HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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11508 N

Pokon Onkruid Weg !, 20182405 NLRG

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 22 november 2018 is van

Evergreen Garden Care Belgium bvba Voshol 8

B-9160 LOKEREN Belgium

een zonale aanvraag tot aanpassing van de verlenging van de toelating ontvangen als bedoeld in artikel 43 van Verordening (EG) 1107/2009 (verder te noemen: de Verordening) met Nederland als betrokken lidstaat voor het gewasbeschermingsmiddel

Pokon Onkruid Weg ! op basis van de werkzame stoffen 2,4-D en dicamba.

Op 2 februari 2018 is de middeltoelating verlengd volgens art 43 van Verordening (EG) 1107/2009 volgende op de verlenging van de goedkeuring van de werkzame stof 2,4-D van 1 januari 2016.

De stof 2,4-DB is per 1 november 2017 opnieuw goedgekeurd (renewal) volgens Verordening (EG) 1107/2009 (Uitvoeringsverordening (EU) 2017/1491 d.d. 21 augustus 2017. Daarbij zijn

conservatievere grenswaarden vastgesteld voor humane toxicologie voor 2,4-D (een metaboliet van 2,4-DB) en zijn de voorwaarden voor de goedkeuring van 2,4-D aangepast.

Op grond van het herziene Review Report van 2,4-D, SANCO/11961/2014 Rev 5 d.d.6 oktober 2017, dienen middeltoelatingen die zijn gebaseerd op oude grenswaarden van 2,4-D herzien te worden.

Dit besluit volgt op de herbeoordeling van aspect humane toxicologie voor de middeltoelating in Nederland met Oostenrijk als beoordelend lidstaat.

HET COLLEGE BESLUIT tot verlenging van de toelating van bovenstaand middel.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van dit besluit.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

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1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld:

De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder

“verpakkingsinformatie” in bijlage I.

Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de

voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Bij de verlenging worden geen wijzigingen in het WG doorgevoerd. Daarom is het niet noodzakelijk dat het volgnummer van het etiket wordt verhoogd, blijft het etiket met volgnummer W.3

onverminderd van kracht en zijn respijttermijnen niet van toepassing.

2. WETTELIJKE GRONDSLAG

Besluit artikel 43 van de Verordening (EG) 1107/2009

Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader De beoordeling van deze aanvraag is conform Bgb en Rgb d.d. 16

december 2011 en Evaluation Manual Zonaal 2.0.

3. BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en

ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar

geacht.

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik.

3.3 Risico voor de mens

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.

Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het Registration Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel bekendmaken delen A en B van het Registration Report.

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11508 N

Pokon Onkruid Weg !, 20182405 NLRG Bezwaarmogelijkheid

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.

Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

Ede, 3 mei 2019

Het College voor de toelating van

gewasbeschermingsmiddelen en biociden, voor deze:

de voorzitter,

Ir. J.F. de Leeuw

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BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 2.1 Aanvraaginformatie

Aanvraagnummer: 20182405 NLRG

Type aanvraag: Zonale aanvraag tot verlenging van

gewasbeschermingsmiddeltoelating met Nederland als betrokken lidstaat

Middelnaam: Pokon Onkruid Weg !

Ontvangstdatum aanvraag: 22 november 2018 Formele registratiedatum: * 28 november 2018 Datum in behandeling name: 5 maart 2019

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

2.2 Stofinformatie

Werkzame stof Gehalte

dicamba 1,2 g/kg

2,4-D 8 g/kg

• De stof 2,4-D is per 1 januari 2016 opnieuw goedgekeurd (renewal) volgens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) 2015/2033 d.d. 13 november 2015). De

voorwaarden De goedkeuring van deze werkzame stof expireert op 31 december 2030.

• De stof dicamba is per 1 januari 2009 geplaatst op Annex I van Richtlijn 91/414/EEG (Richtlijn 2008/69/EC d.d. 1 juli 2008) en vervolgens bij Uitvoeringsverordening (EU 540/2011 d.d.25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof expireert op 31 december 2019.

2.3 Toelatingsinformatie

Toelatingsnummer: 11508 N

Expiratiedatum: 31 december 2020

Afgeleide parallel of origineel: Origineel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Niet-Professioneel

W-coderingen en aflever- en opgebruiktermijnen:

W-codering niet-professioneel gebruik: W3 Vorige w-codering niet-professioneel gebruik: W3 Aflevertermijn niet-professioneel gebruik: n.v.t.

Opgebruiktermijn niet-professioneel gebruik: n.v.t.

2.4 Verpakkingsinformatie

Aard van het preparaat: Granulaat

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11508 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Pokon Onkruid Weg!

Niet-professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

-

Pictogram Signaalwoord

Gevarenaanduidingen

Voorzorgsmaatregelen P101 Bij het inwinnen van medisch advies, de verpakking of het etiket ter beschikking houden.

