APPROVED: 17 March 2015 PUBLISHED: 27 March PDF Free Download

TECHNICAL REPORT APPROVED: 17 March 2015 PUBLISHED: 27 March 2015 Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for tall oil crude in light of confirmatory data Abstract European Food Safety Authority The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment of confirmatory data following approval of an active substance in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for tall oil crude are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Greece and presents EFSA s scientific views and conclusions on the individual comments received. European Food Safety Authority, 2015 Key words: tall oil crude, peer review, confirmatory data, risk assessment, pesticide, repellent Requestor: European Commission Question number: EFSA-Q-2015-00105 Correspondence: pesticides.peerreview@efsa.europa.eu www.efsa.europa.eu/publications EFSA Supporting publication 2015:EN-781

Outcome of the consultation on confirmatory data used in risk assessment for tall oil crude Suggested citation: European Food Safety Authority, 2015. Outcome of the consultation with Member States, applicant and EFSA on the pesticide risk assessment of confirmatory data for tall oil crude. EFSA supporting publication 2015:EN-781. 14 pp. European Food Safety Authority, 2015 Reproduction is authorised provided the source is acknowledged. www.efsa.europa.eu/publications 2 Supporting publication 2015:EN-781

Outcome of the consultation on confirmatory data used in risk assessment for tall oil crude Summary Tall oil crude was included in Annex I to Directive 91/414/EEC on 20 December 2008 by Commission Directive 2008/127/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies on (a) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers by 1 May 2013; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude by 31 May 2014. In accordance with the specific provision, the applicant, NerAgro, submitted an updated dossier in April 2013, which was evaluated by the designated rapporteur Member State (RMS), Greece, in the form of an Addendum to the Draft Assessment Report. In compliance with Guidance Document SANCO 5634/2009 rev.6.1, the RMS distributed the Addendum to Member States, the applicant and EFSA for comments on 18 November 2014. The RMS collated all comments in the format of a Reporting Table, which was submitted to EFSA on 16 February 2015. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the Reporting Table. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Greece and presents EFSA s scientific views and conclusions on the individual comments received. As stated by the RMS in the addendum, no data have been submitted regarding the toxicological profile of tall oil crude and therefore the critical area of concern identified in the EFSA conclusion (EFSA, 2012) remain, that the toxicological database is not suitable either to establish NOAELs, to set reference values or to adequately assess the hazard. As no AOEL could be set, the exposure risk assessment could not be concluded. Furthermore the equivalence between the specification of the technical material, as commercially manufactured and those of the test material used in the toxicity dossier could only be addressed when submitting a toxicological data package. www.efsa.europa.eu/publications 3 Supporting publication 2015:EN-781

Outcome of the consultation on confirmatory data used in risk assessment for tall oil crude Table of contents Abstract... 1 Summary... 3 1. Introduction... 5 1.1. Background and Terms of Reference as provided by the requestor... 5 1.2. Interpretation of the Terms of Reference... 5 2. Assessment... 6 Documentation provided to EFSA... 6 References... 6 Abbreviations... 7 Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment of confirmatory data for the active substance tall oil crude and the conclusions drawn by EFSA on the specific points raised... 8 www.efsa.europa.eu/publications 4 Supporting publication 2015:EN-781

Outcome of the consultation on confirmatory data used in risk assessment for tall oil crude 1. Introduction 1.1. Background and Terms of Reference as provided by the requestor Tall oil crude was included in Annex I to Directive 91/414/EEC 1 on 20 December 2008 by Commission Directive 2008/127/EC 2, and has been deemed to be approved under Regulation (EC) No 1107/2009 3, in accordance with Commission Implementing Regulation (EU) No 540/2011 4, as amended by Commission Implementing Regulation (EU) No 541/2011 5. EFSA previously finalised a Conclusion on this active substance on 16 December 2011 (EFSA, 2012). It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies on (a) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers by 1 May 2013; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude by 31 May 2014. In accordance with the specific provision, the applicant, NerAgro, submitted an updated dossier in April 2013, which was evaluated by the designated rapporteur Member State (RMS), Greece, in the form of an Addendum to the Draft Assessment Report (Greece, 2014). In compliance with Guidance Document SANCO 5634/2009 rev.6.1 (European Commission, 2013), the RMS distributed the Addendum to Member States, the applicant and the EFSA for comments on 18 November 2014. The RMS collated all comments in the format of a Reporting Table, which was submitted to EFSA on 16 February 2015. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the Reporting Table. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Greece and presents EFSA s scientific views and conclusions on the individual comments received. 1.2. Interpretation of the Terms of Reference On 22 December 2014 the European Commission requested EFSA to provide scientific assistance with respect to the risk assessment of confirmatory data following approval of an active substance in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. EFSA s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for tall oil crude are presented. To this end, a Technical Report containing the finalised Reporting Table is prepared by EFSA. The deadline for providing the finalised report is 17 March 2015. On the basis of the Reporting Table, the European Commission may decide to further consult EFSA to conduct a full or focussed peer review and to provide its conclusions on certain specific points. 1 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.08.1991, p.1-32. 2 Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances. OJ L 344, 20.12.2008, p. 89-111. 3 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1-50. 4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p.1-186. 5 Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p.187-188. www.efsa.europa.eu/publications 5 Supporting publication 2015:EN-781

