REGISTRATION REPORT Part A. Risk Management

Transcription

1 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 1 of 33 REGISTRATION REPORT Part A Risk Management Product name: Product code: Active Substance: Netzschwefel Stulln Sulfur 80 % WG Netzschwefel Stulln Sulfur 80 % WG Sulfur 800 g/kg COUNTRY: Germany Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: agrostulln GmbH, Germany Submission date: Finalisation of draft: Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

2 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 2 of 33 Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

3 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 3 of 33 Table of Contents PART A Risk Management 5 1 Details of the application Application background Annex I inclusion Regulatory approach Data protection claims Letters of Access 7 The applicant submitted own data or made reference to own data, respectively. A Letter of Access was not necessary. 7 2 Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC Classification and labelling under Regulation (EC) No 1272/ Standard phrases under Regulation (EC) No 547/ Other phrases notified under Regulation (EC) No 547/ Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses 11 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 Acute Toxicity Operator Exposure Bystander Exposure Worker Exposure Residues and Consumer Exposure Residues 17 Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

4 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 4 of Consumer exposure Environmental fate and behaviour (Part B, Section 5, Point 9) Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) Ecotoxicology (Part B, Section 6, Point 10) Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Effects on Aquatic Species (Part B, Section 6, Point 10.2) 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) Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 29 Appendix 1 Copy of the product authorisation (see Appendix 4) 30 Appendix 2 Copy of the product label 31 Appendix 3 Letter of Access 32 Appendix 4 Copy of the product authorisation 33 Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

5 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 5 of 33 PART A Risk Management This document describes the acceptable use conditions required for the label extension of Netzschwefel Stulln (code used in core assessment: SULFUR 80 % WG, Netzschwefel Stulln ) containing 800 g/kg sulfur in Germany. This evaluation is required subsequent to the inclusion of sulfur on Annex I. The risk assessment conclusions are based on the information, data and assessments provided in, Part B Sections 1-7 and Part C of the core assessment and where appropriate in the national addenda 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 Netzschwefel Stulln where that data has not been considered in the EU review. Otherwise assessments for the safe use of Netzschwefel Stulln have been made using endpoints agreed in the EU review of sulfur. This document describes the specific conditions of use and labelling required for Germany for the label extension of Netzschwefel Stulln. Appendix 1 should include the authorisation of the final product in Germany. Due to technical reasons, the authorisation of the final product in Germany is inserted under Appendix 4. Appendix 2: 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 made by the competent authority. The final version of the label has to fulfil the requirements according to Article 31 of Regulation (EC) No 1107/2009. Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Appendix 4 of this document provides a copy of the final product authorisation Germany. It will be inserted in the final version. 1 Details of the application 1.1 Application background The application for re-registration of Netzschwefel Stulln in Germany, Austria, Belgium, Slovenia, Romania and Hungary as countries of the Central EU Zone was submitted to zrms Slovenia by the authorisation holder agrostulln GmbH in June The application for re-registration comprised a number of professional uses. In this application it is applied for label extension for amateur uses of the product Netzschwefel Stulln in Germany. In the amateur area (HuK) the product will be marketed by W. Neudorff GmbH KG (distributor) under the trade name Netz-Schwefelit WG. The product is a water dispersible granular formulation (WG) containing 800 g/kg sulfur. It is used as non-systemic, contact and protectant fungicide for the control of a range of fungal pathogens, including those causing powdery mildew, and/or as acaricide for the control of mite in a wide variety of different crop types as specified in 2.3. Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

6 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 6 of 33 The product Netzschwefel Stulln (EU review name: Netzschwefel Stulln ) is one of the four sulfur formulations produced by the members of the Sulfur Working Group (SWG) Syngenta Crop Protection AG ( Thiovit Jet 80 WG ), BASF SE ( Kumulus WG ), agrostulln GmbH ( Netzschwefel Stulln ) and Cerexagri s.a.s. ( Microthiol Special Disperss (EU review name: Microthiol Disperss )) that are considered to be equivalent and which are collectively referred to as SULFUR 80 % WG. The Sulfur 80 % WG products were the representative formulations of the notifier SWG during the Annex I inclusion of sulfur and have already been evaluated in the context of the EU review according to Uniform Principles (EFSA Scientific Report (2008) 221, sulfur). The fungicide Netzschwefel Stulln (800 g/kg sulfur) has been proposed for application in grape, gooseberry, peas, cucumber, root- and tuber vegetables, and ornamentals at a total maximum application rate of 75 kg/ha and year (15 applications in ornamentals). This corresponds to 6.7 kg active substance/ha and year. 1.2 Annex I inclusion Sulfur was included on Annex I of Directive 91/414/EEC under Commission Directive 2009/70/EC of 25 June 2009 (entry into force on 1 January 2010). ). In the context of transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, sulfur was taken over into the list of approved substances as given in Regulation (EU) No 540/2011. The Annex I Inclusion Directive for sulfur (Commission Directive 2009/70/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 for sulfur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account. In this overall assessment: Member States shall pay particular attention to: the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. These concerns were all addressed in the submission. Further, there was a request on confirmatory data: The Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulfur has been included in this Annex provide such data to the Commission at latest by 30 June The confirmatory data were submitted by the Sulfur Working Group on 29 June 2011 (date of covering letter) to the RMS France, ANSES, DPR-UGAMM for evaluation. The confirmatory data have already been reviewed and accepted by the RMS (Addendum to the DAR for Sulfur Confirmatory Data, December 2011). Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

