REGULATORY SCRUTINY BOARD OPINION Revision of list of pollutants affecting surface and groundwaters

EUROPEAN COMMISSION
24.6.2022
SEC(2022) 540
REGULATORY SCRUTINY BOARD OPINION
{COM(2022) 540}
{SWD(2022) 540, 543}
Revision of list of pollutants affecting surface and groundwaters
Offentligt
KOM (2022) 0540 - SEK-dokument
Europaudvalget 2022
________________________________
This opinion concerns a draft impact assessment which may differ from the final version.
Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 08/010. E-mail: regulatory-scrutiny-board@ec.europa.eu
EUROPEAN COMMISSION
Regulatory Scrutiny Board
Brussels,
RSB
Opinion
Title: Impact assessment / Revision of list of pollutants affecting surface and
groundwaters
Overall opinion: POSITIVE WITH RESERVATIONS
(A) Policy context
The sustainable management of the EU’s surface water and groundwater bodies is
regulated by three Directives. This legislation lists a number of polluting substances and
their threshold values, also in combination, as well as monitoring and reporting
arrangements for these substances. A recent fitness check of EU water legislation
identified areas of improvement in relation to tackling chemical pollution.
This initiative aims to address the legal obligation to review the lists of water pollutants
and their corresponding standards. At the same time, it follows up on the findings of the
water fitness check regarding implementation shortcomings, aiming to improve the
regulatory response to emerging environmental and health risks.
(B) Summary of findings
The Board notes the additional information provided in advance of the meeting and
commitments to make changes to the report.
However, the report still contains significant shortcomings. The Board gives a
positive opinion with reservations because it expects the DG to rectify the following
aspects:
(1) The design of the options is overly complex and does not bring out clearly the key
policy choices.
(2) The impacts on SMEs and on citizens are not analysed sufficiently. The report
does not assess how individual Member States may be affected.
(3) The report is not clear about the order of magnitude of the expected impacts. It
does not critically assess the validity of the illustrative benefit and cost estimates
and their relevance to this initiative. The comparison of options is not based on
their effectiveness, efficiency and coherence.
2
(C) What to improve
(1) The design of options should allow the identification of impacts, separately for each
option or their combination. The options and their presentation should be simplified, and
purely technical elements moved to the Annexes. The report should provide more
aggregated and more relevant options and sub-options. Options linked to administrative
simplification and burden reduction should be grouped together.
(2) The analysis of the impacts on SMEs and citizens should be further developed. The
report should elaborate on the impacts on SMEs, including in terms of the compliance
costs and administrative burden, and present the results of the application of the
proportionate SME test. The impacts on consumers should also be further analysed
(indicatively, in relation to pharmaceuticals, personal care products, consumers’ health,
cost of water services) and the evidence should be clearly presented for the conclusions
reached. The report should be more explicit on the implementation deficits in the problem
analysis and examine the different possible impacts across Member States. It should map
out the respective efforts required from different Member States to meet the targets set.
(3) The report should critically examine the validity of the benefit and cost estimates
presented as the examples of the potential impacts, provide more detail on the scope and
methods used and indicate how relevant the examples are to this initiative. It should
strengthen a summary of the results of the cost benefit analysis, taking into account all
qualitative and quantitative evidence and indicating the overall order of magnitude of the
expected impacts of the preferred option. Given the link with many existing and ongoing
initiatives, the report should discuss the relevance and attribution of costs and benefits to
this initiative. Annex 3 should be simplified to integrate in a concise manner the qualitative
and quantitative evidence. The analysis should reflect any changes to the options’
structure.
(4) The report should clarify the costs and cost savings in scope of the One In, One Out
approach. The dedicated section and Annex 3 seem incomplete. All costs and benefits
related to the One In, One Out approach should be identified and clearly presented.
(5) The report should systematically integrate the criteria of effectiveness, efficiency and
coherence in the comparison of options.