P102 Buiten het bereik van kinderen houden.

P103 Alvorens te gebruiken, het etiket lezen.

P270 Niet eten, drinken of roken tijdens het gebruik van dit product.

P273 Voorkom lozing in het milieu.

P501 Inhoud/verpakking afvoeren naar ....

SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.

Aanvullende etiketelementen

EUH208 Bevat 2,4-D. Kan een allergische reactie veroorzaken.

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee

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part A

National Addendum – The Netherlands

Pokon Onkruid Weg ! Registration Report – Central Zone Page 6 of 49

Applicant: Evergreen Garden Care Belgium bvba Evaluator: NL, Ctgb

Date : April 2019

REGISTRATION REPORT Part A

Risk Management

Product code: UKS118A

Product name: Pokon Onkruid Weg !

Active substance: Dicamba (1.2 g/kg) 2,4-D (8 g/kg)

COUNTRY: The Netherlands Central Zone

Zonal Rapporteur Member State: Austria

NATIONAL ASSESSMENT

Applicant: Evergreen Garden Care Belgium bvba

Date: April 2019

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Part B – Section 9

Date : April 2019

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 21 3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 22 3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) ... 24

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) ... 25

3.1.7 Efficacy (Part B, Section 7, Point 8) ... 29

IIIA1 6.1 Efficacy data ... 29

IIIA1 6.1.1 Preliminary range-finding tests ... 29

IIIA1 6.1.2 Minimum effective dose tests ... 29

IIIA1 6.1.3 Efficacy tests ... 29

IIIA1 6.1.4 Effects on yield and quality ... 29

IIIA1 6.2 Adverse effects ... 29

IIIA1 6.2.1 Phytotoxicity to host crop... 29

IIIA1 6.2.2 Adverse effects on health of host animals ... 30

IIIA1 6.2.3 Adverse effects on site of application ... 30

IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) ... 30

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ... 30

IIIA1 6.2.6 Impact on succeeding crops ... 30

IIIA1 6.2.7 Impact on other plants including adjacent crops ... 30

IIIA1 6.2.8 Possible development of resistance or cross-resistance ... 30

IIIA1 6.3 Economics ... 30

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Date : April 2019

IIIA1 6.4 Benefits ... 30

IIIA1 6.4.1 Survey of alternative pest control measures ... 30

IIIA1 6.4.2 Compatibility with current management practices including IPM ... 31

IIIA1 6.4.3 Contribution to risk reduction ... 31

IIIA1 6.5 Other/special studies ... 31

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ... 31

IIIA1 6.7 List of test facilities including the corresponding certificates... 31

3.2 Conclusions ... 31

3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation ... 31

Appendix 1 – Copy of the product label ... 32

Appendix 2 – Letter of Access ... 33

Appendix 3 – List of data submitted in support of the evaluation ... 34

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part A

Date : April 2019

Please note:

Paragraph 3.1.3 ‘Mammalian Toxicology’ provides an up-dated exposure assessment triggered by the revision of endpoints for 2,4-D in accordance with the

“Revised Renewal report for the active substance 2,4-D”, SANCO/11961/2014 Rev 5, published on 6th October 2017.

The following reference values for 2,4-D have been set during this re-evaluation:

ADI: 0.02 mg/kg bw per day ARfD: 0.3 mg/kg bw

AOEL: 0.02 mg/kg bw per day

As the AOEL was lowered, acceptability of exposure scenarios needs to be confirmed for each plant protection product.

No amendment of the Dutch national authorisation is triggered by the results of this re-evaluation.

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Date : April 2019

PART A – Risk Management

This document describes the acceptable use conditions required for the re-registration of Pokon Onkruid Weg ! containing 2,4-D which was included into Annex I of Directive 91/414 on 01/01/2009 by EU Directive 2008/69/EC and was renewed and included to the Commission Implementing Regulation (EU) No 540/2011 on 13/11/2015 by EU Commission Implementing Regulation 2015/2033, respectively and dicamba which was included into Annex I of Directive 91/414 on 13/11/2015 by EU Commission Implementing Regulation 2015/2033, respectively, in The Netherlands.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for The Netherlands. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national re-registration by the EU review. It also includes assessment of data and information relating to Pokon Onkruid Weg ! where that data has not been considered in the EU review. Otherwise assessments for the safe use of Pokon Onkruid Weg ! have been made using endpoints agreed in the EU reviews of 2,4-D and dicamba.

As this re-assessment was triggered by the renewal of 2,4-D, only the relevant sections for 2,4-D have been evaluated in the current assessment and sections referring to combitox of both active sustances.

Sections relevant for only dicamba have not been assessed and will be taken up once the renewal of dicamba has been decided on.

This document describes the specific conditions of use and labelling required for The Netherlands for the re-registration/registration of Pokon Onkruid Weg !.

Appendix 1 of this document is a copy of the approved product label for The Netherlands.

Appendix 2 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation.

