Conclusion on the peer review of the pesticide risk assessment of the active substance acetic acid 1

Transcription

1 EFSA Journal 2013;11(1):3060 CONCLUSION ON PESTICIDE PEER REVIEW Conclusion on the peer review of the pesticide risk assessment of the active substance acetic acid 1 European Food Safety Authority 2 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance acetic acid are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007 and Commission Regulation (EU) No. 114/2010. The conclusions were reached on the basis of the evaluation of the representative uses of acetic acid as a herbicide in pome fruit, stone fruit, paths and roads, ornamental trees and shrubs, turf, and lawns. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. European Food Safety Authority, 2013 KEY WORDS Acetic acid, peer review, risk assessment, pesticide, herbicide 1 On request from the European Commission, Question No EFSA-Q , approved on 18 December Correspondence: pesticides.peerreview@efsa.europa.eu Suggested citation: European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance acetic acid. EFSA Journal 2013;11(1):3060. [57 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2013

2 SUMMARY Acetic acid is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007. Acetic acid was included in Annex I to Directive 91/414/EEC on 1 September 2009 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to as the Regulation ) and has subsequently 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. In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010, the European Food Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report submitted by the European Commission in accordance with Article 25(1) of the Regulation. This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report. Germany being the designated rapporteur Member State submitted the DAR on acetic acid in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 17 September The peer review was initiated on 13 June 2008 by dispatching the DAR to the notifier, the Task Force for Acetic Acid, and on 24 February 2011 to the Member States, for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the areas of mammalian toxicology and environmental fate and behaviour and deliver its conclusions on acetic acid. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of acetic acid as a herbicide in pome fruit, stone fruit, paths and roads, ornamental trees and shrubs, turf, and lawns, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report. In the area of identity, physical/chemical/technical properties and methods of analysis a data gap was identified for a specification with supporting batch analysis and methods of analysis. Data gaps were identified for some physical/chemical properties of the active substance as well as specific methods for the active substance in the technical and the formulated product. Data gaps were also identified for the representative formulations. As a residue definition is set for environmental compartments a data gap has been identified for methods of analysis. In the section mammalian toxicology, no data gap and no critical area of concern were identified. No significant residues of acetic acid are expected to be present in edible crops and a quantitative risk assessment is not necessary. The information on environmental fate and behaviour in the environment is sufficient to carry out the necessary environmental exposure assessments at the EU level, with the exception that information is missing on volatilisation and re-deposition of acetic acid in the short range, that is needed to complete the aquatic exposure assessment for all the representative uses except for the representative use on turf grass, where application is by watering. The potential for groundwater exposure from the representative uses by acetic acid and its salts above the parametric drinking water limit of 0.1 µg/l was concluded to be high in geoclimatic situations that are represented by 5 out of 9 FOCUS groundwater scenarios for the representative use on pome fruits, stone fruits and ornamental shrubs at 4x40.8 kg a.s./ha, 4 out of 9 FOCUS scenarios for the representative use on trees and ornamental shrubs at 2x60 kg a.s./ha and 3 out of 9 FOCUS scenarios for the representative use on turf, lawn at 2x102 kg a.s./ha. Acetic acid has the potential for long-range atmospheric transport. EFSA Journal 2013;11(1):3060 2

3 The acute and long-term risk assessments for birds and the acute risk assessment for mammals could not be finalised. A high long-term risk was identified for mammals for all representative uses. A low risk for aquatic organisms could only be concluded for the representative uses on turf and lawns, for the other representative uses either a high risk was identified or the assessments could not be finalised. The risk to honeybees and non-target arthropods was also assessed as high for all representative uses. The risk to soil-dwelling organisms was assessed as low, however data on carbon mineralisation are outstanding. The risk assessment for non-target plants could not be finalised. The risk to biological methods of sewage treatment was considered to be low for all representative uses, except roads and paths for which a data gap was identified. EFSA Journal 2013;11(1):3060 3

4 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 4 Background... 5 The active substance and the formulated product... 7 Conclusions of the evaluation Identity, physical/chemical/technical properties and methods of analysis Mammalian toxicity Residues Environmental fate and behaviour Ecotoxicology Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments Soil Ground water Surface water and sediment Air List of studies to be generated, still ongoing or available but not peer reviewed Particular conditions proposed to be taken into account to manage the risk(s) identified Concerns Issues that could not be finalised Critical areas of concern Overview of the concerns identified for each representative use considered References Appendices Abbreviations EFSA Journal 2013;11(1):3060 4

