This draft has not been adopted or endorsed by the European Commission.
Any views expressed are the preliminary views of the Commission services
and may not in any circumstances be regarded as stating an official position
of the Commission. The information transmitted is intended only for the
Member State or entity to which it is addressed for discussions and may
contain confidential and/or privileged material.

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Part A
Parts of the EFSA guidance document to be used for applications submitted after 31
December 2019

HONEYBEES
Screening step
spray applications

Trigger value

Acute contact
adults

HQ > 42 (downwards spray); OECD Test Guideline 214 Chapter 3.2.1
HQ > 85 (upwards/sideways)
Table 2

Acute oral adults

ETR > 0.2

OECD Test Guideline 213 Chapter 3.2.2
Table 3

Exposure from
surface water

ETRacute adults > 0.2;

Use highest PECsw from Chapter 3.5.2
FOCUS step 1 or RAC for
aquatic organisms.

Exposure from
puddle water

ETRacute adults > 0.2;

Use run-off PEC values
from FOCUS

Guideline/test protocol

Exposure to plant
metabolites

Reference to
the EFSA
Guidance
Document of
4 July 2014

Chapter 3.5.3
Chapter 3.6

Screening step solid Trigger value
formulations

Guideline/test protocol

Acute contact
adults

HQ >14

OECD Test Guideline 214 Chapter 3.3.1
fdep from
Table H1b

Acute oral adults

ETR > 0.2

OECD Test Guideline 213 Chapter 3.3.2
Table 7

3

Reference to
the EFSA
Guidance
Document of
4 July 2014

Deleted: 30
Deleted: June

 Exposure from
surface water

ETRacute adults > 0.2;

Use highest PECsw from
FOCUS step 1 or RAC
for aquatic organisms.

Exposure from
puddle water

ETRacute adults > 0.2;

Use run-off PEC values Chapter 3.5.3
from FOCUS

Exposure to plant
metabolites

Chapter 3.5.2

Chapter 3.6

Refined risk
assessment for
exposure via nectar
and pollen
following spray
applications

Trigger value

Guideline/test protocol

Reference to
the EFSA
Guidance
Document of
4 July 2014

Refined exposure
estimates

ETRacute > 0.2

OECD Test Guideline 213 Chapter 3.2.2
Ef-values
from
tables
X1a and X2a
as appropriate
for
the
relevant
scenario

ETRacute; for all
relevant scenarios

SV-values
from Tables
Jx and Jy as
appropriate
for
the
relevant
scenario
Consider risk
mitigation measures

Chapter 9
Appendix S

Consider further
refinement of
exposure estimate

4

 Semi-field and field
effects studies

Based on EPPO 2010 and Chapter 6.1.2
OECD 2007 with further and Appendix
details as provided in O
Appendix O

Refined risk
assessment for
contact exposure
following spray
application

Trigger value

Refined exposure
estimate

HQ > 42 (downwards spray); OECD Test Guideline 214 fdep values
from Table
HQ > 85 (upwards/sideways)
H1a and
further
guidance in
Appendix H

Guideline/test protocol

Consider risk
mitigation measures

Reference to
the EFSA
Guidance
Document of
4 July 2014

Chapter 9
Appendix S

Consider further
refinement of
exposure estimate
Semi-field and field
effects studies

EPPO 2010 and OECD Chapter 6.1.2
2007 with further details and Appendix
as provided in Appendix O O
especially regarding the
use of statistics and the
number of colonies and
fields needed.

Refined risk
assessment for
exposure via nectar
and pollen
following seed
treatment or
granule application
applications

Trigger value

Guideline/test protocol

Reference to
the EFSA
Guidance
Document of
4 July 2014

Refined exposure
estimates

ETRacute > 0.2

OECD Test Guideline 213 Chapter 3.3.2
SV-values
from Tables
Jxx and Jyy as
5

 ETRacute; for all
relevant scenarios

appropriate
for
the
relevant
scenario
Ef values
from Table
X1c

Consider risk
mitigation measures

Chapter 9
Appendix S

Consider further
refinement of
exposure estimate
Semi-field and field
effects studies

EPPO 2010 and OECD Chapter 6.1.2
2007 with further details and Appendix
as provided in Appendix O O
especially regarding the
use of statistics and the
number of colonies and
fields needed.

