulative risk assessment of combination products, follow the Northern zone GD (2016)............................. 27

Terrestrial organisms ............................................................................................................................................... 27

Bees........................................................................................................................................................................... 28

Arthropods ................................................................................................................................................................ 29

In-soil organisms ...................................................................................................................................................... 30

Microorganisms ........................................................................................................................................................ 31

Biological methods of wastewater treatment ............................................................................................................ 31

Non-target plants (NTP) ........................................................................................................................................... 31

LIST OF ANNEXES ........................................................................................................................................................ 33

NNEX

1: D

ATA REQUIREMENTS ON PLANT PROTECTION PRODUCTS

........................................................................... 34

NNEX

2: S

OIL CLASSIFICATIONS IN

ENMARK

............................................................................................................. 36

NNEX

3: C

LIMATE CONDITIONS IN

ENMARK

.............................................................................................................. 38

NNEX

4: P

AVEMENTS AND SIMILAR USE AREAS

............................................................................................................ 39

NNEX

5: A

PPRAISAL OF FIELD STUDIES AND LYSIMETER TESTS FOR POLLUTION OF GROUNDWATER

....................... 40

NNEX

6: A

PPRAISAL OF MATHEMATICAL MODELLING OF RISK OF POLLUTION OF GROUNDWATER

......................... 41

NNEX

7: G

ROUNDWATER MONITORING DATA

.............................................................................................................. 43

NNEX

8: D

EFINITION OF READILY BIODEGRADABLE

.................................................................................................... 44

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NNEX

9: N

SPRAYING BUFFER ZONES TO THE AQUATIC AND TERRESTRIAL ENVIRONMENT

.................................. 45

NNEX

10: A

SSESSMENT FACTOR IN MESOCOSM STUDIES

............................................................................................. 46

NNEX

11 V

EGETATION COVER AND DEPOSITION ON SOIL

............................................................................................ 47

NNEX

12: E

NVIRONMENTAL RISK ASSESSMENT OF CUMULATIVE EFFECTS FOR COMBINATION PRODUCTS

.............. 49

NNEX

13: C

ROP ROTATION

NORMAL CULTIVATION PRACTICES IN

ENMARK

......................................................... 50

NNEX

14: C

RITERIA FOR PESTICIDES THAT CAN BE USED BY AND SOLD TO NON

PROFESSIONAL USERS

................... 51

NNEX

15: B

ENEFICIAL ORGANISMS

(

OTHER THAN BEES

). ............................................................................................ 53

NNEX

16: A

BBREVIATIONS

............................................................................................................................................ 55

REFERENCES ............................................................................................................................................................... 57

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Introduction

Purpose of this document

The aim of this document is to provide the principles framework for the assessment of plant protec-

tion product for national registration in Denmark. The document may serve as guidance to applicant

on how to perform an assessment for human health and for the environment for plant protection

products. I.e. which issues shall be addressed and how. Moreover, the document shall facilitate a

harmonised assessment by the Danish EPA.

Legal framework

The legal basis for authorization and evaluation of plant protection products is provided in the plant

protection product regulation (Regulation (EC) No. 1107/2009 of The European Parliament and of

The Council of 21 October 2009 concerning the placing of plant protection products on the market

and repealing Council Directives 79/117/EEC and 91/414/EEC). Regulation 1107/2009/EC is di-

rectly applicable and binding in all member states and the framework is therefore not necessary to

implement into national legislation.

Article 29 of Regulation 1107/2009/EC establishes the main criteria for authorization of plant pro-

tection products. Article 29 (1) determines that a plant protection product is only acceptable if it ac-

cording to the uniform principles as mentioned in Article 29 (6), meets the requirements set out in

Article 29.

Article 29 (6) determines that the uniform principles for evaluation and authorization of plant pro-

tection products shall contain the requirements set out in Annex VI to Directive 91/414/EEC and

shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in

Article 79 (2) without any substantial modifications, as determined by regulations adopted under the

advisory procedure in Article 79 (2). Subsequent amendments to these Regulations shall be adopted

in accordance with Article 78 (1) (c) in Regulation 1107/2009/EC.

Annex VI to Directive 91/414/EEC is now transferred to the Commission Regulation (EU) No.

546/2011 of 10 June 2011 on the implementation of the European Parliament and Council Regula-

tion (EC) No 1107/2009 as regards the uniform principles for evaluation and authorization of plant

protection products. Therefore, the Regulation 546/2011/EU will henceforth set out the framework

for evaluation and authorization of plant protection products.

The uniform principles shall ensure that all member states make a uniform evaluation of each ap-

plied plant protection product, whatever country you apply in.

This document expands and complements Regulation 546/2011/EU, which transfer the uniform

principles from Directive 91/414/EEC to Regulation 1107/2009/EC, and also takes into account the

specific Danish conditions that are important for the evaluation of the impacts on human and animal

health and of the impact on the environment the plant protection products may have. The document

applies to all plant protection products which are to be approved under the Regulation

1107/2009/EC, including products authorized or re-authorized in accordance with the transitional

provisions as laid down in Regulation 1107/2009/EC.

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Framework for the human health risk assessment

Background

This part of the document concerns the human toxicological assessment of plant protection products

(PPP) in accordance with Regulation (EC) No 1107/2009. The main toxicological related updates in

this version 1.5 concerns the use of gloves for workers, re-entry and drift reducing equipment as a risk

mitigation measure, waiting periods for roof fogging application in greenhouses, clarification of buffer

strips as well as overall principles for specific considerations concerning toxicological assessment of

metabolites with respect to leaching to groundwater.

LEGISLATIVE USER RESTRICTIONS

To comply with EU regulations the PPPs are split into two user groups as follows:

Group 1) For professional users: Products which can only be purchased and used by professional users

who possess a valid spraying certificate or spraying permit.

Group 2) For non-professional users: Products which can be purchased and used by everyone, includ-

ing garden owners without a spraying certificate or spraying permit.

PPPs intended to be sold to and used by non-professional users have to fulfil the criteria outlined in

Annex 14.

Furthermore, Ministry of Environment’s Statutory Order on pesticides

states that pesticides classified

acute toxic in categories 1, 2, or 3 or with specific target organ toxicity SE in category 1 according to

the CLP regulation

, may not be used in private gardens, public areas and similar areas which are ac-

cessible to the public, areas around residential buildings, childcare institutions and similar, or to treat

vegetation on borders with public roads or private gardens, except for professional control of rats, wa-

ter voles and moles. In addition, these products cannot be sold to, or used by, non-professionals.

General approach to human health risk assessment

In order to carry out a risk assessment of the effects of a PPP on humans, information on the PPP’s ef-

fects and of the active substance's intrinsic properties must be available as well as an estimate of the

exposure.

The human health risk assessment is traditionally made up of hazard identification, hazard characteri-

sation, exposure assessment, risk characterisation and risk management.

The overall principles for assessing these areas are described individually in the following.

HAZARD IDENTIFICATION – classification

Hazard identification is the determination of the potentially adverse effects of the PPP based on studies

on the PPP and active substance.

The data requirements are provided in Commission Regulation (EU) No 283/2013 for the active sub-

stance and Commission Regulation (EU) No 284/2013 for the PPP. The criteria for classification of the

adverse effects are described in the CLP regulation.

Statutory order no. 1750 of 14 December 2015 on Pesticides as amended

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,

labelling and packaging of substances and mixtures amending and repealing 67/548/EC and 1999/45/EC and amending

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HAZARD CHARACTERISATION – setting of the AOEL and AAOEL

Hazard characterisation is the determination of a level of systemic exposure to the active substance that

is acceptable based on the critical effect, the dose-effect level, route, duration, and timing (e.g. terato-

genicity studies) of exposure. For risk assessment of PPPs these levels are called the acceptable opera-

tor exposure level (AOEL) and the acute AOEL (AAOEL).

The basis for the AOEL is the no observed adverse effect level (NOAEL). The NOAEL is defined as

the highest daily dose of the active substance that does not cause an adverse effect in the most sensitive

species. In case of several adverse effects, then the lowest relevant NOAEL is used. Usually the basis

for the AOEL is studies where the animals have been given the active substance via the oral route (ga-

vage or diet) for a sub-chronic period of time. Sub-chronic exposure is considered an appropriate mod-

el for the actual operator exposure.

After determining the relevant NOAEL a default uncertainty factor (UF) of 100 is usually applied. This

factor is made up of a 10-fold factor for interspecies variability and a 10-fold factor for intra-human

variability. The 10-fold factors for variability cover toxicokinetics as well as toxicodynamics. Some-

times additional UFs

can be attributed if there are severe irreversible effects such as toxicity to repro-

duction/teratogenicity or carcinogenicity. They could also be applied if the data package is too limited

or a LOAEL (lowest observed adverse effect level) is used to derive the AOEL.

The AOEL is refined if the oral absorption is less than 80 %.

The acute AOEL was introduced with the EFSA guidance on operator, worker, bystander and resident

exposure assessment and the EFSA calculator. Guidance on the setting of an acute AOEL is being de-

veloped in the EU.

The Danish EPA applies the AOEL and the acute AOEL determined in the EU.

EXPOSURE ASSESSMENT

Exposure assessment is the estimation of the exposure to the active substance. The estimation takes the

dermal absorption, the worst-case use and the possible use of personal protective equipment (PPE) or

other risk mitigating measures into consideration. To estimate the exposure different models have been

developed. These are considered more reliable than field studies due to statistical power. In general,

field studies are not accepted, when the application scenario is included in the Northern Zone Guidance

Document (newest version).

Usually exposure assessment and comparison to the AOEL or the acute AOEL is conducted in one

step. However, for simplicity risk characterisation is discussed in the next section.

Exposure assessments should be conducted for the operator, worker, bystander, and resident. For the

two latter both child and adult exposure are considered. The exposure assessments should be per-

formed for each active substance present in the PPP. As a first tier the worst-case scenario should be

used, this is defined from the intended use and application method of the product. Spraying technique

and equipment should be indicated on the label.

Exposure assessments are performed according to the Northern Zone Guidance Document (newest

version).

Regulation (EC) No 1907/2006

EFSA Scientific Committee; Guidance on selected default values to be used by the EFSA Scientific Committee, Sci-

entific Panels and Units in the absence of actual measured data. EFSA Journal 2012;10(3):2579.

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Dermal absorption

For operators, workers, bystanders and residents dermal exposure of pesticides is considered being the

major route of exposure. Therefore, an estimate of the dermal absorption of the concentrated PPP and

the in-use dilution of the PPP is necessary to refine the estimate of the exposure (See Northern Zone

Guidance Document, newest version).

Operators

Operators are persons involved in activities related to the application of the PPP, including mixing,

loading the PPP into the application machinery, as well as operating and repairing the application ma-

chinery. Operators might be professionals or non-professional users (home and garden users). Non-

professional users are assumed to use handheld spray equipment and have no PPE to protect them.

Workers

Workers are persons who, as part of their employment, enter an area that has previously been treated

with a PPP or who handle a crop that has been treated with a PPP. Examples of exposure scenarios are

re-entry into treated crops (e.g. crop inspection in fields or handling of crops in greenhouses) and sow-

ing of treated seeds (assessed as part of the exposure assessment of seed treatment).

The main routes of exposure during post-application activities are dermal and inhalation. The sources

of dermal exposure are contact with foliage (leaves and fruits), soil and possibly dust. Inhalation expo-

sure occurs by vapour and/or airborne aerosols (including dust).

After outdoor application of PPPs, there will be a more rapid dissipation of vapour and aerosols, lead-

ing to a lower inhalation potential than from indoor treatments.

Bystanders

Bystanders are persons who are located within or directly adjacent to the area where application or

treatment is in process or has recently been completed, whose presence is quite incidental and unrelat-

ed to work and who take no action to avoid or control exposure.

Relevant exposure sources are spray drift at the time of application, vapour, surface deposits, and entry

into treated crops.

Residents

Residents are persons who live, work or attend school or any other institution adjacent to an area that is

or has been treated with a pesticide, whose presence is quite incidental and unrelated to work involving

pesticides, who take no action to avoid or control exposure and might be in the location for 24 hours

per day.

Relevant exposure sources are spray drift at the time of application, vapour, surface deposits, and entry

into treated crops. However, it is assumed that there is no re-entry into treated cereal fields. The expo-

sures are summed.

Persons walking, playing, sitting, lying on lawns in gardens and public areas are recreational residents.

The relevant exposure to PPPs used directly on these lawns are dermal contact to the lawn (both adults

and children) and hand to mouth as well as object to mouth (children).

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Out-door treatment - fields, lawns, orchards

EFSA Guidance Exposure Calculator (EFSA calculator) is used for the exposure estimation of operator

(professional), worker, bystander (child and adult) and resident (child and adult). EFSA calculator does

not apply to non-professional operators. Hence, the Northern Zone has agreed on acceptable models

for this exposure assessment (see Northern Zone Guidance Document, newest version).