7 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 7 of Regulatory approach To obtain approval, the product Netzschwefel Stulln 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 label extension of an already approved product in Germany in accordance with the above 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of Netzschwefel Stulln, it is indicated in the reference lists in Appendix 1 of the, Part B, sections 1-7 and Part C. 1.5 Letters of Access The applicant submitted own data or made reference to own data, respectively. A Letter of Access was not necessary. 2 Details of the authorisation 2.1 Product identity Product Name Authorization Number (for re-registration) Function Applicant Composition Formulation type Packaging Netzschwefel Stulln (SULFUR 80 % WG ) /02 Fungicide, Acaricide agrostulln GmbH 800 g/kg sulfur Water dispersible granules [Code: WG] Professional product: Paper bag with PE-inlay of 10 and 25 kg Amateur product: Cardboard box including 5 sachets (15 g product each) 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not proposed Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

8 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 8 of 33 Hazard classes and categories: None Hazard pictograms: None Signal word: None Hazard statements: None Precautionary statemtents: None Special rule for labelling of PPP: EUH401 To avoid risks to man and the environment, comply with the instructions for use. EUH066 Repeated exposure may cause skin dryness or cracking. Further labelling statements under Regulation (EC) No 1272/2008: None Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

9 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 9 of Standard phrases under Regulation (EC) No 547/2011 None 2.3 Other phrases notified under Regulation (EC) No 547/ Restrictions linked to the PPP The authorisation of the PPP is linked to the following conditions (mandatory labelling): Human health protection SB001 SB005 SB010 SB110 SB166 SF SS110 SS206 Avoid any unnecessary contact with the product. Misuse can lead to health damage. If medical advice is needed, have product container or label at hand. 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. Do not eat, drink or smoke when using this product. Treated areas/crops may not be entered until the spray coating has dried. Wear standard protective gloves (plant protection) when handling the undiluted product. Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. Integrated pest management (IPM)/sustainable use WMFM2 WH952 NB6641 Ecosystem protection NW263 NW468 Mode of action (FRAC-Group): M2 The indication identifying the mode of action must be assigned directly to each corresponding name of the active substance as supplementary information on the packaging and in the instructions for use. 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 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. The authorisation of the PPP is linked to the following conditions (voluntary labelling): Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

10 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 10 of 33 Integrated pest management (IPM)/sustainable use NN1001 NN1002 The product is classified as non-harmful for populations of relevant beneficial insects. The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): See 2.4 (Product uses) Human health protection HS110 HS206 SS202 SS205-1 Labelling instruction SS110 ("Wear standard protective gloves (plant protection) when handling the undiluted product.") does not apply to home and garden use. Labelling instruction SS206 ("Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products.") does not apply to home and garden use. Wear protective gloves when handling the product. Wear long-sleeved shirt, long trousers and sturdy footwear during handling and applying plant protection products. Integrated pest management (IPM)/sustainable use use -001 NN234 use -005 WH915 use -005 WP732 use -008 WP747 use -010 WH915 Ecosystem protection The product is classified as slightly harmful for populations of the species Typhlodromus pyri (predatory mite). The instructions for use must include a list of species and/or varieties of crops which are compatible with the application rate provided for (positive list). Damage may be caused to crops by the sun after application. Depending on the crop, cultivar and cultural method, damage cannot be excluded to the crop to be treated. Therefore, crop tolerance must be tested under typical working conditions before the product is used. The instructions for use must include a list of species and/or varieties of crops which are compatible with the application rate provided for (positive list). Uses , 005, 006, 007, 008, 010 NW642-1 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. Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

