Conclusion on the peer review of the pesticide risk assessment of the active substance tall oil pitch 1

Transcription

1 CONCLUSION ON PESTICIDE PEER REVIEW Conclusion on the peer review of the pesticide risk assessment of the active substance tall oil pitch 1 European Food Safety Authority 2 European Food Safety Authority (EFSA), Parma, Italy SUMMARY Tall oil pitch 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/ Tall oil pitch was included in Annex I to Directive 91/414/EEC on 18 December 2008 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 5, in accordance with Commission Implementing Regulation (EU) No 540/2011 6, as amended by Commission Implementing Regulation (EU) No 541/ In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010 8, 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. Greece being the designated rapporteur Member State submitted the DAR on tall oil pitch in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 31 March The peer review was initiated on 22 July 2008 by dispatching the DAR for consultation of the notifier Fluegel GmbH. Subsequently the DAR was dispatched on 20 October 2010 for consultation of the Member States. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the area of mammalian toxicology and deliver its conclusions on tall oil pitch. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of tall oil pitch as a repellent in forestry, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report. 1 On request from the European Commission, Question No EFSA-Q , adopted on 16 December Correspondence: pesticides.peerreview@efsa.europa.eu 3 OJ L 379, , p.13 4 OJ L 246, , p.19 5 OJ L 309, , p.1 6 OJ L 153, , p.1 7 OJ L 153, , p OJ L 37, , p.12 Suggested citation: European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance tall oil pitch. [33 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2012

2 Data gaps were identified for the section identity, physical and chemical properties and analytical methods. The toxicological database is not suitable either to establish NOAELs, to set references values or to adequately assess the hazard. An AOEL could not be set leading to a critical area of concern and therefore the risk assessment for non-dietary exposure cannot be concluded. In addition, the limit information was based on tall oil crude and the data available are not sufficient for bridging from tall oil crude to tall oil pitch and a data gap has been also identified. No significant residues in plant or animal matrices were expected based on the representative use. Consumer risk assessments were not required due to the unlikelihood of significant residues. The environmental fate and behaviour assessment has identified a data gap for the volatilisation potential from treated trees of representative tall oil materials to be addressed, before the environmental exposure assessment can be finalised A data gap was identified in the ecotoxicology section, pending on the outcome of the fate and behaviour section. If the environmental exposures via air will occur, the applicant needs to address the risk to non-target wild species. No critical area of concern was identified. KEY WORDS tall oil pitch, peer review, risk assessment, pesticide, repellent 2

3 TABLE OF CONTENTS Summary... 1 Table of contents... 3 Background... 4 The active substance and the formulated product... 6 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 for each representative use considered References Appendices Abbreviations

4 BACKGROUND Tall oil pitch is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004 9, as amended by Commission Regulation (EC) No 1095/ Tall oil pitch was included in Annex I to Directive 91/414/EEC on 18 December 2008 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/ , in accordance with Commission Implementing Regulation (EU) No 540/ , 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. Greece being the designated rapporteur Member State submitted the DAR on tall oil pitch in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 31 March 2008 (Greece 2008). The peer review was initiated on 22 July 2008 by dispatching the DAR for consultation of the notifier Fluegel GmbH. Subsequently the DAR was dispatched on 20 October 2010 for consultation of the Member States. 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 15 February 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 area of mammalian toxicology. 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 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 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 repellent in forestry and orchards, as proposed by the notifier. A list of the relevant end points for the 9 OJ L 379, , p OJ L 246, , p OJ L 309, , p.1 12 OJ L 153, , p.1 13 OJ L 153, , p OJ L 37, , p.12 4

5 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, 2011) 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 (10 February 2011), the Evaluation Table (14 December 2011) the report 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 May 2011 containing all individually submitted addenda (Greece, 2011)) and the Peer Review Report, both documents are considered respectively as background documents A and B to this conclusion. 5

