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APPENDIX I

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APPENDIX I

    EUROPEAN COMMISSION

    HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

    Directorate E Safety of the food chain Unit E.3 - Chemicals, contaminants, pesticides

     Spinosad

     SANCO/1428/2001 rev. 3

     7 July 2006

    EU RESTRICTED

COMMISSION WORKING DOCUMENT - DOES NOT NECESSARILY REPRESENT

    THE VIEWS OF THE COMMISSION SERVICES

    DRAFT

    Review report for the active substance spinosad Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 14

    July 2006 in view of the inclusion of spinosad in Annex I of Directive 91/414/EEC.

    1. Procedure followed for the evaluation process

This review report has been established as a result of the evaluation of the new active substance

    spinosad, made in the context of the work provided for in Articles 5 and 6 of Directive

    91/414/EEC concerning the placing of plant protection products on the market, with a view to

    the possible inclusion of this substance in Annex I to the Directive.

In accordance with the provisions of Article 6(2) of Directive 91/414/EEC, the Netherlands

    authorities received on 19 July 1999 an application from Dow AgroSciences, hereafter referred

    to as the applicant, for the inclusion of the active substance spinosad in Annex I to the Directive.

    The Netherlands authorities indicated to the Commission on 19 August 1999 the results of a first

    examination of the completeness of the dossier, with regard to the data and information

    requirements provided for in Annex II and, for at least one plant protection product containing

    the active substance concerned, in Annex III to the Directive. Subsequently, and in accordance

    with the requirements of Article 6(2), a dossier on spinosad was distributed to the Member States

    and the Commission.

The Commission referred the dossier to the Standing Committee on the Food Chain and Animal

    Health in the meeting of the working group ‘legislation’ thereof on 17 August 1999, during

    which the Member States confirmed the receipt of the dossier.

In accordance with the provisions of Article 6(3), which requires the confirmation at Community

    level that the dossier is to be considered as satisfying, in principle, the data and information

    requirements provided for in Annex II and, for at least one plant protection product containing

    the active substance concerned, in Annex III to the Directive and in accordance with the

    - 2 -

    procedure laid down in Article 20 of the Directive, the Commission confirmed in its Decision 12000/210/EC of 25 February 2000 that these requirements were satisfied.

    Within the framework of that decision and with a view to the further organisation of the works related to the detailed examination of the dossier provided for in Article 6(2) and (4) of Directive 91/414/EEC, it was agreed between the Member States and the Commission that the Netherlands would, as rapporteur Member State, carry out the detailed examination of the dossier and report the conclusions of its examination accompanied by any recommendations on the inclusion or non-inclusion and any conditions relating thereto, to the Commission as soon as possible and at the latest within a period of one year.

The Netherlands submitted to the Commission on 5 March 2001 the report of its detailed

    scientific examination, hereafter referred to as the draft assessment report, including, as required, a recommendation concerning the possible inclusion of spinosad in Annex I to the Directive.

    On receipt of the draft assessment report, the Commission forwarded it for consultation to all the Member States as well as to Dow AgroSciences being the sole applicant on 23 March 2001.

    The Commission organised further an intensive consultation of specialised scientific experts from a representative number of Member States, to review the draft assessment report and the comments received thereon (peer review), in particular on each of the following disciplines :

- identity and physical /chemical properties ;

    - fate and behaviour in the environment ;

    - ecotoxicology ;

    - mammalian toxicology ;

    - residues and analytical methods ;

    - regulatory questions.

    The meetings for this consultation were organised on behalf of the Commission by the Biologische Bundesanstalt für Land und Forstwirtschaft (BBA) in Braunschweig, Germany, from November 2001 to July 2002.

    The report of the peer review (i.e. full report) was circulated, for further consultation, to Member States and the sole applicant on 11 September 2002.

    The dossier, draft assessment report and the peer review report (i.e. full report) including in particular an outline resumé of the remaining technical questions, were referred to the Standing Committee on the Food Chain and Animal Health, and specialised working groups of this Committee, for final examination, with participation of experts from all Member States. This final examination took place from May 2003 to July 2006, and was finalised in the meeting of the Standing Committee on 14 July 2006.