The Board notes the estimated costs and benefits of the preferred option in this initiative,
as summarised in the attached quantification tables.
Some more technical comments have been sent directly to the author DG.
(D) Conclusion
The DG must revise the report in accordance with the Board’s findings before
launching the interservice consultation.
If there are any changes in the choice or design of the preferred option in the final
version of the report, the DG may need to further adjust the attached quantification
tables to reflect this.
Full title Revision of the lists of pollutants affecting surface and
groundwaters and the corresponding regulatory standards in the
Environmental Quality Standards, Groundwater and Water
Framework Directives
3
Reference number PLAN/2020/8554
Submitted to RSB on 25 May 2022
Date of RSB meeting 22 June 2022
________________________________
This opinion concerns a draft impact assessment which may differ from the final version.
Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 08/010. E-mail: regulatory-scrutiny-board@ec.europa.eu
ANNEX: Quantification tables extracted from the draft impact assessment report
The following tables contain information on the costs and benefits of the initiative on which the Board has given its opinion, as presented above.
If the draft report has been revised in line with the Board’s recommendations, the content of these tables may be different from those in the final version
of the impact assessment report, as published by the Commission.
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Direct benefits
Improved surface
water quality
Additions: total benefits not quantified for EU27, but:
- Avoided/reduced environmental impacts and potential toxic effects on aquatic species. E.g. Carbamazepine has population effects for aquatic species
through impacts on fertility and reproduction (particularly crustaceans). Ibuprofen exhibits potential toxic effects for some aquatic species including
fertility effects (hormone levels) in fish while nicosulfuron has aquatic toxicity (particularly to flora) and concerns over carcinogenicity as a secondary
poisoning issue. Diclofenac is one of the highest concern pharmaceuticals for environmental impacts with potential toxic effects on avian populations
via surface water species. Estrone E1, 17- Beta estradiol (E2), Ethinyl estradiol (EE2) are associated with chronic ecosystem level impacts from
exposure to hormones and EDC. PFAS has a widespread and very long-lasting environmental effects while Bisphenol A causes population level effects
as an endocrine disrupting chemical for aquatic organisms. Triclosan is toxic for aquatic organisms particularly larvae and fish eggs with effects
identified on a range of aquatic species including amphibians. Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam Bifenthrin,
Deltamethrin Esfenvalerate and Permethrin are associated with toxic aquatic effects against invertebrates, arthropods, and crustaceans with wider
environmental concerns for terrestrial pollinators (with Bifenthrin, Deltamethrin Esfenvalerate, Permethrin being highly toxic to the aquatic environment
even at low concentrations). Glyphosate is associated with potential harm to aquatic environments given the very high usage rates and risks for loss to
water, including non-target aquatic flora.
- Avoided/reduced human health impacts (Glyphosate, Triclosan, PFAS, Bisphenol A via reduced exposure through drinking water) including from
specific exposure to Neonicotinoids (Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam), EDC (Bifenthrin, Deltamethrin
Esfenvalerate, Permethrin) and (potential) carcinogenic effects (Ethinyl estradiol (EE2), Nicosulfuron). E.g. Annual costs related to endocrine disruptors
exposure were estimated to be €163 billion (above €22 billion with a 95% probability and above €196 billion with a 25% probability) (59). This is due to
the fact that endocrine disruptors in Europe contribute substantially to neurobehavioral deficits and disease, with a high probability of >€150 billion
costs annually (69) as well as childhood obesity which costs €1.54 billion annually. Protection against AMR has clear societal benefits and avoided costs
to healthcare from protections against the development of AMR within health settings (Azithromycin, Clarithromycin, Erythromycin). E.g. it is
estimated that AMR costs the EU €1.5 billion per year in healthcare costs and productivity losses
1
(47) (70) (71).