6 THE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT Tall oil pitch is considered by the International Organization for Standardization not to require a common name. Tall oil pitch is a complex mixture of esters of fatty acids and rosin and small amounts of dimers and trimers of resin acids and fatty acids. The representative formulated product for the evaluation was Morsuvin a paste, water-based, filmforming composition (PA), containing 50 g/kg tall oil pitch, 418 g/kg calcium carbonate, 43 g/kg fish oil and 87.5 g/kg sodium aluminium silicate, registered in several EU countries. It should be noted that the representative formulations with the same trade name, but originating from different manufacturers may differ in composition. The representative uses evaluated comprise applications by coating with brush on coniferous trees in forestry as a repellent against game browsing damage. 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 following guidance documents were followed in the production of this conclusion: SANCO/3030/99 rev.4 (European Commission, 2000), and SANCO/825/00 rev. 7 (European Commission, 2004a). Tall oil pitch is the residue from the distillation of tall oil, primarily made up of high boiling, high molecular weight compounds formed at the temperatures encountered during the fractionation process. It contains esters of fatty acids and rosin and also neutral materials, free fatty acids and resin acids. The composition of the tall oil pitch depends on the species of tree from which it was derived. The specification of the tall oil pitch is open as a data gap was identified for batch analytical data. No FAO specification exists. The assessment of the data package revealed no issues that need to be included as critical areas of concern with respect to the identity of tall oil pitch, however a data gap was identified for appropriate parameters to be included in the specification in order to correlate with the purity of the active substance. With respect to the physical, chemical and technical properties of tall oil pitch and the representative formulation the following data gaps were identified: physical and chemical properties for the active substance tall oil pitch evaluated in the DAR, shelf life study, the content and stability of the a.s. in the formulation in the accelerated storage test, suitability of packaging and flammability, auto-flammability, oxidising and explosive properties of the representative formulation. Data gaps were identified for analytical methods for the determination of the active substance in the tall oil pitch and in the representative formulation. The need for methods of analysis for monitoring this compound in food of plant and animal origin and in the environment have been waived due to the use of the compound. As no conclusion was taken on the classification of the active substance, the need for a method for body fluids and tissues could not be concluded on. 2. Mammalian toxicity The following guidance document was followed in the production of this conclusion: SANCO/222/2000 rev. 7, March 2004 (European Commission, 2004b). Tall oil pitch was discussed at the PRAPeR TC 55 Expert s Meeting on mammalian toxicology. The risk assessment has been based on a published summary report sent to the US-EPA but not peer reviewed and based on tall oil crude. The report is available in the DAR. The original studies have not been available to the RMS for their own evaluation. During the expert s meeting it was concluded that 6

7 the database was too limited to either assess exposure and hazard or to set an acceptable operator exposure level (AOEL); in particular a concern was raised over the genotoxicity of the tall oil, with regard to the exact composition of the material tested (i.e a mixture of different substances not present in fixed percentage) and to the representative specification and a data gap is identified. Dermal absorption cannot be considered negligible because of the complete lack of specific data and should considered to be 100%. In addition, the data available are not sufficient to bridge data from tall oil crude to tall oil pitch and a data gap has been identified. The database is not suitable either to establish NOAELs, to set references values or to adequately assess the hazard. An AOEL could not be set leading to a critical area of concern and therefore the risk assessment for non-dietary exposure cannot be concluded. As for consumer exposure, the acceptable daily intake (ADI) and acute reference dose (ARfD) are not set because of unlikelihood of significant residues (see section 3). 3. Residues Metabolism and residue studies were not considered relevant for the evaluation due to the nature of the active substance and the representative uses. Tall oil pitch will be used only as protection coating for trees in forestry. Crops destined for human and animal consumption are not treated, and therefore no residues on food and feed may occur. Consumer risk assessments were not required due to the unlikelihood of significant residues. 4. Environmental fate and behaviour The dossier considered by the rapporteur Member State on the fate and behaviour of the mixture of substances that make up tall oil pitch was essentially empty. However when preparations containing tall oil pitch are applied to trees by brush (the representative use being assessed), it is expected that exposure of soil and natural surface water systems will be negligible. For the representative use where soil exposure is expected to be negligible, the potential for groundwater exposure can also be concluded to be negligible. However an uncertainty in the environmental exposure assessment remains, as reliable information on the potential for volatilisation of tall oil components from the treated trees was not available. Therefore a data gap was identified for, at the very least, some experimental observations / measurements of the vapour pressure of representative tall oil materials. 5. Ecotoxicology No toxicity studies were submitted, except for aquatic toxicity with the formulation. Based on these data it was proposed not to classify neither the formulation nor tall oil pitch (96 hour LC 50 >100 mg /L for Zebra fish). Tall oil pitch is applied to trees by brush, it is expected that exposure of soil and natural surface water systems will be negligible. However, an uncertainty remains for volatilisation of tall oil components from the treated trees because no data were available (see section4). Therefore, pending on these data, if the environmental exposures via air will occur, then the risk assessment for non-target species would be necessary and therefore a data gap was identified pending on the outcome of the fate and behaviour section, the applicant to address the risk of tall oil to non-target species. 7

