﷡﷡﷡﷡﷡

HET COLLEGE VOOR DE TOELATING VAN BESTRIJDINGSMIDDELEN

BIJLAGE II bij het besluit d.d. 27 juli 2007 tot toelating van het middel ADMIRE O-TEQ, toelatingnummer 12942 N

Contents Page

1. Identity of the plant protection product 2

2. Physical and chemical properties 5

3. Methods of analysis 10

4. Mammalian toxicology 12

5. Residues 21

6. Environmental fate and behaviour 25

7. Ecotoxicology 44

8. Efficacy 70

9. Conclusion 72

10. Classification and labelling 72

1. Identity of the plant protection product

1.1 Applicant

Bayer Crop Science B.V.

Energieweg 1

3641 RT Mijdrecht

1.2 Identity of the active substance

Common name	Imidacloprid
Name in Dutch	Imidacloprid
Chemical name	1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine
CAS nr	138261-41-3
EEG nr	-

The active substance is not included in the Annex 1 list of directive 91/414/EC. A draft assessment report (DAR) of the active substance is available (RMS: Germany).

1.3 Identity of the plant protection product

Name	ADMIRE O-TEQ
Formulation type	OD (Oil Dispersion)
Content active substance	350 g/L

The formulation is not part of the assessment of the active substance for inclusion in the Annex 1 list of 91/414/EC.

1.4 Function

Insecticide.

1.5 Uses applied for

Intended uses of ADMIRE O-TEQ are listed in Table 1.

Table 1: Intended uses ADMIRE O-TEQ

Uses	Dose a.s. (g a.s./ha)	Number of appli-cations	Interval between applications	Application time (growth stage and season)
Apple against common green capsid bug (Lygus pabulinus), European apple sawfly (Hoplocampa testudinea)	Young crop 0.07 Adult crop 0.105	2	7-14 days	April-July
Apple against rosy apple aphid (Dysaphis plantaginea), apple aphid (Aphis pomi), rosy leaf-curling aphid (Dysaphid devecta, Dysaphis anthrisci), apple-grass aphid (Rhopalosiphum insertum	Young crop 0.07 Adult crop 0.105	2	7-14 days	April-Sept
Pear against common green capsid bug (Lygus pabulinus), pear sawfly (Hoplocampa brevis)	Young crop 0.07 Adult crop 0.084	2	7-14 days	April-July
Pear against pear aphid (Dysaphis pyri), pear coltsfoot aphid (Anuraphis farfarae), Melanaphis pyaria, black bean aphid (Aphis fabae)	Young crop 0.07 Adult crop 0.084	2	7-14 days	April-Sept
Aubergine, gherkins, courgettes, cucumber, tomato, red pepper, and sweet pepper on artificial substrate (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)	2.45 g a.s./1000 plants	2	1 day	March-Nov
Aubergine, gherkins, courgettes, cucumber, tomato, red pepper, and sweet pepper on artificial substrate (protected culture) against greenhouse whitefly (Trialeurodes vaporariorum)	28 ml/1000 plants	2	1 day	March-Nov
Floriculture crops on artificial substrate (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)	2.45 g a.s./1000 plants	2	1 day	March-Nov
Floriculture crops on artificial substrate (protected culture) against greenhouse whitefly (Trialeurodes vaporariorum)	9.8 g a.s /1000 plants	2	1 day	March-Nov
Floriculture crops in the open ground (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)	0.084	2	7-10 days	Jan-Dec
Gerbera and chrysanthemum (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae), greenhouse whitefly (Trialeurodes vaporariorum)	0.084	2	7-10 days	Jan-Dec
Perennial floriculture crops in the open ground against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), black bean aphid (Aphis fabae), greenhouse whitefly (Trialeurodes vaporariorum)	0.084	2	7-10 days	Jan-Dec
Flower bulb- and bulb flower crops (open field) against green peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)	0.07	2	7-10 days	March-Sept
Flower bulb- and bulb flower crops (protected culture) against green peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)	0.07	2	7-10 days	March-Sept
Flower bulb- and bulb flower crops (dip treatment) against green peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae)	0.08%	1	-	Jan-Dec
Gladiolus against gladiolus thrips (Taeniothrips simplex)	0.07	3	7-10	May-Sept
Gladiolus against gladiolus thrips (Taeniothrips simplex)	0.07	3	7-10	Jan-Dec
Gladiolus (dip treatment) against gladiolus thrips (Taeniothrips simplex)	0.08%	1	-	Jan-Dec
Tree nursery crops and perennials (protected culture) against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), cotton aphid (Aphis gossypii), black bean aphid (Aphis fabae), rose aphid (Macrosiphum rosae), shallot aphid (Myzus ascolonicus), plum leaf-curling aphid (Brachycaudys helichrysi)	0.07	2	7-10 days	Jan-Dec
Tree nursery crops and perennials in the open ground against glasshouse potato aphid (Aulacorthum solani), green and red peach aphid (Myzus persicae), black bean aphid (Aphis fabae), rose aphid (Macrosiphum rosae), shallot aphid (Myzus ascolonicus), plum leaf-curling aphid (Brachycaudys helichrysi), potato aphid (Macrosiphum euphorbiae), black cherry aphid (Myzus cerasi), apple aphid (Aphis pomi), green spruce aphid (Elatobium abietinum), bird cherry aphid (Rhopalosiphum padi), woolly beech aphid (Phyllaphis fagi)	0.084	2	7-10 days	March-Sept
Tree nursery crops and perennials in the open ground against Boxwood psyllids (Psylla buxi)	0.084	1	-	April-May
Hop against hop vine aphid (Phorodon humuli)	0.032 g a.s./1000 shouts	1	-	May-June
Root growing culture of witloof chicory against lettuce root aphid (Pemphigus bursarius)	0.0875	1	-	April-May

1.6 Background to the application

ADMIRE O-TEQ is a new formulation.

As a consequence of the European assessment of the active substance in the light of the decision whether it can be placed upon Annex I of Directive 91/414/EEG or not, a concept for a monograph has been conceived. The CTB has evaluated this concept-monograph and has given comments upon its contents. With full consideration of these comments, the CTB has made the contents of the concept-monograph her own and applies them in the handling of the present application. In the List of Endpoints underneath, the Dutch comments are typed in italics.

1.7 Packaging details

1.7.1 Packaging description

Material:	High Density Polyethylene (HDPE) or Ethylvinylalcohol (EVOH) or Polyamide + HDPE
Capacity:	1 L
Type of closure and size of opening:	White cap, liner-less or induction seal, 50 mm
Other information	-

1.7.2 Detailed instructions for safe disposal

See application form and MSDS.

2. Physical and chemical properties

2.1 Active substance: Imidacloprid

Data about the identity and the physical and chemical properties are taken from the List of Endpoints (DAR, December 2005). Changes and/or additions are made in italics.

Identity

Active substance (ISO Common Name)	Imidacloprid
Chemical name (IUPAC)	1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine
Chemical name (CA)	1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine
CIPAC No	582
CAS No	138261-41-3
EEC No (EINECS or ELINCS)	Not available
FAO Specification (including year of publication)	Not available
Minimum purity of the active substance as manufactured (g/kg)	970
Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)	None identified
Molecular formula	C₉H₁₀ClN₅O₂
Molecular mass	255.7
Structural formula

Physical-chemical properties

Melting point (state purity)	144 °C (99.9 %)
Boiling point (state purity)	–
Temperature of decomposition	>200 °C
Appearance (state purity)	Colourless crystals (99.8 %) or cream coloured powder (98.5 %)
Relative density (state purity)	= 1.54 g/cm³ (pycnometer with air) = 1.41 g/cm³(pycnometer with n‑heptane)
Surface tension	72.20 mN/m (458.91 mg/L) at 20 °C
Vapour pressure (in Pa, state temperature)	20 °C: 4 x 10^-10 Pa 25 °C: 9 x 10^-10 Pa extrapolated from measurement between 50 to 70 °C
Henry’s law constant (in Pa·m³·mol^-1)	1.7 * 10^-10 Pa m³ mol^-1 (20 °C)
Solubility in water (in g/l or mg/l, state temperature)	610 mg/L (demineralised water, 20 °C), independent of the pH in the range between 4 and 9.
Solubility in organic solvents (in g/l or mg/l, state temperature)	Solvent Solubility (20 °C) n-Hexane < 0.1 g/L Toluene 0.69 g/L Dichloromethane 67 g/L 2-Propanol 2.3 g/L Acetone 50 g/L Ethylacetate 6.7 g/L Acetonitrile 50 g/L Dimethylsulfoxide > 200 g/L Dimethylformamide > 200 g/L
Partition co-efficient (log P_ow) (state pH and temperature)	log P_o/w = 0.57, demineralised water, 21 °C
Hydrolytic stability (DT₅₀) (state pH and temperature)	No degradation at pH 5 and at 25 °C during 30 d. Slightly degradation at pH 9 at 25 °C during 30 d, calculated DT₅₀ ≈ 1 a.
Dissociation constant	No pk_a in aqueous systems
UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength)	l_max[nm] e 212 13346 270 22054
Photostability (DT₅₀) (aqueous, sunlight, state pH)	pH 7, 23 – 24.5 °C: DT₅₀ = 57 min environmental: DT₅₀ = 4.2 h (calculated)
Quantum yield of direct photo- transformation in water at λ > 290 nm	Φ = 0.014 (highly pure water, 25 °C)
Photochemical oxidative degradation in air	DT₅₀0.85 hours (calculation according to Atkinson 1987, 12 h daytime, 1.5 x 10⁶ OH-radicals/cm³) 24 h time period, 5 x 10⁵ OH-radicals/cm³ DT₅₀ 2.54 h
Flammability	Not highly flammable. No gases were liberated.
Auto-flammability	>144°C (melting point)
Oxidative properties	Oxidising
Explosive properties	Not explosive.

2.2 Plant protection product: ADMIRE O-TEQ

Data about the plant protection product are based on information provided by the applicant.

The range of the application concentration of the plant protection product is 0.02-0.2 %.

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP: no

Method: visual

suspension

acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP: no

Method: visual

beige

acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP: no

Method: olfactory

weak chemical

acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP: yes

Method: EEC A.14

not sensitive to shock, not explosive when heated

acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

GLP: yes

Method: EEC A.21

no oxidizing properties

acceptable

B.2.2.6 (IIIA 2.3)

Flammability

not applicable for an oil dispersion

acceptable

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP: yes

Method: EEC A.15

auto-ignition temperature 335°C

acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP: yes

Method: EEC A.9

no flash point up to 110°C

acceptable

B.2.2.9 (IIIA 2.4)

Acidity/

alkalinity

not applicable (4£ pH £ 10)

acceptable

B.2.2.10 (IIIA 2.4)

GLP: yes

Method: CIPAC MT 75.3

1% in CIPAC D water under N₂ atmosphere at room temperature: pH = 8.9

acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP: yes

Method: OECD 115

At 25°C, undiluted product:

29 mN/m

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114

dynamic viscosity

shear rate

(s^-1)

viscosity at 20°C

(mPa.s)

viscosity at 40°C

(mPa.s)

100

423

45.3

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114

dynamic viscosity
shear rate (s^-1)	viscosity at 20°C (mPa.s)	viscosity at 40°C (mPa.s)
20	499	528
100	403	296

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114, calculated from dynamic viscosity and density

kinematic viscosity

shear rate

(s^-1)

viscosity at 20°C

(m².s^-1)

viscosity at 40°C

(m².s^-1)

100

3.88E-04

4.21E-05

acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP: yes

Method: OECD 114, calculated from dynamic viscosity and density

kinematic viscosity
shear rate (s^-1)	viscosity at 20°C (m².s^-1)	viscosity at 40°C (m².s^-1)
20	4.59E-04	4.90E-04
100	3.71E-04	2.75E-04

acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP: yes

Method: OECD 109

D₄²⁰ = 1.090

D₄⁴⁰ = 1.077

acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP: yes

Method: OECD 109

D₄²⁰ = 1.086

D₄⁴⁰ = 1.077

acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

not relevant for an oil dispersion

acceptable

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

Method: CIPAC MT 46.3

In HDPE, COEX/E-VAL & COEX/PA pack:

Physically and chemically stable for 14 days at 54°C. In HDPE pourability after storage was just outside acceptable limits (5.13% residue, 0.30% rinsed residue).

acceptable; the applicant states that the residue will be negligible under practical conditions with the use of an injection hopper, which is well established in Northern Europe.

B.2.2.14 (IIIA 2.7)

Storage stability

GLP: no

Method: CIPAC MT 39.3

In HDPE, COEX/E-VAL & COEX /PA pack:

Stable for 7 days at 0°C.

acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

study ongoing, results except in 2007

acceptable provided that results are submitted in 2007.

B.2.2.16

(IIIA 2.8)

Wettability

not relevant for an oil dispersion

acceptable

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP: no

Method: CIPAC MT 47.2

0.26%, CIPAC D water:

20.5/15/12/8.5 mL after 10 s/1 min/3 min/12 min.

6.4%, CIPAC D water:

71/31/12/7 mL after 10 s/1 min/3 min/12 min.

acceptable

B.2.2.18

(IIIA 2.8)

Suspensibility

not relevant for an oil dispersion

acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

not relevant for an oil dispersion

acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

not relevant for an oil dispersion

acceptable

B.2.2.21

(IIIA 2.8)

Dry sieve test

not relevant for an oil dispersion

acceptable

B.2.2.22

(IIIA 2.8)

Wet sieve test

GLP: no

Method: CIPAC MT 185

<0.01% residue on 75 µm sieve

acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

not relevant for an oil dispersion

acceptable

B.2.2.24

(IIIA 2.8)

Content of dust/fines

not relevant for an oil dispersion

acceptable

B.2.2.25

(IIIA 2.8)

Attrition and friability

not relevant for an oil dispersion

acceptable

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

GLP: no

Method: CIPAC MT 180

0.02%, 0.26% and 6.4% of the preparation in CIPAC A and D water: initial dispersion complete; after 30 min £0.8 mL cream, 0.0 mL oil; after 24 h redispersibility complete; after 24.5 h £0.9 mL cream, 0.0 mL oil.

acceptable

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

not relevant for an oil dispersion

acceptable

B.2.2.28

(IIIA 2.8)

Flowability

not relevant for an oil dispersion

acceptable

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

GLP: no

Method: CIPAC MT 148

residue 2.46%, rinsed residue 0.10%

acceptable

B.2.2.30

(IIIA 2.8)

Dustability

not relevant for an oil dispersion

acceptable

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

not relevant for an oil dispersion

acceptable

2.9.1

Physical compatibility with other products

not applicable

2.9.2

Chemical compatibility with other products

not applicable

No mixing with other plant protection products or adjuvants is proposed. No information is available on the behaviour of this product when mixed with other products. Mixing with another product or adjuvant can therefore result in unexpected behaviour.

Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions. The claimed shelf life of 2 years is supported by the results of accelerated storage stability testing (14 days, 54°C). The shelf-life study is still in progress (report expected in May 2007) and the report should be submitted as soon as it becomes available.

2.3 Data requirements

The report of the shelf-life study should be submitted as soon as it becomes available.

3. Methods of analysis

Description and data about the analytical methods are taken from the List of Endpoints (DAR, December 2005), except where noted. Changes and/or additions are made in italics.

3.1. Analytical methods in technical material and plant protection product

Technical as (principle of method)	HPLC-UV
Impurities in technical as (principle of method)	HPLC-UV
Preparation (principle of method)	HPLC-UV^(A)

(A) Report with validation for ADMIRE O-TEQ was not included in DAR but submitted to CTB along with the application for registration.

Conclusion

The analytical methods for the technical active substance and the impurities have been assessed in the monograph and are considered to be acceptable. The method for the determination of the active substance in the preparation was evaluated by CTB and found to be acceptable.

3.2 Residue analytical methods

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)	LC-MS/MS 0.02 mg/kg for each separately^(A) (a.s., metabolite M01, M06); apple, cotton seed, potato GC/MS 0,05 mg/kg^(B) (total residue^(C)); all crop categories LC-MS/MS^(D) 0.01 mg/kg (a.s.); wheat grain, green material & straw, olive fruit, oil & pomace, cocoa bean, chocolate & cocoa powder LC-MS/MS^(D) 0.05 mg/kg (total residue^(C)); apple, bean, citrus fruit & peel, olive fruit, pepper, tomato
Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)	GC/MS 0.02 mg/kg (total residue)^(E) LC-MS/MS 0.02 mg/kg (total residue)
Soil (principle of method and LOQ)	LC-MS/MS 0.005 mg/kg (as) HPLC/UV 0.01 mg/kg (as)
Water (principle of method and LOQ)	HPLC/UV 0.05 µg/L (as) HPLC-MS/MS 0,10 µg/L (as)
Air (principle of method and LOQ)	HPLC-UV 5 µg/m³
Body fluids and tissues (principle of method and LOQ)	Not required, non toxic compound

(A) The List of Endpoints of the DAR stated 0.02 mg/kg for the sum of a.s., M01 and M06, but the text in vol. 1, point 2.2.3 confirmed that 0.02 mg/kg was the LOQ for the individual compounds.

(B) The List of Endpoints of the DAR stated that the LOQ was 0.05 …0.10 mg/kg, which was the range for LOQs from the various validation reports.

(D) Report with validation for ADMIRE O-TEQ was not included in DAR but submitted to CTB along with the application for registration; an ILV was not submitted but is not required since the methods evaluated in the DAR are suitable for monitoring of the proposed MRLs.

(E) The List of Endpoints of the DAR stated that the LOQ was 0.02 …0.08 mg/kg. The initial validated level was 0.02 mg/kg, the level of 0.08 mg/kg pertained to the LOQ of the ILV.

Based on the proposed use of the plant protection product, analytical methods for determination of residues in food/feed of plant origin are required for watery matrices (apple, pear, egg plant, gherkin, courgette, cucumber, tomato, chilli pepper, sweet pepper and chicory root).

Definition of the residue and proposed MRL’s for imidacloprid
Matrix	Proposed definition of the residue for monitoring	Proposed MRL
Food/feed of plant origin	Sum of imidacloprid and its metabolites imidacloprid-5-hydroxy (M1) and imidacloprid-olefine (M6), expressed as imidacloprid	watery crops: 0.2-1 mg/kg
Food/feed of animal origin	Sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid	0.05*
		Required LOQ
Soil	Imidacloprid	0.05 mg/kg (default)
Drinking water	Imidacloprid	0.1 µg/L (Dutch drinking water guideline)
Surface water	Imidacloprid	2.2 µg/L (NOEC for C. riparius)
Air	Imidacloprid	45 µg/m³ (derived from the AOEL according to SANCO/825/00)
Body fluids and tissues	The active substance is not classified as (very) toxic thus no definition of the residue is proposed.	not applicable

The residue analytical methods, included in the above List of Endpoints, are suitable for monitoring of the proposed MRL’s.

The residue analytical methods for water, soil and air, evaluated in the monograph, are acceptable and suitable for monitoring of residues in the environment.

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRLs and for monitoring of residues in the environment.

3.3 Data requirements

None.

3.4 Physical-chemical classification and Labelling

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification) concerning physical chemical properties

Symbol(s):

oxidising

Indication(s) of danger: O

Risk phrase(s)

Contact with combustible material may cause fire

This labeling is in accordance with the proposal in the DAR (2005).

Proposal for the classification and labeling of the formulation concerning physical chemical properties for professional use:

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application, the following labeling of the preparation is proposed:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):
-
Symbol:	-	Indication of danger:	-
R phrases	-	-
S phrases	21	When using do not smoke
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?			N.a.
Tactile warning of danger obligatory?			N.a.

Explanation:
Hazard symbol:
Risk phrases:
Safety phrases:
Other:

4. Mammalian toxicology

List of End-points

Imidacloprid is an existing active substance. The toxicological profile presented below is based on the Draft Assessment Report (DAR) prepared by the RMS Germany. The Dutch comments on the DAR and some additional information, when relevant, are also presented (in italic). Since the active substance is still in the process of evaluation/discussion, the toxicological profile below should be regarded as provisional (comments from the Member States are received; subsequently the substance has to be discussed in the first WG evaluation meeting). The list of endpoints presented below is copied from the DAR (d.d. 30 December 2005).

Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)
Rate and extent of absorption	High bioavailability (> 92 %) based on urinary (56 %) and biliary (35 %) excretion in biliary excretion study, within 48 h
Distribution	Uniformly and rapidly distributed, highest residues in the liver, kidney, lung and skin; plasma C_max = 0.85 (10.8) mg/mL within 1 h after administration of 1 (20) mg/kg bw
Potential for accumulation	No evidence for accumulation
Rate and extent of excretion	Rapidly and completely (21 % in faeces, 75 % in urine within 48 h); evidence for enterohepatic circulation
Metabolism in animals	Extensive (85 - 90 %); oxidative cleavage and conjugation, hydroxylation of the imidazolidine ring giving rise to at least 16 metabolites
Toxicologically significant compounds (animals, plants and environment)	Parent compound and animal metabolites

Acute toxicity (Annex IIA, point 5.2)
Rat LD₅₀ oral	~ 500 mg/kg bw/d Xn, R 22
Rat LD₅₀ dermal	> 5000 mg/kg bw/d
Rat LC₅₀ inhalation	> 0.69 mg/L air/4 hr (aerosol, maximum technically attainable concentration, head-nose-exposure)
Skin irritation	Non-irritant
Eye irritation	Non-irritant
Skin sensitisation (test method used and result)	Not sensitising (M & K)

Short term toxicity (Annex IIA, point 5.3)
Target / critical effect	Body weight gain (rat, dog), liver (clinical chemistry and histopathological findings: rat, dog), trembling/tremor (dog)
Lowest relevant oral NOAEL / NOEL	90-d rat: 14 mg/kg bw/d 1-yr dog: 15 mg/kg bw/d
Lowest relevant dermal NOAEL / NOEL	15-d, rabbit: 1000 mg/kg bw/d
Lowest relevant inhalation NOAEL / NOEL	4-wk, rat: 0.0055 mg/L air

Genotoxicity (Annex IIA, point 5.4)
	No evidence for genotoxicity ¹

¹ In vitro tests for point‑mutation effects (Salmonella/microsome reverse‑mutation and CHO‑HGPRT tests) gave negative results. In vitro tests for DNA-damaging properties (yeast mitotic recombination assay, B. subtilis rec‑assay, rat hepatocyte UDS test) were also negative. A weak indication of sister chromatid exchange (SCE) induction in CHO cells was found in an in vitro test. However, this was not confirmed by the in vivo SCE test in bone marrow of Chinese hamsters. In the cytogenetic study with human lymphocyte cultures, a slight, reproducible increase in the aberration rate was observed in the cytotoxic concentration range without metabolic activation; an equivocal result was obtained with metabolic activation. All in vivo tests for chromosome damage (micronucleus test, bone marrow cytogenetics and spermatogonia cytogenetics) were negative, however, so that a clastogenic potential of imidacloprid in vivo can be excluded. The overall conclusion is that imidacloprid exhibits no genotoxic potential in vivo.

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)
Target / critical effect	Body weight gain (rat, mouse), liver (blood chemistry: rat, mouse; organ weight decrease: mouse ); thyroid (mineralisation in the follicular colloid: rat)
Lowest relevant NOAEL / NOEL	2-yr rat: 5.7 mg/kg bw/d 2-yr mouse: 65.6 mg/kg bw/d
Carcinogenicity	No evidence for carcinogenicity

Reproductive toxicity (Annex IIA, point 5.6)
Reproduction target / critical effect	Parental bw gain decreased; fertility parameters unaffected; pup weight gain reduction at parentally toxic doses
Lowest relevant NOAEL	Rat, 2-generation: parental: 20 mg/kg bw/d reproduction: 50 mg/kg bw/d offspring: 40 mg/kg bw/d
Developmental target / critical effect	Rat: maternal bw gain and food consuption decreased; developmental toxicity indicated by increase in skeletal variant (wavy rib) Rabbit: maternal bw gain and food consumption decreased, mortality; increased prenatal litter loss, reduced fetal weight, delayed ossification and skeletal anomalies at maternally toxic doses
Lowest relevant NOAEL / NOEL	Rat, maternal: 30 mg/kg bw/d Rat, developmental: 30 mg/kg bw/d Rabbit, maternal: 8 mg/kg bw/d Rabbit, developmental: 24 mg/kg bw/d

Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)
	Clinical signs and neurobehavorial effects ascribed to acute cholinergic toxicity; subchronic effects related to the general toxicity.
NOAEL (acute neurotoxicity study)	42 mg/kg bw ²
NOEL (subacute neurotoxicity study)	9.3 mg/kg bw/d
NOEL (developmental neurotoxicity study)	30 mg/kg bw/d

² The RMS considers the decreases in motor and locomotor activity at 42 mg/kg bw not test substance-related. However, the real question probably is whether the decreases at this dose level are adverse or not, because the decreases might be dose-related. Based on the results in this study, an additional study was performed with females with a dose level of 20 mg/kg bw. 20 mg/kg bw may also be regarded as the NOAEL for acute neurotoxicity.

Other toxicological studies (Annex IIA, point 5.8)
	NTN 33893-nitrosimine (WAK 3839; metabolite) and nitroguanidine (impurity) tested for kinetics and metabolism, acute toxicity, subchronic effects, reproduction toxicity (nitroguanidine only) and mutagenicity revealing no evidence of a special risk

Medical data (Annex IIA, point 5.9)
	No evidence of adverse effects, some formulations sensitising to humans

Summary (Annex IIA, point 5.10)
	Value	Study	Safety factor
ADI	0.06 mg/kg bw	Rat, 2-yr	100
AOEL systemic	0.15 mg/kg bw/d	Dog, 1-yr	100
ARfD (acute reference dose)	0.4 mg/kg bw/d ³	dog 90-day study (acute effects), rat acute neurotoxicity study,	100

³ NL commented on the NOAEL in the 90-day dog study and on the NOAEL in the acute neurotoxicity study. This might change the calculation of the ARfD.

Dermal absorption (Annex IIIA, point 7.3)
	100 % (default value, based on physicochemical data)

Classification and proposed labelling (Annex IIA, point 10)

with regard to toxicological data

Xn, R 22 (Harmful if swallowed)

Data requirements active substance

Data requirements identified in the EU-assessment are also applicable to the Dutch assessment.

4.1 Toxicity of the formulated product (IIIA 7.1)

The formulation ADMIRE O-TEQ needs to be classified as R22 ‘Harmful if swallowed, based on the acute oral toxicity (LD₅₀ rat = 2000 mg/kg bw).

The formulation ADMIRE O-TEQ does not need to be classified on the basis of its acute dermal (LD₅₀ rat >4000 mg/kg bw), and inhalation toxicology (no study available; not necessary for this formulation).

The formulation is considered irritating to skin and needs to be classified as R38 ‘Irritating to skin’.

The formulation is considered irritating to eyes and needs to be classified as R36 ‘Irritating to eyes’.

The formulation ADMIRE O-TEQ is positive in an LLNA test for skin sensitisation and needs to be classified as R43 ‘May cause sensitisation by skin contact’.

4.1.1 Data requirements formulated product

No additional data requirements are identified.

4.2 Dermal absorption (IIIA 7.3)

The dermal absorption in the list of endpoints is 100% (default based on physico-chemical properties). For the current registration request, an in vitro dermal absorption study was submitted. The dermal absorption of imidacloprid formulated as OD 200 was investigated in vitro in human and rat skin (ADMIRE O-TEQ is an OD 350 formulation; the results of the in vitro study can be used for the current risk assessment).

The results show that dermal absorption for human skin is 0.3% for the concentrate and 8% for the spray dilution.

4.3 Available toxicological data relating to non-active substances (IIIA 7.4)

Other formulants: no reason for toxicological concern.

4.4 Exposure/risk assessments

Overview of the intended uses

An application was submitted for the authorisation of the plant protection product
ADMIRE O-TEQ, an insecticide based on the active substance imidacloprid.

ADMIRE O-TEQ is an OD formulation (oil dispersion) and contains 350 g/L imidacloprid.

The formulation is applied by:

- mechanical upwards spraying (apple/pear)

- drip treatment (eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper, floriculture crops): only exposure during mixing/loading

- downwards spraying in the greenhouse (floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials; this is however calculated with the Dutch greenhouse model for up- and downwards spraying)

- mechanical downwards spraying (open field culture of floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials). For the culture of chicory, the application is by spray treatment in the seed drill. As a worst-case, the exposure is estimated with the model for mechanical downwards spraying open field.

- dip treatment (flower bulbs and bulb flower crops). The dipping fluid contains 80 ml formulation per 100 L water. Dipping of the bulbs occurs shortly before planting of the bulbs or before storage of the bulbs. Planting of the flower bulbs occurs automatically. The operator can only be exposed to ADMIRE O-TEQ during mixing/loading of the dipping fluid (the packing cases with bulbs are placed in and out the dipping unit with a lift truck). Therefore, a risk assessment is performed for the operator during mixing/loading. A realistic estimate is that per day a maximum amount of 1200 L dipping fluid is prepared by the operator.

- brush application (hop). No exposure model available. Most relevant model is the biocide model 2 (for dermal exposure) and model 3 (for respiratory exposure) of the section “consumer product painting”, a model for the painting of sheds and fences. Since this model is worst-case for the brush application in hop and since the exposure during mixing and loading (90 ml formulation in 1.5 L water) will be low, no exposure calculation is performed for mixing/loading.

The formulation is applied 1-3 times per year with a spray interval of at least 7 days. Therefore, a semi-chronic exposure duration is applicable for the operator (contract workers included).

AOEL for the worker:

ADMIRE O-TEQ is applied only 1-3 times per year. Imidacloprid is taken up by the crop very fast. Furthermore, Admire is rapidly absorbed, distributed and excreted in the rat. Therefore, also for the worker a semi-chronic AOEL is applicable.

Calculation of the AOEL

Imidacloprid is not yet included in Annex I of 91/414/EEC. This means that The Netherlands may calculate the AOEL according to the Dutch method. This method takes into account the caloric need of the studied species and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied.

The calculation of the systemic AOEL for semi-chronic exposure is based on the ‘overall’ NOAEL of 15 mg/kg bw/day in the short-term studies in rats and dogs (taking into account the dose-spacing in the short-term studies, this is the most relevant NOAEL).

Safety factors are used to compensate for the uncertainties, which arise from for example extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

Used factors are:

extrapolation rat® man on basis of caloric need: 4

other interspecies differences: 3

intraspecies differences: (professional use) 3

biological availability via oral route: 92%

weight of professional operator/worker: 70 kg

AOEL_systemic: 15 x 0.92 x 70 / (4 x 3 x 3) = 27 mg/day

4.4.1 Operator exposure/risk

Exposure to imidacloprid during mixing and loading and application of ADMIRE O-TEQ is estimated with models. The exposure is estimated for the unprotected operator. In the Table below the estimated internal exposure is compared with the systemic AOEL. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

Table T.1 Internal operator exposure to imidacloprid and risk assessment for the use of ADMIRE O-TEQ

	Route	Estimated internal exposure (mg /day)	Systemic AOEL (mg/day)	Risk-index ^a
Mechanical upward spraying on apple and pear ^b
Mixing/ Loading	Respiratory	<0.01	27	<0.01
Mixing/ Loading	Dermal	0.04	27	<0.01
Application	Respiratory	0.02	27	<0.01
Application	Dermal	3.83	27	0.1
	Total	3.9	27	0.1
Drip treatment in the protected culture of eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper and floriculture crops (only exposure during mixing/loading) ^b
Mixing/ Loading	Respiratory	<0.01	27	<0.01
Mixing/ Loading	Dermal	0.02	27	<0.01
	Total	0.02	27	<0.01
Manual up-and downward spraying in the protected culture of gerbera and chrysanthemum, flower bulbs and bulb flowers, tree nursery crops and perennials ^c
Mixing/ Loading/ Application	Respiratory	0.08	27	<0.01
Mixing/ Loading/ Application	Dermal	1.34	27	0.05
	Total	1.4	27	0.05
Mechanical downward spraying (open field) on floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials, and chicory ^b
Mixing/ Loading	Respiratory	<0.01	27	<0.01
Mixing/ Loading	Dermal	0.05	27	<0.01
Application	Respiratory	<0.01	27	<0.01
Application	Dermal	0.2	27	0.01
	Total	0.25	27	0.01
Dipping of flower bulbs ^b
Mixing/ Loading	Respiratory	<0.01	27	<0.01
Mixing/ Loading	Dermal	0.02	27	<0.01
	Total	0.02	27	<0.01
Brush application in hop ^e
Application	Respiratory	0.4	27	0.01
Application	Dermal	8.1	27	0.3
	Total	8.5	27	0.3

a The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

b External exposure was estimated by EUROPOEM. Internal exposure was calculated with:

biological availability via the dermal route: 0.3% for the concentrate; 8% for the spray dilution (see 4.2)

biological availability via the respiratory route: 100% (worst case)

c External exposure was estimated by the Dutch greenhouse model.

d External exposure was estimated by the Dutch model.

e External exposure was estimated by the biocide model 2 and 3 of the section “consumer product painting”

4.4.2 Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

4.4.3 Worker exposure/risk

Since imidacloprid is taken up by the crops very fast and a negligible amount will be present on the crops, the exposure estimates below for the worker can be regarded as worst-case.

Re-entry activities with intensive contact with the treated crop can be expected in the culture of apple, pear, and floriculture crops.

The exposure is estimated for the unprotected worker. In the Table below the estimated internal exposure is compared with the systemic AOEL.

Table T.2 Internal worker exposure to imidacloprid and risk assessment after application of ADMIRE O-TEQ

	Route	Estimated internal exposure(mg /day)	Systemic AOEL (mg/day)	Risk-index ^c
Re-entry activities in apple and pear ^a
	Respiratory	-	27	-
	Dermal	1.13	27	0.04
	Total	1.13	27	0.04
Re-entry activities in floriculture crops ^b
	Respiratory	0.03	27	<0.01
	Dermal	0.6	27	0.02
	Total	0.63	27	0.02

a External dermal exposure was estimated by EUROPOEM II (DFR module). There is no model available for exposure by the respiratory route. Internal exposure was calculated with:

biological availability via the dermal route: 8% (see 4.2)

b External exposure was estimated by Dutch greenhouse model. Internal exposure was calculated with:

biological availability via the dermal route: 8% (see 4.2)

biological availability via the respiratory route: 100% (worst case)

c The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

4.4.4 Re-entry

See 4.4.3 Worker exposure/risk.

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

Operator exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to imidacloprid as a result of the application of ADMIRE O-TEQ in apple, pear, eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper, floriculture crops, flower bulbs and bulb flowers, tree nursery crops, perennials, hop, and chicory.

Bystander exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to imidacloprid during application of Admire
O-Teq in apple, pear, eggplant, gherkins, courgettes, cucumber, tomato, red pepper, sweet pepper, floriculture crops, flower bulbs and bulb flowers, tree nursery crops, perennials, hop, and chicory.

Worker exposure

Based on the risk assessment it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in apple, pear and floriculture crops due to exposure to imidacloprid after application of Admire
O-Teq.

4.5 Appropriate mammalian toxicology and operator exposure end-points relating to
the product and approved uses

See List of end-points.

4.6 Data requirements

Based on this evaluation no additional data requirements are identified.

4.7 Combination toxicology

ADMIRE O-TEQ contains only one active substance and it is not described that it should be used in combination with other formulations.

4.8 Mammalian toxicology classification and labelling

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification)

Symbol:

Indication of danger: harmful

Risk phrases

R22

Harmful if swallowed

Proposal for the classification and labelling of the formulation concerning health

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labelling of the preparation is proposed:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):
-
Symbol:	Xn	Indication of danger:	Harmful
R phrases	22	Harmful if swallowed.
	36/38	Irritating to eyes and skin.
	43	May cause sensitisation by skin contact.
S phrases	36/37	Wear suitable protective clothing and gloves.
	46	If swallowed, seek medical advice immediately and show this container or label.
Special provisions: DPD-phrases³	-	-

Plant protection products phrase: DPD-phrase	DPD01	To avoid risk for man and the environment, comply with the instructions for use
Child-resistant fastening obligatory?			n.a.
Tactile warning of danger obligatory?			n.a.

Explanation:
Hazard symbol:	-
Risk phrases:	-
Safety phrases:	S24 is not assigned as this safety-phrase is not obligatory in combination with the risk-phrases assigned S46 is assigned by the CTB to formulations classified with R22 and R36/38 when this does not lead to more than six safety-phrases. S36 is concomitantly assigned by the CTB to formulations classified with R43.
Other:	-

5. Residues

List of End-points

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered	Apple, corn cotton, eggplant, potato, tomato, tobacco, rice, sugar beet
Rotational crops	Chard, wheat, red beet
Plant residue definition for monitoring	Sum of imidacloprid and its metabolites imidacloprid-5-hydroxy (M1) and imidacloprid-olefine (M6), expressed as imidacloprid
Plant residue definition for risk assessment	Sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid
Conversion factor (monitoring to risk assessment)	None. The residue definition for monitoring covers more than 80 % of the total residue. A conversion factor is therefore not considered neccessary.

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered	Lactating goat, laying hen
Animal residue definition for monitoring	Sum of imidacloprid and its metabolites imidacloprid-5-hydroxy (M1) and imidacloprid-olefine (M6), expressed as imidacloprid
Animal residue definition for risk assessment	Sum of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as imidacloprid
Conversion factor (monitoring to risk assessment)	None. The residue definition for monitoring covers more than 80 % of the total residue. A conversion factor is therefore not considered neccessary.
Metabolism in rat and ruminant similar (yes/no)	yes
Fat soluble residue: (yes/no)	no

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

Residues in succeeding crops do not exceed 0.01 mg/kg

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

Wheat grain, wheat forage, wheat straw, cotton seed, tomato, cauliflower, lettuce, orange whole fruit, orange dried pulp, orange juice, orange oil, sugar beet root, sugar beet leaf, barley grain, barley forage, barley straw, sunflower seed, hops green cone, hops dried cone >24 months

Milk, fat (bovine), kidney (bovine), egg, liver (poultry), muscle (poultry) >12 months

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock ³ 0.1 mg/kg diet/day:	Ruminant: yes	Poultry: yes	Pig: no
Muscle	0.001	0.00014	-
Liver	0.0053	0.001	-
Kidney	0.0032	-	-
Fat	0.0006	0.00005	-
Milk	0.0015	-	-
Eggs	-	0.00035	-

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Crop/processed crop

Number of studies

Transfer factor imidacloprid total

% Transference

Apple/washed

Apple/juiced

Apple/sauce

Apple/dried

Apple/pomace, wet

Apple/pomace, dry

Tomato/washed

Tomato/preserve

Tomato/juice

Tomato/ketchup

Tomato/puree

Tomato/paste

Tomato/pomace, wet

Tomato/pomace, dry

Citrus fruit/pulp

Citrus fruit/peel

Citrus fruit/juice

Citrus fruit/marmalade

Citrus fruit/oil

Citrus fruit/molasses

Citrus fruit/pulp, dried

Grape bunches/must

Grape bunches/wine

Grape bunches/washed berries

Grape bunches/juice

Grape bunches/retentate

Grape bunches/pomace, wet

Grape bunches/pomace, dry

Grape bunches/raisin

0.9

0.656

0.75

0.865

1.6

5.2

2.09

0.91

1.37

1.8

2.3

5.73

1.54

4.3

0.31

2.78

0.28

0.625

0.26

6.47

7.47

1.53

1.17

<0.5

0.73

<0.5

2.23

4.3

1.05

* Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies

Comments on/additions to List of End-points

NL provided comments to the draft assessment report of imidacloprid and its list of end points. Since it was observed in the metabolism studies that parent + M01 + M06 varies from 30-60% of total extractable residues, and most of the metabolites contain the 6-chloropyridinyl moiety, a conversion factor is proposed for the residue definition for risk assessment. However, at the moment in the current residue trials the total residue containing the 6-chloropyridinyl moiety is still determined, so a conversion factor is not necessary for these residue data.

5.1 Summary of residue data

5.1.1 Metabolism in plants

Metabolism was investigated in apple, corn, cotton, eggplant, potato, tomato, tobacco, rice, and sugar beet in seed/soil treatment or foliar application. Metabolism was found to be identical in the different crop groups with parent imidacloprid, metabolite M01 and metabolite M06 being the main residue.

5.1.2 Metabolism in livestock

Metabolism was investigated dairy goat and laying hen. Metabolism was found to be similar in both species and in rat, so no pig study is required.

5.1.3 Residue definition (plant and animal)

The proposed residue definition is parent imidacloprid + metabolite M01 + metabolite M06, expressed as imidacloprid (monitoring, all crops). In the Netherlands all metabolites containing the 6-chloropyridinyl moiety are included in the residue definition for risk assessment.