Appendix 3 of this document provides a list of data in support of the evaluation.

1 Details of the application 1.1 Application background

This application was submitted by Scotts Benelux bvba in August 2016.

The application was for approval of Pokon Onkruid Weg !, a granular (GR) type formulation containing 0.8 % 2,4-D and 0.12 % dicamba for use as a herbicide in lawn, as a Home and garden product.

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Date : April 2019

1.2 Annex I inclusion

The Annex I Inclusion Directives (01/103/EC) and renewal (Reg. (EU) 2015/2033) for 2,4-D and dicamba (2008/69/EC), provide specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,4-D and dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 02 October 2001 and 14 March 2008 shall be taken into account. In this overall assessment:

For 2,4-D, Member States must pay particular attention to the: On the basis of the proposed and supported uses (as listed in Appendix II), the following issue have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate:

• the risk to aquatic organisms from the parent substance and photolysis metabolite 1,2,4- benzenetriol;

• the risk to aquatic organisms and terrestrial organisms from metabolite 4-CP in anaerobic conditions;

• the consumer risk from residues of 2,4-D and metabolite 2,4-DCP in cases of uses above 750 g/ha.

Conditions of use shall include risk mitigation measures, where appropriate.

For dicamba, no particular issues have been identified as requiring particular and short-term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate.

These concerns were all addressed in the submission.

1.3 Regulatory approach

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

This application was submitted in order to allow the re-registration of an already approved product. The Netherlands in accordance with the above.

1.4 Data protection claims

Where studies are owned by Scotts, data protection is claimed under Art. 59 of Reg. 1107/2009. The identities of these studies have been clearly indicated in Part B.

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Date : April 2019

1.5 Letters of Access

LOA are available for this application:

LOA from BASF for Dicamba data LOA from Nufarm for 2,4-D data package

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Date : April 2019

2 Details of the authorisation 2.1 Product identity

Product Name Pokon Onkruid Weg ! (UKS 118A) Authorization Number

(for re-registration)

11508-N

Function Herbicide

Applicant Scotts Benelux bvba

Composition 0.8% 2,4-D

0.12% Dicamba Formulation type Granule [Code: GR]

Packaging

1. Bag in carton LDPE/paper/cardboard Up to 5kg

2. Lined carton LDPE/cardboard Up to 5kg

3. Lined carton

with sachet LDPE, LDPE/cardboard Up to 5kg

4. Tub Polypropylene Up to 6kg

5. Bottle HDPE Up to 5kg

6. Bag LDPE Up to 15kg

2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC

Regulation /EC) No 1272/2008

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

The identity of all substances in the mixture that contribute to the classification of the mixture *:

-

Pictogram: - Signal word: -

H-statements: -

P-statements: P101 If medical advice is needed, have product container or label at hand.

P102 Keep out of reach of children.

P103 Read label before use.

P270 Do not eat, drink or smoke when using this product.

P273 Avoid release to the environment.

P501 Dispose of contents/container to ....

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Date : April 2019

Supplemental Hazard information:

EUH208 Contains 2,4-D. May produce an allergic reaction.

EUH401 To avoid risks to human health and the

environment, comply with the instructions for use.

SP1 Do not contaminate water with the product or its container.

Child-resistant fastening obligatory? No

Tactile warning of danger obligatory? No

Explanation:

Pictogram: -

H-statements: -

P-statements: P-statements as proposed by the applicant are accepted.

Other: EUH208 is assigned based on the presence of 2,4-D above the concentration limit.

* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

2.2.2 Proposals for Hazard and Precautionnary Statements

See 2.2.1.

2.2.3 Other phrases

The following restriction and warning sentences need to be included on the Legal Instructions for Use as a result of the GAP applied for:

See Appendix 1

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part A

Date : April 2019

2.3 Product uses

PPP (product name/code) UKS 118A active substance 1 2,4-D active substance 2 Dicamba

Formulation type: GR Conc. of as 1: 0.8% w/w Conc. of as 2: 0.12 % w/w

Applicant: Scotts Celaflor Austria

Zone(s): Central /EU

professional use non professional use

1 2 3 4 5 6 7 8 10 11 12 13 14

Use- No.

Member state(s)

Crop and/

or situation

(crop destination / purpose of crop)

F, Fn, Fpn, G,Gn, Gpn, or I

Pests or Group of pests controlled

(additionally:

developmental stages of the pest or pest group)

Application Application rate PHI

(days)

Remarks:

e.g. safener/synergist per ha

e.g. recommended or mandatory tank mixtures Method /

Kind

Timing / Growth stage of crop &

season

Max. number (min. interval between applications) a) per use

b) per crop/

season

Kg, L product / ha a) max. rate per appl.

b) max. total rate per crop/season

kg as/ha

a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha

min / max

1 NL Lawns (Home and

Garden).