11 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 11 of Product uses GAP rev. (3), date: PPP (product name/code): Active substance: Netzschwefel Stulln Sulphur Formulation type: Conc. of as: WG g/kg Applicant: Zone(s): Agrostulln GmbH central/eu Professional use: Non-professional use: No Yes Verified by MS: yes 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) Method / Kind 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 b) per crop/ season b) max. total rate per crop/season b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE Grape VITVI (utilisation as table and wine grape) F powdery mildew of grape Uncinula necator UNCINE spraying or fine spraying (low volume spraying) at beginning of infestation and/or when first symptoms become visible BBCH a) 8 b) 8 (7-14 days) a) ES09: 36.0 g/ 100m² ES61: 48.0 g/ 100m² ES71: 24.0 g/ 100m² a) ES09: 28.8 g as/ 100m² ES61: 38.4 g as/ 100m² ES71: 19.2 g as/ 100m² 4 L water /100m² 8 L water /100m² 12 L water /100m² 28* 56** NN234 *table grape ** wine grape NW642-1 ES 75: 32.0 g/ 100m" ES75: 25.6 g as/ 100m² 16 L water /100m² Applicant (insert company name) Evaluator Date.2017

12 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 12 of 33 b) g/ 100m² b) g as/100m² 002 DE Pome fruit NNNOK F powdery mildew ERYSSP* spraying or fine spraying (low volume spraying) at beginning of infestation and/or when first symptoms become visible a) 14 b) 14 (7-10 days) a) 35.0 g/100m² and per m crown height 20.0 g /100m² and per m crown height b) max g/100m² ² a) 28.0 g/100m² and per m crown height 16.0 g/100m² and per m crown height b) max. 5 L water/ 100m² and per m crown height withdrawn by the applicant with letter from risk assessment in DE is conducted with 3m crown heights: 2.25 kg as/ha application rate before flowering decreases to 25 g per 100 m² and per m crown height, after flowering decreases to 10 g per 100 m² and per m crown height 003 DE Pome fruit NNNOK F scab Venturia spp. VENTSP spraying or fine spraying (low volume spraying) at beginning of infestation and/or when first symptoms become visible a) 14 b) 14 (7-10 days) a)35 g/100m² and per m crown height 20.0 g/100m² and per m crown height a) 28 g/100m² and per m crown height 16 g/100m² and per m crown height max. 5 L water/ 100m² and per m crown height withdrawn by the applicant with letter from risk assessment in DE is conducted with 3m crown heights: 2.25 kg as/ha b) max g/100m² b) application rate before flowering decreases to 25 g per 100 m² and per m crown height, after flowering decreases to 10 g per 100 m² and per m crown height 004 DE Pome fruit NNNOK F scab Venturia spp. VENTSP spraying or fine spraying (low volume spraying) at beginning of infestation and/or when first symptoms become visible a) 27 b) 27 (5-7 days) a) 25.0 g/100m² and per m crown height g/100m² and per m crown height b) max g/100m² a) 20.0 g/100m² and per m crown height g/100m² and per m crown height b) max. 5 L water/ 100m² and per m crown height 7 withdrawn by the applicant with letter from risk assessment in DE is conducted with 3m crown heights: 2.25 kg as/ha for treatments with lower doses (reduced efficacy, e.g. in organic farming) the maximum number of treatments can be Applicant (insert company name) Evaluator Date.2017

13 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 13 of 33 increased as long as the specified total application rate is not exceeded per crop and year 005 DE Gooseberrry RIBUC F american powdery mildew Sphaerotheca mors-uvae SPHRMU spraying at beginning of infestation and/or when first symptoms become visible a) 6 b) 6 (7-10 days) a) before sprouting: 50.0 g/100m² after sprouting: 40.0 g/100m² b) g/100m² a) before sprouting: 40.0 g/100m² after sprouting: 32.0 g/100m² b) g/100m² before sprouting: 10 L water /100m² after sprouting: 10 L water /100m² 7 WH915, WP732 NW DE Peas PIBST F powdery mildew Erysiphe pisi ERYSPI spraying at beginning of infestation and/or when first symptoms become visible a) 3 b) 3 (6-8 days) a) 15.0 g/100m² b) 45.0 g/100m² a) 12.0 g/100m² b) 36.0 g/100m² 6 L water /100m² 7 NW DE Cucumber CUMSA F powdery mildew Sphaerotheca fuliginea SPHRFU powdery mildew Erysiphe cichoracearum ERYSCI spraying at beginning of infestation and/or when first symptoms become visible BBCH a) 6 b) 6 (6-8 days) a) 15.0 g /100m² b) 90.0 g/100m² a) 12.0 g /100m² b) 72.0 g/100m² max. 6 L water /100m² 1 NW DE Root-and tubervegetables NNNVW F powdery mildew ERYSSP* spraying at beginning of infestation and/or when first symptoms become visible BBCH a) 6 b) 6 (5-7 days) a) 15.0 g /100m² b) 90.0 g/100m² a) 12.0 g /100m² b) 72.0 g/100m² max. 6 L water /100m² 7 WP747 NW DE Oak QUESS F powdery mildew Microsphaera alphitoides MICRAL spraying after the sprouting; spring to summer a) 3 b) 3 (10-14 days) a) 12.0 g/100m² b) 36.0 g/100m² a) 9.6 g/100m² b) 28.8 g/100m² 2-6 L water /100m² - withdrawn by the applicant with from DE Ornamentals NNNZZ F powdery mildew ERYSSP* spraying at beginning of infestation and/or when first a) 15 b) 15 (6-8 days) a) a) N* First true leaf, leaf pair or whorl unfolded; First leaves unfolded Applicant (insert company name) Evaluator Date.2017

