EUROPEAN COMMISSION
Brussels, 22.6.2022
COM(2022) 305 final
ANNEXES
to the proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115
{SEC(2022) 257 final} - {SWD(2022) 169 final} - {SWD(2022) 170 final} - {SWD(2022) 171 final}
ANNEX I
referred to in Article 4
METHODOLOGY FOR CALCULATING PROGRESS TOWARDS ACHIEVING THE TWO UNION AND TWO NATIONAL 2030 REDUCTION TARGETS
This Regulation is the instrument used to achieve the pesticide reduction targets contained in the Farm to Fork Strategy by requiring each Member State to contribute to achieving by 2030 a 50 % Union-wide reduction of both the use and risk of chemical plant protection products (‘Union 2030 reduction target 1’) and the use of more hazardous plant protection products (‘Union 2030 reduction target 2’). This Regulation also regulates the contribution of each Member State to these Union targets. Each Member State contribution, set in the form of a national target, to Union 2030 reduction target 1 is referred to as a ‘national 2030 reduction target 1’, while a Member State contribution to Union 2030 reduction target 2 is referred to as a ‘national 2030 reduction target 2’. The methodology for calculating progress towards achieving these targets is set out below:
SECTION 1
National 2030 reduction target 1: methodology for estimating progress towards the reduction in use and risk of chemical plant protection products
1.The methodology shall be based on statistics on the quantities of chemical active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission (Eurostat) under Annex I to Regulation (EC) No 1185/2009 of the European Parliament and of the Council 1 .
2.The following general rules shall apply for the calculation of progress towards achieving reduction target 1:
(a)progress shall be calculated on the basis of the categorisation of chemical active substances into the 4 groups set out in the Table in this Annex;
(b)the chemical active substances in group 1 shall be those listed in Part D of the Annex to Commission Implementing Regulation (EU) No 540/2011 2 ;
(c)the chemical active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;
(d)the chemical active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408;
(e)the chemical active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;
(f)the weightings in row (iii) in the Table in this Annex shall apply.
3.Progress towards achieving reduction target 1 shall be calculated by multiplying the annual quantities of active substances in plant protection products placed on the market for each group in the Table in this Annex by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations.
Table
Categorisation of active substances and hazard weightings for the purpose of calculating progress towards national 2030 reduction target 1
|
Row |
Groups |
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|
1 |
2 |
3 |
4 |
|
|
(i) |
Low-risk chemical active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 |
Chemical active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011 |
Chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408. |
Chemical active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 |
|
(ii) |
Hazard Weightings applicable to quantities of chemical active substances placed on the market in products authorised under Regulation (EC) No 1107/2009 |
|||
|
(iii) |
1 |
8 |
16 |
64 |
4.The baseline for reduction target 1 shall be set at 100, and is equal to the average result of the above calculation for the period 2015-2017.
5.The progress towards achieving reduction target 1 shall be expressed by reference to the baseline.
6.The Commission shall calculate the progress towards achieving reduction target 1 in accordance with Article 34(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which progress towards the reduction target 1 is being calculated.
SECTION 2
National reduction reduction target 2: methodology for estimating progress towards reduction in the use the more hazardous plant protection products
1.The methodology shall be based on statistics on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission under Annex I to Regulation (EC) No 1185/2009.
2.Progress towards achieving target 2 shall be calculated by adding together the annual quantities of chemical active substances contained in more hazardous plant protection products placed on the market each year.
3.The baseline for reduction target 2 shall be set at 100, and is equal to the average result of the above calculation for the period 2015-2017.
4.Progress towards achieving reduction target 2 shall be expressed by reference to the baseline.
5.The Commission shall calculate progress towards achieving reduction target 2 in accordance with Article 34(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which progress towards reduction target 2 is being calculated.
SECTION 3
Union reduction targets
1.The methodology for calculating trends towards the two Union 2030 reduction targets shall be the same as the methodology for calculating trends at national level as set out in Sections 1 and 2.
2.The trend at national level shall be calculated using national statistics on the quantities of chemical active substances as defined in point 3 of Article 3 of this Regulation placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission under Annex I (Statistics on the placing on the market of pesticides) to Regulation (EC) No 1185/2009.
3.The trend at Union level shall be calculated using Union statistics on the quantities of chemical active substances as defined in point 3 of Article 3 of this Regulation placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission under Annex I (Statistics on the placing on the market of pesticides) to Regulation (EC) No 1185/2009.
