Registration Report Part A · Part A National Assessment - Country – FRANCE (RESOLVA 24 H ACTION)...

Part A National Assessment - Country – FRANCE

(RESOLVA 24 H ACTION) of 28

Registration Report – Southern Zone

Applicant: Syngenta France S.A.S Evaluator: FRANCE Date: 21/12/2016

REGISTRATION REPORT

Part A

Risk Management

Product code: A12877S

Product name(s): RESOLVA 24H ACTION

(Non professional garden uses)

Active Substance(s): Glyphosate, 8.39 g/L

COUNTRY: FRANCE

Southern Zone

Zonal Rapporteur Member State: France

NATIONAL ASSESSMENT FRANCE

(marketing authorisation/non-professional use)

Applicant: Syngenta France S.A.S

Date: 21/12/2016





Table of Contents

1 DETAILS OF THE APPLICATION ...................................................................................................................... 3

1.1 APPLICATION BACKGROUND ................................................................................................................................... 3 1.2 ACTIVE SUBSTANCE APPROVAL ................................................................................................................................ 3 1.3 REGULATORY APPROACH ....................................................................................................................................... 4 1.4 DATA PROTECTION CLAIMS .................................................................................................................................... 5 1.5 LETTER(S) OF ACCESS ........................................................................................................................................... 5

2 DETAILS OF THE AUTHORISATION ................................................................................................................ 5

2.1 PRODUCT IDENTITY .............................................................................................................................................. 5 2.2 CLASSIFICATION AND LABELLING .............................................................................................................................. 5

2.2.1 Classification and labelling under Directive 99/45/EC .......................................................................... 6 2.2.2 Classification and labelling in accordance with Regulation (EC) No1272/2008 .................................... 6 2.2.3 Other phrases in compliance with Regulation (EU) No 547/2011 ......................................................... 6 2.2.4 Other phrases linked to the preparation ............................................................................................... 6

2.3 PRODUCT USES .................................................................................................................................................... 8

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 ........................................................................................................ 12 3.1.2 Methods of analysis ............................................................................................................................ 12 3.1.3 Mammalian Toxicology ....................................................................................................................... 12 3.1.4 Residues and Consumer Exposure ....................................................................................................... 13 Summary of the evaluation ............................................................................................................................... 14 3.1.5 Environmental fate and behaviour ...................................................................................................... 15 3.1.6 Ecotoxicology....................................................................................................................................... 15

3.2 CONCLUSIONS ARISING FROM FRENCH ASSESSMENT ................................................................................................. 15 3.3 SUBSTANCES OF CONCERN FOR NATIONAL MONITORING ............................................................................................ 16 3.4 FURTHER INFORMATION TO PERMIT A DECISION TO BE MADE OR TO SUPPORT A REVIEW OF THE CONDITIONS AND RESTRICTIONS

ASSOCIATED WITH THE AUTHORISATION ........................................................................................................................... 16 3.4.1 Post-authorisation monitoring ............................................................................................................ 16 3.4.2 Post-authorisation data requirements ................................................................................................ 16 3.4.3 Label amendments .............................................................................................................................. 16

APPENDIX 1 – COPY OF THE FRENCH DECISION .................................................................................................... 17

APPENDIX 2 – COPY OF THE DRAFT PRODUCT LABEL AS PROPOSED BY THE APPLICANT ...................................... 24

APPENDIX 3 – LETTER(S) OF ACCESS ..................................................................................................................... 28





PART A – Risk Management

The company Syngenta France S.A.S has requested marketing authorisation in France for the product RESOLVA

24H ACTION (formulation code: A12877S), containing 8,39 g/L glyphosate for use as a herbicide for non

professional garden uses. It is a RTU product (Ready To Use) for the non-professional use (home and garden (HG)).

The risk assessment conclusions are based on the information, data and assessments provided in Registration

Report, Part B Sections 1-7 and Part C, and where appropriate the addenda for France. The information, data and

assessments provided in Registration Report, Part B include assessment of further data or information as required at

national registration by the EU peer review. It also includes assessment of data and information relating to

RESOLVA 24H ACTION (A12877S) where those data have not been considered in the EU peer review process.

