EURPEAN CMMISSIN DIRECTRATE-GENERAL FR HEALTH AND FD SAFETY Food and feed safety, innovation Pesticides and biocides Straight Chain Lepidopteran Pheromones (SCLPs) SANC/2633/08 rev. 13 20 July 2017 1 Review report for the active substance Straight Chain Lepidopteran Pheromones (SCLPs) Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 28 ctober 2008 in view of the inclusion of Straight Chain Lepidopteran Pheromones (SCLPs) in Annex I of Directive 91/414/EEC 2 1 2 The Standing Committee on Food Chain and Animal Health took note of revision 3 of the review report on 5 May 2011. The review report was amended to include Appendix III related to new evaluated substances which belong to the SCLP group. The Standing Committee on Food Chain and Animal Health took note of revision 4 of the review report on 1 June 2012. The review report was amended to include in Appendix III a new evaluated substance which belongs to the SCLP group. The Standing Committee on Food Chain and Animal Health took note of revision 5 of the review report on 20 November 2012. The review report was amended to include in Appendix III a new evaluated substance which belongs to the SCLP group. n 11 July 2014, the Standing Committee on Food Chain and Animal Health took note of the revision 6 of the review report taking into account the EFSA conclusions referred to in chapters 1, 2, 3, 4, 5 and 9 of this report (cfr. infra) and the entry into force of Regulation (EC) No 1107/2009. As already stated in Chapter 1 of this review report, documents providing clarifications on the assessment finalised after a decision has been taken shall be considered as background document C and as such they are part of this review report. The Standing Committee on Plants, Animals, Food and Feed took note of revision 7 of the review report on 12 December 2014. The review report was amended to include in Appendix III new evaluated substances which belong to the SCLP group. The Standing Committee on Plants, Animals, Food and Feed took note of revision 8 of the review report on 9 ctober 2015. The review report was amended to include in Appendix III new evaluated substances which belong to the SCLP group. The Standing Committee on Plants, Animals, Food and Feed took note of revision 9 of the review report on 29 January 2016. The review report was amended to include in Appendix III new evaluated substances which belong to the SCLP group. The Standing Committee on Plants, Animals, Food and Feed took note of revision 10 of the review report on 8 March 2016. The review report was amended to include in Appendix III new evaluated substances which belong to the SCLP group. The Standing Committee on Plants, Animals, Food and Feed took note of revision 11 of the review report on 19 May 2016. The review report was amended for the specifications of blend CAS No 1011528-52-1 (pag. 9). The Standing Committee on Plants, Animals, Food and Feed took note of revision 12 of the review report on 7 ctober 2016. The review report was amended for the conclusions on confirmatory studies as reported under Chapter 7 (pag. 6). The Standing Committee on Plants, Animals, Food and Feed took note of revision 13 of the review report on 20 July 2017. The review report was amended for the conclusions on confirmatory studies as reported under Chapter 7 and to include in Appendix III a new evaluated substance which belongs to the SCLPs group. Report initially established within the Standing Committee on the Food Chain and Animal Health and revised according to the principles of Article 13 of Regulation (EU) No 1107/2009; it does not necessarily represent the views of the European Commission. 1
