HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 12915 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 BESLUIT Op 30 september 2015 is van BELCHIM Crop Protection nv/sa Technologielaan 7 B-1840 LONDERZEEL BELGIE een aanvraag tot uitbreiding kleine toepassing van gewasbeschermingsmiddeltoelating ontvangen voor het middel op basis van de werkzame stof pyridaat. LENTAGRAN WP HET COLLEGE BESLUIT tot uitbreiding 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: Lentagran WP, NLKUG 1

2 12915 N - 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. - 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 HTB 0.2 en later 3 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). Lentagran WP, NLKUG 2

3 12915 N 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, 4 maart 2016 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, Ir. J.F. de Leeuw Voorzitter Lentagran WP, NLKUG 3

4 12915 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 kleine toepassing van gewasbeschermingsmiddeltoelating Middelnaam: Lentagran WP Formele registratiedatum: * 30 oktober 2015 Datum in behandeling name: Datum compliance check: N.v.t. * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof Gehalte pyridaat 45% De stof pyridaat is per 1 januari 2002 geplaatst op Annex I van Richtlijn 91/414/EEG (01/21 EC) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. Inmiddels is een besluit tot renewal van de goedkeuring genomen: Reg (EU) 2015/1115, van kracht per 1 januari De goedkeuring van deze werkzame stof expireert op 31 december Toelatingsinformatie Toelatingsnummer: N Expiratiedatum: 31 december 2016 Afgeleide of parallel: n.v.t. Biocide, gewasbeschermingsmiddel of Gewasbeschermingsmiddel toevoegingsstof: Gebruikers: Professioneel W-codering professioneel gebruik: 6 4 Aflever- en opgebruiktermijnen voor oude etiket Vorige W-codering professioneel gebruik: 5 Aflevertermijn professioneel gebruik: Nvt Opgebruiktermijn professioneel gebruik: Nvt 5 Verpakkingsinformatie Aard van het preparaat: Spuitpoeder Lentagran WP, NLKUG 1

5 12915 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Lentagran WP Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pyridaat Pictogram GHS07 GHS09 Signaalwoord WAARSCHUWING Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken. H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen. Voorzorgsmaatregelen P272 Verontreinigde werkkleding mag de werkruimte niet verlaten. P273 Voorkom lozing in het milieu. P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen. P333 + P313 Bij huidirritatie of uitslag: een arts raadplegen. P391 Gelekte/gemorste stof opruimen. Aanvullende etiketelementen P501 Inhoud/verpakking afvoeren naar... Lentagran WP, NLKUG 1

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 onkruidbestrijdingsmiddel in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden Toepassingsgebied Sluitkoolachtigen Bloemkoolachtigen (onbedekte teelt) Boerenkool Zaaiui Eerstejaars plantui Type toepassing Te bestrijden organisme Dosering (middel) per toepassing Na uitplanten Na uitplanten Na uitplanten/ na opkomst Na opkomst Na opkomst Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Maximaal aantal toepassingen per teeltcyclus of per 12 maanden Maximaal aantal kg middel per ha per teeltcyclus of per 12 maanden Minimum interval tussen toepassing en in dagen 2 kg/ha 1 per 12 - maanden 2 kg/ha per 1 kg/ha 2 per maanden 7 42 maanden 2 kg/ha 1 per 12 - maanden 2 kg/ha per 1 kg/ha 2 per maanden 7 42 maanden 2 kg/ha 1 per teeltcyclus 2 kg/ha per - 1 kg/ha 2 per teeltcyclus teeltcyclus ,25-0,5 kg/ha* 4 per teeltcyclus 1,5 kg/ha 5 56 per teeltcyclus 0,25-0,5 kg/ha* 4 per teeltcyclus 1,5 kg/ha per teeltcyclus 5 56 Veiligheids termijn in dagen LENTAGRAN WP, NLKUG 2

7 Tweedejaars plantui Sjalotten Asperge (onbedekte teelt) Na opkomst Na opkomst Voor het steken of onderbladbehandeling na het steken Na het steken, onderblad bespuiting Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden 0,25-0,5 kg/ha* 4 per teeltcyclus 1,5 kg/ha per teeltcyclus 0,25-0,5 kg/ha* 4 per teeltcyclus 1,5 kg/ha per 2 kg/ha 1 per 12 maanden 1 kg/ha 2 per 12 maanden 2 kg/ha 1 per 12 Na planten/ na Eenjarige breedbladige maanden Prei opkomst onkruiden 1 kg/ha 2 per 12 maanden * maximaal 2 keer toepassen met 0,25 kg/ha en 2 keer met 0,5 kg/ha of maximaal 3 keer toepassen met 0,5 kg/ha teeltcyclus 2 kg/ha per 12 maanden 2 kg/ha per 12 maanden Het gebruik in de onbedekte teelt van lupine, blauwmaanzaad, koolzaad, klaver, luzerne, koolrabi, schorseneer, zilverui, picklers, bosuien, knoflook, asperge (zaaibed, eerstejaars aanplant), zaaiprei, suikermaïs, maggiplant, valeriaan, gladiool, bloemisterijgewassen, coniferen en sierheesters is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in dit toepassingsgebied, komt voor risico en verantwoordelijkheid van de gebruiker. Toepassingsgebied Type toepassing Te bestrijden organisme Dosering (middel) per toepassing Maximaal aantal toepassingen per teeltcyclus Maximaal aantal kg middel per ha per teeltcyclus of per 12 maanden Minimum interval tussen toepassingen in dagen Veiligheids termijn in dagen Lupine (Peulvrucht) Na opkomst Eenjarige breedbladige onkruiden 1 kg/ha 2 2 kg/ha per teeltcyclus 7 - Blauwmaanzaad Na opkomst Eenjarige 1 kg/ha 2 2 kg/ha per teeltcyclus 7 - LENTAGRAN WP, NLKUG 3

