REGISTRATION REPORT Part A. Risk Management. COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT

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1 Part A National Assessment Germany - Central Zone Page 1 of 20 REGISTRATION REPORT Part A Risk Management Product code: Active Substance: 6-Benzyladenine (20 g/l) COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Date: 18/02/2013 Fine Agrochemicals Limited Evaluator: Germany Date: 18/02/2013

2 Part A National Assessment Germany - Central Zone Page 2 of 20 Table of Contents PART A Risk Management 4 1 Details of the application Application background Annex I inclusion Regulatory approach Data protection claims Letters of Access 5 2 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 8 3 Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties (Part B, Section 1, Points 2 and 4) Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) Analytical methods for residues (Part B, Section 2, Points ) Mammalian Toxicology (Part B, Section 3, Point 7) Acute Toxicity (Part B, Section 3, Point 7.1) Operator Exposure (Part B, Section 3, Point 7.4) Bystander and Resident Exposure (Part B, Section 3, Point 7.4) Worker Exposure (Part B, Section 3, Point 7.4) Residues and Consumer Exposure (Part B, Section 4, Point 8) Residues (Part B, Section 4, Points 8.2) Consumer exposure (Part B, Section 4, Point 8.3) Environmental fate and behaviour (Part B, Section 5, Point 9) Ecotoxicology (Part B, Section 6, Point 10) Effects on Aquatic Species (Part B, Section 6, Point 10.2) 14 Evaluator: DE Date: 18/02/2013

3 Part A National Assessment Germany - Central Zone Page 3 of Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) Effects on organic matter breakdown (Part B, Section 6, Point 10.6) Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Efficacy (Part B, Section 7, Point 8) Adverse Effects Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 19 Appendix 1 Copy of the product authorisation 20 Appendix 2 Copy of the product label 20 Appendix 3 Letter of Access 20 Evaluator: DE Date: 18/02/2013

4 Part A National Assessment Germany - Central Zone Page 4 of 20 PART A Risk Management This document describes the acceptable use conditions required for the re-registration/registration of containing 6-Benzyladenine in Germany. This evaluation is required subsequent to the inclusion of 6-Benzyladenine on Annex 1. The risk assessment conclusions are based on the information, data and assessments provided in, Part B Sections 1-7 and Part C and the addendum for Germany. The information, data and assessments provided in, Parts B includes assessment of further data or information as required at national re-registration/registration by the EU review. It also includes assessment of data and information relating to where that data has not been considered in the EU review. Otherwise assessments for the safe use have been made using endpoints agreed in the EU review of 6-Benzyladenine. This document describes the specific conditions of use and labelling required for Germany for the reregistration/registration of. Appendix 1 of this document provides a copy of the final product authorisation for Germany. Appendix 2 of this document is a copy of the approved product label for Germany. The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions drawn by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again. Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation. Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. 1 Details of the application 1.1 Application background This application was submitted by Fine Agrochemicals Limited on 11/10/2011. The application was for approval of, a soluble concentrate containing 20 g/l 6-Benzyladenine for use as a plant growth regulator for apple and pear orchards. 1.2 Annex I inclusion 6-Benzyladenine was included on Annex I of Directive 91/414/EEC on 3 January 2011 under Inclusion Directive 2011/1/EC and implemented under Regulation (EU) No 540/2011. Evaluator: Germany Date: 18/02/2013

5 Part A National Assessment Germany - Central Zone Page 5 of 20 The Annex I Inclusion Directive for 6-Benzyladenine (2011/1/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 6- Benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23/11/2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to the: protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate. These concerns were all addressed in the decision. Expiration of approval: 31/05/ Regulatory approach To obtain approval the product must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points. This application was submitted in order to allow the first approval of this product/use in Germany in accordance with the above. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of, it is indicated in the reference lists in Appendix I of the, Part B, sections 1-7 and Part C. 1.5 Letters of Access In the EU Review Report for 6-Benzyladenine (SANCO/12667/2010 final of 4 January 2011) it is indicated that subsequent to the Commission decision 2008/941/EC and in accordance with Article 13 of Regulation (EC) No 33/2008 Fine and Valent Biosciences Corporation (VBC) were the sole data submitters who presented a dossier on 5 May 2009 to the UK as the designated RMS for the active substance. The RMS finalised their examination in October 2009 in the form of an Additional Report to the original Draft Assessment Report. The Additional Report concluded with a recommendation to include 6-benzyladenine in Annex I on the basis of the evaluated uses. Fine and VBC collaborated from the outset of the original dossier submission to the RMS within the framework of an EU Task Force (TF) and an EU TF agreement. It is therefore implicit that Fine as a data submitter and full TF member has full access to the requisite data supporting the Annex I inclusion. This position is substantiated by LOA issued specifically to Fine by the secretariat to the TF the law firm Field Fisher Waterhouse LLP. The LOA is self explanatory and lays down the terms, rights and obligations incumbent upon Fine s access to the essential Annex II data supporting the Annex I inclusion. Evaluator: DE Date: 18/02/2013

