kom (2022) 0540 - Ingen titel

Europaudvalget 2022
KOM (2022) 0540
Offentligt

EUROPEAN COMMISSION

24.6.2022

SEC(2022)

540

REGULATORY SCRUTINY BOARD OPINION

Revision of list of pollutants affecting surface and groundwaters

{COM(2022)

540}

{SWD(2022)

540, 543}

kom (2022) 0540 - Ingen titel kom (2022) 0540 - Ingen titel

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.

________________________________

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: [email protected]

kom (2022) 0540 - Ingen titel

(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

kom (2022) 0540 - Ingen titel

Reference number

Submitted to RSB on

Date of RSB meeting

PLAN/2020/8554

25 May 2022

22 June 2022

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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

Direct benefits

Improved surface

water quality

Amount

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 (47) (70) (71).

Avoided/reduced impacts on pollinators and agriculture (Acetamiprid, Clothianidin, Imidacloprid, Thiacloprid, Thiamethoxam, Bifenthrin, Deltamethrin

Comments

Based on an exchange rate of 1 EUR = 1.09 USD

________________________________

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: [email protected]

kom (2022) 0540 - Ingen titel

I. Overview of Benefits (total for all provisions) – Preferred Option

Description

Amount

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.

Comments

kom (2022) 0540 - Ingen titel

I. Overview of Benefits (total for all provisions) – Preferred Option

Description

Amount

Comments

PFAS:

total benefits not quantified for EU27, but

Improved

groundwater quality



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

kom (2022) 0540 - Ingen titel

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,

Option 2 (Guidelines

on the monitoring of groups/mixtures of pollutants):

not quantified for EU27, but the guidance document itself has limited impact,

administrative

however a provision for monitoring estorgens with EBM could have substantial positive impacts.

streamlining and better

risk management

Option 6 (An

obligatory groundwater watchlist):

not quantified for EU27, but positive impacts due to better decision-making processes regarding substances

options

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

Surface

water

Direct

adjustment

costs

Citizens / Consumers

One-off

Not applicable

- €0

Businesses

One-off

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

Administrations

Recurrent

One-off

Not quantified

Recurrent

Not applicable

- €0

Recurrent

Not quantified

kom (2022) 0540 - Ingen titel

II. Overview of costs – Preferred option

Cost type

Citizens / Consumers

One-off

Recurrent

One-off

Businesses

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

. 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 dm

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

Administrations

One-off

Recurrent

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.

kom (2022) 0540 - Ingen titel

II. Overview of costs – Preferred option

Cost type

Citizens / Consumers

One-off

Recurrent

One-off

Businesses

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).

Not quantified

Administrations

One-off

Recurrent

Surface

water

Surface

water

Surface

water

Direct

administrative

costs

Direct

regulatory fees

and charges

Direct

enforcement

costs

Not applicable

- €0

Not applicable

- €0

Not applicable

- €0

Not applicable

- €0

Not applicable

- €0

Not applicable

- €0

Not quantified

Not applicable - Not applicable - €0

€0

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)

Not quantified

kom (2022) 0540 - Ingen titel

II. Overview of costs – Preferred option

Cost type

Citizens / Consumers

One-off

Recurrent

One-off

Businesses

Recurrent

Administrations

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.

Not applicable - Not applicable - €0

€0

Surface

water

Indirect costs

Groundwater

Direct

adjustment

Additions:

Not quantified

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 applicable Not applicable

PFAS:

Not quantified for EU27, but:

PFAS:

Not

- €0

Restriction of use: €6.8 billion over a 30-year period or €390 million per year (22) quantified for

Not quantified

kom (2022) 0540 - Ingen titel

II. Overview of costs – Preferred option

Cost type

costs

Citizens / Consumers

One-off

Recurrent

One-off

Businesses

Recurrent

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

Administrations

One-off

Recurrent

EU27, but:

Contaminated

soil remediation:

€5 million (10

sites) - €760

million (20 sites)

Cost of legacy

Pharmaceuticals:

Not quantified for EU27, but:

pollution

from

Returns program / Green Pharmacy initiatives in a small number of MS (<€1-10 landfill sites –

million per MS)

average

€690,000 up to

nrMs:

Not quantified for EU27, but:

€77 million per

Costs to pesticide sector through loss of approved substances, costs of product site

development and product substitution to the farming sector.

Not applicable - Not applicable - Not quantified

Not quantified

Not quantified but no

Groundwater

Direct

€0

significant additional

administrative

€0

costs for risk / status

costs

assessments

Not quantified

Not applicable - €0 Not applicable - €0

Direct regulatory

Not applicable - Not applicable - Not quantified

€0

fees and charges

Not applicable - Not applicable - Not quantified

Not quantified

Additional analytical

Direct

€0

costs for EU27:

enforcement

PFAS: €45-48 million

costs

Pharma: €2 million

nrMs: €4-5 million

Not quantified but proposals could Not quantified but proposals could lead to:

Not applicable - €0 Not applicable - €0

Indirect costs

lead to:

Possible societal impacts Pharmaceuticals:

from loss of use of

additional costs associated with substitution of pharmaceuticals and

pharmaceuticals - Restricting

availability of alternatives (product substitution viable for Sulfathemoxazole

use could impact on health

but unlikely for Carbamazepine)

and well-being of people and nrMs:

animals where alternatives

Restrictions on use impact on farming sector and crop yields. Substitute

have side effects / different

pesticides are available and can be cheaper or up to 100 times more costly

efficacy.

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

kom (2022) 0540 - Ingen titel

II. Overview of costs – Preferred option

Cost type

Citizens / Consumers

One-off

Recurrent

Businesses

One-off

Recurrent

Administrations

One-off

Recurrent

agricultural fields over winter

Increased data requirements could make gaining authorisation of new

products more challenging.

Not applicable - Not applicable - Not quantified for EU27, but:

Not quantified for Not quantified for EU27,

Digitalisation,

Direct

€0

EU27, but:

but:

administrative

adjustment costs

Option 2 (Guidelines on the monitoring of groups/ mixtures of pollutants): Costs due

streamlining

to monitoring of estrogen are low, but possible measure to be taken due to monitoring Option 2

Option 6 (An obligatory

and better

results may be substantial.

(Guidelines on the groundwater watchlist):

risk

monitoring of

Additional cost for

management

Option 8 (Repository of standards of EQSs for the RBSPs): agreeing on RBSPs EQSs groups/mixtures of monitoring and reporting

options

would likely lead to substantial costs for MS for implementation of substantive

pollutants):

measures where necessary.

Limited cost to

develop the

Option 9 (Allowing flexible adaptation to scientific progress and knowledge by

guidance

updating the lists of pollutants and their EQS (under both SWD and GWD) by way of document.

delegated acts

Not applicable - Not applicable -

Not quantified

Digitalisation,

Direct

€0

administrative

streamlining

and better

risk

management

options

costs

Direct regulatory

Not applicable -

fees and charges

€0

Not applicable -

Direct

€0

enforcement

costs

Not applicable - Not quantified

€0

Not applicable - Not quantified

€0

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

kom (2022) 0540 - Ingen titel

II. Overview of costs – Preferred option

Cost type

Citizens / Consumers

One-off

Recurrent

One-off

Businesses

Recurrent

Administrations

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

Costs related to the ‘one in, one out’ approach

Total

Direct

adjustment

costs

Indirect

adjustment costs

Administrative

costs (for

offsetting)

Electronically signed on 24/06/2022 10:29 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121