Refined risk
assessment for
contact exposure
following seed
treatment or
granule application

Trigger value

Guideline/test protocol

Reference to
the EFSA
Guidance
Document of
4 July 2014

Refined exposure
estimate

HQ >14

OECD Test Guideline 214 Chapter 3.3.2
Ef-values
from
Table
X1b
SV-values
from
Table
Jxx

Consider risk
mitigation measures

Chapter 9
Appendix S

Consider further
refinement of
exposure estimate

6

 Semi-field and field
effects studies

EPPO 2010 and OECD Chapter 6.1.2
2007 with further details and Appendix
as provided in Appendix O O
especially regarding the
use of statistics and the
number of colonies and
fields needed.

7

 Part B
Parts of the EFSA guidance document to be used for applications submitted at a date
to be specified in a further Commission Notice on the implementation of a revised
EFSA Guidance Document on the risk assessment for bees .

Deleted: to be used for applications submitted after
publication of the revised EFSA Guidance Document on the
risk assessment for bees

HONEYBEES

Chronic adults

Larvae

Exposure from
surface water
(chronic risk)

Guideline/test protocol

Implementation date

Reference to
the EFSA
Guidance
Document of
4 July 2014

OECD Test Guideline 245

To be used for
applications submitted at
a date to be specified in a
further Commission
Notice on the
implementation of a
revised EFSA Guidance
Document on the risk
assessment for bees .

Chapter 3.2.2
Table 3

OECD Guidance Document
239

To be used for
applications submitted at
a date to be specified in a
further Commission
Notice on the
implementation of a
revised EFSA Guidance
Document on the risk
assessment for bees.
Use highest PECsw from To be used for
FOCUS step 1 or RAC for applications submitted at
a date to be specified in a
aquatic organisms.
further Commission
Notice on the
implementation of a
revised EFSA Guidance
Document on the risk
assessment for bees.

Chapter 3.3.2
Table 7
Chapter 3.5.2
Chapter 3.5.3
Ef-values
from tables
X1a and X2a
as
appropriate
for the
relevant
scenario
SV-values
from Tables
Jx and Jy as
appropriate
for the
relevant
scenario
Ef values
from Table
X1c

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Formatted: Highlight

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

8

 Guideline/test protocol

Exposure from
puddle water
(chronic risk)

Accumulative risk
assessment

Implementation date

Use run-off PEC values from To be used for
applications submitted at
FOCUS
a date to be specified in a
further Commission
Notice on the
implementation of a
revised EFSA Guidance
Document on the risk
assessment for bees.
Research still ongoing
No protocols yet available

Reference to
the EFSA
Guidance
Document of
4 July 2014
Chapter 9
Appendix S
Formatted: Highlight

Chapter 6.1.2
and
Appendix O

To
be
used
for Chapter 8
applications submitted 1
year after availability of
internationally
agreed
protocols

Repeated exposure No protocols yet available
laboratory test on
larval development
beyond pupation of
honeybees

To
be
used
for
applications submitted 1
year after availability of
internationally
agreed
protocols

Screening step for
No protocols yet available
assessment of
exposure to residues
in honeydew

To
be
used
for Chapter 3
applications submitted 1 and Chapter
year after availability of 9
internationally
agreed
protocols

Exposure from
guttation fluid

To be used for
applications submitted at
a date to be specified in a
further Commission
Notice on the
implementation of a
revised EFSA Guidance
Document on the risk
assessment for bees.

More information is needed
on which crops and under
what circumstances guttation
droplets are produced and to
what extent guttation droplets
are used as a water source

Extrapolation rules [to be verified if necessary to To be used for
for residue trials maintain this line ]
applications submitted at
a date to be specified in a

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Chapter 3.5.1

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

9

 Guideline/test protocol

(minor crops, northsouth, etc.)

Reference to
the EFSA
Guidance
Document of
4 July 2014

Implementation date

further Commission
Notice on the
implementation of a
revised EFSA Guidance
Document on the risk
assessment for bees.

