ARMICARB /00 Page 1 of 22. REGISTRATION REPORT Part A. Risk Management. Potassium hydrogen carbonate

Transcription

1 Part A National Assessment Germany ARMICARB /00 Page 1 of 22 Registration Report Central Zone REGISTRATION REPORT Part A Risk Management Product code: Active Substance: ARMICARB (Armicarb 85 SP) 850 g/kg Potassium hydrogen carbonate COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Netherlands NATIONAL ASSESSMENT Applicant: Agronaturalis Ltd. Date: 31/05/2013 Applicant: Agronaturalis Ltd. Evaluator: BVL / DE Date: 31/05/2013

2 Part A National Assessment - Germany Armicarb 85 SP Page 2 of 22 Registration Report Central Zone 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 Regulation (EC) No 547/ Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses 9 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 ) Acute Toxicity (Part B, Section 3, Point 7.1) Operator Exposure (Part B, Section 3, Point 7.3) Bystander Exposure (Part B, Section 3, Point 7.4) Worker Exposure (Part B, Section 3, Point 7.5) Residues and Consumer Exposure (Part B, Section 4, Point 8) Residues (Part B, Section 4, Points 8.3 and 8.7) Consumer exposure (Part B, Section 4, Point 8.10) Environmental fate and behaviour (Part B, Section 5, Point 9) Predicted Environmental Concentration in Soil (PEC soil ) (Part B, Section 5, Points 9.4 and 9.5) Predicted Environmental Concentration in Ground Water (PEC GW ) (Part B, Applicant: Agronaturalis Ltd. April 2013 Evaluator: BVL / DE

3 Part A National Assessment - Germany Armicarb 85 SP Page 3 of 22 Registration Report Central Zone Section 5, Point 9.6) Predicted Environmental Concentration in Surface Water (PEC SW ) (Part B, Section 5, Points 9.7 and 9.8) Predicted Environmental Concentration in Air (PEC Air ) (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 Marco-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 19 Appendix 1 Copy of the product authorisation 20 Appendix 2 Copy of the product label 21 Appendix 3 Letter of Access 22 Applicant: Agronaturalis Ltd. April 2013 Evaluator: BVL / DE

4 Part A National Assessment Germany ARMICARB /00 Page 4 of 22 Registration Report Central Zone PART A Risk Management This document describes the acceptable use conditions required for the registration of ARMICARB containing potassium hydrogen carbonate in Germany. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C from the Netherlands and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to ARMICARB where that data has not been considered in the EU review. Otherwise assessments for the safe use of ARMICARB have been made using endpoints agreed in the EU review of potassium hydrogen carbonate. This document describes the specific conditions of use and labelling required for Germany for the registration of ARMICARB. Appendix 1 of this document provides a copy of the final product authorisation Germany. 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 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(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 Agchem Project Consulting on behalf of Agronaturalis Ltd. to Germany as concerned Member State for the registration of ARMICARB in Germany on 16 november The Netherlands are the zonal Rapporteur Member State for the registration of ARMICARB (Armicarb 85 SP) in the Central Zone of Europe. The application is for approval of ARMICARB, a water soluble powder (SP) containing 850 g/kg potassium hydrogen carbonate for use as a fungicide to control apple scab (Venturia inaequalis) in apple. 1.2 Annex I inclusion Potassium hydrogen carbonate was included on Annex I of Directive 91/414/EEC on 1 September 2009 under Inclusion Directive 2008/127/EC of 18 December Potassium hydrogen carbonate is deemed to be approved under Regulation (EC) No 1107/2009 (Commission Implementing Regulation (EU) No 735/2012 of 14 August 2012 amending Implementing Regulation (EU) No 540/2011). Applicant: Agronaturalis Ltd. Evaluator: BVL / DE Date: 31/05/2013