6 Part A National Assessment Germany - Central Zone Page 6 of 20 2 Details of the authorisation 2.1 Product identity Product Name Authorization Number (for re-registration) Function Applicant Composition Formulation type Packaging /00 growth regulator Fine Agrochemicals Limited 20 g/l 6-benzyladenine Soluble concentrate [Code: SL] co-extruded PE: 5 and 10 L fluorinated HDPE: 20 L 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC The following is proposed in accordance with Directive 99/45/EC in combination with the latest classification and labelling guidance under Directive 67/548/EEC (i.e. in the 18th ATP published as Directive 93/21/EEC): Hazard Symbol: Indication of danger: Risk Phrases: Safety Phrases: R52 S R and S phrases under Directive 2003/82/EC (Annex IV and V) Risk Phrases: Safety Phrases: Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): SB001 SB010 SB110 SF SS110 NW 262 Avoid any unnecessary contact with the product. Misuse can lead to health damage. Keep out of the reach of children. 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. Treated areas/crops may not be entered until the spray coating has dried. Wear standard protective gloves (plant protection) when handling the undiluted product. The product is toxic for algae. Evaluator: DE Date: 18/02/2013

7 Part A National Assessment Germany - Central Zone Page 7 of 20 NW 264 NW 265 NW 468 WH963 [6-benzyladenine: EbC50 = 7.6 mg/l (N. pelliculosa)] The product is toxic for fish and aquatic invertebrates. [6-benzyladenine: LC50 > 2.03 mg/l (O. mykiss), EC50 > 2.03 mg/l (Daphnia magna)] The product is toxic for higher aquatic plants. [6-benzyladenine: EbC50 = 0,31 mg/l (Lemna gibba)] 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. The use of plant growth modifiers can cause undesired side effects depending on the species and variety of the crops and also external conditions. It is recommended to apply the product according to the advice of the plant protection service and taking into consideration the instructions given. The authorization of the PPP is linked to the following conditions (voluntory labelling): NB6641 NN1001 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) The product is classified as non-harmful for populations of relevant beneficial insects 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) NW The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to EUR. Evaluator: DE Date: 18/02/2013

8 Part A National Assessment Germany - Central Zone Page 8 of Product uses PPP (product name/code) ( ) active substance 6-Benzyladenin Formulation type: Conc. of as 1: SL 20 g/l Applicant: Zone(s): Fine Agrochemicals Ltd. central professional use non professional use X Verified by MS: y 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 Apple F Enhancing fruit size, Thinning of fruit 002 DE Pear F Enhancing fruit size, Thinning of fruit Method / Kind Application Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use b) per crop/ season spraying a) 1 b) 1 spraying a) 1 b) 1 kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season a) 3,75 L/ha and per m crown height b) 7,5 L/ha a) 3,75 L/ha and per m crown height b) 7,5 L/ha Application rate g, kg as/ha a) max. rate per appl. b) max. total rate per crop/season a) kg a.i./ha and per m crown height b) 0,15 kg a.i./ha a) kg a.i./ha and per m crown height b) 0,15 kg a.i./ha Water L/ha min / max 500 L/ha and per m crown height 500 L/ha and per m crown height PHI (days) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 90 NW NW642 Evaluator: Germany Date: 18/02/2013

9 Part A National Assessment Germany - Central Zone Page 9 of 20 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) 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 plants - type 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) The minimum and maximum number of application possible under practical conditions of use must be provided (l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions Evaluator: Germany Date: 18/02/2013

