Part A
National Assessment
Germany
ARMICARB
007547-00/00
Page 1 of 22
Registration Report – Central Zone
REGISTRATION REPORT
Part A
Risk Management
Product code:
ARMICARB (Armicarb 85 SP)
Active Substance:
850 g/kg
Potassium hydrogen carbonate
COUNTRY: Germany
Central Zone
Zonal Rapporteur Member State: Netherlands
NATIONAL ASSESSMENT
Applicant:
Date:
Applicant: Agronaturalis Ltd.
Agronaturalis Ltd.
31/05/2013
Evaluator: BVL / DE
Date: 31/05/2013
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
4
1.1
Application background
4
1.2
Annex I inclusion
4
1.3
Regulatory approach
5
1.4
Data protection claims
5
1.5
Letters of Access
5
2
Details of the authorisation
5
2.1
Product identity
5
2.2
Classification and labelling
6
2.2.1
Classification and labelling under Directive 99/45/EC
6
2.2.2
R and S phrases under Regulation (EC) No 547/2011
6
2.2.3
Other phrases
7
2.2.3.1
Restrictions linked to the PPP
7
2.2.3.2
Specific restrictions linked to the intended uses
8
2.3
Product uses
9
3
Risk management
10
3.1
Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles
10
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
10
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
10
3.1.2.1
Analytical method for the formulation (Part B, Section 2, Point 5.2)
10
3.1.2.2
Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
11
3.1.3.1
Acute Toxicity (Part B, Section 3, Point 7.1)
11
3.1.3.2
Operator Exposure (Part B, Section 3, Point 7.3)
11
3.1.3.3
Bystander Exposure (Part B, Section 3, Point 7.4)
11
3.1.3.4
Worker Exposure (Part B, Section 3, Point 7.5)
11
3.1.4
Residues and Consumer Exposure (Part B, Section 4, Point 8)
13
3.1.4.1
Residues (Part B, Section 4, Points 8.3 and 8.7)
13
3.1.4.2
Consumer exposure (Part B, Section 4, Point 8.10)
13
3.1.5
Environmental fate and behaviour (Part B, Section 5, Point 9)
13
3.1.5.1
Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5,
Points 9.4 and 9.5)
13
3.1.5.2
Predicted Environmental Concentration in Ground Water (PECGW) (Part B,
Applicant: Agronaturalis Ltd.
April 2013
Evaluator: BVL / DE
Part A
National Assessment - Germany
Armicarb 85 SP
Page 3 of 22
Registration Report – Central Zone
Section 5, Point 9.6)
13
Predicted Environmental Concentration in Surface Water (PECSW) (Part B,
Section 5, Points 9.7 and 9.8)
14
Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5,
Point 9.9)
14
3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
15
3.1.6.1
Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
15
3.1.6.2
Effects on Aquatic Species (Part B, Section 6, Point 10.2)
15
3.1.6.3
Effects on Bees and Other Arthropod Species (Part B, Section 6, Points
10.4 and 10.5)
16
Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6,
Point 10.6)
17
3.1.6.5
Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
17
3.1.6.6
Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
17
3.1.6.7
Assessment of Potential for Effects on Other Non-target Organisms
(Flora and Fauna) (Part B, Section 6, Point 10.8)
17
3.1.7
Efficacy (Part B, Section 7, Point 8)
18
3.2
Conclusions
19
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
19
3..5.3
3.1.5.4
3.1.6.4
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
Part A
National Assessment
Germany
ARMICARB
007547-00/00
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
2011. 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 2008.
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
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: 31/08/2019.
1.3
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
Applicant: Agronaturalis Ltd.
ARMICARB (Armicarb 85SP
007547-00
fungicide
Agronaturalis Ltd.
850 g/kg potassium hydrogen carbonate
Water soluble powder (Code: SP)
5 kg kraft PE bag with polyethylene lining
April 2013
Evaluator: BVL / DE
Part A
National Assessment - Germany
Armicarb 85 SP
Page 6 of 22
2.2
Classification and labelling
2.2.1
Classification and labelling under Directive 99/45/EC
Registration Report – Central Zone
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
To avoid risks to man and the environment, comply with the instructions for use.
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).
2.2.2
R and S phrases under Regulation (EC) No 547/2011
None
Applicant: Agronaturalis Ltd.
April 2013
Evaluator: BVL / DE
Part A
National Assessment - Germany
2.2.3
Armicarb 85 SP
Page 7 of 22
Registration Report – Central Zone
Other phrases
2.2.3.1 Restrictions linked to the PPP
The authorization of the PPP is linked to the following conditions (mandatory labelling):
human health protection
SB001
Avoid any unnecessary contact with the product. Misuse can lead to health damage.
SB010
Keep out of children’s reach.
SF245-01
Treated areas/crops may not be entered until the spray coating has dried.