Otherwise assessments for the safe use of RESOLVA 24H ACTION (A12877S) have been made using endpoints

agreed in the EU peer review of glyphosate.

RESOLVA 24H ACTION (A12877S) do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2)

This document describes the specific conditions of use and labelling required for France for the registration of

RESOLVA 24H ACTION (A12877S).

Appendix 1 of this document provides a copy of the French Decision.

Appendix 2 of this document is a copy of the draft product label as proposed by the applicant.

Appendix 3 of this document is a copy of the letter(s) of Access.

1 DETAILS OF THE APPLICATION

1.1 Application background

The present registration report concerns the evaluation of Syngenta France S.A.S’s application to market RESOLVA

24H ACTION (A12877S) in France as a herbicide (product uses described under point 2.3) for non professional

garden uses. France acted as a zonal Rapporteur Member State (zRMS) for this request and assessed the application

submitted for the first authorisation of this product in France and in other MSs of the Southern zone.

1.2 Active substance approval

Glyphosate

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No

1107/2009 of the European Parliament and of the Council as regards the list of approved active substances.

Commission Implementing Regulation (EU) 2016/1056 of 29 June 2016 amending Implementing Regulation (EU)

No 540/2011 as regards the extension of the approval period of the active substance glyphosate

Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending Implementation Regulation

(EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate (Text with EEA

relevance).

Specific provisions of Regulation (EU) No 540/2011 were as follows:

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No

1107/2009, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof,

as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this

overall assessment Member States:

— must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with

respect to non-crop uses

Specific provisions of Regulation (EU) 2016/1056 of 29 June 2016 were as follows :

In the sixth column, ‘expiration of approval’, of entry 25 on glyphosate in Part A of the Annex to Implementing





Regulation (EU) No 540/2011, the words ‘30 June 2016’ are replaced by the words ‘6 months from the date of

receipt of the opinion of the Committee for Risk Assessment of the European Chemicals Agency by the

Commission or 31 December 2017, whichever is the earlier’

Specific provisions of Regulation (EU) 2016/1313 of 1 August 2016 were as follows :

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009,

the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as amended in the

Standing Committee on Plants, Animals, Food and Feed on 27 June 2016 shall be taken into account. In this overall

assessment Member States

- must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with

respect to non-crop use

- must pay particular attention to risks from the use in specific areas referred to in Article 12(a) of Directive

2009/128/EC

- must pay particular attention to compliance of pre-harvest uses with good agricultural practices

Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant

POE-tallowamine (CAS No 61791-26-2)

There is no definitive EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance.

A Review Report is available (6511/VI/99-final 21 January 2002) and an addendum to the Review report

(Glyphosate SANTE/11051/2016 rev 0 11 July 2016).

1.3 Regulatory approach

The present application (2012-2971) was evaluated in France by the French Agency for Food, Environmental and

Occupational Health & Safety (Anses)1 in the context of the zonal procedure for all Member States of the Southern

zone, taking into account the worst-case uses (“risk envelope approach”)2 – the highest application rates over the

Southern Zone. When risk mitigation measures were necessary, they are adapted to the situation in France.

According to the French law and procedures, specific conditions of use are set out in the Decision letter.

The French Order of 12 September 20063 provides that:

- unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least three days;

- unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is five

metres;

- unless formally stated in the product authorisation, the minimum re-entry period is six hours for field uses and

eight hours for indoor uses.

Drift reduction measures such as low-drift nozzles are not considered within the decision-making process in France.

However, drift buffer zones may be reduced under some circumstances as explained in Appendix 3 of the above-

mentioned French Order.

The current document (RR) based on Anses’s assessment of the application submitted for this product is in

compliance with Regulation (EC) no 1107/20094, implementing regulations and French regulations.

The data taken into account are those deemed to be valid either at European Union level or at zonal/national level.

This part A of the RR presents a summary of essential scientific points upon which recommendations are based and

is not intended to show the assessment in detail.