10 Part A National Assessment Country insert Product code Page 10 of 20 Northern/Central/Southern Zone 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of clear liquid with a slightly sweet odour. It has no explosive or oxidising properties, the self ignition temperature is above 400 C. In aqueous solution, it has a ph value around 4.4. The stability data indicate a shelf life of at least 2 years at ambient temperature. The technical characteristics are acceptable for a soluble concentrate formulation. Implications for labelling: none Compliance with FAO specifications: There is no FAO specification for 6-benzyladenine. Compliance with FAO guidelines: The product complies with the general requirements of the FAO/WHO manual (2010). Compatibility of mixtures: There are no recommendations for tank mixtures. Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable. Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of has been provided and is considered to be acceptable Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) A method using analysis by HPLC-UV is provided. Linearity, Precision, Accuracy and Specificity have been checked and found acceptable. According to the data, the method for the determination of the active substance in the formulated product is validated. No further data are required Analytical methods for residues (Part B, Section 2, Points ) Sufficiently sensitive and selective analytical methods are not available for all for kinds of food and feed of plant origin. Based on the Guidance Document SANCO/825/00 (rev. 8.1 of ) independently validated analytical methods and confirmatory methods have to be provided for all matrix groups. This general requirement is independent from the intended use. Evaluator: DE Date: 18/02/2013

11 Part A National Assessment Germany - Central Zone Page 11 of 20 Noticed data gaps are: 1. An analytical method for the determination of residues of 6-benzyladenine in commodities with high oil content has to be provided. 2. Independent validations of analytical methods for the determination of residues of 6-benzyladenine in dry commodities and in commodities with high oil content have to be provided. 3. Confirmatory methods for the determination of residues of 6-benzyladenine in commodities with high oil content and commodities with high acid content have to be provided Mammalian Toxicology (Part B, Section 3, Point 7) Acute Toxicity (Part B, Section 3, Point 7.1) Acute toxicity studies for were not evaluated as part of the EU review of the 6-benzyladenine. The relevant data were provided and are considered adequate., containing 20 g/l 6-benzyladenine, has a low toxicity in respect to acute oral, dermal and inhalation toxicity and is not irritating to the rabbit skin and eye. It is not found to be a skin sensitiser to the guinea pig. Taking into account all submitted data no classification or labelling including risk- and safety-phrases is necessary Operator Exposure (Part B, Section 3, Point 7.4) The risk assessment according to the German model has shown that the estimated exposure towards 6- benzyladenine in will not exceed the systemic AOEL (0.03 mg/kg bw/d) for operators if prescribed PPE (gloves during mixing/loading) is worn. The risk assessment according to the UK-POEM has shown that the estimated exposure towards 6- benzyladenine in will not exceed the systemic AOEL for operators if hand-held equipment is used. To achieve this, the use of PPE (gloves during mixing/loading and application as well as with impermeable coverall) is mandatory for operators. In the case of tractor-mounted equipment, the systemic AOEL will be exceeded referred to the UK POEM even if PPE is used Bystander and Resident Exposure (Part B, Section 3, Point 7.4) The risk assessment has shown that the estimated exposure towards 6-benzyladenine in will not exceed the systemic AOEL for bystanders and residents Worker Exposure (Part B, Section 3, Point 7.4) The risk assessment has shown that the estimated exposure towards 6-benzyladenine in will not exceed the systemic AOEL for workers. No specific PPE is necessary for workers. Implications for labelling resulting from operator, worker, bystander assessments: Hazard Symbol: -- Indication of danger: -- Risk Phrases: -- Safety Phrases: -- SP001: To avoid risks to man and the environment, comply with the instructions for use. For mandatory labelling specifying the PPE required, please refer to Evaluator: Germany Date: 18/02/2013