Integrated pest management (IPM)/sustainable use
WMFUN
Mode of action not classified
NN334
The product is classified as harmful for populations of the species Typhlodromus pyri
(predatory mite).
Ecosystem protection
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 50 000 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
The authorization of the PPP is linked to the following conditions (voluntary labelling):
Integrated pest management (IPM)/sustainable use
NB6641
The product is classified as non-hazardous to bees, even when the maximum application
rate, or concentration if no application rate is stipulated, as stated for authorisation is
applied. (B4)
NN1001
The product is classified as non-harmful for populations of relevant beneficial insects.
Applicant: Agronaturalis Ltd.
April 2013
Evaluator: BVL / DE
Part A
National Assessment - Germany
Armicarb 85 SP
Page 8 of 22
Registration Report – Central Zone
2.2.3.2 Specific restrictions linked to the intended uses
Some of the authorised uses are linked to the following conditions (mandatory labelling):
WP7371
Russetting is possible on sensitive plants.
WW750
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.
WW764
In order to prevent resistance, alternate with other products from different active substance
groups.
Applicant: Agronaturalis Ltd.
April 2013
Evaluator: BVL / DE
Part A
National Assessment
Germany
2.3
ARMICARB
007547-00/00
Page 9 of 22
Registration Report – Central Zone
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
Zone
Product
code
(a)
F
G
or
I
(b)
Pests or
Group of
pests
controlled
Formulation
Application
Application rate per treatment
MABSD
DE
Armicarb
(zentral
zone)
F
Remarks:
(m)
(c)
Apple
PHI
(days
)
Venturia
inaequalis
VENTSP
(l)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
SP
850
growth
stage &
season
(j)
number
min max
(k)
spraying or BBCH 72fine spraying
89
(low volume
spraying)
6
interval
between
applications
(min)
1
kg as/hL
water L/ha
kg as/ha
min max
min max
min max
0.425 1.063
200 – 500
L/m
crown
height
2.125 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
Applicant: Agronaturalis Ltd.
(i)
(j)
g/kg or g/l
Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(k) The minimum and maximum number of application possible under practical conditions of use
must be provided
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use/economic importance/restrictions
Evaluator: BVL / DE
Date: 31/05/2013
Part A
National Assessment
Germany
ARMICARB
007547-00/00
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
3.1.1
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
2010.
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.
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 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
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.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
In the EU review it was concluded that residue analytical methods are not required due to the nature of
the compound.
3.1.3
Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1 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.
3.1.3.2 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.
3.1.3.3 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.
3.1.3.4 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
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
Part A
National Assessment Country – insert
3.1.4
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.
3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)
Not relevant (see 3.1.4)
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
No risk for consumers to be expected.
3.1.5
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.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (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 6.375 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 11.95 mg/kg and 18.67 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.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (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
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.
3..5.3 Predicted Environmental Concentration in Surface Water (PECSW) (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 6.375 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.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (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
Part A
National Assessment Country – insert
3.1.6
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
3.1.6.1 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.
3.1.6.2 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
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aquatic organisms; appropriate risk assessments have been provided and are considered adequate.
Relevant for the risk assessment is an EC50 of > 85.75 mg/L from a study on Pseudokirchneriella
subcapitata. Together with an assessment factor of 10 the regulatory acceptable concentration in surface
waters is > 8.575 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 50 000 EUR. :
3.1.6.3 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 00-001 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
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shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on
agriculturally or horticulturally used areas
3.1.6.4 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.
3.1.6.5 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.
3.1.6.6 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.
3.1.6.7 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
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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 50 000 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
3.1.7
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.
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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
2.7.5
New study on ambient temperature shelf life in LDPE should be submitted after
finalisation in June 2013.
…
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Appendix 1 – Copy of the product authorisation
•
See below.
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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.
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Appendix 3 – Letter of Access
•
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
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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:
Agchem Project Consulting
Date:
May 2013
Agchem Project Consulting (APC)
Evaluator: Germany
Date
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) ........................................3
5.1
GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3
5.2
PROPOSED USE PATTERN ........................................................................................................................ 3
5.3
INFORMATION ON THE ACTIVE SUBSTANCES........................................................................................... 4
5.3.1 Potassium hydrogen carbonate .......................................................................................................... 4
5.4
SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 4
5.4.1 Rate of degradation in soil................................................................................................................. 4
5.4.2 Adsorption/desorption ....................................................................................................................... 4
5.4.3 Rate of degradation in water ............................................................................................................. 4
5.5
ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ........................................................................ 5
5.6
ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ............................ 6
5.7
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 01.11.2012) .... 11
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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 26.08.2011 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
Armicarb 85 SP
applicant
Agchem Project Consulting
date of application
16.11.2011
Formulation type
(WP, EC, SC, …; density)
SP
active substance (as)
Potassium hydrogen carbonate
Concentration of as
850 g/kg
Data pool/task force
None
letter of access/cross reference
None
existing authorisations in DE
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 5.2-1. Full details of the proposed uses that will
be assessed is included in Appendix 2.
