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EFSA Journal 2015;13(11):4302

CONCLUSION ON PESTICIDE PEER REVIEW

Conclusion on the peer review of the pesticide risk assessment of the active

substance glyphosate

European Food Safety Authority (EFSA)

European Food Safety Authority (EFSA), Parma, Italy

BSTRACT

The conclusions of the European Food Safety Authority (EFSA), following the peer review of the initial risk

assessments carried out by the competent authority of the rapporteur Member State Germany, for the pesticide

active substance glyphosate are reported. The context of the peer review was that required by Commission

Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The

conclusions were reached on the basis of the evaluation of the representative uses of glyphosate as a herbicide on

emerged annual, perennial and biennial weeds in all crops [crops including but not restricted to root and tuber

vegetables, bulb vegetables, stem vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf

vegetables and fresh herbs, legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar- and fodder beet;

orchard crops and vine, before planting fruit crops, ornamentals, trees, nursery plants etc.] and foliar spraying for

desiccation in cereals and oilseeds (pre-harvest). The reliable endpoints, concluded as being appropriate for use

in regulatory risk assessment and derived from the available studies and literature in the dossier peer reviewed,

are presented. Missing information identified as being required by the regulatory framework is listed. Concerns

are identified. Following a second mandate from the European Commission to consider the findings from the

International Agency for Research on Cancer (IARC) regarding the potential carcinogenicity of glyphosate or

glyphosate-containing plant protection products in the on-going peer review of the active substance, EFSA

concluded that glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support

classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008.

EY WORDS

glyphosate, peer review, risk assessment, pesticide, herbicide

On request from the European Commission, Question No EFSA-Q-2014-00546 and EFSA-Q-2015-00279, approved on 30

October 2015.

Correspondence:

[email protected]

Suggested citation: EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk

assessment of the active substance glyphosate. EFSA Journal 2015;13(11):4302, 107 pp. doi:10.2903/j.efsa.2015.4302

Available online:

www.efsa.europa.eu/efsajournal

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

UMMARY

Commission Regulation (EU) No 1141/2010 (hereinafter referred to as ‘the Regulation’), as amended

by Commission Implementing Regulation (EU) No 380/2013, lays down the procedure for the renewal

of the approval of a second group of active substances and establishes the list of those substances.

Glyphosate is one of the active substances listed in the Regulation.

The rapporteur Member State (RMS) provided its initial evaluation of the dossier on glyphosate in the

Renewal Assessment Report (RAR), which was received by EFSA on 20 December 2013. The peer

review was initiated on 22 January 2014 by dispatching the RAR for consultation of the Member

States and the applicants of the European Glyphosate Task Force, represented by Monsanto Europe

S.A.

Following consideration of the comments received on the RAR, it was concluded that EFSA should

conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and

behaviour and ecotoxicology and EFSA should adopt a conclusion on whether glyphosate can be

expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 of the

European Parliament and the Council. On 6 August 2014 EFSA received a mandate from the

European Commission for the peer review of the active substance glyphosate.

On 30 April 2015 EFSA received another mandate from the European Commission to consider the

findings by the International Agency for Research on Cancer (IARC) regarding the potential

carcinogenicity of glyphosate or glyphosate-containing plant protection products in the ongoing peer

review of the active substance. EFSA accepted the mandate on 19 May 2015 and has included its

views in the conclusion of the peer review. After the IARC monograph 112 was published, EFSA

asked the European Commission for an extension of the overall deadline to 30 October 2015, which

was accepted, to take into account the findings of IARC as regards the potential carcinogenicity in line

with the Commission’s request.

The conclusions laid down in this report were reached on the basis of the evaluation of the

representative uses of glyphosate as a herbicide on emerged annual, perennial and biennial weeds in

all crops [crops including but not restricted to root and tuber vegetables, bulb vegetables, stem

vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf vegetables and fresh herbs,

legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar- and fodder beet; orchard crops and

vine, before planting fruit crops, ornamentals, trees, nursery plants etc.] and foliar spraying for

desiccation in cereals and oilseeds (pre-harvest), as proposed by the applicants. Full details of the

representative uses can be found in Appendix A to this report.

A series of data gaps was identified in the section identity concerning additional validation data for the

determination of impurities, batch data and updated specifications. Data gaps were also identified for

further information on analytical methods of residues in order to get a complete database to enable an

evaluation according to EU Guidance Document SANCO/825/00 rev. 8.1.

Data gaps were identified in the mammalian toxicology area to address the relevance of all individual

impurities present in the technical specifications (except for the two already identified relevant

impurities, formaldehyde and

N-Nitroso-glyphosate),

in particular impurities that elicited toxicological

alerts according to quantitative structure-activity relationship (QSAR) assessments and the ones

specified at higher level than the reference specification, in comparison with the toxicity profile of the

parent compound. Regarding carcinogenicity, the EFSA assessment focused on the pesticide active

substance and considered in a weight of evidence all available information. In contrast to the IARC

evaluation, the EU peer review experts, with only one exception, concluded that glyphosate is unlikely

to pose a carcinogenic hazard to humans and the evidence does not support classification with regard

to its carcinogenic potential according to Regulation (EC) No 1272/2008 on classification, labelling

and packaging (CLP Regulation). Glyphosate is not classified or proposed to be classified as

carcinogenic or toxic for reproduction category 2 in accordance with the provisions of Regulation

EFSA Journal 2015;13(11):4302

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

(EC) No 1272/2008 (harmonised classification supported by the present assessment), and therefore,

the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009

concerning human health for the consideration of endocrine disrupting properties are not met. To

address the potential for endocrine-mediated mode of action, the full battery of Tier I screening assays

according to the US Environmental Protection Agency Endocrine Disruptor Screening Program

(EDSP), or Level 2 and 3 tests currently indicated in the OECD Conceptual Framework are needed.

Toxicological data allowing a consumer risk assessment to be performed for the metabolites

N-acetyl-

glyphosate and

N-acetyl-AMPA,

which are relevant for uses on genetically modified (GM)

glyphosate-tolerant plant varieties that are imported into the EU, are missing.

Based on the available information, residue definitions for monitoring and risk assessment were

proposed for plant and animal commodities. These residue definitions were proposed considering the

metabolism observed in conventional and in glyphosate-tolerant GM plants. Additional residue trials

on olives and rapeseed were requested. Based on the representative uses, that were limited to

conventional crops only, chronic or acute risks for the consumers have not been identified.

Regarding fate and behaviour in the environment, further information is needed to assess the

contamination route through run off (especially in situations where application to hard surfaces might

occur) and subsequent surface water contamination and bank infiltration to groundwater. In addition,

degradation of the major soil metabolite AMPA needs to be investigated in acidic soils (pH = 5–6).

For the section on ecotoxicology, two data gaps were identified to provide an assessment to address

the long-term risk for small herbivorous mammals and for insectivorous birds. For aquatic organisms,

the risk was considered low, using the FOCUS step 2 PEC

values. The risk for bees, non-target

arthropods, soil macro- and micro-organisms and biological methods for sewage treatment was

considered low. The risk to non-target terrestrial plants was considered low, but only when mitigation

measures are implemented.

EFSA Journal 2015;13(11):4302

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

ABLE OF CONTENTS

Abstract .................................................................................................................................................... 1

Summary .................................................................................................................................................. 2

Table of contents ...................................................................................................................................... 4

Background .............................................................................................................................................. 5

The active substance and the formulated product .................................................................................... 8

Conclusions of the evaluation .................................................................................................................. 8

1. Identity, physical/chemical/technical properties and methods of analysis ...................................... 8

2. Mammalian toxicity ......................................................................................................................... 9

3. Residues ......................................................................................................................................... 13

4. Environmental fate and behaviour ................................................................................................. 16

5. Ecotoxicology ................................................................................................................................ 18

6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment

of effects data for the environmental compartments .............................................................................. 21

6.1.

Soil ........................................................................................................................................ 21

6.2.

Ground water ........................................................................................................................ 21

6.3.

Surface water and sediment .................................................................................................. 22

6.4.

Air ......................................................................................................................................... 22

7. List of studies to be generated, still ongoing or available but not peer reviewed .......................... 23

8. Particular conditions proposed to be taken into account to manage the risk(s) identified............. 24

9. Concerns ........................................................................................................................................ 25

9.1.

Issues that could not be finalised .......................................................................................... 25

9.2.

Critical areas of concern ....................................................................................................... 25

9.3.

Overview of the concerns identified for each representative use considered ....................... 25

References .............................................................................................................................................. 27

Appendices ............................................................................................................................................. 30

Abbreviations ....................................................................................................................................... 104

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

ACKGROUND

Commission Regulation (EU) No 1141/2010

(hereinafter referred to as ‘the Regulation’), as amended

by Commission Implementing Regulation (EU) No 380/2013

lays down the detailed rules for the

procedure of the renewal of the approval of a second group of active substances. This regulates for the

European Food Safety Authority (EFSA) the procedure for organising the consultation of Member

States and applicants for comments on the initial evaluation in the Renewal Assessment Report (RAR)

provided by the rapporteur Member State (RMS), and the organisation of an expert consultation,

where appropriate.

In accordance with Article 16 of the Regulation, if mandated, EFSA is required to adopt a conclusion

on whether the active substance is expected to meet the conditions provided for in Article 4 of

Regulation (EC) No 1107/2009 of the European Parliament and the Council within 6 months from the

end of the period provided for the submission of written comments, subject to an extension of up to 9

months where additional information is required to be submitted by the applicant(s) in accordance

with Article 16(3).

In accordance with Article 9 of the Regulation, Germany (hereinafter referred to as the ‘RMS’)

received an application from the applicants of the European Glyphosate Task Force for the renewal of

approval of the active substance glyphosate. Complying with Article 11 of the Regulation, the RMS

checked the completeness of the dossier and informed the applicants, the Commission and the

Authority about the admissibility.

The RMS provided its initial evaluation of the dossier on glyphosate in the RAR, which was received

by EFSA on 20 December 2013 (Germany, 2013). The peer review was initiated on 22 January 2014

by dispatching the RAR to Member States and the applicants of the European Glyphosate Task Force

for consultation and comments. In addition, EFSA conducted a public consultation on the RAR. The

comments received were collated by EFSA and forwarded to the RMS for compilation and evaluation

in the format of a Reporting Table. The applicants were invited to respond to the comments in column

3 of the Reporting Table. The comments and the applicants’ response were evaluated by the RMS in

column 3.

The need for expert consultation and the necessity for additional information to be submitted by the

applicants in accordance with Article 16(3) of the Regulation were considered in a telephone

conference between EFSA, the RMS, and the European Commission on 5 August 2014. On the basis

of the comments received, the applicants’ response to the comments and the RMS’s evaluation thereof

it was concluded that additional information should be requested from the applicant and EFSA should

organise an expert consultation in the areas of mammalian toxicology, residues, environmental fate

and behaviour and ecotoxicology. In accordance with Art. 16(2) of the Regulation the European

Commission decided to consult EFSA. The mandate was received on 6 August 2014

The outcome of the telephone conference, together with EFSA’s further consideration of the

comments is reflected in the conclusions set out in column 4 of the Reporting Table. All points that

were identified as unresolved at the end of the comment evaluation phase and which required further

consideration, including those issues to be considered in an expert consultation and the additional

information to be submitted by the applicants, were compiled by EFSA in the format of an Evaluation

Table.

Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the

inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of

those substances. OJ L 322,8.12.2011, p. 10–19.

Commission Implementing Regulation (EU) No 380/2013 of 25 April 2013 amending Regulation (EU) No 1141/2010 as

regards the submission of the supplementary complete dossier to the Authority, the other Member States and the

Commission. OJ L 116, 26.4.2013, p.4

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

The conclusions arising from the consideration by EFSA, and as appropriate by the RMS, of the points

identified in the Evaluation Table, together with the outcome of the expert consultation where this

took place, were reported in the final column of the Evaluation Table.

On 30 April 2015 EFSA received another mandate from the European Commission to consider the

findings by the International Agency for Research on Cancer (IARC) regarding the potential

carcinogenicity of glyphosate or glyphosate containing plant protection products in the on-going peer

review of the active substance. EFSA accepted the mandate on 19 May 2015 and included its views in

the conclusion of the peer review.

A consultation on the conclusions arising from the peer review of the risk assessment excluding any

consideration of the findings of IARC took place with Member States via a written procedure in July

2015. After the IARC monograph 112 was published EFSA asked the European Commission for an

extension of the overall deadline to 30 October 2015, which was accepted to take into account the

findings of IARC as regards the potential carcinogenicity in line with the Commission’s request.

Following the publication of the IARC monograph 112, the RMS prepared an assessment thereof in

the format of an addendum (Germany, 2015), which EFSA circulated for comments to all Member

States. On the basis of the comments received EFSA organised an expert consultation in the section on

mammalian toxicology in particular dedicated to carcinogenicity. The conclusion was updated

accordingly and a final consultation on the conclusions arising from the peer review of the risk

assessment took place with Member States in October 2015.

This conclusion report summarises the outcome of the peer review of the risk assessment on the active

substance and the representative formulation evaluated on the basis of the representative uses as a

herbicide on emerged annual, perennial and biennial weeds in all crops [crops including but not

restricted to root and tuber vegetables, bulb vegetables, stem vegetables, field vegetables (fruiting

vegetables, brassica vegetables, leaf vegetables and fresh herbs, legume vegetables), pulses, oil seeds,

potatoes, cereals, and sugar- and fodder beet; orchard crops and vine, before planting fruit crops,

ornamentals, trees, nursery plants etc.] and foliar spraying for desiccation in cereals and oilseeds (pre-

harvest), as proposed by the applicants. A list of the relevant end points for the active substance as

well as the formulation is provided in Appendix A. In addition, a key supporting document to this

conclusion is the Peer Review Report, which is a compilation of the documentation developed to

evaluate and address all issues raised in the peer review, from the initial commenting phase to the

conclusion. The Peer Review Report (EFSA, 2015a) comprises the following documents, in which all

views expressed during the course of the peer review, including minority views, can be found:

•

the comments received on the RAR,

the Reporting Tables (6 August 2014),

the Evaluation Table (21 October 2015),

the report(s) of the scientific consultation with Member State experts (where relevant),

the comments received on the assessment of the additional information (where relevant),

the comments received on addendum 1 (RMS’s assessment of the IARC monograph),

the comments received on the draft EFSA conclusion.

Given the importance of the RAR including its addendum (compiled version of October 2015

containing all individually submitted addenda (Germany, 2015)) and the Peer Review Report, both

documents are considered respectively as background documents to this conclusion.

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It is recommended that this conclusion report and its background documents would not be accepted to

support any registration outside the EU for which the applicant has not demonstrated to have

regulatory access to the information on which this conclusion report is based.

EFSA Journal 2015;13(11):4302

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

HE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT

Glyphosate is the ISO common name for

N-(phosphonomethyl)glycine

(IUPAC).

It should be mentioned that the salts glyphosate-isopropylammonium, glyphosate-potassium, glypho-

sate-monoammonium, glyphosate-dimethylammonium are the modified ISO common names for iso-

propylammonium

N-(phosphonomethyl)glycinate,

potassium

N-[(hydroxyphosphinato)

methyl]glycine, ammonium

N-[(hydroxyphosphinato)methyl]glycine

and dimethylammonium

N-

(phosphonomethyl)glycinate (IUPAC), respectively. These salts are derivatives of the active substance

glyphosate.

The representative formulated product for the evaluation was ‘MON 52276’, a soluble concentrate

(SL) containing 360 g/L glyphosate as isopropylammonium salt (486 g/L).

The representative uses evaluated are spraying applications against emerged annual, perennial and

biennial weeds in all crops [crops including but not restricted to root and tuber vegetables, bulb

vegetables, stem vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf vegetables

and fresh herbs, legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar- and fodder beet;

orchard crops and vine, before planting fruit crops, ornamentals, trees, nursery plants etc.] and foliar

spraying for desiccation in cereals and oilseeds (pre-harvest). Full details of the GAPs can be found in

the list of end points in Appendix A.

ONCLUSIONS OF THE EVALUATION

Identity, physical/chemical/technical properties and methods of analysis

The following guidance documents were followed in the production of this conclusion:

SANCO/3030/99 rev.4 (European Commission, 2000), SANCO /10597/2003 rev. 10.1 (European

Commission, 2012), and SANCO/825/00 rev. 8.1 (European Commission, 2010).

The proposed minimum purity of the active substance as manufactured by the members of the

European Glyphosate Task Force (GTF) comprising 24 applicants varied between 950 g/kg and

983 g/kg. The technical grade active ingredient is manufactured in the majority of cases as a TC but

also as a TK. In 21 cases the proposed individual specifications of the technical active substances

complied with the composition of the representative batches, in 3 cases they did not. The GTF

proposed a common specification covering all sources. The RMS proposed certain changes to the

reference specification proposed by the GTF based on toxicological considerations. The proposed

minimum purity of the active substance as manufactured was 950 g/kg, meeting the requirements of

the FAO specification 284/TC (2014), applicable to the materials of Monsanto, Cheminova, Syngenta

and Helm. The RMS compared each individual specification to the new proposed reference

specification and concluded that in 17 cases the proposed specification was regarded as equivalent

according to the criteria given in Tier I of Guidance Document SANCO/10597/2003 rev 10.1.

N-nitroso-glyphosate

and formaldehyde were considered relevant impurities at a maximum content of

less than 1 mg/kg and 1 g/kg respectively (see Section 2).

The assessment of the data package revealed no issues that need to be included as critical areas of

concern with respect to the identity, physical, chemical and technical properties of glyphosate or the

representative formulation; however data gaps were identified for:

an analytical method for formaldehyde with a sufficiently low LOQ and demonstrate that the

technical material meets the proposed maximum content (relevant for Brokden S.L.)

additional data/information regarding the validation of the analytical methods used for the

quantification of the significant impurities and justification for the proposed limits of some

impurities (relevant for Bro Spolka Jawna B.P. Miranowscy)

new GLP 5 batch data (relevant for Excel Crop Care Europe NV)

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additional validation data for the determination of one of the impurities (relevant for Helm

AG)

an updated technical specification for the TC and TK based on batch data or QC data

supporting the proposed limits for impurities, additional information concerning the methods

for impurities and revised evaluation of the precision of one of the methods with respect to

one impurity (relevant for Monsanto)

an updated technical specification and validation data for the determination of the impurities

(relevant for Sabero Europe B.V.)

additional validation data for the determination of one impurity (relevant for Sinon

Cooperation)

additional validation data for the determination of one impurity (relevant for United

Phosphorous)

The main data regarding the identity of glyphosate and its physical and chemical properties are given

in Appendix A.

Appropriate methods of analysis are available for the determination of the active substance in the

technical material and formulations and also for the determination of relevant impurities.

Considering additional analytical methods evaluated by the RMS which were not provided with the

dossier of the GTF, residues of glyphosate and

N-acetyl-glyphosate

in food and feed of plant origin

can be monitored by HPLC-MS/MS methods with LOQs of 0.05 mg/kg for both compounds in all

representative commodity groups, however a data gap was identified for a confirmatory method for

N-

acetyl-glyphosate in dry plant materials and those with high water and high fat content. An HPLC-

MS/MS method was available for the determination of residues of glyphosate and

N-acetyl-glyphosate

in all animal matrices with LOQs of 0.025 mg/kg in meat, milk and egg and 0.05 mg/kg in liver,

kidney and fat respectively. Data gaps were identified for confirmatory method for glyphosate in

animal fat and kidney/liver and a confirmatory method for

N-acetyl-glyphosate

in all animal matrices.

The residue definition for monitoring in soil was defined as glyphosate and AMPA. Compounds of the

residue definition in soil can be monitored by GC-MS after derivatisation, with LOQs of 0.05 mg/kg

for both compounds. A data gap was identified for a confirmatory method for glyphosate and AMPA

in soil. An appropriate HPLC-MS/MS method is available for monitoring residues of glyphosate and

AMPA in ground water and surface water with LOQs of 0.03 µg/l for both substances. Residues of

glyphosate in air can be monitored by GC-MS with a LOQ of 5 µg/m

The active substance is not classified as toxic according to Regulation (EC) No 1272/2008

(CLP

Regulation), therefore a method of analysis is not required for body fluids and tissues.

Mammalian toxicity

The following guidance documents were followed in the production of this conclusion:

SANCO/221/2000 rev. 10 – final (European Commission, 2003), SANCO/222/2000 rev. 7 (European

Commission, 2004) and SANCO/10597/2003 – rev. 10.1 (European Commission, 2012) and Guidance

on Dermal Absorption (EFSA PPR Panel, 2012).

Glyphosate was discussed at the Pesticides Peer Review Experts’ Meeting 125 in February 2015 and

the carcinogenic potential of glyphosate was re-discussed at the Pesticides Peer Review

Teleconference 117 in September 2015 after the publication of the Monograph 112 by the

International Agency for Research on Cancer (IARC, 2015).

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,

labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008 p.1–1355.

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The new proposed reference specification as proposed by the RMS (Germany, 2015) is supported by

the toxicological studies; however eight out of the 24 applicants presented specifications that were not

supported by the toxicological assessment (Industrias Afrasa S.A., Arysta Lifescience SAS, Bros

Spolka Jawna B.P. Miranowscy, Dow AgroScience S.r.l, three out of seven sources of Helm AG,

Monsanto Europe, Société Financière de Pontarlier and one of the two Syngenta Limited

manufacturing routes) which is a critical area of concern for the respective applicants/sources. In some

cases, the applicants have to comply with the respective revised technical specification as proposed by

the RMS to conclude on their equivalence to the new reference specification.

Two relevant impurities were identified, formaldehyde due to its harmonised classification in

accordance with the provisions of Regulation (EC) No 1272/2008 (CLP Regulation) as Toxic, Carc 1B

and Muta 2 and

N-nitro-glyphosate

(belonging to a group of impurities of particular concern as they

can be activated to genotoxic carcinogens); at the specified levels these impurities are not of concern.

The relevance of other impurities should be further assessed, in particular impurities that elicited

toxicological alerts according to QSAR assessments and the ones specified at a higher level than in the

reference specification; this was identified as a data gap.

The glyphosate dossier consists of an exceptionally large database, therefore the toxicological

evaluation adopted by the RMS and agreed during the peer review rely on a magnitude of valid studies

rather than on one ‘key study’ for each endpoint. Glyphosate is rapidly but incompletely absorbed

after oral administration (around 20 % of the administered dose based on urinary excretion after 48

hours and comparison of kinetic behaviour after oral and iv administrations), being mostly eliminated

unchanged via faeces. Absorbed glyphosate is poorly metabolised, widely distributed in the body, does

not undergo enterohepatic circulation and is rapidly eliminated; showing no potential for

bioaccumulation. Low

acute toxicity

was observed when glyphosate (as glyphosate acid or salts) was

administered by the oral, dermal or inhalation routes; no skin irritation or potential for skin

sensitisation were attributed to the active substance. Glyphosate acid was found to be severely irritant

to the eyes (harmonised classification in Annex VI of CLP Regulation

as Eye Dam. 1, H318, ‘Causes

serious eye damage’), while salts of glyphosate do not need classification regarding eye irritation. The

main target organs of glyphosate are the gastro-intestinal tract, salivary glands, liver and urinary

bladder in rodents; furthermore, upon chronic exposure, rats developed cataracts. An overall

long

term NOAEL

of 100 mg/kg bw per day was obtained considering a number of long term studies in

rats. Dogs presented reduced body weight gain, gastrointestinal signs and liver toxicity upon short

term exposure to glyphosate and a number of severe findings in one of the six studies investigating

high doses of glyphosate (around 1000 mg/kg bw per day). Glyphosate did not present

genotoxic

potential and no evidence of

carcinogenicity

was observed in rats or mice. Out of five mice studies

considered, one study with Swiss albino mice showed a statistically significant increased incidence of

malignant lymphomas at the top dose of 1460 mg/kg bw per day. This study was discussed at length

during the first Pesticides Peer Review Experts’ Meeting (PPR 125). Although observed above the

(limited) historical control data of this study, the increased incidence of malignant lymphomas

occurred at a dose level exceeding the limit dose of 1000 mg/kg bw per day recommended for the oral

route of exposure in chronic toxicity and carcinogenicity studies (OECD, 2012a) and was not

reproduced in four other valid long term studies in mice. The large majority of the experts had

considered it highly unlikely that glyphosate would present carcinogenic potential due to the generally

recognised high background incidence of malignant lymphomas in this strain (confirmed by a post-

meeting literature search made by the RMS that nevertheless did not include valid historical control

data) and the high dose at which it occurred. The study was re-considered during the second experts’

teleconference (TC 117) as not acceptable due to viral infections that could influence survival as well

as tumour incidence – especially lymphomas.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,

labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1–1355.

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After the PPR 125 expert meeting took place, the IARC released a summary of its evaluation in an

article published by the Lancet (Guyton et al, 2015), classifying glyphosate as ‘probably carcinogenic

to humans’ (group 2A). More detailed information is available in the IARC monograph 112 (IARC,

2015), which was published in July 2015. In order to address the European Commission mandate,

EFSA asked the RMS to evaluate the IARC monograph 112, prepare an addendum (Germany, 2015)

on the carcinogenicity potential addressing the IARC assessment to be examined in the peer review

and support the discussion during the teleconference 117 with Member States experts and observers

from international agencies including IARC.

There are several reasons explaining the diverging views between the different groups of experts. On

one hand, the IARC did not only assess glyphosate but also glyphosate-based formulations, while the

EU peer review is focused on the pure active substance; the peer review recognised that the issue of

toxicity of the formulations should be considered further as some published genotoxicity studies (not

according to GLP or to OECD guidelines) on formulations presented positive results

in vitro

and

vivo.

In particular, it was considered that the genotoxic potential of formulations should be addressed;

furthermore EFSA noted that other endpoints should be clarified, such as long-term toxicity and

carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential of

formulations (EFSA, 2015b). The assessment of the few epidemiological studies included in the IARC

monograph, which were not reported in the original RAR (three out of ten cohort studies, six out of 19

case-control studies) was presented in the addendum of August 2015 to the RAR (Germany, 2015).

With regard to the studies on experimental animals, three of the five mice studies used by the EU peer

review and three of the nine studies in rats were not assessed by IARC. Importantly, there is a different

interpretation of the statistical analysis used to assess the carcinogenic findings in the animal studies

and on the use of historical control data; the EU peer review considered relevant historical control data

from the performing laboratory. Additionally, referring to the unusually large data base available, it

was considered appropriate by the EU peer review to adopt consistently a weight of evidence

approach.

