HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1. BESLUIT
Op 11 februari 2014 is van
Menno Chemie-Vertrieb GmbH Xxxxxx Xxxx 000
D-22850 NORDERSTEDT
Germany
een aanvraag tot toelating ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel
XXXXX Xxxxxxxx
op basis van de werkzame stof benzoëzuur. Nederland is in deze een betrokken lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is Duitsland.
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van dit besluit.
1.1 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.
1.2 Gebruik
Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.
1.3 Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld:
▪ De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie” in bijlage I.
▪ Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.
▪ Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
▪ De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van deel A van het registratierapport.
1.4 Aflever- en opgebruiktermijn (respijtperiode)
Niet van toepassing. Het betreft een nieuwe toelating.
2. WETTELIJKE GRONDSLAG
Besluit | artikel 28 en artikel 36, derde lid, van de Verordening (EG) 1107/2009 |
Classificatie en etikettering | artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 |
Gebruikt toetsingskader | Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual Zonaal |
3. BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.
Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het Registration Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel bekendmaken delen A en B van het Registration Report.
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, 29 december 2017
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. X.X. xx Xxxxx Xxxxxxxxxx
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraaginformatie
Aanvraagnummer: 20140177 NLTG
Type aanvraag: aanvraag tot nationale toelating gewasbeschermingsmiddel (NL=CMS)
Middelnaam: XXXXX Xxxxxxxx
Verzenddatum aanvraag: 25 januari 2014
Formele registratiedatum: * 25 februari 2014
Datum in behandeling name: 19 september 2017
Datum compliance check: n.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2.2 Stofinformatie
Werkzame stof Gehalte
benzoëzuur 90 g/L
• De stof is geplaatst op Annex I van Richtlijn 91/414/EEG (2004/30/EC d.d. 10 maart 2004) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd.
De goedkeuring van de werkzame stof is per 1 september 2017 verlengd volgens Verordening EG 1107/2009 (Uitvoeringsverordening (EU) 2017/1113 d.d. 22 juni 2017).
De goedkeuring van de werkzame stof expireert op 31 augustus 2032. Dit besluit is nog gebaseerd op de oude eindpunten voor benzoëzuur die ook gebruikt zijn door de beoordelende lidstaat Duitsland.
2.3 Toelatingsinformatie
Toelatingsnummer: 15526 N
Expiratiedatum: 1 september 2018
Afgeleide parallel of origineel: Origineel
Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel
Gebruikers: Professioneel
2.4 Verpakkingsinformatie
Aard van het preparaat:
Met water mengbaar concentraat
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel XXXXX Xxxxxxxx
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: 1-propanol, benzoëzuur
Pictogram GHS02
GHS05 GHS07 GHS08
Signaalwoord Gevaar
Gevarenaanduidingen H225 Licht ontvlambare vloeistof en damp.
H318 Veroorzaakt ernstig oogletsel
H336 Kan slaperigheid of duizeligheid veroorzaken.
H373 Kan schade aan organen <of alle betrokken organen vermelden indien bekend> veroorzaken bij langdurige of herhaalde blootstelling.
Voorzorgsmaatregelen P102 Buiten het bereik van kinderen houden.
P210 Verwijderd houden van warmte, hete oppervlakken, vonken, open vuur en andere ontstekingsbronnen. Niet roken.
P233 In goed gesloten verpakking bewaren.
P261 Inademing van stof/rook/gas/nevel/damp/spuitnevel vermijden. P270 Niet eten, drinken of roken tijdens het gebruik van dit product. P271 Alleen buiten of in een goed geventileerde ruimte gebruiken.
P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen.
P305 + P351 + P338 + P310 BIJ CONTACT MET DE OGEN: voorzichtig
afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen.
P403 + P235 Op een goed geventileerde plaats bewaren. Koel bewaren.
P405 Achter slot bewaren.
SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.
Aanvullende etiketelementen
EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.
Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee
REGISTRATION REPORT
Part A
Risk Management
Product name:
XXXXX Xxxxxxxx
Active Substance: 90 g/L Benzoic acid
All Zones
Zonal Rapporteur Member State: Germany
NATIONAL ADDENDUM NL
Applicant: MENNO Chemie-Vertrieb GmbH
Date: December 2017 Evaluator: Ctgb, NL
The summaries and evaluations contained in this monograph or review report may be based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority that prepared it.
Other registration authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this Monograph or review report unless they have received the data on which the summaries and evaluation are based, either -
• From the owner of the data, or
• From a second party that has obtained permission from the owner of the data for this purpose or, alternatively,
• the applicant has received permission from the data owner that the summaries and evaluation contained in this Monograph or review report may be used in lieu of the data, or
• Following expiry of any period of exclusive use, by offering - in certain jurisdictions - mandatory compensation,
unless the period of protection of the proprietary data concerned has expired.
Applicants wishing to avail of information in this Monograph or review report should seek advice from the regulatory authority to which application is made concerning the requirements in their country.
PART A – Risk Management
This document describes the acceptable use conditions required for the re-registration/registration of XXXXX Xxxxxxxx containing Benzoic acid in all zones (application in protected areas). This evaluation is required subsequent to the inclusion of Benzoic acid on Annex 1.
The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national re-registration/registration by the EU review. It also includes assessment of data and information relating to XXXXX Xxxxxxxx where that data has not been considered in the EU review. Otherwise assessments for the safe use of XXXXX Xxxxxxxx have been made using endpoints agreed in the EU review of Benzoic acid.
This document describes the specific conditions of use and labelling required for all zones for the re- registration/registration of XXXXX Xxxxxxxx.
For a copy of the proposed product label, please refer to Appendix 1. For information on access to protected data, please refer to Appendix 2. For the reference list, please refer to Appendix 3.
Comparability of intended uses between Germany and other member states
Since there is no direct treatment on plants or plant products, and the product is a disinfectant on surfaces and tools, the biological assessment dossier has been structured according to the pests and not according to the crop. This is reflected also in the GAP provided under point 2.3, product uses.
For Germany, cultures have to be listed separately, therefore the GAP is extended compared to the “EU- GAP”, although the same uses are intended. The GAP for Germany is attached as Appendix 4.2.
1 Details of the application
1.1 Application background
Applicant:
Name MENNO Chemie-Vertrieb GmbH
Address: Xxxxxx Xxxx 000
D-22850 Norderstedt
This application was submitted by MENNO Chemie-Vertrieb GmbH in January 2014. The application was for approval of XXXXX Xxxxxxxx, a SL formulation containing 90g Benzoic acid/L for use as a as disinfectant of surfaces in protected areas (e.g. greenhouses, culture rooms, storage and processing rooms).
1.2 Annex I inclusion
The active substance Benzoic acid was included into Annex I of Directive 91/414 (2004/30/EC 10 March 2004) and thereafter approved according to Regulation (EC) No 1107/2009 amended by Regulation (EC) No. 823/2012 of the Commission.
The Annex I Inclusion Directive for Benzoic acid (2004/30/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.
For the implementation of the uniform principles of Xxxxx XX, the conclusions of the review report on benzoic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account.
These concerns have, where relevant, been addressed within the current submission.
1.3 Regulatory approach
To obtain re-approval/approval the product XXXXX Xxxxxxxx must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Xxxxx XX and Xxxxx XXX, with an assessment to Uniform Principles, using Annex I agreed end-points. New Annex II data were included because they are considered essential for the evaluation (mainly data from open sources) and in this case a full study summary has been provided.
The product has been previously evaluated in Germany (Reg. No. 024407-00) and other member states according to Uniform Principles. This application was submitted in order to allow the re-registration in accordance with the above.
1.4 Data protection claims
Data protection is claimed on the following:
The information and data provided in Part C of this assessment are considered by the applicants to represent industrial and commercial secrets, and therefore strict confidentiality is requested in accordance
with Article 14 of Directive 91/414/EEC and of Council Directive 90/313/EEC of 7 June 1990 or Article 63 of the new Regulation on the freedom of access to information.
1.5 Letters of Access
No Letters of Access are required as protected data were matched with equivalent studies. Besides, the applicant provides own studies on the product XXXXX Xxxxxxxx and the active substance. For these studies data protection is requested. All submitted studies are listed in Appendices 1 of Part B of each section in the reference lists.
2 Details of the authorisation
2.1 Product identity
Product Name | XXXXX Xxxxxxxx Trade names: Country Tradename AT Menno-Florades BE MENNO CLEAN CH Xxxxx Xxxxxxxx DE XXXXX Xxxxxxxx FI XXXXX Xxxxxxxx HR Xxxxx Xxxxxxxx HU MENNO-FLORADES LT Xxxxx Xxxxxxxx LV Xxxxx Xxxxxxxx š.k. NL XXXXX Xxxxxxxx PL Xxxxx Xxxxxxxx 90 SL UK XXXXX Xxxxxxxx | ||
Authorization Number (for re- registration) | Country Product Name Reg. No. | ||
DE | XXXXX Xxxxxxxx | 024407-00 | |
NL | MENNO CLEAN | 12784 | |
BE | MENNO CLEAN | 10212P/B | |
LV | Xxxxx Xxxxxxxx š.k. | 0254 | |
UK | XXXXX Xxxxxxxx | 13985, 15091 | |
LT | Xxxxx Xxxxxxxx | 0257/05 | |
HR | Xxxxx Xxxxxxxx | UP/I-320-20/08-01/152 | |
PL | Xxxxx Xxxxxxxx 90 SL | R-127/2009 | |
AT | Menno-Florades | 2753 | |
CH | Xxxxx Xxxxxxxx | W-5792, W-6699 | |
HU | MENNO-FLORADES | 45545/1999 (04.2/6568-1/2012) | |
FI | Xxxxx Xxxxxxxx | 1913 | |
Function | Disinfectant (bactericide, fungicide, virucide, viroicide) | ||
Applicant | MENNO Chemie-Vertrieb GmbH |
Composition | 90 g/L benzoic acid for use in protected areas |
Formulation type | soluble concentrate [SL] |
Packaging | HDPE (high density polyethylene ) bottles / containers: - 1.0 L HDPE-flask with 20 mm opening - 2.0 L HDPE-bottle incorporating a handle with 43.50 mm opening - 10.0 L HDPE-container with 49.6 mm opening - 20.0 L HDPE-container with 59 mm opening - 30.0 L HDPE-container with 59.5 mm opening - 220.0 L HDPE-container with 2 inch opening |
2.2 Classification and labelling under Regulation 1272/2008/EC
The identity of all substances in the mixture that contribute to the classification of the mixture *: benzoic acid, n-propanol
Pictogram: GHS02 Signal word: Danger
GHS05 GHS07 GHS08
H-statements: H225 Highly flammable liquid and vapour.
