Art. 51 Extension of authorisation for minor uses. Risk Management

Transcription

1 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 1 of 11 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Flordimex 420 Active Substance: Ethephon 420 g/l COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: CBW Chemie GmbH Date: 17/07/2014 BVL_FO_05_2422_200_V1.0 Applicant CBW Chemie GmbH Date: 17/07/2014

2 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 2 of 11 Table of Contents PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC R and S phrases under Directive 2003/82/EC (Annex IV and V) Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access BVL_FO_05_2422_200_V1.0 Applicant CBW Chemie GmbH Date: 17/07/2014

3 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 3 of 11 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Flordimex 420 containing Ethephon in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. The following sections of Registration Report, Part B were prepared on basis of new data: Section 4. Assessments for the safe use of Flordimex 420 have been made using endpoints agreed in the EU reviews of Ethephon. Appendix 1 of this document provides a copy of the final product authorisation in Germany. See below. 1 Details of the application Application to extend the authorisation of a plant protection product (PPP) already authorised in Germany to minor uses not yet covered by that authorisation. The application is intended for use in Germany only. 1.1 Application background Details on applicant and application Plant protection product Flordimex 420 Type of application Registration number /02 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS=DE, first application (GV1) Nufarm Deutschland GmbH on behalf of CBW Chemie GmbH, Bitterfeld- Wolfen, Greppiner Str. 19, Wolfen CBW Chemie GmbH Bitterfeld-Wolfen Greppiner Str Wolfen Growth regulator Expiration of authorisation Water soluble concentrate (SL) BVL_FO_05_2422_200_V1.0 Applicant CBW Chemie GmbH Date: 17/07/2014

4 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Ethephon (0481) Content in PPP 420 g/l Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/07/ Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 001 Tomato (greenhouse) Increase of fruit-ripening Authorise Public interest and minor use According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In Germany the cultivated area of tomato in greenhouse is about 315 ha, of which approx. 126 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested use. Upon this calculation and the examination of available alternative measures for the applied use it can be stated that the applied use is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims The applicant is owner of the new studies submitted and claims data protection. 1.5 Letters of Access BVL_FO_05_2422_200_V1.0 The applicant is owner of the new studies submitted. Authorisation holder agrees to the current application to extend the authorisation. Applicant CBW Chemie GmbH Date: 17/07/2014

5 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 5 of 11 2 Details of the authorisation 2.1 Product identity Product name Flordimex 420 Authorisation number Composition Ethephon 420 g/ Type of formulation Function Authorisation holder 2.2 Classification and labelling Water soluble concentrate (SL) Growth Regulator CBW Chemie GmbH Bitterfeld-Wolfen Greppiner Str Wolfen Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 N Xi R 41 R 51/53 S 2 S 26 S 35 S 39 S 46 S 57 SP001 Dangerous for the environment Irritant Risk of serious damage to eyes Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment Keep out of the reach of children. In case of contact with the eyes, rinse thoroughly and seek medical advice. This material and its container must be disposed of in a safe way. Wear eye/face protection. If swallowed, seek medical advice immediately and show this container or label. Use appropriate container to avoid environmental contamination. To avoid riks to man and the environment, comply with the instructions for use R and S phrases under Regulation (EC) No 547/2011 EO005-2 SPo 5: Ventilate greenhouses thoroughly before re-entry Other phrases BVL_FO_05_2422_200_V Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection Applicant CBW Chemie GmbH Date: 17/07/2014

6 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 6 of 11 SB001 SB110 SE110 SF1891 SS110 SS120 SS2202 ST1203 Avoid any unnecessary contact with the product. Misuse can lead to health damage. The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. Wear tight fitting eye protection when handling the undiluted product. Re-entering the treated areas/crops are only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. Wear standard protective gloves (plant protection) when handling the undiluted product. Wear standard protective gloves (plant protection) when handling/applying the product ready for application. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. Wear particle-filtering half mask FFP2 or half mask with particle filter P2 (identification colour: white) according to the BVL guideline "Personal protective equipment for handling plant protection products", current version, when applying/handling the product ready for application. Ecosystem protection NW262 NW263 NW468 Honeybee The product is toxic for algae. The product is toxic for aquatic invertebrates. Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. Integrated Pest Management (IPM) NN291 The product is classified as slightly harmful for populations of the species Episyrphus balteatus (hover fly). Mode of action (FRAC/HRAC/IRAC-Group): none Active substance VH361 The content of 2-chlorethylphosphonacid-mono-2-chlorethylester may not exceed 20 g/kg and the content of 1,2-dichlorethane may not exceed 0,5 g/kg in the technical active substance ethephon. The authorization of the PPP is linked to the following conditions (voluntary labelling): BVL_FO_05_2422_200_V1.0 Honeybee NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4) Integrated Pest Management (IPM) NN130 The product is classified as harmless for populations of the species Pardosa amentata and Applicant CBW Chemie GmbH Date: 17/07/2014