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Page 4 of 11
Table 5.2-1: Classification of intended uses in Germany for Armicarb 85 SP
Group/ Crop/growth
use No* stage
00-001
Apple/
BBCH 72-89
Application
Number of applications, Application rate
method Drift Minimum application
(kg as/ha)
scenario
interval, application
a) max. rate per
time, interception
appl.
b) max. total rate
per crop/season
Soil effective
application rate
(kg as/ha)
a) max. rate per
appl.
b) max. total
rate per
crop/season
Field,
spraying
) 1.9125 kg/ha
per 3 m crown
height
b) 11.475 kg/ha
per 3 m crown
height
6 applications
a) 6.375 kg/ha per
8 days minimum intervall
3 m crown
height
from BBCH 72
b) 38.25 kg/ha per
interception: 70 %
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
5.3.1
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
5.4.1
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.
5.4.2
Adsorption/desorption
Potassium hydrogen carbonate
Please refer to the core assessment, part B, section 5 of the plant protection product Armicarb 85 SP.
5.4.3
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)
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Page 5 of 11
5.5
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 26.08.2011, 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 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc
< 500 a soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of
1 cm is applied. As soil bulk density 1.5 g cm-3is assumed.
No Kf,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 PECsoil values of potassium hydrogen carbonate and for the potassium and the bicarbonate ion.
Calculations of initial PECsoil 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 38.25 kg/ha potassium hydrogen carbonate in its
intended use in apple provided in Table 5.2-1 was used for PECsoil calculations. The input parameter
used for PECsoil calculations are summarized in table 5.5-1.
Table 5.5-1:
Input parameters considered for PECsoil calculations of potassium hydrogen
carbonate, K+ and HCO3- for the intended use 00-001 of Armicarb 85
Parameter
K+
KHCO3
HCO3-
% content in formulation
99.9%
39%
61%
Total appl. rate per season [kg/ha]
38.25
14.92
23.33
70 %
Interception by plants
Total effective application rate [kg/ha]
11.48
4.48
7.0
Soil depth [cm]
2.5
2.5
2.5
The calculated PECsoil used for German risk assessment are summarized in Table 5.5-2.
No short-term and long-term PECsoil were calculated since PECsoil,act is considered sufficient for
German risk assessment.
Table 5.5-2:
Results of PECsoil calculation for the intended use in apple used for German risk
assessment
plant protection product:
Armicarb 85 SP
use:
00-001 (Apple)
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Page 6 of 11
Number of applications/intervall
6/8 d
application rate:
6.375 kg/ha/3m/Application
crop interception:
70 %
active substance/
formulation
soil relevant
application rate
(g/ha)
soil depthact PECact
(cm)
(mg/kg)
tillage
depth (cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
2.5
30.61
-
-
-
4480
11.95
-
-
-
7000
18.67
-
-
-
potassium hydrogen 11480
carbonate
K+
HCO3
-
5.6
Estimation of concentrations in surface water and sediment (KIIIA1 9.7)
For authorization in Germany, exposure assessment of surface water generally considers the two
routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage
separately in order to allow risk mitigation measures separately for each entry route.
However, since potassium hydrogen carbonate is not volatile and immediately dissociates to K+ and
HCO3- in the presence of water, only entry via spray drift is considered likely for Armicarb 85 and the
intended use.
Thus, the initial PECsw values calculated for entry via spray drift using drift values according to
Rautmann, 20011 are considered sufficient also for risk assessment in Germany. The results of the
calculations are summarized in tables 5.6-1, 5.6-2 and 5.6-3.
Table 5.6-1
PECSW for the active substance potassiumhydrogencarbonate after exposure via
spray drift with subsequent deposition modelled with EVA 2.1
active substance
Potassimhydrogencarbonate
use pattern/gap:
00-001 (apple)
application rate/number of
applications / interval
6.375 kg/ha/3m; 6 (restriction of 4.25 kg as/ha not considered)
8d
DissT50 (SFO) in water
No degradation
scenario/percentile:
orcharding early / 70
distance
(m)
PECsw via drift
PECsw via
volatilisation
PECsw (via drift and volatilisation) (µg/L)
depending on application technique (drift reduction)
(%)
(µg/L)
(%)
(µg/L)
common
100
12748.23
-
-
12748.23
-
-
0
1
1
-
90% red.
1274.82
75% red.
3187.06
50% red.
6374.12
Rautmann, D; Streloke, M., Winkler, R. (2001): New basic drift values in the authorisation procedure for plant protection
products. In Forster, R.; Streloke, M. Workshop on Risk Assessment and Risk Mitigation Measures in the Context of the
Authorization of Plant Protection Products (WORMM). Mitt.Biol.Bundesanst.Land- Forstwirtsch. Berlin-Dahlem, Heft 381.