The proposed residue definition is parent imidacloprid + metabolite M01 + metabolite M06, expressed as imidacloprid (monitoring, all animal products). In the Netherlands all metabolites containing the 6-chloropyridinyl moiety are included in the residue definition for risk assessment.

5.1.4 Stability of residues

Potato is a watery matrix. Storage stability was proven for at least 24 months is watery matrices. For animal products, storage stability was proven for 12 months. See List of End points.

5.1.5 Residue data

For this national authorisation request, trials were provided already evaluated for the authorisation of Admire and Gaucho Tuinbouw.

apple and pear (pome fruit)

Twelve trials were provided performed with apple: 9 trials are acceptable, 6 of them since they were performed according to cGAP-NL and 3 since they were performed with an overdose, however, their residue levels overlapped with the 6 other trials. Residues were determined from 1-30 DAT. The highest residue values were used to calculate the MRL:

2x<0.05, 0.06, 2x0.07, 0.08, 0.09, 0.11 mg/kg. Trials with apple can be used for extrapolation to pear.

MRL = 0.2 mg/kg, STMR = 0.07 mg/kg and HR = 0.11 mg/kg.

cucumber, courgette, gherkin

Twelve trials were provided performed with cucumber: 6 with drip irrigation and 6 with plant sticks. Eight of the trials were according to cGAP-NL. Residues were determined from
1-30 DAT. The highest residue values were used to calculate the MRL:

0.16; 0.18; 0.20; 0.23; 0.25; 0.31 en 2x0.39 mg/kg.

Trials with cucumber can be used for extrapolation to gherkin and courgette.

MRL = 0.5 mg/kg, STMR = 0.24 mg/kg and HR = 0.39 mg/kg.

tomato and eggplant

Twelve trials were provided performed with tomato: 6 with drip irrigation and 6 with plant sticks. Trials were 50-100% overdosed compared to cGAP-NL when expressed in g ai/ha. However, expressed in mg ai/plant, trials fitted tot the cGAP-NL (the plant density was somewhat higher than usual). Residues were determined from 1-30 DAT. The highest residue values were used to calculate the MRL:

2x0.05; 0.07; 2x0.07; 0.08; 2x0.11; 2x0.14; 0.15 en 0.16 mg/kg.

Trials with tomato can be used for extrapolation to eggplant.

MRL = 0.3 mg/kg, STMR = 0.08 mg/kg and HR = 0.16 mg/kg.

sweet pepper and spanish pepper

Six trials were provided performed with sweet pepper: 4 with drip irrigation and 2 with plant sticks. Trials were according to cGAP-NL. Residues were determined from 1-63 DAT.

The highest residue values were used to calculate the MRL:

0.15; 0.16; 2x0.17; 0.24 en 0.27 mg/kg.

Trials with sweet pepper can be used for extrapolation to spanish pepper.

MRL= 0.5 mg/kg, STMR = 0.17 mg/kg, HR = 0.27 mg/kg

hops

Four trials were evaluated before. It was concluded that the trials were not performed with the right application method (brushing in stead of rubbing). However, the trials were performed with 0.14 kg/ha with a plant density of 4000 plants/ha. This is considered to be an overdose compared the application request (0.027 kg/1000 shoots, applied only locally).

Selected residue data:

4x<0.05 mg/kg (fresh, 4x<0.2 mg/kg (dry).

MRL= 0.2* mg/kg, STMR = 0.2 mg/kg, HR = 0.2 mg/kg

5.1.7 Residues from livestock feeding studies

Livestock feeding was evaluated in the draft assessment report. For the Dutch authorisation of AMIGO, the intake of residues via intake of potato was already included in the total livestock dietary burden of imidacloprid. MRLs were already set and are therefore still valid.

5.1.9 Calculation of the ADI and the ARfD

The ADI and ARfD were taken from the most recent list of end points on Human Toxicology, d.d. December 2005.

The ADI was based on the NOAEL of 6 mg/kg bw/d from de 2-y dietary study with rats giving rise to effects on increased incidence of follicular colloid mineralisation in the thyroid at the near higher dose group of 17 mg/kg bw/d. Using a safety factor of 100, the ADI was established at 0.06 mg/kg bw/d.

The ARfD was based on the NOAEL of 40 mg/kg bw/d from the acute neurotoxicity study with rats and the 28-d, 90-d and 1-y dietary study with dogs, based on tremors at the near higher dose group of 70 mg/kg bw/d. Using a safety factor of 100, the ARfD was established at
0.4 mg/kg bw/d.

5.2 Maximum Residue Levels

Imidacloprid is an existing active substance with national MRLs. The crop groups for which authorisation is requested are already assessed before for the formulation Admire and Gaucho Tuinbouw. The product complies with the national MRL directive, except for hops. An MRL off 0.2 mg/kg should be adopted for the Regeling Residuen for the product hops.

Notification of the MRL is not necessary, awaiting the harmonisation of MRLs after Annex I inclusion.

5.3 Consumer risk assessment

Risk assessment for chronic exposure through diet

Based on the proposed residue tolerances, a calculation of the National Theoretical Maximum Daily Intake (NTMDI) was carried out using the National Dutch diet and the Dutch MRLs. Calculation of the NTMDI shows that 6.5% and 14.6% of the ADI is used for the general population and for children, respectively.

Risk assessment for acute exposure through diet

A calculation of the National Estimated Short Term Intake (NESTI) was carried out using the National Dutch diet (‘large portion sizes’; 97,5 percentile from dietary data), the UK ‘unit weights’ and previously mentioned MRL’s. Calculation of the NESTI shows that 7.9% and 17.1% of the ADI is used for table grapes for the general population and for for oranges for children of 1-6y, respectively.

Conclusion

Authorisation of ADMIRE O-TEQ on the requested crops will not result in any unacceptable risk from intake of imidacloprid to consumers. ADMIRE O-TEQ can be authorised for the requested claims.

5.4 Data requirements

6. Environmental fate and behaviour

In the Dutch Pesticide Law the Uniform Principles are implemented in the Regulation of Uniform Principles for Plant protection products (BUBG). This Regulation is also the legal basis for the Dutch specific criteria.

List of Endpoints Fate/behaviour

Fate and Behaviour in the Environment of imidacloprid

Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)
Mineralisation after 100 days ‡	Investigated: pyridinyl-¹⁴C-methylene labelled imidacloprid Loamy sand: 10 % after 100 days (study end) Silt loam 6.4 % after 100 days (study end) Sandy loam: 3.3 % after 100 days 7.4 % after 366 days (study end) Sandy loam: 2.7 % after 100 days 4.9 % after 366 days (study end) Sandy loam: 16.6 % after 91 days 20.3 % after 126 days (study end)
Non-extractable residues after 100 days ‡	Investigated: pyridinyl-¹⁴C-methylene labelled imidacloprid Loamy sand: 21.6 % after 100 days (study end) Silt loam 21.5 % after 100 days (study end) Sandy loam: 16.6 % after 100 days 23.0 % after 366 days (study end) Sandy loam: 25.0 % after 100 days 39.5 % after 366 days (study end) Sandy loam: 26.9 % after 91 days 28.1 % after 126 days (study end)
Relevant metabolites - name and/or code, % of applied (range and maximum) ‡	Investigated: pyridinyl-¹⁴C-methylene labelled imidacloprid In all studies (soils see above): 7 metabolites NTN33893-olefin (1.8 % TAR after 100 d), NTN33893-ring-open-nitroguanidine (max. 3.4 % TAR after 77 d) and NTN33893-desnitro (1.6 % TAR after 201 d).

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Anaerobic degradation ‡

no study conducted, reference to anaerobic water/sediment study (see saturated zone)

Soil photolysis ‡

Investigated: pyridinyl-¹⁴C-methylene labelled imidacloprid in sandy silt loam/sandy loam. Continuous irradiation 15 d, Xenon lamp, 3,24x10¹⁷ photon/sec., 25 °C:
DT₅₀:38.9 d, best fit according to Timme and Frehse, formal 2^nd order; normalised to sun light, and natural conditions , 40°N: 171 days.

Recoveries in % of total applied radioactivity:

active substance: 58.5-103 % at all sampling dates; 61.5 % after 15 days (study end)

metabolites: max. 6.3 % after 15 days (NTN33893-5-hydroxy), other metabolites < 5 %, 2 unknown 2,2 %; 1.3 % TAR

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Method of calculation

Lab. DT₅₀ aerob:
Imidacloprid, best fit and 1^st order, and standardised to field capacity according to FOCUS

Laboratory studies (range or median, with n value,

with r2 value) ‡

DT_50lab (20 °C, aerobic): measured at 40 % WHC

best fit 1^st order

Loamy sand 188 d (2^nd order) 154

Silt loam 248 d (2^nd order) 193

Sandy loam 341 d (sqrt 1^st order) 186

Sandy loam 77 d (sqrt 1^st order) 106

geometric mean: 187 d 156 d

1^st order fit standardised to field capacity (according to FOCUS):

Loamy sand 128.4 d

Silt loam 129.3 d

Sandy loam 117.0 d

Sandy loam 98.9 d

geometric mean DT_50lab: 117.7 d

DT_90lab(20 °C, aerobic): not determined

DT_50lab (10 °C, aerobic): calculated from 1^st order 20 °C values using Q10 of 2.2
Loamy sand 339 d

Silt loam 425 d

Sandy loam 409 d

Sandy loam 233 d

geometric mean DT_50lab: 343 d

DT_50lab (20°C, anaerobic):

not determined, reference to anaerobic water/sediment study (saturated zone)

Degradation in the saturated zone

Degradation in the saturated zone:

Investigated: pyridinyl-¹⁴C-methylene imidacloprid
anaerobic water/sediment-study

DT_50lab (20°C, anaerobic): 36 days total system

DT_90lab (20°C, anaerobic, calc. by RMS): 89 days total system, water 107 d /best fit, 1st order, Timme & Frehse)

parent: water: 11.8 % TAR after 120 days, < 0.1 % after 358 days (study end)
sediment: 16.8 % after 14 d, 1.4 % after 120 d, < 0.1 % after 358 days (study end)

metabolite NTN33893-desnitro:
water: 20 % TAR after 60 days, 14.3 % after 358 days (study end)
sediment: 2.2 % after 120 days, 1.5 % after 358 days (study end).

non-extracted: 16 % after 120 d, 22.6 % after 358 d.

Field studies (state location, range or median with

n value) ‡

DT₅₀f

DT_50f(in days)
Investigated: imidacloprid 1^st

Germany soil best fit order r²

Swisttal Hohn silt loam 173 208 0.92

Swisttal Hohn silt loam 140 185 0.88

Burscheid-Höfchen silt loam 62 104 0.88

Burscheid-Höfchen silt loam 79 131 0.61

Kirchlauter sandy loam 142 178 0.82

Kirchlauter sandy loam 180 216 0.85

Worms loam 151 197 0.50

Worms loam 196 228 0.74

Laacher Hof sandy loam 119 152 0.81

Laacher Hof sandy loam 160 186 0.86

median (d) 147 186

Investigated: Confidor 200 SL

soil best fit 1^st order

France silty loam 63 d ¹ 111

Italy silty clay 183 d ² 288

Italy loamy sand 28 d ¹ 40

Spain silty clay loam 77 d ¹ 116

geometric mean 71 d 110 d

¹ square root 1^st order

_{square root 1.5st order}

normalised values according to FOCUS

location DT₅₀ (d)

Kirchlauter-Pettstadt 85.8

Swisstal-Hohn 89.8

Höfchen 50.6

Worms-Heppenheim 94.3

Laacher Hof 86.0

Kirchlauter-Pettstadt 70.8

Swisstal-Hohn 98.2

Höfchen 41.0

Worms-Heppenheim 82.0

Laacher Hof 71.6

Bagnolo di Nogarole Rocca 179.8

St. Etienne du Gres 65.7

Ca Degli Oppi, Italy 27.0

Castellarnau 58.5

median 76.8

geometric mean 71.9

DT_90f

DT_90f : investigated: Confidor 200 SL

NE soil 1^st order

sandy loam 717^*)

sandy loam 591^*)

silt loam 614^*)

silt loam 690^*)

silt loam 435^*)

silt loam 345

loam 757^*)

loam 654^*)

sandy loam 618^*)

sandy loam 504^*)

geometric mean 578 d

SE soil 1^st order

France silty loam 956^*)

Italy silty clay 368

Italy loamy sand 133

Spain silty clay loam 385

geometric mean 366 d

^*) extrapolated value, longer than study duration

Soil accumulation and plateau concentration ‡

Study 1: Germany, apple orchards, 3 test sites, duration 6 years, silt loam (1)/ silty clay (2)/sandy loam (3), annual application rate nearly 105 g as/ha directly onto ground.

measured (µg as/kg) residue after last application (6 years) 0-10 cm soil layer:

max min after ~1 year

site 1 55.4 (day 0) 23.2 (day 180) 23.3 (364 d)
site 2 77.1 (day 0) 20.0 (day 80) 34.5 (356 d)

site 3 44.6 (day 0) 20.5 (day 175) 23.1 (357 d)

soil layer 20-30 cm: generally < 6 µg as/kg (LOQ)

Study 2, Great Britain, seed dressing of winter barley. 2 study sites, sandy loam, duration 6 years, application rate 56/133 g product (Zelmone 350FS)/ha, soil was cultivated to a depth of 19cm

measured (µg as/kg) residue after last harvest (6 years appl.) 0-10 cm soil layer 10-20 cm soil layer

site 1 31.4/49.4 18.5/38.2
site 2 17.8/36.3 16.2/29.8

soil layers 20-50 cm: £ 2 µg as/kg soil (LOD)

Soil adsorption/desorption (Annex IIA, point 7.1.2)

K_f /K_oc_‡

_{Imidacloprid: Koc 109 – 411, arithmetic mean 225
(n=10)}

_{soil pH Koc Kf 1/n}

_{Sand 5.1 411 0.956 0.783}

_{(98.7 % sand, 0.3 % silt, 1.0 % clay, 0.23 % org
.C.)}

_{Sandy
soil, low humus 5.6 157 1.17 0.77}

_{(87.8 % sand, 8.7 % silt, 3.5 % clay, 0.75 % org.
C.)}

_{Sandy
loam 5.2 256 3.59 0.744}

_{(67 % sand, 27 % silt, 6 % clay, 1.4 % org. C.)}

_{Sandy
loam 5.7 153 1.83 0.888}

_{(68.3% sand, 24.5 % silt, 7.2 % clay, 1.2 % org. C.)}

_{Sandy
loam 6.4 235 3.17 0.782}

_{(72.4% sand, 22.6 % silt, 5.0 % clay, 1.35 % org.
C.)}

_{Sandy
loam 6.4 109 1.52 0.783}

_{(72.4% sand, 22.6 % silt, 5.0 % clay, 1.4 % org. C.)}

_{Sandy
loam 5.6 165 2.14 0.786}

_{(71.6% sand, 21.5 % silt, 6.9 % clay, 1.3 % org. C.)}

_{Loamy
sand 4.5 292 1.02 0.878}

_{(79.3 % sand, 15.5 % silt, 5.5 % clay, 0.35 %
org.C.)}

_{Silt loam 5.8 277 4.18 0.775}

_{(29.3 % sand, 51.3 % silt, 19.5 % clay, 1.51 %
org.C.)}

_{Silt soil 5.3 132 2.38 0.827}

_{(2 % sand, 89 % silt, 9 % clay, 1.8 % org.C.)}

_{Silty
clay 7.4 212 1.36 0.851}

_{(15 % sand, 42.3 % silt, 42.7 % clay, 0.64 % org.C.)}

_{Loam 6.5 296 3.45 0.755}

_{(29.3 % sand, 47.2 % silt, 23.5 % clay, 1.16 %
org.C.)}

_{arithmetic
mean, n=12 225±87 0.80}

_{median 212}

K_d_‡

pH dependence (yes / no) (if yes type of

dependence) _‡

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching _‡

Studies regarded as not valid, not relevant for the assessment. Lysimeter studies are of higher relevance.

Aged residues leaching _‡

Guideline: BBA IV 4-2, pyridinyl-¹⁴C-methylene imidacloprid. 30 and 90 day ageing in the dark, 22 °C, 40 % WHC, Application rate 200 g as/ha. Height 14.5 cm.

Soil: Monheim I, sandy loam soil (1.27 % C_org, pH 5.2, biomass 264 mg microbial carbon/kg soil at test start).

and BBA 2.1 (slightly humous sand, 0.75 % Corg, pH 5.6, 146 - 264 mg microbial carbon/kg soil at test start

Percolation 393 mL/48 h.

30 d ageing: < 3 % of applied radioactivity in eluate

90 d ageing: < 2 % of applied radioactivity in eluate

Imidacloprid remained mainly in upper column segment: Monheim I, 90 d: 98.3 % of applied radioactivity
BBA 2.1, 30 d: 71.4 % segment 1, 28.6 % segment 2

BBA 2.1, 90 d: 70.6 % segment 1, 20.7 % segment 2.

Guideline EPA 163-1

Pyridinyl-¹⁴C-methylene imidacloprid. 4 different soils

30 day ageing in the dark, 22 °C, 40 % WHC, Application rate 250 g as/ha. Height 30 cm.

Soils:

sandy loam #411 (75 % sand, 9 % clay, 0.93 % C_org, pH 6.2), fine sand #396 (98.7 % sand, 1 % clay, 0.12 % C_org, pH 5.1); silty clay loam Illinois #413 (22.7 % sand, 51 % silt, 26 % clay, pH 6.2, Corg 1.92); silty clay loam Kansas #414 (17 % sand, 41 % silt, 42 % clay, pH 5.6, Corg 1.22). Percolation 1200 mL/55 h.
Percent of applied radioactivity in leachates:

sand #396: 64 %

sandy loam #411: 0.8 %

silty clay loam #413: 0.4 %

silty clay loam #414 dry packed: 9.3 %

silty clay loam #414 moist packed: 3.6 %

Mobility depends on the soil type.

Imidacloprid remained mainly in upper column segments (0-15 cm) of soils containing loam. In soils with high sand content, distribution through column:
Percent of applied radioactivity in aged soil layer and per 5 cm segment:

sandy loam #411: 16.5/24.1/25.5/19.0/3.2 %

silty clay loam #413: 22.6/43.9/18.4/2.7 %

silty clay loam #414 dry packed:
21.6/14.4/17.2/12.6/ 8.5/6.9 %

silty clay loam #414 moist packed:
18.7/34.6 segment 1+2) /19.0/11.9/4.8 %

sand #396: 13.1 % aged layer, 10.6 % (10-15 cm)/ 11.9 % (20-25 cm)

Lysimeter/ field leaching studies _‡

3 lysimeter studies, Germany, soil: Laacherhof Monheim, sandy soil, lysimeter surface: 100 x 100 cm, depth 110 cm. ¹⁴C-methylene imidacloprid.

1. study: 2 lysimeters; application: 500 g as/ha on potato tubers already lying in their planting holes.
Cultural practice: potatoes/winter wheat/winter barley

Precipitation: 800 mm/year. Soil Monheim (72-78.3 % sand, 5.0-9.5 % clay. 0.18-1.35 % C_org, pH 6.9-7.1)

Leachate: distribution of radioactivity:

as-equivalents (µg/L) eluate (L)

1^st year 0.036/0.047 95.5/95.5

1^st+2^nd year 0.069/0.081 175.2/213.7

Neither parent compound nor any relevant metabolite was detected (LOQ 0.01 µg/L).

In soil: after 2 years 54.6/57.5 % of applied radioactivity;
93 % of that in 0-20 cm soil layer. Extractable residues mainly as: 0.04 mg as/kg 0-20 cm layer; 0.0036 mg as/kg 20-30 cm layer. Below 30 cm as < LOD (0.5 µg/kg).

2. study: 2 lysimeters, study duration 5 years, 2 application as seed treatment: 117 g as/ha (1991); 126 g as/ha (1994). Cultural practice: sugar beet/ winter wheat/ winter barley/ intermediate crop Phacelia/ sugar beet/ winter wheat/ winter barley.

Precipitation: 800 mm/year. Soil Monheim (71.8-79.4 % sand, 11.0-16.5 % silt, 9.7-11.8 % clay. 0.19-1.41 % C_org, pH 6.9-7.1): 0-60 cm sandy loam, 60-115 cm loamy sand.

