Appendix A List of end points for the active …...Peer review of the pesticide risk assessment of...

Peer review of the pesticide risk assessment of the active substance mancozeb

www.efsa.europa.eu/efsajournal 1 EFSA Journal 2019;17(7):5755

Appendix to:

EFSA (European Food Safety Authority), 2019. Conclusion on the peer review of the pesticide risk assessment of the active substance mancozeb. EFSA Journal 2019;17(7):5755, 138 pp. doi:10.2903/j.efsa.2019.5755

© European Food Safety Authority, 2019

Appendix A – List of end points for the active substance and the representative formulation

Identity, Physical and Chemical Properties, Details of Uses, Further Information

(Regulation (EU) N° 283/2013, Annex Part A, points 1.3 and 3.2)

Active substance (ISO Common Name) Mancozeb

Function (e.g. fungicide) Fungicide

Rapporteur Member State UK

Co-rapporteur Member State Greece

Identity (Regulation (EU) N° 283/2013, Annex Part A, point 1)

Chemical name (IUPAC) manganese ethylenebis(dithiocarbamate) (polymeric)

complex with zinc salt

Chemical name (CA) [[2-[(dithiocarboxy)amino]ethyl]carbamodithioato(2−)-

κS,κS′]manganese mixture with [[2-

[(dithiocarboxy)amino]ethyl]carbamodithioato(2−)-

κS,κS′]zinc

CIPAC No 34

CAS No 8018-01-7 (formerly 8065-67-5)

EC No (EINECS or ELINCS) 006-076-00-1

FAO Specification (including year of publication) FAO (1980) min. 85% mancozeb, min. 20% manganese,

min. 2% zinc, max. 1% water and ETU content should

not exceed 0.5% of mancozeb content.

Minimum purity of the active substance as

manufactured

850 g/kg (EU MTF)

915 g/kg (Agria)

Identity of relevant impurities (of toxicological,

ecotoxicological and/or environmental concern) in

the active substance as manufactured

ethylene thiourea (ETU) < 0.3 %w/w

Molecular formula (C4H6MnN2S4)x(Zn)y

Molar mass 271.3 g/mol (per monomer unit based on x=1 y =0.091)

http://www.efsa.europa.eu/efsajournal



Structural formula Mancozeb is a polymeric complex of the monomer

illustrated

CH2CH2C

HN

-S

S

CNH

S-

S

Mn++

x

(Zn) y




Physical and chemical properties (Regulation (EU) N° 283/2013, Annex Part A, point 2)

Melting point (state purity) 189 °C (mancozeb, 92.3%)

Boiling point (state purity) Mancozeb decomposes before reaching boiling point

Temperature of decomposition (state purity) 210 °C (mancozeb, 92.3%)

Appearance (state purity) Yellow powder (mancozeb, 92.3%)

Vapour pressure (state temperature, state purity) < 5.6 x 10-5 Pa at 25°C (mancozeb, 89%)

3.1 x 10-6 Pa at 20 °C (ETU, 99.9%)

Henry’s law constant (state temperature) < 6.17 x 10-2 Pa m3 mol-1 (20°C)

Solubility in water (state temperature, state purity

and pH)

Mancozeb 92.3%, in mg/L at 20 °C

pH 4 – 5 0.2

pH 6 – 8 0.2

pH 9 – 10 0.3

Solubility in organic solvents

(state temperature, state purity)

Mancozeb 92.3%, in g/L at 20 °C

heptane 0.1

xylene 0.1

1,2-dichloroethane 0.0

2-propanol 0.0

acetone 0.0

ethyl acetate 0.0

Mancozeb has poor solubility in organic solvents.

Surface tension

(state concentration and temperature, state purity)

In accordance with the EC method A.5, surface tension

is not required for substances with a water solubility < 1

mg/L.

Partition coefficient

(state temperature, pH and purity)

log POW = 2.3 at 20 - 25 °C (pH 6- 8) (mancozeb

92.3%)

log Pow = -0.66 (predicted, ETU)

Dissociation constant (state purity) Mancozeb has no affinity to water and the solubility is

low. It will not dissociate in water. This has been

confirmed using conductometric method.

K = 8.2 x 10-13 (theoretical determination from water

solubility)

UV/VIS absorption (max.) incl.

(state purity, pH)

The mancozeb (92.3%) spectrum in distilled water shows

an absorbance at 284 nm of 0.0038 absorbance units: the

identity is confirmed.

Due to the very low solubility of mancozeb and the

instability in these concentrations in water, it is not

relevant or possible to determine a molar extinction

coefficient of mancozeb. Additionally when dissolved in

acidic or basic solution mancozeb will break down

rapidly to other chemical compounds.

Flammability (state purity) Not highly flammable in the sense of EC A.10

Explosive properties (state purity) Not explosive

Oxidising properties (state purity) Not oxidising




Summary of representative uses evaluated, for which all risk assessments needed to be completed (mancozeb) (Regulation (EU) N° 284/2013, Annex

Part A, points 3, 4) Representative Uses and GAP by the Mancozeb Task Force (MTF) for the products Penncozeb 80WP and Dithane M45

Crop

and/or

situation

(a)

Member

State

or

Country

Product

Name

F

G

or

I (b)

Pests or

Group of pests

controlled

(c)

Preparation Application Application rate per

treatment PHI

(days

)

(m)

Remarks Type (d-f)

Conc.

a.s.

(i)

method

kind

(f-h)

range of growth

stages

& season (j)

Min-max

number

(k)

Interval

between application

(min)

kg a.s /hL

min-

max (l)

Water

L/ha min-

max

kg a.s./ha

min-max

(l)

Wheat

(winter/spring)

All zones Penncozeb

80WP / Dithane

M45

F Mycosphaerella

graminicola

(SEPTTR)

Puccinia

triticina

(PUCCRT)

WP 800 Broadcast

foliar

spray

Post-

emergence / BBCH 30-

65, spring-

summer

3

14 0.4 -

0.8

200-

400

1.6

NA None

Grapevine Central zone Penncozeb

80WP /

Dithane

M45

F Plasmopara

viticola

(PLASVI)

Cryptosporella

viticola

(PHOPVI)

Phyllosticta

ampelicida

(GUIGBI)

WP 800 Air-

assisted

foliar

spray

Post-

emergence /

BBCH 15-85, spring-

summer

4

7 0.2-

0.8

200-

800

1.6

56 None

Grapevine Southern zone Penncozeb

80WP / Dithane

M45

F Plasmopara

viticola

(PLASVI)

Cryptosporella

viticola

(PHOPVI)

Phyllosticta

ampelicida

(GUIGBI)

WP 800 Air-

assisted foliar

spray

Post-


85, spring-

summer

4

7 0.2-

0.8

200-

800

1.6

28 None

Potato All zones Penncozeb

80WP /

F Phytophthora

infestans

(PHYTIN)

WP 800 Broadcast

foliar

spray

Post-


8

7 0.2-

0.8

200-

800

1.6

7 None




Crop

and/or

situation

(a)

Member

State

or

Country

Product

Name

F

G

or

I

(b)

Pests or

Group of pests

controlled

(c)

Preparation Application Application rate per

treatment PHI

(days

)

(m)

Remarks Type

(d-f)

Conc.

a.s. (i)

method

kind (f-h)

range of

growth

stages & season

(j)

Min-

max

number (k)

Interval between

application

(min)

kg a.s

/hL

min-max

(l)

Water L/ha

min-

max

kg a.s./ha

min-max (l)

Dithane

M45

Alternaria solani

(ALTESO)

89, spring-

summer

(a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the

use situation should be described (e.g. fumigation of a structure)

(b) Outdoor or field use (F), greenhouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil born insects, foliar fungi, weeds

(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide

(f) All abbreviations used must be explained

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of

equipment used must be indicated

(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for

the variant in order to compare the rate for same active substances used in different variants (e.g.

fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to

give the rate for the variant (e.g. benthiavalicarb-isopropyl).

(j) Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application

(k) Indicate the minimum and maximum number of applications possible under practical conditions of use

(l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200 000 g/ha or 12 5 g/ha instead of 0.0125 kg/ha

(m) PHI - minimum pre-harvest interval

Representative Uses and GAP by Agria SA for the product Agria Mancozeb 800 g/kg WP

Crop

and/or

situation

(a)

Member

State

or

Country

Product

name

F

G

or

I

(b)

Pests or

Group of pests

controlled

(c)

Preparation Application Application rate per treatment

PHI

(days) (m)

Remarks Type

(d-f)

Conc. a.s.

(i)

method kind

(f-h)

range of

growth stages

& season

(j)

Min-max

number

(k)

Interval

between

application

(min)

kg a.s

/hL

min-max

(l)

Water L/ha

min-max

kg a.s./ha min-max

(l)

Tomato Central

and Southern

zone

Agria

Mancozeb

800 WP

G Fungal disease

Early blight

Alternaria

solani

Late blight

Phytophthora

infestans

WP 800

g/kg

Hand-held

knapsack

sprayer

BBCH

13 - 89

1-5 7 days 0.200 -

0.320

500-

800

1.6

3

(a) For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure)

(i) g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in different variants (e.g.




(b) Outdoor or field use (F), greenhouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil born insects, foliar fungi, weeds

(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide

(f) All abbreviations used must be explained

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant- type of

equipment used must be indicated

fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to

give the rate for the variant (e g. benthiavalicarb-isopropyl).

(j) Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application

(k) Indicate the minimum and maximum number of applications possible under practical conditions of use

(l) The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha

(m) PHI - minimum pre-harvest interval

Summary of additional intended uses for which MRL applications have been made, that in addition to the uses above, have also been considered in

the consumer risk assessment (mancozeb)

Regulation (EC) N° 1107/2009 Article 8.1(g))

Not considered in this renewal




Further information, Efficacy

Effectiveness (Regulation (EU) N° 284/2013, Annex Part A, point 6.2)

The representative uses/ GAPs are supported.

Adverse effects on field crops (Regulation (EU) N° 284/2013, Annex Part A, point 6.4)


Observations on other undesirable or unintended side-effects (Regulation (EU) N° 284/2013,

Annex Part A, point 6.5)


Groundwater metabolites: Screening for biological activity (SANCO/221/2000-rev.10-final Step

3 a Stage 1)

Activity against target organism

N/A




Methods of Analysis

Analytical methods for the active substance (Regulation (EU) N° 283/2013, Annex Part A, point

4.1 and Regulation (EU) N° 284/2013, Annex Part A, point 5.2)

Technical a.s. (analytical technique) EU MTF : CIPAC method 34/TC/M/3 converts

mancozeb to CS2 and quantification is by titration with

iodine and levels expressed as mancozeb.

Total manganese and total zinc content by CIPAC

method 34/TC/M/4.

Agria SA : Mancozeb content by CIPAC methods

MT34/WG/M/3 and 61/TC/M/3.

Total manganese and zinc content by ICP-OES.

Impurities in technical a.s. (analytical technique) EU MTF : HPLC-UV, UV-Vis, IC, flame photometry

and CIPAC methods.

Agria SA : GC-MSD, HPLC-UV, LC/MS, IC, ICP-OES,

CIPAC methods.

Plant protection product (analytical technique) EU MTF : For mancozeb content, CIPAC method

34/3/M/6.3 (CS2 expressed as mancozeb) is used.

ETU in PPP by HPLC-UV (based on CIPAC MT 162).

Agria SA : mancozeb content by CIPAC methods MT

34/WG/M/3 and 61/TC/M/3.

ETU in PPP by GC-FID.

Analytical methods for residues (Regulation (EU) N° 283/2013, Annex Part A, point 4.2 & point

7.4.2)

Residue definitions for monitoring purposes

Food of plant origin dithiocarbamates (mancozeb expressed as CS2)

Food of animal origin dithiocarbamates (mancozeb expressed as CS2)

Soil At least mancozeb, open for EBIS, EU and M11

Sediment dithiocarbamates (expressed as mancozeb)

Water surface At least mancozeb, open for EDA, hydantoin and

unknown 2a

drinking/ground dithiocarbamates (expressed as mancozeb)

Air dithiocarbamates (expressed as mancozeb)

Body fluids and tissues ETU




Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique and

LOQ for methods for monitoring purposes)

EU MTF: Conversion of mancozeb to CS2 and detection

by GC-MS.

LOQ = 0.03 mg/kg (expressed as CS2) for high water

content, dry, high oil content matrices

LOQ = 0.05 mg/kg (expressed as CS2) for high acid

content matrices

Agria SA : data gap: ILV

Food/feed of animal origin (analytical technique

and LOQ for methods for monitoring purposes)


by GC-MS, LOQ = 0.03 mg/kg (expressed as CS2) for

each matrix. (meat, fat, liver, milk and egg)

Agria SA : Data gaps identified including ILV for all

animal matrices.

Soil (analytical technique and LOQ)


by GC-MS, confirmation by different GC column. LOQ

= 0.05 mg/kg (expressed as mancozeb)

Water (analytical technique and LOQ)

EU MTF: Conversion of mancozeb to methylated

derivative and detection by LC-MS/MS, two ions

monitored. LOQ = 0.1 µg/L (expressed as mancozeb) in

each of drinking, surface and ground water.

Agria SA : Data gap identified.

Air (analytical technique and LOQ)

EU MTF: Conversion of mancozeb to methylated

derivative and detection by LC-MS/MS, two ions

monitored. LOQ = 5 µg/m3

Agria SA : Data gap identified.

Body fluids and tissues (analytical technique and

LOQ)

EU MTF: Mancozeb in body tissue not required. Animal

tissue methods are considered suitable.

tissues: ETU by LC-MS/MS, two ions monitored. LOQ

= 0.01 mg/kg

ETU in body fluids by LC-MS/MS, two ions monitored,

LOQ = 10 µg/L in both plasma and urine.

Agria SA : Data gap identified for ETU in body fluids.

Classification and labelling with regard to physical and chemical data (Regulation (EU) N°

283/2013, Annex Part A, point 10)

Substance Mancozeb




Harmonised classification according to Regulation

(EC) No 1272/2008 and its Adaptations to

Technical Process [Table 3.1 of Annex VI of

Regulation (EC) No 1272/2008 as amended]1:

Not classified for phys-chem properties

Peer review proposal 2 for harmonised classification

according to Regulation (EC) No 1272/2008:

N/A

1 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 Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355. 2 It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with Regulation

(EC) No 1272/2008.




Impact on Human and Animal Health

Absorption, distribution, metabolism and excretion (toxicokinetics) (Regulation (EU) N°

283/2013, Annex Part A, point 5.1)

Rate and extent of oral absorption/systemic

bioavailability

50 % (based on urinary (42%) and biliary (7%) excretion

within 24 h and tissue (2.5%) within 96 h)

based on single administration at 1.5 and 100 mg/kg bw

in rats

Toxicokinetics Tmax = 3-6 hr; absorption T1/2 = 0.7-1.7 hr

Distribution Widely distributed with thyroid having the highest levels

of radioactivity

Potential for bioaccumulation No evidence for accumulation

Rate and extent of excretion Rapid and extensive (app. 74-94 % within 24 h),

via urine (42 % within 24 h), 42% % via faeces (within

24 h) and 7 % via bile (within 96 h)

Metabolism in animals Extensively metabolised (> 95 %); main metabolite ETU

(ethylenethiourea) (18% of dose in urine in rats); other

significant metabolites: EBIS, EDA and EU. One

pathway involves hydrolysis of the dithiocarbamate

linkages to produce EDA; EDA is then oxidised to

glycine. The other involves oxidation to EBIS and then

to ETU, various derivatives of ETU and EU.

Major rat metabolites (≥ 10% of administered dose):

ETU, EU, EDA and N-acetyl-EDA).

In vitro metabolism Not technically feasible; however, information on the in

vivo metabolism of mancozeb in different species,

including humans (epidemiology and health surveys)

show a qualitatively similar metabolism.

Toxicologically relevant compounds

(animals and plants)

ETU

Toxicologically relevant compounds

(environment)

ETU

Acute toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.2)

Rat LD50 oral > 5000 mg/kg bw

Rat LD50 dermal > 2000 mg/kg bw

Rat LC50 inhalation > 5 mg/L air /4h (5 studies,whole body or

head/nose-only)

Skin irritation Non-irritant

Eye irritation Non-irritant

Skin sensitisation Sensitising (Buheler and M+K) H317

Phototoxicity One positive study and one negative study –

Phototoxicity potential cannot be concluded

(data gap and issue not finalised)




Short-term toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.3)

Target organ / critical effect Rat: thyroid (hormone level) and body weight

Dog: thyroid (hormone level and weight),

food consumption and body weight

Mouse: thyroid (hypertrophy), liver

(decreased enzyme activity) and body weight

Relevant oral NOAEL 1-year, dog: mg/kg bw per day

90-day rat: 6.8, liver mg/kg bw per day

90-day mouse: 18 mg/kg bw per day

Relevant dermal NOAEL 28-day, rat: 120 mg/kg bw per day

Relevant inhalation NOAEL 90-day, rat: 36 mg/m3 (6 h) respirable; 79

mg/m3 total

Genotoxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.4)

In vitro studies 2 gene mutations assays with the formulated

product: one negative and one equivocal;

chromosomal aberrations in vitro: positive but

only in the presence of DMSO and therefore

this result is considered invalid

In vivo studies Negative in bone marrow cytogenetics and

micronucleus assays

Photomutagenicity Negative in an in vitro photomutagenicity

assay with Salmonella thyphimurium

Potential for genotoxicity Overall the genotoxic potential is of low

concern.

Long-term toxicity and carcinogenicity (Regulation (EU) N°283/2013, Annex Part A, point 5.5)

Long-term effects (target organ/critical effect) Rat & mouse: thyroid (hypertrophy and

hyperplasia)

Relevant long-term NOAEL 2-year, rat: 4.8 mg/kg bw per day

18-month, mouse: 13 mg/kg bw per day

Carcinogenicity (target organ, tumour type) Rat: thyroid tumours (adenomas and

carcinomas)

Mouse: no tumours

Relevant NOAEL for carcinogenicity 2-year, rat: 4.8 mg/kg bw per day;

18-month, mouse: 130 mg/kg bw per day




Reproductive toxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.6)

Reproduction toxicity

Reproduction target / critical effect Parental toxicity: bw reduction, FC reduction,

thyroid

Reproductive toxicity: no adverse effect

observed in two rat 2-generation studies

Offspring’s toxicity: Reduced viability and

reduced weight, delayed eye opening

Relevant parental NOAEL 7 mg/kg bw per day

Relevant reproductive NOAEL 70 mg/kg bw per day

Relevant offspring NOAEL 7 mg/kg bw per day

Developmental toxicity

Developmental target / critical effect Rat:

Maternal toxicity: mortality, paralysis,

suffering, litter loss, bw reduction, FC

reduction.

Developmental toxicity: malformations

(mainly of head), resorptions, retarded

development

Rabbit:

Maternal toxicity: mortality, abortions,

clinical signs, bw reduction, FC reductions.

Developmental toxicity: none

Relevant maternal NOAEL Rat: 60 mg/kg bw per day

Rabbit: 55 mg/kg bw per day

Relevant developmental NOAEL Rat: 160 mg/kg bw per day

Rabbit: 80 mg/kg bw per day

Neurotoxicity (Regulation (EU) N° 283/2013, Annex Part A, point 5.7)

Acute neurotoxicity Data not available

Repeated neurotoxicity 90-day study available: neurotoxicity (myelin

damage with Schawnn cells proliferation of

nerve tissue) observed from a dose of 49

mg/kg bw per day

NOAEL = 8.2 mg/kg bw per day

Additional studies (e.g. delayed neurotoxicity,

developmental neurotoxicity)

DNT study in rats:

- developmental neurotoxicity: no effect up to

30 mg/kg bw per day (top dose)

- maternal toxicity: bw reduction and thyroid

pathology, NOAEL 15 mg/kg bw per day

Other toxicological studies (Regulation (EU) N° 283/2013, Annex Part A, point 5.8)

Supplementary studies on the active substance Immunotoxicity: Mancozeb has no immunotoxic

potential based on the available toxicity data package.




Endocrine disrupting properties

Studies performed on metabolites or impurities Metabolites:

ETU

Major rat metabolite of mancozeb

Oral abs 100%

Human dermal abs 12% (high dose), 17% (low dose)

from human in vitro study;

Rat dermal abs 5-6% (intermediate and high dose), 22%

(low dose) from in vivo rat study (10 hrs exposure);

- Acute Tox 4 (H302), Repr.1B (H360D)

- ADI = 0.002 mg/kg bw per day (NOAEL = 0.2 mg/kg

bw/d from 1-yr dog study (also supported by parental

NOAEL of 0.2 mg/kg bw per day in the rat EOGRTS)

based on effects on thyroid, liver and body weights at the

LOAEL of 2 mg/kg bw per day; UF = 100)

-

EBIS

Minor metabolite of mancozeb.

Oral abs = 100%

Acute Tox 3 (H301)

-ADI = 0.023 mg/kg bw per day (the same value as the

parent)

- ARfD = 0.15 mg/kg bw (the same value as the parent)




Studies performed on metabolites or impurities EU


Oral abs = 100%

ADI = 0.06 mg/kg bw/day (NOAEL = 37 mg/kg bw per

d from oral rat reproduction screening study based on

reduced pup viability and parental effects on body

weight, food/water consumption and thyroid at the


ARfD = 0.37 mg/kg bw (NOAEL = 37 mg/kg bw per d

from oral rat reproduction screening study based on

reduced pup viability and parental effects on body

weight, food/water consumption and thyroid at the


EDA


Oral abs = 100%

Acute Tox. 4 (H302), Acute Tox. 4 (H312), Skin Corr.

1B (H314), Skin Sens. 1 (H317), Resp. Sens. 1 (H334)

ADI = 0.023 mg/kg bw per day (the same value as the

parent)

ARfD = 0.15 mg/kg bw (the same value as the parent)

Studies performed on metabolites or impurities Jaffe’s base




Minor rat metabolite of mancozeb.

Not genotoxic based on data (Ames, in vitro MN and

QSAR analysis).

Toxicological profile cannot be concluded.

2-imidazoline and 2-imidazoline sulfonic acid

Not rat metabolites of mancozeb.

Not genotoxic based on QSAR analysis.


TDIT

Not a rat metabolite of mancozeb.



Hydantoin




N-acetyl-EDA

Major rat metabolite of mancozeb.

The ADI and ARfD of the parent substance can be used.

ADI = 0.023 mg/kg bw per day

ARfD = 0.15 mg/kg bw

Glycine and N-formylglycine

Rat metabolites of mancozeb.

Considered to be of low toxicity.

No toxicological concern.

M222F001


No conclusion on genotoxicity or general toxicity can be

drawn based on the available data.

Medical data (Regulation (EU) N° 283/2013, Annex Part A, point 5.9)

No health conditions which could be associated with

mancozeb exposure have been detected.




Summary3 (Regulation (EU) N°1107/2009,

Annex II, point 3.1 and 3.6)

Value

(mg/kg bw (per

day))

Study

Uncertainty

factor

Acceptable Daily Intake (ADI) dog, 1-year 100

Acute Reference Dose (ARfD) rat, DNT (maternal

toxicity)

100

Acceptable Operator Exposure Level (AOEL) dog, 1-year 100*

Acute Acceptable Operator Exposure Level

(AAOEL)

rat, DNT (maternal

toxicity)

100*

* Including correction for limited oral absorption/bioavailability

(50 %).

European Commission, 2009:

ADI was 0.05 mg/kg bw per day based on the 2-year study in rat

and using an UF of 100.

ARfD was 0.6 mg/kg bw based on teratogenicity study in rat and

using an UF of 100.

AOEL was 0.035 mg/kg bw based on the overall short-term

NOAEL in rats and dogs, applying an UF of 100 and considering

an oral absorption value of 50%.

Dermal absorption (Regulation (EU) N° 284/2013, Annex Part A, point 7.3)

Representative formulation (indicate name,

type e.g. EC and concentration of active

substance)

Penncozeb 80 WP/Dithane M-45

Concentrate (80% a.s.): 0.7%

Spray dilution (0.14% a.s): 1 %

Based on in vivo rat study using Mancozeb 80

WP /Dithane M-45 (representative product).

Mancozeb 800WP

Concentrate (80% a.s.): 0.7%

Spray dilution (0.14% a.s): 1 %

Based on in vivo rat study using Mancozeb 80WP

(very similar to Agria Mancozeb 800WP).

Exposure scenarios (Regulation (EU) N° 284/2013, Annex Part A, point 7.2)

Operators Penncozeb 80WP/Dithane M45

Use: potatoes, tractor mounted field crop boom sprayer, application rate 1.6

kg a.s/ha, 200 L/ha – the same calculations apply to the use on wheat.

EFSA Calculator % AOEL

of a.s.

%

AOEL

of ETU

%

AAOEL

of ETU

%

AAOEL

of a.s.

With gloves and RPE

FP2/P2 during mix/load

and gloves during

application

Combined exposure




Use: grapes, tractor mounted broadcast air-assisted sprayer, application rate

1.6 kg a.s/ha, 200 L/ha

EFSA Calculator

With gloves and RPE

FP2/P2 during mix/load

and gloves during

application, closed cab

(i) Combined exposure

*exposure to ETU during mixing/loading (as impurity at 0.03%) and

application (as metabolite). NOTE: It was acknowledged during the written

procedure on the draft conclusion that the impurity level could be up to

0.3% (this is not expected to change the outcome of exposure to ETU

during mixing/loading).

Mancozeb 800WP

Use: protected tomatoes, hand-held (tank and lance) sprayer, application

rate 1.6 kg a.s/ha

EUROPOEM

With gloves and

coveralls during mixing,

loading and application

53

**

**

N/A

**The notifer has not provided any data in order to determine the level of

ETU in spray solution and it is therefore not possible to conduct a risk

assessment for operator exposure to ETU or for combined exposure to ETU

and mancozeb.

Workers Penncozeb 80WP/Dithane M45

EFSA Calculator

Without PPE:

Potatoes

Wheat

Grapes

Grapes (+ DFR study*)

Grapes (DFR study + re-

entry period 35

days)

Combined exposure for

- use on potatoes

- use on wheat

- use on grapes (+DFR

and entry 35d)

Mancozeb 800WP




EUROPOEM II worker

re-entry model

Without PPE

Normal work wear

(arms, body and legs

covered) and PPE gloves

Total potential exposure

(body) and PPE gloves

**The notifer has not provided any data in order to determine the level of

ETU in spray solution and it is therefore not possible to conduct a risk

assessment for worker exposure to ETU or for combined exposure to ETU

and mancozeb.