    The present review report contains the conclusions of this final examination; given the importance of the draft assessment report, the peer review report (i.e. full report) and the comments and clarifications submitted after the peer review as basic information for the final examination process, these documents are considered respectively as background documents A, B and C to this review report and are part of it.

     1 OJ L 64, 11.3.2000, p.24

    - 3 -

    The review of spinosad did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee.

2. Purposes of this review report

    This review report, including the background documents and appendices thereto, have been developed and finalised in support of the Directive 2007/6/EC concerning the inclusion of

    spinosad in Annex I to Directive 91/414/EEC, and to assist the Member States in decisions on individual plant protection products containing spinosad they have to take in accordance with the provisions of that Directive, and in particular the provisions of article 4(1) and the uniform principles laid down in Annex VI.

    This review report provides also for the evaluation required under Section A.2.(b) of the above mentioned uniform principles, as well as under several specific sections of part B of these principles. In these sections it is provided that Member States, in evaluating applications and granting authorisations, shall take into account the information concerning the active substance in Annex II of the directive, submitted for the purpose of inclusion of the active substance in Annex I, as well as the result of the evaluation of those data.

    In parallel with the provisions of Article 7(6) of Regulation 3600/92 for existing active substances, the Commission and the Member States will keep available or make available this review report for consultation by any interested parties or will make it available to them on their specific request. Moreover the Commission will send a copy of this review report (not including the background documents) to the applicant.

    The information in this review report is, at least partly, based on information which is confidential and/or protected under the provisions of Directive 91/414/EEC. It is therefore recommended that this review report would not be accepted to support any registration outside the context of Directive 91/414/EEC, e.g. in third countries, for which the applicant has not demonstrated possession of regulatory access to the information on which this review report is based.

3. Overall conclusion in the context of Directive 91/414/EEC

    The overall conclusion from the evaluation is that it may be expected that plant protection products containing spinosad will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. This conclusion is however subject to compliance with the particular requirements in sections 4, 5, 6 and 7 of this report, as well as to the implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each spinosad containing plant protection product for which Member States will grant or review the authorisation.

    Furthermore, these conclusions were reached within the framework of the uses which were proposed and supported by the sole data submitter and mentioned in the list of uses supported by available data (attached as Appendix IV to this Review Report).

    Extension of the use pattern beyond those described above will require an evaluation at Member State level in order to establish whether the proposed extensions of use can satisfy the

    - 4 -

    requirements of Article 4(1) and of the uniform principles laid down in Annex VI of Directive

    91/414/EEC.

4. Specific conclusions which are highlighted in this evaluation

     4.1 Residues of spinosad in foodstuffs

The review has established that the residues arising from the proposed uses, consequent on

    application consistent with good plant protection practice, have no harmful effects on human or

    animal health. The Theoretical Maximum Daily Intake (TMDI) for a 60 kg adult is 5.5% of the

    Acceptable Daily Intake (ADI), based on the FAO/WHO European Diet (August 1994). This

    low intake value reflects the current limited use pattern for this active substance.

     4.2 Exposure of operators, workers and bystanders

The review has identified acceptable exposure scenarios for operators, workers and bystanders,

    which require, however, confirmation for each plant protection product in accordance with the

    relevant sections of the above mentioned uniform principles.

     4.3 Ecotoxicology

The review has also concluded that under the proposed and supported conditions of use there are

    no unacceptable effects on the environment, as provided for in Article 4 (1) (b) (iv) and (v) of

    Directive 91/414/EEC, provided that certain conditions are taken into account as detailed in

    section 7 of this report.

5. Identity and Physical/chemical properties

The main identity and the physical/chemical properties of spinosad are given in Appendix I.

The active substance shall have a minimum purity of 85%, with 50-95% spinosyn A and 5-50%

    spinosyn D g/kg technical product.

The review has established that for the active substance notified by the applicant (Dow

    AgroSciences), none of the manufacturing impurities considered are, on the basis of information

    currently available, of toxicological or environmental concern.

    6. Endpoints and related information

In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately

    the provisions of Article 4(1) of Directive 91/414/EEC and the uniform principles laid down in

    Annex VI of that Directive, the most important endpoints as identified during the evaluation

    process are listed in Appendix II.

