TECHNICAL REPORT APPROVED: 03/05/2017 doi:10.2903/sp.efsa.2017.en-1223 Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for L-ascorbic acid in light of confirmatory data Abstract European Food Safety Authority (EFSA) The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval 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 L-ascorbic acid are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State the Netherlands and presents EFSA s scientific views and conclusions on the individual comments received. European Food Safety Authority, 2017 Keywords: L-ascorbic acid, peer review, confirmatory data, risk assessment, pesticide, fungicide, bactericide Requestor: European Commission Question number: EFSA-Q-2017-00268 Correspondence: pesticides.peerreview@efsa.europa.eu www.efsa.europa.eu/publications EFSA Supporting publication 2017:EN-1223
Suggested citation: EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for L-ascorbic acid in light of confirmatory data. EFSA supporting publication 2017:EN-1223. 16 pp. doi:10.2903/sp.efsa.2017.en-1223 ISSN: 2397-8325 European Food Safety Authority, 2017 Reproduction is authorised provided the source is acknowledged. www.efsa.europa.eu/publications 2 EFSA Supporting publication 2017:EN-1223
Summary L-ascorbic acid has been approved in accordance with Regulation (EC) No 1107/2009 by Commission Implementing Regulation (EU) No 149/2014, amending the Annex to 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 by 30 June 2016 further studies on (1) the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms; (2) the risk to contaminate groundwater. In accordance with the specific provision, the applicant, C-United, submitted an updated dossier in June 2016, which was evaluated by the designated rapporteur Member State (RMS), the Netherlands, 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 19 December 2016. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 5 April 2017. 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 RMS, the Netherlands, and presents EFSA s scientific views and conclusions on the individual comments received. Commenters agreed with the RMS assessment which confirmed the potential for the representative uses assessed to result in groundwater exposure to L-ascorbic acid above the parametric drinking water limit of 0.1 µg/l in the vulnerable situations represented by the FOCUS groundwater scenarios. It is this potential for groundwater exposure that is the relevant decision making criterion in the uniform principles that is relevant for both product authorisation and approval decisions following the regulatory framework. A consumer risk assessment from the consumption of groundwater that might contain ascorbic acid is not within the scope of the regulatory framework. No suitable information was submitted to perform a risk assessment for aquatic organisms and therefore the risk assessment remains open. As the representative uses of L-ascorbic acid will result in concentrations in soil less than the natural background levels a low risk to soil organisms was concluded. www.efsa.europa.eu/publications 3 EFSA Supporting publication 2017:EN-1223
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 for the active substance L-ascorbic acid in light of confirmatory data and the conclusions drawn by EFSA on the specific points raised... 8 www.efsa.europa.eu/publications 4 EFSA Supporting publication 2017:EN-1223
1. Introduction 1.1. Background and Terms of Reference as provided by the requestor L-ascorbic acid has been approved under Regulation (EC) No 1107/2009 1 by Commission Implementing Regulation (EU) No 149/2014 2, amending the Annex to in accordance with Commission Implementing Regulation (EU) No 540/2011 3, as amended by Commission Implementing Regulation (EU) No 541/2011 4. EFSA previously finalised a Conclusion on this active substance on 16 April 2013 (EFSA, 2013). It was a specific provision of the approval that the applicant was required to submit by 30 June 2016 to the European Commission further studies regarding:. (1) the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms; (2) the risk to contaminate groundwater. In accordance with the specific provision, the applicant, C-United, submitted an updated dossier in June 2016, which was evaluated by the designated rapporteur Member State (RMS), the Netherlands, in the form of an addendum to the draft assessment report (Netherlands, 2016). 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 19 December 2016. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 5 April 2017. 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 RMS, the Netherlands, 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 risk assessment of confirmatory data for L-ascorbic acid are presented. To this end, a technical report containing the finalised reporting table is being prepared by EFSA. The deadline for providing the finalised report is 4 May 2017. On the basis of the reporting table, the European Commission may decide to further consult EFSA to conduct a full or focused peer review and to provide its conclusions on certain specific points. 1 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. 2 Commission Implementing Regulation (EU) No 149/2014 of 17 February 2014 approving the active substance L-ascorbic acid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011. OJ L 46, 18.2.2014, p. 3 7 3 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. 4 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 EFSA Supporting publication 2017:EN-1223