5 BACKGROUND Acetic acid is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004, 3 as amended by Commission Regulation (EC) No 1095/ Acetic acid was included in Annex I to Directive 91/414/EEC 5 on 1 September 2009 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to as the Regulation ) and has subsequently been deemed to be approved under Regulation (EC) No 1107/2009, 6 in accordance with Commission Implementing Regulation (EU) No 540/2011, 7 as amended by Commission Implementing Regulation (EU) No 541/ In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/ the European Food Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report submitted by the European Commission in accordance with Article 25(1) of the Regulation (European Commission, 2008). This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report. Germany being the designated rapporteur Member State submitted the DAR on acetic acid in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 17 September 2007 (Germany, 2007). The peer review was initiated on 13 June 2008 by dispatching the DAR to the notifier, the Task Force for Acetic Acid, and on 24 February 2011 to the Member States, for consultation and comments. In addition, the EFSA conducted a public consultation on the DAR. The comments received were collated by the EFSA and forwarded to the RMS for compilation and evaluation in the format of a Reporting Table. The notifier was invited to respond to the comments in column 3 of the Reporting Table. The comments were evaluated by the RMS in column 3 of the Reporting Table. The scope of the peer review was considered in a telephone conference between the EFSA, the RMS, and the European Commission on 20 June On the basis of the comments received and the RMS evaluation thereof it was concluded that the EFSA should organise a consultation with Member State experts in the areas of mammalian toxicology and environmental fate and behaviour. The outcome of the telephone conference, together with EFSA s further consideration of the comments is reflected in the conclusions set out in column 4 of the Reporting Table. All points that were identified as unresolved at the end of the comment evaluation phase and which required further consideration, including those issues to be considered in consultation with Member State experts, and 3 Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further 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. OJ L 379, , p Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and Regulation (EC) No 2229/2004 laying down further 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. OJ L 246, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p. 1-32, as last amended. 6 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, , p 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, , p 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, , p Commission Regulation (EU) No 114/2010 of 9 February 2010 amending Regulation (EC) No 2229/2004 as regards the time period granted to EFSA for the delivery of its view on the draft review reports concerning the active substances for which there are clear indications that they do not have any harmful effects. OJ L 37, , p.12. EFSA Journal 2013;11(1):3060 5

6 additional information to be submitted by the notifier, were compiled by the EFSA in the format of an Evaluation Table. The conclusions arising from the consideration by the EFSA, and as appropriate by the RMS, of the points identified in the Evaluation Table, together with the outcome of the expert discussions where these took place, were reported in the final column of the Evaluation Table. A final consultation on the conclusions arising from the peer review of the risk assessment took place with Member States via a written procedure in November-December This conclusion report summarises the outcome of the peer review of the risk assessment on the active substance and the representative formulation evaluated on the basis of the representative uses as a herbicide in pome fruit, stone fruit, paths and roads, ornamental trees and shrubs, turf, and lawns, as proposed by the notifier. A list of the relevant end points for the active substance as well as the formulation is provided in Appendix A. In addition, a key supporting document to this conclusion is the Peer Review Report, which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review, from the initial commenting phase to the conclusion. The Peer Review Report (EFSA, 2012) comprises the following documents, in which all views expressed during the course of the peer review, including minority views, can be found: the comments received on the DAR, the Reporting Table (16 June 2011), the Evaluation Table (17 December 2012), the reports of the scientific consultation with Member State experts (where relevant), the comments received on the assessment of the points of clarification (where relevant), the comments received on the draft EFSA conclusion. Given the importance of the DAR including its addendum (compiled version of November 2012 containing all individually submitted addenda (Germany, 2012)) and the Peer Review Report, both documents are considered respectively as background documents A and B to this conclusion. EFSA Journal 2013;11(1):3060 6