12 Part A National Assessment Germany - Central Zone Page 12 of Residues and Consumer Exposure (Part B, Section 4, Point 8) The data available is considered sufficient for risk assessment. An exceedance of the default MRL of 0.01*mg/kg for 6-benzyladenine is not expected (no MRLs set in Reg. (EC) No 396/2005 yet). The chronic and the short-term intake of 6-benzyladenine residues are both unlikely to present a public health concern Residues (Part B, Section 4, Points 8.2) Sufficient residue trial data are available indicating that no residues above LOQ (<0.005 mg/kg) are to be expected following the GAP applied for. Therefore an exceedance of the default MRL of 0.01*mg/kg for 6-benzyladenine is not expected Consumer exposure (Part B, Section 4, Point 8.3) The chronic and the short-term intake of 6-benzyladenine residues are both unlikely to present a public health concern when applied according to the recommendations whereas no ARfD was allocated for 6- benzyladenine. Further details are shown in IIIA Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1 of Part B, Section Environmental fate and behaviour (Part B, Section 5, Point 9) The environmental fate and behaviour of the active substance 6-benzyladenin was assessed in the context of Annex I inclusion and the results of the peer review are summed up in the Review Reports (SANCO/12667/2010 final, 04/01/2011). All environmental fate studies performed with the active substance or metabolites for Annex I inclusion are adequate to evaluate the proposed use of the formulation product. New environmental fate studies were performed and evaluated in the core assessment (Section 5, Appendix 2). Based on the data provided in this submission, appropriate endpoints were used to calculate PEC values for and 6-benzyladenine and its metabolite M8 in soil, surface water, ground water and air for the intended use patterns Predicted Environmental Concentration in Soil (PEC soil ) (Part B, Section 5, Points 9.4 and 9.5) For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ , UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. Using a soil bulk density of 1.5 g cm-3 and a DT50 of 8 d (SFO, Maximum, Field studies, nonnormalized), a PEC act of 0,3 mg/kg soil and a PEC twa (21 d) of 0,1382 mg/kg soil were calculated for 6- benzyladenin. Due to the fast degradation of 6-benzyladenine in soil (DT90 < 365 d, SFO, laboratory data) the accumulation potential of 6-benzyladenine does not need to be considered. Evaluator: Germany Date: 18/02/2013

13 Part A National Assessment Germany - Central Zone Page 13 of Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) For authorization in Germany exposure assessment of surface water the routes of entry (spraydrift and deposition following volatilisation; run-off, drainage) are considered separately to derive risk mitigation measures separately for each entry route. For the intended use pattern, no entries of 6-benzyladenine and its metabolite M8 into the groundwater with concentrations 0.1 µg/l are expected. Thus, no risk management measures for groundwater protection are required for the intended use pattern Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzelmeier. The vapour pressure at 20 C of the active substance 6-benzyladenine is < 10-5 Pa. Hence the active substance 6-benzyladenine is regarded as non-volatile. Therefore exposure of surface water by the active substance 6-benzyladenine due to deposition following volatilization does not need to be considered. The calculation of PECsw after exposure by spraydrift and deposition following volatilization using the model EVA 2.1 is not required. The concentration of the active substance 6-benzyladenine in adjacent ditch due to surface runoff and drainage is shown in the following table as calculated using the model EXPOSIT Exposure by surface runoff vegetated buffer strip (m) PECsw in adjacent ditch (µg/l) Exposure by drainage Time of application PECsw in adjacent ditch (µg/l) Autumn/winter/early spring 0.33 Spring/summer Predicted Environmental Concentration in Air (PEC Air ) (Part B, Section 5, Point 9.9) The vapour pressure at 20 C of the active substance 6-benzyladenine is < 10-5 Pa. Hence the active substance 6-benzyladenine is regarded as non-volatile. Therefore volatilization does not need to be considered Implications for labelling resulting from environmental fate assessment: none Ecotoxicology (Part B, Section 6, Point 10) Only information relevant for the prescription of national labelling and environmental restrictions are mentioned in the following chapters. Details of ecotoxicological studies are described in the National Addendum of Germany. Risk assessment is presented in the National Addendum Germany, Part B, Section 6. Evaluator: Germany Date: 18/02/2013