    - 5 -

    7. Particular conditions to be taken into account on short term basis by Member States in relation to the granting of authorisations of plant protection products containing spinosad

    On the basis of the proposed and supported uses, the following particular issues have been identified as requiring particular and short term (within 12 months at the latest) attention from the Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate:

Member States

    - must pay particular attention to the protection of aquatic organisms;

    - must pay particular attention to the risk to earthworms when the substance is used in

    glasshouses.

    Conditions of use shall include risk mitigation measures, where appropriate.

8. List of studies to be generated

    No further studies were identified which were considered at this stage, and under the current inclusion conditions necessary in relation to the inclusion of spinosad in Annex I.

    Some endpoints however may require the generation or submission of additional studies to be submitted to the Member States in order to ensure authorisations for use under certain conditions. This may be particularly the case for studies addressing the off-crop risk for non-target arthropods.

9. Updating of this review report

    The technical information in this report may require periodic updating to take account of technical and scientific developments as well as of the results of the examination of any information referred to the Commission in the framework of Articles 7, 10 or 11 of Directive 91/414/EEC. Such adaptations will be examined and finalised in the Standing Committee on the Food Chain and Animal Health, in connection with any amendment of the inclusion conditions for spinosad in Annex I of the Directive.

     - 1 -

    SPINOSAD APPENDIX I

    Identity, physical and chemical properties

    08 March 2006

    APPENDIX I

    Identity, physical and chemical properties

    SPINOSAD

    Common name (ISO) SPINOSAD

    a mixture of 50-95% spinosyn A and 5-50% spinosyn D

    Code Factor Used between Development Code (for new actives

    only) 232105 A From discovery

    to March 1989

    275043 D From discovery

    to March 1989

    XR-105 A + D March 1989 -

    January 1991

    XDE-105 A + D January 1991 -

    November 1994

    DE-105 A + D November 1994 -

    present

    Chemical name (IUPAC) Spinosyn A:

    (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-

    2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-

    dimethylamino-2,3,4,6-tetradeoxy-ß-D-

    erythropyranosyloxy)-9-ethyl-

    2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-

    hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-

    indacene-7,15-dione

    Spinosyn D:

    (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-

    2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-

    dimethylamino-2,3,4,6-tetradeoxy-ß-D-

    erythropyranosyloxy)-9-ethyl-

    2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-

    hexadecahydro-4,14-dimethyl-1H-8-

    oxacyclododeca[b]as-indacene-7,15-dione

     - 2 -

    SPINOSAD APPENDIX I

    Identity, physical and chemical properties

    08 March 2006 Chemical name (CA) Spinosyn A:

    (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-

    2,3,4-tri-O-methyl-a-L-mannopyranosyl)oxy]-13-

    [[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-

    pyran-2-yl]oxy]-9-ethyl-

    2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-

    14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-

    dione

    Spinosyn D:

    (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-

    2,3,4-tri-O-methyl-a-L-mannopyranosyl)oxy]-13-

    [[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-

    pyran-2-yl]oxy]-9-ethyl-

    2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-

    4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-

    7,15-dione

    CIPAC No 636

    CAS No Spinosyn A:

    131929-60-7

    Spinosyn D:

    131929-63-0

     168316-95-8 (mixture)

    EEC No 434-300-1 (mixture of spinosyn A and D) FAO SPECIFICATION not established

    Minimum purity 850 g/kg, with 50-95% spinosyn A and 5-50%

    spinosyn D

    Molecular formula Spinosyn A: CHNO 416510

    Spinosyn D: CHNO 426710

    Molecular mass Spinosyn A: 731.98

    Spinosyn D: 746.00

    Structural formula Spinosyn A:

    O3OCH(CH)N3CHO32CHO3OCH3CHOCH33

    OHHOO

    HOCHCHH32H

Spinosyn D:

     - 3 -

    SPINOSAD APPENDIX I

    Identity, physical and chemical properties

    08 March 2006

    O3OCH(CH)NCH3O32CHO3OCH3CHOCH33

    OHHOO

    HOCHCHH32H

    CH3

     - 4 -

    SPINOSAD APPENDIX I

    Identity, physical and chemical properties

    08 March 2006 Melting point Spinosyn A: 84-99.5?C (98.3%)

    Spinosyn D: 161.5 to 170?C (98.0%) Boiling point Spinosyn A: Not required

    Spinosyn D: Not required

    Appearance Light grey-white solid (88.0% pure) Relative density 1.19 (88% pure)