Application techniques outdoor are upward and downward spraying by tractor mounted equipment or

manual spraying by e.g. knapsack.

Recreational resident exposure on lawns should also be assessed for both child and adult. However,

golf courses are not considered public recreational lawns for which children has access to. Hence, a

risk assessment for child is not required.

In-door treatment - greenhouse

Until the new greenhouse model is incorporated into the EFSA calculator the Dutch model is used to

estimate professional and non-professional operator exposure. However, already now the EFSA calcu-

lator is used for worker exposure assessment. Resident and bystander exposure assessments are not

considered relevant for in-door use.

Spraying techniques in greenhouses are manual e.g. lance sprayers or knapsack or automated applica-

tion e.g. roof fogger or low-volume mist sprayer.

Contrary to out-door treatment, inhalation exposure of the worker is important after indoor treatment.

Both the spraying technique and the following crop handling may result in airborne pesticide drop-

lets/particles.

In the EFSA calculator task specific factors are used for the worker exposure assessment (see Table 14

in the EFSA GD

). The factors are depending on the application method and tasks to be performed e.g.

handling ornamentals. Be aware, that none of these task specific factors apply to volatile pesticides or

products applied as vapours. In such cases additional data may be required.

A worst case worker exposure scenario will be cutting, sorting and bundling of ornamentals after roof

fogger application.

Seed treatment

SeedTROPEX model is used for both operator (during the treatment or coating of seeds with the

PPP) and worker (handling and sowing of treated seeds) exposure assessment.

Exposure from all operator tasks (mixing, calibration, bagging and cleaning) should be summed as

it is assumed the same person performs these tasks. The same is applicable for all the worker tasks

(loading, sowing).

RISK CHARACTERISATION

Risk characterisation is the comparison of the actual exposure to the effect level/exposure limit. It is

concluded if and when there is a risk of harmful effects, and if there is options to circumvent the risk

(e.g. PPE).

If safe use is not demonstrated after taking PPE into consideration or PPE is not accepted as a refine-

EFSA (2014), Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assess-

ment for plant protection products. EFSA journal 2014; 12(10):3874, 55 pp.

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ment (bystander and resident), then exposure assessment considering risk mitigation measures such as

buffer strips, drift-reducing nozzles or re-entry interval can be performed (see below). If a risk mitigat-

ing measure is necessary to demonstrate safe use, the risk mitigation measure shall be mentioned on

the label as specified in the text below.

If the level of exposure does not become less than 100% of the AOEL or AAOEL taking PPE or other

acceptable risk mitigation measures into consideration then the use of the PPP is unacceptable, and the

PPP cannot be approved.

Risk characterisation is determined in two levels – acute risk and long term risk. In addition, cumula-

tive risk should be assessed if more than one active substance is present in the PPP (see Northern Zone

Guidance Document, newest version).

Acute risk

The acute risk assessment should be performed for the operator, worker, bystander and resident if the

PPP is potentially acute systemic toxic. However, acute exposure of residents is essentially the by-

stander scenario and thus covered by the bystander risk assessment in the EFSA calculator.

For the operator scenarios not included in the EFSA calculator, e.g. seed treatment and application in

greenhouses, it is not possible to assess acute exposure because the underlying data might not be suffi-

cient for acute exposure assessment.

Acute worker exposure cannot be assessed in the EFSA calculator because the current data are not ad-

equate.

Currently, acute risk assessment can only be performed for those PPPs containing an active substance

for which a reference value (acute AOEL) is set in the EU.

Long term risk

Comparison between the exposure assessment and the AOEL should be done for operators, work-

ers, bystanders and residents. However, long term exposure of bystanders is essentially the resident

scenario and thus covered by the resident risk assessment in the EFSA calculator.

Out-door Treatment - fields, lawns, orchards

Operators:

As a first tier the estimated exposure using workwear but no gloves is compared to the acceptable

operator exposure level (AOEL). If the level of exposure is greater than 100% of the AOEL, then a

second or higher tier can be conducted taking PPE into consideration:

Tier1 – workwear during mixing and loading and application but no gloves

Tier 2 – workwear during mixing and loading and application and gloves during mixing and loading

Tier 3 – workwear and gloves during mixing and loading and application

Higher Tier – e.g. head protection, respiratory PPE, closed cabin, or drift reducing equipment

Workers:

As a first tier the estimated exposure with normal working clothing, but no gloves is compared to

the acceptable operator exposure level (AOEL). If the level of exposure is greater than 100% of the

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AOEL, then a refinement of the exposure considering gloves or a consideration of a realistic re-

entry interval is appropriate depending on the task.

The table below specifies that gloves are not considered realistic for crop inspection tasks in cereals

and other field crops, but shorter re-entry intervals of 1-3 days are realistically reflecting re-entry to

check the result of spraying or start up of irrigation.

The availability and use of gloves during manual harvest activities varies, thus gloves cannot be

considered to demonstrate safe use. However, a calculated re-entry interval is considered realistic if

it is within the pre-harvest interval.

Cropping, reduction and propping up is performed in trees and bushes, tasks that require working

gloves, but they are not chemical resistant gloves. Hence, gloves cannot be considered for refine-

ment in this type of scenario. Therefore, re-entry intervals should be calculated to demonstrate safe

use.

Ornamentals are a very diverse group and both gloves and re-entry interval can be considered de-

pending on the ornamental and timing of spraying. It is for example possible to require gloves for a

limited interval until a re-entry interval demonstrate safe use without gloves.

Table: Realistic risk mitigation measures for the outdoor worker scenario.

Task

Crop inspection/ irriga-

tion (2 hour scenario)

Manual harvest (8 hour

scenario)

Searching, reaching,

picking including crop-

ping, reduction and

propping (8 hours)

Cutting, sorting, bun-

dling, carrying (8 h)

*list not exhaustive

Crop*

Cereals, root and tuber

vegetables, oilseeds,

Vegetables (brassica,

bulb, fruiting, legume),

strawberries

Pome and stone fruit,

berries, Christmas trees

Chemical resistant

gloves

Re-entry

1-3 days

A realistic re-entry inter-

val should be within the

PHI

Yes

Ornamentals

Yes

Re-entry is calculated from the equation for dermal exposure with an extra factor for decay using

dissipation time or half-life. A default dissipation half-life of 30 days should be used for organic

substances only if no DT

value or half-life data representative of the supported use(s)

are report-

ed. Link to a spreadsheet for calculation of re-entry will be available.

Bystanders and residents:

Bystanders and residents are not likely to use PPE. However, a risk mitigation measure could be to

increase the buffer strip from the default 2 meter in a tiered manner to either 5 or 10 meters. It is

possible to reduce the buffer strip by the use of drift reducing equipment from 10 meters to 5 meters

and from 5 meters to 2 meters if this is confirmed in the exposure assessment. The buffer strip in

In the EFSA calculator drift reducing nozzles reduces the drift by 50%.

6 Supported use includes crop type and dose according to GAP

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orchards is per default 5 meters and can similarly be increased to10 meters and be reduced from 10

to 5 meters with the use of drift reducing equipment. However, it cannot be reduced from 5 to 2 me-

ters because of lack of data. If a 10 meters buffer strip is not sufficient, drift reducing equipment can

be added.

Should the use of drift reducing equipment be necessary as a risk mitigation measure for the opera-

tor then this can be used for bystander and resident as well - instead of a buffer strip.

A buffer strip to roads, residential and public areas etc. should always be indicated on the label also

when it is the default 2 meters mentioned above.

Higher tier risk assessment using EUROPOEM II or German Guidance (Martin et al) is not accepted

for bystander and resident. Neither is the use of re-entry interval as a refinement for recreational resi-

dent risk assessment.

In-door treatment - greenhouse

Operators:

As a first tier the estimated exposure using work wear but no gloves is compared to the acceptable

operator exposure level (AOEL). If the level of exposure is greater than 100% of the AOEL, then a

second tier assessment can be conducted taking gloves into consideration and third tier considering

RPE.

Workers:

As a first tier the estimated exposure with normal working clothing, but no gloves is compared to

the acceptable operator exposure level (AOEL). If the level of exposure is greater than 100% of the

AOEL, then a second tier with normal working clothing and gloves should be considered.

The risk assessment also has to show that re-entry is safe. This includes both a) the re-entry interval

to do work and b) the waiting period with no access to the greenhouse for roof-fogging application.

Re-entry

If work is not safe even when using gloves, a re-entry interval can be used as a risk mitigation

measure and this should always be indicated on the label. Re-entry is calculated from the equation

for dermal exposure with an extra factor for decay using dissipation time or half-life. The inhalation

exposure should be added without considering decay. A default dissipation time value of 30 days

should be used for organic substances only if no data are reported for DT

or half-life representa-

tive for the proposed uses. Link to a spreadsheet for calculation of re-entry will be available.

Waiting period

The greenhouse will always be closed-off during spraying and for at least 8 hours afterwards.

Spraying is assumed to be performed in the evening where there is no access until the next morning.

Hence, it is not relevant to assess a waiting period. Whereas, when fogging equipment is used and

the contribution from inhalation exposure is greater than1% of the AOEL a waiting period is rele-

vant. The reason is that the data set behind the model is from 16 h after application. If the green-

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house should be closed for all access for more than 8 h, such a waiting period should be indicated

on the label.

RISK MANAGEMENT – Decision making

The final decision on approval and possible risk mitigation measures, restrictions on and require-

ments to the use of the PPP are made on the basis of the risk assessment. Restrictions and require-

ments should be indicated on the label if they are necessary for demonstrating safe use.

These are for example;



use of personal protective equipment

specification of the application methods

specification of by whom (professional or non-professional) and where the product is to be

used

reduction of exposure by use of drift reducing equipment and/or increasing of buffer strips

specification of re-entry intervals and/or waiting periods

reduced work rate, i.e. by limitation of the area sprayed/day or reduction in e.g. time to per-

form at task

METABOLITES OF NO CONCERN – Groundwater contamination

For metabolites without pesticide effect which fulfil specific Danish requirements for no toxicological

concern a limit value of 0.75 µg/L can be set based on an "ad hoc" assessment.

It must be demonstrated that such metabolites do not give rise to harmful effects on human health.

More specific guidance on data requirements and assessment criteria will be developed.

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Framework for the environmental assessment

Background

This part of the document concerns the environmental assessment of plant protection products in ac-

cordance with Regulation (EC) No 1107/2009 (hereafter ‘The Regulation’) replacing Directive

91/414/EEC by 14 June 2011.

This document was major revised in June 2011 in order to accommodate the new Regulation and fa-

cilitate more harmonized risk assessments in the Northern zone. The main change in this revision of

the framework for environmental risk assessment includes use of FOCUSsw modelling tools to predict

surface water exposure, inclusion of the Non Target Arthropods and Not Target Plants in the environ-

mental risk assessment. It is noted that it is a living document with continues need for updates. The ba-

sis of an environmental risk assessment is the data requirements provided in Commission Regulation

(EU) No 283/2013 for the active substance and Commission Regulation (EU) No 284/2013 for the

product.

As its point of departure, the environmental assessment of plant protection products covers areas con-

sidered to be of crucial environmental importance and on which sufficient knowledge for an assess-

ment is available. This particularly applies to persistence and mobility in soil, to bioaccumulation and

to effects on terrestrial and aquatic plant and animal species considered not to be pests (non-target or-

ganisms). In order to carry out risk assessment of the effect of plant protection products on the envi-

ronment, information on the products' effects on plants and animals must be available as well as ad-

equate information to calculate exposure, i.e. expected concentrations in soil, water, sediment and

relevant animal food items. According to the Uniform Principles

, assessment of the fate and distri-

bution/behaviour in the environment must consider all parts of the environment. To the extent pos-

sible therefore, the assessment should also cover dispersal to other parts of the environment, such as

air.

The assessment of the individual products in Denmark is based on their areas of use, so that only the

subordinate areas considered relevant to a given area of use are assessed (requirements on data for

the different areas of use are shown in Annex 1)

In principle, risk assessment should be carried out on the basis of a realistic worst case. In practice, a

tiered approach is used (cf. the Uniform Principles), in which assessment from a simple worst-case

is gradually refined towards a more realistic worst case.

This is done by initially carrying out an assessment of the substance's intrinsic properties (based on

laboratory results), which is possibly compared to a rough worst-case estimate of the expected con-

centration in the environment (PEC). If this is immediately acceptable the procedure stops at this ti-

er - if not, the procedure continues to higher tiers, where the assessment is gradually made more re-

Laid down in Regulation 546/2011 (see Article 29,6 in The Regulation), which was former Annex VI of Directive

91/414/EEC.