Leachate: distribution of radioactivity:

as-equivalents

(µg/L) mean eluate(L) mean

1^st year 0.012/0.020 0.02 94.4/102.6 98

2^nd year 0.040/0.091 0.07 231.5/218.0 225

3^rd year 0.045/0.104 0.07 281.7/320.2 301

4^th year 0.070/0.108 0.09 378.6/334.7 357

5^th year 0.062/0.114 0.09 114.4/89.3 102

Neither parent compound nor any relevant metabolite was detected throughout the 5 years (LOQ 0.01 µg/L).

In soil: after 5 years in 0-10, 10-20, 20-30 cm:
in lysimeter 1. 22.6/15.6/4.22 %TAR (0-30 cm 42.4 %)

in lysimeter 2. 21.7/14.0/4.26 %TAR (0-30 cm 39.96 %)

Extracted parent compound:
in % TAR: µg as/kg fresh weight soil

0-10 cm 7.685/6.408 13.2/11.0

10-20 cm 5.590/5.611 9.5/9.6

20-30 cm 1.698/1.921 2.7/3.1

30-40 cm 0.323/0.501 0.5/0.8

40-50 cm 0.034/0.162 0.1/0.3

50-60 cm 0.005/0.094 < LOQ/0.1

60-70 cm < LOQ/0.019 < LOQ

< 70 cm < LOQ < LOQ

Residues in plants (total): 2.46 %/1.97 % TAR

Residues in leachates (total) 0.23 %/0.42 % TAR

Total recovery 47.01 %/46.22 % TAR

Loss (CO₂ etc.) 52.99 %/53.78 % TAR

3. study: 2 lysimeters, study duration 2.5 years, 2 application as seed treatment: 90 g as/unit= 117 g as/ha (1996); 140 g as/ha (1997). Cultural practice: sugar beet/ winter wheat/ winter barley.

Precipitation: 841 mm/year. Soil Monheim (71.8-79.4 % sand, 11.0-16.6 % silt, 9.7-11.8 % clay. 0.19-1.41 % C_org, pH 6.05-6.42): 0-60 cm sandy loam, 60-100 cm loamy sand. 100-115 cm loamy sand.

Distribution of total recovered radioact. (TRR):

as-equivalents/ CO₂

leachate (µg/L) leachate (L) % TRR

1^st year 0.018/0.026 133.3/146.7 43/31

2^nd year 0.025/0.038 119.8/132.8 32/17

last 6 months 0.38/0.057 28.5/38.5 19/12

total 281.6/318.0

Imidacloprid and metabolites not analysed, since equivalent-conc. < 0.1 µg/L.

In soil: predominant portion 86 %/89 % of total recovered radioactivity. (TRR) in 0-30 cm soil layer after 2.5 years:

TAR: 0-30 cm 47.6 %/ 45.53 %; 30-60 cm 6.75 %/ 4.6 %; < 60 cm 1.09 %/0.83 %

Besides as metabolites NTN33893-ring open nitro guanidine (Z1) and NTN33893-desnitro (Z2).

Extractable residues µg/kg soil

as equivalents Z1 Z2

0-10 cm 15.2/13.3 3.3/2.8 1.6/1.2

10-20 cm 16.4/15.0 2.7/2.5 0.4/0.3

20-30 cm 4.7/4.3 0.3/0.3 <LOQ

30-40 cm 1.8/1.1 0.270.2 <LOQ

40-50 cm 0.9/0.4 0.1/0.1 <LOQ

50-60 cm 0.6/0.4 0.1/0.1 <LOQ

60-70 cm 0.2/< LOQ 0.1/<LOQ <LOQ

< 70 cm < LOQ/<LOQ <LOQ <LOQ

Residues in soil (total) 55.46 %/50.77 % TAR

Residues in plants (sum all crop): 3.67 %/3.95 % TAR

Residues in leachate (total) 0.02 %/0.04 % TAR

Total recovery 59.16 %/54.77 % TAR

Loss (CO₂ etc.) 38.48 %/43.26 % TAR

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Hydrolysis of active substance and relevant metabolites (DT₅₀) (state pH and temperature) _‡	pH 5: stable at 25 °, DT₅₀ > 1 year
	pH 7: stable at 25 °, DT₅₀ > 1 year
	pH 9: slow hydrolysis at 25 °, DT₅₀ approximately 1 year
Photolytic degradation of active substance and relevant metabolites _‡	(1) Photolysis artificial light: in sterile water up to 120 min, pH 7, natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 6.31 and 5.18 mg as/L Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid Results: - Imidacloprid: absorption coefficient e = 5714 L/Mole x cm at 295 nm and e = 20 L/Mole x cm at 363 nm, quantum yield 0.0142 - Imidacloprid: 28.7 % TAR after 120 min. - DT₅₀ 57 minutes under test conditions - Environmental DT₅₀, latitude 50° (GC-solar) spring 0.24 d summer 0.17 d - 10° longitude, 50° latitude (Frank & Klöpffer) April-summer 0.4 - 0.28 d November-December 3.1 - 6.73 d (2a) Photolysis artificial light: in sterile buffer solution pH 7 up to 120 min, natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 5.4 mg as/L Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid Results: - Imidacloprid: 28.7 % TAR after 2 h - Photo-transformation products after 2 h: NTN33893-desnitro 17.2 % TAR NTN33893- desnitro olefine 12.6 % NTN33893-urea 9.8 % others unknown 8.4 % volatile degradates none Photolysis natural sunlight: 4 and 7 h (greenhouse, Yuki, Japan). Conc. 10 mg as/L Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid Results: - Imidacloprid: 60 % was degraded after 4 hours (2b) Photolysis artificial light, study for identification of metabolites, 21 h natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 100 mg as/L: Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid Results: - 46.2 % of TAR assigned to parent and degradates NTN33893- ring open guanidine 14.9 % in fraction NTN33893-desnitro 11.0 % in fraction NTN33893-urea minor amounts 6-chloro-nicotinic acid minor amounts (2b) Photolysis artificial light, study for identification of metabolites, 21 h natural sunlight mimic, cut off 290 nm (SUN-TEST apparatus). Conc. 100 mg as/L: Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid Results: - 46.2 % of TAR assigned to parent and degradates NTN33893- ring open guanidine 14.9 % in fraction NTN33893-desnitro 11.0 % in fraction NTN33893-urea minor amounts 6-chloro-nicotinic acid minor amounts
Readily biodegradable (yes/no) _‡	Study not performed, thus considered ‘not readily biodegradable’
Dissipation in water/sediment _‡ Dissipation in - DT₅₀ water _‡ water/sediment - DT₉₀ water _‡ - DT₅₀ whole system _‡ - DT₉₀ whole system _‡ - DT₅₀ sediment _‡ - DT₉₀ sediment _‡ - DT₅₀ water (only degradation) _‡	(1) Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid, application rate 2x335 g as/ha (=0.67 mg as/L 10 cm water body); 1 sediment type (Stillwell, Kansas, silty clay, 2.2 % sand, 50 % silt, 47.9 % clay, pH 7.62) Water: hardness 9 °DH=90 mg CaO equivalents. EPA Guideline §162-4 1982 (2) Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid, application rate 1x200 g as/ha (=0.2 mg as/L 10 cm water body); 2 sediment types, 2 replicates (Ijzendoorn NL, loamy silt, 15.3 % sand, 69.7 % silt, 14.9 % clay, Corg 4.09, water pH 8.1-804; Lienden NL, loamy sand, 73.9 % sand, 16.8 % silt, 9.2 % clay, Corg 0.89,Water pH 8.1-8.9). EPA Guideline §162-4 1982 Imidacloprid as: (1^st order), Standard tests (- no data) _StillwellIJzendoorn Lienden _{DT50,water > 30 d - -} _{DT90,water - - -} _{r² - - -} _{DT50,system 129 d 32 d 142 d} _{DT90,system - - -} _{r² - - -} _{DT50,sediment - - -} _{DT90,sediment - - -} _{r² - - -} ModelMaker 4.0 (evaluation by RMS) IJzendoorn Lienden _{DT50,water as no degradation 138.8 d} _{DT50 sedimnet as 13.7 d no degradation} _{r² 0.998 0.998} _{DT50,water no degradation no degradation DT50,sediment no degradation no degradation} _{Model ecosystem with light} (3) Tested: [pyridinyl-¹⁴C-methylene]-imidacloprid, application rate 2x335 g as/ha (1x=0.67 mg as/L 10 cm water body); 1 sediment type (Stillwell, Kansas, silty clay, 2.2 % sand, 50 % silt, 47.9 % clay, pH 7.62). Water: hardness 9 °DH=90 mg CaO equivalents.). Irradiation with sunlight 21 d, natural cycle; Xenon light 95 h in 21 d test duration, 141 h in 30 d test duration Imidacloprid as: (1^st order) _{Stillwell/Light} _{Xenon light DT50,water < 5 d} _{Mineralisation rate 5.8 % at day 21 d} _{Natural sun light Mineralisation rate 9.8 % at day 21 d} _{Outdoor pond system} (4) Tested: Confidor SL200, 198 g as/L. Application rate 6 µg as/L. Mesocosm: latitude N 51°,Germany, Monheim. test duration 70 d. Sediment type Nespen Wiehltalsperre: silt loam, 23.4 % sand, 62.3 % silt, 14.2 % clay, Corg 4.1. _{Natural light DT50,water approximately 7 d} _{Monheim (FRG) DT50,total system approximately 14 d} (5) Tested: Imidacloprid. Concentrations 0, 2, 6, 20, 180 µg/L. Mesocosm: Denton, North Texas USA. Test duration 70 d. Sediment type: sandy loam, sandy clay loam, 62-78 % sand, 7-15 % silt, 8-24 % clay, Corg 0.6-1.4 %). _{Natural light DT50,water 1.4 d} _{Texas (USA) DT50,sediment 14 d} (6) Tested: Confidor SL200 (17.3 % as). 2 spray application, resulting in nominal concentrations of 0.6, 1.5, 3.8, 9.4, 23.5 µg as/L. Mesocosm: at Aachen, Germany. Test duration 70 d. Sediment type: Nespen Wiehltalsperre: silt loam, 24.3 % sand, 62.3 % silt, 12.4 % clay, Corg 3.4 %, pH 6.5). _{Natural light DT50,water, after 2}_nd_{appl. 13 d} _{Aachen (FRG) DT50,total system 30 d}
Mineralisation	Water/sediment studies Study (1) after 30 d (study end) in % TAR: 0.7 % Study (2) after 92 d (study end) in % TAR: IJzendoorn 1.3/1.4 %; Lienden 1.4/2.5 %
Non-extractable residues	Water/sediment studies Study (1) after 30 d (study end) in % TAR: 8.2 % Study (2) after 92 d (study end) in % TAR: IJzendoorn 66.4/66.1 %; Lienden 17.4/13.4 %
Distribution in water / sediment systems (active substance) _‡	Maximum values in sediment: (as in % TAR) Study (1) after 7 d: 23.5 % Study (2) IJzendoorn (IJ) after 14 d: 31.9 % Study (2) Lienden (L) after 60 d : 13.6 % Imidacloprid % total applied radioactivity (TAR) days after ([pyridinyl-¹⁴C-methylene]-imidacloprid l) applicat. (1) water (2)IJ/L (1) sediment (2)IJ/L 0 90.7 78.5/90.3 7.6 13.5/5.5 3 77.2 19.3 7 69.4 23.5 14 67.8 41.2/76.7 22.1 31.9/9.0 21 66.0 19.0 30/29(2) 64.0 26.8/68.1 20.4 22.8/9.4 60 9.8/64.8 13.6/10.3 92 5.1/52.8 6.6/8.9
Distribution in water / sediment systems (metabolites) _‡	Maximum values: NTN33893-desnitro (in % TAR) Study (1) after 7 d: water 2.4 % after 7, 21, 30 d sediment 0.4 % Study (2) IJzendoorn (IJ) after 92 d: water 6.0 % after 92 d: sediment 6.3 % Study (2) Lienden (L) after 92 d: water 4.5 % after 92 d: sediment 4.3 % NTN33893-desnitro % total applied radioactivity (TAR) days after (as [pyridinyl-¹⁴C-methylene]-imidacloprid l) applicat. (1) water (2)IJ/L (1) sediment (2)IJ/L 0 <0-1 < 0.1/<0.1 <0.1 < 0.1/<0.1 3 <0.1 0.1 7 2.4 0.4 14 0.9 0.8/0.7 0.3 1.1/1.2 21 1.4 0.4 30/29(2) 1.4 2.3/1.9 0.4 3.0/1.7 60 4.4/1.7 5.6/2.4 92 6.0/4.5 6.3/4.3 other metabolites in lower concentrations, max 3.8 % in water, 0.7 in sediment for 6-chloro-nicotinic acid: NTN33893-PEDA; NTN33893-nitrosimine; NTN33893-urea; 6-chloro-nicotinic acid; 6-hydroxy-nicotinic acid

PEC (ground water) (Annex IIIA, point 9.2.1)

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

modelling, monitoring, lysimeter )

FOCUS-PELMO 3.3.2 modelling. Soil DT₅₀ standardised 20 °C, geometric mean from 4 laboratory studies 118 d; Koc 225 mL/g, 1/n = 0.8

Application rate

Annual rate: sugar beet seeds 117 g as/ha; apples 1^st 70 g (BBCH 10) and 2^nd 105 g as/ha (BBCH69/71), tomatoes 2 x 100 g as/ha, 14 d interval Apples and tomatoes: spraying (Confidor SL200), sugar beets: seed treatment (Gaucho FS600)

Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)

Direct photolysis in air _‡	Study not performed - not measurable, due to low vapour pressure.
Quantum yield of direct phototransformation	_{criteria for the determination not reached (A > 10 L/mol x cm), determination is not necessary.}
Photochemical oxidative degradation in air _‡	DT₅₀..0.85 hours. (calculation according to Atkinson 1987, 12 h daytime, 1.5 x 10⁶ OH-radicals/cm³) 24 h time period, 5 x 10⁵ OH-radicals/cm³ DT₅₀..2.54 h
Volatilisation _‡	(field experiment in container arrangement, 1 m², apple seedlings). Methylene-¹⁴C labelled and formulated imidacloprid. from plant surfaces: _‡ No as evaporated from plant and soil surfaces within 24 h after application
	from soil: _‡ no evaporation within 24 h

Definition of the Residue (Annex IIA, point 7.3)

Relevant to the environment

Relevant for quantitation (> 5 % at 2 sequential measurements during the soil and water/sediment study)

Soil : parent compound

Water: parent compound

Sediment parent compound

Ground water: parent compound

Air: parent compound

Monitoring data, if available (Annex IIA, point 7.4)
Soil (indicate location and type of study)	not available
Surface water (indicate location and type of study)	not available
Ground water (indicate location and type of study)	Germany, groundwater monitoring programme Data from 4 Federal States number total <LOQ £0.1 >0.1-1.0 >1.0 µg/L 2000 9 9 0 0 0 2001 23 22 1 0 0 2002 279 278 1 0 0 total 627 625 2 0 0
Air (indicate location and type of study)	not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data

R 53

Additional study: Spray drift and required crop-free buffer zones when applying Admire in nursery tree and plant, flower and bulb flower crops in the Netherlands (Zande, J.C. van de, Michielsen, J.M.G.P. and Stallinga, H.)

This study was summarised and evaluated by the CTB (05/2007)

Bufferzones were calculated in order to meet the standards for aquatic organisms. With these bufferzones, drift is reduced to 0.76% for nursery trees and plants, and flowers, and to 0.65% for Flowerbulbs. With these bufferzones, the expected concentration should be below 0.6 µg/L (NOEC for aquatic organisms).

Substance	Application technique	Crop	Required minimum crop-free buffer zone [m]
			Conventional*	Air-assisted*
Admire	Field sprayer with nozzle XR110-04	Nursery trees and plants	4.3	<1.5
Admire	Field sprayer with nozzle DG110-04	Nursery trees and plants	1.7	<1.0
Admire	Field sprayer with nozzle XLTD02-110/!D120-02	Nursery trees and plants	<1.5	<1.0
Admire	Field sprayer with nozzle XLTD04-110/!D120-04	Nursery trees and plants	<1.0	<1.0
Admire	Field sprayer with low boom height	Nursery trees and plants	2.0	<1.0
Admire	Field sprayer with low boom height	Nursery trees and plants	<1.0	<0.5
Admire	Field sprayer with Släpduk system	Nursery trees and plants	<1.0	x
Admire	Field sprayer with Släpduk system	Nursery trees and plants	<1.0	x
Admire	Field sprayer with nozzle XR110-04	Flowers	3.9	<0.5
Admire	Field sprayer with nozzle DG110-04	Flowers	1.3	<0.5
Admire	Field sprayer with nozzle XLTD02-110/!D120-02	Flowers	<0.5	<0.5
Admire	Field sprayer with nozzle XLTD04-110/!D120-04	Flowers	<0.5	<0.5
Admire	Field sprayer with low boom height	Flowers	1.55	<0.5
Admire	Field sprayer with low boom height	Flowers	<0.5	<0.5
Admire	Field sprayer with Släpduk system	Flowers	<0.5	x
Admire	Field sprayer with Släpduk system	Flowers	<0.5	x
Admire	Field sprayer with nozzle XR110-04	Flower bulbs	5.5	<1.5
Admire	Field sprayer with nozzle DG110-04	Flower bulbs	2.2	<1.0
Admire	Field sprayer with nozzle XLTD02-110/!D120-02	Flower bulbs	<1.5	<1.0
Admire	Field sprayer with nozzle XLTD04-110/!D120-04	Flower bulbs	<1.0	<1.0
Admire	Field sprayer with low boom height	Flower bulbs	2.5	<1.0
Admire	Field sprayer with low boom height	Flower bulbs	<1.0	<0.5
Admire	Field sprayer with Släpduk system	Flower bulbs	<1.0	x
Admire	Field sprayer with Släpduk system	Flower bulbs	<1.0	x
Admire	Tunnel sprayer for bed grown crops	Flower bulbs	<1.0	x

* If a value is indicated with <, it means that the calculated bufferzones are within the standard crop free zones applicable to the crop.

6.1 Fate and behaviour in soil

6.1.1 Persistence in soil

imidacloprid

The following laboratory DT₅₀ values are available for the active substance(s) imidacloprid: 128, 129, 117 and 99 days (geomean 117.7 days). It can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (non-extractable) residues together with the formation of less than 5% of the initial dose as CO₂.

Due to the exceeding of the threshold value of 60 days for the mean DT₅₀ (lab) for imidacloprid, it has to be demonstrated by means of field dissipation studies that the field DT₅₀ is < 90 days. The following field data are provided: normalised values; 85.8, 89.8, 50.6, 94.3, 86, 70.8, 98.3, 41, 82, 71.6, 179.8, 65.7, 27 and, 58.5 days (geometric mean: 71.9/ median: 76.8).

From the results it is shown that the average field DT50 is < 90 days. Therefore, the standards for persistence as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

PECsoil

The concentration of the a.s. in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m³and the normalised field DT₅₀ value. See Table M.1 for input values and results.

Table M.1 PECsoil calculations (5 cm (and HotSpot))

Use	Substance	Rate [kg a.s./ha]	Frequency	Fraction on soil	PECsoil 5 cm [mg a.s./kg]	*PECsoil* *Hot spot* *[mg a.s./kg]*
Apples and pears	imidacloprid	0.105	2	0.2	0.054
Gerbera and chrysanthemum (greenhouse)	item	0.084	3	0.8	0.252
Floriculture (field)	item	0.084	2	0.8	0.173
Flowerbulbs and bulbflowers, (field)	item	0.07	3	0.8	0.210
Flowerbulbs and bulbflowers (protected)	item	0.07	3	0.8	0.210
Flowerbulbs and bulbflowers (dipping)	item	0.210	1	1	0.140¹
Tree nursery and perennial (field)	item	0.084	2	0.8	0.173
Tree nursery and perennial (protected)	item	0.07	2	0.8	0.144
Chicory (spray treatment in seed drill)	item	0.0875	1	1	0.117

¹ value assuming equal distribution over the top 10 cm of the total dose

²value assuming no degradation in soil during cultivation phase and no transport into plants

³ concentration calculated assuming the total dose is equally distributed over the top 5 cm.

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.2. For applications on artificial soil and the application in hop no exposure of soil is expected.