8 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) Persistence Ecotoxicology None in relation to the representative use assessed 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 None in relation to the representative use assessed Surface water and sediment Compound (name and/or code) Ecotoxicology None in relation to the representative use assessed. - 8

9 6.4. Air Compound (name and/or code) Components of tall oil pitch. Data gap Toxicology No information available. 9

10 7. List of studies to be generated, still ongoing or available but not peer reviewed Batch analytical data (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1) Appropriate parameters to be included in the specification in order to correlate with the purity of the active substance (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1) Physical and chemical properties for the active substance tall oil pitch evaluated in the DAR (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1) Shelf life study, the content and stability of the a.s. in the formulation in the accelerated storage test, suitability of packaging and closures (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1) Flammability, auto-flammability, oxidising and explosive properties of the representative formulation (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1) Analytical method(s) for the determination of the active substance in the tall oil pitch and in the representative formulation (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see section 1) Studies to address the toxicological profile of tall oil pitch and their representativeness to the specification in particular regarding to genotoxicity potential (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 2). Information for bridging data from tall oil crude to tall oil pitch (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 2). Information to address the fate and behaviour in air of tall oil pitch that could be relied on was not available. At the very least some experimental observations / measurements of the vapour pressure of representative tall oil materials would be necessary, (relevant for all representative uses evaluated; submission date proposed by the notifier: unknown; see sections 1 and 4) Pending on the outcome of the fate and behaviour section if the environmental exposure via air will occur, then the applicant to address the risk of tall oil pitch to non-target species needs to be addressed (relevant for all representative uses evaluated; 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 10

11 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 assessment of the fate and behaviour of tall oil pitch components that may reach all environmental compartments via the air compartment is not finalised whilst satisfactory information on the vapour pressure of these components is not available. 2. Pending on the outcome of the fate and behaviour section if the environmental exposure via air will occur, the risk of tall oil to non-target wild species can not be addressed with the available data. 9.2 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. 3. The toxicological database is not suitable either to establish NOAELs, to set references values or to adequately assess the hazard. An AOEL could not be set and therefore the risk assessment for operators, workers and bystanders cannot be concluded. 11

12 9.3 Overview of the concerns 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.). All columns are grey as the specification is missing and the toxicological data are too limited to set an AOEL. Representative use Manual application by brush to saplings and young trees (forestry) Manual application by brush to tree trunks (forestry) 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 Groundwater exposure active substance Groundwater exposure metabolites Risk identified Assessment not finalised X 3 X 3 Risk identified Assessment not finalised X 3 X 3 Risk identified Assessment not finalised X 3 X 3 Risk identified Assessment not finalised Risk identified Assessment not finalised X 1,3 X 1,3 Risk identified Assessment not finalised X 1,2 X 1,2 Risk identified Assessment not finalised X 1,2 X 1,2 Legal parametric value breached Assessment not finalised Legal parametric value breached Parametric value of 10µg/L (a) breached Assessment not finalised The superscript numbers in this table relate to the numbered points in sections 9.1 and 9.2 (a): Value for non relevant metabolites prescribed in SANCO/221/2000-rev 10-final, European Commission,