Further guidance for registration of Plant Protection Products in the Northern zone will be given in the ‘Guidance

Document on the process for work-sharing in the Northern zone in the registration of Plant Protection Products follow-

ing approval of active substance in EU in accordance with the Plan Protection Regulation (EC) No. 1107/2009/EEC.

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alistic by refining the estimate of the environmental concentration (exposure) towards a more realis-

tic value (e.g. by including degradation of the substance or by applying buffer zones or drift reduc-

ing equipment) and by including studies conducted under more realistic conditions (e.g. field stud-

ies).

The active substance, any metabolites

and the product must all be considered in the risk assess-

ment.

The requirements on data (and, thus, on the areas to be covered by the assessment) for the active

substance are clearly defined. The concept of metabolite is defined very broadly in the Uniform

Principles, where the concept of "relevant metabolites, degradation and reaction products" is used.

The Uniform Principles also place metabolites on the same footing as active substances, when the

metabolites are "of toxicological or environmental significance". Thus, there are no precise guide-

lines for this assessment in the Uniform Principles. Subsequent to the Uniform Principles, in 2003

the Commission published a guidance document on relevant metabolites which focuses on ground-

water and discusses the criteria that are relevant for metabolites and sets limits for the occurrence of

relevant metabolites in groundwater. In the opinion of the Danish Environmental Protection Agency

this document does not deal with the problem in accordance with the intentions of the Directive, es-

pecially in regards of contamination of groundwater (for more details see the section “Mobility”)

and consequently this document is not used by the Danish Environmental Protection Agency in its

national evaluations. The Danish Environmental Protection Agency carries out ad hoc appraisals of

the extent to which metabolites are significant with respect to health and the environment. As a rule,

a metabolite is included in the assessment (either in the form of considerations based on studies of

the active substance or on the basis of independent studies of the metabolite) if one of the following

conditions apply: a) Metabolites, which account for more than 10 % of the amount of active sub-

stance added in soil at any time during the degradation studies; or b) which account for more than 5

% of the amount of active substance added in soil in at least two sequential measurements during

the studies; or c) for which at the end of soil degradation studies the maximum of formation is not

yet reached. If, based on the available documentation, there are indications that metabolites ac-

counting for lower levels could prove problematical (e.g. in relation to groundwater pollution), they

must also be assessed. The Danish Environmental Protection Agency has decided that metabolites

that occur commonly in nature (for example pyrimidine) or which are simple substances such as

saccharine are not to be considered as relevant.

The environmental assessment is divided into two main areas:



Fate and distribution/behaviour in the environment



Effects on non-target organisms.

The overall principles for assessing these factors are described individually in the following.

Fate and distribution/behavior in the environment: persistence, mobility and bioaccumulation

A plant protection product containing a persistent or bio-accumulating active substance can impact

Metabolites are defined here as all degradation, reaction and transformation products of pesticides that differ from the

ultimate mineralisation products, i.e. CO

, H

O and mineral salts.

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the environment over a long period, whereas a mobile active substance can pollute groundwater.

These properties are appraised to determine whether there is any risk of the limit values or cut-off

values (called "triggers" in the Uniform Principles) being exceeded by a given use.

According to the Uniform Principles, products can be authorized despite the fact that they exceed

the cut-off values for persistence and bioaccumulation, provided that it can be shown scientifically

or by an appropriate risk assessment that the proposed use will have no unacceptable impact/effects

on the environment (a so-called “unless clause”).

For active substances that are subject to a national reassessment, the Danish Environmental Protec-

tion Agency find that it is not at present possible to appraise the long-term consequences of the use

of highly persistent substance (i.e. with half-lives of more than six months). Neither does the Danish

Environmental Protection Agency find it possible to assess the long-term consequences of the bio-

accumulation of active substances.

The Danish Environmental Protection Agency therefore continues to be of the opinion that authori-

zation cannot be granted to products with an active substance that is very persistent (DT

> 6

month) or where the bioaccumulation of the active substance exceeds the cut-off value (see section

on Bioaccumulation), if the products will be used in a way that involves exposure of the external

environment.

Concerning mobility (pollution of groundwater), there is no actual "unless clause" in the Uniform

Principles, as only reference is made to the fact that it must be possible to observe the limit values

under relevant field conditions.

Effects on non-target organisms: aquatic and terrestrial organisms

Plant protection products may constitute a risk of unacceptable impact on aquatic and terrestrial

non-target organisms. For the effect area, the main risk assessment's point of departure is the so-

called quotient method, in which the toxicity towards a given organism is compared to the level to

which that organism can be expected to be exposed (i.e. the Toxicity Exposure Ratio, TER, cf. the

Uniform Principles)

Assessment is done for relevant areas (soil, water, sediments etc.), with the point of departure in the

(few) species tested in connection with the application for authorization. There is, however, great

variation in sensitivity to different substances between individuals within a species and, especially,

between species within the same taxon/in different taxa. In order to protect more species than just

the species tested, the risk assessment includes an assessment factor (also called safety factor or un-

certainty factor), according to which the risk is assessed on the basis of comparing the quotient

(TER) with the assessment factor (cut-off value)

When determining toxicity or exposure, the quotient method gives no consideration to a number of

issues, for instance:

Following the revised Aquatic GD (EFSA PPR, 2013) Regulatory Acceptable Concentration (RAC) will be referred to in the

aquatic section, in accordance with the Northern zone Guidance Document.

An assessment factor is incorporated in the Regulatory Acceptable Concentration (RAC). I.e. the RAC can be directly compared to

a use specific PEC value.

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

extrapolation is done from only a few species to all species



no compensation is made for differences between laboratory tests and the actual conditions in na-

ture



the method cannot be used to estimate indirect effects (interactions through the food chain, etc.)



uncertainties cannot be fully quantified



exposure is often estimated on the basis of uncertain assumptions.

For these reasons, a risk assessment based on the quotient method can only yield an approximate es-

timate of whether or not a particular pesticide could carry the risk of unacceptable effects in the en-

vironment.

According to the Uniform Principles, the so-called triggers must not be used as actual cut-off crite-

ria, and products can be authorized despite the fact that triggers cannot be complied with, if an ap-

propriate risk assessment can clearly demonstrate that there are no unacceptable effects after using

the plant protection product under the proposed conditions of use (an unless clause). The Uniform

Principles do not, however, offer a more specific definition of how this should be proven.

In order to clarify the unless clauses in the Uniform Principles, EU guidance documents are drafted

on an on-going basis and are used in the EU assessments when substances are approved for the Eu-

ropean marked (Regulation (EC) No 1107/2009) . The guidance documents are not legally binding

but are used as a starting point in the EU assessments and to a growing degree also in the Danish as-

sessments. However, for areas without guidance documents it can be extremely difficult to conduct

a risk assessment and to determine which effects are acceptable or unacceptable. Therefore trigger

values from the Uniform Principles will in practice act as cut-off values.

The guidelines for the environmental risk assessment and decisions for the individual areas are de-

scribed in the following. It should, however, be emphasised that each individual decision will be based

on an overall assessment of the risk constituted by the product.

Assessment of cumulative ecotoxicological effects of products containing chemical mixtures are re-

quired for groups of organisms where the risk assessment is based on a quotient calculation, i.e.

birds, aquatic organisms, mammals, earthworms and bees (see annex 12).

ENVIRONMENTAL RISK ASSESSMENT AND DECISIONS

Fate and behaviour/distribution in the environment

The assessment of a substance's fate and behaviour/distribution is based on laboratory and field

tests, which investigate the degradation, mobility and bioaccumulation of the active substance and

its possible metabolites.

Each individual area is described in greater detail in the following sections.

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Fate in air

When recommendations on the assessment of evaporation and degradation in air are included in the

EU-assessments (FOCUS Air 2008), these issue will be included in the Danish assessments.

Persistence in soil

Persistent active substances can affect the environment over long periods of time, as such substanc-

es can be distributed and accumulated within and outside the areas in which they are used. Persis-

tent substances constitute a long-term and difficult-to-quantify risk of spreading in the environment

and effects on organisms. Persistent substances can also cause effects on and lead to residues in

subsequent crops. This also applies to the metabolites of an active substance. Therefore active sub-

stances with a DT

above 180 days cannot be approved in Denmark.

The persistency evaluation is based on an assessment of available reliable half-lives from both la-

boratory and field studies. All half-lives should be normalised to 20 °C and pF2. Assessment of per-

sistency should not be based on average or percentiles of the data. Instead data are assessed by con-

sidering the soil types used and focusing on soil types representative for Danish conditions. If in

general these soils have a DT

above 180 days, the active substance cannot be approved. If only

some of the soil DT

values are above 180 days, an ad hoc assessment is performed to decide if

these data constitute the major part of data and if it is likely that DT

for Danish soils is above 180

days under field conditions relevant to the intended use.

The persistency evaluation should be performed for both the active substance and metabolites.

However, metabolites which fulfil the following requirements is considered to be of no concern re-

garding persistence if:



The metabolite fulfil the Danish requirements for metabolites of no toxicological concern

(see section on human health risk assessment)



The metabolite does not constitute a risk of leaching to groundwater in concentrations > 0.1

µg/L.



The metabolite does not constitute a risk to soil living organisms (i.e. it does not trigger a

higher tier risk-assessment)

If the active substance or metabolites has a DT

< 180 days they do

not constitute an unaccepta-

ble risk to the environment, from the standpoint of persistence.

If a metabolite of no concern has a DT

> 180 days it does

not constitute an unacceptable risk to

the environment, from the standpoint of persistence.

If the active substance and metabolites of concern have a DT

> 180 days they do

constitute an

unacceptable risk to the environment,

and products containing such an active substance cannot be

authorised for outdoor use.

Biological effects require that there is bioavailability, i.e. that exposure of biota occurs. Therefore a

distinction is made between substances that are persistent because they degrade slowly and sub-

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stances that are not bio-available. It is therefore important to consider the extraction methods used

in the degradation tests. The extraction method can lead to substances being extracted from the soil

regardless of where and how they reside in the soil matrix. Even substances that are more or less

bio-unavailable can be extracted by some methods and thereby the normally bio-unavailable portion

is included in the pool of substances that define persistence. This can result in a substance being as-

sessed as persistent. On the other hand, extraction methods that are too harsh can destroy the mo-

lecular structure of an active substance and thereby lead to an underestimation of the percentage of

active substance in the soil. Applicants must therefore be able to document that this is not the case.

Therefore, in 2002, the Danish Environmental Protection Agency decided to change its practices

(cf. meeting of the Pesticide Advisory Board 7 March 2002) because sufficient information is avail-

able on some substances that it must be concluded that the connection between degradation, adsorp-

tion and bioavailability is well documented. In such cases an ad hoc assessment can be carried out

with a view to make an exception from the persistence criteria below.

Therefore, in special circumstances an exception can be made if adequate information is available

on the connection between the substance’s rate of degradation and adsorption, such that it is possi-

ble to assess with certainty the degradation rate of a substance in its free (i.e. non-adsorbed) state.

Furthermore the connection between adsorption (including possible saturation of binding sites), ex-

traction methods and bioavailability must be fully documented.

PEC

soil

Calculation of PEC

soil

follows the Northern Zone guidance document.

Groundwater/Mobility

Mobile active substances entail a risk of unacceptable leaching through the soil to groundwater, wa-

tercourses and lakes, which can cause pollution of groundwater and/or undesirable effects on the

environment. The same applies to mobile metabolites.

The Uniform Principles specify limit values

for the pollution of groundwater. These values are:



0.1 µg/l for each individual substance



0.5 µg/l for the sum of substances

Limit values may however be lower for some substances, if the limit values are set by specific

health risk assessments of the individual substances, cf. footnote 7.

Point C 2.5.1.2 of the Directive mentions that authorization cannot be granted if the concentration of the active sub-

stance or its relevant metabolites, degradation or reaction products in groundwater resulting from the proposed use, can

be expected to exceed the lowest of the following limit values: i) the maximum permissible concentration laid down in

the Directive on drinking water (80/778 /EEC), ii) the maximum concentration which the Commission has set on entry

of the active substance in Annex I or, where such a limit is not set, one tenth of the ADI that was set on entry in Annex

To be interpreted as the sum of the active substance and its metabolites.

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For metabolites without pesticide effect which fulfil the Danish requirements for no concern (see

section on human health risk assessment) and which do not constitute a risk to non-target organisms

(see section above) a limit value of 0.75 µg/L can be set based on an "ad hoc" assessment.

If the proposed use entails exposure of the external environment, the Danish Environmental Pro-

tection Agency (cf. below) considers whether or not there is an unacceptable risk of the concen-

tration of the active substance and/or its metabolites exceeding the above limit values for

groundwater.