5 Part A National Assessment - Germany Armicarb 85 SP Page 5 of 22 Registration Report Central Zone For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the potassium hydrogen carbonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on SANCO/2625/2008, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures. These concerns are addressed in the decision. Expiration of approval: 31/08/ Regulatory approach To obtain approval the product ARMICARB must meet the conditions of EU approval of potassium hydrogen carbonate and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using agreed EU-end-points. This application was submitted in order to allow the first approval of this product/use in Germany in accordance with the above. A zonal evaluation is to be made by the zonal Rapporteur Member State (The Netherlands). 1.4 Data protection claims The Annex III data submitted will be protected in accordance with Regulation 1107/2009 EG. Additional uses will attract data protection on a national basis. 1.5 Letters of Access The Annex II data are protected and a letter of access is provided by the main notifier. In addition, some of the Annex III data are protected and letters of access are provided as appropriate. 2 Details of the authorisation 2.1 Product identity Product Name Authorization Number (for re-registration) Function Applicant Composition Formulation type Packaging ARMICARB (Armicarb 85SP fungicide Agronaturalis Ltd. 850 g/kg potassium hydrogen carbonate Water soluble powder (Code: SP) 5 kg kraft PE bag with polyethylene lining Applicant: Agronaturalis Ltd. April 2013 Evaluator: BVL / DE

6 Part A National Assessment - Germany Armicarb 85 SP Page 6 of 22 Registration Report Central Zone 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC The following labelling is proposed in accordance with Directive 1999/45/EC: Symbol(s)/Indication(s) of danger: Risk phrases: Safety phrases: Specific labelling requirement: To avoid risks to man and the environment, comply with the instructions for use. Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Hazard classes and categories: Hazard pictograms: Signal words: Hazard statements: Precautionary statetments: none Special rule for labelling of PPP: EUH401 SP 1 To avoid risks to man and the environment, comply with the instructions for use. Do not contaminate water with the product or its container (Do not clean application equipment near surface water./avoid contamination via drains from farmyards and roads) R and S phrases under Regulation (EC) No 547/2011 None Applicant: Agronaturalis Ltd. April 2013 Evaluator: BVL / DE

7 Part A National Assessment - Germany Armicarb 85 SP Page 7 of 22 Registration Report Central Zone Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): human health protection SB001 SB010 SF Avoid any unnecessary contact with the product. Misuse can lead to health damage. Keep out of children s reach. Treated areas/crops may not be entered until the spray coating has dried. Integrated pest management (IPM)/sustainable use WMFUN NN334 Ecosystem protection NW NT 105 Mode of action not classified The product is classified as harmful for populations of the species Typhlodromus pyri (predatory mite). 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. In a strip at least 20 m wide which is adjacent to other areas, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 % (except agriculturally or horticulturally used areas, roads, paths and public places). If it is not possible to apply the product with loss reducing equipment, a buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (e.g. field boundaries, hedges, groups of woody plants) are less than 3 m wide or if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures. A buffer zone of at least 5 m is also not necessary if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas The authorization of the PPP is linked to the following conditions (voluntary labelling): Integrated pest management (IPM)/sustainable use 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. Applicant: Agronaturalis Ltd. April 2013 Evaluator: BVL / DE

8 Part A National Assessment - Germany Armicarb 85 SP Page 8 of 22 Registration Report Central Zone Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): WP7371 WW750 WW764 Russetting is possible on sensitive plants. The maximum number of applications is limited due to active substance-specific reasons. Sufficient control is therefore not expected in all cases. If necessary, use products containing other active substances afterwards or alternately. In order to prevent resistance, alternate with other products from different active substance groups. Applicant: Agronaturalis Ltd. April 2013 Evaluator: BVL / DE

9 Part A National Assessment Germany ARMICARB /00 Page 9 of 22 Registration Report Central Zone 2.3 Product uses The draft Part A will be applicant s proposal for product use; this should be modified by the reviewer following the evaluation. Crop and/ or situation (a) Zone Product code F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment PHI (days ) (l) Remarks: (m) Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg as/hl min max water L/ha min max kg as/ha min max Apple MABSD DE (zentral zone) Armicarb F Venturia inaequalis VENTSP SP 850 spraying or fine spraying (low volume spraying) BBCH L/m crown height kg as / m crown height 1 = 2.5 kg product/ha / m crown height Max: 5 kg product /ha NW642-1 NT105 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 Applicant: Agronaturalis Ltd. Evaluator: BVL / DE Date: 31/05/2013