13 REFERENCES Greece Draft Assessment Report (DAR) on the active substance tall oil pitch. prepared by the rapporteur Member State Greece in the framework of Directive 91/414/EEC, March Greece Final Addendum to Draft Assessment Report on tall oil pitch., compiled by EFSA, May EFSA (European Food Safety Authority), Peer Review Report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance tall oil pitch European Commission, Review Report for the active substance tall oil pitch finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 7 August 2008 in view of the inclusion of tall oil pitch. in Annex I of Directive 91/414/EEC.SANCO/2632/08 rev. 1 European Commission, Guidelines for the generation of data concerning residues as provided in Annex II part A, section 6 and Annex III, part A, section 8 of Directive 91/414/EEC concerning the placing of plant protection products on the market, 1607/VI/97 rev.2, 10 June European Commission, Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. SANCO Doc 7525/VI/95-rev.7. pp JMPR, Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues Rome, Italy, September 2004, Report 2004, 383 pp. JMPR, Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues Geneva, Switzerland, September 2007, Report 2007, 164 pp. OECD (Organisation for Economic Co-operation and Development), Guidance Document on Overview of Residue Chemistry Studies. ENV/JM/MONO(2006)32, 10 October 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. 13

14 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) tall oil pitch (No ISO common name) Repellent Rapporteur Member State Co-rapporteur Member State - Hellas Identity (Annex IIA, point 1) Chemical name (IUPAC) Chemical name (CA) CIPAC No 912 CAS No EC No (EINECS or ELINCS) FAO Specification (including year of publication) Minimum purity of the active substance as manufactured Identity of relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured Molecular formula Molecular mass Structural formula tall oil pitch (no IUPAC name) tall oil pitch (no CA name) Not available Data gap identified. Open Not applicable. Tall oil pitch is a complex mixture difficult to characterize and is composed of numerous chemicals. It contains esters of fatty acids and rosin and also neutral materials, free fatty acids and resin acids. the most common of which are rosin and fatty acids. Its composition is variable and cannot be presented by a definite chemical structure diagram. Not applicable. See explanation above. Not applicable. See explanation above. 14

15 Physical and chemical properties (Annex IIA, point 2) Melting point (state purity) Boiling point (state purity) Temperature of decomposition (state purity) Appearance (state purity) Data gap identified. Data gap identified. Data gap identified. Data gap identified. Data gap identified. Semi-solid, paste-like dark colored material with a slight mouldy odour of resin of pines. (Anonymous 2003) Vapour pressure (state temperature, state purity) Data gap identified. Henry s law constant Solubility in water (state temperature, state purity and ph) Solubility in organic solvents (state temperature, state purity) Surface tension (state concentration and temperature, state purity) Partition co-efficient (state temperature, ph and purity) Dissociation constant (state purity) UV/VIS absorption (max.) incl. (state purity, ph) Flammability (state purity) Explosive properties (state purity) Oxidising properties (state purity) Not applicable. Data gap identified. Data gap identified. Not applicable. Data gap identified. Not applicable. Not applicable. Data gap identified. Data gap identified. Data gap identified. 15

16 Summary of representative uses evaluated (Tall oil pitch) Crop and/or situation (a) Deciduous and coniferous trees in forestry Deciduous and coniferous trees in forestry Member State or Country n. a. = not applicable Product name F G or I (b) Pests or Group of Pests controlled (c) Germany Morsuvin F Game repellent Germany Morsuvin F Game repellent Formulation Application Application rate per treatment Type Conc. method growth number interval kg as/hl water of as kind stage & season min max between min-max L/ha (d-f) (i) (f-h) (j) (k) applications min max PA 50.0 g/kg coating with brush; individual plants; entire plants PA 50.0 g/kg coating with brush; individual plants; terminal sprouts PHI (days) (l) kg as/1000 plants min max (days) September-March months n. a n. a. September-March months n. a n. a. Remarks (m) (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the planttype of equipment used must be indicated (i) g/kg or g/l (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (k) Indicate the minimum and maximum number of application possible under practical conditions of use (l) PHI - minimum pre-harvest interval( (m) Remarks may include: Extent of use/economic importance/restrictions 16