6.1.2 Leaching to shallow groundwater

The leaching potential of the a.s. (and metabolites) is calculated in the first tier according to the RUUBG, using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. The methodology as described in the report "The new decision tree for the evaluation of pesticide leaching from soils", A.M.A van der Linden, J.J.T.I. Boesten, A.A. Cornelese, R. Kruijne, M. Leistra, J.B.H.J Linders, J.W. Pol, A. Tiktak and A.J Verschoor, RIVM report 601450019/2004, RIVM, Bilthoven (2004) has to be used. Input variables are the actual worst-case application rate 0.175 kg/ha for different crops, the crop and an interception value appropriate to the crop (or no interception). The following input data are used for the calculation:

PEARL:

Active substance imidacloprid:

Mean DT₅₀ for degradation in soil (20°C): 117.7 days

Mean K_om (pH-independent): 130.5 L/kg

Saturated vapour pressure: 4·10^-10 Pa (20ºC)

Solubility in water: 610 g/L (20ºC)

Molecular weight: 255.7 g/mol

Other parameters: standard settings of PEARL 2.2.2

Proposed use to artificial soil and the application to hop (nr. 2, 4 and 12) have no exposure to soil and therefore no leaching potential has to be calculated.

The following concentrations are predicted for the a.s. imidacloprid following spring and autumn applications for the other proposed uses, see Table M.2.

Table M.2(a) Leaching of a.s. imidacloprid as predicted by PEARL 2.2.2

Use	Rate substance	Freq	Interval	Fraction intercepted	PEC groundwater	PEC groundwater
	[kg/ha]		[days]		spring [mg/L]	autumn [mg/L]
Apples and pears	0.105	2	7	0.7	0.09	-
Gerbera and chrysanthemum; greenhouse use	0.084	3	7	0.7	0.048	0.053
Floriculture crops; field use	0.084	2	7	0.7	0.026	0.029
Flower bulbs & bulb flowers; field use	0.07	3	7	0.4	0.102	-
Flower bulbs & bulb flowers; protected use	0.07	3	7	0.4	0.102	0.113
Flower bulbs, bulb flowers (dipping)	0.336	1		-	0.446	0.535
Tree nursery crops; field	0.084	2	7	0.7	0.026	-
Tree nursery crops; protected	0.07	2	7	0.7	0.02	0.022
Chicory (spray treatment in seed drill)	0.0875	1		-	0.128

Results of Pearl 2.2.2. using the Kremsmünster scenario are examined against the standard of 0.01 µg/l. This is the BUBG standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

From Table M.2(a) it reads that the expected leaching based on the PEARL-model calculations for the a.s. imidacloprid larger than 0.01 µg/L but smaller than 0.1 µg/L, except for the proposed use in flowerbulbs and bulbflowers, and chicory where concentration are >0.1 mg/L. As the predicted concentration for imidacloprid is larger than 0.01 µg/L, a restriction on the use in groundwater protection areas should be placed on the label. Or further study into the leaching behaviour is necessary as is required for the use in flowerbulbs and bulbflowers, and chicory.

PEARL refined risk assessment

From field degradation studies normalised DegT50 values could be derived which can be used for groundwater modelling (checklist appendix 3 HTB 0.2). From the large dataset on sorption behaviour an arrhythmic mean value for Koc and 1/n can be used.

PEARL:

Active substance imidacloprid:

Geometric mean DegT₅₀ for degradation in soil (normalised field value): 71.9 days

Mean K_om (pH-independent): 130.5 L/kg; 1/n: 0.8.

Saturated vapour pressure: 4·10^-10 Pa (20ºC)

Solubility in water: 610 g/L (20ºC)

Molecular weight: 255.7 g/mol

Other parameters: standard settings of PEARL 2.2.2

Table M.2(b) Leaching of a.s. imidacloprid as predicted by PEARL 2.2.2

Use	Rate substance	Freq	Interval	Fraction intercepted	PEC groundwater	PEC groundwater
	[kg/ha]		[days]		spring [mg/L]	autumn [mg/L]
Apples and pears	0.105	2	7	0.7	<0.001	-
Gerbera and chrysanthemum; greenhouse use	0.084	3	7	0.7	<0.001	<0.001
Floriculture crops; field use	0.084	2	7	0.7	<0.001	<0.001
Flower bulbs & bulb flowers; field use	0.07	3	7	0.4	<0.001	-
Flower bulbs & bulb flowers; protected use	0.07	3	7	0.4	<0.001	<0.001
Flower bulbs, bulb flowers (dipping)	0.210	1		-	<0.001	<0.001
Tree nursery crops; field	0.084	2	7	0.7	<0.001	-
Tree nursery crops; protected	0.07	2	7	0.7	<0.001	<0.001
Chicory (spray treatment in seed drill)	0.0875	1		-	<0.001	-

From Table M.2(b) it reads that the expected leaching based on the refined PEARL-model calculations for imidacloprid is smaller than 0.01 µg/L for all proposed applications. Hence, the applications meet the standards for leaching.

Lysimeter/field leaching studies

For the admission of the product Admire is in March 1997 a lysimeter study was submitted with an imidacloprid seed treatment. This study was evaluated under number 97/0469 by the RIVM and included in the RIVM reportnumber 0865a01. The concentration imidacloprid in the yearly leachate was <0.01 mg/L. A standardisation calculation of the study revealed a concentration of 0.0013 mg/L. A simulation error however could not be calculated correctly. Therefore extrapolation to the Dutch standard situation according to Verschoor et al. could not be done.

The lysimeter conditions however, were classified as vulnerable for soil and comparable to the Dutch situation for climatologic conditions. Because the amount of leachate in the first year was small there could have been enhanced biodegradation. This was however included in the simulation of the lysimeter. It must be considered here that the way of application in the lysimeter study is less representative for the proposed applications of ADMIRE O-TEQ.

Monitoring data

The active substance imidacloprid was observed in the groundwater [DAR]. In Table M.3 observed concentrations in the shallow groundwater are presented.

Table M.3 Monitoring data in groundwater

Location/year	Detection limit [mg/L]	a/n^*	Mean conc. [mg/L]	Maximum conc. [mg/L]
Germany 2000	?	0/9		<LOQ
Germany 2001	?	1/23		£0.1
Germany 2002	?	1/279		£0.1

^*number of observations above detection limit (a)/total number observations (n).

Monitoring results indicate that the substance imidacloprid was detected on some occasions. Concentrations do not exceed the limit for drinking water. Hence, the monitoring data confirm the predicted concentrations.

Conclusions

The proposed application of the product complies with the requirements laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) concerning persistence and leaching in soil.

6.2 Fate and behaviour in water

6.2.1 Rate and route of degradation in surface water

The exposure concentrations of the active substance imidacloprid in the surface water are estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percentage depends on the use. Concentrations in surface water are calculated using the model TOXSWA. For the active substance the following input is required (all on the basis of mean values):

TOXSWA:

Active substance:

DT₅₀ for degradation in water at 20°C: 113 days

DT₅₀ for degradation in sediment at 20°C: 10000 days (default).

K_om for suspended organic matter: 130.5 L/kg

K_om for sediment: 130.5 L/kg

Saturated vapour pressure: 4·10^-10 Pa (temperature dependent)

Solubility in water: 610 mg/L (temperature dependent)

Molecular weight: 255.7 g/mol

Other parameters: standard settings TOXSWA

Because there is no standard method to determine separate degradation rates in water and sediment from the water/sediment study, the DT₅₀ system is used for the water phase and degradation in the sediment is assumed to be zero, which is simulated using a DT₅₀ value of 10000 days.

The proposed uses in drip treatment (2 and 4), dipping of flowerbulbs (9), hops (12), and chicory (14) are considered to have no potential for exposure of surface water.

In Table M.4, the drift percentages and calculated surface water concentrations for the active substance imidacloprid for each intended use are presented.

Table M.4 Overview of surface water concentrations for active substance and metabolite(s) following spring and autumn application

Use	Rate a.s. [kg/ha]	Freq	Drift [%]	PIEC [mg/L]^*		PEC21 [mg/L]^*		PEC28 [mg/L]^*
				Spring	autumn	spring	autumn	spring	autumn
Apple & pear	0.105	2	7	6.7	-	6.0	-	5.5	-
Apple & pear**	0.105	2	1.5	1.42	-	1.26	-	1.06
Gerbera and chrysanthemum; greenhouse use	0.084	3	0.1	0.11	0.04	0.09	0.017	0.09	0.013
Floriculture crops; field use	0.084	2	1	0.76	0.40	0.78	0.11	0.73	0.08
Flowerbulbs, bulb flowers; field	0.07	3	1	0.91	0.336	0.78	0.140	0.73	0.106
Flowerbulbs, bulb flowers; protected	0.07	3	0.1	0.09	0.033	0.08	0.014	0.07	0.011
Tree nursery crop; field	0.084	2	1	0.76	0.40	0.78	0.11	0.73	0.08
Tree nursery crop; protected	0.07	2	0.1	0.09	0.033	0.055	0.009	0.050	0.007

^*calculated according to TOXSWA

** Calculated with drift reducing measures, maximum permissible drift 1.5%. This can be achieved by the following drift reducing measures (in Dutch):

Voor 1 mei (kaal)

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilatorstand uit

Na 1 mei (volblad)

-Tunnelspuit

-Combinatie windhaag op de rand van het rijpad en éénzijdige bespuiting van de laatste bomenrij.

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilatorstand hoog

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilatorstand laag

These exposure concentrations are examined against ecotoxicological threshold values in section 7.2.

Monitoring data

There are no data available regarding the presence of the substance imidacloprid in surface water.

Drinking water criterion

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Act Administrative Law)) that the Ctb should for an authorisation, on the basis of the scientific and technical knowledge, considering the data submitted with the application, also test against the drinking water criterion as regards surface water intended for drinking water production. A mathematical model for this aspect is not available. This means that possibly available data cannot be taken into account adequately. It is therefore not possible to arrive at a scientifically well-based assessment of an expectation for this criterion. The Ctb has not been given the instruments for testing surface water from which drinking water is produced against the drinking water criterion. In order to meet the Court decision, however - from which it can be concluded that the Ctb should make an effort to arrive at a judgement on this point – and as transitional period, to prevent that not a single authorisation can be granted in the period during which a model is being developed and data need to be generated for the application for authorisation, the Ctb has investigated whether the product under consideration and the active substance could give cause for concern about the drinking water criterion.

From the general scientific knowledge collected by the Ctb about the product and its active substance, the Ctb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the BUBG are met.

6.3 Fate and behaviour in air

Route and rate of degradation in air

The vapour pressure is 4 x 10^-10 Pa at 20°C. The Henry constant is at 20°C. The half-life in air is 0.85 hours (Atkinson calculation 24 h day)

At present there is no framework to assess fate and behaviour in air of plant protection products.

6.4 Appropriate fate and behaviour end-points relating to the product and approved uses

See List of End-points.

6.5 Data requirements

none

Overall conclusions fate and behaviour

It can be concluded that:

1. the active substance imidacloprid meets the standards for persistence in soil as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

2. all proposed applications of the active substance imidacloprid meet the standards for leaching to the shallow groundwater as laid down in the BUBG.

3. all proposed applications of the active substance imidacloprid meet the standards for surface water destined for the production of drinking water.

7. Ecotoxicology

List of Endpoints Ecotoxicology

Imidacloprid is an old substance, not placed on Annex I. A DAR is available, RMS is Germany. For the risk assessment the LoEP of January 2006 is used. Comments are added in italic.

Effects on Non-target Species

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to mammals _‡	Mouse LD₅₀: 131 mg as/kg bw
Long-term toxicity to mammals	Rat NOEL: 17 mg as/kg bw NOEC: 250 mg as/kg diet
Acute toxicity to birds _‡	Coturnix japonica LD₅₀: 31 mg as/kg bw _{Confidor SL200 Colinus virginianus LD50: 503 mg prod./kg bw equiv. to 101 mg as/kg bw}
Short term dietary toxicity to _{birds ‡}	Coturnix japonica NOEL: 28.5 mg as/kg bw NOEC: 144 mg as/kg diet LC₅₀:392 mg a.s./kg diet (DAR)
Reproductive toxicity to birds _‡	Colinus virginianus NOEL: 9.3 mg as/kg bw NOEC: 126 mg as/kg diet

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2) _‡
Group	Test substance	Time-scale	Endpoint	Toxicity (mg/L) *
Selenastrum capricornutum	imidacloprid	72 h	E_bC₅₀ biomass E_rC₅₀ growth rate NOEC biomass, NOEC growth rate	> 100 > 100 < 100 < 100
Scenedesmus subspicatus	imidacloprid	72 h	E_bC₅₀ biomass E_rC₅₀ growth rate NOEC biomass, NOEC growth rate	> 10 > 10 10 10
Daphnia magna	imidacloprid	48 h acute	EC₅₀ immobilisation	85
Oncorhynchus mykiss	imidacloprid	96 h acute	LC₅₀	211
Chironomus riparius	imidacloprid	24 h acute	LC₅₀	0.0552

Daphnia magna	imidacloprid	21 d, static renewal	NOEC reproduction	1.8
Oncorhynchus mykiss	imidacloprid	91 d, flow-through	NOEC early life stage	9.02
Chironomus riparius	imidacloprid	28 d, static	NOEC emergence ¹⁾ LC₅₀ emergence	0.00225 0.00311

Chironomus riparius	Confidor SL 200	28 d, static	NOEC emergence ¹⁾ LC₅₀ emergence	0.0027 0.0036

Chironomus riparius	imidacloprid-5-hydroxy (M01)	24 h acute	LC₅₀	0.668
Chironomus riparius	imidacloprid-nitroso (M07)	24 h acute	LC₅₀	0.283
Chironomus riparius	imidacloprid-desnitro (M09)	28 d, static	NOEC emergence ¹⁾ LC₅₀ emergence	33.6 46.0
Chironomus riparius	imidacloprid-urea (M12)	28 d, static	NOEC emergence ¹⁾ LC₅₀ emergence	73.6 249
Chironomus riparius	imidacloprid-AMCP (M16)	28 d, static	NOEC emergence ¹⁾ LC₅₀ emergence	> 105 > 105
Chironomus riparius	imidacloprid-desnitro-olefine (M23)	28 d, static	NOEC emergence ¹⁾ LC₅₀ emergence	12.4 21.3

* nominal concentrations, confirmed by chemical analyses

¹⁾ EC15

Microcosm or mesocosm tests

Outdoor microcosms with sediment, middle Europe: Aachen, Germany, under GLP conditions. Static systems with 2 applications of Confidor SL 200. Test conc: 0.6 -23.5 µg as/L (3.5 - 135.8 µg product/L). Time interval for application 21 d. NOEAEC considering recovery for chironomids and Batidae , most sensitive taxa, was 0.0006 mg/L.

DT₅₀ of imidacloprid in the water phase at all concentrations after both applications: 5.8-13 d.

Bioconcentration
Bioconcentration factor (BCF)	not relevant, logP_ow 0.57
Annex VI Trigger for the bioconcentration factor	100 (for bioaccumulation studies logP_ow 3)
Clearance time (CT₅₀) (CT₉₀)	not relevant
Level of residues (%) in organisms after the 14 day depuration phase	not relevant

Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)

Acute oral toxicity

_LD₅₀_{=
0.0037 µg as/bee (active substance)}

_LD₅₀_{=
0.0056 µg as/bee (formulation)}

Acute contact toxicity

LD₅₀ = 0.081 µg as/bee (active substance)

_LD₅₀_{=
0.042 µg as/bee (formulation)}

Field or semi-field tests

Because of the high toxicity of the active substance all spray applications have to be classified as hazardous for bees. Because of the distinct systemical mode of action in combination with the high toxicity a large number of practical tests have been performed regarding effects on bees by seed treatment. In total 14 cage tests and 11 field tests have been regarded for the evaluation. By all results the seed treatment with imidacloprid containing products has been proved as not hazardous for bees.

Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)

Species	Stage	Test³ substance	Dose (kg as/ha)	Endpoint	Adverse effect⁴	Trigger
Laboratory tests with inert substrate
Typhlodromus pyri	proto-nymphs	Confidor SL 200		mortality	LR₅₀ 4.23 g as/ha	30 %¹
Aphidius rhopalosiphi	adults	Confidor SL 200		mortality	LR₅₀ 0.022 g as/ha	30 %¹
Extended laboratory tests with natural substrate
Typhlodromus pyri	proto-nymphs	Confidor SL 200 on apple leaves		mortality	LR₅₀ 19.13 g as/ha	50 %²
Typhlodromus pyri	proto-nymphs	Confidor SL 200 on apple leaves	0.011	reproduction	no effect (0 %)	50 %²
Aphidius rhopalosiphi	adults	Confidor SL 200 on apple leaves		mortality	LR₅₀ 0.45 g as/ha	50 %²
Aphidius rhopalosiphi	adults	Confidor SL 200 on apple leaves	0.00032	reproduction	no reduction (+11 %)	50 %²
Coccinella septumpunctata	adults	Confidor SL 200 on apple leaves		mortality	LR₅₀ 11.38 g as/ha	50 %²
Coccinella septumpunctata	adults	Confidor SL 200 on apple leaves	0.0047	reproduction	no reduction (+16%)	50 %²
Chrysoperla carnea	Larvae	Confidor SL 200 on apple leaves		mortality	LR₅₀ 10.51 g as/ha	50 %²
Chrysoperla carnea	Larvae	Confidor SL 200 on apple leaves	0.025	reproduction	32 %	50 %²
Poecilus cupreus	adults	Confidor SL 200 on soil		mortality	LR₅₀ 497 g as/ha	50 %²
Poecilus cupreus	adults	Confidor SL 200 on soil	0.33	feeding rate	30 % inhibition	50 %²
Poecilus cupreus	larvae	imidacloprid (as)	mg/kg soil 0.04 0.4 4	mortality	0 % 100 % 100 %	50 %²
Poecilus cupreus	larvae	imidacloprid (as)	mg/kg soil 0.01 0.1	mortality	0 % 40.5 %	50 %²
Poecilus cupreus	larvae	imidacloprid (as)		mortality	LR₅₀ 0.136 mg as/kg soil	50 %²
Poecilus cupreus	larvae	imidacloprid (as)	mg/kg soil 0.015 0.020 0.025 0.030 0.035	mortality	5 % 10 % 15 % 10 % 0 %	50 %²
Poecilus cupreus	larvae	Confidor WG 70	0.029 0.059 0.116	mortality	32 % 56 % 79 %	50 %²

Poecilus cupreus	adults	Gaucho FS 350 on wheat seeds		mortality	77.8 % at seeds coated with 200 mL/dt; drilled at 200 kg/ha	50 %²
Poecilus cupreus	adults	Gaucho WS70 sugar beet seeds		mortality	80.6 % at seeds coated with 90 g as/U; drilled at 25 U/ha	50 %²
Poecilus cupreus	adults	Gaucho WS70 sugar beet seeds		mortality	30 % at 14 seeds/m² 10 % at 40 seeds/m²	50 %²
Aleochara bilineata	adults	Gaucho WS70, sugar beet seeds		reproduction	101 % offspring at seeds coated 90 g as/U; drilled at 10.5 U/ha	50 %²
Pardosa spp.	adults	Gaucho FS 600 on corn seeds	54.9 g as/U drilled at 3.4 U/ha	mortality	4.2 %	50 %²
Pardosa spp.	adults	Gaucho FS 600 on corn seeds	54.9 g as/U drilled at 3.4 U/ha	feeding rate	2.5 %	50 %²

Extended laboratory tests with natural substrate and aged residues
Typhlodromus pyri	proto-nymphs	Confidor SL 200 on apple leaves	2 x 0.1, 14 d interval	mortality	7 days - 33 %	50 %²
				reproduction	21 days - 5 % reduced
				Significant effects were found up to three weeks ageing. After four weeks ageing no effect on mortality and reproduction was found
Aphidius rhopalosiphi	adults	Confidor SL 200 on apple leaves	2 x 0.1, 14 d interval	mortality	7 days - 0 %	50 %²
				reproduction	14 days - (-13 %)
				Significant effects were found at day 0 and 7 after treatment. After fourteen days ageing no effect on mortality and reproduction was found
Aphidius rhopalosiphi	adults	Confidor SL 200 on tomato leaves	2 x 0.1, 14 d interval	mortality	0 days - 83 % 7 days - 54 % 14 days - 54 % 21 days – 3 %	50 %²
				reproduction	14 days - 54 % 21 days - (-28 %)
Poecilus cupreus	larvae	Gaucho FS350 on soil	aged residue conc.	mortality	after 247 d ageing: 0.03 mg as/kg - 11 % 0.06 mg as/kg - (-5.6 %) 0.13 mg as/kg - 0 % 0.25 mg as/kg - 0 % 0.5 mg as/kg - 5.6 %	50 %²

Field or semi-field tests
Species	Stage	Test Substance³	Dose (kg as/ha)	Endpoint	Adverse effect⁴
Semi-field studies
Aphidius rhopalosiphi	adults	Confidor SL 200 on barley, Germany	0.0025 0.0045 0.008 0.014 0.025	reproduction	53 % 88 % 80 % 91 % 96 %
Aphidius rhopalosiphi	adults	Confidor SL 200 on barley, Spain	0.00046 0.0011 0.0024 0.0056 0.0112	reproduction	14.4 % (n.s.) 42.7 % 42.4 % 45.3 % 76.5 % ER₅₀ 3.5 g as/ha
Aphidius rhopalosiphi	adults	Confidor SL 200 on barley, Spain	0.009	reproduction	day 0 - 69.9 % day 3 - 31.2 % day 7 - 20.6 %
Aphidius rhopalosiphi	adults	Confidor SL 200 on barley, Spain	0.018	reproduction	day 0 - 95.3 % day 3 - 30.6 % day 7 - (-9.6 %)
Aphidius rhopalosiphi	adults	Confidor SL 200, drift residues, wind tunnel	0.0028 0.0036 0.0058 0.0085 0.0288	reproduction	47.1 % 62.9 % 82.0 % 93.1 % 98.9 %; ER₅₀ 2.9 g as/ha
Trichogramma dendrolimi	adult	Confidor WG 70, apple	0.015 % as in 1500 L/ha	parasitic efficiency	51.2 %
Poecilus cupreus	adult	Confidor SC 200, apple	2 x 0.75 L/ha. 7 d interval	mortality	not increased (‑5.2 %)
Poecilus cupreus	larvae	Gaucho WS70	80 g as/U drilled at 1.1 U/ha	larvae development influence on indigenous arthropod species	no significant effect no influence
Field studies
Mite fauna		Confidor SC 200, apple	0.244 + 0.227; 10 d interval	reduced abundance	day 7 - 36.6 % day 28 - no effects

¹ Trigger according to Annex VI 91/414/EEC

² Trigger at field rate according to Sanco/10329/2002 (apple 70+105 g as/ha; tomato 2 ´ 100 g as/ha)

³ Test substance Confidor SC 200 = 200 g/L imidacloprid

Gaucho FS350 = 350 g/L imidacloprid

⁴ Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)

Acute toxicity

LC₅₀: 10.7 mg as/kg soil dw

Confidor SL 200:

LC₅₀: 109 mg product /kg soil dw

LC₅₀: 21.8 mg as/kg soil dw

Gaucho WS 70 coated on seeds:

NOEC, 4-5 weeks ³ 100 g as/ha (³ 1.2 U/ha)

Reproductive toxicity

NOEC ³ 0.178 mg as/kg soil dw

Confidor SL 200:

NOEC ³ 0.562 mg as/kg soil dw

Gaucho WS 600 coated on seeds:

NOEC ³ 585 g as/ha (³ 6.5 U/ha)

Field study

Confidor WG 70:

natural earthworm population, duration 6 years

NOEC for abundances ³ 6 x 105 g as/ha (1 application per year).