H318 Causes serious eye damage.
H336 May cause drowsiness or dizziness.
H373 May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure.
P-statements: P102 Keep out of reach of children.
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233 Keep container tightly closed.
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P270 Do not eat, drink or smoke when using this product.
P271 Use only outdoors or in a well-ventilated area.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P305+P351+P338+P310 IF IN EYES: Rinse cautiously with water for
several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor/....
P403 + P235 Store in a well-ventilated place. Keep cool. P405 Store locked up.
Supplemental Hazard information:
SP1 Do not contaminate water with the product or its container.
EUH401 To avoid risks to human health and the environment, comply with the instructions for use.
Child-resistant fastening obligatory? not applicable
Tactile warning of danger obligatory? not applicable
15526 N
(90 g Benzoic acid/L)
All Zones Page 13 of 44
2.3 Product uses
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 10 | 11 | 12 | 13 | 14 |
Use- No. | Member state(s) | Crop and/ or situation (crop destination / purpose of crop) | F G or I | Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) | Application | Application rate | PHI (days) | Remarks: Disinfection concentration (time) | ||||
Method / Kind | Timing / Growth stage of crop & season | Max. number (min. interval between applications) a) per use b) per crop/ season | ml product / m2 a) max. rate per appl. b) max. total rate per crop/season | g as/ m2 a) max. rate per appl. b) max. total rate per crop/season | Water ml/ m2 min / max | |||||||
1 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Small tools (e.g. knifes, secateurs) | G, I | Plantpathogenic bacteria and fungi, viruses and viroids | Dipping | n.a. | a) 1 b) n.a. | a) n.a. b) n.a. | a) n.a. b) n.a. | a) n.a. b) n.a. | n.a . | Dose rate: 4% (400 ml / 10 L water), during 3 minutes Only application on tools, not on soil or plants |
Amount of dipping fluid: Please prepare as necessary and appropriate to the size and amount of tools. | ||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 10 | 11 | 12 | 13 | 14 |
Use- No. | Member state(s) | Crop and/ or situation (crop destination / purpose of crop) | F G or I | Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) | Application | Application rate | PHI (days) | Remarks: Disinfection concentration (time) | ||||
Method / Kind | Timing / Growth stage of crop & season | Max. number (min. interval between applications) a) per use b) per crop/ season | ml product / m2 a) max. rate per appl. b) max. total rate per crop/season | g as/ m2 a) max. rate per appl. b) max. total rate per crop/season | Water ml/ m2 min / max | |||||||
2 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Surfaces of tables, benches, trays, walls, machines, container and vessels | G, I | Plantpathogenic bacteria | Directed coarse spray or foaming (lathering) | n.a. | a) 1 b) not relevant | a) 8 OR 16 | a) 0.72 OR 1.44 | a) 800 | n.a. | 1% (100 ml / 10 L water): max. 1h OR 2% (200 ml / 10 L water): max. 0.5h No direct treatment of plants, soil or substrates. Only for disinfection. |
3 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Hard surfaces and container | G, I | Plantpathogenic bacteria | Watering | n.a. | a) 1 b) not relevant | a) 8 OR 16 | a) 0.72 OR 1.44 | a) 800 | n.a. | |
4 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Sealed, plain, and non- profiled hard surfaces | G, I | Plantpathogenic bacteria | Flooding | n.a. | a) 1 b) not relevant | a) 8 OR 16 | a) 0.72 OR 1.44 | a) 800 | n.a. | |
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 10 | 11 | 12 | 13 | 14 |
Use- No. | Member state(s) | Crop and/ or situation (crop destination / purpose of crop) | F G or I | Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) | Application | Application rate | PHI (days) | Remarks: Disinfection concentration (time) | ||||
Method / Kind | Timing / Growth stage of crop & season | Max. number (min. interval between applications) a) per use b) per crop/ season | ml product / m2 a) max. rate per appl. b) max. total rate per crop/season | g as/ m2 a) max. rate per appl. b) max. total rate per crop/season | Water ml/ m2 min / max | |||||||
5 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Surfaces of tables, benches, trays, walls, machines, container and vessels | G, I | Plantpathogenic fungi | Directed coarse spray or foaming (lathering) | n.a. | a) 1 b) not relevant | a) 8 OR 16 | a) 0.72 OR 1.44 | a) 800 | n.a. | 1% (100 ml / 10 L water): max. 16h OR 2% (200 ml / 10 L water): max. 4h – time/rate conditions depending on the difficulties of control of the pest species. No direct treatment of plants, soil or substrates. Only for disinfection. |
6 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Hard surfaces and container | G, I | Plantpathogenic fungi | Watering | n.a. | a) 1 b) not relevant | a) 8 OR 16 | a) 0.72 OR 1. 44 | a) 800 | n.a. | |
7 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Sealed, plain, and non- profiled hard surfaces | G, I | Plantpathogenic fungi | Flooding | n.a. | a) 1 b) not relevant | a) 8 OR 16 | a) 0.72 OR 1.44 | a) 800 | n.a. | |
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 10 | 11 | 12 | 13 | 14 |
Use- No. | Member state(s) | Crop and/ or situation (crop destination / purpose of crop) | F G or I | Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) | Application | Application rate | PHI (days) | Remarks: Disinfection concentration (time) | ||||
Method / Kind | Timing / Growth stage of crop & season | Max. number (min. interval between applications) a) per use b) per crop/ season | ml product / m2 a) max. rate per appl. b) max. total rate per crop/season | g as/ m2 a) max. rate per appl. b) max. total rate per crop/season | Water ml/ m2 min / max | |||||||
8 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Surfaces of tables, benches, trays, walls, machines, container and vessels | G, I | Viruses and viroids | Directed coarse spray or foaming (lathering) | n.a. | a) 1 b) not relevant | a) 8 - 32 | a) 0.72 - 2.88 | a) 800 | n.a. | 1 % (100 ml / 10 L water), max. 4 hours OR 2 % (200 ml / 10 L water), max. 8 hours OR 4 % (400 ml / 10 L water), max. 1 h OR 4 % (400 ml / 10 L water), max. 16 h time/rate conditions depending on the difficulties of inactivation of the pes speciest No direct treatment of plants, soil or substrates. Only for disinfection. |
9 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Hard surfaces and container | G, I | Viruses and viroids | Watering | n.a. | a) 1 b) not relevant | a) 8 - 32 | a) 0.72 - 2.88 | a) 800 | n.a. | |
10 | NL | Rooms, buildings or greenhouses in agriculture and horticulture: Sealed, plain, and non- profiled hard surfaces | Viruses and viroids | Flooding | n.a. | a) 1 b) not relevant | a) 8 - 32 | a) 0.72 - 2.88 | a) 800 | n.a. | ||
3 Risk management
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles
3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4)
Overall Summary: The product XXXXX Xxxxxxxx is an SL-formulation. The appearance of the product is that of a clear, yellowish liquid. It is not explosive, has no oxidising properties. It has a self-ignition temperature of 435 °C and a flash point of 19.2 °C (and an estimated boiling point >35˚C, although no boiling point study was provided) and therefore the formulation is considered an flammable liquid cat. 2 and H225 is assigned. The pH of a 1% solution in water is 3.0 at 19.8 oC, however no study on the corrosiveness of the formulation was carried out it is not expected that the formulation has corrosiveness properties based on the fact that no H290 classified components are present in the formulation. The surface tension is 53.4 mN/m at 20 oC and therefore the formulation is considered surface active. The density is 0.999 g/cm3 at 20 oC. The kinematic viscosity is between 3.9-5.5 mm2/s at 40 oC, however as the hydrocarbon content (H304 classified components) is <10% no classification is required. The formulation is a Newtonian liquid. The stability data indicate a shelf life up to 68 months at ambient temperature in HDPE and therefore a 2 year shelf life at ambient temperature in HDPE can be assigned. Its technical characteristics are acceptable for a SL-formulation.
Implications for labelling:
According to EU regulation (no.) 1272/2008 based on the flash-point of 19.2 ˚C (and an estimated boiling point >35˚C), Flam. Liq. 2, H225 Highly Flammable liquid and vapour is assigned.
Compliance with FAO specifications: The product XXXXX Xxxxxxxx complies with FAO specifications.
Nature and characteristics of the packaging:
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.
Nature and characteristics of the protective clothing and equipment:
Information regarding the required protective clothing and equipment for the safe handling of XXXXX Xxxxxxxx has been provided and is considered to be acceptable.