14 Part A National Assessment Germany - Central Zone Page 14 of Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) The risk assessment of the effects on birds and mammals was carried out according to the Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA, EFSA Journal 2009; 7(12):1438 (EFSA/2009/1438). Birds Based on the highly conservative presumptions of the screening step, the acute risk of exposure of birds to the active ingredient 6-benzyladenine according to the GAP of the formulation achieves the acceptability criteria TER 10, according to directive 1107/2009 (EG), Annex IV, uniform principles, point for acute effects. Based on the highly conservative presumptions of the screening step, the long term risk of exposure of birds to 6-benzyladenine at the submitted GAP of the formulation achieves the acceptability criteria TER 5, according to directive 1107/2009 (EG), Annex IV, uniform principles, point for long term effects. Mammals Based on the highly conservative presumptions of the screening step, the acute risk of exposure of terrestrial vertebrates to the active ingredient 6-benzyladenine according to the GAP of the formulation achieves the acceptability criteria TER 10, according to directive 1107/2009 (EG), Annex IV, uniform principles, point for acute effects no further refinement is necessary. Based on the highly conservative presumptions of the screening step, the long-term risk of exposure of mammals to 6-benzyladenine when applied according to the GAP achieves the acceptability criteria TER 5, according to directive 1107/2009 (EG), Annex IV, uniform principles, point for long term effects. Birds and mammals: Secondary poisening The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a log Kow 3 is used to indicate that there might be a potential for bioaccumulation (see Section 5.6 Bioaccumulation and food chain behaviour). The log K ow of 6-benzyladenine is 2.16, so this active substances has a (negligible) potential to bioaccumulate in animal tissues Effects on Aquatic Species (Part B, Section 6, Point 10.2) For the active ingredient the most sensitive endpoint divided by the safety factor is EC 50 = 0.31 mg/l (Lemna gibba). was not the representative formulation during the EU Review of 6-benzyladenine, but its active ingredient concentration and proposed use (1 x 150 g a.s. on apples and pears) are within what was considered for Annex I inclusion of 6-benzyladenine. However, the EFSA Conclusion (EFSA Journal 2010; 8(9):1716) states that the risk assessment for aquatic organisms could not be finalised. This was driven by the formulated product MaxCel being significantly more toxic than expected based on the content of the active substance. The toxicity data which are available show that is less toxic for aquatic organisms compared to 6-benzyladenine. For 6-benzyladenine as active substances the calculated TER values are above the trigger of 10 therefore a buffer zone and spray drift reduction is not considered necessary. Regarding the entry pathway spray drift and run-off or drainage it is concluded by the MS that the proposed use of will not pose an unacceptable risk to aquatic organisms, if applied according to the recommended use pattern. Therefore a low risk to aquatic organism is indicated. Based on the intrinsic property of the active substance 6-benzyladenine, the national labellings and restrictions NW262, NW264, NW265 and NW642 are prescribed as mandatory. Evaluator: Germany Date: 18/02/2013

15 Part A National Assessment Germany - Central Zone Page 15 of 20 Based on the toxicity of the product to Lemna gibba (EC 50 : mg/l), the classification and Labelling R52 according to Guideline 1999/45/EC is assigned Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees The proposed use of in orchards fits within the risk envelope of the uses that were assessed under the EU Review of 6-benzyladenine. Showing an oral or contact toxicity of µg as/bee or 69.0 µg as/bee is less toxic than the product evaluated during EU assessment. The resulting Hazard Quotients (HQs) were substantially below the trigger of 50, indicating an acceptable risk. Even at the maximum application rate the product is non-hazardous to bees. The national labeling NB6641 is assigned. Other non-target arthropods Toxicity Exposure Ratios (TER) are calculated for the off-field exposure of non-target arthropods via spray drift, following the application of according to the submitted use patterns.the off-field TER values for A. rhopalosiphi and T. pyri are above the trigger value, indicating that does not pose an unacceptable risk to non-target arthropods in off-field areas. The risk for Orius laevigatus is slightly below the trigger value. But due to the conservative first tier assessment this deemed to be acceptable. The application of according to good agricultural practice will cause no unacceptable risk to nontarget arthropods. The national labeling NN1001 is assigned. There is no need of additional specific mitigation measures Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) In conclusion, all acute TERs for the active and major soil degradation products are above the respective trigger values. Earthworms and other soil non-target macro-organisms are not at risk following treatment with. There is no need to address the long term risk of the active substance 6-benzyladenine and its metabolite M8 for earthworms, because their degradation in soil (DT90 < 365 d, Kinetic, laboratory/field data) is fast. 6-benzyladenine forms one major metabolite in soil: M8 (9.9 % at day 3). There are no toxicological studies for the metabolite M8 available. The metabolite reaches his maximum at day 3 after the application. Therefore the ZRMS considers the risk from the Metabolite M8 covered with the studies from the parent compound 6-benzyladenine. According to SANCO/10329/2002 rev2 final tests on other soil non-target organisms are triggered by breaching the soil persistence criteria (DT90 > 365 d). This is not the case for the major soil degradation product M8. For the parent compounds, studies on other non-target soil macro-organisms are not triggered. It is concluded that the application of according to good agricultural practice will cause no unacceptable risk to earthworms and other soil macro organism. There is no need of additional specific mitigation measures. Evaluator: Germany Date: 18/02/2013