The risk of leaching is assessed from mathematical modelling. The requirements of the Danish En-

vironmental Protection Agency’s for mathematical modelling are listed in annex 6. The most im-

portant requirements are:



The PELMO 5.5.3 model (or comparable model) with the Hamburg scenario or MACRO

5.5.3 with the Danish scenarios. If both models are used then the results of both models

must fulfil the limit values.



Substance specific parameters: 80 percentiles for degradation rates and sorption ratios (1/n)

must be used and for K

20 percentiles must be used



Separate model runs must be executed for at least three individual days of the period in which

use of the product is proposed.



Use every 2

, 3

and 4

year can only be used as a refinement option if the crop can only be

grown 2

, 3

og 4

year. A list of crops where this refinement option can be used can be

found in Annex 13.



The results must be reported as annual averages. This also applies if the substance is used eve-

ry second, third or fourth year. All output files must be submitted.

In this way the assessment is done for a realistic worst-case situation, based on the annual average

concentration in the water that percolates to the ground water. If this concentration does not exceed

the limit values in more than 1 of 20 years, the product is considered

not to constitute an unac-

ceptable risk of polluting groundwater

for the proposed use. If one or both of the limit values are

exceeded, the product cannot be approved for the proposed use, unless other studies (lysimeter stud-

ies, field studies, and/or monitoring data) very convincingly demonstrate that unacceptable leaching

will not occur in the Danish context. When evaluating such studies, consideration must be given to

whether soil, climate and conditions of application (crops, vegetation cover, application method,

formulation of the product, its quantity and time of application) correspond to Danish conditions.

Data from the Pesticide Leaching Assessment Programme

(PLAP) can be used in the assessments.

When evaluating risk of leaching to groundwater only data from the groundwater installations in

PLAP are used and not samples from drains or suction cups. Considerations may also be given to

conditions of use (e.g. use on paved areas

). The assessment is done for a realistic worst-case situa-

tion, based on the annual average concentration in the water that percolates down from the root

zone (a depth of about 1 metre).

Formation factions and DT

values should be from the same tier (i.e. lab or field) if data are available.

http://pesticidvarsling.dk/om_os_uk/uk-forside.html

Special documentation is required for paved areas and a special assessment is carried out, see Annex 4 (cf. Newslet-

ter, Nov. 1999).

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Surface water

Assessment of the concentration of an active substance or its metabolites in surface water is not an

end in itself but must be considered in relation to the ecotoxicity data of the active substance or me-

tabolites. The assessment of the concentration in surface water follows the guidance by FOCUS

(2001). The assessment is a stepwise approach with 4 steps. Step 1 accounts for an ‘all at once’

worst-case loading without specific additional characteristics. The Step 2 calculation accounts for a

more realistic loading based on sequential application patterns, while no specific additional charac-

teristics of the scenario are defined. Step 3 performs an estimation of the PECs using realistic worst

case scenarios but taking into account agronomic, climatic conditions relevant to the crop and a se-

lection of typical water bodies. Finally, Step 4 estimates the PECs based on specific scenarios in-

cluding risk mitigation, which should be used on a case-by-case basis if Step 3 fails.

The special requirements of the Danish EPA are describes below. Aside from this the assessment

follows the FOCUS guidance document (2003).

FOCUSsw Step 1 and 2: The assessment follows the FOCUS guidance.

FOCUSsw Step 3: Scenarios D3 (sandy soil, Vredepeel, Netherlands) and D4 (loamy soil, Skousbo,

Denmark) are considered to be the relevant scenarios representing geological and climate conditions

of Danish agricultural soil, i.e. only inputs from spray drift and drainage are considered relevant for

Danish conditions. The highest PECsw derived from D3 and D4 is used in the aquatic risk assess-

ment. Noted that FOCUSsw Step 3 operates with default crop specific distances between crops and

the top of the bank that defines the edge of the water body (0.5-3m). If the aquatic risk assessment

is based on FOCUSsw Step 3, a no-spray zone of 2 meters has to be added on the label in order to

cover the FOCUSsw Step 3 model assumptions. It is noted, however, that if a FOCUSsw Step 3 risk

assessment is requested to ensure a FOCUSsw Step 2 risk assessment where the TER value is not

10x the required trigger (to take account of possible higher PEC values at FOCUSsw Step 3), a 2

meter buffer zone is not required. Step 4: Risk mitigation measures can be applied at this step. In

accordance with the recommendations in the FOCUS Landscape and Mitigation report (2007), up to

95% drift reduction (compared to Step 3) based on no spray buffer zones can be applied

. Guidance

on crop type specific maximum acceptable no spray buffer zones is provided in Annex 9. Mitigation

of drainage contributions shall follow the recommendations in the FOCUS Landscape and Mitiga-

tion report (2007) i.e. maximum 90% reduction of drain contributions (e.g. prohibit application to

drained soil).

Input parameters must be in accordance with FOCUS surface water guidance.

Metabolites are modelled in accordance with FOCUS surface water guidance.

Bioaccumulation

Bio-accumulating active substances entail a risk of accumulation in organisms. Accumulation

can occur when aquatic organisms absorb the active substance from water and accumulate it in

tissue in a concentration higher than the concentration in the water. Similarly, an active substance

can accumulate in the food chain, so that the highest levels of the chain receive higher concentra-

DK EPA does not approve PPP's intended for spot application in field crops, since it is not considered realistic or

practically possible, that such an application restriction would be respected.

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tions in tissue than the lower levels (biomagnification). The same applies to bio-accumulating me-

tabolites.

Tier 0:

Potentially bio-accumulating substances (i.e. log Kow > 3) are assessed on the background

of laboratory tests to determine whether the active substance or relevant metabolites:



can be expected to accumulate in aquatic organisms with a bio-concentration factor of greater

than 1000

, if they are easily degradable



are expected to accumulate in aquatic organisms with a bio-concentration factor of greater than

100, if they are not easily degradable



are expected to accumulate in terrestrial food chains with a biomagnification factor (BMF) of

greater than 1

If the above values are not exceeded, products containing the relevant active substance are not con-

sidered to constitute any unacceptable risk to the environment with respect to bioaccumulation. If

any of the values are exceeded, the procedure continues to Tier 1.

Tier 1:

The active substance or its metabolites are evaluated to determine whether the elimination

rate for the organ from which elimination is slowest has a DT

< 3 days and a DT

< 14 days (the

latter trigger is used in the Uniform Principles). If this is the case, products containing the relevant

active substance are considered not to constitute any unacceptable risk to the environment, from the

standpoint of bioaccumulation. If these elimination rates are exceeded, products containing the rele-

vant active substance cannot be authorized for outdoor use.

Effects on non-target organisms and risk assessment.

Plant protection products may present a risk of unacceptable effects to non-target organisms in the

aquatic and terrestrial environments. Appraisal of the extent to whether these effects are unaccepta-

ble (or not) is based on laboratory tests in a number of standard organisms. The risk is estimated on

basis of toxicity towards tested organisms, predicted exposure (which is modelled on the basis of

the product's use/dossing and substance properties) and use of an Assessment Factor (AF) in order

to take account of uncertainties. A tiered assessment is carried out, in which the estimate of toxicity

and exposure are gradually refined towards a more realistic worst case or introduction of risk miti-

gation measures, as described below.

Assessment of toxicity

The toxicity assessment

is initially (Tier 0) carried out on the basis of the available laboratory end-

point. These endpoints will in many cases have been derived and agreed during the EU process of

the active substance; in such case, the studies are appraised to determine whether they are repre-

sentative of the metabolites and product. In the cases for which studies of the active substance and

metabolite, or studies of the product, are available, assessments are made for each of the subordi-

Assessed on the basis of bioaccumulation studies in fish, in which whole fish are the point of departure.

Cf. the OECD guidelines for the testing of chemicals, see Annex 8.

See EFSA guidance on Risk Assessment for Birds and Mammals (EFSA, 2009).

Biomagnification and food chain behaviour for birds and mammals are addressed in the section on risk assessment for

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nate areas to determine whether it is most likely that exposure will be to the active substance and/or

metabolite or to the product (e.g. birds will be exposed to the product, where seed dress-

ings/granulated formulations are concerned and non-target arthropods are exposed to sprayed for-

mulations) and consideration is given to this in the risk assessment.

The risk assessment includes data for all relevant test organisms. The risk assessment is normally

made on the basis of the most sensitive organism. The assessment includes the short-term (acute)

effects and effects over longer periods (chronic), if such data are available and if there is a question

of exposure for longer periods.

The LD

, LC

or EC

values obtained from laboratory tests are used as the initial measure of

acute toxicity.

In the case of

chronic toxicity,

the no observed effect level (NOEL) or no observed

effect concentration (NOEC) have hitherto been used, but in the future more and more chronic stud-

ies are expected where an EC

(x is normally 5 or 10) is derived and should be used in the chronic

risk assessment (cf. the data requirements and test guidelines). When ECx values are available from

chronic studies they should be used in the chronic risk assessment.

The Danish Environmental Protection Agency does check that no effects are really observed for the

NOEC or NOEL. The mathematical/statistical NOEC can be disregarded if there is an obvious but

not statistically significant effect, which can be the case if the statistical uncertainty is high. If the

NOEC value is considered credible (i.e. if it is only a question of marginal numerical differences

relative to the control group), it is used in the risk assessment; if not, the data can be re-analysed, for

instance, to determine the EC

or a corresponding value considered to constitute a negligible effect

level when viewed from the standpoint of the population (the determination of this level demands

expert assessment for each individual species).

Use of acute geometric mean effect endpoints is accepted in line with recommendation in the

Northern zone GD (2016).

At higher tiers, the toxicity data from additional laboratory tests and subsequent semi-field and field

studies of effects on aquatic and terrestrial organisms are included in the risk assessment.

If formulation toxicity data are not available, mixture toxicity should always be considered for acute

and long-term risk assessment in accordance with the Northern zone GD (2016).

Assessment of exposure

With regard to

exposure,

the concentration and bioavailability of a given substance in the environ-

ment will vary considerably, depending on local conditions and the substance's intrinsic properties.

It goes without saying that it is not possible to include all of the conditions that determine the con-

centration when estimating exposure and neither is it possible to work with a large number of dif-

ferent values. To allow for the probably considerable variations in environmental concentrations, a

birds and mammals.

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"normal use" situation with respect to the dose and crop will be treated as a realistic worst-case sit-

uation.

In the aquatic compartment the estimation of exposure follow the tired approach provided for FO-

CUSsw modelling (see fate section). When adjusting the PECsw, consideration must always be giv-

en to the toxicity value with which it will be compared (e.g. consideration must be given to the form

of exposure used in the test (static or flow-through, etc.) and to the point in time at which the effects

start). Possible use of a time weighted average (TWA) exposure when conducting risk assessments

chronic effects

should follow the recommendations in the EFSA PPR (2013) and the Northern

zone GD (2016) i.e. addressing all concerns regarding use of TWA.

Additional information (in the form of specific laboratory, semi-field or field studies of the sub-

stance's fate) can be included at higher tiers in a realistic worst-case estimate of the PEC. In addi-

tion it is possible to include mitigation measures.

Since June 2016 DEPA has accepted the use of drift reducing equipment as a mean to reduce buffer

zones stated on the label in accordance with statutory Order no. 1750 of 14/12/2015 and the associ-

ated guidance document 17 (2016)

. However, as drift may not be mitigated more than 95% in to-

tal (no-spray buffer zones and/or use of drift reducing equipment) comparted to drift estimated in

FOCUSsw Step 3 it is not possible to further mitigate the risk by imposing drift reducing tech-

niques.

The following section describes risk assessment and decision making for each individual subordi-

nate area in more detail.

Aquatic organisms

The Danish risk assessment for aquatic organisms generally follows the Northern Zone GD that again

builds on the guidance given in the EFSA aquatic GD (2013). Only specific national requirements and

exceptions to the Northern zone GD regarding aquatic risk assessment are given below.

Details on how to perform exposure estimates required for Denmark are given in fate section of this

document. Aquatic risk assessments relevant for Denmark require PEC estimates for the FOCUSsw

scenarios D3 and D4.

Mesocosm and Assessment Factor

The Danish EPA accept the use of Ecological Recovery Option (ERO) derived from mesocosm studies.

However, the recovery period must not exceed 4 weeks. The appraisal of the quality of the tests study

is given in the EFSA Aquatic GD (2013).

The assessment factor (AF) is associated with an ERO

from a mesocosm studies. As the point of de-

parture, a minimum assessment factor of 5 will be used (as individual tests cannot be expected to be

representative of all of the organisms or biotopes in the landscape at any time that may be exposed).

http://www2.mst.dk/Udgiv/publikationer/2016/06/978-87-93435-79-7.pdf

The Ecological Threshold option (ETO) is used by all other MS in the Northern zone and the AF is set in accordance with

the Northern zone GD (2016) for this option.