8 (Oliehoudende zaden) breedbladige onkruiden Koolzaad (Oliehoudende zaden) Na opkomst Eenjarige breedbladige onkruiden Klaver Na opkomst Eenjarige (Voedergewassen) breedbladige onkruiden Luzerne Na opkomst Eenjarige (Voedergewassen) breedbladige onkruiden Koolrabi Na uitplanten Eenjarige breedbladige onkruiden Schorseneer Na opkomst Eenjarige breedbladige onkruiden Zilverui Na opkomst Eenjarige breedbladige onkruiden Picklers Na opkomst Eenjarige breedbladige Bosuien (onbedekte teelt) Na opkomst onkruiden Eenjarige breedbladige onkruiden Knoflook Na opkomst Eenjarige breedbladige onkruiden Asperge (zaaibed, eerstejaars aanplant, onbedekte teelt) Na opkomst Eenjarige breedbladige onkruiden 1 kg/ha 2 2 kg/ha per teeltcyclus 7-1 kg/ha 2 2 kg/ha per teeltcyclus kg/ha 2 2 kg/ha per teeltcyclus ,65 kg/ha 1 1,65kg/ha per 12 maanden 0,5 kg/ha 3 1,5 kg/ha per teeltcyclus 0,25 kg/ha +0,5 kg/ha ** 2 kg/ha per teeltcyclus ,25 + 0,5 kg/ha 2+3** 2 kg/ha per teeltcyclus ,25 + 0,5 kg/ha 2+3** 2 kg/ha per teeltcyclus ,25 + 0,5 kg/ha 2+3** 2 kg/ha per teeltcyclus kg/ha 2 2 kg/ha per 12 maanden 7 - LENTAGRAN WP, NLKUG 4

9 Zaaiprei Na opkomst Eenjarige breedbladige onkruiden Suikermaïs Na opkomst Eenjarige breedbladige Maggiplant (onbedekte teelt) Valeriaan (onbedekte teelt) Gladiool (onbedekte teelt) Bloemisterijgewasse n (onbedekte teelt) Coniferen (onbedekte teelt) Sierheesters (onbedekte teelt) Na opkomst Na opkomst Na opkomst Onderbladbehan deling Onder het gewas Onderbladbehan deling onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden Eenjarige breedbladige onkruiden 0,25 + 0,5 kg/ha 2+3** 2 kg/ha per teeltcyclus kg/ha 1 2 kg/ha per teeltcyclus kg/ha kg/ha 2 2 kg/ha per 12 maanden 0,5 kg/ha 3 1,5 kg/ha per teeltcyclus ,25 + 0,5 kg/ha 2+3** 2 kg/ha per teeltcyclus 5-2 kg/ha 1 2 kg/ha per 12 maanden 2 kg/ha 1 2 kg/ha per 12 maanden 2 kg/ha 1 2 kg/ha per 12 maanden ** maximaal 2 keer toepassen met 0,25 kg/ha en 3 keer met 0, 5 kg/ha Toepassingsvoorwaarden Draag beschermende kleding, handschoenen en adembescherming met een minimale beschermingsfactor van 10 bij toepassingen met een handspuit. Om het grondwater te beschermen mag dit product niet worden toegepast in grondwaterbeschermingsgebieden. LENTAGRAN WP, NLKUG 5

10 Om het grondwater te beschermen is toepassing in de periode van 1 september tot 1 maart niet toegestaan. Om niet tot de doelsoorten behorende planten te beschermen is de toepassing in lupine, blauwmaanzaad, koolzaad, klaver, luzerne, koolrabi, schorseneer, asperge (zaaibed, eerstejaars aanplant), zaaiprei, suikermais, maggiplant, valeriaan, gladiool, bloemisterijgewassen, coniferen en sierheesters uitsluitend toegestaan indien er gebruik wordt gemaakt van driftarme spuitdoppen. Om niet tot de doelsoorten behorende planten te beschermen is de toepassing in ui en ui-achtigen uitsluitend toegestaan indien er gebruik wordt gemaakt van driftarme spuitdoppen en een kantdop. Om de zoogdieren te beschermen is toepassing in schorseneren uitsluitend toegestaan tot BBCH 40, het begin van de wortelverdikking/groei In koolgewassen kan er kort na toediening enige gewasschade ontstaan. Dit verschijnsel is van voorbijgaande aard en leidt niet tot opbrengstderving en/of kwaliteitsverlies. Ter voorkoming van gewasschade dienen de onderstaande toepassingstijdstippen in acht te worden genomen: In ter plaatse gezaaide kool het middel toepassen na opkomst van het gewas vanaf het 4 tot 6 bladstadium van het gewas. In geplante kool het middel 2 tot 4 weken na het uitplanten toepassen als het gewas goed is aangeslagen en tenminste 4 bladeren heeft ontwikkeld. In uien toepassen na het vlagbladstadium in een LDS-systeem op een afgehard gewas. Vanaf het 2 bladstadium van het gewas bespuitingen uitvoeren. In prei toepassen na opkomst (vanaf het 2 tot 3 bladstadium) of na het uitplanten. In de productieteelt van asperges toepassen voor het steken of na het steken door middel van een onderbladbehandeling. In 1 e jaars aanplant en op zaaibedden van asperges toepassen vanaf het 2 tot 3 bladstadium van het gewas. LENTAGRAN WP, NLKUG 6