    -11Vapour pressure Spinosyn A: 3.0x10 kPa (25?C)

    -11Spinosyn D: 2.0x10 kPa (25?C)

    -73-1Henry's law constant Spinosyn A: 1.89 x 10 Pa mmol

    -5 3-1Spinosyn D: 2.32 x 10 Pa mmol Solubility in water Spinosyn A: Spinosyn D:

    pH5 290 mg/L (20 ?C) pH5 28.7 mg/L (20?C)

    pH7 235 mg/L (20 ?C) pH7 0.332 mg/L (20?C)

    pH9 16 mg/L (20 ?C) pH9 0.053 mg/L (20?C)

    Dist. Water 89.4 mg/L Water (pH 8.36) 0.495

    mg/L Solubility in organic solvents Spinosyn A: Spinosyn D:

    Solvent Solubility mg/L

    dichloromethane 525000 448000

    methanol 190000 2520

    acetone 168000 10100

    acetonitrile 134000 2550

    amyl acetate 36900 23000

    hexane 4480 743

    1-octanol 9260 1270

    toluene 457000 152000

    isopropyl alcohol 39800 1290

    ethyl acetate 194000 19000

    n-heptane 12400 300

    xylene >250000 64000 Partition co-efficient (log P) Spinosyn A: Spinosyn D: ow

    Log K = 3.91 at 23?C = 4.38 at 23?C Log Kowow

    (water) (water)

    Log KLog K = 2.78 at 23?C (pH = 3.23 at 23?C (pH owow

    5) 5)

    Log KLog K = 4.01 at 23?C (pH = 4.53 at 23?C (pH owow

    7) 7)

    Log KLog K = 5.16 at 23?C (pH = 5.21 at 23?C (pH owow

    9) 9)

    Effect of pH (4 to 10) on the n-octanol/water partition is

    not required since spinosad is neither acidic or basic

    (spinosyn A pKa = 8.10; spinosyn D pKa = 7.87)

     - 5 -

    SPINOSAD APPENDIX I

    Identity, physical and chemical properties

    08 March 2006 Hydrolytic stability (DT) Spinosyn A: Spinosyn D: 50

    pH Hydrolysis pH Hydrolysis

    5 No 5 No

    7 No 7 No

    9 t9 = 200 t = 259 ??

    days days Dissociation constant Spinosyn A: Spinosyn D:

    pKa of protonated pKa of protonated

    spinosyn A = 8.10 at 20?C, ?C, spinosyn D = 7.87 at 20-9-8equivalent Ka = 7.94 x 10equivalent Ka = 1.35 x 10. .

    Spinosyn A: Spinosyn D: Quantum yield of direct photo-

    transformation in water at >290 nm 0.019 0.021 Flammability Non-flammable

    Explosive properties Not explosive

    UV/VIS absorption (max.) Spinosyn A: Spinosyn D:

    No absorption at >290nm No absorption at >290nm

    5 -1-15 -1-1? = 1.08x10molcm at ? = 1.10x10molcmat 244.2nm 243.8nm 4 -1-14 -1-1? = 5.73x10molcm at ? = 9.88x10molcm at 200.2nm 202.8nm 5 -1-15 -1-1? = 1.10x10molcm at ? = 1.09x10molcm at 243.6nm 244.0nm 5 -1-15 -1-1? = 1.10x10molcm at ? = 1.10x10molcm at 243.2nm 242.6nm 4 -1-15 -1-1? = 6.77x10molcm at ? = 1.08x10molcm at 201.0nm 203.0nm Photostability in water (DT) Spinosyn A: Spinosyn D: 50

    The half-life for the The half-life for the

    degradation of spinosyn A degradation of spinosyn D

    in dilute aqueous buffer in dilute aqueous buffer

    (pH7) was calculated to be (pH7) was calculated to be

    0.96 days, in summer 0.84 days, in summer

    sunlight. sunlight

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