Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council

For the group of polyaromatic hydrocarbons (PAHs) (No 28), the biota EQS refers to the sum of the concentrations of eight of the nine PAHs listed in footnote 15 expressed as benzo(a)pyrene equivalents based on the carcinogenic potencies of the substances relative to that of benzo(a)pyrene, i.e. the RPFs in footnote 15. Benzo(g,h,i)perylene does not need to be measured in biota for the purposes of determining compliance with the overall biota EQS. The biota EQS for fluoranthene in row 15 must also be complied with.

Tributyltin compounds including tributyltin-cation (CAS 36643-28-4).

Sediment EQS.

There is insufficient information available to set a MAC-EQS for these substances.

This refers to the following compounds:

7 polychlorinated dibenzo-p-dioxins (PCDDs): 2,3,7,8-T4CDD (CAS 1746-01-6, EU 217-122-7), 1,2,3,7,8-P5CDD (CAS 40321-76-4), 1,2,3,4,7,8-H6CDD (CAS 39227-28-6), 1,2,3,6,7,8-H6CDD (CAS 57653-85-7), 1,2,3,7,8,9-H6CDD (CAS 19408-74-3), 1,2,3,4,6,7,8-H7CDD (CAS 35822-46-9), 1,2,3,4,6,7,8,9-O8CDD (CAS 3268-87-9)

10 polychlorinated dibenzofurans (PCDFs): 2,3,7,8-T4CDF (CAS 51207-31-9), 1,2,3,7,8-P5CDF (CAS 57117-41-6), 2,3,4,7,8-P5CDF (CAS 57117-31-4), 1,2,3,4,7,8-H6CDF (CAS 70648-26-9), 1,2,3,6,7,8-H6CDF (CAS 57117-44-9), 1,2,3,7,8,9-H6CDF (CAS 72918-21-9), 2,3,4,6,7,8-H6CDF (CAS 60851-34-5), 1,2,3,4,6,7,8-H7CDF (CAS 67562-39-4), 1,2,3,4,7,8,9-H7CDF (CAS 55673-89-7), 1,2,3,4,6,7,8,9-O8CDF (CAS 39001-02-0)

12 dioxin-like polychlorinated biphenyls (PCB-DLs): 3,3’,4,4’-T4CB (PCB 77, CAS 32598-13-3), 3,3’,4’,5-T4CB (PCB 81, CAS 70362-50-4), 2,3,3’,4,4’-P5CB (PCB 105, CAS 32598-14-4), 2,3,4,4’,5-P5CB (PCB 114, CAS 74472-37-0), 2,3’,4,4’,5-P5CB (PCB 118, CAS 31508-00-6), 2,3’,4,4’,5’-P5CB (PCB 123, CAS 65510-44-3), 3,3’,4,4’,5-P5CB (PCB 126, CAS 57465-28-8), 2,3,3’,4,4’,5-H6CB (PCB 156, CAS 38380-08-4), 2,3,3’,4,4’,5’-H6CB (PCB 157, CAS 69782-90-7), 2,3’,4,4’,5,5’-H6CB (PCB 167, CAS 52663-72-6), 3,3’,4,4’,5,5’-H6CB (PCB 169, CAS 32774-16-6), 2,3,3’,4,4’,5,5’-H7CB (PCB 189, CAS 39635-31-9).

For the group of Dioxins and dioxin-like compounds (No 37), the biota EQS refers to the sum of the concentrations of the substances listed in footnote 20 expressed as toxic equivalents based on the World Health Organisation 2005 Toxic Equivalence Factors.

CAS 52315-07-8 refers to an isomer mixture of cypermethrin, alpha-cypermethrin (CAS 67375-30-8, EU 257-842-9), beta-cypermethrin (CAS 65731-84-2, EU 265-898-0), theta-cypermethrin (CAS 71691-59-1) and zeta-cypermethrin (CAS 1315501-18-8, EU 257-842-9).