The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU)

1 French Food Safety Agency, Afssa, before 1 July 2010 2 SANCO document “risk envelope approach”, European Commission (14 March 2011). Guidance document on the preparation and

submission of dossiers for plant protection products according to the “risk envelope approach”; SANCO/11244/2011 rev. 5 3 http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000000425570 4 REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant

protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

http://ec.europa.eu/food/plant/protection/resources/risk_envelope_gd_rev_14032011_en.pdf

http://ec.europa.eu/food/plant/protection/resources/risk_envelope_gd_rev_14032011_en.pdf





No 546/20115, and are expressed as “acceptable” or “not acceptable” in accordance with those criteria.

Finally, the French Order of 26 March 20146 provides that:

- an authorisation granted for a “reference” crop applies also for “linked” crops, unless formally stated in the

Decision

- the “reference” and “linked” crops are defined in Appendix 1 of that French Order.

Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from

“reference” crops to “linked” ones are undertaken even if not clearly requested by the applicant in their dRR, and a

conclusion is reached on the acceptability of the intended uses on those “linked” crops. The aim of this Order,

mainly based on the EU document on residue data extrapolation7 is to supply “minor” crops with registered plant

protection products.

Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the

applicant.

The Decision, as reproduced in Appendix 1, takes also into account national provisions, including national

mitigation measures.

1.4 Data protection claims

Where protection for data is being claimed for information supporting registration of RESOLVA 24H ACTION

(A12877S), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7.

1.5 Letter(s) of Access

The applicant has provided the supporting data in Document K; the ownership of the data is indicated in the

reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. A copy of the letter(s) of access is

reproduced in Part A, Appendix 3.

2 DETAILS OF THE AUTHORISATION

2.1 Product identity

Product name (code) RESOLVA 24H ACTION (A12877S)

Authorisation number 2161027

Function Herbicide

Applicant Syngenta France S.A.S.

Composition 8,39 g/L glyphosate

Formulation type (code) Soluble concentrate (SL)

Packaging RTU product (Ready To Use) for the non-professional use (home and garden

(HG) in trigger-sprayer form

High-density polyethylene containers holding (500 ml, 1 L)

f- High-density polyethylene containers holding (500 ml, 1 L)

The product does not contain tallowamine (n° CAS 61791-26-2).

2.2 Classification and labelling

5 COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European

Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products 6 http://www.legifrance.gouv.fr/eli/arrete/2014/3/26/AGRG1407093A/jo 7 SANCO document “guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting

MRLs”: SANCO/ 7525/VI/95 - rev.9

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:155:0127:0175:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:155:0127:0175:EN:PDF

http://www.legifrance.gouv.fr/eli/arrete/2014/3/26/AGRG1407093A/jo





2.2.1 Classification and labelling under Directive 99/45/EC

Not applicable after 1st June 2015.

2.2.2 Classification and labelling in accordance with Regulation (EC) No1272/2008

Physical hazards No classification

Health hazards No classification

Environmental

hazards

No classification

Hazard pictograms -

Signal word -

Hazard statements - -

Precautionary

statements –

For the P phrases, refer to the extant legislation

Supplementary

information (in

accordance with

Article 25 of

Regulation (EC) No

1272/2008)

EUH 208 Contains 1,2-benzisothiazol-3(2H)-one. May produce an allergic reaction.

See Part C for justifications of the classification and labelling proposals.

2.2.3 Other phrases in compliance with Regulation (EU) No 547/2011

The authorisation of the preparation is linked for non-professional uses only to the following conditions:

Do not discharge into the sink, gutter or any other surface water body the unused dregs from

containers

Avoid spray drift and run-off to neighbouring plants.

2.2.4 Other phrases linked to the preparation

Re-entry period8: Not relevant for Home and Garden uses. Ensure complete drying of the treated area or of treated

plants before handling them

Pre-harvest interval9:

- Pome fruits: 28 days

- Stone fruits : Cherries: 14 days , Peaches, Apricots and Plums: 7 days

Other mitigation measures:

- Avoid fruits contact with active substance or with soil treated with active substance.