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Page 7 of 11
3
22.760
2901.498 -
-
2901.498
290.15
725.37
1450.75
5
14.640
1866.341 -
-
1866.341
186.63
466.59
933.17
10
8.040
1024.958 -
-
1024.958
102.50
256.24
512.48
15
3.710
472.959
-
-
472.959
47.30
118.24
236.48
20
1.750
223.094
-
-
223.094
22.31
55.77
111.55
PECSW for K+ after exposure via spray drift and volatilization with subsequent
deposition modelled with EVA 2.1
Table 5.6-2
active substance
K+
use pattern/gap:
00-001 (apple)
application rate/number of
applications / interval
2.49 kg/ha/3m; 6 (restriction of 4.25 kg as/ha not considered)
8d
DissT50 (SFO) in water
No degradation
scenario/percentile:
orcharding early / 70
distance
(m)
PECsw via drift
PECsw via
volatilisation
PECsw (via drift and volatilisation) (µg/L)
depending on application technique (drift reduction)
(%)
(µg/L)
(%)
common
90% red.
75% red.
50% red.
0
100.00
4979.31
4979.31
497.93
1244.83
2489.65
1
-
3
22.760
1133.29
1133.29
113.33
283.32
566.65
5
14.640
728.97
728.97
72.90
182.24
364.49
10
8.040
400.34
400.34
40.03
100.08
200.17
15
3.710
184.73
184.73
18.47
46.18
92.37
20
1.750
87.14
87.14
8.71
21.78
43.57
(µg/L)
PECSW for HCO3- after exposure via spray drift and volatilization with
subsequent deposition modelled with EVA 2.1
Table 5.6-3
active substance
HCO3-
use pattern/gap:
00-001 (apple)
application rate/number of
applications / interval
3.89 kg/ha/3m; 6 (restriction of 4.25 kg as/ha not considered)
8d
DissT50 (SFO) in water
No degradation
scenario/percentile:
orcharding early / 70
distance
(m)
PECsw via drift
PECsw via
volatilisation
PECsw (via drift and volatilisation) (µg/L)
depending on application technique (drift reduction)
(%)
(µg/L)
(%)
common
90% red.
75% red.
50% red.
0
100.00
7778.92
7778.92
777.89
1944.73
3889.46
1
-
3
22.760
1770.48
1770.48
177.05
442.62
885.24
5
14.640
1138.83
1138.83
113.88
284.71
569.42
Agchem Project Consulting (APC)
(µg/L)
Evaluator: Germany
Date
Part B – Section 5
National Addendum– Germany
Armicarb 85 SP
Registration Report
Central Zone
zRMS: Netherlands
Page 8 of 11
10
8.040
625.43
625.43
62.54
156.36
312.71
15
3.710
288.60
288.60
28.86
72.15
144.30
20
1.750
136.13
136.13
13.61
34.03
68.07
5.7
Risk assessment for groundwater (KIIIA1 9.6)
Generally, for authorization in Germany, risk assessment for groundwater considers two pathways, (i)
direct leaching of the active substance into the groundwater after soil passage and (ii) surface run-off
and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the
groundwater.
However, potassium hydrogen carbonate spontaneously dissociates in humid soils to give potassium
and bicarbonate ions. The potassium ion is stable and does not degrade but it is taken by plant and
microbials. In fact, potassium is often applied to soil as a supplement in fertilizers in order to improve
the plant growth. Bicarbonate on the other hand will equilibrate with carbonate and carbonic acid to
yield carbon dioxide and water. The potassium and bicarbonate ions can potentially leach through the
soil to groundwater resources. However, these ions are not of toxicological relevance and background
levels are significantly higher than those likely to arise from the use of VitiSan.
Thus, following the argumentation in the core assessment, no risk of groundwater contamination is
expected from the use of Armicarb 85 SP and PECGW calculations are not considered necessary.
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Date
Part B – Section 5
National Addendum– Germany
Armicarb 85 SP
Registration Report
Central Zone
zRMS: Netherlands
Page 9 of 11
Appendix 1 List of data submitted in support of the evaluation
No additional data for national assessment submitted.
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National Addendum– Germany
Armicarb 85 SP
Registration Report
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Page 11 of 11
Appendix 2 Table of Intended Uses in Germany (according to BVL 01.11.2012)
PPP (product name/code)
active substance 1
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
(crop destination /
purpose of crop)
00001
DE
Apple scab
Agchem Project Consulting (APC)
Formulation type:
Conc. of as 1:
Armicarb 85
Potassium hydrogen carbonate
4
F
G
or
I
F
5
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Venturia spp.
