HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

14814 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 WEDERZIJDSE ERKENNING Op 12 juni 2014 is van Bayer CropScience SA-N.V. Energieweg 1 3641 RT MIJDRECHT een aanvraag tot toelating van een gewasbeschermingsmiddel op basis van wederzijdse erkenning ontvangen voor het middel Flocter op basis van de werkzame stof Bacillus firmus I-1582. HET COLLEGE IS VOORNEMENS TE BESLUITEN tot toelating van bovenstaand middel. Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit. Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen: - Bijlage I voor details van de aanvraag en toelating; - Bijlage II voor de etikettering; - Bijlage III voor wettelijk gebruik; - Bijlage IV voor de onderbouwing. 1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2 Gebruik Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven. 1.3 Classificatie en etikettering Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld: -

De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie” in bijlage I.

Flocter, 20145441 NLWERGZ

1

14814 N - Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III. - Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

2 WETTELIJKE GRONDSLAG Besluit artikel 40 Verordening (EG) 1107/2009 van het Europees Parlement en de Raad Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011 E.M. zonaal 2.0

BEOORDELINGEN 3.1 Inleiding 3

Gezien de aard van de wederzijdse erkenning wordt ervan uitgegaan dat de beoordeling door het Verenigd Koninkrijk is uitgevoerd conform de Uniforme Beginselen (annex VI bij richtlijn 91/414/EEG). Voor de beoordeling van de aspecten fysische en chemische eigenschappen, analysemethoden, werkzaamheid en delen van de aspecten risico voor de mens en risico voor het milieu refereert het Ctgb aan het toelatingsbesluit in het Verenigd Koninkrijk. Op een aantal hieronder weergegeven voor de Nederlandse situatie specifieke punten, toetst het Ctgb zelf inhoudelijk.

3.2

Risico voor de mens

De volgende aspecten worden nationaal ingevuld: •Arbeidsomstandigheden - nationale modellen en arbeidshygiënische strategie •Volksgezondheid - de criteria voor residuen in volggewassen. Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, van Bijlage IV bij dit besluit.

3.3

Risico voor het milieu

De volgende aspecten worden nationaal ingevuld: •Uitspoeling naar grondwater •Drift naar oppervlaktewater; van toepassing op: Waterorganismen, vogels, zoogdieren, nietdoelwitplanten, niet-doelwitarthropoden en oppervlaktewater bestemd voor de bereiding van drinkwater •Drinkwatercriterium oppervlaktewater. Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten: •de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater, •de gevolgen voor niet-doelsoorten. (artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden). De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage IV bij dit besluit.

Zienswijzenprocedure Ingevolge artikel 2:3 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007 geldt dat dit ontwerpbesluit gedurende twee weken ter inzage wordt gelegd op het Ctgb; hiervan wordt mededeling gedaan in de Staatscourant. Het ontwerpbesluit wordt gedurende deze periode tevens op de website van het Ctgb geplaatst. Belanghebbenden kunnen gedurende de ter inzagenlegging schriftelijk bij het Ctgb aangeven dat zij een zienswijze zullen indienen; de zienswijze dient schriftelijk binnen twee weken na de inzagenperiode te worden ingediend. Flocter, 20145441 NLWERGZ

2

14814 N Wageningen, 1 mei 2015

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

Ir. J.F. de Leeuw Voorzitter


3

14814 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: Type aanvraag: Middelnaam: Verzenddatum aanvraag: Formele registratiedatum: * Datum in behandeling name:

20145441 NLWERGZ aanvraag tot toelating van een gewasbeschermingsmiddel op basis van wederzijdse erkenning Flocter 6 juni 2014 12 juni 2014 4 november 2014

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. Aangezien Flocter een voor Nederland nieuwe werkzame stof bevat (zie hieronder), is de zienswijzenprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007 van toepassing. 2 Stofinformatie Werkzame stof Bacillus firmus I-1582

Gehalte 50 g/kg

De werkzame stof is per 1 oktober 2013 goedgekeurd krachtens Verordening (EG) No 1107/2009 (Commission Implementing Regulation (EU) No 366/2013 d.d. 22 april 2013). De goedkeuring van deze werkzame stof expireert op 30 september 2023. 3 Toelatingsinformatie Toelatingsnummer: Expiratiedatum: Afgeleide parallel of origineel: Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gebruikers:

14814 N 24 juli 2017 Origineel Gewasbescherming Professioneel

4 Verpakkingsinformatie Aard van het preparaat: WP


1

Part A National Assessment

Bacillus firmus I-1582 WP 5 (Flocter) Specification: 102000024952

Registration Report – Netherlands Page 2 of 23

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Flocter Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram GHS07 Signaalwoord WAARSCHUWING Gevarenaanduidingen H319 Veroorzaakt ernstige oogirritatie. Voorzorgsmaatregelen P280C Beschermende handschoenen en beschermende kleding dragen. P284 Adembescherming dragen. SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. Aanvullende EUH401 Volg de gebruiksaanwijzing om gevaar voor de etiketelementen menselijke gezondheid en het milieu te voorkomen. Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee

Applicant: Bayer CropScience

Evaluator: Ctgb, NL Date: April 2015




REGISTRATION REPORT Part A Risk Management

Product name: Flocter

Product code: 102000024952 Active Substance: Bacillus firmus I-1582 WP 5 (50 g/kg)

Country: Netherlands Zonal Rapporteur Member State: The Netherlands

NATIONAL ASSESSMENT

Applicant: Bayer CropScience Date: April 2015






OECD Statement on Confidentiality 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.






Table of Contents PART A – Risk Management....................................................................................................... 7 1

Details of the application....................................................................................... 8

1.1

Application background........................................................................................ 8

1.2

Annex I inclusion ................................................................................................... 8

1.3

Regulatory approach............................................................................................. 8

1.4

Data protection claims........................................................................................... 8

1.5

Letters of Access .................................................................................................... 8

2

Details of the authorisation................................................................................... 9

2.1

Product identity ..................................................................................................... 9

2.2

Classification and labelling ................................................................................... 9

2.2.1

Classification and labelling under Regulation (EC) 1272/2008......................... 9

2.2.2

Other phrases......................................................................................................... 9

2.3

Product uses ......................................................................................................... 10

3

Risk management ................................................................................................ 11

3.1

Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles .............................................................................................. 11

3.1.1

Physical and chemical properties (Part B, Section 1, Points 2 and 4) ............ 11

3.1.2

Methods of analysis (Part B, Section 2, Point 5) ............................................... 11

3.1.2.1

Analytical method for the formulation (Part B, Section 2, Point 5.1) ............ 11

3.1.2.2

Analytical methods for residues (Part B, Section 2, Points 5.4) ...................... 11

3.1.3

Mammalian Toxicology (Part B, Section 3, Point 7) ........................................ 11

3.1.3.1

Acute Toxicity (Part B, Section 3, Point 7.1)..................................................... 11

3.1.3.2

Operator Exposure (Part B, Section 3, Point 7.2)............................................. 12

3.1.3.3

Bystander Exposure (Part B, Section 3, Point 7.3) ........................................... 12

3.1.3.4

Worker Exposure (Part B, Section 3, Point 7.3) ............................................... 12

3.1.4

Residues and Consumer Exposure (Part B, Section 4, Point 8) ...................... 12

3.1.5

Environmental fate and behaviour (Part B, Sect. 5, Point 9 and Sect. 6, Point 11).......................................................................................................................... 12

3.1.5.1

Predicted Environmental Concentration in Soil (PECsoil) (Part B, Sect. 6, Point 11.1)............................................................................................................. 13

3.1.5.2

Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 6, Point 11.1) ........................................................................................... 13

3.1.5.3

Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 6, Point 11.1) ........................................................................................... 13






3.1.5.4

Predicted Environmental Concentration in Air (PECAir) (Part B, Section 6, Point 11.1)............................................................................................................. 14

3.1.6

Ecotoxicology (Part B, Section 6, Point 10 & 11).............................................. 14

3.1.6.1

Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 11.2). 14

3.1.6.2

Effects on Aquatic Species (Part B, Section 6, Point 10.2 and 11.2) ............... 14