10 Part A National Assessment Germany ARMICARB /00 Page 10 of 22 Registration Report Central 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: The product Armicarb 85 SP is a water soluble powder. Most studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The appearance of the product is that of white odourless powder. It is not explosive, not highly flammable and has no oxidising properties. In aqueous solution, it has a ph value around 8.3. The stability data provisionally indicate a shelf life of at least 2 years in LDPE at ambient temperature (a new study is still on-going and a final report is expected in May-June 2013). The technical characteristics are acceptable for a water soluble powder formulation. Due to its chemical nature (salts), Armicarb 85 SP is hygroscopic under ambient conditions with humidity and aggregates tend to form during storage. However specific test on aggregates show that the dissolution degree and stability is acceptable, including after accelerated stability storage. Implications for labelling: None Compliance with FAO specifications: There is no FAO specification for potassium hydrogen carbonate. Compliance with FAO guidelines: The product Armicarb 85SP complies with the general requirements according to the FAO/WHO manual Compatibility of mixtures: No tank mixes are recommended and no studies on physical or chemical compatibility have been submitted. 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 Armicarb 85 SP 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) Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. Analytical methods for determination of potassium hydrogen carbonate, impurities and relevance of CIPAC methods in Armicarb 85 SP were evaluated as part of the EU review of potassium hydrogen Applicant: Agronaturalis Ltd. Evaluator: BVL / DE Date: 31/05/2013

11 Part A National Assessment Country insert Product code Page 11 of 22 Registration Report Northern/Central/Southern Zone carbonate. Validation of the analytical method for the quantitation of potassium hydrogen carbonate active ingredient is provided Analytical methods for residues (Part B, Section 2, Points ) In the EU review it was concluded that residue analytical methods are not required due to the nature of the compound Mammalian Toxicology (Part B, Section 3, Point 7) Acute Toxicity (Part B, Section 3, Point 7.1) Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. The acute toxicity studies for Armicarb 85 SP were evaluated during the review and were considered adequate. Armicarb 85 SP, containing 850 g/kg potassium hydrogen carbonate, has a low toxicity in respect to acute oral and dermal toxicity and is not classified as skin or an eye irritant. All studies are acceptable. None of the co-formulants of Armicarb 85 SP raise any concerns for hazards additional to those tested for in the acute toxicology Operator Exposure (Part B, Section 3, Point 7.3) Armicarb 85 SP was the representative formulation in the EU review of potassium hydrogen carbonate. The intended use pattern for national re-registration is within the use pattern considered for EU review. Therefore, an appropriate operator exposure assessment of Armicarb 85 SP was evaluated as part of the EU review of potassium hydrogen carbonate. All data were considered adequate. Operator exposure was assessed against the normal daily requirement (NDR) agreed in the EU review (128 mg / kg bw /day). Data on dermal absorption of Armicarb 85 SP was provided and considered acceptable. Operator exposure was modelled using according to the Dutch guidelines (Ctgb, evaluation manual for the authorisation of plant protection products version 1.0, 2010) which included the NL model and EUROPOEM I. According to the model calculations, it can be concluded that the risk for the operator using Armicarb 85 SP on apple is acceptable without the use of personal protective equipment Bystander Exposure (Part B, Section 3, Point 7.4) Bystander exposure to Armicarb 85 SP was evaluated as part of the EU review of potassium hydrogen carbonate. Bystander exposure was assessed against the NDR agreed in the EU review (128 mg / kg bw /day). Data on dermal absorption of Armicarb 85 SP was provided and considered acceptable. Bystander exposure was modelled using EUROPOEM II according to the Dutch guidelines. It is concluded that there is no undue risk to any bystander after accidental short-term exposure to Armicarb 85 SP. This has no labelling implications Worker Exposure (Part B, Section 3, Point 7.5) Worker exposure to Armicarb 85 SP was evaluated as part of the EU review of potassium hydrogen carbonate. Therefore, all relevant data and risk assessments have been provided and are considered adequate. Applicant (insert company name) Date Evaluator