7 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 7 of 11 NN134 NN165 NN170 palustris (lycosid spiders). The product is classified as harmless for populations of the species Typhlodromus pyri (predatory mite). The product is classified as harmless for populations of the species Poecilus cupreus (ground beetle). The product is classified as harmless for populations of the species Chrysoperla carnea (lacewing). NN1842 The product is classified as harmless for populations of the species Aphidius rhopalosiphi (braconid wasp) Specific restrictions linked to the intended uses Some of the authorized uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Ecosystem protection BVL_FO_05_2422_200_V1.0 Applicant CBW Chemie GmbH Date: 17/07/2014

8 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 8 of Product uses PPP (product name/code) Flordimex 420 ( ) Formulation type: SL active substance Ethephon Conc. of as: 420 g/l safener - synergist - Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): Verified by MS:y Nufarm on behalf of CBW Chemie GmbH central EU professional use non professional use Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) 001 DE Tomato (LYPES) G Increase of fruitripening (YREIF) Method / Kind spraying Application Application rate PHI Max. number kg, L product / g, kg as/ha Water L/ha (days) (min. interval ha between a) max. rate per a) max. rate min / max applications) appl. per appl. a) per use Timing / Growth stage of crop & season 7 days before harvest b) per crop/ season a) 1 b) 1 b) max. total rate per crop/season a) 1 L/ha b) 1 L/ha b) max. total rate per crop/season a) 0.42 kg as/ha b) 0,42 kg as/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Restrictions (see ) BVL_FO_05_2422_200_V1.0 Applicant CBW Chemie GmbH Date: 17/07/2014

9 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 9 of 11 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues Analytical methods for commodities of high water content such as tomatoes are available and acceptable for enforcing Ethephon Mammalian Toxicology The PPP is already registered in Germany according to Directive 91/414/EEC. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Residues and Consumer Exposure The residue behaviour of the active substance Ethephon has been evaluated as part of the national authorisation process. Information about metabolism is sufficient to evaluate the intended use in tomatoes Residues The available residue information is sufficient to perform an adequate assessment. Residues that are expected from the intended use of the plant protection product will not exceed the MRL set in Regulation (EC) No 396/2005 for Ethephon (1 mg/kg) Consumer exposure An assessment of residue uptake by consumers (TMDI calculation, EFSA PRIMo) results in the following maximum ADI consumptions: BVL_FO_05_2422_200_V1.0 ADI 0.03 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 127 % (based on WHO Cluster diet B) NTMDI (% ADI) according to German NVS II model 64 % (based on children aged 2-4 years) IEDI (EFSA PRIMo) (% ADI) 64 % (based on WHO Cluster diet B) NEDI (German NVS II model) (% ADI) Factors included in IEDI ARfD Not necessary PF Olive oil: 0.02, STMR tomato 0.14 mg/kg 0.05 mg/kg bw Applicant CBW Chemie GmbH Date: 17/07/2014

10 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 10 of 11 IESTI (EFSA PRIMo) (% ARfD) NESTI (German NVS II model) (% ARfD) Factors included in IESTI and NESTI Tomato: 84 % (based on BE children) Tomato: 71 % (based on DE children aged 2-4 years) none The chronic and the short-term intake of Ethephon residues are not expected to present a public health concern. As far as consumer health protection is concerned Germany agrees with the authorization of the intended use Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. No risk mitigation is necessary to avoid harmful effects on groundwater considering use patterns as laid down in Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. The PPP Flordimex 420 and the active substance Ethephon are toxic to the aquatic environment (Daphnia magna: Ethephon NOEC (21 d) semistat. = 86 µg a.i./l). Subsequently no additional entries as those according to the evaluated use pattern and good agricultural practise are acceptable. Therefore the safety phrases and conditions of use NW262, NW263 and NW468 are assigned, see also 2.2. Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 1107/2009 (see also point 2.2) Efficacy Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the use applied for under the terms of Article 51 of regulation (EC) No 1107/2009. According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. BVL_FO_05_2422_200_V Conclusions PPP Flordimex 420 is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of use. Applicant CBW Chemie GmbH Date: 17/07/2014