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Further advice regarding application of AF is given in annex 10.

If the data on a specific substance does not indicate that fish are more sensitive than invertebrates,

mesocosm studies of invertebrates are considered to be representative of fish in connection with a

higher-tier risk assessment.

If there are signs that fish are more sensitive, for example to endocrine disrupters, the total data set is

assessed for the specific case.

If specially designed semi-field or field tests are available, an ad hoc assessment will be made on the

basis of a realistic worst-case situation.

Accepted mitigation

Risk mitigation of spray drift should follow the specifications in Annex 9, including the limitations on

maximum no-spray buffer zones for different types of crop.

If several mesocosm tests of high quality have been submitted that illustrate the difference there can

be between the various natural systems, the assessment factor can be reduced in accordance with the

guidelines in Annex 10. Tests that are different in terms of time and space can be used to lower the

assessment factor if they represent different population mixes or biotopes.

If there is considered to be no question of unacceptable effects (possibly conditional on the use of

preservation zones) and the studies are satisfactory, the product is

not considered to constitute any

unacceptable risk to aquatic organisms,

in the proposed use.

If no such documentation is available, or if it is not possible to ascertain on the basis of the available

documentation that no unacceptable effects will occur, the product cannot be authorized for outdoor

use.

For cumulative risk assessment of combination products, follow the Northern zone GD (2016).

Sediment-dwelling organisms

Following the data requirements the risk for sediment-dwelling organisms should be assessed if a

substance can accumulate in sediment (see Annex 13).

PECsed values are derived from FOCUSsw modelling (see fate section).

For cumulative risk assessment of combination products, follow the Northern zone GD (2016).

Terrestrial organisms

The risk assessment for terrestrial organisms is based on standard laboratory tests in birds, mam-

mals, earthworms, micro-organisms and, possibly, arthropods.

Typical conditions of significance to the concentration and bioavailability of active substances and

metabolites in terrestrial environments include adsorption, mobility, run-off, vegetation cover, ab-

sorption by plants, evaporation and chemical, biological or photolytic degradation, etc.

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Birds and mammals

The toxicity assessment is based on standard laboratory tests in birds and mammals. In the case of

spray products, it is assumed that birds and mammals are exposed through their food, due to deposi-

tion of pesticide on plants or insects, including residual concentrations in plants. For granules and

dressed seeds, the exposure is assessed on the basis of ingestion of these.

The risk assessment is carried out as a tiered risk assessment on the basis of the scenarios and prin-

ciples that are used in the Community assessments in accordance with the revised guidelines in ”

Guidance of EFSA on Risk Assessment for Birds and Mammals” (EFSA, 2009). The initial risk as-

sessment - Screening tire and Tier 1 risk assessment - follows the Guidance Document (EFSA,

2009).

If higher tier refinements are required in order to address the risk to birds and/or mammals from an

applied use of a product, guidance is give in the Northern zone guidance document “Pesticide risk

assessment for birds and mammals - Selection of relevant species and development of standard sce-

narios for higher tier risk assessment in the Northern Zone in accordance with Regulation EC

1107/2009” and an associated calculation tool is provided in the form of an Excel spreadsheet

The intention of the guidance is to provide risk assessments for birds and mammals, based on

Northern zone focal species relevant for the crop type and its growth stage. Biological background

information on crop stage specific relevant focal species and available refinement options are pre-

sented in this document and it is applied in the calculation tool.

All the higher tier refinement options given in this document are agreed among the Northern zone

member states and as such accepted in the core assessment.

If needed, further higher tier refinements, accepted by Denmark, are given in “Guidance Note on

Higher Tier Birds & Mammals Risk Assessment in Denmark”

The risk from food chain poisoning shall be addressed for products with potential for bioaccumula-

tion (see section on bioaccumulation for definitions). The risk assessment shall follow the Guidance

Document (EFSA, 2009).

If TER values are greater than the trigger values in the Uniform Principles, the product is consid-

ered not to constitute any unacceptable risk to birds or mammals for the proposed use.

For the acute cumulative risk the assessment shall follow the Bird and Mammal Guidance Docu-

ment (EFSA, 2009). For the chronic cumulative risk the assessment shall follow guidance given in

Annex 12.

Bees

The risk assessment for bees follows the Guidance document on terrestrial Ecotoxicology (2002).

Available on the Danish EPA website

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For products applied as sprays where risk as assessed according to the HQ approach exposure should

be established as the maximum single application rate of the product expressed as g/ha because the HQ

was validated on this measure.

For systemic plant protection products, exposure considerations and calculations should be based on

the a.s. (or metabolite) present in the respective plant parts (e.g. nectar, pollen) to which honeybees

could be exposed.

The hazard quotient is stated to be application rate/oral LD50 or application rate/contact LD50,

where the LD50 is expressed as ug a.s./bee and the application rate is in g a.s./ha. As stated above,

the maximum single application rate should be used to calculate the oral and contact HQ-values. If

the oral and contact HQ < 50, low risk to bees is concluded and no further testing is required. If the

oral or contact HQ > 50, further higher tier testing is required to evaluate the risk to bees. The criti-

cal HQ of 50 was validated against incidents (EPPO 2002b); it is only applicable to spray products.

Higher tier refinements should follow the Guidance document on terrestrial Ecotoxicology (2002).

Arthropods

The initial risk assessment for non-target arthropods (NTA) is based on glass plate tests with the

two standard species (Aphidius

rhopalosiphi

and

Typhlodromus pyri)

in accordance with the Guid-

ance Document on Terrestrial Ecotoxicology (SANCO 10329/2002). By comparing the endpoint of

these studies are LR50 values (i.e. lethal rate that causes 50 % mortality) which the predicted expo-

sure both in-field and off-field, hazard quotients (HQ) are derived. Hence, the assessment of risk for

arthropods living in- and off-field is conducted separately.

If the resulting HQ is greater than or equal to 2, then further data and/or risk management measures

are required.

There are several options for higher-tier testing or combinations of adequate tests: extended labora-

tory tests (tests with natural substrate aiming at lethal and sub-lethal effects), aged-residue studies,

semi-field tests and field tests. Depending on the individual case testing on additional species might

be triggered.

For further details please refer to the Guidance Document on Terrestrial Ecotoxicology (SANCO

10329/2002) and the recommendations of ESCORT 2.

Mitigation:

In order to reduce effects in off-field areas, Danish EPA considers that buffer zones, as described in

Annex 9, specifically to protected paragraph3-habitats

must be considered in order to mitigate ex-

posure to non-target arthropods.

Beneficial arthropods:

The appraisal of beneficial arthropods other than bees is described in annex 15.

beneficial arthropods, which are a natural part of integrated pest control. The compatibility of greenhouse products

with the principles of biological pest control set by the Danish Institute of Agricultural Sciences (DJF) is assessed.

habitat types encompassed by section 3 of The Protection of Nature Act, with exception of aquatic habitats like lakes,

ponds, streams etc.

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In-soil organisms

The assessment is based on standard laboratory tests of earthworms (chronic tests). The exposure of

earthworms is assessed on the basis of deposition of the substance on soil and, in the case of spray

products, subsequent exposure through the soil. In the case of dressed seeds and granulates, expo-

sure is assessed on an ad hoc basis.

Tier 0:

PEC is estimated in accordance with the Northern zone GD (2016) If dressed seed or granulate is

used an ad hoc assessment is carried out. In the case of active substances that bind strongly to soil

(log Kow > 2), correction for this is made by dividing the effect values by 2, as laboratory tests in

earthworms are conducted in artificial soil with a high content of organic material (and, thus re-

duced availability of the test substance).

The toxicity exposure ratio (TER) is estimated on the basis of the toxicity data and the PEC and is

compared to the relevant assessment factor as shown below:

Chronic toxicity:

TER = NOEC or ECx/PEC > 5

The chronic toxicity for earthworms is assessed on the basis of reproduction studies.

If the quotient is greater than the assessment factors used, the product is considered not to constitute

any unacceptable risk to earthworms/terrestrial invertebrates in the proposed use. If, on the other

hand, the TER quotient is lower than the assessment factors, the procedure continues to Tier 1.

Tier 1:

The PEC is adjusted with respect to the vegetation cover (see Annex 11) (as the test is regarded as a

simulation test, in which the exposure is expected to reflect a natural degradation process, the PEC

is not initially adjusted with respect to degradation of the substance) and compared to the toxicity. If

the TER value is greater than the assessment factors used, the product is considered not to constitute

any unacceptable risk to earthworms/terrestrial organisms in the proposed use. If, on the other hand,

the quotient is lower than the assessment factors, the procedure continues to Tier 2.

Tier 2:

If relevant data is available in the form of specially designed laboratory, semi-field or field tests, an

ad hoc assessment of a realistic worst-case situation is carried out. In this connection, the Danish

Environmental Protection Agency has set an acceptable effect level of a 50 percent reduction in

earthworm populations ("Probable high risk", in the classification proposed in "Earthworms as eco-

toxicological test organisms", Christensen & Mather, 1994), on condition, however, that recovery

occurs within one season/within the intervals between spraying (cf. EPPO Bulletin). The assessment

factors that are associated with this effect level depend on the quality of the toxicity studies. In this

context, consideration must be given to the fact that this assessment is not necessarily representative

of other terrestrial organisms. For other species, ad hoc assessments of the effect levels are carried

out.

If there is not considered to be any question of unacceptable effects and the studies are satisfactory,

the product is considered not to constitute any unacceptable risk to earthworms/soil-dwelling organ-

isms in the proposed use.

If no such documentation has been presented, or if the available documentation does not make it

possible to ascertain that no unacceptable effects can occur in earthworms and other soil-dwelling

invertebrates, the product cannot be approved for outdoor use.

For cumulative risk assessment of combination product, where product effect data are not available,

follow the guidance in Annex 12.

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Microorganisms

The assessment of effects on microorganisms is based on an appraisal of microbial processes, in

which an evaluation is carried out of whether or not the microbial metabolisation of N and C are in-

fluenced by the active substance or its metabolites. In the case of spray products, the exposure of

microorganisms is assessed on the basis of the deposition of the substance on soil and the resulting

exposure through the soil. Where granulates and dressed seeds are concerned, the exposure assess-

ment is based on a mixture of the active substance in the soil, unless special tests are available.

Tier 0:

PEC is estimated in accordance with the Northern zone GD (2016)

The trigger for effects on the microbial metabolisation of N (N mineralisation) is set to 25 per cent

reduction after 100 days. The Danish Environmental Protection Agency will initially use this trigger

as a cut-off value in risk assessments in relation to the initial concentration in the soil. If the inhibi-

tion of microbial processes is below 25 per cent, the product is not considered to constitute an unac-

ceptable risk to microorganisms in the proposed use. If the inhibition exceeds 25 per cent, the pro-

cedure continues to Tier 1.

Tier 1:

As the test methods used are a simulation test (in which the exposure is expected to reflect a natural

degradation process), the PEC is not adjusted in relation to degradation of the substance unless there

are major differences in the degradation rates between laboratory and field tests. The PEC is adjust-

ed in proportion to how great a quantity of the sprayed product/active substance is deposited on the

soil for a given crop, at a given time of application (see Annex 11 for a more detailed description).

Tier 2:

An ad hoc appraisal of specially designed laboratory, semi-field or field tests is carried out. These

tests must be able to demonstrate that, in the proposed use, the product has no unacceptable influ-

ence on microbial activity with respect to the microorganisms' reproductive capacity.

If there are not considered to be any unacceptable effects and if the study is satisfactory, the product

is not considered to constitute any unacceptable risk to microorganisms in the proposed use.

If no such documentation is available, or if it is not possible ascertain on the basis of the available

documentation that no unacceptable effects will occur, the product cannot be authorised for outdoor

use.

Biological methods of wastewater treatment

Within the scope of the Regulation (EC) No. 1107/2009 the risk to Biological Methods of Wastewater

Treatment will be assessed where use can cause exposure of the wastewater treatment plant (e.g. for

greenhouse products and post-harvest use). There are no specific guidelines for risk assessment of this

area, and therefore an ad hoc assessment will be done on the basis of whether a realistic worst-case

PEC can cause unacceptable effects.

Non-target plants (NTP)

The risk assessment shall follow the Northern zone GD (2016) regarding NTP. I.e. repeated appli-

cation needs to be considered in a risk assessment, by relating drift values to number of applications

(See appendix IV in Escort 2 (Candolfi et al., 2001).

Non-target plants are considered to be non-crop plants located outside the treatment area.

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In order to reduce effects in off-field areas, DEPA considers that buffer zonesand/or drift reducing

equipment, as described in Annex 9, specifically to protected paragraph 3-habitats

should be con-

sidered in order to mitigate exposure to non-target plants.

