Part A – Core Registration Report

Assessment
Page 1 of 78

REGISTRATION REPORT

Ecotoxicological Studies Detailed

summary of the risk assessment

Product code: GIBBER_9

Active Substance: 10 % w/w of Gibberellic acid

CORE ASSESSMENT

Applicant: F. Khalili
Date: July 2015

Evalud: Date : 12 /18

Applicant Document ID - 4522***_F dRR GIBBER GOBBI
10 Applicant Author: F. Khalili
 Part A – Core Registration Report
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Table of Contents
IIIA 10 ECOTOXICOLOGICAL STUDIES ................................................................... 5
IIIA 10.1 Effects on Birds...................................................................................................... 7
IIA 10.1.1 Acute toxicity exposure ratio (TERA).................................................................. 9
IIIA 10.1.2 Short and long-term toxicity exposure ratio (TERST) .................................... 11
IIIA 10.1.3 Baits: Concentration of active substance in bait in mg/kg ............................. 13
IIIA 10.1.4 Pellets, granules, prills or treated seed .............................................................. 13
IIIA 10.1.4.1 Amount of active substance in or on each item ................................................ 13
IIIA 10.1.4.2 Proportion of active substance LD50 per 100 items and per gram of
items...................................................................................................................... 13
IIIA 10.1.5 Size and shape of pellet, granule or prill........................................................... 14
IIIA 10.1.6 Acute toxicity of the formulation ....................................................................... 14
IIIA 10.1.7 Supervised cage or field trials ............................................................................ 14
IIIA 10.1.8 Acceptance of bait, granules or treated seeds (palatability testing) ............... 14
IIIA 10.1.9 Effects of secondary poisoning ........................................................................... 14
IIIA 10.2 Effects on Aquatic Organisms............................................................................ 15
IIIA 10.2.1 Toxicity exposure ratios...................................................................................... 19
IIIA 10.2.1.1 TERA for fish ....................................................................................................... 19
IIIA 10.2.1.2 TERLT for fish...................................................................................................... 19
IIIA 10.2.1.3 TERA for Daphnia ............................................................................................... 20
IIIA 10.2.1.4 TERLT for Daphnia ............................................................................................. 21
IIIA 10.2.1.5 TERA for aquatic insect ...................................................................................... 21
IIIA 10.2.1.6 TERLT for aquatic insect..................................................................................... 21
IIIA 10.2.1.7 TERA for aquatic crustacean.............................................................................. 22
IIIA 10.2.1.8 TERLT for aquatic crustacean ............................................................................ 22
IIIA 10.2.1.9 TERA for aquatic gastropod mollusc................................................................. 22
IIIA 10.2.1.10 TERLT for aquatic gastropod mollusc ............................................................... 23
IIIA 10.2.1.11 TERLT for algae ................................................................................................... 23
IIIA 10.2.1.12 TER for aquatic plants ....................................................................................... 24
IIIA 10.2.2 Acute toxicity of the formulation ....................................................................... 25
IIIA 10.2.2.1 Fish........................................................................................................................ 26
IIIA 10.2.2.2 Aquatic invertebrates (Daphnia) ....................................................................... 26
IIIA 10.2.2.3 Algae ..................................................................................................................... 26
IIIA 10.2.2.4 Marine or estuarine organisms .......................................................................... 29
IIIA 10.2.2.5 Marine sediment invertebrates .......................................................................... 29
IIIA 10.2.3 Microcosm or mesocosm study .......................................................................... 29
IIIA 10.2.4 Residue data in fish ............................................................................................. 29
IIIA 10.2.5 Chronic toxicity to fish........................................................................................ 29
IIIA 10.2.5.1 28 day study ......................................................................................................... 29
IIIA 10.2.5.2 Fish early life stage test ....................................................................................... 30
IIIA 10.2.5.3 Fish life cycle test................................................................................................. 30
IIIA 10.2.6 Chronic toxicity to aquatic invertebrates.......................................................... 30
IIIA 10.2.6.1 21 day test (Daphnia magna).............................................................................. 30
IIIA 10.2.6.2 Aquatic insect....................................................................................................... 30
IIIA 10.2.6.3 Aquatic gastropod mollusc ................................................................................. 30
IIIA 10.2.7 Accumulation in aquatic non-target organisms ............................................... 30
IIIA 10.3.1 Toxicity exposure ratios...................................................................................... 32

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
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IIIA 10.3.1.1 Acute toxicity exposure ratio (TERA)................................................................ 32