11 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT Contents 1 Identity of the plant protection product Physical and chemical properties Methods of analysis Analytical methods in technical material and plant protection product Conclusion Mammalian toxicology Residues Environmental fate and behaviour Ecotoxicology Efficacy Conclusion Classification and labelling LENTAGRAN WP, NLKUG 7

12 1 Identity of the plant protection product 1.1 Applicant Belchim Crop Protection nv/sa Technologielaan Londerzeel Belgium 1.2 Identity of the active substance The identity of the active substance(s) does not change. Common name Pyridate Name in Dutch Pyridaat Chemical name O-6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate CAS no EC no (EINECS) The active substance approval was renewed under Reg. (EC) No 1107/2009 on 1 January Identity of the plant protection product The identity of the plant protection product does not change. Name Formulation type Content active substance Lentagran WP WP 45% pure pyridate Lentagran WP was the representative formulation for the renewal evaluation. 1.4 Function Herbicide 1.5 Uses applied for See GAP (Appendix I) for uses applied for, which are authorized and the table below in which the withdrawn uses are stated. The following uses were applied for, but where withdrawn by the applicant during the assessment. Minor uses according to table Application Application rate Use- No. Member state(s) 6 NL Crop and/ or situation (crop destination / purpose of crop) Dill, caraway and fennel F G or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Annual broadleaved weeds Method / Kind Foliar Spray Timing / Growth stage of crop & season After sowing at 5-10 cm crop development BBCH Max. number (min. interval between applications) a) per use b) per season a,b) 2 (7 days interval) kg product / ha a) max. rate per appl. b) max. total rate per season a) 0.75 b) 1.5 g, as/ha a) max. rate per appl. b) max. total rate per crop/season a) b) 675 Water L/ha min / max PHI (days) - Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Splitting method (2 x 0,75 kg product per ha) LENTAGRAN WP, NLKUG 8

13 March- August 7 NL Globe artichoke F Annual broadleaved weeds Foliar Spray After planting after 5 cm crop development BBCH a,b) 2 (7 days interval) a) 1.0 b) 2.0 a) 450 b) Splitting method (2 x 1 kg product per ha) March- August LENTAGRAN WP, NLKUG 9

14 1.6 Background to the application It concerns a simplified extension of the authorization with minor uses. 1.7 Packaging details Packaging details do not change. 2 Physical and chemical properties The physical and chemical properties of the active substance(s) and the formulation do not change. 3 Methods of analysis 3.1 Analytical methods in technical material and plant protection product The analytical methods for the technical material and the plant protection product do not change. 3.2 Residue analytical methods The new uses do not fall within the risk-envelope of the existing authorization of Lentagran WP. To address this, new methods for monitoring of residues in crops and animal products were submitted. These methods were previously evaluated for a zonal application of Lentagran WP, by ZRMS Austria (AT). The methods are therefore not re-evaluated. The endpoints below are based on the Registration Report by AT. Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) LC-MS/MS, common moiety method LOQ 0.03 mg/kg CL 9673 (including hydrolysed conjugates) equivalent to 0.05 mg/kg pyridate (sweet corn, leek, cauliflower, broccoli, oilseed rape) LC-MS/MS LOQ 0.03 mg/kg CL 9673 equivalent to 0.05 mg/kg pyridate (bovine meat, milk) Based on the proposed extension for use, residue analytical methods for food/feed of plant origin are required for all matrix types. Definition of the residue and MRLs for pyridate Matrix Definition of the residue for monitoring MRL Food/feed of plant origin Sum of pyridate, its hydrolysis product CL 9673 (6-chloro-4-hydroxy-3-phenylpyridazin) and hydrolysable conjugates of CL 9673 expressed as pyridate) 0.05 mg/kg or higher Food/feed of animal origin Sum of pyridate and its hydrolysis product CL 9673 (6-chloro-4-hydroxy-3- phenylpyridazin), expressed as pyridate* 0.05 mg/kg or higher * conjugates are no longer included according to the peer review in the scope of the approval renewal of pyridate (see EFSA Journal 2014;12(8):3801) LENTAGRAN WP, NLKUG 10