Gaucho WS 70:

coated on seeds, natural earthworm population, duration 12 months

NOEC ³ 100 g as/ha (1 application) = 1.2 Units/ha. No effects on mortality after 5 and 12 months.

Zelmone 350FS:

on barley seeds, natural earthworm population, duration 6 years

NOEC for abundances ³ 200 mL product/100 kg seed (annual sowing of winter barley)

ConfidorSC 200:

Natural earthworm population. No effects of 2 x 0.105 and 2 x 0.150 kg a.s./ha (interval 7, days, sampling 0.5 and 1.5 years). Study has been evaluated and accepted by the RIVM, but rejected in the DAR. Discussion is pending.

Effects on other soil macro-organisms (Annex IIIA, point 10.6.2)

Reproductive toxicity with collembolan species		Folsomia candida Imidacloprid NOEC 1.25 mg as/kg soil Confidor SL 200 NOEC 0.32 mg as/kg soil Gaucho FS 600 in soil NOEC 0.20 mg as/kg soil Gaucho FS 600 on seeds: NOEC 7.1 U/ha 656 g as/ha Metabolite M06 NOEC 10 mg/kg soil Metabolite M07 NOEC 1.0 mg kg/soi Hypoaspis aculeifer Imidacloprid NOEC ³ 2.67 mg as/kg soil
Field study: Decomposition of organic matter (litter bag test)
Application rate (kg as/ha)	Test level (kg as/ha)	Effects
2 x 0.1, tomato, 0.07 + 0.105 apple	plateau conc. (45.8 µg as/kg soil measured) plus 1 application of 0.1 kg as/ha	Confidor SL 200, Germany, 182 days: no influence on organic matter breakdown after 1, 2, 3, and 6 months
1.3 U/ha (sugar beet seeds, 90 g as/U)	treated winter barley seeds (65.4 g as/100 kg seeds =131 g as/ha) measured soil conc: 22.2-45.3 µg as/kg	Gaucho FS 600, Germany, 196 days: no influence on organic matter breakdown after 28 d, 91 d, 196 d.

Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)

Nitrogen mineralisation	Imidacloprid: 0.2 and 2.0 kg as/ha, 28 d no effects Confidor SL 200: 0.225 and 2.25 kg as/ha, 28 d no effects
Carbon mineralisation	Imidacloprid: 0.2 and 2.0 kg as/ha, 28 d no effects Confidor SL 200: 0.225 and 2.25 kg as/ha, 28 d no effects
Fungi	mg as/kg soil Inhibition Phytophthora nicotianae 30 11.9 % Suillus granulatus 30 1.5 % Mucor circinelloides 30 0 % Paecilomyces marquandii 30 0 % Agaricus bisporus ³ 0.32 NOEC
Field study	-

Impact on water treatment procedures (Annex IIA, point 8.7)

Oxygen consumption by activated sludge

27.9 % inhibition of respiration at 10 000 mg as/L
(highest test conc.)

NOEC: 5600 mg as/L (18.4 % inhibition)

Effects on other non-target organisms (flora and fauna) (Annex IIA, point 8.6)

Flora species	Parameter	Test Substance	Effect plant weight visible damage				Trigger
Limit test, 14 days	mean plant weight and visible damage	imidacloprid	1000 g as/ha pre-emergence		1000 g as/ha post-emergence		50 %*
Avena fatua			no effect		no effect
Echinochloa crus-galli			no effect		no effect
Abutilon theoprasti			no effect		no effect
Galium aparine			no effect		no effect
Sinapis arvensis			no effect		< 50 % (also 500 g)
Xanthium spec.			no effect		no effect
Alopecurus myodonae			< 50 %		no effect
Setaria viridis			< 50 %		no effect
Amaranthus retroflexus			< 50 %		< 50 % (also 500 g)
Zea mays			no effect		no effect
Beta vulgaris			no effect		no effect
			mg as/kg soil)				PEC_{s ini} 0.119 mg as /kg soil
OECD 208	emergence		NOEC	LOEC		EC₅₀
Avena sativa			> 100	³ 100		> 100
Brassica rapa			> 100	³ 100		> 100
Lepidum sativum			> 100	³ 100		> 100
Avena sativa	growth		10	100		> 100
Brassica rapa			> 100	³ 100		> 100
Lepidum sativum			10	100		> 100

* Trigger at field rate according to Sanco/10329/2002

Fauna species	Parameter	Test substance	Effect
Steinernema carpocapsae	viability	imidacloprid 1.5 mg as/L	no effects at 1.5 mg as/L after exposure of 7 days
	parazitation efficacy
	reproduction

Classification and proposed labelling (Annex IIA, point 10)

with regard to ecotoxicological data

N, R 50/53

Formulation ADMIRE O-TEQ

Several new submitted studies are available for ADMIRE O-TEQ. These are summarised and evaluated by the RIVM (03/2006). These studies are performed with a different formulation (imidacloprid 200 OD) instead of ADMIRE O-TEQ (Admire 350 OD), but the different formulations are considered comparable.

Toxicity aquatic organisms

Substance

Species

Method

Duration

[d]

Criterion

Value

[µg product/L]

Value

[µg as/L]

Imidacloprid OD 200

Chironomus riparius

static

NOEC

3.2

Toxicity (bumble)bees

Substance

Species

Method

Duration

[h]

Criterion

Value

product

[μg/bee]

Value

[μg as/bee]

NTN 33893 200 OD

Apis mellifera

oral

LD₅₀

0.296

0.057

contact

LD₅₀

0.406

0.078

Effects on arthropod species

Substance¹	Species	Method	Dose [L/ha]	Dose [kg/ha]	Dose [kg as/ha]	Exposure duration [h]	Parameter	Adverse Effect² [%]
NTN 33893 200 OD	Aphidius rhopalosiphi	residues on leaves	0.00050	0.00052	0.0001	48	mortality parasitisation	46 +9.9
NTN 33893 200 OD	Aphidius rhopalosiphi	residues on leaves	0.0020	0.0021	0.0004	48	mortality parasitisation	17 8.2
NTN 33893 200 OD	Aphidius rhopalosiphi	residues on leaves	0.0090	0.0094	0.0018	48	mortality parasitisation	37 10.8
NTN 33893 200 OD	Aphidius rhopalosiphi	residues on leaves	0.034	0.036	0.0070	48	mortality parasitisation	63 n.d.
NTN 33893 200 OD	Aphidius rhopalosiphi	residues on leaves	0.14	0.147	0.0282	48	mortality parasitisation	94 n.d.
NTN 33893 200 OD	Aphidius rhopalosiphi	residues on leaves, LC₅₀		0.058	0.0012		LC₅₀	50

¹ Test substance NTN 33893 200 OD = 200 g/L imidacloprid

² Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

n.d. = not determined

Toxicity earthworms

Substance

Species

Soil type

[%]

Duration

[d]

Criterion

Value

[g as/ha]

Value

[mg as/kg]¹

imidacloprid OD 200

Eisenia fetida

artificial

NOEC_{body weight}

NOEC_reproduction

56.2

30.0

0.075

0.040

1: assuming 5 cm soil depth and soil bulk density 1500 kg/m³

Toxicity collembola

Substance

Species

Soil type

[%]

Duration

[d]

Criterion

Value

[mg/kg]

Value

[mg as/

kg]

imidacloprid OD 200

Folsomia candida

artificial

10%

NOEC_reproduction

2.03

0.41

Toxicity Terrestrial Non-Target Higher Plants

A vegetative vigour test was performed. Results are given in the table below. A seedling emergence test showed the same results but is less reliable.

Substance	Species	Duration [d]	Criterion	Value [g as/ha]
imidacloprid OD 200	Brassica napus	21	NOEL	>200
imidacloprid OD 200	Lactuca sativa	21	NOEL	>200
imidacloprid OD 200	Glycine max	21	NOEL	>200
imidacloprid OD 200	Cucumis sativus	21	NOEL	>200
imidacloprid OD 200	Zea mays	21	NOEL	>200
imidacloprid OD 200	Avena sativa	21	NOEL	>200

7.1 Effects on birds

Birds can be exposed to the active substance imidacloprid by natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning. For greenhouse uses, no exposure by natural food is expected. Since imidacloprid is a systemic substance, for tray applications before planting, exposure is assessed.

7.1.1 Natural food and drinking water

The threshold value for birds is based on the trigger from the BUBG. The threshold value for acute and short-term exposure is set to 0.1 times the LD₅₀ en LC₅₀ value, and the threshold value for chronic exposure is set to 0.2 times the NOEC. In Table E.1 an overview of toxicity data and resulting threshold values are presented.

In the risk assessment a small bird with a body weight (BW) of 10 gram, a daily food intake (DFI) of 2.9 g/day and a daily water intake (DWI) van 3 g is chosen as representative target species.

Table E.1 Overview of threshold values for birds

Test substance	Exposure		Endpoint	Safety factor	Threshold value
			[mg/kg bw]		[mg/bird]
imidacloprid	Acute	LD50	31	10	0.031
			[mg/kg food]		[mg/kg food]
	Short term	LC50	392	10	39.2
	Long term	NOEC	126	5	25.2

The initial concentration in food is calculated using the relationship of Luttik et al. for leafs, leafy crops, fodder crop and small seeds and insects as 25 * application rate* number of applications. For the non-spray treatments it is assumed that this will result in a worst-case residue concentration in leaves. In first instance, acute, short term and long term exposure is examined against the PIEC_food, without taking decline of the residue between applications into account.

Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In first instance, acute exposure is compared to the PIEC_water.

In Table E.2 an overview is presented of the calculated concentrations of the active substance imidacloprid in food.

Table E.2 Overview of concentrations in food

Use	Substance	Rate	RUD *	freq.	PIEC_food
		[kg a.s./ha]			[mg/kg]
Apples and pears	Imidacloprid	0.105	25	2	5.25
Gerbera and chrysanthemum, greenhouse use	Imidacloprid	0.084	25	3	6.3
Floriculture crops, field use	Imidacloprid	0.084	25	2	4.2
Flower bulbs, bulb flower crops	Imidacloprid	0.070	25	3	5.25
Tree nursery crops and perennials (field)	Imidacloprid	0.084	25	2	4.2
Hops	Imidacloprid	0.126	25	1	3.15
Root growing culture of chicory witloof	Imidacloprid	0.175	25	1	4.38

* residue per unit dose according to Luttik

In Table E.3, threshold exceeding factors at exposure to food and drinking water are presented.

Table E.3 Threshold exceeding factors for natural food and drinking water

Use	Substance	Threshold exceeding factors
		water, acute	food, acute	food, short term	food, long term
		*PIECDWI/ 0.1LD_{50target species}*	*PIECDFI/ 0.1LD_{50target species}*	*PIEC/ 0.1LC**₅₀	*PIEC/ 0.2NOEC**
Apples and pears	Imidacloprid	<0.001	0.491	0.13	0.21
Gerbera and chrysanthemum, greenhouse use	Imidacloprid	<0.001	0.589	0.16	0.25
Floriculture crops, field use	Imidacloprid	<0.001	0.393	0.11	0.17
Flower bulbs, bulb flower crops	Imidacloprid	<0.001	0.491	0.13	0.21
Tree nursery crops and perennials (field)	Imidacloprid	<0.001	0.393	0.11	0.17
Hops (brush application)	Imidacloprid	-	0.29	0.080	0.13
Root growing culture of chicory witloof	Imidacloprid	-	0.410	0.11	0.17

Taking the results in Table E.3 into account, a low risk for birds can be expected due to foraging and drinking of surface water for all proposed uses.

7.1.2 Secondary poisoning

Since the log Pow of imidacloprid amounts 0.57, a low risk as a result of secondary poisoning is expected.

Hence, the proposed uses meet the standards for secondary poisoning as laid down in the BUBG.

Conclusions birds

The proposed application of the product complies with the Regulation of Uniform Principles for Plant protection products (BUBG).

7.2 Effects on aquatic organisms

7.2.1 Aquatic organisms

The threshold values based on toxicity data for aquatic organisms are presented in Table E.4 for the active substance imidacloprid. Threshold values for acute exposure are 0.01 times the lowest L(E)C₅₀-value (daphnids and fish) and 0.1 times the lowest EC₅₀-value for algae.

Threshold values for chronic exposure are 0.1 times the lowest NOEC-value for daphnids and fish. See Table E.4 for the derivation of acute and chronic threshold values.

Table E.4 Overview toxicity endpoints and threshold values for the active substance Imidacloprid

Substance	Organism	Lowest		Safety factor	Threshold value
		L(E)C₅₀ [mg/L]	NOEC [mg/L]		[mg/L]	[mg/L]
imidacloprid	Acute
	Algae	>100		10	>10	>1000
	Daphnids	85		100	0.85	850
	Chironomid	0.0552		100	0.00055	0.552
	Fish	211		100	2.11	2110
	Chronic
	Daphnids		1.8	10	0.18	180
	Fish		9.02	10	0.90	902

The risk for aquatic organisms at the proposed use(s) of the active substance imidacloprid is assessed by comparing calculated surface water exposure concentrations (from section 6.2) with the trigger values mentioned above. In Table E.5 it is indicated if and to what extent exceeding of the threshold values for aquatic organisms occurs.

Table E.5 Threshold exceeding factors for active substance imidacloprid

Use	Substance	*PIEC/ (0.1EC₅₀)*		*PIEC/ (0.01LC₅₀)*		*PIEC/ (0.01LC₅₀)*		*PIEC/ (0.01LC₅₀)*
		Algae		Daphnid		Chironomid		Fish
		Sp.	Aut.	Sp.	Aut.	Sp.	Aut.	Sp.	Aut.
Apple & pear	Imidacloprid	<0.007	-	0.008	-	12.14	-	0.003	-
Gerbera and chrysanthemum; greenhouse use	Imidacloprid	<0.001	<0.001	0.001	<0.001	0.20	0.072	<0.001	<0.001
Floriculture crops; field use	Imidacloprid	<0.001	<0.001	0.001	<0.001	1.38	0.72	<0.001	<0.001
Flower bulbs, bulb flowers; greenhouse	Imidacloprid	<0.001	<0.001	<0.001	<0.001	0.16	0.061	<0.001	<0.001
Flower bulbs, bulb flowers; field	Imidacloprid	<0.001	<0.001	<0.001	<0.001	1.65	0.61	<0.001	<0.001
Tree nursery crop; field	Imidacloprid	<0.001	<0.001	0.001	<0.001	1.38	0.72	<0.001	<0.001
Tree nursery crop; protected	Imidacloprid	<0.001	<0.001	<0.001	<0.001	0.16	0.061	<0.001	<0.001
Use	Substance	*PEC21/ (0.1NOEC)*		*PEC28/ (0.1NOEC)*
		Daphnid		Fish
		Sp.	Aut.	Sp.	Aut.
Apple & pear	Imidacloprid	0.033	-	0.006	-
Gerbera and chrysanthemum; greenhouse	Imidacloprid	0.005	<0.001	<0.001	<0.001
Floriculture crops; field use	Imidacloprid	0.005	<0.001	<0.001	<0.001
Flower bulbs, bulb flowers; field	Imidacloprid	<0.001	<0.001	<0.001	<0.001
Flower bulbs, bulb flowers; greenhouse	Imidacloprid	<0.001	<0.001	<0.001	<0.001
Tree nursery crop; field	Imidacloprid	0.005	<0.001	<0.001	<0.001
Tree nursery crop; protected	Imidacloprid	<0.001	<0.001	<0.001	<0.001

^* calculated with TOXSWA

Taking the results in Table E.5 into account, it appears that for the active substance imidacloprid the proposed uses meet the standards for aquatic organisms as laid down in the BUBG, except for chironomids in the proposed spring uses in the field in apple and pear, floriculture crops, flower bulbs and bulb flowers, and tree nursery crops. A higher tier risk assessment is made in section 7.2.3, together with the sediment organisms.

7.2.2 Risk assessment for bioconcentration

Since the Log Pow of imidacloprid is 0.57, a low risk for bioconcentration is expected.

Hence, imidacloprid meets the standards for bioconcentration as laid down in the BUBG.

7.2.3 Risk assessment for sediment organisms

Since the NOEC for daphnids is below 0.1 mg/L and the water–sediment study indicates that over 10% of the a.s. imidacloprid is found in the sediment after 14 days, there is a potential risk for sediment organisms.

For imidacloprid an EC₁₅ of 0.00225 mg/L is available. For formulation Admire OD 200 an NOEC of 0.0032 mg/L is available.

The lowest threshold value for Chironomus is 0.1 x NOEC = 0.225 µg/L.

In Table E.6 it is indicated if and to what extent exceeding of the threshold values for aquatic organisms occurs.

Table E.6 Threshold exceeding factors for active substance imidacloprid

Use	Substance	*PEC28/ (0.1NOEC)*
		Chironomid
		Sp.	Aut.
Apple & pear	Imidacloprid	24	-
Gerbera and chrysanthemum; greenhouse	Imidacloprid	0.40	0.058
Floriculture crops; field use	Imidacloprid	3.24	1.78
Flower bulbs, bulb flowers; field	Imidacloprid	4.04	1.49
Flower bulbs, bulb flowers; greenhouse	Imidacloprid	0.40	0.15
Tree nursery crop; field	Imidacloprid	3.24	1.78
Tree nursery crop; protected	Imidacloprid	0.40	0.15

^* calculated with TOXSWA

When this value is examined against the PIEC in water, there is no exceeding of the threshold value for the use in flower bulbs and bulb flowers (protected), and tree nursery crops (protected).

For the use in apple and pear, floriculture crops (field), flowerbulbs and bulbflowers (field) and tree nurseries (field), the threshold is exceeded. Higher tier assessment is necessary.