This refers to 1,3,5,7,9,11-Hexabromocyclododecane (CAS 25637-99-4, EU 247-148-4), 1,2,5,6,9,10-Hexabromocyclododecane (CAS 3194-55-6, EU 221-695-9), α-Hexabromocyclododecane (CAS 134237-50-6), β-Hexabromocyclododecane (CAS 134237-51-7) and γ-Hexabromocyclododecane (CAS 134237-52-8).

For freshwater used for the abstraction and preparation of drinking water.

For freshwater not used for the abstraction and preparation of drinking water.

This refers to the following compounds, listed with their CAS number, EU number and Relative Potency Factor (RPF):

Perfluorooctanoic acid (PFOA) (CAS 335-67-1, EU 206-397-9) (RPF 1), Perfluorooctane sulfonic acid (PFOS) (CAS 1763-23-1, EU 217-179-8) (RPF 2), Perfluorohexane sulfonic acid (PFHxS) (CAS 355-46-4, EU 206-587-1) (RPF 0,6 ), Perfluorononanoic acid (PFNA) (CAS 375-95-1, EU 206-801-3) (RPF 10), Perfluorobutane sulfonic acid (PFBS) (CAS 375-73-5, EU 206-793-1) (RPF 0,001 ), Perfluorohexanoic acid (PFHxA) (CAS 307-24-4, EU 206-196-6) (RPF 0,01 ), Perfluorobutanoic acid (PFBA) (CAS 375-22-4, EU 206-786-3) (RPF 0,05 ), Perfluoropentanoic acid (PFPeA) (CAS 2706-90-3, EU 220-300-7) (RPF 0,03 ), Perfluoropentane sulfonic acid (PFPeS) (CAS 2706-91-4, EU 220-301-2) (RPF 0,3005 ), Perfluorodecanoic acid (PFDA) (CAS 335-76-2, EU 206-400-3) (RPF 7), Perfluorododecanoic acid (PFDoDA or PFDoA) (CAS 307-55-1, EU 206-203-2) (RPF 3), Perfluoroundecanoic acid (PFUnDA or PFUnA) (CAS 2058-94-8, EU 218-165-4) (RPF 4), Perfluoroheptanoic acid (PFHpA) (CAS 375-85-9, EU 206-798-9) (RPF 0,505 ), Perfluorotridecanoic acid (PFTrDA) (CAS 72629-94-8, EU 276-745-2) (RPF 1,65 ), Perfluoroheptane sulfonic acid (PFHpS) (CAS 375-92-8, EU 206-800-8) (RPF 1,3 ), Perfluorodecane sulfonic acid (PFDS) (CAS 335-77-3, EU 206-401-9) (RPF 2), Perfluorotetradecanoic acid (PFTeDA) (CAS 376-06-7, EU 206-803-4) (RPF 0,3 ), Perfluorohexadecanoic acid (PFHxDA) (CAS 67905-19-5, EU 267-638-1) (RPF 0,02 ), Perfluorooctadecanoic acid (PFODA) (CAS 16517-11-6, EU 240-582-5) (RPF 0,02 ), 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid (HFPO-DA) (CAS 13252-13-6) (RPF 0,06 ), 2,2,3-trifluoro-3-(1,1,2,2,3,3-hexafluoro-3-(trifluoromethoxy)propoxy)propanoic acid (CAS 919005-14-4) (RPF 0,03 ), 2- (Perfluorohexyl)ethyl alcohol (6:2 FTOH) (CAS 647-42-7, EU 211-477-1) (RPF 0,02 ), 2-(Perfluorooctyl)ethanol (8:2 FTOH) (CAS 678-39-7, EU 211-648-0) (RPF 0,04 ) and 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy) acetic acid (C6O4) (CAS 1190931-41-9) (RPF 0,06 ), Trifluoroacetic acid (TFA) (CAS 76-05-1, EU 200-929-3) (RPF 0,002 ).