Habitat types encompassed by section 3 of The Protection of Nature Act, with exception of aquatic habitats like lakes,

ponds, streams etc.

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List of Annexes

Annex 1: Data requirements on plant protection products

Annex 2: Soil classifications in Denmark

Annex 3: Climate conditions in Denmark

Annex 4: Paved areas

Annex 5: Appraisal of field studies and lysimeter tests for pollution of groundwater

Annex 6: Appraisal of mathematical modelling of risk of pollution of groundwater

Annex 7: Monitoring data

Annex 8: Definition of readily biodegradable

Annex 9: Non-spraying buffer zones to the aquatic and terrestrial environment

Annex 10: Assessment of mesocosm studies

Annex 11: Vegetation cover and deposition on soil

Annex 12: Environmental risk assessment of cumulative effects for combination products

Annex 13: Crop rotation - normal cultivation practices in Denmark

Annex 14: Criteria for pesticides that can be used by and sold to non-professional users

Annex 15: Beneficial organisms (other than bees).

Annex 16: Abbreviations

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Annex 1: Data requirements on plant protection products

The basis for the specific data requirements are provided in the Commission regulations (EU) lay-

ing down the data requirements for the dossier to be submitted for the approval of active substances

contained in plant protection products (COMMISSION REGULATION (EU) No 283/2013) and for

the authorisation of plant protection products (COMMISSION REGULATION (EU) No 284/2013).

In the tables below, the main data requirements are listed according to the application form and

subdivided into the following areas of use:

1. Agriculture; outdoor use

Forestry; outdoor use

Fruit growing; outdoor use

Nursery gardens, market gardening; outdoor use

Soil disinfection; outdoor use

2. Private use in gardens

Greenhouses

Soil disinfection; indoor use

Products for controlling algal growth; indoor use

Products for controlling algal growth; outdoor use

3. Seed dressings

4. Granulates

5. Repellents

Insecticides; indoor use

Insecticides; in stored grain

Please notice, the tables only give an initial overview without details and are no intended to repli-

cate the formal data requirements.

For these uses the standard data requirements apply as a rule, but an ad hoc assessment can be carried out based on

the extent/crop etc. of the use.

For private use in gardens data on adsorption/desorption is also required.

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Data requirements on active substance for area of use:

Plant metabolism

Metabolisation in 1 soil type

Degradation, 3 soil types, aerobic

Photolysis on soil

Adsorption/desorption

Accumulation of active substance and significant metabolites

soil(if DT50 > 3 months)

Evaporation from soil (only if vapour pressure > 10

-3

Pa)

Biological degradation in water/water-sediment studies

Effects on water treatment plants

Acute toxicity in fish

Long-term toxicity in fish

Acute toxicity in daphnia (and additional species for insecticides)

Reproduction test in daphnia

Acute toxicity in algae (and macro-algae for herbicides)

Effects on other aquatic organisms

Bioaccumulation (Kow > 1000)

Long-term effects in earthworms

Effect on soil micro-organisms

Acute toxicity in one bird and mammal species

Reproduction test in one bird and mammal species

Effect on honey bees

Any information on toxic effects towards other useful species

Data requirements on product for area of use:

Content of substances harmful to honey bees

Other ecotoxicological effects

Non-target arthropods

(Aphidius rhopalosiphi and Typhlodromus

pyri).

Non-target plants

Acute toxicity in fish

Acute toxicity in daphnia

Acute toxicity in algae

See p.2 for description of significant metabolites.

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Annex 2: Soil classifications in Denmark

The Danish soil types are classified according to the distribution of their particle sizes and humus

content:

Texture defini- Symbol JB Clay less Silt

Fine sand Sand

Humus

Cultivat-

tion for soil

(insert

No. than

2-20



m 20-200

20-2000 58.7 % C ed land

type

footnote



in DK*,

here:

Abbrevi-

ations

refer to

the Dan-

ish text)

Coarsely sand- GR.S.

0- 5

0 - 20

0 - 50

75 - 100

< 10

Finely sanded

F.S.

0- 5

0 - 20

50 - 100 75 - 100

< 10

Coarse clay-

GR.L.S. 3

5 - 10

0 - 25

0 - 40

65 - 95

< 10

mixed sand

Fine clay-

F.L.S.

5 - 10

0 - 25

40 - 95

65 - 95

< 10

mixed sand

Coarse sand-

GR.S.L. 5

10 - 15

0 - 30

0 - 40

55 - 90

< 10

mixed clay

Fine sand-

F.S.L.

10 - 15

0 - 30

40 - 90

55 - 90

< 10

mixed clay

Clay

15 - 25

0 - 35

40 - 85

< 10

Heavy clay

SV.L.

25 - 45

0 - 45

10 - 75

< 10

Very heavy

M.SV.L. 9

45 - 100

0 - 50

0 - 55

< 10

clay

Silt

SI.

0 - 50

20 - 100

0 - 80

< 10

Humus

HU.

> 10

Special

SPEC.

Source: Ministry of Agriculture; Bureau of Land Data (1980)

* From: The Danish Agricultural Advisory Service (2005)

Percentage content of sand and clay in Danish soils:

Sand content, per-

Samples with

Clay content, per-

centage of top soil.

more than:

centage of top soil.

40 % sand

50 % sand

60 % sand

70 % sand

> 99 %

= 99 %

= 97 %

= 81 %

2% clay

5% clay

10% clay

15% clay

Samples with

more than or equal

to:

= 99 %

= 70 %

= 35 %

= 10 %

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80 % sand

= 49 %

20% clay

=2%

90 % sand

=9%

30%clay

= 0.4 %

95 % sand

<1%

50% clay

= 0.01 %

Total number of

38927

Total number of

38930

samples is

Source: Danish Institute of Agricultural Sciences (personal communication).

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Annex 3: Climate conditions in Denmark

Average precipitation (mm):

Normal

Jan Feb Mar

1971-00*

1961-90** 57

1931-60** 55

* Cappelen (2002)

** Frich et al. (1997)

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec Year

59 641

66 712

55 664

Average air temperature (°C):

Normal

Jan Feb Mar

1971-00*

0.9 0.8 2.7

1961-90** 0.0 0.0 2.1

* Cappelen (2002)

** Cappelen (1997)

Apr May Jun Jul Aug Sep

6.1 11.0 14.2 16.3 16.3 12.9

5.7 10.8 14.3 15.6 15.7 12.7

Oct

9.1

Nov

5.0

4.7

Dec Year

2.4 8.1

1.6 7.7

Average soil temperature at a depth of 10 cm (°C) (1988-2006):

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov

Average

2.0 2.0 3.1 7.2 12.2 15.8 17.9 17.4 14.4 10.2 6.1

Source: University of Aarhus, Faculty of Agricultural Science

Dec Year

3.5 9.3

Average soil temperature at a depth of 10 cm (°C):

Normal

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov

France 1993 6.1 5.9 8.4 12.8 18.6 22.3 24.8 2.3 20.3 15.1 9.4

Germany *

2.7 3.5 6.0 8.3 13.8 16.8 19.8 20.2 15.0 9.8 5.5

1982-92

Sweden

-0.9 -1.3 -0.6 2.3 9.1 13.9 15.9 14.7 10.5 6.0 2.2

1973-85

England

2.6 3.0 4.6 8.3 12.5 17.1 18.6 17.1 14.6 9.8 6.1

30 years

* Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA) Speyer.

Dec

6.9

2.2

0.0

3.7

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Annex 4: Pavements and similar use areas

Curbsides along major roads, bare soil with old topsoil and railways are considered special (and

seldom/never applied for) areas of usage, which The Danish Environmental Protection Agency will

consider on an ad hoc basis on the receipt of applications.

The following categories are acknowledged by The Danish Environmental Protection Agency:



“Real” paved areas comprised of flag or cobblestones, laid over gravel directly on the earth

from which the topsoil has been removed. This includes asphalted areas. These areas are

characterised by having a bearing layer which is impermeable. Water which falls on these

areas must be lead away, usually via a sewer. It is vital for the stability of these paved areas

that water does not permeate the layers otherwise they lose their load- bearing capability.

There is therefore no risk of leaching in areas such as these, which are typically roads or

larger parking areas.

Partially paved areas of flag or cobblestones laid directly onto the earth, from which the top-

soil has been removed, or gravel or stone covering laid directly onto topsoil. These types of

areas are typically driveways, terraces, smaller footpaths, storage depots, etc. The private ar-

eas are often so small that it is not necessary to perform any risk assessment in accordance

with the Framework for assessment, as they constitute a negligible exposure of the general

environment.



Applications for the use on paved areas will always be assessed on an ad hoc basis and specific

evaluations based on available data will be carried out.

References:

Miljøstyrelsens ”Notat til Bekæmpelsesmiddelrådet om ophævelse af gældende praksis for befæ-

stede arealer af 10. november 2008”.

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Annex 5: Appraisal of field studies and lysimeter tests for pollution of groundwater

Experience has shown that field studies and lysimeter tests do not yield incontrovertible descrip-

tions of the risk of polluting groundwater. Several active substances are frequently found (in con-

centrations above the limits) in groundwater, even though lysimeter tests with the same substances

have not indicated unacceptable leaching. The probable reason for this is that the degradation condi-

tions in the lysimeters were more favourable than those in the field. It is, therefore, vital that the re-

sults of such tests be appraised very carefully and compared to the other information (intrinsic

properties, mathematical modelling and monitoring results).

In the case of lysimeter tests (which are conducted according to standardised principles) it is espe-

cially important to decide whether they were conducted under conditions that were representative of

Danish conditions and that were "realistic worst cases". As far as field studies are concerned (where

there are no guidelines), it is also important to ensure that the sampling resolution is sufficiently

high with respect to time and depth - especially in relation to the pattern of precipitation - to permit

the detection of any leaching of the active substance and its metabolites.

The following requirements on scenarios and tests must be satisfied:



the soil type must be representative of Danish conditions (see Annex 2) and must represent a re-

alistic worst case for the specific active substance or its metabolites, with respect to degradation

rate and sorption conditions (for instance, if the substance degrades slowly at a relatively high

pH or in sandy soil, the test must be conducted in such a soil type)



the climate conditions must be representative of Danish conditions (including precipitation and

temperature, and including trends over the year, cf. Annex 3)



the use must represent a realistic worst case with respect to the time of spraying (e.g. early spring

or in the autumn), crop (including vegetation cover, root development), as well as the dose and

number of applications. Furthermore, the formulation of the product must correspond to that of

the product for which authorization is sought (e.g. for granulates)



the test must extend over a period long enough to permit assessment of the leaching of the active

substance and metabolites (2 years, minimum)



compensatory watering must be comparable to realistic worst-case precipitation under Danish

conditions, with respect to the quantity and timing



sampling and assays of eluate or soil/water samples must be arranged so that there is no signifi-

cant degree of degradation of the active substance or metabolites



the detection threshold for the active substance and metabolites must be << 0.1 µg/l.

In the case of lysimeter tests, appraisal must be based on the annual average concentration of the ac-

tive substance and/or metabolites in the eluate.

No such appraisal is possible for field tests. When appraising field tests, every effort must be made to

estimate the areal leaching. This also means that the individual samples must be appraised in relation to

the heterogeneity of the field.

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Annex 6: Appraisal of mathematical modelling of risk of pollution of groundwater

The leaching of active substances and metabolites will be assessed based on mathematical model-

ling.

The following requirements on modelling and scenarios must be satisfied:



Models: a model code, usable for Danish conditions must be used. The PELMO model with the

Hamburg scenario from FOCUS can be used, and the MACRO and MIKE-SHE models. If an-

other model code is used, the report must document the way in which the calibrated water bal-

ance corresponds to the Danish scenarios.



Soil types and localities: the soils/localities specified by the Danish Environmental Protection

Agency are used - at present, two typical Danish soils, representing sandy soil (Karup) and boul-

der clay with preferential flow (Langvad) or the Hamburg scenario from FOCUS.



Climate data: time series over 30 and 24 years, respectively, for the two Danish localities must

be used and 20 years (+ 6 years' calibration) for the Hamburg scenario.



If a substance is used every second year the time series is run for 40 years in PELMO with use

every second year. If use is every third year the time series is for 60 years with use every third

year. If use is every fourth year then this cannot be modelled within the PELMO shell and at tier

1 use is every third year. If refinement is required then the run must be completed outside the

shell by constructing weather files and running 80 years with application every fourth year.



Substance specific parameters: 80 percentiles for degradation rates and sorption ratios (1/n) must

be used and for K

20 percentiles must be used. All available data should be included, but a re-

finement can be made by selecting the studies that are relevant/representative for Danish condi-

tions e.g. with respect to soil texture or pH. If there are less than three endpoints available then a

worst case value should be used for modelling.