6
7
8
SP
850 g/kg
10
Application
Method /
Kind
spray
Timing / Growth
stage of crop &
season
BBCH 72-89
11
12
Application rate
Max. number
(min. interval
between
applications)
kg, L product /
ha
g, kg as/ha
Water L/ha
a) max. rate per
appl.
a) max. rate
per appl.
min / max
a) per use
b) per crop/
season
b) max. total rate b) max. total
per crop/season rate per
crop/season
a) 6 (every 8 10 days)
a) 2.5 kg/ha per
m crown height
b) 6 (every 8 10 days)
b) 15 kg/ha per
m crown height
Evaluator: Germany
Date
a) 2.125 kg/ha
per m crown
height
b) 12.75 kg/ha
per m crown
height
200/500
13
14
Remarks:
PHI
(days)
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
1
= 2.5 kg product/ha / meter crown
height
Max: 5 kg product/ha
ARMICARB 85 SP
Part B – Section 6
Core Assessment – DE
Registration Report
Central Zone
Page 1 of 13
REGISTRATION REPORT
Part B
Section 6 Ecotoxicological Studies
Detailed summary of the risk assessment
Product code:
Armicarb 85 SP
Active Substance:
potassium hydrogen carbonate
850 g/kg
Central Zone
Zonal Rapporteur Member State: The Netherlands
NATIONAL ADDENDA – Germany
Applicant:
Compiled by:
Company:
Contact:
Phone:
Fax:
E-Mail:
On behalf of:
Company:
Contact:
Phone:
E-Mail:
Date:
Agchem Project Consulting (APC)
APC
Mr François Walker
+ 33 (0) 4 32 52 93 53
+ 33 (0) 4 32 52 93 54
[email protected]
Agronaturalis Ltd
Mr Stephen Shires
+ 44 (0)1425 483 782
[email protected]
May 2013
Evaluator: zRMS DE
Date: May 2013
ARMICARB 85 SP
Part B – Section 6
Core Assessment – DE
Registration Report
Central Zone
Page 2 of 13
Table of content
SEC 6
ECOTOXICOLOGICAL STUDIES ............................................................................... 3
6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES .............................................................. 3
6.1.1 Proposed use pattern .............................................................................................................. 3
6.2 EFFECTS ON BIRDS............................................................................................................................ 3
6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS ...................................................... 3
6.4 EFFECTS ON AQUATIC ORGANISMS .................................................................................................. 3
6.4.1 Overview and summary ......................................................................................................... 3
6.4.2 Toxicity to Exposure ratio ...................................................................................................... 4
6.5 EFFECTS ON BEES ............................................................................................................................. 5
6.6 EFFECTS ON ARTHROPODS OTHER THAN BEES................................................................................ 5
6.6.1 Overview and summary ......................................................................................................... 5
6.6.2 Toxicity .................................................................................................................................. 5
6.6.3 Exposure................................................................................................................................. 6
6.6.4 Risk assessment for non-target arthropods............................................................................. 7
6.7 EFFECTS ON EARTHWORMS, OTHER NON-TARGET SOIL ORGANISMS AND ORGANIC MATTER
BREAKDOWN ............................................................................................................................................ 9
6.7.1 Overview and summary ......................................................................................................... 9
6.7.2 Exposure................................................................................................................................. 9
6.7.3 Risk assessment –TER values and overall conclusions ......................................................... 9
6.7.4 Toxicity to Exposure Ratio .................................................................................................... 9
6.7.5 Residue content of earthworms .............................................................................................. 9
6.8 EFFECTS ON SOIL MICROBIAL ACTIVITY ......................................................................................... 9
6.8.1 Overview and summary ......................................................................................................... 9
6.8.2 Toxicity .................................................................................................................................. 9
6.8.3 Exposure................................................................................................................................. 9
6.8.4 Risk assessment –overall conclusions .................................................................................... 9
6.9 EFFECTS ON NON-TARGET PLANTS .................................................................................................. 9
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Sec 6
ECOTOXICOLOGICAL STUDIES
No additional, National information available, see appendix 2 for justification. Refer to Core assessment document
for further information.
6.1
Proposed use pattern and considered metabolites
Please refer to the core assessment.
6.1.1
Proposed use pattern
Please refer to the core assessment.
6.2
Effects on Birds
No additional, National information available, see appendix 2 for justification. Refer to Core assessment document
for further information.
6.3
Effects on Terrestrial Vertebrates Other Than Birds
No additional, National information available, see appendix 2 for justification. Refer to Core assessment document
for further information.
6.4
Effects on Aquatic Organisms
6.4.1
Overview and summary
No additional, National information available. Refer to Core assessment document for further information.
6.4.1.1
Toxicity
A summary of the toxicity exposure ratios for potassium hydrogen carbonate following the proposed use on apples
is shown below.
