HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 14862 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 BESLUIT Op 27 februari 2018 is van Fine Agrochemicals Ltd. Hill End House Whittington WR5 2RQ WORCESTER United Kingdom een aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating ontvangen voor het middel op basis van de werkzame stof gibberellinezuur. HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel. Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit. Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen: - Bijlage I voor details van de aanvraag en toelating. - Bijlage II voor de etikettering. - Bijlage III voor wettelijk gebruik. - Bijlage IV voor de onderbouwing. 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 met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven. 1.3 Classificatie en etikettering Mede gelet op de onder wettelijke grondslag vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld: - De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder verpakkingsinformatie in bijlage I bij dit besluit. - Het toelatingsnummer met een cirkel met daarin de aanduiding van de W-codering zoals vermeld onder toelatingsinformatie in bijlage I bij dit besluit. - De etikettering zoals opgenomen in bijlage II bij dit besluit., NLKUG 1

2 14862 N - Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III bij dit besluit. - Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. 1.4 Aflever- en opgebruiktermijn (respijtperiode) Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt. 2 WETTELIJKE GRONDSLAG Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en artikel 2.2 Rgb Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Conform Bgb en Rgb d.d. 16 december 2011, Evaluation Manual Zonaal, GD Birds & Mammals 2012 en GD Dermal Absorption BEOORDELINGEN 3.1 Fysische en chemische eigenschappen De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof wijzigen niet. 3.2 Analysemethoden De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten toepassingen voldoen de vereiste residuanalysemethoden. 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 Gelet op artikel 51 Verordening (EG) 1107/2009 is de aanvraag niet beoordeeld voor het aspect werkzaamheid (inclusief fytotoxiciteit). 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, 5 april 2019 Het College voor de toelating van gewasbeschermingsmiddelen en biociden, voor deze: de voorzitter, Ir. J.F. de Leeuw, NLKUG 2

3 14862 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: NLKUG Type aanvraag: aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating Middelnaam: Formele registratiedatum: * 22 februari 2018 Datum in behandeling name: 22 mei 2018 Datum compliance check: N.v.t. * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof gibberellinezuur Gehalte 0,9 G/STUK De stof is per 1 september 2009 geplaatst op Annex I van Richtlijn 91/414/EEG (Directive 2008/127/EC d.d. 18 december 2008) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof expireert na verlenging op 31 augustus Toelatingsinformatie Toelatingsnummer: N Expiratiedatum: 31 augustus 2020 Afgeleide of parallel: n.v.t. Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewas Gebruikers: Professioneel W-codering professioneel gebruik: W1 4 Aflever- en opgebruiktermijnen voor oude etiket Vorige W-codering professioneel gebruik: - Aflevertermijn professioneel gebruik: nvt Opgebruiktermijn professioneel gebruik: nvt 5 Verpakkingsinformatie Aard van het preparaat: Wateroplosbaar tablet, NLKUG 1

4 14862 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram Signaalwoord Gevarenaanduidingen Voorzorgsmaatregelen Aanvullende etiketelementen P102 Buiten het bereik van kinderen houden. P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen. P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. P391 Gelekte/gemorste stof opruimen. P501 Inhoud/verpakking afvoeren naar... SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. EUH210 Veiligheidsinformatieblad op verzoek verkrijgbaar. EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen., NLKUG 1

5 14862 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel A. WETTELIJK GEBRUIKSVOORSCHRIFT Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als groeiregulator door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden. Toepassingsvoorwaarden: Toepassingsgebied Type toepassing Doel groeiregulatie Dosering middel per toepassing Maximale dosering middel per toepassing Maximaal aantal toepassingen per 12 maanden Peer Wijndruif Rabarber (bedekte teelt) Bloemisterijgewassen (bedekte teelt) over het gewas bevordering van de vruchtzetting 6 tabletten per 1000L water 6 tabletten/ha 1 over het verlaging van de tros 16 tabletten per 500L water 16 tabletten/ha 1 gewas compactheid aangieten vervroegen van de oogst 4-10 tabletten per 100L water en 1250 tabletten/ha 1 0,25L oplossing per plant over het vegetatieve groei bevordering en 6-16 tabletten per100l water 160 tabletten/ha 1 gewas bloei stimulering Het gebruik in de teelt van kers (zoete en zure kers), is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing/en geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit/deze toepassingsgebied/en valt onder verantwoordelijkheid van de gebruiker. Toepassingsgebied Type toepassing Werkzaamheid aannemelijk tegen Kers, zoete en zure kers (onbedekte teelt) gewasbehandeling Verhoging van de vruchthardheid, bevordering van de vruchtgrootte, Dosering* middel per toepassing 20 tabletten per 1000L water Maximale dosering middel per toepassing Maximaal aantal toepassingen per 12 maanden 20 tabletten/ha 1 - Minimum interval tussen toepassingen in dagen, NLKUG 1

6 14862 N Toepassingsgebied Type toepassing Werkzaamheid aannemelijk tegen Dosering* middel per toepassing Maximale dosering middel per toepassing Maximaal aantal toepassingen per 12 maanden oogstvertraging * Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Minimum interval tussen toepassingen in dagen Toepassingsvoorwaarden In de teelt van peer het middel toepassen gedurende de bloei (tussen 20-30% bloei en het einde van de bloei, BBCH 62-69). In de teelt van kers het middel toepassen bij begin van het rijpen van de vruchten (BBCH 81) In de teelt van druif toepassen vanaf het uitkomen van de bloesem tot aan volle bloei (BBCH 53-65). In de teelt van druif kan bij gevoelige rassen in het jaar na behandeling een beperkte terugkerende bloei worden geconstateerd indien een hogere dosering is toegepast. In bloemisterijgewassen kan het middel afhankelijk van het tijdstip van toepassing een vegetatieve groeistimulatie, een eerdere bloei of meer overdadige bloei tot resultaat hebben. De exacte positionering van de toepassing dient daarom aan het gewas en het beoogde effect te worden aangepast. Voer een kleinschalige proef uit om de dosering aan te passen aan plaatselijke omstandigheden (gewas, soort en andere specifieke plaatselijke omstandigheden). Om het grondwater te beschermen mag dit product in de bedekte grondgebonden teelten niet worden gebruikt in grondwaterbeschermingsgebieden., NLKUG 2

7 14862 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT ONDERBOUWING, NLKUG 3

8 Page 1 of 29 REGISTRATION REPORT Risk Management Product code: Active Substances: Gibberellic acid (GA 3 ) 204 g/kg COUNTRY: The Netherlands NATIONAL ASSESSMENT Applicant: Fine Agrochemicals Ltd

9 Page 2 of 29 Table of Contents PART A Risk Management Details of the application Application background Approval Regulatory approach Uses applied for Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Regulation (EC) No 1272/ R and S phrases under Regulation (EC) No 547/ Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses for extension (minor uses) Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Acute toxicity Operator exposure Bystander exposure Worker exposure Residues and Consumer Exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access... 22

10 Page 3 of 29 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of containing gibberellic acid in The Netherlands. The risk assessment conclusions are based on the already existing registration of in The Netherlands (risk envelope approach). The following sections of Registration Report, Part B were prepared on basis of new data (see also table below): Part B3 NL Addendum Part B5 NL Addendum Part B6 NL Addendum Risk envelope overview: section worst case critical GAP used covered by risk envelope (decision) remarks 1 Identity, physical and chemical 2 analytical methods not relevant for extension of authorisation according Article 51. formulation: not relevant for extension of authorisation according Article 51. residues: covered by the main authorisation yes - yes for residues see: mammalian toxicology Field, spray application (upward, mechanical and hand-held): 0.02 kg a.s./ha no Refer to Part B3 NL addendum 4 metabolism and residues covered by the main authorisation yes - 5 environmental fate Dependent on aspect soil, groundwater and/or surface water/sediment. Please refer to for details. no Please refer to and Part B5 NL addendum for details. 6 ecotoxicological studies Depending on aspect. Please refer to for details no Please refer to and Part B6 NL addendum for details 7 efficacy data not relevant for extension of authorisation according Article 51 n/a - 8 relevance of metabolites in groundwater covered by the main authorisation yes -

11 1 Details of the application Page 4 of 29 Application to extend the authorisation of a plant protection product (PPP) already authorised in The Netherlands to minor uses not yet covered by that authorisation. The application is intended for use in The Netherlands only. 1.1 Application background Details on applicant and application Plant protection product Type of application National application according to Article 51 Registration number Applicant Function Type of formulation N Fine Agrochemicals Ltd. Plant growth regulator Water soluble tablet (ST) Expiration of authorisation 31 August 2020 The expiration date of the active was postponed. The authorisation date of the PPP will be adapted accordingly. 1.2 Approval The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance(s) Gibberellic acid (GA 3) Content in PPP 0.9 G/tablet Approval status approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/08/2020

12 Page 5 of Regulatory approach is already registered in The Netherland according to Directive 91/414/EEC or Reg.(EC) No. 1107/2009 taking into account the Uniform Principles of Reg.(EC) No. 546/2011. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for See GAP (2.3) Public interest and minor use According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In The Netherlands the cultivated area of Cherry fall within the areas that are indicated to be minor uses (= field use maximum ha and indoor use max ha). 1.4 Data protection claims Not applicable, no new studies are submitted. 1.5 Letters of Access Not applicable. 2 Details of the authorisation 2.1 Product identity Product name Authorisation number Composition Type of formulation Function Authorisation holder N Gibberellic acid Water soluble tablet (ST) Plant growth regulator Fine Agrochemicals Ltd. 2.2 Classification and labelling Classification and labelling under Regulation (EC) No 1272/2008 The classification and labelling do not change. Please refer to the original authorisation authorization of 05/06/2015 (14826 N) R and S phrases under Regulation (EC) No 547/2011 Please see

13 Page 6 of Other phrases Please refer to the original authorisation authorization of 05/06/2015 (14826 N) Restrictions linked to the PPP The authorisation of the PPP is linked to the conditions (mandatory labelling) as stated on the label of the already authorized uses Specific restrictions linked to the intended uses See Appendix 2 (copy of the product label).

14 Page 7 of Product uses for extension (minor uses) The crossed out uses have been withdrawn by the applicant. PPP (product name/code) active substance 1 safener - synergist - Gibberellic acid GA3 Formulation type: water soluble tablet Conc. of as 1: 1g GA3 technical/tablet (corresponding to 0.9g GA3 pure/tablet and g technical/kg or pure g/kg) Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): Fine Agrochemicals Ltd National application professional use non professional use Field of use: plant growth regulator Use- No. (e) Member state(s) Crop and/ or situation (crop destination / purpose of crop) Minor uses according to Article 51 1 NL Cherry (sweet cherry, sour cherry, black cherry, capulin, chokecherry, cornelian cherry, nanking cherry) F, Fn, Fpn G, Gn, Gpn or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Increase fruit firmness, increase fruit size, delay harvest Method / Kind Full cover foliage spray until run-off Timing / Growth stage of crop & season BBCH 81 at the onset of ripening Application Application rate PHI Remarks: Max. number Min. kg product / ha g as/ha (days) Water a) per use interval a) max. rate per L/ha b) per crop/ between appl. a) max. rate season applications b) max. total per appl. min / (days) rate per b) max. total max crop/season rate per crop/season a) 1 b) 1 Not applicable a)0.098 b)0.098 a)20 b) e.g. g safener/synergist per ha (f) n.a. 20 tablets per ha Includes use on all cherries subgroup

15 Page 8 of Use- No. (e) 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) Method / Kind Timing / Growth stage of crop & season Application Application rate PHI Remarks: Max. number Min. kg product / ha g as/ha (days) Water a) per use interval a) max. rate per L/ha b) per crop/ between appl. a) max. rate season applications b) max. total per appl. min / (days) rate per b) max. total max crop/season rate per crop/season e.g. g safener/synergist per ha (f) 2 NL Zantedeschia I/G Increase flowering Dip Before planting BBCH00-01 Jan-Dec c) 1 d) 2 per crop cycle (4 per year) 10 a) b) per crop cycle ( per year) a) 56 b) 112 (224 per year) 200 n.a. 2 applications per crop cycle and 4 per year 28 tablets/100l 224 Tablets of per ha per year (based on 100,000 pl/ha and 2 ml dripping fluid per plant 3 NL Zantedeschia I/F Increase flowering Dip Before planting BBCH00-01 Jan-Dec a) 1 b) 2 per crop cycle (2 per year) 10 a) b) per crop cycle ( per year) a) 56 b) n.a. 2 applications per crop cycle and 2 per year 28 tablets/100l 112 Tablets of per ha per year (based on 100,000 pl/ha and 2 ml dripping fluid per plant 4 NL Pot plants F Increase flowering Foliar spray BBCH Jan-Dec a) 1 b) 4 per crop (4 per year) 7 a) b) per crop ( per year) a) 72 b) 288 per crop (288 per year) n.a 4/crop cycle and 4/year 1-6 tablets/100l 288 Tablets of per ha per year

16 Page 9 of Use- No. (e) 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) Method / Kind Timing / Growth stage of crop & season Application Application rate PHI Remarks: Max. number Min. kg product / ha g as/ha (days) Water a) per use interval a) max. rate per L/ha b) per crop/ between appl. a) max. rate season applications b) max. total per appl. min / (days) rate per b) max. total max crop/season rate per crop/season e.g. g safener/synergist per ha (f) 5 NL Cut flowers F Increase flowering, stretching of cells and earlier harvest Foliar spray BBCH Jan-Dec a) 1 b) 4 per crop (4 per year) 7 a) b) per crop ( per year) a) 72 b) 288 per crop (288 per year) n.a 4/crop cycle and 4/year 1-6 tablets/100l 288 Tablets of per ha per year 6 NL Forced shrubs G Increase flowering Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year tablets/100l 1320 Tablets of per ha per year 7 NL Forced shrubs F Increase flowering Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year tablets/100l 1320 Tablets of per ha per year 8 NL Ornamental shrubs G Increase flowering and earlier harvest Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year tablets/100l

17 Page 10 of Use- No. (e) 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) Method / Kind Timing / Growth stage of crop & season Application Application rate PHI Remarks: Max. number Min. kg product / ha g as/ha (days) Water a) per use interval a) max. rate per L/ha b) per crop/ between appl. a) max. rate season applications b) max. total per appl. min / (days) rate per b) max. total max crop/season rate per crop/season e.g. g safener/synergist per ha (f) 1320 Tablets of per ha per year 9 NL Ornamental shrubs F Increase flowering and earlier harvest Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year tablets/100l 1320 Tablets of per ha per year 10 NL Perennials G Increase flowering and improve number of berries Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year tablets/100l 1100 Tablets of per ha per year 11 NL Perennials F Increase flowering and improve number of berries Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year tablets/100l 1100 Tablets of per ha per year 12 NL Plant breeding and seed production G Increase flowering and earlier harvest Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year 1-11 tablets/100l

18 Page 11 of Use- No. (e) 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) Method / Kind Timing / Growth stage of crop & season Application Application rate PHI Remarks: Max. number Min. kg product / ha g as/ha (days) Water a) per use interval a) max. rate per L/ha b) per crop/ between appl. a) max. rate season applications b) max. total per appl. min / (days) rate per b) max. total max crop/season rate per crop/season e.g. g safener/synergist per ha (f) 110 Tablets of per ha per year 13 NL Plant breeding crops and flower seed production, vegetable seed production and production of herb seeds F Increase flowering and earlier harvest Foliar spray BBCH Jan-Dec a) 1 - a) a) n.a 1/crop and 1/year 1-11 tablets/100l 110 Tablets of per ha per year

19 Page 12 of 29 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according Article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according Article Analytical methods for residues The new uses are on plant commodities intended to be used for food for human consumption, therefore MRL/matrix combination extrapolation is required for the section analytical methods. However, no MRL s have been established for gibberellic acid in plant matrices (intended to be used for human consumption) and therefore no analytical methods for the determination of residues are required Mammalian Toxicology Acute toxicity For the acute toxicity study data it is referred to the core assessment of the original authorization of 05/06/2015 (14826 N) Operator exposure According to the model calculations, it can be concluded that the risk for the operator using on high level crops for mechanical and manual field application is within acceptable levels. No PPE is required Bystander exposure Based on the model calculations provided in the NL addendum, it is concluded that the bystander and the resident exposure of children and adults living next to a field treated with is considered to be safe Worker exposure The risk is acceptable for the worker wearing appropriate work clothing but no PPE for re-entry activities in cherry Residues and Consumer Exposure

20 Page 13 of 29 The proposed extension for use involves an application on cherry and non-edible crops (Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production). The uses on Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production have been withdrawn by the applicant. The active substance Gibberellic acid (GA 3) is a natural plant hormone and occurs in a wide range of plants. GA 3 is included in Annex IV (Reg. (EC) 396/2005), hence no MRL applies. The proposed extension on cherries remains within the existing risk envelope for the section residues and consumer risk assessment. No risk for the consumer is expected Environmental fate and behaviour Prior to performing this risk assessment the following was concluded: The new field uses of applied for in a range of new uses do not have an equal (or lower) risk for persistence in soil, leaching to groundwater, and emission to surface water and sediment as the already authorised uses. The new glasshouse uses of applied for in forced shrubs, ornamental shrubs and perennials do not have an equal (or lower) risk for leaching to groundwater and emission to surface water and sediment (only relevant for forced shrubs and ornamental shrubs) as the already authorised uses. The new glasshouse uses of have an equal (or lower) risk for persistence in soil as the already authorized uses. The new glasshouse uses of applied for in Zantedeschia and plant breeding and seed production have an equal (or lower) risk for leaching to groundwater, and emission to surface water and sediment (also relevant for perennials) as the already authorised uses. Substance has been on the Dutch market for > 3 years (authorised since 1988). This period is sufficiently large to consider the market share to be established. The substance was not mentioned on the latest (2015) VEWIN list with problematic substances. The now proposed extension of the use concerns a minor use with limited acreage. Therefore it is considered that this will not contribute substantially to the use of the active substance. The drinking water criterion is considered to be met. The available and most recent monitoring data in groundwater and surface water have been reviewed and have no consequences for the proposed uses. In the B.5 NL Addendum Fate and behaviour, PEC values for the field uses and glasshouse uses (applied for in forced shrubs, ornamental shrubs and perennials) applied for are reported. Predicted Environmental Concentrations in Soil (PECs) for the Active Substance PECsoil (PECs) values for GA3 were calculated for the critical use from the field uses listed in Table 9-1, assuming residues are evenly distributed throughout the upper 5 cm of soil and the soil has a bulk density of 1.5 g/cm3. The input parameters are listed below for ease of reference. A risk envelope approach was followed regarding the newly applied field uses. Therefore, a single dose rate of 1320 tablets (= 1320 g a.s.) applied for in ornamental shrubs and forced shrubs was accounted for in PECsoil calculations assuming 25% interception (based on the interception values of cabbage and beans respectively). This calculations is deemed to cover the risk of the remaining field uses applied for.

21 Page 14 of 29 Initial PECsoil value for use in ornamental shrubs and forced shrubs is mg/kg. Predicted Environmental Concentrations in Ground Water (PECgw) The groundwater assessment of the field uses applied for regarding active substance gibberellic acid is directly performed in GeoPEARL, as both DT50 and Kom are smaller than 10. Application of Gibberellic acid according to the field uses listed in Table 9-1 are summarised in Table showing the input parameters used for the simulations using GeoPEARL GeoPEARL is not appropriate to account for glasshouse uses. Therefore, PECgw simulations regarding the glasshouse uses were performed using PEARL Application of Gibberellic acid according to the critical uses from the glasshouse uses listed in Table 9-1 are summarised in Table showing the input parameters used for the simulations using FOCUS PEARL Results of GeoPEARL and PEARL using the Kremsmünster scenario are examined against the standard of 0.01 µg/l. This is the standard of 0.1 µg/l with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation). Field uses From Table it reads that the expected leaching based on the GeoPEARL-model calculations for the active substance is smaller than 0.01 µg/l for the spring applications. GeoPEARL calculations show that the predicted leachate concentrations are equal to or larger than 0.1 µg/l for application in autumn (except application in Plant breeding crops and flower seed production, vegetable seed production and production of herb seeds). Therefore, the proposed use of the active substance is not permissible in the proposed field uses except Plant breeding crops and flower seed production, vegetable seed production and production of herb seeds from September up to and including February. As the predicted concentration for the active substance in the proposed field use in Plant breeding crops and flower seed production, vegetable seed production and production of herb seeds is equal to or larger than 0.01 µg/l, a restriction on the use in groundwater protection areas should be placed on the label. Om het grondwater te beschermen mag dit middel in de onbedekte teelt van veredeling en bloemenzaadteelt, groentezaadteelt en zaadteelt van kruiden niet worden gebruikt in grondwaterbeschermingsgebieden in de periode van 1 september tot 1 maart. However, the applicant decided to withdraw the uses on Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production. The warning sentence is therefore not required on the label. Glasshouse uses From Table it reads that the expected leaching based on the PEARL-model calculations for the active substance is equal to or larger than 0.01 µg/l for the proposed glasshouse use in ornamental shrubs, forced shrubs and perennials, a restriction on the use in groundwater protection areas should be placed on the label. Om het grondwater te beschermen mag dit product in de bedekte grondgebonden teelten niet worden gebruikt in grondwaterbeschermingsgebieden. The proposed glasshouse uses have been withdrawn by the applicant, but the sentence was already on the WG after the original authorization.

22 Page 15 of 29 Predicted environmental concentrations in surface water (PECsw) for the active substance PECsw for GA3 were calculated according to Dutch National Guidance (CTGB 2011). The TOXSWA GUI model (Version 1.0) was used to model the surface water exposure from GA3 arising from the use of on a range of field uses. As a worst case approach, only the use in ornamental shrubs/ forced shrubs and cherries have been modelled regarding the field uses. Regarding glasshouse application, the use in ornamental shrubs/ forced shrubs has been modelled. PECinitial values are µg/l, µg/l and µg/l for ornamental shrubs/ forced shrubs (field), cherries and ornamental shrubs/ forced shrubs (glasshouse) respectively. The exposure concentrations in surface water are compared to the ecotoxicological threshold values in the ecotoxicological section Ecotoxicology The risk of the applied indoor/greenhouse use in forced and ornamental shrubs, Zantedeschia, perennials and plant breeding and seed production is equal to or lower than the risk of the authorised uses with regard to the environment for all aspects addressed above. The risk of the use in cherry is not included in the risk envelope for the aspects birds, aquatic organisms, mammals, NTA (in-field), earthworms, soil micro-organisms, and non-target plants. For these aspects a separate risk assessment is required. The risk for outdoor use in Zantedeschia, pot plants, cut flowers, forced and ornamental shrubs, perennials, and plant breeding and seed production is not included in the risk envelope for all ecotox aspects (except for bees for use in Zantedeschia, pot plants, perennials and plant breeding and seed production). For these aspects a separate risk assessment is required. Effects on Terrestrial Vertebrates Effects on birds from the critical uses proposed for have not been evaluated as part of the EU review of Gibbrellic acid (GA 3). Therefore, all risk assessments and supporting data for with the proposed use pattern are provided here and are considered adequate. The risk assessment for effects on mammals is carried out according to the latest EFSA Guidance document draft of the EFSA Guidance Document on Risk Assessment for Birds and Mammals (Anonymous 2009). The acute and long-term risks of to wild mammals were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with GA 3, and maximum residues occurring on food items following applications according to the use pattern. The risk to mammals from exposure via drinking water has also been assessed. The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and 5 for long-term risk, thus indicating acceptable risk to mammals from the proposed uses. Effects on Aquatic Species The TER values using worst-case PEC SW values for GA 3 exceed the triggers for fish, aquatic invertebrates and algae indicating that the risk to these groups is acceptable following use of according to the proposed use pattern. TERA for fish

23 Page 16 of 29 The TER values for the acute risk assessment exceed the trigger of 100 and therefore the risk is acceptable. TERLT for fish and Daphnia A chronic risk assessment for fish was considered unnecessary during the EU review of gibberellic acid (GA 3) based on the expected levels of natural occurrence and rapid degradation of GA 3 by hydrolysis (DAR, 2008, B & ). However the new proposed uses are expected to reach concentrations higher than the background concentration. Therefore a chronic risk assessment has been performed in a qualitative way. Based on the expected exposure concentrations, the chronic endpoint should be a factor of 1000 times lower than the lowest acute endpoint, which is considered to be unlikely. Therefore the risk is acceptable. TER A for Daphnia The aquatic risk assessment conducted at EU level for uses on vines in accordance with SANCO/3268/2001 demonstrated that the acute risk to aquatic invertebrates was acceptable. It has been demonstrated that the proposed uses of lead to PEC max values in surface water and sediment that are considerably lower than the equivalent values used for risk assessment purposes during the EU review. The risk therefore fits within the risk envelope of the EU assessment and no further TER values are necessary. TER LT for algae The calculated TER values for aquatic plants are greater than the trigger value indicating an acceptable risk to aquatic plants following exposure to when used according to the GAP. TER for aquatic plants The calculated TER values for aquatic plants are greater than the trigger value indicating an acceptable risk to aquatic plants following exposure to when used according to the GAP. Effects on Bees and Other Arthropod Species The risk of to honey-bees was assessed from hazard quotients between toxicity endpoints, estimated from an acute contact study with GA 3, and the maximum single application rate of 1320 g a.s./ha. The hazard quotient for GA 3 is more than < 53, indicating that a possible risk to bees. However as at the highest dose rate, no mortality was observed, the actual HQ will be below the trigger of 50.Other non-target Arthropods Effects on non-target arthropods of the formulation were not evaluated as part of the review of gibberellic acid (GA 3) for Annex I inclusion (DAR, 2008). However, a standard tier 1 glass-plate study conducted using with Typhlodromus pyri is available. The calculated first tier in-field and off-field HQ values for the indicator species are lower than the ESCORT 2 trigger value of 2 for the use in cherry, indicating an acceptable risk to non-target arthropods following the proposed uses of. For the other uses, the in-field HQ was above the trigger of 2. For the off-field the HQ was above the trigger for the use in forced and ornamental shrubs. A second species (Aphidius colemani) had a lower endpoint. Therefore the risk is not acceptable for the proposed outdoor uses, except the use in cherry. However, these risks were resolved subsequently as the applicant decided to withdraw the uses in Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production. No unresolved risks remain for the use in cherry.

24 Page 17 of 29 For greenhouse uses an in-field risk cannot be excluded. Therefore the following warning sentence should be included on the label: Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg deskundigen (uw leverancier van natuurlijke vijanden, de producent van dit middel, uw adviseur) over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden However, the applicant decided to withdraw the greenhouse uses. The warning sentence is therefore not required on the label. Effects on Earthworms and Other Soil Macro-organisms During the EU review of gibberellic acid (GA 3), it was considered that exposure from the representative use on grapevines would not exceed naturally occurring levels of gibberellins in soil. It was noted in the DAR that the maximum estimated PEC in soil after multiple applications was mg/kg and that GA 3 is found in plant material at levels of up to 10 mg/kg and in soil at levels up to 1 mg/l. The DAR also noted that rapid degradation in soil (DT 50 of ca 4.5 days) means that GA 3 will not persist. The DAR concluded that: As both acute and long-term exposure of earthworms from the use of GA 3 on grapes will be insignificant compared to naturally occurring levels of GAs it is considered that there will be no risk to such organisms from the uses proposed and therefore that no earthworm data are required. For most uses, the proposed use will give concentrations below the background concentration. However the proposed uses in forced and ornamental shrubs, and perennials are expected to have higher concentration than the natural occurrence. For these uses further data is required. However the applicant decided to withdraw the uses in Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production and therefore no risk remains. Effects on Soil Non-target Micro-organisms During the EU review of gibberellic acid (GA 3), it was considered that exposure from the representative use on grapevines would not exceed naturally occurring levels of gibberellins in soil. It was noted in the DAR that the maximum estimated PEC in soil after multiple applications was mg/kg and that GA 3 is found in plant material at levels of up to 10 mg/kg and in soil at levels up to 1 mg/l. The DAR also noted that rapid degradation in soil (DT 50 of ca 4.5 days) means that GA 3 will not persist. The DAR concluded that:for most uses, the proposed use will give concentrations below the background concentration. However the proposed uses in forced and ornamental shrubs, and perennials are expected to have higher concentration than the natural occurrence. For these uses further data is required. However the applicant decided to withdraw the uses in Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production and therefore no risk remain. Effects on non-target plants The exposure from the proposed field uses is expected to be lower than the background concentrations. Therefore the risk is acceptable Efficacy According to Article 51 of the Regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products does not need to be checked.