2. Assessment The comments received on the pesticide risk assessment for the active substance L-ascorbic acid 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 Appendix A of this report. Documentation provided to EFSA 1. Netherlands, 2016. Addendum to the assessment report on L-ascorbic acid, confirmatory data, December 2016, updated in April 2017. Available online: www.efsa.europa.eu. 2. Netherlands, 2017. Reporting table, comments on the pesticide risk assessment for L-ascorbic acid in light of confirmatory data, April 2017. References EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance L-ascorbic acid. EFSA Journal 2013;11(4):3197, 54 pp. doi:10.2903/j.efsa.2013.3197. 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 Netherlands, 2013. Final Addendum to Draft Assessment Report on L-ascorbic acid, compiled by EFSA, February 2013. www.efsa.europa.eu/publications 6 EFSA Supporting publication 2017:EN-1223
Abbreviations a.s. active substance DAR draft assessment report DT 50 K OC PEC QSAR REACH RMS period required for 50% dissipation Organic Carbon-Water Partitioning Coefficient predicted environmental concentration Quantitative structure activity relationship Registration, Evaluation, Authorisation and Restriction of Chemicals rapporteur Member State www.efsa.europa.eu/publications 7 EFSA Supporting publication 2017:EN-1223
Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment for the active substance L-ascorbic acid in light of confirmatory data and the conclusions drawn by EFSA on the specific points raised Environmental fate and behaviour Route and rate of degradation in soil No. Column 1 Reference to addendum to assessment report 4(1) Vol 3 Add. on Conf data, B.8.1, Fate and Behaviour in Soil 4(2) Vol 3 Add. on Conf data, B.8.1, Fate and Behaviour in Soil Column 2 Comments from Member States / applicant / EFSA Applicant: On page 7 it is mentioned that underlying reports were not submitted to RMS. Reports are available at the applicant and can be submitted at request. Reference is made to a list of over 30 publications from the public domain. Only most relevant ones are provided, such as Moser & Bendich in Volume 1 of the Appendices of the dossier (# 1.5). All underlying reports have not been submitted by mistake. Applicant: On page 11 it is mentioned that the Tu and Uren study reports were not submitted to RMS. Reports are available at the applicant and can be submitted at request. The reports have not been submitted by mistake. They are documents published in the public domain. Column 3 Evaluation by rapporteur Member State The studies have been submitted to the RMS after the receipt of the comments. They have not been thoroughly evaluated since the time for confirmatory data submission has expired in June 2016. The literature have been briefly reviewed, this does not lead to new insights. A note has been added to the Addendum. Applicant is requested to provide the full data package to EFSA and member states for completeness. The studies have been submitted to the RMS after the receipt of the comments. The Tu and Uren studies have not been thoroughly evaluated since the time for confirmatory data submission has expired in June 2016. They have been briefly reviewed to Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data It remains that the underlying reports were not provided in the confirmatory data submission that had a deadline of June 2016. It remains that the underlying reports were not provided in the confirmatory data submission that had a deadline of June 2016. www.efsa.europa.eu/publications 8 EFSA Supporting publication 2017:EN-1223
see whether this would solve some of the deficiencies/comments raised by RMS in the addendum, this does not lead to new insights. A note has been added to the Addendum. Applicant is requested to provide the full data package to EFSA and member states for completeness. 4(3) Vol 3 Add. on Conf data, B.8.1, Fate and Behaviour in Soil Applicant: On page 12 it is mentioned that underlying reports were not submitted to RMS. Reports are available at or can be obtained by the applicant and can be submitted at request. Underlying reports have not been submitted by mistake. They are documents published in the public domain. The studies have been submitted to the RMS after the receipt of the comments. They have not been thoroughly evaluated since the time for confirmatory data submission has expired in June 2016. As in this case all mentioned literature studies did not provide information on degradation in soil but rather in other matrices like food RMS did not evaluate the studies. A note has been added to the Addendum. It remains that the underlying reports were not provided in the confirmatory data submission that had a deadline of June 2016. Applicant is requested to provide the full data package to EFSA and member states for completeness. 4(4) Vol 3 Add. on Conf data, B.8.1, Fate and Behaviour in Soil Applicant: On page 27 it is mentioned that the study by Eisner (2010) was not submitted to RMS. This study is available at the applicant and can be submitted at request. The report has not been submitted by mistake. It is a document published in the The study of Eisner has been submitted to the RMS after the receipt of the comments. This does not lead to new insights. A note has been added to the It remains that the underlying reports were not provided in the confirmatory data submission that had a deadline of June 2016. www.efsa.europa.eu/publications 9 EFSA Supporting publication 2017:EN-1223