14 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 14 of 33 *non EPPO Code symptoms become visible BBCH < 50 cm: 36.0 g/ 100m² 50cm < 125cm: 48 g/ 100m² >125cm: 24 g/ 100m² b) g/ 100m² < 50 cm: 28.8 g/ 100m² 50cm< 125cm: 38.4 g/ 100m² >125cm: 19.2 g/ 100m² b) g/ 100m² 10 L water /100m² 15 L water /100m² 20 L water /100m² Fully ripe: fruit shows fullyripe colour, beginning of fruit abscission WH915 *The setting of a PHI is without any relevance. NW642-1 Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (2) Member State(s) or zone for which use is applied for (3) 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) (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (8) The maximum number of applications possible under practical conditions of use for each single application and per year (permanent crops) or crop (annual crops) must be provided Min. interval between applications (days) where relevant (9) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. kg or L product / ha) (10) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha) (11) The range (min/max) of water volume under practical conditions of use must be given (L/ha) (12) PHI - minimum pre-harvest interval (13) Remarks may include: Extent of use/economic importance/restrictions/minor use etc. Applicant (insert company name) Evaluator Date.2017

15 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 15 of 33 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: Please refer to Part B, Section 1 of the main application submitted to the zrms Slovenia and the concerned member states including Germany, in June No additional data were submitted. No changes compared to the main submission Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) Please refer to Part B, Section 2 of the main application submitted to the zrms Slovenia and the concerned member states including Germany, in June No additional data were submitted. No changes compared to the main submission Analytical methods for residues (Part B, Section 2, Points ) Please refer to Part B, Section 2 of the main application submitted to the zrms Slovenia and the concerned member states including Germany, in June No additional data were submitted. No changes compared to the main submission Mammalian Toxicology See RR of the main authorisation where Germany has accepted the evaluation from Slovenia Acute Toxicity See main authorisation: Netzschwefel Stulln has a low toxicity in respect to acute oral, dermal and inhalation toxicity, and has no skin irritating, eye irritating or skin sensitisation properties Operator Exposure Different from the main evaluation and with respect to the non-professional uses included in this application the following label instructions are set: Wear protective gloves when handling the product. and Wear long-sleeved shirt, long trousers and sturdy footwear during handling and applying plant protection products Bystander Exposure The bystander and/or resident exposure estimations indicated that the reference value for sulphur will not be exceeded under conditions of intended uses Worker Exposure Applicant (insert company name) Evaluator Date.2017

16 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 16 of 33 It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate clothing (but no PPE), when re-entering crops treated with Netzschwefel Stulln according to the intended uses. As a standard rule, it should be mentioned on the label that treated crops should not be re-entered before spray deposits on leaf surfaces have completely dried. Implications for labelling resulting from operator, worker, bystander assessments: See 2.2 Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

17 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 17 of Residues and Consumer Exposure Residues Residue studies were not considered relevant for evaluation nor were they considered necessary for the approval of sulphur due to the nature and properties of the active substance. As no MRLs are required, the substance was included in annex IV to Regulation (EC) No 396/ Consumer exposure No risk assessment is necessary due to the intrinsic properties of the active ingredient. Chronic as well as short-term intake of sulphur residues is unlikely to present a public health concern. Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