15 The method for animal products does not cover the conjugates. During the renewal evaluation of pyridate, the conjugates were not included in the residue definition for food/feed of animal origin (see EFSA Journal 2014;12(8):3801). Therefore, the methods provided are considered acceptable. 3.3 Conclusion The analytical methods for MRL monitoring purposes are acceptable. 4 Mammalian toxicology List of Endpoints Pyridate is an existing active substance, included in Annex I of 91/414/EEC. The final list of endpoints presented below is copied from the final review report on pyridate (7576/VI/97 final, d.d. 22 March 2001). When relevant, some additional remarks/information is given in italic. Absorption, distribution, excretion and metabolism in mammals Rate and extent of absorption: oral > 80% within 24 hours, rat (single and repeated dose of 20 mg/kg bw); at higher dose (200 mg/kg bw) lower absorption rate (70%) Distribution: widely; higher residues in liver and kidney Potential for accumulation: No signs of accumulation. Rate and extent of excretion: > 90% within 96 hours, most via urine Toxicologically significant compounds: CL 9673 (main metabolite) and glucuronides of CL 9673 Metabolism in animals: Cleavage of the ester bond and conjugation Acute toxicity Rat LD 50 oral: Rat LD 50 dermal: Rat LC 50 inhalation: Skin irritation: Eye irritation: Skin sensitization (test method used and result): > 2000 mg/kg bw > 2000 mg/kg bw > 4.37 mg/l air Irritant. Not irritant. Sensitizing in the Maximization test as well as in the Buehler test. Short term toxicity Target / critical effect: Lowest relevant oral NOAEL / NOEL: Lowest relevant dermal NOAEL / NOEL: Lowest relevant inhalation NOAEL / NOEL: Clinical (neurotoxic) symptoms, minimale degenerative myelopathy at high dosage; decreased enzyme activity (ALT); dog studies 30 mg/kg bw/d (52 weeks dog study; in reality this study is comparable to a 3 month study with preapplication not allocated not allocated Genotoxicity Negative. 1 1 Pyridate was negative in the following in vitro tests: Ames test, chromosome abberation test with CHO cells, a REC-assay, and a UDS-test with rat hepatocytes. Pyridate was negative in an in vivo mouse spot test, in vivo micronucleus test in mice, and an in vivo/in vitro UDS test in rats. LENTAGRAN WP, NLKUG 11

16 Long term toxicity and carcinogenicity Target / critical effect: Lowest relevant NOAEL: Carcinogenicity: Decreased body weight. 400 ppm equivalent to 18 mg/kg bw/d (long term toxicity study in rats) Negative. Reproductive toxicity Target / critical effect - Reproduction: Increased kidney weight (Parents F 1 and F 2 ). Decreased thyroid weight (parental males (F 2 ). No reproductive effects. Lowest relevant reproductive NOAEL / NOEL 3.6 mg/kg bw/d 2 NOEL: Target / critical effect - Developmental Embryotoxic only at maternal toxic doses. toxicity: Lowest relevant developmental NOAEL / NOEL 150 mg/kg bw/d; rabbit 3 NOEL: 2 Parental and offspring NOAEL. There were no effects on reproduction in this study, so the NOAEL for reproduction 110 mg/kg bw/d. 3 Maternal NOAEL. Developmental NOAEL is 300 mg/kg bw/d. There were no teratogenic effects observed, so the NOAEL for teratogenicity 600 mg/kg bw/d. Delayed neurotoxicity Clinical (neurotoxic) symptoms, minimal degenerative myelopathy at high dosage (dog studies). Other toxicological studies Metabolite CL9673: acute oral LD mg/kg bw; not sensitizing; no point mutations. Medical data No cases of poisoning reported. Summary ADI: AOEL systemic: Value Study Safety factor mg/kg bw/d mg/kg bw/d multigeneration study in rats multigeneration study in rats ARfD (acute reference dose): not allocated - - Dermal absorption Not required; assumed 10% dermal absorption rate on the properties of the molecule. Data requirements active substance No additional data requirements are identified. LENTAGRAN WP, NLKUG 12

17 4.1 Toxicity of the formulated product (IIIA 7.1) The formulation Lentagran WP does not need to be classified on the basis of its acute oral (LD 50 rat=2330 mg/kg bw), dermal (LD 50 rat >4000 mg/kg bw), and inhalation toxicology (LC 50 rat >2.14 mg/l; maximum attainable concentration). The formulation Lentagran WP does not need to be classified for dermal irritation or eye irritation. The formulation Lentagran WP is positive in a Maximisation test for skin sensitisation and needs to be classified as R43 May cause sensitisation by skin contact Data requirements formulated product No additional data requirements are identified. 4.2 Dermal absorption (IIIA 7.3) One in vivo dermal absorption study on rats with Lentagran 450 EC formulation and two in vitro dermal absorption studies with rat and human skin (one with Lentagran 450 EC formulation and one with Lentagran WP formulation) were submitted. Based on the results of the studies, dermal absorption of pyridate in the formulation Lentagran WP is 0.6% for the concentrate and 12% for the spray dilution. 4.3 Available toxicological data relating to non-active substances (IIIA 7.4) Other formulants: no reason for toxicological concern. 4.4 Exposure/risk assessments Overview of the intended uses An application has been submitted for the minor use extension of the authorisation of the plant protection product Lentagran WP, a herbicide based on the active substance pyridate. Lentagran WP is a WP formulation and contains 450 g/kg pyridate. Calculation of the AOEL Since pyridate is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of mg/kg bw/day (= 2.52 mg/day for a 70-kg operator), based on the multigeneration study in rats, is applied (see List of Endpoints) Operator exposure/risk The formulation Lentagran WP is authorised for mechanical downward spraying in leek, onions, shallots, cabbages, asparagus at an application rate of 2 kg product/ha. For the current application, the use in asparagus is now indicated with a split application, therefore, the risk assessment for this intended use can be extrapolated from the current authorisation. Besides the split-application in asparagus, the current application includes several minor uses for which the mechanical downward spraying at maximally 0.9 kg pyridate/ha can be extrapolated from the current authorisation. However, manual downward spraying in these minor crops cannot be excluded. These crops include lupin, lovage, valerian, dill/caraway/fennel, globe artichoke, kohlrabi, floriculture, conifers and ornamental shrubs. Therefore, a risk assessment is performed for the operator for the manual spraying of Lentagran WP. The highest intended dose in these crops is 2 kg product/ha, corresponding to 0.9 kg pyridate/ha. LENTAGRAN WP, NLKUG 13