public domain. Addendum. Applicant is requested to provide the full data package to EFSA and member states for completeness. 4(5) Normalisation of DT50 values AT: We agree with procedure of normalisation of DT50 values. Noted and acknowledged. The FOCUS reference condition soil DT50 of 14.1 days can be used in FOCUS modelling for a readily biodegradable active substance, when using REACH guidance for readily biodegradable compounds. Adsorption, desorption and mobility in soil No. Column 1 Reference to addendum to assessment report 4(6) Geometric mean values of Koc values Column 2 Comments from Member States / applicant / EFSA AT: We agree that geometric mean values as presented by the applicant cannot be accepted due to the different character of the sources of the values. Column 3 Evaluation by rapporteur Member State Noted and acknowledged. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data It is inappropriate to use a geometric mean of QSAR values in a regulatory exposure assessment. Should a QSAR ever be accepted to be used, the QSAR approach that best fulfils the applicability domain of the substance has to be selected, not a geomean value of different QSAR approaches. Fate and behaviour in water and sediment and effect of water treatment procedures on the nature of residues No. Column 1 Reference to addendum to assessment report 4(7) Vol 3 Add. on Conf data, B.8.2, Fate and Column 2 Comments from Member States / applicant / EFSA Applicant: On page 28 it is mentioned that underlying reports were not Column 3 Evaluation by rapporteur Member State The studies (particularly the Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data It remains that the underlying reports were not provided in the confirmatory www.efsa.europa.eu/publications 10 EFSA Supporting publication 2017:EN-1223
Behaviour in Water and sediment (PECgw) submitted to RMS. Reports are available at the applicant and can be submitted at request. Underlying reports have not been submitted by mistake. The study report with the references to public domain publications was made by a third party Laboratory. We were not aware that the references should also be provided. references related to the plant uptake factor) have been submitted to the RMS after the receipt of the comments. They have not been thoroughly evaluated since the time for confirmatory data submission has expired in June 2016. The newly submitted literature has been briefly reviewed, this does not lead to new insights. A note has been added to the Addendum. Applicant is requested to provide the full data package to EFSA and member states for completeness. data submission that had a deadline of June 2016. PEC in surface water and ground water No. Column 1 Reference to addendum to assessment report 4(8) PEC ground water calculations Column 2 Comments from Member States / applicant / EFSA AT: We agree on the PEC values presented by the RMS; the risk of leaching into ground water still cannot be excluded, even on higher tier approaches. Yes, AT agrees also on the opinion of the RMS that ascorbic acid is to be a substance of low risk. Column 3 Evaluation by rapporteur Member State Noted and acknowledged. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data Noted and agreed. However managers should note that a consumer risk assessment is not what the regulatory framework stipulates for approved pesticide active substances, but rather a comparison to a legal parametric limit. EFSA s mandate for this confirmatory data submission relates to the regulatory framework and not the risk from consumption of drinking water containing ascorbic acid. 4(9) Vol. 3, B.8.2, PEC GW DE: We agree with the RMS that Agreed that the representative use www.efsa.europa.eu/publications 11 EFSA Supporting publication 2017:EN-1223
several refinements are not considered appropriate and that a risk for leaching can still not be excluded. Furthermore we are very critical of the normalisation process of DT 50 values derived from results from standardised biodegradation test results according to REACH guidance (TGD 2003). The additional information submitted by the applicant is not considered sufficient to exclude the risk for leaching to groundwater. Therefore, reliable DT 50 values derived from soil degradation studies should be provided by the applicant. Noted and acknowledged. Normalisation to 20 C of the REACH default DT50 value of 30 days is novel but as this value is valid for assessments performed at 12 C it is in our view justified to correct the value to 20 C. This was approved by AT and EFSA (see 4(5) and 4(10)) (and also recently accepted in the peer review of another substance, February 2017) Agree that data on soil degradation would have been helpful to address the confirmatory data with regard to groundwater. This was also pointed out in the Kolnaar 2015 study (Annex II, 7.1.1.1, Study 2). However, as far as RMS is aware there is no period for additional data submission at this stage of the peer review for confirmatory data. assessed results in indications of a potential exposure to vulnerable groundwater by ascorbic acid above the parametric drinking water limit. Soil incubations and batch adsorption measurement should they ever be provided would allow further groundwater modelling to be completed that might be less conservative than the available modelling. However without these data it is unclear if enough of an improvement in the exposure characterisation might be achieved if better input data was available for regulatory simulations. Other comments incl. available monitoring data No. Column 1 Reference to addendum to assessment report 4(10) Vol. 3 (AS) B.8 addendum on confirmatory data Column 2 Comments from Member States / applicant / EFSA EFSA: We agree with the RMS assessment of the submitted information. We also agree with the Column 3 Evaluation by rapporteur Member State Noted and acknowledged. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data The comment was agreeing the RMS assessment. The addendum was updated to acknowledge that Koc www.efsa.europa.eu/publications 12 EFSA Supporting publication 2017:EN-1223