3.1.2 Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)
XXXXX Xxxxxxxx (90g Benzoic acid/L) was a representative formulation in the EU review of Benzoic acid Analytical methods for determination of Benzoic acid, impurities and relevance of CIPAC methods in XXXXX Xxxxxxxx were evaluated as part of the EU review of Benzoic acid. All data are considered adequate.
Purpose | Description of the method | LOQ | Recovery [%] | RSD and CV [%] | Reference |
Determination of Benzoic acid in XXXXX Xxxxxxxx Guideline: SANCO/3030/99 rev 4 (11.07.2000) | System: HPLC /DAD equipped with a RP 18 column (250 * 4 mm, 5 µm) Detector: UV-VIS GLP study | A content of 1 % Benzoic acid in the formulation can be determined with sufficient precision and accuracy | Benzoic acid: 1% a.i: 97% 5% a.i.: 98 % 10% a.i.: 98% | RSD: 1.9 -2.7 CV: 0.4-0.9 | Xxxxxxxxxx, M. (2008) KIIIA1- 5.2.1/01 |
There is no CIPAC method available for the determination of Benzoic acid.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
The plants protection product XXXXX Xxxxxxxx containing 90g Benzoic acid /L is applied in protected areas (indoor/ glasshouse) only and no direct treatment of plants or the soil is intended.
The setting of maximum residue level (MRL) is not necessary and a residue relevant to MRL is not defined.
Background – Annex I inclusion:
It was confirmed by authorities (for Annex I inclusion) that due to the ubiquitous occurrence in soil and the kind of application relevant residues in the environmental compartments arising from the use of benzoic acid are not expected to occur. Therefore, residue analytical methods for the determination of the active substance in soil, water and air are not required.
Natural occurrence of the active substance:
Benzoic acid is a naturally occurring non-toxic substance in almost every environmental compartment (soil, water, air, plants, animals, humans). Furthermore, Benzoic acid is approved and extensively used as a preservative for food (E210) and feeding stuff.
According to SANCO/825/00 rev. 8.1 (2010), methods for naturally occurring non-toxic substances are usually not required.
Taken into account the intended uses of XXXXX Xxxxxxxx and the omnipresence of Benzoic acid and because it is classified as non toxic, residue analytical methods were considered not relevant.
3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)
XXXXX Xxxxxxxx was a representative formulation in the EU review of Benzoic acid and has been reviewed previously in a Member States according to Uniform Principles. The acute toxicity studies for XXXXX Xxxxxxxx were evaluated during the review. All data were considered adequate.
Acute toxicological data obtained with XXXXX Xxxxxxxx
Parameter [Reference] | Species | Result mg/kg or mg/m3 or effect | Classification |
Parameter [Reference] | Species | Result mg/kg or mg/m3 or effect | Classification |
Acute oral [KIIIA-7.1.1/01, DAR (2000) B.6.11.1,page 100 ] | Rats | LD50 > 2000 mg/kg bw | -- |
Acute dermal [KIIIA-7.1.2/01, DAR (2000) B.6.11.2,page 101] | Rats | LD50 > 2000 mg/kg bw | -- |
Acute inhalation [DAR (2000) B.6.11.3,page 101] | A study was not conducted. It is considered not necessary on the basis of the available information about the active substance, the preparation and the intended uses. Based on the calculation method no classification is required. | ||
Acute skin irritation [KIIIA-7.1.4/01, DAR (2000) B.6.11.4,page 102] | Rabbits | Not irritant | -- |
Acute eye irritation [KIIIA-7.1.5/01, DAR (2000) B.6.11.5,page 102] | Rabbits | The test article caused moderate to severe ocular reactions. In 2 of 3 animals, the observed findings were not reversible within 21 days after treatment. | Eye Dam. 1, H318 |
Skin sensitisation [KIIIA-7.1.6/01, DAR (2000) B.6.11.6,page 104] | Guinea pigs | Non sensitising | -- |
Taken into account that XXXXX Xxxxxxxx containing 90 g/L Benzoic acid causes moderate to severe ocular reactions in acute eye irritation tests with rabbits, the product does need to be classified.
3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)
Operator exposure to XXXXX Xxxxxxxx was not evaluated as part of the EU review of Benzoic acid for this submitted rate. Therefore all relevant data and risk assessments have been provided and are considered to be adequate.
Operator exposure was assessed against the AOEL agreed in the EU review (Benzoic acid: AOEL = 5 mg/kg bw). For dermal absorption default values of 25 and 75 % were used for model calculations according to TNsG Spraying Model 1 for spraying or foaming of surfaces, TNsG Watering-can for watering and flooding and TNsG Dipping Model 1 and 4 for dipping of small tools. In addition, in the reporting table the RMS DE has only included an exposure calculation in line with ConsExpo for the watering and flooding scenario.
According to the model calculations, it can be concluded that the risk for the operator using XXXXX Xxxxxxxx on surfaces, cultivation vessels and equipment in protected crop systems is acceptable with the use of personal protective equipment (gloves).
3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)
Bystander exposure to XXXXX Xxxxxxxx was not evaluated as part of the EU review of Benzoic acid for this submitted rate. A bystander exposure is typically not expected from the professional use of plant protection products in protected areas, such as greenhouses or storage rooms.
3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)
Worker exposure to XXXXX Xxxxxxxx was not evaluated as part of the EU review of Benzoic acid for this submitted rate. Therefore, all relevant data and risk assessments have been provided and are considered adequate. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing (but no PPE), when re-entering protected areas treated with XXXXX Xxxxxxxx.
3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)
3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)
Neither plants nor soil will be treated with XXXXX Xxxxxxxx. The application of XXXXX Xxxxxxxx takes place in protected areas only (indoor/ glasshouse). Considering the representative uses and the natural occurrence of benzoic acid in many plants, no studies on metabolism, distribution and expression of residues in plants were deemed necessary. The MRLs for Benzoic acid are published in Annex IV of Regulation (EC) No 396/2005, meaning that no MRL is required.
The proposed uses of XXXXX Xxxxxxxx are within those supported for the EU MRL assessment; therefore no further evaluation is required for national re-registration/registration. Application for additional crops or uses should be made by the appropriate process to establish an EU MRL and any additional risk assessment necessary to support additional uses should be submitted via relevant national label extension processes.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
The product XXXXX Xxxxxxxx is used as disinfectant on surfaces in protected areas, such as greenhouses and storage rooms. Following the intended uses, the product will not come into contact with plants, food or feeding stuff. Dietary exposure of consumers in relation to the representative uses is expected to be negligible when compared to exposure to benzoic acid via the regular diet. It can therefore be concluded that acceptable margins of safety exist for consumers and it is not required to perform TMDI calculations.
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)
The active substance benzoic acid is a natural compound from plants and soil and it is also largely produced by the industry. Consequently, it is almost ubiquitous in the environment (present in air, rain, surface waters, soils and agricultural commodities, milk, honey and nuts as well as many processed products). The use of benzoic acid as plant protection product represents less than 0.001% of the overall industrial production (RAR, Benzoic acid, volume 3, B.8 (AS), December 2015 (Revised August 2016), B 8.5 Monitoring data, page 134), so no relevant additional load to the background concentration will be expected.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5)
The plant protection product XXXXX Xxxxxxxx is used as a disinfectant of equipment (watering of surfaces on which plants in pots or other culture vessels stand, soaking of culture vessels, dipping of tools like knives etc.). Taking into account the kind of application the contamination of soil following use as a
disinfectant according to the GAP is not expected. The estimation of predicted environmental concentrations in soil is therefore deemed to be not necessary.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)
Benzoic acid has to be regarded as mobile in soil. Taking into account the kind of application the contamination of soil following use as a disinfectant of equipment (watering of surfaces on which plants in pots or other culture vessels stand, soaking of culture vessels, dipping of tools like knives etc.) is not expected. Since the active substance is a natural component of soils which is readily degraded a risk of ground water contamination resulting from application of benzoic acid according to the GAP is not expected.
Groundwater monitoring data
There are no data available regarding the presence of the benzoic acid in groundwater.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)
As the plant protection product is applied as a disinfectant of horticulture equipment (watering of surfaces on which plants in pots or other culture vessels stand, soaking of culture vessels, dipping of tools like knives etc.) a direct contamination of surface water via spray drift or run- off can be excluded. Thus, the only possible entry route into water bodies is via disposal into waste water.
Application is made using an 1 – 4 % solution of the plant protection product which corresponds to concentrations of 0.9 – 3.6 g a.s./l. Disposal into waste water will result in considerable dilution (i.e. factor 1/1000). According to EUSES 2.0, 0.2 m3 water per day is being disposed by every inhabitant to the waste water system. Since a local waste water treatment plant receives water from 10000 inhabitants, there is 2000 l water per day to be treated. Assuming a single disposal of XXXXX Xxxxxxxx being lower than 0.5 m3, a dilution factor of 1000 is found acceptable.
During waste water treatment, biological degradation of the active substance is considered to be 95%. Further dilution of possibly remaining active substance in the effluent of waste water treatment plant will occur in the receiving waterbody. In EUSES 2.0 a factor 10 is used as a standard dilution factor for a disposal into a large surface waterbody with low stream velocity.
It can be anticipated that these factors will lead to a decline of the concentration of benzoic acid by several orders of magnitude. Accounting for the three mentioned factors by rough estimates (pre- treatment dilution 1/1000, 95% degradation, post-treatment dilution 1/10, no adsorption to sediment) the environmental concentration expected in aquatic ecosystems (river receiving effluent from waste water treatment) will be 18 μ g/l which will add to benzoic acid due to natural or non-agricultural anthropogenic sources. Therefore, it is concluded that the use of the plant protection product XXXXX Xxxxxxxx according to the GAP will not lead to an additional relevant load.
of benzoic acid in the aquatic environment.