Fn Broad-leaved weeds Suitable granular applicator

During vegetation period

March - September

Growth stage:

lawn should at least be 1 year old.

a) 1

b) 1

a) 200 kg/ha

b) 200 kg/ha

a) 0.24 Dicamba

1.6 2,4-D

b) 0.24 Dicamba

1.6 2,4-D

n.a. n.a.

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part A

Date : April 2019

3 Risk management

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

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4)

Overall Summary: The product Pokon Onkruid Weg ! is a granular formulation. All studies have been performed in accordance with the current requirements for GR formulations and the results are deemed to be acceptable. The appearance of the product is that of a free-flowing opague/beige and white solid granule. It is not explosive, has no oxidising properties and it is not flammable and has no auto-flammable properties. The pH value of a 1% dilution is between 3.73 and 3.85. The product has a pour density of 0.92 g/mL and a tab density of 1.03 g/mL. The stability data after 14 days at 54˚C in LDPE, 8 weeks at 40˚C in LDPE and Cardboard/LDPE and 2 year at ambient temperature in LDPE and Cardboard/LDPE indicate a shelf life of 2 years in LDPE and cardboard/LDPE. These results can be extrapolated to the applied for packaging LDPE/paper/cardboard, PP and HDPE as LDPE (or Cardboard/LDPE) is considered worst-case.

It should however be noticed that the original analytical method (FAM207) to determine the active substance content of 2,4-D and dicamba in the formulation, used in the storage stability study for 14 days at 54˚C and 8 weeks at 40˚C and 2 year shelf-life at ambient temperature (Cems-4991), did not perform adequate. Therefore the content of the active substance 2,4-D was not determined correctly. A high variability in the results of the analytical method was observed due to the fact no hydrolysis step was used in the extraction to convert all possible formed esters coming from 2,4-D. Therefore a new analytical method (CEM-3563/001) was developed with an hydrolysis step to determine (more exact) the active substance content in the formulation. Only the samples after 2 year storage at ambient temperature (Cems-6050) were re-analysed with this new method. The results could not be compared to the initial results, as these were determined with the ‘old’ analytical method (FAM207). However it was concluded that, based on the increase of the content of the 2,4-D (after 2 year storage) compared to the content determined with the ‘old’ method, the stability was shown after 2 year shelf-life at ambient temperature study in LDPE and Cardboard/LDPE.

Its technical characteristics are acceptable for a GR formulation.

Implications for labelling: None

Compliance with FAO specifications: The product Pokon Onkruid Weg ! complies with FAO specifications.

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.

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Date : April 2019

Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of Pokon Onkruid Weg ! has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)

The analytical method (FAM207) for the determination of the active substances 2,4-D and dicamba in the formulation was fully validated according to SANCO/3030/99 rev. 4. However, this method did not perform sufficient, as the 2,4-D content was not determined correctly, due to the fact no hydrolysis step was used in the extraction to convert all possible formed esters coming from 2,4-D. Therefore a new analytical method (CEM-3563/001) for determination of both a.s. 2,4-D and dicamba in the formulation was developed with a hydrolysis step included and is provided and is fully validated according to SANCO/3030/99 rev. 4..

No CIPAC method is available for the determination of the active substances 2,4-D and dicamba in GR- formulation.

In technical 2,4-D the relevant impurities free phenols and the sum of dioxins and furans (expressed as WHO-TCDD TEQ) are identified. As these relevant impurities will not increase (or formed) during manufacturing and storage of the formulation the content before and after storage does not have to be determined. As 2,4-D is an AIR II renewal substance, the old data requirements still apply and therefore according Reg. (EU) 545/2011 no analytical method have to be provided if no relevant impurities will be formed during manufacturing and storage of the formulation.

Technical dicamba does not contain any relevant impurities and therefore no analytical methods for the determination of the relevant impurities is required.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) Methods in crops are not relevant for this type of use (lawn).

For residues in soil, water and air all analytical methods are active substance data and were provided in the EU review of 2,4-D and dicamba and found acceptable.

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)

The results of the animal tests for Pokon Onkruid Weg ! are summarised in the table below. The formulation is of low acute oral and dermal toxicity. Pokon Onkruid Weg ! is a granule of approximately 0.5-2.5 mm diameter and is a dust-free formulation. It does not contain >1 % w/w of particles of a diameter <50 µm and thus an inhalation study is not required.

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The results are summarised in Table 3.1.3.1-1.

Table 3.1.3.1-1: Summary of acute toxicity of relevant formulations and extrapolation to Pokon Onkruid Weg !

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)

Operator exposure to Pokon Onkruid Weg ! was not evaluated as part of the EU review of any of the active substances containing the plant protection product (2,4-D and dicamba) for this submitted rate/crop. Therefore all relevant data and risk assessments have been provided and are considered to be adequate.

