Hymexazol final RR 1107 Part B8 nat. add. Tachigaren 70 WP Mitsui Chem. Agro. DE 2017-10-16

72 Pages·2017·0.52 MB·English

Part A Tachigaren 70WP Registration Report –Central Zone
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Federal Republic of Germany

REGISTRATION REPORT
Part A

Risk Management

Product code: Tachigaren 70 WP
Active Substance: Hymexazol 700 g/kg

COUNTRY: Germany
All Zones
Zonal Rapporteur Member State: Finland

NATIONAL ASSESSMENT
Applicant: MITSUI CHEMICALS AGRO
Date: 16/10/2017

Applicant: MITSUI CHEMICALS AGRO Date 16/10/2017
Part A Tachigaren 70WP Registration Report –Central Zone
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Federal Republic of Germany

Table of Contents

PART A – Risk Management 4
1 Details of the application 4
1.1 Application background 4
1.2 Annex I inclusion 4
1.3 Regulatory approach 5
1.4 Data protection claims 5
1.5 Letters of Access 5
2 Details of the authorisation 5
2.1 Product identity 5
2.2 Classification and labelling 6
2.2.1 Classification and labelling under CLP Regulation (EC) No 1272/2008 6
2.2.2 Standard phrases under Regulation (EC) No 547/2011 8
2.3 Other phrases notified under Regulation (EC) No 547/2011 8
2.3.1 Restrictions linked to the PPP 8
2.3.2 Specific restrictions linked to the intended uses 9
2.4 Product uses 10
3 Risk management 12
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles 12
3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 12
3.1.2 Methods of analysis (Part B, Section 2, Point 5) 13
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 13
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 13
3.1.3 Mammalian Toxicology 13
3.1.3.1 Acute Toxicity 13
3.1.3.2 Operator Exposure 13
3.1.3.3 Bystander Exposure 13
3.1.3.4 Worker Exposure 13
3.1.4 Residues and Consumer Exposure 15
3.1.4.1 Residues 15
3.1.4.2 Consumer exposure 15
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and
9.5) 15
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3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5,
Point 9.6) 15
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5,
Points 9.7 and 9.8) 16
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) 16
3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 17
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 17
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 17
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
17
3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)
18
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 18
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 18
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)
(Part B, Section 6, Point 10.8) 18
3.1.7 Efficacy (Part B, Section 7, Point 8) 19
3.2 Conclusions 20
3.3 Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation 20
Appendix 1 – Copy of the product authorisation 21
Appendix 2 – Copy of the product label 22
Appendix 3 – Letter of Access 23
Appendix 4 – Copy of the product authorisation 24

Applicant: MITSUI CHEMICALS AGRO 16/10/2017
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PART A – Risk Management
This document describes the acceptable use conditions required for the re-registration/registration of
Tachigaren 70 WP containing hymexazol in Germany. This evaluation is required subsequent to the
approval of hymexazol.

The risk assessment conclusions are based on the information, data and assessments provided in
Registration Report, Part B Sections 8, 9 and where appropriate the addendum for Germany. The
information, data and assessments provided in Registration Report, Parts B includes assessment of further
data or information as required at national re-registration/registration by the EU review. It also includes
assessment of data and information relating to Tachigaren 70 WP where that data has not been considered
in the EU review. Otherwise assessments for the safe use of Tachigaren 70 WP have been made using
endpoints agreed in the EU review of hymexazol.

This document describes the specific conditions of use and labelling required for Germany for the re-
registration/registration of Tachigaren 70 WP.

Appendix 1. See Appendix 4.

Appendix 2: The submitted draft product label has been checked by the competent authority. The
applicant is requested to amend the product label in accordance with the decisions drawn by the
competent authority. The final version of the label is not available, because the layout is the sole
responsibility of the applicant and will not be checked again.

Appendix 3 of this document contains copies of the letters of access to the protected data / third party data
that was needed for evaluation of the formulation.

Appendix 4 of this document provides a copy of the final product authorisation for Germany.

1 Details of the application
1.1 Application background

This application was submitted by LKC UK Ltd on behalf of Sumi Agro Europe Ltd. on 31 May 2013.

