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Environment Protection Act (Cap. 435) Water Policy Framework (Amendment) Regulations, 2011 (L.N. 16 Of 2011 )

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Scope.

Amends use of the term “Annex” in the principal regulations.

Amends regulation

4 of the principal regulations.

ENVIRONMENT PROTECTION ACT (CAP. 435)Water Policy Framework (Amendment) Regulations, 2011

IN exercise of the powers conferred by article 28(1) of the Malta Resources Authority Act, and by articles 6, 9, 11 and 23 of the Environment Protection Act, the Prime Minister and the Minister for Resources and Rural Affairs, after consultation with the Malta Resources Authority and the Malta Environment and Planning Authority, have made the following regulations:-

( 2 ) T h e s e r e g u l a t i o n s a l s o e s t a b l i s h m i n i m u m performance criteria for methods of analysis to be applied by the competent authority when monitoring water status, sediment and biota, as well as rules for demonstrating the quality of analytical results, by transposing 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.

“(9) The competent authority shall not be in breach of its obligations under these regulations as a result of any excess of an EQS in coastal waters, if it can demonstrate that:
(a) the excess was due to a source of pollution outside its national jurisdiction;
(b) it was unable as a result of such transboundary pollution to take effective measures to comply with the relevant EQS;
(c) it had applied the coordination mechanisms set out in relevant international agreements and, as appropriate, taken advantage of the provisions of sub- regulations (4), (5) and (6) of this regulation, for those water bodies affected by transboundary pollution; and
(d) in the circumstances set out in point (a) above, the competent authority shall communicate a summary of the measures taken in relation to transboundary pollution in the relevant water catchment management plans as laid down in sub-regulation (3) of regulation 12 of these regulations.”

“(3) The competent authority shall adhere to technical s p e c i fi c a t i o n s a n d s t a n d a r d i s e d m e t h o d s f o r a n a l y s i s and monitoring of water status in accordance with the requirements of Schedules V and XI.”.

1. The competent authority shall establish an inventory, including maps, if available, of emissions, discharges and losses of all priority substances and pollutants listed in Part A, Table 1 of Schedule IX on the basis of the information collected in accordance with regulation 5 and regulation 8 of these regulations, the European Pollutant Release and Transfer Register Reporting Obligations Regulations, 2007 (L.N. 152 of 2007

), environmental permits and/or operational
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Amends regulation

8 of the principal regulations.

Amends Schedule II to the principal regulations.

B 352

Amends Schedule VII to the principal regulations.

Amends Schedule IX to the principal regulations.

permits as issued by the relevant competent authority and other available data, for the water catchment district lying within the Maltese territory, including their concentrations in sediment and biota, as appropriate. In fulfilling the requirement to establish and maintain the inventory of emissions, discharges and losses, the competent authority may request any further information it deems necessary from any relevant installation.
2. The reference period for the estimation of pollutant values to be entered in the inventories referred to in point (1) above shall be one year between 2008 and 2010. However, for priority substances or pollutants covered by the Plant Protection Products Regulations,
2004 (L.N. 115 of 2004

), the entries may be calculated as the average of the years 2008, 2009 and 2010.
3. The inventories shall be updated as part of the reviews of the analyses specified in sub-regulation (2) of regulation 5 of these regulations. The reference period for the establishment of values in the updated inventories shall be the year before that analysis is to be completed. For priority substances or pollutants covered by Plant Protection Products Regulations, 2004, the entries may be calculated as the average of the three years before the completion of that analysis. The updated inventories shall be published in the updated water catchment management plans as laid down in sub-regulation (5) of regulation 12 of these regulations.”.

“5. a description of the designation of any mixing zones, a communication of the measures in relation to transboundary pollution and the updated inventory of emissions, discharges and losses.”.