The results for PEC surface water for the active substance and its metabolites were used for the eco- toxicological risk assessment.
Surface water monitoring data
There are no data available in the Pesticide Atlas1 regarding the presence of the benzoic acid in surface water.
Drinking water criterion
The active substance benzoic acid is not included in the current list of problematic substances (period 2011- 2015) published on xxx.xxxxx.xx/xxxxxxxxxxxxxxx (accessed on 9th August 2017).
Benzoic acid has been on the Dutch market for > 3 years (authorised since 20th January 2006). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the 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. The 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 are met.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)
Considering the vapour pressure (new endpoint) of the active substance Benzoic acid of 0.04 – 0.07 Pa at 20°C, a volatilisation is relevant according to the FOCUS Air Guidance (SANCO/10553/2006)2. A long- range transport is possible, but entrance in the natural compartments by plant protection is very low (about 0.001 %) compared to other sources in industry.
3.1.6 Ecotoxicology (Part B, Section 6, Point 10)
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
Birds
XXXXX Xxxxxxxx was a representative formulation in the EU review of Benzoic acid. However new risk assessment parameters are now considered in the assessment of risk to birds; appropriate risk assessments have been provided and are considered adequate.
The evaluation of the risk for birds was performed in accordance with the recommendations of the "Guidance Document on Risk Assessment for Birds and Mammals” (The EFSA Journal (2009) 7(12):1438).
The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and short-term risk and 5 for long-term risk (including secondary poisoning), thus indicating no unacceptable risk to birds from the proposed use.
Risk of secondary poisoning was not assessed, as Benzoic acid has log POW < 3.0.
Terrestrial vertebrates (other than birds)
1 xxxx://xxx.xxxxxxxxxxxxxxxxxxxxxxxxx.xx/xxxxx.xxxx , checked on 9th August 2017.
2 FOCUS (2008). “Pesticides in Air: Considerations for Exposure Assessment”. Report of the FOCUS Working Group on Pesticides in Air, EC Document Reference SANCO/10553/2006 Rev 2 June 2008. 327 pp.
XXXXX Xxxxxxxx was a representative formulation in the EU review of Benzoic acid. However new risk assessment parameters are now considered in the assessment of risk to terrestrial vertebrates other than birds; an appropriate risk assessment has been provided and is considered adequate.
The evaluation of the risk for vertebrates other than birds was performed in accordance with the "Guidance Document on Risk Assessment for Birds and Mammals” (The EFSA Journal (2009) 7(12):1438).
The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and short-term risk and 5 for long-term risk (including secondary poisoning), thus indicating no unacceptable risk to mammals from the proposed use.
Risk of secondary poisoning was not assessed, as Benzoic acid has log POW < 3.0.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
XXXXX Xxxxxxxx was a representative formulation in the EU review of Benzoic acid.
Exposure in the field and to sewage treatment plant was estimated using factors from EUSES model: pre-treatment dilution 1/1000, 95% degradation, post-treatment dilution 1/10, no adsorption to sediment (see Environmental Fate Part A). The resulting PECsw of benzoic acid is 18 μg/L.
The TER using worst-case PEC values for the metabolites exceed the relevant triggers, indicating that these metabolites do not pose an unacceptable risk to aquatic organisms following applications of XXXXX Xxxxxxxx according to the recommended use pattern.
Because the product XXXXX Xxxxxxxx will be used the whole year round, there will be discharge on the surface water very regularly by the sewage system or RWZI. Therefore there will be a chronic exposure of aquatic organisms. No chronic toxicity data for benzoic acid is available. However, from the data on fate and behaviour in water it has been found that benzoic acid was found to be mineralised to 94.5- 98.6% in water samples from two lakes. Benzoic acid is also classified as readily biodegradable. In that case it is more or less a repetition of acute exposure. Based on this argument together with the fact that the acute toxicity is very low, Ctgb can agree that chronic data is not necessary.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
The product XXXXX Xxxxxxxx (90 g/L benzoic acid) is used as disinfectant on surfaces and tools in protected areas only (e.g. greenhouse, machine halls etc.). The representative uses do not foresee direct application on plants or soil, but on hard surfaces (from standing areas, containers, walls, machinery or equipment).
Bees
For the intended use of the product, exposure to the active substance of pollinators used in pollinator programs is deemed negligible. Hence, the risk to bees is considered acceptable for the intended use.
Other non-target arthropods
For the intended use of the product, exposure to the active substance of natural enemies used in IPM programs is deemed negligible. Hence, the risk for non- target arthropods is considered acceptable for the intended use.
3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)
XXXXX Xxxxxxxx was a representative formulation in the EU review of Benzoic acid. However new risk assessment parameters are now considered in the assessment of risk to earthworms and other soil macro- organisms; appropriate risk assessments have been provided and are considered adequate.
Earthworms
The long-term risk of XXXXX Xxxxxxxx to earthworms was assessed from long-term toxicity exposure ratio (TERs) between the selected toxicity endpoint (NOEC) for the active ingredient and the maximum soil PECs.
The chronic TER value for Benzoic acid is greater to than the Annex IV trigger of 5, respectively, indicating an acceptable risk to earthworms following application of XXXXX Xxxxxxxx for the proposed use (see also summary table below).
Effects on other soil non-target macro-organisms
The TER value is greater than the recommended trigger of 5, indicating no unacceptable risk to soil macro-organisms as represented by Folsomia candida following application of XXXXX Xxxxxxxx for the proposed use (see also summary table below).
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
No tests are required considering the persistence trigger in accordance with the EU Guidance Document, since the field DT90 is <365 days for Benzoic acid and only a single application is recommended per year, indicating that there will be no long-term exposure or accumulation of residues.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
The risk of XXXXX Xxxxxxxx to soil micro-organisms was evaluated by comparison of no-effect concentrations, derived from a laboratory test (N-transformation), with soil PECs.
All no effect levels exceed the relevant PEC values indicating that XXXXX Xxxxxxxx does not pose an unacceptable risk to soil micro-organisms.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)
Non-Target Plants
The product XXXXX Xxxxxxxx is used as disinfectant of surfaces and tools in protected areas only (e.g. greenhouse, machine halls etc.). A discharge of the product to the environment is unlikely and the intended use of the product does not include a direct treatment of plants. Considering this, no risk for non- target plants from the use of XXXXX Xxxxxxxx is assumed and no assessments were performed.
Other non-target species (Flora and Fauna)
Tests on other non-target species are not required.
3.1.7 Efficacy (Part B, Section 7, Point 8)
This dossier concerns the new product XXXXX Xxxxxxxx (active substance: 90 g/L benzoic acid), which is claimed to be a disinfectant in standing areas, surfaces, equipment, and containers in storage and processing rooms, and small tools in agriculture and horticulture, against plant pathogenic fungi, bacteria, and viruses.
Application technique
Trials of foaming are not available. The zRMS concluded that no further trials are required, because of possibilities of extrapolation from spraying/watering to foaming. The zRMS considers that flooding does not differ from watering or spraying with the same spray volume. The Netherlands agrees with the zRMS.
Minimum effective dose
Bacteria/ Suspension tests:
For the control of bacteria, 23 results testing XXXXX Xxxxxxxx 0.25 - 3 % are presented, including 9 suspension trials and 1 agar plate trial, with different bacteria. The exposure times tested are different per trial, covering 1, 2, 3, 5, 15, 30 min. ZRMS accepted the conclusion: in the control of plant pathogenic bacteria 3 to 5 minutes exposure time to 1% XXXXX Xxxxxxxx.
Fungi/Tests with contaminated carriers:
In total 37 results testing XXXXX Xxxxxxxx 0.1 – 3 % are provided, including 7 suspension- and 1 agar plate tests, on different fungus species.
The zRMS concluded that the control of all tested fungi was given at the latest after 16 h exposure time to 1% XXXXX Xxxxxxxx (except Mucor sp.) and 4 h exposure time to 2% XXXXX Xxxxxxxx, respectively.
Viruses and virus like organisms/In vitro tests:
Five plant juice inocculum trials testing XXXXX Xxxxxxxx in concentrations of 1 – 4% are provided. One fixed MED concentration and time exposure is not concluded, because concentration and exposure times necessary for inactivation depend very much on the viruses and viroids tested.
It was decided to provide minimum concentration in combination of exposure time for the inactivation of viruses:
- inactivation of viruses and viroids is difficult: 4 % (max. 16 h)
- inactivation of viruses and viroids is medium difficult: 2 % (max. 16 h)
- inactivation of viruses and viroids is easy: 1 % (max. 16 h)
The zRMS pointed out that the wording “max. 16h” is to be understood like control will be achieved at the latest after 16h. No disadvantages for efficacy are expected if a longer exposure time is used. Specific doses and treatment timings according to virus classification are provide in the efficacy section.
It should be noted that the information on temperature during the test is not given. Presented data is only with peat, which is considered as the worst case.
Efficacy tests
In general, disinfection depends on the combination of the concentration of the disinfectant and the exposure time. A higher concentration generally allows a reduced exposure time and vice versa. This allows adaption of the used concentrations and exposure times to the practical background. In the production of cuttings for propagation, for example, knives must be disinfected repeatedly in a short time span. Disinfection of tables on the other hand can possibly be done overnight.
XXXXX Xxxxxxxx was tested against various plant pathogens of different crops in horticulture and agriculture. Therefore the use of the disinfectant in these areas can be justified.
Bacteria/surfaces
6 suspension tests with 16 results of different bacteria species were provided. Additionally two practical tests (on surfaces and on small tools) are available. Suspension tests on bacteria showed complete control after 3-5 minutes of exposure to 1% XXXXX Xxxxxxxx. In total 21 bacteria were tested on 1% and for 16 of them reference product was not tested. 2 % was only tested on five bacteria, but on most of the species 100% kill was shown at different exposure timings.