From the wealth of epidemiological studies, the majority of experts concluded that there is very

limited evidence for an association between glyphosate-based formulations and non-Hodgkin

lymphoma, overall inconclusive for a causal or clear associative relationship between glyphosate and

cancer in human studies. Minority views nevertheless were expressed that there was either inadequate

or limited evidence of an association. No evidence of carcinogenicity was confirmed by the large

majority of the experts (with the exception of one minority view) in either rats or mice due to a lack of

statistical significance in pair-wise comparison tests, lack of consistency in multiple animal studies

and slightly increased incidences only at dose levels at or above the limit dose/MTD, lack of pre-

neoplastic lesions and/or being within historical control range. The statistical significance found in

trend analysis (but not in pair-wise comparison)

per se

was balanced against the former

considerations. During the teleconference 117, the experts also agreed to the conclusion of the RMS,

that for the active substance glyphosate no classification for mutagenicity is warranted. However,

there were two minority views, that a Comet assay should be requested for confirmation.

In contrast to the IARC evaluation, the EU peer review experts, with only one exception, concluded

that glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support

classification with regard to its carcinogenic potential according to the CLP Regulation.

Reproductive and fertility parameters were not affected by glyphosate administration although a

decrease in homogenisation on resistant spermatids (cauda

epididymis)

was observed in the parental

generation (F

) at the high dose level of 1000 mg/kg bw per day, not reproduced in the following

generations, and a delay in preputial separation was seen at the same dose level in males of the filial

generation F

. Concomitant parental toxicity was observed at this dose level consisting of reduced

It should be noted that the harmonised classification is formally proposed and decided in accordance with Regulation (EC)

No 1272/2008. Proposals for classification made in the context of the evaluation procedure under Regulation (EC) No

1107/2009 are not formal proposals for harmonised classification.

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body weight gain, gastrointestinal signs and organ weight changes. Developmental effects (delayed

ossification, increased incidence of skeletal anomalies) were observed in rats in the presence of

maternal toxicity. Pregnant rabbits were found to be particularly vulnerable to glyphosate

administration and developmental effects were linked to severe maternal toxicity, including maternal

deaths. The occurrence of developmental anomalies (cardiac malformations) in one rabbit study was

discussed by the experts. As the finding was associated with severe maternal toxicity and was not

reproduced in the three newly submitted studies, the majority of the experts agreed that classification

regarding developmental toxicity would not be required. The relevant overall maternal and

developmental NOAEL were 50 mg/kg bw per day considering all developmental toxicity studies in

rabbits.

Glyphosate is not classified or proposed to be classified as carcinogenic or toxic for the reproduction

category 2 in accordance with the provisions of Regulation (EC) No 1272/2008 (harmonised

classification supported by the present assessment), and therefore, the conditions of the interim

provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the

consideration of endocrine disrupting properties are not met. Apical studies did not show adverse

effects on the reproduction, however signs of endocrine activity, even if appearing at parental toxic

doses, could not be completely ruled out regarding delay in preputial separation in F

males and

decrease in homogenisation resistant spermatids (cauda

epididymis)

observed in the most recent multi-

generation study. Glyphosate was selected by the US EPA Endocrine Disruptor Screening Program’s

(EDSP) to undergo a full battery of Tier I screening assays for evaluation of glyphosate’s potential to

interact with the oestrogen, androgen and thyroid endocrine pathways. The RMS mentions that the

first published data revealed no effects on the androgenic and oestrogenic pathways (from the

Hershberger and Uterotrophic assays), that glyphosate did not show evidence of endocrine disruption

in male and female pubertal assays and no impact on steroidogenesis was observed in the

in vitro

assays. However these studies were not submitted for the renewal procedure and a data gap has been

identified for the full battery of Tier I screening assays on the hazard assessment of endocrine

disruptors in accordance with the EDSP, or the Level 2 and 3 tests currently indicated in the OECD

Conceptual Framework (OECD, 2012b), and analysed in the EFSA Scientific Opinion (EFSA SC,

2013). Although the experts agreed that there is no evidence for endocrine-mediated effects for

glyphosate, a firm conclusion cannot be reached now and a data gap was proposed. No potential for

neurotoxicity or immunotoxicity was detected in glyphosate-administered rats.

Single and repeated administration of glyphosate in goats and cattle at high dose levels (1000 mg/kg

bw) demonstrated that systemic intoxication in these animals was mainly characterised by

gastrointestinal and neurological signs; the kidneys and GIT (mucosal irritation) were identified as

target organs in ruminants by histopathological examination. Although these animals may be more

sensitive than monogastric animals, urinary levels of glyphosate reported from farm animals,

converted to the respective systemic dose levels, were estimated to remain well below the NOAEL for

these animals in toxicological studies (with a margin of

ca.

1:4200). A postulated adverse effect of

glyphosate on quantitative composition of ruminal microflora or ruminal metabolism in ruminants

could not be substantiated by means of the ‘Rumen Simulation Technique’, in particular, there was no

evidence of

Clostridium botulinum

overgrowth. The gastro-intestinal signs that were observed after

administration of high doses of glyphosate in mammals (laboratory and farm animals) were considered

to be most likely due to the well-established irritating properties of glyphosate acid and could not be

ascribed to alterations of the intestinal microflora.

A number of toxicological studies are available on the metabolite

AMPA

relevant to the

environmental and plant/livestock residue assessments, but only found at trace levels in the rat

metabolism studies. Overall it was concluded that AMPA presents a similar toxicological profile to

glyphosate and the reference values of the latter apply to its metabolite AMPA. No toxicological data

were provided on

N-acetyl-glyphosate

(NAG) and

N-acetyl-AMPA

which were identified as relevant

compounds in plant/livestock residues where glyphosate tolerant genetically modified (GM) plant

varieties are eaten by humans or farm animals. The need for information on this was identified as a

data gap.

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The acceptable daily intake (ADI) of glyphosate is 0.5 mg/kg bw per day, based on the maternal and

developmental NOAEL of 50 mg/kg bw per day from the developmental toxicity study in rabbits and

applying a standard uncertainty factor (UF) of 100. The previous EU evaluation had set an ADI of 0.3

mg/kg bw per day based on the four long term toxicity studies in rats that were available at that time.

In line with the former regulatory practice, NOELs instead of NOAELs were used. An overall NOEL

of 30 mg/kg bw per day was established. One of these studies has been found to no longer meet the

current testing guideline criteria due to the low doses tested (the NOEL is the highest dose tested in

this study) and in the current evaluation, an overall long term NOAEL of 100 mg/kg bw per day is

based on six valid combined long term toxicity/carcinogenicity studies in rats.

The acute reference dose (ARfD) is 0.5 mg/kg bw, based on the same NOAEL of 50 mg/kg bw per

day as the ADI (from the developmental toxicity in rabbits) due to the occurrence of severe toxicity

including mortality observed in pregnant does and the increased incidences of post-implantation losses

observed in two of the seven developmental toxicity studies in rabbits, applying an UF of 100. An

ARfD had not been allocated in the previous EU evaluation.

The acceptable operator exposure level (AOEL) is 0.1 mg/kg bw per day on the same basis as the ADI

and ARfD, applying a correction factor to account for the limited oral absorption of 20%. The

previous EU evaluation had set an AOEL of 0.2 mg/kg bw per day based on a maternal NOEL

(assumed to be a NOAEL) of 75 mg/kg bw per day from a rabbit developmental study, with an UF of

100 and 30% oral absorption.

Dermal absorption of the representative formulation ‘MON 52276’ (SL formulation containing 360 g

glyphosate/L), was conservatively set at 1% for the concentrate and in-use spray dilutions to account

for uncertainties and limitations identified in the

in vitro

dermal absorption study through human skin.

Personal protective equipment (PPE) such as gloves during mixing and loading operations have to be

considered to ensure that operator exposure does not exceed the AOEL according to the German

model for hand-held applications, while estimated operator exposure was below the AOEL for tractor-

mounted applications even when PPE is not worn. Worker exposure without PPE, bystander and

residential exposure were estimated to be below the AOEL.

Human biomonitoring of urine samples from several publications did not give indications of health

concern as the highest urine concentration value, converted for a systemic dose, was estimated to

represent at most 8.4% of the AOEL, with the mean value of samples representing

ca.

0.1% of the

AOEL; generally lower values were obtained from urine samples assumed to result from dietary intake

of glyphosate, representing 0.1-0.66 % of the ADI. Similarly, when AMPA was biomonitored, its

maximum levels were estimated to remain below 0.1 % of the ADI however no direct correlation

between glyphosate and AMPA could be established, indicating that AMPA’s presence in urine may

originate from other sources than from the metabolism of glyphosate in plants.

Residues

The assessment in the residue section is based on the guidance documents listed in the guideline

1607/VI/97 rev.2 and the guideline on extrapolation SANCO 7525/VI/95 rev. 9 (European

Commission, 1999, 2011), the recommendations on livestock burden calculations stated in the JMPR

reports (JMPR, 2004, 2007) and the OECD publication on MRL calculations (OECD, 2011).

Glyphosate was discussed at the Pesticides Peer Review Experts’ Meeting 127 on residues in March

2015.

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The metabolism of glyphosate in primary crops was investigated in numerous crop groups, including

genetically modified plants containing the CP4-EPSPS,

GOX

or GAT

modifications.

In non-tolerant plants,

metabolism was studied in the fruit, root, pulses/oilseeds, cereal and

miscellaneous crop groups, using either soil, foliar, hydroponic or trunk application of

C-glyphosate

and in some experiments, with

C-AMPA. Following soil application, the uptake of glyphosate was

very low and amounted to mostly less than 1% of the applied radioactivity (AR) in plant matrices.

Limited translocation was also observed after local foliar application, most of the applied radioactivity

(80%) remaining in the treated parts of the plants. Hydroponic studies were therefore the key studies

to identify the metabolic pattern of glyphosate in conventional plants. Globally without soil present as

substrate, less than 5% AR was recovered in the aerial parts, up to 20% AR in the roots. No significant

degradation was observed and unchanged glyphosate was observed as the major component of the

residues in most of the samples (ca. 50% to 80% TRR) with low amounts of AMPA (4% to 10% TRR)

and N-methyl-AMPA (0.3 to 5% TRR in root samples).

In genetically modified plants,

the metabolic pattern of glyphosate is driven by the modifications

introduced into the genome of the plant.

In the metabolism studies conducted on GM soya bean, cotton and sugar beet containing the

CP4-

EPSPS

modification, parent glyphosate was detected as the major component of the residues,

accounting for 24% to 95% TRR in forage, hay, tops and roots and for 12% to 25% TRR in seeds.

AMPA was present at much lower amounts (mostly 1% to 13% TRR) up to 49% TRR in soya

bean seeds. Overall, the metabolic pattern was similar to that observed in conventional plants as

the CP4-EPSPS modification does not affect the metabolism of glyphosate in genetically modified

plants.

The metabolism resulting from the introduction of the

GOX

modification was investigated in rape

seed and maize in combination with the CP4-EPSPS modification. Following two foliar

applications, glyphosate was observed in maize forage, silage and fodder (67% to 83% TRR), but

almost not detected in seeds at harvest (7% TRR), where the main component of the residues was

identified as AMPA, representing up to 8% TRR in rape seeds and 60% TRR in maize seeds.

The impact of the

GAT

modification was investigated in three metabolism studies conducted on

genetically modified rapeseed, soya bean and maize, following one pre-emergence application and

three post emergence treatments, up to 7 or 14 days before harvest. Parent glyphosate was detected

in the soya bean and maize forage and foliage (9% to 75% TRR) and in rape seeds (21%), but was

almost absent in soya bean and maize seeds at harvest (0.1% to 3% TRR). In all plant matrices, the

main component of the radioactive residues was identified as the

N-acetyl-glyphosate

metabolite

formed by the action of the GAT enzyme, and accounting for 51% to 57% of the TRR in seeds and

18% to 93% TRR in the other plant parts. In addition

N-acetyl-AMPA

was also identified as a

major metabolite in rape and soya bean seeds, representing 15 to 24% TRR.

Cultivation of glyphosate tolerant GM crops is not authorised in most of the EU member states, but

since an import of glyphosate tolerant commodities is possible, the two following residue definitions

were proposed for monitoring:

CP4-EPSPS: In conventional plants, glyphosate inhibits the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein,

a key enzyme in the biosynthesis of aromatic amino acids (e.g. tyrosine, phenylalanine…), leading to plant death.

Tolerance to glyphosate is obtained by the introduction of a gene from

Rhizobium radiobacter

that codes for the expression

of a modified EPSPS protein, insensitive towards glyphosate inhibition.

GOX: Glyphosate oxidoreductase, protein obtained by the introduction of a gene from

Ochrobactrum anthrop

acting by

breaking down glyphosate to AMPA and glyoxylate which have no herbicidal activity.

GAT: Glyphosate N-acetyltransferase, protein obtained by the introduction of a gene from

Bacillus licheniformis,

giving

rise to N-acetyl glyphosate which denotes no herbicidal activity.

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- ‘sum

glyphosate and N-acetyl glyphosate expressed as glyphosate’

for plants with glyphosate

tolerant GM varieties available on the market (mostly maize, oilseed rape and soya bean) and

considering that glyphosate alone is not an appropriate maker for some GAT-modified plants,

- ‘glyphosate’, for the other plant commodities.

For risk assessment the residue definition was proposed as:

- ‘sum

glyphosate, N-acetyl glyphosate, AMPA and N-acetyl-AMPA expressed as glyphosate’

and

considering that the N-acetyl glyphosate and N-acetyl-AMPA metabolites are relevant for the GM

crops containing the GAT modification.

In the framework of the renewal, representative uses were proposed for conventional crops only and

residue trials on glyphosate tolerant GM crops were not provided. A very large number of residue

trials were submitted where samples were almost all analysed for glyphosate and AMPA. AMPA

residues were all below the LOQ values, except in the trials related to the pre-harvest uses on cereals

and oilseeds. Since in conventional plants, the metabolism studies have shown AMPA to be present in

very low amounts compared to glyphosate residues, it was agreed for risk assessment to consider the

glyphosate LOQ value only, and not the sum of the glyphosate and AMPA LOQs as usually requested.

Considering the low contribution of AMPA to the overall consumer intakes, conversion factors for

risk assessment were not proposed for plant commodities from conventional crops. MRLs were

derived for a large number of crops and extrapolated to all crop groups, having regard to the no-

residues situations generally observed. Data gaps were identified for the clarification of the GAP and

for additional residue trials for olives (oil production) and further trials on rape seed conducted

according to the proposed GAPs were required.

The residue data were supported by storage stability studies showing that glyphosate and AMPA

residues are stable for at least 2 years to more than 3 years in the different matrix types.

N-acetyl-

glyphosate was stable for at least 1 year in high acid, high water and dry/starch matrices and

N-acetyl-

AMPA is stable for at least 1 year in high water and dry/starch matrices and 1 month in high oil

matrices. Glyphosate and N-acetyl-glyphosate were stable under standard hydrolysis conditions.

Processing studies were submitted and processing factors were proposed for several crop

commodities. Significant residues of glyphosate or AMPA are not expected in rotational crops.

Several livestock metabolism studies on goat and hen using

C-glyphosate and

C-AMPA labelled on

the phosphonomethyl-moiety and conducted with glyphosate, glyphosate trimesium or a 9/1

glyphosate/AMPA mixture were submitted. Parent glyphosate was identified as the major component

of the radioactive residues, accounting for 21% to 99% TRR in all animal matrices and AMPA was

detected in significant proportions in liver (up to 36% TRR), muscle and fat (up to 19% TRR) and egg

yolk (14% TRR). In addition, metabolism studies on goat and hen using

C-N-acetyl-glyphosate were

provided. In these studies, N-acetyl-glyphosate was identified as the major component of the

radioactive residues, accounting for 17% to 77% TRR. Degradation to N-acetyl-AMPA was observed

in fat (10% to 15% TRR), to glyphosate in liver (15% TRR), poultry fat (37% TRR) and egg white

(11% TRR) and to AMPA in poultry muscle and fat (11% to 17% TRR). Based on these studies and

considering that it cannot be excluded that livestock are exposed to feed items from genetically GAT-

modified crops imported from third countries, the residue definition for monitoring was proposed as

‘sum

of glyphosate and N-acetyl-glyphosate expressed as glyphosate’

for monitoring and as ‘sum

glyphosate, N-acetyl glyphosate, AMPA and N-acetyl-AMPA expressed as glyphosate’

for risk

assessment. Feeding studies conducted on dairy cows and laying hens fed with either glyphosate,

glyphosate trimesium or a 9/1 glyphosate/AMPA mixture were submitted. A feeding study on pig

using the glyphosate/AMPA mixture was also provided. Based on these studies and the estimated

residue intakes by livestock, MRLs were proposed for animal matrices. However, it should be

highlighted that these proposals are based on the representative uses limited to conventional crops

only. Calculated intakes by livestock and therefore MRL proposals might be significantly changed if

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the nature and levels of residues present in feed commodities from glyphosate tolerant GM crops are

taken into account.

The consumer risk assessment was performed using the EFSA PRIMo model and the STMR and HR

values derived for plant and animal commodities. Based on the available data limited to only the uses

on conventional crops, a risk for the consumer was not identified. The maximum chronic intake was

calculated to be 3% of the ADI (IE, adult) and the highest acute intake 9% of the ARfD for barley

(NL, adult).

Environmental fate and behaviour

Glyphosate was discussed in the Pesticides Peer Review Meeting 126 in February 2015.

The route of degradation in soil of glyphosate under aerobic conditions was investigated in two

reliable experiments presented in the draft assessment report (DAR, Germany, 1998). Two other

experiments were provided for information only on the rate of degradation of glyphosate.

Additionally, two studies on the route of degradation of glyphosate-trimesium were submitted during

the first EU review of glyphosate. The RMS re-evaluated the previously submitted studies and

considered that the arguments presented in the DAR (Germany, 1998) for the non-acceptability of the

study Kesterson & Atkins (1991, BVL no 1932061)/ Honegger (1992, BVL no 2325652) (Germany

2013) are no longer consistent with current evaluation practice. Therefore, these studies have now

been considered acceptable regarding the results of the incubation of glyphosate in the silt loam soil

Dupo. The Glyphosate Task Force (GTF) submitted a new soil metabolism study for the renewal

process. Additionally four route of degradation studies under aerobic conditions in soil were available

in the renewal dossier from the GTF. These studies were not considered during the first review of

glyphosate. Results of an additional rate of degradation study submitted in the renewal dossier are also

considered to provide route of degradation information. Therefore, the peer review considered that up

to 12 experiments for aerobic degradation in soil at 20ºC were acceptable to characterise the route and

rate of degradation of glyphosate. Three additional experiments were considered to provide only

information on persistence or rate of degradation. From these twelve experiments, it is observed that

glyphosate exhibits low to very high persistence in soil. The principal soil metabolite was

aminomethylphosphonic acid (AMPA). The maximum amount of AMPA detected ranged from 13.3 to

50.1% AR. This metabolite exhibits moderate to high persistence in the nine laboratory experiments in

which a reliable half-life was determined.

Glyphosate comprises of one alkaline amino functional group and three ionisable acidic sites;

therefore, it is present, as multiple chemical species, at most pH values, although the di-anion

predominates at the typical environmental pH range of 5-9. Furthermore, the molecule exists as a

zwitterion at pH values < 10 due to protonation of the amino nitrogen. A moderate positive correlation

between the pH of the soil and the mineralisation has been observed in the available studies (max. CO

23.6 % AR [pH 6.5] – 79.6 % AR [pH 7.5]). However, no robust correlation has been observed

between pH of the soil and glyphosate half-lives (SFO DT

). For AMPA the RMS proposed to

exclude one soil due to the loss of microbial viability after 120 d. With this exclusion, the range of pH

values in the soils tested with AMPA was 6.5–7.5 and a conclusion on the effect of the pH of soil on

the degradation rate could not be reached. Reliable experiments on the pH range 5-6 were not

available for AMPA, neither within the laboratory studies nor within the field dissipation studies. This

range of pH values needs to be covered by experimental data according to the data requirements.

Therefore, a data gap has been identified to investigate the degradation rate of the major metabolite

AMPA in soils having pHs in the acidic range.

Degradation of glyphosate in soil under anaerobic conditions was investigated in three soils.

Glyphosate exhibits high to very high persistence under these conditions (DT

50 anaerobic

= 135 - > 1000

d). The same major metabolite AMPA, as identified under aerobic conditions, was also formed under

anaerobic conditions.

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Photolysis of glyphosate at the soil surface was investigated in four experiments with simulated and

natural sun light at 20 ºC (three experiments submitted for the first authorisation and one experiment

submitted for the renewal procedure). In these studies, irradiation does not significantly enhance

degradation of glyphosate in soil. The main metabolite identified in the irradiated and dark samples

was AMPA.

Field dissipation studies were available for glyphosate (eight sites) and the major metabolite AMPA

(five sites). AMPA exhibited higher persistence in the field dissipation studies than in the laboratory

aerobic degradation experiments. AMPA was also captured as being formed at a comparable (but

numerically higher) proportion of the precursor glyphosate (53.8 % on a molar basis) to that which

was observed in the available laboratory soil incubations.

Predicted environmental concentrations (PEC) soil values were calculated for the parent glyphosate

and the metabolite AMPA for the representative uses in annual and permanent crops based on standard

calculation approaches, the worst case field degradation pattern and the maximum application rate

proposed for the representative uses. Plateau PEC soil values for glyphosate and the metabolite AMPA

were calculated to be reached after 10 years of continuous application of glyphosate.

Batch soil adsorption / desorption studies were performed with glyphosate (24 soils were tested, 20

reliable experiments were identified and used to derive mean end points) and the metabolite AMPA

(17 soils were tested, 16 reliable experiments were identified and used to derive mean end points).

According to these studies glyphosate and AMPA may be considered to exhibit low mobility or be

immobile in soil. Four column leaching studies in a total of 16 soils are available (three performed

applying glyphosate trimesium salt). In addition, two aged (8 days and 30 days) column leaching

studies in sandy soils were also available. These column leaching studies are considered to provide

supplementary information on the leaching behaviour of glyphosate and its metabolite AMPA. No

lysimeter studies have been submitted in the original and the supplementary EU dossiers.

Glyphosate is stable to hydrolysis in the range of environmentally relevant pH (pH 5–9) at 25 ºC and

40 ºC. Aqueous photolysis of glyphosate and glyphosate trimesium were investigated in buffered

aqueous solutions (pH 5, pH 7 and pH 9 for glyphosate and pH 7 for the trimesium variant) under

simulated sunlight. Aqueous photolysis could contribute to a limited extent to the degradation of

glyphosate in aqueous environments. Glyphosate is not readily biodegradable according the available

studies (OECD 301 F and OECD 302B; OECD 1992a and OECD 1992b). Degradation and dissipation

of glyphosate in the aquatic environment under aerobic conditions was investigated in eight

water/sediment systems. Glyphosate partitioned in the sediment to a substantial extent (max 61.4 %

AR after 14 d). The persistence of glyphosate in these systems was relatively variable going from

moderate to high persistence (DT

50 whole system (SFO)

= 13.82 d to > 301 d). Two major metabolites were

found in the water phase: AMPA (max. 15.7 % AR after 14 d) and HMPA (max. 10.0 % AR after 61

d). Only the metabolite AMPA exceeded 10 % AR in the sediment (max. 18.7 % AR after 58 d).

Mineralisation ranged from 5.9 % AR to 47.9 % AR at the end of the studies. Un-extractable residue

in the sediment increased to up to 49 % AR after 120 d, at study end. PEC

values were calculated up

to step 3

for glyphosate and up to Step 2 for the major metabolites AMPA and HMPA with FOCUS

SW tools using the FOCUS (2001) approach.

The potential for ground water exposure was assessed calculating the 80th percentile of 20 years

annual average concentrations of glyphosate and AMPA at 1 m depth with FOCUS GW PELMO 4.4.3

model

for the representative uses in winter and spring cereals, potatoes and apples (FOCUS, 2009).

The parametric drinking water limit of 0.1 µg/L was not exceeded by the parent or the metabolite

AMPA for any of the uses and relevant scenarios. Simulations with a second model would be needed

according to the EFSA PPR panel opinion (EFSA PPR, 2013). However, taking into account the low

At Step 3, simulations correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient

of 0.7

Simulations correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient of 0.7

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levels calculated in the available simulations (all < 0.001 µg/L) it was considered very unlikely that

calculations with a second model would result in an exceedance of the parametric drinking water limit

of 0.1 µg/L.

The applicant submitted several studies on groundwater monitoring. Glyphosate and AMPA have been

detected in Europe above the parametric limit of 0.1 µg/L in a number of instances. Detailed

groundwater monitoring studies demonstrating that glyphosate exceeded the limit of 0.1 µg/l were

available from Italy, Germany, the Netherlands, Sweden, France and Spain. In some cases, the authors

presented some clarifications of possible causes for glyphosate findings in groundwater aquifers at

levels greater than 0.1µg/L. These were that they were not directly related to representative uses and

other authorised good agricultural practices. However, it often remains unclear which findings above

the parametric limit originate from an authorised use in agricultural areas and which from misuses. In

considering these findings, it should be also taken into account that there are other sources of

glyphosate than agricultural applications, e.g. the control of weeds in streams and drains, on railways,

roads, sports fields and industrial areas. Nevertheless, due to the specific ionic characteristics of

glyphosate and AMPA the chromatographic leaching mechanisms and routes simulated by FOCUS

GW may not be the most relevant ones to assess the potential for groundwater contamination of these

compounds. In particular, further information is needed to assess the contamination route through run

off (especially in situations where application to hard surfaces might occur) and subsequent surface

water contamination and bank infiltration to groundwater. This route was considered relevant for the

representative uses on ‘all seeded or transplanted crops’ and ‘all seeded crops’ as horticultural

practices can mean that containers or seed trays can be placed on hard surfaces. Therefore a data gap

has been identified during the peer review (see section 7).

The criteria for active substances laid down in Art 4.3 (b) of Regulation No 1107/2009 have been

appropriately addressed with respect to situations when water, potentially containing residues of

glyphosate and AMPA, is abstracted for drinking water and treated by chlorination procedures.

Ecotoxicology

The risk assessment was based on the following documents: European Commission (2002a, 2002b,

2002c), SETAC (2001), and EFSA (2009).

The new proposed reference specification as proposed by the RMS (Germany, 2015) is not supported

by the specifications of all applicants. Therefore a critical area of concern was identified.

Some aspects of the risk assessment of glyphosate were discussed at the Pesticides Peer Review

Meeting 128 (3–5 March 2015). The RMS raised concerns regarding the indirect effects (biodiversity)

on non-target organisms via trophic interaction of extensively used herbicides such as glyphosate. At

the meeting there was also an exchange of views on this issue. The experts considered this as an

important risk management issue.

For the risk assessment to

birds and mammals,

it is acknowledged that no specific scenarios are

available in the Guidance Document on Risk Assessment for Birds and Mammals (EFSA, 2009) for

the spraying applications against emerged annual, perennial and biennial weeds for the representative

use ‘all crops pre-planting and post planting’. The RMS used, as surrogate, the worst case scenarios

related to the early stage of several crops for the representative uses ‘all crops’ (pre and post-planting).