ANNEX II
DATA TO BE PROVIDED IN ANNUAL PROGRESS AND IMPLEMENTATION REPORTS BY 31 AUGUST OF EACH CALENDAR YEAR
Part 1: Annual trends in progress towards achieving national 2030 reduction targets
1.the trends in a Member State’s progress towards achieving the two national 2030 reduction targets referred to in Article 10(2), point (a);
2.all other national indicative targets indicated in Article 9(2), point (a), Article 9(3), point (a) and Article 9(4).
Part 2: All other quantitative data relevant to implementation of this Regulation and level of compliance with it
Use of plant protection products:
1.the percentage of professional users controlled for integrated pest management implementation;
2.the percentage of professional users failing to comply with the obligation to keep electronic records on integrated pest management implementation;
3.the percentage of professional users that failed to comply with the obligation to keep pesticide use data electronically;
4.the number of aerial application permits, the validity period of the permit, as well as the size and the location of the areas concerned, and reasons for the permit granted;
5.the percentage of utilised agricultural areas and other areas covered by aerial application permits;
6.the number of permits for use of plant protection products in sensitive areas;
7.the percentage of utilised agricultural area and other areas covered by permits for use of plant protection products in sensitive areas;
8.the estimated quantities of illegal plant protection products used and the quantities of illegal plant protection products detected;
9.whether Member States have applied derogations allowing for
(a)different inspection requirements to application equipment in professional use that represents a very low scale of use, or
(b)exemptions from inspection for handheld application equipment or knapsack sprayers, in professional use.
Training and advisory services:
10.the percentage of professional users, advisors and distributors trained in the subjects listed in Annex III and holding a training certificate in accordance with Article 25 or who has a proof of entry in a central electronic register in accordance with Article 25(5), broken down by professional users, advisors and distributors;
11.the percentage of professional users that failed to comply with the obligation to use independent advisory services at least once a year.
Application equipment in professional use:
12.the estimated percentage of application equipment in professional use registered on the electronic register of application equipment in professional use;
13.the percentage of registered application equipment in professional use and due for inspection that has been inspected;
14.the percentage, at time of inspection, of application equipment in professional use fitted with risk mitigation devices.
Member State further measures to implement integrated pest management:
15.the percentage of utilised agricultural area in each Member State that is covered by crop-specific rules that have been made legally binding under national legislation.
ANNEX III
TRAINING SUBJECTS REFERRED TO IN ARTICLE 25
1.All relevant legislation regarding plant protection products and their use and risk and in particular this Regulation. While not exclusive, the following legislation is relevant:
Regulation (EC) No 1107/2009 of the European Parliament and of the Council 3
Regulation (EC) No 396/2005 of the European Parliament and of the Council 4
Regulation (EU) No 528/2012 of the European Parliament and of the Council 5
Regulation (EC) No 1185/2009 of the European Parliament and of the Council 6
Regulation EC No 1272/2008 of the European Parliament and of the Council 7
Regulation (EU) 2017/625 of the European Parliament and of the Council 8
Regulation (EU) 2021/2115 of the European Parliament and of the Council 9
Directive 2006/42/EC of the European Parliament and of the Council 10
Directive 2009/127/EC of the European Parliament and of the Council 11
Directive 2000/60/EC of the European Parliament and of the Council 12
Council Directive 89/391/EEC 13
Council Directive 89/656/EEC 14
Council Directive 98/24/EC 15
Directive 2004/37/EC of the European Parliament and of the Council 16
Directive 2009/104/EC of the European Parliament and of the Council 17
Regulation (EC) No 1907/2006 of the European Parliament and of the Council 18
Directive 2008/68/EC of the European Parliament and of the Council 19
2.The existence and risks of illegal and counterfeit plant protection products, the methods to identify such products, and the penalties associated with sale or use of illegal plant protection products.
3.The hazards of and risks associated with plant protection products, and how to identify and control them, including the following subjects:
(a)risks to human health;
(b)symptoms of plant protection product poisoning and appropriate first aid measures in case of such poisoning;
(c)risks to non-target plants and insects, wildlife, biodiversity and the environment in general.
4.Integrated pest management strategies and techniques, integrated crop management strategies and techniques, organic farming principles, biological pest control methods, harmful organism control methods, the obligation to apply integrated pest management as set out in Articles 12 and 13 of this Regulation, and the obligation to enter records in the electronic integrated pest management and plant protection product use register, as set out in Article 14 of this Regulation.