7 THE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT Acetic acid is the IUPAC name for this compound there is no ISO common name. The representative formulated products for the evaluation were CEL H a formulation to be applied undiluted (AL) containing 102 g/l acetic acid and Natural Weed spray No. 1 a soluble concentrate formulation (SL) containing 240 g/l acetic acid. The representative uses evaluated comprise outdoor spraying to control weeds in pome fruit, stone fruit, paths and roads, ornamental trees and shrubs, turf, and lawns. Full details of the GAP can be found in the list of end points in Appendix A. CONCLUSIONS OF THE EVALUATION 1. Identity, physical/chemical/technical properties and methods of analysis The minimum purity of acetic acid and the specification for impurities cannot be concluded on the basis of the available information, and a data gap has been identified for batch analysis with supporting data for each manufacturing source. The following data gaps have been identified for the active substance: melting point, boiling point, vapour pressure, Henry s law constant, spectra, hydrolysis and dissociation constant. The main data regarding the identity of acetic acid and its physical and chemical properties are given in Appendix A. For the formulation Natural Weed Spray No. 1 the acidity of the product and shelf life were identified as data gaps. For the other formulation CEL H it should be noted that after storage the output of the trigger spray may be reduced. A data gap was identified for a specific method of analysis for the active substance in the technical material and the formulations. A method of analysis for plants and animals is not required as no MRLs are proposed. As residue definitions have been set for the environmental compartments data gaps are identified for methods of analysis for soil, water, and air. A method of analysis for body fluids and tissues is not required as the active substance is not classified as toxic or very toxic. 2. Mammalian toxicity The following guidance document was followed in the production of this conclusion: SANCO/222/2000 rev. 7 (European Commission, 2004). Acid acetic was discussed by the experts in mammalian toxicology during the Pesticides Peer Review Experts Meeting 88 (September 2011). It is noted that the batches tested in the available toxicological studies have not been demonstrated to be representative of the technical specification (see also data gap in section 1). For acute oral and inhalation toxicity in rats, only supplementary studies were provided. Acetic acid is classified for its irritating properties according to its concentration: if it is equal or above 90%, the classification is Skin Corr. 1A with the hazard statement H314 Causes severe skin burns and eye damage 10. With regard to short-term toxicity, most of the available data with rats were considered supplementary, indicating severe effects at high doses, but insufficient to derive a reliable NOAEL at lower doses. In a 8-week dietary study with rats, considered as acceptable, no adverse effects were observed at 290 mg/kg bw per day (single dose tested). During a 6-month dietary study with pigs, 10 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, , p EFSA Journal 2013;11(1):3060 7

8 presenting several limitations, no adverse effects were observed up to 450 mg/kg bw per day. No repeat dose study by inhalation with animals is available in the dossier. Based on the available studies, acetic acid is not considered to be a genotoxic compound. The results of two 8-month studies, neither GLP nor guideline compliant, were provided in the DAR. In these studies performed by oral gavage in rats and by dermal application in mice, local irritative effects (including irritation and hyperplasia) in both species were observed but no tumours were induced. In mice, several mortalities were observed when the acid was put on the skin more than once a week, and this was considered to be a consequence of the sustained dermal irritation/inflammation at the application site and not as an effect related to the systemic bioavailability of acetic acid after dermal exposure. In rats, the systemic NOAEL was <150 mg/kg bw (3 doses/week) and in mice, the systemic NOAEL was 30 mg/animal (1 time/week). No multigeneration study with rats was provided. Developmental toxicity studies were conducted in rats, mice and rabbits. Neither maternal nor developmental toxicity was observed in rats up to 1600 mg/kg bw per day. In mice, the maternal NOAEL was 74.3 mg/kg bw per day based on decreased body weight gain, and the developmental NOAEL was 345 mg/kg bw per day based on increased foetal mortality and incomplete ossification of the sternebrae. The rabbit is not considered to be an adequate animal model (due to the high sensitivity of its gastrointestinal bacterial flora). In the absence of experimental data, the default dermal absorption value is 100%. The adverse effects described in the available human data are all related to the irritating properties of concentrated acetic acid by oral, dermal or inhalation exposure. Based on the widespread presence of acetic acid in human foods, together with the fact that it is a normal metabolite in humans and animals, the establishment of an Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) for oral intake of acetic acid by consumers is not considered necessary. Considering that no systemic effects are expected after dermal exposure, the critical effects of acetic acid for operators/workers/bystanders are related to its irritating properties by inhalation, triggering neurobehavioural signs and changes in red blood cells at 15 mg/m³ in a valid human volunteer study. Based on a NOAEC of 10 mg/m³, and with the application of an uncertainty factor of 10 for intra-species variability, the Acceptable Operator Exposure Concentration (AOEC) is 1 mg/m³. Estimates of operator exposure by inhalation were provided for representative uses with the ready-touse formulation CEL H (pome and stone fruits, paths, ornamental shrubs, turf, and lawn) and with the formulation Natural Weed Spray No.1 (roads, ornamental trees and shrubs). The estimated exposure during tractor application (with the German model or UK POEM) is below the AOEC without the use of personal protective equipment for both formulations. The predicted exposure during hand-held application is below the AOEC for Natural Weed Spray No.1 but is 117% of the AOEC for CEL H, without the use of personal protective equipment (UK POEM). Bystander exposure by inhalation is expected to be 10 times lower than operator exposure by inhalation during hand-held application (UK POEM), according to spray drift data from Lloyd and Bell (Germany, 2012). Exposure by inhalation of workers re-entering the treated area to check the efficiency of the treatment is expected to be negligible, occurring after the spray solution has dried. 3. Residues The only edible crop use is as a spray around the base of fruit trees so there will be no direct application to the fruit trees or the fruit. It is considered highly unlikely that any significant residues will be present in the fruit at harvest. In addition, neither an ADI nor an ARfD have been set because it is not considered necessary based on the widespread presence of acetic acid in human food and the fact that the substance is a normal metabolite in humans and animals. Therefore a quantitative consumer risk assessment is not necessary. EFSA Journal 2013;11(1):3060 8