12 Part A National Assessment Country insert Product code Page 12 of 22 Registration Report Northern/Central/Southern Zone Worker exposure was assessed against the NDR agreed in the EU review (128 mg / kg bw /day). Data on dermal absorption of Armicarb 85 SP was provided and considered acceptable. Worker exposure was modelled using according to the Dutch guidelines (Ctgb, evaluation manual for the authorisation of plant protection products version 1.0, 2010) which included the EUROPOEM II DFR. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing (but no PPE), when re-entering crops treated with Armicarb 85 SP. Implications for labelling resulting from operator, worker, bystander assessments: Hazard Symbol: none Indication of danger: none Risk Phrases: none Safety Phrases: none R and S phrases under Directive 2003/82/EC (Annex IV and V): none Other phrases: none Applicant (insert company name) Date Evaluator

13 Part A National Assessment Country insert Product code Page 13 of 22 Registration Report Northern/Central/Southern Zone Residues and Consumer Exposure (Part B, Section 4, Point 8) Metabolism and residue studies were not considered relevant for evaluation nor were they considered necessary for Annex I inclusion due to the nature and properties of the active substance. The use of the plant protection product is indistinguishable from naturally occurring residues present in any treated crop Residues (Part B, Section 4, Points 8.3 and 8.7) Not relevant (see 3.1.4) Consumer exposure (Part B, Section 4, Point 8.10) No risk for consumers to be expected Environmental fate and behaviour (Part B, Section 5, Point 9) No new studies are presented; all data were reviewed in the EU review (potassium hydrogen carbonate). Appropriate endpoints from the EU review were used to calculate PECs in the core assessment for potassium hydrogen carbonate in soil, surface water, ground water and air for the intended use patterns. The rate of degradation in soil of potassium hydrogen carbonate was evaluated during the Annex I Inclusion. No additional studies have been performed. No degradation endpoints have been derived. Instead a description of the behaviour of the compound in soil is presented in the DAR Predicted Environmental Concentration in Soil (PEC soil ) (Part B, Section 5, Points 9.4 and 9.5) The PEC of potassium hydrogen carbonate in soil has been assessed assuming no breakdown between the applications. Based on the recommended use rate of 6 applications of kg a.s./ha/3 m crown height (note: restriction of 4.25 kg as/ha is not considered) the maximum initial predicted environmental concentration in soil (PECs) of will be mg/kg and mg/kg for potassium and bicarbonate, respectively. The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment Predicted Environmental Concentration in Ground Water (PEC GW ) (Part B, Section 5, Point 9.6) The PEC of potassium hydrogen carbonate in ground water has been assessed during the EU review. Potassium bicarbonate spontaneously dissociates in water to give potassium and bicarbonate ions. The potassium ion is stable and does not degrade. Bicarbonate on the other hand will equilibrate with carbonate and carbonic acid to yield carbon dioxide and water. The potassium and bicarbonate ions potentially leach through the soil to groundwater resources. However, these ions are not of toxicological relevance. In the event of reaching groundwater it would be impossible to distinguish these ions by Applicant (insert company name) Date Evaluator

14 Part A National Assessment Country insert Product code Page 14 of 22 Registration Report Northern/Central/Southern Zone analytical means from natural sources of these ions. Given the nature of potassium bicarbonate it is considered inappropriate to use the FOCUS groundwater tools Predicted Environmental Concentration in Surface Water (PEC SW ) (Part B, Section 5, Points 9.7 and 9.8) The PEC of potassium hydrogen carbonate in surface water (PECsw and PECsed) has been assessed assuming no breakdown between the applications and overspray based on data established in the EU review. Based on the recommended use rate of 6 applications of kg a.s./ha/3 m crown height (note: restriction of 4.25 kg as/ha is not considered), the maximum PEC values for surface water will be 2.90 mg/l (using Rautman drift value for apple at early stage with a 3 m buffer zone). The PEC sediment was not considered relevant because if potassium hydrogen carbonate is present in aquatic systems it is likely to be predominantly in the water column or in the pore-water of the sediment. The results for PEC surface water for the active substance were used for the eco-toxicological risk assessment Predicted Environmental Concentration in Air (PEC Air ) (Part B, Section 5, Point 9.9) The fate and behaviour in the air of potassium hydrogen carbonate was evaluated during Annex I inclusion. No additional studies have been performed. KHCO3 is not volatile as it is composed of ionic species. Carbon dioxide is the main component that would be released to the atmosphere from the dissociation of KHCO3 and from the carbonate equilibria mechanism, which forms part of the natural carbon cycle. However, it is considered that the amounts of CO2 released to the atmosphere would be minimal following the application of Armicarb 85 SP when compared to the natural biological respiration process. Implications for labelling resulting from environmental fate assessment: none Applicant (insert company name) Date Evaluator