- Avoided/reduced impacts on pollinators and agriculture (Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam, Bifenthrin, Deltamethrin
1
Based on an exchange rate of 1 EUR = 1.09 USD
5
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Esfenvalerate, Permethrin). E.g. across Europe, crop pollination by insects accounted for approximately €14.6 billion annually (72).
- Avoided costs of water treatment for drinking water, agriculture and industry (Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam
Bifenthrin, Deltamethrin Esfenvalerate, Permethrin, glyphosate, triclosan, bisphenol A, PFAS) (in the case of source control and pathway disruption
measures). E.g. in 2015, approximately €0.5 billion was spent annually to remove pesticides in wastewater treatment plants (WWTP) in Europe (73).
- Economic benefits for aquaculture from improved food quality (Estrone E1, 17- Beta estradiol (E2), Ethinyl estradiol (EE2), Acetamiprid, Clothianidin,
Imidacloprid, Thiacloprid, Thiamethoxam Bifenthrin, Deltamethrin Esfenvalerate, Permethrin, Diclofenac, Carbamazepine, ibuprofen, Nicosulfuron,
triclosan, PFAS, bisphenol A)
- Innovation for development of alternative chemicals and technologies (e.g. Bisphenol A)
Amendments: total benefits not quantified for EU27, but:
- Updated EQS based on new science and re-appraisal of risk would provide more appropriate protections (all substances)
- Improved protections for human health particularly in relation of POP substances, issues around bioaccumulation (dioxins and furans, chlorpyrifos,
hexachlorobutadiene, HBCDD), EDC (diuron, chlorpyrifos), exposure to chronic pollutants (mercury, nickel). E.g. chlorpyrifos and PBDE as endocrine
disruptors were associated with attention deficit hyperactivity disorder (ADHD) and with other cognitive deficiencies. The productivity loss caused by
these disorders is estimated to be €124 billion annually in EU. Additionally, prenatal exposure to chlorpyrifos across the EU would cost an additional
€21.4 billion in social costs. The neurotoxicity of chlorpyrifos is estimated to be 70 to 100% according to the epidemiological and toxicological
evidence, which corresponds to a social cost of €46.8 billion and €195 billion annually in the EU (69). It was also estimated that the cognitive deficits
caused by chlorpyrifos and methylmercury would cost the EU €177 billion and €9.89 billion, respectively
- Reduced environmental concentrations, improved environmental protections for ecosystem services (cypermethrin, nonylphenols, PAHs)
- Avoided health costs for aquaculture (cypermethrin, tributyltin, mercury, nickel)
- Cost savings and efficiencies: the proposed EQS is less stringent for heptachlor/heptachlor oxide, hexachlorobenzene, PBDEs and fluoranthene,
meaning resources can be reallocated and costs saved from measures no longer needed.
- Potential innovation opportunity to remove use as an intermediate in manufacture of rubber products (diuron)
Other eight pollutants: total benefits not quantified for EU27, but:
- Three of the four cyclodiene pesticides (aldrin, dieldrin, endrin;,isodrin is an isomer of aldrin) are listed as POPs under the Stockholm Convention and
have been banned in the EU for many years. The rate of EQS exceedance suggests environmental risk is low, and benefits of continued monitoring may
be limited. However, monitoring data are needed anyway under the POPs Regulation and could inform decontamination measures.
- DDT is also a recognised POP. Use in EU has long since ceased and rate of EQS exceedance is extremely low. Maintaining the monitoring time-series
would support the tracking of DDT in the environment, and link with monitoring of, e.g. imported foods.
- While tetrachloroethylene and trichloroethylene are still in use, and health concerns well founded, the monitoring data shows exceedances in only 6 and
3 surface water bodies out of 97,000 suggesting a very low environmental risk at present. However, these substances are still of concern in groundwater
and drinking water, and in marine waters, and the links between surface and groundwater bodies mean that for the moment it is prudent to continue
monitoring them in surface waters.