IIIA 10.3.1.2 Short-term toxicity exposure ratio (TERST) ..................................................... 35
IIIA 10.3.1.3 Long-term toxicity exposure ratio (TERLT)...................................................... 35
IIIA 10.3.2 Other studies........................................................................................................ 38
IIIA 10.3.2.1 Acute oral toxicity of the preparation ............................................................... 38
IIIA 10.3.2.2 Acceptance of bait, granules or treated seed (palatability testing)................. 38
IIIA 10.3.2.3 Effects of secondary poisoning ........................................................................... 38
IIIA 10.3.3 Supervised cage or field trials ............................................................................ 38
IIIA 10.4 Effects on Bees ..................................................................................................... 39
IIIA 10.4.1 Hazard quotients for bees................................................................................... 40
IIIA 10.4.1.1 Oral exposure QHO .............................................................................................. 41
IIIA 10.4.1.2 Contact exposure QHC ......................................................................................... 41
IIIA 10.4.2 Acute toxicity of the formulation to bees .......................................................... 41
IIIA 10.4.2.1 Oral....................................................................................................................... 41
IIIA 10.4.2.2 Contact ................................................................................................................. 42
IIIA 10.4.3 Effects on bees of residues on crops................................................................... 44
IIIA 10.4.4 Cage tests.............................................................................................................. 44
IIIA 10.4.5 Field tests.............................................................................................................. 44
IIIA 10.4.6 Investigation into special effects......................................................................... 44
IIIA 10.4.6.1 Larval toxicity...................................................................................................... 44
IIIA 10.4.6.2 Long residual effects ........................................................................................... 44
IIIA 10.4.6.3 Disorienting effects on bees ................................................................................ 44
IIIA 10.4.7 Tunnel tests .......................................................................................................... 44
IIIA 10.5 Effects on Arthropods Other Than Bees........................................................... 45
IIIA 10.5.1 Using artificial substrates ................................................................................... 51
IIIA 10.5.2 Extended laboratory studies............................................................................... 56
IIIA 10.5.3 Semi-field tests ..................................................................................................... 56
IIIA 10.5.4 Field tests.............................................................................................................. 56
IIIA 10.6 Effects on Earthworms and Other Soil Non-target Macro-organisms .......... 57
IIIA 10.6.1 Toxicity exposure ratios, TERA and TERLT ..................................................... 59
IIIA 10.6.2 Acute toxicity ....................................................................................................... 60
IIIA 10.6.3 Sublethal effects................................................................................................... 62
IIIA 10.6.4 Field tests.............................................................................................................. 62
IIIA 10.6.5 Residue content of earthworms.......................................................................... 62
IIIA 10.6.6 Effects on other non-target macro-organisms .................................................. 62
IIIA 10.6.7 Effects on organic matter breakdown ............................................................... 62
IIIA 10.7 Effects on Soil Microbial Activity ...................................................................... 63
IIIA 10.7.1 Laboratory testing............................................................................................... 64
IIIA 10.7.2 Additional testing ................................................................................................ 64
IIIA 10.8 Effects on Non-Target Plants ............................................................................. 64
IIIA 10.8.1 Terrestrial plants................................................................................................. 64
IIIA 10.8.1.1 Seed germination ................................................................................................. 65
IIIA 10.8.1.2 Vegetative vigour................................................................................................. 65
IIIA 10.8.1.3 Seedling emergence ............................................................................................. 65
IIIA 10.8.1.4 Field testing.......................................................................................................... 65
IIIA 10.8.2 Aquatic plants...................................................................................................... 65
IIIA 10.8.2.1 Lemna growth test............................................................................................... 65
IIIA 10.8.2.2 Field tests.............................................................................................................. 68
Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18
Applicant Author: F. Khalili
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IIIA 10.9 Other Non-Target Species (Flora and Fauna).................................................. 69

IIIA 10.9.2 Critical assessment of relevance of preliminary test data ............................... 69
IIIA 10.10 Other/Special Studies.......................................................................................... 69
IIIA 10.10.2 Field studies ......................................................................................................... 69
IIIA 10.11 Summary and Evaluation of Points 9 and 10.1-10.10 ...................................... 69
IIIA 10.11.1 Predicted distribution and fate in the environment and time courses
involved ................................................................................................................ 71
IIIA 10.11.2 Non-target species at risk and extent of potential exposure............................ 71
IIIA 10.11.3 Short and long term risks for non-target species, populations,
communities and processes................................................................................. 71
IIIA 10.11.4 Risk of fish kills and fatalities in large vertebrates or terrestrial
predators .............................................................................................................. 71
IIIA 10.11.5 Precautions necessary to avoid/minimise environmental contamination
and to protect non-target species ....................................................................... 71
Appendix 1: List of data submitted in support of the evaluation ......................................... 72
Appendix 2: Critical Uses – justification and GAP tables..................................................... 74
Appendix 3: Additional information provided by the applicant (e.g. detailed
modelling data) .................................................................................................... 78