Bystanders and residents Penncozeb 80WP/Dithane M45

Tractor mounted field crop boom spray application to potatoes (child) -

Buffer zone 2-3m

EFSA Calculator

Spray drift

Vapour

Surface deposits

Entry into treated crops

All pathways (mean)

Combined exposure Spray drift:

Vapour:

Surface dep:

Entry:

All (mean):

Tractor mounted field crop boom spray application to wheat (child) - Buffer

zone 2-3m

EFSA Calculator

Spray drift

Vapour

Surface deposits


All pathways (mean)


Vapour:

Surface dep:

Entry:

All (mean):

Spray drift:

Vapour:

Surface dep:

Entry:

Tractor mounted field crop boom spray application to potatoes (adult) -

Buffer zone 2-3m




EFSA Calculator

Spray drift

Vapour

Surface deposits


All pathways (mean)


Vapour:

Surface dep:

Entry:

All (mean):

All (mean):

Tractor mounted field crop boom spray application to wheat (adult) - Buffer

zone 2-3m

EFSA Calculator

Spray drift

Vapour

Surface deposits


All pathways (mean)


Vapour:

Surface dep:

Entry:

All (mean):

Spray drift:

Vapour:

Surface dep:

Entry:

All (mean):

Tractor mounted broadcast air-assisted spray application to grapes (child) –

Buffer zone 5m

EFSA Calculator

Spray drift

Vapour

Surface deposits


All pathways (mean)


Vapour:

Surface dep:

Entry:

All (mean):

Tractor mounted broadcast air-assisted spray application to grapes (adult) –

Buffer zone 5m

EFSA Calculator

Spray drift

Vapour

Surface deposits





All pathways (mean)


Vapour:

Surface dep:

Entry:

All (mean):

Mancozeb 800WP

Data gap for further consideration of exposure to vapour from ventilation

systems.

Classification with regard to toxicological data (Regulation (EU) N° 283/2013, Annex Part A,

Section 10)

Substance : mancozeb




Regulation (EC) No 1272/2008 as amended]4 :

Skin Sens 1, H317

Peer review proposal 5 for harmonised classification


See box above

4 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 Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355. 5 It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with Regulation

(EC) No 1272/2008..




Residues in or on treated products food and feed

Metabolism in plants (Regulation (EU) N° 283/2013, Annex Part A, points 6.2.1, 6.5.1, 6.6.1 and

6.7.1)

Primary crops

(Plant groups covered)

OECD Guideline 501

Crop groups Crop(s) Application(s) DAT (days)

Fruit crops Tomatoes 2.7 kg a.s./ha (9 appl.

with a 7 day interval) 5

Root crops Potatoes

4 kg a.s./ha (3 appl.) and

1.7 kg a.s./ha (3 appl.) 7, 14

Sugar beet 2.24 kg a.s./ha (3 appl.) At harvest

Cereals/grass crops Wheat

2.24 kg a.s./ha (3 appl. at

intervals of 1-2 weeks) 46

1.6 kg a.s./ha (3 appl. at

intervals of 7 and 10

days)

14, 20, 61

Pulses/Oilseeds Soybeans

3.36 kg a.s./ha (2 appl.

treated 56 and 69 days

prior to harvest)

At harvest

Rotational crops

(metabolic pattern)

OECD Guideline 502

Crop groups Crop(s) PBI (days) Comments

Root/tuber crops radish root 7/123/207 Bare soil application at

2.02 kg as/ha.

Neither the parent

mancozeb nor the

metabolites identified in

primary crops were

detected in any plant part

and only glycine was

found in significant

proportions in wheat

forage and straw (up to

35% TRR), in lettuce (up

to 50% TRR) and in radish

root (52% TRR) at 7 and

123 days plant back

intervals (PBIs)

Leafy crops lettuce 7/123/207

Cereal (small grain) wheat 7/123/207

Rotational crop and

primary crop metabolism

similar?

Similar as a major part of the radioactive residues were incorporated into natural

plant constituents. Specific residue definitions are not deemed necessary for

rotational crops.

Processed commodities

(standard hydrolysis

study)

OECD Guideline 507

Conditions ETU

20 min, 90°C, pH 4 52% The processing study was conducted using

metiram. In view of the similar structures of

metiram and mancozeb, similar behaviour of

both compounds under hydrolysis conditions

is expected.

60 min, 100°C, pH 5 88.4%

20 min, 120°C, pH 6 98.6%

Residue pattern in

processed commodities

similar to residue pattern

in raw commodities?

Results expressed as % of the applied radioactivity

No, processing leads to the formation of the metabolite ETU.




Plant residue definition for monitoring (RD-Mo)

OECD Guidance, series on pesticides No 31

Dithiocarbamate (mancozeb) determined and expressed

as CS2 - All crop categories.

Plant residue definition for risk assessment (RD-

RA)

Mancozeb and ETU - All crop categories.

Processed commodities: Mancozeb and ETU

Conversion factor (monitoring to risk assessment) 1.78 (CS2 to mancozeb) – does not take into account the

ETU component of the residue definition for risk

assessment.

Metabolism in livestock (Regulation (EU) N° 283/2013, Annex Part A, points 6.2.2, 6.2.3, 6.2.4,

6.2.5 6.7.1)

OECD Guideline 503 and

SANCO/11187/2013 rev. 3 (fish) Animal

Dose

(mg/kg bw/d)

Duration

(days)

N rate/comment

Animals covered Laying hen 3.4, 16.4, 41.4, 42.3

mg mancozeb/kg

feed

7 -

Goat/Cow 0.15, 0.7, 1.7 mg/kg

bw per day

7 -

Pig A metabolism study for swine was not conducted as

commonality was demonstrated between the metabolic

pathways of poultry, ruminants and rats.

Fish Fish metabolism data are not required as mancozeb and

ETU are considered as not fat soluble (log Pow<3).

Time needed to reach a plateau concentration in

milk and eggs (days)

Eggs: Not available

Milk: Not reached within 7 days.

Animal residue definition for monitoring (RD-Mo)

OECD Guidance, series on pesticides No 31

Dithiocarbamate (mancozeb) determined and expressed

as CS2

Animal residue definition for risk assessment (RD-

RA)

Mancozeb and ETU.

Conversion factor (monitoring to risk assessment) 1.78 (CS2 to mancozeb) – does not take into account the

ETU component of the residue definition for risk

assessment.

Metabolism in rat and ruminant similar (Yes/No) Yes

Fat soluble residues (Yes/No)

(FAO, 2009)

No - LogPow<3 and higher TRR values in fat free muscle

compared to fat from the metabolism data.

Residues in succeeding crops (Regulation (EU) N° 283/2013, Annex Part A, point 6.6.2)

Confined rotational crop study

(Quantitative aspect)

OECD Guideline 502

Mancozeb and its major soil metabolites showed very low to moderate

persistence in soil (DT90 <100 days). Available confined rotational crop

metabolism studies in cereal small grains (wheat), leafy crops (lettuce) and

root crops (radish) showed that neither the parent mancozeb nor the

metabolites identified in primary crops were detected in any plant part and

only glycine was found in significant proportions in wheat forage and straw




(up to 35% TRR), in lettuce (up to 50% TRR) and in radish root (52% TRR)

at 7 and 123 days plant back intervals (PBIs). Besides a major fraction of the

radioactive residues was characterized as polar components with further

incorporation into natural constituents of the plants.

Based on these studies, it is not expected that mancozeb, or any of its known

metabolites will be present >0.01 mg eq./kg in food and feed edible

commodities harvested from crops grown in rotation when the representative

uses are considered.

Field rotational crop study

OECD Guideline 504

Not required

Stability of residues (Regulation (EU) N° 283/2013, Annex Part A, point 6.1)

OECD Guideline 506

Plant products

(Category) Commodity

T

(°C)

Stability

Mancozeb ETU

High water content Apple -18 24.5 months 2 month

Tomato -18 24.5 months 12 months

Cucumber -18 12 months -

Onion -18 - 6 months

High oil content Olive -18 12 months 0 month

High protein content Dry bean -18 12 months

High starch content

Wheat grain -18 24.5 months 12 months3

Cereal (not

specificed) grain -18 12 months 0 month3

High acid content Orange -18 12 months -

Grape -18 12 months

Others Cereal straw -18 12 months -4

Wheat flour -18 - 7 weeks

Wheat bran -18 - 7 weeks

Bread -18 - 7 weeks

3 The two studies testing ETU stability in cereal matrices are contradictory. Data gap: Clarification on the discrepancies in

regard to the frozen storage stability results for ETU observed in wheat and cereal grain and the validity of the field

residue trials analysing ETU residues in wheat grain should be demonstrated in regard to the work-up and the

maximum storage time interval of the residue samples. 4 Data gap: storage stability data on ETU in cereal straw and covering the maximum storage time interval of the wheat

residue trials.

Animal Animal

commodity

T

(°C)

Stability

Mancozeb ETU




Bovine Muscle -18 4 months

Bovine Liver -18 4 months

Bovine Kidney -18 4 months

Bovine Fat -18 4 months

Bovine Milk -18 4 months

Poultry Egg -18 4 months




Summary of residues data from the supervised residue trials (Regulation (EU) N° 283/2013, Annex Part A, point 6.3) OECD Guideline 509, OECD

Guidance, series on pesticides No 66 and OECD MRL calculator

Crop

Region/

Indoor

(a)

Residue levels (mg/kg) observed in the supervised

residue trials relevant to the supported GAPs

(b)

Recommendations/comments (OECD calculations)

MRL

proposals

(mg/kg)

HR

(mg/kg)

(c)

STMR

(mg/kg)

(d)

Representative uses

Tomatoes Indoor

- Data gap: A complete GAP compliant residue

dataset on indoor tomatoes and covering the

residue definitions for monitoring and risk

assessment is required.

- - -

Grapevines

NEU

RD-Mo (mancozeb, expressed as CS2)

0.30; 0.59; 0.60; 0.73; 0.78; 1.0; 1.6; 2.3 8 GAP compliant trials analysing for both CS2

and ETU 4 2.3 0.76

RD-RA (mancozeb, expressed as mancozeb)

0.54; 1.1; 1.1; 1.3; 1.4; 1.9; 2.8; 4.1 N/A 4.1 1.35

RD-RA (ETU, expressed as ETU):

<0.01; 2 x 0.01; 2 x 0.02; 0.04; 0.05; 0.06 N/A 0.06 0.02

SEU

- Data gap: a complete residue dataset on grapes

compliant with the SEU GAP that determine

mancozeb (CS2) and ETU and supported by

acceptable storage stability data is required.

- - -

Potatoes

NEU


- Data gap: Complete NEU and SEU residue data

packages are required on potatoes with

immediate residue analysis and covering the

residue definitions for monitoring and risk assessment.

-


- N/A


0.02 N/A

0.02

0.02

SEU


<0.03

-

<0.03 <0.03


<0.053 N/A <0.053 <0.053


N/A

Wheat grain NEU RD-Mo (mancozeb, expressed as CS2)

3x <0.006; 0.02, 7x <0.03; 2x 0.03; 0.06; 0.07; 2x 0.09

Data gap: Clarification on the discrepancies in

regard to the frozen storage stability results for

0.15 (provisional)

0.09

0.03




Crop

Region/

Indoor

(a)



(b)


MRL

proposals

(mg/kg)

HR

(mg/kg)

(c)

STMR

(mg/kg)

(d)


3x <0.01; 0.04; 7x <0.05; 2x 0.05; 0.11; 0.12; 2x 0.16

ETU observed in wheat and cereal grain and the

validity of the field residue trials analysing ETU

residues in wheat grain should be demonstrated

in regard to the work-up and the maximum

storage time interval of the residue samples.

N/A 0.16 0.05


7x <0.01; 0.01 N/A 0.01 <0.01

SEU


1x <0.006; 2x 0.02; 2x 0.04; 2 x 0.05; 0.08; 0.11; 2x

0.15

Data gap: additional residue trials compliant

with the SEU GAP are required for the

determination of ETU residues in wheat grain.

Data gap: Clarification on the discrepancies in

regard to the frozen storage stability results for

ETU observed in wheat and cereal grain and the

validity of the field residue trials analysing ETU

residues in wheat grain should be demonstrated

in regard to the work-up and the maximum

storage time interval of the residue samples.

0.3 (provisional)

0.15

0.05


1x <0.01; 2x 0.04; 2x 0.07; 2x 0.09; 0.13; 0.20;

0.27

N/A

0.27

0.09


<0.01; 0.01; 0.05 N/A 0.05 <0.01

Wheat straw

NEU


0.29; 0.36; 0.48; 3x 0.50; 0.73;0.75; 0.90; 0.91; 1.13;

1.20; 1.60; 1.68; 1.94; 3.63; 4.50

N/A

4.5

0.90


0.52; 0.64; 0.85; 3x 0.89; 1.30; 1.34; 1.60; 1.62; 2.01;

2.2; 2.80; 2.99; 3.45; 6.46; 8.01

N/A 8

1.60


0.01; 0.02; 0.03; 0.04; 0.07; 2x 0.08, 0.12 N/A 0.12

(provisional

)(4)

0.06 (provisional

)(4)

SEU


0.24; 0.46; 1.71; 2.35; 3.90; 4.08; 4.70; 5.70; 5.80;

6.80; 16.0

N/A 16.0

4.08


0.43; 0.82; 3.04; 4.18; 6.94; 7.61; 8.3; 10.15; 10.32;

12.10; 28.0

N/A 28

7.61


0.06; 0.30; 0.33; 0.43; 0.55 N/A 0.55

(provisional

)(4)

0.33 (provisional

)(4)

Summary of data on residues in pollen and bee products (Regulation (EU) No 283/2013, Annex Part A, point 6.10.1)




Crop

Region/

Indoor

(a)



(b)


MRL

proposals

(mg/kg)

HR

(mg/kg)

(c)

STMR

(mg/kg)

(d)

Product(s) Region Residue data (mg/kg) Recommendations/comments

(a): NEU or SEU for northern or southern outdoor trials in EU member states (N+SEU if both zones), Indoor for glasshouse/protected crops, Country if non-EU location.

(b): Residue levels in trials conducted according to GAP reported in ascending order (e.g. 3x <0.01, 0.01, 6x 0.02, 0.04, 0.08, 3x 0.10, 2x 0.15, 0.17). When residue definition for monitoring and risk

assessment differs, use Mo/RA to differentiate data expressed according to the residue definition for Monitoring and Risk Assessment.

(c): HR: Highest residue. When residue definition for monitoring and risk assessment differs, HR according to residue definition for monitoring reported in brackets (HRMo).

(d): STMR: Supervised Trials Median Residue. When residue definition for monitoring and risk assessment differs, STMR according to definition for monitoring reported in brackets (STMRMo).




Inputs for animal burden calculations

(Mancozeb, expressed as mancozeb) - Provisional

Feed commodity Median dietary burden Maximum dietary burden

(mg/kg) Comment (mg/kg) Comment

Representative uses

Wheat straw 7.61 STMR (SEU) 28 HR (SEU)

Potato culls 0.053 STMR (EU) 0.053 HR (EU)

Wheat grain 0.09 STMR (SEU) 0.09 STMR (SEU)

Distiller’s grain 0.30

STMR x default PF

(3.3)(5) 0.30

STMR x default PF

(3.3)(5)

Potato (process waste) 1.06

STMR x default PF (20)

(5) 1.06


(5)

Potato (dried pulp) 2.01


(5) 2.01


(5)

Wheat (gluten meal) 0.16

STMR x default PF (1.8)

(5) 0.16


(5)

Wheat (milled by-products) 0.63 STMR x default PF (7)(5) 0.63 STMR x default PF (7)(5)

(5) The livestock dietary intakes calculated using these default Pf values are provisional. Data gap: Sufficient processing

residue trials analysing for mancozeb and ETU in potato processed matrices that may be fed to livestock and

within a time interval for which acceptable storage stability is demonstrated for both compounds.

Input values for potato have been included – but these are provisional values in view of the identified data gap.

(ETU, expressed as ETU) - Provisional

Feed commodity Median dietary burden Maximum dietary burden

(mg/kg) Comment (mg/kg) Comment

Representative uses

Wheat straw 0.33 STMR (SEU)(4) 0.55 HR (SEU)(4)

Potato culls 0.02 STMR (EU) 0.02 HR (EU)

Wheat grain 0.01 STMR (SEU) 0.01 STMR (SEU)

Distiller’s grain 0.03 STMR x default PF (3.3)

(5) 0.03


(5)

Potato (process waste)

0.40


(5)

0.40


(5)

Potato (dried pulp)

0.76


(5)

0.76


(5)

Wheat (gluten meal) 0.02 STMR x default PF (1.8)

(5) 0.02


(5)

Wheat (milled by-products) 0.07 STMR x default PF (7) (5) 0.07 STMR x default PF (7) (5)

(5)The livestock dietary intakes calculated using these default Pf values are provisional. Data gap: Sufficient processing residue

trials analysing for mancozeb and ETU in potato processed matrices that may be fed to livestock and within a

time interval for which acceptable storage stability is demonstrated for both compounds.

Input values for potato, wheat grain and straw have been included – but these are provisional values in view of the identified

data gaps.




Residues from livestock feeding studies (Regulation (EU) N° 283/2013, Annex Part A, points 6.4.1, 6.4.2, 6.4.3 and 6.4.4) OECD Guideline 505 and OECD Guidance, series on pesticides No 73

MRL calculations Ruminant Pig/Swine Poultry Fish

Highest expected intake

(mg/kg bw/d)-

Mancozeb(6)

(mg/kg DM for fish)

Beef cattle 0.240 Ram/Ewe 0.544 Breeding 0.045 Broiler 0.039 Carp -

Dairy cattle 0.351 Lamb 0.619 Finishing 0.019 Layer 0.248 Trout -

Turkey 0.018

Intake >0.004 mg/kg bw Yes Yes Yes Yes

Feeding study

submitted(7)

Yes (assessed in the

original DAR)

No (feeding study provided

for ruminants was relied

upon)

No (feeding study

provided for ruminants

was relied upon)


original DAR)

Not required

Representative feeding

level (mg/kg bw/d,

mg/kg DM for fish) and

N rates

Level

Beef: N

Dairy: N

Level

Lamb: N

Ewe: N

Level

N rate

Breed/Finish

Level

B or T: N

Layer: N

Level

N rate

Carp/Trout

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Muscle - -

Fat - -

Meat(b)

Liver

Kidney

Milk(a)

Eggs

Method of calculation(c) (a): Estimated HR calculated at 1N level (estimated mean level for milk). (b): HR in meat calculated for mammalian on the basis of 20% fat + 80% muscle and 10% fat + 90% muscle for poultry

(c): The OECD guidance document on residues in livestock (series on pesticides 73) recommends three different approaches to derive MRLs for animal products; by applying a transfer factor (Tf), by

intrapolation (It) or by linear regression (Ln). Fill in method(s) considered to derive the MRL proposals. (6): Provisional dietary burden calculation in regard to mancozeb and ETU residues, respectively. (7):

. Provided the finalisation of the dietary burden calculation and whether feeding studies are triggered, new poultry and ruminant feeding studies and covering

the residue definitions for monitoring and risk assessment .




Residues from livestock feeding studies (Regulation (EU) N° 283/2013, Annex Part A, points 6.4.1, 6.4.2, 6.4.3 and 6.4.4) OECD Guideline 505 and OECD Guidance, series on pesticides No 73

MRL calculations Ruminant Pig/Swine Poultry Fish

Highest expected intake

(mg/kg bw/d)-ETU(6)

(mg/kg DM for fish)

Beef cattle 0.036 Ram/Ewe 0.053 Breeding 0.017 Broiler 0.013 Carp -

Dairy cattle 0.045 Lamb 0.040 Finishing 0.007 Layer 0.014 Trout -

Turkey 0.003

Intake >0.004 mg/kg bw Yes Yes Yes Yes

Feeding study

submitted(7)


original DAR)

No (feeding study provided

for ruminants was relied

upon)

No (feeding study

provided for ruminants

was relied upon)


original DAR)

Not required

Representative feeding

level (mg/kg bw/d,

mg/kg DM for fish) and

N rates

Level

Beef: N

Dairy: N

Level

Lamb: N

Ewe: N

Level

N rate

Breed/Finish

Level

B or T: N

Layer: N

Level

N rate

Carp/Trout

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Estimated

HR(a) at 1N

MRL

proposals

Muscle - -

Fat - -

Meat(b)

Liver

Kidney

Milk(a)

Eggs

Method of calculation(c) (a): Estimated HR calculated at 1N level (estimated mean level for milk). (b): HR in meat calculated for mammalian on the basis of 20% fat + 80% muscle and 10% fat + 90% muscle for poultry

(c): The OECD guidance document on residues in livestock (series on pesticides 73) recommends three different approaches to derive MRLs for animal products; by applying a transfer factor (Tf), by

intrapolation (It) or by linear regression (Ln). Fill in method(s) considered to derive the MRL proposals. (6): Provisional dietary burden calculation in regard to mancozeb and ETU residues, respectively. (7):

. Provided the finalisation of the dietary burden calculation and whether feeding studies are triggered, new poultry and ruminant feeding studies and

covering the residue definitions for monitoring and risk assessment .




Conversion Factors (CF) for monitoring to risk assessment

-




Crop (RAC)/Edible part or

Crop (RAC)/Processed product

Number

of

studies(a)

(mancozeb /

ETU)

Processing Factor (PF)

Mancozeb (CS2) ETU/CS2(d) ETU/ETU(e)

Representative uses

Grape/ red wine 2/2 0.01 0.03 1.60

Grape/white wine 1/1 <0.02 0.031 >1.8

Grape/ fresh wine (red&white, heated) 18/16 0.04 0.03 5.60

Grape/raisins 3/3 0.31 0.008 2.5

Tomato/ canned puree 2/2 <0.36 0.23 12

Tomato/canned paste 2/2 0.67 0.3 15

Tomato/canned juice 2/2 <0.36 0.06 3.7

Potato/French fries 0/6 (c) - - -

Potato/flakes 0/6 (c) - - -

Wheat/bran 2/2 0.25 0.06 0.75

Wheat/White bread 2/2 <0.2 <0.5 <0.06

Wheat/Whole meal flour 2/2 0.7 0.75 <0.06

Wheat/Whole meal bread 2/2 <0.25 0.75 <0.06 (a): Studies with residues in the RAC at or close to the LOQ should be disregarded (unless concentration) (b): When the residue definition for risk assessment differs from the residue definition for monitoring (c): The storage time interval of the processing trials is not covered by acceptable storage stability data for ETU. (d): ETU residues in processed commodity/CS2 residues in RAC. (e): ETU residues in processed commodity/ETU residues in RAC.

Mancozeb - Consumer risk assessment (Regulation (EU) N° 283/2013, Annex Part A, point 6.9)

Including all uses (representative uses and uses related to an MRL application).

ADI 0.023 mg/kg bw per day

TMDI according to EFSA PRIMo Not relevant

ARfD 0.15 mg/kg bw

IESTI (% ARfD), according to EFSA PRIMo Not relevant

Consumer risk assessment limited to the representative uses(8)

TMDI (% ADI), according to EFSA PRIMo Open

NTMDI (% ADI), according to PSD model Open

IESTI (% ARfD, according to EFSA PRIMo) Provisional:

21.2% ARfD for wine grapes (UK infant)

2.6% ARfD for wheat (UK 4-6 year child)

NESTI (% ARfD, according to PSD model

ETU - Consumer risk assessment (Regulation (EU) N° 283/2013, Annex Part A, point 6.9)

Including all uses (representative uses and uses related to an MRL application).

ADI 0.002 mg/kg bw per day

TMDI according to EFSA PRIMo Not relevant




ARfD 0.01 mg/kg bw

IESTI (% ARfD), according to EFSA PRIMo Not relevant

Consumer risk assessment limited to the representative uses(8)

TMDI (% ADI), according to EFSA PRIMo Open

NTMDI (% ADI), according to PSD model Open

IESTI (% ARfD, according to EFSA PRIMo) Provisional:

39.3% ARfD for table grapes (DE child)

7.2% ARfD for wheat (UK 4-6 year child)

4.7% ARfD for wine grapes (UK infant)

NESTI (% ARfD, according to PSD model

(8): The consumer dietary risk assessment cannot be finalised in regard to the identified data gaps to complete the

residue datasets for all the representative uses in compliance with the agreed residue definitions for monitoring

and risk assessment in plants which will impact the livestock dietary burden calculation and exposure

assessment.

Proposed MRLs (Regulation (EU) No 283/2013, Annex Part A, points 6.7.2 and 6.7.3)

Code(a) Commodity/Group MRL/Import tolerance(b) ( mg/kg) and Comments

Plant commodities

Representative uses (row to be deleted if not relevant)

0151000 Grapevines -

0211000 Potatoes -

0231010 Tomatoes -

0500090 Wheat 0.3 Provisional

1000000 Products of animal

origin-Terrestrial

animals

- Open(9)

(a): Commodity code number, as listed in Annex I of Regulation (EC) No 396/2005 (b): MRLs proposed at the LOQ, should be annotated by an asterisk (*) after the figure. (9): The livestock exposure assessment cannot currently be finalised considering the outstanding data.




Environmental fate and behaviour

Route of degradation (aerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A, point

7.1.1.1)

Mineralisation after 100 days

41.1 – 52.4 % after 120 d, [14C-ethylene carbons]-label

(n6= 3; 20°C)

Other studies: 2.4% after 30 days (n=1; 25°C); 44.9%

after 93 days (n = 1; 23°C); 51.8% after 103 days (n =

1; temperature uncertain)

Non-extractable residues after 100 days

48.4 – 59.5 % 120 d, [14C-ethylene carbons]-label (n= 3;

20°C); maximum 58.9 – 72.2% at 7 – 28 days.

Other studies: 79.2% after 30 days (n=1; 25°C); 46.1%

after 93 days, maximum 69.4% after 13 days (n = 1;

23°C)

Metabolites requiring further consideration

- name and/or code, % of applied (range and

maximum)

EBIS – 24.8-29.1 % at 0.06 d, [14C-ethylene carbons]-

label (n= 3)

ETU – 14.7-24.8 % at 1 d, [14C-ethylene carbons]-label

(n= 3)

EU – 11.7-18.5 % at 1-7 d, [14C-ethylene carbons]-label

(n= 3)

Unknown M11 – 16.6-20.3 % at 0.06 d, [14C-ethylene

carbons]-label (n= 3) (postulated to be a dimer of EBDC

monomer units with formula C8H12N4S8)

Route of degradation (anaerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A, point

7.1.1.2)

Mineralisation after 100 days

1.0 – 1.7% after 61 d, [14C- ethylene carbons]-label (n=

1)

Non-extractable residues after 100 days

43.4 – 48.1 % after 61 d, [14C- ethylene carbons]-label

(n= 1)

Metabolites that may require further consideration

for risk assessment - name and/or code, % of

applied (range and maximum)

ETU – 2.1% % at 1 d [14C-ethylene carbons]-label (n= 1)

EU – 9.0 % at 61 d, [14C-ethylene carbons]-label (n= 1)

6 n corresponds to the number of soils.