16 Part A National Assessment Germany - Central Zone Page 16 of 20 No risk management measures are required for the protection of earthworms and other soil macroorganisms for the intended use pattern Effects on organic matter breakdown (Part B, Section 6, Point 10.6) For 6-benzyladenine, no study on organic matter breakdown is triggered. Therefore, the risk of to soil-dwelling organism communities is considered to be low and application according to good agricultural practice will not cause unacceptable risk to organic matter decomposition. There is no need of additional specific mitigation measures Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) The results of these studies showed no effects of > 25% compared to the control (trigger value as according to SANCO/10329/2002 ) on soil microbial activity up to a maximum tested concentration of 1.0 mg a.s./kg soil, after 28 days. As this maximum tested concentration was much higher than the maximum initial PEC from the proposed use of 6-benzyladenine l (0.040 mg a.s./kg, EFSA Journal 2010; 8(9):1716), as assessed under the EU Review, an acceptable risk to soil microbial activity was concluded. As the proposed use of in orchards fits within the risk envelope of the uses that were assessed during the EU Review of 6-benzyladenine the risk to soil micro-organisms is considered to be acceptable. No risk management measures are required for the protection of non-target soil micro-organisms for the intended use pattern Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Based on the worst case risk assessment it can be concluded that the proposed use of poses no unacceptable risk to non-target terrestrial plants. No risk management measures are required for the protection of other non-target organisms (Flora and Fauna) for the intended use pattern. Implications for labelling resulting from ecotoxicological assessment: see Efficacy (Part B, Section 7, Point 8) Minimum effective dose tests (IIIA ) Results from the Maritime, the Mediterranean, the North Eastern and the North Western EPPO zone from the years 2003 to 2010 were submitted and analysed together to assess and compare the performance and efficacy of under the various regional climatic conditions within the EU. There is a clear tendency of fruit set reduction with increasing dose rate over all climatic zones and no discrete clouds of data points originating from a specific climatic zone are shown. It is therefore reasoned that the comparability of trial data is not intrinsically dependent on the climatic zone in which the product was evaluated, but rather on the weather conditions at and directly following application. Apple Evaluator: Germany Date: 18/02/2013

17 Part A National Assessment Germany - Central Zone Page 17 of 20 Rates from 2.5 to 5 L/ha showed good results with an average reduction in fruit set of 10% in comparison with the untreated, but data on varieties which are very difficult to thin like were not sufficient or no efficacy was observed in too many trials. The rate of 7.5 L/ha presented an average fruit set index of 84, i.e. a fruit set reduction of 16 %. and in only 3 of 28 situations where this rate was tested, no reduction in fruit set was reported. Higher rate of 10 L/ha does not show any further efficacy The same analysis was performed on relative mean fruit weight in comparison with the untreated. This comparison does not show any clear dose effect between the different tested rates, with a fruit weight increase in the order of 6-9% in average in comparison to the untreated: Pear A similar analysis of the data obtained in pear was performed. Even if the number of data available on pear is lower than on apple, the same conclusion can be drawn: 7.5 L/ha is required to ensure at least 10% fruit set reduction in most of the situations: The average fruit weight increase is 3% when is applied at 7.5 L/ha: Final considerations about minimum effective dose for apple and pear Overall, results presented in the previous tables indicate that an average crop load reduction of 15% (compared to the untreated) and a fruit size increase of >10% are obtained in most of the situations when is applied at 7.5 L/ha on apple and pear. All the results exposed in this section indicate that the minimum effective dose of is 7.5 L/ha Efficacy tests (IIIA ) For the assessment of efficacy the same trials from all zones were considered as in the previous chapter. at 7.5 L/ha (without adjuvant) was tested in a total of 33 trials, with 22 in apple and 11 in pear (Table 20). Two trials were carried out on apple by non GEP official institutes (1 in Spain and 1 in Southern France) but all other trials were GEP-compliant. These trials cover a large period of time and different climatic conditions. In apple as well as in pear, the trials show the same level of activity of in the Maritime and Mediterranean zone, as already proved in the previous section. The results confirm that at 7.5 L/ha ensures an average reduction in fruit set of 10 to 15 % on apple and about 10 % on pear. At the same time, fruit weight is increased by about 5 % in apple and 3 % in pear (more limited set of data). A number of trials also showed that could be successfully used in the frame of a thinning programme including other chemical thinners Effects on yield and quality (IIIA ) Impact of treatment with on quality of plants and plant products was evaluated in the efficacy trials presented in section where different parameters were assessed. Main findings are summarised in the following. did not have any negative effect on leaf quality, shoot growth, fruit shape or the ratio between fruit length and fruit diameter, fruit skin quality, fruit colour, fruit firmness, An improved flowering in the year following the application of was observed in some trials, probably as a side effect of thinning. No increase of the production of pygmy fruit was in comparison with the untreated control was observed using alone or mixed with an adjuvant. However, when is combined with NAA or NAD at a late timing of treatment, it seems to amplify the production of pygmy fruit induced by auxin application. Evaluator: Germany Date: 18/02/2013

