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REPORT

BILAGA 2

2015-04-29

Our reference

Authorisations and Guidance

F-3422-B13-00357

F-3542-B13-00352

Swedish Chemicals Agency

Mailing address Visit Invoicing address Phone & fax Internet VAT No Box 2

SE-172 13 Sundbyberg

Sweden

Esplanaden 3A,

Sundbyberg

FE 124

SE-838 80 Hackås

Sweden

Phone +46 8 519 41 100

Fax +46 8 735 76 98

www.kemi.se kemi@kemi.se

SE202100388001

Product Assessment Report

Related to product authorisation under Regulation (EU) No

528/2012

VectoBac G and VectoBac GR

Type of application

Re-authorisation

Product type

Insecticide PT18

Swedish authorisation number

4889,
4924

Date of decision/Entry into

force

01 May 2015

Active substance

Bacillus thuringiensis subspecies israelensis serotype H-14, strain AM65-52, 2.8 % (w/w)

Date of expiry

30 April 2025

2013/26755/7930/SE/ANP/11088

2013/26755/7930/SE/APP/11090

User category

Trained professional

Product Assessment Report

Ref-MS Sweden

Product name

VectoBac G and VectoBac GR

Date

2015-04-29

1 (68)

CONTENTS

1 GENERAL INFORMATION ABOUT THE PRODUCT APPLICATION ............................ 4

1.1 Applicant................................................................................................................................................... 4

1.1.1 Person authorised for communication on behalf of the applicant .......................................................... 4

1.2 Current authorisation holder .................................................................................................................. 4

1.3 Proposed authorisation holder ................................................................................................................ 5

1.4 Information about the product application ........................................................................................... 5

1.5 Information about the biocidal product ................................................................................................. 5

1.5.1 General information ............................................................................................................................... 5

1.5.2 Information on the intended use(s) ........................................................................................................ 6

1.5.2.1 Uses claimed by the applicant ....................................................................................................... 6

1.5.2.2 Uses authorised by the Reference member state ........................................................................... 6

1.5.3 Information on active substance(s) ........................................................................................................ 7

1.6 Identity related issues .............................................................................................................................. 8

1.6.1 Information on the substance(s) of concern ........................................................................................... 8

1.7 Documentation ......................................................................................................................................... 8

1.7.1 Data submitted in relation to product application .................................................................................. 8

1.7.2 Access to documentation ....................................................................................................................... 8

2 SUMMARY OF THE PRODUCT ASSESSMENT .................................................................... 9

2.1 General product information ......................................................................................................................... 9

2.1.1 Identification of the biocidal product .................................................................................................... 9

2.1.1 Identity of ingredients of the biocidal product ..................................................................................... 10

2.1.2 Physico-chemical properties ................................................................................................................ 10

2.1.3 Analytical methods for detection and identification ............................................................................ 17

2.1.4 Classification and labelling ................................................................................................................. 17

2.2 Efficacy ................................................................................................................................................... 18

2.2.1 Use and product type ........................................................................................................................... 18

2.2.2 Details of intended use ........................................................................................................................ 18

2.2.3 Application rate ................................................................................................................................... 19

2.2.4 Conditions under which the product may not be used ......................................................................... 19

2.2.5 Method of application .......................................................................................................................... 19

2.2.6 Number and timing of applications ..................................................................................................... 19

2.2.7 Proposed instructions for use ............................................................................................................... 19

2.2.8 Efficacy information ............................................................................................................................ 19

2.2.9 Information on the possible occurrence of the development of resistance .......................................... 23

2.2.10 Effects on the quality of materials or products treated .................................................................... 25

2.3 Exposure Assessment ............................................................................................................................. 25

2.3.1 Intended uses ....................................................................................................................................... 25

2.3.1.1 Human exposure assessment ....................................................................................................... 25

2.3.1.2 Identification of main paths of human exposure to the active substance from its use in the

biocidal product ............................................................................................................................................ 26

2.3.1.3 Professional exposure ................................................................................................................. 26

2.3.1.4 Non-professional exposure ......................................................................................................... 26

Product Assessment Report

Ref-MS Sweden

Product name

VectoBac G and VectoBac GR

Date

2015-04-29

2 (68)

2.3.1.5 Indirect exposure......................................................................................................................... 27

2.3.2 Environmental exposure assessment ................................................................................................... 27

2.3.2.1 Fate and distribution in the environment .................................................................................... 27

2.3.2.2 PEC in soil .................................................................................................................................. 28

2.3.2.3 PEC in surface water, ground water, sediment and STP ............................................................. 29