Deselection: total benefits not quantified for EU27, but
 Deselection of substances that no longer represent an EU-wide risk could free up resources for reallocation by Competent Authorities to the monitoring
and/or management of emerging pollutants, including watch-list substances and the new priority substances.
 The pesticides alachlor, simazine and chlorfenvinphos are clearly hazardous but no longer approved for use; the risk of exposure is very low and would
be expected to remain so.
 Carbon tetrachloride and trichlorobenzenes are still in use. However, the rate of exceedance of the EQS is very low. Deselection of trichlorobenzenes is
questionable compared to other substances given that its risk quotient RQ and MSFD relevance.
6
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Improved
groundwater quality
PFAS: total benefits not quantified for EU27, but
 Lower risk of (irreversible) damage to natural resources such as groundwater and connected surface waters and ecosystems (i.e. reduced impact on
sensitive water bodies such as wetlands and rivers, and fish);
 Avoided illness / death through low level exposure through drinking water / food to PFAS: estimated the annual health expenditure due to kidney cancer
€12.7 to €41.4 million in the EEA countries; hypertension in the EEA countries estimated at €10.7 to 35 billion per year (based on 207.8 million
population);
 Improved availability of clean raw groundwater for abstraction and lower production and maintenance costs (for drinking water, irrigation, livestock
watering)
 Benefits to sectors requiring a high quality of groundwater such as bottled water and other water uses (angling, swimming, etc).
 Avoided costs of (pre)treatment as a result of improved quality for potable water and process water for drinking water supply, agriculture and industry
(GAC treatment costs € millions per site) in the case of source control and pathway disruption measures
 Reduced energy costs and related process costs for wastewater treatment to tackle PFAS (in the case of source control and pathway disruption measures)
 Increased knowledge and understanding of the risks of PFAS posed to the water environment.
 Consistent approach to data collection at EU level and improved knowledge (more data collected) on the impact of
PFAS.
Pharmaceuticals: total benefits not quantified for EU27, but
 Reduced pollution of groundwater and connected aquatic ecosystems with reduced impact on sensitive habitats.
 Increased reuse and recovery of pharmaceutical-free materials (e.g. use of sludge, treated wastewater).
 Reduction in AMR likely to be small (mainly covered by baseline measures) - Reduction in AMR through control of anti-biotic use (costs avoided of
€1.5 billion to the EU)
 Small increase in well-being from reduced risk of chronic ingestion in drinking water / improved ecosystem health.
 Positive impact on shellfish and fisheries where groundwater inputs to rivers and estuaries is significant
 Reduced energy, carbon emissions and chemicals use associated with reduced treatment of drinking water (in the case of source control and pathway
disruption measures)
 Improved efficiency - specific risks to groundwater are investigated and dealt with locally rather than through EU wide schemes which may be too high
level to be effective
 Consistent approach to data collection at EU level and improved knowledge (more data collected) on the impact of these two pharmaceuticals.
nrMs: total benefits not quantified for EU27, but
 Reduced risk of damage to natural resources such as groundwater and connected ecosystems
 Benefits to sectors requiring a high quality of groundwater such as bottled water or aquaculture and other water uses (angling, swimming, etc.).
 Increased availability of clean raw groundwater for abstraction (for drinking water, irrigation, livestock watering)
 Avoided costs of (pre)treatment as a result of improved quality for potable water and process water for agriculture and industry
 Increased ecosystems services from groundwater biota not impacted by nrMs and cocktail effects
 Climate change impacts through reduced energy use (e.g. due to changes to wastewater and drinking water treatment processes) (in the case of source
control and pathway disruption measures).
 Increased knowledge and understanding of the risks of metabolites of pesticides posed to the water environment.
 plus reduced impacts on groundwater biota
7
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
 Consistent approach to data collection at EU level and improved knowledge (more data collected) on nrMs in groundwater leading to better
understanding of risks.
 Improved knowledge and better data for use during pesticide parent authorisation process.
