# L_2015078EN.01004001.xml

| 24.3.2015 | EN | Official Journal of the European Union | L 78/40 |
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24.3.2015

EN

Official Journal of the European Union

L 78/40

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COMMISSION IMPLEMENTING DECISION (EU) 2015/495

of 20 March 2015

establishing a watch list of substances for Union-wide monitoring in the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council

(notified under document C(2015) 1756)

(notified under document C(2015) 1756)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 8b(5) thereof,

1

Whereas:

| (1) | Article 8b(1) of Directive 2008/105/EC provides for the establishment of a watch list of, in the first instance, up to 10 substances or groups of substances for which Union-wide monitoring data are to be gathered for the purpose of supporting future prioritisation exercises in accordance with Article 16(2) of Directive 2000/60/EC of the European Parliament and of the Council (2). The list should include an indication of the monitoring matrices and possible methods of analysis not entailing excessive costs. |
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(1)

Article 8b(1) of Directive 2008/105/EC provides for the establishment of a watch list of, in the first instance, up to 10 substances or groups of substances for which Union-wide monitoring data are to be gathered for the purpose of supporting future prioritisation exercises in accordance with Article 16(2) of Directive 2000/60/EC of the European Parliament and of the Council (2). The list should include an indication of the monitoring matrices and possible methods of analysis not entailing excessive costs.

2

| (2) | Article 8b of Directive 2008/105/EC specifies, inter alia, the conditions and modalities for the monitoring of the substances included in the watch list, for the reporting of the monitoring results by the Member States, and for the updating of the list. |
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(2)

Article 8b of Directive 2008/105/EC specifies, inter alia, the conditions and modalities for the monitoring of the substances included in the watch list, for the reporting of the monitoring results by the Member States, and for the updating of the list.

| (3) | The substances in the watch list should be selected from amongst those for which the information available indicates that they may pose a significant risk, at Union level, to or via the aquatic environment, but for which monitoring data are insufficient to come to a conclusion on the actual risk posed. Highly toxic substances, used in many Member States and discharged to the aquatic environment but not or rarely monitored, should be considered for inclusion in the watch list. That selection process should take into account information as itemised in points (a) to (e) of Article 8b(1) of Directive 2008/105/EC, giving particular consideration to emerging pollutants. |
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(3)

The substances in the watch list should be selected from amongst those for which the information available indicates that they may pose a significant risk, at Union level, to or via the aquatic environment, but for which monitoring data are insufficient to come to a conclusion on the actual risk posed. Highly toxic substances, used in many Member States and discharged to the aquatic environment but not or rarely monitored, should be considered for inclusion in the watch list. That selection process should take into account information as itemised in points (a) to (e) of Article 8b(1) of Directive 2008/105/EC, giving particular consideration to emerging pollutants.

| (4) | The monitoring of the substances in the watch list should generate high-quality data on their concentrations in the aquatic environment, fit for the purpose of supporting, in a separate review exercise according to Article 16(4) of Directive 2000/60/EC, the risk assessments that underpin the identification of priority substances. In that review, substances found to pose a significant risk should be considered for inclusion in the priority substances list. An environmental quality standard would then also be set, which Member States would have to meet. The proposal of a substance for inclusion in the priority substances list would be subject to an impact assessment. |
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(4)

The monitoring of the substances in the watch list should generate high-quality data on their concentrations in the aquatic environment, fit for the purpose of supporting, in a separate review exercise according to Article 16(4) of Directive 2000/60/EC, the risk assessments that underpin the identification of priority substances. In that review, substances found to pose a significant risk should be considered for inclusion in the priority substances list. An environmental quality standard would then also be set, which Member States would have to meet. The proposal of a substance for inclusion in the priority substances list would be subject to an impact assessment.

| (5) | In accordance with Article 8b(1) of Directive 2008/105/EC, diclofenac, 17-beta-estradiol (E2) and 17-alpha-ethinylestradiol (EE2) should be included in the first watch list, in order to gather monitoring data for the purpose of facilitating the determination of appropriate measures to address the risk posed by those substances. Estrone (E1) should also be included in the watch list because of its close chemical relationship to 17-beta-estradiol, of which it is a breakdown product. |
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(5)

In accordance with Article 8b(1) of Directive 2008/105/EC, diclofenac, 17-beta-estradiol (E2) and 17-alpha-ethinylestradiol (EE2) should be included in the first watch list, in order to gather monitoring data for the purpose of facilitating the determination of appropriate measures to address the risk posed by those substances. Estrone (E1) should also be included in the watch list because of its close chemical relationship to 17-beta-estradiol, of which it is a breakdown product.