Although it is not clearly indicated in the guidance document (EFSA, 2009), likely the most suitable

scenarios might have been those related to ‘not crop directed applications’, which were specifically

developed for herbicides applied in orchards. However, the RMS’s approach covered both the latter

scenarios and other more conservative ones. Therefore the RMS’s approach was considered

acceptable.

It is noted that for all the representative uses, the maximum cumulative application rate per year was

reported to be 4.32 kg a.s./ha. For the representative uses in orchards, the RMS considered a

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combination of possible use patterns, which included worst case situations. Furthermore, since the

applications are made intra-row, it was assumed that the actual application rates per hectare of cropped

areas were 50% of the rates per hectare of treated areas (i.e. 2.16 kg a.s. /ha of cropped areas).

The acute risk to

birds

via dietary exposure was assessed as low with the screening level for all the

representative uses. The first tier long-term risk to birds was indicated as high for some of the

scenarios for the representative uses ‘all crops,’ pre-planting (in particular for herbivorous birds) and

for ‘cereals, pre-harvest application’ (in particular, for insectivorous birds), while the risk was low for

the uses in ‘all crops’(post-planting, oilseeds and orchards).

The acute risk to mammals was assessed as low at the first tier level for all the representative uses,

except for the worst-case scenario ‘small herbivorous mammals (e.g. common vole,

Microtus arvalis)’

for the uses in ‘all crops’ (pre-planting). No further risk assessment refinement was available for this

scenario. The first tier long-term risk to mammals was indicated as high for all the representative uses.

The residue decline of glyphosate in grass was considered to refine the time weight average factor

twa

) and the Multiple Application Factor (MAF) for herbivorous birds and mammals and for

omnivorous mammals. Based on this refinement the long-term risk to herbivorous birds was indicated

as low. The long-term risk to mammals was indicated as high for the representative uses ‘all crops’

pre-planting’ and ‘all crops’ post-planting, in particular, to herbivorous mammals; the long-term risk

to small herbivorous mammals was indicated high for the representative uses in orchards based on the

application pattern of 1×2880 g a.s/ha reduced by 50% (see above). A low long-term risk to small

herbivorous mammals was demonstrated for orchards only when the substance is applied 3 × max.

1440 g a.s./ha of treated area (i.e. 3 × max. 720 g a.s./ha of cropped area, which means half of the

annual cumulative maximum application rate of 4.32 kg a.s./ha). The refined risk assessment indicated

a low long-term risk for the uses on cereals and oilseeds.

Overall, a data gap was identified to further assess the risk to herbivorous mammals for the

representative uses in orchards (long-term risk) and ‘all crops’, pre-planting (acute and long-term) and

post planting (long-term). The risk refinement proposed by the RMS for insectivorous birds for the

representative use in cereals (pre-harvest application) was based on unjustified assumptions (i.e.

refinement of PD and consequently use of different RUD values for the generic indicator focal

species) and thus it could not be considered acceptable. Therefore, a data gap was also identified to

further address the risk to insectivorous birds for the representative use in cereals (pre-harvest

application).

The risk to birds and mammals via consumption of contaminated water or via secondary poisoning

was considered as low.

A number of studies were available to investigate the effects on aquatic organisms of glyphosate, the

representative formulated product and the pertinent metabolites (AMPA, HMPA). The risk

assessments indicated a low risk to aquatic organisms with the highest FOCUS step 2 PEC

values for

all the representative uses.

A large dataset from the literature review was also available on amphibians. On the basis of these data,

amphibians are less acutely and chronically sensitive than fish.

A low risk was concluded based on first tier risk assessments for bees, non-target arthropods

earthworms, soil macro-organisms, soil micro-organisms and biological methods for sewage

treatment.

For the risk assessment for non-target arthropods and for terrestrial non target plants, the use of

modified drift values was proposed by the RMS for the pre-harvest applications (i.e. representative

uses in cereals and oilseeds), because the scenario ‘pre-harvest’ is currently not considered by the

FOCUS default drift values. This proposal was discussed at the experts’ meeting. The experts

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considered more appropriate to use the FOCUS default drift values rather than the corrected values,

but it was also agreed to highlight that the drift depositions might be underestimated with the default

values for these particular uses of glyphosate.

For the risk assessment to terrestrial non target plants, the use of MAF values was discussed at the

experts’ meeting. The RMS proposed to consider the default MAF values reported in SETAC (2001)

(i.e. 1.7 for 2 applications and 2.3 for 3 applications), which are recommended for the exposure

assessment to non-target arthropods in the off-crop vegetated habitats, where dissipation time

information is not available. The RMS explained that, considering the mode of action of glyphosate

and the onset of the effect to plants is immediate, plants will be affected at each single application

event and therefore, it would be not appropriate to consider any degradation of the substance. It was

also acknowledged that further guidance would be needed on how to address effects to non-target

plants of multiple exposure events. Overall, the RMS’s proposal was agreed. The risk to terrestrial

non-target plants was indicated as low when mitigation measures including drift reduction and/or in-

field no-spray buffer zones were taken into account for all the representative uses.

On the basis of the available data in the area of ecotoxicology, there was no indication of endocrine

disrupting adverse effects. However, pending on the outcome of the data gaps identified in section 2,

further ecotoxicology data may be needed.

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6.1.

Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental

compartments

Soil

Persistence

Low to very high (DT

= 2.8 – 500.3 d)

Moderate to high (lab studies DT

= 38.98 – 300.71 d)

High to very high (field studies DT

SFO 50

= 288.4 – > 374.9 d)

Data gap identified to investigate degradation rate in acidic soils (pH 5-6).

Ecotoxicology

Low risk for earthworms

Compound

(name and/or code)

glyphosate

AMPA

6.2.

Ground water

Mobility in soil

>0.1 μg/L 1m depth for the

representative uses

(at least one FOCUS scenario or relevant

lysimeter)

(a)

Compound

(name and/or code)

Pesticidal

activity

Toxicological relevance

Ecotoxicological

activity

glyphosate

Immobile to low mobility

Foc

= 884 – 60000 mL / g)

FOCUS GW: No

Lysimeter: not available

Monitoring data: equivocal results.

Exceedances are reported for which it

is not possible to rule out that

contamination was caused by uses

following GAP

FOCUS GW: No

Lysimeter: not available

Monitoring data: equivocal results.

Exceedances are reported for which it

is not possible to rule out that

contamination was caused by uses

following GAP

Yes

Low risk for

organisms of surface

water

AMPA

Immobile to low mobility

Foc

= 1119 – 45900 mL / g)

Genotoxicity: consistently negative

in Ames tests, mammalian cell gene

mutation and UDS tests

in vitro

and

in micronucleus assays

in vivo

AMPA and glyphosate elicit similar

toxicological profile; reference

values of glyphosate apply to

AMPA

Low risk for

organisms of surface

water

(a): Note there is uncertainty in the assessment, as the standard FOCUSgw models, scenarios and approach do not account for the specific ionic characteristics of glyphosate and AMPA.

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6.3.

Surface water and sediment

Ecotoxicology

Low risk

Compound

(name and/or code)

glyphosate

AMPA

HMPA

6.4.

Air

Toxicology

Rat LC

inhalation > 5 mg/L air (4-h nose-only exposure); no classification required

Compound

(name and/or code)

glyphosate

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List of studies to be generated, still ongoing or available but not peer reviewed

This is a list of data gaps identified during the peer review process, including those areas where a

study may have been made available during the peer review process but not considered for procedural

reasons (without prejudice to provisions of Article 56 of Regulation (EC) No 1107/2009 concerning

information on potentially harmful effects).



Analytical method for formaldehyde with a sufficiently low LOQ and demonstrate that the

technical material meets the proposed maximum content (relevant for applicant Brokden, for all

representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1)

Additional data/information regarding the validation of the analytical methods used for the

quantification of the significant impurities and justification for the proposed limits of some

impurities (relevant for applicant Bros Spolka Jawna B.P. Miranowscy, for all representative uses

evaluated; submission date proposed by the applicant: unknown; see section 1)

New GLP 5 batch data (relevant for applicant Excel Crop Care (Europe) NV, for all representative

uses evaluated; submission date proposed by the applicant: unknown; see Section 1)

Additional validation data for the determination of one impurity (relevant for applicant Helm AG,

for all representative uses evaluated; submission date proposed by the applicant: unknown; see

Section 1)

Updated technical specification for the TC and TK based on batch data or QC data supporting the

proposed limits for impurities (relevant for applicant Monsanto Europe N.V./S.A, for all

representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1)

Revised evaluation of the precision of one of the methods with respect to one impurity (see

confidential Reporting Table) (relevant for applicant Monsanto Europe N.V./S.A., for all

representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1)

Updated technical specification and validation data for the determination of the impurities

(relevant for applicant Sabero Europe B.V., for all representative uses evaluated; submission date

proposed by the applicant: unknown; see Section 1)

Additional validation data for the determination of one impurity (see confidential RT) (relevant for

applicant Sinon Cooperation, for all representative uses evaluated; submission date proposed by

the applicant: unknown; see Section 1)

Additional validation data for the determination of one impurity (see confidential RT) (relevant for

applicant United Phosphorous Ltd, for all representative uses evaluated; submission date proposed

by the applicant: unknown; see Section 1)

Confirmatory method for N-acetyl-glyphosate in dry plant materials and those with high water and

high fat content (relevant for all representative uses evaluated; submission date proposed by the

applicant: unknown; see Section 1)

Confirmatory method for glyphosate in animal fat and kidney/liver (relevant for all representative

uses evaluated; submission date proposed by the applicant: unknown; see Section 1)

Confirmatory method for

N-acetyl-glyphosate

in all animal matrices (relevant for all

representative uses evaluated; submission date proposed by the applicant: unknown; see Section 1)

Confirmatory method for glyphosate and AMPA in soil (relevant for all representative uses

evaluated; submission date proposed by the applicant: unknown; see Section 1)



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

Relevance of all individual impurities present in the technical specification (except the two already

identified relevant impurities, formaldehyde and N-Nitroso-glyphosate), in particular impurities

that elicited toxicological alerts according to QSAR assessments and the ones specified at higher

level than the reference specification, in comparison with the toxicity profile of the parent

compound (relevant for all representative uses evaluated; submission date proposed by the

applicant: unknown; see Section 2)

The full battery of Tier I screening assays according to the EDSP, or Level 2 and 3 tests currently

indicated in the OECD Conceptual Framework, and analysed in the EFSA Scientific Opinion on

the hazard assessment of endocrine disruptors are needed to address the potential for endocrine-

mediated mode of action regarding delay in preputial separation in F1 males and decrease in

homogenisation resistant spermatids (cauda

epididymis)

observed in the most recent

multigeneration study (relevant for all representative uses evaluated; submission date proposed by

the applicant: unknown; see Section 2 and 5)

Toxicological data allowing a consumer risk assessment to be performed for metabolites

N-

acetyl-glyphosate and

N-acetyl-AMPA

(relevant for uses on glyphosate tolerant GM varieties;

submission date proposed by the applicant: unknown; see Section 2 and 3)

GAP for olives (ground picked) and additional trials conducted according to this GAP are required

(relevant for representative use on olives (oil production); submission date proposed by the

applicant: unknown; see section 3)

Additional trials on rape-seed conducted according to the proposed GAP are required (relevant for

representative use in rape seed; submission date proposed by the applicant: unknown; see

Section 3)

A data gap has been identified to investigate the degradation rate of major metabolite AMPA in

soils with pHs in the acidic range (pH

H2O

= 5-6; relevant for all representative uses evaluated;

submission date proposed by the applicant: unknown; see Section 4)

Further information is needed to assess the contamination route through run off (especially in

situations where applications to hard surfaces might occur) and subsequent surface water

contamination and bank infiltration to groundwater (relevant for all seeded or transplanted crops’

and ‘all seeded crops’ representative uses; submission date proposed by the applicant: unknown;

see Section 4)

The risk to small herbivorous mammals for the representative uses in orchards (long-term risk)

and to herbivorous mammals for the representative uses ‘all crops’, pre-planting (acute and long-

term) and post planting (long-term) needs to be further addressed (relevant for orchards, ‘all

crops’, pre-planting and post planting; submission date proposed by the applicant: unknown; see

Section 5)

Data gap to further assess the long-term risk assessment for insectivorous birds (relevant for pre-

harvest application in cereals; submission date proposed by the applicant: unknown; see Section 5)

Particular conditions proposed to be taken into account to manage the risk(s) identified

Personal protective equipment (PPE), such as gloves during mixing and loading operations have to

be considered for hand-held applications to ensure that operator exposure does not exceed the

AOEL (see Section 2).

Mitigation measures including drift reduction and/or in-field no-spray buffer zone were needed to

achieve a low risk to terrestrial non-target plants for all the representative uses.



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9.1.

Concerns

Issues that could not be finalised

An issue is listed as an issue that could not be finalised where there is not enough information

available to perform an assessment, even at the lowest tier level, for the representative uses in line

with the Uniform Principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as

set out in Commission Regulation (EU) No 546/2011

and where the issue is of such importance that

it could, when finalised, become a concern (which would also be listed as a critical area of concern if

it is of relevance to all representative uses).

Glyphosate is not classified or proposed to be classified as carcinogenic or toxic for the

reproduction category 2 in accordance with the provisions of Regulation (EC) No. 1272/2008

(harmonised classification supported by the present assessment) and therefore the conditions of

the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning

human health for the consideration of endocrine disrupting properties are not met. Apical studies

did not show adverse effects on the reproduction, however as an endocrine-mediated mode of

action could not be ruled out (see Section 2). Data gaps for the full battery of Tier I screening

assays according to the EDSP, or the Level 2 and 3 tests currently indicated in the OECD

Conceptual Framework, are identified and the assessment could not be finalised (see Sections 2

and 5).

Critical areas of concern

9.2.

An issue is listed as a critical area of concern where there is enough information available to perform

an assessment for the representative uses in line with the Uniform Principles in accordance with

Article 29(6) of Regulation (EC) No. 1107/2009 and as set out in Commission Regulation (EU) No

546/2011, and where this assessment does not permit to conclude that for at least one of the

representative uses it may be expected that a plant protection product containing the active substance

will not have any harmful effect on human or animal health or on groundwater or any unacceptable

influence on the environment.

An issue is also listed as a critical area of concern where the assessment at a higher tier level could not

be finalised due to a lack of information, and where the assessment performed at the lower tier level

does not permit to conclude that for at least one of the representative uses it may be expected that a

plant protection product containing the active substance will not have any harmful effect on human or

animal health or on groundwater or any unacceptable influence on the environment.

An issue is also listed as a critical area of concern the active substance is not expected to meet the

approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

Eight out of the 24 applicants presented specifications that were not supported by the

toxicological assessment (Industrias Afrasa S.A., Arysta Lifescience SAS, Bros Spolka Jawna

B.P. Miranowscy, Dow AgroScience S.r.l, three out of seven sources of Helm AG, Monsanto

Europe, Société Financière de Pontarlier and one of the two Syngenta Limited manufacturing

routes).

Overview of the concerns identified for each representative use considered

9.3.

(If a particular condition proposed to be taken into account to manage an identified risk, as listed in

section 8, has been evaluated as being effective, then ‘risk identified’ is not indicated in this table.)

All columns are grey, as the technical material specification proposed was not comparable to the

material used in the testing (Sections 2 and 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.

OJ L 155, 11.6.2011, p. 127–175.

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All seeded

transplanted

crops -

pre-planting

Risk identified

Assessment not

finalised

Risk identified

Assessment not

finalised

Risk identified

Assessment not

finalised

Risk identified

Assessment not

finalised

Risk identified

Assessment not

finalised

Risk identified

Assessment not

finalised

Risk identified

Assessment not

finalised

Legal

parametric

value breached

Assessment not

finalised

Legal

parametric

value breached

Parametric

value of 10µg/L

breached

Assessment not

finalised

Representative use

All seeded

crops –

post-planting

- pre

emergence

Cereals

Pre-harvest

Oilseeds

pre-

harvest

Orchard

crops and

grapes

Operator risk

Worker risk

Bystander risk

Consumer risk

Risk to wild non

target terrestrial

vertebrates

Risk to wild non

target terrestrial

organisms other

than vertebrates

Risk to aquatic

organisms

Groundwater

exposure active

substance

Groundwater

exposure

metabolites

Comments/Remarks

The superscript numbers in this table relate to the numbered points indicated in Sections 9.1 and 9.2. Where there is no

superscript number, see Section 5 for further information.

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IARC (International Agency for Research on Cancer), 2015. Monographs, Volume 112: Some

organophosphate insecticides and herbicides: tetrachlorvinphos, parathion, malathion, diazinon and

glyphosate. IARC Working Group. Lyon; 3–10 March 2015. IARC Monogr Eval Carcinog Risk

Chem Hum.

JMPR (Joint Meeting on Pesticide Residues), 2004. Report of the Joint Meeting of the FAO Panel of

Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group

on Pesticide Residues Rome, Italy, 20–29 September 2004, Report 2004, 383 pp.

JMPR (Joint Meeting on Pesticide Residues), 2007. Report of the Joint Meeting of the FAO Panel of

Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group

on Pesticide Residues Geneva, Switzerland, 18–27 September 2007, Report 2007, 164 pp.

OECD (Organisation for Economic Co-operation and Development), 1992a. OECD Guidelines for the

Testing of Chemicals, Section 3. Degradation and Accumulation Test No 301: Ready

Biodegradability. ISBN: 9789264070349, 62 pp.

OECD (Organisation for Economic Co-operation and Development), 1992b. OECD Guidelines for the

Testing of Chemicals, Section 3. Degradation and Accumulation Test No 302B: Inherent

Biodegradability: Zahn-Wellens/ EVPA Test. ISBN: 9789264070387, 8 pp.

OECD (Organisation for Economic Co-operation and Development), 2011. OECD MRL calculator:

spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide

Publications/Publications on Pesticide Residues. Available online: http://www.oecd.org

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OECD (Organisation for Economic Co-operation and Development), 2012a. Series on Testing and

Assessment: No 116: Guidance document 116 on the conduct and design of chronic toxicity and

carcinogenicity studies, supporting test guidelines 451, 452 and 453 2nd edition.

ENV/JM/MONO(2011)47, 156 pp.

OECD (Organisation for Economic Co-operation and Development), 2012b. Series on Testing and

Assessment: No 150: Guidance document on Standardised Test Guidelines for Evaluating

Chemicals for Endocrine Disruption. ENV/JM/MONO(2012)22, 524 pp.

SETAC (Society of Environmental Toxicology and Chemistry), 2001. Guidance Document on

Regulatory Testing and Risk Assessment procedures for Plant Protection Products with Non-Target

Arthropods. ESCORT 2.

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PPENDICES

PPENDIX

A – L

IST OF END POINTS FOR THE ACTIVE SUBSTANCE AND THE REPRESENTATIVE

FORMULATION

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

Active substance (ISO Common Name)

Function (e.g. fungicide)

Rapporteur Member State

Co-rapporteur Member State

Glyphosate

Herbicide

Germany

Slovakia

Identity (Annex IIA, point 1)

Chemical name (IUPAC)

Chemical name (CA)

CIPAC No

CAS No

EC No (EINECS or ELINCS)

FAO Specification (including year of publication)

N-(phosphonomethyl)glycine

284

1071-83-6

213-997-4

284/TC (2014) applicable to material of Monsanto,

Cheminova, Syngenta and Helm

Glyphosate: ≥ 950 g/kg

Formaldehyde: maximum 1.3 g/kg of the glyphosate acid

content found

N-Nitroso-glyphosate:

maximum 1 mg/kg

Insolubles in 1 M NaOH: maximum 0.2 g/kg

Minimum purity of the active substance as

manufactured

Identity of relevant impurities (of toxicological,

ecotoxicological and/or environmental concern) in

the active substance as manufactured

Molecular formula

Molar mass

Structural formula

950

g/kg

Formaldehyde

< 1 g/kg

< 1 mg/kg

N-Nitroso-glyphosate

169.1

g/mol

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity)

Boiling point (state purity)

Temperature of decomposition (state purity)

Appearance (state purity)

Vapour pressure (state temperature, state purity)

Henry’s law constant

Solubility in water (state temperature, state purity

and pH)

Solubility in organic solvents

(state temperature, state purity)

189 °C (99.9 %)

Not applicable because glyphosate decomposes during

melting.

Pure glyphosate decomposes at about 200 °C (99.6 %)

White solid (99.6 %)

1.31 x 10

-5

Pa at 25 °C (98.6%)

2.1 x 10

-7

Pa m

mol

-1

(25 °C)

10.5 g/L at 20 °C (pH 1.90 – 1.98) (99.5 %)

Solubility at 20 °C in g/L (96.9 %)

acetone

1,2-dichloroethane

ethyl acetate

heptane

methanol

octan-1-ol

xylenes

acetonitrile

< 0.6 mg/L

10 mg/L

< 0.6 mg/L

0.8 mg/L

Surface tension

(state concentration and temperature, state purity)

Partition co-efficient

(state temperature, pH and purity)

Dissociation constant (state purity)

UV/VIS absorption (max.) incl.



(state purity, pH)

Flammability (state purity)

Explosive properties (state purity)

72.2 mN/m (1 g/L H

O solution, 20 °C) (96.9 %)

log P

O/W

= - 3.2 at 25 °C (pH buffer 5–9) (99.9 %)

= 2.34

= 5.73



at 290 nm < 10 L mol

1

all at 20 °C (99 %)

No maximum in the range 200-340 nm

Glyphosate is not highly flammable under the conditions

of this test (98.7 %)

From the structural formula of glyphosate technical it

can be concluded that the substance is not explosive. The

substance does not contain any chemically instable or

highly energetic groups that might lead to an explosion.

Glyphosate technical material is not classified as an

oxidising substance (96.9 %)

Oxidising properties (state purity)

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Summary of representative uses evaluated (Glyphosate)*

Crop and/

or situation

(a)

Member

State or

Country

Product

name

(b)

Pests or

Group

of pests

controlled

(c)

Emerged

annual,

perennial

and biennial

weeds

Emerged

annual,

perennial

and biennial

weeds

Formulation

Type

(d-f)

Conc.

a.s.

(i)

360

g/L

method

kind

(f-h)

Spray

Application

growth

stage &

season

(j)

Pre planting

of crop

number

min-max

(k)

1-2

interval

between

applications

(min)

21 d

(see

remark)

Application rate per treatment

L/ha

product

min-max

1-6

water

L/ha

min-max

kg as/ha

min-max

PHI

(days)

(l)

Remarks:

(m)

All crops**

(all seeded or

transplanted

crops)

All crops**

(all seeded

crops)

MON

52276

100-400 0.36-2.16

MON

52276

360

g/L

Spray

Post planting/

pre

emergence

of crop

1-3

100-

400

0.36-1.08

Spring & autumn after harvest

(incl. stubble and/or seedbed prep.)

For all crops:

Max. application rate 4.32 kg/ha

glyphosate in any 12 month period

across use categories, equivalent to the

sum of pre-plant, pre-harvest and post-

harvest stubble applications.

The interval between applications is

dependent on new weed emergence

after the first treatment, relative to the

time of planting the crop.

Max. application rate 4.32 kg/ha

glyphosate in any 12 month period

across use categories, equivalent to the

sum of pre-plant, pre-harvest and post-

harvest stubble applications

Pre-harvest uses in all crops include

uses for weed control (higher doses)

and harvest aid, sometimes referred to

as desiccation (lower doses). The

critical GAP is the high dose

recommended used for weed control.

Cereals

(pre-harvest)

wheat, rye,

triticale,

Cereals

(pre-harvest)

barley and

oats

MON

52276

Emerged

annual,

perennial

and biennial

weeds

Emerged

annual,

perennial

and biennial

weeds

Emerged

annual,

perennial

and biennial

weeds

360

g/L

Spray

Crop

maturity

< 30 % grain

moisture

Crop

maturity

< 30 % grain

moisture

Crop

maturity

< 30 % grain

moisture

2-6

100-400 0.72-2.16

MON

52276

360

g/L

Spray

2-6

100-

400

0.72-2.16

Oilseeds

(pre-harvest)

rapeseed,

mustard seed,

linseed

MON

52276

360

g/L

Spray

2-6

100-

400

0.72-2.16

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(b)

Pests or

Group

of pests

controlled

(c)

Emerged

annual,

perennial

and biennial

weeds

Formulation

Type

(d-f)

Conc.

a.s.

(i)

360

g/L

method

kind

(f-h)

Spray

Application

growth

stage &

season

(j)

Post

emergence of

weeds

number

min-max

(k)

1-3

interval

between

applications

(min)

28 d

Application rate per treatment

L/ha

product

min-max

2-8

water

L/ha

min-max

kg as/ha

min-max

PHI

(days)

(l)

Remarks:

(m)

Crop and/

or situation

(a)

Member

State or

Country

Product

name

Orchard

crops, vines,

including

citrus & tree

nuts

MON

52276

100-400 0.72-2.88

N/A

Stone & pome fruit, olives

Applications to avoid contact with tree

branches.

Maximum cumulative application rate

4.32 kg/ha glyphosate in any 12 month

period

Note: Because applications are made

to the intra-rows (inner strips between

the trees within a row), application

rates per ha are expressed per ‘unit of

treated surface area’ the actual

application rate per ha orchard or

vineyard will roughly only be 33 %

Stone & pome fruit, olives

Applications made round base of trunk

[0.0 L/ha water addresses ULV

application of the undiluted product]

Max. cumulative application rate 4.32

kg/ha glyphosate in any 12 month

period

Note: Because applications are made

round base of trunk and to the intra-

rows , (inner strips between two trees

within a row), application rates per ha

are expressed per ‘unit of treated

surface area’ the actual application rate

per ha orchard or vineyard will

roughly only be 33 % - 50 %

Orchard

crops, vines,

including

citrus & tree

nuts

MON

52276

Emerged

annual,

perennial

and biennial

weeds

360

g/L

(ULV)

Sprayer or

Knapsack

use (spot

treatment)

Post

emergence of

weeds

1-3

28d

2-8

0-400

0.72-2.88



For uses where the column ‘Remarks’ is marked in grey further consideration is necessary.

Uses should be crossed out when the notifier no longer supports this use(s).

** Crops including but not restricted to: root & tuber vegetables, bulb vegetables, stem vegetables, field

vegetables (fruiting vegetables, brassica vegetables, leaf vegetables and fresh herbs, legume

vegetables), pulses, oil seeds, potatoes, cereals, and sugar- & fodder beet; before planting fruit crops,

ornamentals, trees, nursery plants etc.