The application is for approval of Tachigaren 70 WP, a water dispersible powder for slurry seeds
treatment containing 700 g/kg of hymexazol for use as a seed treatment for sugar beet against “damping
off” in the EU.
1.2 Annex I inclusion
Hymexazol was included on Annex I of Directive 91/414/EEC on 20 January 2011 under Inclusion
Commission Directive 2011/5/EU.
The Annex I Inclusion Directive for hymexazol (2011/5/EU) provides specific provisions under Part A:
Only uses as fungicide for seed pelleting of sugar beets in professional sees treatment facilities may be
authorised,
Furthermore specific provisions under Part B are summarised which need to be considered by the
applicant in the preparation of their submission and by the MS prior to granting an authorisation.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing
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Committee on the Food Chain and Animal Health on 23/11/2010 shall be taken into account. In this
overall assessment:
Member States shall pay particular attention to:
• the operators and workers safety. Conditions of authorisation shall include protective measures,
where appropriate
• the risk to granivorous birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate. The Member States
concerned shall request the submission of confirmatory information as regards the nature of residues in
root crops and the risk for granivorous birds and mammals. The Member States concerned shall ensure
that the applicant submits such confirmatory information to the Commission by 31 May 2013.

These concerns have been addressed within the current submission.

1.3 Regulatory approach

To obtain re-approval/approval the product Tachigaren 70 WP must meet the conditions of Annex I
inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an
assessment to Uniform Principles, using Annex I agreed end-points.

This application was submitted in order to allow the re-registration of an already approved product in
Germany in accordance with the above.
1.4 Data protection claims
Where protection for data is being claimed for information supporting registration of Tachigaren 70 WP,
it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1, 5, 6 and
7.
1.5 Letters of Access
Not necessary. The applicant addressed all data requirements by own data.
2 Details of the authorisation
2.1 Product identity

Product Name Tachigaren 70 WP
Authorization Number 043185-00
(for re-registration)
Function Fungicide
Applicant MITSUI CHEMICALS AGRO
Composition 700 g/kg hymexazol
Formulation type water dispersible powder for slurry seeds treatment
[Code: WS]
Packaging 80 L cardboard/fibre drum containing 25 kg product in
an inner polyethylene bag

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2.2 Classification and labelling
2.2.1 Classification and labelling under CLP Regulation (EC) No 1272/2008
The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:

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Hazard classes and categories:
Flam. Sol. 2, Skin Sens. 1, Eye Dam. 1
Hazard pictograms:
GHS02 flame
GHS05 corrosion
GHS07 exclamation mark
GHS09 environment
Signal word:
Danger
Hazard statements:
H228 Flammable solid.
H317 May cause an allergic skin reaction.
H318 Causes serious eye damage.
H411 Toxic to aquatic life with long lasting effects.
Precautionary statemtents:
Not proposed by zRMS Germany, to be decided by applicant
P101 If medical advice is needed, have product container or label at hand.
P102 Keep out of reach of children.
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. No smokung. - No smoking.
P240 Ground and bond container and receiving equipment.
P241 Use explosion-proof [electrical/ventilating/lighting/...] equipment.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352 IF ON SKIN: Wash with plenty of water/...
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing.
P308+P310 IF exposed or concerned: Immediately call a POISON CENTER or a
doctor/physician.
P362+P364 Take off contaminated clothing and wash before reuse.
P391 Collect spillage.
P501 Dispose of contents/container to ...
Special rule for labelling of PPP:
EUH401 To avoid risks to man and the environment, comply with the instructions for use.
Further labelling statements under Regulation (EC) No 1272/2008:
EUH 208 - Contains hymexazol. May produce an allergic reaction.

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2.2.2 Standard phrases under Regulation (EC) No 547/2011
None
2.3 Other phrases notified under Regulation (EC) No 547/2011
2.3.1 Restrictions linked to the PPP
The authorization of the PPP is linked to the following conditions (mandatory labelling):