3.1.6.3

Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.3 and 10.4) ............................................................................................................... 15

3.1.6.4

Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.5 and 11.2) ............................................................................................. 15

3.1.6.5

Effects on organic matter breakdown (Part B, Section 6, Point 10.6 and 11.2)15

3.1.6.6

Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.6 and 11.2)....................................................................................................................... 15

3.1.6.7

Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 11.2) ........................................................ 15

3.1.7

Efficacy (Part B, Section 7, Point 8)................................................................... 16

3.2

Conclusions........................................................................................................... 16

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 .............. 16

Appendix 1 – Copy of the product label.................................................................................... 17 Appendix 2: List of data submitted in support of the evaluation ......................................... 18






PART A – Risk Management This document describes the acceptable use conditions required for the registration of the Microbial Pest Control Product BFI WP 5 which contains 50 g/kg (3.5 x 1012 CFU/kg) of the Microbial Pest Control Agent Bacillus firmus I-1582, in conformity with the specification 1020000024952-01. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C. Appendix 1 of this document provides a copy of the proposed product label. Appendix 2 of this document contains the list of references submitted in support of the evaluation. Appendix 3 of this document contains the Letter of Access.




1

Details of the application

1.1

Application background



The authorisation of Flocter is based on mutual recognition of the authorisation of the product in the United Kingdom. This document describes the acceptable use conditions required for the registration of Flocter containing Bacillus firmus I-1582 in the Netherlands. This evaluation is required subsequent to the inclusion of Bacillus firmus I-1582 on Annex I. Registration of Flocter is through mutual recognition from the United Kingdom. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report Part B Sections 1-7 and Part C (the Core dossier for Flocter is the UK National Assessment) and where appropriate the addenda for the Netherlands. The information, data and assessments provided in Registration Report, Parts B, includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to Flocter where that data has not been considered in the EU review. Otherwise assessments for the safe use of Flocter have been made using endpoints agreed in the EU review of Bacillus firmus I1582. This document describes the specific conditions of use and labelling required for the Netherlands for the registration of Flocter.

1.2

Annex I inclusion

See point 1.1 above.

1.3

Regulatory approach

See point 1.1 above.

1.4

Data protection claims

The reference lists included in the dossier define the list of studies and reports, submitted with the application, for which a claim for data protection was made. This claim for protection was made as the studies and reports were submitted and used as the basis for approval for the first time in Netherlands. Based on Article 59 of Regulation 1107/2009, Bayer S.A.S. (Bayer CropScience) claims 10 years protection for these studies and reports. The authority confirms that these studies and reports are protected for 10 years from the data of authorisation of the product and thus can not be used for the benefit of another applicant.

1.5

Letters of Access

Please refer to Appendix 3.





2

Details of the authorisation

2.1

Product identity


Product Name

Bacillus firmus I-1582 WP 5 (short name: BFI WP 5) Specification n° 102000024952-01-1 Trade name: Flocter

Authorisation Number

-

Function

Nematode suppressant

Applicant

Bayer CropScience SA-NV

Composition

50 g/kg (3.5 x 1012 CFU/kg) of Bacillus firmus I-1582

Formulation type

Wettable Powder (WP) Bag in box : 1 x 5 kg, 1 x 10 kg, 1 x 15 kg or 1 x 20 kg (bag: Kraft/PE/Alu/PE ; box: corrugated case)

Packaging

2.2

Classification and labelling

2.2.1

Classification and labelling under Regulation (EC) 1272/2008

The identity of all substances in the mixture that contribute to the classification of the mixture *: Pictogram: GHS07 Signal word: Warning H-statements: H319 Causes serious eye irritation. P-statements: P280c Wear protective gloves and protective clothing. P284 Wear respiratory protection. Supplemental Hazard information:

To avoid risks to human health and the environment, comply with the instructions for use. SP1 Do not contaminate water with the product or its container. Child-resistant fastening obligatory? not applicable Tactile warning of danger obligatory? not applicable

2.2.2

EUH401

Other phrases

The standard classification and labelling criteria apply only to substances, defined as “a chemical element and its compounds..., and mixtures containing them”. Live organisms are considered to be outside the scope of the classification and labelling scheme. However, since a primary concern for pesticides based on live organisms is skin and respiratory sensitisation it has been agreed at EU level that all such products should include the following phrase on the label: ‘Micro-organisms may have the potential to provoke sensitising reactions’ As a result of the above, the Netherlands consider that precautionary PPE/RPE are appropriate to products containing microbial active substances, see operator exposure section for full details.