Operator exposure was assessed against the AOEL agreed in the EU review of dicamba (0.3 mg/kg bw/day) and in the Revised Renewal report for the active substance 2,4-D (0.02 mg/kg bw/day). No safe use could be demonstrated by the zRMS using the default values of the Guidance on Dermal Absorption (EFSA Journal 2012;10(4):2665). Therefore, the default values from the more recent Guidance on Dermal Absorption (EFSA Journal 2017;15(6):4873) of 10% for the concentrate is used in the risk assessment by the zRMS.

As described in the previous paragraph, based on the risk assessment performed with the EFSA model as presented in the core dossier, adverse health effects after dermal and respiratory exposure to 2,4-D and dicamba cannot be excluded for the unprotected non-professional operator. However, in the risk assessment, zRMS used default values for dermal absorption of 75%, which are generally considered as worst-case leading to an overestimation of the risk. Therefore, the zRMS refined the risk assessment using the default values for dermal absorption according to the 2017 EFSA Guidance on dermal Absorption of 10%. However, the operator exposure still exceeds 100% of the AOEL using the EFSA OPEX model (6561%) or UK PHED model (239%) without PPE.

A further refinement using the Puffer Pack model and UPJ model was performed by the zRMS, demonstrating a safe use for the non-professional operator without the use of PPE. However, these models are not considered acceptable by the Netherlands as these models are either not harmonized (UPJ model) or not applicable for manual spreading of granules (Puffer Pack model).

Parameter

[Reference] Test species

Results mg/kg or mg/m³ or

effect

Classification Acute oral toxicity

[1995] Rat

LD50

> 2000 mg/kg None

Acute dermal toxicity

[1995] Rat

LD50

> 2000 mg/kg None

Acute inhalation toxicity Not conducted

Dermal irritation

[1998] Rabbit Not skin irritant None

Eye irritation

[2012] Rabbit Not irritant None

Skin sensitisation

[1997] Guinea pig Non sensitizer None

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However, it is not expected that due to exposure to 2,4-D and dicamba as a result of the application of Pokon Onkruid Weg ! an unacceptable risk occurs for the unprotected non-professional operator:

- the default dermal absorption value (10%) is still considered to be too worst-case. Experience with other formulations containing 2,4-D and dicamba shows that the dermal absorption values are much lower; which would lead to safe use (UK PHED model) and;

- Austria performed the risk assessment in the core dossier and concluded a safe use without PPE based on the Puffer Pack model (with limited applicability) and the UPJ model (not harmonized).

Therefore, no adverse health effects are expected for the unprotected non-professional operator after exposure to 2,4-D and dicamba as a result of the application of Pokon Onkruid Weg !. This conclusion is also valid for the simultaneous exposure to both active substances in this product. This is in line with the conclusion taken in the core dossier, therefore The Netherlands (cMS) follows.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)

Bystander exposure to UKS 118A was not evaluated as part of the EU review of EU review of any of the active substances containing the plant protection product (2,4-D and dicamba). Therefore, all relevant data and risk assessments have been provided and are considered adequate. It is referred to the core dossier, where a risk assessment was performed for bystanders and residents (including re-entry on treated lawns) using the EFSA model. It is concluded that there is no undue risk to any bystander or resident after accidental exposure to Pokon Onkruid Weg !. This conclusion is also valid using the adapted AOEL for 2,4-D and considering combined exposure to 2,4-D and dicamba.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)

Worker exposure has not been estimated. The bystander exposure is considered in this case as a worst case and the worker exposure is covered by the bystander exposure assessment. Therefore, it can be concluded that there is no unacceptable risk anticipated for the unprotected worker when re-entering to the area treated with Pokon Onkruid Weg !. This conclusion is also valid using the adapted AOEL for 2,4-D and considering combined exposure to 2,4-D and dicamba.

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)

UKS 118A is not intended for use on food crops. Since application is only on lawn (Home & garden) residues are not relevant.

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)

UKS 118A is not intended for use on food crops. Since application is only on lawn (Home & garden) residues are not relevant.

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3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)

Appropriate endpoints from the EU review were used to calculate PECs for 2,4-D and its metabolites in soil, surface water, ground water and air for the intended use patterns. The following was mentioned by zRMS in the Core dossier: The active substance Dicamba is not yet renewed. As EU (interzonally) agreed, the substance related sections are not reviewed by the zRMS. The review will be performed once the active is renewed. Therefore, in the Core dossier and NL Addendum, only the substance 2.4-D and its metabolites have been taken into account. PECs values for active substance dicamba have been included in the risk assessment with regards to the ecotoxicological aspect.

3.1.5.1 Predicted Environmental Concentration in Soil (PEC

soil

) (Part B, Section 5, Points 9.4 and 9.5)

The PEC of UKS 118A, 2,4-D, dicamba and their metabolites in soil has been assessed with the FOCUS model and the FOCUS groundwater interception values and the DT50 values established in the EU review.