5.When plant protection products are needed, how to choose the plant protection products with the least side effects on human health, non-target organisms and the environment among all authorised products for a given pest problem, in a given situation.
6.Measures to minimise risks to humans, non-target organisms and the environment, including:
(a)safe working practices for storing, handling and mixing plant protection products;
(b)safe working practices for disposing of empty packaging, other contaminated materials and surplus plant protection products (including tank mixes), whether in concentrate or dilute form;
(c)the recommended way to control operator exposure (including personal protection equipment);
(d)information on the correct and safe disposal of plant protection products that are no longer authorised and where any grace period for their use under Article 20(2) or 46 of Regulation 1107/2009 has expired.
7.Procedures for preparing application equipment for operation, including its calibration, with minimum risks to the user, other persons, non-target animal and plant species, biodiversity and the environment, including water resources.
8.Practical training on the use of application equipment and its maintenance, and on risk mitigation measures including specific spraying techniques, use of new technology including precision farming techniques, as well as the technical check of sprayers in use and ways to improve spray quality. In this subject special attention shall be paid to the drift-reduction nozzles and the recommendations made by the manufacturers concerning optimal conditions of their use. Specific risks linked to use of handheld application equipment or knapsack sprayers and the relevant risk management measures. Practical training shall also cover the specific risks linked to the sowing of seeds treated with plant protection products.
9.Emergency action to protect human health and the environment, including water resources in case of accidental spillage and contamination and extreme weather events that would result in plant protection products leaching risks.
10.Special care in sensitive areas as defined in Article 2(15) of this Regulation and protection areas established under Articles 6 and 7 of Directive 2000/60/EC and an awareness of contamination caused by particular plant protection products in their respective region.
11.Facilities providing health monitoring and access to health care to which information on acute and chronic poisoning incidents can be reported..
12.Record keeping of the sale, purchase and use of plant protection products, in accordance with the relevant legislation.
13.How to minimise or eliminate applications of certain plant protection products classified as “harmful to aquatic life with long lasting effects”, “very toxic to aquatic life with long lasting effects” or “toxic to aquatic life with long lasting effects” pursuant to Regulation (EC) 1272/2008 on or along roads, railway lines, very permeable surfaces or other infrastructure close to surface water or groundwater or on sealed surfaces with a high risk of run-off into surface water or sewage systems.
14.The protection of the aquatic environment and drinking water supplies from the impact of plant protection products, including in relation to the following subjects:
(a)the use of plant protection products in accordance with the restrictions indicated on the label in accordance with Article 31, point (4)(a) of Regulation (EC) No 1107/2009, while giving preference to plant protection products that are not classified as “(very) persistent”, “(very) bioaccumulative”,
“very toxic to aquatic life with long lasting effects”, “toxic to aquatic life with long lasting effects” or “harmful to aquatic life with long lasting effects” pursuant to Regulation (EC) No 1272/2008 20 or containing priority substances included in the list adopted by the Commission in accordance with Article 16 of Directive 2000/60/EC implemented via Directives 2008/105/EC and 2013/39/EU, or pesticides having been identified as river basin specific pollutants under Annex V, point 1.2.6 of Directive 2000/60/EC, in particular those affecting water used for the abstraction of drinking water in accordance with Article 7 of Directive 2000/60/EC and Directive (EU) 2020/2184;
(b)potential hazards of and risks for human health and the environment from the use of plant protection products, as well as methods to minimise emissions to the environment and occupational exposure to more hazardous plant protection products;
(c)use of drift reducing technology in all field crops;
(d)use of other mitigation measures which minimise the risk of off-site pollution caused by spray drift, drain-flow and run-off, including in particular mandatory buffer zones adjacent to surface waters courses and groundwater and aquifers;
(e)how to comply with restrictions set out in Regulation (EC) 1107/2009 for minimising or substituting uses of the plant protection products classified as “harmful to aquatic life with long lasting effects”, “very toxic to aquatic life with long lasting effects” or “toxic to aquatic life with long lasting effects” pursuant to Regulation (EC) No 1272/2008, on or along roads, railway lines, very permeable surfaces or other infrastructure close to surface water or groundwater or on sealed surfaces with a high risk of run-off into surface water or sewage systems.
ANNEX IV
INSPECTION OF APPLICATION EQUIPMENT IN PROFESSIONAL USE
The inspection of application equipment in professional use shall cover all aspects important to ensure a high level of safety and protection of human health and the environment. Full effectiveness and safety of the application operation shall be ensured by proper performance of any device or apparatus of the equipment to guarantee the following objectives are met.