2.3


Product uses

1

UseNo.

Bacillus firmus I-1582 WP 5 (BFI WP 5) (Flocter) Specification: 102000024952

2

Member state(s)

3

Crop and/ or situation

4

F G or I

5

Pests or Group of pests controlled

6

7

8

10

Application Method / Kind

Timing / Growth stage of crop & season

11

12

Application rate per treatment Number / (min. Interval between applications)

kg, L product / ha

CFU/ha (, kg/ha)

80 kg /ha

12

Water L/ha

13

14

PHI (days)

Remarks:

a) max. no. of applications per crop and season

b) Maximum product rate per season

min / max

c) additional remarks

1

2

NL

NL

Carrots

Carrots


F

F

Reduction of damage caused by Nematodes

Spraying – soiltreatment with immediate incorporation to a depth of 5 to 10 centimeters

0-7 days before sowing (BBCH 0)

Reduction of damage caused by Nematodes

Spraying – soil treatment with immediate incorporation to a depth of 5 to 10 centimeters presowing and no incorporation postsowing

1) 0-7 days before 2 (5) sowing(BBCH 0)

1

284 x 10 CFU/ha, 4 kg/ha

500 – 800 L/ha

-

b) In total, 80 kg product/ha can be applied per year.

April-june 40 kg/ha

April-june 2) up to 5 days after sowing (BBCH 0)

500 - 800 L/ha

- Post planting/ drilling application by spraying to soil must be made before emergence B) In total, 80 kg product/ha can be applied per year.

April-june


Part B – Section 5 National Assessment

Bacillus firmus I-1582 WP 5 (BFI WP5) (Flocter) Specification: 102000024952

Registration Report UK Page 11 of 23

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)

BFI WP 5 (Flocter) is a wettable powder formulation containing 50 g/kg of Bacillus firmus I-1582. Its appearance is that of a light and dark beige powder, marmorate, with a musty odour. It is not explosive. It has no oxidizing properties. It has a self-ignition temperature of 373 °C. Its pH is within the range that naturally occurs e.g. in soil. Its stability tested at elevated temperatures allows storage under practical and commercial conditions. Its technical properties indicate that no particular problems have to be expected, when it is used as recommended. The technical characteristics of the product are acceptable for a wettable powder formulation. Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leak proofness, resistance to normal transport and handling, resistance and 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 BFI WP 5 has been provided and is considered to be acceptable. The formulation is the representative formulation submitted for the Annex I inclusion of Bacillus firmus I-1582. A complete table of physical, chemical and technical properties can be found in the DAR; however, results are summarised in the Part B for completeness.

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 5.1) Analytical methods for determination of Bacillus firmus I-1582 and impurities in Flocter were evaluated and accepted as part of the EU-review of Bacillus firmus I-1582. Therefore all relevant data were provided and are considered adequate.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.4) No method needed because no residue is expected further to the use of BFI WP 5 (see 3.1.4.1 below). Residues will be within LoQ pending the outcome the Annex IV (residues exemption) application. No further consideration is required.

3.1.3

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

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Acute toxicity studies for Flocter were evaluated as part of the EU-review of Bacillus firmus I-1582. Therefore, all relevant data were provided and are considered adequate.

Applicant: Bayer CropScience Evaluator Applicant Document ID : Date Applicant Authors : Suteau, P. ; Hauschild, R., Hutin, P.


Bacillus firmus I-1582 WP 5 (BFI WP5) Specification: 102000024952


Flocter has a very low toxicity profile: it is not toxic through oral, dermal or inhalation routes. The formulation is only slightly irritating to the skin but does not warrant any classification. It is however irritant to the eyes (H319), and due to precautionary measures, it is considered that this formulation containing a microorganism may have the potential to provoke sensitising reactions. This is the representative formulation in the DAR and therefore EU agreed end points have been established and no further consideration is considered necessary.