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

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

(b) Outdoor or field use (F), greenhouse application (G) or indoor application (I)

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

(h) Kind,

e.g.

overall, broadcast, aerial spraying, row, individual plant, between the plant- type of

equipment used must be indicated

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

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

fluoroxypyr).

In certain cases, where only one variant is synthesised, it is more appropriate to give

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

(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-

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

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(c)

(d)

(e)

(f)

e.g.

biting and suckling insects, soil born insects, foliar fungi, weeds

e.g.

wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

GCPF Codes - GIFAP Technical Monograph No 2, 1989

All abbreviations used must be explained

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

former information on kg a.s.s/hl replaced by RMS

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

instead of 200 000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha

(m) PHI - minimum pre-harvest interval

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Methods of Analysis

Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique)

Impurities in technical as (analytical technique)

Plant protection product (analytical technique)

AOAC/CIPAC; HPLC-UV

Formaldehyde & NNG (FAO), HPLC-colorimeter,

HPLC-UV, Titration

AOAC/CIPAC; HPLC-UV

Analytical methods for residues (Annex IIA, point 4.2)

Residue definitions for monitoring purposes

Food of plant origin

For sweet corn, oilseed rape, soya beans and maize:

sum of glyphosate and

N-acetyl-glyphosate,

expressed as

glyphosate

For other plant commodities: glyphosate

Food of animal origin

Soil

Water

surface

drinking/ground

Air

sum of glyphosate and

N-acetyl-glyphosate,

expressed as

glyphosate

glyphosate and AMPA

glyphosate

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique and

LOQ for methods for monitoring purposes)

HPLC-MS/MS of underivatised analytes with phenyl-

hexyl column; LOQ = 0.05 mg/kg for glyphosate and

N-

acetyl-glyphosate all commodity groups, ILV available

For glyphosate confirmatory methods by HPLC with

post-column derivatization or by GC-MS after

derivatization with trifluoroacetic acid and

heptafluorobutanol are available.

A confirmatory method for

N-acetyl-glyphosate

missing in crops of high water and high fat content.

Food/feed of animal origin (analytical technique

and LOQ for methods for monitoring purposes)

HPLC-MS/MS of underivatised analytes with phenyl-

hexyl column; ILV available

LOQ = 0.025 mg/kg in meat, milk and egg and 0.05

mg/kg in liver, kidney and fat for glyphosate and

N-

acetyl-glyphosate

A confirmatory GC-MS method based on derivatization

with a mixture of trifluoroacetic anhydride and

trifluoroethanol is only available for glyphosate in milk,

eggs and meat, but not for fat and kidney/liver.

A confirmatory method for glyphosate in fat and

liver/kidney as well as a confirmatory method for

N-

acetyl-glyphosate in all matrices are missing.

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Soil (analytical technique and LOQ)

GC-MS after derivatization in a mixture of

trifluoroacetic anhydride and trifluoroethanol,

LOQ = 0.05 mg/kg for glyphosate and AMPA

A confirmatory method is missing for glyphosate

AMPA.

Water (analytical technique and LOQ)

LC-MS/MS after derivatization with 9-

Fluorenylmethylchlorformate (FMOC),

LOQ = 0.03 µg/L for glyphosate and AMPA in drinking,

ground and surface water, confirmatory LC-MS/MS

transition with LOQ = 0.03 µg/L validated,

independent laboratory validation for drinking water

successfully conducted

GC-MS after derivatization in a mixture of

trifluoroacetic anhydride and trifluoroethanol,

LOQ = 5 µg/m

for glyphosate

Not required, not classified as toxic or very toxic

Air (analytical technique and LOQ)

Body fluids and tissues (analytical technique and

LOQ)

Classification and proposed labelling with regard to physical and chemical data (Annex IIA,

point 10)

RMS/peer review proposal

Active substance

none

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Impact on Human and Animal Health

Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 5.1)

Rate and extent of oral absorption

Rapid but limited, about 20 %, based on urinary

excretion and comparison of kinetic behaviour after oral

and iv administrations

Wide, highest residues after 7 d in bone, liver and

kidney; C

max

in plasma: 0,7-1,8 µg/mL (after 3-4 h),

AUC: 18.6-23.1 µg h/mL, t

1/2

: 6-12 h

No evidence for accumulation (after 7 d total residues ≤

1 % of the administered dose)

Virtually complete within 7 d with major portion

excreted within 48 h; absorbed amount eliminated via

urine, unabsorbed via faeces; biliary excretion and

exhalation negligible

Poorly metabolised with the only biotransformation

product aminomethylphosphonic acid (AMPA)

accounting for up to 1 % of the total excreted amount

(probably resulting from bacterial metabolism in the gut)

Glyphosate

Distribution

Potential for accumulation

Rate and extent of excretion

Metabolism in animals

Toxicologically relevant compounds

(animals and plants)

Toxicologically relevant compounds

(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD

oral

Rat LD

dermal

Rat LC

inhalation

Skin irritation

> 2000 mg/kg bw (glyphosate acid & salts)

> 5 mg/L air (4-h nose only exposure)

(glyphosate acid & salts)

Evidence of very slight irritation; classification

and labelling not required (glyphosate acid &

salts)

Irritant, classification needed for glyphosate

acid but not for its salts

Negative (M&K test, LLNA, Buehler)

(glyphosate acid)

Negative (M&K test) (IPA salt)

Cat.

H318

Eye irritation

Skin sensitisation

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Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Rats & mice: GIT (irritation with diarrhoea and bw

effects, caecum distension), urinary bladder (cystitis),

liver (clinical chemistry findings), salivary glands

(histology);

Dogs: gastrointestinal signs, bw/bw gain↓ and evidence

of weak liver toxicity with severe clinical signs and

pathological lesions in different organs in a single 90-d

dog study with capsule administration of 1000 mg/kg bw

per day

Relevant oral NOAEL

Rat, 90-d: 414 mg/kg bw per day

Mouse, 90-d: 500 mg/kg bw per day

Dog, 90-d & 1-yr: 300 mg/kg bw per day

Relevant dermal NOAEL

Rat, 21/28-d: 1000 mg/kg bw per day

(systemic), 500 mg/kg bw per day (local,

irritation)

Rabbit, 21/28-d: 5000 mg/kg bw per day

(systemic), 1000 mg/kg bw per day (local,

irritation)

Relevant inhalation NOAEL

No valid data – not required

Genotoxicity (Annex IIA, point 5.4)

Not genotoxic

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect

Rat: Bw gain↓, salivary glands (wt↑, histological

changes), liver (AP activity↑, wt↑), stomach (mucosal

irritation) caecum (distension and wt↑), eye (cataracts),

Mouse: Bw gain↓, food consumption/efficiency↓, liver

(histological changes), caecum (distension and wt↑),

prolapse and ulceration of anus, urinary bladder

(histology)

Relevant NOAEL

Rat, 2-yr: 100 mg/kg bw per day (overall NOAEL from a

number of long-term studies)

Mouse, 18-month/2-yr: 150 mg/kg bw per day (overall

NOAEL)

Carcinogenicity

Not carcinogenic in rats and mice;

Very limited evidence for an association

between glyphosate-based formulations and

NHL in epidemiological studies. Overall

inconclusive for a causal or clear associative

relationship between glyphosate and cancer in

human studies; classification and labelling not

required

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Reproductive toxicity (Annex IIA, point 5.6)

Reproduction toxicity

Reproduction target / critical effect

Adult: bw gain↓, gastrointestinal signs, organ wt

changes

Reproduction and fertility: Homogenisation

resistant spermatids↓ (in

Cauda epididymidis)

F0 and delay in preputial separation in F1 males

at very high dose of ca. 1000 mg/kg bw per day

(15000 ppm) but no evidence for impairment of

fertility and reproductive performance

Offspring: bw gain↓, delayed preputial

separation (in one study at 1000 mg/kg bw per

day, 15000 ppm)

Relevant parental NOAEL

Relevant reproductive NOAEL

Relevant offspring NOAEL

overall 300 mg/kg bw per day

351 mg/kg bw per day

overall 300 mg/kg bw per day

Developmental toxicity

Developmental target / critical effect

Maternal:

Rat: bw gain↓, gastrointestinal signs

Rabbit: mortality, gastrointestinal signs, bw

gain↓, abortions

Developmental:

Rat: ossification↓, skeletal anomalies;

at excessive dose levels: post-implantation loss

Rabbit: post-implantation loss, foetal wt &

ossification↓; at excessive dose level:

interventricular septal defects

Relevant maternal NOAEL

Relevant developmental NOAEL

Rat: 300 mg/kg bw per day

Rabbit: 50 mg/kg bw per day

Rat: 300 mg/kg bw per day

Rabbit: 50 mg/kg bw per day

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity

Rat, no evidence up to highest dose of 2000

mg/kg bw causing some systemic effects

(clinical signs and one death)

Overall NOAEL 1000 mg/kg bw

Repeated neurotoxicity

Rat, 90-day, no evidence up to highest dose of

20000 ppm (1546 mg/kg bw per day) causing

lower bw (gain) and impaired food utilization

Overall NOAEL 617 mg/kg bw per day

Delayed neurotoxicity

Chicken, no evidence up to highest dose of 2000

mg/kg bw

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Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies

Severity of salivary gland findings is strain-specific in

rats; effects are likely due to low pH in oral cavity but an

adrenergic mechanism may be also involved;

No evidence of immunotoxicity (humoral immune

response, thymus and spleen weights) in mice

Pharmacological effects: No haematological,

electrocardiographic or behavioural/functional changes

after oral administration; contractile response similar to

that seen with known parasympatho-mimetic agents in

isolated guinea pig ileum; no neuromuscular blocking

activity on innervated rat gastrocnemius muscle

Toxicity studies on farm animals:

Goat LD

oral = 3530 mg/kg bw (glyphosate acid)

Goat LD

oral = 5700 mg/kg bw (IPA salt)

7-day, cow: NOAEL 540 mg/kg bw per day, based on

diarrhoea, decreased feed intake (IPA salt)

Studies performed on metabolites or impurities

Aminomethylphosphonic acid (AMPA, metabolite in

glyphosate tolerant GM plants and in soil and water:

Rat & mice LD

oral > 5000 mg/kg bw,

Rat LD

dermal > 2000 mg/kg bw;

Skin sensitisation: negative (M&K test);

90-day, rat: NOAEL: 400 mg/kg bw per day based on

bw gain↓, urothelial hyperplasia (bladder) and gastro-

intestinal clinical signs;

90-day, dog: NOAEL 263 mg/kg bw per day, the highest

dose tested;

Genotoxicity: consistently negative in Ames tests,

mammalian cell gene mutation and UDS tests

in vitro

and in micronucleus assays

in vivo;

Rat developmental toxicity: No evidence of

teratogenicity, maternal NOAEL 150 mg/kg bw per day,

based on clinical signs, bw gain/food consumption↓,

developmental NOAEL 400 mg/kg bw per day, based on

mean foetal wt↓;

AMPA presents a similar toxicological profile as

glyphosate and the reference values of the latter apply to

its metabolite AMPA.

Data gaps were identified for toxicological data on the

metabolites N-acetylglyphosate and N-acetyl-AMPA as

they were included in the residue definition for plants

with glyphosate tolerant GM plant varieties.

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Medical data (Annex IIA, point 5.9)

No critical health effects reported from occupational

health surveillance; no convincing evidence of

carcinogenicity, neurotoxicity or effects on fertility and

development in epidemiological studies; poisoning

incidents after accidental or voluntary (suicidal) oral

intake of large amounts of glyphosate-based herbicides;

transient eye irritation as most frequent sign in operators

following accidental exposure.

Summary (Annex IIA, point 5.10)**

ADI

AOEL

Value

0.5 mg/kg bw per

day

0.1 mg/kg bw per

day

0.5 mg/kg bw

Study

Developmental

toxicity, rabbit

Developmental

toxicity, rabbit

Developmental

toxicity, rabbit

Uncertainty

factor

100

Overall 500*

(100 +

20%*)

100

ARfD

* Correction for low oral absorption (20 %).

** The proposed reference values are different than those

mentioned in the review report 6511/VI/99-final

(European Commission, 2002)

Dermal absorption (Annex IIIA, point 7.3)

Formulation MON 52276 (360 g glyphosate/L SL)

1 % for concentrate and dilutions based on human skin

vitro

Exposure scenarios (Annex IIIA, point 7.2)

Operator

Field crop tractor-mounted (application rate: 2.16 kg

glyphosate/ha):

% of AOEL

German model

Without PPE (T-shirt and shorts)

28 %

UK POEM

Without PPE (long sleeved shirt, long trousers) 261 %

With PPE (gloves during mixing/loading and

application):

49 %

Hand-held spray applications (application rate: 2.88 kg

glyphosate/ha) under high crops

German model

(high crop, which is a worst case)

Without PPE (T-shirt and shorts)

With PPE (gloves during mixing/loading):

115 %

32 %

UK POEM

Without PPE (long sleeved shirt, long trousers): 568 %

PPE (gloves during mixing/loading and application and

gloves, impermeable coverall during application)149 %

Workers

29 % of AOEL without PPE:

worker wearing long sleeved

shirt, long trousers (‘permeable’) but no gloves

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Bystanders & Residents

Bystanders:

Adults: 4.1 % of AOEL, children: 3.4 % of AOEL

Residents:

Adults: 5.5 % of AOEL, children: 20.8 % of AOEL

(both for assumed applications on pasture, lawn or

meadow, ‘worst case’)

Classification and proposed labelling with regard to toxicological data (Annex IIA, point 10)

Substance

Harmonised classification – Annex VI of

Regulation (EC) No 1272/2008

glyphosate (acid)

Danger

GHS05 (corrosion)

Eye Damage 1

H318

- Causes serious eye damage

the same as above

RMS/peer review proposal

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,

labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1–1355.

It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)

No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation

(EC) No 1272/2008.

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Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

Non-tolerant crops

Fruits

Oilseeds

Rotational crops

Rape/canola (CP4-EPSPS & GOX, GAT)

Soya beans (CP4-EPSPS, GAT)

Cotton (CP4-EPSPS)

Sugarbeet (CP4-EPSPS)

Maize (CP4-EPSPS & GOX, GAT)

Beets, carrots, radish

Lettuce, cabbage

Peas

Soya beans

Barley, wheat

Mandarins (soil, foliar, hydroponic)

Almond, waltnut and pecan (soil, foliar)

Apples (soil, foliar, trunk)

Grapes (soil, foliar, trunk, hydroponic)

Avocado (foliar, direct fruit treatment)

Potato (soil, foliar)

Sugar beets (soil)

Cotton (soil, hydroponic)

Soya beans (soil, hydroponic)

Barley (soil, hydroponic)

Maize (soil, hydroponic)

Oats (soil, hydroponic)

Rice (soil, hydroponic)

Sorghum (soil, hydroponic)

Wheat (soil, hydroponic, foliar - dessication)

Coffee (soil, foliar, stem, hydroponic)

Sugar cane (soil, foliar)

Root and tuber crops

Pulses and oilseeds

Cereal grains

Miscellaneous crops

Transgenic crops (all foliar sprayed)

Root and tubers

Cereal grains

Metabolism in rotational crops similar to

metabolism in primary crops?

Processed commodities

Residue pattern in processed commodities similar

to residue pattern in raw commodities?

Plant residue definition for monitoring

yes, in rotational crops higher relative amounts of

AMPA are expected due to its formation in soil

Stable

yes

Sweet corn, oilseed rape, soya beans and maize (non-

tolerant and tolerant, all modifications):

sum of glyphosate and N-acetyl-glyphosate, expressed as

glyphosate

Other plant commodities:

glyphosate

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Plant residue definition for risk assessment

Conversion factor (monitoring to risk assessment)

Sum of glyphosate, AMPA, N-acetyl-glyphosate and N-

acetyl-AMPA, all expressed as glyphosate.

For non-tolerant crops, the contribution of AMPA to the

consumer exposure is minor, making a CF unnecessary.

Residues in glyphosate tolerant GM crops and

application type (pre-emergence/desiccation) should be

considered to derive CF for plant commodities.

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

Time needed to reach a plateau concentration in

milk and eggs

Animal residue definition for monitoring

Animal residue definition for risk assessment

Conversion factor (monitoring to risk assessment)

Goats, chicken

Milk: <7 days

Eggs: 14 days (based on 28 day feeding study, no plateau

reached within 8 days in metabolism studies)

Sum of glyphosate and N-acetyl-glyphosate, expressed

as glyphosate

Sum of glyphosate, AMPA, N-acetyl-glyphosate and N-

acetyl-AMPA, all expressed as glyphosate

Not proposed, since assessment based on conventional

crops only while ratio of metabolites in animal matrices

strongly depends on the ratio of metabolites in animal

diet and therefore on the amount of GMO-feedstuff in

diets.

For non-tolerant feed crops, a conversion factor for

animal commodities was considered unnecessary.

Metabolism in rat and ruminant similar (yes/no)

Fat soluble residue: (yes/no)

yes

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

Based on the supported uses, glyphosate and AMPA

residues not expected in rotational crops

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

High acid content matrices

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

High water content matrices

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

High oil content matrices

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

High starch content matrices

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

High protein content matrices

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

Other plant matrices

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

Animal commodities

Glyphosate

AMPA

N-acetyl-glyphosate

N-acetyl-AMPA

>14 to >31 months

not investigated

>9 to 31 months

6 to 24 months

6 to >12 months

>1 to >12 months

>18 to >24 months

>24 months

>12 months

>1 month

18 to >48 months

10 to >31 months

>12 months

>18 months

not investigated

18 to >45 months

6 to >24 months

>12 months

>1 months

14 to >26 months

not investigated

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

Ruminant:

Poultry:

Pig:

Conditions of requirement of feeding studies

Expected intakes by livestock



0.1 mg/kg diet (dry

weight basis) (yes/no - If yes, specify the level)

Yes

Dairy cattle:

1.58 mg/kg bw

Beef cattle:

4.5 mg/kg bw

Potential for accumulation (yes/no):

Metabolism studies indicate potential level of

residues ≥ 0.01 mg/kg in edible tissues (yes/no)

yes

Feeding studies:

EFSA Journal 2015;13(11):4302

yes

Yes

0.29 mg/kg bw

Yes

0.21 mg/kg bw

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Ruminant:

Poultry:

Pig:

Cattle study 1 (glyphosate:AMPA 9:1):

1.4/0.156; 4.0/0.48 and 12.8/1.4 mg eq/kg bw

Cattle study 2 (glyphosate-trimesium):

0.012; 0.13; 1.44; 7.38 and 19.4 mg eq/kg bw

Poulty:

0.24 and 2.2 mg/kg bw

Pig:

1.08 mg/kg bw

Estimated residue levels in animal matrices (mg/kg) at

the expected intake levels:

Muscle

Liver

Kidney

Fat

Milk

Eggs

<0.05

0.07

1.6

0.06

<0.02

<0.01

<0.05

0.08

<0.05

0.12

<0.05

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Summary of residues data according to the representative uses on raw agricultural commodities (Annex IIA, point 6.3, Annex IIIA, point 8.2)

Northern/

Southern

Region

(a)

Trials results relevant to the representative uses

(b)

Comments/remarks

(c)

MRL

(mg/kg)

(d)

STMR

(e)

Crop

Unless otherwise stated, all samples were analysed for glyphosate and AMPA separately, achieving the same LOQ values. Since AMPA was never detected above the LOQs,

residue levels measured in the trials listed below are reported for glyphosate only. In addition, since AMPA was always observed in much lower levels than glyphosate in the

metabolism studies on conventional crops, when residue for glyphosate and AMPA were both <LOQ, the LOQ reported for glyphosate was considered for risk assessment

(and not the sum of the LOQs as usually required)

Hazelnut

Apples &

pears

Cherries

Peaches

Grapes

SEU

NEU

SEU

NEU

SEU

NEU

4x <0.05

<0.02, 3x <0.05

17x <0.05

2x <0.05

6x <0.05, 0.07, 0.30

Residue of 0.07 and 0.30 mg/kg measured in low

hanging fruits (following application at a lower

rate of 2x 720 g/ha) were considered to derived a

MRL of 0.5 mg/kg for grapes; MRL

OECD

: 0.43/0.5

Additional trials requested to derived MRL for

olives (oil production)

MRL

OECD

: 2.0/2

Based on pre-sowing application trials conducted

on potato and carrots where residue levels were

all <LOQ, a MRL of 0.05* mg/kg is proposed for

the root and tuber vegetable group (including

potato).

The MRL proposal of 0.05* mg/kg is extrapolated

to the whole group ‘bulb vegetables’

Based on pre-sowing application trials conducted

0.05*

0.05

0.5

0.3

0.05

Based on the trials conducted on hazelnuts,

apples, pears, cherries and peaches following soil

application beneath trees, where residue levels

were all <LOQ, a MRL of 0.05* mg/kg is

proposed for the citrus, tree nuts, pome and stone

fruits groups.

0.05*

0.05

Table

Olives

SEU

tree-picked:

ground-picked:

12x <0.05, 6x <0.05

0.11, 0.14, 0.53, 0.93

0.93

0.335

Potato

NEU

SEU

2x <0.05

6x <0.05

3x <0.05

2x <0.05

Carrots

NEU

SEU

Onions

(bulb)

Tomato

NEU

SEU

NEU

0.05*

0.05

0.05*

0.05

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Northern/

Southern

Region

(a)

SEU

NEU

SEU

NEU

SEU

Head

cabbage

Lettuce

NEU

SEU

NEU

SEU

Leek

NEU

SEU

Sugar beet

(Roots)

Sugar beet

(Tops)

NEU

SEU

NEU

SEU

Crop

Cucumber

Courgette

(Zucchini)

Cauliflower

Trials results relevant to the representative uses

(b)

<0.05

2x <0.05

6x <0.05

2x <0.05

6x <0.05

2x <0.05

Comments/remarks

(c)

on tomato, cucumber and courgette where residue

levels were all <LOQ, a MRL of 0.05* mg/kg is

proposed for the whole group. ‘fruiting

vegetables’

The MRL proposal of 0.05* mg/kg is extrapolated

to the whole group ‘brassica vegetables’ (pre-

emergence or pre-planting application)

MRL

(mg/kg)

(d)

STMR

(e)

0.05*

0.05

MRL proposal of 0.05* mg/kg extrapolated to the

whole group ‘leaf vegetables and fresh herbs’

MRL proposal of 0.05 mg/kg extrapolated to the

whole group ‘stem vegetables’

MRL proposal of 0.05 mg/kg extrapolated to the

whole group ‘Sugar plants’

0.05*

0.05

0.05*

0.05

0.05*

0.05

All residue trails here below, were conducted on conventional crops and therefore samples were analysed for glyphosate and AMPA only.

Mo:

Residue level according to the residue definition for monitoring (conventional crops): glyphosate.

RA:

Residue level according to the residue definition for risk assessment (conventional crops): sum glyphosate + AMPA expressed as glyphosate

STMR and HR values are expressed according to the residue definition for risk assessment (sum glyphosate + AMPA expressed as glyphosate)

Rape seed

NEU

Mo:

1.4, 6.4, 9.0

RA:

1.7, 6.5, 9.0

(f)

Data not sufficient to derive an MRL proposal

proposal

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Northern/

Southern

Region

(a)

NEU

Crop

Barley, oats

(grain)

Trials results relevant to the representative uses

(b)

Mo:

1.2, 1.5, 2.0, 2.1, 2.1, 2.2, 2.4, 2.5, 2.6, 2.6, 2.8, 3.95;

4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.2, 5.2, 5.3, 5.4, 5.5, 5.5,

5.7, 5.9, 5.9, 6.2, 6.5, 6.7, 7.4, 7.7, 7.8, 8.0, 8.1, 8.4, 9.8,

10, 10.3, 12.4, 12.5, 14, 15.5, 16.5, 17, 17.5, 18.4, 21, 21.4

RA:

1.3, 1.5

(f)

, 2.1, 2.2, 2.2, 2.3, 2.5, 2.5, 2.7, 2.9, 3.2, 4.2,

4.4, 4.6, 4.9, 5.0, 5.1

(f)

, 5.2, 5.3, 5.3, 5.3

(f)

, 5.5, 5.5

(f)

, 5.6,

5.8, 5.8, 5.9, 6.2, 6.2

(f)

, 6.6, 6.9, 7.5, 7.9, 8.0, 8.2, 8.3,

8.4

(f)

, 10, 10.3, 10.4, 12.4

(f)

, 12.8, 14.4, 16, 16.6, 17.2,

17.8, 18.4

(f)

, 21.4

(f)

, 21.6

Comments/remarks

(c)

Almost all values are the mean of replicates

MRL

OECD

: 28.3/30 (NEU)

Having regard to the large number of residue

trials in NEU and since levels in SEU tria ls are in

the same order of magnitude, additional trials in

SEU are not requested.