1. Procedure followed for the re-evaluation process This review report has been established as a result of the re-evaluation of the group of pheromones defined as Straight Chain Lepidopteran Pheromones (SCLPs), made in the context of the work programme for review of existing active substances provided for in Article 8(2) 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. Commission Regulation (EC) No 1112/2002( 3 ) laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC, as last amended by Regulation (EC) No 2229/2004( 4 ), has laid down the detailed rules on the procedure according to which the re-evaluation has to be carried out. Straight Chain Lepidopteran Pheromones is the common definition for a group of existing active substances covered by this Regulation and listed under Appendix I of this report. In accordance with the provisions of Article 4 of Regulation (EC) No 2229/2004, Agrisense-BCS, Agrochem, BASF, Isagro Biofarming, Suterra, Russell Fine Chemicals, Sociedad Espanolas de Desarollos Quimicos, Shin-Etsu International, DKSH Switzerland, Exosect formed a task force with International Biocontrol Manufacturing Association (IBMA) as Task Force representative and notified to the Commission of their wish to secure the inclusion of various active substances falling under the definition of Straight Chain Lepidopteran Pheromones in Annex I to the Directive. In Annex I to Regulation (EC) No 2229/2004, the Commission designated Austria as rapporteur Member State to carry out the assessment of Straight Chain Lepidopteran Pheromones on the basis of the dossier submitted by the notifier. In Article 12 of Regulation (EC) No 2229/2004 the Commission specified furthermore that the deadline for the notifier with regard to the submission to the rapporteur Member States of the dossiers required, as well as for other parties with regard to further technical and scientific information was 30 November 2005. Agrisense-BCS, Agrochem, BASF, Isagro Biofarming, Suterra, Russell Fine Chemicals, Sociedad Espanolas de Desarollos Quimicos, Shin-Etsu International, DKSH Switzerland and Exosect as task force submitted by the deadline a dossier to the rapporteur Member State which did not contain substantial data gaps, taking into account the supported uses. Therefore the task force was considered to be the sole main data submitter. In accordance with the provisions of Article 22(1) of Regulation (EC) No 2229/2004, Austria submitted in April 2008 to the EFSA the report of their examination, hereafter referred to as the draft assessment report, including, as required, a recommendation concerning the possible inclusion of Straight Chain Lepidopteran Pheromones in Annex I to the Directive. Moreover, in accordance with the provisions of Article 20(2) of Regulation (EC) 2229/2004, the Commission and the Member States received also the summary dossier on May 2008 from the Task force. In accordance with the provisions of Article 24 of Regulation (EC) No 2229/2004 as last amended by Regulation (EC) 1095/2007, the EFSA organised the consultation on the draft assessment report 3 4 J No L 168, 27.06.2002, p.14. J No L 379, 24.12.2004, p. 13. 2
by all the Member States as well as by the Task force represented by IBMA being the sole data submitter, on 22 July 2008 by making it. n the basis of the provisions of Article 24a of Regulation 2229/2004 as last amended by Regulation (EC) 1095/2007 the Commission examined the draft assessment report, the recommendations by the rapporteur Member State and the comments received from other Member States in consultation with experts from Member States. In accordance with the provisions of Article 24b and Article 25 (1) a of Regulation (EC) No 2229/2004 as last amended by Regulation (EC) 1095/2007, the Commission referred on 28 ctober 2008 a draft review report to the Standing Committee on the Food Chain and Animal Health, for final examination. The draft review report was finalised in the meeting of the Standing Committee