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.2) Operator exposure to Flocter was evaluated as part of the EU-review of Bacillus firmus I-1582. Therefore all relevant data and risk assessments have been provided and are considered to be adequate. Due to the low toxicity of Flocter, the risks anticipated for occupational exposure are considered as minimal to non-existent. Nevertheless, based on the potential sensitising properties of micro-organisms it is recommended as precautionary measure that personal protective equipment (PPE) should be used to mitigate any potential risks to operators (protective gloves, coverall and respiratory protection). Based on the DAR there are no indications from a suitable dataset (studies, literature) that the Bacillus firmus has any toxicological concerns. No critical endpoints were considered appropriate in the DAR, and thus a quantitative assessment of operator exposure is not considered necessary.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.3) Due to the low toxicity of Flocter, the anticipated risks are considered as minimal to non-existent.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.3) Due to the low toxicity of Flocter, the anticipated risks are considered as minimal to non-existent.

3.1.4

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

For the aspect ‘Residues’ and risk for consumers we refer to the member state of the original authorisation (the United Kingdom). The Guidelines for the generation of data concerning residue data Appendix C 7524/VI/95 rev.2 require that the residue situation in rotational crops must always be considered if, after the treated crop has been harvested (or in the event of early ploughing), it is possible to sow or plant a crop which can be used as a foodstuff and/or feed. Since the product was assessed according to the Uniform Principles by the member state of the original authorisation, residues in succeeding crops need no further consideration.

3.1.5

Environmental fate and behaviour (Part B, Sect. 5, Point 9 and Sect. 6, Point 11)

This is the representative formulation in the DAR and the evaluating MS considers that all areas of risk assessment for the proposed GAP are sufficiently considered in the DAR, EFSA conclusions, and the Pesticides Peer Review Meeting TC 71 (12 June 2012) for the environmental fate and behaviour risk assessment. No critical areas of concern were identified in the EU review. The evaluating MS considers that fate and behaviour in the environment is sufficiently addressed by the active substance inclusion to recommend authorisation for this product. With regard to safety issues, it is important to note that Bacillus firmus and all members of the genus Bacillus are naturally present in our environment. Therefore, their application in pest control means only






a fluctuation of the bacterium titre in the habitat of the target-organism. The experience that Bacillus firmus presents no risk for the environment has been confirmed by numerous studies.

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Sect. 6, Point 11.1) After application to the soil B. firmus spores will start to germinate and multiply if humidity and nutrients are available. Due to the absence of growth under unfavourable, competitive conditions in the soil the highest densities of B. firmus populations are expected in the rhizosphere, where root exudates provide sufficient nutrients and where the majority of nematode eggs are found. Once conditions become unsuitable for continued growth and survival, sporulation takes place. Whereas vegetative cells are sensitive towards UV radiation, elevated temperatures, low humidity and particularly nutrient depletion, spores as the resting stage are highly resistant against these environmental stressors except UV radiation. Populations of spores are reduced in the soils mainly through UV exposure and predation by soil organisms declining to background levels within relatively long time periods (90 days)*. Mobility of Bacillus spores in soils is generally considered to be very low as the hydrophobic nature of the spores coat results in strong adsorption to soil particles. Nevertheless, PECsoil were calculated and the results were used for the eco-toxicological risk assessment. *Comment NL: Citation from EFSA conclusion: The results indicated that after 90 days bacteria cfu numbers remained 20-40% higher than before application, at between 1 x 106 and 2.5 x 106 cfu / g soil (background levels had been determined at up to 2 x 105 cfu / g soil before application).