A test from Canada on disinfection of contaminated greenhouse surfaces showed insufficient control of Clavibacter michiganensis ssp. michiganensis under fast drying conditions on polyethylene and rubber after an exposure time of 30 minutes at 1%. Control was achieved after 30 minutes at 2% and under slow drying conditions at 60 min/1% and 60 min/2%. ZRMS considered these trials as supportive as it was not carried out by one of the European member states. NL considers that Disinfection is not different in Canada than in EU thus these data can be taken into account for the Dutch evaluation.
Fungi/surfaces
21 results on different (sub-)species from 7 suspension tests are available. Additionally 3 practical tests on surfaces with 7 results of different (sub-)species was provided. Disinfection against fungi was completed at the latest after 16 hours of exposure to 1% XXXXX Xxxxxxxx (except Mucor sp.) or 4 hours/2% of the disinfectant. The application type proposed includes watering, spray/foaming and flooding. It is assumed that thorough cleaning followed by a longer exposure time might have led to complete disinfection. ZRMS concluded that the claim for disinfection after 16h (at the latest) at 1% or 4h (at the latest) at 2% is sufficiently supported by trials. NL agrees with this conclusion. It is noted on the Dutch label that Surface should stay wet during the contact time.
Viruses and virus like organisms/surfaces
In total, 31 results are available for viruses and viroids. 4 inoculum tests on plants with 8 results of different (sub-)species are provided. Additionally 3 tests with 9 results on surfaces and 9 tests with 14 results on Small tools area available. A classification of the viral pathogens according to the difficulty for their inactivation as intended for Germany is possible (see GAP-table for Germany) as well as advice on reduced concentrations/exposure times in the instructions for use. The Tobacco mosaic tobamovirus (TMV) turned out to be the most difficult virus to inactivate among the tested organisms. Only after thorough cleaning the virus could be controlled by 4% XXXXX Xxxxxxxx and an exposure time of 16 hours. For other viruses/viroids disinfection could already be achieved at lower concentrations and/or exposure times. ZRMS pointed out that in most cases only one trial per virus/viroid was performed. Therefore it might be risky to reduce the exposure time to the minimum given in the trial results like in the label proposal above. ZRMs left the decision open to member states, on a classification of viruses for treatment with different concentrations and/or additional advice on concentrations/exposure times in the instructions. The applicant proposed the following classification for the virus and viroids:
Table 6.1.3- 1: Classification of viruses and viroids
Minimum recommended concentration and exposure time for inactivation of virus and viroid species
Pathogen
1 % | 2 % | 4 % | |
Viruses and viroids: Easy to inactivate (maximum for the product application: 1 %, max. 16 hours) | |||
Pelargonium leaf curl tombusvirus | 1 hour | 1 hour | 1 hour |
Potato spindle tuber viroid | 1 hour | 1 hour | 1 hour |
Arabis mosaic nepovirus | Not tested | 1 hour | 1 hour |
Chrysanthemum stunt viroid | Not tested | 1 hour | 1 hour |
Pelargonium line pattern virus | Not tested | 1 hour | 1 hour |
Xxxxxx spotted wilt tospovirus | 4 hours | 1 hour | 1 hour |
Cymbidium mosaic virus | 4 hours | 4 hours | 4 hours |
Viruses and viroids: Not easy to inactivate (maximum for the product application: 2 %, max. 16 hours) | |||
Melon necrotic spot carmovirus | No inactivation within 16 h | 1 hour | 1 hour |
Pepino mosaic potexvirus | No inactivation within 16 h | 8 hours | 1 hour |
Zucchini yellow mosaic potyvirus | No inactivation within 16 h | 8 hours | 1 hour |
Pelargonium flower break carmovirus | 16 hours | 8 hours | 1 hour |
Pathogen | Minimum recommended concentration and exposure time for inactivation of virus and viroid species | ||
1 % | 2 % | 4 % | |
Viruses and viroids: Difficult to inactivate (maximum for the product application: 4 %, max 16 hours) | |||
Tobacco streak virus | 16 hours | 16 hours | 1 hour |
Bell Pepper mottle Virus | No inactivation within 16 h | No inactivation within 16 h | 1 hour |
Odontoglossum ringspot tobamovirus | No inactivation within 16 h | No inactivation within 16 h | 1 hour |
Pepper mild mottle tobamovirus | No inactivation within 16 h | No inactivation within 16 h | 1 hour |
Tobacco mosaic tobamovirus | No inactivation within 16 h | No inactivation within 16 h | 16 hours |
On the Dutch label some uses require 4, 8, or 16 hours exposure time. It is not clearly described how such long contact time can be realised in practice. It is noted on the Dutch label that Surface should stay wet during the contact time.
Bacteria, fungi, viruses and viroids/small tools
Disinfection of small tools was successful for all tested pathogens at 3 min exposure to 4% XXXXX Xxxxxxxx including TMV as the worst case. The claim for disinfection of small tools according to the GAP-table (3min/4%) is supported by the trials.
It should be noted that the information on temperature during the test is not given. Only the results with peat are presented.
Effects on yield and quality
Not relevant for the uses according to the GAP-table as no direct application to plants is intended.
Phytotoxicity
No direct application of XXXXX Xxxxxxxx to plants is intended. Therefore direct contact to the disinfectant is limited to residues directly after disinfection or unintended contact with plants when disinfection is carried out close to them. The use of the disinfectant according to the GAP (no direct application to the plants) is unlikely to cause phytotoxicity while direct application to the plants may cause undesired effects. ZRMs recommended, as a measure of precaution in the instructions for use to perform a small scale tolerance test with plants which might have contact to disinfected material.
Adverse effects on beneficial organisms
The product XXXXX Xxxxxxxx (benzoic acid: 90 g/L) has been developed for use as disinfectant of surfaces and tools in protected areas only (e.g. flower pots, trays, transport containers, benches and storage rooms, cultivation rooms, greenhouses). Applications as fungicide, bactericide and viricide are indoor post-harvest spraying, foaming, dipping, watering and flooding. Due to the applications specified in the registration procedure (area of application: ornamentals, vegetable crops, mushroom production, potatoes and tobacco; timing of application: post-harvest; application: spraying, foaming, dipping, watering, flooding), populations of relevant arthropods will not be affected.
Resistance
No resistance or cross-resistance of plant pathogens to benzoic acid has been observed so far and the risk for the development of resistance is considered to be low. Therefore no resistance management strategy is recommended.
3.2 Conclusions
The assessment conducted for XXXXX Xxxxxxxx was in accordance with the Uniform Principles and demonstrates an acceptable risk to human health and the environment. An authorisation can therefore be granted.
3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation
No further information is required.
Appendix 1 – Copy of the proposed product label
Wettelijk Gebruiksvoorschrift
Toegestaan is uitsluitend het professionele gebruik als gewasbeschermingsmiddel door middel van ontsmetten (landbouwkundig, tuinbouwkundig) in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1 Ctgb juni 2015) onder de hierna toepassingsvoorwaarden.
Toepassings- Gebied | Type Toepassing | Werkzaamheid getoetst op | Dosering* middel per toepassing | Inwerktijd** | Maximale dosering (middel) per toepassing |
Klein gereedschap | Dompelen | Plantenpathogene bacteriën1, schimmels2 virussen, en viroiden3 | 4% (100 ml middel per 2.5 liter water) | 3 minuten | --- |
Niet- doorlatende, vlakke, harde oppervlakken | Onder laten lopen | Plantenpathogene bacteriën1 | 1% (100 ml middel per 10 liter water) | 1 uur | 8 ml/ m2 |
2 % (200 ml middel per 10 liter water) | 0.5 uur | 16 ml/ m2 | |||
Plantenpathogene schimmels2 m.u.v. Mucor | 1% (100 ml middel per 10 liter water) | 16 uur | 8 ml/ m2 | ||
Plantenpathogene schimmels2 | 2% (200 ml middel per 10 liter water) | 4 uur | 16 ml/ m2 | ||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4 | 1% (100 ml middel per 10 liter water) | 4 uur | 8 ml/ m2 | ||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4 niet gemakkelijk te inactiveren 5 | 2% (200 ml middel per 10 liter water) | 8 uur | 16 ml/ m2 | ||
4% (400 ml middel per 10 liter water) | 1 uur | 32 ml/ m2 | |||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4, niet gemakkelijk te inactiveren 5 en moeilijk te inactiveren6 | 4% (400 ml middel per 10 liter water) | 16 uur | 32 ml/ m2 | ||
Harde oppervlakken en containers | Gieten | Plantenpathogene bacteriën1 | 1% (100 ml middel per 10 liter water) | 1 uur | 8 ml/ m2 |
2 % (200 ml middel per 10 liter water) | 0.5 uur | 16 ml/ m2 | |||
Plantenpathogene schimmels2 m.u.v. Mucor | 1% (100 ml middel per 10 liter water) | 16 uur | 8 ml/ m2 |
Toepassings- Gebied | Type Toepassing | Werkzaamheid getoetst op | Dosering* middel per toepassing | Inwerktijd** | Maximale dosering (middel) per toepassing |
Plantenpathogene schimmels2 | 2% (200 ml middel per 10 liter water) | 4 uur | 16 ml/ m2 | ||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4 | 1% (100 ml middel per 10 liter water) | 4 uur | 8 ml/ m2 | ||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4 en niet gemakkelijk te inactiveren 5 | 2% (200 ml middel per 10 liter water) | 8 uur | 16 ml/ m2 | ||
4% (400 ml middel per 10 liter water) | 1 uur | 32 ml/ m2 | |||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4, niet gemakkelijk te inactiveren 5 en moeilijk te inactiveren6 | 4% (400 ml middel per 10 liter water) | 16 uur | 32 ml/ m2 | ||
Oppervlakken (tafels, trays, machines, containers, potten etc. | Spuiten of Schuimen | Plantenpathogene bacteriën1 | 1% (100 ml middel per 10 liter water) | 1 uur | 8 ml/ m2 |
2 % (200 ml middel per 10 liter water) | 0.5 uur | 16 ml/ m2 | |||
Plantenpathogene schimmels2 m.u.v. Mucor | 1% (100 ml middel per 10 liter water) | 16 uur | 8 ml/ m2 | ||
Plantenpathogene schimmels2 | 2% (200 ml middel per 10 liter water) | 4 uur | 16 ml/ m2 | ||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4 | 1% (100 ml middel per 10 liter water) | 4 uur | 8 ml/ m2 | ||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4 en niet gemakkelijk te inactiveren 5 | 2% (200 ml middel per 10 liter water) | 8 uur | 16 ml/ m2 | ||
4% (400 ml middel per 10 liter water) | 1 uur | 32 ml/ m2 | |||
Plantenpathogene virussen en viroiden3 gemakkelijk te inactiveren4, niet gemakkelijk te inactiveren 5 en moeilijk te inactiveren6 | 4% (400 ml middel per 10 liter water) | 16 uur | 32 ml/ m2 |
* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is bij lagere dosering niet beoordeeld.