Indirect benefits
Digitalisation,
administrative
streamlining and better
risk management
options
Option 2 (Guidelines on the monitoring of groups/mixtures of pollutants): not quantified for EU27, but the guidance document itself has limited impact,
however a provision for monitoring estorgens with EBM could have substantial positive impacts.
Option 6 (An obligatory groundwater watchlist): not quantified for EU27, but positive impacts due to better decision-making processes regarding substances
posing risks and better comparability of data.
Option 8 (Repository of standards of EQSs for the RBSPs): not quantified for EU27, but positive impact through harmonization of EU-wide standards allowing
more effective measures. Positive impacts for social well-being and health, providing equal standard of water resource across EU
Option 9 (Allowing flexible adaptation to scientific progress and knowledge by updating the lists of pollutants and their EQS (under both SWD and
GWD) by way of delegated acts): not quantified for EU27, but positive impact due to quicker actions to address new substances. Positive impacts as innovation
and research will lead to possible employment opportunities
Administrative cost savings related to the ‘one in, one out’ approach*
(direct/indirect) Deselection of existing PS: €3.8 million - €11.7 million per year (monitoring of 5 substances).
The deselection of substances is likely to bring cost savings from no longer needing to monitor the deselected substances.
II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Surface
water
Direct
adjustment
costs
Not applicable
- €0
Not applicable
- €0
Additions: Not quantified for EU27, but:
Significant costs to ensure compliance with proposed EQS for Ethinyl estradiol
(EE2), Ibuprofen, Clothianidin, Imidacloprid, Thiamethoxam, Bifenthrin,
Deltamethrin, Esfenvalerate, Permethrin, Glyphosate, Triclosan, PFAS and
Bisphenol A implementing a range of source control, pathway disruption, targeted
end of pipe treatment measures. E.g. the cost of a take-back scheme for unused
pharmaceuticals in France is €10 million. The 2022 Annex XV restriction report for
the proposed restriction of PFASs in firefighting foams estimates that the ban is
estimated to cost society €6.8 billion over a 30-year period or €390 million per year
(22). Costs of pathway disruption measures (e.g. buffer strips) is €472 million per
Not quantified Not quantified
8
II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
year for pharmaceuticals; for pesticides these range from €162 million for
clothianidin and imidacloprid to €285 million for glyphosate. Wastewater treatment
range is €10- €32 per population equivalent, per annum (technology dependent).
Moderate/Small costs to ensure compliance for Estrone E1, 17- Beta estradiol
(E2), Diclofenac, Carbamazepine, Azithromycin, Clarithromycin, Erythromycin,
Acetamiprid, Thiacloprid, Nicosulfuron due to small distance to target, availability
of source control and pathway disruption measures and/or positive impact of
forthcoming revision of the UWWTD on quaternary end of pipe treatment. E.g.
costs of pathway disruption measures (e.g. buffer strips) for pesticides range from
€1.6 million for acetamiprid to €12.8 million for nicosulfuron. Wastewater
treatment cost range is €10- €20 per population equivalent, per annum (technology
dependent).
Amendments:
Not quantified for EU27, but:
Significant costs to ensure compliance for Cypermethrin, Chlorpyrifos, Diuron,
PAHs, Mercury, Nickel implementing a range of source control, pathway
disruption, targeted end of pipe treatment measures. E.g. the restriction proposal
which would ensure that granules or mulches (in particular from end-of-life tyres)
are not placed on the market for use or used as infill material in synthetic turf
pitches or similar applications if they contain more than 20 mg/kg in total of the
eight indicator-PAHs would cost €45m (74) over a 10-year period. Costs of
additional controls and treatment for farmed animal use of cypermethrin are €27.6
m2
. Wastewater treatment (Mercury, Nickel, PAH, Cypermethrin) - €1.17- €26.2
per population equivalent, per annum (technology dependent).