- Do not harvest fruits that have been in direct contact with soil.

8 The legal basis for this is Titre I Article 3 of the French Order of 12 September 2006 concerning the marketing and use of products

encompassed by article L. 253-1 of the rural code [that is, plant protection products/pesticides] 9 According to the French Order of 12 September 2006, PHI cannot be lower than 3 days unless specifically stated in the assessment and

decision.

http://admi.net/jo/20060921/AGRG0601345A.html

http://admi.net/jo/20060921/AGRG0601345A.html





- Avoid glyphosate treatment on water-filled ditches or the adjacent ground.

To notify users that the dose limitation for glyphosate in the plot concerns all glyphosate-based products (and not

just a single product), the following label amendment is proposed:

- Do not apply this or any other product containing glyphosate at greater than the maximum rates of application

defined in the Notice to all authorisation holders of glyphosate products, published in the Official Journal of the

French Republic on 8 October 2004.(NOR : AGR0402105V)

The label must reflect the conditions of authorisation.





2.3 Product uses

Please note: The GAP Table below reports the intended uses proposed by the applicant, and possible extrapolation according to French Order of 26 March 2014 (highlighted in green), evaluated and concluded as safe uses by France as zRMS. Those uses are then granted in France.

When a use is “acceptable” with GAP restrictions, the modifications of the GAP are in bold.

GAP rev. , date: 21/12/2016

PPP (product name/code) RESOLVA 24H ACTION /A12877S

active substance 1 Glyphosate

Formulation type: < SL>

Conc. of as 1: 8,39 g/L/g/kg

RTU (Ready To Use) product for the non-professional home and garden use.

Applicant: Syngenta France S.A.S.

Zone(s): southern/EU

professional use

non professional use

Verified by MS: yes

Crop and/

or situation

(a)

Country Product

code

F

G

or

I

(b)

Pests or

Group of pests

controlled

(c)

Formulation

Application

Application rate per

treatment

PHI

(days)

(l)

Remarks:

(m) Type

(d-f)

Conc.

of as

(i)

method

kind

(f-h)

growth

stage &

season

(j)

numb

er

min

max

(k)

interval

between

applicati

ons (min)

g as/hL

min

max

water

L/ha

min

max

g as/ha

min

max

Uncultivated

areas (pathways,

places,

terraces…)

France A12877

S

F Annuals & biannuals

weeds (easy to

control)

SL

RTU

(read

y to

use)

8.39

g/L

Foliar spray

Spot application

During

vegetation

period

1 n/a n/a n/a 1795 n/a Acceptable

Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period


Ornamentals France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period,

after

emergence

of weeds,

prior to

planting






Crop and/

or situation

(a)

Country Product

code

F

G

or

I

(b)

Pests or

Group of pests

controlled

(c)

Formulation

Application


treatment

PHI

(days)

(l)

Remarks:

(m) Type

(d-f)

Conc.

of as

(i)

method

kind

(f-h)

growth

stage &

season

(j)

numb

er

min

max

(k)

interval

between

applicati

ons (min)

g as/hL

min

max

water

L/ha

min

max

g as/ha

min

max

Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period,

after

emergence

of weeds,

prior to

planting


France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Post-

emergence


Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Post-

emergence


Cultivated (pome

fruit and stone

fruit) or

ornamentals

areas before

planting, sowing

France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Up to two

days

before

sowing or

planting

the

following

crop


Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Up to two

days

before

sowing or

planting

the

following

crop


Paths and places

with woody

plants

(from year of

planting)

France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period,

after

emergence

of weeds






Crop and/

or situation

(a)

Country Product

code

F

G

or

I

(b)

Pests or

Group of pests

controlled

(c)

Formulation

Application


treatment

PHI

(days)

(l)

Remarks:

(m) Type

(d-f)

Conc.

of as

(i)

method

kind

(f-h)

growth

stage &

season

(j)

numb

er

min

max

(k)

interval

between

applicati

ons (min)

g as/hL

min

max

water

L/ha

min

max

g as/ha

min

max

Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period,

after

emergence

of weeds


Ornamental trees

and shrubs

(from year of

planting)