9 Acetic acid could be considered a candidate for inclusion in Annex IV of Commission Regulation (EC) No 396/ Environmental fate and behaviour In soil laboratory incubations under aerobic conditions in the dark, acetic acid and its salts exhibited very low persistence, with no evidence of any extractable transformation products being formed. Mineralisation of uniformly labelled acetate to carbon dioxide accounted for % AR after 120 days. The formation of unextractable residues (not extracted by Soxhlet extraction with ethanol:benzene) accounted for % AR after 120 days. Under anaerobic soil conditions soil bacteria produce acetate as a consequence of primary metabolic pathways (of any utilisable carbon source). Therefore acetic acid is not transformed in soil under anaerobic conditions. Acetic acid salts exhibited very high mobility in soil. In laboratory incubations of a natural water system taken from the Scheldt estuary, acetic acid and its salts exhibited very low persistence. Predicted environmental concentrations (PEC) in surface water and sediment were calculated for acetic acid and its salts, using the FOCUS (FOCUS, 2001) step 1, 2 and 3 12 approaches for the representative uses where application will result in more direct soil exposure. The SWAN tool (version 1.1.4) was appropriately used to implement ground spray applications (downward hydraulic spray applications) where pome fruit was the FOCUS scenario crop selected for simulating the representative uses, as the standard assumption for spray drift for this crop is air-assisted broadcast spraying which would not have been appropriate for the representative uses as a herbicide. For the representative uses on roads and paths data gaps are identified. Step 4 calculations implementing spray drift buffer zones for the representative uses where application will result in more direct soil exposure according to FOCUS air (FOCUS, 2008) and FOCUS landscape and mitigation (FOCUS, 2007) guidance and any PEC for the uses on roads and paths could not be provided whilst information on volatilisation and short range re-deposition potential are outstanding (data gap identified). Step 4 calculations are triggered for all of the representative uses assessed where application will result in more direct soil exposure, except for turf and lawn applications by watering. The necessary groundwater exposure assessments were appropriately carried out using FOCUS (FOCUS, 2009) scenarios and the model PELMO for the active substance acetic acid and its salts. The potential for groundwater exposure from the representative uses by acetic acid and its salts above the parametric drinking water limit of 0.1 µg/l was concluded to be high in geoclimatic situations that are represented by 5 out of 9 FOCUS groundwater scenarios for the representative use on pome fruits, stone fruits and ornamental shrubs at 4x40.8 kg a.s./ha (0.42 to 19.7µg/L), 4 out of 9 FOCUS scenarios for the representative use on trees and ornamental shrubs at 2x60 kg a.s./ha (0.37 to 42.56µg/L) and 3 out of 9 FOCUS scenarios for the representative use on turf and lawn at 2x102 kg a.s./ha (0.92 to 26.38µg/L). Acetic acid is highly volatile and will be subject to long-range atmospheric transport (the atmospheric half-life from indirect photolytic reaction with hydroxyl radicals is estimated at 26 days). However with annual sales volumes estimated by the notifier to be only up to 60 tons per ha for the EU (see point of clarification 4.1 of the Evaluation Table), this contribution would be insignificant compared to other anthropogenic sources and natural emissions. All emissions are subject to long-range atmospheric transport, however, future changes in herbicide active substance availability could mean that the market estimate would need revision. Consequently the consideration of the significance of acetic acid emissions from herbicide use compared to other emissions would also need revision. 11 Regulation (EC) No 396/2005 of the European Parliament and the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, , p Simulations correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient of Simulations utilised a Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient of 0.7 EFSA Journal 2013;11(1):3060 9