(a) for the first paragraph thereof, there shall be
substituted the following:

“ T h e ‘ l i m i t v a l u e s ’ e s t a b l i s h e d u n d e r t h e regulations following the Pollution Caused by Certain Dangerous Substances Discharged into the Aquatic Environment Regulations, 2001 (L.N. 213 of 2001

) shall be considered emission limit values for the purposes of these regulations. They are established in the following regulations:”; and
(b) immediately at the end of the said Schedule there shall be added the following new provisions:

, L.N. 221 of2001, L.N. 219 of 2001

, L.N. 218 of 2001

and L.N. 227 of 2001

:

1. Annex II of L.N. 220 of 2001

, L.N. 221 of 2001

, L.N. 219 of 2001

and L.N. 218 of 2001

, respectively shall be deleted.
2. Heading B in Sections I to XI of Annex II
to L.N. 227 of 2001

shall be deleted.

1. The competent authority shall apply the EQS laid down in Part A of Table 1 below to bodies of surface waters in Malta and Gozo, in accordance with the requirements laid down in Part B of Table
1 below.
2. The following EQS for biota shall apply instead of those laid down in Part A of Table 1 in certain categories of surface water:
(a) mercury and its compounds an
EQS of 20 μg/kg applies;
(b) hexachlorobenzene an EQS of 10
μg/kg applies;
(c) hexachlorobutadiene an EQS of 55
μg/kg applies.
These EQS are applicable for prey tissue
(wet weight), choosing the most appropriate
B 353

B 354
indicator among fish, molluscs, crustaceans
and other biota.
3 . E Q S o t h e r t h a n t h o s e m e n t i o n e d i n point (2) above may be applied by the competent authority for sediment and/or biota for specified substances. These EQS shall offer at least the same level of protection as the EQS for water set out in Part A of Table 1.
4 . F o r s u b s t a n c e s m e n t i o n e d i n p o i n t s (2) and (3) above, the competent authority shall determine the frequency of monitoring in biota and/or sediment. However the competent authority shall undertake monitoring at least once every year, unless technical knowledge and expert judgment justify another interval. The competent authority shall apply its technical knowledge and expert judgment to justify the reasons and basis for using the methodologies in points (2) and (3).

1. The competent authority shall arrange for the long-term trend analysis of concentrations of those priority substances listed in Part A of Table 1 that tend to accumulate in sediment and/or biota, giving particular consideration to substances numbers 2, 5, 6, 7, 12, 15, 16, 17, 18, 20, 21, 26,
28 and 30 on the basis of the monitoring of water status carried out in accordance with regulation 8 of these regulations.
2. Measures shall be taken by the competent authority aimed at ensuring, subject to regulation 4 of these regulations that such concentrations do not significantly increase in sediment and/or relevant biota.
3. The competent authority shall determine the frequency of monitoring in sediments and/or biota so as to provide sufficient data for a reliable long-term trend analysis. Monitoring should take place every three years, unless technical knowledge and expert judgment justify another interval.

1. Adjacent to the points of discharge, the competent authority may designate mixing zones where the concentrations of one or more substances listed in Part A of Table 1 may exceed the relevant EQS within such mixing zones and provided they do not affect the compliance of the rest of the body of surface water with those standards.
2 . I f m i x i n g z o n e s a r e d e s i g n a t e d , t h e water catchment management plans as required by regulation 12 of these regulations, shall include a description of:
(a) the approaches and methodologies
applied to define such zones; and
(b) measures taken with a view to reducing the extent of the mixing zones in the future, such as those pursuant to sub-regulation (3k) of regulation 11 of these regulations or by reviewing permits referred to in the Integrated Pollution Prevention and Control Regulations,
2002 (L.N. 234 of 2002

) or prior regulations referred to in sub-regulation (3g) of regulation
11 of these regulations.
3. The competent authority shall ensure that the extent of any designated mixing zone is:
(a) restricted to the proximity of the point of discharge;
(b) proportionate, having regard to the concentrations of pollutants at the point of discharge and to the conditions on emissions of pollutants contained in the prior regulations, such as authorizations and/or permits, referred to in sub-regulation (3g) of regulation 11 of these regulations and any other relevant national law, in accordance with the application of best available techniques and regulation 10 of these regulations, in particular after those prior regulations are reviewed.
B 355

B 356

Table 1:

Environmental Quality Standards for Priority Substances and Certain Other

Pollutants

PART A: ENVIRONMENTAL QUALITY STANDARDS (EQS) AA: annual average

MAC: maximum allowable concentration

Unit: [g/l]

B 357

0,01 ( )

0,1 ( )

0,05 ( )

B 358

(1) CAS: Chemical Abstracts Service.