[^E0042]: (²⁷)

For the group of PFAS (No 65), the EQS refer to the sum of the concentrations of the 25 PFAS listed in footnote 26 expressed as PFOA-equivalents based on the potencies of the substances relative to that of PFOA, i.e. the RPFs in footnote 26. The critical EQS is the biota EQS (relating to fish consumption) and must therefore be complied with. The AA-EQS are not equivalently protective.

‘Pesticides’ means plant protection products as referred to in Article 2 of Regulation (EC) No 1107/2009 and biocidal products as defined in Article 3 of Regulation (EU) No 528/2012.

The minimum performance criteria laid down in Directive 2009/90/EC apply to each individual substance within the group of substances but taking account of the need to quantify the contribution of each substance to the total concentration for comparison with the EQS.

With the following exceptions: the four pesticides to be monitored in biota or sediment, i.e. the substances numbered 16, 30, 34 and 44, and glyphosate.

PART B:   **APPLICATION OF THE EQS SET OUT IN PART A**

• 1. For any given surface water body, applying the AA-EQS means that, for each representative monitoring point within the water body, the arithmetic mean of the concentrations measured at different times during the year does not exceed the standard.

The calculation of the arithmetic mean, the analytical method used and, where there is no appropriate analytical method meeting the minimum performance criteria, the method of applying an EQS must be in accordance with implementing acts adopting technical specifications for chemical monitoring and quality of analytical results, in accordance with Directive 2000/60/EC.

• 1. For any given surface water body, applying the MAC-EQS means that the measured concentration at any representative monitoring point within the water body does not exceed the standard.

However, in accordance with Section 1.3.4 of Annex V to Directive 2000/60/EC, Member States may introduce statistical methods, such as a percentile calculation, to ensure an acceptable level of confidence and precision for determining compliance with the MAC-EQS. Where Member States do so, such statistical methods shall comply with detailed rules laid down in accordance with the examination procedure referred to in Article 9(2) of this Directive.

• 1. The water EQS laid down in this Annex are expressed as total concentrations in the whole water sample.

By way of derogation from the first subparagraph, in the case of cadmium, lead, mercury and nickel (hereinafter ‘metals’), the water EQS refer to the dissolved concentration, i.e. the dissolved phase of a water sample obtained by filtration through a 0,45 μm filter or any equivalent pre-treatment, or, where specifically indicated, to the bioavailable concentration.

Member States may, when assessing the monitoring results against the relevant EQS, take into account:

- (a) natural background concentrations for metals and their compounds where such concentrations prevent compliance with the relevant EQS;

• (b) hardness, pH, dissolved organic carbon or other water quality parameters that affect the bioavailability of metals, the bioavailable concentrations being determined using appropriate bioavailability modelling.

ANNEX II

ENVIRONMENTAL QUALITY STANDARDS FOR RIVER BASIN SPECIFIC POLLUTANTS

PART A: INDICATIVE LIST OF CATEGORIES OF RIVER BASIN SPECIFIC POLLUTANTS

• 1.Organohalogen compounds and substances which may form such compounds in the aquatic environment.

• 2.Organophosphorous compounds.

• 3.Organotin compounds.

• 4.Substances and preparations, or the breakdown products of such, which have been proved to possess carcinogenic or mutagenic properties or properties which may affect steroidogenic, thyroid, reproduction or other endocrine-related functions in or via the aquatic environment.

• 5.Persistent hydrocarbons and persistent and bioaccumulable organic toxic substances.

• 6.Cyanides.

• 7.Metals and their compounds.

- 8.Arsenic and its compounds.

• 9.Biocides and plant protection products.

• 10.Materials in suspension, including micro/nanoplastics

• 11.Microorganisms, genes or genetic material reflecting the presence of microorganisms resistant to antimicrobial agents, in particular microorganisms pathogenic to humans or livestock.