on 28 ctober 2008. Regulation (EC) No 1107/2009 5 repealed and replaced Directive 91/414/EEC and the active substance Straight Chain Lepidopteran Pheromones is deemed to be approved under that Regulation and included in the Annex to Regulation (EC) No 540/2011 6. Finally, in compliance with the provisions of Article 25a of Regulation (EC) No 2229/2004, EFSA delivered its conclusions on Straight Chain Lepidopteran Pheromones on 18 December 2013 7. The Commission referred on 11 July 2014 an updated review report to the Standing Committee on the Food Chain and Animal Health, for examination. The present review report contains the conclusions of the final examination by the Standing Committee. 2. Purposes of this review report This review report, including the background document appendices thereto, has been developed in support of the Directive 2008/127/EC 8 concerning the inclusion of Straight Chain Lepidopteran Pheromones in Annex I to Directive 91/414/EEC, as amended by Commission Implementing Regulation (EC) No 918/2014 9. The Commission requested EFSA to deliver its view on the draft review reports. When the Member States decide on individual plant protection products containing Straight Chain Lepidopteran Pheromones they shall take into account this review report in accordance with the provisions of Regulation (EC) No 1107/2009, and in particular the provisions of Article 4(1), (2) and (3) of that Regulation and uniform principles laid down in Regulation (EC) No 546/2011. 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. 5 6 7 8 9 J No L309, 24.11.2009, p.1. J No L 153, 11.6.2011, p. 1. European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Straight Chain Lepidopteran Pheromones. EFSA Journal 2014;12(1):3524. [537 pp.] doi:10.2903/j.efsa.2013.3058. Available online: www.efsa.europa.eu/efsajournal. Commission Directive 2008/127/EC (J L 344, 20.12.2008, p. 89)..J L 251, 23.8.2015, p.24-26. 3
In accordance with the provisions of Article 26 of Regulation (EC) No 2229/2004, Member States will keep or make this review report for consultation by any interested parties or will make it to them on their specific request. The information in this review report is, at least partly, based on information which is confidential and/or protected under the provisions of Regulation (EC) No 1107/2009. It is therefore recommended that this review report would not be accepted to support any registration outside the context of Regulation (EC) No 1107/2009, e.g. in third countries, for which the applicant has not demonstrated to have regulatory access to the information on which this review report is based. 3. verall conclusion in the context of Directive 91/414/EEC The overall conclusion from the draft assessment report, the recommendations by the rapporteur Member State and the result of the examination in accordance with the provisions of Article 24a of Regulation 2229/2004 is that there are clear indications that it may be expected that Straight Chain Lepidopteran Pheromones, when they are applied via retrievable sized dispensers, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex VI of regulation (EC) 2229/2004 as last amended by Regulation (EC) 1095/2007. For other types of application it could not be evaluated if there are harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, due to a lack of data. These indications are however subject to compliance with the particular requirements in sections 4 and 5 of this report, as well as to the implementation of the provisions of Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EC) No 546/2011, for each Straight Chain Lepidopteran Pheromones containing plant protection product for which Member States will grant or review the authorisation. Furthermore, these indications were reached within the framework of the uses