REPUBLIKA SLOVENIJA
MINISTRSTVO ZA KMETIJSTVO IN OKOLJE
UPRAVA REPUBLIKE SLOVENIJE ZA VARNO HRANO,
VETERINARSTVO IN VARSTVO RASTLIN
Dunajska cesta 22, 1000 Ljubljana
T: 01 300 13 00
F: 01 300 13 56
E: gp.uvhvvr@gov.si
www.uvhvvr.gov.si
Sector for plant protection products
Dr. Jernej Drofenik
Jernej.Drofenik@gov.si
NATIONAL REQUIREMENTS FOR REGISTRATION OF
PLANT PROTECTION PRODUCTS (PPPs) IN SLOVENIA
FOR: EFFICACY, TOXICOLOGY WITH EXPOSURE
ASSESSMENT, FATE AND BEHAVIOUR IN THE
ENVIRONMENT and ECOTOXICOLOGY
Last amended: 19 October 2011
Contents:
1. EFFICACY
2. TOXICOLOGY WITH EXPOSURE ASSESSMENT
3. FATE AND BEHAVIOUR IN THE ENVIRONMENT
4. ECOTOXICOLOGY
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1. EFFICACY
1.1 Phytotoxicity
Data of the phytotoxicity assessment on pome fruits have to be provided for apple
and pear separately. The same principle is expected for stone fruits where the report
must include data for peach, cherry, apricot and plum separately.
1.2 Succeeding crops
The applicant must propose appropriate planting interval following crop failure.
1.3 Adjacent crops
Field trial drift study is required.
1.4 Resistance
The applicant must provide a specific country (Slovenia) anti resistance strategy with
included justification.
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2. TOXICOLOGY
EXPOSURE
INCLUDING
OPERATOR
AND
WORKER
2.1 General
For acute toxicity Standard EU formulation package is required.
Waiving/bridging of tox studies for formulation? If proposed by the applicant,
scientifically valid argumentation/calculations to be provided and MSDS with all
relevant information
The toxicity profile of metabolites predicted to occur in groundwater should be
provided.
2.2 Classification and labelling of plant protection products
C&L of active substances (short history of C&L and criteria – ATP, EFSA conclusion,
RAC opinion, etc..) and formulations.
Within the central zone the Draft Position Paper on classification of active substances
was prepared by Austria and agreed by the Member States (with the exception of
UK, GER). The paper proposes to use the most recent evaluation (EFSA conclusion,
RAC opinion) of the active substance.
C&L of formulation also according to 1272/2008 is appreciated (but not mandatory).
2.3 Classification of plant protection products containing quartz
At the EU level crystalline silica has not yet been assessed according to classification
criteria for dangerous substances.
However, crystalline silica (SiO2) is classified by the IARC as carcinogenic to
humans, group 1, when inhaled in the form of quartz from occupational sources.
Since the criteria for classification of substances as Carcinogen category 1 are the
same in IARC, in the Directive 67/548 EC (Sufficient evidence of carcinogenicity in
humans; when a causal relationship has been established between the exposure and
cancer) and in the Regulation 1272/2008 (for category 1A), our opinion is that any
product containing > 0.1 % of crystalline silica ≤ 10 m should be classified as
Carcinogen category 1, T, R49.
Our proposal is based on the proposed split entry of quartz sand in Annex I; R49,
proposed for respirable fraction ≤ 10 m.
Regarding submitted data on plant protection product containing quartz sand the
proposal for classification of PPP will be based on toxicological properties of
respirable particles of quartz sand if all of the following criteria are fulfilled:
- inhalatory exposure to PPP can be expected; as is the case for WP and WG
formulation, considering dusting.
- silica is in crystalline form; if no information on silica form is available, it is
considered that the form is crystalline
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- PPP contains ≥ 0.1 % (w/w) particles ≤ 10 µm. If PPP contains larger particles of
quartz sand, the effect on lower respiratory tract needs not to be considered. If no
information is available on size of silica particles, it should be considered smaller than
10 µm.
If product contains less than 0.1 % w/w of crystalline silica it does not trigger the
classification as carcinogen category 1 independently of particle size.
2.4 Operator exposure (OPEX)
2.4.1 OPEX models
The OPEX model required for "higher” crops is the GERMAN model with two
scenarios: tractor mounted/trailed broadcast air-assisted sprayer and a hand-held
sprayer: hydraulic nozzles. Outdoor, high level target
For "lower" crops, two models are required depending on the application. The
GERMAN model is used for the application with tractor mounted/trailed boom sprayer
and the UK POEM model for hand-held sprayer (15 L tank): hydraulic nozzles,
outdoor, low level target is used when relevant.