18 Part A National Assessment Germany - Central Zone Page 18 of 20 Therefore, a warning will be included in the label recommending not to mix with NAD or NAA (where available) on apple cultivars known to be prone to produce pygmy fruit. Therefore, a warning will be included in the label recommending not to mix with NAD or NAA (where available) on apple cultivars known to be prone to produce pygmy fruit. Based on all the facts exposed above, it can be considered that applied at 7.5 L/ha in apple and pear will not have any negative impact on quality of plant and plant products. On the contrary, it will have a positive impact on fruit quality by improving fruit size and weight on the year of treatment Effects on the processing procedure Because the residues in fruit are not significant (< 0.1 mg/kg=loq), processing study was not required. However, a study with another 6-benzyladenine formulation was performed with apples which were processed into juice or wet pomace. No concentration of residues during processing. As 6-BA is very similar to natural cytokinins, it can be concluded that use of in apple will not have any negative impact on fruit processing and on the quality of the final product. Because of the similarities between apple and pear uses, this also applies for processed pears Effects on the yield of treated plants or plant products No specific trials were conducted to assess the decrease in yield as quantitative assessments of crop load are an essential part of standard fruit thinning trials for product registration. Most of the trials did only show a limited or no difference in yield between the treated trees and the untreated, because the reduction in fruit number was compensated for by better fruit growth of the remaining fruit Adverse Effects Phytotoxicity to host crop (IIIA 6.2.1) The active substance of, 6-BA is similar to a naturally occurring plant hormone and at the rates of use recommended for, no serious levels of phytotoxicity is to be expected. This is supported by the absence of phytotoxicity in the field trials described in section and No phytotoxic effects on the target plant product like skin or stem end russet or reduction of red pigmentation of the fruit have been reported in the efficacy and crop safety trials included in this dossier. No impact on vegetative growth was observed either Adverse effects on beneficial organisms (other than bees) (IIIA ) Effects on relevant beneficial organisms Laboratory tests (glass-plate and extended) with several non-target species. No harmful effects were observed on Aphidius rhopalosiphi, Typhlodromus pyri and Orius laevigatus. Results to sublethal effects of on Typhlodromus pyri are not available. Therefore, the effect of on the predatory mite Typhlodromus pyri cannot be evaluated finally. can be classified as not harmful for populations of relevant beneficial insect species. Effects on soil quality The acute TER for earthworms based on the active substance data is greatly in excess of the trigger value (>2500). Studies on the formulated product or long-term studies are not considered necessary. The results of studies on soil microbial activity showed no effects of > ± 25% compared to the control. It was agreed Evaluator: Germany Date: 18/02/2013

19 Part A National Assessment Germany - Central Zone Page 19 of 20 during the EU Review that studies on other non-target macro-organisms or organic matter breakdown are not required. There is no indication of any unacceptable adverse effects on soil macro- or soil micro-organisms relevant for the maintenance of soil quality Impact on succeeding crops (IIIA ) Given the rapid degradation of the active substance in soil, no effect of the treatment on succeeding crops is expected, even if treated trees would be removed and replaced by a young orchard or any other crop Impact on other plants including adjacent crops (IIIA ) applied on pome fruit tree will not have any detrimental effect on neighbouring crop because of spray drift or volatilisation, because the TER ratio is well above the trigger value for non-target plants Possible development of resistance or cross-resistance (IIIA ) 6-BA is a naturally occurring plant hormone. 6-BA resistant plant phenotypes will have a very low fitness as normal plant growth and development will be severely affected. Resistance development is therefore not relevant. 3.2 Conclusions Considering an application in accordance with the evaluated use pattern and good agricultural practice 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. Further, no adverse health effects for operators, workers, bystanders and residents are to be expected if used properly and according to the intended conditions of use. The intended use in apples and pears will not result in residues above the default MRLs. A risk for consumers through consumption of food with residues of 6-BA is not expected. 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 No further data are required. Evaluator: Germany Date: 18/02/2013

20 Part A National Assessment Germany - Central Zone Page 20 of 20 Appendix 1 Copy of the product authorisation See below. Appendix 2 Copy of the product label The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions drawn by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again. Appendix 3 Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Evaluator: Germany Date: 18/02/2013