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 6, Point 11.1) Due to the absence of growth outside the rhizosphere, low survival rates in the environment and restricted mobility in soils, B. firmus I-1582 is unlikely to reach groundwater habitats after field application. Spore populations are strongly degraded in the upper soil layers and remaining spores are likely to be absorbed to soil particles. Even if motility of the small B. firmus spores might be slightly enhanced compared to other Bacillus species, aquifers should only be reached exceptionally and at extremely low numbers. Germination and proliferation will not take place due to absence of nutrients and low temperatures in aquifers and spores are likely to be quickly degraded by indigenous groundwater organisms. Therefore, no threat of contamination of groundwater exists following applications of Bacillus firmus I-1582 WP5 according to the intended uses (i.e. GAPs). Comment NL: Citation from EFSA conclusion: Studies on the mobility of Bacillus firmus strain I-1582 were not available. Information on the behaviour of Bacillus sp. presented in the DAR (France 2011) was considered sufficient to conclude that mobility of spores vertically in the soil column would be limited with most spores being retained in upper soil horizons. A groundwater exposure assessment is not necessary for Bacillus firmus strain I-1582 as it is neither pathogenic nor toxic to humans (see section 2).

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 6, Point 11.1) Bacillus firmus is a common constituent of the microflora in eutrophic freshwater lakes. Environmental bacteria are considered to be well adapted to thrive in freshwater habitats and it is assumed that B. firmus I-1582 will be less competitive due to its origin from soil. Nutrient availability, competition/predation and UV-related inactivation are apparently the limiting factors for survival and multiplication of B. firmus in freshwater. Once nutrient availability is limited as in water courses, B. firmus will be present as spores and multiplication will not occur. Spores will settle down and persist inactively in water, but will finally be degraded by sediment-dwelling organisms.






Nevertheless, PECsw were calculated and the results were used for the eco-toxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 6, Point 11.1) B. firmus I-1582 is intended to be applied to the soil either by drip irrigation or drench application and subsequent incorporation into the soil. Therefore only spores that stay on the soil surface or those that are dispersed by spray drift during application will be exposed to the air. A rapid degradation of B. firmus I1582 spores in air is assumed since inactivation by solar radiation is a very important factor causing loss of activity and degradation of vegetative Bacillus cells and spores in the field environment.

3.1.6

Ecotoxicology (Part B, Section 6, Point 10 & 11)

This is the representative formulation in the DAR and the evaluating MS considers that all areas of risk assessment for the proposed GAP are sufficiently considered in the DAR, EFSA conclusions, and the Pesticides Peer Review Meeting TC 71 (12 June 2012). No critical areas of concern or critical endpoints were identified in the EU review. The EFSA conclusions concluded that potential risks were low or not expected for each environmental key non-target species. As a result of the above the evaluating MS considers that ecotoxicological risk assessment is sufficiently addressed by the active substance inclusion/review to allow a recommendation of authorisation for this product and its associated GAP. B. firmus is widely distributed in the environment and is a common member of soil microbial communities. Therefore, its application in nematode control means only a fluctuation of the bacteria population in the biotope of the target nematodes. The association between B. firmus and a variety of aquatic and terrestrial species including mammals, insects, fishes and plants is well documented and recorded as non-hazardous, or even beneficial. B. firmus is not related to species within the genus Bacillus that are pathogenic to humans (B. anthracis, B. cereus) or animals (B. thuringiensis). Bee pathogens in the species Paenibacillus larvae (foulbrood pathogen) are even more distantly related to B. firmus than the species from the B. cereus group. B. firmus I-1582 is not expected to have any harmful effects on non-target species, human health and the environment. The experience that B. firmus I-1582 can be considered as non-hazardous has been confirmed by numerous studies.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 11.2) Birds Birds may be exposed to B. firmus I-1582 mainly by the consumption of contaminated feed. The presented risk assessment for birds was performed according to SANCO document 4145/2000. All TER values exceed by far the trigger-value, indicating that no risk for birds following the use of FLOCTER according to the intended uses is expected. Terrestrial vertebrates (other than birds) Mammals may be exposed to B. firmus I-1582 mainly by the consumption of contaminated feed. The risk assessment for mammals was performed according to SANCO document 4145/2000. All TER values exceed by far the trigger-value indicating that no risk for mammals following the use of Flocter according to the intended uses is expected.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2 and 11.2)