Outcome of the consultation on confirmatory data used in risk assessment for tall oil crude 2. Assessment The comments received on the pesticide risk assessment for the active substance tall oil crude in light of confirmatory data and the conclusions drawn by the EFSA are presented in the format of a reporting table. The comments received are summarised in column 2 of the Reporting Table. The RMS considerations of the comments are provided in column 3, while EFSA s scientific views and conclusions are outlined in column 4 of the table. The finalised Reporting Table is provided in the Appendix of this report. Documentation provided to EFSA 1. Greece, 2014. Addendum to the Assessment Report on tall oil crude, confirmatory data, November 2014. 2. Greece, 2015. Reporting Table, comments on the pesticide risk assessment of confirmatory data for tall oil crude, February 2015. References EFSA (European Food Safety Authority), 2012. Conclusion on the peer review of the pesticide risk assessment of the active substance tall oil crude. EFSA Journal 2012;10(2):2543, 40 pp. doi:10.2903/j.efsa.2011.2543 European Commission, 2013. Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009. SANCO 5634/2009 rev. 6.1 www.efsa.europa.eu/publications 6 Supporting publication 2015:EN-781

Outcome of the consultation on confirmatory data used in risk assessment for tall oil crude Abbreviations C degree Celsius (centigrade) µg microgram a.s. DAR GAP DG SANCO EFSA EU kg L LC 50 LD 50 mg ml mm MRL MS NESTI OSR PBI PEC PEC sed PEC soil PEC sw PRIMo RMS TMDI UK active substance Draft Assessment Report good agricultural practice European Commission Directorate General Health and Consumers European Food Safety Authority European Union kilogram litre lethal concentration, median lethal dose, median; dosis letalis media milligram millilitre millimetre maximum residue limit or level Member State national estimated short-term intake oilseed rape plant back interval predicted environmental concentration predicted environmental concentration in sediment predicted environmental concentration in soil predicted environmental concentration in surface water Pesticide Residue Intake Model rapporteur Member State theoretical maximum daily intake United Kingdom www.efsa.europa.eu/publications 7 Supporting publication 2015:EN-781

Outcome of the consultation on the confirmatory data risk assessment for tall oil crude Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment of confirmatory data for the active substance tall oil crude and the conclusions drawn by EFSA on the specific points raised No. Column 1 Column 2 Column 3 Column 4 Reference to addendum to assessment report Comments from Member States / applicant / EFSA Evaluation by rapporteur Member State EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS assessment of confirmatory data (1) Addendum to Annex C / confirmatory data notifier /applicant According to RMS the evaluation of the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossier is not possible since the toxicity evaluation has been based on the US-EPA data for which no data on the tall oil crude profile is available. The assessment of the equivalence will be possible following the submission of the complete toxicological profile of tall oil crude. It is mentioned by RMS, that the tall oil CAS Number 8002-26-4 (same with tall oil crude) is registered under the REACH Regulation (EU), and a full data package on the physicochemical RMS: The RMS confirms that the Kemina Austria (Kemira Chemie GesmbH), together with Kemina Poland, are the manufacturing plants for Tall Oil Crude of NeraAgro (see Addendum to Annex C of April 2011). The Quality data of Tall Oil Crude from Kemira Steti production site, which are cited in Table 3 B, in the explanation letter of the notifier (dated from 22 December 2014), and which were submitted to support the expert s findings from University of Pardubice (for details on University expert s findings see APPENDIX in the ADDENDUM to Annex C-Post Annex I inclusion CONFIRMATORY DATA of November 2014) have already been submitted during the EU assessment of Crude Tall oil (see Addendum to Annex C of April 2011-point C.1.2.3). Indeed, based on these analytical data, a data gap for rosin content range was identified. As stated in the Review Report Appendix I (SANCO/2631/08 rev. 4 of 1 June 2012): However for rosin acid content the proposed specification Data gap: The applicant should clarify its position concerning the EU accepted specifications for Tall Oil Crude and the limits for acid number, water content, rosin acid content, ash content, ph, unsaponifiables and free mineral acids, which are cited in the Commission Implementing Regulation (EU) No 637/2012, and if these limits for qualitative parameters in the specifications are practically applicable for its Tall Oil Crude. The data submitted on the equivalence between technical material, and the tox batches are considered inappropriate for the evaluation of the equivalence issue. The applicant should clarify if the CAS no www.efsa.europa.eu/publications 8 EFSA Supporting publication 2015:EN-781