which were proposed and supported by the main data submitter and mentioned in the list of uses supported by data (attached as Appendix II 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 requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EC) No 546/2011. The review has concluded that there are acceptable exposure scenarios for consumers, operators, workers and bystanders which require however to be confirmed for each plant protection products in accordance with the relevant sections of the above-mentioned uniform principles. It has also been 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 6 of this report. 4
4. Identity and biological properties Straight Chain Lepidopteran Pheromones has been considered as a group on the basis of the following considerations: pheromones naturally produced by insects in the order of Lepidoptera; common structural definition which was agreed upon with Guidance on the assessment of new substances falling into the group of Straight Chain Lepidopteran Pheromones included in Annex I of Council Directive 91/414/EEC (SANC/5272/2009: "unbranched aliphatic having a chain of nine to eighteen carbons, containing up to three double bonds, and ending in a alcohol, or aldehyde functional group"); target specificity; mechanism of action : act modifying behaviour of target pests not directly killing; high volatility; low toxicity; low rates of application, comparable to natural background level. The main identity of pheromones evaluated and falling under the definition of the common group Straight Chain Lepidopteran Pheromones are given in Appendix I and III, the latter relating to the new compounds assessed after approval of the representative compounds of the group. The review has established that for the active substance notified by the main data submitter none of the manufacturing impurities considered are, on the basis of information currently, of toxicological or environmental concern. To note that BHT [2,6-di(1,1-dimethylethyl)-4-methylphenol] can be added as stabiliser and being eco-toxicologically relevant it has to be considered as relevant impurity and in the case of blend composed of E7,E/Z9-Dodecadienyl (E7,E/Z9-12Ac) and n-dodecyl (12Ac) - CAS: 1011528-52-1 and CAS: 112-66-3 its presence must be < 5 g/kg. 5. Endpoints and related information In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately the provisions of Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EC) No 546/2011, the most important endpoints were identified during the reevaluation process. These endpoints are listed in the EFSA Conclusions. 6. 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 Straight Chain Lepidopteran Pheromones n the basis of the proposed and supported uses (as listed in Appendix II), no particular issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn. - Member States should pay particular attention as for plant protection products containing SCLPs only when applied via retrievable sized dispensers a safe use was identified. For spray applications of SCLPs no sufficient data package was. Conditions of use shall include, where appropriate, risk mitigation measures. 5
7. List of studies to be generated Further studies were identified which were at this stage considered necessary in relation to the approval of Straight Chain Lepidopteran Pheromones under the current approval conditions. The notifier shall submit confirmatory information as regards: (1) the genotoxic profile of aldehyde group compounds; (2) exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016. n 7 ctober 2016 the Standing Committee on Plants, Animals, Food and Feed took note of the revision 12 of this review report after the assessment of the confirmatory data concerning the genotoxic profile of aldehyde group compounds. This assessment has been