Route of degradation (photolysis) on soil (Regulation (EU) N° 283/2013, Annex Part A, point

7.1.1.3)

Metabolites that may require further consideration

for risk assessment - name and/or code, % of

applied (range and maximum)

Mancozeb does not photodegrade in dry soil. In wet

soils, oxidative processes induce a degradation of

mancozeb that is much more rapid than the photo-

degradation process. Soil photolysis is not significant in

comparison with other degradation processes.

Mineralisation at study end

No data but not applicable

Non-extractable residues at study end

No data but not applicable




Rate of degradation in soil (aerobic) laboratory studies active substance (Regulation (EU) N°

283/2013, Annex Part A, point 7.1.2.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point

9.1.1.1)

Parent mancozeb Dark aerobic conditions

Soil type pHa) t. oC / % MWHC DT50 /DT90 (d) DT50 (d)

20 C

pF2/10kPab)

St.

(χ2)

Method of

calculation

Speyer 2.3 sandy loamg 6.5 20°C/40%

MWHC

0.043 d 0.036 d 1.01g SFO

Speyer 2.2 loamy sandh 5.7 20°C/40%

MWHC

0.027 d 0.027 d 1.01g SFO

Senozan silt loamh 5.8 20°C/40%

MWHC

0.027 d 0.024 d 1.01g SFO

Silt loam (20 ppm)i 6.1c 23°C/22.5%

moisture content

0.105 /1.35 d

0.68 de

3.1

13.7

DFOP

SFO

Silt loam (10 ppm)i 6.1c 23°C/22.5%

moisture content

0.159 /2.53 d

0.74 de

7.0

11.5

FOMC

SFO

Marsh h 6.8c 20°C/40%

MWHC

0.017 /0.35 d

0.082 d

8.8

8.8

FOMC

FOMC

(DT90/3.32)

Silty sand 1 sandy loami 6.3c 20°C/40%

MWHCd

0.027 /29.6 d

0.015 d

11.3

11.3

DFOP

DFOP (k1)

Silty sand 2 sandy loami 6.8c 20°C/40%

MWHCd

0.039 /33.3 d

0.028 d

10.3

10.3

DFOP

DFOP (k1)

Humous sandy loami 7.2c 20°C/40%

MWHCd

0.055 /11.4 d

0.048 d

11.5

13.3

FOMC

DFOP (k1)

Geometric mean (if not pH dependent)e 0.05 d (0.1

d)f

pH dependence No

a) Measured in calcium chloride solution b) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7, used for exposure modelling c) Medium in which pH measured not known d) Study stated to have been run at 40% MWHC but as moisture content not reported, no moisture correction

made e) Geomean of Silt loam 20 ppm and 10 ppm incubations calculated first as 0.7 days prior to overall calculation

of geomean f) Applicant rounded value up to 0.1 days for exposure modelling g) Only three data points, hence ‘default’ low χ2 value. h) Analysis was mancozeb-specific i) Analysis was not specific for mancozeb (i.e. via CS2 generation)

For endpoint selection of metabolites, kinetic parameters from studies where metiram was applied have not been

included due to the influence of formation fraction on the estimated degradation rates for metabolites.




Rate of degradation in soil (aerobic) laboratory studies transformation products (Regulation

(EU) N° 283/2013, Annex Part A, point 7.1.2.1.2 and Regulation (EU) N° 284/2013, Annex Part

A, point 9.1.1.1)

Metabolite EBIS Dark aerobic conditions. 1 Mancozeb dosed study; f.f. derived from mancozeb.

Soil type

pHa) t. oC / %

MWHC

DT50/ DT90

(d)

f. f. kf

/ kdp

DT50 (d)

20 C

pF2/10kPab)

St.

(χ2)

Method of

calculation

Speyer 2.3 sandy loam1 6.5 20°C/40%

MWHC 0.29 / 0.95 0.467 0.24 9.4 SFO/SFO

Speyer 2.2 loamy sand1 5.7 20°C/40%

MWHC 0.24 / 0.78 0.387 0.24 10.5 SFO/SFO

Senozan silt loam1 5.8 20°C/40%

MWHC 0.42 / 1.40 0.307 0.38 17.0 SFO/SFO

Heerewaarden sandy

loam

7.4 20°C/50%

MWHC 0.1 / 0.3 - 0.1 6.8 SFO

Wageningen sand 4.8 20°C/50%

MWHC 0.1 / 0.4 - 0.1 10.6 SFO

Lelystad loam 7.5 20°C/50%

MWHC 0.2 / 0.5 - 0.1 3.6 SFO

Geometric mean (if not pH dependent) 0.17

Arithmetic mean 0.387

pH dependence, Yes or No No a) Measured in calcium chloride solution b) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7






A, point 9.1.1.1)

Met ETU Dark aerobic conditions. 1 Mancozeb dosed study; f.f. derived from EBIS.

Soil type

pHa) t. oC / %

MWHC

DT50/ DT90

(d)

f. f. kf

/ kdp

DT50 (d)

20 C

pF2/10kPab)

St.

(χ2)

Method of

calculation


MWHC 15.3 / 50.4 0.452 12.8 20.6 SFO/SFO


MWHC 4.6 / 15.3 0.647 4.6 20.0 SFO/SFO


MWHC 8.8 / 29.4 0.515 7.9 10.2 SFO/SFO

New York silt loam 6.1

(H2O)

25°C/40%

MWHC 3.1 / 10.2 - 2.8 7.7 SFO

New York silt loam 6.1

(H2O)

25°C/70%

MWHC

1.0 / 4.7

-

1.5

3.8

6

DFOP

SFO

New York sand 6.8

(H2O)

25°C/70%

MWHC 1.8 / 6.0 - 1.8 5.0 SFO

St. Maartensbrug sand 7.1

(KCl)

20°C/pF2 0.4 / 1.3 0.4 5.3 SFO

Am Fischteich silt loam 5.5 20°C/40%

MWHC

0.2 / 1.3

-

0.2

5.6

7.8

FOMC

SFO

LUFA 2.2 loamy fine

sand

5.8 20°C/40%

MWHC 0.1 / 0.3 - 0.1 12.0 SFO

LUFA 2.3 sandy loam 5.4 20°C/40%

MWHC 0.1 / 0.3 - 0.1 4.6 SFO

Senozan silty clay loam 5.6 20°C/40%

MWHC

0.1 / 0.9

-

0.1

1.1

9.3

DFOP

SFO

LUFA 5M sandy loam 7.0 20°C/40%

MWHC 0.5 / 1.5 - 0.3 5.2 SFO

Li10 loamy fine sand 6.3 20°C/40%

MWHC 0.1 / 0.5 - 0.1 5.1 SFO









A, point 9.1.1.1)

Met EU Dark aerobic conditions. 1 Mancozeb dosed study; f f. derived from EBIS.

Soil type

pHa) t. oC / %

MWHC

DT50/ DT90

(d)

f. f. kf

/ kdp

DT50 (d)

20 C

pF2/10kPab)

St.

(χ2)

Method of

calculation


MWHC 8.0 / 26.5 0.394 6.7 52.4 SFO/SFO


MWHC 2.1 / 7.0 0.353 2.1 15.2 SFO/SFO


MWHC 2.3 / 7.7 0.485 2.1 14.1 SFO/SFO

Humic sand 5.3

(KCl)

20°C/pF2.5 6.1 / 20.1 - 5.7 11.5 SFO

Sandy loam 7.7

(KCl)

20°C/pF2.5 4.5 / 20.4

-

4.1

2.0

8.1

DFOP

SFO

Low humic sand 7.8

(KCl)

20°C/pF2.5 4.3 / 14.3 - 2.1 9.9 SFO

LUFA 2.2 loamy sand 5.7 20°C/45

MWHC 0.7 / 2.4 - 0.7 5.6 SFO

Li 10 loamy sand 6.2 20°C/45

MWHC 0.6 / 1.9 - 0.6 12.8 SFO

Bruch West sandy

loam

7.5 20°C/45

MWHC 0.5 / 1.6 - 0.4 10.5 SFO







Rate of degradation in soil (aerobic) laboratory studies transformation products (Regulation (EU) N°

283/2013, Annex Part A, point 7.1.2.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.1)

Met Hydantoin Hydantoin applied as parent.

Soil type

pHa) t. oC / %

MWHC

DT50/ DT90

(d)

f. f. kf

/ kdp

DT50 (d)

20 C

pF2/10kPab)

St.

(χ2)

Method of

calculation

Lufa 2.2 5.7 20 / 45 0.2 - 0.2 2.2 SFO

Li 10 6.2 20 / 45 0.3 - 0.3 12.9 SFO

Bruch West 7.5 20 / 45 0.1 - 0.1 1.7 SFO


Arithmetic mean -




A, point 9.1.1.1)

Met Unknown M11

(postulated to be a dimer

of EBDC monomer units

with formula C8H12N4S8)

Dark aerobic conditions. 1 Mancozeb dosed study; f.f. derived from mancozeb

Soil type

pHa) t. oC / %

MWHC

DT50/ DT90

(d) total

residue

mancozeb +

M11

f. f. kf

/ kdp

DT50 (d)

20 C

pF2/10kPab)

M11 from

sequential fit

St.

(χ2)c)

Method of

calculation (for

sequential fit)


MWHC 0.076 / 0.44 0.1 0.1 SFO/SFO


MWHC 0.042 / 0.24 0.3 2.7 SFO/SFO


MWHC 0.048 / 0.35 0.1 0.1 SFO/SFO



pH dependence, Yes or No No a) Measured in calcium chloride solution b) Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7 c) Insufficient data points for χ2 for the sequential fitting of mancozeb followed by M11.

Rate of degradation field soil dissipation studies (Regulation (EU) N° 283/2013, Annex Part A,

point 7.1.2.2.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.1)

No studies submitted, none required as neither mancozeb or its metabolites are sufficiently persistent under

laboratory conditions to trigger field studies.




Soil accumulation (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.2.2 and Regulation

(EU) N° 284/2013, Annex Part A, point 9.1.1.2.2)

Soil accumulation and plateau concentration

Not relevant due to impersistence of mancozeb and its

metabolites.

Rate of degradation in soil (anaerobic) laboratory studies active substance (Regulation (EU) N°

283/2013, Annex Part A, point 7.1.2.1.3 and Regulation (EU) N° 284/2013, Annex Part A, point

9.1.1.1)

Persistence of mancozeb not estimated under anaerobic conditions as substance had completely degraded by

imposition of anaerobic conditions at 1 day after treatment. Given rapid degradation and GAPs, it is unlikely

that residues of mancozeb will persist until a time when anaerobic conditions in soils will occur.

Rate of degradation on soil (photolysis) laboratory active substance (Regulation (EU) N°

283/2013, Annex Part A, point 7.1.1.3

No significant difference in mancozeb levels between irradiated and dark controls in dry soil. Mancozeb did not degrade in

dry soil under dark conditions. Any potential soil photolytic effect on mancozeb is unlikely to be significant in comparison

with rapid hydrolytic/biotic processes in moist soil.

Soil adsorption active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.3.1.1

and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Mancozeb

Soil Type OC % Soil pHa) Kd

(mL/g)

Kdoc

(mL/g)

KF

(mL/g)

KFoc

(mL/g)

1/n

Sand 0.5 5.7 11.67 2334 0.753

Sandy loam 1.6 5.9 9.89 618 0.749

Silt loam 2.0 6.4 7.26 363 0.686

Clay loam 1.5 7.4 10.13 675 0.777

Geometric mean (if not pH dependent) 771

Arithmetic mean (if not pH dependent) 0.741

pH dependence, Yes or No No a) Medium in which measured not stated

Note that soil adsorption values for mancozeb reflect overall adsorption of mancozeb and its soil metabolites after 24 hours

incubation. As mancozeb itself is unlikely to ionise, any apparent pH relationship may be reflective of metabolites.




Soil adsorption transformation products (Regulation (EU) N° 283/2013, Annex Part A, point

7.1.3.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Metabolite EBIS


(mL/g)

Kdoc

(mL/g)

KF

(mL/g)

KFoc

(mL/g)

1/n

Birnbaum loamy sand 1.4 5.4 15.96 1140

Sora silty loamy sand 1.7 6.5 7.57 445

Stetten sandy clay loam 1.0 7.5 6.15 615

Borgeby loamy sand 1.4 5.6 3.90 279

LUFA 2.2 silty sand 2.2 6.1 7.87 356

Geometric mean (if not pH dependent)

499

499

Arithmetic mean (if not pH dependent) 1.0**

pH dependence, Yes or No No b) Measured in calcium chloride solution

** Kd only measured at single concentration. Consequently 1/n assumed to be 1.0



Metabolite ETU


(mL/g)

Kdoc

(mL/g)

KF

(mL/g)

KFoc

(mL/g)

1/n

LUFA 2.1 sand 0.60 5.6 0.027 4.6 0.743

Nierswalde Wildacker silt loam 1.85 5.7 0.067 3.6 0.884

Li 10 loamy sand 0.95 6.2 0.037 3.8 0.632

LUFA 2.3 sandy loam 0.99 6.7 0.037 3.8 0.817

Fiorentino Poggio Renatico 1 loam 1.00 7.4 0.034 3.4 1.041



pH dependence, Yes or No No a) Measured in calcium chloride solution






Metabolite EU


(mL/g)

Kdoc

(mL/g)

KF

(mL/g)

KFoc

(mL/g)

1/n

Empingham clay loam 4.6 7.6 0.22 5 1.0464

Middleton loam 3.8 5.6 0.16 4 1.0099

Warsop loamy sand 0.8 4.2 0.15 19 0.9152

South Witham clay loam 2.1 7.3 0.22 11 0.9772






Metabolite Hydantoin


(mL/g)

Kdoc

(mL/g)

KF

(mL/g)

KFoc

(mL/g)

1/n

LUFA 2.2 loamy sand 1.95 5.7 0.156 8.0

Li 10 loamy sand 0.86 6.2 0.060 7.0

Bruch West sandy loam 1.37 7.5 0.101 7.4


Arithmetic mean (if not pH dependent)


Mobility in soil column leaching active substance (Regulation (EU) N° 283/2013, Annex Part A,

point 7.1.4.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Column leaching

Elution (mm): 200 mm

Time period (d): 2 d

Three soils used. Nonradiolabelled mancozeb applied as

a formulation. Leachate: 0 % total residues in leachate

as determined by CS2.

44-83% total residues retained in columns.




Mobility in soil column leaching transformation products (Regulation (EU) N° 283/2013, Annex

Part A, point 7.1.4.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Column leaching

Four soils tested, results for three available (sandy loam,

silt loam, clay loam).


Time period (d): 1 day in two soils, 6-8 days in one soil,

25-34 days in one soil.

24 hour aging period

Leachate: 4.2 – 19.2% total /radioactivity in leachate,

77.8 – 98.9% in soil column.

No characterisation of radioactivity in soil or leachate.

Column leaching

One soil tested (sand)


Time period (d): 2 d

52 hour aging period (based on CS2 generation

determined half-life; incubation at 20°C, moisture

conditions unspecified.)

Leachate: 4.2 – 4.7% total radioactivity in leachate

No mancozeb in leachate, 1.9 – 2.2% AR EU, 0.02 –

0.03% AR ETU, 2.3 – 2.5% AR other unidentified.

77.3 - 81.9 % AR retained in soil, 14.9 – 18.6% AR

extractable. 70.7 - 72.7% AR retained in application

layer, 26.6% AR as mancozeb.

Kom calculated as >438 l/kg, however this relates to the

combination of mancozeb and its metabolites.

Lysimeter / field leaching studies (Regulation (EU) N° 283/2013, Annex Part A, points 7.1.4.2 /

7.1.4.3 and Regulation (EU) N° 284/2013, Annex Part A, points 9.1.2.2 / 9.1.2.3)

Lysimeter/ field leaching studies

Not submitted




Hydrolytic degradation (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.1.1

Hydrolytic degradation of the active substance and

metabolites > 10 %

Note: one hydrolysis study condicted at three

temeperatures, 10°C, 25°C and 50°C. For

consistency with other hydrolysis studies, results at

25°C are quoted.

pH 4: DT50 0.39 – 1.2 h at 20 - 25 °C (SFO, χ2= 0.2 –

4.4), n=3

ETU: 90.7% % AR ( 32 d); 94.8 % AR (2.47 hrs)

EBIS: 33.4% at 2 d (2.4% AR at 66 d)

EU: 5.9% AR (66 d)

2-(aminoethyl)carbamodithioic acid/EDA: 48.5% AR at

0.06 hours)

M11, M12, M14 all >10% AR

pH 5: DT50 2.8 h at 25 °C (SFO, χ2=12.12), n=1

ETU: 100% % AR (24 – 48 hrs)

pH 7: 0.53 – 7.5 h at 20 - 25 °C (SFO, χ2= 4.5 – 15.8),

n=4

ETU: 57.4 – 87.3% % AR (14 hrs - 18 d)

EBIS: 41.3% AR (0.06 d)

EU: 13.1% AR (32 d)

N-formyl ETU: 29.0% AR (2.05 days)

TCIT: 22.2% AR (1.07 days)

CPII (probably N-formyl ETU): 13.1% AR at 6.8 hours

CPIII: 20.41% AR at 4.5 hours

Degradate with proposed formula C7H9N3O2S3: 12.3%

AR

M4, M14 >10% AR

pH 9: DT50 0.34 – 14.4 h at 20 - 25 °C (SFO, χ2=0.2 –

15.4), n=4

ETU: 57.4 – 90.8% % AR (26.5 hrs - 66 d)

EBIS: 30.6% AR (0.06 d)

EU: 11.5 – 55.1% AR (96 hrs - 32 d)

N-formyl ETU: 26.4% AR (0.95 days)

Unknown 1, Unknown 2 (and additional unknown), M6,

M7, M8, M11 all >10% AR

Note: Data gap for confirmation of identity of CPIII.




Aqueous photochemical degradation (Regulation (EU) N° 283/2013, Annex Part A, points 7.2.1.2

/ 7.2.1.3)

Photolytic degradation of active substance and

metabolites above 10 %

Mancozeb exhibits very rapid decline in dark control,

with no influence of illumination on mancozeb decline.

Note that study used mercury vapour lamp thus spectral

distribution may not be sufficiently similar to natural

sunlight. Unlikely to influence decline of mancozeb, but

might influence behaviour of metabolites.

Major metabolites:

EBIS – 74.2% AR at 0 hours

ETU – 56.5% AR at 24 hours

EU - 12.1% AR at 24 – 72 hours

EDA – 18.7% AR at 72 hours

Quantum yield of direct phototransformation in

water at > 290 nm

Not available

‘Ready biodegradability’ (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.1)

Readily biodegradable

(yes/no)

No

Aerobic mineralisation in surface water (Regulation (EU) N° 283/2013, Annex Part A, point

7.2.2.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.2.1)

Mancozeb

System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)

DT50 /DT90 whole sys.

(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalise

d to x oCc)

At

study

temp

(20°C)

Norma

lised

to 12 oCc)

Carsington fresh

water

8.81 Not

appli

cable

20 DT90

< 3d

DT90

< 7d

- No mancozeb

detectable at

2nd sample

time (i.e. at 3

DAT) a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C c) Normalised using a Q10 of 2.58 to 12°C in line with ECHA (2017a) R11 PBT/vPvB guidance.

Major metabolites (>10% AR) in at least one of the two dose systems were M1 (max 11.15% AR at 60 days),

M4 (ethanolamine; max 15.4% AR at 14 days), M8 (glycolic acid; 15.46% AR at 28 days), EU (41.22% AR at

60 days), M13 (ethylene glycol; 24.69% AR at 49 days) and ETU (35.00% AR at 3 days). No other metabolites

occur at >5% at two consecutive sample times or are increasing (>5%) at the final sample time.




Metabolite

ETU

Max in total system 35.0% AR after 3 days

System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)


(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to x oC

At

study

temp

Norm

alised

to x oC

Carsington fresh

water

8.81 Not

appli

cable

20 DT50

2.2 –

4.5 d

DT90

7.3 –

14.9 d

1.36

–

11.6

SFO top-

down, two

incubations at

different

doses

a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C

Metabolite EU Max in total system 41.22% AR after 60 days

System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)


(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to x oC

At

study

temp

Norm

alised

to x oC

Carsington fresh

water

8.81 Not

appli

cable

20 51.7 /

172 d

2.56 SFO top-

down from

one

incubation

where peak

occurred

before study

end a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C




Metabolite M1

(unidentified,

possibly oxalic

acid/insoluble

oxalates or

‘biomass’)


System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)


(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to x oC

At

study

temp

Norm

alised

to x oC

Carsington fresh

water

8.81 Not

appli

cable

20 37.8 /

126

0.63

(3

samp

le

time

s)

SFO top-

down, one

incubation (3

sample times

only, thus

only

indicative) a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C

Metabolite M4

(ethanolamine)


System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)


(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to x oC

At

study

temp

Norm

alised

to x oC

Carsington fresh

water

8.81 Not

appli

cable

20 20.2 /

67 d

18.6 SFO top-

down, one

incubation a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C




Metabolite M8

(glycolic acid)


System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)


(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to x oC

At

study

temp

Norm

alised

to x oC

Carsington fresh

water

8.81 Not

appli

cable

20 2060 /

6830 d

13.8 SFO top-

down, one

incubation a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C

Metabolite

M13 (ethylene

glycol)


System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed a)

t. oCb)


(suspended sediment

test)

St.

(χ2)

DT50 /DT90

Water (pelagic

test)

St.

(χ2)

Method of

calculation

At study

temp

Normalis

ed to x oC

At

study

temp

Norm

alised

to x oC

Carsington fresh

water

8.81 Not

appli

cable

20 11.9 /

39.5 d

Not

calc

SFO top-

down, one

incubation,

only 2 sample

times. a) Medium of pH measurement of sediment not applicable as sediment not included in the test b) Temperature of incubation=temperature that the environmental media was collected or std temperature of 20°C

Mineralisation and non extractable residues (for parent dosed experiments)

System

identifier

(indicate fresh,

estuarine or

marine)

pH

water

phase

pH

sed

Mineralisation

x % after n d. (end

of the study).

Non-extractable

residues. max x %

after n d (suspended

sediment test)

Non-extractable

residues. max x % after

n d (end of the study)

(suspended sediment

test)

Carsington fresh

water

8.81 Not

appli

cable

16.8% after 60 days

(low dose

incubation; 8.1% in

high dose

incubation)

Not applicable,

pelagic test

Not applicable, pelagic

test




Water / sediment study (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.3 and

Regulation (EU) N° 284/2013, Annex Part A, point 9.2.2)

Mancozeb Distribution: None detected in sediment. DT50/DT90 values represent complexed

mancozeb, i.e. nabam.

Water /

sediment

system

pH

water

phase

pH

sed a)

(KCl)

t. oC DT50 /DT90

whole sys.

(d)

St.

(χ2)

DT50 /DT90

water

St.

(χ2)

DT50 /DT90

sed

St.

(χ2)

Method of

calculation

River (Müller-

Kallert)

7.72 7.6 20 0.05 / 0.36

0.09

2.8

5.6

FOMC

SFO

Pond (Müller-

Kallert)

7.31 7.3 20 0.12 / 0.42

0.12

0.3

3.8

DFOP

SFO

River (Völkel) 8.02 6.85 20 0.06 / 2.0

0.60

2.4

2.4

HS

HS DT90/3.32

Pond (Völkel) 7.37 6.61 20 0.28 / 0.92

0.29

2.7

7.6

HS

SFO

Geometric mean at 20oCb) 0.21 d a) Measured in KCl b) Normalised using a Q10 of 2.58

Alternative endpoints are presented below to represent the sum of complexed fractions representing

mancozeb.

Water / sediment study (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.3 and Regulation (EU) N°

284/2013, Annex Part A, point 9.2.2)

Mancozeb Distribution: None detected in sediment. DT50/DT90 values are for the sum of

complexed fractions representing mancozeb

Water /

sediment system

pH

water

phase

pH

sed a)

(KCl)

t. oC DT50 /DT90

whole sys.

(d)

St.

(χ2)

DT50 /DT90

water

St.

(χ2)

DT50 /DT90

sed

St.

(χ2)

Method of

calculation

River (Müller-

Kallert)

7.72 7.6 20 0.56 / 6.78

1.67

2.1

3.6

DFOP

FOMC1

Pond (Müller-

Kallert)

7.31 7.3 20 0.67 / 6.81

1.80

1.8

3.8

DFOP

FOMC1

River (Völkel) 8.02 6.85 20 0.17 / 1.93

0.51

1.3

4.6

HS

FOMC1

Pond (Völkel) 7.37 6.61 20 0.31 / 1.02 7.2 SFO

Geometric mean at 20oCb) 0.83 d a) Measured in KCl b) Normalised using a Q10 of 2.58 1 DT50 = FOMC DT90/3.32




Metabolite

EBIS

Distribution: max in water 8.9 – 30.9% AR after 0 – 0.25 d. Max. sed 0.1 – 3.8% AR

after 1 - 14 d. Max in total system 8.9 – 30.9% AR after 0 – 0.25 d

Kinetic formation fraction (kf/kdp): dissipation values used in surface water modelling,

kinetic formation fraction not required.

Water /

sediment

system

pH

water

phase

pH

sed a)

(KCl)

t. oC DT50 /DT90

whole sys.

(d)

St.

(χ2)

DT50 /DT90

water

St.

(χ2)

DT50 /DT90

sed

St.

(χ2)

Method of

calculation

River (Müller-

Kallert)

7.72 7.6 20 0.8 /9.1

2.7

1.7

1.7

HS TDc)

HS TD

DT90/3.32

Pond (Müller-

Kallert)

7.31 7.3 20 0.5 / 1.8 4.3 SFO TD

River (Völkel) 8.02 6.85 20 0.2 / 36.3

10.9

2.9

2.9

DFOP TD

DFOP TD

DT90/3.32

Pond (Völkel) 7.37 6.61 20 0.000006 /

6.6

2.9

9.2

9.2

DFOP

DFOP TD

DT90/3.32

Geometric mean at 20oCb) 2.6 d a) Measured in KCl b) Normalised using a Q10 of 2.58 c) TD = ‘top down’ calculation

Apparent pH dependence of degradation of EBIS – DT90 increases with increasing water pH, but range of pH

limited. No clear relationship with sediment pH.

Metabolite

ETU

Distribution: max in water 29.8 – 48.5% AR after 0.25 - 2 d. Max. sed 5.6 – 8.1% AR

after 2 - 14 d. Max in total system 33.6 – 51.6 % AR after 2 days.

Kinetic formation fraction (kf/kdp): dissipation values used in surface water modelling,


Water /

sediment

system

pH

water

phase

pH

sed a)

(KCl)

t. oC DT50 /DT90

whole sys.