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

(3) Inland surface waters refer to all standing or flowing waters on the surface of the land and related artificial or heavily modified water bodies.

(4) Other surface waters refer to transitional waters, coastal waters, territorial waters and related artificial or heavily modified water bodies.

(5) 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.

(6) For the group of priority substances covered by brominated diphenylethers (No 5) listed in Decision No 2455/2001/EC, an EQS is established only for congener numbers 28, 47, 99, 100, 153 and 154.

(7) For cadmium and its compounds (No 6) the EQS values vary depending on the hardness of the water as specified in five class categories (Class 1: < 40 mg CaCO3/l, Class 2: 40 to < 50 mg

CaCO3/l, Class 3: 50 to < 100 mg CaCO3/l, Class 4: 100 to < 200 mg CaCO3/l and Class 5:  200 mg

CaCO3/l).

(8) This substance is not a priority substance but one of the other pollutants for which the EQS are identical to those laid down in the legislation that applied prior to 13 January 2009.

(9) DDT total comprises the sum of the isomers 1,1,1-trichloro-2,2 bis (p-chlorophenyl) ethane (CAS number 50-29-3; EU number 200-024-3); 1,1,1-trichloro-2 (o-chlorophenyl)-2-(p- chlorophenyl) ethane (CAS number 789-02-6; EU number 212-332-5); 1,1-dichloro-2,2 bis (p- chlorophenyl) ethylene (CAS number 72-55-9; EU number 200-784-6); and 1,1-dichloro-2,2 bis (p- chlorophenyl) ethane (CAS number 72-54-8; EU number 200-783-0).

(10) For certain categories of surface water, if the competent authority does not apply EQS for biota, stricter EQS for water shall be introduced in these categories of surface water; in order to achieve the same level of protection as the EQS for biota set out in the section above ‘Environmental Quality Standards’, point (2). The competent authority shall notify the Commission and the Member States, through the Committee referred to in Article 21 of Directive 2000/60/EC, of the reasons and basis

for using this approach, the alternative EQS for water established, including the data and the methodology by which the alternative EQS were derived, and the categories of surface water to which they would apply.

(11) For the group of priority substances of polyaromatic hydrocarbons (PAH) (No 28), each individual EQS is applicable, i.e. the EQS for Benzo(a)pyrene, the EQS for the sum of Benzo(b)fluoranthene and Benzo(k)fluoranthene and the EQS for the sum of Benzo(g,h,i)perylene and Indeno(1,2,3-cd)pyrene must be met.

B 359

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

1. Columns 4 and 5 of the table: 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 these regulations.

2. Columns 6 and 7 of the table: 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 Schedule V to these regulations, the competent authority 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. If it does so, such statistical methods shall comply with detailed rules laid down in accordance with the regulatory procedure referred to in Article 9(2) of Directive 2008/105/EC.

3. With the exception of cadmium, lead, mercury and nickel (hereinafter "metals") the EQS set up in this Schedule are expressed as total concentrations in the whole water sample. In the case of metals the EQS refers to the dissolved concentration, i.e. the dissolved phase of a water sample obtained by filtration through a 0,45 m filter or any equivalent pre-treatment.

The competent authority may, when assessing the monitoring results against the EQS, take into account:

(a) natural background concentrations for metals and their compounds, if they prevent compliance with the EQS value; and

(b) hardness, pH or other water quality parameters that affect the bioavailability of metals.”.

Amends Schedule X to the principal regulations.

9. For Schedule X to the principal regulations there shall be substituted the following:

B 360

“Schedule X

B 361

(1) CAS: Chemical Abstracts Service.

(2) EU number: European Inventory of Existing Commercial Substances (Einecs) or European List of Notified Chemical Substances (Elincs).

(3) Where groups of substances have been selected, typical individual representatives are listed as indicative parameters (in brackets and without number). For these groups of substances, the indicative parameter must be defined through the analytical method.