Table 6.4-1 Overview of Toxicity exposure ratios (TER) for aquatic species (most sensitive species of each
group)
Test
substance
Organism
Endpoint type
Toxicity endpoint (mg as
/L)
PEC
(mg/L)
TER
TER risk
assessment
trigger
KHCO3
Oncorhynchus
mykiss
acute
1400
2.57
545
100
KHCO3
Daphnia magna
acute
1200
2.57
467
100
Armicarb 85
SP
Pseudokirchneriella
subcapitata
Long term
(population growth)
> 85.75 (yield and growth
rate)
2.57
>33.4
10
6.4.1.2
Exposure
For authorization in Germany, exposure assessment of surface water generally considers the two routes of
entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in
Agchem Project Consulting (APC)
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Date: May 2013
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Page 4 of 13
order to allow risk mitigation measures separately for each entry route. However, since potassium
hydrogen carbonate is not volatile and immediately dissociates to K + and HCO3- in the presence of water,
only entry via spray drift is considered likely for Armicarb 85 and the intended use. Thus, the initial
PECsw values calculated for entry via spray drift using drift values according to Rautmann, 2001 1 are
considered sufficient also for risk assessment in Germany. The results of the calculations are summarized
in tables 5.6-1, 5.6-2 and 5.6-3 (national addendum – section 5).
6.4.1.3
Overall conclusions
Overall it is concluded that no unacceptable risk to aquatic organisms is expected from the proposed use
of Armicarb 85 SP.
6.4.2
Toxicity to Exposure ratio
6.4.2.1
TER values for the entry into surface water via spraydrift
The Armicarb 85 SP and potassium hydrogen carbonate risk assessments were carried out following according to
the proposed use.
The initial risk assessments were carried out by comparing the PEC SW values with the acute toxicity endpoints.
Acute toxicity exposure ratios (TERA) were calculated using the following equations:
TER
A
EC 50 / LC 50

PEC SW
Table 10.2-2: TER-values regarding the exposure via spraydrift scenario “orchard (apple)” (Model: EVA 2.1)
active substance
Potassimhydrogencarbonate
use pattern/gap:
00-001 (apple)
application rate/number of
applications / interval
6.375 kg as/ha/3m; 6 (restriction of 4.25 kg as/ha not considered)
8d
DissT50 (SFO) in water
No degradation
scenario/percentile:
orchards early (3 m) / 70
distance
(m)
PECsw via drift
PECsw via
volatilisation
PECsw (via drift and volatilisation) (µg/L)
depending on application technique (drift reduction)
(%)
(µg/L)
(%)
(µg/L)
common
0
100.0
12748.23
-
-
12748.23
1
-
-
-
90% red.
1274.82
75% red.
50% red.
3187.06
6374.12
1
Rautmann, D; Streloke, M., Winkler, R. (2001): New basic drift values in the authorisation procedure for plant protection
products. In Forster, R.; Streloke, M. Workshop on Risk Assessment and Risk Mitigation Measures in the Context of the
Authorization of Plant Protection Products (WORMM). Mitt.Biol.Bundesanst.Land- Forstwirtsch. Berlin-Dahlem, Heft 381.
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3
22.76
2901.50
-
-
2901.5
290.15
725.37
1450.75
Relevant toxicity endpoint: EC50 > 85750 µg a.s./L (Pseudokirchneriella subcapitata)
Relevant TER: 10
distance
(m)
0
1
3
Risk mitigation measures
TER-value
>6.8
>29.6
no risk mitigation measures needed
-
-
The TER value is above the trigger value of 10 for long term risks in algae, the most sensitive aquatic
endpoint. However, a very conservative approach was used for the input values (PEC values calculated
from drift overspray from 6 applications, toxicity endpoint derived from a limit test). Overall it is
concluded that no unacceptable risk to aquatic organisms is expected from the proposed use of Armicarb
85 SP.
6.5
Effects on Bees
No additional National information available. Refer to Core assessment document for further information.
6.6
Effects on Arthropods Other Than Bees
6.6.1
Overview and summary
The risk to non-target arthropods following exposure to ARMICARB 85 SP via spraydrift is not
acceptable without risk mitigation measures for the use in orchards (apple).
6.6.2
Toxicity
The critical endpoints employed in the risk assessment for non-target arthropods are indicated in the table
below.
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Table 6.6-1:
Toxicity of ARMICARB to non-target arthropods with reference to agreed
endpoints
Test
substance
Species
Exposed life
stage
Study type
LR50
(g product/ha)
Sub-lethal
effects
Armicarb 85
SP
Aphidius
rhopalosiphi
Adult
LR50 > 8750
No repellent
effect
Reduction of
reproduction:
11.57%
Typhlodromus
pyri
Protonymph
Extended
laboratory
study on
barley
seedlings,
3D exposure
(limit test)
Extended
laboratory
study on
bean leaf
discs, 2D
exposure
(multi dose
test)
6.6.3
(>7438 g as/ha)
LR50 = 6493
(5519 g as/ha)
ER50  3162 *
(2688 g as/ha)
*approximation
Reduction of
reproduction:
42% (1000 g/ha)
30% (1778 g/ha)
48% (3162 g/ha)
Not significant
reduction at 1778
g/ha
Reference
(author/date/report
no.)