Second tier assessment

Two outdoor microcosm studies provide information about effects on aquatic populations and communities. The first study was conducted in Texas. The identification of the mayfly (Ephemeroptera), midges (Chironomidae), caddisflys (Trichoptera) and beetles (Coleoptera), and amphipods as the most sensitive taxa are in line with the findings in the single species tests. The NOEAEC considering recovery was derived to be 2 µg/L (nominal). However, the half-life of test item was very short, which might be a result of higher light intensities in Texas compared to conditions in middle Europe.

Therefore, the second study, conducted in Germany, is considered to be more reliable. In this study, the average DT₅₀ in water was determined to be 6 – 13 days. Zooplankton, phytoplankton, chlorophyll-a of phytoplankton, emerging insects (collected by emergence traps), and macrozoobenthos (macroinvertebrates, collected by means of artificial substrate samplers and by sediment sampling) were regularly monitored. The NOEC for Chironomids and Baetidae as the most sensitive taxa, was 0.6 µg as/L for two applications. The measured primary effects at 1.5 µg as/L are considered as long-term effects with substantial consequences on the composition of the biocoenosis. Secondary effects as a result of the direct effects on the most sensitive group (insects) could also be documented at the abiotic level. There was no recovery of the community in a tolerable period of time. Therefore, a NOEC of 0.6 µg as/L is suggested.

An expert evaluation of T. Brock is also included in the DAR. In this evaluation Brock concluded that at 3.8 µg a.s./L (nominal value, measured concentration is 4.4 µg/L) only transient effects are found and that recovery did take place within 8 weeks.

Because only one micro-/mesocosm study is available, conducted on only one site during one time period, the spatio-temporal variation must be taken into account. From research done by Alterra, it became clear that this variation depends on the toxicity endpoint, which is used for risk assessment. If the NOEC-value is taken as the relevant endpoint, the variation in space and time is in general not large. However, if recovery is taken into account and a NOEAEC-value is established, the spatio-temporal variation is much greater. In that case a safety factor is necessary. Based on available data from Alterra a safety factor of 3 has to be applied to the NOEAEC-value. This value is in most cases sufficiently protective.

This results in a corrected NOEAEC value of 4.4/3 = 1.47 µg a.s./L.

Since the NOEAEC value is used and not the NOEC value, the bufferzones proposed by the notifier for the use in nursery trees, plants, flowers and flower bulbs (see LOEP, fate section) are not necessary.

Only the use in apple and pear has higher expected concentrations in surface water. All other applications have lower PIEC values and the risk for these uses is considered acceptable.

Drift reducing measures

The applicant proposes several drift reducing measures for fruit. However, not all proposed drift reducing measures are considered adequate. To get an acceptable risk the drift in apple and pear should be below 1.5% (the applicant proposed 2.5%). The following drift reducing measures are considered acceptable (in Dutch):

Voor 1 mei (kaal)

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilatorstand uit

Na 1 mei (volblad)

-Tunnelspuit

-Combinatie windhaag op de rand van het rijpad en éénzijdige bespuiting van de laatste bomenrij.

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilator aan.

With these drift reducing measures an acceptable risk is expected for aquatic organisms.

Therefore, the active substance imidacloprid meet the standards for aquatic insects (based on chironomids) and sediment organisms as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG), if the drift reducing measures mentioned above are placed on the label.

Conclusions aquatic organisms

The proposed applications of the product comply with the Regulation of Uniform Principles for Plant protection products (BUBG).

7.3 Effects on terrestrial vertebrates other than birds

Mammals can be exposed to the active substance imidacloprid by natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning. Since imidacloprid is a systemic substance, for tray applications before planting, exposure is assessed.

7.3.1 Natural food and drinking water

The threshold value for mammals is based on the trigger from the BUBG. The threshold value for acute exposure is set to 0.1 times the LD₅₀ value, and the threshold value for chronic exposure is set to 0.2 times the NOEC. In Table E.6 an overview of toxicity data and resulting threshold values are presented.

In the risk assessment a small mammal with a body weight (BW) of 6 gram (i.e., a mouse), a daily food intake (DFI) of 1.025 g/day and a daily water intake (DWI) van 1.8 g is chosen

Table E.6 Overview of threshold values for mammals

Substance	Exposure		Endpoint	Safety factor	Threshold value
			[mg/kg bw]		[mg/mammal]
imidacloprid	Acute	LD₅₀	131	10	0.0786
			[mg/kg food]		[mg/kg food]
	Long term	NOEC	250	5	50

The initial concentration in food is calculated using the relationship of Luttik et al. for leafs, leafy crops, fodder crop and small seeds and insects as 25 * application rate* number of applications. In first instance, acute and long-term exposure is examined against the PIEC_food, without taking decline of the residue between applications into account.

Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In first instance, acute exposure is compared to the PIEC_water.

In Table E.7 an overview is presented of the calculated concentrations of the active substance imidacloprid in food.

Table E.7 Overview concentrations in food

Use	Substance	Rate	RUD *	freq.	PIEC_food
		[kg a.s./ha]			[mg/kg]
Apples and pears	Imidacloprid	0.105	25	2	5.25
Gerbera and chrysanthemum, greenhouse use	Imidacloprid	0.084	25	3	6.3
Floriculture crops, field use	Imidacloprid	0.084	25	2	4.2
Flower bulbs, bulb flower crops	Imidacloprid	0.070	25	3	5.25
Tree nursery crops and perennials (field)	Imidacloprid	0.084	25	2	4.2
Hops	Imidacloprid	0.126	25	1	3.15
Root growing culture of chicory witloof	Imidacloprid	0.175	25	1	4.38

residue per unit dose according to Luttik

In Table E.8, threshold-exceeding factors at exposure to food and drinking water are presented.

Table E.8 Threshold exceeding factors for natural food and drinking water

Use	Substance	Threshold exceeding factors
		water, acute	food, acute	food, long term
		*PIECDWI/ 0.1LD_{50target species}*	*PIECDFI/ 0.1LD_{50target species}*	*PIEC/ 0.2NOEC**
Apples and pears	Imidacloprid	<0.001	0.068	0.11
Gerbera and chrysanthemum, greenhouse use	Imidacloprid	<0.001	0.082	0.13
Floriculture crops, field use	Imidacloprid	<0.001	0.055	0.084
Flower bulbs, bulb flower crops	Imidacloprid	<0.001	0.068	0.11
Tree nursery crops and perennials (field)	Imidacloprid	<0.001	0.055	0.084
Hops (brush application)	Imidacloprid	-	0.041	0.063
Root growing culture of chicory witloof	Imidacloprid	-	0.057	0.088

Taking the results in Table E.8 into account, it appears that a low risk for mammals can be expected due to foraging and drinking of surface water for all proposed uses.

Therefore all proposed uses meet the standards for mammals as laid down in the BUBG.

7.3.2 Secondary poisoning

Since the log Pow of imidacloprid amounts 0.57, a low risk as a result of secondary poisoning is expected.

Hence, the proposed application of the product ADMIRE O-TEQ meet the standards for secondary poisoning as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

Conclusions mammals

The proposed application of the product complies with the Regulation of Uniform Principles for Plant protection products (BUBG)

7.4 Effects on bees

The risk assessment for bees and bumblebees is based on the ratio between the single application rate and toxicity endpoint (LD₅₀ value). An overview of the risk at the proposed uses is given in Table E.9.

Table E.9 Risk for bees and bumblebees

Use

Application rate a.s.

LD₅₀

Rate/LD₅₀

[g/ha]

[µg/bee]

All uses

70 -336

0.0037 (oral)

18919-90811

Since the ratio rate/LD₅₀ is above 50, there is a high risk for bees.

In the DAR 25 cage tests and field studies are described. From these studies can be concluded that when applied before flowering (apples, at mouse ear stage), no effects on bees were found during flowering at a dose of 0.105 kg a.s./ha.

On the instructions for use, the following restrictions are given (in Dutch):

“Gevaarlijk voor bijen en hommels, om de bijen te beschermen mag u dit product niet gebruiken op in bloei staande gewassen. Gebruik dit product niet op plaatsen waar bijen actief naar voedsel zoeken, gebruik dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het bloeit.”

Due to this restriction no exposure via nectar and/or pollen is expected. Furthermore, bees do not forage on potatoes and the insecticidal mechanism of imidacloprid prevents the formation of honey dew (this statement was given for the risk assessment of Amigo (350 g/L imidacloprid) and accepted by the CTB (C.140.3.8, 11/2003)).

With these restrictions a low risk is expected for all applications of ADMIRE O-TEQ

Hence, all proposed uses meet the standards for bees and bumblebees as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG). On the instructions for use the following warning sentence is placed:

Conclusions bees

The product complies with the Regulation of Uniform Principles for Plant protection products (BUBG).

7.5 Effects on any other organisms (see annex IIIA 10.5-10.8)

7.5.1 Effects on non-target arthropods

The proposed applications of ADMIRE O-TEQ can be divided in several exposure groups:

-Spray applications (apple and pear, floriculture crops, flower bulbs and bulb flowers, tree nursery crops and perennials)

-Dripping applications on artificial substrate (eggplant, gherkins, courgettes, cucumber, tomato, red- and sweet pepper, gerbera and chrysanthemum)

-Brush application (hops)

-Dipping (flower bulbs and bulb flowers)

-Soil treatment (chicory)

For dripping and brush applications no exposure to non-target arthropods is expected. For dipping and soil treatment applications only exposure to soil is expected.

Spray applications

The risk for non-target arthopods is assessed by calculating Hazard Quotients. To enable this, Lethal Rate values (LR₅₀) are needed. Based on LR₅₀-values from studies with the two standard species Aphidius rhopalosiphi (LR₅₀ =0.0022 g/ha) and Typhlodromus pyri (LR₅₀ = 4.23 g/ha) an in-field and an off-field Hazard Quotient (HQ) can be calculated according to the (new) assessment method established in the SETAC/ESCORT 2 workshop and described in the HTB (v 0.2). Hazard Quotients should be below the trigger value of 2 to meet the standards.

No exposure is expected for drip treatments on artificial substrate. Off-field exposure is only expected for the field uses in apple and pears, floriculture crops, flower bulbs and tree nursery crops and perennials. For the dipping application of flower bulbs, application in witloof only exposure to soil arthropods is expected.

DT₅₀ values from leaves vary from <1 day to 2.6 days (reported in the DAR, tested crops: ryegrass, tomato leaves). The MAF can thus be set on 1.3.

Resulting Hazard Quotients are presented in Table E.10.

Table E.10 HQ-values for A. rhopalosiphi and T. pyri (first tier, laboratory studies)

	Application rate (g a.s./ha)	MAF¹	Drift factor/ Vegetation factor²	Safety factor²	LR₅₀ (g a.s./ha)	HQ
Flower bulbs, bulb flowers
In-field
A. rhopalosiphi	70	1.3	-	-	0.0022	41364
T. pyri	70	1.3	-	-	4.23	21.5
Off-field
A. rhopalosiphi	70	1.3	0.01	10	0.0022	4136
T. pyri	70	1.3	0.01	10	4.23	2.15
Floriculture crops, tree nursery crops and perennials
In-field
A. rhopalosiphi	84	1.3	-	-	0.0022	49636
T. pyri	84	1.3	-	-	4.23	25.8
Off-field
A. rhopalosiphi	84	1.3	0.01	10	0.0022	4964
T. pyri	84	1.3	0.01	10	4.23	2.58
Apple and pear
In-field
A. rhopalosiphi	105	1.3	-	-	0.0022	62045
T. pyri	105	1.3	-	-	4.23	32.3
Off-field
A. rhopalosiphi	105	1.3	0.0375	10	0.0022	23267
T. pyri	105	1.3	0.0375	10	4.23	12.1

¹: Multiple Application Factor

²: off-field: drift factor = 10% (early fruit 37.5%), vegetation dilution factor = 10, safety factor = 10 (default values)

From the above table, it reads that both in- and off-field HQ values are above the trigger value of 2.

Based on the data presented above a risk for non-target arthropods cannot be excluded. Therefore higher tier studies are required. In the second tier, LC50 and EC50 values are used to calculate the hazard quotients. Hazard Quotients should be below the trigger value of 2 to meet the standards. For imidacloprid only the LC50 values are used, since these are lower than the EC50 values.

Table E.11 HQ-values for A. rhopalosiphi and T. pyri (second tier, extended laboratory studies)

	Application rate (g a.s./ha)	MAF¹	Drift factor/ Vegetation factor²	Safety factor²	LR₅₀ (g a.s./ha)	HQ
Flower bulbs and bulb flowers
In-field
A. rhopalosiphi	70	1.3	-	-	1.2	75.8
T. pyri	70	1.3	-	-	19.13	4.76
Off-field
A. rhopalosiphi	70	1.3	0.01	10	1.2	7.58
T. pyri	70	1.3	0.01	10	19.13	0.48
Floriculture crops, tree nursery crops and perennials
In-field
A. rhopalosiphi	84	1.3	-	-	1.2	105
T. pyri	84	1.3	-	-	19.13	5.71
Off-field
A. rhopalosiphi	84	1.3	0.01	10	1.2	10.5
T. pyri	84	1.3	0.01	10	19.13	0.57
Apple and pear
In-field
A. rhopalosiphi	105	1.3	-	-	1.2	114
T. pyri	105	1.3	-	-	19.13	7.14
Off-field
A. rhopalosiphi	105	1.3	0.0375	10	1.2	51.19
T. pyri	105	1.3	0.0375	10	19.13	2.68

¹: Multiple Application Factor

²: off-field: drift factor = 10% (early fruit 37.5%), vegetation dilution factor = 10, safety factor = 10 (default values)

From table E.11, it reads that both in- and off-field HQ values are above the trigger value of 1, except the off-field risk for T. pyri in the use in flower bulbs and bulb flowers, floriculture crops, tree nursery crops and perennials.

Based on the data presented above a risk for non-target arthropods cannot be excluded. Therefore further higher tier studies are required.

For T. pyri an extended laboratory test with aged residues is available. After four weeks ageing no effects on mortality and reproduction were found at an application rate of 2 x 0.105 kg a.s./ha. This shows that recovery within a relevant period is possible. Also a field study with mites is available. At an application rate of 0.244 + 0.277 kg a.s./ha a maximum reduced abundance of 36.6% was found after seven days. After four weeks no effects on abundance was found.

Therefore no unacceptable risk is expected for this species.

For A. rhopalosiphi, several aged residue and field studies are available. The semi-field tests in off-field scenario’s show ER₅₀ values of 2.9 and 3.5 g a.s./ha. Compared to the off-field exposure concentration of minimum 9.1 g/ha (2 x 70 g/ha for flower bulbs) and maximum of 51.19 g/ha (fruit), an off-field risk is expected for all proposed applications.

The aged residue tests show that at relevant application rates, no effects on mortality and reproduction are found, after 2-3 weeks ageing. This shows that recovery within a relevant period is possible and no unacceptable long term risk is expected.

For greenhouse applications no off-field exposure is expected, but recovery for in-field use is only possible by re-introduction. Therefore the following warning sentence should be placed on the label (in Dutch): “Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling”.

The applicant agrees with this warning sentence. Therefore, no risk is expected for the standard species.

Leaf dwelling species: Coccinella septempunctata and Chrysoperla carnea.

In extended laboratory studies LR₅₀ values were derived for Coccinella septempunctata and Chrysoperla carnea. The LR₅₀ value for C. septempunctata was 11.38 g a.s./ha, and for C. carnea 10.51 g a.s./ha. Reproduction was not affected at these rates. For both species the LC50 value is lower than all proposed rates in-field and the expected off field rate in apple and pear (51.2 g a.s./ha). For the off-field situation the dose-rates are comparable with the expected off-field doses for flower bulbs and bulb flowers (9.1 g a.s./ha) and floriculture crops, tree nursery crops and perennials (10.9 g a.s./ha). For the use in flower bulbs and bulb flowers, floriculture crops, tree nursery crops and perennials, the off-field risk is acceptable. Since the DT₅₀ value from leaves is < 1-2.6 days, it is expected that for the in-field situation for the field uses recovery will take places. The risk is acceptable. For the use in apple and pear and for the greenhouse uses a risk is still expected.

Therefore the following warning sentence should be placed on the label (in Dutch): “Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling”.

The applicant agrees with this warning sentence. Therefore, no risk is expected for the leaf dwelling species.

Soil dwelling arthropods: Poecilus cupreus, Aleochara bilineata, Pardosa sp.

For P. cupreus an extended laboratory for spray treatments is available. An LR50 of 497 g/ha was derived. Food consumption was inhibited with 30% at a rate of 330 g/ha. These rates are higher than all proposed rates. For spay treatments no unacceptable effects are expected for this species.

Conclusion spray treatment

The most sensitive species is A. rhopalosiphi. An aged residue test shows that effects will disappear after 2-3 weeks of ageing. Semi-field tests with off-field exposure rates show low ER50 values of 2.9-3.5 g a.s./ha. An unacceptable off-field risk is expected for the use in apple and pear. Also for leaf dwelling arthropods an off-field risk is expected for the use in apple and pear.

For greenhouse applications no off-field exposure is expected, but recovery for in-field use is only possible by re-introduction. Therefore the following warning sentence will be placed on the label (in Dutch): “Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling”.

Hence, the standards for non-target arthropods for spray applications, as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

Soil applications

Soil arthropods: Folsomia candida and Hypoaspis aculeifer

For the application in bulb flowers and flower bulbs, and chicory only exposure to soil is expected. For these applications only soil arthropods are assessed.

Examination of the PIEC takes place against the trigger of 0.2*NOEC. See table E.12.

Table E.12 Overview of soil concentrations and threshold exceeding factors at chronic exposure

Use	Substance	Application rate [kg/ha]	Frequency	PIECsoil [mg/kg]	NOEC [mg/kg]	Threshold exceeding factor
Folsomia candida
Flower bulbs and bulb flowers (dipping)	Imidacloprid (a.s.)	0.210	1	0.140	1.25	0.56
	Imidacloprid 200 OD (a.s.)	0.210	1	0.140	0.41	1.71
Chicory	Imidacloprid (a.s.)	0.0875	1	0.117	1.25	0.47
	Imidacloprid 200 OD (a.s.)	0.0875	1	0.117	0.41	1.43
Hypoaspis aculeifer
Flower bulbs and bulb flowers (dipping)	Imidacloprid (a.s.)	0.210	1	0.140	≥ 2.67	0.39
Chicory	Imidacloprid (a.s.)	0.0875	1	0.117	≥ 2.67	0.22

Table E.12 show that a risk is expected for all soil application treatments for Folsomia candida. For Hypoaspis aculeifer only a low risk is expected for both soil application treatments. Since F. candida is more sensitive than H. aculeifer, only higher tier testing with F. candida is required. No higher tier studies are available.

However, data for other soil arthropods are available.

Other soil arthropods: Poecilus cupreus, Aleochara bilineata, Pardosa sp.

Several studies with several formulations containing imidacloprid are available for soil dwelling arthropods.

Most information is available for P. cupreus. Available LC50 values are 497 g/ha for adults and 0.136 mg a.s./kg soil for larvae. Compared with the expected concentration in the soil an acceptable risk is expected for the use in Chicory (0.117 mg/kg). For the use in Flower bulbs and bulb flowers, the expected concentration in soil is 0.140 mg/kg. Since this expected concentration is close to the LC50 of 0.136 mg/kg, it is assumed that no long term effects are expected for this use.

An extended laboratory test on larvae of P. cupreus with the formulation Gaucho showed no effects at an application rate of 0.5 mg/kg after 247 days of ageing. A semi-field study showed no effects on larvae at an application rate of 88 g/ha.

Both test are considered of little relevance for the proposed application of ADMIRE O-TEQ, since the applied dose was too low.

Therefore it is unclear whether effects are to be expected at proposed application rates of imidacloprid.

For A. bilineata and Pardosa sp. no effects were found on reproduction (A. bilineata) and mortality and reproduction (Pardosa). At rates of 945 g a.s./ha and 187 g a.s/ha respectively. These application rates are higher than the proposed application rate of 175 g imidacloprid/ha for the use in chicory. For the use in flower bulbs and bulb flower, the proposed application rate is 336 g/ha. A low risk is expected for A. bilineata. For Pardosa sp. It is unclear, since the tested concentration was too low.

Conclusion soil applications

F. candida, H. aculeifer and A. bilineata are all relevant species that are tested in the soil, while P. cupreus and Pardosa spec. are tested on the soil and are thus less relevant.

Larvae of P. cupreus, however are also tested in soil and could also be considered relevant.