10 The PEC in soil, surface water, sediment, and groundwater covering the representative uses assessed can be found in Appendix A. 5. Ecotoxicology For the risk assessments the following documents were considered: European Commission, 2002a, 2002b, 2002c and SETAC, The batches tested in the available studies have not been demonstrated to be representative of the technical specification (see also data gap in section 1). Since it is assumed that acetic acid has high volatility, in addition to the standard routes of exposure, the inhalation route of exposure for terrestrial organisms may also be relevant. No reliable experimental data were available to perform quantitative risk assessments for birds and mammals for acetic acid. However, long-term assessments based on an endpoint from a developmental toxicity study on mouse were provided. A developmental toxicity study on rabbits resulting in a lower endpoint was also available. Although rabbit was not considered to be an adequate animal model in relation to human assessments (see section 2) it was considered to be appropriate for ecotoxicological risk assessments. Therefore EFSA repeated the long-term assessments for mammals based on the endpoint from the study on rabbit, which resulted in TER values below the relevant trigger, indicating a high risk. The calculations are given in Appendix A. It is noted that considering the standard exposure scenarios, a low acute, short-term or long-term risk to birds and mammals could only be achieved if endpoints indicating extremely low toxicity were available (some order of magnitude lower than those predicted by the available endpoints including even the non-validated endpoints). It is unlikely that birds or mammals could be tested at such high doses/concentrations and if so, it is unlikely that acetic acid would indicate low toxicity at these doses/concentrations. This is mainly because the application rates of acetic acid based on the representative uses are very high. Since either no quantitative risk assessments were available, or where they were available a high risk was identified, a data gap was identified. Regarding the toxicity, it was noted that the irritating properties of acetic acid depend on its concentration (see section 2). Assuming that the main effects in wild vertebrates after oral exposure will also be due to the acidic properties, the potential adverse effects (i.e. corrosive action) depend on the concentration of the acid on the food items. Therefore the concentration of the tank mix and the dilution rate of the acid on plants or insects following application might highly affect adverse effects via corrosiveness. It is noted that acute toxicity data on rat were available for a formulation of about 10 % acetic acid concentration. If these data were used in a standard risk assessment, a high risk to wild mammals could also not be excluded. Regarding potential refinements, it was noted that degradation and dissipation (e.g. via volatilisation) from food items is likely to be rapid. It was also proposed that the likely acrid taste and pungent smell might reduce the consumption of contaminated feed items. Furthermore the risk is likely to be lower for those uses where only a part of the area is to be treated (e.g. spot applications, applications only in rows in orchards) or for applications on hard surfaces. These parameters however were not supported by reliable data, and therefore a realistic risk characterisation (risk refinement) could not be performed (see identified data gap above). Based on the available studies on 99.9% acetic acid or 60% technical material, acetic acid might be classified as harmful to aquatic organisms. Based on these data, a high risk was identified for the majority of scenarios at FOCUS step 3 for the representative uses on pome and stone fruits and ornamental shrubs. For these uses four applications of 41 kg a.s./ha was considered. For the representative uses on ornamental trees and shrubs with two applications of 60 kg a.s./ha, all scenarios indicated a high risk. For the representative uses on turf and lawn, the risk assessment for all FOCUS step 3 scenarios indicated a low risk. Regarding the representative uses on paths and roads no reliable PEC calculations were available (see section 4), and therefore the risk assessment could not be finalised and a data gap was identified. Since there were some outstanding data, FOCUS step 4 calculations implementing spray drift buffer zones could not be performed (see section 4). Therefore a EFSA Journal 2013;11(1):

11 data gap for further assessments was identified for the uses where the assessments resulted in high risk at FOCUS step 3. Based on the available toxicological data with a formulation containing approximately 10% acetic acid a high risk to honeybees was identified. No reliable higher tier data were available and therefore a data gap was identified to further address the risk to honeybees. Similarly, the risk assessment with the available laboratory data for non-target arthropods resulted in a high risk, and the higher tier data were not well representative for appropriate refinements. A data gap was therefore identified to further address the risk assessment for non-target arthropods. It was noted that the exposure of bees and other arthropods will not be uniform in fields where application is by spot treatment, and that such applications might reduce the risk to some extent. It is also noted that the exposure route of volatilisation followed by deposition might be considered once the risk assessments for off-crop areas are updated. Based on the available data, the risk to earthworms from the representative uses was assessed as low. Based on data for a formulation containing approximately 10% acetic acid the effect on nitrogen transformation was lower than the relevant trigger, and therefore the risk to this soil function was considered to be low. No data were available for carbon mineralisation, and therefore a data gap was identified. Since the exposure assessments for the off-crop areas were not complete (see data gap for volatilisation and deposition), the risk assessment for non-target plants could not be finalised. Additionally, no reliable plant emergence tests were available, therefore relevant data gaps for these issues were identified. Regarding the potential effects on biological methods of sewage treatment, no data and assessments were available. It was concluded that the risk to sewage treatment plants for the representative uses could be considered as low, except for the uses on roads and paths for which a data gap was identified. EFSA Journal 2013;11(1):