carried out in line with the Guidance document on the procedures for submission and assessment of confirmatory data following inclusion of an active substance in Annex to Regulation (EC) No 540/2011 10. Two Ames tests and a chromosome aberration test were submitted to address the genotoxic potential of SCLP aldehydes and were negative. Being these findings in line with data evaluated for other SCLPs compounds it can be concluded that SCLP are of no concern with respect to genotoxicity. EFSA Technical report 11 underlined the need for further testing in compliance with data requirements which would currently imply at least the submission of another in vitro micronucleus test in line with the ECD test guideline (TG) 487. However, considering several experts retain sufficient the text battery submitted and given also the properties of the SCLP and their imminent renewal assessment, the Committee agreed that, on the basis of the outcome, the conclusions of the original risk assessment are not modified by the evaluation of the submitted confirmatory data and consequently, the approval conditions may remain unchanged. n 20 July 2017 the Standing Committee on Plants, Animals, Food and Feed took note of the revision 13 of this review report after the assessment of the confirmatory data concerning the exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones. This assessment has been carried out in line with the Guidance document on the procedures for submission and assessment of confirmatory data following inclusion of an active substance in Annex to Regulation (EC) No 540/2011 12. The Committee agreed that, on the basis of the outcome and considering also the ongoing renewal assessment of the SCLP the conclusions of the original risk assessment are not modified 10 11 12 Doc. SANC/5634/2009 rev. 6.1, dated December 2013. EFSA 2016. Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) in light of confirmatory data. EFSA supporting publication 2016:EN-1031. 17 pp. Doc. SANC/5634/2009 rev. 6.1, dated December 2013. 6
by the evaluation of the submitted confirmatory data and consequently, the approval conditions remain unchanged. ther endpoints 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. The complete list of studies to be generated, still ongoing or but not peer reviewed can be found in the relevant part of the EFSA Conclusion. 8. Information on studies with claimed data protection For information of any interested parties, the rapporteur Member State will keep a document which gives information about the studies for which the main data submitter has claimed data protection and which during the re-evaluation process were considered as essential with a view to annex I inclusion. This information is only given to facilitate the operation of the provisions of Article 13 of Directive 91/414/EEC and Articles 59 to 62 of Regulation (EC) No 1107/2009 in the Member States. It is based on the best information but it does not prejudice any rights or obligations of Member States or operators with regard to its uses in the implementation of the provisions of Article 13 of the Directive 91/414/EEC and Articles 59 to 62 of Regulation (EC) No 1107/2009 and neither does it commit the Commission. 9. Updating of this review report The information in this report may require to be updated from time to time in order 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 21 or 56 of Regulation (EC) No 1107/2009. Any such adaptation will be finalised in the Standing Committee on Plants, Animals, Food and Feed, in connection with any amendment of the inclusion conditions for Straight Chain Lepidopteran Pheromones in Annex of the Regulation (EC) No 540/2011. Taking into account the considerations expressed under Chapter 4, in order to allow for a simplified assessment procedure, it was