Mine drainage (Mercury) - €100,000 -€10,000,000 per plant and €0.4 per dm3
operating costs.
Moderate/Small costs to ensure compliance for Dioxins and furans,
Hexachlorobutadiene, Nonyl Phenol, Tributyltin due to small distance to target
and/or limited scope for additional measures (likely to be natural attenuation and
baseline end of pipe treatment (under the revised UWWTD)). E.g. the costs of
2
Cost calculation is based on the average cost of dip pens and containment areas to allow drying €1,120 as a one-off cost multiplied by the number of sheep farms in Eurostat (24,600) rounded to three significant figures.
9
II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
restricting nonylphenol (NP) and its ethoxylates (NPE) in textiles was estimated to
cost the EU €3.2m per annum for a reduction of 15 tonnes of NP/NPE released to
surface water (74).
No additional costs for Dicofol, Heptachlor/ Heptachlor oxide,
Hexachlorobenzene, Fluoranthene, PBDEs.
Other 8 pollutants: Not quantified, but minor additional compliance costs
(extremely low current exceedances).
Surface
water
Direct
administrative
costs
Not applicable
- €0
Not applicable
- €0
Not quantified Not quantified Not quantified Not quantified
Surface
water
Direct
regulatory fees
and charges
Not applicable
- €0
Not applicable
- €0
Not quantified Not quantified Not applicable -
€0
Not applicable - €0
Surface
water
Direct
enforcement
costs
Not applicable
- €0
Not applicable
- €0
Not quantified Not quantified Not quantified Additions:
Not quantified for EU27
but additional analytical
costs range from €11-
100 per sample for all
substances except for
PFAS. For PFAS
analytical costs are up to
€250 per sample.
Amendments:
Not quantified, but
amendments for
Chlorpyrifos and
Dioxins and furans could
lead to additional
analytical costs (due to
the proposed EQS being
considerably lower than
the existing one)
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II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Other 8 pollutants: Not
quantified, but
cyclodiene pesticides,
DDT,
tetrachloroethylene and
trichloroethylene have an
EQS that warrants
monitoring and analysis
by MS.
Surface
water
Indirect costs Additions:
Not quantified but additions of
new substances could lead to:
Possible societal impacts from
loss of use (contraceptive pill,
HRT, hormone treatments if
Ethinyl estradiol (EE2) is
restricted/banned
Societal impacts from loss of use
/restricted use of Diclofenac,
Carbamazepine, Ibuprofen if
controls implemented and
increased costs for other types of
medicine (including prescription
only medications)
Possible food security issues if
loss of use without chemical/non-
chemical alternatives in place
(Bifenthrin, Deltamethrin
Esfenvalerate, Permethrin)
Societal impacts for domestic pet
owners if use of Imidalcoprid is
restricted
Increased prices of goods and
services as a result of source
control measures.
Not quantified Not quantified Not applicable -
€0
Not applicable - €0
Groundwater Direct
adjustment
Not applicable
- €0
Not applicable
- €0
PFAS: Not quantified for EU27, but:
Restriction of use: €6.8 billion over a 30-year period or €390 million per year (22)
PFAS: Not
quantified for
Not quantified
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II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
costs per substitute use.
Management of contaminated biosolids (water industry): €201 million/yr
(landfilling) to €503-€755 million/yr high temperature incineration of 10% of all
biosolids
Paper manufacturing: €77 million/yr (landfilling) to €192 -€288 million/yr high
temperature incineration of paper mill wastes
Pharmaceuticals: Not quantified for EU27, but:
Returns program / Green Pharmacy initiatives in a small number of MS (<€1-10
million per MS)
nrMs: Not quantified for EU27, but:
Costs to pesticide sector through loss of approved substances, costs of product
development and product substitution to the farming sector.