MRL

(mg/kg)

(d)

21.6

STMR

(e)

5.85

SEU

NEU

Mo:

6.0, 7.8, 13.5, 19

RA:

6.0, 7.9, 13.7, 19.3

Mo:

4.6, 6.9, 9.6, 10.5, 11, 11.5, 12.8, 12.8, 14.5, 16, 17,

18, 22, 24, 26, 26.3, 26.5, 27, 27.3, 28.4, 32.2, 33.3,

36.9, 37, 41.5, 44, 49.7, 54, 56, 60.5, 69.6, 80.5, 86,

90.2, 109, 115, 117, 136, 140

RA:

4.7, 6.9

(f)

, 10, 10.6, 11.3, 12.1, 13.1, 13.2, 14.6, 16.3,

17.7, 18

(f)

, 22

(f)

, 24.5, 26.7, 27.1, 27.6, 28.6, 28.7,

29.3, 29.6, 32.7, 33.9, 37.8, 38, 42.1, 44.4, 51.3, 56

(f)

60.8, 61.9, 70.7, 83.6, 89.8, 92, 109

(f)

, 115

(f)

, 119,

140, 142

Almost all values are the mean of replicates

142

29.45

Barley, oats

(straw)

SEU

Mo:

34, 49.5, 66, 102

RA:

34.9, 51, 68.1, 105

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Northern/

Southern

Region

(a)

NEU

Crop

Wheat, rye

(grain)

Trials results relevant to the representative uses

(b)

Mo:

0.05, 0.11, 0.16, 0.19, 0.22, 0.23, 0.23, 0.26, 0.33,

0.5, 0.5, 0.6, 0.64, 0.67, 0.7, 0.7, 0.7(3), 0.71, 0.74,

0.75, 0.75, 0.77, 0.85, 1.3, 1.4, 1.5, 1.55, 1.6, 1.7, 1.7,

1.75, 2.2, 2.4, 2.9, 3.1, 3.45, 3.5, 3.7, 3.85, 4.7, 4.8,

4.85, 5.4, 9.5, 12.4, 17.5

RA:

0.125, 0.18, 0.24, 0.26, 0.27, 0.27, 0.28, 0.29, 0.36,

1.1, 0.58, 0.64

(f)

, 0.7, 0.74, 0.74

(f)

, 0.75, 0.77, 0.78,

0.78, 0.78, 0.78, 0.83, 0.83, 0.84, 0.93, 1.3

(f)

, 1.5, 1.6,

1.6, 1.6

(f)

, 1.7

(f)

, 1.8, 1.9, 2.3, 2.4

(f)

, 2.9

(f)

, 3.1

(f)

, 3.5,

3.6, 3.8, 3.9, 4.9, 5.0, 5.0, 5.4

(f)

, 9.5

(f)

, 13.3, 18.1

Comments/remarks

(c)

Almost all values are the mean of replicates

MRL

OECD

: 17.5/20 (NEU)

MRL

(mg/kg)

(d)

18.1

STMR

(e)

0.885

SEU

NEU

Mo:

0.07, 0.38, 0.4, 0.4, 0.47, 0.6, 0.95, 1.2, 2.8

RA:

0.15, 0.45, 0.48, 0.48, 0.55, 0.68, 1.0, 1.3, 3.0

Mo:

1.4, 5.3, 8.4, 9.5, 10.3, 10.6, 11.4, 14.7, 14.9, 17.3,

18.5, 19.1, 19.7, 21.5, 24.8, 26.9, 27.4, 27.5, 29.6,

31.4, 34.8, 42, 43.2, 43.8, 44.5, 46, 52.8, 63.3, 68,

70.5, 84.5, 85, 95.3, 95.5, 95.7, 96.5, 99, 175

RA:

1.5, 5.4, 9.3, 10.5, 10.9, 11, 12.6, 15.7, 15.7, 17.6,

19.2, 19.4, 19.9, 22.1, 25.5, 28, 28.2, 28.9, 29.6

(f)

31.8, 35.9, 42.6, 43.2, 44.2, 45.4, 46(f), 52.8(f), 64.3,

(f)

, 71.4, 87.5, 88.5, 96.5

(f)

, 97.3, 97.6, 98, 103, 179

Almost all values are the mean of replicates

179

30.7

Wheat, rye

(straw)

SEU

(a)

(b)

(c)

(d)

(e)

(f)

Mo:

3.4, 15.5, 16, 20, 22, 28, 28.5, 55.5, 98

RA:

3.5, 16.9, 18.6, 20.9, 23.2, 29.6, 29.7, 56.5, 99

NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non-EU trials.

Individual residue levels considered for MRL calculation are reported in ascending order (2x <0.01, 0.01, 6x 0.02, 0.04, 0.08, 2x 0.10, 0.15, 0.17),

Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values)

HR: Highest residue level according to the residue definition for risk assessment.

STMR: Median residue level according to residue definition for risk assessment

AMPA not analysed for

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Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)

ADI

TMDI (% ADI) according to EFSA PRIMo model

TMDI (% ADI) according (to be specified) diets

IEDI according to EFSA PRIMo model

NEDI (% ADI) according to German NVS II model

Factors included in IEDI and NEDI

ARfD

IESTI (% ARfD) according to EFSA PRIMo model

NESTI (% ARfD) according to German NVS II

model

Factors included in IESTI and NESTI

0.5 mg/kg bw per day

not calculated

Highest IEDI: 3% ADI (IE, Adult)

1.5% DE general population aged 14-80 yrs.

STMR values, PFs if applicable

0.5 mg/kg bw

Children: 5% for Oats (German children aged 2-4 y)

Adults: 9% for barley (Netherland adults)

Children: 5% for Oats (German children aged 2-4 y)

Adults: 6% for barley (General population aged 14-80 y)

PF Rye:

bran (1.5), flour (0.44), wholemeal flour (1.0)

PF Wheat: bran (1.8), flour (0.57), wholemeal flour: (1.1)

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

Crop/processed

product

Citrus

juice

peel

feed meal

press liquor

Potato

chips

flakes

wet peel

dry peel

granules

Olives

crude oil (vergine)

refined oil

Linseed

oil

press cake

Rape seed

crude oil

refined oil

press cake

Soya beans

fat free meal

hulls

crude oil

soapstock

Number of

studies

Processing factors

Glyphosate

0.83

2.6

0.09

0.22

0.25

1.6

0.14

0.13

1.4

0.98

4.8

0.01

0.045

AMPA

1.3

1.5

0.31

1.5

2.3

0.95

2.45

0.055

0.29

Comments

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Processing factors

Glyphosate

1.1

0.1

0.9

0.75

0.9

1.5

0.44

0.63

1.35

1.8

0.57

1.1

0.37

0.61

0.15

1.8

AMPA

0.64

0.5

0.59

0.76

1.3

0.31

0.61

0.79

1.2

0.81

Comments

Crop/processed

product

Maize

fat free meal

crude oil

refined oil

soapstock

small grits

medium grits

large grits

flour

Rye

bran

flour

wholemeal flour

wholemeal bread

middlings

Wheat

bran

flour

wholemeal flour

wholemeal bread

middlings

semolina

semolina bran

Number of

studies

4 (2 AMPA)

4 (0 AMPA)

2 (0 AMPA)

2 (2 AMPA)

13 (1 AMPA)

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)

Citrus, tree nuts, pome fruits, stone fruits

Strawberries

Root and tuber vegetables, bulb vegetables,

Fruiting vegetables except sweet corn,

Brassica vegetables,

Leaf vegetables and fresh herbs

Stem vegetables,

Herbal infusions,

Sugar plants

Pulses

Oilseeds

Buckwheat, maize, millet, rice, sorghum, other

cereals,

0.05* mg/kg

Trials were not provided, but having regard to the no

residue situation (all values <0.05 mg/kg) observed when

glyphosate is used before sowing/emergence of annual

crops and since metabolism studies suggest a negligible

uptake from roots, a MRL of 0.05* mg/kg is proposed to

cover the pre-sowing/emergence uses of the active

substances on these crops.

0.5 mg/kg

2 mg/kg

30 mg/kg

20 mg/kg

Grapes

Table Olives

Barley, oats

Wheat, rye

Swine

Muscle

Fat

Liver

Kidney

Muscle

Fat

Liver

Kidney

Milk

Muscle

Fat

Liver

Kidney

Eggs

0.05* mg/kg

0.2 mg/kg

0.05* mg/kg

0.1 mg/kg

2.0 mg/kg

0.05* mg/kg

0.1 mg/kg

0.025* mg/kg

Bovine

Poultry

When the MRL is proposed at the LOQ, this should be annotated by an asterisk (*) after the figure.

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Mineralisation after 100 days

Non-extractable residues after 100 days

Metabolites requiring further consideration

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

maximum)

16.9 - 79.6 % after 60 – 366 d (n = 12)

2.5 - 43.2 % after 60 – 366 d (n = 12)

AMPA: 13.3 - 50.1 % max. at 7- 120 d (n = 12)

Field:

AMPA: 19.65 - 53.8 % max. after 56 - 271 d (n = 10)

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

Anaerobic degradation

Mineralisation after 100 days

Non-extractable residues after 100 days

Metabolites that may require further consideration

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

applied (range and maximum)

Soil photolysis

Metabolites that may require further consideration

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

applied (range and maximum)

study:

in d (experimental): 90 d (irradiated), 96 d (dark)

AMPA: max. 13.0 % max. (irradiated), 9.6% max. (dark)

study:

in d (experimental): 101 d (irradiated), 1236 d

(dark)

AMPA: max.8.2% (irradiated), 6.1 % (dark)

study:

in d: 5.5 d (at 50°N)

AMPA: max.24 %

0.87 - 45.42 % after 66 - 120 d (n = 3)

20.88 - 24.6 % 66 - 120 d (n = 3)

AMPA: max. 30.2 % after 84 days (n = 3)

= 142 d (n = 1), no significant degradation (n = 1),

no DT

calculated (n = 1)

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

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

Laboratory studies

Glyphosate

Aerobic conditions

T (

C) /

soil

moisture

20/ pF2.5

20/ 40%

MWHC

25/ 75%

of 1/3 bar

[b]

Persistence endpoints at 20 and 25°C

Soil type

(d)

Kinetic

(d)

parameters

: 0.2474

: 0.0304

g: 0.4459

α: 0.45389

β: 10.47275

α: 0.6565

β: 0.6406

: 0.23497

: 0.00826

g: 0.541289

: 0.2638

: 0.0192

g: 0.6715

: 1.2566

: 0.1161

g: 0.4038

α: 0.8550

β: 3.1539

: 0.1129

: 0.0040

g: 0.3453

: 0.1277

: 2.3e-014

g: 0.9578

: 0.4736

: 0.0372

g: 0.3278

α: 0.5770

β: 8.0642

: 0.3162

: 0.0494

g: 0.8355

α: 1.01

β: 9.31

k: 0.0159

Fit

χ2 error

(%)

3.0

2.31

Method of

calculation

Gartenacker, loam

7.1

7.86

56.29

DFOP

Arrow, sandy loam

Soil B, sandy loam

6.5

[a]

6.7

37.75

1.2

1661

20.8

FOMC

6.9

Les Evouettes, Silt Loam

6.1

20/ 40%

MWHC

20/ 1/3

bar

8.55

83.92

5.93

DFOP

Maasdjik, sandy loam

7.5

[a]

4.61

62.00

0.84

DFOP

Drusenheim, loam

7.4

20/ pF2.5

2.06

15.38

2.4

DFOP

Pappelacker, loamy sand

7.0

20/ pF2.5

3.94

43.45

4.1

FOMC

18-Acres, clay loam

5.7

20/ pF2.5

67.72

471.4

2.9

DFOP

Speyer 2.3, Loamy Sand

6.9

20/40%

MWHC

[a]

5.78

21.99

2.41

DFOP

Speyer 2.1, sand

6.5

20/ 45%

MWHC

20/ 45%

MWHC

20/ 45%

MWHC

25/ 75%

20/ 40%

MWHC

20/ 40%

MWHC

8.3

51.3

2.45

DFOP

Speyer 2.2, loamy sand

6.2

[a]

18.7

428

4.04

FOMC

Speyer 2.3, loamy sand

6.9

2.70

13.03

7.45

DFOP

Dupo, silt loam

Speyer 2.2, loamy sand

7.3

[b]

6.0

1.01

43.53

9.31

144.61

3.8

6.95

FOMC

SFO

Speyer 2.1, sand

6.9

[b]

11.11

144.25

α: 0.7683

β: 7.5833

3.91

FOMC

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

α: 0.45389

β: 10.47275

Arrow

FOMC

Maximum* (n = 15)

[a]

[b]

37.75

1661

converted from given pH in CaCl

or KCl

buffer solution unknown

labelled in the phosphonomethyl-glycine anion of glyphosate-trimesium

maximum, which would result to the highest PECsoil

Aerobic conditions

Glyphosate

Persistence endpoints at 10°C

T ( C) / soil

moisture

Soil type

(d) DT

(d)

Kinetic

parameters

: 0.300

: 0.0361

g: 0.3756

Fit

χ2

error

(%)

2.31

Method of

calculation

Speyer 2.3, loamy

sand

[a]

6.9

[a]

10/ 45% MWHC 8.07

50.79

DFOP

converted from given pH in CaCl

or KCl

Laboratory studies

Glyphosate

Aerobic conditions

Endpoint in regard to P-criterion

Soil type

Gartenacker,

loam

Arrow, sandy

loam

Soil B, sandy

loam

Les Evouettes,

Silt Loam

Maasdjik, sandy

loam

Drusenheim,

loam

Pappelacker,

loamy sand

18-Acres, clay

loam

Speyer 2.3,

Loamy Sand

Speyer 2.1,

sand

Speyer 2.2,

loamy sand

Speyer 2.3,

loamy sand

Dupo, silt loam

Speyer 2.2,

loamy sand

recalculated SFO

T (

C) / soil

(days)

O) moisture

actual

7.1

6.5

[a]

6.7

6.1

[b]

7.5

[a]

7.4

7.0

5.7

6.9

6.5

[a]

6.2

[a]

6.9

[a]

7.3

[b]

6.0

20/ pF2.5

20/ 40%

MWHC

25/ 75% of

1/3 bar

20/ 40%

MWHC

20/ 1/3 bar

20/ pF2.5

20/40%

MWHC

20/ 45%

MWHC

20/ 45%

MWHC

20/ 45%

MWHC

25/ 75%

20/ 40%

MWHC

16.95

500.3

6.27

25.28

18.7

4.63

13.09

141.9

6.6

15.45

129

3.93

2.80

43.53

Normalised SFO

(days)

20 °C, pF2

15.2

427.8

6.7

22.6

14.1

3.6

12.0

133.8

6.6

15.45

129

3.93

3.70

40.6

Fit

χ2 error

(%)

3.0

2.31

6.9

5.93

0.84

2.4

4.1

2.9

2.41

2.45

4.04

7.45

3.8

6.95

Method of

calculation

DFOP,

/3.32

FOMC

/3.32

FOMC

/3.32

DFOP,

/3.32

DFOP,

/3.32

DFOP,

/3.32

FOMC

/3.32

DFOP,

/3.32

DFOP,

/3.32

DFOP,

/3.32

FOMC

/3.32

DFOP,

/3.32

FOMC

/3.32

SFO

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FOMC

/3.32

Speyer 2.1,

sand

6.9

[b]

20/ 40%

MWHC

43.06

427.8

3.91

Maximum (n = 15)

Geometric mean (n = 15)

19.74

according to EFSA DG

SANCO working document

on evidence needed to

identify POP, PBT and vPvB

properties for pesticides from

25.09.2012- rev.3

[a]

[b]

converted from given pH in CaCl

or KCl in order to allow pH dependency tests of the degradation

buffer solution unknown

labelled in the phosphonomethyl-glycine anion of glyphosate-trimesium

Glyphosate

Modelling endpoints

Soil type

Gartenacker, loam

Arrow, sandy loam

Soil B, sandy loam

Les Evouettes, Silt

Loam

Maasdjik, sandy

loam

Drusenheim, loam

Pappelacker, loamy

sand

Aerobic conditions

7.1

6.5

[a]

6.7

6.1

[b]

7.5

[a]

7.4

7.0

T (

C) / % soil

moisture

20/ pF2.5

20/ 40% MWHC

25/ 75% of 1/3 bar

20/ 40% MWHC

20/ 1/3 bar

20/ pF2.5

20/40% MWHC

20/ 45% MWHC

25/ 75% FC

20/ 40% MWHC

(d)

C

pF2

16.0

159.6

6.6

93.3

15.2

4.2

12.0

160.5

7.2

19.5

72.2

3.76

3.70

40.6

43.06

Fit

χ2 error (%)

4.6

3.52

6.92

6.17

3.79

3.5

4.1

2.9

3.84

5.72

4.97

7.67

3.80

6.95

3.91

Method of

calculation

FOMC/ 3.32

DFOP slow phase

FOMC/ 3.32

DFOP slow phase

FOMC/ 3.32

DFOP slow phase

FOMC/ 3.32

SFO

FOMC/ 3.32

Endpoint for

modelling of PEC

and PEC

/ PEC

Sed

18-Acres, clay loam 5.7

Speyer 2.3, Lomay

Sand

Speyer 2.1, sand

Speyer 2.2, loamy

sand

Speyer 2.3, loamy

sand

Dupo, silt loam

Speyer 2.2, loamy

sand

Speyer 2.1, sand

6.9

6.5

[a]

6.2

[a]

6.9

[a]

7.3

[b]

6.0

6.9

[b]

Geometric mean (n = 15)

pH dependency

[a]

[b]

20.51

converted from given pH in CaCl

or KCl

buffer solution unknown

labelled in the phosphonomethyl-glycine anion of glyphosate-trimesium

EFSA Journal 2015;13(11):4302

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

Metabolite AMPA

Aerobic conditions

Persistence endpoints at 20 and 25°C

Soil type

7.1

6.7

T (

C) /

% soil

moisture

20/ pF2.5

25/ 75% of

1/3 bar

20/ 40%

MWHC

20/ pF2.5

20/ 40%

MWHC

20/ 45%

MWHC

25/ 75% FC

20/ 40%

MWHC

(d)

120.07

99.1

300.71

38.98

126.57

77.50

41.87

48.32

230.7

300.71

(d)

398.9

329

998.9

129.5

420.5

257.43

139.10

160.5

766

998.9

Fit

Method of

χ2 error (%) calculation

9.2

6.98

16.06

3.3

6.2

10.18

16.23

7.57

4.29

DFOP (par) –

SFO (met)

FOMC (par) –

SFO (met)

DFOP (par) –

SFO (met)

DFOP (par) –

SFO (met)

FOMC (par) –

SFO (met)

DFOP (par) –

SFO (met)

DFOP (par) –

SFO (met)

FOMC (par) –

SFO (met)

FOMC (par) –

SFO (met)

SFO

Gartenacker, loam

Soil B, sandy loam

Les Evouettes, Silt Loam 6.1

[b]

Drusenheim, loam

7.4

Pappelacker, loamy sand 7.0

Speyer 2.3, loamy sand

Dupo, silt loam

Speyer 2.1, sand

Maximum (n = 9)

[a]

[b]

6.9

[a]

7.3

[b]

6.9

[b]

converted from given pH in CaCl

or KCl

buffer solution unknown

Aerobic conditions

Metabolite AMPA

Modelling endpoints

Soil type

7.1

6.7

6.1

[b]

7.4

T (

C) /

% soil

moisture

20/ pF2.5

25/ 75% of

1/3 bar

20/ 40%

MWHC

20/ pF2.5

f. f.

par



met

)

0.1817

0.2646

0.3618

0.2578

(d)

Fit

Method of

C

χ2 error (%) calculation

pF2/10kPa

119.9

106.2

300.9

36.8

8.9

6.98

14.00

2.1

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

Gartenacker, loam

Soil B, sandy loam

Les Evouettes, Silt

Loam

Drusenheim, loam

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Metabolite AMPA

Modelling endpoints

Soil type

7.0

5.7

6.9

6.5

[a]

6.2

[a]

6.9

[a]

7.3

[b]

6.9

[b]

T (

C) /

% soil

moisture

20/ pF2.5

20/ 40%

MWHC

20/ 45%

MWHC

20/ 45%

MWHC

20/ 45%

MWHC

25/ 75% FC

20/ 40%

MWHC

f. f.

par



met

)

0.1835

0.2169

0.3435

0.520

0.6076

0.4283

0.3637

0.5851

0.3595

(d)

Fit

Method of

C

χ2 error (%) calculation

pF2/10kPa

116.3

70.92

42.14

30.5

230.7

88.84

6.2

11.41

16.48

7.57

4.29

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

DFOP (par) – SFO

(met)

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

FOMC (par) – SFO

(met)

Aerobic conditions

Pappelacker, loamy

sand

18-Acres, clay loam

Speyer 2.3, loamy sand

Speyer 2.1, sand

Speyer 2.2, loamy sand

Speyer 2.3, loamy sand

Dupo, silt loam

Speyer 2.1, sand

Geometric mean (n = 9)

pH dependency

Arithmetic mean (n = 12)

[a]

[b]

converted from given pH in CaCl

or KCl

buffer solution unknown

Acceptable visual fit for formation phase of AMPA, however no statistically acceptable fit for AMPA

could be obtained in this pathway

Field studies

Persistence endpoints

Parent

glyphosate

Soil type

Location

Applica-

Depth

tion rate

(cm)

(kg a.s/ha)

7.1 0-30

Aerobic conditions

(d) DT

(d) Kinetic

actual

parameters

k1 0.1437

k2 0.0033

g 0.854

k1 0.1786

k2 0.0041

g 0.771

k1 0.019

k2 2.3E-14

g 0.927

k1 0.0384

k2 0.0037

g 0.575

Fit

χ2

error

(%)

4.96

Method of

calculation

Sandy clay

Diegten

3.53

Switzerland

Menslage

Germany

Buchen

Germany

3.67

6.1

116.1

DFOP

Sandy loam

4.7 0-30

5.7

200.8

9.4

DFOP

Loamy sand

5.20*

6.4 0-30

40.9

187.3

6.6

DFOP

Sandy loam

Kleinzecher

5.7*

Germany

7.0 0-30

38.3

386.6

11.7

DFOP

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Field studies

Persistence endpoints

Parent

glyphosate

Soil type

Location

Applica-

Depth

tion rate

(cm)

(kg a.s/ha)

4.8*

5.0*

4.6*

6.7 0-30

8.5 0-30

8.0 0-30

Aerobic conditions

(d) DT

(d) Kinetic

actual

parameters

k1 0.0280

k2 8.9E-4

g 0.922

k 0.0344

k 0.0206

Fit

χ2

error

(%)

8.4

3.8

10.6

Method of

calculation

Loam

Silt loam

Clay loam

Unzhurst,

Germany

Rohrbach

Germany

Herrngiers-

dorf

Germany

Wang-

Inzkofen

Germany

27.7

20.1

33.7

122.3

66.9

111.9

DFOP

SFO

Top down

SFO

Silt loam

4.8*

7.2 0-30

17.8

165.5

alpha 0.975

8.7

beta 17.207

FOMC

Worst case kinetics for PEC

Soil

and as trigger for higher

38.3

tier studies (n = 8)

Maximum with regard to P-criterion (n = 8)

116.4

386.6

Geomean with regard to P-criterion (n = 8)

45.2

149.96

* Glyphosat-trimesium as test substance

** according to EFSA DG SANCO working document on evidence needed to identify POP, PBT and vPvB

properties for pesticides from 25.09.2012- rev.3

Metabolite

AMPA

Soil type

Sandy loam

Loam

Silt loam

Clay loam

Aerobic conditions

Location

Kleinzecher

, Germany

Unzhurst,

Germany

Rohrbach,

Germany

Herrngiers-

dorf,

Germany

Wang-

Inzkofen,

Germany

7.0

6.7

8.5

8.0

Depth

(cm)

0-30

(d)

actual

514.9

633.1

374.9

288.4

(d)

actual

>1000

958.1

formation

fraction

(ff)

0.508

0.332

n.d.

Fit

χ2 error

(%).

15.9

13.3

8.6

10.9

k1 0.0384

DFOP

k2 0.0037

Kleinzecher,

g 0.575

Germany

maximum overall DT

(DFOP)/3.32**

trial Kleinzecher

based on overall DT90/3.32**

Method of

calculation

DFOP-SFO

SFO

Top down

SFO

Top down

FOMC-SFO

Silt loam

Maximum (n = 5)

7.2

0-30

283.6

633.1

942.3

>1000

0.547

15.6

SFO

Unzhorst, Germany

0.462

Arithmetic mean (n = 3)

Soil accumulation and plateau concentration

no experimental data

calculation of plateau concentration see PEC

Soil

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Parent glyphosate

Soil Type

Drummer, silty clay loam

Dupo, silt loam

Spinks, loamy sand

Greenan sand, sand

Auchincruive, sand loam

Headley Hall, sandy clay loam

Californian sandy soil, loamy sand

Les Evouettes II, silt loam

Darnconner sediment, loam

(Sediment)

Lilly Field, sand

Visalia, sandy loam

Wisborough Green, silty clay loam

Champaign, silty clay loam

18 Acres, sandy loam

Speyer 2.1, sand

Speyer 2.2, loamy sand

Speyer 2.3, loamy sand

Soil 2.1, sand

Soil 2.3, loamy sand

Soil F3, sandy loam

Arithmetic mean (n = 20)

pH dependency

OC %

1.45

0.87

1.10

0.80

1.60

1.40

0.60

1.40

3.00

0.29

0.58

2.26

2.15

1.80

0.62

2.32

1.22

0.70

1.34

1.20

Soil pH

6.5

7.4

5.2

5.7

7.1

7.8

8.3

6.1

7.1

5.7

8.4

5.7

6.2

7.4

6.5

6.2

6.9

5.9

6.3

7.3

66.4

76.5

54.4

9486

5709

4533

263

811

510

32838

50660

3598

884

3404

17010

(mL/g)

324.0

33.0

660.0

64.0

9.4

470.0

700.0

90.0

29.5

71.7

37.7

foc

doc

1/n

(mL/g)

22300

3800

60000

32838

50660

3598

884

3404

17010

22000

1600

21000

33000

5000

4762

3091

3092

9486

5709

4533

15388

0.92

0.80

1.16

1.00

0.75

0.72

0.93

0.94

0.76

0.84

1.00

0.93

Metabolite AMPA

Soil Type

SLI Soil #1, c

lay loam

SLI Soil #2, s

and

OC %

2.09

18.68

1.33

0.93

1.57

0.29

Soil pH

7.7

4.7

7.4

7.6

6.3

4.6

5.7

(mL/g)

77.1

foc

(mL/g)

3640

1/n

0.79

0.9

0.75

0.79

0.77

0.79

0.86

(mL/g) (mL/g)

1570.0

8310

15.7

53.9

110.0

73.0

133.0

1160

5650

6920

24800

45900

SLI Soil #4, sand

SLI Soil #5, c

lay loam

SLI Soil #9, l

oamy sand

SLI Soil #11, s

and

Lilly Field, s

and

EFSA Journal 2015;13(11):4302

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Visalia, s

andy loam

Wisborough Green, s

ilty clay loam

Champaign, s

ilty clay loam

0.58

2.26

2.15

1.80

1.59

1.24

2.25

0.90

2.30

2.60

8.4

5.7

6.2

7.4

6.1

8.3

5.8

6.2

7.6

10.0

509.0

237.0

74.2

137.4

87.9

33.9

16.7

189.7

29.1

1720

22500

11100

4130

8642

7089

1507

1861

8248

1119

9749

0.78

0.91

0.86

0.84

0.98

0.92

0.91

0.6650

0.5506

0.67109

0.81

18 Acres, sandy loam

Schwalbach, silt loam

Hofheim, silt loam

Bergen-Enkheim, silty clay

Soil 2.1, sand

Soil 2.2, l

oamy sand

Soil 3A, s

andy silty loam

Arithmetic mean (n = 16)

pH dependency

Not included for calculation of statistics (mean values, correlations) due to high OC - content

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

Column leaching

study (glyphosate):

7 soils, Eluation : 508 mm water

Leachate: 0.03 - 6.56% of applied radioactivity in

leachate

study (glyphosate):

3 soils, Eluation: 200 mm water

Leachate: 0.12 - 1.45% of applied radioactivity in

leachate

study (glyphosate):

3 soils

Leachate: <1 µg/L - 2.6 µg/L

glyphosate derivatives

study (glyphosate trimesium):

3 soils, Eluation: 200 mm water

Leachate: <2% of applied glyphosate-trimesium

Aged residues leaching

study (glyphosate):

1 sand soil

Aged for (d): 8 days

Eluation (mm): 380mm over 48 h

C distribution after 8 days: Glyphosate: 48.6% of

applied radioactivity, AMPA: 21.45% of applied

radioactivity, non-extractable: 1.65% of applied

radioactivity, CO

: 2.35% of applied radioactivity

study (glyphosate-trimesium):