(d)

St.

(χ2)

DT50 /DT90

water

St.

(χ2)

DT50 /DT90

sed

St.

(χ2)

Method of

calculation

River (Müller-

Kallert)

7,72 7.6 20 9.0 / 29.8 d

9.0

18.0

18.0

SFO TDc)

SFO TD

Pond (Müller-

Kallert)

7.31 7.3 20 7.6 / 25.4 d

7.6

29.0

29.0

SFO TD

SFO TD

River (Völkel) 8.02 6.85 20 3.0 / 18.3 d

4.4

0.4

8.2

DFOP TD

SFO TD

Pond (Völkel) 7.37 6.61 20 6.8 / 37.9 d

8.9

9.1

14.4

DFOP TD

SFO TD

Geometric mean at 20oCb) 7.2 d a) Measured in KCl b) Normalised using a Q10 of 2.58 c) TD = ‘top down’ calculation




Metabolite EU Distribution: max in water 22.5 – 37.5% AR after 7 - 59 d. Max. sed 6.4 – 9.1% AR

after 7 - 30 d. Max in total system 30.7 – 43.5% AR after 7 - 59 days.

kinetic formation fraction (kf/kdp): dissipation values used in surface water modelling,


Water /

sediment

system

pH

water

phase

pH

sed a)

(KCl)

t. oC DT50 /DT90

whole sys.

(d)

St.

(χ2)

DT50 /DT90

water

St.

(χ2)

DT50 /DT90

sed

St.

(χ2)

Method of

calculation

River (Müller-

Kallert)

7,72 7.6 20 9.8 / 32.6 22.3 SFO TDd)

Pond (Müller-

Kallert)

7.31 7.3 20 Not calcc)

River (Völkel) 8.02 6.85 20 Not calcc)

Pond (Völkel) 7.37 6.61 20 Not calcc)

Geometric mean at 20oCb) a) Measured in KCl b) Normalised using a Q10 of 2.58 c) Insufficient timepoints (3 sample times only). RMS indicative calculations give Pond (Müller-Kallert) DT50 6 days;

River (Völkel) DT50 8.7 days; Pond (Völkel) DT50 188 days. Subsequent geomean is 17.6 days. d) TD = ‘top down’ calculation

Other metabolites in mancozeb water/sediment studies:

Unknown 1: max water 5.5% at 4 days (>5% at 2 consecutive time points); max total system 6.3% AR at 7 d

(>5% at 2 consecutive time points).

Unknown 2a (in Müller-Kallert): max water 13.4% AR at 0.25 days (not detected by 2 days); max total system

13.4% AR at 0.25 d. Not detected – 0.2% in total system at 2 days.

Unknown 2b (in Völkel): max water 11.7% AR at 14 days (not detected by 59 days); max total system 15.2%

AR at 14 d.

Unknown 3: max water/total system 8.3% at 0.25days (>5% at 2 consecutive time points); max total system

8.4% at 1 d (>5% at 2 consecutive time points).

Hydantoin: max water 8.6% AR at 14 d (>5% at 2 consecutive time points); max total system 11.7% AR at 14

d.

Mineralisation and non extractable residues (from parent dosed experiments)

Water /

sediment

system

pH

water

phase

pH

sed

(KCl

)

Mineralisation

x % after n d. (end

of the study).

Non-extractable

residues in sed. max

x % after n d

Non-extractable residues

in sed. max x % after n d

(end of the study)

River (Müller-

Kallert)

7.72 7.6 57.8% AR at 106 d 43.0% AR at 30 d 36.7% AR at 106 d

Pond (Müller-

Kallert)

7.31 7.3 57.7% AR at 106 d 37.2% AR at 30 d 35.4% AR at 106 d

River (Völkel) 8.02 6.85 47.1% AR at 105 d 43.0% AR at 59 d 39.5% AR at 105 d

Pond (Völkel) 7.37 6.61 17.6% AR at 105 d 43.6% AR at 105 d 43.6% AR at 105 d

Fate and behaviour in air (Regulation (EU) N° 283/2013, Annex Part A, point 7.3.1)

Direct photolysis in air Not studied - no data requested

Photochemical oxidative degradation in air Mancozeb:




DT50 of 0.6 hours derived by the Atkinson model

(version 1.91). OH (12 h) concentration assumed =

1.5x106 mol/cm3

ETU:

DT50 of 0.9 hours derived by the Atkinson model

(version 1.92). OH (12 h) concentration assumed =

1.5x106 mol/cm3

EBIS:

DT50 of 1.0 hour derived by the Atkinson model (version

1.88). OH (24 h) concentration assumed = 8x105

mol/cm3

EU:

DT50 of 16 hours derived by the Atkinson model (version

1.92). OH (12 h) concentration assumed = 1.5x106

mol/cm3

Volatilisation No data submitted for mancozeb.

Metabolites ETU: no radioactivity recovered as ETU in traps

following ETU application to soil at 40°C and 30 days

incubation.

Residues requiring further assessment (Regulation (EU) N° 283/2013, Annex Part A, point 7.4.1)

Environmental occurring residues requiring further

assessment by other disciplines (toxicology and

ecotoxicology) and/or requiring consideration for

groundwater exposure

Soil: Mancozeb, EBIS, ETU, EU, M11

Surface water: Mancozeb, EBIS, ETU, EU, M11,

unknown 2aa, unknown 2ba, EDAb, unknown 1a, unknown

3a and hydantoina

Sediment: Mancozeb, EBIS, ETU, EU, M11,

unknown 2aa, unknown 2ba, EDAb, unknown 1a, unknown

3a and hydantoina

Ground water: Mancozeb, EBIS, ETU, EU, M11

Air: Mancozeb

a metabolites triggering assessment from results of

water/sediment studies. b metabolite triggering assessment from results of aqueous

photolysis study.

Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A, point

7.4.2)

See section 5, Ecotoxicology

Monitoring data, if available (Regulation (EU) N° 283/2013, Annex Part A, point 7.5

Soil (indicate location and type of study) None for mancozeb.

Manganese – wide range in agricultural topsoils, e.g. <10

– 6480 mg/kg, median 382 mg/kg (FOREGS data,

n=837)




Zinc - wide range in agricultural topsoils, e.g. 4 – 2270

mg/kg, median 48 mg/kg (FOREGS data, n=837)

Surface water (indicate location and type of study)

None

Ground water (indicate location and type of study)

NL field leaching study (Boland et al, 1995): average

ETU concentration under 32 potato fields 0.11 µg/L, 90th

percentile 0.27 µg/L (LOQ 0.05 µg/L). Relationship

between soil type and concentration measured (higher in

sandy/peat versus clay/loam) can be hypothesized.

Application rates <1.5 kg as/ha for 63% and from 1.5 to

2 kg as/ha for 22% of all fields, 7 day interval mostly

adopted. Sampled depth 0-1 m. 1993 extremely wet year.

3 Swedish potato sandy soil sites, sampled for 1 year

(1992-93) at 12-16.8 kg as/ha/y, supplementary irrigation

175-200 mm, rainfall 511-803 mm, LOQ 0.1 µg/L, 2

pipes for each site at 2.5 and 5 m depth, no data on pH.

ETU <0.1 µg/L

US monitoring study: out of 1393 samples for

representative agricultural areas in different regions, 1

positive finding for ETU (16 ppb), however LOQ all

above 0.1 ppb (range 0.1- 25 ppb).

NL monitoring study (2002) in deep groundwater

(10 ± 4 m) in potato and flower bulb growing areas. 91%

of 119 wells <0.1 µg/L ETU, 90th percentile

concentration 0.078 µg/L. All detections >0.1 µg/L

related to special, very vulnerable soils in NL (parent

material dune and eolian sands) with very little

agricultural importance elsewhere in the EU.

Air (indicate location and type of study)

None

PEC soil (Regulation (EU) N° 284/2013, Annex Part A, points 9.1.3 / 9.3.1)

Parent

Method of calculation

DT50 (d): 0.74 days

Kinetics: SFO

Field or Lab: worst case from laboratory studies.

Application data Crop: see below

Depth of soil layer: 5cm

Soil bulk density: 1.5g/cm3

% plant interception: Post-emergence, see below

Number of applications: see below

Interval (d): see below

Application rate(s): 1600 g a.s./ha

Model (s) used ESCAPE 2.0 (Microsoft Excel for metabolite M11)




Crop Growth

stage

(BBCH)

Max. mancozeb

individual

application rate

(g/ha)

Number of

applications

Interval

(days)

Crop

interception

(%)

Soil loading

(g/ha)

Wheat

(winter/spring)

30-65 1600 3 14 80 320 x 3

Vines 15-85 1600 4 7 60 640 x 4

Potato 15-89 1600 8 7 15 (1st 3

applications)

60 (final five

applications)

1360 x 3 +

640 x 5

Tomato

(greenhouse)

13-89 1600 5 7 50 800 x 5

Parameter Unit Mancozeb EBIS ETU EU M11

Molar mass [g/mol] 271.3 176.2 102.2 86.2 271.3

DT50 soil maximum [days] 0.74 1.7 15.3 8.0 0.3

Formation fraction

maximum

- 0.467 0.647a 0.485a 20.3b

a Formation fraction from EBIS b Maximum observed formation (%)

Maximum PECsoil (mg/kg)

Crop Mancozeb EBIS ETU EU M11

Wheat

(winter/spring)

0.427 0.084 0.073 0.016 0.087

Vines 0.854 0.182 0.177 0.099 0.173

Potato 1.816 0.386 (0.384) 0.401 (0.322) 0.188 (0.150) 0.368 (0.368)

Tomato

(greenhouse)

1.067 0.247 0.312 0.131 0.217

(Values in parentheses for potato use assume the first two applications rather than the first three are made at 15%

interception)

Parent and metabolites are not persistent thus accumulation is not expected.

Soil loading and PECsoil for manganese from mancozeb application

Crop Total annual

loading of

mancozeb (g/ha)a

Proportion of

manganese (%)

Annual soil loading

of manganese

(g/ha)

PECsoil (mg/kg)

Wheat

(winter/spring)

960 20.25 194.4 0.259

Vines 2560 20.25 518.4 0.691

Potato 7280 20.25 1474.2 1.966

Tomato

(greenhouse)

4000 20.25 810 1.080




Soil loading and PECsoil for zinc from mancozeb application

Crop Total annual

loading of

mancozeb (g/ha)

Proportion of zinc

(%)

Annual soil loading

of zinc (g/ha)

PECsoil (mg/kg)

Wheat

(winter/spring)

960 2.2 21.12 0.028

Vines 2560 2.2 56.32 0.075

Potato 7280 2.2 160.16 0.214

Tomato

(greenhouse)

4000 2.2 88 0.117

PEC ground water (Regulation (EU) N° 284/2013, Annex Part A, point 9.2.4.1)

Method of calculation and type of study (e.g.

modelling, field leaching, lysimeter)

For FOCUS gw modelling, values used –

Modelling using FOCUS model(s), with appropriate

FOCUSgw scenarios, according to FOCUS guidance.

Model(s) used: FOCUS PEARL (version 4.4.4), FOCUS

PELMO (version 5.5.3) and FOCUS MACRO (version

5.5.4)

Details of substance input parameters and GAPs

simulated given below.

Application rate See below.

* Only relevant after implementation of the published EFSA

guidance.

Substance input parameters

Parameter Unit Mancozeb EBIS ETU EU

Molar mass [g/mol] 271.3 176.2 102.2 86.2

Water solubility 20oC [mg/L] 0.3 1000 1000 596

Vapour pressure 20oC [Pa] 0 0 0 0

DT50 (20oC pF2) [days] 0.1 0.2 0.7 1.8

Koc [mL/g] 771 499 3.8 8.0

Kom [mL/g] 447.22 289.4 2.2 4.64

1/n (-) [-] 0.741 1.0 1.0 1.0

Formation fraction [-] -

0.387

from

mancozeb

0.538

from

EBIS

0.411

from

EBIS

Plant uptake factor [-] 0 0 0 0

GAPs simulated

Crop Growth

stage

(BBCH)

Max. mancozeb

individual

application rate

(g/ha)

Number of

applications

Interval

(days)

Crop

interception

(%)

Soil loading

(g/ha)

Wheat

(winter/spring)

30-65 1600 3 14 80 320 x 3

Vines 15-85 1600 4 7 60 640 x 4

Potato 15-89 1600 8 7 15 (1st 3

applications)

60 (final five

applications)

1360 x 3 +

640 x 5




Application dates simulated

Crop Scenario Application dates

(PEARL/PELMO)

Application dates

(MACRO)

Spring

cereals

Châteaudun 20/04, 04/05, 18/05 20/04, 04/05, 18/05

Hamburg 20/04, 04/05, 18/05

Jokioinen 20/04, 04/05, 18/05

Kremsmünster 20/04, 04/05, 18/05

Okehampton 20/04, 04/05, 18/05

Porto 20/04, 04/05, 18/05

Winter

cereals

Châteaudun 20/04, 04/05, 18/05 20/04, 04/05, 18/05

Hamburg 20/04, 04/05, 18/05

Jokioinen 25/05, 08/06, 22/06

Kremsmünster 20/04, 04/05, 18/05

Okehampton 20/04, 04/05, 18/05

Piacenza 20/04, 04/05, 18/05

Porto 20/04, 04/05, 18/05

Sevilla 01/03, 15/03, 29/03

Thiva 01/03, 15/03, 29/03

Potato Châteaudun

15/05, 22/05, 29/05, 05/06,

12/06, 19/06, 26/06, 03/07

15/05, 22/05, 29/05, 05/06,

12/06, 19/06, 26/06, 03/07

Hamburg 15/05, 22/05, 29/05, 05/06,

12/06, 19/06, 26/06, 03/07

Jokioinen 23/06, 30/06, 07/07, 14/07,

21/07, 28/07, 04/08, 11/08

Kremsmünster 15/05, 22/05, 29/05, 05/06,

12/06, 19/06, 26/06, 03/07

Okehampton 15/05, 22/05, 29/05, 05/06,

12/06, 19/06, 26/06, 03/07

Piacenza 15/05, 22/05, 29/05, 05/06,

12/06, 19/06, 26/06, 03/07

Porto 01/04, 08/04, 15/04, 22/04,

29/04, 06/05, 13/05, 20/05

Sevilla 13/02, 20/02, 27/02, 03/03,

10/03, 17/03, 24/03, 31/03

Thiva 14/03, 21/03, 28/03, 04/04,

11/04, 18/04, 25/04, 02/05

Vines Châteaudun 15/05, 22/05, 29/05, 05/06 15/05, 22/05, 29/05, 05/06

Hamburg 15/05, 22/05, 29/05, 05/06

Kremsmünster 15/05, 22/05, 29/05, 05/06

Piacenza 15/05, 22/05, 29/05, 05/06

Porto 15/04, 22/04, 29/04, 06/05

Sevilla 15/04, 22/04, 29/04, 06/05

Thiva 15/04, 22/04, 29/04, 06/05

Tomato

(outdoor)1 Châteaudun

25/05, 01/06, 08/06, 15/06,

22/06 Not simulated

Piacenza 25/05, 01/06, 08/06, 15/06,

22/06

Porto 30/03,06/04, 13/04, 20/04, 27/04

Sevilla 30/04, 07/05, 14/05, 21/05,

28/05

Thiva 25/04, 02/05, 09/05, 16/05,

23/05

1 Use on tomato not simulated with PEARL or MACRO as PELMO results very low.PEC(gw) - FOCUS modelling results

(80th percentile annual average concentration at 1m)




Crop

Scenario 80th Percentile PECgw at 1 m Soil Depth

[µg/L]

Mancozeb EBIS ETU EU

PELMO PELMO PELMO PELMO

Spring cereals Châteaudun < 0.001 < 0.001 < 0.001 < 0.001

Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Jokioinen < 0.001 < 0.001 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Okehampton < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001

Winter cereals Châteaudun < 0.001 < 0.001 < 0.001 < 0.001

Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Jokioinen < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Okehampton < 0.001 < 0.001 < 0.001 < 0.001

Piacenza < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001

Potatoes Châteaudun < 0.001 < 0.001 < 0.001 < 0.001

Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Jokioinen < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Okehampton < 0.001 < 0.001 < 0.001 0.001

Piacenza < 0.001 < 0.001 < 0.001 0.001

Porto < 0.001 < 0.001 0.001 0.003

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001

Vines Châteaudun < 0.001 < 0.001 < 0.001 < 0.001

Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Piacenza < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001

Tomato

(outdoor)

Châteaudun < 0.001 < 0.001 < 0.001 < 0.001

Piacenza < 0.001 < 0.001 0.001 0.002

Porto < 0.001 < 0.001 < 0.001 0.002

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001




Crop


[µg/L]


PEARL PEARL PEARL PEARL


Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Jokioinen < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Okehampton < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001


Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Jokioinen < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Okehampton < 0.001 < 0.001 < 0.001 < 0.001

Piacenza < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001


Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Jokioinen < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Okehampton < 0.001 < 0.001 < 0.001 < 0.001

Piacenza < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001


Hamburg < 0.001 < 0.001 < 0.001 < 0.001

Kremsmünster < 0.001 < 0.001 < 0.001 < 0.001

Piacenza < 0.001 < 0.001 < 0.001 < 0.001

Porto < 0.001 < 0.001 < 0.001 < 0.001

Sevilla < 0.001 < 0.001 < 0.001 < 0.001

Thiva < 0.001 < 0.001 < 0.001 < 0.001

Crop


[µg/L]


MACRO MACRO MACRO MACRO





Manganese and zinc not simulated – FOCUSgw models unlikely to be able to simulate behaviour of metals.

PEC surface water and PEC sediment (Regulation (EU) N° 284/2013, Annex Part A, points 9.2.5

/ 9.3.1)

Parent

Parameters used in FOCUSsw step 1 and 2

Version control no. of FOCUS calculator: FOCUSsw

Steps 1-2 v 3.2


simulated given below.

Parameters used in FOCUSsw step 3 (if performed) Version control no.’s of FOCUS software:

FOCUS surface water STEP 3 SWASH v. 5.3




FOCUS surface water STEP 3 TOXWA v. 4.4.3

FOCUS surface water STEP 3 PRZM v. 4.3.1

FOCUS surface water STEP 3 MACRO v. 5.5.4


simulated given below. Mancozeb only simulated.

Application rate See GAP details below.

Steps 1 and 2 application windows and interception

Crop scenario Maximum individual

application rate

(g a.s./ha)

Minimum

application interval

(days)

Interception

(%)

Worst-case

application

window (Step 2)

Potatoes 8 x 1600 7 minimal Mar-May

Spring/winter

cereals1 3 x 1600 14 Average Mar-May

Vines-Early 4 x 1600 7 Minimal Mar-May

Vines-Late 4 x 1600 7 Minimal Mar-May

Fruiting vegetables

(tomato)

5 x 1600 7 Average Mar-May

1 Only winter cereals simulated as the scenario assumptions for winter and spring cereals are identical for application timing

Substance parameters for mancozeb and metabolites in surface water and sediment exposure assessment,

FOCUSsw Steps 1-2

Parameter Unit Mancozeb EBIS ETU EU Unknown

2b

Molar mass [g/mol] 271.3 176.2 102.2 86.2 271.3

Water solubility 20oC [mg/L] 0.3 1000 1000 596 1000

DT50 soil (20oC pF2) [days] 0.1 0.2 0.7 1.8 1000

Maximum in soil [%] - 29.1 24.8 18.5 0.01

Koc [mL/g] 771 499 3.8 8.0 10/10000

DT50 water [days] 0.21 2.6 7.2 17.6 1000

DT50 sediment [days] 0.21 2.6 7.2 17.6 1000

DT50 total [days] 0.21 2.6 7.2 17.6 1000

Maximum in w/sed [%] - 30.9 51.6 43.5 15.2

Parameter Unit EDA M11 Hydantoin Unknown

1

Unknown

3

Molar mass [g/mol] 60.1 271.3 100.1 271.3 271.3

Water solubility 20oC [mg/L] 1000 1000 1000 1000 1000

DT50 soil (20oC pF2) [days] 1000 0.3 0.2 1000 1000

Maximum in soil [%] 0.01 20.3 0.01 0.01 0.01

Koc [mL/g] 10/10000 10/10000 7.5 10/10000 10/10000

DT50 water [days] 1000 1000 1000 1000 1000

DT50 sediment [days] 1000 1000 1000 1000 1000

DT50 total [days] 1000 1000 1000 1000 1000

Maximum in w/sed [%] 18.7 0.001 11.7 6.3 8.4

Note that whilst metabolite Unknown 2a is included in the reside definition for risk assessment of surface water

and sediment, calculations for Unknown 2a have not been presented. The calculations for Unknown 2b address

FOCUSsw Steps 1-2 exposure for Unknown 2a as occurrence of Unknown 2b in water/sediment is higher (15.2%




for Unknown 2b compared to 13.4% for Unknown 2a) and all other parameters used in the calculation are identical.

Note that Unknown 2a declines from a peak of 13.4% at 0.25 hours to not detected – 0.2% by 2 days after treatment.




Step 1-2

Overall initial PECSW and PECSED of mancozeb, EBIS, ETU, EU, EDA, M11, Unknown 2, hydantoin,

Unknown 1 and Unknown 3 (Steps 1-2) – Potatoes at 8 x 1600 g/ha

Compound

Northern Europe

Step 1 Step 2 (single) Step 2 (multiple)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.7 2030 14.715 1.375 8.064 0.753

EBIS 1020 4980 2.953 4.519 1.824 2.999

ETU 1240 46.43 2.86 0.07 3.18 0.08

EU 847.900 66.530 2.855 0.219 4.703 0.361

EDA H1 17.21 1270 0.61 4.25 0.57 18.38

EDA_L2 179.39 17.92 0.61 0.06 2.61 0.26

M11_H1 60.432 6040 0.000 0.014 0.000 0.017

M11 L2 854.780 85.478 0.002 0.000 0.002 0.000

Unknown 2b H1 63.17 4650 2.24 15.61 2.08 67.53

Unknown 2b_L2 658.31 65.76 2.24 0.22 9.60 0.96

Hydantoin 187.60 14.06 0.64 0.05 2.72 0.20

Unknown 1 H1 26.20 1930 0.93 6.51 0.86 28.28

Unknown 1 L2 273.10 27.28 0.93 0.09 4.02 0.40

Unknown 3_H1 34.92 2570 1.24 8.66 1.15 37.54

Unknown 3_L2 363.99 36.36 1.24 0.12 5.34 0.53 1H = Koc of 10000 used in simulation 2L = Koc of 10 used in simulation

Note: calculated exposure from Unknown 2b addresses exposure from Unknown 2a

Compound

Southern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.7 2030 14.715 1.375 8.064 0.753

EBIS 1020 4980 2.953 4.519 1.824 2.999

ETU 1240 46.43 2.86 0.08 3.18 0.09

EU 847.900 66.530 3.985 0.306 5.915 0.454

EDA H1 17.21 1270 0.61 4.25 0.57 18.38

EDA_L2 179.39 17.92 0.61 0.06 2.63 0.26

M11_H1 60.432 6040 0.000 0.026 0.000 0.029

M11_L2 854.780 85.478 0.004 0.000 0.004 0.000

Unknown

2b_H1

63.17 4650 2.24 15.68 2.08 68.02

Unknown

2b_L2

658.31 65.76 2.24 0.22 9.67 0.96

Hydantoin 187.60 14.06 0.64 0.05 2.72 0.20

Unknown 1_H1 26.20 1930 0.93 6.57 0.86 28.77

Unknown 1 L2 273.10 27.28 0.93 0.09 4.09 0.41

Unknown 3_H1 34.92 2570 1.24 8.72 1.15 38.04







Unknown 1 and Unknown 3 (Steps 1-2) – Winter cereals at 3 x 1600 g/ha

Compound

Northern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.700 2030 14.715 1.375 10.795 1.008

EBIS 127.750 622.738 2.953 4.519 2.203 3.409

ETU 466.74 17.41 2.86 0.07 2.78 0.07

EU 317.962 24.949 2.789 0.214 3.483 0.267

EDA H1 6.46 475.10 0.61 4.25 0.54 9.28

EDA_L2 67.27 6.72 0.61 0.06 1.32 0.13

M11_H1 22.662 2270 0.000 0.013 0.000 0.014

M11 L2 320.543 32.054 0.002 0.000 0.002 0.000

Unknown 2b H1 23.69 1740 2.24 15.61 1.97 34.07

Unknown 2b_L2 246.87 24.66 2.24 0.22 4.85 0.48

Hydantoin 70.35 5.27 0.64 0.05 1.38 0.10

Unknown 1_H1 9.82 723.27 0.93 6.50 0.82 14.22

Unknown 1 L2 102.41 10.23 0.93 0.09 2.02 0.20

Unknown 3_H1 13.10 963.99 1.24 8.65 1.09 18.91



Compound

Southern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.700 2030 14.715 1.375 10.795 1.008

EBIS 127.750 622.738 2.953 4.519 2.203 3.409

ETU 466.74 17.41 2.86 0.08 2.78 0.08

EU 317.962 24.949 3.852 0.296 4.552 0.349

EDA H1 6.46 475.10 0.61 4.26 0.54 9.32

EDA_L2 67.27 6.72 0.61 0.06 1.32 0.13

M11_H1 22.662 2270 0.000 0.024 0.000 0.026

M11_L2 320.543 32.054 0.004 0.000 0.004 0.000

Unknown 2b H1 23.69 1740 2.24 15.67 1.97 34.25

Unknown 2b_L2 246.87 24.66 2.24 0.22 4.87 0.48

Hydantoin 70.35 5.27 0.64 0.05 1.38 0.10

Unknown 1 H1 9.82 723.27 0.93 6.56 0.82 14.40

Unknown 1 L2 102.41 10.23 0.93 0.09 2.05 0.20

Unknown 3_H1 13.10 963.99 1.24 8.71 1.09 19.08 Unknown 3_L2 136.50 13.64 1.24 0.12 2.71 0.27

1H = Koc of 10000 used in simulation 2L = Koc of 10 used in simulation



Unknown 1 and Unknown 3 (Steps 1-2) – vines Early at 4 x 1600 g/ha




Compound

Northern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.380 2030 14.395 1.345 13.328 1.245