** Voor de bestrijding van plantpathogene bacteriën, schimmels, virussen en viroiden geldt dat de oppervlakken gedurende de gehele inwerktijd nat blijven.
1 Plantenpathogene bacteriën: Acidovorax, Agrobacterium, Clavibacter, Erwinia, Pseudomonas, Ralstonia, Xanthomonas, etc.
2 Plantenpathogene schimmels (inbegrip van een permanente vorm): Alternaria, Aspergillus, Botrytis, Cercospora, Chalara, Colletotrichum, Cylindrocladium, Dactylium, Didymella, Erysiphe, Fusarium, Helminthosporium, Mucor, Ophiostoma, Peronospora, Pythium, Phytophthora, Ramularia, Rhizoctonia, Rhizopus, Thielaviopsis, Trichoderma, Verticillium, etc.
3 Plantenpathogene virussen, viroiden:
4 gemakkelijk te inactiveren: Pelargonium leaf curl tombusvirus, Potato spindle tuber viroid, Arabis mosaic nepovirus, Chrysanthemum stunt viroid, Pelargonium line pattern virus, Tomato spotted wilt tospovirus, Cymbidium mosaic virus,etc
5Niet gemakkelijk te inactiveren: Melon necrotic spot carmovirus, Pepino mosaic potexvirus, Zucchini yellow mosaic potyvirus, Pelargonium flower break carmovirus etc.
6moeilijk te inactiveren: Tobacco streak virus, Bell Pepper mottle Virus, Odontoglossum ringspot tobamovirus, Pepper mild mottle tobamovirus, Tobacco mosaic tobamovirus, etc
Appendix 2 – Letter of Access
Not required.
Appendix 3 – List of references submitted in support of the evaluation Identity, physical and chemical properties, other information
No new studies were submitted.
Analytical methods
Annex point/ reference No. OECD | Author(s) | Year | Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not | Data protection claimed | Owner | Studies relied on | Data protection granted |
KIIIA1 5.2.1 | Xxxxxxxxxx, M., Xxxxxxxxx, X. | 2008 | Validation of an Analytical Method for the Determination of Benzoic Acid in Formulation, 43964101, GLP: yes, unpublished | Y | MEN | Y | Y |
Human toxicology
No new studies were submitted.
Residues
No new studies were submitted.
Fate and environmental behaviour
No new studies were submitted.
Ecotoxicology
No new studies were submitted.
Efficacy
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 1996 | Bactericidal effectiveness test of | N | Y | Y | Y | MEN |
01 | Florades against Clavibacter | ||||||
michiganensis ssp. michiganensis. | |||||||
KIIIA1- | Research Institute of Geisenheim, | ||||||
6.1.2/01 | Geisenheim, Germany | ||||||
Report No.: project no. V9609 | |||||||
Report date: 03.09.1996 | |||||||
Non-GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 1997 | Bactericidal effectiveness test of | N | Y | Y | Y | MEN |
03 | Florades against Clavibacter | ||||||
michiganensis ssp. sepedonicus and | |||||||
KIIIA1- | Pseudomonas solanacearum. | ||||||
6.1.2/03 | Research Institute of Geisenheim, | ||||||
Geisenheim, Germany; | |||||||
Report No.: project no. V9713 | |||||||
Report date: 28.04.1997 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1995 | Expert Opinion on the disinfectant | N | Y | Y | Y | MEN |
04 | Florades (Menno Chemie) and its | ||||||
practical application in horticulture. | |||||||
KIIIA1- | FLORA-NOVA Pflanzen GmbH, | ||||||
6.1.2/04 | Hillscheid, Germany | ||||||
and KIIIA1- 6.2.1/15 | Report No.: -- Report date: 06.09.1995 Non-GEP, unpublished | ||||||
MEN-07- | 1994 | Bacterial effectiveness test of Florades | N | Y | Y | Y | MEN |
05 | against Xanthomonas campestris pv. | ||||||
Pelargonii. | |||||||
KIIIA1- | Research Institute of Geisenheim, | ||||||
6.1.2/05 | Geisenheim, Germany | ||||||
Report No.: project no. V9413 | |||||||
Report date: 30.08.1994 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1996 | XXXXX Xxxxxxxx effectiveness against | N | Y | Y | Y | MEN |
06 | Xanthomonas campestris pv. Pelargonii | ||||||
for knive disinfection with a 2-minute | |||||||
KIIIA1- | exposure time. | ||||||
6.1.3/06 | Research Institute of Geisenheim, | ||||||
Geisenheim, Germany | |||||||
Report date: 23.08.1996 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1995 | Disinfecting activity test of Florades | N | Y | Y | Y | MEN |
07 | against Cylindrocladium spathiphylli in | ||||||
the practice test (surface and immersion | |||||||
KIIIA1- | treatment). | ||||||
6.1.3/07 | Research Institute of Geisenheim, | ||||||
and | Geisenheim, Germany | ||||||
KIIIA1- 6.2.1/07 | Report No.:project no. V9507 Report date: 02.07.1995 | ||||||
GEP, unpublished | |||||||
MEN-07- 08 KIIIA1- 6.1.3/08 | no stated | Expert opinion on the virudical effect of the disinfectant FLORADES to disinfect standing areas. Universität Hamburg, Hamburg, Germany Report No.: -- Report date: -- Non-GEP, unpublished | N | Y | Y | Y | MEN |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- 11 KIIIA1- 6.2.1/01 | 2003 | Effectiveness of XXXXX Xxxxxxxx against silver scurf in Seed potatoes Applied Plant Research, Research , AGV Research Unit, Lelystad, The Netherlands Report No: 510238 Report date: April 2003 not GEP, unpublished | N | Y | Y | Y | MEN |
MEN-07- 12 KIIIA1- 6.1.3/12 | 1998 | Test of XXXXX Xxxxxxxx (X. Xxxxxx AG, Kradolf) for its effect as a disinfectant on the fire blight pathogen Xxxxxxx xxxxxxxxx. Confederate Research Institute for fruit growing, viniculture and horticulture, Wädenswil, Switzerland Report No.: --. Report date: 06.04.1998 Non-GEP, unpublished | N | Y | Y | Y | MEN |
MEN-07- 13 KIIIA1- 6.1.3/13 and KIIIA1- 6.2.1/03 | 1998a | Expert opinion on the effectiveness of XXXXX Xxxxxxxx against orchid viruses (Odontoglossum ring spot virus and Cymbidium mosaic virus). Xxxxxx-Xxxxxxx-Universität Freiburg, Freiburg, Germany Report No.: -- Report date: 14.07.1998 Non-GEP, unpublished | N | Y | Y | Y | MEN |
MEN-07- | 1998d | Expert Opinion on the effectiveness of | N | Y | Y | Y | MEN |
14 | XXXXX Xxxxxxxx and Venno Oxygen - | ||||||
Here: Effectiveness comparison | |||||||
KIIIA1- | between both these preparations with | ||||||
6.1.1/09 | respect to disinfecting panicle cuttings | ||||||
of orchids. | |||||||
Xxxxxx-Xxxxxxx-Universität Freiburg, | |||||||
Freiburg, Germany | |||||||
Report No.: -- | |||||||
Report date: 30.12.1998 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2000a | Expert opinion, Effectivity of XXXXX | N | Y | Y | Y | MEN |
15 | Florades on viroids. | ||||||
Humboldt-University of Berlin, Berlin, | |||||||
KIIIA1- | Germany | ||||||
6.1.2/15 and KIIIA1- 6.1.3/15 | Report No.: -- Report date: 08.02.2000 Non-GEP, unpublished | ||||||
and | |||||||
KIIIA1- | |||||||
6.2.1/08 |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 2000b | Expert opinion, Testing the disinfectant | N | Y | Y | Y | MEN |
16 | XXXXX Xxxxxxxx | ||||||
Here: the effectiveness against Xxxxxx | |||||||
KIIIA1- | mosaic virus (PEPMV) | ||||||
6.1.2/16 and KIIIA1- 6.1.3/16 | Humboldt-University of Berlin, Berlin, Germany Report No.: -- Report date: 02.05.2000 | ||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2000c | Expert opinion, Effectivity of XXXXX | N | Y | Y | Y | MEN |
17 | Florades on viroids. - Here: Viroicidal | ||||||
effectivity of XXXXX Xxxxxxxx for | |||||||
KIIIA1- | knife and floor space disinfection by the | ||||||
6.1.2/17 | example of chrysanthemum stunt viroid | ||||||
and | (CSVd) on chrysanthemums. | ||||||
KIIIA1- | Humboldt-University of Berlin, Berlin, | ||||||
6.1.3/17 | Germany | ||||||
Report No.: -- | |||||||
Report date: 02.06.2000 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2001 | Expert Opinion -Testing the disinfectant | N | Y | Y | Y | MEN |
18 | XXXXX Xxxxxxxx effect on Zucchini | ||||||