18 Table T.1 Internal operator exposure to pyridate and risk assessment for the use of Lentagran WP Route Estimated internal exposure a (mg/day) Systemic AOEL (mg/day) Risk-index b Manual downward spraying on the intended crops (uncovered, 2 kg product/ha, 200L/ha) Mixing/ Loading and application c Respiratory Dermal Total a Internal exposure was calculated with: * biological availability via the dermal route: 0.6% for the concentrate and 12% for spray dilution (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 with Dutch greenhouse model Since the AOEL is exceeded, a risk assessment with the use of PPE is required. Table T.2 Internal operator exposure to pyridate and risk assessment for the use of Lentagran WP Route Estimated internal exposure a (mg/day) Systemic AOEL Risk-index b without PPE with PPE (mg/day) without PPE with PPE Manual downward spraying on the intended crops (uncovered, 2 kg product/ha, 200L/ha) Mixing/ Loading and application c Respiratory Dermal Total d a Internal exposure was calculated with: * biological availability via the dermal route: 0.6% for the concentrate and 12% for spray dilution (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 with Dutch greenhouse model d PPE: gloves, coverall and respiratory protection during mixing/loading and application The AOEL is not exceeded with the use of full PPE, including respiratory protection during mixing and loading and application for handheld spraying scenarios. This restriction sentence has to be included in the WG Bystander exposure/risk The formulation Lentagran WP is authorised for leek, onions, shallots, cabbages and asparagus. The current authorisation is for an application rate of 2 kg product/ha with a minimum spray volume of 200L/ha. This also applies for the current application and therefore, the bystander exposure assessment is within the risk envelope Worker exposure/risk The formulation Lentagran WP is authorised for leek, onions, shallots, cabbages and asparagus. The current authorisation is for an application rate of 2 kg product/ha with a minimum spray volume of 200L/ha. This also applies for the current application and therefore, the worker exposure assessment is within the risk envelope. LENTAGRAN WP, NLKUG 14

19 4.4.4 Re-entry See Worker exposure/risk. Overall conclusion of the exposure/risk assessments of operator, bystander, and worker The product complies with the Uniform Principles. Operator exposure Silver onions/picklers/scallion/garlic/sown leek, gladiolus, oil seeds, clover/alfalfa (fodder crops), sweet corn and asparagus: The proposed extension in these crops can be extrapolated from the current authorisation based on the method of application and dosage (downward spraying with a maximum dosage of 2 kg product/ha with a minimum spray volume of 200L/ha). Therefore, the proposed extension remains within the existing risk envelope for the protected operator. Lupin, lovage, valerian, dill/caraway/fennel, globe artichoke, kohlrabi, floriculture, conifers and ornamental shrubs: For the unprotected operator, adverse health effects after dermal/respiratory exposure to pyridate as a result of the application of Lentagran WP cannot be excluded. Correct use of personal protective equipment will reduce the dermal exposure and respiratory exposure and results in a sufficient reduction of the exposure to pyridate for the application of Lentagran WP in Lupin, lovage, valerian, dill/caraway/fennel, globe artichoke, kohlrabi, floriculture, conifers and ornamental shrubs. Bystander exposure The proposed extension for use involves an application for several minor crops for which the risk assessment can be extrapolated from the current authorisation based on the method of application and dosage (downward spray application with a maximum dosage of 2 kg product/ha with a minimum spray volume of 200 L/ha). Therefore, the proposed extension remains within the existing risk envelope for the bystander. Worker exposure The proposed extension for use involves an application for several minor crops for which the risk assessment can be extrapolated from the current authorisation based on the method of application and dosage (downward spray application with a maximum dosage of 2 kg product/ha with a minimum spray volume of 200 L/ha). Therefore, the proposed extension remains within the existing risk envelope for the worker. The current classification and labelling of the formulation can be maintained. 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 No additional data required. 4.7 Combination toxicology Lentagran WP contains only one active substance and it is not described that it should be used in combination with other formulations. LENTAGRAN WP, NLKUG 15

20 5 Residues List of Endpoints The List of Endpoints for pyridate presented below is obtained from RMS Austria (available on CIRCABC, last revised April 2000). Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered cereals (maize), pulses and oilseeds (peanuts), leafy crops (broccoli) Rotational crops Plant residue definition for monitoring Plant residue definition for risk assessment Conversion factor (monitoring to risk assessment) lettuce, carrots, barley Sum of pyridate, its hydrolysis product CL 9673 [(6-chloro- 4-hydroxy-3-phenylpyridazin)] and hydrolysable conjugates of CL 9673, expressed as pyridate as above none Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered lactating cow, goat, poultry Animal residue definition for monitoring Sum of pyridate and its hydrolysis product CL 9673, expressed as pyridate Animal residue definition for risk assessment Conversion factor (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) as above none yes Fat soluble residue (yes/no) no, due to rapid hydrolysis of pyridate to CL 9673 Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) no residues above LoD expected Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction) stable for 2 years as shown for maize, peanuts, broccoli, alfalfa Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Intakes by livestock 0.1 mg/kg diet/day: Ruminant: yes/no Poultry: yes/no Pig: yes/no Muscle 0.03 * mg/kg 1) 0.03 * mg/kg 1) - LENTAGRAN WP, NLKUG 16