Based on the recommended use rate of 200 kg product/ha, the maximum initial predicted environmental concentration in soil (PECs) of 2,4-D and dicamba will be 0.533 mg/kg and 0.080 mg/kg, respectively.

For the metabolites 2,4-DCP, 2,4-DCA and DCSA, the proposed use pattern will lead to maximum initial PECs of 0.0342 mg/kg, 0.0641 mg/kg and 0.0562 mg/kg, respectively, which is acceptable according to the uniform principles.

The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PEC

GW

) (Part B, Section 5, Point 9.6)

The PEC of 2,4-D and its metabolites in ground water has been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS PELMO, FOCUS PEARL and FOCUS MACRO models and the Koc

values established in the EU review, including the for NL relevant Kremsmünster scenario.

The predicted environmental concentrations (PECGW) at 1m depth for active substances following 26 years use on grass/alfalfa at 200 kg product/ha with 75 % foliar interception, were less than 0.01 µg/L in the Kremsmünster scenario using FOCUS PEARL 4.4.4. The potential for the metabolites 2,4-DCP and 2,4-DCA to leach to groundwater has been assessed in the same way. As the assessment is requested for non-professional use, the dose rate should have been corrected to match a maximum acreage of 500 m². However the full dose rate was applied in the PECgw calculations as a conservative approach.

The models predict that the active substance and its metabolites will not be found in ground water at concentrations greater than 0.1 μg/L. Based on the assessment, the use of UKS 118A is not expected to lead to leaching into groundwater at levels that would be unacceptable when applied according to the recommended use pattern.

Monitoring data groundwater

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Active substance 2,4-D

The active substance 2,4-D was observed in the groundwater [RIVM Report 607310001/2007].

Regarding the presence of metabolite 2,4-DCA no monitoring data are available.

Monitoring data were collected in 2006 in the framework of groundwater monitoring for the WFD starting situation (so-called nulmeting) in the Dutch provinces Drenthe, Flevoland, Friesland, Gelderland, Groningen, Noord-Holland, Overijssel, Utrecht and Zeeland.

In Table 3.1.5.2-1 observed concentrations in groundwater are presented.

Table 3.1.5.2-1 Monitoring data for 2,4-D in Dutch groundwater (2006) Location/year Detection

limit [µg/L]

a/n^* Filter depth Maximum conc.

[µg/L]

90^th percentile conc. [µg/L]

The Netherlands, 2006

<0.1 3/675 2-25 m - mv 6.69 <0.05

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

It must be noted that (page 19 of the report, translated by Ctgb) “no check was performed on the

measurements as is required for use of the data in registration assessment, as this was not included in the current project remit. Presented values can therefore not be used as such in registration procedures.”

3.1.5.3 Predicted Environmental Concentration in Surface Water (PEC

SW

) (Part B, Section 5, Points 9.7 and 9.8)

As the application concerns granular application, no drift will occur, and therefore no PECsw/sed values have been calculated.

Monitoring data surface water

In 2015, version 3 of the Pesticide Atlas was launched, which includes a statistical correlation analysis between concentrations, threshold exceedance and land use, which may indicate probable relationships. In this version also the correlation analysis of land use with the environmental quality standards (EQS) of the Water Framework Directive (WFD) is included.

Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold and environmental quality standards (MKN in Dutch, data source http://www.rivm.nl/rvs/Normen). These environmental quality standards consist either of the harmonised WFD thresholds derived according to the Fraunhofer methodology¹ (AA-EQS and MAC-EQS) or of an MPC value (which is usually derived on the basis of outdated guidance). When EQS values according to the Water Framework Directive are available, the MPC value is not used further in the analysis of monitoring data for the purpose of the registration.

2,4-D

1 P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’. RIVM report 601782001.

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The active substance 2,4-D was observed in the surface water (most recent data from 2015). In Table 9.8.7.2-1 the number of observations in the surface water are presented.

The authorisation threshold equals 29 µg a.s./L (consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.05*EC50 Lemna gibba).

The relevant MPC for this substance equals 26 µg/L.

The currently available MPC value is reported here for information purposes when no EQS values are available.

Table 3.1.5.3-1 Monitoring data in Dutch surface water for 2,4-D (from www.pesticidesatlas.nl, version 3)

Total no of locations (2015)

n > authorisation threshold

n > EQS MAC-

EQS AA-EQS MPC (ad-

hoc/indicative)

227* 0 n.a. n.a. 0

* the number of observations at each location varies between 1 and 30, total number of measurements is 1530 in 2015.

n.a. not available

As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed use of the product.

Drinking water criterion

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’.

The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635².

Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).

- For new substances, a pre-registration calculation is performed.

- For existing substances, the assessment is based on monitoring data of Vewin (drinking water board).

o If for an existing substance based on monitoring data no problems are expected by Vewin, Ctgb follows this Vewin assessment.

o If for an existing substance based on monitoring data a potential problem is identified by Vewin, Ctgb assesses whether the 90^th percentile of the monitoring data meet the

drinking water criterion at each individual drinking water abstraction point.