In general, the acute and also the chronic risk of Bacillus firmus to aquatic organisms can be considered to be very low, though, as it is used as a single application on bare soil and will be incorporated into the soil immediately. Drainage can be excluded due to the low mobility of B. firmus in soil and run-off from treated areas is not expected to produce any effects not seen from natural populations of B. firmus. The exposure of aquatic organisms can be therefore considered to be negligible. All TER values exceed by far the trigger-value indicating that no risk for aquatic species following the use of Flocter according to the intended uses is expected.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.3 and 10.4) Bees Due to non-exposure and the absence of oral and contact toxicity to bees observed in acute studies with FLOCTER, no risk to bees following the application of Flocter according to intended uses is expected. Other non-target arthropods Leaf-dwelling arthropods are not expected to be exposed to B. firmus I-1582 WP 5 after the application to bare soils. The low exposure risk and the absence of toxicity in an acute test with Aphidius rhopalosiphi indicate that no risk to terrestrial arthropods following the application of Flocter according to the intended uses is expected.

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.5 and 11.2) Soil-dwelling organisms might be exposed to B. firmus I-1582 WP5 after application via contact and oral exposure. Although the TER values calculated for Hypoaspis aculeifer, Folsomia candida and Eisenia foetida are slightly below the trigger-value, the risk to soil organisms appears to be negligible as calculations are based on no observed effect doses (NOEC) that are considered to be higher than the highest dose tested in the acute studies. Comment NL: In the DAR, with the same intended use as proposed for the current registration of Flocter in NL, the TER-values were Hypoaspis aculeifer and Folsomia candida were above the chronic trigger of 5, indicating an acceptable risk. For earthworms the acute TER-value in the DAR was slightly below the trigger of 10 (>9.4), but the risk is considered as low, since the NOEC was based on the highest tested concentration and during the test, no mortality, no difference in body weights, no morphological or behavioural side effects were observed among the earthworms exposed at all test concentrations.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6 and 11.2) B. firmus I-1582 WP 5 applied at the highest use rate showed no long term effect on the microbial nitrogen or carbon mineralisation. The test substance can be therefore considered as non-hazardous to the soil microflora.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.6 and 11.2) B. firmus I-1582 WP 5 applied at the highest use rate showed no long term effect on the microbial nitrogen or carbon mineralisation. The test substance can be therefore considered as non-hazardous to the soil microflora.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 11.2) Non-Target Plants






B. firmus has not been named as, or is not suspected to be a plant pathogen. No adverse effects on plants were seen in efficacy trials using Flocter on vegetables, fruits, and turf. In all trials, the quality and yield of plants treated with Flocter were equivalent to or greater than those treated with conventional chemicals. It can be concluded that non-target plants will not be at risk when exposed to B. firmus containing products according to the intended uses. Therefore studies on non-target plants are not considered to be necessary. Conclusion from the ecotoxicological assessment: The risk assessment proves that Flocter is not toxic to non-target organisms.

3.1.7

Efficacy (Part B, Section 7, Point 8)

It concerns a mutual recognition from the United Kingdom. A national addendum has been prepared for the Netherlands, for the full efficacy evaluation reference is made to the National assessment of the United Kingdom. According to the UK label the product has to be applied in a minimum volume of 500 L water/ha. Thus the following sentence needs to be included on the label: In de teelt van wortelen dient Flocter te worden toegepast met een spuitvolume van 500 - 800 L water.

3.2

Conclusions

The assessment conducted for Flocter was in accordance with 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 product label Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als nematodenbestrijdingsmiddel door middel van een grondbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden. Toepassin gebied

Te bestrijde n organis me

Dosering (middel) per toepassi ng

Maximaal aantal toepassing en per teeltcyclus

Maxima al aantal kg middel per ha per teeltcycl us

Minimum interval tussen toepassing en in dagen

Veiligheidster mijn in dagen of uiterst gewasstadium waarop toegepast mag worden

Wortelen Aaltjes1 80 kg/ha 12 80 kg/ha 1 3 (onbedekte Aaltjes 40 kg/ha 2 5 teelt) 1 Vermindert de schade door vrijlevende nematoden, wortelknobbelaaltjes, Meloidogyne spp.) en wortellesieaaltjes (Pratylenchus spp.); 2 0-7 dagen voor zaaien; 3 1e toepassing: 0-7 dagen voor zaaien; 2e toepassing: tot 5 dagen na zaaien, voor opkomst. Toepassingsvoorwaarden In de teelt van wortelen dient Flocter te worden toegepast met een spuitvolume van 500 - 800 L water. Micro-organismen kunnen mogelijk sensibiliserende reacties veroorzaken.




Bacillus firmus I-1582 WP 5 (BFI WP5) (Flocter) Specification: 102000024952


Appendix 2: List of data submitted in support of the evaluation Annex point / reference number

Year

Title Source (where different from company) Company name, Report No., Date, GLP/GEP status (where relevant), published or not

Data protection claimed Yes/No

Data protection granted Yes/No

Study relied on Yes/No

Owner

KIIIM 2.2/02

2012

Storage stability and shelf life of bacillus firmus I1582 WP 5 (50 g/kg) - [Packaging material: Al–composite foil] Final Report (2 years at ambient temperature) Report No.: FM0082(SL04)N01, Edition Number: M-394971-02-1 Date: 2012-11-05 GLP/GEP: yes, unpublished

Yes

Yes

Yes

Bayer CropScience

KIIIM 2.1 /01, 2.2 /01, 2.3.3 /01, 2.4.1 /01, 2.4.2 /01, 2.4.3 /01, 2.4.4 /01, 2.4.5 /01, 2.5 /01,

2010

Storage stability of Bacillus firmus I-1582 WP 5 (50 g/kg) - [Packaging material: Al-composite foil] Interim report (8 weeks) Bayer CropScience, Report No.: FM0082(AC04)N01, Edition Number: M-394971-01-1 Date: 2010-11-16 GLP/GEP: yes, unpublished

Yes

Yes

Yes

Bayer CropScience

KIIIM 2.3.1 /01, 2.3.2 /01

2010

Determination of safety-relevant data of Bacillus firmus strain I-1582 WP 5 (50 g/kg) (50 g/kg) Currenta GmbH & Co. OHG, Leverkusen, Germany BCS, Report No.: 2009/01835, Edition Number: M-365378-01-1 Date: 2010-03-08 GLP/GEP: yes, unpublished

Yes

Yes

Yes

Bayer CropScience

KIIIM 5.1.2 /01

2010

Yes

Yes

Yes

Bayer CropScience

KIIIM 5.1.3 /01

2009

Methods to detect spontaneous change in major characteristics of micro-organism Bayer CropScience Bayer CropScience, Report No.: M-371083-01-1, Edition Number: M-371083-01-1 Date: 2010-06-14 GLP/GEP: n.a., unpublished BIOLOGICAL METHOD ; Biological Stability Counts Report No.: BM000109MF1, Edition Number: M-358114-01-1 Date: 2009-10-28 GLP/GEP: no, unpublished

Yes

Yes

Yes

Bayer CropScience

5.2 /01





Annex point / reference number

Year

Title Source (where different from company) Company name, Report No., Date, GLP/GEP status (where relevant), published or not

Data protection claimed Yes/No

Data protection granted Yes/No

Study relied on Yes/No

Owner

KIIIM 5.1.3 /02

2010

Yes

Yes

Yes

Bayer CropScience

KIIIM 5.1.3 /03, 5.1.6 /01

2010

Determination of spore content - Microscopic method - Method according to SGS IF SOP M 2144 - Method validated for: Spore powder Bacillus firmus I-1582 (technical product) VAL 09 TS ML 061 - Spore powder Bacillus firmus I-1582 WP5 - VAL 09 TS ML 062 Fresenius GmbH, Bad Homburg, Germany BCS, Report No.: SGS IF SOP M 2144, Edition Number: M-375058-01-1 Date: 2010-06-24 GLP/GEP: no, unpublished Validation report of the microbial examination of spore powder Bacillus Firmus I-1582 WP5 SGS Institut Fresenius GmbH, Taunusstein, Germany Bayer CropScience, Report No.: VAL 09 TS ML062, Edition Number: M-365127-03-1 Date: 2010-03-02 ...Amended: 2011-03-23 GLP/GEP: no, unpublished

Yes

Yes

Yes

Bayer CropScience






Appendix 3 – Letter of Access



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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