Of all the relevant species tested, larvae of P. cupreus seem to be the most sensitive with an LC50 of 0.136 mg a.s./kg tested with the active substance, compared to F. candida: NOEC = 1.25 mg a.s./kg (a.s. tested) or 0.41 mg a.s./kg (formulation tested). Since an acceptable risk is shown for P. cupreus larvae for the use in flower bulbs and bulb flowers, and chicory, it is assumed that the risk for the other soil arthropods is also acceptable for these uses.

Hence, the standards for non-target arthropods for soil applications as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG) are met.

7.5.2 Earthworms

The trigger value for acute toxicity to earthworms is based on the standards from the BUBG and amounts 0.1 * LC₅₀. The initial PEC soil is examined against that value. Since the logPow of the active substance imidacloprid < 2, correction to the reference soil containing 4.7 % organic matter is not necessary. The trigger value for earthworms based on this normalised
14-day LC₅₀(10.7 mg/kg) of the active substance amounts 1.07 mg/kg. PECsoil is taken from section 6.1.1. Table E.13 presents the PECsoil and the threshold exceeding for the active substance imidacloprid.

Table E.13 Overview of soil concentrations and exceeding of threshold values at acute exposure

Use	Substance	Application rate [kg/ha]	Freq.	Fraction on soil	PIECsoil [mg/kg]	LC₅₀	Exceeding of threshold
Apples and pears	imidacloprid	0.105	2	0.2	0.054	10.7	0.050
Floriculture (greenhouse)	item	0.084	3	0.8	0.252	10.7	0.24
Floriculture (field)	item	0.084	2	0.8	0.173	10.7	0.16
Flower bulbs and bulb flowers	item	0.07	3	0.8	0.210	10.7	0.20
Flower bulbs and bulb flowers (dipping)	item	0.210	1	1	0.140¹	10.7	0.13
Tree nursery and perennial (field)	item	0.084	2	0.8	0.173	10.7	0.16
Tree nursery and perennial (protected)	item	0.07	2	0.8	0.144	10.7	0.13
Chicory (spray treatment in seed drill)	item	0.0875	1	1	0.117	10.7	0.11

¹ value assuming equal distribution over the top 10cm of the total dose

In view of the results presented in Table E.13, a low acute risk for earthworms is expected at the proposed uses in apple and pear, floriculture, flower bulbs and bulb flowers, tree nurseries and chicory.

Since the DT₉₀-value of the active is > 100 days, sublethal studies are required for all uses.

Examination of the PIEC takes place against the trigger of 0.2*NOEC. See Table E.14.

Table E.14 Overview of soil concentrations and threshold exceeding factors at chronic exposure

Use	Substance / formulation [a.s.]	Application rate [kg/ha]	Freq.	Fraction on soil	PIECsoil [mg/kg]	NOEC [mg/kg]	Threshold exceeding factor
Apples and pears	imidacloprid	0.105	2	0.2	0.054	≥ 0.178	1.52
	Imidacloprid 200 OD (a.s.)					0.040	6.75
Floriculture (greenhouse)	imidacloprid	0.084	3	0.8	0.252	≥ 0.178	7.08
Floriculture (greenhouse)	Imidacloprid 200 OD (a.s.)					0.040	31.5
Floriculture (field)	imidacloprid	0.084	2	0.8	0.173	≥ 0.178	4.86
	Imidacloprid 200 OD (a.s.)					0.040	21.6
Flower bulbs and bulb flowers	imidacloprid	0.07	3	0.8	0.210	≥ 0.178	5.90
Flower bulbs and bulb flowers	Imidacloprid 200 OD (a.s.)					0.040	26.3
Flower bulbs and bulb flowers (dipping)	imidacloprid	0.210	1	1	0.140¹	≥ 0.178	3.93
Flower bulbs and bulb flowers (dipping)	Imidacloprid 200 OD (a.s.)					0.040	28
Tree nursery and perennial (field)	imidacloprid	0.084	2	0.8	0.173	≥ 0.178	4.86
Tree nursery and perennial (field)	Imidacloprid 200 OD (a.s.)					0.040	17.5
Tree nursery and perennial (protected)	imidacloprid	0.07	2	0.8	0.144	≥ 0.178	4.04
Tree nursery and perennial (protected)	Imidacloprid 200 OD (a.s.)					0.040	18.0
Chicory (spray treatment in seed drill)	imidacloprid	0.0875	1	1	0.117	≥ 0.178	3.29
Chicory (spray treatment in seed drill)	Imidacloprid 200 OD (a.s.)					0.040	14.6

¹ value assuming equal distribution over the top 10cm of the total dose

The threshold value for earthworms at chronic exposure to the active substance imidacloprid is exceeded. Higher tier assessment is necessary.

Second tier

Several field studies are available. One field study concerns a spray application in apple. One application of 0.105 kg a.s./ha was applied for a period of 6 years. The PIEC soil after the last application (directly after the application in the sixth year), corrected for the fraction on the soil of 0.2, is calculated to be 0.0289 mg a.s./kg. This is lower than the expected PIEC values of all spray applications.

In a study performed with Confidor 200 SC, no effects on biomass, numbers and biodiversity was found at application rates of 2 x 0.105 and 2 x 0.150 kg a.s./ha. The interval was 7 days.

The acceptability for the monograph is still under discussion. The RMS requested more background information. However, the RIVM has evaluated the study for previous authorisation purposes and concluded that the study was acceptable. For current risk assessment this conclusion is followed until a final conclusion for the European dossier is made.

Since the tested dose (2 x 0.150 mg a.s./kg) is higher than all the application rates applied for, the risk for earthworms is acceptable for all spayed treatments.

For the use in flower bulbs and bulb flowers (dipping), and chicory, imidacloprid is incorporated into the soil. Exposure is more comparable (although not completely) to seed treatments than to spray treatment. Field tests performed with seed treatments are available. In the first test with Gaucho WS70 no effects were found at the highest tested application rate of 100 g a.s./ha (=1.2 Unit beet seeds).

In the second field test with Zelmone 350 FS no effects were found after 6 years sowing of treated barley seed, with an application rate of 70 g a.s./100 kg seed. No information is given about the amount of seeds/ha. Assuming 140 kg seed/ha, the application rate amounts
119 g a.s./ha.

The proposed application in flower bulb and bulb flowers is 210 g a.s./ha (0.140 mg a.s./kg), for chicory is 175 g a.s./ha (0.233 mg a.s./kg) and for chicory is 87.5 g a.s./ha (0.117 mg a.s./kg). These application rates are higher than the application rates in the field studies.

When using the study performed with confidor 200 SC as used for the spray treatments, some the endpoint has to be recalculated to mg a.s./kg soil, in order to be comparable. When using a application rate of 0.150 kg a.s./ha, a frequency of 2, interval of seven days, a DT₅₀field of 71.9 days and a interception of the crop of 0.5, assuming an equal distribution of 5 cm and a soil density of 1500 g/dm², the calculated concentration in soil is 0.194 mg a.s./kg soil.

When comparing this concentration to the PIEC of the proposed soil applications, it appears that the expected concentration in soil for the applications in flower bulb, bulb flowers, and chicory is lower than the tested concentration, and a low risk is expected.

Hence, the all proposed applications meet the standards for earthworms as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

7.5.3 Effects on soil micro-organisms

In the tested soils no effects are observed on nitrogen and carbon metabolism processes at relevant application rates of 2.0 kg a.s./ha with the active substance imidacloprid. Since the effect percentage is below 25% after 28 days, the standards from the Regulation of Uniform Principles for Plant protection products (BUBG) regarding soil micro-organisms are met.

This conclusion is confirmed by toxicity data for fungi. A maximum effect of 12% was found at 30 mg a.s./kg soil (four species).

7.5.4 Effects on activated sludge

An EC₅₀ value of >10000 mg/L is available. The trigger is set to 0.01* EC₅₀.corresponding to >100000 µg/L. The concentration in the influent of the sewage treatment plant (STP) has to be examined against this trigger using the model application USES. However, to date there is no module available to calculate influent concentrations for most application types (with the exception of mushroom use, public gardens and amenity uses). Considering the low toxicity to activated sludge, no risk is expected.

Therefore, the proposed applications meet the standard for activated sludge as laid down in the Regulation of Uniform Principles for Plant protection products (BUBG).

7.5.5 Effects on non target-plants

The risk assessment for non-target plants is based on an off-crop situation with a drift percentage of 10%. The exposure thus equals 0.1 * the application rate. The threshold value is 0.2 times the lowest EC₅₀ value. This EC₅₀ is >200 g a.s./ha (NOEL). The ratio between EC₅₀ and the maximum exposure concentration is < 0.483 (floriculture crops).

For apple and pear the drift percentage is 37.5% before May and 7% for May till September. For this application the ratio between EC₅₀ and the maximum exposure concentration is
0.375 x 105 x 1.7 / 0.2 x 200 < 1.67 before May and 0.07 x 105 x 1.7 / 0.2 x 200 < 0.31 from May till September.

The risk for non-target plants is low for all proposed applications, except apple and pear in April. Therefore the standards from the Regulation of Uniform Principles for Plant protection products (BUBG) regarding effects on non-target terrestrial plants are not met. An adequate risk evaluation with ADMIRE O-TEQ (e.g. field test, drift reducing measures) is required.

Because the risk assessment to non-target terrestrial plants is not officially part yet of the actual framework of environmental assessment this requirement does not have to be fulfilled for the current assessment.

Conclusions any other organisms

The proposed applications of the product do not comply with the Regulation of Uniform Principles for Plant protection products (BUBG).

7.6 Appropriate ecotoxicological end-points relating to the product and approved uses

See List of End-points.

7.7 Data requirements

No additional data requirements.

7.8 Classification and Labeling

Proposal for the classification of imidacloprid (symbols and R phrases)
(EU classification)

Symbol:

Indication of danger: Dangerous for the environment

Risk phrases

R50/53

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Proposal for the classification and labeling of the formulation concerning the environment

Symbol:	N	Indication of danger:	Dangerous for the environment.
R phrases	50/53	Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

S phrases	60	This material and its container must be disposed of as hazardous waste. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt: 1) Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven. 2) Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd. 3) Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)
	S61	Avoid release to the environment. Refer to special instructions/safety data sheets.

Explanation:
Hazard symbol:	The assignment of the hazard symbol N follows from a study with the active substance for sediment organisms. As this is the far most sensitive group classification is based on this study, as has been done in the EU evaluation for Annex I classification.
Risk phrases:	The assignment of R50 follows from a study with the active substance for sediment organisms. As this is the far most sensitive group classification is based on this study, as has been done in the EU evaluation for Annex I classification. R53 follows from the classification of imidacloprid being not readily biodegradable.
Safety phrases:	With the proposed classification with R50/53 instead of R52 together with S61 also S60 has to be assigned
Other:	The proposed sentences for bees and non-target arthropods follow from the ecotox assessment.

In the GAP/instructions for use the following has to be stated:

“Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling”.

“Om in het water levende organismen te beschermen is toepassing in de teelt van appel en peer als insecticiden uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater in de periode voor of na 1 mei gebruik wordt gemaakt van één van de onderstaande drift reducerende maatregelen:

Voor 1 mei (kaal)

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilatorstand uit

Na 1 mei (volblad)

-Tunnelspuit

-Combinatie windhaag op de rand van het rijpad en éénzijdige bespuiting van de laatste bomenrij.

-Venturidop + éénzijdige bespuiting laatste bomenrij; ventilator aan.”

7.9 Overall conclusions ecotoxicology

It can be concluded that:

· all proposed applications of the active substance imidacloprid meet the standards for birds as laid down in the BUBG.

· all proposed applications of the active substance imidacloprid meet the standards for aquatic and sediment organisms as laid down in the BUBG, if the proposed drift reducing measures are placed on the label.

· the active substance imidacloprid meets the standards for bioconcentration as laid down in the BUBG.

· all proposed applications of the active substance imidacloprid meet the standards for mammals as laid down in the BUBG.

· all proposed applications of the active substance imidacloprid meet the standards for bees as -laid down in the BUBG. The following restriction sentence is placed on the label (in Dutch): “Gevaarlijk voor bijen en hommels, om de bijen te beschermen mag u dit product niet gebruiken op in bloei staande gewassen. Gebruik dit product niet op plaatsen waar bijen actief naar voedsel zoeken, gebruik dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het bloeit.”

· all proposed applications of the active substance imidacloprid meet the standards for non-target arthropods as laid down in the BUBG.

· the proposed field-applications of the active substance imidacloprid in apples and pears; floriculture crops; tree nursery crops and perennials; hops, chicory and witloof meet the standards for earthworms as laid down in the BUBG.

· all proposed applications of the active substance imidacloprid meet the standards for soil micro-organisms as laid down in the BUBG.

· all proposed applications of the active substance imidacloprid meet the standards for activated sludge as laid down in the BUBG.

· the proposed applications of the active substance imidacloprid in apples and pears (May-September); gerbera and chrysanthemum, greenhouse use; floriculture crops, field use; tree nursery crops and perennials; hops and chicory witloof meet the standards for non-target plants as laid down in the BUBG.

· the proposed application of the active substance imidacloprid in apple and pear before May does not meet the standards for non-target plants. An adequate risk assessment (i.e. higher tier study or drift reducing measures) is required. Because the risk assessment to non target plants is not officially part yet of the actual framework of environmental assessment, this requirement dos not have to be fulfilled for the current assessment.

8 Efficacy

ADMIRE O-TEQ is a product based on imidacloprid that has -in the claimed dosage- the same concentration imidacloprid as Admire 70 WG. The formulations differ.

The evaluation is partially based on the summary and evaluation prepared by the Plant Protection Service on behalf of the applicant.

8.1 Efficacy evaluation

Dose justification Admire 70 WG based on imidacloprid have been authorized for many years. In support of these authorization experimental data have been provided, justifying the claimed dosages. It can be concluded that the claimed dosages are the correct dosages for an adequate control as insecticide to control a broad spectrum of insects in various crops. The rate of active substance in the claimed dosage of Admire 70 WG and ADMIRE O-TEQ is equal.

The claimed dose for the spray treatment during seed drilling is based on the dose for the coating treatment with Gaucho. The rate of the active substance imidacloprid is equal.

With the use of a phytodrip treatment the product is dosed precisely on the seed at the moment of sowing, also the rate of active substance per seed is equal to the coating treatment. The method holds the middle between a seed treatment and a low-volume drench method, as a droplet of product is dripped on the seed.

Efficacy

Bridging trials:

The results of the trials show that there were no differences in efficacy of ADMIRE O-TEQ against several aphid species in comparison with Admire 70 WG. The number of trials in apple was low, but trials in iceberg lettuce and Brussels sprouts could be used to give supplementary information. The results of these trials are consistent and confirm that there are no differences in efficacy of ADMIRE O-TEQ in comparison with Admire 70 WG.

Control of lettuce root aphid (Pemphigus bursarius):

For evaluation purposes the number of trials with the claimed application of Admire 70 WG was sufficient. In all trials an application with Admire 70 WG in the seed drill lead to a significant lower index of infestation with lettuce root aphid in comparison with the untreated control.

Control of hop vine aphid

The applicant requested extension of use, based on mutual recognition with Germany. In Germany this use is authorized as a kind of third party extension of use. In general no mutual recognition can be granted on third party extension of use. However, in this case German data are available. Furthermore imidacloprid is known to be effective, due to its systemic transport through the plant, against a wide range of aphids; even aphids with a more hidden life style.

Based on this it can be concluded that ADMIRE O-TEQ is effective against the hope vine aphid in hops.

Extrapolation

The efficacy of the claimed use of Admire 70 WG in all authorized uses can be extrapolated to claimed uses of ADMIRE O-TEQ.

Conclusion

The product complies with the Uniform Principles because it controls, in accordance with article 2.1., insects to a level of control comparable to or better than a set of reference products.

8.2 Harmful effects

8.2.1 Phytotoxicity

Trials were conducted in several crops were ADMIRE O-TEQ in comparison with Admire 70 WG was tested. In none of the trials differences in phytotoxicity were found compared to the different formulations. In the trials conducted in witloof chicory a negative effect was found on the number of seedlings per meter and the number of roots after a treatment with
Admire 70 WG. A warning has to be added on the label.

Hops

Though no data was provided, it can be concluded, based on the experience in the field in Germany and the fact that imidacloprid based products never or hardly ever give phytotoxicity, that the application of ADMIRE O-TEQ will be safe for the hop plant. No phytotoxicity is expected.

Extrapolation

The phytotoxicity of the claimed use of Admire 70 WG in all authorized uses can be extrapolated to claimed uses of ADMIRE O-TEQ.

8.2.2 Yield

Spray treatment in the seed drill, witloof chicory roots

In the efficacy trials yield assessments were conducted. No significant difference in yield was found in comparison with the untreated control.

8.2.3 Effects on succeeding crops or substitution crops

Admire 70 WG has a registration in several crops. Taken into account the experiences in practice with imidacloprid, also as seed treatment, it can be assumed that the claimed applications will have no harmful effect on succeeding or substitution crops.

8.2.4 Effects on plants or plant products to be used for propagation

Not relevant to the claim, as the crops are not intended for propagation purposes.

8.2.5 Effects on adjacent crops

Products based on imidacloprid have been tested over the past 10 years on a large number of crops and in different formulations. In none of these tests any unacceptable harmful effect was encountered. Furthermore no phytotoxicity were found in the efficacy and phytotoxicity tests. Therefore it can be concluded that ADMIRE O-TEQ will not have any harmful effect on adjacent crops.

Conclusion

The product complies with the Uniform Principles because it does not, in accordance with article 2.2., induce any unacceptable side effects on plants or plant products, when used and applied in accordance with the proposed label.

Resistance

Imidacloprid belongs to the group of chloro-nicotinyl-insecticides. The mode of action of imidacloprid is based on interference in the central nervous system of the insect.

In the United States resistance in Colorado beetle appeared after one-sided, repeated use of products based on imidacloprid. A one-sided use of products based on imidacloprid must be dissuaded, especially in the controlling of insects with a broad host spectrum like greenhouse whitefly, green peach aphid and black bean aphid.

Conclusion

The product complies with the Uniform Principles, article 2.1.3 as the level of control on the long term is not influenced by the use of this product because of the possible build up of resistance.

8.4 For vertebrate control agents: impact on target vertebrates

Not relevant as no vertebrates are controlled.

8.5 Any other relevant data / information

No other relevant data or information was used.

9 Conclusion

The product complies with the Uniform Principles.

The evaluation is in accordance with the Uniform Principles laid down in appendix VI of Directive 91/414/EC. The evaluation has been carried out on basis of a dossier that meets the criteria of appendix III of the Directive.

10. Classification and labelling

Proposal for the classification and labeling of the formulation

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):
-
Symbol:	Xn	Indication of danger:	Harmful
	N	Indication of danger:	Dangerous for the environment

R phrases	22	Harmful if swallowed.
	36/38	Irritating to eyes and skin.
	43	May cause sensitisation by skin contact.
	50/53	Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

S phrases	21	When using do not smoke
	36/37	Wear suitable protective clothing and gloves.
	46	If swallowed, seek medical advice immediately and show this container or label.
	60	This material and its container must be disposed of as hazardous waste. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt: 1) Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven. 2) Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd. 3) Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)
	S61	Avoid release to the environment. Refer to special instructions/safety data sheets.

Special provisions: DPD-phrases	-	-

Plant protection products phrase: DPD-phrase	DPD01	To avoid risk for man and the environment, comply with the instructions for use
Child-resistant fastening obligatory?			N.a.
Tactile warning of danger obligatory?			N.a.

Explanation:
Hazard symbol:	The assignment of the hazard symbol N follows from a study with the active substance for sediment organisms. As this is the far most sensitive group classification is based on this study, as has been done in the EU evaluation for Annex I classification.
Risk phrases:	The assignment of R50 follows from a study with the active substance for sediment organisms. As this is the far most sensitive group classification is based on this study, as has been done in the EU evaluation for Annex I classification. R53 follows from the classification of imidacloprid being not readily biodegradable.
Safety phrases:	S24 is not assigned as this safety-phrase is not obligatory in combination with the risk-phrases assigned S46 is assigned by the CTB to formulations classified with R22 and R36/38 when this does not lead to more than six safety-phrases. S36 is concomitantly assigned by the CTB to formulations classified with R43
	With the proposed classification with R50/53 instead of R52 together with S61 also S60 has to be assigned
Other:	The proposed sentences for bees and non-target arthropods follow from the ecotox assessment.

- Werkzame stof:		- Gehalte:
	imidacloprid		350 g/l

- Gevaarsymbool:		- Aanduiding:
	Xn		Schadelijk
	N		Milieugevaarlijk