12 6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments 6.1. Soil Compound (name and/or code) Acetic acid and its salts Persistence Very low to low persistence Single first-order DT and 1.23 days (20ºC pf 2 soil moisture) Ecotoxicology The risk to earthworms and soil nitrogen transformation was assessed as low. A data gap was identified for carbon mineralisation Ground water Compound (name and/or code) Mobility in soil >0.1 μg/l 1m depth for the representative uses (at least one FOCUS scenario or relevant lysimeter) Pesticidal activity Toxicological relevance Ecotoxicological activity Acetic acid and its salts Very high mobility K Foc 0 ml/g Yes, at between 3/9 and 5/9 scenarios depending on the representative use, with concentrations being 0.37 to µg/l Yes Yes Yes 6.3. Surface water and sediment Compound (name and/or code) Acetic acid and its salts Ecotoxicology Harmful to aquatic organisms. High risk was identified for some of the representative uses. EFSA Journal 2013;11(1):

13 6.4. Air Compound (name and/or code) Acetic acid and its salts Toxicology AOEC is 1 mg/m 3 (human study) EFSA Journal 2013;11(1):

14 7. List of studies to be generated, still ongoing or available but not peer reviewed This is a complete list of the data gaps identified during the peer review process, including those areas where a study may have been made available during the peer review process but not considered for procedural reasons (without prejudice to the provisions of Article 7 of Directive 91/414/EEC concerning information on potentially harmful effects). Specification with supporting batch data and methods of analysis (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1). Melting point, boiling point, vapour pressure, Henry s law constant, spectra, hydrolysis and dissociation constant of the active substance (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1). Acidity and shelf life study (relevant for the representative formulation Natural Weed Spray No. 1 ; submission date proposed by the notifier: unknown; see section 1). Specific method for the active substance in the technical material and the formulations (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1). Methods of analysis for soil, water and air (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1). Surface water exposure assessment consequent to the requested uses on hard surfaces (roads and paths) (relevant for use on man-made hard surfaces; submission date proposed by the notifier: unknown; see section 4). Information on volatilisation and re-deposition of acetic acid in the short range would be needed to complete surface water exposure assessment consequent to all the requested uses where Step 4 FOCUS surface water estimates are triggered (i.e. all representative uses except turf and lawn applications by watering; submission date proposed by the notifier: unknown; see section 4). Risk assessments for birds and mammals considering all the standard scenarios. Relevant data for refinements and higher tier assessments will also be necessary (relevant for all uses evaluated; submission date proposed by the notifier: unknown; see section 5). Risk assessments for aquatic organisms relevant for use on hard surfaces, once the exposure assessment is available (relevant for use on roads and paths; submission date proposed by the notifier: unknown; see section 5). Risk assessments for aquatic organisms needs to be further addressed (relevant for the representative uses in pome fruit, stone fruit, and ornamental trees and shrubs; submission date proposed by the notifier: unknown; see section 5). The risk assessment for honeybees needs to be further addressed (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 5). The risk assessment for non-target arthropods needs to be further addressed (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 5). A carbon mineralisation test and subsequent assessment is required (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 5). EFSA Journal 2013;11(1):

15 Risk assessments for non-target plants that consider all relevant exposure routes of the off-crop areas are required (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 5). A plant emergence test and subsequent assessment is required (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 5). An assessment of the potential effects on biological methods for sewage treatment (relevant for the representative uses on hard surfaces (roads and paths); submission date proposed by the notifier: unknown; see section 5). 8. Particular conditions proposed to be taken into account to manage the risk(s) identified None. 9. Concerns 9.1. Issues that could not be finalised An issue is listed as an issue that could not be finalised where there is not enough information available to perform an assessment, even at the lowest tier level, for the representative uses in line with the Uniform Principles of Annex VI to Directive 91/414/EEC and where the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses). 1. The surface water exposure assessment and consequent aquatic risk assessments could not be finalised for the representative uses on man-made hard surfaces. 2. The acute and long-term risk assessment for birds and the acute risk assessment for mammals could not be finalised. 3. The risk assessment for non-target plants could not be finalised. 4. The risk assessment for sewage treatment plant processes could not be finalised for the representative uses on man-made hard surfaces Critical areas of concern An issue is listed as a critical area of concern where there is enough information available to perform an assessment for the representative uses in line with the Uniform Principles of Annex VI to Directive 91/414/EEC, and where this assessment does not permit to conclude that for at least one of the representative uses it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater or any unacceptable influence on the environment. An issue is also listed as a critical area of concern where the assessment at a higher tier level could not be finalised due to a lack of information, and where the assessment performed at the lower tier level does not permit to conclude that for at least one of the representative uses it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater or any unacceptable influence on the environment. 5. Acetic acid has the potential for long-range atmospheric transport. Although using the estimates of sales volumes provided by the notifier the contribution to exposure in remote areas from use as a herbicide is indicated to be insignificant when compared to other anthropogenic emission sources. Note: potential for long-range atmospheric transport is not a criterion in the Uniform Principles of Annex VI to Directive 91/414/EEC for decision making on product authorisations, EFSA Journal 2013;11(1):