The application equipment in professional use shall function reliably and be used only in accordance with its manual of operation for its intended purpose ensuring that plant protection products can be accurately applied in line with good agricultural practice (GAP) as defined in Article 3(2), point (a), of Regulation (EC) 396/2005 of the European Parliament and the Council 21 .
The equipment shall be in such a condition to allow it to be filled and emptied safely, easily and completely and to prevent any leakage of either spray solution or concentrated product. It shall permit easy and thorough cleaning. It shall also allow for safe operation, and be capable of being immediately stopped from the position of the operator. It shall be simple to perform any necessary adjustments. Such adjustments shall be accurate and capable of being reproduced.
During inspection, compliance with the following requirements shall be checked:
1.Safety
The equipment shall be clean and safe before the inspection starts. The following shall be checked:
●the power take off driveshaft guard and all protective devices for the power take off and other rotating power transmission parts,
●leakage from the hydraulic system and general condition of hydraulic cylinders and pipes,
●safety and functioning of all electrical parts, including solenoid switches,
●functioning of safety valves,
●condition of structural parts, framework, and booms/nozzle holders,
●locking of foldable parts, and
●in the case of any equipment that uses air assistance, the guards and condition of the blower, including the physical condition of the blower unit, fan and sleeves.
2.Leakage
Both in stationary and working conditions there shall be no leakage or dripping from any part of the equipment. There shall be no dripping or unintended application after the equipment has been switched off. For equipment to apply liquid products there shall be no leakages from pipes or hoses when running at the maximum obtainable pressure for the system and no liquid shall have been applied directly to the sprayer itself.
3.Pump (for equipment used to apply liquid products)
The pump capacity shall be suited to the needs of the application equipment and the pump shall function properly in order to ensure a stable and reliable application rate.
4.Agitation or mixing (for equipment to apply liquid products)
Agitation or mixing devices shall ensure a proper recirculation in order to achieve an even concentration of the whole volume of the liquid spray mixture in the tank.
5.Spray liquid tank/hopper
Spray tanks and hoppers including filling level indicators, filling devices, filters, emptying and rinsing systems and mixing devices shall operate in such a way as to minimise accidental spillage, uneven concentration distribution, operator exposure and residual content.
6.Measuring systems, control and regulation systems
All devices for measuring, switching on and off and adjusting pressure or flow rate shall be properly calibrated and work correctly. The controls to be operated during the application operation shall be operable from the operator’s position, the necessary instruments to control the operation shall be present and accurate and the instrument displays shall be readable from the operator’s position. For equipment to apply liquid products, pressure adjustment devices shall maintain a constant working pressure at constant revolutions of the pump, in order to ensure that a stable volume application rate is applied. Additional equipment to dose or inject plant protection products shall function accurately and correctly.
7.Pipes and hoses
Pipes and hoses shall be in properly functioning condition to avoid disturbance of product flow or accidental spillage in case of failure. Pipes and hoses shall not be kinked, excessively worn or in a position which would allow stretching.
8.Filtering (for equipment to apply liquid products)
In order to avoid turbulence and heterogeneity in spray patterns, filters shall be present and in good condition and the mesh size of the filters shall correspond and be appropriate to the size of nozzles fitted on the sprayer. Where applicable the filter blockage indication system shall operate correctly.
9.Spray boom (for equipment applying plant protection products by means of a horizontally or vertically positioned boom, located close to the crop or the material to be treated)
The boom shall be in good condition and stable in all directions. The fixation and adjustment systems and the devices for damping unintended movements and slope compensation shall work correctly.
10.Nozzles (for equipment to distribute liquid products)/ outlets (for solid products)
Nozzles and outlets shall work properly. The flow rate of each individual nozzle and outlet shall not deviate significantly from the data of the flow rate tables provided by the manufacturer.
11.Distribution
Where relevant, the longitudinal, transversal and vertical (in case of applications in vertical crops) distribution of the product in the target area shall be even.
12.Blower (for equipment distributing plant protection products by air assistance)
The blower shall be in good condition and shall ensure a stable and reliable air stream.
13.Cleaning
If present, the rinsing/cleaning systems for emptied containers, e.g. fitted on induction hoppers of application equipment, shall work reliably. Moreover, if provided, tank cleaning devices, devices for external cleaning, devices for cleaning of induction hoppers and devices for the internal cleaning of the complete application equipment shall function correctly.