1 sand soil

Aged for (d): 30 d

Eluation (mm): 200 mm water over 48 h

C distribution after 30 days: Glyphosate-

C: 52 %

extractable (AMPA 26 %), 12 % unextractable, 33 %

; TMS-

C: 10 % extractable, 21 % unextractable, 57

% CO

0.1% / 0.5% (Glyphosate /TMS) of applied radioactivity

in leachate

EFSA Journal 2015;13(11):4302

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Lysimeter/ field leaching studies

No lysimeter or field leaching studies submitted

PEC (soil) (Annex IIIA, point 9.1.3)

Parent

Method of calculation

ESCAPE 2.0: input parameters

k1 0.0384 (DT

50 fast

(d): 18.05 days)

k2 0.0037 (DT

50 slow

(d): 187.34 days )

g 0.575

Kinetics: DFOP (best fit, trial Kleinzecher/ Germany)

Field: worst case kinetics (best fit) from field studies

(not normalized)

Application data

Crop: all crops

Depth of soil layer: 5 cm for PEC

initial

20 cm for PEC

plateau

concentration for annual crops

5 cm for PEC

plateau

concentration for permanent crops

Soil bulk density: 1.5 g/cm

% plant interception: 0

Number of applications: 1

Application rate: 4320 g as/ha (maximum application

rate per ha/year for all crops as worst case approach))

PEC

(s)

(mg/kg)

Single

application

Actual

5.7600

5.6262

5.4971

5.2524

4.9167

3.3372

2.5201

1.7621

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

Long term 7 d

28 d

50 d

100 d

Plateau concentration

5.6931

5.6274

5.5005

5.3211

4.3549

3.7072

2.8902

annual

crops

(tillage

depth

cm):

0.2140 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

5.974 mg/kg

permanent crops (tillage depth 5 cm):

0.8562 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration.) =

6.6162 mg/kg

EFSA Journal 2015;13(11):4302

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Application data

Crop: all crops

Depth of soil layer: 5 cm for PEC

initial

20 cm for PEC

plateau

concentration for annual crops

5 cm for PEC

plateau

concentration for permanent crops

Soil bulk density: 1.5 g/cm

% plant interception: 0

Number of applications: 1

Application rate: 2 x 2160 g as/ha , interval 21 days

PEC

(s)

(mg/kg)

Single

application

Actual

4.7514

4.6524

4.5568

4.3755

4.1263

2.9408

2.3084

1.6779

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

Long term 7 d

28 d

50 d

100 d

Plateau concentration

4.7019

4.6533

4.5593

4.4263

3.7186

3.2353

2.7075

annual

crops

(tillage

depth

cm):

0.2058 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

4.957 mg/kg

permanent crops (tillage depth 5 cm):

0.8232mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration.) =

5.5746 mg/kg

Application data

Crop: all crops

Depth of soil layer: 5 cm for PEC initial

20 cm for PEC

plateau

concentration for annual crops

5 cm for PEC

plateau

concentration for permanent crops

Soil bulk density: 1.5 g/cm

% plant interception: 0

Number of applications: 1

Application rate: 1 x 1080 g as/ha

PEC

(s)

(mg/kg)

Single

application

Actual

1.440

1.4065

1.3742

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

1.4233

1.4068

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PEC

(s)

(mg/kg)

Single

application

Actual

1.3131

1.2291

0.8340

0.6297

0.4402

Single

application

Time weighted

average

1.3751

1.3302

1.0886

0.9266

0.7223

Multiple

application

Actual

Multiple

application

Time weighted

average

Long term 7 d

28 d

50 d

100 d

Plateau concentration

annual

crops

(tillage

depth

cm):

0.0535 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

1.4935 mg/kg

permanent crops (tillage depth 5 cm):

0.2138 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration.) =

1.6538 mg/kg

Crop: cereals

Depth of soil layer: 5 cm for PEC

initial

20 cm for PEC

plateau

concentration for annual crops

Soil bulk density: 1.5 g/cm

% plant interception: 90

Number of applications: 1

Application rate: 1 x 2160 g as/ha , pre-harvest

Application data

PEC

(s)

(mg/kg)

Single

application

Actual

0.2880

0.2813

0.2748

0.2626

0.2458

0.1668

0.1259

0.0880

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

Long term 7 d

28 d

50 d

100 d

Plateau concentration

0.2847

0.2814

0.2750

0.2660

0.2177

0.1853

0.1445

annual

crops

(tillage

depth

cm):

0.0107 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

0.2987 mg/kg

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Application data

Crop: oil seed rape

Depth of soil layer: 5 cm for PEC

initial

20 cm for PEC

plateau

concentration for annual crops

Soil bulk density: 1.5 g/cm

% plant interception: 80

Number of applications: 1

Application rate: 1 x 2160 g as/ha , pre-harvest

PEC

(s)

(mg/kg)

Single

application

Actual

0.576

0.5626

0.5497

0.5252

0.4916

0.3336

0.2519

0.1761

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

Long term 7 d

28 d

50 d

100 d

Plateau concentration

0.5693

0.5627

0.5500

0.5321

0.4354

0.3706

0.2889

annual

crops

(tillage

depth

cm):

0.0214 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

0.5974 mg/kg

Application data

Crop: orchard crop, vines, citrus & tree nuts

Depth of soil layer: 5 cm for PEC

initial

5 cm for PEC

plateau

concentration for permanent crops

Soil bulk density: 1.5 g/cm

% plant interception: 0

Number of applications: 3

Application rate: 3 x 2880 g as/ha , interval 28 days

Soil relevant application rate*: 3 x 960 g as/ha

*Because applications are made to the intra-rows (inner

strips between the trees within a row) application rates

per ha are expressed per ‘unit of treated surface area’ the

actual application rate per ha orchard or vineyard will

roughly only be 33 %

PEC

(s)

(mg/kg)

Single

application

Actual

2.5490

2.5031

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

2.5260

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PEC

(s)

(mg/kg)

Single

application

Actual

2.4587

2.3744

2.2582

1.6966

1.3837

1.0422

Single

application

Time weighted

average

2.5035

2.4599

2.3980

2.0670

1.8440

1.6473

Multiple

application

Actual

Multiple

application

Time weighted

average

Long term 7 d

28 d

50 d

100 d

Plateau concentration

permanent crops (tillage depth 5 cm):

0.5159 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

3.0648 mg/kg

Crop: orchard crop, vines, citrus & tree nuts

Depth of soil layer: 5 cm for PEC

initial

5 cm for PEC

plateau

concentration for permanent crops

Soil bulk density: 1.5 g/cm

% plant interception: 0

Number of applications: 3

Application rate: 3 x 2880 g as/ha , interval 28 days

Soil relevant application rate*: 3 x 1440 g as/ha

*Because applications are made round base of trunk and

to the intra-rows (inner strips between the trees within a

row) application rates per ha are expressed per ‘unit of

treated surface area’ the actual application rate per ha

orchard or vineyard will roughly only be 33 % - 50 %)

Application data

PEC

(s)

(mg/kg)

Single

application

Actual

3.8235

3.7546

3.6881

3.5617

3.3873

2.5449

2.0755

1.5633

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

Initial

Short term 24 h

Long term 7 d

28 d

50 d

100 d

3.7890

3.7552

3.6898

3.5970

3.1005

2.7661

2.4709

Plateau concentration

permanent crops (tillage depth 5 cm):

0.7738 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

4.5973 mg/kg

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Metabolite AMPA

Method of calculation

Molecular weight relative to the parent: 0.657

(d): 633 days (k 0.0013)

Kinetics: SFO (best fit, trial Unzhorst/ Germany)

Field: Maximum value from field studies (not

normalized)

Application data

Application rate assumed: 1527 g as/ha (assumed AMPA

is formed at a maximum of 53.8 % of the applied dose

Single

application

Actual

2.0360

2.0338

2.0315

2.0271

2.0205

1.9745

1.9275

1.8248

2.0349

2.0338

2.0315

2.0282

2.0051

1.9813

1.9285

Single

application

Time weighted

average

Multiple

application

Actual

Multiple

application

Time weighted

average

PEC

(s)

(mg/kg)

Initial

Short term 24 h

Long term 7 d

28 d

50 d

100 d

Plateau concentration

annual crops (tillage depth 20 cm):

1.0359 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

3.0719 mg/kg

permanent crops (tillage depth 5 cm):

4.1437 mg/kg after 10 years

PEC

accu

(PEC

initial

+ plateau concentration) =

6.1797 mg/kg

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

Hydrolytic degradation of the active substance and

metabolites > 10 %

Glyphosate:

pH 5: stable (25°C)

pH 7: stable (25°C)

pH 9: stable (25°C)

Glyphosate trimesium:

pH 5: stable (25°C and 40°C)

pH 7: stable (25°C and 40°C)

pH 9: stable (25°C and 40°C)

AMPA:

no data

Photolytic degradation of active substance and

metabolites above 10 %

Glyphosate:

(experimental): 33 d (at pH 5), 69 d (at pH 7), 77 d

(at pH 9)

Metabolite AMPA: 16% max (at pH5), 11.6% max. (at

pH 7), 6.5% max. (at pH 9)

Glyphosate trimesium:

(37°N): 81 d (at pH 7), TMS cation: stable

Quantum yield of direct phototransformation in

water at



> 290 nm

EFSA Journal 2015;13(11):4302

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Readily biodegradable

(yes/no)

OECD 301F : < 60 % after 28 days)

OECD 302B : 0 - 2 % after 28 days

Degradation in water / sediment

Parent

Glyphosate

Distribution: max. 61.4 % in sediment after 14 days

Persistence

at Level P-I

Study

System

Model

Glyphosate (total system)

Bowler

Johnson (1999)

Cache

Putah

Loamy

Sediment

Sandy

Sediment

Creek

Pond

TNO

Muttzall (1993)

Kromme Rijn

Minimum

Maximum

Geometric mean (n = 7/6

)

Glyphosate (water phase)

Bowler

Johnson (1999)

Cache

Putah

Loamy

Sediment

Sandy

Sediment

Creek

Pond

TNO

Muttzall (1993)

Kromme Rijn

Minimum

Maximum

Geometric mean (n = 6)

EFSA Journal 2015;13(11):4302

FOMC

DFOP

SFO

4.98

8.25

1.06

2.03

13.15

1.00

26.84

72.40

24.11

22.63

43.67

26.89

8.08

21.81

7.26

6.82

13.15

8.10

6.82

21.81

9.88

SFO

FOMC

DFOP

SFO

6.94

21.81

7.26

6.82

13.15

8.10

6.82

21.81

9.63

DFOP

28.86

232.92

FOMC

DFOP

FOMC

SFO

FOMC

8.47

210.66

70.48

16.03

16.78

67.45

93.06

45.89

976.54

∞

346.81

55.74

281.39

> 1000

13.82

294.14

104.46

16.78

84.76

>301.20

)

endpoints

904)

(days)

SFO

504)

(days)

Modelling

at Level P-I

Model

endpoints

SFO DT

504)

(days)

504)

(days)

FOMC

DFOP

SFO

DFOP

13.82

329.85

154.19

16.78

92.42

88.67

13.82

329.85

67.74

Möllerfeld

Römbke (1993)

Heintze

(1996)

70.16

13.82

301.20

74.52

Möllerfeld

Römbke (1993)

Heintze

(1996)

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Glyphosate (sediment phase):

Bowler

Johnson (1999)

Cache

Putah

Loamy

Sediment

Sandy

Sediment

Creek

Pond

TNO

Muttzall (1993)

Kromme Rijn

Minimum

Maximum

Geometric mean (n = 2)

Calculated from slower k-rate

no reliable fit achieved

DT50 = degradation DT50 for total system, Dissipation DT50 for water and sediment phase

Back-calculated SFO to derive endpoints for P criteria (SFO DT50 = DT90/3.32)

Back-calculation of SFO DT50 not possible

Not calculated, since a sufficient number of DT50 values were not available

Number of values for deriving persistence endpoint (SFO DT50) and the modelling endpoint

SFO

FOMC

SFO

34.05

383.86

75.61

113.10

∞

251.16

34.05

75.61

34.05

75.61

SFO

34.05

75.61

34.05

75.61

Möllerfeld

Römbke (1993)

Heintze

(1996)

Back-calculated from DT90 of bi-phasic model (DT90/3.32)

Metabolite AMPA

Distribution: max. 15.7 % AR in water after 14 d, max. 18.7 % AR in sediment after

58 d

Persistence

at Level P-I

endpoints

904)

(days)

SFO

504)

(days)

Modelling endpoints

at Level P-I

Model

SFO

504)

(days)

Study

System

Model

504)

(days)

AMPA (total system)

Feser-Zügner

(2002)

Knoch

(2003)

Knoch

Spirlet

(1999)

McEwen

(2004b)

Minimum

Maximum

Geometric mean (n = 5/4

)

AMPA (water phase)

EFSA Journal 2015;13(11):4302

Rückhaltebecken

Schäphysen

Bickenbach

Unter-Widdersheim

Bickenbach

Unter-Widdersheim

FOMC

13.80

10.54

77.36

44.53

20.13

1513.00

191.25

307.19

205.21

885.03

455.72

57.61

92.53

61.81

266.58

57.61

455.72

131.97

DFOP

102.87

77.83

98.98

69.31

102.87

86.09

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Feser-Zügner

(2002)

Knoch

(2003)

Knoch

Spirlet

(1999)

McEwen

(2004b)

Minimum

Maximum

Geometric mean (n = 8)

AMPA (sediment phase)

Feser-Zügner

(2002)

Knoch

(2003)

Knoch

Spirlet

(1999)

McEwen

(2004b)

Rückhaltebecken

Schäphysen

Bickenbach

Unter-Widdersheim

Bickenbach

Unter-Widdersheim

Rückhaltebecken

Schäphysen

Bickenbach

Unter-Widdersheim

Bickenbach

Unter-Widdersheim

FOMC

DFOP

FOMC

DFOP

FOMC

DFOP

2.20

1.00

2.54

2.13

6.59

2.02

0.69

1.28

22.50

7.80

47.57

26.31

51.47

17.15

8.87

6.87

6.78

2.35

14.33

7.92

15.50

5.17

2.67

2.07

15.50

5.47

FOMC

DFOP

FOMC

DFOP

FOMC

DFOP

6.78

2.35

14.33

7.92

15.50

5.17

2.67

2.07

15.50

5.47

Back-calculated from DT90 of bi-phasic model (DT90/3.32)

Calculated from slower k-rate

no reliable fit achieved

DT50 = DegT50 for total system but DT50 for water and sediment phase

Back-calculated SFO to derive endpoints for P criteria (SFO DT50 = DT90/3.32)

excluded from kinetic evaluation due to analytical problems

Number of values for deriving persistence endpoint (SFO DT50) and the modelling endpoint

excluded from kinetic evaluation due to different amounts of AMPA in the sediment reported in the study

Metabolite

HMPA

Distribution: 10.0 % & 7.5 % max. in water after 61 & 100 d (consecutive data points)

Mineralisation and non extractable residues

Water / sediment

system

Cache

Putah

Bickenbach

Unter Widdersheim

Creek

Pond

water

phase

8.2

8,4

8.6

8.1

7,5

7.8

7.7

6.64

7.85

sed.

Mineralisation

x % after n d

(end of the study)

47.9 (100 d)

5.9 (100 d)

23.5 (100 d)

17.8 (100 d)

14.77 (120 d)

30.08 (120 d)

Non-extractable

Non-extractable residues

residues in sed. max in sed. max x % after n d

x % after n d

(end of the study)

13.5 (100 d)

20.3 (58 d)

22.0 (100 d)

13.6 (100 d)

17.15 (120 d)

49 (120 d)

13.5 (100 d)

16.7 (100 d)

22.0 (100 d)

13.6 (100 d)

17.15 (120 d)

.49 (120 d)

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

TNO

Kromme Rijn

7,6

7,2

5.8 (91 d)

25.7% (91 d)

35.1 (91 d)

30.5 (91 d)

35.1 (91 d)

30.5 (91 d)

PEC surface water and PEC sediment (Annex IIIA, point 9.2.3)

Parent

Parameters used in FOCUS

step 1 and 2

Version control no. of FOCUS calculator: Step1-2

(version 2.1)

Molecular weight (g/mol): 169.07

Water solubility (mg/L): 10500 (pH2, 20 °C)

(L/kg): 15844

soil (d): 20.51days (Laboratory, geometric mean,

SFO at 20°C and pF 2)

water/sediment system (d): 67.74 d (SFO,

geometric mean at 20°C)

water (d): 67.74 d (DT

value of total system)

sediment (d): 67.74 d (DT

value of total system)

Parameters used in FOCUS

step 3

Version control no.’s of FOCUS software: SWASH

(version 3.1)

Vapour pressure: 1.31⋅ 10

-5

Pa (calculated at 25°C)

(L/kg): 15844 (arithmetic mean)

1/n: 0.91 (arithmetic mean)

soil (d): 20.51 (Laboratory, geometric mean, SFO

at 20°C and pF 2)

water (d): 1000 d (default)

sediment : 67.74 d (DT

value of total system,

geometric mean at 20°C)

crop: 10 days (default)

As an outcome of the discussions in the Pesticides Peer

Review Meeting 126 the arithmetic mean Kfoc and 1/n values

for glyphosate have been amended. The experts agreed that for

the EU approval no additional exposure calculations were

necessary, due to the limited effect on the mean endpoints. The

correct values to be used in future PEC simulations are

Kfoc:15388 and 1/n: 0.93

Application rate

Step 1:

Crop: Not crop specific,

crops interception: no interception

number of applications: 1

Application rates: 4.32 kg a.s./ha

Interval (d): -

Crop: Field crops (= Spring & winter cereals, field

beans, maize, spring & winter oil-seed rape, sugar

beets, vegetables (bulb, fruiting, leafy), grass&

alfalfa & legumes)

Crop interception: no interception

Number of applications: 2

Application rates: 2.16 kg a.s./ha

Interval (d): 21

Crop: Appl. Hand (crop < 50 cm) for perennials

Crop interception: no interception

Step 2:

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Number of applications: 1

Application rates: 4.32 kg a.s./ha

Interval (d): -

Step 3:

Crop: Various Field Crops (= winter cereals, winter

rape, spring cereals, potatos, spring oilseed, maize

legumes)

Crop interception: Calculated internally by

MACRO or PRZM (Step 3 & 4)

Number of applications: 1 & 2

Application rate: 2.16 kg a.s./ha

Interval (d): 21

Application windows: August - November

(1 application) and July - December (2 applications)

for autumn applications; February - May (1

application) and Jan - May (2 applications) for

spring applications - The actual dates are set by the

PAT within MACRO and PRZM (Step 3 & 4)

Crop: pome/ stone fruit with manually set drift rates for

application to soil and trunks

Crop interception: Calculated internally by MACRO or

PRZM (Step 3 & 4)

Number of applications:1 & 3

application rate:1 x 2.88 kg a.s./ha & 1 x 2.88 kg a.s./ha

+ 2 x 0.72 kg a.s./ha

Application window: February - April

(1 application) and February - May (3 applications)

Main routes of entry

Spray drift

1 x 4.32 kg a.s./ha, not crop-specific

FOCUS STEP 1

Scenario

Day after overall

maximum

global max PEC

(µg/L)

Actual

104.81

2 x 2.16 kg/ha to Field crops

FOCUS STEP 2

Scenario

Northern EU, Oct-Feb

Northern EU, Mar- May

Northern EU, Jun-Sep

Southern EU, Oct-Feb

Southern EU, Mar- May

Southern EU, Jun-Sep

Day after overall

maximum

global max PEC

(µg/L)

Actual

23.38

18.49

19.14

18.49

global max PEC

Sed

(µg/kg)

Actual

3570

1560

2900

2230

global max PEC

Sed

(µg/kg)

Actual

10300

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

FOCUS STEP 2

Scenario

Day after overall

maximum

1 x 4.32 kg a.s./ha to the trunks of pome/stone fruit (Appl. Hand

(crop < 50 cm))

global max PEC

(µg/L)

Actual

global max PEC

Sed

(µg/kg)

Actual

4770

2070

3870

2970

2 x 2.16 kg/ha to winter cereals

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

14.170

10.293

12.765

11.182

11.777

0.582

10.054

0.591

10.849

12.184

0.592

7.687

10.841

7.694

117.576

10.531

85.108

73.995

12.344

9.389

3.582

9.878

5.128

67.199

13.831

47.807

1696.174

214.027

Northern EU, Oct-Feb

Northern EU, Mar- May

Northern EU, Jun-Sep

Southern EU, Oct-Feb

Southern EU, Mar- May

Southern EU, Jun-Sep

Water

body

ditch

stream

ditch

stream

ditch

pond

stream

pond

stream

ditch

pond

stream

Water

body

ditch

stream

ditch

pond

stream

pond

stream

39.73

1 x 2.16 kg/ha to winter cereals

global max

PEC

(µg/L)

13.608

11.899

13.622

12.116

13.394

0.461

11.627

0.461

12.546

13.566

0.461

8.850

12.277

8.355

global max

PEC

Sed

(µg/kg)

71.425

7.722

57.576

51.082

6.991

5.694

2.557

6.024

4.798

45.680

7.989

25.962

815.228

468.878

FOCUS STEP 3

Scenario

Day after

overall

maximum

FOCUS STEP 3

Scenario

Day after

overall

maximum

1 x 2.16 kg/ha to spring cereals

global max

PEC

(µg/L)

13.546

11.161

13.404

0.461

10.447

0.460

8.591

global max

PEC

Sed

(µg/kg)

28.478

0.975

7.557

5.319

0.434

5.224

0.107

2 x 2.16 kg/ha to spring cereals

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

11.857

9.650

11.751

0.531

9.033

0.541

8.977

31.442

1.039

12.097

8.505

0.535

8.360

0.316

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Water

body

stream

Water

FOCUS STEP 3

Scenario

body

ditch

stream

ditch

pond

stream

pond

stream

pond

stream

Water

FOCUS STEP 3

Scenario

body

ditch

stream

ditch

pond

stream

pond

stream

pond

stream

Water

body

ditch

pond

stream

ditch

Day after

overall

maximum

Day after

overall

maximum

Day after

overall

maximum

1 x 2.16 kg/ha to spring cereals

global max

PEC

(µg/L)

8.809

global max

PEC

Sed

(µg/kg)

63.360

2 x 2.16 kg/ha to spring cereals

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

7.686

105.090

FOCUS STEP 3

Scenario

1 x 2.16 kg/ha to winter oil seed

rape

global max

PEC

(µg/L)

13.622

12.116

13.538

0.461

11.627

0.461

12.546

0.462

8.887

12.490

global max

PEC

Sed

(µg/kg)

57.427

50.942

28.639

5.694

2.557

5.541

3.617

5.193

7.750

160.896

2 x 2.16 kg/ha to winter oil seed

rape

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

12.345

10.660

11.940

0.522

10.054

0.581

10.849

0.568

7.684

10.801

78.794

58.093

40.701

8.657

3.134

8.693

4.919

8.198

11.546

227.865

1 x 2.16 kg/ha to spring oilseed

rape

global max

PEC

(µg/L)

13.546

11.161

13.427

0.461

10.447

0.460

8.591

0.463

8.616

global max

PEC

Sed

(µg/kg)

28.478

0.975

9.793

5.323

0.434

5.225

0.107

9.748

76.161

2 x 2.16 kg/ha to spring oilseed

rape

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

11.857

9.650

11.738

0.531

9.033

0.541

8.977

0.777

7.591

31.442

1.039

12.996

8.509

0.535

8.362

0.316

28.795

366.862

FOCUS STEP 3

Scenario

D6, early app.

Day after

overall

maximum

1 x 2.16 kg/ha to potatoes

global max

PEC

(µg/L)

11.115

0.446

9.298

11.205

global max

PEC

Sed

(µg/kg)

7.604

4.828

0.485

32.899

2 x 2.16 kg/ha to potatoes

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

9.649

0.526

8.001

9.518

10.454

7.871

0.615

4.286

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Water

body

ditch

pond

stream

Water

body

ditch

pond

stream

pond

stream

ditch

pond

stream

Water

body

ditch

pond

stream

pond

stream

ditch

pond

stream

Day after

overall

maximum

1 x 2.16 kg/ha to potatoes

global max

PEC

(µg/L)

11.205

0.447

7.685

10.115

10.824

global max

PEC

Sed

(µg/kg)

32.899

6.964

35.792

46.144

26.095

2 x 2.16 kg/ha to potatoes

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

9.743

0.569

6.634

8.742

9.360

31.731

14.265

110.556

1730.618

54.887

FOCUS STEP 3

Scenario

D6, late app.