17 Methods of Analysis Analytical methods for the active substance (Annex IIA, point 4.1) Technical as (analytical technique) Impurities in technical as (analytical technique) Plant protection product (analytical technique) Data gap identified. Not applicable. Data gap identified. Analytical methods for residues (Annex IIA, point 4.2) Residue definitions for monitoring purposes Food of plant origin Food of animal origin Soil Water Air Blood No residue definition. No residue definition. No residue definition. No residue definition. No residue definition. No residue definition. No residue definition. Analytical methods for residues (Annex IIA, point 4.2) Food/feed of plant origin (analytical technique and LOQ for methods for monitoring purposes) Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) Soil (principle of method and LOQ) Water (principle of method and LOQ) Air (principle of method and LOQ) Body fluids and tissues (principle of method and LOQ) Caused by the use and the nature of the active substance as a game repellent no residues will occur on plants. Therefore no analytical method for the determination of residues in products of plant origin is required. Caused by the use and the nature of the active substance as a game repellent no residues will occur on animals. Therefore no analytical method for the determination of residues in products of animal origin is required. No analytical method has been developed for the determination of tall oil pitch residues is soil because no residue definition exists for monitoring of this compound in soil. No residue definition exists for monitoring, therefore no analytical method for the determination of residues in water is required. No residue definition exists for monitoring, no analytical method for the determination of residues in air is required. As no conclusion was taken on the classification of the active substance, the need for a method for body fluids and tissues could not be concluded on 17

18 Classification and proposed labelling with regard to physical and chemical data (Annex IIA, point 10) RMS/peer review proposal Active substance RMS proposal: None 18

19 Impact on Human and Animal Health Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 5.1) Rate and extent of absorption No data available (1) Distribution No data available; (1) Potential for accumulation No data available (1) Rate and extent of excretion No data available (1) Metabolism in animals No data available; (1) Toxicologically relevant compounds No data available (1) (animals and plants) Toxicologically relevant compounds (environment) Acute toxicity (Annex IIA, point 5.2) Rat LD 50 oral Limited information available (1) Rabbit LD 50 dermal No data available (1) Rat LC 50 inhalation No data available; (1) Skin irritation No data available (1) Eye irritation No data available (1) Skin sensitisation No data available (1). One of the components of tall oil pitch (i.e rosin) is a skin sensitizer. Short term toxicity (Annex IIA, point 5.3) Target / critical effect Limited information available (1) Relevant oral NOAEL Relevant dermal NOAEL No data available (1) Relevant inhalation NOAEL No data -available (1) Genotoxicity (Annex IIA, point 5.4) Limited information available (1) Long term toxicity and carcinogenicity (Annex IIA, point 5.5) Target/critical effect No data available (1) Relevant NOAEL No data available (1) Carcinogenicity No data available (1) 19

20 Reproductive toxicity (Annex IIA, point 5.6) Reproduction toxicity Reproduction target / critical effect Limited information available (1) Relevant parental NOAEL - Relevant reproductive NOAEL Relevant offspring NOAEL No data available Developmental toxicity Developmental target / critical effect No data available (1) Relevant maternal NOAEL No data available (1) - Relevant developmental NOAEL No data available (1) Relevant developmental neurotoxicity NOAEL No data available (1) Neurotoxicity (Annex IIA, point 5.7) Acute neurotoxicity No data available; (1) Other toxicological studies (Annex IIA, point 5.8) Mechanism studies No data available (1) Studies on metabolites No data available (1) Studies on impurities No data available (1) Medical data (Annex IIA, point 5.9) Limited information available (1) Summary (Annex IIA, point 5.10) Value Study Safety factor ADI Not data - - available; not required AOEL Limited - - information available. (1) ARfD Not data - - available; not required Dermal absorption (Annex IIIA, point 7.3) Default value of 100 % in the absence of data. 20