ANNEX V
NOTIFICATION FORM
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Reason for notification (Please tick) |
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New equipment or first registration of used equipment |
Removal from use |
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Change of ownership |
Return to use |
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Current owner |
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Name: |
Unique personal / company identifier:
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Address 1: |
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Address 2: |
Occupation:
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Address 3: |
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Address 4: |
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Country: |
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Previous owner if applicable |
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Name: |
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Address 1: |
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Address 2: |
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Address 3: |
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Address 4: |
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Country: |
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Pesticide application equipment type (Please tick most appropriate) |
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Boom sprayer |
PPP application equipment which produces droplets and which uses a fan to distribute these droplets vertically and/or laterally |
Fogger (cold & hot) |
Seed dresser |
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|
Granule applicator |
Vapour generator |
Vertical sprayer |
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|
Aircraft (winged) |
Aircraft (rotor) |
Unmanned aircraft (e.g. drone) |
Handheld application equipment |
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Other |
Please describe: |
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Is equipment air assisted? |
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Is equipment fitted with GPS controlled nozzle or section shut off? |
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Pesticide application equipment |
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Make: |
Model: |
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Chassis No.: |
Tank/hopper capacity: |
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Manufacture year: |
Working width: |
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Other information: |
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ANNEX VI
referred to in Article 35
METHODOLOGY FOR CALCULATING HARMONISED RISK INDICATORS AT UNION AND NATIONAL LEVEL
SECTION 1
Harmonised risk indicators
The methodology for calculating harmonised risk indicators at both Union and national levels is listed in Sections 2 to 4 of this Annex. While the methodology for both Union and national indicators is the same, the former is based on Union wide statistics while the latter are based on national statistics. These indicators shall be calculated annually.
SECTION 2
Harmonised risk indicator 1: hazard-based harmonised risk indicator based on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009
1.This indicator shall be based on statistics on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission (Eurostat) under Annex I of Regulation (EC) No 1185/2009. Those data are categorised into 4 groups.
2.The following general rules shall apply for the calculation of harmonised risk indicator 1:
(a)harmonised risk indicator 1 shall be calculated on the basis of the categorisation of all active substances into the 4 groups set out in Table 1;
(b)the active substances in group 1 shall be those listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;
(c)the active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;
(d)the active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408;
(e)the active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;
(f)the weightings in row (iii) in Table 1 shall apply.
3.Harmonised risk indicator 1 shall be calculated by multiplying the annual quantities of active substances in plant protection products placed on the market for each group in Table 1 by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations.
Table 1
Categorisation of active substances and hazard weightings for the purpose of calculating harmonised risk indicator 1
|
Row |
Groups |
|||
|
1 |
2 |
3 |
4 |
|
|
(i) |
Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 |
Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011 |
Active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408. |
Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 |
|
(ii) |
Hazard weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009 |
|||
|
(iii) |
1 |
8 |
16 |
64 |
4.The baseline for harmonised risk indicator 1 shall be set at 100, and is equal to the average result of the above calculation for the period 2011-2013.
5.The result of harmonised risk indicator 1 shall be expressed by reference to the baseline.
6.The Commission shall calculate and publish the results of harmonised risk indicator 1 at Union level in accordance with Article 35(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 1 is being calculated.
7.The Member States shall calculate and publish the results of harmonised risk indicator 1 at national level in accordance with Article 35(3) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 1 is being calculated.
SECTION 3
Harmonised risk indicator 2: harmonised risk indicator based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009
1.This indicator shall be based on the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 as communicated to the Commission in accordance with Article 53(1) of that Regulation. Those data are categorised into 4 groups.
2.The following general rules shall apply for the calculation of harmonised risk indicator 2:
(a)harmonised risk indicator 2 shall be based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009, and it shall be calculated on the basis of the categorisation of active substances into the 4 groups set out in Table 2 of this Section;
(b)the active substances in group 1 shall be those listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;
(c)the active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;
(d)the active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408;
(e)the active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;
(f)The weightings in row (iii) in Table 2 of this Section shall apply.
3.Harmonised risk indicator 2 shall be calculated by multiplying the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 for each group in Table 2 by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations.
Table 2
Categorisation of active substances and hazard weightings for the purpose of calculating harmonised risk indicator 2
|
Row |
Groups |
|||
|
1 |
2 |
3 |
4 |
|
|
(i) |
Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 |
Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011 |
Active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408. |
Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 |
|
(ii) |
Hazard weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009 |
|||
|
(iii) |
1 |
8 |
16 |
64 |
4.The baseline for harmonised risk indicator 2 shall be set at 100, and is equal to the average result of the above calculation for the period 2011-2013.