11 Part A National Assessment Flordimex 420 Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Registration Report Central Zone Country Germany Page 11 of 11 The intended use in tomatoes will not result in residues above the MRL as set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of tomatoes with residues of Ethephon is not expected. There is no special risk mitigation necessary which deviates from the existing registration. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. An authorisation can be granted. 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation None Appendix 1 Copy of the product authorisation See below. Appendix 2 Copy of the product label No product label available. Not mandatory according to Article 51 (5) Appendix 3 Letter of Access No letter of access necessary. The applicant is owner of the new studies submitted. Authorisation holder agrees to the current application to extend the authorisation. BVL_FO_05_2422_200_V1.0 Applicant CBW Chemie GmbH Date: 17/07/2014

12 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Dietmar Gottschild Referent CBW Chemie GmbH Bitterfeld-Wolfen Greppiner Straße Wolfen IHR ZEICHEN IHRE NACHRICHT VOM TELEFON +49 (0) TELEFAX +49 (0) AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 19. August 2014 GV /02 Flordimex 420 Verfahren zur Erweiterung einer Zulassung nach Artikel 51 Abs. 1 der Verordnung (EG) Nr. 1107/2009 Bescheid Die Zulassung des oben genannten Pflanzenschutzmittels mit dem Wirkstoff: 420 g/l Ethephon Zulassungsnummer: Versuchsbezeichnung: BIT W-0-SL Antrag vom: 7. Juni 2013 wird wie in Anlage 1 beschrieben auf der Grundlage von Art. 51 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (Abl. L 309 vom , S. 1) um folgende Anwendungsgebiete bzw. Anwendungen erweitert: BVL_FO_05_2468_200_V1.3 Anwendungsnummer Zweckbestimmung Objekte Schadorganismus/ Pflanzen/-erzeugnisse/ / Reifebeschleunigung Tomate Verwendungszweck Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet:

13 SEITE 2 VON 3 Festgesetzte Anwendungsbestimmungen Es werden folgende Anwendungsbestimmungen gemäß 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz- PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 87 des Gesetzes vom 7. August 2013 (BGBl. I S. 3154) festgesetzt: Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. Auflagen Die Zulassung wird mit folgenden Auflagen gemäß 36 Abs. 3 S. 1 PflSchG verbunden: Siehe Anlage 1, jeweils unter Nr. 2. Vorbehalt Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden. Abgelehnte Anwendungsgebiete bzw. Anwendungen Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine - Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. Rechtsbehelfsbelehrung Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, Braunschweig, schriftlich oder zur Niederschrift einzulegen. Mit freundlichen Grüßen im Auftrag gez. Dr. Gerhard Joermann Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. BVL_FO_05_2468_200_V1.3 Anlage

14 SEITE 3 VON 3 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Reifebeschleunigung Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Tomate 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Anwendungszeitpunkt: Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: Aufwand: Gemüsebau Gewächshaus Nein 7 Tage vor der Ernte spritzen - 1 l/ha in maximal 1200 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten 7 Tage Gewächshaus: Tomate 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2468_200_V1.3

15 Flordimex /02 Part B Section 4 - Core Assessment zrms version REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Flordimex 420 Active Substance: 420 g/l Ethephon Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: CBW Chemie GmbH Date: March 2014 Page 1 / 14

16 Flordimex /02 Part B Section 4 - Core Assessment zrms version Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Evaluation of the intended use(s) Selection of critical use and justification Tomato Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Consumer intake and risk assessment Proposed maximum residue levels (MRLs) Conclusion... 7 Appendix 1 List of data submitted in support of the evaluation... 7 Appendix 2 Detailed evaluation of the additional studies relied upon... 8 A 2.1 Storage stability... 8 A 2.2 Residues in primary crops... 8 A Nature of residues... 8 A Magnitude of residues in Tomatoes... 9 A Additional data from German production sites A 2.3 Residues in processed commodities A 2.4 Residues in rotational crops A 2.5 Residues in livestock A 2.6 Other studies/information Appendix 3 Pesticide Residue Intake Model (PRIMo) Page 2 / 14