FOCUS STEP 3

Scenario

Day after

overall

maximum

1 x 2.16 kg/ha to maize

global max

PEC

(µg/L)

11.102

0.446

9.064

0.446

9.802

11.110

0.447

7.685

10.223

10.825

7.682

global max

PEC

Sed

(µg/kg)

7.605

5.156

0.376

5.022

0.423

8.379

6.931

35.102

24.159

244.954

60.609

2 x 2.16 kg/ha to maize

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

9.644

0.517

7.800

0.551

8.443

9.646

0.569

6.634

8.810

9.392

6.621

10.945

8.237

0.469

7.891

0.507

10.476

14.217

109.876

678.650

244.742

393.570

FOCUS STEP 3

Scenario

Day after

overall

maximum

1 x 2.16 kg/ha to legumes

global max

PEC

(µg/L)

11.103

0.446

9.064

0.446

7.453

11.110

0.446

7.710

10.198

10.828

7.678

global max

PEC

Sed

(µg/kg)

7.575

5.149

0.376

5.062

0.0929

8379

8.786

73.485

678.046

244.935

208.671

2 x 2.16 kg/ha to legumes

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

9.640

0.479

8.154

0.523

7.751

9.646

0.648

6.502

8.765

9.330

6.611

9.281

8.234

0.585

8.088

0.273

10.476

14.159

100.506

196.543

505.314

344.072

EFSA Journal 2015;13(11):4302

MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

Water

FOCUS STEP 3

Scenario

body

ditch

pond

stream

pond

stream

pond

stream

Day after

overall

maximum

2.88 kg/ha

to pome/stone fruit

global max

PEC

(µg/L)

6.209

0.213

4.594

0.213

3.971

0.213

6.505

5.358

5.794

4.063

global max

PEC

Sed

(µg/kg)

4.161

2.500

0.137

2.459

0.0495

2.531

1.605

3.725

2.117

17.616

2.88 + 0.72 + 0.72 kg/ha

to pome/stone fruit

global max

PEC

(µg/L) PEC

Sed

(µg/kg)

4.537

0.238

3.748

0.245

3.811

0.252

2.978

3.937

4.203

2981

6.484

4.802

0.446

4.764

0.242

4.820

3.179

5.612

4.378

25.323

Metabolite AMPA

Parameters used in FOCUS

step 1 and 2

Molecular weight (g/mol): 111

Water solubility (mg/L): 10500 (pH 2, 20°C) - water

solubility of parent

Max. occurrence in soil & water/sediment system:

Soil: max. 50.1 %

Water/sediment: max. 27.1 %

(L/kg): 9749

soil (d): 88.84 days ((Laboratory, geometric mean,

SFO at 20°C and pF 2)

water/sediment system (d): 86.09 days (SFO,

geometric mean, n = 5)

water (d): 86.09 days (DT

value of total system)

sediment (d): 86.09 days (DT

value of total

system)

Parameters used in FOCUS

step 3

not performed

EFSA Journal 2015;13(11):4302

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

Application rate

Step 1:

Crop: Not crop specific,

crops interception: no interception

number of applications: 1

Application rates: 4.32 kg a.s./ha

Interval (d): -

Crop: Field crops (= Spring & winter cereals, field

beans, maize, spring & winter oil-seed rape, sugar

beets, vegetables (bulb, fruiting, leafy), grass&

alfalfa & legumes)

Crop interception: no interception

Number of applications: 2

Application rates: 2.16 kg a.s./ha

Interval (d): 21

Crop: Appl. Hand (crop > 50 cm) for perennials

Crop interception: no interception

Number of applications: 1

Application rates: 4.32 kg a.s./ha

Interval (d): -

Step 2:

Main routes of entry

Spray drift

1 x 4.32 kg a.s./ha, not crop-specific

FOCUS STEP 1

Scenario

Day after overall

maximum

global max PEC

(µg/L)

Actual

40.90

2 x 2.16 kg/ha to Field crops

global max PEC

Sed

(µg/kg)

Actual

3300

FOCUS STEP 2

Scenario

Northern EU, Oct-Feb

Northern EU, Mar- May

Northern EU, Jun-Sep

Southern EU, Oct-Feb

Southern EU, Mar- May

Southern EU, Jun-Sep

Day after overall

maximum

global max PEC

(µg/L)

Actual

15.76

6.67

12.73

9.70

global max PEC

Sed

(µg/kg)

Actual

1520

628.4

1220

924.0

FOCUS STEP 2

Scenario

Day after overall

maximum

1 x 4.32 kg/ha to to the trunks of pome/stone fruit (Appl. Hand

(crop < 50 cm))

global max PEC

(µg/L)

Actual

global max PEC

Sed

(µg/kg)

Actual

1640

685.1

1320

Northern EU, Oct-Feb

Northern EU, Mar- May

Northern EU, Jun-Sep

Southern EU, Oct-Feb

17.16

7.32

13.88

EFSA Journal 2015;13(11):4302

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

1 x 4.32 kg/ha to to the trunks of pome/stone fruit (Appl. Hand

(crop < 50 cm))

global max PEC

(µg/L)

Actual

Southern EU, Mar- May

Southern EU, Jun-Sep

13.88

10.60

global max PEC

Sed

(µg/kg)

Actual

1320

1000

FOCUS STEP 2

Scenario

Day after overall

maximum

Metabolite HMPA

Parameters used in FOCUS

step 1 and 2

Molecular weight (g/mol): 112

Water solubility (mg/L): not relevant, only maximum

values were determined

Max. occurrence in soil & water/sediment system:

Soil: 0%

Water phase: max. 10.0 %

(L/kg): not relevant, only maximum values were

determined

soil (d): not relevant

water/sediment system (d): not relevant, only

maximum values were determined

water (d): not relevant, only maximum values were

determined

sediment (d): not relevant, only maximum values

were determined

Parameters used in FOCUS

step 3

Application rate

not performed

Step 1:

Crop: Not crop specific,

crops interception: no interception

number of applications: 1

Application rates: 4.32 kg a.s./ha

Interval (d): -

Crop: Field crops (= Spring & winter cereals, field

beans, maize, spring & winter oil-seed rape, sugar

beets, vegetables (bulb, fruiting, leafy), grass&

alfalfa & legumes)

Crop interception: no interception

Number of applications: 2

Application rates: 2.16 kg a.s./ha

Interval (d): 21

Crop: Appl. Hand (crop > 50 cm) for perennials

Crop interception: no interception

Number of applications: 1

Application rates: 4.32 kg a.s./ha

Interval (d): -

Step 2:

Main routes of entry

Formation in water

EFSA Journal 2015;13(11):4302

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

1 x 4.32 kg a.s./ha, not crop-specific

FOCUS STEP 1

Scenario

Day after overall

maximum

global max PEC

(µg/L)

Actual

6.71

2 x 2.16 kg/ha to Field crops

FOCUS STEP 2

Scenario

Northern EU, Oct-Feb

Northern EU, Mar- May

Northern EU, Jun-Sep

Southern EU, Oct-Feb

Southern EU, Mar- May

Southern EU, Jun-Sep

Day after overall

maximum

global max PEC

(µg/L)

Actual

1.22

global max PEC

Sed

(µg/kg)

Actual

196

86.8

160

123

global max PEC

Sed

(µg/kg)

Actual

696

FOCUS STEP 2

Scenario

Day after overall

maximum

1 x 4.32 kg/ha to the trunks of pome/stone fruit (Appl. Hand (crop

< 50 cm))

global max PEC

(µg/L)

Actual

global max PEC

Sed

(µg/kg)

Actual

294

128

238

183

Northern EU, Oct-Feb

Northern EU, Mar- May

Northern EU, Jun-Sep

Southern EU, Oct-Feb

Southern EU, Mar- May

Southern EU, Jun-Sep

2.63

EFSA Journal 2015;13(11):4302

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

PEC groundwater (Annex IIIA, point 9.2.1)

Method of calculation and type

of study (e.g. modelling, field

leaching, lysimeter)

Modelling using FOCUS model with appropriate FOCUS

scenarios

according to FOCUS guidance:

Model: FOCUS PELMO 4.4.3

Scenarios: Châteaudun, Hamburg , Jokioinen, Kremsmünster, Okehampton,

Piacenza, Porto, Sevilla, Thiva

Crops: Winter cereals, spring cereals, potatoes, pome fruit (apples)

Input parameters for glyphosate:

: Geometric mean of the DT

values of all soils

20.51d (normalisation

to 20

C

and pF2 with Q10 = 2.58)

: Arithmetic mean of the Koc values of all soils: 15844 ml/g

Freundlich exponent (1/n): Arithmetic mean of the 1/n values of all soils:

0.914

Plant uptake factor: 0 (worst case assumption)

As an outcome of the discussions in the Pesticides Peer Review Meeting 126 the

arithmetic mean Kfoc and 1/n values for glyphosate have been amended. The experts

agreed that for the EU approval no additional exposure calculations were necessary,

due to the limited effect on the mean endpoints. The correct values to be used in

future PEC simulations are Kfoc:15388 and 1/n: 0.93

Input parameters for the metabolite AMPA:

: Geometric mean of the DT

values of all soils: 88.84 d (normalisation

to 20

C

and pF2 with Q10 = 2.58)

: Arithmetic mean of the Koc values of all soils: 9749 ml/g

Freundlich exponent (1/n): Arithmetic mean of the 1/n values of all soils:

0.853

Formation fraction: 0.36

Plant uptake factor: 0 (worst case assumption)

As an outcome of the discussions in the Pesticides Peer Review Meeting 126 the

arithmetic mean 1/n value for AMPA has been amended. The experts agreed that for

the EU approval no additional exposure calculations were necessary, due to the

limited effect on the mean endpoints. The correct arithmetic mean 1/n value to be

used in future PEC simulations is 0.81

Application rate

Application rate (maximum yearly for all crops): 4320 g/ha

Crop

FOCUS

GW-

crop

Appli-

cation rate

(g /ha)

No. of

appl.

Min.

interval

(d)

Application

period

Various crops

(autumn

appl.)

Various crops

(spring +

autumn appl.)

Various crops

(spring appl.)

Orchards,

citrus, vines,

tree nuts

Winter

cereals

2160

Pre-planting

/pre-emergence

Spring

cereals

2160

Pre-planting

/pre-emergence

Pre-planting

/pre-emergence

Post-emergence

of weeds

Potatoes

2160

2880/

720/

720

Pome fruit

(apples)

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PEC

- FOCUS modelling results (80

percentile annual average concentration at 1 m)

Scenario

FOCUS

PELMO

4.4.3/ winter

cereals

Châteaudun

Hamburg

Jokioinen

Kremsmünster

Okehampton

Piacenza

Porto

Sevilla

Thiva

Châteaudun

Hamburg

Jokioinen

Kremsmünster

Okehampton

Porto

Châteaudun

Hamburg

Jokioinen

Kremsmünster

Okehampton

Piacenza

Porto

Sevilla

Thiva

Châteaudun

Hamburg

Jokioinen

Kremsmünster

Okehampton

Piacenza

Porto

Sevilla

Thiva

Parent (µg/L)

Glyphosate

<0.001

Metabolite (µg/L)

AMPA

<0.001

FOCUS

PELMO

4.4.3/ spring

cereals

FOCUS

PELMO

4.4.3/

potatoes

FOCUS

PELMO

4.4.3/ apples

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

Direct photolysis in air

Quantum yield of direct phototransformation

Photochemical oxidative degradation in air

Not studied - no data requested

Not determined

of 1.6 hours derived by the Atkinson model

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

1.5x10

-3

Volatilization from plants and soil surfaces (BBA

guideline): not detectable after 24 hours (n = 2)

Volatilisation

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PEC

air

Method of calculation

Glyphosate: vapour pressure: 1.31 x 10

-5

Pa at 25°C;

Henry's Law Constant: 2.1 × 10

-7

Pa m³ mol

-1

(25 °C)

Glyphosate trimesium: < 1

⋅

-11

Pa (20 °C), Henry's

Law Constant: < 2

⋅

-9

Pa m

mol

-1



No volatilisation expected from soil and plants

The calculated atmospheric life time of glyphosate is < 2

days, thus long range transport via air can be excluded

PEC

(a)

Maximum concentration

negligible

Residues requiring further assessment

Environmental occurring residues requiring

assessment by other disciplines (toxicology and

ecotoxicology) and or requiring consideration for

groundwater exposure.

Soil: Glyphosate, AMPA

Surface Water: Glyphosate, AMPA, HMPA

Sediment: Glyphosate, AMPA

Groundwater: Glyphosate, AMPA

Air: Glyphosate

Monitoring data, if available (Annex IIA, point 7.4)

Soil

Surface water

no data

One study (Member states of European Union plus

Norway and Switzerland, 2012):

Review of surface water monitoring results throughout

Europe; Glyphosate has been analyzed in 75000 surface

water samples from about 4000 sites (from 1993-2011)

and was detected in 33% of samples, with 23% above

0.1µg/L. The maximum concentrations of glyphosate

acid found in surface water reached from 1.3 to 370

µg/L. The highest glyphosate values in surface water

were detected in Sweden (370 µg/L), Ireland (186 µg/L)

and Belgium (139 µg/L). The main metabolite AMPA

has been analysed in about 56700 samples from nearly

3000 sites (1997-2011) and was detected in 54% of

samples, with 46% above 0.1 µg/L and maximum

concentrations reaching from 0.22 to > 200 µg/L

study (Italy, 2012):

Investigation of glyphosate concentrations > 0.1 µg/L in

5 groundwater wells in Italy in 2007 and again in four of

these wells in 2010/ 2011, glyphosate concentrations of 4

wells allocated to surface water inflow or point source

contamination; for 1 well investigations still ongoing

study (Germany, 2006):

Officially requested investigation of glyphosate findings

in concentrations > 0.1 µg/L in 5 wells and and AMPA

findings in concentrations > 0.1 µg/L in 21 wells in

Germany from 2005 - 2003; Five wells showed inflow

of surface water or bank filtrate; one well was affected

EFSA Journal 2015;13(11):4302

Groundwater

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by a waste deposit; one well was located inside a sewage

plant and showed influence of waste water; in one well

the sample was contaminated since it serves as

processing water well for a tank filling place. 16 findings

were due to an analysis which was obviously deficient

study (The Netherlands, 2010):

two reports on groundwater monitoring in The

Netherlands: in 6 out of 189 wells (report of 2008) and in

4 out of 169 wells (report of 2007) glyphosate

concentrations were > 0.1 µg/L; some wells were not

fully protected and contact with surface water may have

occurred; Uncertainty was identified regarding the data

processing; for 6 wells, no explanation could be found

during this investigation

study (Sweden, 2005):

investigation on glyphosate findings in concentrations of

0.045 µg/L (1

well) and 0.18 plus 0.035 µg/L (2

well)

of a groundwater catchment between August 2004 and

February 2005; potential reason is a direct hydrological

connectivity between surface water and shallow

groundwater via an artificial drainage systems

study (France, 2012):

Glyphosate and AMPA were detected in concentrations

> 0.1 µg/L at several groundwater sampling sites

throughout France; 27wells were investigated further;

two sites were not further investigated due to their low

vulnerability; from the 25 sites, in 19 cases, the

detections in concentrations > 0.1 µg/L were sporadic

(one sample of several analysis), demonstrating that the

contamination was not widespread in the aquifer; in 2

wells used as drinking water supply the contaminations

only occurred in one year; at four sites not used as

drinking water supply, the contaminations occurred over

several years, potential causes were not further

investigated

study (Member states of European Union plus

Norway and Switzerland, 2012):

Review of groundwater monitoring results throughout

Europe; Glyphosate has been analyzed in 66662 samples

from about 675 sites (1993-2010) and detected in 1 % of

samples, with 0.64 % above 0.1 µg/L; AMPA has been

analyzed in 51652 samples from 1345 sites (1993 -

2011) and detected in 2.6 % of samples, with 0.77 %

above 0.1 µg/L. The glyphosate detections have been

reported from Denmark (4.7 µg/L) and France (24 µg/L).

Findings > 0.1 µg/l have also been measured in Austria,

Ireland, The Netherlands and the UK:

Austria: the findings of glyphosate were only in

isolated cases , findings from AMPA were more

frequent; AMPA in 2 spring water samples might also

be related to aminophosphonates from detergents

France: early contaminations before 2001 most likely

due to sample contamination or analytical problems;

findings from 2001-2003 and more recent may

warrant further investigation. From a recent study to

analyze the potential contamination of groundwater

with glyphosate (and AMPA) at 27 sites from 2007-

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2010, it is clear that none of the glyphosate detections

could be attributed to long-term contamination of

typical groundwater; majority of detections occurred

once only and the small number of multiple

detections occurred in shallow groundwater (spring

water) or wells unsuitable for groundwater

monitoring, suggesting superficial short-term

contamination

Ireland: no clarification for the glyphosate

groundwater findings > 0.1 µg/L presented

Switzerland: detection of glyphosate attributable to

short-term contamination of shallow groundwater or

spring water

The Netherlands: glyphosate and AMPA were

detected once each in 10 different wells; 5 of the

results were uncertain (high margins of error of

measured concentration), all sampling points with

positive detections were in cultivation areas with

sandy or highly sandy soils, samples were taken

mainly from shallow groundwater

UK: a number of positive samples and high

maximum concentrations were found in Wales ,

which may warrant further investigation

study (Spain, 2012):

129 groundwater samples were collected from wells

located in 11 different sampling sites in Catalonia, Spain,

in an area with intensive agriculture between May and

September in 2007, 2008, 2009 and 2011; the

concentrations of glyphosate range from MLQQ to 2.6

µg/L, average: 202 ng/L; the pathways of glyphosate into

groundwater are not investigated by the authors, several

possible pathways like preferential flow or bank

infiltration, etc. were suggested.

Regular Federal groundwater monitoring program in

Germany (1997-2009 & 2011):

89 to 430 samples taken from 1997-2007, >1500 samples

taken from 2008-2009 & 2011): glyphosate was not

detected in groundwater in concentrations > 0.1 µg/l for

many years (1997-2001, 2003, 2006-2007). In 1996 2

samples (1.4 %), in 2002 1 sample (0.4 %), in 2004 1

sample (0.5 %) and in 2005 5 samples (2.1 %) contained

glyphosate in concentrations > 0.1 µg/L; In 2008

glyphosate concentrations > 0.1 µg/L were detected in 7

samples (0.5 %), in 2009 in 6 samples (0.4 %) and in

2011 in 7 samples (0.4 %)

Drinking water

One study (2008, selected European countries):

Belgium, Germany and Ireland: no exceedances >

0.1 μg/l of glyphosate

France, The Netherlands and UK: some sporadic

exceedances > 0.1 μg/l of glyphosate reported; some

were attributed to problems with the analysis, once

raw water was analyzed instead of rather than

finished drinking water, some exceedances remain

unclear but there seem to be no indication of a

persistent presence in drinking water.

France and Sweden: some exceedances > 0.1 μg/l of

AMPA

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Denmark: no exceedances > 0.1 μg/l in public

supplies but some in small private supplies affected

by shallow groundwater with was rapid infiltration of

surface water

Sweden: some glyphosate and AMPA exceedances >

0.1 μg/l were found in drinking water; no further

sample details were available

Air

no data

Points pertinent to the classification and proposed labelling with regard to fate and behaviour

data

Candidate for Chronic (long-term) aquatic hazard. (as it is ‘not readily biodegradable’)

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

Species

Test substance

Time scale

End point

(mg/kg

bw/day)

Birds

Bobwhite quail

Glyphosate acid.

Acute

4334

(extrapolated

with factor

2.167)

> 2250

>5200

>5620

96.3

125.3

End point

(mg/kg feed)

Bobwhite quail

Mallard duck

Mammals

Rat

Rabbit

Additional higher tier studies

- /-

AMPA

Glyphosate acid

AMPA

Glyphosate acid

Acute

Short-term

Long-term

1000

Glyphosate acid

Acute

Long-term

> 2000

197

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)

Crop and application rate

Indicator species/Category²

Screening –

uptake via diet

(Birds)

All crops (all seeded or transplanted crops)/

Pre-planting of crop,

Max. 2 × 2160 g a.s./ha , Min. 21 d interval

Worst case scenario: Small omnivorous bird

All crops (all seeded crops)/

Post planting/pre emergence of crop,

Max. 1 × 1080 g a.s./ha

Worst case scenario: Small omnivorous bird

Cereals pre harvest /crop maturity,

Max. 1 × 2160 g a.s./ha

Small omnivorous bird

Oilseed (pre harvest) /Crop maturity

Max. 1 × 2160 g a.s./ha

Small omnivorous bird

411.60

Time

scale

DDD

(mg/kg)

TER

1, 4

Annex VI

Trigger³

171.5

Acute

343.0

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Indicator species/Category²

Orchard crops (vines, including citrus & and tree nuts)

Post emergence of weeds

Worst case use pattern and worst case scenario

1 × max. 2880 g a.s./ha

3 × max. 1440 g a.s./ha (Interval 28d)

Small omnivorous bird

Tier1

– uptake via diet

(Birds)

All crops (all seeded or transplanted crops)/ Pre-planting of

crop, Max. 2 × 2160 g a.s./ha

, Min. 21 d interval

Worst case scenarios:

Medium herbiv.graniv. bird ‘pigeon’ Wood pidgeon

(Columba

palumbus)

Shortcut value: 22.7, MAF: 1.23, fwa:

0.53/

Large herbiv. bird ‘goose’ Pink-foot goose (Anser

brachyrhynchus)

Shortcut value: 16.2, MAF: 1.23, fwa: 0.53

All crops (all seeded crops)/

Post planting/pre emergence of crop,

Max. 1 × 1080 g a.s./ha

Worst case scenarios:

Med. herbiv./ graniv. bird ‘pigeon’ Wood pidgeon

(Columba

palumbus)

Shortcut value: 22.7, fwa 0.53

Cereals pre harvest /crop maturity,

Max. 1 × 2160 g a.s./ha

Worst case scenario:

Small insectivorous bird ‘passerine’ (Cisticola

juncidis)

Shortcut value: 22.4, fwa 0.53

Oilseed (pre harvest) /Crop maturity

Max. 1 × 2160 g a.s./ha

Worst case scenario:

Small granivorous bird ‘finch’(Carduelis

cannabina)

Shortcut value: 11.4, fwa 0.53

Orchard crops (vines including citrus & and tree nuts)

Post emergence of weeds

Worst case use pattern and worst case scenario

1 × max. 2880 g a.s./ha

3 × max. 1440 g a.s./ha, interval 28d (MAF 1.16)

Worst case scenario

Small graniv. bird ‘finch’ Serin

(Serinus serinus)

Shortcut value: 12.6, fwa 0.53

Higher tier refinement

– uptake via diet (Birds)

The decline of glyphosate residue in grass was characterised using data from 22 residue trials. The average

for the 22 trials was 2.8 days. The 21-day time weighted average (twa) for glyphosate in grass foliage has

been used to calculate a refined f

twa

. The 21-day twa is calculated to be 0.19 and the refined MAF is 1.

137.2

/89.2

/49

Time

scale

DDD

(mg/kg)

TER

1, 4

Annex VI

Trigger³

31.96

22.81

4.2

7.41

Long-

term

25.64

3.8

13.05

7.38

9.6

/5.6

/17

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Indicator species/Category²

All crops (all seeded or transplanted crops)/ Pre-planting of

crop, Max. 2 × 2160 g a.s./ha , Min. 21 d interval

Worst case scenarios:

Medium herbiv.graniv. bird ‘pigeon’ Wood pidgeon

(Columba

palumbus),

shortcut value 22.7, MAF: 1, fwa:

0.19/

Large herbiv. bird ‘goose’ Pink-foot goose (Anser

brachyrhynchus),

shortcut value 16.2, MAF: 1, fwa: 0.19

Cereals pre harvest /crop maturity,

Max. 1 × 2160 g a.s./ha

Small insectivorous bird ‘passerine’ (Cisticola

juncidis)

DATA GAP

Tier 1– uptake via drinking water (Birds)

Not required

Tier 1 – secondary poisoning (Birds)

Not required

Tier 1

– uptake via diet

(Mammals)

All crops (all seeded or transplanted crops)/ Pre-planting of

crop,

Max. 2 × 2160 g a.s./ha , Min. 21 d interval (MAF 1.14)

Worst case scenarios:

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

Shortcut value 136.4

Large herbivorous mammal lagomorph (rabbit,

Oryctolagus

cuniculus),

Shortcut value 42.1

All crops (all seeded crops)/

Post planting/pre emergence of crop,

Max. 1 × 1080 g a.s./ha

Worst case scenarios:

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 136.4

Cereals (pre harvest) wheat, rye, triticale, barley and oats/

Crop maturity

Max. 1 × 2160 g a.s./ha

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 40.9

Oilseed (pre harvest) rapeseed, mustard seed, linseed/ Crop

maturity

Max. 1 × 2160 g a.s./ha

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 34.1

335.9

/103.67

/>19.2

Long-

term

Acute

Time

scale

DDD

(mg/kg)

TER

1, 4

Annex VI

Trigger³

6.65

Long-

term

9.32

14.48

10.34

Acute

147.3

>13.6

88.34

>23

73.66

> 27

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Indicator species/Category²

Orchard crops (vines including citrus & tree nuts)

Post emergence of weeds

28 d.interval bet.applic.

Worst case use pattern and worst case scenario

1 × max. 2880 g a.s./ha

3 × max. 1440 g a.s./ha ((MAF 1.1)

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 136.4

All crops (all seeded or transplanted crops)/ Pre-planting of

crop,

Max. 2 × 2160 g a.s./ha , Min. 21 d interval (MAF 1.23)

Worst case scenarios

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

Shortcut value 72.3, ftwa 0.53

Small omnivorous mammals, wood mouse (Apodemus

sylvaticus),

Shortcut value 7.8, ftwa 0.53

Large herbivorous mammal lagomorph (rabbit,

Oryctolagus

cuniculus),

Shortcut value 22.3

ftwa 0.53

All crops (all seeded crops)/

Post planting/pre emergence of crop,

Max. 1 × 1080 g a.s./ha

Worst case scenarios:

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

Shortcut value 72.3, ftwa 0.53

Long-

term

41.48

/5.49

/15.7

1.21

/9.1

/3.2

101.8

/10.98

/31.4

0.49

/4.55

/1.6

196.42

/108.03

> 10

>18.5

Time

scale

DDD

(mg/kg)

TER

1, 4

Annex VI

Trigger³

Small omnivorous mammals Wood mouse (Apodemus

sylvaticus),

Shortcut value 7.8, ftwa 0.53

Large herbivorous mammal lagomorph (rabbit,

Oryctolagus

cuniculus),

Shortcut value 22.3

ftwa 0.53

Cereals (pre harvest) wheat, rye, triticale, barley and oats/

Crop maturity

Max. 1 × 2160g a.s./ha

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 21.7 ftwa 0.53

Oilseed (pre harvest) rapeseed, mustard seed, linseed/ Crop

maturity

Max. 1 × 2160 g a.s./ha

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 18.1 ftwa 0.53

24.69

2.0

20.72

2.4

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Indicator species/Category²

Orchard crops (vines including citrus & tree nuts)

Post emergence of weeds

28 d.interval bet.applic.

Worst case use pattern and worst case scenario

1 × max. 2880 g a.s./ha

3 × max. 1440 g a.s./ha (MAF 1.16)

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

Shortcut value 72.3 ftwa 0.53

Higher tier refinement – uptake via diet (Mammals)

The decline of glyphosate residue in grass was characterised using data from 22 residue trials. The average

for the 22 trials was 2.8 days. The 21-day time weighted average (twa) for glyphosate in grass foliage has

been used to calculate a refined f

twa

. The 21-day twa is calculated to be 0.19. Also the MAF values were

refined

All crops (all seeded or transplanted crops)/ Pre-planting of

crop,

Max. 2 × 2160 g a.s./ha , Min. 21 d interval

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

shortcut value 72.3, MAF 1, ftwa 0.19

Small omnivorous mammals, wood (Apodemus

sylvaticus),

shortcut value 7.8, MAF 1, ftwa 0.19

Large herbivorous mammal lagomorph (rabbit,

Oryctolagus

cuniculus),

Shortcut value 22.3

ftwa 0.53

All crops (all seeded crops)/

Post planting/pre emergence of crop,

Max. 1 × 1080 g a.s./ha

Worst case scenarios:

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

shortcut value 72.3, MAF 1, ftwa 0.19

Large herbivorous mammal lagomorph (rabbit,

Oryctolagus

cuniculus),

Shortcut value 22.3 ftwa 0.19

Cereals (pre harvest) wheat, rye, triticale, barley and oats/

Crop maturity

Max. 1 × 2160g a.s./ha

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

Shortcut value 21.7 ftwa 0.19

Oilseed (pre harvest) rapeseed, mustard seed, linseed/ Crop

maturity

Max. 1 × 2160 g a.s./ha

Small herbivorous mammal ‘vole’ (Microtus

arvalis),

Shortcut value 18.1 ftwa 0.19

55.17

/32

0.9

/1.6

Time

scale

DDD

(mg/kg)

TER

1, 4

Annex VI

Trigger³

29.67

/3.2

/9.15

1.69

/15.6

/5.5

Long-

term

14.84

/4.6

3.37

/11

8.9

5.6

7.43

6.7

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Indicator species/Category²

Orchard crops (vines including citrus & tree nuts)

Post emergence of weeds

28 d.interval bet.applic.