Sublethal
effects, More information is needed
HPG and other
methods to address No protocols yet available
physiological
effects, and effects
on homing flight

To
be
used
for Appendix W
applications submitted 1
year after availability of
internationally
agreed
protocols

Risk from exposure No protocols yet available
to
residues
in
succeeding crops

To
be
used
for
applications submitted 1
year after availability of
internationally
agreed
protocols

Development
of No protocols yet available
landscape-level
exposure assessment
criteria/methods

To
be
used
for Chapter 5.1.5
applications submitted 1
year after availability of
internationally
agreed
protocols

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

BUMBLEBEES

Screening
step spray
applications

Guideline/test
protocol

Implementation
date

Reference to
the EFSA
Guidance

10

 Document of 4
July 2014
Acute
adults

oral

Acute contact
adults

Screening step
solid
formulations

OECD Test
Guideline 247

OECD Test
Guideline 246

Guideline/test
protocol

To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees

Chapter 3.2.2
Table 3 8.2.1.1
Appendix P

To be used for Chapter
applications
Table 2
submitted at a
date
to
be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the
risk
assessment for
bees

Implementation
date

3.2.1

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Reference to the
EFSA
Guidance
Document of 4
July 2014

11

 Acute
adults

oral

Acute contact
adults

Chronic
toxicity

OECD Test
Guideline 247

To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees

Chapter 3.3.2.
Table 7

To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees

Chapter 3.3.1
fdep from Table
H1b

Guideline/test
protocol

Implementation
date

Reference to
the EFSA
Guidance
Document of 4
July 2014

No protocols
yet available

To be used for
applications
submitted at a
date to be
specified in a
further
Commission

Chapter 6.2.1

OECD Test
Guideline 246

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

12

 Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees
Risk to larvae

Higher
studies

tier

No protocols
yet available

To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees
To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees

Chapter 6.2.1

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

13

 Study
with
microcolonies

Semi-field and
combined
field-tolaboratory
tests

To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees

Chapter 6.2.2
and Appendix
P (with
possibility for
applicants to
modify)

To be used for
applications
submitted at a
date to be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA
Guidance
Document on
the risk
assessment for
bees

Chapter 6.2.2
and Appendix
P (with
possibility for
applicants to
modify)

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

SOLITARY BEES

14

 Guideline/test
protocol

Implementation
date

Reference
to the EFSA
Guidance
Document
of 4 July
2014

Acute contact

A ring test is
currently and the
test itself is
ready to be
implemented.
However lack of
guidance
for
higher
tier
testing.

To be used for Chapter
applications
6.3.1
submitted 1 year
after availability
of internationally
agreed protocols

Acute oral

A ring-test is
currently
ongoing
but
more work is
needed
regarding
feeding
of
Osmia with a
specific amount
of food.

To be used for Chapter
applications
6.3.1
submitted 1 year
after availability
of internationally
agreed protocols

Chronic toxicity

No protocols yet To be used for Chapter
applications
available.
6.3.1
submitted at a
date
to
be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA Guidance
Document on the
risk assessment
for bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

15

 No protocols yet To be used for Chapter
applications
available.
6.3.2.1
submitted at a
date
to
be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA Guidance
Document on the
risk assessment
for
bees
Document on the
risk assessment
for bees.

Risk to larvae

Semi-field
field test

and

To be used for Chapter
applications
6.3.2.2 and
submitted at a 6.3.2.3
date
to
be
specified in a
further
Commission
Notice on the
implementation
of a revised
EFSA Guidance
Document on the
risk assessment
for bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

Deleted: To be used for applications submitted after publication of
the revised EFSA Guidance Document on the risk assessment for
bees

16

 Part C
Further actions proposed in order to allow for full implementation of the EFSA
Guidance Document.

•

A review of the Guidance Document based on new scientific information and data.

•

Reconsideration of background mortality and trigger values.

•

Validation (cross-check) by using available higher tier data whether the level of
conservatism introduced with current trigger values seems appropriate for different
toxicity tests and exposure routes.

•

Detailed definition of protection goals for bumble bees and solitary bees.

•

Development of the following test:
o Chronic oral toxicity test with bumble bees.
o Larval toxicity test with bumble bees.
o Accumulative toxicity risk assessment for bumble bees.
o Field tests with bumble bees.
o Chronic oral toxicity test with solitary bees.
o Larval toxicity test with solitary bees.
o Accumulative toxicity risk assessment for solitary bees.

17