5.The result of harmonised risk indicator 2 shall be expressed by reference to the baseline.
6.The Commission shall calculate and publish the results of harmonised risk indicator 2 at Union level in accordance with Article 35(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 2 is being calculated.
7.The Member States shall calculate and publish the results of harmonised risk indicator 2 at national level in accordance with Article 35(3) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 2 is being calculated.
8.With effect from 1 January 2027, the methodology of harmonised risk indicator 2 shall be replaced by the methodology of harmonised risk indicator 2a referred to in section 4 of this Annex.
SECTION 4
Harmonised risk indicator 2a: harmonised risk indicator based on the number of and areas treated under authorisations granted under Article 53 of Regulation (EC) No 1107/2009
1.This indicator shall be based on the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009, and the extent of the areas treated under these authorisations, as communicated to the Commission in accordance with Article 53(1) of that Regulation.
2.The following general rules shall apply for the calculation of harmonised risk indicator 2a:
(a)harmonised risk indicator 2a shall be based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009 and the extent of the areas treated under these authorisations. It shall be calculated on the basis of the categorisation of active substances into the 4 groups set out in Table 3 of this Section;
(b)the areas treated shall be in hectares;
(c)the active substances in group 1 shall be those listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;
(d)the active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;
(e)the active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408;
(f)the active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;
(g)The weightings in row (iii) in Table 3 of this Section shall apply.
3.Harmonised risk indicator 2a shall be calculated by multiplying the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 for each group in Table 3 by the relevant hazard weighting set out in row (iii), and by the areas treated under these authorisations, followed by the aggregation of the results of these calculations.
Table 3
Categorisation of active substances and hazard weightings for the purpose of calculating harmonised risk indicator 2a
|
Row |
Groups |
|||
|
1 |
2 |
3 |
4 |
|
|
(i) |
Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 |
Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011 |
Active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408. |
Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 |
|
(ii) |
Hazard weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009 |
|||
|
(iii) |
1 |
8 |
16 |
64 |
4.The baseline for harmonised risk indicator 2a shall be set at 100, and is equal to the average result of the above calculation for the period 2022-2024.
5.The result of harmonised risk indicator 2a shall be expressed by reference to the baseline.
6.The Commission shall calculate and publish the results of harmonised risk indicator 2a at Union level in accordance with Article 35(2) of this Regulation. This shall be done for the first time in 2027 using data from calendar years 2022 to 2025, and subsequently for each calendar year, at the latest 20 months after the end of the year for which harmonised risk indicator 2a is being calculated.
7.The Member States shall calculate and publish the results of harmonised risk indicator 2a at national level in accordance with Article 35(3) of this Regulation. This shall be done for the first time in 2027 using data from calendar years 2022 to 2025, and subsequently for each calendar year, at the latest 20 months after the end of the year for which harmonised risk indicator 2a is being calculated.
ANNEX VII
CORRELATION TABLE REFERRED TO IN ARTICLE 43(2)
|
Directive 2009/128/EC |
This Regulation |
|
Article 1 |
Article 1 |
|
Article 2 |
Article 2 |
|
Article 3 |
Article 3 |
|
Article 4 |
Articles 8 to 9 |
|
Article 5 |
Articles 17(1), 23 and 25 |
|
Article 6 |
Article 24 |
|
Article 7 |
Article 27 |
|
Article 8 |
Article 17(3) to (5) and Articles 29 to 33 |
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Article 9 |
Articles 20 to 21 |
|
Article 10 |
|
|
Article 11 |
Article 19 |
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Article 12 |
Article 18 |
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Article 13 |
Article 22 |
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Article 14 |
Articles 12 to 16 |
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Article 15 |
Articles 35 and 36 |
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Article 16 |
Articles 11(7), 15(13) and 42(2) |
|
Article 17 |
Article 38 |
|
Article 18 |
|
|
Article 19 |
Article 39 |
|
Article 20 |
Article 31(11) |
|
Article 21 |
Article 41 |
|
Article 22 |
— |
|
Article 23 |
— |
|
Article 24 |
Article 44 |
|
Article 25 |
— |
|
Annex I |
Annex III |
|
Annex II |
Annex IV |
|
Annex III |
|
|
Annex IV |
Annex VI |