Worst case use pattern and worst case scenario

1 × max. 2880 g a.s./ha

3 × max. 1440 g a.s./ha (MAF 1)

Small herbivorous mammal ‘vole’ (Microtus

arvalis)

Shortcut value 72.3 ftwa 0.19

Tier 1– uptake via drinking water (Mammals)

Not required

Tier 1 – secondary poisoning (Mammals)

Not required

Time

scale

DDD

(mg/kg)

TER

1, 4

Annex VI

Trigger³

19.78

/9.89

2.53

/5.06

Acute

Long-

term

in higher tier refinement provide brief details of any refinements used (e.g. residues, PT, PD or AV)

for cereals indicate if it is early or late crop stage

If the Annex VI Trigger value has been adjusted during the risk assessment of the active substance (e.g. many single

species data), it should appear in this column

TER in bold do not meet the acceptability criteria.

Because applications are made round base of trunk and to the intra-rows, (inner strips between two trees within a row),

application rates per ha are expressed per ‘unit of treated surface area’ the actual application rate per ha orchard or

vineyard will only be 50%. Exposure estimations took into account the 50 % of the total application rate.

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

(Test type)

Laboratory tests

Fish

Oncorhynchus mykiss

Lepomis macrochirus

Danio rerio

Cyprinus carpio

Oncorhynchus mykiss

Cyprinus carpio

Oncorhynchus mykiss

Pimephales promelas

Brachydanio rerio

Oncorhynchus mykiss

Pimephales promelas

Glyphosate acid

MON 52276

AMPA

Glyphosate acid

AMPA

96 hr (static)

96 hr (semi-static)

96 hr (static)

255days

168 hr

85 days

33 days

Mortality, EC

Growth NOEC

38 (nom.)

47 (nom.)

123 (nom.)

> 100 (nom.)

> 989 (mm.)

> 306 a.e.

> 277 a.e.

520 (mm.)

25.7 (mm.)

1 (nom.)

9.6 (mm.)

12 (mm.)

End point

Toxicity

(mg/L)

> 895 (mm.)

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Group

Test substance

Time-scale

(Test type)

Aquatic invertebrate

Daphnia magna

Glyphosate acid

AMPA

HMPA

MON 52276

Glyphosate acid

AMPA

48 h (static)

21 d

(semi-static)

21 d

(semi-static)

Mortality, EC

Reproduction,

NOEC

Reproduction,

NOEC

40 (nom.)

690 (nom.)

> 100 (nom.)

676 (nom.)

209 a.e.

12.5 (nom.)

15 (nom.)

End point

Toxicity

(mg/L)

Sediment dwelling organisms

Chironomus riparius

Algae

Anabaena flos-aquae

Glyphosate acid

72 h (static)

Biomass: E

Growth rate: E

NOErC

Skeletonema costatum

Glyphosate acid

72 h (static)

Biomass: E

Growth rate: E

NOErC

Pseudokirchneriella

subcapitata

Glyphosate acid

72 h (static)

Biomass: E

Growth rate: E

NOErC

Desmodesmus

subspicatus

AMPA

72 h (static)

Biomass: E

Growth rate: E

NOErC

NOEC

Pseudokirchneriella

subcapitata

AMPA

72 h (static)

Biomass: E

Growth rate: E

NOErC

Pseudokirchneriella

subcapitata

HMPA

72 h (static)

Biomass: E

Growth rate: E

NOAEC

Pseudokirchneriella

subcapitata

MON 52276

72 h (static)

Biomass: E

Growth rate: E

NOEC

Higher plant

Lemna gibba

Glyphosate acid

14 d (semi-static)

Fronds, EC

NOEC

empiric

EFSA Journal 2015;13(11):4302

12 (nom.)

1.5 (nom.)

8.5 (nom.)

22 (nom.)

12 (nom.)

11 (nom.)

18 (nom.)

1.82 (nom.)

18 (nom.)

19 (nom.)

10 (nom.)

89.8 (nom.)

452 (nom.)

0.96(nom.)

24(nom.)

110 (nom.)

200 (nom.)

46 (nom.)

> 115 (nom.)

60 (nom.)

178 (55 a.e.)

(nom.)

284 (88 a.e.)

(nom.)

90 (28 a.e.)

Glyphosate acid

28 d (static)

NOEC

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Group

Test substance

Time-scale

(Test type)

Lemna gibba

HMPA

MON 52276

7 d (semi-static)

Fronds, EC

NOEC

Fronds, EC

NOEC

Myriophyllum

aquaticum

Glyphosate acid

14 d (static)

Fresh weight,

relative increase,

NOEC

Myriophyllum

aquaticum

AMPA

14 d (static)

Fresh weight,

relative increase,

dry weight,

relative increase,

for root length

NOEC

Myriophyllum

aquaticum

MON 52276

14 d (static)

Fresh weight,

relative increase,

NOEC

End point

Toxicity

(mg/L)

> 123 (nom.)

123 (nom.)

67 (nom.)

21(a.e.)

0.9(nom.)

0.3(a.e.)

12.3(nom.)

(

MON 77973

)

<< 5(nom.)

70.8 (mm.)

63.2 (mm.)

31.1(mm)

<< 5.4 (nom.)

4.44 a.e.

(mm.)

< 0.3 a.e.

(mm.)

Microcosm or mesocosm tests - /-

Indicate if not required

- /-

indicate whether based on nominal (

nom

) or mean measured concentrations (

). In the case of preparations indicate

whether end points are presented as units of preparation or a.s.

a.e.: acid equivalents

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Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)

Maximum PEC

values and TER values for Glyphosate acid – not crop specific application for all crops with maximum application rate 4.32 kg/ha glyphosate in any 12 month period across use

categories, equivalent to the sum of pre-plant, pre-harvest and post-harvest stubble applications (Focus

Step 1)

and for field crops (spring & winter cereals, field beans, maize, spring & winter oil-

seed rape, sugar beets, vegetables (bulb, fruiting, leafy), grass & alfalfa & legumes) with maximum application rate 2 x 2.16 kg/ha glyphosate (Focus

Step2)

Scenario

PEC global

max

(µg L)

PEC twa,

28d*

(µg L)

Fish acute

O. mykiss

38000 µg/L

Fish

prolonged

B. rerio

NOEC

1000 µg/L

9.5

Fish

prolonged

P. promelas

NOEC

25700 µg/L

245

Daphnia

acute

D. magna

40000 µg/L

382

Daphnia

prolonged

D. magna

NOEC

12500 µg/L

119

Algae

acute

flosaquae

8500 µg/L

Aquatic

plants

M. aquaticum

4400 µg/L

Sed. dweller

prolonged

NOEC

µg/L

FOCUS Step 1

FOCUS Step 2

North Europe (Oct-

Feb)

North Europe (Mar –

May) and (Jun-Sep)

South Europe (Oct –

Feb) and (Mar - May)

Annex VI Trigger

104.81

363

23.38

1625

1099

1711

535

364

188

18.49

2055

1390

2163

676

460

240

19.14

1985

100

1343

2090

100

653

444

230

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Maximum PECsw values and TER values for AMPA, Focus Step 1

Scenario

PEC global

max

(µg L)

PEC twa,

28d*

(µg L)

Fish acute

O. mykiss

520000 µg/L

Fish

prolonged

P. promelas

NOEC

12000 µg/L

293

Daphnia

acute

D. magna

690000 µg/L

16858

100

Daphnia

prolonged

D. magna

NOEC

15000 µg/L

366

Algae

acute

subspicatus

89900µg/L

2196

Aquatic plants

M. aquaticum

31100µg/L

760

Sed. dweller

prolonged

NOEC

µg/L

FOCUS Step 1

Annex VI Trigger

40.93

12705

100

Maximum PECsw values and TER values for HMPA, Focus Step 1

PEC global

max

(µg L)

PEC twa,

28d*

(µg L)

Scenario

Fish acute

Fish

prolonged

NOEC

Daphnia

acute

D. magna

>100000

µg/L

14903

100

Daphnia

prolonged

NOEC

Algae

acute

subspicatus

>115000

µg/L

17139

Aquatic plants

M. aquaticum

>123000

µg/L

18331

Sed. dweller

prolonged

NOEC

µg/L

FOCUS Step 1

Annex VI Trigger

6.71

100

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Bioconcentration

Active substance

log P

O/W

log P

of glyphosate acid and its metabolites was < 3,

accumulation potential in aquatic non-target organisms is

hence considered to be low

BCF = 1.1 ± 0.61; steady state after 120 ± 59 d (56 d bio-

concentration flow-through;

Lepomis macrochirus)

1000

Not relevant

Bioconcentration factor (BCF)

Annex VI Trigger for the BCF

Clearance time (days) (CT

)

(CT

)

Level and nature of residues (%) in organisms

after the 14 day depuration phase

only required if log PO/W > 3.

based on total 14C or on specific compounds

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Test substance

Preparation

Metabolite 1

Field or semi-field tests

A field study (Thompson, 2012) was undertaken to determine the potential for toxicity to developing honey

bee larvae and pupae to glyphosate (tested as the IPA salt) when fed directly to honey bee colonies. In this

study the overall NOAEL (No Observed Adverse Effect Level) for brood development of honey bee colonies

was 301 mg glyphosate a.e./L sucrose solution, the highest dose tested.

Acute oral toxicity

(LD

µg a.s./bee)

100

> 77

Acute contact toxicity

(LD

µg a.s./bee)

> 100

for preparations indicate whether endpoint is expressed in units of as or preparation

Hazard quotients for honey bees (Annex IIIA, point 10.4)

2880 g a.s. /ha; all crops*

Test substance

Preparation

Route

contact

oral

contact

oral

Hazard quotient

< 29

< 38

Annex VI

Trigger

the HQs calculated with this application rate covered all the representative uses

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

Laboratory tests with standard sensitive species

Species

Test

Substance

Mortality (Extended laboratory

Aphidius rhopalosiphi

Typhlodromus pyri

MON 52276

(whole plant), 3D)

Mortality (Extended laboratory

(leaf discs), 2D)

Mortality (Extended Laboratory

(soil))

Endpoint

Effect

(LR

g/ha

)

> 16.0 L product/ha

(5760 g a.s./ha)

≥ 12.0 L product /ha

(4320 g a.s./ha)

> 12.0 L product /ha

(4320 g a.s./ha)

Aleochara bilineata

MON 52276

for preparations indicate whether endpoint is expressed in units of as or preparation

Crop and application rate ‘All crops’ 2x 2160 g a.s./ha*

Test substance

Species

Effect

(LR

g/ha)

MON 52276

Aphidius rhopalosiphi

Typhlodromus pyri

> 5760

> 4320

< 0.6

≤ 0.9

< 0.1

HQ in-field

HQ off-field

Trigger

the HQs calculated with this application rate covered all the representative uses

Further laboratory and extended laboratory studies

Species

Life

stage

Test substance,

substrate and

duration

MON 52276

Extended

laboratory

(barley plants,

3D)

Dose

(g/ha)

1,2

5760,

4320,

2880,

2160,

1080 g

a.s./ha

5760,

4320,

2880,

2160,

1080 g

a.s./ha

4320,

2880,

2160 g

a.s./ha

Endpoint

% effect

Trigger

value

>5760 g a.s./ha

Mortality

Repro-

duction

Increase in no. of

mummies /female of

46.8%, 43.0% and

32.3% at 5760, 4320,

2880 g a.s./ha

>5760 g a.s./ha

Mortality

Repro-

duction

5760 g a.s./ha >ER

≥

4320 g a.s./ha

(reduction in no. of

egg/female 45 % at

4320 g a.s./ha )

> 4320 g a.s./ha )

(effects between 1.9-

18.1% on reproduction)

50 %

Aphidius

rhopalosiphi

Adults

approx.

48 h

old

Typhlodromus

pyri

< 24 h

MON 52276

Extended

laboratory

(leaf discs, bean

plants, 2D)

MON 52276

(Extended

Laboratory soil,

LUFA 2.1)

Aleochara

bilineata

3-4

days

Mortality

Repro-

duction

50 %

Field or semi-field tests - /-

Indicate if not required - /-

indicate whether initial or aged residues

for preparations indicate whether dose is expressed in units of as or preparation

indicate if positive percentages relate to adverse effects or not

EFSA Journal 2015;13(11):4302

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

Effects on earthworms, other soil macro-organisms and soil micro-organisms (Annex IIA,

points 8.4 and 8.5, Annex IIIA, points 10.6 and 10.7)

Test organism

Earthworms

Eisenia fetida

Glyphosate acid

Acute 14 days

50=

5600 mg as/kg d.w.soil (mg

as/ha)

> 1250 mg/kg dry soil

equivalent to

> 388 mg a.e./kg dry soil

Eisenia andrei

Eisenia fetida

Soil mesofauna

Hypoaspis aculeifer

Folsomia candida

Soil micro-organisms

Glyphosate acid

(MON 77973)

Nitrogen mineralisation

AMPA

MON 52276

Glyphosate acid

Carbon mineralisation

AMPA

MON 52276

Field studies

-/-

Indicate if not required -/-

Test substance

Time scale

Endpoint

Eisenia fetida

MON 52276

AMPA

MON 0139

(63.81% w/w

Glyphosate IPA salt)

AMPA

Acute 14 days

Chronic 56 days

> 1000 mg AMPA/kg dry

NOEC > 1000 mg /kg dry soil

equivalent to

NOEC > 473 mg a.e. /kg dry soil.

NOEC = 131.90 mg/kg dry soil

Glyphosate IPA-salt

AMPA

Glyphosate IPA salt

AMPA

14 d

chronic

14 d

chronic

28 d

chronic

28 d

chronic

NOEC=1000 mg/kg

472.8 mg a.e./kg

NOEC=320 mg/kg dry soil

NOEC= 1000 mg/kg

587 mg a.e./kg

NOEC= 315 mg/kg

28-day study

6 % effect at day 28 when

applied at 33.1 mg a.e./kg dry soil

(23 kg/ha)

21% effect at day 28 at 160 mg

/kg d.w.soil (120kg /ha)

8% effect at day 28 at 94 mg /kg

d.w.soil (60L/ha)

9.3% effect at day 28 at 6.4 mg

/kg d.w.soil (4.8kg /ha)

28/56-day study

28-day study

28/56-day study

28-day study

18% effect at day 28 at 160 mg

/kg d.w.soil (120kg /ha)

15% effect at day 28 at 94 mg /kg

d.w.soil (60L/ha)

indicate where endpoint has been corrected due to log Po/w > 2.0 (e.g. LC50corr)

litter bag, field arthropod studies not included at 8.3.2/10.5 above and earthworm field studies

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Toxicity/exposure ratios for soil organisms

Maximum application rate per ha/year for all crops as worst case approach

Test organism

Earthworms

Eisenia fetida

Eisenia andrei

Eisenia fetida

Glyphosate acid

MON 52276

(rec. acid equivalent)

AMPA

MON0139

(rec. acid equivalent)

AMPA

Acute, 14 d

Chronic, 56 d

6.6162

6.1797

6.6162

6.1797

846

Test substance

Time scale

Soil PEC

TER

Trigger

Other soil macro-organisms

Hypoaspis aculeifer

Folsomia candida

Glyphosate IPA-salt

AMPA

Glyphosate IPA salt

AMPA

Chronic, 14 d

Chronic, 28 d

Chronic ,28 d

6.6162

6.1797

6.6162

6.1797

to be completed where first Tier triggers are breached

PECaccu = PECinitial + plateau concentration. a tillage depth of 5 cm was considered for calculating the background

concentration

Effects on non-target plants (Annex IIA, point 8.6, Annex IIIA, point 10.8)

Preliminary screening data

Not required for herbicides as ER

tests should be provided

Laboratory dose response tests

Scenario

a.s./ha)

PERin-

field

a.s./ha)

2 x 2160

(MAF 1.7)

Distance

(m)

PERoff-

field

(g a.s./ha)

87.4

17.3

9.9

TER

TER with TER with TER with

50 % drift

75 %

90 % drift

reduction

drift

reduction

0.6

3.3

5.7

1.3

6.6

11.5

3.2

16.4

28.7

All crops

(all seeded

and

28.4

transplanted

crops)

0.3

1.6

2.9

EFSA Journal 2015;13(11):4302

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Scenario

a.s./ha)

PERin-

field

a.s./ha)

1 x 1080

Distance

(m)

PERoff-

field

(g a.s./ha)

29.9

6.2

3.1

79.8 x 0.5 *

16.4 x 0.5*

8.4 x 0.5*

TER

TER with TER with TER with

50 % drift

75 %

90 % drift

reduction

drift

reduction

1.9

9.2

1.4

6.9

3.8

2.8

9.5

7.1

All crops

(all seeded

post planted

crops)

Orchard

crops, vines

including

citrus & tree

nuts

Intra-row &

Spot

treatment

(50% applic.

rate)

0.9

4.6

9.2

0.7

3.5

1 x 2880

6.7

3 x 1440

(MAF 2.3)

66.6 x 0.5*

13.6 x 0.5*

6.6 x 0.5*

79.8

16.4

8.4

0.9

4.2

8.6

0.4

1.7

3.4

1.7

8.4

0.7

3.5

6.8

3.4

1.4

6.9

8.6

3.6

1 x 2880

Orchard

crops, vines

including

citrus & tree

nuts

3 x 1440

Cereals,

Oilseeds

(pre-harvest)

1 x 2160

TER in bold are below the relevant trigger of 5.

5.2

66.6

13.6

6.6

59.83

12.31

6.32

5.4

0.4

2.1

4.3

0.5

2.3

4.5

0.9

4.2

8.6

0.9

4.6

9.0

1.7

8.4

1.9

9.2

4.3

4.7

23.1

Because applications are made round base of trunk and to the intra-rows, (inner strips between two trees within a row),

application rates per ha are expressed per ‘unit of treated surface area’ the actual application rate per ha orchard or

vineyard will only be 50 % of the reported rate

Additional studies (e.g. semi-field or field studies)

-/-

Effects on biological methods for sewage treatment (Annex IIA, point 8.7)

Test type/organism

Inhibition of respiration rate of the activated

sludge

EFSA Journal 2015;13(11):4302

endpoint

> 1000 mg /L

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Ecotoxicologically relevant compounds (consider parent and all relevant metabolites requiring

further assessment from the fate section)

Compartment

soil

water

sediment

groundwater

Parent (glyphosate), Metabolite (AMPA)

Parent (glyphosate), Metabolite (AMPA*)

AMPA is not ecotoxicologically relevant for the compartments water, sediment and groundwater. For precautionary

reasons AMPA is proposed as relevant residue due to the frequent detections in surface waters and groundwater and the

widespread intended uses of glyphosate in almost all crops.

Classification and proposed labelling with regard to ecotoxicological data (Annex IIA, point 10

and Annex IIIA, point 12.3)

RMS/peer review proposal

Active substance

Chronic 2,

H411,

GHS09

P273

P391

P501

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PPENDIX

B – U

SED COMPOUND CODE

(

)

Code/Trivial name*

N-nitroso-glyphosate

(NNG)

Chemical name/SMILES notation**

[nitroso(phosphonomethyl)amino]acetic

acid

O=NN(CC(=O)O)CP(=O)(O)O

Structural formula**

formaldehyde

C=O

N-acetyl-glyphosate

N-acetyl-N-(phosphonomethyl)glycine

OC(=O)CN(CP(=O)(O)O)C(C)=O

AMPA

(aminomethyl)phosphonic acid

NCP(=O)(O)O

HMPA

(hydroxymethyl)phosphonic acid

OCP(=O)(O)O

N-acetyl-AMPA

(acetamidomethyl)phosphonic acid

CC(=O)NCP(=O)(O)O

N-methyl-AMPA

[(methylamino)methyl]phosphonic acid

CNCP(=O)(O)O

Glyphosate-trimesium

trimethylsulfonium

N-

[(hydroxyphosphinato)methyl]glycine

O=C([O-])CNCP(=O)(O)O.C[S+](C)C

The metabolite name in bold is the name used in the conclusion.

ACD/ChemSketch, Advanced Chemistry Development, Inc., ACD/Labs Release: 12.00 Product version: 12.00 (Build

29305, 25 Nov 2008)

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BBREVIATIONS

1/n



°C

µg

µm

a.s.

AChE

ADE

ADI

AOAC

AOEL

ARfD

AST

AUC

BCF

BUN

ca.

CAS

CFU

ChE

CIPAC

CLP

Cmax

DAA

DAR

DAT

EbC

ECHA

EDSP

EEC

EINECS

ELINCS

EMDI

ErC

slope of Freundlich isotherm

wavelength

decadic molar extinction coefficient

degree Celsius (centigrade)

microgram

micrometer (micron)

active substance

acetylcholinesterase

actual dermal exposure

acceptable daily intake

assessment factor

AOAC international

acceptable operator exposure level

alkaline phosphatase

applied radioactivity

acute reference dose

aspartate aminotransferase (SGOT)

area under the blood concentration/time curve

avoidance factor

bioconcentration factor

blood urea nitrogen

body weight

circa

(about)

Chemical Abstracts Service

colony forming units

cholinesterase

confidence interval

Collaborative International Pesticides Analytical Council Limited

confidence limits

classification, labelling and packaging

centimetre

concentration achieved at peak blood level

day

days after application

draft assessment report

days after treatment

dry matter

period required for 50 percent disappearance (define method of estimation)

period required for 90 percent disappearance (define method of estimation)

dry weight

effective concentration (biomass)

effective concentration

European Chemical Agency

endocrine disruption

(US Environmental Protection Agency) Endocrine Disruptor Screening

Program

European Economic Community

European Inventory of Existing Commercial Chemical Substances

European List of New Chemical Substances

estimated maximum daily intake

emergence rate/effective rate, median

effective concentration (growth rate)

European Union

104

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EUROPOEM

f(twa)

FAO

FID

FIR

FOB

FOCUS

GAP

GCPF

GGT

GHS

GHS05

GIT

GMO

GSH

GTF

H318

Hct

HPLC

HPLC-MS

IARC

IEDI

IESTI

IPA

ISO

IUPAC

JMPR

doc

Foc

LC-MS

LC-MS-MS

LDH

LLNA

LOAEL

LOD

European Predictive Operator Exposure Model

parental generation

filial generation

time weighted average factor

Food and Agriculture Organisation of the United Nations

flame ionisation detector

Food intake rate

functional observation battery

Forum for the Co-ordination of Pesticide Fate Models and their Use

gram

good agricultural practice

gas chromatography

Global Crop Protection Federation (formerly known as GIFAP)

gamma glutamyl transferase

globally harmonized system

hazard pictogram (corrosion) according to GHS

gastro-intestinal tract

genetically modified

genetically modified organism

growth stage

Glutathione

Glyphosate Task Force

hour(s)

hazard statement for serious eye damage according to Reg. (EC) No. 1272/2008

hectare

haemoglobin

haematocrit

hectolitre

high pressure liquid chromatography

or high performance liquid chromatography

high pressure liquid chromatography – mass spectrometry

hazard quotient

International Agency for Research on Cancer

international estimated daily intake

international estimated short-term intake

isopropylamine

International Organisation for Standardisation

International Union of Pure and Applied Chemistry

intravenous

Joint Meeting on the FAO Panel of Experts on Pesticide Residues in Food and

the Environment and the WHO Expert Group on Pesticide Residues (Joint

Meeting on Pesticide Residues)

organic carbon linear adsorption coefficient

kilogram

Freundlich organic carbon adsorption coefficient

litre

liquid chromatography

lethal concentration, median

liquid chromatography-mass spectrometry

liquid chromatography with tandem mass spectrometry

lethal dose, median; dosis letalis media

lactate dehydrogenase

local lymph node assay

lowest observable adverse effect level

limit of detection

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LOQ

M/L

MAF

MCH

MCHC

MCV

M&K

MRL

MSDS

MTD

MWHC

NESTI

NOAEC

NOAEL

NOEL

NOEC

NOEL

NPD

OECD

PEC

air

PEC

sed

PEC

soil

PEC

PHED

PHI

PIE

POEM

PPE

ppm

ppp

PTT

QSAR

RAR

REACH

RMS

RPE

RUD

limit of quantification (determination)

metre

mixing and loading

multiple application factor

mean corpuscular haemoglobin

mean corpuscular haemoglobin concentration

mean corpuscular volume

milligram

Maximisation test of Magnusson & Kligman

millilitre

millimetre

milli-newton

maximum residue limit or level

mass spectrometry

material safety data sheet

maximum tolerated dose

maximum water holding capacity

national estimated short-term intake

nanogram

no observed adverse effect concentration

no observed adverse effect level

no observed effect level

no observed effect concentration

no observed effect level

nitrogen phosphorous detector

Organisation for Economic Co-operation and Development

organic matter content

pascal

proportion of different food types

predicted environmental concentration

predicted environmental concentration in air

predicted environmental concentration in ground water

predicted environmental concentration in sediment

predicted environmental concentration in soil

predicted environmental concentration in surface water

pH-value

pesticide handler's exposure data

pre-harvest interval

potential inhalation exposure

negative logarithm (to the base 10) of the dissociation constant

Predictive Operator Exposure Model

partition coefficient between

n-octanol

and water

personal protective equipment

parts per million (10

-6

)

plant protection product

proportion of diet obtained in the treated area

partial thromboplastin time

quality control

quantitative structure-activity relationship

coefficient of determination

renewal assessment report

Registration, Evaluation, Authorisation of CHemicals

rapporteur Member State

respiratory protective equipment

residue per unit dose

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MOF, Alm.del - 2015-16 - Bilag 108: EFSAs konklusion vedr. glyphosat m.v., fra miljø- og fødevareministeren

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

SANCO

SFO

SSD

STMR

1/2

TER

TLV

TMDI

TRR

TSH

TWA

UDS

W/S

w/v

w/w

WBC

WHO

↓

↑

Directorate-General for Health and Consumers

suspension concentrate

standard deviation

single first-order

soluble concentrate

species sensitivity distribution

supervised trials median residue

half-life (define method of estimation)

technical material

toxicity exposure ratio

toxicity exposure ratio for acute exposure

toxicity exposure ratio following chronic exposure

toxicity exposure ratio following repeated exposure

technical concentrate

threshold limit value

theoretical maximum daily intake

total radioactive residue

thyroid stimulating hormone (thyrotropin)

time weighted average

unscheduled DNA synthesis

uncertainty factor

ultraviolet

water/sediment

weight per volume

weight per weight

white blood cell

water dispersible granule

World Health Organization

week

weight

year

decrease

increase

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