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
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IIIA 10 ECOTOXICOLOGICAL STUDIES

This document reviews the eco-toxicological studies for the product GIBER GOBBI 10 containing the
Gibberellic acid which was included into Annex I of Directive 91/414 (Commission Directive
2008/127/EC). A full risk assessment according to Uniform Principles is provided which demonstrates
that the product is safe for the environment. (Note: if during the EU review the risk assessments were
performed according to the current requirements and the risk was deemed to be acceptable then no further
assessments would be needed).

Where appropriate this document refers to the conclusions of the EU review of the Gibberellic acid. This
will be where:
x the active substance data is relied upon in the risk assessment of the formulation; or when
x the EU review concluded that additional data/information should be considered at national re-
registration.

Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has
not previously been considered within the EU review process, as part of the Annex I inclusion decision.
New annex II data must only be included if they are considered essential for the evaluation and in this
case a full study summary must be provided. In the case where the formulation has been previously
evaluated, at European level, detailed summaries have not been provided.

This product was not the representative formulation. The product has not been previously evaluated
according to Uniform Principles.

The SANCO report (SANCO/2613/08– rev. 2, 1 June 2012) and the EFSA conclusions (EFSA Journal
2012;10(1):2507) for Gibberellic acid are considered to provide the relevant review information or a
reference to where such information can be found. Each section will begin with a table providing the EU
endpoints to be used in this evaluation.

The Annex of the Regulation (EC) No 1107/2009 (Regulation No 540/2011 of 25 May 2011) provides
specific provisions under Part B which need to be considered by the applicant in the preparation of their
submission and by the MS prior to granting an authorisation.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
Gibberellic acid (SANCO/2613/08) and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health shall be taken into account.

Appendix 1 of this document contains the list of references included in this document for support of the
evaluation.

Appendix 2 of this document is the table of intended uses for GIBER GOBBI 10

Appendix 3 of this document contains any additional information provided by the applicant.

Information on the detailed composition of GIBER GOBBI 10 can be found in the confidential dossier of
this submission (Registration Report - Part C).

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
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Introduction
This section of the submission summarises the ecotoxicological effects of the formulation and evaluates
the potential risk to various representatives of terrestrial, aquatic and soil organisms. Full details or the
proposed use pattern that will be assessed are shown in Appendix 2 of this document and summarised in
Table 10-1.

Table 10-1: Proposed use pattern of GIBER GOBBI 10

Maximum Minimum
application Maximum Minimum
Growth Application
Crop rate Number of PHI
stage Interval
Applications (days)
(g ai/ha) (days)
Pear 60-69 12 1 - -
Cherry 79 20 1 - -
Grape (table, wine and for 53-79 30 2 5 -
raisins)
Citrus (orange, clementine, 65-81 20 1 - -
mandarin and lemon
Artichoke 11-19 20 3 15 -
Tomato, eggplant 61-69 10 3 7 -

Consideration of metabolites
The occurrence and risk from potentially ecotoxicologically relevant metabolites have been considered,
detailed discussion was provided in the EU review (Gibberellic acid) and in Part B, Section 5.
Considering that Gibberellic acid is naturally occurring, any formed metabolites are also naturally
occurring. Therefore, it was concluded that there is no relevant metabolite.

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
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IIIA 10.1 Effects on Birds

Overview and summary

EU Endpoints: Toxicity of Gibberellic acid to birds

EU agreed endpoints
Study Test species
(EFSA Journal 2012;10(1):2507)
Acute toxicity Mallard duck LD50 > 2000 mg/kg bw
Dietary toxicity (short-
Bobwhite quail LD50 > 904 mg/kg bw/day
term)
Reproductive toxicity
- No data submitted
(long-term)

Effects on birds for GIBER GOBBI 10 were not evaluated as part of the EU review of Gibberellic acid.
However further data on GIBER GOBBI 10 is not relevant as active substance data on toxicity to birds is
used and additional formulation data are not considered essential. Therefore all relevant data were
assessed in the EU review. Risk assessments for GIBER GOBBI 10 with the proposed use pattern are
provided here and are considered adequate.