yellow mosaic virus (ZYMV), Melon | |||||||
KIIIA1- | necrotic spot virus (MNSV), Pepper | ||||||
6.1.2/18 | mild mottle virus (PMMoV) and Bell | ||||||
and | pepper mottle virus (BePMV). | ||||||
KIIIA1- | Humboldt-University of Berlin, Berlin, | ||||||
6.1.3/18 | Germany | ||||||
Report No.: -- | |||||||
Report date: 23.03.2001 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2002 | Expertise on Menno-Florades, - Here: | N | Y | Y | Y | MEN |
19 | Pepino mosaic virus (PEPMV). | ||||||
Humboldt-University Of Berlin, Berlin, | |||||||
KIIIA1- | Germany | ||||||
6.1.1/05 | Report No.: -- | ||||||
and KIIIA1- 6.1.2/19 | Report date: 04.06.2000 Non-GEP, unpublished | ||||||
MEN-07- | 2004 | Expert opinion on the virucidal | N | Y | Y | Y | MEN |
20 | effectivity of the product Menno- | ||||||
Florades on asparagus under | |||||||
KIIIA1- | consideration of the Tobacco streak | ||||||
6.1.2/20 | virus. | ||||||
and | Humboldt-University of Berlin, Berlin, | ||||||
KIIIA1- | Germany | ||||||
6.1.3/20 | Report No.: -- | ||||||
Report date: 31.01.2004 | |||||||
Non-GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 2000 | Elimination of Plant viruses by | N | Y | Y | Y | MEN |
21 | Horticultural Disinfectant . | ||||||
Humboldt-University Of Berlin, Berlin, | |||||||
KIIIA1- | Germany | ||||||
6.1.3/21 and KIIIA1- 6.2.1/09 | Report No.: -- Report date: 2000 Non-GEP, unpublished | ||||||
MEN-07- | 2001 | In-vitro testing of Mushroom | N | Y | Y | Y | MEN |
24 | Disinfectant H410 | ||||||
Horticultural Research International, | |||||||
KIIIA1- | Wellesbourne, Warwick, U.K. | ||||||
6.1.2/24 | Report No.: HRI W 105/22425, | ||||||
ORETO No. 076 | |||||||
Report date: 15.11.2001 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2003 | Final Report on testing the “Menno | N | Y | Y | Y | MEN |
31 | Florades” effectiveness against potato | ||||||
nematodes by applying different | |||||||
KIIIA1- | application methods. | ||||||
6.1.1/01 | Chamber of Agriculture Weser-Ems, | ||||||
Oldenburg, Germany | |||||||
Report no.: -- | |||||||
Report date: 10.02.2003 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2001 | Narcissus: Disinfectant for the Control | N | Y | Y | Y | MEN |
33 | of Stem Nematode on Bulb Handling | ||||||
Hardware and the Fabric of Buildings. | |||||||
KIIIA1- | ADAS Wolverhamptom, United | ||||||
6.1.1/02 | Kingdom | ||||||
Report no.: Project no. BOF 49 | |||||||
Trial ID: MEN-07-33 | |||||||
Report date: November 2001 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1998 | Expert evidence - Testing the virucidal | N | Y | Y | Y | MEN |
34 | activity of the disinfectant FLORADES. | ||||||
Universität Hannover, Hannover, | |||||||
KIIIA1- | Germany | ||||||
6.1.3/34 | Report No.: -- | ||||||
Report date: 12.01.1998 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1995 | Pre test for the sensibility of a | N | Y | Y | Y | MEN |
35 | rifamycin-resistant strain of | ||||||
Xanthomonas campestris pv. Pelargonii | |||||||
KIIIA1- | against XXXXX Xxxxxxxx | ||||||
6.1.2/35 | Research Institute of Geisenheim, | ||||||
Geisenheim, Germany; | |||||||
Report No.: V9509 | |||||||
Report date: 15.09.1995 | |||||||
Non-GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 2001b | Results of effectiveness test of plant | N | Y | Y | Y | MEN |
37 | protection products for disinfection in | ||||||
plant production 2002 / Agrobacterium | |||||||
KIIIA1- | tumefaciens (according BBA-Guideline | ||||||
6.1.2/37 | 16-4) | ||||||
Research Institute of Geisenheim, | |||||||
Geisenheim, Germany | |||||||
Report No.: -- | |||||||
Report date: 31.01.2001 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2002a | Results of effectiveness test of plant | N | Y | Y | Y | MEN |
38 | protection products for disinfection in | ||||||
plant production 2002 / Fusarium | |||||||
KIIIA1- | oxysporum (Strain from Elatiorbegonia) | ||||||
6.1.2/38 | (according BBA-Guideline 16-4) | ||||||
Research Institute of Geisenheim, | |||||||
Geisenheim, Germany | |||||||
Report No.: -- | |||||||
Report date: 12.02.2002 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2002b | Results of effectiveness test of plant | N | Y | Y | Y | MEN |
39 | protection products for disinfection in | ||||||
plant production 2002 / Fusarium | |||||||
KIIIA1- | oxysporum f.sp. cyclaminis (according | ||||||
6.1.2/39 | BBA-Guideline 16-4). | ||||||
Research Institute of Geisenheim, | |||||||
Geisenheim, Germany, | |||||||
Report No.: -- | |||||||
Report date: 12.08.2002 | |||||||
GEP, unpublished | |||||||
MEN-07- | 1998 | Bactericidal and fungicidal | N | Y | Y | Y | MEN |
40 | effectiveness test of XXXXX Xxxxxxxx | ||||||
against various phytopathogenic agents. | |||||||
KIIIA1- | Research Institute of Geisenheim, | ||||||
6.1.2/40 | Geisenheim, Germany | ||||||
Report No: project no. 9803 | |||||||
Report date: 06.04.1998 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1999 | Fungicidal effectiveness test of | N | Y | Y | Y | MEN |
41 | XXXXX Xxxxxxxx against various | ||||||
pathogens relevant for fungal culture | |||||||
KIIIA1- | (mushroom). | ||||||
6.1.2/41 | Research Institute of Geisenheim, | ||||||
Geisenheim, Germany | |||||||
Report No: project no. 9916 | |||||||
Report date: 10.12.1999 | |||||||
GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 2000a | Bactericidal effectiveness of MENNO | N | Y | Y | Y | MEN |
42 | Florades against Ralstonia | ||||||
solanacearum in a germ carrier test | |||||||
KIIIA1- | (metal surfaces). | ||||||
6.1.3/42 | Research Institute of Geisenheim, | ||||||
Geisenheim, Germany | |||||||
Report No: project no. 9913 | |||||||
Report date: 31.05.2000 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2000b | Bactericidal and fungicidal | N | Y | Y | Y | MEN |
43 | effectiveness of XXXXX Xxxxxxxx | ||||||
assayed in the Laboratory test | |||||||
KIIIA1- | (according to BBA guideline 16-4). | ||||||
6.1.2/43 | Research Institute of Geisenheim, | ||||||
Geisenheim, Germany | |||||||
Report No: project no. 0010 | |||||||
Report date: 06.09.2000 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2000c | Efficacy of the Disinfectants MENNO | N | Y | Y | Y | MEN |
44 | Florades and MENNO Ter forte for the | ||||||
control of the „new Erica fungus“ | |||||||
KIIIA1- | Research Institute of Geisenheim, | ||||||
6.1.2/44 | Geisenheim, Germany | ||||||
Report No: project no. 0008 | |||||||
Report date: 19.09.2000 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2005 | Report on the effect of benzoic acid | N | Y | Y | Y | MEN |
45 | (XXXXX Xxxxxxxx®) on the causal | ||||||
agent of peach leaf curl (Taphrina | |||||||
KIIIA1- | deformans). | ||||||
6.1.1/03 | DLR Rheinhessen-Nahe Hunsrück, Bad | ||||||
Kreuznach, Germany | |||||||
Report no.: -- | |||||||
Report date: 11.01.2005 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2005 | Efficacy evaluation of MENNO | N | Y | Y | Y | MEN |
46 | Florades as a fungicide against silver | ||||||
scurf in seed potatoes | |||||||
KIIIA1- | Applied Plant Research, Research , | ||||||
6.1.4/01 | AGV Research Unit, Lelystad, The | ||||||
and | Netherlands | ||||||
KIIIA1- 6.2.1/14 | Report No: 510394 Report date: August 2005 | ||||||
GEP, unpublished | |||||||
MEN-07- | 2005 | Evaluation of MENNO Floradestm for | N | Y | Y | Y | MEN |
47 | Efficacy Against Selected Bacterial, | ||||||
Fungal and Viral Pathogens of | |||||||
KIIIA1- | Greenhouse Vegetable Crops. | ||||||