EBIS 510.744 2490 2.889 4.420 3.013 4.954

ETU 622.08 23.21 2.80 0.07 4.92 0.12

EU 423.773 33.265 2.485 0.191 5.188 0.398

EDA_L2 89.64 8.95 0.60 0.06 2.18 0.22

EDA_H1 8.55 633.10 0.60 4.16 0.72 15.28

M11 L2 427.390 42.739 0.001 0.000 0.002 0.000

M11_H1 30.216 3020 0.000 0.010 0.000 0.013

Unknown 2b_H1 31.39 2320 2.19 15.26 2.64 56.11

Unknown 2b L2 328.96 32.86 2.19 0.22 7.99 0.79

Hydantoin 93.75 7.02 0.62 0.05 2.27 0.17

Unknown 1_H1 13.02 963.80 0.91 6.35 1.09 23.36

Unknown 1_L2 136.47 13.63 0.91 0.09 3.32 0.33

Unknown 3 H1 17.35 1280 1.21 8.45 1.46 31.09

Unknown 3 L2 181.89 18.17 1.21 0.12 4.42 0.44 1H = Koc of 10000 used in simulation 2L = Koc of 10 used in simulation


Compound

Southern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.380 2030 14.395 1.345 13.328 1.245

EBIS 510.744 2490 2.889 4.420 3.013 4.954

ETU 622.08 23.21 2.80 0.07 4.92 0.12

EU 423.773 33.265 2.485 0.191 6.043 0.464

EDA_L2 89.64 8.95 0.60 0.06 2.18 0.22

EDA H1 8.55 633.10 0.60 4.17 0.72 15.32

M11 L2 427.390 42.739 0.001 0.000 0.003 0.000

M11_H1 30.216 3020 0.000 0.019 0.000 0.021

Unknown 2b_H1 31.39 2320 2.19 15.30 2.64 56.29

Unknown 2b_L2 328.96 32.86 2.19 0.22 8.00 0.80

Hydantoin 93.75 7.02 0.62 0.05 2.27 0.17

Unknown 1_H1 13.02 963.80 0.91 6.39 1.09 23.54

Unknown 1_L2 136.47 13.63 0.91 0.09 3.35 0.33

Unknown 3_H1 17.35 1280 1.21 8.50 1.46 31.26




Unknown 1 and Unknown 3(Steps 1-2) – vines Late at 4 x 1600 g/ha




Compound

Northern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 305.801 2030 42.816 4.000 35.365 3.304

EBIS 533.559 2490 8.593 13.148 7.994 13.144

ETU 644.17 23.21 8.32 0.20 13.05 0.31

EU 439.486 33.265 5.918 0.446 13.491 0.947

EDA_L2 94.35 9.42 1.77 0.17 5.78 0.57

EDA_H1 13.26 665.93 1.77 12.34 1.91 40.49

M11 L2 427.391 42.739 0.002 0.000 0.003 0.000

M11_H1 30.217 3020 0.000 0.012 0.001 0.019

Unknown 2b_H1 48.67 2440 6.51 45.29 6.99 148.59

Unknown 2b L2 346.24 34.57 6.51 0.64 21.21 2.10

Hydantoin 98.65 7.39 1.85 0.14 6.03 0.45

Unknown 1_H1 20.18 1010 2.70 18.80 2.90 61.69

Unknown 1_L2 143.63 14.34 2.70 0.27 8.79 0.87

Unknown 3 H1 26.90 1350 3.60 25.05 3.86 82.19



Compound

Southern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 305.801 2030 42.816 4.000 35.365 3.304

EBIS 533.559 2490 8.593 13.148 7.994 13.144

ETU 644.17 23.21 8.32 0.20 13.05 0.31

EU 439.486 33.265 6.615 0.507 13.491 1.013

EDA_L2 94.35 9.42 1.77 0.17 5.78 0.57

EDA H1 13.26 665.93 1.77 12.35 1.91 40.53

M11 L2 427.391 42.739 0.003 0.000 0.004 0.000

M11_H1 30.217 3020 0.000 0.021 0.001 0.027

Unknown 2b_H1 48.67 2440 6.51 45.34 6.99 148.77

Unknown 2b_L2 346.24 34.57 6.51 0.64 21.21 2.10

Hydantoin 98.65 7.39 1.85 0.14 6.03 0.45

Unknown 1_H1 20.18 1010 2.70 18.84 2.90 61.87

Unknown 1_L2 143.63 14.34 2.70 0.27 8.80 0.88

Unknown 3_H1 26.90 1350 3.60 25.09 3.86 82.37




Unknown 1 and Unknown 3(Steps 1-2) – outdoor fruiting vegetables (tomato) at 5 x 1600 g/ha with 7 day

intervals




Compound

Northern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.70 2030 14.71 1.37 9.57 0.89

EBIS 638.75 3110 2.95 4.52 2.16 3.56

ETU 777.91 29.02 2.86 0.07 3.66 0.09

EU 529.94 41.58 2.39 0.18 4.20 0.32

EDA_H1 10.76 791.83 0.61 4.25 0.55 13.69

EDA_L2 112.12 11.20 0.61 0.06 1.95 0.19

M11 H1 37.77 3780 0.00 0.01 0.00 0.01

M11_L2 534.24 53.42 0.00 0.00 0.00 0.00

Unknown 2b_H1 39.48 2910 2.24 15.59 2.04 50.25

Unknown 2b L2 411.45 41.10 2.24 0.22 7.15 0.71

Hydantoin 117.25 8.79 0.64 0.05 2.03 0.15

Unknown 1_H1 16.37 1210 0.93 6.48 0.84 20.94

Unknown 1_L2 170.69 17.05 0.93 0.09 2.98 0.30

Unknown 3 H1 21.83 1610 1.24 8.63 1.13 27.85



Compound

Southern Europe


PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

PECsw

(µg/L)

PECsed

(µg/kg)

Mancozeb 277.70 2030 14.71 1.37 9.57 0.89

EBIS 638.75 3110 2.95 4.52 2.16 3.56

ETU 777.91 29.02 2.86 0.07 3.66 0.09

EU 529.94 41.58 3.05 0.23 4.91 0.38

EDA_H1 10.76 791.83 0.61 4.25 0.55 13.73

EDA L2 112.12 11.20 0.61 0.06 1.95 0.19

M11 H1 37.77 3780 0.00 0.02 0.00 0.02

M11_L2 534.24 53.42 0.00 0.00 0.00 0.00

Unknown 2b_H1 39.48 2910 2.24 15.62 2.04 50.44

Unknown 2b_L2 411.45 41.10 2.24 0.22 7.17 0.71

Hydantoin 117.25 8.79 0.64 0.05 2.03 0.15

Unknown 1_H1 16.37 1210 0.93 6.52 0.84 21.12

Unknown 1_L2 170.69 17.05 0.93 0.09 3.00 0.30

Unknown 3_H1 21.83 1610 1.24 8.67 1.13 28.04






Step 3

Modelling input parameters for mancozeb at Step 3 and 4

Parameter Unit Mancozeb

Molar mass [g/mol] 271.3

Water solubility 20oC [mg/L] 0.3

Vapour pressure 20oC [Pa] 0

DT50 soil (20oC pF2) [days] 0.1

Koc [mL/g] 771

1/n [-] 0.741

DT50 water [days] 0.21 (0.83

also used)

DT50 sediment [days] 1000

DT50 total [days] 0.21

Plant uptake factor [-] 0

Application pattern for mancozeb

Crop Timing of

application

Number of

applications1

Application

interval

[days]

Maximum

label rate

[kg/ha]

Maximum

application rate,

individual

treatment

[g a.s./ha]

Cereals (winter

and spring) BBCH 30-65

3 14 2.0 1600

Potatoes BBCH 20-90 8 7 2.0 1600

Vines, late

applications BBCH 15-85

4 7 2.0 1600

Vegetables,

fruiting (tomato) BBCH 13-89

5 7 2.0 1600

1 Due to rapid degradation in both soil and water, single applications always give the highest PECsw concentrations with no

or negligible drainage/run-off entry

As single applications always give the highest PECsw values and global maximum PECsw is only used in the

risk assessment, application schemes for single applications only are shown.




FOCUSsw Step 3 application details for mancozeb on winter cereals, single application

FOCUSsw Step 3 application details for mancozeb on spring cereals, single application




FOCUSsw Step 3 application details for mancozeb on potatoes, single application

FOCUSsw Step 3 application details for mancozeb on vines (late application), single application




FOCUSsw Step 3 application details for mancozeb on vegetable (fruiting), single application

Global maximum PECsw values are only shown as these values only are used in risk assessment. PECsed not

used as no mancozeb was found in sediment in water/sediment studies.

Maximum Step 3 PECsw values for mancozeb

Scenario PECsw (µg/l)

Spring cereals

D1 ditch 10.177

D1 stream 8.148

D3 ditch 10.131

D4 pond 0.348

D4 stream 8.280

D5 pond 0.348

D5 stream 8.803

R4 stream 6.695

Winter cereals

D1 ditch 10.225

D1 stream 8.723

D2 ditch 10.251

D2 stream 9.054

D3 ditch 10.120

D4 pond 0.348

D4 stream 7.770

D5 pond 0.348

D5 stream 8.079

D6 ditch 10.175

R1 pond 0.348

R1 stream 6.666

R3 stream 9.420

R4 stream 6.695

Late Vines




D6 ditch 26.890

R1 pond 0.974

R1 stream 19.650

R2 stream 26.470

R3 stream 28.050

R4 stream 19.720

Potato

D3 ditch 8.369

D4 pond 0.337

D4 stream 6.540

D6 ditch (1st) 8.227

D6 ditch (2nd) 8.232

R1 pond 0.337

R1 stream 5.805

R2 stream 7.669

R3 stream 8.163

Outdoor tomato

D6 ditch 10.03

R2 stream 8.837

R3 stream 9.438

R4 stream 6.510

For the use on protected tomato, an alternative approach would be to assume an emission of 0.2% (from a fully

enclosed glasshouse) for each application. PECsw from such an assumption is 1.070 µg/l.

Step 4

Simulations performed with SWAN 4.0.1.




Scenario PECSW [µg a.s./L]

PECSED

[µg a.s./kg]

single multiple single multiple

Spring cereals, 3 x 1.6 kg a.s./ha, 14-d intervals

FOCUS Step 4 – 5m drift buffer zone

D1 ditch 2.756 1.975 1.227 1.199

D1 stream 2.974 2.328 0.161 0.967

D3 ditch 2.744 1.957 0.711 0.829

D4 pond 0.301 0.211 0.148 0.171

D4 stream 3.023 2.259 0.197 0.492

D5 pond 0.301 0.211 0.177 0.185

D5 stream 3.214 2.451 0.189 0.592

R4 stream 2.444 1.739 0.317 0.449


D1 ditch 1.461 1.035 0.666 0.666

D1 stream 1.577 1.220 0.086 0.531

D3 ditch 1.454 1.025 0.381 0.456

D4 pond 0.216 0.151 0.107 0.125

D4 stream 1.602 1.183 0.104 0.267

D5 pond 0.217 0.151 0.128 0.136

D5 stream 1.704 1.284 0.100 0.318

R4 stream 1.295 0.911 0.176 0.271


D1 ditch 0.998 0.702 0.460 0.468

D1 stream 1.077 0.827 0.058 0.370

D3 ditch 0.993 0.695 0.262 0.319

D4 pond 0.173 0.119 0.086 0.101

D4 stream 1.094 0.802 0.071 0.185

D5 pond 0.173 0.119 0.103 0.110

D5 stream 1.163 0.871 0.069 0.219

R4 stream 0.885 0.618 0.148 0.205


D1 ditch 0.759 0.531 0.353 0.363

D1 stream 0.819 0.626 0.044 0.285

D3 ditch 0.755 0.526 0.200 0.246

D4 pond 0.145 0.100 0.072 0.086

D4 stream 0.832 0.607 0.054 0.142

D5 pond 0.145 0.100 0.087 0.093

D5 stream 0.885 0.659 0.052 0.167

R4 stream 0.673 0.468 0.133 0.170





PECSED

[µg a.s./kg]


Winter cereals, 3 x 1.6 kg a.s./ha, 14-d intervals


D1 ditch 2.769 1.975 1.804 1.604

D1 stream 3.184 2.328 0.543 1.072

D2 ditch 2.776 1.978 1.185 1.368

D2 stream 3.305 2.371 1.402 1.247

D3 ditch 2.741 1.954 1.010 1.032

D4 pond 0.301 0.211 0.244 0.201

D4 stream 2.837 2.259 0.105 0.440

D5 pond 0.301 0.211 0.176 0.207

D5 stream 2.949 2.454 0.084 0.587

D6 ditch 2.756 1.969 1.034 1.189

R1 pond 0.301 0.211 0.181 0.237

R1 stream 2.433 1.732 0.306 0.399

R3 stream 3.439 2.448 0.674 0.772

R4 stream 2.444 1.739 0.317 0.310


D1 ditch 1.468 1.035 0.988 0.886

D1 stream 1.688 1.220 0.289 0.584

D2 ditch 1.472 1.036 0.643 0.760

D2 stream 1.752 1.242 0.761 0.686

D3 ditch 1.453 1.023 0.543 0.571

D4 pond 0.216 0.151 0.177 0.148

D4 stream 1.504 1.184 0.056 0.237

D5 pond 0.216 0.151 0.128 0.153

D5 stream 1.563 1.286 0.044 0.315

D6 ditch 1.461 1.032 0.559 0.657

R1 pond 0.216 0.151 0.132 0.174

R1 stream 1.290 0.907 0.163 0.221

R3 stream 1.823 1.282 0.360 0.447

R4 stream 1.295 0.911 0.185 0.201

D1 ditch 0.762 0.531 0.529 0.479


D1 stream 0.877 0.626 0.151 0.312

D2 ditch 0.764 0.532 0.341 0.414

D2 stream 0.910 0.637 0.404 0.370

D3 ditch 0.754 0.525 0.286 0.310

D4 pond 0.144 0.100 0.120 0.102

D4 stream 0.781 0.607 0.029 0.125

D5 pond 0.144 0.100 0.086 0.105

D5 stream 0.812 0.660 0.023 0.165

D6 ditch 0.758 0.529 0.295 0.356

R1 pond 0.144 0.100 0.089 0.119

R1 stream 0.670 0.466 0.085 0.130

R3 stream 0.947 0.658 0.188 0.267

R4 stream 0.673 0.468 0.141 0.157


PECSED

[µg a.s./kg]






PECSED

[µg a.s./kg]


Vines, late applications, 4 x 1.6 kg a.s./ha, 7 d intervals


D6 ditch 5.884 4.892 1.367 3.178

R1 pond 0.622 0.505 0.281 0.467

R1 stream 5.183 4.313 0.431 0.937

R2 stream 6.980 5.776 0.406 0.857

R3 stream 7.398 6.096 1.063 1.827

R4 stream 5.201 4.241 0.451 0.925


D6 ditch 3.196 2.646 0.750 1.813

R1 pond 0.421 0.341 0.192 0.327

R1 stream 2.815 2.333 0.235 0.530

R2 stream 3.791 3.124 0.221 0.487

R3 stream 4.018 3.298 0.580 1.036

R4 stream 2.825 2.294 0.246 0.531


D6 ditch 1.107 0.910 0.264 0.682

R1 pond 0.200 0.160 0.093 0.166

R1 stream 0.975 0.802 0.082 0.197

R2 stream 1.313 1.075 0.077 0.183

R3 stream 1.392 1.134 0.203 0.388

R4 stream 0.978 0.789 0.085 0.206





PECSED

[µg a.s./kg]


Potato, 8 x 1.6 kg a.s./ha, 7-d intervals


D3 ditch 2.742 1.491 0.635 1.154

D4 pond 0.301 0.163 0.109 0.199

D4 stream 2.751 1.544 0.082 0.134

D6 ditch

(1st) 2.695 1.490 0.383 0.776

D6 ditch

(2nd) 2.697 1.495 0.288 0.994

R1 pond 0.301 0.163 0.100 0.197

R1 stream 2.442 1.327 0.301 0.576

R2 stream 3.226 1.778 0.195 0.692

R3 stream 3.434 1.870 0.584 1.025


D3 ditch 1.453 0.788 0.340 0.651

D4 pond 0.216 0.117 0.079 0.148

D4 stream 1.459 0.815 0.043 0.076

D6 ditch

(1st) 1.428 0.787 0.204 0.437

D6 ditch

(2nd) 1.429 0.789 0.153 0.560

R1 pond 0.216 0.117 0.072 0.146

R1 stream 1.294 0.701 0.160 0.325

R2 stream 1.710 0.939 0.103 0.492

R3 stream 1.821 0.988 0.311 0.581


D3 ditch 0.755 0.178

D4 pond 0.144 0.053

D4 stream 0.757 0.022

D6 ditch

(1st) 0.742 0.106

D6 ditch

(2nd) 0.742 0.080

R1 pond 0.144 0.049

R1 stream 0.672 0.083

R2 stream 0.888 0.054

R3 stream 0.945 0.163

Step 4 for tomato has not been conducted as the notified use is greenhouse use.

Estimation of concentrations from other routes of exposure (Regulation (EU) N° 284/2013, Annex Part A,

point 9.4)

Method of calculation

Not calculated, not applicable

PEC

Maximum concentration

Not calculated, not applicable




Ecotoxicology

Effects on birds and other terrestrial vertebrates (Regulation (EU) N° 283/2013, Annex Part A,

point 8.1 and Regulation (EU) N° 284/2013, Annex Part A, point 10.1)

Species Test substance Time scale End point

Toxicity

(mg/kg bw per

day)

Birds

Mallard duck a.s. Acute LD50 3776

Japanese quail a.s. Acute LD50 >2000

Geometric mean a.s. Acute LD50 2748

Zebra finch ETU Acute LD50 2000

Bobwhite quail ETU Acute LD50

LD50 extrapolated

>2250

4248

Geometric mean ETU Acute LD50 2915

Japanese quail a.s. Long-term LD50/10 200

Mallard duck a.s. Long-term NOEL 18.6

Bobwhite quail a.s. Long-term NOEL 27.8

Northern bobwhite ETU Long-term NOEL 1.8

Mallard duck ETU Long-term NOEL 2.6

Mammals

Rat a.s. Acute LD50 >2000

Rat a.s. Acute

geomean

LD50 4560.3

Rat ETU Acute (lowest) LD50 545

Rat ETU Acute

(geomean)

LD50 1062

Mouse ETU Acute (lowest) LD50 2400

Mouse ETU Acute

(geomean)

LD50 3049

Hamster ETU Acute (lowest) LD50 >2400

Hamster ETU Acute

(geomean)

LD50 >2683

Rat, mouse, hamster

(geometric mean of all

species)

ETU Acute LD50 2056

Rat EBIS Acute LD50 240

Rat EU Acute LD50 >5000

Mouse EDA Acute LD50 400-600

Rat EDA Acute (lowest) LD50 637

Rat EDA Acute

(geomean)

LD50 1167




Rat a.s. Long-term NOAEL

15

Rat ETU Long-term NOAEL 2

Endocrine disrupting properties (Annex Part A, points 8.1.5)

Adversity in mammals was based on thyroid follicular cell hypertrophy, increased thyroid weight, thyroid

follicular cell hyperplasia, tumours of the thyroid gland (adenomas and carcinomas).

According to the assessment strategy in ECHA/EFSA Guidance, the relevance of the observed effects in the

mammalian toxicology dataset at population level for wild mammals was discussed.

Considering that no other apical effects for example on growth and development were observed in the

available data package for mammals, including a development neurotoxicity studies, the experts agreed that

the observed effects cannot be considered relevant at population level.

Additional higher tier studies (Annex Part A, points 10.1.1.2):

A range of residue decline studies prodiced a DT50 for leafy crops / non grass herbs (i.e. all broadleaved

plants) of 2.7 days.

Focal species, PT (90th percentile, consumer only) and PD data:

For cereals the focal species identified are: yellow wagtail (central and southern zones),

yellowhammer (central zone), winchat (northern zone), fan tailed warbler (southern zone, BBCH >56) and

Of these, suitable PT data have been provided for t

the yellowhammer (PT = 0.87). Sufficient data were not available to define a diet

for the skylark or corn bunting, so these species were not used as a focal species and was covered by the tier 1

generic focal species small omnivorous bird.

For grapevines the focal species identified are: serin (southern zone), linnet (central zone), blackbird (central

and southern zones), great tit (central and southern zones), crested lark (southern zone) and woodlark (central

zone). Of these, suitable PT data have been provided for the linnet (PT = 0.86).

For potatoes a focal species study was available and the focal species identified are: yellow wagtail (central

and southern zones), (all zones) and white wagtail (northern zone). Of these, suitable PT data have

been provided for the ). Sufficient data were not available to define a diet for the skylark,

so this species was not used as a focal species and was covered by the tier 1 generic focal species small

omnivorous bird.

No higher tier risk assessment was presented for the representative use to tomatoes in greenhouses which are

not high technology (permanent).

Terrestrial vertebrate wildlife (birds, mammals, reptile and amphibians) (Annex Part A, points 8.1.4, 10.1.3):

No data available.

Toxicity/exposure ratios for terrestrial vertebrates (Regulation (EU) N° 284/2013, Part A, Annex

point 10.1)

Mancozeb: Wheat at 1600 g a.s./ha [3 of applications with a 14 day interval, BBCH 30 – 65, All

zones]

Growth stage Indicator or focal species Time scale

DDD

(mg/kg bw per

day)

TER Trigger

Screening Step (Birds)

All Small omnivorous bird Acute 330.304 8.32 10

All Small omnivorous bird Long-term 82.426 0.226 5

Tier 1 (Birds)

30-39 Small omnivorous bird Acute 24.96 110.10 10

≥40 Small omnivorous bird Acute 14.976 183.49 10

30-39 Small omnivorous bird Long-term 6.869 2.708 5

≥40 Small omnivorous bird Long-term 4.198 4.431 5





DDD

(mg/kg bw per

day)

TER Trigger

Higher tier (birds): Focal species (wood mouse), DT50 on leafy plants, crop interception

NOTE: no focal species are available to cover the risk small omnivorous birds, s

30-39 Yellow wagtail Long-term 5

30-39 Yellowhammer (seeds) Long-term 2.117 8.8 5

30-39 Yellowhammer (inverts) Long-term 2.679 6.9 5

30-39 Winchat Long-term 15.561 1.2 5

41-65 Yellow wagtail Long-term 8.791 2.1 5

41-65 Yellowhammer (seeds) Long-term 1.059 17.6 5

41-65 Yellowhammer (inverts) Long-term 2.679 6.9 5

41-65 Winchat Long-term 15.379 1.2 5

41-65 Fan tailed warbler Long-term 28.446 0.7 5

Screening Step (Mammals)

All Small Herbivorous Acute 246.272 8.12 10

All Small Herbivorous Long-term 61.434 0.244 5

Tier 1 (Mammals)

≥20 Small insectivorous Acute 11.232 >178.06 10

≥40 Small herbivorous Acute 85.072 >23.51 10

30-39 Small omnivorous Acute 17.888 >111.81 10

≥40 Small omnivorous Acute 10.816 >184.91 10

≥20 Small insectivorous Long-term 2.417 6.207 5

≥40 Small herbivorous Long-term 27.602 0.543 5

30-39 Small omnivorous Long-term 4.961 3.024 5

≥40 Small omnivorous Long-term 2.926 5.127 5

Higher tier (Mammals): Focal species, DT50 on leafy plants, crop interception, PT, PD

30-39 Small insectivorous Long-term 2.448 6.129 5

30-39 Wood mouse Long-term 1.700 8.824 5


40-6 Small herbivorous Long-term 9.169 1.636 5

40-6 Common vole Long-term 9.169 1.636 5


Risk from bioaccumulation and food chain behaviour

Not required because Log kow≤3

Risk from consumption of contaminated water

Leaf scenario

Not required for wheat

Puddle scenario, Screening step

Worst case total application rate (12800g a.s./ha)/relevant endpoint = 853 which is <3000 (koc500 L/kg),

TER calculation not needed

ETU: Wheat at 1600 g a.s./ha [3 of applications with a 14 day interval, BBCH 30 – 65, All zones]


DDD

(mg/kg bw per

day)

TER Trigger







DDD

(mg/kg bw per

day)

TER Trigger


Tier 1 (Birds)





Higher tier (birds): Measured residues of ETU





Tier 1 (Mammals)

≥20 Small insectivorous Acute 11.232 48.52 10

≥40 Small herbivorous Acute 85.072 6.41 10

30-39 Small omnivorous Acute 17.888 30.47 10

≥40 Small omnivorous Acute 10.816 50.39 10





Higher tier (Mammals): Measured residue of ETU


All Small insectivorous Long-term 0.088 22.727 5

All Small herbivorous Long-term 1.2861 1.555 5

All Small omnivorous Long-term 0.1408 14.206 5

Higher tier (Mammals): Measured residue of ETU and crop interception

BBCH 41-65 Small herbivorous Long-term 0.1286 15.55 5


Not required because Log kow≤3

Mancozeb: Grapevine at 1600 g a.s./ha [4 of applications with a 7 day interval, BBCH 15 – 85,

Contral and Southern Zone]


DDD

(mg/kg bw per

day)

TER Trigger


All Small herbivorous bird Acute 274.464 10.01 10

All Small herbivorous bird Long-term 72.572 0.256 5

Tier 1 (Birds)



10-19 Small granivorous Long-term 12.87 1.445 5


≥40 Small granivorous Long-term 6.343 2.932 5

Ripening Frugivorous Long-term 26.86 0.692 5




Higher tier (birds): Focal species, DT50 on leafy plants, crop interception, PT, PD

10-69 Serin Long-term 9.450 2.0 5

10-69 Linnet Long-term 7.327 2.5 5

10-69 Blackbird a Long-term 2.821 6.6 5

10-69 Blackbird b Long-term 0.180 103.4 5

10-69





DDD

(mg/kg bw per

day)

TER Trigger

10-69 5

10-69 Crested lark Long-term 6.118 3.0 5

10-69 Woodlark Long-term 10.271 1.8 5

71-85 Serin Long-term 5.906 3.1 5


71-85

71-85 Great tit a Long-term 30.169 0.6 5

71-85 Great tit b Long-term 17.598 1.1 5


71-85 Woodlark Long-term 7.022 2.6 5

Great tit a = 100% foliar invertebrates

Great tit b = mixture of foliar and ground dwelling invertebrates

Blackbird a = feeding on invertebrates

Blackbird b = feeding on earthworms

Blackbird c = feeding on fruit




Tier 1 (Mammals)

10-19 Large herbivorous Acute 46.944 >42.60 10


≥40 Large herbivorous Acute 23.328 >85.73 10

10-19 Small insectivorous Acute 21.888 >91.37 10


10-19 Small herbivorous Acute 235.872 >8.48 10

20-29 Small herbivorous Acute 196.416 >10.18 10





10-19 Large herbivorous Long-term 12.500 1.200 5


≥40 Large herbivorous Long-term 6.156 2.436 5









Higher tier (Mammals): [geometric mean LD50 = 4560]

10-19 Small herbivorous Acute 235.872 19.3 10

Higher tier (Mammals): Focal species (wood mouse), DT50 on leafy plants, crop interception














DDD

(mg/kg bw per

day)

TER Trigger



Not required because Log kow ≤3


Leaf scenario

Not required for grapevines



TER calculation not needed

ETU: Grapevine at 1600 g a.s./ha [4 of applications with a 7 day interval, BBCH 15 – 85, Contral

and Southern Zone]


DDD

(mg/kg bw per

day)

TER Trigger


All Small herbivorous bird Acute 274.464 7.29 10

All Small herbivorous bird Long-term 72.572 0.025 5

Tier 1 (Birds)

10-19 Small insectivorous Acute 78.912 25.34 10


10-19 Small granivorous Acute 42.624 46.92 10

20-39 Small granivorous Acute 35.712 56.00 10

≥40 Small granivorous Acute 21.312 93.84 10

Ripening Frugivorous Acute 83.232 24.03 10








≥40 Small granivorous Long-term 6.343 0.284 5

Ripening Frugivorous Long-term 26.86 0.067 5






All Small granivorous Long-term 0.4116 4.373 5

All Frugivorous Long-term 0.0346 52.023 5


Higher tier (birds): Focal species, crop interception, PT, PD

15-69 Serin Long-term 0.137 13.1 5


15-69 5

15-69 5

15-69 5

15-69 5






DDD

(mg/kg bw per

day)

TER Trigger

71-85 Serin Long-term 0.086 21.0 5


71-85 5

71-85 5

71-85 Great tit a Long-term 0.865 2.1 5

71-85 Great tit b Long-term 0.516 3.5 5


Great tit a = 100% foliar invertebrates

Great tit b = mixture of foliar and ground dwelling invertebrates

Blackbird a = feeding on invertebrates

Blackbird b = feeding on earthworms




Tier 1 (Mammals)

10-19 Large herbivorous Acute 46.944 11.61 10


≥40 Large herbivorous Acute 23.328 23.36 10




















Higher tier (Mammals): Measured residues of ETU

All Small herbivorous Acute 8.21142 66.37 10

All Large herbivorous Long-term 0.22581 8.857 5


All Small herbivorous Long-term 1.97239 1.014 5


Higher tier (Mammals): Measured residue of ETU and crop interception

BBCH 10-69 Small herbivorous Long-term 0.7890 2.53 5

BBCH71-85 Small herbivorous Long-term 0.4931 4.06 5






Mancozeb: Potato at 1600 g a.s./ha [8 of applications with a 7 day interval, BBCH 15-89, All

zones]


DDD

(mg/kg bw per

day)

TER Trigger




Tier 1 (Birds)

10-19 Small insectivorous bird Acute 81.472 33.729 10


≥20 Small insectivorous bird Acute 76.608 35.871 10


10-19 Small insectivorous bird Long-term 23.956 0.776 5


≥20 Small insectivorous bird Long-term 20.564 0.904 5


Higher tier (birds): Focal species, DT50 on leafy plants, crop interception, PT, PD

NOTE: no focal species are available to cover the risk small omnivorous birds, s


15-39 White Wagtail Long-term 23.866 0.8 5


40-85 White Wagtail Long-term 19.470 1.0 5




Tier 1 (Mammals)





≥40 Large herbivorous Acute 31.92 >62.66 10










Higher tier (Mammals): Focal species (wood mouse), DT50 on leafy plants, crop interception, PT















DDD

(mg/kg bw per

day)

TER Trigger


Leaf scenario

Not required for potato



TER calculation not needed.