RMS conclusion that the issues that the confirmatory data was designed to give the applicant the opportunity to address remains open. We agree that as L-ascorbic acid has been shown to be readily biodegradable, the first order DT50 in soil to be used in FOCUS simulation modelling can be 14.1 days (30 day value from REACH guidance used as input in EUSES fugacity modelling approaches where the REACH reference temperature is 12 C, so it can be justified to normalise 30 days at 12 C to 14.1 days at 20 C using a Q10 of 2.58). We agree it unjustified to take a geomean Koc from different QSAR values, (though make the observation of no consequence to the RMS conclusion, that a range of measured Koc values would be expected to fit a log normal distribution, rather than a normal distribution). We agree it unjustified with the available information to use a TSCF of 1 as input in FOCUS modelling Log normal distribution is added to the addendum instead of normal distribution values investigated in a range of soils would typically be expected to follow a Log normal distribution. www.efsa.europa.eu/publications 13 EFSA Supporting publication 2017:EN-1223
Ecotoxicology Aquatic organisms No. Column 1 Reference to addendum to assessment report Column 2 Comments from Member States / applicant / EFSA Column 3 Evaluation by rapporteur Member State Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data 5(1) Confirmatory data addendum, B.9, Ecotoxicology EFSA: No suitable data were submitted in order to perform a quantified risk assessment for aquatic organisms. The RMS referred to an argument regarding the natural background levels that was already presented in the addendum to the DAR (Netherlands, 2013). However, the argument regarding background levels was not previously accepted. No additional information was provided to support the proposed natural background level in surface water. Consequently, the risk assessment for aquatic organisms remains open. Noted and acknowledged. The risk assessment for aquatic organisms remains open. Earthworms and other non-target soil macro- and mesofauna No. Column 1 Reference to addendum to assessment report 5(2) Confirmatory data addendum, B.9, Ecotoxicology Column 2 Comments from Member States / applicant / EFSA EFSA: No suitable toxicity data were submitted in order to perform a quantified risk assessment for soil organisms. The RMS referred to an Column 3 Evaluation by rapporteur Member State Noted and acknowledged. Please note that PECsoil for potaties according to the EFSA conclusion is 0.057 mg Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data The risk to soil organisms is low. The representative uses of ascorbic acid as a PPP will not result in exposure to soil organisms greater www.efsa.europa.eu/publications 14 EFSA Supporting publication 2017:EN-1223
argument regarding the natural background levels that was already presented in the addendum to the DAR (Netherlands, 2013). However, the argument regarding background levels was not previously accepted for the reasons discussed in the response to data requirement 4.1 in column E of the Evaluation Table. Nevertheless, the RMS has agreed to the new information available on natural background levels in soil provided in the B.8 of the confirmatory data (0.1333 mg/kg). This value is greater than the soil PECs predicted for the representative uses of ascorbic acid (0.059, 0.027, 0.027 mg a.s./kg soil for tomatoes, potatoes and flower bulbs, see LoEP in the EFSA Conclusion, EFSA Journal 2013;11(4):319). It is therefore concluded that the use of ascorbic acid as a PPP will not result in exposure to soil organisms greater than the natural background levels and as such a low risk can be concluded. a.s./kg instead of 0.027. than the natural background levels and as such a low risk can be concluded. Soil nitrogen transformation No. Column 1 Reference to addendum to assessment report Column 2 Comments from Member States / applicant / EFSA Column 3 Evaluation by rapporteur Member State Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data 5(3) Confirmatory data EFSA: No suitable toxicity data were The risk to soil organisms is low. www.efsa.europa.eu/publications 15 EFSA Supporting publication 2017:EN-1223
addendum, B.9, Ecotoxicology submitted in order to perform a quantified risk assessment for soil organisms. The RMS referred to an argument regarding the natural background levels that was already presented in the addendum to the DAR (Netherlands, 2013). However, the argument regarding background levels was not previously accepted for the reasons discussed in the response to data requirement 4.1 in column E of the Evaluation Table. Nevertheless, the RMS has agreed to the new information available on natural background levels in soil provided in the B.8 of the confirmatory data (0.1333 mg/kg). This value is greater than the soil PECs predicted for the representative uses of ascorbic acid (0.059, 0.027, 0.027 mg a.s./kg soil for tomatoes, potatoes and flower bulbs, see LoEP in the EFSA Conclusion, EFSA Journal 2013;11(4):319). It is therefore concluded that the use of ascorbic acid as a PPP will not result in exposure to soil organisms greater than the natural background levels and as such a low risk can be concluded. Noted and acknowledged. Please note that PECsoil for potatoes according to the EFSA conclusion is 0.057 mg a.s./kg instead of 0.027. The representative uses of ascorbic acid as a PPP will not result in exposure to soil organisms greater than the natural background levels and as such a low risk can be concluded www.efsa.europa.eu/publications 16 EFSA Supporting publication 2017:EN-1223