17 Flordimex /02 Part B Section 4 - Core Assessment zrms version 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances Not conducted in this context. 4.2 Evaluation of the intended use(s) Selection of critical use and justification The only GAP reported for the zone is presented in Table It has been used for consumer intake and risk assessment. Page 3 / 14

18 Flordimex /02 Part B Section 4 - Core Assessment zrms version Table 4.2-1: Critical Use (worst case) used for consumer intake and risk assessment Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) (a) 1 DE Tomatoes ( ) F G or I (b) Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) (c) Application Application rate PHI Method / Kind (d-f) Timing / Growth stage of crop & season G Fruit ripening Spraying 7 days before harvest (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) a) 1 b) 1 L product / ha a) max. rate per appl. b) max. total rate per crop/season a) 1 b) 1 kg as/ha a) max. rate per appl. b) max. total rate per crop/season a) 0.42 b) 0.42 Water L/ha min / max max (days) (i) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) Remarks: (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) All abbreviations used must be explained (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (h) The minimum and maximum number of application possible under practical conditions of use must be provided (i) PHI - minimum pre-harvest interval (j) Remarks may include: Extent of use/economic importance/restrictions Page 4 / 14

19 Flordimex /02 Part B Section 4 - Core Assessment zrms version Tomato Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of ethephon in tomatoes grown in glasshouse. For the detailed evaluation of the trials it is referred to Appendix 2. The submitted dataset is based on four supervised field trials conducted in Germany and on additional data from commercial production. The latter received a limited approval for the application of ethephon in compliance with the intended GAP. Harvested tomatoes had to be analysed by the responsible Federal surveillance laboratories before marketing. This provided further knowledge on the magnitude of residues after treatment. However, the additional information is only available in summary reports and does not include detailed geographic site locations, actual application rates (only nominal rates reported), crop information (variety, planting or harvest dates), the maximum storage interval or validation data of the analytical methods used. Table 4.2-2: Overview of the selected supervised residue trials for ethephon in tomatoes Commodity Region (a) Supervised trial data Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (ethephon) Risk assessment (ethephon) STMR (mg/kg) (b) HR (mg/kg) (c) Median CF (d) Tomato - Indoor 0.2, 0.22, 0.24, 0.45 Not applicable Additional data (see text above for explanation) Tomato (Baden- Württemberg, ASB ) Tomato (Brandenburg, ASB ) Tomato (Niedersachsen, ASB ) Tomato (Thüringen, ASB ) Combined data - Indoor 0.1, 0.12, 0.72 Not applicable - Indoor 0.16, 0.19, 0.36 Not applicable - Indoor 0.087, 0.14, 0.18, 0.18, 0.27, Indoor 0.04(3), 0.06(4), 0.07, 0.08, 0.09, 0.09, 0.1, 0.12(4), 0.14(3), 0.16, 0.18, 0.18, 0.21 Tomato - Indoor 0.04(3), 0.06(4), 0.07, 0.08, 0.087, 0.09, 0.09, 0.1, 0.1, 0.12(5), 0.14(4), 0.16, 0.16, 0.18(4), 0.19, 0.2, 0.21, 0.22, 0.24, 0.27, 0.36, 0.45, 0.48, (3), 0.06(4), 0.07, 0.08, 0.087, 0.09, 0.09, 0.1, 0.1, 0.12(5), 0.14(4), 0.16, 0.16, 0.18(4), 0.19, 0.2, 0.21, 0.22, 0.24, 0.27, 0.36, 0.45, 0.48, 0.72 Not applicable Not applicable Not applicable (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Page 5 / 14

20 Flordimex /02 Part B Section 4 - Core Assessment zrms version Analytical methods for commodities of high water content such as tomatoes are available and acceptable for enforcing ethephon Distribution of the residue in peel/pulp Not relevant Residues in processed commodities No data submitted. Glasshouse grown tomatoes are normally intended for direct consumption Proposed pre-harvest intervals, withholding periods Proposed preharvest interval: 7 days 4.3 Consumer intake and risk assessment The consumer intake and risk assessment is based on the appropriate input values given in Table and the toxicological reference values stated in Table For the detailed calculation results it is referred to Appendix 3. Table 4.3-1: Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Acute risk assessment Input value (mg/kg) Tomato 0.14 STMR 0.72 HR Olives for olive oil production variable MRL 0.02 (PF, EFSA 2009) Comment - Not necessary Other commodities variable MRL - Not necessary Table 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI 0.03 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 127 % (based on WHO Cluster diet B) NTMDI (% ADI) according to German NVS II model 64 % (based on children aged 2-4 years) IEDI (EFSA PRIMo) (% ADI) 64 % (based on WHO Cluster diet B) NEDI (German NVS II model) (% ADI) Factors included in IEDI ARfD IESTI (EFSA PRIMo) (% ARfD) NESTI (German NVS II model) (% ARfD) Factors included in IESTI and NESTI Not necessary PF Olive oil: 0.02, STMR tomato 0.14 mg/kg 0.05 mg/kg bw Tomato: 84 % (based on BE children) Tomato: 71 % (based on DE children aged 2-4 years) none 4.4 Proposed maximum residue levels (MRLs) No new MRLs are required. Page 6 / 14