ETU: Potato at 1600 g a.s./ha [8 of applications with a 7 day interval]


DDD

(mg/kg bw per

day)

TER Trigger




Tier 1 (Birds)

10-19 Small insectivorous bird Acute 81.472 24.55 10


≥20 Small insectivorous bird Acute 76.608 26.11 10


10-19 Small insectivorous bird Long-term 23.956 0.075 5


≥20 Small insectivorous bird Long-term 20.564 0.088 5




All Small omnivorous Long-term 5




Tier 1 (Mammals)





≥40 Large herbivorous Acute 31.92 17.07 10










Higher tier (Mammals): Measured residue values for metabolite

All Small herbivorous Acute 8.66761 62.88 10


All Small herbivorous Long-term 5

All Large herbivorous Long-term 4.950 5


Higher tier (Mammals): Measured resdiues, focal species, PT





DDD

(mg/kg bw per

day)

TER Trigger



Mancozeb: tomatoes in greenhouses which are not high technology (permanent) greenhouses at

1600 g a.s./ha [5 of applications with a 7 day interval, BBCH 15-89, Central and Southern zones]


DDD

(mg/kg bw per

day)

TER Trigger




Tier 1 (Birds)

71-89 Frugivorous bird Acute 174.5 15.75 10

10 - 49 Small granivorous bird Acute 75.1 36.60 10

≥ 50 Small granivorous bird Acute 22.5 122.16 10

10 - 49 Small omnivorous bird Acute 73.0 37.66 10

≥ 50 Small omnivorous bird Acute 21.9 125.55 10

71-89 Frugivorous bird Acute 150.2 18.30 10

10 - 19 Small insectivorous bird Acute 81.5 33.73 10

≥ 20 Small insectivorous bird Acute 76.6 35.87 10

71-89 Frugivorous bird Long-term 65.1 0.29 5

10 - 49 Small granivorous bird Long-term 23.2 0.80 5

≥ 50 Small granivorous bird Long-term 6.9 2.69 5

10 - 49 Small omnivorous bird Long-term 22.2 0.84 5

≥ 50 Small omnivorous bird Long-term 6.7 2.77 5

71-89 Frugivorous bird Long-term 42.1 0.44 5

10 - 19 Small insectivorous bird Long-term 23.0 0.81 5

≥ 20 Small insectivorous bird Long-term 19.7 0.94 5

Higher tier (birds):

No available




Tier 1 (Mammals)



10 - 49 Small herbivorous Acute 414.7 >4.82 10


10 - 49 Small omnivorous Acute 52.3 >38.25 10


71-89 Frugivorous Acute 137.4 >14.56 10



10 - 49 Small herbivorous Long-term 147.1 0.10 5


10 - 49 Small omnivorous Long-term 15.9 0.94 5


71-89 Frugivorous Long-term 51.3 0.29 5





DDD

(mg/kg bw per

day)

TER Trigger

Higher tier (Mammals):

Acute:

Refined TER for small herbivorous mammal using geometric mean endpoint (4560.3 mg a.s./kg bw) is 11.28

which is greater than the trigger of 10.

Long-term:

Not available.




Leaf scenario

Not required for tomato



TER calculation not needed.

Mancozeb and ETU: Tomatoes at 1600 g a.s./ha high technology (permanent) greenhouse [5 of

applications with a 7 day interval]


DDD

(mg/kg bw per

day)

TER Trigger


Not required as applicant stated the use in high technology (permanent) greenhouse


Not required as applicant stated the use in high technology (permanent) greenhouse




Leaf scenario

Not required uses in high technology (permanent) greenhouse


Not required uses in high technology (permanent) greenhouse

Toxicity data for all aquatic tested species (Regulation (EU) N° 283/2013, Annex Part A, points

8.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.2)*

Group Test substance Time-scale

(Test type)

End point Toxicity1

Laboratory tests

Fish

Oncorhynchus mykiss a.s.

Mancozeb

Tech.

(purity > 90%)

Acute 96 hr

(semi-static)

Mortality, LC50 74 µg a.s./L

(mm)





(Test type)

End point Toxicity1

Lepomis macrochirus a.s.

Mancozeb Tech.

(purity > 90%)

Acute 96 hr

(semi-static)


(mm)

Oncorhynchus mykiss a.s.

Mancozeb Tech.

(purity > 85%)

Acute 96 hr

(semi-static)


(mm)

Oncorhynchus mykiss Preparation

Penncozeb 80

WP

(Mancozeb:

82.0%)

Acute 96 hr

(flow-through)

Mortality, LC50

150 µg a.s./L

(mm)

Oncorhynchus mykiss Preparation

Dithane M-45

(Mancozeb:

81.3%)

Acute 96 hr

(flow-through)

Mortality, LC50

Solubility limit2

200 µg a.s./L

(nom)

Cyprinus carpio Preparation

Penncozeb 80

WP

(Mancozeb:

82.0%)

Acute 96 hr

(flow-through)

Mortality, LC50

Solubility limit2

200 µg a.s./L

(mm)

Lepomis macrochirus Preparation

Dithane M-45

(Mancozeb: Not

stated)

Acute 96 hr

(flow-through)

Mortality, LC50

Solubility limit2

200 µg a.s./L

(mm)

Pimephales promelas a.s.

Mancozeb

Tech.

(purity: 84.7%)

Chronic (flow-

through)

Full Life-Cycle

Reproduction NOEC,

No. eggs/female/day

and Cum. No. eggs.

1.35 µg a.s./L

(mm)

Reproduction EC10,

No. eggs/female/day

1.27 µg a.s./L

(mm)

Pimephales promelas a.s.

Mancozeb Tech.

(purity 79.3%)

Chronic (flow-

through)

Early Life Stage

Survival NOEC, 34

days

2.19 µg a.s./L

(mm)

Survival EC10, 34 days 2.04 µg a.s./L

(mm)

Cyprinodon variegatus Preparation.

Dithane M-45

(Mancozeb:

78.8%)

Chronic (flow-

through)

Early Life Stage

Growth NOEC, 39

days

0.918 µg a.s./L

(mm)

Growth EC10, 39 days 2.88 µg a.s./L

(mm)

Pimephales promelas Preparation

Dithane M-45

(Mancozeb:

82.4%)

Chronic (flow-

through)

Early Life Stage

Survival NOEC, 33

days

5.2 µg a.s./L

(mm)





(Test type)

End point Toxicity1

Oncorhynchus mykiss Metabolite 1

ETU

(purity: 99.9%)

96 hr (static) Mortality, LC50 >500000 µg

a.s./L (nom)

Lepomis macrochirus Metabolite 1

ETU

(purity: 100%)

96 hr (static) Mortality, LC50 > 990000 µg

a.s./L (mm)

Cyprinodon variegates Metabolite 1

ETU

(purity: 100%)

96 hr (static) Mortality, LC50 > 900000 µg

a.s./L (mm)

Oncorhynchus mykiss Metabolite 2

EU

(purity: 90.8%)

96 hr (static) Mortality, LC50 >122000 µg

a.s./L (mm)

Xenopus laevis Metabolite 1

ETU

(purity 99.9%)

Chronic (28 day

semi-static)

Development NOEC

10000 µg

a.s./L (nom)

Xenopus laevis Metabolite 1

ETU

(purity 99.9%)

Chronic (90 day

semi-static)

Development NOEC,

1000 µg a.s./L

(nom)

Aquatic invertebrates

Daphnia magna a.s.

Mancozeb Tech.

(purity > 90%)

48 h (static) Mortality, EC50 73 µg a.s./L

(mm)

Daphnia magna Preparation.

Penncozeb 80

WP (Mancozeb:

82.0%)

48 h (static) Mortality, EC50

Solubility limit2

200 µg a.s./L

(nom)

Daphnia magna Preparation

Sancozeb 800

WP (Mancozeb:

80%)


Solubility limit2

200 µg a.s./L

(nom)


Dithane M-45

(Mancozeb:

81.3%)

48 h (flow-

through)

Mortality, EC50

Solubility limit2

200 µg a.s./L

(mm)


Fortuna 800 WP

(Mancozeb:

79.4%)


(nom)





(Test type)

End point Toxicity1

Lymnea stagnalis Preparation

Penncozeb 80

WP

(Mancozeb:

80%)


Solubility limit2

2000 µg a.s./L

(mm)

Americamysis bahia Preparation.

Dithane M-45

(Mancozeb:

78.8%).

39 d (flow-

through)

Survival NOEC,

F0 28d, F1 4, 7, and

11d.

1.64 µg a.s./L

(mm)

Survival EC10,

F0 28d

1.71 µg a.s./L

(mm)

Daphnia magna Preparation.

Dithane M-45

(Mancozeb:

82.4%)

28 d (flow-

through)

Reproduction NOEC,

No.

offspring/female/day

and Cum. No. of

offspring per surviving

parent

7.3 µg a.s./L

(mm)

Reproduction EC10,

Cum. No. of offspring

per surviving parent

10.9 µg a.s./L

(mm)

Americamysis bahia Metabolite 1

ETU

(purity:

97.69%)


(mm)

Daphnia magna Metabolite 1

ETU

(purity: 99.6%)

48 h (static) Mortality, EC50 21600 µg

a.s./L (nom)

Crassostrea virginica Metabolite 1

ETU

(purity: 100%)

48 h (flow-

through)

Mortality, EC50 >110000 µg

a.s./L (mm)


EU

(purity: 90.8%)

48 h (static) Mortality, EC50 >985000 µg

a.s./L (mm)


ETU

(purity 96.2%)

28 d (flow-

through)

Reproduction NOEC 2000 µg a.s./L

(mm)

Sediment-dwelling organisms

Chironomus riparius Preparation

Mancozeb 80

WP (Mancozeb:

80.5%)

spiked –water

28 d (static) Emergence NOEC

Solubility limit2

200 µg a.s./L

(init)

Emergence EC10

Solubility limit2

200 µg a.s./L

(init)





(Test type)

End point Toxicity1

Lumbriculus variegatus Preparation

Mancozeb 80

WP (Mancozeb:

80.5%)

spiked –water

28 d (static) Development NOEC 30 µg a.s./L

(init)

Development EC10 40 µg a.s./L

(init)

Algae

Selenastrum

capricornutum

(Raphidocelis subcapitata)

Preparation

Dithane M-45

(Mancozeb:

82.4%)

120 h (static) Growth rate: ErC50 32.2 µg a.s./L

(mm)

Growth rate: ErC10 9.05µg a.s./L

(mm)

Yield: EyC50 8.79 µg a.s./L

(mm)

NOEC n.d.

Pseudokirchneriella

subcapitata


a.s.

Mancozeb Tech.

(Purity: 86.1%)

72 h (static) Growth rate: ErC50 50.9 µg a.s./L

(mm)

Growth rate: ErC10 16.0 µg a.s./L

(mm)


(mm)


(mm)

NOEC 2.01 µg a.s./L

(mm)

Pseudokirchneriella

subcapitata


Metabolite 1

ETU

(purity: 99.6%)

72 h (static) Growth rate: ErC50

93800 µg

a.s./L (nom)

Selenastrum

capricornutum

(Raphidocelis subcapitata

Metabolite 2

EU

(purity: 90.8%)

72 h (static) Growth rate: ErC50

>119000 µg

a.s./L (nom)

Higher plant

Lemna minor Preparation.

Mancozeb 80

WP

(Mancozeb:

80.5%)

7 day (semi-

static)

Fronds number,

ErC50

1811 µg a.s./L

(mm)

Fronds number,

ErC10

82.2 µg a.s./L

(mm)

Biomass, ErC50 1042 µg a.s./L

(mm)

Biomass, ErC10 37.1 µg a.s./L

(mm)





(Test type)

End point Toxicity1

Frond

number/Biomass,

NOEC

24.6 µg a.s./L

(mm)

Lemna minor Metabolite 1

ETU

(purity: 100%)

7 day (semi-

static)

Fronds number,

ErC50 (NOEC)

>960000 µg

a.s./L (mm)

Further testing on aquatic organisms

Tier 2a Geometric mean for acute fish endpoints

As acceptable endpoints were available for multiple fish species, the geometric mean of individual species was

calculated, followed by the overall geometric mean between species. The limit of solubility was used where

the endpoints were greater than this value.

Table: Geometric mean calculations for the acute fish endpoints.

Species Endpoint

(µg a.s./L)

Geomean Species

(µg a.s./L)

Overall Geomean

(µg a.s./L)

O. mykiss 74

99.22

118.1

O. mykiss 88

O. mykiss 150

L. macrochirus 83 -

C. carpio 200* -

* Limit of solubility for mancozeb

The standard acute assessment factor of 100 applies for the geometric mean, therefore the tier 2a RAC for

acute fish endpoints was concluded to be 1.18.

Tier 2a Geometric mean for acute invertebrate endpoints

Two valid D. magna endpoints were available and considered acceptable for use in calculating a geometric

mean endpoint. The limit of solubility was used where the endpoints were greater than this value.

Species Endpoint (µg a.s./L) Geomean Species (µg a.s./L)

D. magna 73 120.83

D. magna 200*

* Limit of solubility for mancozeb

The standard acute assessment factor of 100 applies for the geometric mean, therefore the tier 2a RAC for

acute invertebrate endpoints was concluded to be 1.21.





(Test type)

End point Toxicity1

A modified exposure fish early life stage study was performed on reproducing adult and resulting offspring D.

rerio. The EC10 value was in terms of nomal concentrations was 10.5 μg a.s./L but as it was derived form a

study with modified exposure nominal concentrations are not appropriate for expressing the endpoint.

This is then divided

by the assessment factor to give a regulatory acceptable profile (RAP).

The RAP was then considered against the predicted exposure profiles (with mitigation) where available:

Potatoes: Low risk with 20m buffer zone.

Tomatoes in greenhouses which are not high technology (permanent): Exposure profile not considered.

Tomatoes in high technology (permanent) greenhouse: Exposure profile not considered butmodified

refinement using pulsed exposure not suitable.

D. rerio Mancozeb

Tech.

(Purity:

87.4%)

Adult (F0) fish

exposed for 28

days. Offspring

(F1) exposed for

35 days

following this.

EC10 for total 35 day

F1 survival.

10.5 µg a.s./L

(nom)

NOEC for total 35

day F1 survival.

5.0 µg a.s./L

(nom)

Several species of aquatic

invertebrates and algae,

with aquatic macrophytes

included for microcosm

structure. Aimed to

simulate natural

ecosystems.

Mancozeb 800

g/kg WP

(Purity:

81.0%)

First dosing:

05/06/17.

Final

sampling:

30/08/17.

ETO RAC for

invertebrates based

on the most sensitive

species: Lecane gr.

Lunaris (rotifer)

NOEC = 10 μg

a.s./L

AF = 4

ETO RAC =

2.5 μg a.s./L

ERO RAC =

n/a

Potential endocrine disrupting properties (Annex Part A, point 8.2.3)

A number of amphibian metamorphosis studies were available with the ETU metabolite, showing clear effects

on thyroid histopathology coupled with delay in development. These effects were considered to be consistent

with the effects and the mode of action identified in mammals i.e. inhibition of the peroxidase activity of TPO

probably via ETU metabolite leading in the case of amphibians to delayed development.

Although data on amphibians were only available for ETU, considering the available evidence from

metabolism studies showing that ETU is formed in animal body (rat and hen), similar metabolism can be

expected in amphibians

For the E, A and S modalities, a Fish Full Life Cycle Test (FFLCT) and a partial life cycle test were available.

However, the FFLCT did not include any ED relevant parameters. In the partial life cycle effects on female

and male gonads were observed. However, no mechanistic information was available. No further data are

however requested, considering the conclusion on the T modality. 1 (nom) nominal concentration; (mm) mean measured concentration; prep.: preparation; a.s.: active substance 2 Where endpoints on formulations or the active substance were greater than the limit of solubility, the limit of solubility (200

μg a.s./L) is given as the endpoints




Bioconcentration in fish (Annex Part A, point 8.2.2.3)

Active

substance

Mancozeb

ETU

Metabolite4

Glycolic

acid**

EDA** EBIS**

logPO/W 2.3 -0.66 -1.067 -1.618 1.600

Steady-state bioconcentration factor

(BCF)

(total wet weight/normalised to 5%

lipid content)

X*

n/r

n/r n/r n/r n/r

Uptake/depuration kinetics BCF

(total wet weight/normalised to 5%

lipid content)

n/r n/r n/r n/r n/r

Annex VI Trigger for the

bioconcentration factor

3 3 3 3 3

Clearance time (days) (CT50) n/r n/r n/r n/r n/r

(CT90) n/r n/r n/r n/r n/r

Level and nature of residues (%) in

organisms after the 14 day depuration

phase

n/r n/r n/r n/r n/r

Higher tier study

n/r

* based on total 14C or on specific compounds

n/r: not required. logPow is below the trigger therefore no further assessment of bioaccumulation is require

**Predicted by QSAR




Active substance toxicity/exposure ratios for the most sensitive aquatic organisms (Regulation (EU) N° 284/2013, Annex Part A, point 10.2) For MTF

representative uses:

FOCUSsw step 1-2- Risk for mancozeb to Potatoes at 8 x 1600 g/ha Northern and Southern Europe.

Scenario PEC global max

(µg L) Fish acute

Fish chronic

(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum Lemna minor

Endpoint LC50 EC10 EC50 EC10 EC10 ErC50 ErC50

Toxicity 118.1 µg/L 1.27 µg/L 120.83 µg/L 1.71 µg/L 40 32.2 µg/L 1042 µg/L

Assessment factor 100 10 100 10 10 10 10

RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 104.2

FOCUS Step 1 277.7 High risk High risk High risk High risk High risk High risk High risk

FOCUS Step 2

PEC

Single Application 14.715 14.715 14.715 14.715 14.715 14.715 14.715

Multiple

Application 8.064 8.064 8.064 8.064 8.064 8.064 8.064

1 Regulatory Acceptable Concentration

FOCUSsw step 1-2- Risk for mancozeb to Winter cereals at 3 x 1600 g/ha Northern and Southern Europe.

Scenario

PEC global

max

(µg L)

Fish acute Fish chronic

(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum





RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 104.2





Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

FOCUS Step 2

PEC


Multiple

Application 10.795 10.795 10.795 10.795 10.795 10.795 10.795


FOCUSsw step 1-2- Risk for mancozeb to Early vines at 4 x 1600 g/ha Northern and Southern Europe.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum





RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 104.2


FOCUS Step 2

PEC


Multiple

Application 13.328 13.328 13.328 13.328 13.328 13.328 13.328


FOCUSsw step 1-2- Risk for mancozeb to Late vines at 4 x 1600 g/ha Northern and Southern Europe.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum





Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant




RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 104.2


FOCUS Step 2

PEC


Multiple

Application 35.365 35.365 35.365 35.365 35.365 35.365 35.365


FOCUSsw step 3- Risk for mancozeb to Potatoes at 8 x 1600 g/ha, 7-d intervals.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum Danio rerio

Endpoint LC50 EC10 EC50 EC10 EC10 ErC50 EC10

Toxicity 118.1 µg/L 1.27 µg/L 120.83 µg/L 1.71 µg/L 40 32.2 µg/L 10.5 µg/L


RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 1.05

FOCUS Step 3

PEC D3 Ditch Single 8.369 8.369 8.369 8.369 8.369 8.369 8.369

D3 Ditch Multiple 4.582 4.582 4.582 4.582 4.582 4.582 4.582

D4 Pond Single 0.337 0.337 0.337 0.337 0.337 0.337 0.337

D4 Pond Multiple 0.182 0.182 0.182 0.182 0.182 0.182 0.182

D4 Stream Single 6.540 6.540 6.540 6.540 6.540 6.540 6.540

D4 Stream Multiple 3.687 3.687 3.687 3.687 3.687 3.687 3.687

D6 Ditch (1st) Single 8.227 8.227 8.227 8.227 8.227 8.227 8.227




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)

D6 Ditch (1st)

Multiple 4.579 4.579 4.579 4.579 4.579 4.579 4.579

D6 Ditch (2nd) Single 8.232 8.232 8.232 8.232 8.232 8.232 8.232

D5 Ditch (2nd)

Multiple 4.592 4.592 4.592 4.592 4.592 4.592 4.592

R1 Pond Single 0.337 0.337 0.337 0.337 0.337 0.337 0.337

R1 Pond Multiple 0.182 0.182 0.182 0.182 0.182 0.182 0.182

R1 Stream Single 5.805 5.805 5.805 5.805 5.805 5.805 5.805

R1 Stream Multiple 3.169 3.169 3.169 3.169 3.169 3.169 3.169

R2 Stream Single 7.669 7.669 7.669 7.669 7.669 7.669 7.669


R3 Stream Single 8.163 8.163 8.163 8.163 8.163 8.163 8.163

R3 Stream Multiple 4.468 4.468 4.468 4.468 4.468 4.468 4.468 1 Regulatory Acceptable Concentration

FOCUSsw step 3- Risk for mancozeb to Spring cereals at 3 x 1600 g/ha, 14-d intervals.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum





RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 1.05




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)

FOCUS Step 3


D1 Ditch Multiple 7.473 7.473 7.473 7.473 7.473 7.473 7.473

D1 Stream Single 8.148 8.148 8.148 8.148 8.148 8.148 8.148


D3 Ditch Single 10.131 10.131 10.131 10.131 10.131 10.131 10.131

D3 Ditch Multiple 7.402 7.402 7.402 7.402 7.402 7.402 7.402

D4 Pond Single 0.348 0.348 0.348 0.348 0.348 0.348 0.348

D4 Pond Multiple 0.245 0.245 0.245 0.245 0.245 0.245 0.245

D4 Stream Single 8.280 8.280 8.280 8.280 8.280 8.280 8.280


D5 Pond Single 0.348 0.348 0.348 0.348 0.348 0.348 0.348

D5 Pond Multiple 0.245 0.245 0.245 0.245 0.245 0.245 0.245

D5 Stream Single 8.803 8.803 8.803 8.803 8.803 8.803 8.803


R4 Stream Single 6.695 6.695 6.695 6.695 6.695 6.695 6.695


FOCUSsw step 3- Risk for mancozeb to Winter cereals at 3 x 1600 g/ha, 14-d intervals.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum







Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)


RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 1.05

FOCUS Step 3


D1 Ditch Multiple 7.472 7.472 7.472 7.472 7.472 7.472 7.472

D1 Stream Single 8.723 8.723 8.723 8.723 8.723 8.723 8.723


D2 Ditch Single 10.251 10.251 10.251 10.251 10.251 10.251 10.251

D2 Ditch Multiple 7.482 7.482 7.482 7.482 7.482 7.482 7.482

D2 Stream Single 9.054 9.054 9.054 9.054 9.054 9.054 9.054


D3 Ditch Single 10.120 10.120 10.120 10.120 10.120 10.120 10.120

D3 Ditch Multiple 7.390 7.390 7.390 7.390 7.390 7.390 7.390

D4 Pond Single 0.348 0.348 0.348 0.348 0.348 0.348 0.348

D4 Pond Multiple 0.245 0.245 0.245 0.245 0.245 0.245 0.245

D4 Stream Single 7.770 7.770 7.770 7.770 7.770 7.770 7.770


D5 Pond Single 0.348 0.348 0.348 0.348 0.348 0.348 0.348

D5 Pond Multiple 0.245 0.245 0.245 0.245 0.245 0.245 0.245

D5 Stream Single 8.079 8.079 8.079 8.079 8.079 8.079 8.079


D6 Ditch Single 10.175 10.175 10.175 10.175 10.175 10.175 10.175

D6 Ditch Multiple 7.450 7.450 7.450 7.450 7.450 7.450 7.450

R1 Pond Single 0.348 0.348 0.348 0.348 0.348 0.348 0.348

R1 Pond Multiple 0.245 0.245 0.245 0.245 0.245 0.245 0.245

R1 Stream Single 6.666 6.666 6.666 6.666 6.666 6.666 6.666




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)