15 Part A National Assessment Country insert Product code Page 15 of 22 Registration Report Northern/Central/Southern Zone Ecotoxicology (Part B, Section 6, Point 10) No new studies are presented; all data were reviewed in the EU review (potassium hydrogen carbonate). Appropriate endpoints from the EU review were used Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Birds Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. However new risk assessment parameters are now considered in the zonal core assessment of risk to birds; an appropriate risk assessments has been provided and is considered adequate. In the final LoE, the endpoint for birds is given as >8,075 mg/kg bw/d. The risk assessment for effects on birds is carried out using the EFSA guidance on birds and mammal (EFSA Journal 2009, 7(12): 1438). The reproduction risks of Armicarb 85 SP to birds were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with potassium hydrogen carbonate, and maximum residues occurring on food items following applications according to the proposed use pattern. The TERrepro values, calculated for recommended scenarios, all exceed the trigger values of 5 for reproduction risk, thus indicating no unacceptable risk to birds from the proposed use. No acute study and acute TER were performed on birds and argumentation is provided and considered adequate. Terrestrial vertebrates (other than birds) Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. However new risk assessment parameters are now considered in the zonal core assessment of risk to terrestrial vertebrates other than birds; an appropriate risk assessment has been provided and is considered adequate. The endpoint for female rats of 2064 mg/kg bw is usedthe lower endpoint for female rats of 2064 mg/kg bw is used The risk assessment for effects on terrestrial vertebrates other than birds is carried out using the EFSA guidance on birds and mammals1. The acute risks of Armicarb 85 SP to wild mammals were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with potassium hydrogen carbonate, and maximum residues occurring on food items following applications according to the use pattern. The TER values, calculated for recommended scenarios, all exceed the trigger values for acute risk (including refinement for the vole based on feeding behaviour), thus indicating no unacceptable risk to mammals from the proposed use. Reproductive toxicity exposure ratios were not required at EU level for higher use rate of the same product and thus the argumentation is presented here and is considered adequate Effects on Aquatic Species (Part B, Section 6, Point 10.2) Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. However new risk assessment parameters are now considered in the zonal core assessment of risk to Applicant (insert company name) Date Evaluator

16 Part A National Assessment Country insert Product code Page 16 of 22 Registration Report Northern/Central/Southern Zone aquatic organisms; appropriate risk assessments have been provided and are considered adequate. Relevant for the risk assessment is an EC50 of > mg/l from a study on Pseudokirchneriella subcapitata. Together with an assessment factor of 10 the regulatory acceptable concentration in surface waters is > mg/l Armicarb 85 Sp. indicating that potassium hydrogen carbonate does not pose an unacceptable risk to aquatic organisms following applications of Armicarb 85 SP according to the recommended use pattern. Studies of the acute toxicity of Armicarb 85 SP for fish, daphnia and algae showed that this product does not have to be labelled. But nevertheless the application of plant protection products in the direct vicinity of surface waters is generally to be omitted. There for a labelling with NW642-1 is imposed. No additional risk mitigation measures are required. The TER using worst-case PEC values for potassium hydrogen carbonate exceed the relevant triggers, 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. : Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees All the hazard quotients are less than 50, indicating that the product used as recommended poses a low risk to bees. Therefore a low risk to bees is expected from the application of Armicarb 85 SP. No mitigation measures are proposed. Other non-target arthropods Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. However new studies on representative species (A. rhopalosiphi and T. pyri) on the formulated product were provided, new risk assessment parameters are now considered in the zonal core assessment of risk to arthropods other than bees; appropriate risk assessments have been provided and are considered adequate. Based on the calculated rates of ARMICARB in off-field areas under consideration of the restricted application rate of 4.25 kg a.s./ha, the calculated TER values for the risk resulting from an exposure of non-target arthropods to the formulation was below the acceptance criteria of TER > 10, indicating an unacceptable risk. Thus, the following risk mitigation measures need to be implemented for the intended use in orchards: NT 105: In a strip at least 20 m wide which is adjacent to other areas, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 % (except agriculturally or horticulturally used areas, roads, paths and public places). If it is not possible to apply the product with loss reducing equipment, a buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (e.g. field boundaries, hedges, groups of woody plants) are less than 3 m wide or if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures. A buffer zone of at least 5 m is also not necessary if evidence can be Applicant (insert company name) Date Evaluator