France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Spring or

summer,

after

emergence

of weeds


Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Spring or

summer,

after

emergence

of weeds


Pome fruit (from

year of planting)

France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Spring or

summer,

after

emergence

of weeds

1 n/a n/a n/a 1795 28 days Acceptable

Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

Spring or

summer,

after

emergence

of weeds

1 n/a n/a n/a 2271 28 days Acceptable

Stone fruit (from

year of planting)

France A12877

S


weeds (easy to

control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period,

after

emergence

of weeds

1 n/a n/a n/a 1795 Peach,

apricot,

plum : 7

days

Cherry : 14

days

Acceptable





Crop and/

or situation

(a)

Country Product

code

F

G

or

I

(b)

Pests or

Group of pests

controlled

(c)

Formulation

Application


treatment

PHI

(days)

(l)

Remarks:

(m) Type

(d-f)

Conc.

of as

(i)

method

kind

(f-h)

growth

stage &

season

(j)

numb

er

min

max

(k)

interval

between

applicati

ons (min)

g as/hL

min

max

water

L/ha

min

max

g as/ha

min

max

Perennials weeds

(hard to control)

SL

RTU

8.39

g/L

Foliar spray

Spot application

During

vegetation

period,

after

emergence

of weeds

1 n/a n/a n/a 2271 Peach,

apricot,

plum : 7

days

Cherry : 14

days

Acceptable





3 RISK MANAGEMENT

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles

3.1.1 Physical and chemical properties

RESOLVA 24H ACTION (A12877S) is an SL formulation. All studies have been performed in accordance with the

current requirements and the results are deemed to be acceptable. The appearance of the product is that of liquid,

with no odour. It is not explosive and has no oxidizing properties. The product is not has a flash point above 100°C.

It has no a self-ignition at ambient temperature. In aqueous solution (1%), it has a pH value of 7.0 at 25°C. There is

no effect of low and high temperature on the stability of the formulation, since after 7 days at 0°C and 14 days at

54°C; neither the active ingredient content nor the technical properties were changed. The stability data indicates a

shelf life of at least 2 years at ambient temperature when stored in HDPE. As the formulation is (SL) and as the

stability was performed on HDPE packaging, the f-HDPE packaging can be considered as acceptable. Its technical

characteristics are acceptable for a SL formulation.

The formulation is not classified for the physico-chemical aspect.

3.1.2 Methods of analysis

3.1.2.1 Analytical method for the formulation

Analytical methods for the determination of the active substance in the formulation are available and validated.

3.1.2.2 Analytical methods for residues

Analytical methods for the determination of active substance and relevant impurities (formaldehyde and N-

nitrosoglyphosate) in the formulation are available and validated.

Analytical methods are available in the monograph/this dossier and validated for the determination of residues of

glyphosate in plants, soil, water (surface and drinking) and air.

Analytical methods for the determination of residues of glyphosate in foodstuffs of animal origin are not necessary

The active substance is neither toxic nor very toxic, hence no analytical method is required for the determination of

residues in biological fluids and tissues.

3.1.3 Mammalian Toxicology

Endpoints used in risk assessment :

Active Substance: glyphosatee

ADI 0.3 mg kg bw/d

EU (2015) ARfD Not necessary

AOEL 0.2 mg/kg bw/d

Dermal

absorption

Based on a default value (oral absorption) according to guidance on dermal absorption (Efsa 2012):

Concentrate (used in formulation)

8,83 g/L

Dermal absorption endpoints % 20 %

3.1.3.1 Acute Toxicity

RESOLVA 24H ACTION (A12877S) containing 8.83 g/L glyphosate has a low toxicity in respect to acute oral,

inhalation and dermal toxicity and is not irritating to the rabbit skin or eye and is not a skin sensitizer.





The proposed packaging has been described in sufficient detail, and its compliance can therefore be finalised.

In summary, compliance with the provisions of French Decree No. 2010-1755 of 30 December 2010 and Orders of

30 December 2010 relating to the use of certain plant protection products by non-professional users is considered to

be finalised.