Juan, D.
03 Feb 2011
EPA-BHT-02-10
Juan, D.
04 Jan 2011
EPA-BHT-01-10
Exposure
Exposure of non-target arthropods living in non-target off-field areas to ARMICARB will mainly be due
to spray drift from field applications. Off-field predicted environmental rates (PER-values) were
calculated from in-field PERs in conjunction with drift values published by the BBA (2000 2) as shown in
the following equation:
drift percentile

Maximum in  field PER x 
100 

Off  field PER 
vegetation distributi on factor ( vdf )
where:
vdf =
vegetation distribution factor used in combination with test results derived from 2dimensional exposure set-ups
To account for interception and dilution by three-dimensional vegetation in off-crop areas, a vegetation
distribution or dilution factor (vdf, see above) is incorporated into the equation when calculating off-field
exposure in conjunction with toxicity endpoints derived from two-dimensional studies (e.g. glass plate or
leaf discs). A dilution factor of 10 is recommended by the Guidance Document, but has been questioned.
The risk assessment procedure here considers a dilution factor of 5 more appropriated. For endpoints
resulting from 3-dimensional studies, i.e. where spray treatment is applied onto whole plants, the dilution
factor is not used. For the results of the study with T. pyri exposed to ARMICARB, a vegetation
2
BBA (Biologische Bundesanstalt für Land- und Forstwirtschaft) (2000): Abtrifteckwerte für Flächen- und Raumkulturen sowie
für den gewerblichen Gemüse-, Zierpflanzen- und Beerenobstanbau. Bundesanzeiger 100, 26. Mai 2000, Köln, pp.
9879.
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distribution factor of 5 has to be considered (study conducted in 2D environment). A MAF of 3.2 is used,
according to ESCORT II and the EC Guidance Document on Terrestrial Ecotoxicology.
Off-field PER values are presented in the following table:
Table 6.6-3:
Use No.
Off-field PER values for the use groups following the use of ARMICARB
Application rate
(kg as/ha)
00-001
6.6.4
max. 4.25
Drift scenario
Drift rate
(% appl. rate)
Orchard (early)
MAF
Off-field PER
(kg as/ha)
22.76
3.2
0.619
Risk assessment for non-target arthropods
The assessment of the risk to non-target arthropods following exposure to ARMICARB was performed
on basis of the calculation of toxicity-exposure ratios (TER values) according the following formula:
TER 
L ( E ) R 50 ( L product / ha )
Off  field PER ( L product / ha )
The risk is considered acceptable if the values obtained are TERoff-field > 10 based on Tier 1 tests on glass
plates (laboratory tests) or TERoff-field > 5 based on Tier 2/higher-Tier tests (extended lab or field tests)
with additional test species. In the present case, laboratory tests on glass plates are lacking, however
extended laboratory tests are available with A. rhopalosiphi and T. pyri, respectively. Since only two
species were tested in extended laboratory studies, a critical TERoff-field trigger of >10 is used.
The resulting TERoff-field value for the use of ARMICARB in orchards is given in the following table:
Table 6.6-4:
Species
T. pyri
TER value for non-target arthropods after the use of ARMICARB in orchards
use group no.
00-001
Application rate
ER50
PERoff-field
(kg as./ha)
(kg as/ha)
(kg as/ha)
4.25
2.688
TERoff-field
0.619
4.34
Based on the calculated rates of ARMICARB in off-field areas, the calculated TER values for the risk
resulting from an exposure of non-target arthropods to the formulation according to the GAP does not
achieve the acceptability criteria of TER > 10, according to commission implementing regulation (EU)
No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2, for the use 00-00, indicating an
unacceptable risk. Thus, risk mitigation measures need to be implemented.
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6.6.4.1
Risk mitigation for non-target arthropods
Spray drift can be reduced by either the use of drift-reducing nozzles or by implementing a vegetated
buffer strip between in-field crop and off-field areas. The following tables presents off-field PER and
TER values for the use 00-001 with implemented drift reduction opportunities and 3 to 5 meters vegetated
buffer strips.
Table 6.6-5:
TER values for T. pyri exposed to ARMICARB considering different risk mitigation
measures
active substance
Potassimhydrogencarbonate
use pattern/gap:
00-001 (apple)
application rate/number of
applications / interval
4250 g as/ha; 6 (limit dose restriction)
8d
MAF:
3.2 (default value for six applications according to ESCORT II)
Correction factor (2D/3D):
5 (exposure in the test system is based on a 2D exposure scenario)
scenario/percentile:
orchards early (3 m) / 70
distance
(m)
PECact via drift
PECact via
volatilisation
PECact (via drift and volatilisation) (g/ha)
consid. of correction factor
depending on application technique (drift reduction)
(%)
(g/ha)
(%)
(g/ha)
common
90% red.