21 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Dietmar Gottschild Referent Einschreiben mit Rückschein Fine Agrochemicals Ltd. Hill End House WR5 2RQ Worcester VEREINIGTES KÖNIGREICH (UK) TELEFON TELEFAX INTERNET IHR ZEICHEN IHRE NACHRICHT VOM AKTENZEICHEN (bitte bei Antwort angeben) +49 (0) (0) / DATUM 25. Februar 2013 ZV /00 Zulassungsverfahren für Pflanzenschutzmittel Bescheid Das oben genannte Pflanzenschutzmittel mit dem Wirkstoff: 20 g/l 6-Benzyladenin Zulassungsnummer: Versuchsbezeichnung: FIN W-0-SL Antrag vom: 11. Oktober 2011 wird auf der Grundlage von Art. 29 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), wie folgt zugelassen: Zulassungsende BVL_FO_05_2437_200_V1.1 Die Zulassung endet am 31. Mai Dienstsitz Braunschweig Bundesallee 50, Geb Braunschweig Abt. Pflanzenschutzmittel Messeweg 11/ Braunschweig Dienststelle Berlin Mauerstraße Berlin Referatsgr. Untersuchungen Diedersdorfer Weg Berlin Tel: +49 (0) Tel: +49 (0) Tel: +49 (0) Tel: +49 (0) Fax: +49 (0) Fax: +49 (0) Fax: +49 (0) Fax: +49 (0)

22 SEITE 2 VON 9 Festgesetzte Anwendungsgebiete bzw. Anwendungen Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1): Anwendungsnummer Zweckbestimmung Schadorganismus/ / Förderung der Fruchtgröße, Fruchtausdünnung / Förderung der Fruchtgröße, Fruchtausdünnung Pflanzen/-erzeugnisse/ Objekte Apfel Birne Verwendungszweck 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) festgesetzt: (NW468) Anwendungsflüssigkeiten und deren Reste, Mittel und dessen Reste, entleerte Behältnisse oder Packungen sowie Reinigungs- und Spülflüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. Verpackungen Gemäß 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen: Verpackungsarmaterial Verpackungs- Anzahl Inhalt von bis von bis Einheit Kanister Coex 1 5,00 10,00 l Kanister HDPE, fluoriert 1 20,00 l Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen: Anwendung nur durch berufliche Anwender zulässig. BVL_FO_05_2437_200_V1.1 Auflagen Die Zulassung wird mit folgenden Auflagen gemäß 36 Abs. 3 S. 1 PflSchG verbunden:

23 SEITE 3 VON 9 Kennzeichnungsauflagen: (NW262) Das Mittel ist giftig für Algen. (NW264) Das Mittel ist giftig für Fische und Fischnährtiere. (NW265) Das Mittel ist giftig für höhere Wasserpflanzen. (SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschäden führen. (SB010) Für Kinder unzugänglich aufbewahren. (SB110) Die Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflanzenschutz "Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit ist zu beachten. (SF245-01) Behandelte Flächen/Kulturen erst nach dem Abtrocknen des Spritzbelages wieder betreten. (SS110) Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten Mittel. Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2. Sonstige Auflagen: BVL_FO_05_2437_200_V1.1 (WH963) Die Anwendung von Wachstumsregulatoren kann in Abhängigkeit von Art und Sorte der Kulturpflanzen sowie von äußeren Rahmenbedingungen unerwünschte Nebenwirkungen mit sich bringen. Es wird empfohlen, die Anwendung gemäß der Beratung durch den Pflanzenschutzdienst und unter Beachtung der dabei gegebenen Anweisungen vorzunehmen.

24 SEITE 4 VON 9 Vorbehalt Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden. Angaben zur Einstufung und Kennzeichnung gemäß 4 Gefahrstoffverordnung Gefahrenhinweise (R-Sätze): R 52 : Schädlich für Wasserorganismen Sicherheitshinweise (S-Sätze): S 35: Abfälle und Behälter müssen in gesicherter Weise beseitigt werden Zur Vermeidung von Risiken für Mensch und Umwelt ist die Gebrauchsanleitung einzuhalten. Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/ keine - Abgelehnte Anwendungsgebiete bzw. Anwendungen Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine - Hinweise Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB6641) Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienengefährlich eingestuft (B4). (NN1001) Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft. BVL_FO_05_2437_200_V1.1 Weitere Hinweise und Bemerkungen Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben, soweit sie noch nicht erfüllt sind.

25 SEITE 5 VON 9 Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulassungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen. 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. Hans-Gerd Nolting Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_05_2437_200_V1.1

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