Human health protection
SB001 Avoid any unnecessary contact with the product. Misuse can lead to health
damage.
SB005 If medical advice is needed, have product container or label at hand.
SB010 Keep out of the reach of children.
SB110 The directive concerning requirements for personal protective gear in plant
protection, "Personal protective gear for handling plant protection products" of
the Federal Office of Consumer Protection and Food Safety must be observed.
SB166 Do not eat, drink or smoke when using this product.
SE1201 Wear tight fitting eye protection when applying/handling the product.
SF613 When bagging the dressed seeds, make sure that the dust exhaust system is
functioning.
SF6142 Wear standard protective gloves and a protective suit against pesticides when
handling dressed seeds.
SF6161 While sacking the treated seed protective suits against pesticides and standard
protective gloves (plant protection) must be worn.
SF623 When cleaning the seed dressing equipment, a half mask with combination filter
A1-P2 (identification colour: brown/white) must be worn according to the BVL
Directive on requirements regarding personal protective equipment in plant
protection, as amended.
SF634 Working clothes (at least a long-sleeved shirt and long trousers), sturdy footwear
(e.g. rubber boots), universal protective gloves (plant protection) and a liquid-
tight protective suit must be worn when cleaning the spraying device or the seed
dressing plant.
SF635 When cleaning the seed dressing equipment wear tight fitting eye protection.
SS207 Working clothes (at least a long-sleeved shirt and long trousers), sturdy footwear
(e.g. rubber boots), universal protective gloves (plant protection) and a liquid-
tight protective suit must be worn when handling/applying the product.
ST2102 Wear half mask with combination filter A1-P2 (identification colour:
brown/white) according to the BVL guideline "Personal protective equipment for
handling plant protection products", current version, when handling the undiluted
product.
ST2202 Wear half mask with combination filter A1-P2 (identification colour:
brown/white) according to the BVL guideline "Personal protective equipment for
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handling plant protection products", current version, when applying/handling the
product ready for application.
VA265 Only for use in commercial, stationary seed dressing plants.
Integrated pest management (IPM)/sustainable use
WMFA3 Mode of action (FRAC-group): A3 (for hymexazol)
Ecosystem protection
NW263 The product is toxic for aquatic invertebrates.
NW467 The product and its remains, empty containers and packaging and rinsing fluids
must not be dumped in water. This also applies to indirect entry via the urban or
agrarian drainage system and to rain-water and sewage canals.
NH677 On packaging containing dressed seeds, the following label is necessary: "Sweep
up and remove spilled seeds immediately"
NH679 On packaging containing dressed seeds, the following label is necessary: "This
product is poisonous for birds. For this reason, do not leave seeds exposed.
Switch off the dosing equipment on time before lifting out the shares to prevent
trickling afterwards".
NH680 On packaging containing dressed seeds, the following label is necessary: "Do not
allow treated seeds and remains such as broken grain and dust, empty containers
or packaging or rinsing liquid to come into contact with water. This also applies
to indirect entry via the urban or agrarian drainage system and to rainwater and
sewage canals".

The authorization of the PPP is linked to the following conditions (voluntary labelling):

Integrated pest management (IPM)/sustainable use
NN1001 The product is classified as non-harmful for populations of relevant beneficial insects.
NB663 Due to the manner in which authorisation governs application of the product, bees are not
endangered.(B3)

2.3.2 Specific restrictions linked to the intended uses
Some of the authorised uses are linked to the following conditions (mandatory labelling):
See 2.4 (Product uses)

Ecosystem protection
---

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2.4 Product uses

GAP rev.1, date: 2016-10-17
PPP (product name/code): Tachigaren 70 WP Formulation type: WS (a, b)
Active substance 1: Hymexazol Conc. of as 1: 700.00 g/kg (c)
Applicant: MITSUI CHEMICALS AGRO Professional use: Yes
Zone(s): central/interzonal (d) Non professional use: No
Verified by MS: Yes Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14
Use Membe Crop and/ F, Pests or Group of Application Application rate PHI Remarks:
- r or situation Fn, pests controlled Method / Timing / Max. Min. kg or L g as/ha Water (days
No. state(s) Fpn Kind Growth number interval product / ha L/ha ) e.g. g safener/synergist
(e) (crop G, (additionally: stage of a) per between a) max. rate a) max. rate per ha
destination / Gn, developmental crop & use applicatio per appl. per appl. min / (f)
purpose of Gpn stages of the pest or season b) per ns (days) b) max. total b) max. total max
crop) or pest group) crop/ rate per rate per
I season crop/season crop/season
001 DE fodder beet F Aphanomyces seed Before a) 1 a) 60 g/ha** 42 g a.s./ha -/ F*
(BEAVC), species treatment sowing b) **information on dose
sugar beet (Aphanamyces rate: maximum
(BEAVA) spp.) (APHASP) application rate 60 g/ha
(equivalent to 1.5 seed
units per ha; 1 unit
includes 100 000 grains)
002 DE fodder beet F Pythium species seed Before a) 1 a) 60 g/ha** 42 g a.s./ha -/ F*
(BEAVC), (Pythium spp.) treatment sowing b) **information on dose
sugar beet (PYTHSP) rate: maximum
(BEAVA) application rate 60 g/ha
(equivalent to 1.5 seed
units per ha; 1 unit
includes 100 000 grains)
* The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a
PHI in days is not required resp.

Applicant: MITSUI CHEMICALS AGRO Date 16/10/2017