21 Liver 0.03 * mg/kg 1) 0.03 * mg/kg 1) - Kidney 0.2 mg/kg 2) 0.03 * mg/kg 1) - Fat 0.03 * mg/kg 1) 0.03 * mg/kg 1) - Milk 0.03 * mg/kg 1) - - Eggs * mg/kg 1) - 1) 0.03 mg CL 9673/kg equivalent to 0.05 mg pyridate/kg 2) 0.2 mg CL 9673/kg equivalent to 0.4 mg pyridate/kg Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/processed crop Number of studies Transfer factor %Transference * maize/oil 1 14 C study, not determinable peanut/oil 1 14 C study, not determinable * Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies Comments on/additions to List of Endpoints In 2014 EFSA published the Conclusion on the peer review of the pesticide risk assessment of the active substance pyridate (EFSA Journal 2014; 12 (8):3801), where the most recent List of Endpoints is included. However, since this is an NLKUG application, the List of Endpoints from the existing authorisation applies and has been used for this evaluation. 5.1 Summary of residue data The following assessment is based on the Reasoned Opinion on the review of the existing maximum residue levels (MRLs) for pyridate according to Article 12 of Regulation (EC) No 396/2005 (EFSA Journal 2012; 10(4):2687), the Pyridate Monograph (Austria, October 1996), an Evaluation Report (RMS Austria, August 2001), another Evaluation Report (MS Germany, February 2012), and an internal evaluation of submitted studies ( Evaluation Report Ctgb, February 2016) Metabolism in plants Metabolism of pyridate in plants was investigated on broccoli (leafy crops), peanuts (pulse/oilseed) and maize (cereals). Metabolism was similar in all investigated crops. The parent compound was almost completely degraded and if present, was detected in very low amounts. The main metabolite in plants, which also has biological activity, was CL 9673 (pyridafol) Metabolism in livestock Metabolism of pyridate in livestock was investigated in lactating ruminants and laying hens. Based on the studies, it was concluded that pyridate was fast eliminated (95% of the applied dose was recovered in urine, 24h after treatment). It was also concluded that pyridate was extensively metabolised and no accumulation in animals tissues takes place. Parent pyridate was not detected in animal matrices, while CL 9673 was the predominant compound. Conjugates of CL 9673 were identified only in ruminants urine and faeces Residue definition (plant and animal) The residue definition for risk assessment and monitoring in plants is sum of pyridate, its hydrolysis product CL 9673 and hydrolysable conjugates of CL 9673, expressed as pyridate. LENTAGRAN WP, NLKUG 17

22 The current residue definition for risk assessment and monitoring in animals is CL 9673, expressed as pyridate (EFSA Journal 2014;12(8):3801). However, during the evaluation of the existing authorisation (Lentagran WP, 12915N), the residue definition for animal products was for risk assessment and monitoring: sum of pyridate, its hydrolysis product CL expressed as pyridate. The same definition was used during the MRL review for pyridate (EFSA Journal 2012; 10(4):2687). In this evaluation (NLKUG), the residue definitions from the existing authorisation apply Stability of residues Storage stability of pyridate was demonstrated during the peer review for a period of 24 months in commodities of high water content (broccoli, alfalfa), 28 months in commodities of high oil content (peanuts) and 26 months in dry commodities (maize). Storage periods reported in the available trials are covered by the stability data Supervised residue trials Silver onions, picklers, garlic (cgap-nl: 5x 225 gas/ha, interval 5 days, PHI 56 days, maximal per season is 2 kg product/ha, which means 900 g as/ha per season) The use on onions and shallots is currently authorised for the product Lentagran WP (12915N) with a maximal dose of 1.5 kg product/ha with a PHI of 56 days. For this application for extension, the use in silver onions, picklers and garlic is requested with a higher dose of 2 kg product/ ha (PHI 56 days). Therefore, evaluation of possible residues is required. There are four trials available with pyridate in (bulb) onion in Northern Europe. The trials have been evaluated in the DAR for pyridate (Austria, 1996). The same cgap as now requested for the product Lentagran WP in silver onion, pickler and garlic was supported in the DAR. In all four trials, residues (expressed as CL 9673) were below the LOQ of 0.03 mg/kg, which is equivalent to 0.05 mg pyridate/kg. Residue data in onion can be extrapolate to silver onion, picklers and garlic. The current EU-MRL in silver onion, picklers and garlic is 0.05* mg/kg (expressed as pyridate). Based on the trials on onions, the intended uses are covered by the current EU-MRLs. Scallion (spring onion), sown leek (cgap-nl: 2x 0.25 kg product/ha + 3x 0.5 kg product/ha, interval 5 days, PHI 56 days, maximal per season is 2 kg product/ha, which means 900 g as/ha per season) Leek is authorised for the product Lentagran WP (1x 2kg product/ha, with a PHI of 28 days. The requested use in sown leek falls within the risk envelope of the current authorisation of the product Lentagran WP (12915N). According to the guidance document (7525/VI/95 Rev 10.1) residue data in leek can be extrapolated to spring onion (including scallion). The current EU-MRL in scallion and leek is 1 mg/kg and it is covered by the available data in leek. Oilseed rape (cgap-nl: 2x 450 g as/ha, interval 7 days, after sowing/planting, BBCH 13-97) The applicant submitted five trials with pyridate in oilseed rape. The trials were evaluated by Ctgb ( Evaluation Report). The trials were considered not acceptable to support the proposed cgap in oilseed rape, since the time of the application (6 leaf) does not represent the most critical time as proposed for the oilseed rape (BBCH 13-97) and correction for recovery rate is not acceptable. Twenty-one residue trials with pyridate in oilseed rape in NEU are available for this application. The trials have been evaluated in the framework of the Article 12 MRL review for pyridate (EFSA Journal 2021; 10(4):2687). All the trials were performed with an application rate of 1x 900 g as/ha. The total dose in the trials is comparable with the proposed cgap, which is acceptable. In all the trials residues in seeds, expressed as CL 9673 were below the LOQ (0.03 mg/kg), which is equivalent to 0.05 mg/kg pyridate. In the trials, the application took place early in the growing season (BBCH 13) and until approximately BBCH 50 (development of buds). The proposed cgap for oilseed rape is more critical (BBCH 13-97), which is not supported by the available trials. LENTAGRAN WP, NLKUG 18