6.1.2/47 | Alberta Agriculture, Food and Rural | ||||||
and | Development, Alberta, Canada | ||||||
KIIIA1- 6.1.3/47 and KIIIA1- | Report No: -- Report date: 15.08.2005 Non-GEP, unpublished | ||||||
6.2.3/02 |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- 48 KIIIA1- 6.1.1/03 | 2004 | Test of fungicidal activity of MENNO- Florades against Ophiostoma quercus in laboratory test, (according to BBA- guideline 16-4) Research Institute of Geisenheim, Geisenheim, Germany Report no.: Project no.Wo0404 Report date: 15.06.2004 GEP, unpublished | N | Y | Y | Y | MEN |
MEN-07- 49 KIIIA1- 6.1.1/06 and KIIIA1- 6.2.1/16 | 2001 | Report on the disinfection of trays used for tobacco plant seedlings with M&EnnO® Ter forte and Xxxxx Xxxxxxxx® Landesanstalt für Pflanzenbau Forchheim, Rheinstetten, Germany Report No.: Report date: 15.10.2001 GEP, unpublished | Y | y | y | Y | MEN |
MEN-07- 50 KIIIA1- 6.1.2/50 | 2004b | Influence of XXXXX Xxxxxxxx® on the growth of different potato and sugar beet pathogens in a sterile culture. University of Göttingen, Göttingen, Germany Report No: -- Report date: 30.06.2004 Non-GEP, unpublished | N | Y | Y | Y | MEN |
MEN-07- | 1998b | Supplemental report to the expert | N | Y | Y | Y | MEN |
51 | opinion: Effectiveness of XXXXX | ||||||
Xxxxxxxx against orchid viruses. Here: | |||||||
KIIIA1- | Plant tolerance – especially the blossom | ||||||
6.2.1/04 | tolerance – of XXXXX Xxxxxxxx on | ||||||
orchids | |||||||
Xxxxxx-Ludwigs-Universität Freiburg, | |||||||
Freiburg, Germany | |||||||
Report No: -- | |||||||
Report date: 26.08.1998 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 1998c | Supplemental report to the expert | N | Y | Y | Y | MEN |
52 | opinion: Effectiveness of XXXXX | ||||||
Xxxxxxxx against orchid viruses. Here: | |||||||
KIIIA1- | Plant tolerance – especially the tissue | ||||||
6.2.1/05 | cultures – of XXXXX Xxxxxxxx on | ||||||
orchids | |||||||
Xxxxxx-Ludwigs-Universität Freiburg, | |||||||
Freiburg, Germany | |||||||
Report No: -- | |||||||
Report date: 10.11.1998 | |||||||
Non-GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 1999 | Testing of MENNO-florades for | N | Y | Y | Y | MEN |
53 | possible phytotoxic effect on Viola | ||||||
cornuta | |||||||
KIIIA1- | Ministry of Food, Agriculture and | ||||||
6.2.1/11 | Fisheries, Flakkebjerg, Denmark | ||||||
Report No:-- | |||||||
Report date: 14.07.1999 | |||||||
not GEP, unpublished | |||||||
MEN-07- | 1997 | Verträglichkeitsversuch von Florades | N | Y | Y | Y | MEN |
54 | (Statement, German language) | ||||||
Beratungsring Azerca-Süd, | |||||||
KIIIA1- | Großostheim, Germany; | ||||||
6.2.1/12 | Report No:-- | ||||||
Report date: 10.08.1997 | |||||||
Non-GEP, unpublished | |||||||
MEN-07- | 2003 | Testing of tin surfaces for resistance to | N | Y | Y | Y | MEN |
55 | the plant protection product XXXXX | ||||||
Xxxxxxxx | |||||||
KIIIA1- | Institute for Material Control of TÜV | ||||||
6.2.3/01 | Nord e.V., Hamburg, Germany | ||||||
Report No: 3837PR30330 | |||||||
Report date: 18.08.2003 | |||||||
not GLP, unpublished | |||||||
MEN-07- | 2002 | Fungal storage rots of potato / Bacterial | N | Y | Y | Y | MEN |
56 | wet rot on potatoes in storage rooms | ||||||
Chamber of Agriculture Hanover, | |||||||
KIIIA1- | Hanover, Germany | ||||||
6.2.1/10 | Report No:HR1F02MEN002 / | ||||||
HR1F02MEN003 | |||||||
Report date: 2002 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2003 | Follow up of the storage trial 2002/03 | N | Y | Y | Y | MEN |
57 | KTBL Trial Station Dethlingen, | ||||||
Dethlingen, Germany; | |||||||
KIIIA1- 6.1.4/03 and KIIIA1- | Report No: 02/105 Report date: 27.10.2003 Non-GEP, unpublished | ||||||
6.2.1/13 | |||||||
MEN-07- | 1996 | Examination of your plant protection | N | Y | Y | Y | MEN |
58 | chemical XXXXX Xxxxxxxx for | ||||||
licensing the plant compatibility with | |||||||
KIIIA1- | ornamental plants under glass | ||||||
6.2.1/02 | Landwirtschaftskammer Rheinland, | ||||||
Bonn,. Germany | |||||||
Report No: 950036 (Eingangsnummer) | |||||||
Report date: 21.06.1996 | |||||||
Non-GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 1999 | Bekämpfung der Xxxxx- und | N | Y | Y | Y | MEN |
59 | Stengelbakteriose (Xanthomonas | ||||||
campestris pv. Begoniae) an Begonien | |||||||
KIIIA1- | 1999 (German language) | ||||||
6.1.1/07 | LfP Stuttgart Hohenheim, Germany | ||||||
and KIIIA1- 6.2.1/17 | Report No.: -- Report date: 1999 Non-GEP, unpublished | ||||||
MEN-07- | 2004 | Einsatz von MENNO-Florades im | N | Y | Y | Y | MEN |
60 | Spritzverfahren zur Bekämpfung von | ||||||
Bakteriosen an Pelargonien und | |||||||
KIIIA1- | Elatiorbegonien (German language) | ||||||
6.1.1/08 | Forschungsanstalt Geisenheim, | ||||||
and | Geisenheim, Germany | ||||||
KIIIA1- 6.2.1/18 | Report No.: project V9801 Report date: 06.10.2004 | ||||||
GEP, unpublished | |||||||
MEN-07- | 2002 | -Ergebnisse aus Feldversuchen- | N | Y | Y | Y | MEN |
62 | Versuchsjahr 2001 und 2002 - | ||||||
Pflanzenschutz – Blattfrüchte und Mais | |||||||
KIIIA- | Krankheits-, und | ||||||
6.1.4/04 | Schädlingsbekämpfung | ||||||
and KIIIA1- 6.2.1/20 | Bayrische Landesanstalt für Bodenkultur und Pflanzenbau (LBP), Freising, Germany | ||||||
Report No: -- | |||||||
Report date: 2002 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2004 | Versuchsergebnisse aus Bayern 2004 - | N | Y | Y | Y | MEN |
63 | Gezielte Bekämpfung von | ||||||
Kartoffelkrankheiten (Blattfrüchte und | |||||||
KIIIA1- | Mais) | ||||||
6.1.4/05 | Bayerische Landesanstalt für | ||||||
and | Landwirtschaft, Freising- | ||||||
KIIIA1- | Weihenstephan, Germany | ||||||
6.2.1/21 | Report No: -- | ||||||
Report date: 2004 | |||||||
GEP, unpublished | |||||||
MEN-07- | 2005 | Versuchsergebnisse aus Bayern 2005 - | N | Y | Y | Y | MEN |
64 | Gezielte Bekämpfung von | ||||||
Kartoffelkrankheiten (Blattfrüchte und | |||||||
KIIIA1- | Mais) | ||||||
6.1.4/02 | Bayerische Landesanstalt für | ||||||
and | Landwirtschaft, Freising- | ||||||
KIIIA1- | Weihenstephan, Germany | ||||||
6.2.1/19 | Report No: -- | ||||||
Report date: 2005 | |||||||
GEP, unpublished |
MENNO Trial ID evaluated under | Year | Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished | Vertebrate study Y/N | Studies relied on | Data protection claimed Y/N | Justification if data protection granted Y/N | Owner |
MEN-07- | 2013 | Benzoic acid -Earthworm (Eisenia | N | Y | Y | Y | MEN |
66 | fetida), Effects on reproduction | ||||||
Xx.X.Xxxxx-Laboratorien, Sarstedt | |||||||
KIIIA1- | Germany | ||||||
6.2.4/01 | Report No: project no. 130611 DH / | ||||||
RBR 15572 | |||||||
Report date: 22.11.2013 | |||||||
GLP, unpublished | |||||||
MEN-07- | 2013 | Benzoic acid - Collembolan (Folsomia | N | Y | Y | Y | MEN |
67 | candida) Reproduction Test in Soil, acc. | ||||||
to OECD 232 (2009), Verison dated | |||||||
KIIIA1- | 2009 | ||||||
6.2.4/02 | Xx.X.Xxxxx-Laboratorien, Sarstedt, | ||||||
Germany | |||||||
Project-No. 130611DH / Study-No. | |||||||
ICR15572 | |||||||
Report date: 02.12.2013 | |||||||
GLP, unpublished | |||||||
MEN-07- | 2013 | Benzoic acid - Soil Micro-Organisms: | N | Y | Y | Y | MEN |
68 | Nitrogen Transformation Test according | ||||||
to OECD-Test Guideline 216, Version | |||||||
KIIIA1- | dated 21 January 2000 | ||||||
6.2.4/03 | Xx.X.Xxxxx-Laboratorien, Sarstedt, | ||||||
Germany | |||||||
Project-No. 130611DH / Study-No. | |||||||
TBN15572 | |||||||
Report date: 20.12.2013 | |||||||
GLP, unpublished |