2,4-D

2 Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use of plant

protection products for drinking water production from surface waters - A proposal for the registration procedure in the Netherlands. Alterra-Report 1635

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2,4-D has been on the Dutch market for > 3 years (authorised since 29-10-1989). This period is sufficiently large to consider the market share to be established. The existing active substance 2,4-D is included in the list of substances of concern due to its presence in surface water at drinking water abstraction points as established by Vewin/Ctgb. Therefore, an adequate risk assessment is needed based on the highest tier data. There are monitoring data concerning the presence of 2,4-D at drinking water abstraction points. See Table 3.1.5.3-2.

Table 3.1.5.3-2 Monitoring data for 2,4-D at drinking water abstraction points from surface water in the period 2011 – 2015

Abstraction point Number of

measurements above detection limit/ Number of measurements [n/N]

Number of

measurements above drinking water limit/

Number of measurements [n/N]

Overall 90-percentile

[μg/L]

Amsterdam-Rijnkanaal (Nieuwesluis)

2 / 88 0 / 88 0.03

Nieuwegein 0 / 182 0 / 182 0.05

Andijk 2 / 59 0 / 59 0.03

Brakel 7 / 138 0 / 138 0.1

Heel 0 / 85 0 / 85 0.03

Petrusplaat/Keizersveer 3 / 108 1 / 108 0.03

Scheelhoek/Stellendam 0 / 87 0 / 87 0.03

Drentsche Aa (De Punt) 4 / 146 0 / 146 0.03

** Please note that from the raw data, this value is way below 0.1 µg/L (90 P concentration = 0.05 µg/L), but due to rounding the value is reported in the table as 0.1µg/L , as some (raw) measurements were reported only containing 1 decimal behind the comma.

The relevant monitoring data (data set Vewin, 2011-2015) indicate that the overall 90-percentile at individual drinking water abstraction points is ≤ 0.1 μg/L.

Therefore, the application of UKS 118A is not expected to exceed the drinking water criterion.

3.1.5.4 Predicted Environmental Concentration in Air (PEC

Air

) (Part B, Section 5, Point 9.9)

The fate and behaviour in air of 2,4-D and dicamba were evaluated during the Annex I Inclusion. No additional studies have been performed.

Implications for labelling resulting from environmental fate assessment: None.

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3.1.6 Ecotoxicology (Part B, Section 6, Point 10)

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

Birds

Effects on birds for UKS 118A were not evaluated as part of the EU reviews of active substances.

However further data on UKS 118A is not relevant as active substance data on toxicity to birds is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern have been provided and are considered adequate.

The risk assessment for effects on birds is carried out according to the new guidance document of European Food Safety Authority, “Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009³”.

The acute and long-term risks of UKS 118A to birds were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with active substances, and maximum residues occurring on food items following applications according to the proposed use pattern. For birds, the geometric mean LD50 = 544.6 mg/kg bw was used in a higher-tier assessment.

Risk of secondary poisoning has also been assessed when relevant.

The TER values, calculated for recommended scenarios including combination toxicity, all exceed the trigger values of 10 for acute and short-term risk and 5 for long-term risk (including secondary poisoning), thus indicating no unacceptable risk to birds from the proposed use.

Note- The product will in fact be available for birds for acute exposure (e.g. at least for several hours after application) unless a sentence requiring immediate watering of the lawns and grass vegetation is included on the WG.

On the current label it is stated: “if no rain falls within 2 days, water the lawn thoroughly so that the lawn food starts to work”. This sentence was also mentioned on the label of the previous authorization of Pokon onkruid weg (Landscaper : 20120046 THG) and is as follows:

Eén of twee dagen na toepassing moet het gras met water besproeid worden.

Terrestrial vertebrates (other than birds)

Effects on terrestrial vertebrates other than birds for UKS 118A were not evaluated as part of the EU reviews of active substances. However further data on UKS 118A is not relevant as active substance data on toxicity to terrestrial vertebrates other than birds is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern are provided and are considered adequate.

3 European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA.

EFSA Journal 2009; 7(12):1438. doi:10.2903/j.efsa.2009.1438. Available online: www.efsa.europa.eu

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The acute and long-term risks of UKS 118A to wild mammals were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with active substances, and maximum residues occurring on food items following applications according to the use pattern. Acute risk to voles and lagomorphs was refined using critical body burden modelling. Long-term risk to voles and lagomorphs was refined using a refined DT50 value of 0.29, a corrected application rate of 10% (for non-professional applications) and 75% interception.

Risk of secondary poisoning has also been assessed when relevant.

The TER values, calculated for recommended scenarios including combination toxicity, all exceed the trigger values of 10 for acute and short-term risk and 5 for long-term risk (including secondary poisoning), thus indicating no unacceptable risk to mammals from the proposed use.