considered appropriate to approve the Straight Chain Lepidopteran Pheromones as a group and to allow a simplified assessment of new compounds belonging to the group in accordance with the specific Guidance (SANC/5272/2009). Hence, on the basis of an evaluation report to be added to the original DAR (as addendum) finalised by the concerned Member State for each new individual compound demonstrating its belonging to the Straight Chain Lepidopteran Pheromones group, the Standing Committee on Plants, Animals, Food and Feed shall take note of any new update of the list of single individual compound belonging to the SCLP group which is included in Appendix III to this review report. 7
APPENDIX I Identity STRAIGHT CHAIN LEPIDPTERAN PHERMNES SCLP Acetate IUPAC Name CA Name CIPAC No CAS No EEC No Content % E-5-decen-1-yl E-8-dodecenyl E/Z-8-dodecenyl Z-8-dodecenyl Z-9-dodecenyl E,Z-7,9- dodecadien-1-yl E-11-tetradecenyl Z-9-tetradecenyl Z-11-tetradecenyl Z,E-9,12- tetradecadien-1-yl (E)-5-decen-1-yl (E)-8-dodecen-1-yl (E/Z)-8-dodecen-1-yl as individual isomers (E)-8-dodecen-1-yl (Z)-8-dodecen-1-yl (Z)-8-dodecen-1-yl (Z)-9-dodecen-1-yl (E,Z)-7,9-dodecadien-1- yl (E)-11-tetradecen-1-yl (Z)-9-tetradecen-1-yl (Z)-11-tetradecen-1-yl (Z, E)-9, 12- tetradecadien-1-yl (E)-5-decen-1-ol (E)-8-dodecen-1-ol (E/Z)-8-dodecen-1-ol as individual isomers (E)-8-dodecen-1-ol (Z)-8-dodecen-1-ol (Z)-8-dodecen-1-ol (Z)-9-dodecen-1-ol (E,Z)-7,9-dodecadien-1- ol (E)-11-tetradecen-1-ol (Z)-9-tetradecen-1-ol (Z)-11-tetradecen-1-ol (Z, E)-9, 12- tetradecadien-1-ol 38421-90-8 253-923-8 38363-29-0 253-904-4 - as individual isomers 38363-29-0 28079-04-1 - as individual isomers 253-904-4 248-823-6 28079-04-1 248-823-6 422 16974-11-1 241-054-7 54364-62-4 259-127-7 33189-72-9 251-401-4 16725-53-4 240-780-1 20711-10-8 243-982-8 31654-77-0 250-753-6 56% (E isomer) 57% (E isomer) 80% (isomeric mixture) 80% 80% Min. 87% (BASF) 67% 80% 80% 80% 90% Z-11-hexadecen- 1-yl Z,E-7,11- hexadecadien-1-yl E,Z-2, 13- octadecadien-1-yl Z-11-hexadecen-1-yl (Z, E)-7, 11- hexadecadien-1-yl (E, Z)-2, 13- octadecadien-1-yl Z-11-hexadecen-1-ol (Z, E)-7, 11- hexadecadien-1-ol (E, Z)-2, 13- octadecadien-1-ol 34010-21-4 251-791-6-51606-94-4 - 86252-65-5-80% 77% 74% SCLP Alcohol IUPAC Name CA Name CIPAC No CAS No EEC No Content % E-5-decen-1-ol Z-8-dodecenol E,E-8,10- dodecadien-1-ol 1-tetradecanol (E)-5-decen-1-ol (Z)-8-dodecen-1-ol (E,E)-8,10-dodecadien-1- ol tetradecan-1-ol (E)-5-decenol (Z)-8-dodecenol (E,E)-8,10- dodecadienol 1-tetradecanol 56578-18-8 260-267-6 40642-40-8 255-019-9 33956-49-9 251-761-2 112-72-1 204-000-3 56% (E isomer) 79% 75% 79% 8
SCLP Acetate IUPAC Name CA Name CIPAC No CAS No EEC No Content % Z-11-hexadecen-1- ol (Z)-11-hexadecen-1-ol Z-11-hexadecen-1-ol 56683-54-6 260-337-6 SCLP Aldehyde IUPAC Name CA Name CIPAC No CAS No EEC No Content % Z-7-tetradecenal (Z)-7-tetradecenal Z-7-tetradecenal 65128-96-3 265-494-9 Z-9-hexadecenal (Z)-9-hexadecenal (Z)-9-hexadecenal 8172 56219-04-6 260-064-2 Z-11-hexadecenal (Z)-11-hexadecenal (Z)-11-hexadecenal 8173 53939-28-9 258-876-7 Z-13-octadecenal (Z)-13-octadecenal (Z)-13-octadecenal 8235 58594-45-9 261-349-4 78% 76% 75% 77% 77% SCLP Blends s i) Z-8-dodecenyl, ii) Dodecan- 1-yl i) Z-9-dodecenyl, ii) Dodecan- 1-yl (E,E/Z) -7,9- dodecadienyl IUPAC Name CA Name CIPAC No CAS No EEC No Content % i) (Z)-8-dodecen-1-yl ii) Dodecyl i) (Z)-9-dodecen-1-yl ii) Dodecyl (E,E/Z) -7,9-dodecadien-1- yl i) (Z)-8-dodecen-1-ol ii) Dodecyl i) (Z)-9-dodecen-1-ol ii) Dodecyl 7,9 Dodecadien-1-ol, 1, (7E) - 422 28079-04-1 112-66-3 16974-11-1 112-66-3 1011528-52-1 248-823-6 203-995-1 241-054-7 203-995-1 95% (mixture of i & ii) 95% (mixture of i & ii) i) E,Z-7,9- dodecadienyl, ii) E,E-7,9- dodecadienyl i) Z,Z-7,11- hexadecadien-1-yl ii) Z,E-7,11- hexadecadien-1-yl