17 Part A National Assessment Country insert Product code Page 17 of 22 Registration Report Northern/Central/Southern Zone shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) Earthworms Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. A waiver was presented for the effects on earthworms. Further data on Armicarb 85 SP is not relevant as active substance data on toxicity to earthworms is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review. Effects on other soil non-target macro-organisms Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. A waiver was presented for the effects on other soil non-target macro-organisms. Further data on Armicarb 85 SP is not relevant as active substance data on toxicity to other soil non-target macro-organisms is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review Effects on organic matter breakdown (Part B, Section 6, Point 10.6) In view of the high naturally occurring background levels of potassium and bicarbonate in the environment no effect on organic matter breakdown is expected Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. A waiver was presented for the effects on other soil non-target micro-organisms. Further data on Armicarb 85 SP is not relevant as active substance data on toxicity to other soil non-target micro-organisms is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Non-Target Plants Armicarb 85 SP was a representative formulation in the EU review of potassium hydrogen carbonate. Screening data from efficacy trials showed no significant effect on apple at the maximum dose. Further data on Armicarb 85 SP is not relevant as active substance data on toxicity to other non-target plants is used and additional formulation data are not considered essential. Therefore all relevant data were assessed in the EU review and zonal core assessment. Other non-target species (Flora and Fauna) Potassium bicarbonate has been known to have fungicidal properties for more than forty years. Unlike a conventional pesticide there has been no detailed screening of its biological activity spectrum under controlled conditions. It is known to be active against a range of important diseases, particularly powdery mildew and apple scab. However, there are few examples in the literature of the product being active Applicant (insert company name) Date Evaluator

18 Part A National Assessment Country insert Product code Page 18 of 22 Registration Report Northern/Central/Southern Zone against other types of organisms. At the doses proposed it is unlikely that Armicarb will have adverse impacts on organisms other than pathogenic fungi. Implications for labelling resulting from ecotoxicological assessment: Hazard Symbol: none Indication of danger: Risk Phrases: none Safety Phrases: none R and S phrases under Directive 2003/82/EC (Annex IV and V): SP 1: Do not contaminate water with the product or its container (Do not clean application equipment near surface water./avoid contamination via drains from farmyards and roads). Other phrases: NW 642-1: 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. NT 105: In a strip at least 20 m wide which is adjacent to other areas, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 % (except agriculturally or horticulturally used areas, roads, paths and public places). If it is not possible to apply the product with loss reducing equipment, a buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (e.g. field boundaries, hedges, groups of woody plants) are less than 3 m wide or if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures. A buffer zone of at least 5 m is also not necessary if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas Efficacy (Part B, Section 7, Point 8) For Germany the proposed dose rate of 2.5 kg/ha/m crown height is considered to be appropriate. However, the recommended dose rate of 5.0 kg/ha is not sufficient for higher crowns than 2 m. Thus, for 3 m crown height trees 7.5 kg/ha would be needed. Because not more than 5.0 kg/ha is allowed to use, in the GAP 5.0 kg/ha must be covered with an information that not in every case a sufficient control against apple scab will be reached. No phytotoxicity was observed in most of the effectiveness trials. In a few trials some acceptable phytotoxic effects (e.g. fruit russetting) were observed in the effectiveness trials. In one trial the observed russetting was not acceptable. Applicant (insert company name) Date Evaluator