R3 Stream Single 9.420 9.420 9.420 9.420 9.420 9.420 9.420


R4 Stream Single 6.695 6.695 6.695 6.695 6.695 6.695 6.695


FOCUSsw step 3- Risk for mancozeb to Vines at 4 x 1600 g/ha 7-d intervals and tomatoes in greenhouses which are not high technology (permanent)

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum





RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 1.05

FOCUS Step 3


D6 Ditch Multiple 22.580 22.580 22.580 22.580 22.580 22.580 22.580

R1 Pond Single 0.974 0.974 0.974 0.974 0.974 0.974 0.974

R1 Pond Multiple 0.793 0.793 0.793 0.793 0.793 0.793 0.793

R1 Stream Single 19.650 19.650 19.650 19.650 19.650 19.650 19.650


R2 Stream Single 26.470 26.470 26.470 26.470 26.470 26.470 26.470




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Fish Chronic

(Pulsed-Dose

higher tier)


R3 Stream Single 28.050 28.050 28.050 28.050 28.050 28.050 28.050


R4 Stream Single 19.720 19.720 19.720 19.720 19.720 19.720 19.720


FOCUSsw step 4- Risk for mancozeb to Potatoes at 8 x 1600 g/ha, 7-d intervals, 5m drift buffer.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10 EC50 EC10 EC10 ErC50 (NOEC)

ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D3 Ditch Multiple 1.491 1.491 1.491 1.491 1.491 1.491 1.491

D4 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

D4 Pond Multiple 0.163 0.163 0.163 0.163 0.163 0.163 0.163

D4 Stream Single 2.751 2.751 2.751 2.751 2.751 2.751 2.751

D4 Stream

Multiple 1.544 1.544 1.544 1.544 1.544 1.544 1.544




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

D6 Ditch (1st)

Single 2.695 2.695 2.695 2.695 2.695 2.695 2.695

D6 Ditch (1st)

Multiple 1.490 1.490 1.490 1.490 1.490 1.490 1.490

D6 Ditch (2nd)

Single 2.697 2.697 2.697 2.697 2.697 2.697 2.697

D5 Ditch (2nd)

Multiple 1.495 1.495 1.495 1.495 1.495 1.495 1.495

R1 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

R1 Pond Multiple 0.163 0.163 0.163 0.163 0.163 0.163 0.163

R1 Stream Single 2.442 2.442 2.442 2.442 2.442 2.442 2.442

R1 Stream

Multiple 1.327 1.327 1.327 1.327 1.327 1.327 1.327

R2 Stream Single 3.226 3.226 3.226 3.226 3.226 3.226 3.226

R2 Stream

Multiple 1.778 1.778 1.778 1.778 1.778 1.778 1.778

R3 Stream Single 3.434 3.434 3.434 3.434 3.434 3.434 3.434

R3 Stream

Multiple 1.870 1.870 1.870 1.870 1.870 1.870 1.870



Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10 EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D3 Ditch Multiple 0.788 0.788 0.788 0.788 0.788 0.788 0.788

D4 Pond Single 0.216 0.216 0.216 0.216 0.216 0.216 0.216

D4 Pond Multiple 0.117 0.117 0.117 0.117 0.117 0.117 0.117

D4 Stream Single 1.459 1.459 1.459 1.459 1.459 1.459 1.459

D4 Stream

Multiple 0.815 0.815 0.815 0.815 0.815 0.815 0.815

D6 Ditch (1st)

Single 1.428 1.428 1.428 1.428 1.428 1.428 1.428

D6 Ditch (1st)

Multiple 0.787 0.787 0.787 0.787 0.787 0.787 0.787

D6 Ditch (2nd)

Single 1.429 1.429 1.429 1.429 1.429 1.429 1.429

D5 Ditch (2nd)

Multiple 0.789 0.789 0.789 0.789 0.789 0.789 0.789

R1 Pond Single 0.216 0.216 0.216 0.216 0.216 0.216 0.216

R1 Pond Multiple 0.117 0.117 0.117 0.117 0.117 0.117 0.117

R1 Stream Single 1.294 1.294 1.294 1.294 1.294 1.294 1.294

R1 Stream

Multiple 0.701 0.701 0.701 0.701 0.701 0.701 0.701

R2 Stream Single 1.710 1.710 1.710 1.710 1.710 1.710 1.710

R2 Stream

Multiple 0.939 0.939 0.939 0.939 0.939 0.939 0.939

R3 Stream Single 1.821 1.821 1.821 1.821 1.821 1.821 1.821

R3 Stream

Multiple 0.988 0.988 0.988 0.988 0.988 0.988 0.988






Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10

EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC


Assessment factor 100 10

100 10

10 10

4

RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4

PEC*

D3 Ditch Single 0.755 0.755 0.755 0.755 0.755 0.755 0.755

D3 Ditch Multiple - - - - - - -

D4 Pond Single 0.144 0.144 0.144 0.144 0.144 0.144 0.144

D4 Pond Multiple - - - - - - -

D4 Stream Single 0.757 0.757 0.757 0.757 0.757 0.757 0.757

D4 Stream

Multiple - - - - - - -

D6 Ditch (1st)

Single 0.742 0.742 0.742 0.742 0.742 0.742 0.742

D6 Ditch (1st)

Multiple - - - - - - -

D6 Ditch (2nd)

Single 0.742 0.742 0.742 0.742 0.742 0.742 0.742

D5 Ditch (2nd)

Multiple - - - - - - -

R1 Pond Single 0.144 0.144 0.144 0.144 0.144 0.144 0.144




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

R1 Pond Multiple - - - - - - -

R1 Stream Single 0.672 0.672 0.672 0.672 0.672 0.672 0.672

R1 Stream

Multiple - - - - - - -

R2 Stream Single 0.888 0.888 0.888 0.888 0.888 0.888 0.888

R2 Stream

Multiple - - - - - - -

R3 Stream Single 0.945 0.945 0.945 0.945 0.945 0.945 0.945

R3 Stream

Multiple - - - - - - -


*As Single application PEC values are consistently greater than multiple application values, only single application values are presented in the Fate CP for this mitigation.

FOCUSsw step 4- Risk for mancozeb to Spring cereals at 3 x 1600 g/ha, 14-d intervals, 5m drift buffer.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10

EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D1 Ditch Multiple 1.975 1.975 1.975 1.975 1.975 1.975 1.975

D1 Stream Single 2.974 2.974 2.974 2.974 2.974 2.974 2.974

D1 Stream

Multiple 2.328 2.328 2.328 2.328 2.328 2.328 2.328




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

D3 Ditch Single 2.744 2.744 2.744 2.744 2.744 2.744 2.744

D3 Ditch Multiple 1.957 1.957 1.957 1.957 1.957 1.957 1.957

D4 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

D4 Pond Multiple 0.211 0.211 0.211 0.211 0.211 0.211 0.211

D4 Stream Single 3.023 3.023 3.023 3.023 3.023 3.023 3.023

D4 Stream

Multiple 2.259 2.259 2.259 2.259 2.259 2.259 2.259

D5 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

D5 Pond Multiple 0.211 0.211 0.211 0.211 0.211 0.211 0.211

D5 Stream Single 3.214 3.214 3.214 3.214 3.214 3.214 3.214

D5 Stream

Multiple 2.451 2.451 2.451 2.451 2.451 2.451 2.451

R4 Stream Single 2.444 2.444 2.444 2.444 2.444 2.444 2.444

R4 Stream

Multiple 1.739 1.739 1.739 1.739 1.739 1.739 1.739


FOCUSsw step 4- Risk for mancozeb to Spring cereals at 3 x 1600 g/ha, 14-d intervals, 10 m drift buffer.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia

magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10

EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC






Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D1 Ditch Multiple 0.702 0.702 0.702 0.702 0.702 0.702 1.035

D1 Stream Single 1.077 1.077 1.077 1.077 1.077 1.077 1.577

D1 Stream

Multiple 0.827 0.827 0.827 0.827 0.827 0.827 1.220

D3 Ditch Single 0.993 0.993 0.993 0.993 0.993 0.993 1.454

D3 Ditch Multiple 0.695 0.695 0.695 0.695 0.695 0.695 1.025

D4 Pond Single 0.173 0.173 0.173 0.173 0.173 0.173 0.216

D4 Pond Multiple 0.119 0.119 0.119 0.119 0.119 0.119 0.151

D4 Stream Single 1.094 1.094 1.094 1.094 1.094 1.094 1.602

D4 Stream

Multiple 0.802 0.802 0.802 0.802 0.802 0.802 1.183

D5 Pond Single 0.173 0.173 0.173 0.173 0.173 0.173 0.217

D5 Pond Multiple 0.119 0.119 0.119 0.119 0.119 0.119 0.151

D5 Stream Single 1.163 1.163 1.163 1.163 1.163 1.163 1.704

D5 Stream

Multiple 0.871 0.871 0.871 0.871 0.871 0.871 1.284

R4 Stream Single 0.885 0.885 0.885 0.885 0.885 0.885 1.295

R4 Stream

Multiple 0.618 0.618 0.618 0.618 0.618 0.618 0.911






Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10

EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D1 Ditch Multiple 0.702 0.702 0.702 0.702 0.702 0.702 0.702

D1 Stream Single 1.077 1.077 1.077 1.077 1.077 1.077 1.077

D1 Stream

Multiple 0.827 0.827 0.827 0.827 0.827 0.827 0.827

D3 Ditch Single 0.993 0.993 0.993 0.993 0.993 0.993 0.993

D3 Ditch Multiple 0.695 0.695 0.695 0.695 0.695 0.695 0.695

D4 Pond Single 0.173 0.173 0.173 0.173 0.173 0.173 0.173

D4 Pond Multiple 0.119 0.119 0.119 0.119 0.119 0.119 0.119

D4 Stream Single 1.094 1.094 1.094 1.094 1.094 1.094 1.094

D4 Stream

Multiple 0.802 0.802 0.802 0.802 0.802 0.802 0.802

D5 Pond Single 0.173 0.173 0.173 0.173 0.173 0.173 0.173

D5 Pond Multiple 0.119 0.119 0.119 0.119 0.119 0.119 0.119

D5 Stream Single 1.163 1.163 1.163 1.163 1.163 1.163 1.163

D5 Stream

Multiple 0.871 0.871 0.871 0.871 0.871 0.871 0.871

R4 Stream Single 0.885 0.885 0.885 0.885 0.885 0.885 0.885

R4 Stream

Multiple 0.618 0.618 0.618 0.618 0.618 0.618 0.618






Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10

EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D1 Ditch Multiple 0.531 0.531 0.531 0.531 0.531 0.531 0.531

D1 Stream Single 0.819 0.819 0.819 0.819 0.819 0.819 0.819

D1 Stream

Multiple 0.626 0.626 0.626 0.626 0.626 0.626 0.626

D3 Ditch Single 0.755 0.755 0.755 0.755 0.755 0.755 0.755

D3 Ditch Multiple 0.526 0.526 0.526 0.526 0.526 0.526 0.526

D4 Pond Single 0.145 0.145 0.145 0.145 0.145 0.145 0.145

D4 Pond Multiple 0.100 0.100 0.100 0.100 0.100 0.100 0.100

D4 Stream Single 0.832 0.832 0.832 0.832 0.832 0.832 0.832

D4 Stream

Multiple 0.607 0.607 0.607 0.607 0.607 0.607 0.607

D5 Pond Single 0.145 0.145 0.145 0.145 0.145 0.145 0.145

D5 Pond Multiple 0.100 0.100 0.100 0.100 0.100 0.100 0.100

D5 Stream Single 0.885 0.885 0.885 0.885 0.885 0.885 0.885

D5 Stream

Multiple 0.659 0.659 0.659 0.659 0.659 0.659 0.659




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

R4 Stream Single 0.673 0.673 0.673 0.673 0.673 0.673 0.673

R4 Stream

Multiple 0.468 0.468 0.468 0.468 0.468 0.468 0.468


FOCUSsw step 4- Risk for mancozeb to Winter cereals at 3 x 1600 g/ha, 14-d intervals, 5m drift buffer.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10

EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D1 Ditch Multiple 1.975 1.975 1.975 1.975 1.975 1.975 1.975

D1 Stream Single 3.184 3.184 3.184 3.184 3.184 3.184 3.184

D1 Stream

Multiple 2.328 2.328 2.328 2.328 2.328 2.328 2.328

D2 Ditch Single 2.776 2.776 2.776 2.776 2.776 2.776 2.776

D2 Ditch Multiple 1.978 1.978 1.978 1.978 1.978 1.978 1.978

D2 Stream Single 3.305 3.305 3.305 3.305 3.305 3.305 3.305

D2 Stream

Multiple 2.371 2.371 2.371 2.371 2.371 2.371 2.371

D3 Ditch Single 2.741 2.741 2.741 2.741 2.741 2.741 2.741




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

D3 Ditch Multiple 1.954 1.954 1.954 1.954 1.954 1.954 1.954

D4 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

D4 Pond Multiple 0.211 0.211 0.211 0.211 0.211 0.211 0.211

D4 Stream Single 2.837 2.837 2.837 2.837 2.837 2.837 2.837

D4 Stream

Multiple 2.259 2.259 2.259 2.259 2.259 2.259 2.259

D5 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

D5 Pond Multiple 0.211 0.211 0.211 0.211 0.211 0.211 0.211

D5 Stream Single 2.949 2.949 2.949 2.949 2.949 2.949 2.949

D5 Stream

Multiple 2.454 2.454 2.454 2.454 2.454 2.454 2.454

D6 Ditch Single 2.756 2.756 2.756 2.756 2.756 2.756 2.756

D6 Ditch Multiple 1.969 1.969 1.969 1.969 1.969 1.969 1.969

R1 Pond Single 0.301 0.301 0.301 0.301 0.301 0.301 0.301

R1 Pond Multiple 0.211 0.211 0.211 0.211 0.211 0.211 0.211

R1 Stream Single 2.433 2.433 2.433 2.433 2.433 2.433 2.433

R1 Stream

Multiple 1.732 1.732 1.732 1.732 1.732 1.732 1.732

R3 Stream Single 3.439 3.439 3.439 3.439 3.439 3.439 3.439

R3 Stream

Multiple 2.448 2.448 2.448 2.448 2.448 2.448 2.448

R4 Stream Single 2.444 2.444 2.444 2.444 2.444 2.444 2.444

R4 Stream

Multiple 1.739 1.739 1.739 1.739 1.739 1.739 1.739






Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates


ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D1 Ditch Multiple 1.035 1.035 1.035 1.035 1.035 1.035 1.035

D1 Stream Single 1.688 1.688 1.688 1.688 1.688 1.688 1.688

D1 Stream

Multiple 1.220 1.220 1.220 1.220 1.220 1.220 1.220

D2 Ditch Single 1.472 1.472 1.472 1.472 1.472 1.472 1.472

D2 Ditch Multiple 1.036 1.036 1.036 1.036 1.036 1.036 1.036

D2 Stream Single 1.752 1.752 1.752 1.752 1.752 1.752 1.752

D2 Stream

Multiple 1.242 1.242 1.242 1.242 1.242 1.242 1.242

D3 Ditch Single 1.453 1.453 1.453 1.453 1.453 1.453 1.453

D3 Ditch Multiple 1.023 1.023 1.023 1.023 1.023 1.023 1.023

D4 Pond Single 0.216 0.216 0.216 0.216 0.216 0.216 0.216

D4 Pond Multiple 0.151 0.151 0.151 0.151 0.151 0.151 0.151

D4 Stream Single 1.504 1.504 1.504 1.504 1.504 1.504 1.504

D4 Stream

Multiple 1.184 1.184 1.184 1.184 1.184 1.184 1.184

D5 Pond Single 0.216 0.216 0.216 0.216 0.216 0.216 0.216

D5 Pond Multiple 0.151 0.151 0.151 0.151 0.151 0.151 0.151

D5 Stream Single 1.563 1.563 1.563 1.563 1.563 1.563 1.563




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

D5 Stream

Multiple 1.286 1.286 1.286 1.286 1.286 1.286 1.286

D6 Ditch Single 1.461 1.461 1.461 1.461 1.461 1.461 1.461

D6 Ditch Multiple 1.032 1.032 1.032 1.032 1.032 1.032 1.032

R1 Pond Single 0.216 0.216 0.216 0.216 0.216 0.216 0.216

R1 Pond Multiple 0.151 0.151 0.151 0.151 0.151 0.151 0.151

R1 Stream Single 1.290 1.290 1.290 1.290 1.290 1.290 1.290

R1 Stream

Multiple 0.907 0.907 0.907 0.907 0.907 0.907 0.907

R3 Stream Single 1.823 1.823 1.823 1.823 1.823 1.823 1.823

R3 Stream

Multiple 1.282 1.282 1.282 1.282 1.282 1.282 1.282

R4 Stream Single 1.295 1.295 1.295 1.295 1.295 1.295 1.295

R4 Stream

Multiple 0.911 0.911 0.911 0.911 0.911 0.911 0.911



Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates


ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

FOCUS Step 4


D1 Ditch Multiple 0.531 0.531 0.531 0.531 0.531 0.531 0.531

D1 Stream Single 0.877 0.877 0.877 0.877 0.877 0.877 0.877

D1 Stream

Multiple 0.626 0.626 0.626 0.626 0.626 0.626 0.626

D2 Ditch Single 0.764 0.764 0.764 0.764 0.764 0.764 0.764

D2 Ditch Multiple 0.532 0.532 0.532 0.532 0.532 0.532 0.532

D2 Stream Single 0.910 0.910 0.910 0.910 0.910 0.910 0.910

D2 Stream

Multiple 0.637 0.637 0.637 0.637 0.637 0.637 0.637

D3 Ditch Single 0.754 0.754 0.754 0.754 0.754 0.754 0.754

D3 Ditch Multiple 0.525 0.525 0.525 0.525 0.525 0.525 0.525

D4 Pond Single 0.144 0.144 0.144 0.144 0.144 0.144 0.144

D4 Pond Multiple 0.100 0.100 0.100 0.100 0.100 0.100 0.100

D4 Stream Single 0.781 0.781 0.781 0.781 0.781 0.781 0.781

D4 Stream

Multiple 0.607 0.607 0.607 0.607 0.607 0.607 0.607

D5 Pond Single 0.144 0.144 0.144 0.144 0.144 0.144 0.144

D5 Pond Multiple 0.100 0.100 0.100 0.100 0.100 0.100 0.100

D5 Stream Single 0.812 0.812 0.812 0.812 0.812 0.812 0.812

D5 Stream

Multiple 0.660 0.660 0.660 0.660 0.660 0.660 0.660

D6 Ditch Single 0.758 0.758 0.758 0.758 0.758 0.758 0.758

D6 Ditch Multiple 0.529 0.529 0.529 0.529 0.529 0.529 0.529

R1 Pond Single 0.144 0.144 0.144 0.144 0.144 0.144 0.144

R1 Pond Multiple 0.100 0.100 0.100 0.100 0.100 0.100 0.100

R1 Stream Single 0.670 0.670 0.670 0.670 0.670 0.670 0.670




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

R1 Stream

Multiple 0.466 0.466 0.466 0.466 0.466 0.466 0.466

R3 Stream Single 0.947 0.947 0.947 0.947 0.947 0.947 0.947

R3 Stream

Multiple 0.658 0.658 0.658 0.658 0.658 0.658 0.658

R4 Stream Single 0.673 0.673 0.673 0.673 0.673 0.673 0.673

R4 Stream

Multiple 0.468 0.468 0.468 0.468 0.468 0.468 0.468


FOCUSsw step 4- Risk for mancozeb to Vines at 4 x 1600 g/ha 7-d intervals and tomatoes in greenhouses which are not high technology (permanent),

10m drift buffer

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates


ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D6 Ditch Multiple 4.892 4.892 4.892 4.892 4.892 4.892 4.892

R1 Pond Single 0.622 0.622 0.622 0.622 0.622 0.622 0.622

R1 Pond Multiple 0.505 0.505 0.505 0.505 0.505 0.505 0.505

R1 Stream Single 5.183 5.183 5.183 5.183 5.183 5.183 5.183




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

R1 Stream

Multiple 4.313 4.313 4.313 4.313 4.313 4.313 4.313

R2 Stream Single 6.980 6.980 6.980 6.980 6.980 6.980 6.980

R2 Stream

Multiple 5.776 5.776 5.776 5.776 5.776 5.776 5.776

R3 Stream Single 7.398 7.398 7.398 7.398 7.398 7.398 7.398

R3 Stream

Multiple 6.096 6.096 6.096 6.096 6.096 6.096 6.096

R4 Stream Single 5.201 5.201 5.201 5.201 5.201 5.201 5.201

R4 Stream

Multiple 4.241 4.241 4.241 4.241 4.241 4.241 4.241


FOCUSsw step 4- Risk for mancozeb to Vines and tomatoes in greenhouses which are not high technology (permanent) greenhouses at 4 x 1600 g/ha

7-d intervals, 15m drift buffer.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates


ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

FOCUS Step 4


D6 Ditch Multiple 2.646 2.646 2.646 2.646 2.646 2.646 2.646

R1 Pond Single 0.421 0.421 0.421 0.421 0.421 0.421 0.421




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

R1 Pond Multiple 0.341 0.341 0.341 0.341 0.341 0.341 0.341

R1 Stream Single 2.815 2.815 2.815 2.815 2.815 2.815 2.815

R1 Stream

Multiple 2.333 2.333 2.333 2.333 2.333 2.333 2.333

R2 Stream Single 3.791 3.791 3.791 3.791 3.791 3.791 3.791

R2 Stream

Multiple 3.124 3.124 3.124 3.124 3.124 3.124 3.124

R3 Stream Single 4.018 4.018 4.018 4.018 4.018 4.018 4.018

R3 Stream

Multiple 3.298 3.298 3.298 3.298 3.298 3.298 3.298

R4 Stream Single 2.825 2.825 2.825 2.825 2.825 2.825 2.825

R4 Stream

Multiple 2.294 2.294 2.294 2.294 2.294 2.294 2.294


FOCUSsw step 4- Risk for mancozeb to Vines and tomatoes in greenhouses which are not high technology (permanent) greenhouses at 4 x 1600 g/ha

7-d intervals, 30m drift.

Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

Geomean of

fish species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum

capricornutum

Acute and

Chronic

invertebrates

Endpoint LC50 EC10 EC50 EC10

EC10 ErC50

(NOEC)

ETO-RAC



RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 2.5

D6 Ditch Single 1.107 1.107 1.107 1.107 1.107 1.107 1.107




Scenario

PEC global

max

(µg L)


(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae

Aquatic

invertebrates

Mesocosm

FOCUS Step 4

PEC

D6 Ditch Multiple 0.910 0.910 0.910 0.910 0.910 0.910 0.910

R1 Pond Single 0.200 0.200 0.200 0.200 0.200 0.200 0.200

R1 Pond Multiple 0.160 0.160 0.160 0.160 0.160 0.160 0.160

R1 Stream Single 0.975 0.975 0.975 0.975 0.975 0.975 0.975

R1 Stream

Multiple 0.802 0.802 0.802 0.802 0.802 0.802 0.802

R2 Stream Single 1.313 1.313 1.313 1.313 1.313 1.313 1.313

R2 Stream

Multiple 1.075 1.075 1.075 1.075 1.075 1.075 1.075

R3 Stream Single 1.392 1.392 1.392 1.392 1.392 1.392 1.392

R3 Stream

Multiple 1.134 1.134 1.134 1.134 1.134 1.134 1.134

R4 Stream Single 0.978 0.978 0.978 0.978 0.978 0.978 0.978

R4 Stream

Multiple 0.789 0.789 0.789 0.789 0.789 0.789 0.789


Active substance toxicity/exposure ratios for the most sensitive aquatic organisms (Regulation (EU) N° 284/2013, Annex Part A, point 10.2) For Agria

representative uses:

Risk for mancozeb to tomatoes in high technology (permanent) greenhouses at 5 x 1600 g/ha Northern and Southern Europe.


(µg L) Fish acute

Fish chronic

(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

Geomean of fish

species

Pimephales

promelas

Geomean of

Daphnia magna

Americamysis

bahia

Lumbriculus

variegatus

Selenastrum



Toxicity 118.1µg/L 1.27 µg/L 120.83 µg/L 1.71 µg/L 40 32.2 µg/L 1042 µg/L

Assessment

factor 100 10 100 10 10 10 10





(µg L) Fish acute

Fish chronic

(lower tier)

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Sediment-

dwelling

invertebrates

Algae Higher plant

RAC 1 1.18 0.127 1.21 0.171 4.00 3.22 104.2

PEC determined

assuming 0.2%

emission

DT50: 0.83d 1.070 1.070 1.070 1.070 1.070 1.070 1.070


Metabolite Toxicity/exposure ratios for the most sensitive aquatic organisms (Regulation (EU) N° 284/2013, Annex Part A, point 10.2) For

representative uses to wheat, vines, tomatoes in greenhouses which are not high technology (permanent) and potatoes:

FOCUSsw step 1-2- Risk for ETU to Potatoes at 8 x 1600 g/ha Northern and Southern Europe.


(µg L) Fish acute

Vertebrate

chronic

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Algae Higher plant

Oncorhynchus

mykiss Xenopus laevis

Americamysis

bahia Daphnia magna

Pseudokirchneriella

subcapitata Lemna gibba

Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

Toxicity >500000 µg/L 10000 µg/L 9641 µg/L 2000 µg/L 93800 µg/L > 960000 µg/L

Assessment factor 100 10 100 10 10 10

RAC 1 >4900 1000 110 200 9380 >96000

FOCUS Step 1 1620 Low risk High risk High risk High risk Low risk Low risk

FOCUS Step 2

PEC

Single Application 4.133 4.133 4.133 4.133 4.133 4.133

Multiple Application 4.569 4.569 4.569 4.569 4.569 4.569


FOCUSsw step 1- Risk for EU to Potatoes at 8 x 1600 g/ha Northern and Southern Europe.


(µg L) Fish acute

Aquatic

invertebrates Algae

Oncorhynchus

mykiss Daphnia magna

Selenastrum

capricornutum





(µg L) Fish acute

Aquatic

invertebrates Algae

Endpoint LC50 EC50 ErC50

Toxicity >122000 µg/L > 985000 µg/L >119000 µg/L

Assessment factor 100 100 10

RAC 1 >1220 >9850 >11900

FOCUS Step 1 847.900 Low risk Low risk Low risk 1 Regulatory Acceptable Concentration

FOCUSsw step 1-2- Risk for ETU to Winter cereals at 3 x 1600 g/ha Northern and Southern Europe.