i) (E,Z)-7,9-dodecadien-1- yl, ii) (E,E)-7,9-dodecadien-1- yl i) (Z,Z)-7,11- hexadecadien-1-yl ii) (Z,E)-7,11- hexadecadien-1-yl i) (E,Z)-7,9- dodecadien-1-ol, ii) (E,E)-7,9- dodecadien-1-ol i) (Z,Z)-7,11- hexadecadien-1-ol ii) (Z,E)-7,11- hexadecadien-1-ol 864 863 54364-62-4 54364-63-5 i) & ii) 53042-79-8 i) 52207-99-5 ii) 51606-94- 4 259-127-7 93% (mixture of i) and ii)) 257-737-8 90%: (isomeric mixture) single isomers within the two part blend: i) 47% ii) 42% SCLP Blend Aldehydes i) Z-9-hexadecenal ii) Z-11- hexadecenal iii) Z-13- octadecenal SCLP Blend Mixtures i)e- 5-decen-1-yl ii) E-5-decen-1-ol i) E/Z-8-dodecenyl ii) Z-8-dodecen-1-ol IUPAC Name CA Name CIPAC No CAS No EEC No Content % i) (Z)-9-hexadecenal ii) (Z)-11-hexadecenal iii) (Z)-13-octadecenal i) (Z)-9-hexadecenal ii) (Z)-11- hexadecenal iii) (Z)-13- octadecenal 9 8172 8173 8235 56219-04-6 53939-28-9 58594-45-9 260-064-2 258-876-7 261-349-4 94% (mixture) i) 7% ii) 77% iii) 7% IUPAC Name CA Name CIPAC No CAS No EEC No Content % i) (E)-5-decen-1-yl ii) (E)-5-decen-1-ol i) (E/Z)-8-dodecen-1-yl i) (E)-8-dodecen-1-yl i) (E)-5-decen-1-ol ii) (E)-5-decen-1-ol i) (E/Z)-8-dodecen-1- ol i) (E)-8-dodecen-1-ol i) 8131 (Z) 8132 38421-90-8 56578-18-8 as individual isomers 253-923-8 260-267-6 - as individual 90% (mixture) 94% (mixture) i) 84% Z isomer
SCLP Blends s i) Z-11-hexadecenal ii) Z-11-hexadecen- 1-yl IUPAC Name CA Name CIPAC No CAS No EEC No Content % i) (Z)-8-dodecen-1-yl ii) (Z)-8-dodecen-1-ol i) (Z)-11-hexadecenal ii) (Z)-11-hexadecen-1-yl i) (Z)-8-dodecen-1-ol ii) (Z)-8-dodecen-1- ol i) (Z)-11-hexadecenal ii) (Z)-11-hexadecen- 1-ol ii) 8129 (E) 38363-29-0 (Z) 28079-04- 1 ii) 40642-40- 8 53939-28-9 34010-21-4 isomers (E) 253-904-4 (Z) 248-823-6 ii) 255-019-9 258-876-7 251-791-6 i) 7% E isomer ii) 2% 86% (mixture) i) 43% ii) 43% SCLP Acetate Formulae and Mass SCLP Acetate Formula Structural Formula Molecula r Mass [g/mol] E-5-decen-1-yl C 12 H 22 2 198.30 5 E-8-dodecenyl C 14 H 26 2 226.35 9 E/Z-8-dodecenyl E-8-dodecenyl - C 14 H 26 2 - as individual isomers 226.35 9 Z-8-dodecenyl Z-8-dodecenyl C 14 H 26 2 C 14 H 26 2 226.35 9 Z-9-dodecenyl C 14 H 26 2 226.35 9 E,Z-7,9- dodecadien-1-yl C 14 H 24 2 224.34 4 E-11-tetradecenyl C 16 H 30 2 254.41 3 Z-9-tetradecenyl C 16 H 30 2 254.41 3 Z-11-tetradecenyl C 16 H 30 2 254.41 3 10
SCLP Acetate Formula Structural Formula Molecula r Mass [g/mol] Z,E-9,12- tetradecadien-1- yl Z-11-hexadecen- 1-yl Z,E-7,11- hexadecadien-1- yl E,Z-2,13- octadecadien-1-yl C 16 H 28 2 C 18 H 34 2 C 18 H 32 2 C 20 H 36 2 SCLP Alcohol Formulae and Mass SCLP Alcohol Formula Structural Formula 252.39 7 282.46 7 280.45 1 308.50 5 Mass [g/mol] E-5-decen-1-ol C 10 H 20 H 156.269 Z-8-dodecenol C 12 H 22 H 184.32 E,E-8,10- dodecadien-1- C 12 H 22 H 182.306 ol 1-tetradecanol C 14 H 30 H 214.392 Z-11- hexadecen-1- C 16 H 32 H 240.430 ol SCLP Aldehyde Formulae and Mass SCLP Aldehyde Formula Structural Formula Mass [g/mol] Z-7-tetradecenal C 14 H 26 210.360 Z-9-hexadecenal C 16 H 30 210.360 Z-11- hexadecenal C 16 H 30 238.414 Z-13-octadecenal C 18 H 34 266.468 SCLP Blend Formula Structural Formula Mass [g/mol] Acetate Blends Z-8-dodecenyl C 14 H 26 2 226.359 Dodecan-1-yl C 14 H 28 2 Ac 228.375 11
SCLP Blend Formula Structural Formula Mass [g/mol] Z-9-dodecenyl C 14 H 26 2 226.359 Dodecan-1-yl C 14 H 28 2 Ac 228.375 E,Z-7,9- dodecadienyl C 12 H 22 224.344 E,E-7,9- dodecadienyl C 12 H 22 224.344 Z,Z-7,11- hexadecadien-1-yl C 18 H 32 2 280.451 Z,E-7,11- hexadecadien-1-yl C 18 H 32 2 280.451 Aldehyde Blends Z-9-hexadecenal C 16 H 30 238.41 Z-11-hexadecenal C 16 H 30 238.41 Z-13-octadecenal C 18 H 34 266.468 Blend Mixtures E-5-decen-1-yl C 12 H 22 2 198.305 C 10 H 20 H 156.269 E-5-decen-1-ol E/Z-8-dodecenyl C 14 H 26 2 - E/Z as individual isomers 226.359 Z-8-dodecen-1-ol C 12 H 22 H 184.32 12