The following sentence was proposed by the applicant and will be placed on the Dutch label:

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)

Effects on aquatic organisms for UKS 118A were not evaluated as part of the EU review of active substances. However further data on UKS 118A is not relevant as active substance data on toxicity to aquatic organisms is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern are provided here and are considered.

The worst-case PEC values for the active substances and their metabolites do not exceed the relevant RAC values, indicating that these active substances and their metabolites do not pose an unacceptable risk to aquatic organisms following applications of UKS 118A according to the recommended use pattern.

The acute toxicity of the formulation was determined by calculation based on the classification of the components of the product according to the Regulation 1272/2008/EC.

Following the classification by calculation according to Regulation 1272/2008, UKS 118A was determined to not be classified in the aquatic compartment.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

Bees

Effects on bees for UKS 118A were not evaluated as part of the EU review of active substances. However further data on UKS 118A is not relevant as active substance data on toxicity to bees is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern were provided and are considered adequate.

The risks of UKS 118A to honey-bees was assessed from hazard quotients between toxicity endpoints, estimated from acute oral and contact studies with active ingredient and formulated product, and the maximum single application rate of 200 kg product/ha.

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All the hazard quotients are considerably less than 50, indicating that the active ingredients pose a low risk to bees. Therefore a low risk to bees is expected from the application of UKS 118A according to the recommended use pattern.

Other non-target arthropods

Effects on non-target arthropods for UKS 118A were not evaluated as part of the EU review of active substances. However further data on UKS 118A is not relevant as active substance data on toxicity to arthropods other than bees is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern were provided and are considered adequate.

Tier I in-field assessments indicated no potential risk to non-target arthropods. The field rate values are less than the LR50 value indicating that the risk to in-field non target arthropods is acceptable following use of UKS 118A according to the proposed use pattern.

Drift rate values were not calculated because UKS118A is in the form of granules. It is unlikely that non target arthropods will be off-crop exposed.

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)

Effects on earthworms and other soil macro-organisms for UKS 118A were not evaluated as part of the EU review of active substances. However further data on UKS 118A is not relevant as active substance data on toxicity to earthworms and other soil macro-organisms is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern were provided and are considered adequate.

Earthworms

The acute and long-term risk of UKS 118A to earthworms was assessed from acute and long-term toxicity exposure ratios (TERs) between the selected toxicity endpoints for the active ingredient and relevant metabolites, and the maximum soil PECs.

The acute and chronic TER values for active substances and metabolites are greater to than the Annex IV triggers of 10 and 5, respectively, indicating an acceptable risk to earthworms following application of UKS 118A for the proposed use.

Effects on other soil non-target macro-organisms

The risk of UKS 118A to other non-target soil macro-organisms, as represented by Collembola and soil mite, was assessed from toxicity exposure ratios (TERs) between the toxicity endpoints and the maximum soil PECs.

The TER value is greater than the recommended trigger of 5, indicating no unacceptable risk to soil macro-organisms as represented by Folsomia candida and Hypoaspis aculeifer following application of UKS 118A for the proposed use.

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3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)

No tests are required considering the persistence trigger in accordance with the EU Guidance Document, since the field DT90 is <365 days for active substances and only a single application is recommended per year, indicating that there will be no long-term exposure or accumulation of residues.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)

Effects on soil micro-organisms for UKS 118A were not evaluated as part of the EU review of active substances. However further data on UKS 118A is not relevant as active substance data is used on toxicity to soil micro-organisms and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern were provided and are considered adequate.

The risk of UKS 118A to soil micro-organisms was evaluated by comparison of no-effect concentrations, derived from laboratory tests, with soil PECs.

All no effect levels exceed the relevant PEC values by a factor of at least 5.6, indicating that UKS 118A does not pose an unacceptable risk to soil micro-organisms.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)

Non-Target Plants and Other non-target species (Flora and Fauna)

Effects on non-target plants for UKS 118A were not evaluated as part of the EU review of active substances. However further data on UKS 118A is not relevant as active substance data on toxicity to non-target plants is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments for UKS 118A with the proposed use pattern have been provided and are considered adequate.

UKS 118A exhibits herbicidal action to control annual and perennial broad-leaved weed species, post- emergence, in grassland and turf.

2,4-D is known to be phytotoxic to most broad-leaved crops, especially cotton, vines, tomatoes, ornamentals, oilseed rape and beet. Dicamba is phytotoxic to most legumes.

With respect to effects on fauna, it has been demonstrated in the studies on mammals, birds, fish, arthropods and other species included in this dossier that UKS 118A does not pose an unacceptable level of risk to non-target species.

Non-target plants are not relevant, because intended use is on turf only. Granules are applied by hand or spreader and side-effects by wind or by impression of the spreader are negligible.

Implications for labelling resulting from ecotoxicological assessment:

The following sentence was proposed by the applicant and will be placed on the Dutch label:

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN