HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 BESLUIT Op 17 september 2013 is van Chrysal International B.V. Gooimeer DD NAARDEN een aanvraag tot herregistratie van de toelating van het gewasbeschermingsmiddel ontvangen voor het middel Chrysal RVB op basis van de werkzame stof aluminiumsulfaat. HET COLLEGE BESLUIT tot 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. Chrysal RVB, THG 1

2 - 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. - 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) De W-codering van het etiket behorende bij dit besluit wordt opgehoogd van W.1 naar W.2 omdat de formulering van de restrictie ter bescherming van aquatische organismen is aangepast. De strekking van de restrictie is wel in lijn met de bestaande restrictie en daarom is er geen reden om de door aanvrager verzochte maximale respijtperiode te beperken. Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen met W-codering W.1 mogen worden afgeleverd tot 1 september 2015 en worden opgebruikt tot 1 september WETTELIJKE GRONDSLAG Besluit artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Conform Rgb d.d. 13 juni 2011, Evaluation Manual 1.1, GD Birds & Mammals 2012 en GD Dermal Absorption 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. Chrysal RVB, THG 2

3 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 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Wageningen, 6 maart 2015 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, Ir. J.F. de Leeuw Voorzitter Chrysal RVB, THG 3

4 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: THG Type aanvraag: aanvraag tot herregistratie van de toelating van het gewasbeschermingsmiddel Middelnaam: Chrysal RVB Formele registratiedatum: * 17 september 2013 Datum in behandeling name: Datum compliance check: 20 januari 2012 * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof aluminiumsulfaat Gehalte 44 G/L De stof aluminiumsulfaat is per 1 juni 2011 geplaatst op Annex I van Richtlijn 91/414/EEG (Dir 2011/47/EC d.d. 15 april 2011) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof expireert op 31 mei Toelatingsinformatie Toelatingsnummer: N Expiratiedatum: 1 maart 2025 Afgeleide of parallel: n.v.t. Biocide, gewasbeschermingsmiddel of Gewasbeschermingsmiddel toevoegingsstof: Gebruikers: Professioneel W-codering professioneel gebruik: 2 4 Aflever- en opgebruiktermijnen voor oude etiket Vorige W-codering professioneel gebruik: 1 Aflevertermijn professioneel gebruik: 1 september 2015 Opgebruiktermijn professioneel gebruik: 1 september Verpakkingsinformatie Aard van het preparaat: Uiterste gebruiksdatum: Met water mengbaar concentraat 18 maanden na de productiedatum Chrysal RVB, THG 4

5 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Chrysal RVB Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram Signaalwoord Gevarenaanduidingen H413 Kan langdurige schadelijke gevolgen voor in het water levende organismen hebben. Voorzorgsmaatregelen P262 Contact met de ogen, de huid of de kleding vermijden. 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 EUH401 Volg de gebruiksaanwijzing om gevaar voor de etiketelementen menselijke gezondheid en het milieu te voorkomen. Kinderveilige sluiting verplicht n.v.t. Voelbare gevaarsaanduiding verplicht n.v.t. Chrysal RVB, THG 5

6 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als bacteriebestrijdingsmiddel door middel van het in een oplossing zetten van de snijbloem in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden Toepassingsgebied Te bestrijden organisme en doel Dosering (middel) per toepassing Roos Bouvardia Chrysant * behandelingsduur minimaal 12 uur Bestrijden bacteriën met als doel verlengen van de houdbaarheid 10 ml middel/liter water* Het gebruik in de teelt van Hortensia, Symphoricarpus, Achillea, Solidago en Tanacetum (Matricaria) is op basis van een derdenuitbreiding en beoordeeld conform artikel 51 EG 1107/2009. Deze derdenuitbreiding is aangevraagd door Stichting Trustee Bijzondere Toelatingen. Er is voor deze uitbreiding geen werkzaamheids- en fytotoxiciteitsonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbehandeling uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheid van de gebruiker. Toepassingsgebied Te bestrijden organisme en doel Dosering (middel) per toepassing Hortensia Symphoricarpus Achillea Solidago Tanacetum (Matricaria) * behandelingsduur minimaal 12 uur Bestrijden bacteriën met als doel verlengen van de houdbaarheid 10 ml middel/liter water* Toepassingsvoorwaarden Om in het water levende organismen te beschermen is de toepassing uitsluitend toegestaan indien de gebruikte vloeistof wordt afgevoerd naar het riool met aansluiting op de RWZI. Chrysal RVB, THG 6

7 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT Contents Page 1. Identity of the plant protection product 2 2. Physical and chemical properties 3 3. Methods of analysis 9 4. Mammalian toxicology Residues Environmental fate and behaviour Ecotoxicology Efficacy Conclusion Classification and labelling 33 Appendix 1 Table of authorised uses 34 Appendix 2 Reference list 35 Chrysal RVB, THG 1

8 1. Identity of the plant protection product 1.1 Applicant Chrysal International B.V. Gooimeer DD NAARDEN 1.2 Identity of the active substance Common name Aluminium sulphate Name in Dutch Aluminiumsulfaat Chemical name Aluminium sulphate CAS no EC no (EINECS) The active substance was included in Annex I of Directive 91/414/EEC on 1 June From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC. 1.3 Identity of the plant protection product Name Chrysal RVB Formulation type SL Content active substance 44 g/l aluminium sulphate The formulation was not part of the assessment of the active substance for inclusion in Annex I of Directive 91/414/EEC 1.4 Function Plant growth regulator 1.5 Uses applied for See GAP (Appendix I). Uses authorized are equal to uses applied for. It concerns the re-registration of Chrysal RVB. Chrysal RVB is claimed for professional use as a bactericide for the improvement of quality after harvest in cut flowers of Bouvardia, Chrysanthemum and Rose, and through minor uses extension (in Dutch: derdenuitbreiding ) in Hortensia, Symphoricarpus, Achillea, Solidago and Tanacetum (Matricaria). Cut flowers are put in solution of 10 ml Chrysal RVB per litre water directly after harvest for at least 12 hours. 1.6 Background to the application The application for Chrysal RVB concerns a reregistration of existing uses in post harvest treatment of cut flowers to improve vase life Packaging description Material: Professional use: HDPE Capacity: Professional use: 5L, 10L, 25L or 220L Type of closure and size 48.8mm opening with screw cap of opening: 220L: not specified. Other information UN/ADR compliant (tests not required) Detailed instructions for safe disposal No particular recommendations Chrysal RVB, THG 2

9 2. Physical and chemical properties 2.1 Active substance: aluminium sulphate The final List of Endpoints presented below is taken from the EFSA Journal 2010;8(11):1889, also taking into account the final review report (SANCO/13470/2011 final, d.d. 11 March 2011). Where relevant, some additional remarks/information are given in italics. Identity Active substance (ISO Common Name) Chemical name (IUPAC) Chemical name (CA) CIPAC No Aluminium sulphate (No ISO common name) Aluminium sulphate Aluminium sulphate Not available CAS No EEC No (EINECS or ELINCS) EINECS: FAO Specification (including year of publication) Minimum purity of the active substance as manufactured (g/kg) Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg) No FAO specification 970 g/kg* None Molecular formula Al 2 (SO4) 3 Molecular mass Structural formula g/mol (anhydrous) g/mol (with 14 H 2 O) * inclusion Directive 2011/47/EU Because data on physical and chemical properties is not listed in the EFSA Journal, volume 1 of the Additional Report (December 2009) is used. Physical-chemical properties (data from additional report December 2009) Melting point (state purity) 770 C with decomposition (literature data) Boiling point (state purity) Temperature of decomposition Appearance (state purity) At >75 C, crystal water evaporates (99.98%). Meltin g was not observed. Weight loss at 196 C was 25%. not applicable 770 C (literature data) Anhydrous: White, lustrous crystals, pieces, granules, or powder Technical substance: White solid Surface tension 1 g/l at 20 C: 74.5 mn/m (99.98%) Chrysal RVB, THG 3

10 Vapour pressure (in Pa, state temperature) Henry s law constant (in Pa m 3 mol -1 ) Solubility in water (in g/l or mg/l, state temperature) not applicable not applicable The aqueous solution reacts acidic in consequence of hydrolysis. In case of ph-increase, especially in the neutral range of ph, precipitation of Aluminium hydroxide may occur. At low ph values (< 4.0), dissolved Al is almost entirely present as Al 3+. At ph values < 4.5, SO 4 complex form a small percentage of the total soluble Al because the elevated Al concentrations readily complex available SO 4. However, Al-bound forms compose a significant fraction of the total concentration of dissolved SO 4 under acidic conditions. As ph values increase, Al undergoes hydroxy transformation. The distribution of aqueous Al shifts from Al 3+ to largely OH-complexed species. The solubility of Al is minimum near ph 6.5 and increases at ph values above 6.5 due to the formation of Al(OH) 4 -.(literature data) Orientative solubility of Aluminium sulphate in 100 g H 2 O: Solubility in organic solvents (in g/l or mg/l, state temperature) Partition co-efficient (log P ow ) (state ph and temperature) at 0 C 54.2 g Al 2 (SO 4 ) 3 at 10 C 58.2 g Al 2 (SO 4 ) 3 at 20 C 62.9 g Al 2 (SO 4 ) 3 at 30 C 70.4 g Al 2 (SO 4 ) 3 at 50 C 90.7 g Al 2 (SO 4 ) 3 at 100 C154.8 g Al 2 (SO 4 ) 3 Not soluble in ethanol Soluble in dilute acids (literature data) (provisional) No data. Inorganic salts tends to increase surface tension of water. Not surface active. Hydrolytic stability (DT 50 ) (state ph and temperature) Not applicable Dissociation constant Al 3+ + SO = AlSO 4 log K = 3.01 Al SO = Al(SO 4 ) 2 log K = 4.90 Al 3+ + H 2 O = (AlOH) 2+ + H + log K =-5.02 Al H 2 O = (Al(OH) 2 ) + + 2H + log K =-9.30 Al H 2 O = Al(OH) 3 + 3H + log K = Al H 2 O = (Al(OH) 4 ) - + 4H + log K = Al H 2 O = (Al(OH) 5 ) H + log K = Al H 2 O = (2Al 2 (OH) 2 ) H + log K = Al(OH) 3 + H 2 O = Al(OH) - 4 log K = to (literature data) UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength) Photochemical oxidative degradation in air Not applicable Not applicable Chrysal RVB, THG 4

11 Flammability Auto-flammability Oxidising properties Explosive properties Not highly flammable Not self-igniting Not oxidising Not explosive In the EFSA peer-review conclusion, the following data requirements are included: For each source (manufacturing site) a specification with supporting batch data and validated methods of analysis (relevant for the representative use evaluated; submission date proposed by the applicant: unknown; see section 1).; Physical-chemical properties Annex II data package or reasoned cases to waive these requirements (relevant for the representative use evaluated; submission date proposed by the applicant: unknown; see section 1). Shelf-life study to demonstrate the stability of aluminium sulphate or a reasoned case to waive this requirement (relevant for the representative use evaluated; submission date proposed by the applicant: unknown; see section 1). Confirmatory data was evaluated in December 2012 and was considered sufficient by the RMS. The EFSA Journal does not contain data on the annex II data package for physical and chemical properties. The applicant has provided some additional statements and studies. The RMS considers that the dossier is acceptable with the additional data provided by the applicant. New GLP data was generated on the melting point and the surface tension. The study is acceptable and data was added to the list of endpoints above. 2.2 Plant protection product: Chrysal RVB Data on the plant protection product is taken from the studies reports submitted by the applicant. The application concentration of the plant protection product is a 1%v/v solution for a postharvest bactericide treatment of cut flowers. The product is not sprayed, but cut flowers are placed in buckets with the solution for a certain period after harvest. Section (Annex point) B ) B ) B ) B ) B ) Study Appearance: physical state Appearance: colour Appearance: odour Explosive properties Oxidising properties Guidelines and GLP Not to GLP Visual Not to GLP Visual Not to GLP Olfactory Theoretical assessment Theoretical assessment Findings Liquid Colourless Mild odour Not explosive Not oxidising Evaluation and conclusion Acceptable Acceptable Acceptable Acceptable Acceptable Chrysal RVB, THG 5

12 Section (Annex point) B ) B ) B ) B ) B ) B ) B ) Study Flammability Autoflammability Flash point Acidity / alkalinity ph Surface tension Viscosity Guidelines and GLP Theoretical assessment Theoretical assessment GLP CIPAC MT191 Not to GLP OECD 122 GLP OECD 115 Not to GLP Rotational viscometer Findings Not applicable Not self-igniting Not flammable. The product contains no flammable components. 3.47%w/w as H 2 SO 4 1%: 3.84 Undiluted: mn/m at 25 C (undiluted) Evaluation and conclusion Acceptable Acceptable Acceptable Acceptable GLP compliance is not considered essential. The study was performed according to an internationally accepted standard and reported in sufficient detail. The results are therefore considered valid. Acceptable < 20 cp Acceptable, since viscosity is not relevant for this type of formulation. B ) B ) Relative density Bulk (tap) density Not to GLP Mettler densitometer Density: kg/l at 25 C Not applicable The study itself is not acceptable considering temperature and shear rates were not reported and the study was not reported to GLP. Acceptable GLP compliance is not considered essential. Chrysal RVB, THG 6

13 Section (Annex point) B ) B ) Study Storage stability Guidelines and GLP Not to GLP Not stated Not to GLP CIPAC MT46.3 Findings No separated material after 7 days at 0 C. Stable for 2 weeks at 54 C in HDPE. Properties determined before and after storage: appearance, a.s. content (aluminium content determined by ICP-AES). Shelf life Not to GLP Stable for 1 and 2 years in HDPE at ambient temperatures. Properties determined before and after storage: appearance, a.s. content (aluminium and sulphate content determined by ICP- AES), ph. Evaluation and conclusion Acceptable The test method was not described in detail, but the conditions are sufficiently comparable to CIPAC MT39.3. Acceptable Acceptable Considering the intended use and the fact that the product is not sprayed, a determination of the dilution stability is not considered required. No initial values are available and two different batches were tested. It is not expected that the aluminium content will decrease over time. Nor is it likely to happen to the sulphate content. Neither of the two ions is prone to hydrolysis, nor photolysis. In theory, it is possible aluminium sulphate may crystallise, but the report indicates the Chrysal RVB, THG 7

14 Section (Annex point) Study Guidelines and GLP Findings Evaluation and conclusion appearance remains the same over time. No separation was observed in the aged samples. Therefore this does not seem likely to occur. B ) B ) B ) B ) B ) B ) B ) B ) B ) B ) B ) Wettability Persistent foaming Suspensibility Spontaneity of dispersion Dilution stability Dry sieve test Wet sieve test Particle size distribution Content of dust/fines Attrition and friability Emulsifiability, reemulsifiability and emulsion stability B Stability of GLP CIPAC MT47.2 Not to GLP CIPAC MT41 Not applicable 10mL/L (1%v/v)16 ml foam after 1 minute in CIPAC D water Not applicable Not applicable No precipitation or discolouration (10mL/L in CIPAC D) Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable The study claims a 18 month shelf-life, probably due to the deficiencies described above. Acceptable Acceptable Chrysal RVB, THG 8

15 Section (Annex point) 2.8) B ) B ) B ) B ) Study dilute emulsion Flowability Pourability (rinsibility) Dustability Adherence and distribution to seeds Physical compatibility with other products Chemical compatibility with other products Guidelines and GLP Findings Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Evaluation and conclusion Conclusion The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions. The shelf-life of the product is 18 months in HDPE. In the GAP/instructions for use the following has to be stated: None. 2.3 Data requirements None. 3. Methods of analysis The final List of Endpoints presented below is taken from the EFSA Journal 2010;8(11):1889. Where relevant, some additional remarks/information are given in italics. 3.1 Analytical methods in technical material and plant protection product Technical as (principle of method) Complexometric titration with EDTA Impurities in technical as (principle of method) Preparation (principle of method) AAS, ICP-MS Complexometric titration with EDTA, ICP-AES Chrysal RVB, THG 9

16 Conclusion The analytical methods regarding the technical active substance have been assessed in the DAR and are considered to be acceptable. For the formulation, an adequately validated ICP- AES method was provided. 3.2 Residue analytical methods Aluminium sulphate does not need to be monitored in the environment. No residue definitions for food/feed of plant and animal origin, soil, water or air were set during the EU review of the substance. Therefore, no list of endpoints is included in this section. Conclusion The submitted analytical methods meet the requirements. 3.3 Data requirements None. 4. Mammalian toxicology List of Endpoints The final List of Endpoints presented below is taken from the EFSA Scientific Report on aluminium sulphate (2010;8(11); 1889 (d.d. 5 November 2010) Where relevant, some additional remarks/information are given in italics. Impact on Human and Animal Health Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 5.1) (1) Rate and extent of oral absorption Distribution Potential for accumulation Rate and extent of excretion Metabolism in animals Toxicologically relevant compounds (animals and plants) Toxicologically relevant compounds (environment) Less than 1% (for aluminium) with different aluminium chemical species. For the risk assessment a value of 1% was used In blood, aluminium is present in plasma bound to transferring (89%of aluminium in plasma). Aluminium shows slight potential for accumulation in the brain, bone, muscle and kidney (orally exposed animals). Most of aluminium ingested is unabsorbed and excreted in the feces (76-98% oral dose). Absorbed aluminium is eliminated via the urine. No metabolism occurs. Aluminium sulphate Aluminium sulphate (1) Data from different aluminium chemical species (no aluminium sulphate) Acute toxicity (Annex IIA, point 5.2) (2) Rat LD 50 oral Rat LD 50 dermal LD 50 > 5000 mg/kg bw Based on the data from the representative formulation (Chrysal RVB), an LD50 > 2000 Chrysal RVB, THG 10

17 Rat LC 50 inhalation Skin irritation mg/kg bw can be assumed. No classification, based on weight of evidence (no study provided) Not irritating Eye irritation Severe irritating R41 Skin sensitization Non sensitizer (LNNA) Respiratory system irritation Irritating to respiratory system R37 (2) The studies have been performed with ALUM 17 (which is Al2(SO4)3 14 H2O or alternatively as 17 % Al2O3. which is the notified active substance Short term toxicity (Annex IIA, point 5.3) Target / critical effect Liver, kidney and brain in rats. Multifocal degeneration of the liver, swelling and degeneration of cortical and distal renal tubules, degeneration of nerve cells (3) Relevant oral NOAEL 21-days rat: LOAEL 212 mg Al 2 (SO 4 ) 3 /kg bw/day (3). Relevant dermal NOAEL No data, not required Relevant inhalation NOAEL No data, not required (3) This findings should be considered only as an approximation since the data presented in the reports were limited and inadequate. Genotoxicity (Annex IIA, point 5.4) Overall, unlikely to be genotoxic. However, clastogenicity observed in in vitro and in vivo tests with limited validity. Long term toxicity and carcinogenicity (Annex IIA, point 5.5) Target/critical effect Relevant NOAEL Carcinogenicity No specific studies provided. There are no indications for a carcinogenic potential of aluminium (ATSDR 2008, EFSA 2008) No data, not required Increase of undefined tumours in old rodent studies, not in a more recent study. No evidence for carcinogenicity in humans. Reproductive toxicity (Annex IIA, point 5.6) Multigeneration study Reproduction target / critical effect Relevant parental NOAEL Relevant reproductive NOAEL Relevant offspring NOAEL No specific studies provided. Aluminium is not associated with reproductive effects (ATSDR 2008). No data, not required No data, not required No data, not required Chrysal RVB, THG 11

18 Developmental toxicity Developmental target / critical effect Relevant maternal NOAEL Relevant developmental NOAEL No specific studies provided. Aluminium is not associated with developmental effects (ATSDR 2008). No data, not required No data, not required Neurotoxicity (Annex IIA, point 5.7) Acute neurotoxicity Repeated neurotoxicity Delayed neurotoxicity No data, not required Cognitive impairments Histopathological changes in the brain. Significant alterations in motor function, sensory function, and cognitive function have been detected following exposure to adult or weanling rats and mice or following gestation and/or lactation exposure of rats and mice. Not relevant for this type of chemical. Other toxicological studies (Annex IIA, point 5.8) (4) Mechanism studies Studies performed on metabolites or impurities No study provided Not relevant Medical data (Annex IIA, point 5.9) *Data from different aluminium chemical species (no aluminium sulphate) Occupational exposure studies in aluminium reduction plants suggest that the lungs and nervous system may be the most sensitive targets of toxicity following inhalation exposure. Summary (Annex IIA, point 5.10) Value Study Safety factor ADI AOEL ARfD Not relevant mg Al/kg bw/day, equivalent to 0.14 mg Al/day for a 70 kg person Not relevant Risk assessment based on the Tolerable Weekly Intake (TWI) proposed by EFSA (2008). Chrysal RVB, THG 12

19 Dermal absorption (Annex IIIA, point 7.3) Chrysal RVB (T534) 1% based on oral absorption. Local effects Aluminium sulphate produces local effects after a single exposure (severe eye irritation and irritation to the respiratory tract), but these local effects are covered in the risk assessment/management by means of assignment of H- and P-statements. Aluminium sulphate does not produce local effects after repeated exposure. Data requirements active substance No additional data requirements are identified. 4.1 Toxicity of the formulated product 7.1) No studies with Chrysal RVB have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex I of Regulation 1272/2008/EC Data requirements formulated product No additional data requirements are identified. 4.2 Dermal absorption 7.3) A dermal absorption value of 1% is used for the risk assessment, based on the oral absorption. 4.3 Available toxicological data relating to non-active substances 7.4) The available toxicological data relating to non-active substances will be taken into account in the classification and labelling of the formulated product. 4.4 Exposure/risk assessments Operator exposure/risk According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers: Tier 1: Risk assessment using the EU-AOEL without the use of PPE Tier 2: Risk assessment using the NL-AOEL without the use of PPE Tier 3: Refinement of the risk assessment using new dermal absorption data Tier 4: Prescription of PPE Tier 1 Calculation of the EU-AOEL / Tolerable Limit Value (TLV) For aluminium sulphate the Tolerable Weekly Intake (TWI) has been proposed by the EFSA (2008). This TWI will be used for the risk assessment. The TWI for aluminium is mg Al/kg bw/day (= 0.14 mg Al/day for a 70-kg operator). Recalculated for the molecular weight of aluminium sulphate (Al 2 (SO 4 ) 3, MW = 342 g/mol), this corresponds to mg/kg bw/day (0.89 mg/day for a 70-kg operator). Exposure/risk Exposure to aluminium sulphate during mixing and loading and application of Chrysal RVB is estimated with models. The exposure is estimated for the unprotected operator. In the present case the formulation is intended for the pre-treatment of the cut flowers immediately after the harvest. The flowers are put in water pre-treated with the solution of Chrysal RVB and left for 24 hours. The exposure of the operator will therefore not occur during the actual Chrysal RVB, THG 13

20 treatment. The exposure will occur only during the mixing and loading phase and after the treatment due to the contact with wet flower stems. In general, mixing and loading and taking the flowers out of the treatment solution is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and the contact with treated flowers have to be combined. In the Table below the estimated internal exposure is compared with the TWI. Table T.1 Internal operator exposure to aluminium sulphate risk assessment for the use of Chrysal RVB Route Estimated internal TWI (mg/day) Risk-index b exposure a (mg /day) Preparation of the treatment solution and putting the flowers in the solution Mixing/ Respiratory < <0.01 Loading c Dermal Contact with treated flowers Respiratory < <0.01 Dermal Total a Internal exposure was calculated with: biological availability via the dermal route: 1% (concentrate) and 1% (treatment solution) (see 4.2) biological availability via the respiratory route: 100% (worst case) b The risk-index is calculated by dividing the internal exposure by the systemic AOEL. c External exposure is estimated TNsG Model 7 (adjusted) for manual mixing/pouring liquids (HEEG 2008) d External exposure is estimated with Spill Model (HEEG 2008), considering 6 ml of liquid adhering to one hand as a result of spillage. Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required Bystander exposure/risk As the vapour pressure of aluminium sulphate is very low (melting point 770 ºC with decomposition), the active substance will not evaporate from the solution. No bystander and resident exposure is envisaged for the intended application Worker exposure/risk Not applicable, see operator exposure Re-entry Not applicable. Overall conclusion of the exposure/risk assessments of operator, bystander, and worker The product complies with the Uniform Principles. Operator exposure The risk index is 0.54 for the unprotected professional operator. Based on the risk assessment no adverse effects are expected for unprotected professional operator from exposure to aluminium sulphate as a result of application of Chrysal RVB. Bystander exposure Bystander exposure is not envisaged for the intended application. Worker exposure Not applicable. Chrysal RVB, THG 14

21 4.5 Appropriate mammalian toxicology and operator exposure end-points relating to the product and approved uses See List of Endpoints. 4.6 Data requirements Based on this evaluation, no data requirements are identified. 4.7 Combination toxicology The formulation Chrysal RVB contains only one active substance and it is not described that it should be used in combination with other formulation. 5. Residues The application for authorisation of the plant protection product Chrysal RVB does not concern crops used for food or feed and residues in succeeding crops are not expected as the intended uses concern post-harvest treatments. Therefore, an assessment of the residue behaviour of aluminium sulphate is not necessary. The risk for consumers is considered to be negligible. 6. Environmental fate and behaviour The underlying risk assessment is based on the final List of Endpoints (LoEP) from the EFSA Conclusion (EFSA Journal 2010;8(11):1889). Because the active part of the active substance is aluminium, data reported in this section concern mainly aluminium itself and the aluminium speciations (i.e. aluminiumhydroxide in water). The fate and behaviour of sulphate ions was not assessed. Because aluminium is a chemical element, its atoms do not degrade in the environment. In addition, aluminium compounds occur in only one oxidation state, Al 3+. Aluminium can complex with electron-rich species that occur in the environment. List of Endpoints Fate/behaviour (EFSA Journal 2010;8(11):1889) Fate and behaviour in the environment Route of degradation (aerobic) in soil (Annex IIA, point ) No data provided, not required Route of degradation in soil - Supplemental studies (Annex IIA, point ) Anaerobic degradation No data provided, not required Soil photolysis No data provided, not required Rate of degradation in soil (Annex IIA, point , Annex IIIA, point 9.1.1) No data provided, not required Soil adsorption/desorption (Annex IIA, point 7.1.2) No data provided, not required Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2) No data provided, not required Chrysal RVB, THG 15

22 PEC (soil) (Annex IIIA, point 9.1.3) Method of calculation Application rate - Main route of entry - PECsoil Not required Route and rate of degradation in water (Annex IIA, point 7.2.1) No data provided, not required Not required as soil exposure is regulated by directive 86/278 in relation to the use of sludge from sewage treatment plants on agricultural land. PEC (surface water) (Annex IIIA, point 9.2.3) Method of worst case direct exposure calculation calculation Main route Indirect release of waste water of entry PECSW NON EUSES calculation. Based on 1.851*1010 cut flower stems in Europe and 50 stems/l in bucket 3.7 *108 litre water / year Dose rate 2 ml product/l 7.4 *105 L product /year 50% market share 370,000 L Chrysal RVB / year 1 L Chrysal RVB contains 35 gram Al (15.77 %) 370,000 litre Chrysal RVB is corresponding with 12,950 kg = 13 ton aluminium / year NL represents 88% of the European market and is considered worst case scenario. 88% of 13 ton = 11.5 ton aluminium used by 8 auctions (or Dutch clocks). 58% of the sold flowers is transported dry. This means 58% of Chrysal RVB is released by these auctions (42 % released at many different sites mainly out of the country). 58% of 11.5 ton = 6.7 ton aluminium / year in Holland turns up at 8 different WWTP. Simple calculation of the daily dose of aluminium load from Chrysal RVB at the WWTP (based on 365 days of use a year with 100 % release in the sewage and a equally spread towards 8 WWTP) is: 6700 Kg aluminium / 365 = 18.4 kg aluminium a day which is approximately 2.3 kg total aluminium per WWTP / day. Total aluminium load versus dissolved aluminium vary from for the ratio total/dissolved Al a factor of 1000 was used. i.e. influent concentration 2.3 kg total Al per WWTP / day effluent concentration 2.3 gram solved Al per WWTP / day. Capacity of a WWTP of 900 m3 / day (100,000 i.e.) dilution of concentration solved Al: 2300 mg / 900,000L = 2.5 µg / L. Release to large surface water with a dilution factor µg/l Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3) No data provided, not required PEC (air) Maximum concentration According to the worst-case scenario and a very low vapour pressure (value by default for inorganic elements: 1*10-20 Pa at 25 C), the local PEC in air for Aluminium related to the use of Chrysal RVB is estimated to be negligible Chrysal RVB, THG 16

23 Residues requiring further assessment Environmental occurring metabolite requiring further assessment by other disciplines (toxicology and ecotoxicology) or for which an environmental exposure assessment is triggered. All compartments: Aluminium ion. Monitoring data, if available (Annex IIA, point 7.4) Soils No reliable pertinent data identified Sediment No reliable pertinent data identified by the RMS. Surface water (indicate location and type of a) Lake Gardsjon (SE) [Al] µg/l1 study) b) Swedish lakes [Al] µg/l1 c) Scotland [Al] µg/l1 d) Llyn Brianne catchment, Wales (UK) [Al] µg/l1 e) Cumbria (UK) [Al] µg/l1 f) Vosges mountain streams (FR) [Al] µg/l1 g) Boglakes (BE) [Al] < µg/l1 h) River Rhine (NL) [Al] µg/l2 i) Western Netherlands [Al] µg/l2 Ground water (indicate location and type of study) Air (indicate location and type of study) (including suspended solid) Aluminium levels in groundwater wells at neutral ph generally fall below 0.1 mg/l (100 ppb). In areas receiving acid precipitation, Aluminium levels in groundwater may be more than 10 times the levels found in areas with neutral ph levels in the water. Background levels of Aluminium in the atmosphere generally range from to 0.18 ng/m3 In industrialized areas, the concentrations of Aluminium in air are > 1000 ng/m3 1 Environmental Health Criteria 194, WHO 1997: ISBN van Dalen J P, Aluminium: een gevaar voor het aquatische mileu? Working document of Rijksinstituut voor Integraal Zoetwaterbeheer, X. 26 pp. Points pertinent to the classification and proposed labelling with regard to fate and behaviour data No classification is proposed. Appendix A: Metabolite names, codes and other relevant information of the plant protection product Chrysal RVB with active substance aluminium sulphate. The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of active substance aluminium sulphate. The parent compound structure of aluminium sulphate is shown first in this list and followed by degradates or related compounds. Chrysal RVB, THG 17

24 Compound name aluminium sulphate Code number parent IUPAC name Aluminium sulphate Structural formula Structure Molecular Weight [g/mol] Observed in study (% of occurrence/ formation) Al 2 (SO 4 ) Parent substance aluminium metabolite aluminium Al all compartments 6.1 Fate and behaviour in soil Chrysal RVB is intended for exclusive use in enclosed spaces (see GAP) as cut-flower postharvest treatment (i.e. placing of cut-flowers in a solution of the product). This is a nonsoilbound use and hence no exposure to the soil is expected. After use, aluminium sulphate is discharged to a sewage treatment plant (STP) via the domestic sewage system. However, the exposure route via the spreading of sewage sludge is not assessed, because in The Netherlands, spreading of sewage sludge on (agricultural) land is prohibited by law. Therefore there is also no indirect exposure to the soil. This means that persistence and the risk for soil organisms of the active substance do not need to be assessed Leaching to shallow groundwater Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater. As there is no direct or indirect exposure to the soil from the proposed use, the applications meet the standards for leaching as laid down in the RGB. Monitoring data Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90 th percentile. There are no data available regarding the presence of the substance aluminium sulphate in groundwater. Conclusions As there is no direct or indirect exposure of aluminium sulphate to the soil from the proposed use, the persistence criterion does not need to be assessed. The proposed applications of the product Chrysal RVB comply with the requirements laid down in the RGB concerning leaching in soil. 6.2 Fate and behaviour in water Rate and route of degradation in surface water Article 2.10c of the Plant Protection Products and Biocides Regulations (RGB) prescribes the use of Dutch specific drift percentages. Chrysal RVB, THG 18

25 As the proposed uses concern exclusively indoor applications, no direct exposure of surface water occurs, originating from spray drift during application of the active substance. However, after use, aluminium sulphate is discharged to a sewage treatment plant (STP) via the domestic sewage system. An assessment of the discharge to surface water via a STP is presented below. PEC surface water and PEC sediment The exposure concentrations of aluminium ions in surface water have been estimated for the various proposed uses for cut flowers. After using the product, Chrysal RVB is released to the domestic sewage with the cut-flower water. For organic plant protection products, the programme USES (version 2.0) is used to calculate the exposure from emission to surface water via a STP. However, this model is not suitable for inorganic compounds. Therefore, the worst case simplistic exposure calculation from the EFSA Conclusion was used. The only difference with the assessment in the EFSA Conclusion is the capacity of the STP, which was set at 2000 m3 per day (i.e. the standard capacity of a STP in USES). The Predicted Environmental Concentration in surface water (PECsw) is calculated via the predicted concentration of the active substance in the sewage treatment effluent (PECstp). Aluminium sulphate is very soluble (370 g/l), but in water, aluminium can complex with water to form aluminiumhydroxide, which is insoluble. In high dissolved organic carbon (DOC) surroundings like a sewage treatment plant, many more speciations of aluminium can occur (e.g. aluminiumsulphates, -phosphates and - bicarbonates). Interactions with ph and DOC are of primary importance to the fate and behaviour of aluminium. At low ph, aluminium becomes more soluble. In neutral ph surroundings, like in the sewer or the sewage treatment plant, most aluminium is bound to the sludge. In line with the EFSA conclusion on aluminium sulphate, the ratio of total/dissolved aluminium of 1000 is applied. Chrysal RVB, THG 19

26 PECsw Surface water concentration Values 0.2 µg/l. The emission rate of the active substance (kg/day) was estimated by using the application rate as provided by the applicant (0.45 g/l), the total amount of stems cut and sold in The Netherlands per year (16.29 billion according to VBN.nl) and an assumed 50% market share of this product. According to the EFSA conclusion, fifty flowers can be treated with one litre, and therefore kg of aluminium is used per year ( * 0.5 / 50 * = kg active substance, combined with the ratio of the molweight of two aluminium ions (52.96) and the active substance aluminium sulphate ( g/mol) results in * = kg of aluminium). Per day, this is 32 kilograms of aluminium released to the STP s in the country. There are eight flower auctions in NL, and therefore the active substance is released to eight STP s. Assuming equal spread among the STP s, this corresponds to 4 kg/day per STP. Application of the factor 1000 for the total/dissolved aluminium results in an STP influent of 4 grams per day. The capacity of an STP of 2000 m 3 per day ( i.e.) results in a PECstp of 2 µg/l. Release to the surface water is a dilution of 10, and therefore the PECsw is 0.2 µg/l. 1 Van Beelen, P., 2000, RIVM report The predicted environmental concentration for the surface water is 0.2 µg/l. The exposure concentrations in surface water are compared to the ecotoxicological threshold values in section 7.2. Monitoring data Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90 th percentile. In April 2014, version 3.0 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 These environmental quality standards consist either of the Chrysal RVB, THG 20

27 harmonised WFD thresholds derived according to the Fraunhofer methodology 1 (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. For examination against the drinking water criterion, another database (VEWIN) is used, since the drinking water criterion is only examined at drinking water abstraction points. For the assessment of the proposed applications regarding the drinking water criterion, see next section. Aluminiumsulphate There are no data available in the Pesticide Atlas regarding the presence of the substance aluminium sulphate in surface water. Drinking water criterion Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90 th percentile. 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, 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 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 preregistration 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. Active substance aluminium sulphate has been on the Dutch market for > 3 years (authorised since ). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by Ctgb about the product and its active substance, Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met. 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 RIVM report Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use ofplant protection products for drinking water production from surface waters - A proposal for the registration procedure in the Netherlands. Alterra-Report Chrysal RVB, THG 21

28 6.3 Fate and behaviour in air Route and rate of degradation in air The vapour pressure is assumed to be the default for inorganic elements: 1E-20 Pa at 25 C. No half-life in air can be specified for inorganic compounds. As aluminium sulphate does not volatilize from water or moist soil surfaces, the local PEC in air for is estimated to be negligible Since at present there is no framework to assess fate and behaviour in air of plant protection products, for the time being this issue is not taken into consideration. 6.4 Appropriate fate and behaviour end-points relating to the product and approved uses See List of End-points. 6.5 Data requirements None. The following restriction sentences were proposed by the applicant: Gebruikte oplossingen dienen uitsluitend via het riool geloosd te worden. Rechtstreekse lozing op het oppervlaktewater dient te worden uitgesloten. Based on the current assessment, the following has to be stated in the GAP/legal instructions for use (WG): Om in het water levende organismen te beschermen is de toepassing uitsluitend toegestaan indien de gebruikte vloeistof wordt afgevoerd naar het riool met aansluiting op de RWZI 6.6 Overall conclusions fate and behaviour It can be concluded that: 1. As there is no direct or indirect exposure to the soil from the proposed use, the persistence criterion does not need to be assessed. 2. all proposed applications of the active substance aluminium sulphate meet the standards for leaching to the shallow groundwater as laid down in the RGB. 3. all proposed applications of the active substance aluminium sulphate meet the standards for surface water destined for the production of drinking water as laid down in the RGB. 7. Ecotoxicology The List of Endpoints is given in the EFSA Journal 2010;8(11): No critical areas of concern were identified. Because the active part of the active substance is aluminium, data reported in this section concern mainly aluminium itself and the aluminium speciations (i.e. aluminiumhydroxide in water). The fate and behaviour of sulphate ions was not assessed. Because aluminium is a chemical element, its atoms do not degrade in the environment. In addition, aluminium compounds occur in only one oxidation state, Al 3+. Aluminium can complex with electron-rich species that occur in the environment. List of Endpoints Ecotoxicology Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3) Chrysal RVB, THG 22