21 Flordimex /02 Part B Section 4 - Core Assessment zrms version 4.5 Conclusion For the evaluation of the intended use, four supervised field trials were submitted, which is below the minimum of eight trials normally required for a major crop like tomatoes. However, additional data from German production sites were reported based on locally limited approvals. In the opinion of the RMS, this data can be used as supportive information since the magnitude of residues is in the range of the data obtained from supervised trials, which indicates that the actual application rate was close to the nominal rate and samples were harvested and immediately analysed in federal surveillance laboratories. The routine analytical methods are validated according to common EU-Guidances and tested by proficiency tests. In DE s opinion, the data available are considered sufficient for risk assessment. An exceedance of the current MRL of 1 mg/kg for ethephon in tomatoes as laid down in Reg. (EC) No 396/2005 is not expected. The chronic and the short-term intake of ethephon residues is unlikely to present a public health concern. As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended use. Appendix 1 List of data submitted in support of the evaluation Table A 1: Annex point/ reference No List of data submitted in support of the evaluation Author(s) Year Title Report-No. Authority registration No KIIA 6.3 Anon Rückstandsdaten zu Ethephon in Tomaten, Baden-Würtenberg GLP: No Published: No BVL , ASB KIIA 6.3 Anon Ethephon / Flordimex: Zusammenfassung der guten landwirtschaftlichen Praxis - ergänzende Unterlagen Data protection claimed Owner Yes LTZ Y Yes NUD N How considered in drr * GLP: No Published: No BVL , ASB KIIA 6.3 Götz, R Anwendung von Flordimex zur Reifebeschleunigung in Gewächshaustomaten Yes Thüringer Landesanstalt Y GLP: No Published: No BVL , ASB KIIA 6.3 Offenbacher, G Rückstandsanalytik von Ethephon (Flordimex 420) in Tomaten (unter Glas) AP 04/11 GLP: Yes Published: No BVL , ASB KIIA 6.3 Roeder, S Rückstandswerte in Gewächshaustomaten - Brandenburg Yes MZ1 Y Yes LELF Y GLP: No Published: No BVL , ASB Page 7 / 14

22 Flordimex /02 Part B Section 4 - Core Assessment zrms version Annex point/ reference No Author(s) Year Title Report-No. Authority registration No KIIA 6.3 Wichura, A Einsatz von Flordimex 420 zur Reifebeschleunigung in Tomaten unter Glas Data protection claimed Owner Yes HR1 Y How considered in drr * GLP: No Published: No BVL , ASB * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability No further study on storage stability submitted/needed. A 2.2 Residues in primary crops A Nature of residues No further study on nature of residues submitted/needed. Page 8 / 14

23 Flordimex /02 Part B Section 4 - Core Assessment zrms version A Magnitude of residues in Tomatoes Reference: OECD KIIA 6.3 Report Guideline(s): Deviations: GLP: Acceptability: Table A 2: ASB no Not applicable, sufficient information provided on site location, applied active substance, analytical method, storage interval and sampling. Yes Yes Residues of ethephon in tomatoes (indoor) RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : ethephon (Application on agricultural and horticultural crops) Crop / crop group : Tomatoes Crop Code : LYPES Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 420 g/l Indoors / Outdoors : Indoors Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Flordimex 420 (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : ethephon Page 9 / 14