2.3.2.4 PEC in air .................................................................................................................................... 37

2.3.2.5 Non compartment specific exposure relevant to the food chain (primary and secondary

poisoning) 38

2.4 Human health effects assessment .......................................................................................................... 38

2.5 Environmental effects assessment ........................................................................................................ 39

2.5.1 Aquatic compartment .......................................................................................................................... 40

2.5.2 Terrestrial compartment ...................................................................................................................... 41

2.5.3 Atmosphere.......................................................................................................................................... 42

2.5.4 Non compartment effects relevant to the food chain (primary and secondary poisoning) .................. 42

2.6 Hazard identification for biological properties ................................................................................... 43

2.7 Risk characterisation for human health .............................................................................................. 43

2.7.1 General aspects .................................................................................................................................... 43

2.7.2 Professional users ................................................................................................................................ 44

2.7.2.1 Active substance ......................................................................................................................... 44

2.7.2.2 Critical endpoint(s) ..................................................................................................................... 44

2.7.2.3 Relevant exposure paths ............................................................................................................. 44

2.7.2.4 Risk characterisation for production / formulation of a.s. ........................................................... 44

2.7.3 Biocidal product .................................................................................................................................. 44

2.7.3.1 Critical end point(s) .................................................................................................................... 44

2.7.3.2 Relevant exposure paths ............................................................................................................. 45

2.7.3.3 Risk characterisation for the biocidal product ............................................................................ 45

2.7.4 Overall assessment of the risk to professionals for the use of the active substance in the biocidal

product 45

2.7.5 Non-professional users ........................................................................................................................ 45

2.7.6 Indirect exposure as a result of use ...................................................................................................... 45

2.7.6.1 Active substance ......................................................................................................................... 45

2.7.6.2 Critical endpoint(s) ..................................................................................................................... 45

2.7.6.3 Risk characterisation for production / formulation of a.s. ........................................................... 46

2.7.6.4 Biocidal product .......................................................................................................................... 46

2.7.6.5 Overall assessment of the risk to non-users for the use of the active substance in biocidal

product 46

2.7.7 Combined exposure ............................................................................................................................. 46

2.8 Risk characterisation for the environment .......................................................................................... 47

2.8.1 Aquatic compartment (incl. sediment)................................................................................................. 48

2.8.2 Sewage treatment plants (STP) ............................................................................................................ 49

2.8.3 Atmosphere.......................................................................................................................................... 50

2.8.4 Terrestrial compartment ...................................................................................................................... 50

2.9 Measures to protect man, animals and the environment .................................................................... 52

3 PROPOSAL FOR DECISION ................................................................................................... 54

3.1 Background to the decision ................................................................................................................... 54

3.1.1 From the Assessment Report ............................................................................................................... 54

3.1.2 Previous use and authorisation in Sweden ........................................................................................... 55

3.1.3 Risk assessment for aerial application of VectoBac ............................................................................ 55

3.1.4 Conclusions ......................................................................................................................................... 56

Product Assessment Report

Ref-MS Sweden

Product name

VectoBac G and VectoBac GR

Date

2015-04-29

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3.2 Proposal for decision .............................................................................................................................. 57

ANNEX 1. LIST OF STUDIES REVIEWED ................................................................................... 59

ANNEX 2. METHOD TO MEASURE THE BIOPOTENCY ......................................................... 66

Product Assessment Report

Ref-MS Sweden

Product name

VectoBac G and VectoBac GR

Date

2015-04-29

Page 4 of 68

1 GENERAL INFORMATION ABOUT THE PRODUCT

APPLICATION

1.1 APPLICANT

Company Name: Sumitomo Chemical Agro Europe SAS

Address:

City:

Postal Code: 69771

Country: France

Telephone: +33478643260

Fax: +33478472545

E-mail address: Sylvia.plak@sumitomo-chem.fr

1.1.1 Person authorised for communication on behalf of the applicant

Name: Denise Munday

Function: Regulatory Affairs Manager

Address: 36, rue de la Gare

City: Nyon

Postal Code: 1260

Country: Switzerland

Telephone: +41229902125

Fax: +41229902129

E-mail address: Denise.munday@sumitomo-chem.fr

1.2 CURRENT AUTHORISATION HOLDER1

Company Name: Sumitomo Chemical Agro Europe SAS (same as applicant)

Address:

City:

Postal Code: 69771

Country: France

Telephone: +33478643260

Fax: +33478472545

1 Applies only to existing authorisations

Product Assessment Report

Ref-MS Sweden

Product name

VectoBac G and VectoBac GR

Date

2015-04-29

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