23 To support the use on oilseed rape, the application time in the GAP should be amended to BBCH The current EU-MRL for pyridate in oilseed rape is 0.05* mg/kg and based on the available trials the intended use is covered by the current MRL, only when the application time will be changed to BBCH Poppy seed (cgap-nl: 2x 450 g as/ha, interval 7 days, after sowing/planting, BBCH 13-97) No trials with poppy seeds are available. According to the guidance document (7525/VI/95 Rev 10.1) residue data from oilseed rape can be extrapolated to poppy seeds. There are 21 trials available with pyridate in oilseed rape (see above). In all the trials, residues in seeds, expressed as CL 9673 were below the LOQ (0.03 mg/kg), which is equivalent to 0.05 mg/kg pyridate. In the trials, the application took place early in the growing season (BBCH 13), and until approximately BBCH 50 (development of buds). The proposed cgap for poppy seed is more critical regarding application timing (BBCH 13-97), which is not supported by the available trials in oilseed rape. To support the use on poppy seed, based on the trials in oilseed rape, the application time in the GAP should be amended to BBCH The current EU-MRL for pyridate in poppy seed is 0.05* mg/kg and based on the available trials in rape seed, the intended use is covered by the current MRL only when the application time will be changed to BBCH Lupin (pulses) (cgap-nl: 2x 450 g as/ha, interval 7 days, BBCH 13-97) Three trials are available with pyridate on field peas. According to the guidance document (7525/VI/95 Rev 10.10) residue data in field peas can be extrapolated to lupin (pulses). The trials have been evaluated by Germany in the framework of the Article 12 MRL review for pyridate (Evaluation Report, Germany 2012). The trials were performed with an application rate of 1x 900 g as/ha, therefore, the total dose in the trials is comparable with the proposed cgap, which is acceptable. In dry pea seeds, residues expressed as CL 9673 were 3x <0.03 mg/kg, which is equivalent to 0.05 mg/kg for pyridate. Lupin is a minor crop, therefore, four trials are required. Since a zero-residue situation is demonstrated, based on the trials on peas, three trials are acceptable. The current EU-MRL for pyridate in lupin is 0.05* mg/kg and based on the available trials in field peas the intended use is covered by the current MRL. Clover, alfalfa (luzerne; fodder crops) (cgap-nl: 2x 450 g as/ha, interval 7 days, BBCH 13-99) Five residue trials in alfalfa and four trails in clover are available for this application. The trials have been evaluated by Austria in the framework of the Article 12 MRL review for pyridate (Austria, 2001) and in a Registration Report for a Lentagran Evaluation ( zrms: Austria 2012). In all the trials the treated crops received one application of pyridate with an application rate of 900 g as/ha, which in total corresponds to the proposed cgap. In the trials residues in clover and alfalfa were determined at a PHI of 28 days. In the proposed cgap no PHI is defined, despite the fact that the application of the product can be done until late growing stages (up to BBCH 99). To support the requested uses, based on the available trials, the PHI should be defined as 28 days. Residues in alfalfa were (expressed as CL 9673): <0.03; 0.05; 0.14; 0.203; mg/kg. Residues in clover were (expressed as CL 9673): <0.02; 0.065; 0.57; mg/kg. Clover and alfalfa are feed items only and therefore no MRLs apply. The residue levels (expressed as pyridate) selected for risk assessment are presented in table R1. Lovage (leaves) (cgap-nl: 2x 450 g as/ha, interval 7 days, BBCH 14-16) Four residue trials (three in Northern Europe and one in Southern Europe) with pyridate in sorrel have been submitted for this application. The trials were evaluated by Ctgb ( Evaluation Report, February 2016). Only three trials are considered acceptable, since for one NEU trial, no data are available to validate the analytical method. To lovage leaves as well as sorrel the same MRL LENTAGRAN WP, NLKUG 19