24 Flordimex /02 Part B Section 4 - Core Assessment zrms version Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date study AP 04/11 (analytical report), trial RU-H NW BN 1/1 (GLP 11/043) Harvest trial Germany (DE) Bonn Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) unknown 1) ) BBCH fruit ) spraying (planting) ) 3) analytical method: SOP 5505 V01 (LC-MS/MS), LOQ(s): 0.02 mg/kg (fruit), max. sample storage time in month(s): 7 field report is not provided ASB study AP 04/11 (analytical report), trial RU-H NW BN 1/2 (GLP 11/044) Harvest trial Germany (DE) Bonn unknown 1) 2011 (planting) 2) 3) ) BBCH fruit ) spraying analytical method: SOP 5505 V01 (LC-MS/MS), LOQ(s): 0.02 mg/kg (fruit), max. sample storage time in month(s): 7 field report is not provided ASB study AP 04/11 (analytical report), trial RU-H TH EF 1/1 Decline trial Germany (DE) Erfurt-Kühnhausen unknown 1) 2011 (planting) 2) 3) ) BBCH fruit controls > LOQ fruit ) spraying analytical method: SOP 5505 V01 (LC-MS/MS), LOQ(s): 0.02 mg/kg (fruit), max. sample storage time in month(s): 6 field report is not provided ASB Page 10 / 14

25 Flordimex /02 Part B Section 4 - Core Assessment zrms version Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date study AP 04/11 (analytical report), trial RU-H HE WE 1/1 Harvest trial Germany (DE) Wetzlar Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) unknown 1) ) BBCH fruit ) spraying (planting) ) 3) analytical method: SOP 5505 V01 (LC-MS/MS), LOQ(s): 0.02 mg/kg (fruit), max. sample storage time in month(s): 9 field report is not provided Remarks: (a) (b) (c) (d) (e) According to CODEX Classification / Guide Only if relevant Year must be indicated Days after last application (Label pre-harvest interval, PHI, underline) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included ASB Comments of zrms: Acceptable. Page 11 / 14

26 Flordimex /02 Part B Section 4 - Core Assessment zrms version A Additional data from German production sites Baden-Württemberg (ASB ) In Baden-Württemberg small and large tomato varieties in two different kinds of glasshouses (heated and unheated) were treated with one spray application of either 1 L/ha (0.42 kg ai/ha) or 1.5 L ha (0.63 kg ai/ha) in 1200 L water/ha. Samples of mature fruits were collected 5, 7 and 9 days after the application ( ). Table A 3: Residues of ethephon in tomatoes (Baden-Württemberg, 2011) Variety Application Sampling DAT Ethephon [mg/kg] Heated glasshouse Small fruits 1 1 L/ha (0.42 kg ai/ha) in 1200 L water/ha, L/ha (0.63 kg ai/ha) in 1200 L water/ha, Normal fruits 1 1 L/ha (0.42 kg ai/ha) in 1200 L water/ha, L/ha (0.63 kg ai/ha) in 1200 L water/ha, Unheated glasshouse Normal fruits 1 1 L/ha (0.42 kg ai/ha) in 1200 L water/ha, L/ha (0.63 kg ai/ha) in 1200 L water/ha, Brandenburg (ASB ) In Brandenburg tomatoes grown in glasshouse received one spray application of 1 L/ha (0.42 kg ai/ha). Samples of mature fruits were collected after 10 days. Table A 4: Residues of ethephon in tomatoes (Brandenburg, 2011) Variety Application Sampling DAT Ethephon [mg/kg] Not specified 1 1 L/ha (0.42 kg ai/ha), Not specified 1 1 L/ha (0.42 kg ai/ha), Not specified 1 1 L/ha (0.42 kg ai/ha), Niedersachen (ASB ) In Niedersachsen tomatoes grown in glasshouse received one spray application of 1 L/ha (0.42 kg ai/ha) in L water/ha. Samples of mature fruits were collected after 6-10 days. Table A 5: Residues of ethephon in tomatoes (Niedersachsen, 2011) Variety Application Sampling DAT Ethephon [mg/kg] Normal fruits 1 1 L/ha (0.42 kg ai/ha) in 1200 L water/ha, Normal fruits 1 1 L/ha (0.42 kg ai/ha) in 1200 L water/ha, Mecano (normal fruits) 1 1 L/ha (0.42 kg ai/ha) in 1100 L water/ha, Mecano (normal fruits) 1 1 L/ha (0.42 kg ai/ha) in 1100 L water/ha, Normal fruits 1 1 L/ha (0.42 kg ai/ha) in 1100 L water/ha, Normal fruits 1 1 L/ha (0.42 kg ai/ha) in 1000 L water/ha, Thüringen (ASB ) In Thüringen tomatoes grown in glasshouse received one spray application of 1 L/ha (0.42 kg ai/ha). Samples of mature fruits were collected after 6-9 days Page 12 / 14