SCLP Blend Formula Structural Formula Mass [g/mol] Z-11-hexadecenal Z-11-hexadecen- 1-yl C 16 H 30 C 18 H 34 2 238.414 282.467 13
Crop and/or situation (a) Member State or Country Product name F G or I (b) Pests or Group of pests controlled (c) APPENDIX II List of uses supported by data STRAIGHT CHAIN LEPIDPTERAN PHERMNES Formulation Application Application rate per treatment Type (d-f) Conc. of as (i) method kind (f-h) 14 growth stage & season (j) numbe r Pome Fruit Southern F Biting insects VP 240 Manual Prior to (Apple, pear, quince); Stone Fruit (Peach,nectarine, apricot, plum); Tree nuts (Walnut) Europe (Italy) Shin-Etsu (CBC Europe) ISMATE CLR Cydia pomonella, Adoxophyes orana, Pandemis heparana mg (total of 5 as) / dispens er distribution of 1000 dispensers per ha; uniform distribution throughout orchards moth emergence of 1st pest generation or prior to first moth emergence of any other generation Remarks: (a) For crops, the EU and Codex classifications (both) should be used; (i) g/kg or g/l min max (k) interval between applications (min) kg as/hl min max water l/ha min max kg as/ha min max 1 n.a. n. a. n. a. 240 g/ha (1000 dispenser x 240 mg) PHI (days) (l) n.a n. a. where relevant, the use situation should be described (j) Growth stage at last treatment (BBCH Monograph, Growth Stages (e.g. fumigation of a structure) of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including (b) utdoor or field use (F), glasshouse application (G) or indoor application (I) where relevant, information on season at time of application (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (k) The minimum and maximum number of application possible (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) under practical conditions of use must be provided (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (l) PHI - minimum pre-harvest interval (f) All abbreviations used must be explained (m) Remarks may include: Extent of use/economic importance/restrictions (g) (h) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated Remarks: (m)
APPENDIX III New substances evaluated by Member States belonging to the SCLP group New compound Common Identification Numbers Dodecan-1-ol CAS: 112-53-8 Name, IUPAC Name Purity Evaluating MS Date of evaluation report Dodecan-1-ol 998 g/kg AT February 2011 (E/Z)- 9-Dodecen-1- yl- CAS: 16974-34-8 E8, E10 - Dodecadien-1-ol + Tetradecyl Acetate CAS: 33956-49-9 CAS: 638-59-5 (E/Z)-9-Dodecenyl mixt. of (E,E)-8,10- dodecadien-1-ol and n-tetradecyl 980 g/kg AT May 2012 925 g/kg AT September 2012 15
New compound Common Identification Numbers Name, E7,E/Z9-Dodecadienyl (E7,E/Z9-12Ac) and n- Dodecyl (12Ac) CAS: 1011528-52-1 CAS: 112-66-3 IUPAC Name mixt. of E7,E/Z9- dodecadienyl and n-dodecyl Purity 600 g/kg + 310 g/kg < 5 g/kg of the additive BHT [2,6-di(1,1- dimethylethyl)-4- methylphenol] Evaluating MS Date of evaluation report AT July 2014 (E,Z,Z)-3,8,11-Tetradecatrien-1- yl and (E,Z)-3,8- Tetradecadien-1-yl CAS: not applicable CAS: not applicable n-tetradecyl CAS: not applicable Mixture of 750,3 g/kg + 86,6 IT June 2012, amended (3E,8Z,11Z)- tetradeca-3,8,11- trien-1-yl and (3E,8Z)-tetradeca- 3,8-dien-1-yl g/kg February 2014 n-tetradecyl 980 g/kg BE September 2015 (Z,E)-9,11-tetradecadien-1-yl CAS: 50767-79-8 (Z,E)-9,11-tetradecadien- 1-yl- 945 g/kg IT November 2015 16
New compound Common Identification Numbers Name, E,Z-3,13-ctadecadienyl Acetate CAS: 53120-26-6 IUPAC Name (3E,13Z)-ctadeca- 3,13-dienyl Purity 560 g/kg < 5 g/kg of the additive BHT [2,6-di(1,1- dimethylethyl)-4- methylphenol] Evaluating MS Date of evaluation report AT November 2015 Z,Z-3,13-ctadecadienyl Acetate CAS: 53120-27-7 (3Z,13Z)-ctadeca- 3,13-dienyl 870 g/kg < 5 g/kg of the additive BHT [2,6-di(1,1- dimethylethyl)-4- methylphenol] AT November 2015 n-hexadecanyl CAS: 629-70-9 n-hexadecyl 900g/kg FR March 2017 17