16 but is a criterion that risk managers from Member States have asked to be informed about in relation to obligations Member States have under certain international treaties. 6. High long-term risk for mammals was identified. 7. High risk for honeybees was identified. 8. High risk for non-target arthropods was identified Overview of the concerns identified for each representative use considered (If a particular condition proposed to be taken into account to manage an identified risk, as listed in section 8, has been evaluated as being effective, then risk identified is not indicated in this table.) In addition to the issues specified, all columns are grey as the technical material specification was not supported by batch data and therefore it is not possible to compare it with the material used in mammalian toxicity and ecotoxicological studies. All columns are also grey as acetic acid has the potential for long-range atmospheric transport. Representative use Pome and stone fruits 4x40.8 kg a.s./ha Ornamental shrubs 4x40.8 kg a.s./ha Paths 4x40.8 kg a.s./ha Ornamental trees & shrubs 2x60 kg a.s./ha Roads 2x60 kg a.s./ha Turf, lawn 2x102 kg a.s./ha watering application Paths 2x102 kg a.s./ha Operator risk Worker risk Bystander risk Consumer risk Risk to wild non target terrestrial vertebrates Risk to wild non target terrestrial organisms other than vertebrates Risk to aquatic organisms Risk identified Assessment not finalised Risk identified Assessment not finalised Risk identified Assessment not finalised Risk identified Assessment not finalised Risk identified Assessment not finalised Risk identified Assessment not finalised Risk identified Assessment not finalised X X X X X X 6 X 6 X 6 X 6 X 6 X 6 X 6 X 2 X 2 X 2 X 2 X 2 X 2 X 2 X 7,8 X 7,8 X 7,8 X 7,8 X 7,8 X 7,8 X 7,8 X 3 X 3 X 3,4 X 3 X 3,4 X 3 X 3,4 5/7 Step 3 FOCUS scenarios 5/7 Step 3 FOCUS scenarios 7/7 Step 3 FOCUS scenarios X 1 X 1 X 1 EFSA Journal 2013;11(1):

17 Groundwater exposure active substance Legal parametric value breached Assessment not finalised 5/9 FOCUS scenarios 5/9 FOCUS scenarios 4/9 FOCUS scenarios 3/9 FOCUS scenarios Groundwater exposure metabolites Legal parametric value breached Parametric value of 10µg/L (a) breached Assessment not finalised Comments/Remarks The superscript numbers in this table relate to the numbered points indicated in sections 9.1 and 9.2. Where there is no superscript number see sections 2 to 6 for further information. (a): Value for non-relevant metabolites prescribed in SANCO/221/2000-rev 10-final, European Commission, EFSA Journal 2013;11(1):

18 REFERENCES EFSA (European Food Safety Authority), Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil. The EFSA Journal (2007) 622, EFSA (European Food Safety Authority), Peer Review Report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance acetic acid. European Commission, 2002a. Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC. SANCO/10329/2002 rev.2 final, 17 October European Commission, 2002b. Guidance Document on Aquatic Ecotoxicology Under Council Directive 91/414/EEC. SANCO/3268/2001 rev 4 (final), 17 October European Commission, 2002c. Guidance Document on Risk Assessment for Birds and Mammals Under Council Directive 91/414/EEC. SANCO/4145/2000. European Commission, Guidance Document on Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated under Council Directive 91/414/EEC. SANCO/221/2000- rev final, 25 February European Commission, Guidance Document on Dermal Absorption. SANCO/222/2000 rev. 7, 19 March European Commission, Review Report for the active substance acetic acid finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2008 in view of the inclusion of acetic acid in Annex I of Directive 91/414/EEC. SANCO/2602/08 rev. 1, 4 July FOCUS (2001). FOCUS Surface Water Scenarios in the EU Evaluation Process under 91/414/EEC. Report of the FOCUS Working Group on Surface Water Scenarios, EC Document Reference SANCO/4802/2001-rev pp. FOCUS (2007). Landscape And Mitigation Factors In Aquatic Risk Assessment. Volume 1. Extended Summary and Recommendations. Report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment, EC Document Reference SANCO/10422/2005 v pp. FOCUS (2008). Pesticides in Air: Considerations for Exposure Assessment. Report of the FOCUS Working Group on Pesticides in Air, EC Document Reference SANCO/10553/2006 Rev 2 June FOCUS (2009). Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU. Report of the FOCUS Workgroup, EC Document Reference SANCO/13144/2010-version pp, as outlined in Generic Guidance for Tier 1 FOCUS groundwater Assessment, version 2.0 dated January should have this or FOCUS (2000) with EFSA (2004), not both Germany, Draft Assessment Report (DAR) on the active substance acetic acid prepared by the rapporteur Member State Germany in the framework of Directive 91/414/EEC, August Germany, Final Addendum to Draft Assessment Report on acetic acid, compiled by EFSA, November SETAC (Society of Environmental Toxicology and Chemistry), Guidance Document on Regulatory Testing and Risk Assessment procedures for Plant Protection Products with Non-Target Arthropods. ESCORT 2. EFSA Journal 2013;11(1):