Crop: where several crops are involved, the worst-case crop (with respect to vegetation cover,

root development, etc.) must be used where possible. Alternatively, all crops must be modelled.



Application: application of the highest dose for which authorization is sought must be modelled.

In order to investigate the sensitivity to changes in the application date, separate model runs must

be executed for at least three individual days of the period in which use of the product is pro-

posed.



The results must be reported as annual averages. This also applies if the substance is used every

second, third or fourth year. All output files must be submitted.



All use of values/input other than those set by the Danish Environmental Protection Agen-

cy/default values must be justified.

The appraisal is done on the basis of the average annual leaching below the root zone (a depth of

about one metre). The number of occasions when leaching exceeds the limit value is compared

against the total number of runs. If the limit is exceeded on more than a specified proportion of the

occasions (1 of 20 years), the model runs cannot be used to support authorization for the proposed

use.

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If unacceptable leaching occurs in just one of the scenarios (sandy soil or moraine clay) the Danish

Environmental Protection Agency will generally conclude that it is not possible to grant authoriza-

tion on the grounds that there is a risk of leaching.

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Annex 7: Groundwater monitoring data

When assessing the leaching of pesticides and their metabolites to groundwater, relevant monitoring

data must be used. However, it is crucial that the pesticide use/dose can be linked to the monitoring

data in a clear and unambiguous way.

Normally results are used from the national monitoring programmes (groundwater monitoring, the

Agricultural Watershed Catchment Areas), drinking water abstraction wells and the Danish Pesti-

cide Leaching Assessment Programme (PLAP). If the Danish Environmental Protection Agency has

knowledge of other data, e.g. from GEUS or foreign studies, these data are also included/assessed.

The results are either gathered directly from the GEUS or PLAP website or by contacting GEUS,

who have the possibility of carrying out a data run for individual substances.

The monitoring results data should either be presented in a separate study report, or they can be in-

cluded in the groundwater modelling report. are presented with the data on the case. Data should be

a part of the Registration Report. The presentation of the monitoring data should results start by

specifying which the monitoring programmes in which include the substance has been included and

how many filters or boreholes have been examined. For results from PLAP the locations, crops and

application rates and timing should be presented. In the presentation of the monitoring results the

following should be included:



Total number of analyses



Number of detections above the limit of detection but below the limit value



Number of detections above the limit value

how many finds have been made (with the detection limit stated) and the number of results over the

limit value of 0.1 µg/L.

If there are no results this must be noreported so such that it can be seen that the area has been in-

vestigated.

The number of results over the limit value is compared with the total number of analyses. If there

are more than very few sporadic results, then the results must be examined to see which monitoring

systems are involved, depth, times etc.

There are no fixed guidelines for the assessment of monitoring results, but the overall assessment of

the risk of leaching to groundwater is based on a comprehensive assessment of all information on a

substance/metabolites. This includes knowledge about patterns of use and possible changes in the

pattern of use.

In addition to this the Danish Environmental Protection Agency also uses monitoring data on sur-

face water from the NOVANA programme in connection with risk assessment for aquatic organ-

isms.

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Annex 8: Definition of readily biodegradable

The extent to which an organic substance is ready biodegradable is determined in accordance with the

OECD (OECD guidelines for testing of chemicals, section 3, OECD TG No. 301):

The assessment is done on the basis of the following tests, in which the substance must be able to attain

the following levels of biodegradation within 28 days*:

Test

No.

Level

DOC Die-Away

301 A

70 % (DOC)

Evolution

301 B

60 % (BOD)

MITI (I)

301 C

60 % (BOD)

Closed Bottle Test

301 D

60 % (TOD)

Modified OECD Screening

301 E

60 % (CO

)

Manometric respirometry

301 F

70 % (DOC)

* With the exception of MITI (I), degradation must occur within a 10-day window after an initial deg-

radation of 10 per cent has been attained.

These tests include ultimate degradation to CO

and not just primary degradation to possible metab-

olites or bound residual products.

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Annex 9: Non-spraying buffer zones to the aquatic and terrestrial environment

Aquatic environment

Non-spraying buffer zones to the aquatic environment of 2, 5, 10, 20, 30, 40 and up to 50 metres are

used. Maximum no spray buffer zones are set in relation the type of crop (see table below)

The two-metre zones correspond to the uncultivated zones that extend to the aquatic environment.

In Denmark spraying booms are typically divided into sections of 3, 4, 5 or 6 metres for which rea-

son, it is not possible to use non-spraying zones around the aquatic environment that are tailored to

all sprayer types.

Crop type and maximum no spray buffer zones accepted as risk mitigation measure.

Crop type

Maximum buffer zone

Agriculture

20 metres

Fruit trees

50 metres

Vegetables, ornamental plants, fruit bushes

30 metres

Terrestrial environment

No-spraying buffer zones to the terrestrial environment of 1, 3, 5, 10, 20, 30 40 and up to 50 metres

are used (see table below for single application). If GAP uses include more than one application,

please find specific drift values for repeated application in Appendix IV of the Escort 2 GD (Can-

dolfi et al., 2001).

Basic drift values for one application

Ground deposition in % of the application rate (90

percentiles)

Field

Fruit crops

Grapevine

Hops

Vegetables

crops

Ornamentals

Small fruit

Early

Late

Early

Late

Height height

< 50

> 50

2,77

29,20

15,73

2,70

8,02

19,33

0,57

19,89

8,41

1,18

3,62

11,57

0,57

3,62

0,29

11,81

3,60

0,39

1,23

5,77

0,29

1,23

0,15

2,77

1,09

0,13

0,42

1,79

0,15

0,42

1,04

0,54

0,07

0,22

0,56

0,10

0,22

0,52

0,32

0,25

0,30

0,22

0,13

Distance

Field

crops

Water

> 900

L/ha

4,44

0,18

0,05

[m]

A standard, 2 meter buffer zone should be applied if FOCUSsw Step 3 is used as basis for the aquatic risk assesment.

See the section on surface water in fate section.

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Annex 10: Assessment factor in mesocosm studies

The assessment of mesocosms and derivation of an endpoint should follow the recommendations

given in EFSA aquatic GD (2013). The association of an assessment factor to an Ecological Recovery

option (ERO) endpoint (to give a Regulatory Acceptable Concentration (RAC)) deviates from the

EFSA guidance. The procedure is described below.

The assessment factor that is associated with the endpoint established from a mesocosm study is set

on the basis of an appraisal of the study's quality. If the study does not live up to the recommenda-

tions, ”penalty points” are given in the form of a higher assessment factor.

The NOEC or alternatively NOAEC (no observable adverse effect concentration) is used as the

endpoint from mesocosm studies. If NOAEC is determined there must only be relatively limited ef-

fects and recovery must occur within a period of maximum four weeks.

If a specific mesocosm study has been given ”penalty points” because it diverges from the recom-

mendations, it is possible to lower the assessment factor in the overall risk assessment if, for exam-

ple:

- the mesocosm study covers two different periods of time (summer/autumn) in the same lo-

cality such that different stages of growth (e.g. newly hatched organisms) or different max-

imum/minimum population sizes of the same organisms are investigated.

- other higher-tier studies are available that support the NOEC/NOAEC value determined.

- other single species laboratory studies of most sensitive organisms or tests with the most

sensitive stages of these (e.g. newly hatched larvae) are available.

As the point of departure a minimum assessment factor of 5 will be used for some mesocosm stud-

ies as individual tests cannot be expected to be representative of all of the organisms or biotopes.

The assessment factor can be reduced if several studies of high quality are submitted that shed light

on the difference between different natural systems. Studies that differ in terms of both time and

space can be used to lower the assessment factor if they represent different population mixes or bio-

topes.

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Annex 11 Vegetation cover and deposition on soil

The proportion of a spray product deposited on the soil beneath different crops at different times

depends on the vegetation cover. The Danish Environmental Protection Agency uses upper 80 per

cent confidence intervals for pesticide deposition on soil based on the measured values in Jensen

and Spliid (2003). Values for crops for which no Danish measured value for deposition is available

are based on the plant cover estimates in Olofsdotter and Streibig (1997). Values for crops that are

not covered by the above two reports are taken from FOCUS (2002). When using values from

FOCUS groundwater (2002), the assessment takes account of the fact that these are average values

and do not therefore represent realistic worst-case situations, but instead represent an average situa-

tion.

Deposition of spray product on soil beneath various crops. The table shows averages, 95 per cent

upper and lower confidence interval, and approximated 80 per cent upper confidence interval

for

each growth stage interval (based on data from Jensen & Spliid, 2003).

Crop

Winter wheat

Winter barley

Winter rye

Growth stage

(BBCH)

11-13

23-28

30-32

33-34

38-45

51-57

61-71

Growth stage

(BBCH)

11-13

20-24

28-32

33-35

49-50

59-68

87-89

Growth stage

(BBCH)

13-14

15-18

20-22

30-35

Growth stage

(BBCH)

10-19

18-25

30-32

Deposition (% of sprayed)

95 % lower

Average

41.1

59.6

38.5

30.6

36.9

14.5

18.4

6.4

8.2

2.7

3.4

3.5

4.1

11.3

14.7

Deposition (% of sprayed)

95 % lower

Average

53.7

65.1

41.7

34.2

38.9

19.7

23.8

13.0

15.8

14.1

17.3

16.6

20.4

Deposition (% of sprayed)

95 % lower

Average

84.3

99.8

84.1

99.3

81.3

93.1

69.2

76.4

36.6

42.7

24.7

28.9

6.4

7.6

Deposition (% of sprayed)

95 % lower

Average

100

67.6

90.4

74.6

95 % upper

86.7

65.3

44.7

22.9

10.2

4.2

4.7

19.1

95 % upper

79.8

57.5

44.7

28.8

19.5

21.3

24.9

95 % upper

100

84.1

49.9

33.7

8.9

95 % upper

100

99.5

80 % upper

Crop

Spring barley

Spring wheat

Crop

Sugar beet

100

Crop

Potatoes

100

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35-40

40.3

48.5

58.4

59-79

6.4

8.2

The Danish Environmental Protection Agency’s calculation based on the following formula and assuming

normal distribution of the data:

Approximated 80 per cent upper confidence interval = Average value + (1.282 x

√variance).

Vegetation cover and deposition in different crops (Olufsdotter and Streibig, 1997):

Crop

Treatment

Leaf stage

Growth stage

Feekes

Peas

herbicide x 2

insecticide

herbicide

Autumn herbicide

Spring herbicide

Insecticide

Newly germinat-

Before germina-

tion

3 leaves

6 leaves

flowering

3 leaves

before flowering

flowering

5-7

2,3

2,6

3,3-4

2,3

3,2

3,3-4

BBCH

10-12

11-75

60-69

30-59

60-69

Vegetation

cover

5-15

80-100

20-40

60-80

90-100

20-40

40-60

90-100

Deposition

% (of

sprayed)

86-95

5-24

100

62-81

24-43

5-15

62-81

43-62

5-15

Winter

rape

Spring rape herbicide

insecticide

1 calculated on the basis of the following formula: percentage of spray product on soil = 100 - (0.95 x percentage vegetation cover)

2 pests are present in peas from the early stages of leaf development (pea weevil), during pesticide spraying and into the pod-formation stage, 80-100 per cent vegetation cover corre-

sponds to late spraying against tortricidae and aphids.

3 Based on the ranges given and the crop development (cover increases more at higher stages than at lower), the following vegetation cover values are appropriate for BBCH 12 – 16:

12: 10 %, 13: 20 %, 14: 30 %, 15: 45 % and 16: 60 %.

Deposition of spray product on soil (percentage of amount sprayed) beneath various crops (from

FOCUS groundwater, 2002).

Formation of side

shoots/rosette

growth and stem

elongation

BBCH

00-09

10-19

20-39

Beans

100

Cabbage

100

Carrots

100

Grass*

100

Linseed

100

Maize

100

Onions

100

Soybean

100

Strawberries

100

Sunflowers

100

Tobacco

100

Tomatoes

100

* The value 10 is used for spraying on established grass.

Crop

Bare earth –

germination

Leaf develop-

ment

Flowering

Ripening

Senes-

cence

40-89

90-99

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Annex 12: Environmental risk assessment of cumulative effects for combination products

Limitation

Assessment of cumulative ecotoxicological effects of chemical mixtures in products will be limited

to include groups of organisms where the risk assessment is based on a quotient calculation, i.e.

birds, aquatic organisms, mammals, earthworms and bees.

Methods

Two basic concepts for analysis of cumulative toxic effects of chemicals in mixtures are well estab-

lished, i.e. independent action (IA) and concentration addition (CA) (Greco et al., 1995; McCarty

og Borgert, 2006). IA is when toxicants act independently and have different modes of toxic action,

and CA is when toxicants act on the same biological site by the same mode of action.