For the indoor use, the Indoor hand held EUROPOEM model is accepted.
For seed treatment the SEEDTROPEX model is accepted.
For application of granules the model based on the Pesticides Handlers Exposure
Database (PHED), is accepted. The excel spreadsheet can be found on the UK
Chemicals Regulation Directorate (CRD) webpage.
When the PPP are sold to the general public, the models for amateur use should be
taken into consideration. The UK POEM model: home garden sprayer (5 L tank).
Outdoor, low level target; should be used only when the PPP needs to be diluted
before the application. When Ready to Use Products - Aerosol and Trigger Sprays,
Dustable Powder formulations and Granule application can be estimated on the basis
of the data published in TNsG / TNSG on Human Exposure / Report 2002 part 2. The
excel spreadsheet can be found on the UK Chemicals Regulation Directorate (CRD)
webpage. CRD is a Directorate of the Health & Safety Executive (HSE).
For other proposed uses that are less common, the operator exposure should be
estimated by the appropriate model as proposed for the specific use in the Scientific
opinion on preparation of guidance document on pesticide exposure assessment for
workers, operators, bystanders and residents (EFSA Journal 20101; 8(2):1501.
2.4.2 Use of Personal Protective Equipment (PPE)
The PPE should be used in the Operator exposure models when:
1. The exposure exceeds the AOEL and the use of PPE will reduce the exposure
to an acceptable level.
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2. The hazard classification of the PPP requires wearing of specific PPE (PPE
used even though the exposure without wearing PPE does not exceed the
AOEL).
2.5 Worker (re-entry) exposure
2.5.1 Data
The Dislodgeable foliar residues (DFR) and transfer coefficient TC data taken into
consideration are from the EUROPOEM II PROJECT (Post application exposure of
workers to pesticides in agriculture, Report of the re-entry working group, Euorpoem
II Project, FAIR3-CT96-1406, December 2002); the body weight of the worker is 60
kg. Estimations with single or multiple applications are accepted, depending on the
case by case situations. The dermal absorption is taken from the concentrate.
2.5.2 Use of Personal Protective Equipment (PPE)
When the worker exposure exceeds the AOEL, the use of gloves is taken into
consideration which results in the adjusted TC values. Considering the 10 %
penetration through protective gloves the TC values in cm2/hr are: 520 instead of
2500 for vegetable scenario, 750 instead of 3000 for the strawberries scenario, 2250
instead of 4500 for the fruit trees scenario and 1400 instead of 5000 for the
ornamentals scenario.
2.6 Bystanders and children exposure
Bystander exposure is performed for adults, using the data obtained form the studies
Lloyd et al (1987), and Lloyd and Bell, 1983). The dermal absorption for bystanders is
taken from the diluted preparation.
Resident exposure assessment should be performed (adults and children) and
provided according to Martin et al., 2008.
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3. FATE AND BEHAVIOUR
3.1 Predicted Environmental Concentration in Groundwater (PECGW)
PECgw are obtained following FOCUS guidance. The preferred models are PEARL
and PELMO, relevant scenarios are Chateaudun, Hamburg, Kremsmuenster,
Piacenza, Okehampto
3.2 Predicted
(PECSW)
Environmental
Concentration
in
Surface
water/Sediment
Run-off is potentially relevant for Slovenia, but in the current FOCUS Surface Water
Scenarios run-off is simulated with meteorological data from a single year. This
means that the occurrence of a run-off rainfall event in a specified application period
is for a large part a matter of coincidence. Hence, predictions of run-off in the current
R-scenarios are not realistic worst-case and no reliable basis for decision-making.
Only exposure via drift is considered. PEC is calculated with PSD Excel calculator
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4. ECOTOXICOLOGY
4.1 Aquatics
Only exposure via drift is considered. PEC calculated with PSD Excel calculator.
4.2 Birds and mammals
Higher tier assessment following guidance in EFSA (2009).
4.3 Non-target arthropods
In case of HQ>50 for bees, risk phrase 'Dangerous to bees' should be added to the
label.
4.4 Possible Risk Mitigation Options
In certain cases drift reduction nozzles allowed to reduce exposure.
Run-off predictions in the FOCUS Surface Water R-scenarios are not accepted as a
reliable basis for decision-making.
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