75% red.
50% red.
0
100
2720
-
-
2720
-
-
-
1
-
-
-
-
-
-
-
-
3
22.76
619.07
-
-
619.07
6.91
154.77
309.54
5
14.64
398.21
-
-
398.21
39.82
99.55
199.10
0.99
-
-
-
-
4.34
6.75
43.42
67.50
17.37
27.00
8.68
13.50
Relevant toxicity endpoint: ER50  2688 g as/ha (approximation)
Relevant TER: 10
distance
(m)
0
1
3
5
Risk mitigation measures
TER-value
NT 102
For the intended use 00-001, risk mitigation measure NT 102 (loss reducing plant protection equipment:
drift reducing class 75%) has to be implemented.
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6.7
Effects on Earthworms, other Non-target Soil Organisms and Organic
Matter Breakdown
6.7.1
Overview and summary
Please refer to the core assessment.
6.7.2
Exposure
Please refer to the core assessment.
6.7.3
Risk assessment –TER values and overall conclusions
As stated in the core assessment, any potassium added to the soil following application of the product will
be negligible compared to background levels. Bicarbonate (HCO3-) is a natural product, present in soil
pore waters as a result of CO2 liberated from the respiration of soil organisms. Since earthworm will not
be exposed to K+ / HCO3- levels outside the natural range, no unacceptable effects to earthworms is
expected when using ARMICARB according to the proposed GAPs.
6.7.4
Toxicity to Exposure Ratio
Please refer to the core assessment.
6.7.5
Residue content of earthworms
Please refer to the core assessment.
6.8
Effects on Soil Microbial Activity
6.8.1
Overview and summary
Please refer to the core dossier for the central zone.
6.8.2
Toxicity
Please refer to the core dossier for the central zone.
6.8.3
Exposure
Please refer to the core assessment.
6.8.4
Risk assessment –overall conclusions
Please refer to the core assessment.
6.9
Effects on Non-Target Plants
Please refer to the core assessment.
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Appendix 1: List of data submitted in support of the evaluation
No additional, National information available. Refer to Core assessment document for further information.
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Appendix 2: Table of Intended Uses
The core GAPs used for the risk envelope in the core assessment are reported in the table below:
Crop and/
or situation
Zone
Product code
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
Formulation
Application
PHI
(days)
Remarks:
(l)
(m)
4.25
1
= 5 kg
product/ha
4.25
-
= 5 kg
product/ha
Application rate per treatment
(c)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage & season
(j)
number
min
max
interval
between
applications
(min)
kg as/hL
water L/ha
kg as/ha
min max
min max
min max
400 1500
(k)
Apple
Central
zone
Armicarb 85
SP
Armicarb 85
SP
F
Venturia inaequalis
SP
85%
F
Venturia inaequalis
SP
85%
Spraying on BBCH 07-89
crop
March-Sept
1-8
7 -10 days
0.28 – 1.06
Spraying on BBCH 07-91
crop
March-Sept
1-8
7 -10 days
0.425 –
1.06
Tree
nursery of
apple
Central
zone
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)
(j)
g/kg or g/l
Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), 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
The national GAPs which are applied for in Germany are reported in the table below:
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Crop and/
or situation
Zone
Product
code
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
Formulation
Application
Application rate per treatment
PHI
(days)
Remarks:
(l)
(m)
(c)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage & season
(j)
number
min
max
interval
between
applications
(min)
kg as/hL
water L/ha
kg as/ha
min max
min max
min max
(k)
1-6
Apple
Germany
Armicarb
F
Venturia inaequalis
SP
850
Spraying on BBCH 72-89
crop
April-Sept
8-10 days
0.425 –
1.063
200 –
500
(/m
crown
height)
2.125
(/m
crown
height)
1
= 2.5 kg
product/ha /
meter crown
height
Max: 5 kg
product/ha
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)
(j)
g/kg or g/l
Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), 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
It is clear from comparison between the two tables above that the German GAPs are identical (in particular in term of dose rate) or less critical (in particular
maximum number of applications, shorter application period) than the core GAPs used for the risk envelope in the core assessment. Therefore all the PEC,
TER, HQ and risk assessment provided in the core assessment cover the GAPs in Germany and no further national assessment is required.
Agchem Project Consulting (APC)
Evaluator zRMS DE
Date: May 2013
Part B – Section 6
Core Assessment – DE
ARMICARB 85 SP
Registration Report
Central Zone
Page 13 of 13
Agchem Project Consulting (APC)
Evaluator zRMS DE
Date: May 2013