21 Exposure scenarios (Annex IIIA, point 7.2) Operator, workers and bystanders Risk assessment cannot be concluded. (1) Classification and proposed labelling with regard to toxicological data (Annex IIA, point 10) peer review proposal Tall Oil Pitch Limited information available to conclude. (1) 1) Limit information or no data are available. A general data gap has been established in the Mammalian Toxicology Section to address the toxicological profile of tall oil pitch and their representativeness to the specification in particular regarding to genotoxicity potential. 21

22 Residues Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered Rotational crops Metabolism in rotational crops similar to metabolism in primary crops? Processed commodities Residue pattern in processed commodities similar to residue pattern in raw commodities? Plant residue definition for monitoring Plant residue definition for risk assessment Conversion factor (monitoring to risk assessment) Not provided and not required Not provided and not required Not applicable Not provided and not required Not applicable Not applicable Not applicable Not applicable Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Conversion factor (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) Not provided and not required Not Relevant Not Relevant Not Relevant Not Relevant Not Relevant Not Relevant Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) Not applicable Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 Introduction) Not applicable Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Ruminant: Poultry: Pig: Conditions of requirement of feeding studies Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no - If yes, specify the evel) Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) No Νο Νο Νοt Required Νοt Required Νοt Required Feeding studies (Specify the feeding rate in cattle and poultry studies considered as relevant) Residue levels in matrices : Mean (max) mg/kg 22

23 Muscle Liver Kidney Fat Milk - Eggs - 23

24 Summary of residues data according to the representative uses on raw agricultural commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2) Crop Northern or Mediterranean Region, field or glasshouse, and any other useful information Trials results relevant to the representative uses (a) Recommendation/comments MRL estimated from trials according to the representative use HR (c) STMR (b) Not applicable (a) Numbers of trials in which particular residue levels were reported e.g. 3 x <0.01, 1 x 0.01, 6 x 0.02, 1 x 0.04, 1 x 0.08, 2 x 0.1, 2 x 0.15, 1 x 0.17 (b) Supervised Trials Median Residue i.e. the median residue level estimated on the basis of supervised trials relating to the representative use (c) Highest residue 24

25 Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to WHO European diet TMDI (% ADI) according to national (to be specified) diets IEDI (WHO European Diet) (% ADI) NEDI (specify diet) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (% ARfD) NESTI (% ARfD) according to national (to be specified) large portion consumption data Factors included in IESTI and NESTI Not proposed Not proposed Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/ process/ processed product Number of studies Processing factors Amount transferred (%) Transfer Yield factor factor (Optional) Not provided and not required Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6) Not applicable 25

26 Chapter 5: Fate and Behaviour in the Environment Route of degradation (aerobic) in soil (OECD data point number IIA 7.1.1) Mineralization after 100 days Non-extractable residues after 100 days Major metabolites - name and/or code, % of applied (range and maximum) No satisfactory information available, not required when applied with a brush. Route of degradation in soil - supplemental studies (OECD data point numbers IIA and IIA 7.1.3) Anaerobic degradation Soil photolysis Rate of degradation in soil (OECD data point numbers IIA 7.2, IIA 7.3, IIIA 9.1 and IIIA 9.2) Method of calculation Laboratory studies (range or median, with n value, with r 2 value) Degradation in the saturated zone: Field studies (state location, range or median with n value) Soil accumulation and plateau concentration Soil adsorption/desorption (OECD data point numbers IIA and IIA 7.4.2) Kf /Koc Kd ph dependence (yes / no) (if yes type of dependence) Mobility in soil (OECD data point numbers IIA IIA and IIIA IIIA 9.3.3) Column leaching Aged residues leaching Lysimeter/ field leaching studies 26