EU27, but:
Contaminated
soil remediation:
€5 million (10
sites) - €760
million (20 sites)
Cost of legacy
pollution from
landfill sites –
average of
€690,000 up to
€77 million per
site
Groundwater Direct
administrative
costs
Not applicable -
€0
Not applicable -
€0
Not quantified Not quantified Not quantified Not quantified but no
significant additional
costs for risk / status
assessments
Direct regulatory
fees and charges
Not applicable -
€0
Not applicable -
€0
Not quantified Not quantified Not applicable - €0 Not applicable - €0
Direct
enforcement
costs
Not applicable -
€0
Not applicable -
€0
Not quantified Not quantified Not quantified Additional analytical
costs for EU27:
PFAS: €45-48 million
Pharma: €2 million
nrMs: €4-5 million
Indirect costs Not quantified but proposals could
lead to:
- Possible societal impacts
from loss of use of
pharmaceuticals - Restricting
use could impact on health
and well-being of people and
animals where alternatives
have side effects / different
efficacy.
Not quantified but proposals could lead to:
Pharmaceuticals:
- additional costs associated with substitution of pharmaceuticals and
availability of alternatives (product substitution viable for Sulfathemoxazole
but unlikely for Carbamazepine)
nrMs:
- Restrictions on use impact on farming sector and crop yields. Substitute
pesticides are available and can be cheaper or up to 100 times more costly
that permitted parent pesticides
- Un-intentional impacts for example glyphosate is used to destroy cover
crops, which are used to mitigate nutrients in run-off / leaching from
Not applicable - €0 Not applicable - €0
12
II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
agricultural fields over winter
- Increased data requirements could make gaining authorisation of new
products more challenging.
Digitalisation,
administrative
streamlining
and better
risk
management
options
Direct
adjustment costs
Not applicable -
€0
Not applicable -
€0
Not quantified for EU27, but:
Option 2 (Guidelines on the monitoring of groups/ mixtures of pollutants): Costs due
to monitoring of estrogen are low, but possible measure to be taken due to monitoring
results may be substantial.
Option 8 (Repository of standards of EQSs for the RBSPs): agreeing on RBSPs EQSs
would likely lead to substantial costs for MS for implementation of substantive
measures where necessary.
Option 9 (Allowing flexible adaptation to scientific progress and knowledge by
updating the lists of pollutants and their EQS (under both SWD and GWD) by way of
delegated acts
Not quantified for
EU27, but:
Option 2
(Guidelines on the
monitoring of
groups/mixtures of
pollutants):
Limited cost to
develop the
guidance
document.
Not quantified for EU27,
but:
Option 6 (An obligatory
groundwater watchlist):
Additional cost for
monitoring and reporting
Digitalisation,
administrative
streamlining
and better
risk
management
options
Direct
administrative
costs
Not applicable -
€0
Not applicable -
€0
Not quantified Not quantified
Direct regulatory
fees and charges
Not applicable -
€0
Not applicable -
€0
Not quantified Not quantified NA NA
Direct
enforcement
costs
Not applicable -
€0
Not applicable -
€0
Not quantified Not quantified Mon Not quantified for EU27,
but:
Option 2 (Guidelines on
the monitoring of
groups/ mixtures of
pollutants): Minor
monitoring costs of
estrogens.
Option 6 (An obligatory
groundwater watchlist):
Additional cost for
monitoring and reporting
13
II. Overview of costs – Preferred option
Cost type
Citizens / Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
Option 8 (Repository of
standards of EQSs for
the RBSPs): substantial
costs for MS for
implementation of
monitoring (following
the agreement on RBSPs
EQSs)
Indirect costs Substitution
Prices
NA NA
Costs related to the ‘one in, one out’ approach
Total
Direct
adjustment
costs
NA NA NA NA NA NA
Indirect
adjustment costs
NA NA NA NA NA NA
Administrative
costs (for
offsetting)
NA NA NA NA NA NA
Electronically signed on 24/06/2022 10:29 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121