It is found that the model of CA can be recommended as the best reference model for both similarly

and dissimilarly acting chemicals when evaluating cumulative effects of chemical mixtures

(Boekelheide, K., 2007; Cedergreen et al., 2008).

In the workshop report from the “Expert workshop on combination effects of chemicals” held in

January 2009 in Hornbæk, Denmark it is recommended that regulators use the model of CA as a de-

fault when evaluating cumulative effects, as it is a conservative model and further it requires less

data than the model of IA.

Synergistic effects where the cumulative effect is higher than expected from the model of CA are

rarely seen. Procloraz, a chemical causing hormone disrupting effects, has been identified as a po-

tent synergist (Cedergren et al., 2008). However, procloraz is no longer approved in any products in

Denmark and not been sold since 2005.

Based on the current knowledge the model of CA will be used when evaluating cumulative ecotoxi-

cological effects (see also EFSA aquatic GD).

Method for risk assessment

Risk assessment for products containing several active substances (or problematic auxiliary chemi-

cals) will be performed for:



Test with the product



For areas where there is no test of the product, cumulative risk for ecotoxicological effects

for relevant groups of organisms will be calculated based on the model of CA using the fol-

lowing equation:

”TriggerA”-value/TERA + ”TriggerB”-value/TERB + ….= SUM

If SUM < 1 the risk assessment is acceptable

Where:

”Trigger”-value represent the uncertainty factor of chemical A, B etc.

TER is the Toxicity Exposure Ratio calculated from the effect concentration (EC50, NOEC)

divided by the Predicted Environmental concentration (PEC).

For aquatic organisms SUM is calculated for the same taxonomic group (i.e. fish, crusta-

ceans, algae and aquatic plants) for the most sensitive organisms.

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Annex 13: Crop rotation - normal cultivation practices in Denmark

Crops for which normal cultivation practice exceeds one year crop rotation intervals. This is rele-

vant as a potential refinement option in the groundwater leaching assessment.

Crop type and maximum and years between cultivation:

Years between cultivation Crops

Sugar beets

Oil Seed Rape (winter and summer),

potatoes,

legumes (field peas, canned peas, peas for silage,

beans, lupines)

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Annex 14: Criteria for pesticides that can be used by and sold to non-professional users

Products must either comply with 1 and 3, or 2 and 3:

1. Ready-to-use products:

a. Products may not be classified for health effects

. This means that the label must not in-

clude any of the risk sentences as stated in Table 1.

b. It must not be necessary to use personal protective equipment to demonstrate safe use. How-

ever, if applicants recommend gloves on the label for reasons of routine hygiene it is permit-

ted.

2. Concentrated products

a. Products which are not classified for health effects or at the most are classified as local irri-

tant or as contact allergenic with the related risk sentences which are marked with an aster-

isk (*) in Table 1.

b. Products must be apportioned in dosage bags or have a dosage device or similar which ena-

bles easy measurement of the correct amount and ensures that contact with the concentrated

product is restricted (stating the correct dosage on the bottle is not sufficient; it must also be

ensured that the product can be poured or apportioned without the user coming into direct

contact with the product).

In both cases, when ready for use, the solution must comply with requirements a. and b. under point

3. Products sold in packages corresponding to treating a limited area of maximum 1,000 m

(0.1

ha), when used in accordance with the instructions for use.

Table 1

Risk phrases relating to human health

R22 Harmful if swallowed

*R37 Irritating to respiratory system

*R38 Irritating to skin

R65 Harmful: may cause lung damage if swal-

lowed

*R66 Repeated exposure may cause skin dryness

or cracking

R20 Harmful by inhalation

R21 Harmful in contact with skin

*R36 Irritating to eyes

*R43 May cause sensitisation by skin contact

R33 Danger of cumulative effects

Hazard statements with respect to human

health

Acute Tox. 4, H302: Harmful if swallowed

*STOT SE 3, H335: May cause respiratory irrita-

tion

*Skin Irrit. 2 H315: Causes skin irritation

Asp. Tox. 1, H304: may be fatal if swallowed and

enters airways

*EUH066: Repeated exposure may cause skin

dryness or cracking

Acute Tox. 4, H332: Harmful if inhaled

Acute Tox. 4, H312: Harmful in contact with skin

*Eye Irrit.2 H319: Causes serious eye irritation

*Skin sens. 1 H317: May cause an allergic skin

reaction.

EUH208 is not considered a classification but merely a labelling and does not prevent the product from being sold to

non-professionals.

The relevance of labelling dilutions with EUH066 should be made case by case. A weight-of-evidence approach

should be employed, taking into account test data on in-use dilutions, bridging, human use experience, the concentration

of substances labelled with EUH066 or classified as corrosive/irritant to skin in the in-use dilution and the number of

treatments relating to the non-professional use. A concentration limit of ingredients labelled with EUH066 that triggers

labelling of a mixture/dilution with EUH066 is not specified in Regulation (EC) No 1272/2008. However, as labelling

with EUH066 is regarded as less severe than classification for skin irritating properties, the concentration limits speci-

fied for classification of mixtures for skin irritating properties based on data on individual components may be used as a

starting point (point 3.2.3.3. in Annex I of Regulation (EC) No 1272/2008)

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Risk phrases relating to human health

R67 Vapours may cause drowsiness and dizzi-

ness

R42 May cause sensitisation by inhalation

R64 May cause harm to breastfed babies

R34 Causes burns

Carc. Cat. 3: R40 Limited evidence of a carcino-

genic effect

R41 Risk of serious damage to eyes

Xn; R48 Harmful: danger of serious damage to

health by prolonged exposure

Rep. 3; R62 Possible risk of impaired fertility

Rep. 3; R63 Possible risk of harm to the unborn

child

Xn; R68 Harmful: possible risk of irreversible ef-

fects

Mut. 3; R68 Possible risk of irreversible effects

R35 Causes severe burns

Hazard statements with respect to human

health

STOT SE 3, H336: May cause drowsiness or diz-

ziness

Resp. Sens. 1 H334: May cause allergy or asthma

symptoms or breathing difficulties if inhaled

Lact., H362: May cause harm to breast-fed chil-

dren

Skin Corr. 1B H314: Causes severe skin burns

and eye damage

Carc. 2, H351: Suspected of causing cancer (pos-

sible route of exposure)

Eye Dam. 1 H318: Causes serious eye damage

STOT RE 2, H373: May cause damage to organs

through prolonged or repeated exposure (possible

specific organs/route of exposure)

Reper 2, H361 (possibly f and/or d): Suspected of

damaging fertility or the unborn child (possible

specific effect/exposure route)

STOT SE 2, H371: May cause damage to organs

(possible specific organs/route of exposure)

Mut. 2, H341: Suspected of causing genetic de-

fects (possible route of exposure)

Skin Corr. 1A, H314: Causes severe skin burns

and eye damage

1) Directive 67/548/EC

2) Regulation no 1272/2008 (EC) of the European Parliament and of the Council

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Annex 15: Beneficial organisms (other than bees).

For indoor pesticides it must be stated on the label (instructions for use) to what degree the product

is compatible with biological control with beneficial arthropods. If no information regarding the ef-

fects on beneficial arthropods is available this must be mentioned on the label.

Products will be classified by IPM impact in accordance with established IOBC criteria:



Based on field or semi-field test data:

N = harmless or slightly harmful (< 50 % reduction in beneficial capacity)

M = moderately harmful (51-75 % reduction in beneficial capacity)

T = harmful (> 75 % reduction in beneficial capacity)

Based on laboratory test results:

Laboratory 1 (< 30 %)

N (harmless or slightly harmful)

Laboratory 2 (30-79 %)

M (moderately harmful)

Laboratory 3 (80-99 %) and 4 (>99 %) T (harmful)



To obtain a clear label text the following classes will be used for the Danish labels:

< 25% mortality or reduction in beneficial capacity => Class 1 (harmless; skånsomt)

25 to 50 % mortality or reduction in beneficial capacity => Class 2 (relatively harmless; relativt

skånsomt)

50 to 75% mortality or reduction in beneficial capacity => Class 3 (moderately harmful; moderat

skadeligt)

> 75% mortality or reduction in beneficial capacity => Class 4 (harmful; skadeligt)

Products classified 1 or 2 in a worst case laboratory trial are considered harmless or relatively harm-

less to that specific beneficial organism and further testing under semi-field or field conditions is

not required.

Products classified 3 or 4 in a worst case laboratory trial are considered moderately harmful or

harmful to beneficial organisms, respectively, unless further testing under semi-field or field condi-

tions is performed showing < 50% reduction in beneficial capacity, thereby changing the classifica-

tion to 2 relatively harmless.

Some of the most common beneficial organisms in greenhouses are (but not restricted to):

- Lacewings (e.g.

Chrysoperla spp.)

- Ladybugs (e.g.

Harmonia axyridis)

- Parasitoid wasps (e.g.

Aphidius spp.

and

Encarsia formosa)

- Predatory mites (e.g.

Amblyseuis spp.)

- Midges (e.g.

Aphidoletes aphidimyza)

- Pirate bugs (e.g.

Orius spp.)

Wording for the Danish labels:

If no information regarding the effects on beneficial arthropods is available:

“Det er ikke oplyst, om midlet er foreneligt med biologisk bekæmpelse.”

If information regarding the effects on the most common beneficial arthropods is available:

Class 1: ”Midlet er skånsomt overfor populationer af xxxx.”

Class 2: ”Midlet er relativt skånsomt overfor populationer af xxxx.”

Class 3: ”Midlet er moderat skadeligt for xxxx.”

Class 4: ”Midlet er skadeligt for xxxx.”

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In addition, if information regarding the effects on only some beneficial arthropods is available,

then the following sentence should be added:

”Foreneligheden med anvendelse af de øvrige nyttedyr er ukendt.”

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Annex 16: Abbreviations

Acceptable Daily Intake, i.e. the daily amount that can be ingested during a lifetime

without risk of adverse effects on health.

AF -

Assessment Factor, also called an uncertainty factor or safety factor.

AV -

Avoidance Factor; if a bird completely avoids the treated food, then the AV= 0 and

with no avoidance AV=1.

BBA -

Biologische Bundesanstalt für Land- und Forstwirtschaft (The Federal Biological

Research Centre for Agriculture and Forestry - a Federal Authority and Federal

Research Centre affiliated to Germany's Federal Ministry of Food, Agriculture

and Consumer Protection).

DJF -

Formerly

Danmarks JordbrugsForskning,

now

Det Jordbrugsvidenskabelige Fakultet

(The Faculty of Agricultural Sciences)

DOC -

Dissolved Organic Carbon

Time taken for 50 per cent of the substance to degrade/disappear.

Time taken for 90 per cent of the substance to degrade/disappear.

Effective Concentration 50 per cent; the concentration that causes 50 per cent effects

in a dose-response test.

EPPO -

European and Mediterranean Plant Protection Organization

ERO _

Ecological Recovery Option

ETE -

Estimated Theoretical Exposure; either as mg/kg bodyweight or as daily dose in

mg/kg bodyweight/day.

ETO -

Ecological Threshold Option

HARAP -

Higher-Tier Aquatic Risk Assessment for Pesticides; international workshop 1998

JB -

Jordbundsnummer (soil type number)

Distribution coefficient between soil and water

Soil organic carbon - water partitioning coefficient; K

normalised to organic carbon

content in soil.

Octanol/lipid-water partition coefficients; octanol is used as a model for lipids in

organisms or carbon in soil.

Lethal concentration 50 per cent; concentration that kills 50 per cent of test organ-

isms.

–

Lethal dose 50 per cent; dose that kills 50 per cent of test organisms.

LL HC5 -

Lower Level 5th percentile of species-sensitivity

NOAEC -

No observed adverse effect concentration; the highest dose for which no adverse ef-

fects are observed. In mesocosm studies it is interpreted as the highest dose for

which no long-term adverse effects are observed. Recovery within a maximum of

four weeks is regarded as acceptable.

NOEC/NOEL - No observed effect concentration/level; the highest dose in a dose-response test that

is not statistically different from the control.

OECD -

Organisation for Economic Co-operation and Development

PD -

Proportion of a food type in diet (between 0 and 1)

PEC -

Predicted Environmental Concentration

ADI –

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PT -

RAC -

SETAC -

TER -

TG -

TOC -

TSW -

TWA -

US EPA -

Proportion of food that is found in the treated area (between 0 and 1)

Regulatory Acceptable Concentration

The Society of Environmental Toxicology and Chemistry

Toxicity-to-exposure ratio

Test Guideline

Total Organic Carbon

Thousand-seed weight, weight of 1000 grains/seeds (g)

Time Weighted Average

United States Environmental Protection Agency

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