27 PEC (soil) (OECD data point number IIIA 9.4) Method of calculation Not calculated, Application rate Route and rate of degradation in water (OECD data point numbers IIA 2.9 & IIA 7.5 to IIA 7.9) Hydrolysis of active substance and relevant No metabolites metabolites (DT50) (state ph and temperature) Photolytic degradation of active substance and relevant metabolites Readily biodegradable (yes/no) Degradation in - DT50 water water/sediment - DT90 water (20 C) - DT50 whole system - DT90 whole system Mineralisation No (in the absence of satisfactory evidence from ready biodegradability studies dosed with representative test material) Non-extractable residues Distribution in water / sediment systems (active substance) Distribution in water / sediment systems (metabolites) PEC (surface water) (OECD data point numbers IIIA IIIA 9.8.6) Method of calculation Not calculated, Application rate Main routes of entry PEC (ground water) (OECD data point IIIA 9.6) Method of calculation and type of study (e.g. Not calculated, Modelling, monitoring, lysimeter ) Application rate PEC(gw) Maximum concentration Average annual concentration 27

28 Fate and behaviour in air (OECD data point numbers IIA 7.10 and IIIA 9.9) Direct photolysis in air Quantum yield of direct phototransformation Photochemical oxidative degradation in air Volatilization, provided any information provided to fulfil the data gap for information on volatilisation confirms low vapour pressure., provided any information provided to fulfil the data gap for information on volatilisation confirms low vapour pressure. Data gap, relevant for all uses assessed. PEC (air) Method of calculation Not calculated,, provided any information provided to fulfil the data gap for information on volatilisation confirms low vapour pressure. PEC(a) Maximum concentration - Residues requiring further assessment Environmental occurring residues requiring further assessment by other disciplines (toxicology and ecotoxicology) and or requiring consideration for groundwater exposure. A meaningful usable definition for residues was not proposed, but it is considered not required, provided any information provided to fulfil the data gap for information on volatilisation confirms low vapour pressure. Monitoring data, if available (OECD data point number IIA 7.12) Soil (indicate location and type of study) - Surface water (indicate location and type of - study) Ground water (indicate location and type of - study) Air (indicate location and type of study) - Points pertinent to the classification and proposed labelling with regard to fate and behaviour data Candidate for classification as R53. Not readily biodegradable, (in the absence of satisfactory evidence from ready biodegradability studies dosed with representative test material). 28

29 Chapter 6: Effects on Non-target Species Effects on terrestrial vertebrates (Annex IIA, point 8.1; Annex IIIA, points 10.1 and 10.3) Acute toxicity to mammals 2 No data available 1 Acute toxicity to birds No data available 1 Dietary toxicity to birds No data available 1 Reproductive toxicity to birds No data available 1 Reproductive/long term toxicity to No data available 1 mammals 2 Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2) Species Test substance Study Type LC 50 /EC 50 [mg/l] LC 0 /NOEC [mg/l] Zebrafish Morsuvin Static 96h > Daphnia magna Morsuvin Static 48h > Desmodesmus subspicatus Morsuvin Static 72h > Bioconcentration Bioconcentration factor (BCF) Annex VI Trigger for the bioconcentration factor Clearance time (CT 50 ) (CT 90 ) Level of residues (%) in organisms after the 14 day depuration phase No data available. Not required. Not required Not required Not required Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4) Acute oral toxicity No data available 1 Acute contact toxicity No data available 1 Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5) 29

30 Test Test species Summary of design Endpoints No data available 1 Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6) Acute toxicity No data available 1 Chronic and reproductive toxicity No data available 1 Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7) Nitrogen mineralization No data available 1 Carbon mineralization No data available 1 Ecotoxicologically relevant compounds (consider parent and all relevant metabolites requiring further assessment from the fate section) Compartment soil - water - sediment - groundwater - Classification and proposed labelling with regard to ecotoxicological data (Annex IIA, point 10 and Annex IIIA, point 12.3) RMS/peer review proposal Active substance No classification RMS/peer review proposal Preparation No classification 1 A general data gap was indentified in the Ecotoxicolgy Section, pending on fate and behaviour, the risk of tail oil pitch to non-target species should be addressed for the representative use. 30