| (6) | During 2014, the Commission gathered data on a range of other substances that could be included in the watch list. It took account of the information sources referred to in Article 8b(1) of Directive 2008/105/EC, and consulted experts from Member States, and stakeholder groups. A ranking process was conducted. This considered in particular substances which came close to being prioritised in the most recently completed priority substances review, but for which monitoring data were still needed to confirm a significant risk. It also considered several other substances identified as potential emerging pollutants, for which few or no recent monitoring data were available. The risk posed by each of those substances was calculated from the available information on their intrinsic hazard and the exposure of the environment to them. Exposure was estimated from data on the extent of production and use, taking account of any actual monitoring data. |
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(6)

During 2014, the Commission gathered data on a range of other substances that could be included in the watch list. It took account of the information sources referred to in Article 8b(1) of Directive 2008/105/EC, and consulted experts from Member States, and stakeholder groups. A ranking process was conducted. This considered in particular substances which came close to being prioritised in the most recently completed priority substances review, but for which monitoring data were still needed to confirm a significant risk. It also considered several other substances identified as potential emerging pollutants, for which few or no recent monitoring data were available. The risk posed by each of those substances was calculated from the available information on their intrinsic hazard and the exposure of the environment to them. Exposure was estimated from data on the extent of production and use, taking account of any actual monitoring data.

| (7) | In the course of gathering data on the substances in the initial list, additional monitoring data were found for some of those substances. The availability of reliable, up-to-date data for at least four Member States was considered sufficient for not including substances in the watch list. When those substances were discounted, along with some others for which there was particular doubt about their toxicity, or whose use was expected to be discontinued, the following were identified as the most highly ranked: oxadiazon, methiocarb, 2,6-ditert-butyl-4-methylphenol, tri-allate, four neonicotinoid pesticides, the macrolide antibiotic erythromycin, and 2-ethylhexyl 4-methoxycinnamate. Those substances should therefore also be included in the watch list, identified by their Chemical Abstracts Service (CAS) and EU numbers. A fifth neonicotinoid pesticide and two other macrolide antibiotics were also determined to potentially pose a significant risk. The possibility that substances with the same mode of action could have additive effects additionally justifies proposing their simultaneous inclusion in the watch list. It should be possible to analyse the neonicotinoids simultaneously, and likewise the macrolide antibiotics, allowing them to be grouped in the list. |
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(7)

In the course of gathering data on the substances in the initial list, additional monitoring data were found for some of those substances. The availability of reliable, up-to-date data for at least four Member States was considered sufficient for not including substances in the watch list. When those substances were discounted, along with some others for which there was particular doubt about their toxicity, or whose use was expected to be discontinued, the following were identified as the most highly ranked: oxadiazon, methiocarb, 2,6-ditert-butyl-4-methylphenol, tri-allate, four neonicotinoid pesticides, the macrolide antibiotic erythromycin, and 2-ethylhexyl 4-methoxycinnamate. Those substances should therefore also be included in the watch list, identified by their Chemical Abstracts Service (CAS) and EU numbers. A fifth neonicotinoid pesticide and two other macrolide antibiotics were also determined to potentially pose a significant risk. The possibility that substances with the same mode of action could have additive effects additionally justifies proposing their simultaneous inclusion in the watch list. It should be possible to analyse the neonicotinoids simultaneously, and likewise the macrolide antibiotics, allowing them to be grouped in the list.

| (8) | In accordance with Article 8b(1) of Directive 2008/105/EC, the Commission has identified possible methods of analysis for the proposed substances. The method detection limit should be at least as low as the substance-specific predicted no-effect concentration for each substance in the relevant matrix. If new information leads to a decrease in the predicted no-effect concentration for particular substances, the maximum acceptable method detection limit might have to be lowered while those substances remain on the list. The analytical methods are not considered to entail excessive costs. |
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(8)

In accordance with Article 8b(1) of Directive 2008/105/EC, the Commission has identified possible methods of analysis for the proposed substances. The method detection limit should be at least as low as the substance-specific predicted no-effect concentration for each substance in the relevant matrix. If new information leads to a decrease in the predicted no-effect concentration for particular substances, the maximum acceptable method detection limit might have to be lowered while those substances remain on the list. The analytical methods are not considered to entail excessive costs.

| (9) | For comparability, all substances should be monitored in whole water samples. However, it would be appropriate to monitor 2-ethylhexyl 4-methoxycinnamate also in suspended particulate matter or sediment, because of its tendency to partition into this matrix. |
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(9)

For comparability, all substances should be monitored in whole water samples. However, it would be appropriate to monitor 2-ethylhexyl 4-methoxycinnamate also in suspended particulate matter or sediment, because of its tendency to partition into this matrix.

| (10) | The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 21(1) of Directive 2000/60/EC, |
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(10)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 21(1) of Directive 2000/60/EC,

HAS ADOPTED THIS DECISION:

Article 1

The first watch list of substances for Union-wide monitoring referred to in Article 8b of Directive 2008/105/EC is set out in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 20 March 2015.