25 Page 18 of Conclusions is already registered in The Netherlands according to Directive 91/414/EEC or Reg. (EC) No. 1107/2009 taking into account the Uniform Principles of Reg. (EC) No. 546/2011. The uses in Zantedeschia, pot plants, cut flowers, forced shrubs, ornamental shrubs, perennials, plant breeding and seed production have been withdrawn by the applicant. The minor use extension in cherries is considered acceptable. The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of uses. No adverse health effects are expected for operators, workers, bystanders and residents. The active substance Gibberellic acid (GA 3) is a natural plant hormone and occurs in a wide range of plants. GA 3 is included in Annex IV (Reg. (EC) 396/2005), hence no MRL applies. The proposed extension on cherries remains within the existing risk envelope for the section residues and consumer risk assessment. No risk for the consumer is expected. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. 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 None.

26 Page 19 of 29 Appendix 1 Copy of the product authorisation The final product authorisation in The Netherlands can be found on the Ctgb website : English> authorised products database > Search term.

27 Page 20 of 29 Appendix 2 Copy of the product label Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als groeiregulator door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden. Toepassingsvoorwaarden: Toepassingsgebied Type toepassing Doel groeiregulatie Dosering (middel) per toepassing Maximale dosering (middel) per toepassing Maximaal aantal toepassingen per 12 maanden Peer (onbedekte teelt) Wijndruif (onbedekte teelt) Rabarber (bedekte teelt) Bloemisterijgewassen (bedekte teelt) over het gewas bevordering van de vruchtzetting 6 tabletten per 1000L water 6 tabletten/ha 1 over het verlaging van de tros 16 tabletten per 500L water 16 tabletten/ha 1 gewas compactheid aangieten vervroegen van de oogst 4-10 tabletten per 100L 1250 tabletten/ha 1 water en 0,25L oplossing per plant over het vegetatieve groei 6-16 tabletten per100l 160 tabletten/ha 1 gewas bevordering en bloei water stimulering Het gebruik in de teelt van kers (zoete en zure kers), is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing/en geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit/deze toepassingsgebied/en valt onder verantwoordelijkheid van de gebruiker. Toepassingsgebied Type toepassing Doel groeiregulatie Dosering (middel) per toepassing Maximale dosering (middel) per toepassing Maximaal aantal toepassingen per 12 maanden Kers, zoete en zure kers (onbedekte teelt) over het gewas Verhoging van de vruchthardheid, bevordering van de vruchtgrootte, 20 tabletten per 1000L water 20 tabletten/ha 1

28 Page 21 of 29 Toepassingsgebied Type toepassing Doel groeiregulatie Dosering (middel) per toepassing Maximale dosering (middel) per toepassing Maximaal aantal toepassingen per 12 maanden oogstvertraging Toepassingsvoorwaarden In de teelt van peer het middel toepassen gedurende de bloei (tussen 20-30% bloei en het einde van de bloei, BBCH 62-69). In de teelt van kers het middel toepassen bij begin van het rijpen van de vruchten (BBCH 81) In de teelt van druif toepassen vanaf het uitkomen van de bloesem tot aan volle bloei (BBCH 53-65). In de teelt van druif kan bij gevoelige rassen in het jaar na behandeling een beperkte terugkerende bloei worden geconstateerd indien een hogere dosering is toegepast. In bloemisterijgewassen kan het middel afhankelijk van het tijdstip van toepassing een vegetatieve groeistimulatie, een eerdere bloei of meer overdadige bloei tot resultaat hebben. De exacte positionering van de toepassing dient daarom aan het gewas en het beoogde effect te worden aangepast. Voer een kleinschalige proef uit om de dosering aan te passen aan plaatselijke omstandigheden (gewas, soort en andere specifieke plaatselijke omstandigheden). Om het grondwater te beschermen mag dit product in de bedekte grondgebonden teelten niet worden gebruikt in grondwaterbeschermingsgebieden.

29 Page 22 of 29 Appendix 3 Letter of Access Not applicable.