Outcome of the consultation on the confirmatory data risk assessment for tall oil crude No. Column 1 Column 2 Column 3 Column 4 Reference to addendum to assessment report Comments from Member States / applicant / EFSA Evaluation by rapporteur Member State EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS assessment of confirmatory data and toxicological properties is available on ECHA websites. NeraAgro comments: RMS may use this existing toxicological data for the assessment of the equivalence; one of the manufacturers of tall oil (CAS No 8002-26-4) registered under the REACH Regulation is the company Kemira Chemie GesmbH, which is the EU approved reference source of tall oil crude, this company is the only one supplier of Tall Oil Crude of NeraAgro,spol. s r.o. and NeraAgro will be able to provide the Letter of Access on Tall Oil Crude for above mentioned toxicological studies, if necessary. Our detailed explanation is in our letter from 22 December 2014 sent to RMS. (min 35%) is not in line with analytical results. Data gap: the range of rosin content (see also the EFSA Conclusion on Tall Oil Crude 2012;10(2):2543). However, RMS should notice that this data gap, relevant to the specification of Tall Oil Crude, was not clearly required as Confirmatory Information in the Commission Implementing Regulation (EU) No 637/2012 for Tall Oil Crude (probably by mistake) Concerning the Quality data of Crude Tall Oil from Kemira Steti production site (Table 3 B), the applicant stated in its explanation letter of 22 December 2014, that This pulpworks used for production mainly pine and a little less spruce wood from surrounding area (Middle and Northern Bohemia). Despite the unchanged local source of wood that time the results showed differences in content of rosin acids mostly. These differences can be significantly higher if wood from global market is used for production as described in study from University of Pardubice. It is necessary to underline that no sample is fully identical. RMS would like to notice that during the EU assessment of Crude Tall Oil, it was already accepted that the composition of the Tall Oil Crude depends on the species of tree from which it was derived (see DAR and the EFSA Conclusion 2012;10(2):2543) and qualitative parameters comprise the specification of Tall Oil Crude (acid number, water content, rosin acid content, ash 8002-26-4 is now referred only to Tall Oil Distilled (DTO) or if the CAS no 8002-26-4 is referred to both Tall Oil Crude and Tall Oil Distilled. Data gap: The data gap for studies to address the toxicological profile of tall oil crude and their representativeness to the specification in particular regarding to genotoxicity potential as identified in the EFSA conclusion has not been addressed. www.efsa.europa.eu/publications 9 EFSA Supporting publication 2015:EN-781

Outcome of the consultation on the confirmatory data risk assessment for tall oil crude No. Column 1 Column 2 Column 3 Column 4 Reference to addendum to assessment report Comments from Member States / applicant / EFSA Evaluation by rapporteur Member State EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS assessment of confirmatory data Distilled. With regard to the toxicological profile of tall oil crude the submission of the studies available for tall oil produced by Kemira Chemie GesmbH may be required in case the issue of the equivalence is resolved. (2) Addendum to Vol. 4, point (a), p.3 EFSA agrees with the RMS that the evaluation of the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossier is not possible since the toxicity evaluation has been based on the US- EPA data for which no data on the tall oil crude profile is available. It should be noted also that during the evaluation the specification of the tall oil crude was considered open as a data gap was identified for the rosin content range based on analytical data. The confirmatory data did not contain any information about the rosin content. RMS: The Quality data of Crude Tall Oil from Kemira Steti production site, which are cited in Table 3 B, in the explanation letter of the notifier (dated from 22 December 2014), and which were submitted to support the expert s findings from University of Pardubice (for details on University expert s findings see APPENDIX in the ADDENDUM to Annex C-Post Annex I inclusion CONFIRMATORY DATA of November 2014) have already been submitted during the EU assessment of Crude Tall oil (see Addendum to Annex C of April 2011-point C.1.2.3). Indeed, based on these analytical data, a data gap for rosin content range was identified. As stated in the Review Report Appendix I (SANCO/2631/08 rev. 4 of 1 June 2012): However for rosin acid content the proposed specification (min 35%) is not in line with analytical results. Data gap: the range of rosin content (see also the EFSA Conclusion on Tall Oil Crude 2012;10(2):2543). However, RMS should notice Data gap: The specification of the tall oil crude was considered open as a data gap was identified for the rosin content range based on analytical data. (see also the EFSA Conclusion on Tall Oil Crude 2012;10(2):2543) The confirmatory data did not contain any information about the rosin content. See also 1 st data gap in comment 1. www.efsa.europa.eu/publications 11 EFSA Supporting publication 2015:EN-781

Outcome of the consultation on the confirmatory data risk assessment for tall oil crude www.efsa.europa.eu/publications 14 EFSA Supporting publication 2015:EN-781