The risk assessments were conducted in accordance with the Guidance of EFSA: Risk Assessment for
Birds and Mammals (2009)1.

Risk Assessment

Toxicity
Birds are typically exposed to dry residues on their food items following the dilution and spraying of the
formulated product. During these processes, much of the formulation constituents are likely to be lost by
volatilisation. Since oral exposure is the main route of exposure, toxicity data for the active substances are
therefore used in preference to data from tests with the formulated material. On this basis, the risk to birds
from the proposed uses of GIBER GOBBI 10 will be assessed using data on Gibberellic acid.

Avian acute oral and short-term dietary have been carried out with Gibberellic acid. Full details of
Gibberellic acid avian toxicity studies are provided in EU DAR. No studies have been performed to
determine the sub-chronic and reproductive toxicity of Gibberellic acid (GA3) to birds.
However, Gibberellic acid is ubiquitous in the tissues of plants and therefore represents a habitual
component of the diet of herbivorous birds and insectivorous birds that feed upon herbivorous arthropod
prey. Moreover, Gibberellic acid is a plant hormone and as such requires application at only low rates to
elicit the desired response in the target plants. Based on the weight of evidence provided by acute and
short-term dietary toxicity studies summarised below (table 10.1-2), subchronic and reproductive avian
toxicity endpoints for Gibberellic acid (GA3) are not expected to be sufficiently low for any meaningful
risks to arise at the rates applied in the field. Consequently, studies to determine the subchronic and
reproductive avian toxicity of Gibberellic acid (GA3) and the concomitant expenditure of vertebrate test
animals are not justified.

1
Guidance of EFSA: Risk Assessment for Birds and Mammals. European Food Safety Authority (EFSA), Parma, Italy, EFSA
Journal 2009; 7(12):1438

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
Page 8 of 78

Further data on subchronic toxicity and reproductive toxicity to birds is therefore not considered
necessary.

A summary of the relevant acute and short-term endpoints is provided in Table 10.1-2.

Table 10.1-2: Summary of avian toxicity endpoints for Gibberellic acid

Study type Test substance Species Endpoint Value Reference
FALGRO
> 2250 mg/kg Palmer, S.J and
Technical: Northern Bobwhite LD50
bw Beavers, J.B. (1996a)
91.1% (w/w)
Hakin, B. Johnson,
GA3: 91.1% Mallard duck > 2000 mg/kg A.J. Anderson, A. and
Acute oral LD50
(w/w) bw Suzanne Dawe, I.
toxicity
(1991a)
FALGRO
Technical > 2250 mg/kg Campbell, S.M.
Northern Bobwhite LD50
(Encapsulated): bw (1991)
86.9% (w/w)
Hakin, B. Johnson,
GA3: 91.2% > 1509 mg/kg A.J. Anderson, A.
Mallard duck LC50
(w/w) bw/day Suzanne Dawe, I.
(1991c)
Hakin, B. Johnson,
Short-term
GA3: 91.2% > 904 mg/kg A.J. Anderson, A.
dietary toxicity Northern Bobwhite LC50
(w/w) bw/day Suzanne Dawe, I.
(1991b)
FALGRO Palmer, S.J,
> 1376 mg/kg
Technical: Northern Bobwhite LC50 MacGregor J.A. and
bw/day
91.1% (w/w) Beavers, J.B. (1996b)
Values used for the risk assessment are shown in bold

Gibberellic acid metabolites

No metabolites were considered relevant and hence no further evaluation of metabolite toxicity is
considered necessary. GA3 is naturally occurring and any metabolites formed will also be naturally
occurring and therefore will be non-hazardous to terrestrial organisms.

Exposure
Exposure of birds will be predominantly dietary, through the consumption of residues on food items.
Direct exposure of birds to GIBER GOBBI 10 applications is considered unlikely, since at the time of
application and for a short period thereafter, most birds will leave the immediate vicinity of spray
operations in response to the human disturbance.

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
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IIA 10.1.1 Acute toxicity exposure ratio (TERA)

According to the Guidance of EFSA, Risk Assessment for Birds and Mammals (2009)2, a screening
assessment was performed as the first stage in risk assessment. In screening assessment the ‘daily dietary
dose’ (DDD) is calculated by multiplying the rate of application of the product (expressed as kg as/ha) by
the short-cut value (SV) according to formula:

DDDsingle application = application rate (kg as/ha) x SV

The SV is a default value for the species of concern (i.e. the indicator species, the generic focal species or
the focal species), derived according to formula:

SV= FIR/bw x RUD

Where: FIR: food intake rate
bw: body weight
RUD: residue per unit dose

Indicator species relevant for the intended uses and SV values are presented in the Table 10.1.1-1.