3.1.3.2 Operator Exposure

Summary of critical use patterns (worst cases):

Crop F/G10 Equipment

Application rate

mL/10 m2

(g as/ha)

Spray

dilution

(L/ha)

Model

Risk envelop

Uncultivated areas

(pathways, places,

terraces…)

Home

garden

“ready to use”

formulation

Trigger sprayer

270 mL/10 m2

(2384.1 g as:ha)

- French study

2005

UPJ

Considering proposed uses, operator systemic exposure was estimated using the French study 2005 dedicated to amateur use:

Crop Equipment PPE and/or working coverall

% AOEL

Glyphosate

Risk envelop

Uncultivated areas

(pathways, places,

terraces…)

Home garden

“ready to use” formulation

Trigger sprayer

Not relevant for amateur use

16 %

According to the model calculations, it can be concluded that the risk for the operator using RESOLVA 24H

ACTION (A12877S) is acceptable without personal protective equipment.

3.1.3.3 Bystander Exposure

In the context of use by non-professionals, it is considered that the assessment for bystanders is covered by that for

the operator.

3.1.3.4 Resident Exposure

In the context of use by non-professionals, it is considered that the assessment for resident is covered by that for the

operator.

3.1.3.5 Wolker Exposure

RESOLVA 24H ACTION (A12877S) is intended to be used by amateurs during home garden application.

In this case of the non-professional user, the worker is also the user of the product. It will be necessary to ensure

complete drying of the treated area or of treated plants before handling them.

3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

3.1.4.2 Consumer exposure

Critical GAP(s) and overall conclusion

The data available are considered sufficient for risk assessment. An exceedance of the current MRLs for glyphosate

as laid down in Reg. (EU) 396/2005 is not expected.

The chronic and the short-term intakes of glyphosate residues are unlikely to present a public health concern.

10

Open field or glasshouse





As far as consumer health protection is concerned, France, zRMS agrees with the authorization of the intended uses

with the proposed PHI of 28 days for pome fruit, 7 days for peach, apricot and plum and 14 days for cherry.

According to available data, the following specific mitigation measures are recommended for pome fruit and stone

fruit: avoid fruits contact with active substance or with soil treated with active substance.

Summary of the evaluation

The preparation RESOLVA 24H ACTION (A12877S) is composed of glyphosate

Table 1: Summary for glyphosate

Use-

No.* Crop

Plant

metabolism

covered?

Sufficient

residue

trials?

PHI

sufficiently

supported?

Sample

storage

covered

by

stability

data?

MRL

compliance

Reg 293/2013

Chronic risk

for

consumers

identified?

Acute risk

for

consumers

identified?

Comments

1 Pome

fruit

Yes Yes Yes

Yes Yes

with mitigation

measures

No

No Proposed

PHI of 28 days

2 Stone

fruit

Yes Yes

awaiting the

two additional

southern EU

residue trials on apricots

and awaiting

additionnal southern EU

residue trials

on plum

Yes Yes Yes

with

mitigation measures

No Proposed

PHI : Cherry

: 14 days Peach,

apricot and

plum : 7 days

For apricot and plum, additional data are required in post-registration to confirm that a “no-residue” situation occurs

in the worst case application.

The effects of processing on the nature of glyphosate residues have been investigated. Data on effects of processing

on the amount of residue have been submitted.

These data were not considered for risk assessment.

Residues in succeeding crops have been sufficiently investigated taking into account the specific circumstances of

the cGAP uses being considered here. It is very unlikely that residues will be present in succeeding crops.

Considering dietary burden and based on the intended uses, no significant modification of the intake was calculated

for livestock. Further investigation of residues as well as the modification of MRLs in commodities of animal origin

is therefore not necessary.