(4) These groups of substances normally include a considerable number of individual compounds. At present, appropriate indicative parameters cannot be given.

(5) Only Pentabromobiphenylether (CAS-number 32534-81-9).

(6) Fluoranthene is on the list as an indicator of other, more dangerous polyaromatic hydrocarbons.”.

Adds new Schedule XI to the principal regulations.

10. Immediately after Schedule X to the principal regulations, there shall be added the following new Schedule:

“Schedule XI

TECHNICAL SPECIFICATIONS FOR CHEMICAL ANALYSIS AND MONITORING OF WATER STATUS

A: Definitions

For the purpose of these regulations, the following definitions shall apply:

1. ‘limit of detection’ means the output signal or concentration value above which it can be affirmed, with a stated level of confidence that a sample is different from a blank sample containing no determinand of interest;

2. ‘limit of quantification’ means a stated multiple of the limit of detection at a concentration of the determinand that can reasonably be determined with an acceptable level of accuracy and precision. The limit of quantification can be calculated using an appropriate standard or sample, and may be obtained from the lowest calibration point on the calibration curve, excluding the blank;

3. ‘uncertainty of measurement’ means a non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used.

B 362

B: Methods of analysis

The competent authority shall ensure that all methods of analysis, including laboratory, field and on-line methods, used for the purposes of chemical monitoring programmes carried out under these regulations are validated and documented in accordance with MSA EN ISO/IEC-17025: 2005 standard or other equivalent standards accepted at international level.

C: Minimum performance criteria for methods of analysis

1. The competent authority shall ensure that the minimum performance criteria for all methods of analysis applied are based on an uncertainty of measurement of 50 % or below (k = 2) estimated at the level of relevant environmental quality standards and a limit of quantification equal or below a value of 30 % of the relevant environmental quality standards.

2. In the absence of relevant environmental quality standard for a given parameter, or in the absence of method of analysis meeting the minimum performance criteria set out in point C(1) above, the competent authority shall ensure that monitoring is carried out using best available techniques not entailing excessive costs.

D: Calculation of mean values

1. Where the amounts of physico-chemical or chemical measurands in a given sample are below the limit of quantification, the measurement results shall be set to half of the value of the limit of quantification concerned for the calculation of mean values.

2. Where a calculated mean value of the measurement results referred to in D(1) above, is below the limits of quantification, the value shall be referred to as "less than limit of quantification".

3. Point D(1) shall not apply to measurands that are total sums of a given group of physico-chemical parameters or chemical measurands, including their relevant metabolites, degradation and reaction products. In those cases, results below the limit of quantification of the individual substances shall be set to zero.

E: Quality assurance and control

1. The competent authority shall ensure that laboratories or parties contracted by laboratories apply quality management system practices in accordance with MSA EN ISO/IEC-17025:2005 or other equivalent standards accepted at international level.

B 363

2. The competent authority shall ensure that laboratories or parties contracted by laboratories demonstrate their competences in analysing relevant physico- chemical or chemical measurands by:

(a) participation in proficiency testing programmes covering the methods of analysis referred to in ‘B: Methods of analysis’ of this Schedule of measurands at levels of concentrations that are representative of chemical monitoring programmes carried out under these regulations; and

(b) analysis of available reference materials that are representative of collected samples which contain appropriate levels of concentrations in relation to relevant environmental quality standards referred to in point C(1) of ‘C: Minimum performance criteria for methods of analysis’ as included in this Schedule.

3. The proficiency testing programmes referred to in point E(2a) above shall be organised by accredited organisations or internationally or nationally recognised organisations which meet the requirements of ISO/IEC guide 43-1 or of other equivalent standards accepted at international level.

The results of participation in those programmes shall be evaluated on the basis of the scoring systems set out in ISO/IEC guide 43-1 or in the ISO-

13528 standard or in other equivalent standards accepted at international level.

F: Coming into effect of this schedule

The competent authority shall adhere to the technical specifications and standardised methods for analysis and monitoring of water status, as per requirements in this Schedule XI, at the latest 7 years from the publication of these regulations.”.

B 364