19 APPENDICES APPENDIX A LIST OF END POINTS FOR THE ACTIVE SUBSTANCE AND THE REPRESENTATIVE FORMULATION Identity, Physical and Chemical Properties, Details of Uses, Further Information Active substance (ISO Common Name) Function (e.g. fungicide) Acetic acid is the IUPAC name for this compound there is no ISO common name Herbicide Rapporteur Member State Federal Republic of Germany Identity (Annex IIA, point 1) Chemical name (IUPAC) Chemical name (CA) CIPAC No Acetic acid Acetic acid none CAS No EEC No (EINECS or ELINCS) FAO Specification (including year of publication) Minimum purity of the active substance as manufactured (g/kg) Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg) none Open Open Molecular formula C 2 H 4 O 2 Molecular mass Structural formula g/mol EFSA Journal 2013;11(1):

20 Physical-chemical properties (Annex IIA, point 2) Peer review of the pesticide risk assessment of the active substance acetic acid Melting point (state purity) Boiling point (state purity) Temperature of decomposition Appearance (state purity) Relative density (state purity) Surface tension Vapour pressure (in Pa, state temperature) Henry s law constant (Pa m 3 mol -1 ) Solubility in water (g/l or mg/l, state temperature) Solubility in organic solvents (in g/l or mg/l, state temperature) Partition co-efficient (log P OW ) (state ph and temperature) Hydrolytic stability (DT 50 ) (state ph and temperature) Dissociation constant UV/VIS absorption (max.) (if absorption > 290 nm state at wavelength) Photostability (DT 50 ) (aqueous, sunlight, state ph) Quantum yield of direct phototransformation in water at > 290 nm Flammability Explosive properties Open Open Open Colourless clear liquid with vinegar-like, pungent odour 1.05 g/cm³ 27.5 mn/m (20 C) Open Open Miscible in all proportions n-hexane: toluol: dichlormethane: isopropanol: acetone: ethyl acetate: log P O/W = 0.09 Open ph 7: DT 50 of 37.4 years ph 9: DT 50 of 21.1 years Open Open none Not required Not applicable > 200 g/l > 200 g/l > 200 g/l > 200 g/l > 200 g/l > 200 g/l There are no known explosion-enhancing groups in the structure. EFSA Journal 2013;11(1):

21 Summary of representative uses evaluated (acetic acid) Crop and/or situation (a) Member State or Country Product name F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg as/hl min max water L/ha min max kg as/ha min max PHI (days) (l) Remarks (m) Pome and stone fruits EU CEL H F Annual and perennial weeds AL 102 g/l Direct spray Vegetation (spot appl.) period days (undiluted spray) 40.8 (400 L/ha product) Not applicable Paths and places with wood plants Ornamental shrubs EU CEL H F Annual and perennial weeds EU CEL H F Annual and perennial weeds AL 102 g/l Direct spray Vegetation (spot appl.) period AL 102 g/l Direct spray Vegetation (spot appl.) period days (undiluted spray) days (undiluted spray) 40.8 (400 L/ha product) 40.8 (400 L/ha product) Not applicable Not applicable Authorised in DE in home and garden area for annual weeds Turf, lawn EU CEL H F Moss species AL 102 g/l Watering in 2 L/m 2 Paths and places Roads and Places EU CEL H F Annual and perennial weeds EU Natural Weed spray No. 1 F Annual weeds SL 240 g/l Vegetation period AL 102 g/l Spray Vegetation period Direct Vegetation spray (spot appl.) period 2 40 days (1000 L/ha product) weeks (undiluted spray) 102 (1000 L/ha product) Not applicable Not applicable days Not (250 L/ha applicable product) Applied in DE for profession al use Provisional authorisation in UK EFSA Journal 2013;11(1):