Table 10.1.1-1. Acute shortcut values (based on 90th percentile residues) for avian indicator species
Shortcut value
Crop Corresponding crop group Indicator species for acute
assessment
Pear, cherry and Small insectivorous
Orchards and ornamentals/nursery 46.8
citrus bird
Small omnivorous
Grape Vineyard 95.3
bird
Bulbs and onion like crops, cereals, fruiting
vegetables, leafy vegetables, legume
Tomato, eggplant Small omnivorous
forage, maize, oilseed rape, potatoes, pulses, 158.8
and artichokes bird
root and stem vegetables, strawberries, sugar
beet, and sunflower

For multiple applications, the DDD for single application is multiply by an appropriate multiple
application factor for 90th percentile reside data (MAF):

DDDmultiple applications = DDDsingle application x MAF

As recommended, the risk envelope approach was used for the risk assessment for birds according to the
guidance document SANCO/11244/2011 rev. 5.

Rationale for crop groupings

Following the procedure above, the key parameters for the first tier assessment are the application rate,
the number of application and application interval and the shortcut values depending on the generic focal
species.
The crop grouping covering the worst case scenario is presented in the table 10.1.1-2.

2
Guidance of EFSA: Risk Assessment for Birds and Mammals. European Food Safety Authority (EFSA), Parma, Italy, EFSA
Journal 2009; 7(12):1438
Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18
Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
Page 10 of 78

Table 10.1.1-2: Summary of crop grouping for the risk envelope approach
Maximum
Maximum number Interval
Crop group Crops included application rate MAF
of applications (days)
[g as/ha]
Pear 12 1 - -
Orange, lemon,
20 1 - -
Orchards cherry
Clementine,
10 2 7 1.4
mandarin
Vineyard Grapes 30 2 5 1.5
Fruiting Tomato, eggplant 10 3 7 1.6
vegetables and
leafy vegetables Artichoke 20 3 15 1.3
In bold, worst case scenario considered for risk assessment

Screening Step
The acute risk assessment for the use of GIBER GOBBI 10 is presented in Table 10.1.1-3.

Table 10.1.1-3: Acute risk (TERA) to birds from Gibberellic acid

LD50 Multiple Daily
Shortcut App. rate
Crop group (mg a.s./kg MAF Dietary Dose TERA
value (kg a.s./ha)
bw/day) (mg a.s./kg bw/day)
Orchards 46.8 0.020 - 0.94 2136.8
Vineyard 95.3 0.030 1.5 4.29 466.4
Fruiting > 2000
vegetables and 158.8 0.020 1.3 4.13 484.4
leafy vegetables
Note: calculations conducted using the spreadsheet provided by EFSA at: http://www.efsa.europa.eu/en/scdocs/scdoc/1438.htm
Failing TER(s) in bold

The TERA values are greater than the Annex VI trigger of 10, indicating low acute risk to birds from
Gibberellic acid following application of GIBER GOBBI 10 at all proposed label rates.

Risk assessment through drinking water

According to the Guidance of EFSA, Risk Assessment for Birds and Mammals (2009)3, the leaf scenario
is only relevant for leaf vegetables whereas the puddle scenario is relevant for all the intended uses of
GIBER GOBBI 10. The TER values are presented in Tables 10.1.1-4 and 10.1.1-5.
Table 10.1.1-4: TER value through drinking water – Leaf scenario
Concentration Organic adsorption Application LD50 PEC DWR for small
of the spray coefficient – KOC rate (mg a.s./kg pool granivorous birds TERA
solution (g/L) (mL/g) (mg/m²) bw) (mg/L) (L/kg bw/d)
Fruiting vegetables and leafy vegetables
0.05 7.1 2 2000 10 0.46 434.8
Note: calculations conducted using the spreadsheet provided by EFSA at: http://www.efsa.europa.eu/en/scdocs/scdoc/1438.htm
Failing TER(s) in bold

3
Guidance of EFSA: Risk Assessment for Birds and Mammals. European Food Safety Authority (EFSA), Parma, Italy, EFSA
Journal 2009; 7(12):1438
Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18
Applicant Author: F. Khalili