Summary for A12877S

Table 2: Information on RESOLVA 24H ACTION (A12877S) (KCA 6.8)

Crop

PHI for

Product

proposed by

applicant

PHI/ Withholding period*

sufficiently supported for PHI for Product

proposed by zRMS

zRMS Comments

(if different PHI proposed) glyphosate

Pome fruits / Yes 28 days mitigation measures

proposed

Stone fruits / Yes Cherries: 14 d for all SEU countries

Peaches, Apricot and Plum: 7 d for all SEU countries

additionnal SEU residue

trials requested on plum and apricot

mitigation measures

proposed





Post- registration demands:

Trials are required in post registration on apricot and plum in SEU,

- Mitigation measures

According to available data, the following specific mitigation measures are recommended for pome fruit and stone

fruit:

- Avoid fruits contact with active substance or with soil treated with active substance.

- Do not collect fruits in contact with treated soil

3.1.4.3 Waiting periods before planting succeeding crops

Not necessary.

3.1.5 Environmental fate and behaviour

Considering the packaging and the application method of the ready to use preparation RESOLVA 24H ACTION

(A12877S) (low volume container (0.5-1 L) with trigger spray), exposure of environmental compartments to active

substance is considered negligible. Consequently, no risk assessment for environment and non target organisms is

deemed necessary.

Implications for labelling resulting from environmental fate assessment:

There are no specific implications for labelling resulting from environmental assessment.

3.1.6 Ecotoxicology

Considering the packaging and the application method of the preparation RESOLVA 24H ACTION (A12877S)

(ready-to-use product), exposure of environmental compartments to active substance is considered negligible.

Consequently, no risk assessment for environment and non-target organisms is deemed necessary.

3.1.6.1 Efficacy

This is a request for the registration of the preparation RESOLVA 24H ACTION (A12877S) (SL), based on

glyphosate (8.4 g/L), it’s an herbicide.

o The efficacy of RESOLVA 24H ACTION (A12877S) is considered as satisfactory in the claimed

conditions.

o The preparation RESOLVA 24H ACTION (A12877S) cannot be considered to be selective in view of the

mode of action of the active substance. Given the mode of foliar penetration of glyphosate, the preparation

should not be directed to the green parts of crops.

o The risk of negative impact on yield, quality, transformation processes, propagation, non-target organisms,

succeeding crops, adjacent crops is considered as negligible.

Considering all the cases of resistance to glyphosate in the world, France considers that the applicant should put a

resistance monitoring for its active substance glyphosate. This monitoring should allow to study the possible

occurrence or development of resistance on weeds and more especially on:

- Ray grass (Lolium multiflorum Lam., Lolium perenne L. and Lolium rigidum Gaud.),

- Conyza sp.,

- Common ragweed (Ambrosia artemisiifolia L.).

It will be necessary to provide to the competent authorities any new information that may change the risk analysis.

3.2 Conclusions arising from French assessment

Taking into account the above assessment, an authorisation can be granted as proposed in Appendix 1 – Copy of the

product Decision.





3.3 Substances of concern for national monitoring

No information stated.

3.4 Further information to permit a decision to be made or to support a review of the conditions and

restrictions associated with the authorisation

3.4.1 Post-authorisation monitoring

The applicant should put in place a monitoring of resistance cases on weeds, especially on:

- Ray grass (Lolium multiflorum Lam., Lolium perenne L. et Lolium rigidum Gaud.),

- Conyza sp.,

- Common ragweed (Ambrosia artemisiifolia L.).

All new data (that may modify the risks) should be communicated to the authorities.

3.4.2 Post-authorisation data requirements

The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24

months regarding:

- Additional residue trials in southern of Europe are required in post registration for apricot and plum.

3.4.3 Label amendments

The draft label proposed by the applicant in appendix 2 may be corrected with consideration of any new element

under points 2.2.1 (or 2.2.2), 2.2.3 and 2.2.4.

The label shall reflect the detailed conditions stipulated in the Decision.





Appendix 1 – Copy of the French Decision





Appendix 2 – Copy of the draft product label as proposed by the applicant





Appendix 3 – Letter(s) of Access

Not applicable.

Registration Report Part A · Part A National Assessment - Country – FRANCE (RESOLVA 24 H ACTION)...

Documents

Transcript of Registration Report Part A · Part A National Assessment - Country – FRANCE (RESOLVA 24 H ACTION)...