Scenario

PEC global

max

(µg L)

Fish acute Vertebrate

chronic

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Algae Higher plant

Oncorhynchus


Americamysis

bahia Daphnia magna

Pseudokirchneriella





RAC 1 >4900 1000 110 200 9380 >96000

FOCUS Step 1 606.031 Low risk Low risk High risk High risk Low risk Low risk

FOCUS Step 2 PEC


Multiple Application 4.002 4.002 4.002 4.002 4.002 4.002 1 Regulatory Acceptable Concentration

FOCUSsw step 1- Risk for EU to Winter cereals at 3 x 1600 g/ha Northern and Southern Europe.


(µg L) Fish acute

Aquatic

invertebrates Algae

Oncorhynchus


Selenastrum

capricornutum








(µg L) Fish acute

Aquatic

invertebrates Algae

RAC 1 >1220 >9850 >11900


FOCUSsw step 1-2- Risk for ETU to Early vines and tomatoes in greenhouses which are not high technology (permanent) greenhouses at 4 x 1600

g/ha Northern and Southern Europe.


(µg L) Fish acute

Vertebrate

chronic

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Algae Higher plant

Oncorhynchus


Americamysis

bahia Daphnia magna

Pseudokirchneriella





RAC 1 >4900 1000 110 200 9380 >96000


FOCUS Step 2 PEC



FOCUSsw step 1- Risk for EU to Early vines and tomatoes in greenhouses which are not high technology (permanent) greenhouses at 4 x 1600 g/ha

Northern and Southern Europe.


(µg L) Fish acute

Aquatic

invertebrates Algae

Oncorhynchus


Selenastrum

capricornutum




RAC 1 >1220 >9850 >11900





(µg L) Fish acute

Aquatic

invertebrates Algae


FOCUSsw step 1-2- Risk for ETU to Late vines and tomatoes in greenhouses which are not high technology (permanent) greenhouses at 4 x 1600 g/ha



(µg L) Fish acute

Vertebrate

chronic

Aquatic

invertebrates

Aquatic

invertebrates

prolonged

Algae Higher plant

Oncorhynchus


Americamysis

bahia Daphnia magna

Pseudokirchneriella





RAC 1 >4900 1000 110 200 9380 >96000


FOCUS Step 2 PEC



FOCUSsw step 1- Risk for EU to Late vines and tomatoes in greenhouses which are not high technology (permanent) greenhouses at 4 x 1600 g/ha



(µg L) Fish acute

Aquatic

invertebrates Algae

Oncorhynchus


Selenastrum

capricornutum




RAC 1 >1220 >9850 >11900





(µg L) Fish acute

Aquatic

invertebrates Algae





Effects on bees (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.1 and Regulation (EU) N°

284/2013 Annex Part A, point 10.3.1)*

* This section does reflect the new EFSA Guidance Document on bees which has not yet been noted by the Standing Committee

on Plants, Animals, Food and Feed.

Species Test substance Time scale/type of

endpoint

End point

toxicity

Apis mellifera L. Mancozeb

technical

Acute Oral toxicity

(LD50)

140.6 µg a.s./bee

Apis mellifera L. Mancozeb

technical

Acute Contact toxicity

(LD50)

161.7 µg a.s./bee

Apis mellifera L. preparation

Mancozeb 800

WP

(Mancozeb:

85.3%)

Acute Oral toxicity

(LD50)

> 110 µg a.s./bee


Mancozeb 800

WP

(Mancozeb:

85.3%)


(LD50)

> 85.3 µg a.s./bee

Apis mellifera L. a.s.,

Mancozeb Tech.

(Purity: 89.8%)

Chronic 10 d-LD50 >51.37 µg a.s./bee/day

Apis mellifera L. Mancozeb 80 WP

(Mancozeb:

80.4%)

Chronic 10 d-LD50 > 125.4 μg a.s./bee/day


Mancozeb 80 WP

(Mancozeb:

81.6%)

Bee brood

development

Hatching sucess

NOED (120 h)

Mortality LD10

12.5 µg a.s./larva/

developmental period

6.9 μg a.s./larva


Mancozeb 80 WP

(Mancozeb:

80.4%)

Sub-lethal effects

(behavioural and

reproductive)

Bombus terrestris L. Mancozeb 80 WP

(Mancozeb:

81.6%)

Acute Oral toxicity

(LD50)

> 1351 µg a.s./bee

Bombus terrestris L. Mancozeb 80 WP

(Mancozeb:

81.6%)


(LD50)

> 2000 µg a.s./bee




Osmia bicornis L. Mancozeb 80 WP

(Mancozeb:

81.6%)


(LD50)

> 800 µg a.s./bee

No exposure is predicted for the proposed uses from the Applicant Agria.

Potential for accumulative toxicity: No information provided.

Semi-field test (Cage and tunnel test)

-

Field tests

Honeybee (Apis mellifera L.) brood feeding study under field conditions with the formulation Mancozeb 80 WP

(Mancozeb: 80.3 %). No clear indication of adverse effects on survival, behaviour and development of honey

bees was observed at feeding rates equivalent to 1.6 and 2.4 kg a.s./ha.

Risk assessment for worst-case representative use at 1600 g a.s./ha

Species Test substance Risk quotient HQ/ETR Trigger


Mancozeb 800 WP

(Mancozeb: 85.3%)

HQcontact 14.5 50


Mancozeb 800 WP

(Mancozeb: 85.3%)

HQoral 18.8 50

Apis mellifera L a.s.,

preparation

ETRacute adult

oral

-


preparation

ETRchronic

adult oral

-


preparation

ETRlarvae -


preparation

-

Effects on other arthropod species (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.2 and

Regulation (EU) N° 284/2013 Annex Part A, point 10.3.2)

Laboratory tests with standard sensitive species




Species Test

Substance

End point Toxicity

Typhlodromus pyri Dithane M-45

(Mancozeb: 80.5

%)

Mortality, LR50

Reproduction, ER50

26.67 g/ha

>9.2 g/ha

Aphidius rhopalosiphi Sancozeb 800 WP

(Mancozeb:

84.81%)

Mortality, LR50

Reproduction, ER50

>350 g/ha

<350 g/ha

Aphidius rhopalosiphi Manex II

(Mancozeb:

35.1%)

Mortality, LR50

Reproduction, ER50

>913 g/ha

>913 g/ha

First tier risk assessment- all default values

Test substance Species Effect

(LR50 g/ha)

Crop HQ in-field HQ off-field Trigger

Dithane M-45

(Mancozeb: 80.5

%)

Typhlodromus pyri 26.67 g/ha

Cereals1 138 2.77 2

Tomatoes

in

greenhouse

s which are

not high

technology2

180 3.15 2

Grapevine3 162 10.9 2

Potatoes

(foliar)4 210 3.19 2

Potatoes

(soil)4 330 n/a 2

Manex II

(Mancozeb:

35.1%)

Aphidius rhopalosiphi >913 g/ha

Cereals1 <4.03 <0.08 2

Tomatoes

in

greenhouse

s which are

not high

technology2

<5.26 <0.09 2

Grapevine3 <4.73 <0.32 2

Potatoes

(foliar)4 <6.13 <0.09 2





(LR50 g/ha)

Crop HQ in-field HQ off-field Trigger

Potatoes

(soil)4 <9.64 n/a 2

1 Cereals, 1.6 kg a.s./ha, 3 applications, drift at 1 m

2 Tomatoes in greenhouses which are not high technology, 5 applications, drift at 1 m.

3 Grapevine (late), 1.6 kg a.s./ha, 4 applications, drift at 3 m

4 Potatoes, 1.6 kg a.s./ha, 8 applications, drift at 1 m

First tier risk assessment- refined MAF values*


(LR50 g/ha)

Crop HQ in-field Trigger

Dithane M-45

(Mancozeb: 80.5 %) Typhlodromus pyri 26.67 g/ha

Grapevine1 78 2

Potatoes

(foliar)2 78 2

Potatoes

(soil)2 60 2

Manex II

(Mancozeb: 35.1%) Aphidius rhopalosiphi >913 g/ha

Grapevine3 <2.28 2

Potatoes

(foliar)4 <2.28 2

Potatoes

(soil)4 <1.75 2

* Foliar MAFs refined based on refined DT50 value for broadleaf foliage of 2.7 days and soil MAF refined to 1 based on

soil DT50 of 0.6 days.

1 Grapevine (late), 1.6 kg a.s./ha, 4 applications, drift at 3 m

2 Potatoes, 1.6 kg a.s./ha, 8 applications, drift at 1 m

Extended laboratory tests, aged residue tests

Species Life stage Test substance,

substrate

Time

scale

Dose

(g/ha)1

Endpoint

mortality

Endpoint

sublethal

effects

Cydnodromus

californicus

Adult Dithane M-45

(Mancozeb: ca.

80%) b)

Leaf discs

5 d 1600 g

a.s./ha

0% n.d.

Typhlodromus

pyri

Protonymph Dithane M-45

(Mancozeb: 81.8

%)

natural substrate,

2D exposure

scenario

14 days 20.5,

40.9,

81.8,

164,

327 and

654 g

a.s./ha

LR50 = 107 > 50% effects

on

reproduction

at 20.45 g

a.s./ha





substrate

Time

scale

Dose

(g/ha)1

Endpoint

mortality

Endpoint

sublethal

effects

Typhlodromus

pyri

Protonymph Dithane M-45

(Mancozeb: 78.8

%)

natural substrate,

2D exposure

scenario

14 days 591,

338,

193,

110,

63.0

and

36.0 g

a.s./ha

LR50 = 682 <50% effects

on fecundity at

63 g a.s./ha

Orius laevigatus second

instar

nymph

Dithane M-45

(Mancozeb: 80.5

%)

natural substrate,

2D exposure

scenario

23 days 800,

1600,

and

3200 g

a.s./ha

LR50 > 3

200

ER50 > 3 200

reproduction

Pardosa sp. Unknown Dithane M-45

(Mancozeb: 80.5

%)

natural substrate,

2D exposure

scenario

14 days 2 x 800

g a.s./ha

and 2 x

1600 g

a.s./ha*

LR50 > 1600 ER50 > 1600

reproduction

Chrysoperla

carnea

larvae Dithane Neotec

(Mancozeb: 75.1

%)

natural substrate,

2D exposure

scenario

23 days 6290

and

7690 g

a.s./ha

LR50 > 7

690

ER50 > 7 690

reproduction

Aphidius

rhopalosiphi

adult Dithane Neotec

(Mancozeb: 75.1

%)

natural substrate,

3D exposure

scenario**

13 days 6631

and

7698 kg

a.s./ha

LR50 > 7698 ER50 > 7698

reproduction

Coccinella

septempunctata

larvae Penncozeb 80

(Mancozeb:

83.8%)

artificial

substrate, 2D

exposure

scenario

28 days 1676

and

2514 g

a.s./ha

<50%

effects on

mortality at

2514 g

a.s./ha

<50% effects

on

reproduction

at 2514 g

a.s./ha





substrate

Time

scale

Dose

(g/ha)1

Endpoint

mortality

Endpoint

sublethal

effects

Poecilus cupreus adult Penncozeb 80

WP (Mancozeb:

80 %)

artificial

substrate, 2D

exposure

scenario

14 days 1600 g

a.s./ha

LR50 > 1

600

ER50 > 1 600

Poecilus cupreus adult Manex II

(Mancozeb:

35.1%)

natural substrate,

2D exposure

scenario

Unknown 842 g

a.s./ha

0% effect on

mortality

8.6% effect on

feeding

capacity

Chrysoperla

carnea

larvae Manex II

(Mancozeb:

35.1%)

artificial

substrate, 2D

exposure

scenario

Unknown 842 g

a.s./ha

0.3% effect

on mortality

12.2% effect

on

reproduction

Aphidius

rhopalosiphi

adult Penncozeb 75

DG (Mancozeb:

76.5 %)

natural substrate,

3D exposure

scenario

72 hours 15.3,

153,

306 and

1530 g

a.s./ha

LR50 > 1530 50% effects

on

reproduction

at 1530

Typhlodromus

pyri

Protonymph Penncozeb 75

DG (Mancozeb:

76.5 %)

14 days 15.3,

76.5,

153 and

1530 g

a.s./ha

LR50 > 153 ER50 > 76.5

reproduction

Trichogramma

cacoeciae

adult Dithane Ultra

WG e)

(Mancozeb:

75.3%)

natural substrate,

2D exposure

scenario

Aged residues

35 days 1355 g

a.s./ha

n.d. Parasitic

capacity: >

50% decreased

0, 7, 14, 21

and 28 day

aged residues

Parasitic

capacity

<50% effects

after 35 days

aged residues

1 All endpoints expressed in terms of active substance.




Risk assessment for – wheat (foliar) at 1600 g a.s./ha x 3 applications based on extended lab test tests

Species Critial endpoints In-field rate Off-field rate

C. californicus <50% effects at 1600

g a.s./ha 3680 37*

T. pyri >50% effects at 20.45

g a.s./ha 3680 37*

C. carnea <50% effects at 842 g

a.s./ha 3680 37*

O. laevigatus <50% effects at 3200

g a.s./ha n/a 37*

C. septempunctata <50% effects at 2514

g a.s./ha 3680 37*

A. rhopalosiphi 50% effects at 1530 g

a.s./ha 3680 370**

* 2D exposure

** 3D exposure

Risk assessment for – Grapevine (foliar) at 1600 g a.s./ha x 4 applications based on extended lab test tests



g a.s./ha 1040 145*


g a.s./ha 1040 145*


a.s./ha 1040 145*


g a.s./ha 1040 145*


g a.s./ha 1040 145*


a.s./ha 1040 1449**

* 2D exposure

** 3D exposure

Risk assessment for – Potato (foliar) at 1600 g a.s./ha x 8 applications based on extended lab test tests



g a.s./ha 2080 42.6*


g a.s./ha 2080 42.6*


a.s./ha 2080 42.6*


g a.s./ha n/a n/a


g a.s./ha 2080 42.6*


a.s./ha 2080 42.6*

* 2D exposure

** 3D exposure

Risk assessment for – Potato (soil) at 1600 g a.s./ha x 8 applications based on extended lab test tests




Species Critial endpoints In-field rate

C. californicus <50% effects at 1600 g a.s./ha 1600

T. pyri >50% effects at 20.45 g a.s./ha 1600

Semi-field tests

No reliable data available.

Field studies




Study on orchards investigating effects on populations of P. ulmi and C. californicus of an application of

Dithane M-45 applied at 1280 g a.s./ha. Populations were reduced but recovery was seen.

Study on vineyards at three locations covering northern and southern Europe investigating effects on

predacious mite populations. Fields were sprayed with either four applications increasing in rate from 654-

1963 g a.s./ha or eight applications increasing in rate from 654-2618 g a.s./ha. Applications were made

between BBCH 14-73 (Germany) and 14-75 (France). There was a reduction in predatory mite populations in

both groups but this was more pronounced in the eight applications group. Recovery before the end of the

season was observed at all the four applications groups. In the eight applications groups there was evidence

that recovery did not occur before the end of the season in Germany.

Study on vineyards in France investigating effects on in-field populations. Single applications of 58, 128 or

1600 g a.s./ha were made, and four applications of 107 or 1600 g a.s./ha were made between BBCH 63-77.

Effects on single taxa and community seen in all groups, but more pronounced in 4 x 1600 g a.s./ha group.

Potential for recolonisation was indicated following single application of 58, 128 or 1600 g a.s./ha and four

applications every 7-8 days of 107 g a.s./ha;

Study on vineyards in France investigating effects on in-field populations. Single applications of 58, 128 or


Effects on single taxa seen in all groups and effects on community seen in multiple applications scenarios.

Potential for recolonisation was indicated following single application of 58, 128 or 1600 g a.s./ha and four

applications every 7-8 days of 107 g a.s./ha;

Study on orchards in France investigating effects on in-field populations. Single applications of 318, 467 or


Effects on single taxa seen in all groups. It was indicated that the arthropod community may be able to recover

within a year;

Study on orchards in France investigating effects on in-field populations. Single applications of 318, 467 or


Effects on single taxa seen in all groups. Potential for recolonisation was indicated following single

applications up to and including 1600 g a.s./ha and four applications every 6-7 days of up to and including

1600 g a.s./ha recovery of single taxa within a year is indicated to be possible and it was also indicated that

following single applications of up to and including 1600 g a.s./ha and four applications every 6-7 days of up to

and including 1600 g a.s./ha recovery of arthropod communities might be possible;




Effects on non-target soil meso- and macro fauna; effects on soil nitrogen transformation

(Regulation (EU) N° 283/2013, Annex Part A, points 8.4, 8.5, and Regulation (EU) N° 284/2013

Annex Part A, points 10.4, 10.5)

Test

organism

Test substance Application

method of

test a.s./

OM1

Time scale End point Toxicity

Earthworms

Eisenia

fetida

Dithane M-45

(Mancozeb: 81.7

%)

Surface

applications/

unknown

Chronic

Growth,

reproduction,

behaviour

NOEC = 20 mg a.s./kg

soil dw

NOECcorr = 10 mg

a.s./kg soil dw

Eisenia

fetida

Dithane M-45

(Mancozeb: 82.6

%)

Mixed

through/ 5% Chronic

Growth,

reproduction,

behaviour

NOEC = 56.2 mg a.s./kg

soil dw

NOECcorr = 28.1 mg

a.s./kg soil dw

EC10 = 59.4 mg a.s./kg

soil dw

EC10corr = 29.7 mg

a.s./kg soil dw

Eisenia

fetida

ETU (purity:

99.0 %)

Mixed

through/

10%

Chronic

Growth,

reproduction,

behaviour

NOEC = 24 mg a.s./kg

soil dw

Eisenia

fetida

EBIS (purity

96.7%)

Mixed

through/

10%

Chronic

Growth,

reproduction,

behaviour

NOECcorr = 20 mg/kg

soil dw

EC10Corr (56 days) = 29.5

mg /kg dry soil

Eisenia

fetida

EBIS (purity

99.6%)

Mixed

through/

10%

Chronic

Growth,

reproduction,

behaviour

NOEC = 17.15 mg/kg

soil dw

EC10 (56 days) = 21.02

mg /kg dry soil

Other soil macroorganisms




Folsomia

candida

Mancozeb tech.

(purity: 86.0%)

Mixing in*/

5% Chronic

Mortality,

reproduction,

behaviour

EC10 repro = 16.3 mg

a.s./kg soil dw

EC10 corr = 8.2 mg a.s./kg

soil dw

NOEC repro = 10 mg

a.s./kg soil dw

NOECcorr repro = 5 mg

a.s./kg soil dw

Folsomia

candida1

Mancozeb tech.

(purity: 89.8%)

Mixing

in**/5% Chronic

Mortality,

reproduction,

behaviour

Folsomia

candida

Mancozeb 75

WG (75%

mancozeb)

Mixing in*/

5% Chronic

Mortality,

reproduction,

behaviour

LC10 = 11.9 mg a.s./kg

soil dw

LC10 corr = 5.9 mg a.s./kg

soil dw

NOEC repro/mort = 23.2

mg a.s./kg soil dw

NOECcorr repro/mort =

11.6 mg a.s./kg soil dw

Folsomia

candida

Mancozeb 80

WP (80.3%

mancozeb)

Mixing

in*/5% Chronic

Mortality,

reproduction,

behaviour

LC10 = 13.2 mg a.s./kg

soil dw

LC10 corr = 6.6 mg a.s./kg

soil dw


mg a.s./kg soil dw



Folsomia

candida Mancozeb

Technical Mixing

in*/5% Chronic

Mortality,

reproduction,

behaviour

LC10 = 24.8 mg a.s./kg

soil dw

LC10 corr = 12.4 mg

a.s./kg soil dw


mg a.s./kg soil dw



Folsomia

candida Mancozeb

Technical Mixing

in**/5% Chronic

Mortality,

reproduction,

behaviour

LC20 = 21.1 mg a.s./kg

soil dw

LC20 corr = 10.6 mg

a.s./kg soil dw

EC10 = 25.8 mg a.s./kg

soil dw




EC10 corr = 12.9 mg

a.s./kg soil dw


mg a.s./kg soil dw



Hypoaspis

aculeifer

Mancozeb tech.

(purity: 86.0%)

Mixing

in*/5% Chronic

Mortality,

reproduction,

behaviour

EC10 = 72.3 mg a.s./kg

soil dw

EC10 corr = 36.2 mg

a.s./kg soil dw

NOEC repro = 58 mg

a.s./kg soil dw

NOECcorr repro = 27.5

mg a.s./kg soil dw

Hypoaspis

aculeifer

Mancozeb tech.

(purity: 89.8%)

Mixing

in**/5% Chronic

Mortality,

reproduction,

behaviour

EC10 = 26.5 mg a.s./kg

soil dw

EC10 corr = 13.3 mg

a.s./kg soil dw

NOEC mort = 35.6 mg

a.s./kg soil dw

NOECcorr mort = 17.8 mg

a.s./kg soil dw

Hypoaspis

aculeifer

Mancozeb 80

WP (80.3%

mancozeb)

Mixing

in*/5% Chronic

Mortality,

reproduction,

behaviour

EC10 = 89.5 mg a.s./kg

soil dw

EC10 corr = 44.8 mg

a.s./kg soil dw

NOEC repro/mort = 84

mg a.s./kg soil dw


42mg a.s./kg soil dw

Folsomia

candida

ETU (purity

99.7)

incorporation

into the soil

(5% peat)

Chronic;

28-d reproduction

NOEC repro = 10.6

mg/kg soil dw

* Test item mixed into water then mixed into soil




** Test item mixed into sand then mixed into soil

1 This endpoint is considered an outlier and therefore is not selected for risk assessment.

Nitrogen transformation preparation

Dithane M-45

EPPO, Chapter 7,

1994

<25% effect at day 28 at 5.33 mg

a.s./kg d.w. soil


Dithane M-45

OECD 216 <25% effect at day 56 at 10 mg

a.s./kg d.w. soil


Sancozeb 800 WP

BBA Guideline,

Part IV, 1-1

(March 1990),

OECD Draft

Guideline (1981)

Nitrogen transformation activities

not significantly inhibited at day

59 at 23 mg a.s./kg d.w. soil

Nitrogen transformation ETU (purity 99.9%) OECD 216 <25% effect at day 28 at 5.6

mg/kg d.w. soil

Nitrogen transformation EU (purity 88.6%) OECD 216 <25% effect at day 28 at 5.6

mg/kg d.w. soil

The risk from the metabolites is covered by the assessment of mancozeb.

Toxicity/exposure ratios for soil organisms:

Compound Crop Species, study

type Soil PEC1 TER Trigger

Mancozeb

Cereals

(winter & spring)

Earthworm,

reproduction 0.4267 23.4 5

Grapevine Earthworm,


Potatoes Earthworm,


Tomtatoes in

greenhouses which

are non high

technology

Earthworm,


ETU

Cereals

(winter & spring)

Earthworm,

reproduction 0.073 329 5

Grapevine

Earthworm,

reproduction 0.177 136 5

Potatoes Earthworm,


Tomtatoes in

greenhouses which

are non high

technology

Earthworm,





Compound Crop Species, study

type Soil PEC1 TER Trigger

Other soil macroorganisms

Mancozeb

Cereals

(winter & spring)

Folsomia

candida

reproduction

0.4267 19.2 5

Grapevine

Folsomia

candida

reproduction

0.8536 9.6 5

Potatoes

Folsomia

candida

reproduction

1.816 4.5 5

Tomtatoes in

greenhouses which

are non high

technology

Folsomia

candida

reproduction

1.067 7.7 5

Cereals

(winter & spring)

Hypoaspis

aculeifer

reproduction

0.4267 5

Grapevine

Hypoaspis

aculeifer

reproduction

0.8536 5

Potatoes

Hypoaspis

aculeifer

reproduction

1.816 5

Tomtatoes in

greenhouses which

are non high

technology

Hypoaspis

aculeifer

reproduction

1.067 5

1 Maximum PECinitial

Effects on terrestrial non target higher plants (Regulation (EU) N° 283/2013, Annex Part A, point

8.6 and Regulation (EU) N° 284/2013 Annex Part A, point 10.6)

Screening data

Screening test using Dithane M-45 (80% mancozeb) on the species Bidens pilosa, Solanum nigrum, Polygonum

lapathifolium, Abutilon theophrasti, Echinocloa crus-galli, Digitaria sanguinalis, Setaria viridis, and Lolium

multiflorum. ER50 >4000 g a.s./ha. NOER = 4000 g a.s./ha.

Laboratory dose response tests

Species Test

substance

ER50 (g/ha)2

vegetative

vigour

ER50 (g/ha)2

emergence

Exposure1

(g/ha)2

TER Trigger

Allium cepa, Avena

sativa, Solanum

lycopersicon,

Glycine max,

Brassica oleracea,

Daucus carota.

Tridex 75

DG (76.7%

mancozeb)

> 1408

g a.s./ha

n/a Field crops

(cereals and

potatoes):

443

>32 5

Grapevine

(early):

>32.7 5




Species Test

substance

ER50 (g/ha)2

vegetative

vigour

ER50 (g/ha)2

emergence

Exposure1

(g/ha)2

TER Trigger

434

Grapevine

(late) and

tomtatoes

greenhouses

which are

not high

technology:

1284

>11 5

Extended laboratory studies :

Semi-field and field test:

None submitted. 2 g a.s./ha 3 Standard guidance 1 m distance 4 Standard guidance 3 m distance

Effects on biological methods for sewage treatment (Regulation (EU) N° 283/2013, Annex Part A,

point 8.8)

Test type/organism end point

Activated sludge EC50 = 25 mg a.s./L

Pseudomonas sp -

Monitoring data (Regulation (EU) N° 283/2013, Annex Part A, point 8.9 and Regulation (EU) N°

284/2013, Annex Part A, point 10.8)

Available monitoring data concerning adverse effect of the a.s.

Available monitoring data concerning effect of the PPP.

Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A, point 7.4.2)

Ecotoxicologically relevant compounds1

Compartment

soil mancozeb,

water mancozeb,

sediment mancozeb

groundwater mancozeb 1 metabolites are considered relevant when, based on the risk assessment, they pose a risk comparable or higher than the parent




Classification and labelling with regard to ecotoxicological data (Regulation (EU) N° 283/2013,

Annex Part A, Section 10)




Regulation (EC) No 1272/2008 as amended]7:

Aquatic Acute 1, H400, M factor = 10

Aquatic Chronic 1, H410, M factor =10

Peer review proposal8 for harmonised classification


See box above

7 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 Directives 67/548/EEC and 1999/45/EC, and amending

Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355. 8 It should be noted that harmonised classification and labelling is formally proposed and decided in accordance with Regulation

(EC) No 1272/2008.


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