18 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 18 of Environmental fate and behaviour (Part B, Section 5, Point 9) A full exposure assessment for the plant protection product Netzschwefel Stulln in its intended uses in grapevines, pome fruit, stonefruit, cereals, solanaceous crops and cucurbits is documented in detail in the core assessment of the plant protection product Netzschwefel Stulln dated from October 2013 performed by Slovenia. The following chapters summarise specific exposure assessment for soil and surface water and the specific risk assessment for groundwater for the authorisation of Netzschwefel Stulln in Germany. Elemental sulphur occurs abundantly in nature, and it is constantly exposed to all the three environmental compartments (soil, water, air). It is stable under sterile conditions, but readily undergoes degradation through oxidative or reductive processes under aerobic or anaerobic conditions by specific microbial organisms to sulfate ions (SO 4 2- ) or sulfites (-S-), respectively, both of which in turn are abundant in nature. These processes will also govern the fate of sulphur added as a fungicide to the same environment. (EFSA Scientific Report 2008, 221, p. 15) Sulphur is a component of the environment, and there is a natural cycle of oxidation and reduction reactions, which transforms sulphur into both organic and inorganic products. A description of the environmental fate and behaviour of sulphur in soil, based on literature review, was provided by the applicants and summarised in the EU-DAR (2007). This general introduction provided an overview of the processes (chemical and biological transformation, oxidation-reduction) that govern the behaviour of naturally occurring sulphur in the environment, in view of the fact that these processes will also govern the fate of sulphur added as a fungicide to the same environment. Elemental sulphur is known to enter the sulphur cycle immediately after application, i.e. elemental sulphur is transformed by micro-organisms into various stages of oxidation (e.g. sulphate and sulphite), which are soluble and thus made available for uptake by plants and animals. This is an active uptake process, since sulphur is an essential element required for maintaining crucial life functions. (EFSA Scientific Report 2008, 221, p. 15) The rate of oxidation of elemental sulphur is the process that determines the rate, at which sulfate is available to plants. Oxidation is preceded by a short incubation period allowing the formulated granules to absorb moisture from the soil, and then disintegrate to release sulphur. Oxidation then proceeds quickly and smoothly, the kinetics being a function of temperature, soil ph, organic content of soil, and particle size of elemental sulphur. It has been shown on published literature during the EU assessment that the oxidation rate of sulphur increases with the particle size of the elemental sulphur used, and with temperature. The view of the Member State experts was that because of the complexity of the laboratory studies, including the lack of information on the method of calculation of the oxidation rates, the results of these studies should not be used quantitatively (i.e. derived DT 50 ) in the exposure assessment. It was also agreed that taking into account the natural background concentration of sulphur in the top 15 cm layer of agricultural soils of mg S/kg soil, reliable half-life values for elemental sulphur are not necessary to finalise the risk assessment. Sulphur is not expected to be persistent in elemental form, and therefore no accumulation of elemental sulphur is anticipated. (EFSA Scientific Report 2008, 221, p. 15f) The same conclusion can be applied to the oxidation product sulphate. The application of elemental sulphur and its oxidation and chemical reaction in the soil causes soil acidification. It is normally advised to counteract soil acidification by liming in order to preserve the typical soil ph values. This should be a common practice especially in permanent crops (here: vine), where sulphur is typically added in elemental form every year over a long time period. Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

19 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 19 of 33 Table: Critical use pattern of Netzschwefel Stulln grouped according to soil relevance, drift scenario and crop scenario Groups Soil relevance Group Intended uses Application rate (interception) (g as/ha) S (40 %) (70 %) S (65 %) (65 %) (70 %) (80 %) Soil-relevant effective applic. rate, cumulative (g as/ha) S (50 %) S (40 %) (60 %) S , (25 %) (50 %) S (25 %) 2160 S (35 %) (55 %) Groups Drift scenario (single drift event surface water bodies) Group Intended uses Application rate (g as/ha) 2100 Drift scenario D03sng gardening, tr. early >2 m D09sng , gardening, plants >50 cm D10sng gardening, plants >50 cm D11sng gardening, plants >50 cm D12sng , , gardening, plants <50 cm Groups Drift scenario (sequence of drift events terrestrial habitats) Group Intended uses Application rate (g as/ha) D04seq Drift scenario gardening, tr. early >2 m D10seq gardening, plants >50 cm D12seq D14seq gardening, plants >50 cm gardening, plants >50 cm D15seq gardening, plants >50 cm D16seq , gardening, plants <50 cm D17seq gardening, plants <50 cm Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