27 Flordimex /02 Part B Section 4 - Core Assessment zrms version Table A 6: Residues of ethephon in tomatoes (Thüringen, 2011) Variety Application Sampling DAT Ethephon [mg/kg] Annamy (normal fruits) 1 1 L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), Cappricia (normal fruits) 1 1 L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), Lyterno (normal fruits) 1 1 L/ha (0.42 kg ai/ha), Delioso (normal fruits) 1 1 L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), Lyterno (normal fruits) 1 1 L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), L/ha (0.42 kg ai/ha), A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted. A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted. A 2.5 Residues in livestock No new study on residues in livestock has been submitted. A 2.6 None Other studies/information Page 13 / 14

28 Flordimex /02 Part B Section 4 - Core Assessment zrms version Appendix 3 Pesticide Residue Intake Model (PRIMo) Ethephon Status of the active substance: Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0,03 ARfD (mg/kg bw): 0,05 Source of ADI: EFSA Source of ARfD: EFSA Year of evaluation: 2008 Year of evaluation: 2008 Explain choice of toxicological reference values. The risk assessment has been performed on the basis of the MRLs collected from Member States in April For each pesticide/commodity the highest national MRL was identified (proposed temporary MRL = ptmrl). The ptmrls have been submitted to EFSA in September Chronic risk assessment TMDI (range) in % of ADI minimum - maximum No of diets exceeding ADI: --- Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities 64,2 WHO Cluster diet B 28,5 Wheat 11,9 Wine grapes 10,3 Tomatoes 58,1 DE child 24,1 Apples 13,7 Wheat 3,6 Cherries 44,9 NL child 15,8 Wheat 12,7 Apples 4,9 Milk and cream, 44,8 DK child 18,3 Wheat 14,7 Rye 4,6 Apples 42,9 FR all population 26,7 Wine grapes 11,0 Wheat 1,4 Tomatoes 39,0 PT General population 16,6 Wine grapes 13,1 Wheat 3,0 Tomatoes 37,7 WHO cluster diet E 13,1 Wheat 10,7 Wine grapes 2,7 Barley 36,1 WHO cluster diet D 21,7 Wheat 3,4 Tomatoes 2,4 Wine grapes 32,2 IE adult 8,3 Wine grapes 7,7 Wheat 4,1 Barley 31,4 IT kids/toddler 22,2 Wheat 4,8 Tomatoes 1,8 Apples 30,2 UK Toddler 13,1 Wheat 3,8 SUGAR PLANTS 3,4 Milk and cream, 29,8 WHO Cluster diet F 12,0 Wheat 4,0 Wine grapes 2,5 Rye 28,2 FR toddler 8,7 Wheat 6,6 Milk and cream, 5,2 Apples 27,6 ES child 14,8 Wheat 3,3 Tomatoes 2,3 Apples 26,1 UK Infant 8,7 Wheat 6,5 Milk and cream, 3,1 Apples 25,3 WHO regional European diet 9,9 Wheat 3,7 Tomatoes 1,8 Pineapples 23,6 SE general population 90th percentile 10,7 Wheat 2,6 Tomatoes 2,1 Apples 23,5 DK adult 9,3 Wine grapes 6,7 Wheat 2,3 Rye 21,6 IT adult 13,8 Wheat 3,9 Tomatoes 1,6 Apples 20,9 NL general 6,9 Wheat 4,2 Wine grapes 2,4 Apples 20,8 ES adult 7,8 Wheat 2,8 Wine grapes 2,6 Tomatoes 18,7 UK vegetarian 6,8 Wheat 5,4 Wine grapes 2,1 Tomatoes 17,9 UK Adult 7,2 Wine grapes 5,6 Wheat 1,5 Tomatoes 16,3 FR infant 5,0 Apples 4,3 Milk and cream, 2,8 Wheat 15,3 LT adult 3,7 Apples 3,6 Rye 3,5 Wheat 14,4 FI adult 3,3 Wheat 2,3 Rye 2,0 Wine grapes 10,0 PL general population 4,1 Apples 2,9 Tomatoes 0,9 Cherries ptmrls at LOQ (in % of ADI) Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Ethephon is unlikely to present a public health concern. Page 14 / 14