19 Part A National Assessment Country insert Product code Page 19 of 22 Registration Report Northern/Central/Southern Zone At the doses at which Armicarb 85SP is applied, the product has no herbicidal activity and no unacceptable phytotoxic effects were observed in the effectiveness trials. Any drift onto neighbouring crops will not be expected to result in crop damage. At this time there are no known occurrences of resistance to potassium and bicarbonate ions, or crossresistance with other pesticides. Given the fact that the active principals of Armicarb 85SP are found naturally in crops and the environment and because of the non-specific, multi-site mode of action of potassium-bicarbonate, the risk of resistance development is considered to be low. The product is classified as non-harmful for populations of relevant beneficial insects and as nonhazardous to bees, even when the maximum application rate or concentration is used. Armicarb 85 SP is classified as harmful for populations of the predatory mite species Typhlodromus pyri. There is no indication of any unacceptable adverse effects on soil macro- or soil micro-organisms relevant for the maintenance of soil quality. 3.2 Conclusions For Germany the proposed dose rate of 2.5 kg/ha/m crown height is considered to be appropriate and sufficiently effective and has no unacceptable effects on the crop. Fruit russetting is possible on sensitive varieties. However, the recommended dose rate of 5.0 kg/ha is not sufficient for higher crowns than 2 m. Thus, for 3 m crown height trees 7.5 kg/ha would be needed. Because not more than 5.0 kg/ha is allowed to be used, in the GAP 5.0 kg/ha must be covered with an information that not in every case a sufficient control against apple scab will be reached. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. An authorisation can be granted. 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation The following information is required in order to obtain a prolongation of the authorisation: Annex III point Data New study on ambient temperature shelf life in LDPE should be submitted after finalisation in June Applicant (insert company name) Date Evaluator

20 Part A National Assessment Country insert Product code Page 20 of 22 Registration Report Northern/Central/Southern Zone Appendix 1 Copy of the product authorisation See below. Applicant (insert company name) Date Evaluator

21 Part A National Assessment Country insert Product code Page 21 of 22 Registration Report Northern/Central/Southern Zone 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. Applicant (insert company name) Date Evaluator

22 Part A National Assessment Country insert Product code Page 22 of 22 Registration Report Northern/Central/Southern Zone Appendix 3 Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Applicant (insert company name) Date Evaluator

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31 Part B Section 5 National Addendum Germany Armicarb 85 SP Registration Report Central Zone zrms: Netherlands Page 1 of 11 REGISTRATION REPORT Part B Section 5 Environmental Fate Detailed summary of the risk assessment Product code: Armicarb 85 SP Active Substance(s): Potassium hydrogen carbonate 850 g/kg Central Zone Zonal Rapporteur Member State: Netherlands NATIONAL ADDENDUM Germany Applicant: Date: May 2013 Agchem Project Consulting Agchem Project Consulting (APC) Evaluator: Germany Date

32 Part B Section 5 National Addendum Germany Armicarb 85 SP Registration Report Central Zone zrms: Netherlands Page 2 of 11 Table of Contents TABLE OF CONTENTS... 2 SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) GENERAL INFORMATION ON THE FORMULATION PROPOSED USE PATTERN INFORMATION ON THE ACTIVE SUBSTANCES Potassium hydrogen carbonate SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT Rate of degradation in soil Adsorption/desorption Rate of degradation in water ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6)... 8 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION... 9 APPENDIX 2 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL ) Agchem Project Consulting (APC) Evaluator: Germany Date

33 Part B Section 5 National Addendum Germany Armicarb 85 SP Registration Report Central Zone zrms: Netherlands Page 3 of 11 Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) The exposure assessment of the plant protection product Armicarb 85 SP in its intended uses in Apple is documented in detail in the core assessment of the plant protection product Armicarb 85 SP dated from performed by Netherlands. This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for authorization of the plant protection product Armicarb 85 SP in Germany according to uses listed in Appendix 2. Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document. PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary (see National addendum Germany, part B, section 6 and part A). 5.1 General Information on the formulation Table 5.1-1: General information on the formulation Armicarb 85 SP Code - plant protection product applicant Armicarb 85 SP date of application Formulation type (WP, EC, SC, ; density) active substance (as) Concentration of as Agchem Project Consulting SP Potassium hydrogen carbonate 850 g/kg Data pool/task force letter of access/cross reference existing authorisations in DE None None None 5.2 Proposed use pattern The intended uses in Germany classified according the soil effective application rate (cumulative, disregarding degradation in soil) is presented in Table Full details of the proposed uses that will be assessed is included in Appendix 2. Agchem Project Consulting (APC) Evaluator: Germany Date