For the Commission

Karmenu VELLA

Member of the Commission

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(1)  OJ L 348, 24.12.2008, p. 84.

1

(2)  Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

2

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ANNEX

Watch list of substances for Union-wide monitoring as set out in Article 8b of Directive 2008/105/EC

| Name of substance/group of substances | CAS number (1) | EU number (2) | Indicative analytical method (3)
   (4)
   (5) | Maximum acceptable method detection limit (ng/l) |
| --- | --- | --- | --- | --- |
| 17-Alpha-ethinylestradiol (EE2) | 57-63-6 | 200-342-2 | Large-volume SPE — LC-MS-MS | 0,035 |
| 17-Beta-estradiol (E2), Estrone (E1) | 50-28-2,
  53-16-7 | 200-023-8 | SPE — LC-MS-MS | 0,4 |
| Diclofenac | 15307-86-5 | 239-348-5 | SPE — LC-MS-MS | 10 |
| 2,6-Ditert-butyl-4-methylphenol | 128-37-0 | 204-881-4 | SPE — GC-MS | 3 160 |
| 2-Ethylhexyl 4-methoxycinnamate | 5466-77-3 | 226-775-7 | SPE — LC-MS-MS
  or GC-MS | 6 000 |
| Macrolide antibiotics (6) | | | SPE — LC-MS-MS | 90 |
| Methiocarb | 2032-65-7 | 217-991-2 | SPE — LC-MS-MS
  or GC-MS | 10 |
| Neonicotinoids (7) | | | SPE — LC-MS-MS | 9 |
| Oxadiazon | 19666-30-9 | 243-215-7 | LLE/SPE — GC-MS | 88 |
| Tri-allate | 2303-17-5 | 218-962-7 | LLE/SPE — GC-MS
  or LC-MS-MS | 670 |

Name of substance/group of substances

CAS number (1)

EU number (2)

Indicative analytical method (3)
   (4)
   (5)

Maximum acceptable method detection limit (ng/l)

17-Alpha-ethinylestradiol (EE2)

57-63-6

200-342-2

Large-volume SPE — LC-MS-MS

0,035

17-Beta-estradiol (E2), Estrone (E1)

50-28-2,

53-16-7

200-023-8

SPE — LC-MS-MS

0,4

Diclofenac

15307-86-5

239-348-5

SPE — LC-MS-MS

10

2,6-Ditert-butyl-4-methylphenol

128-37-0

204-881-4

SPE — GC-MS

3 160

2-Ethylhexyl 4-methoxycinnamate

5466-77-3

226-775-7

SPE — LC-MS-MS

or GC-MS

6 000

Macrolide antibiotics (6)

SPE — LC-MS-MS

90

Methiocarb

2032-65-7

217-991-2

SPE — LC-MS-MS

or GC-MS

10

Neonicotinoids (7)

SPE — LC-MS-MS

9

Oxadiazon

19666-30-9

243-215-7

LLE/SPE — GC-MS

88

Tri-allate

2303-17-5

218-962-7

LLE/SPE — GC-MS

or LC-MS-MS

670

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(1)  Chemical Abstracts Service.

(2)  European Union number — not available for all substances.

(3)  To ensure comparability of results from different Member States, all substances shall be monitored in whole water samples.

(4)  Extraction methods:

| LLE | — | liquid liquid extraction, |
| --- | --- | --- |
| SPE | — | solid-phase extraction. |

LLE

—

liquid liquid extraction,

SPE

—

solid-phase extraction.

Analytical methods:

GC-MS— Gas chromatography-mass spectrometry,

LC-MS-MS— Liquid chromatography (tandem) triple quadrupole mass spectrometry.

(5)  For monitoring 2-Ethylhexyl 4-methoxycinnamate in suspended particulate matter (SPM) or in sediment (size < 63 μm), the following analytical method is indicated: SLE (solid liquid extraction) — GC-MS, with a maximum detection limit of 0,2 mg/kg.

(6)  Erythromycin (CAS number 114-07-8, EU number 204-040-1), Clarithromycin (CAS number 81103-11-9), Azithromycin (CAS number 83905-01-5, EU number 617-500-5).

(7)  Imidacloprid (CAS number 105827-78-9/138261-41-3, EU number 428-040-8), Thiacloprid (CAS number 111988-49-9), Thiamethoxam (CAS number 153719-23-4, EU number 428-650-4), Clothianidin (CAS number 210880-92-5, EU number 433-460-1), Acetamiprid (CAS number 135410-20-7/160430-64-8).

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