31 ABBREVIATIONS (Please highlight additional entries in Turquoise) 1/n slope of Freundlich isotherm λ wavelength decadic molar extinction coefficient C degree Celsius (centigrade) µg microgram µm micrometer (micron) a.s. active substance AChE acetylcholinesterase ADE actual dermal exposure ADI acceptable daily intake AF assessment factor AOEL acceptable operator exposure level AP alkaline phosphatase AR applied radioactivity ARfD acute reference dose AST aspartate aminotransferase (SGOT) AV avoidance factor BCF bioconcentration factor BUN blood urea nitrogen bw body weight CAS Chemical Abstracts Service CFU colony forming units ChE cholinesterase CI confidence interval CIPAC Collaborative International Pesticides Analytical Council Limited CL confidence limits cm centimetre d day DAA days after application DAR draft assessment report DAT days after treatment DM dry matter DT 50 period required for 50 percent disappearance (define method of estimation) DT 90 period required for 90 percent disappearance (define method of estimation) dw dry weight EbC 50 effective concentration (biomass) EC 50 effective concentration ECHA European Chemical Agency EEC European Economic Community EINECS European Inventory of Existing Commercial Chemical Substances ELINCS European List of New Chemical Substances EMDI estimated maximum daily intake ER 50 emergence rate/effective rate, median ErC 50 effective concentration (growth rate) EU European Union EUROPOEM European Predictive Operator Exposure Model f(twa) time weighted average factor FAO Food and Agriculture Organisation of the United Nations FIR Food intake rate FOB functional observation battery FOCUS Forum for the Co-ordination of Pesticide Fate Models and their Use 31

32 g GAP GCPF GGT GM GS GSH h ha Hb Hct hl HQ IEDI IESTI ISO IUPAC JMPR K doc kg K Foc L LD 50 LDH LOAEL m M/L MAF MCH MCHC MCV mg ml mm mn MRL MSDS MTD MWHC NESTI ng NOAEC NOAEL NOEC NOEL OM PA PD PEC PEC air PEC gw PEC sed PEC soil gram good agricultural practice Global Crop Protection Federation (formerly known as GIFAP) gamma glutamyl transferase geometric mean growth stage glutathion hour(s) hectare haemoglobin haematocrit hectolitre hazard quotient international estimated daily intake international estimated short-term intake International Organisation for Standardisation International Union of Pure and Applied Chemistry Joint Meeting on the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesticide Residues) organic carbon linear adsorption coefficient kilogram Freundlich organic carbon adsorption coefficient litre lethal dose, median; dosis letalis media lactate dehydrogenase lowest observable adverse effect level metre mixing and loading multiple application factor mean corpuscular haemoglobin mean corpuscular haemoglobin concentration mean corpuscular volume milligram millilitre millimetre milli-newton maximum residue limit or level material safety data sheet maximum tolerated dose maximum water holding capacity national estimated short-term intake nanogram no observed adverse effect concentration no observed adverse effect level no observed effect concentration no observed effect level organic matter content paste, water based, film-forming composition proportion of different food types predicted environmental concentration predicted environmental concentration in air predicted environmental concentration in ground water predicted environmental concentration in sediment predicted environmental concentration in soil 32

33 PEC sw predicted environmental concentration in surface water ph ph-value PHED pesticide handler's exposure data PHI pre-harvest interval PIE potential inhalation exposure pk a negative logarithm (to the base 10) of the dissociation constant P ow partition coefficient between n-octanol and water PPE personal protective equipment ppm parts per million (10-6 ) ppp plant protection product PT proportion of diet obtained in the treated area PTT partial thromboplastin time QSAR quantitative structure-activity relationship r 2 coefficient of determination RPE respiratory protective equipment RUD residue per unit dose SC suspension concentrate SD standard deviation SFO single first-order SSD species sensitivity distribution STMR supervised trials median residue t 1/2 half-life (define method of estimation) TER toxicity exposure ratio TER A toxicity exposure ratio for acute exposure TER LT toxicity exposure ratio following chronic exposure TER ST toxicity exposure ratio following repeated exposure TK technical concentrate TLV threshold limit value TMDI theoretical maximum daily intake TRR total radioactive residue TSH thyroid stimulating hormone (thyrotropin) TWA time weighted average UDS unscheduled DNA synthesis UV ultraviolet W/S water/sediment w/v weight per volume w/w weight per weight WBC white blood cell WHO World Health Organisation wk week yr year 33