20 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 20 of 33 Groups Birds and mammals Group Intended uses Application rate (interval) (g as/ha) B04M (7 d) (7 d) B05M (5 d) (5 d) 3 Crop scenario vineyard orchard B07M (5 d) root and stem vegetables B08M (6 d) 4 ornamentals/nursery B09M (6 d) fruiting vegetables B10M (7 d) (7 d) 5 bush and cane fruit B11M (6 d) pulses B13M (10 d) ornamentals/nursery 3 grouping and risk assessment based on a truncated application sequence of g as/ha 4 grouping and risk assessment based on a truncated application sequence of g as/ha 5 grouping and risk assessment based on a truncated application sequence of g as/ha Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) For the intended use of the plant protection product Netzschwefel Stulln PECsoil was calculated for the active substance sulfur considering a soil depth of 1 cm. Sulfur is not expected to be persistent in elemental form and therefore no accumulation of the elemental form is expected. Finally, the calculated initial PECsoil is based on the maximum annual total dose of sulfur applied. Table: Overview of estimated PECsoil values of the worst case use active substance/ formulation soil relevant application rate (g/ha) soil depthact (cm) PECact (mg/kg) tillage depth (cm) PECbkgd (mg/kg) PECaccu = PECact + PECbkgd (mg/kg) Sulfur /- -/- -/- Netzschwefel Stulln /- -/- -/- The results for PECsoil for the active substance Sulphur and the product Netzschwefel Stulln were used for the ecotoxicological risk assessment Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

21 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 21 of Direct leaching into groundwater According to the EU assessment, the elemental Sulphur is not of concern for the contamination of groundwater due to its fast inorganic degradation and its sorption to soil. This was qualitatively confirmed by a non guideline conform lysimeter study. Hence, the active substance Sulphur is not expected to penetrate into groundwater with relevant concentrations for the intended uses. For the oxidation product sulfates of Sulphur a groundwater concentration of 0.1 µg/l cannot be excluded for the intended uses. Maximum PECgw of mg/l for the Hamburg scenario was estimated for the use of Netzschwefel Stulln in ornamentals (02-010). The worst case PECgw estimation based on the flux method gave evidence, that the maximum expected concentrations of sulfates in groundwater are lower than the limit of 250 mg/l for drinking water (Directive 98/83/CE, TrinkwV 2012). Consequences for authorisation: none 2. Ground water contamination by bank filtration due to surface water exposure via run-off and drainage Groundwater contamination at concentrations 0.1 µg/l for the degradation product sulfates due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration cannot be excluded for the intended uses according to the results of the conservative groundwater calculation based on the principles of EXPOSIT A maximum PECgw of 5.49 µg/l was estimated after run-off into the adjacent ditch with subsequent bank filtration for the use of Netzschwefel Stulln in ornamentals (02-010). And a maximum PECgw of 1.80 µg/l was estimated after drainage and subsequent bank filtration for the use of Netzschwefel Stulln in ornamentals (02-010). The conservative PECgw calculation gave evidence that the expected concentrations of sulfates in groundwater are far below the limit concentration of 250 mg/l for drinking water (Directive 98/83/CE, TrinkwV 2012) Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) For the intended use of the plant protection product Netzschwefel Stulln in cereals, vine/grapes, pome fruits, gooseberries, peas, cucumbers, rooty vegetables, oaks and ornamentals PECsw was calculated for the active substance Sulphur considering the route of entry via spraydrift estimated with the models EVA 3.1. The actual concentration of Sulphur in the water phase (PECsw) was calculated considering a single application with the maximum application rate, only. This approach seems justified due to the chemical properties of the elemental Sulphur (fast, oxidation, strong adsorption, low water solubility). It is unlikely, that Sulphur will be accumulated in the water phase from the multiple applications. Elemental Sulphur from Netzschwefel Stulln is classified as semivolatile, because a vapour pressure between 10-5 and 10-4 Pa (9.8 x 10-5 Pa) was measured at 20 C. Therefore, a volatilisation of the active substance from plant surfaces can be expected. However, it is highly questionable, if the deposition rate of the elemental sulphur to adjacent surface water bodies is comparable to measured values from studies with organic pesticides which are usually used in the program EVA 3.1. The deposition rate for elemental sulphur might be quite low under field conditions and the pathway via volatilization and deposition to adjacent water bodies seems negligible. Therefore, only deposition rates from spraydrift are considered in the modelling. Both exposure pathways surface run-off and drainage seem negligible for PECsw estimations due to the chemical properties of the inorganic substance Sulphur (fast oxidation, strong adsorption, low water solubility). The maximum water solubility may also cover concentrations of Sulphur in the water phase Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