34 Part B Section 5 National Addendum Germany Armicarb 85 SP Registration Report Central Zone zrms: Netherlands Page 4 of 11 Table 5.2-1: Classification of intended uses in Germany for Armicarb 85 SP Group/ use No* Crop/growth stage Apple/ BBCH Application method Drift scenario Field, spraying Number of applications, Minimum application interval, application time, interception 6 applications 8 days minimum intervall from BBCH 72 interception: 70 % Application rate (kg as/ha) a) max. rate per appl. b) max. total rate per crop/season a) kg/ha per 3 m crown height b) kg/ha per 3 m crown height Soil effective application rate (kg as/ha) a) max. rate per appl. b) max. total rate per crop/season ) kg/ha per 3 m crown height b) kg/ha per 3 m crown height * For administrative purposes, each intended use of a plant protection product in Germany is assigned with an individual use number from the German Federal Office of Consumer Protection and Food Safety (BVL). A complete list of the individual GAPs in Germany together with their assigned use numbers is given in Appendix 2 of this Addendum. 5.3 Information on the active substances Potassium hydrogen carbonate Please refer to the core assessment, part B, section 5 of the plant protection product Armicarb 85 SP. 5.4 Summary on input parameters for environmental exposure assessment Rate of degradation in soil Potassium hydrogen carbonate Please refer to the core assessment, part B, section 5 of the plant protection product Armicarb 85 SP Adsorption/desorption Potassium hydrogen carbonate Please refer to the core assessment, part B, section 5 of the plant protection product Armicarb 85 SP Rate of degradation in water Potassium hydrogen carbonate Please refer to the core assessment, part B, section 5 of the plant protection product Armicarb 85 SP. Agchem Project Consulting (APC) Evaluator: Germany Date

35 Part B Section 5 National Addendum Germany Armicarb 85 SP Registration Report Central Zone zrms: Netherlands Page 5 of Estimation of concentrations in soil (KIIIA1 9.4) Results of PECsoil calculation for Armicarb 85 SP according to EU assessment considering 5 cm soil depth are given in the core assessment , part B, section 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 K f,oc < 500 a soil depth of 2.5 cm is applied whereas for active substances with a K f,oc > 500 a soil depth of 1 cm is applied. As soil bulk density 1.5 g cm -3 is assumed. No K f,oc are available for the active substance potassium hydrogen carbonate. However,the active substance immediately dissociates to potassium and bicarbonate ions in the presence of water, and is thus expected to be very mobile in soil. Therefore, a soil depth of 2.5 cm was applied for calulating initial PEC soil values of potassium hydrogen carbonate and for the potassium and the bicarbonate ion. Calculations of initial PEC soil values were performed with Escape version 2. No short-term and longterm actual concentrations (PECsoil, actual) and the time weighted average concentrations (PECsoil, twa) were calculated since the active substance potassium hydrogen carbonate doesn t degrade in soil but dissociates to potassium and bicarbonate ions in the presence of water instead. Since Armicarb 85 consists of 99.9% potassium hydrogen carbonate, the calculated initial PEC soil value of potassium hydrogen carbonate is also valid for the formulation Armicarb 85. The cumulative soil effective application rate of kg/ha potassium hydrogen carbonate in its intended use in apple provided in Table was used for PEC soil calculations. The input parameter used for PECsoil calculations are summarized in table Table 5.5-1: Input parameters considered for PEC soil calculations of potassium hydrogen carbonate, K + and HCO 3 - for the intended use of Armicarb 85 Parameter KHCO 3 K + HCO 3 - % content in formulation 99.9% 39% 61% Total appl. rate per season [kg/ha] Interception by plants 70 % Total effective application rate [kg/ha] Soil depth [cm] The calculated PEC soil used for German risk assessment are summarized in Table No short-term and long-term PEC soil were calculated since PEC soil,act is considered sufficient for German risk assessment. Table 5.5-2: Results of PEC soil calculation for the intended use in apple used for German risk assessment plant protection product: use: Armicarb 85 SP (Apple) Agchem Project Consulting (APC) Evaluator: Germany Date