PART B: THE PROCEDURE FOR DERIVING ENVIRONMENTAL QUALITY STANDARDS FOR RIVER BASIN SPECIFIC POLLUTANTS

Methods used for the establishment of EQS for river basin specific pollutants shall include the following steps:

- (a) identification of the receptors and compartments or matrices at risk from the substance of concern;

• (b) collation and quality assessment of data on the properties of the substance of concern, including its (eco)toxicity, in particular from reports on laboratory, mesocosm and field studies which cover both chronic and acute effects in both fresh and saltwater environments;

• (c) extrapolation of (eco)toxicity data to no-effect or similar concentrations using deterministic or probabilistic methods, and selection and application of appropriate assessment factors to address uncertainties and derive EQS;

• (d) comparison of EQS for different receptors and compartments, and selection of critical EQS, i.e. the EQS that provides protection to the most sensitive receptor in the most relevant compartment or matrix.

PART C: REPOSITORY OF HARMONISED ENVIRONMENTAL QUALITY STANDARDS FOR RIVER BASIN SPECIFIC POLLUTANTS

CAS: Chemical Abstracts Service.

EU number: European Inventory of Existing Commercial Substances (EINECS) or European List of Notified Chemical Substances (ELINCS).

This parameter is the EQS expressed as an annual average value (AA-EQS). Unless otherwise specified, it applies to the total concentration of all substances and isomers.

[^E0055]: (⁴)

Inland surface waters encompass rivers and lakes and related artificial or heavily modified water bodies.

This parameter is the EQS expressed as a maximum allowable concentration (MAC EQS). Where the MAC EQS are marked as ‘not applicable’, the AA EQS values are considered protective against short-term pollution peaks in continuous discharges since they are significantly lower than the values derived on the basis of acute toxicity.

If a biota EQS is given, it, rather than the water EQS, shall be applied, without prejudice to Article 3(3) of this Directive allowing an alternative biota taxon, or another matrix, to be monitored instead, as long as the EQS applied provides an equivalent level of protection. Unless otherwise indicated, the biota EQS relate to fish.

Substance previously listed as a priority substance in Annex X to Directive 2000/60/EC or Annex I to Directive 2008/105/EC.

ANNEX III

SUBSTANCES SUBJECT TO REVIEW FOR POSSIBLE IDENTIFICATION AS PRIORITY SUBSTANCES

CAS: Chemical Abstracts Service.

EU number: European Inventory of Existing Commercial Substances (EINECS) or European List of Notified Chemical Substances (ELINCS).

[^E0001]: OJ L 201, 1.8.2009, p. 36;

[^E0002]: OJ L 41, 14.2.2003, p. 26;

[^E0003]: Regulation (EU) 2024/1244 of the European Parliament and of the Council of 24 April 2024 on reporting of environmental data from industrial , establishing an Industrial Emissions Portal and repealing Regulation (EC) No 166/2006 (OJ L, 2024/1244, 2.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1244/oj).

[^E0004]: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj).

[^E0005]: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

[^E0006]: Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).

[^E0007]: Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, p. 71, ELI: http://data.europa.eu/eli/dir/2009/128/oj).

[^E0008]: Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial and livestock rearing emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).

[^E0009]: Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

[^E0010]: Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43, ELI: http://data.europa.eu/eli/reg/2019/6/oj).

[^E0011]: Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the prevention and control of groundwater pollution (OJ L 372, 27.12.2006, p. 19, ELI: http://data.europa.eu/eli/dir/2006/118/oj).

[^E0012]: Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).

[^E0013]: Regulation (EU) 2022/2379 of the European Parliament and of the Council of 23 November 2022 on statistics on agricultural input and output, amending Commission Regulation (EC) No 617/2008 and repealing Regulations (EC) No 1165/2008, (EC) No 543/2009 and (EC) No 1185/2009 of the European Parliament and of the Council and Council Directive 96/16/EC (OJ L 315, 7.12.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2379/oj).

[^E0014]: Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status (OJ L 201, 1.8.2009, p. 36, ELI: http://data.europa.eu/eli/dir/2009/90/oj).

[^E0015]: OJ L 55, 28.2.2011, p. 13;