22 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 22 of 33 from both pathways. Therefore, no PECsw calculations after exposure by surface run-off and drainage are necessary to finalise the aquatic risk assessment for the intended uses of Netzschwefel Stulln. For the intended use of the plant protection product Netzschwefel Stulln PECsed was calculated for the active substance Sulphur taking into account the total annual dose, following the RMS approach in the revised Addendum for confirmatory data from April 2012 Vol. 3, B.8, p. 14ff. Any Sulphur specific parameters (water solubility, DT50, KOC) were not considered and two worst-case assumptions were defined: 100 % of drift entry of Sulphur to the surface water body is deposited immediately to the sediment, and 100 % of Sulphur entering the water body via run-off/erosion is precipitated immediately to the sediment simultaneously with the drift entry event. Both PECs are finally summarized. Crop specific spray drift values from the program EVA 3.1 have been taken into account and interception values and specific run-off/erosion fractions have been selected according to Exposit No dilution factor was considered. The water/sediment system dimension is based on the FOCUS assumptions. Table Overview PECsw values relevant for deriving risk mitigation measures. Group Intended uses Application rate Drift scenario PECsw 90 Perc- 1m or 3 m buffer [µg/l] (g as/ha) D03sng gardening, tr. early >2 m D09sng , gardening, plants >50 cm 9.6 D10sng gardening, plants >50 cm 9.2 D11sng gardening, plants >50 cm 2.3 D12sng , , gardening, plants <50 cm 1.68 The results for PEC surface water and PEC sediment for the active substance Sulphur were used for the ecotoxicological risk assessment Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) As described in the core dossier section 5 of the ZRMS Slovenia the fate and behaviour in air of Sulphur was evaluated during the Annex I inclusion. Additional data were not required as a result of the review. The vapour pressure of sulfur is 9.8 x 10-5 Pa and the Henry s law constant 0.05 Pa m 3 mol -1 at 20 C (EFSA Scientific Report (2008) 221 (sulfur)). The FOCUS Air group (2008) proposes the following assessment scheme for the compartment air with regard to Sulphur-volatilization: In case the vapour pressure is > 10-5 Pa (20 C) for Sulphur-volatilization from plant or > 10-4 Pa (20 C) for Sulphur- volatilization from soil and in case Step 4 modelling is required for FOCUS Surface Water, or if drift mitigation is required for the terrestrial assessment, the short range transport has to be addressed using the German exposure model EVA 3.1 According to this model sulfur is classified as a semi-volatile substance. The calculation of concentrations in surface water is based on spray drift data by Rautmann Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

23 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 23 of 33 and Ganzelmeier. Sulfur has a vapour pressure of 10 5 to 10 4 Pa and is therefore classified as semivolatile. However, it is highly questionable, if the deposition rate of elemental sulfur to adjacent surface water bodies would be comparable to measured values from studies with organic pesticides, on which the estimates in the EVA model are based. The deposition rate for elemental sulfur might be quite low under field conditions, and thus, possible entries into adjacent water bodies via volatilisation and deposition seem negligible. Therefore, only deposition rates from spray drift are considered in the modelling. The investigation of the long range transport potential of sulfur in air has to be considered in case the half-life of the substance in the atmosphere would be > 2 days. For this purpose usually the model AOP is used. However, as sulfur is an inorganic compound and therefore not included in the training data set for the methodology in this program, and thus outside the estimation domain, no atmospheric half-life could be estimated. Implications for labelling resulting from environmental fate assessment: Biodegradability assessment not applicable for a mineral. Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

24 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 24 of Ecotoxicology (Part B, Section 6, Point 10) A full exposure assessment for the plant protection product Netzschwefel Stulln in its intended uses in grapevines, pome fruit, stone fruit, cereals, solanaceous crops and cucurbits is documented in detail in the core assessment of the plant protection product Netzschwefel Stulln dated from October 2013 performed by Slovenia. The following chapters summarise specific risk assessment for non-target organisms and hence risk mitigation measures for the authorisation of Netzschwefel Stulln in Germany according to its intended uses Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) The risk assessment for effects on birds and other terrestrial vertebrates was carried out according to the European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438). Birds The LD 50 for acute toxicity to Coturnix japonica of > 3500 mg a.s./kg bw from the study by Desai (2008) is based on observation of 6 treated animals, none of which showing signs of intoxication after treatment. According to chapter of EFSA/2009/1438, an extrapolation factor of can be applied to the greater-than value of the LD 50 to obtain a still conservative but more realistic definitive value for that endpoint. Hence, an LD 50 of 5649 mg a.s./kg bw can be used in the risk assessment. Mammals The risk assessment is based on a LD 50 of mg/kg bw as described in the core dossier section 6 of ZRMS Slovenia. Dietary risk assessment TER values for birds were calculated, taking into account the relevant toxicity data for sulfur and calculated exposure levels for dietary exposure, according to the intended uses of the product Netzschwefel Stulln. The calculated TER values do achieve, with one exception, the acceptability criterion TER 10 for acute effects on birds, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point The TER of 7.8 for a small insectivorous bird tit in pome fruit was considered acceptable based on weight of evidence. The results of the assessment indicate an acceptable risk for birds due to the intended use of Netzschwefel Stulln. TER values for mammals were calculated, taking into account the relevant toxicity data for sulfur and calculated exposure levels for dietary exposure, according to the intended uses of the product Netzschwefel Stulln. The calculated TER values do achieve the acceptability criterion TER 10 for acute effects on mammals, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point The results of the assessment indicate an acceptable risk for mammals due to the intended use of Netzschwefel Stulln. Risk assessment for exposure via drinking water Due to the characteristics of the exposure scenario in connection with the standard assumptions for water uptake by animals, no specific calculations of exposure and TER were necessary for the intended uses of the product Netzschwefel Stulln. Hence, it can be concluded that the risk for birds and mammals due to the intended use of Netzschwefel Stulln according to the label is acceptable. Risk assessment for exposure via secondary poisoning Due to the low log Pow of sulfur, which does not exceed the trigger value of 3, a calculation of TER values for effects due to secondary poisoning is not required. Hence, it can be concluded that the risk for birds and mammals due to the intended use of Netzschwefel Stulln in cereals, grapevine, pome fruit, gooseberry, peas, cucumber, root & bulb vegetables, oaks, and ornamentals according to the label is acceptable. Applicant agrostulln GmbH Evaluator DE Date.29/06/2017