24 applies as to celery leaves, which belongs to the group of herbs and edible flowers. Extrapolation is possible from any representative of the subgroup of the herbs and edible flowers to the whole subgroup. For extrapolation from a minor crop to a single minor crop, 4 trials should be available. However, only 2 NEU trials are available. Since there is a zero residues situation, and extrapolation is foreseen from 1 minor crop to only 1 other minor crop and not to the whole subgroup, 2 trials are considered sufficient. Furthermore, the 1 acceptable trial in SEU confirms the results from NEU that no residues are expected above LOQ. Celery leaves have an MRL of 0.3 mg/kg, which is sufficient for the requested use. Valerian (cgap-nl: 2x 225 g as/ha, interval 14 days, BBCH 14-16, PHI 56 days No trials with valerian root are available for this application. According to the guidance document (7525/VI95 Rev.10.1), residue data from any representative of the group of root and tuber vegetables can be extrapolated to the subgroup herbal infusions from roots, including valerian. In the current authorisation, the use in black salsifies (root and tuber vegetable) is authorised according to a comparable cgap as the GAP for valerian. Two residue trials with black salsify with an application rate of 3x 200 g as/ha have been evaluated. The trials represent a more critical GAP than proposed for valerian. In both trials a zero-residue situation was demonstrated (residues were below the LOD of mg pyridate/kg in black salsify roots). The current EU-MRL in valerian (dry root) is 0.05* mg/kg. Since in the trials residues of pyridate were measured in fresh roots of black salsify, a conversion factor should be applied to express residues in dry valerian roots. Considering the fact that residues in black salsify roots were not detectable, applying a dry factor would also result in a no-residue situation. It was concluded that based on the available trials in black salsify, the use in valerian roots can be supported and the MRL of 0.05* mg/kg will not be exceeded. Dill, fennel, caraway (herb seed crop) (cgap-nl: 2x g as/ha, BBCH 14-16) No trials in Northern Europe are available to support the requested use in seed spices: dill, caraway seed and fennel. Seed spices are minor crops, therefore four trials, performed according to the proposed GAP in Northern Europe are required. Globe artichoke (cgap-nl: 2x 450 g as/ha, interval 7 days, BBCH 12-14) No trials with globe artichokes have been submitted for this application. Globe artichoke is a minor crop, therefore four trials, performed according to the proposed GAP in Northern Europe are required. Sweet corn (cgap-nl: 1x 900 g as/ha, BCH 14-16) (cgap-nl: 2x 450 g as/ha,interval 7 days, BBCH 14-16) Six independent residues trials with pyridate in maize are available for this application. The trials have been evaluated by Austria in the framework of the Article 12 MRL review for pyridate (EFSA Journal 2012; 10(4):2687). In all six trials, residues were measured in immature (green) maize, which can be used to support the use in sweet corn. Residues in immature maize were in all six trials <0.03 mg/kg (expressed as mg CL 9673/kg, which is equivalent to 0.05 mg pyridate/kg). Sweet corn is a minor crop and therefore six trials are sufficient to support the use in that crop. The current EU-MRL in sweet corn is 0.05* mg/kg and based on the available trials in (immature) maize, the intended use is covered by the MRL. Kohlrabi (cgap-nl: 1x g as/ha, PHI 42 days, BBCH 13-14) LENTAGRAN WP, NLKUG 20

25 No trials with pyridate in kohlrabi in Northern Europe are available for this application. According to the guidance document (7525/VI/95 rev. 10.1), when the application takes place early in the growing season, residues from eight trials in cauliflower and eight trials in head cabbage can be extrapolated to the whole group of brassica vegetables, including kohlrabies. In the existing authorisation, head cabbages and flowering brassicas are authorised with a slightly more critical GAP regarding the application rate than proposed for kohlrabi. For this authorisation five trials in head cabbage, four trials in broccoli and eleven trials in cauliflower have been evaluated. In all the trials, at harvest, residues were below the LOQ (0.03 mg/kg CL 9673, equivalent to 0.05 mg/kg pyridate). The available residue data is considered sufficient to support the use in kohlrabi, according to the proposed cgap. The current EU-MRL in kohlrabi is 0.05* mg/kg and based on the available trials in head cabbage, broccoli and cauliflower, the intended use is covered by the MRL. Asparagus (cgap-nl: 2x 450 g as/ha, interval 7 days, BBCH 12 onwards) The use on asparagus at a similar cgap is already authorised, therefore, the proposed use falls within the risk envelope of the existing authorisation of the product Lentagran WP. Table R1: Selected residue levels from trials with pyridate (a conversion factor of 1,833 was used to convert pyridate from CL 9673) Crop Residue levels (mg/kg) STMR HR (mg/kg) (mg/kg) Clover <0.04; 0.12; 1.05; Alfalfa <0.05; 0.09; 0.26; 0.37; Sorrel --> lovage 2x <0.05 (NEU); <0.05 (SEU) Residues in succeeding crops All crops requested in the framework of this application can be grown in rotation. During the peer review metabolism in rotational crops was investigated. It was concluded that residues of pyridate will not be taken up or accumulated in succeeding crops. No further data is required Residues from livestock feeding studies Several requested crops might be fed to livestock. The maximum dietary burden was calculated during the MRL review for pyridate (EFSA Journal 2012; 10(4):2687) and this calculation covers all the requested uses within this application. During the peer review the magnitude of the residues in livestock was investigated in feeding studies in lactating cows and laying hens. Based on these studies MRLs in animal matrices were derived during the MRL review Processing factors During the MRL review of the existing MRLs for pyridate (EFSA Journal 2012; 10(4): 2687)_ it was concluded that since the chronic exposure to pyridate is less than 10% of the ADI, further investigation of the nature of residues in processed commodities is in principle not required Calculation of the ADI and the ARfD Calculation of the ADI The ADI is based on the NOAEL of 3.6 mg/kg bw/d in the 3 generation study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of mg/kg bw/day (see the most recent List of Endpoints for mammalian toxicology). Calculation of the ARfD The ARfD is based on the NOAEL of 165 mg/kg bw/d in the developmental rat study. Application of a safety factor for inter- and intraspecies differences of 400 results in an ARfD of 0.4 mg/kg bw/day (see the most recent List of Endpoints for mammalian toxicology). LENTAGRAN WP, NLKUG 21