25 Part A National Assessment - Federal Republic of Germany Netzschwefel Stulln Draft Page 25 of Effects on Aquatic Species (Part B, Section 6, Point 10.2) The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with the recommendations of the Guidance Document on Aquatic Ecotoxicology, as provided by the Commission Services (SANCO/3268/2001 rev.4 (final), 17 October 2002). Table: Endpoint used for aquatic risk assessment Species Substance Exposure System Results [mg a.s./l] Reference Internal code Daphnia magna SULFUR 80 % WG 21 d, static renewal (3/week) NOEC = 0.8 mg a.s./l (immobilisation of offspring) Noack M. et al BASF DocID 1991/ /- Results of aquatic risk assessment for the intended uses of Netzschwefel Stulln in grapevines and sugar beet based on sediment PEC values estimated following the concept of FOCUSsw are presented in the core assessment, Part B, Section 6, chapter 6.4 of ZRMS Slovenia. No quantitative risk assessment was performed in the core assessment for organisms in the water phase, because Sulphur is only slightly soluble in water with a maximum determined water solubility of 63 µg/l. It was discussed by the member states and EFSA, that the use of FOCUS modelling would not be appropriate for inorganic substances. And it was finally proposed to use the highest water solubility limit of 63 µg/l as maximum PEC sw, which is well below exposure levels that caused adverse effects in ecotoxicological testing. For Sulphur-volatilization in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and Sulphur-volatilization with subsequent deposition and (ii) run-off, drainage separately in order to allow risk mitigation measures separately for each entry route. The national assessment is based on a chronic daphnid study, where the observed Sulphur-volatilization of neonate daphnids was clearly dependent on nominal sulfur concentrations, i.e. loadings of sulfur in the test vessels. Hence, dose-dependent effects of sulfur could also be caused by non-dissolved material, which justifies a risk assessment that refers to loadings rather than to concentrations of a compound in water. 2. Exposure by spraydrift and deposition following volatilisation TER values for aquatic organisms were calculated, taking into account the relevant toxicity data for sulfur and calculated exposure concentrations or loadings in surface water, according to the intended uses of the product Netzschwefel Stulln. The calculated TER values do achieve the acceptability criterion TER 10 for chronic effects on aquatic organisms, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of Netzschwefel Stulln according to the label. 2. Exposure by surface run-off and drainage As agreed in the EU assessment for Sulphur, run-off and drainage can be neglected as entry pathways for PEC sw estimations, due to the chemical properties of the inorganic substance Sulphur (fast oxidation, strong adsorption, low water solubility). Therefore the maximum water solubility of Sulphur adequately describes the expectable concentrations of Sulphur in the water phase, and no specific calculations with the model EXPOSIT are required. Furthermore, the available toxicity data demonstrate that water concentrations of Sulphur at the solubility limit of 63 µg a.s./l are not toxic for water organisms. The risk for surface water organisms due to entries of Sulphur via run-off and drainage can thus be considered acceptable without calculation of TER values. The risk for sediment dwellers due to entries of particle-bound Sulphur is sufficiently addressed by the calculations in the core assessment Applicant agrostulln GmbH Evaluator DE Date.29/06/2017