P7_TA(2013)0068

Radioactive substances in water intended for human consumption ***I

European Parliament legislative resolution of 12 March 2013 on the proposal for a Council directive laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (COM(2012)0147 — C7-0105/2012 — 2012/0074(COD))

(Ordinary legislative procedure: first reading)

(2016/C 036/32)

The European Parliament,

having regard to Articles 31 and 32 of the Treaty establishing the European Atomic Energy Community, pursuant to which the Council consulted Parliament (C7-0105/2012),

having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

having regard to Article 294(3) and Article 192(1) of the Treaty on the Functioning of the European Union,

having regard to the opinion of the European Economic and Social Committee of 23 May 2012 (1) ,

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Industry, Research and Energy (A7-0033/2013),

Calls on the Commission to alter its proposal accordingly, pursuant to Article 293(2) of the Treaty on the Functioning of the European Union;

Instructs its President to forward its position to the Council and the Commission.

(1) OJ C 229, 31.7.2012, p. 145.

P7_TC1-COD(2012)0074

Position of the European Parliament adopted at first reading on 12 March 2013 with a view to the adoption of Council Directive 2013/…/EU of the European Parliament and of the Council laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption and amending Council Directive 98/83/EC [Am. 1]

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof on the Functioning of the European Union, and in particular Article 192(1) thereof ,

Having regard to the proposal from the European Commissiondrawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States, in accordance with Article 31 of the Treaty,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the European Parliament Acting in accordance with the ordinary legislative procedure (2), [Am. 2]

Whereas:

(-1) In accordance with Article 191 of the Treaty on the Functioning of the European Union (TFEU), Union policy on the environment should be based on the principles of precaution and preventive action and help to achieve objectives such as preserving, protecting and improving the quality of the environment and protecting human health. [Am. 3]

(1) The ingestion of water is one of the pathways of incorporation of radioactive harmful substances into the human body. Ingestion of radioactive isotopes or radionuclides can lead to a number of health problems. In accordance with Council Directive 96/29/Euratom (3), the contribution to the exposure of the population as a whole , taking into account long-term cumulative exposure, from practices which involve a risk from ionizing radiation must be kept as low as reasonably achievable possible . [Am. 4]

(1a) Filtering out radioactive isotopes from water leads to filters becoming radioactive waste that must then be disposed of with caution and in accordance with the procedures in force. [Am. 5]

(1b) The process of removal of radioactive isotopes from water depends on national laboratories, regular update of measurements and research. [Am. 6]

(1c) The information provided by the Member States in the triennial report on the Drinking Water Directive is incomplete or missing with regard to levels of radioactivity in drinking water. [Am. 7]

(1d) In order to reduce the costs of treating drinking water, preventive measures are necessary. [Am. 8]

(2) In view of the importance for human In order to ensure a high level of public health of the quality of water intended for human consumption protection , it is necessary to lay down at Community level common quality standards which have for water intended for human consumption serving an indicator function and to provide for the monitoring of the compliance with those standards. [Am. 9]

(3) Indicator parameters have already been set out in Annex I, Part C relating to radioactive substances, as well as the related monitoring provisions in Annex II to Council Directive 98/83/EC (4). However, those parameters fall within the scope of the basic standards defined in Article 30 of the Euratom Treaty. [Am. 10]

(3a) The parametric values are based on the scientific knowledge available, taking into account the precautionary principle. Those values have been selected to ensure that water intended for human consumption can be consumed safely on a life-long basis, taking as a reference citizens who are most vulnerable, and thus to also ensure a high level of health protection. [Am. 11]

(4) The requirements for monitoring levels of radioactivity in water intended for human consumption should therefore be adopted in specific correlated with the requirements laid down in existing legislation that ensures the for other chemical substances found in water, which have a detrimental effect on the environment and on human health. This measure would ensure the uniformity, coherence and completeness of radiation human health and environmental protection legislation under the Euratom TFEU . [Am. 12]

(5) The provisions of This Directive adopted under the Euratom Treaty updates the indicator parameters set out in Part C of Annex I to should supersede those of the Directive 98/83/EC as regards the contamination of , and lays down rules on the monitoring of the presence of radioactive substances in drinking water by radioactive substances. [Am. 13]

(6) In the event of non-compliance with a parameter that has an indicator function, the Member State concerned should assess whether that non-compliance poses any be required to determine the cause thereof, to assess the level of the risk to human health, including in the long-term, and the possibilities for intervention and, where necessary, take remedial action to restore to ensure that the water supply complies with the quality of the water criteria laid down in this Directive as soon as possible . This necessary remedial action may go as far as shutting down the facility concerned if the quality of water requires such action. Priority should be given to action which rectifies the problem at source. Consumers should be informed immediately of the risks, the measures already taken by the authorities and the time necessary for the remedial action to take effect . [Am. 14]

(7) Consumers should be adequately fully and appropriately informed of the quality of water intended for human consumption via easily accessible publications. Updated information regarding areas at risk from potential sources of radioactive contamination, as well as regional water quality, shall be made available to consumers at all times by local administrations . [Am. 15]

(7a) It is necessary to include in the scope of this Directive water used in the food industry. [Am. 16]

(8) It is necessary to exclude from the scope of this Directive natural mineral waters and waters which are medicinal products, since special rules for those types of water have been established in Directive 2009/54/EC of the European Parliament and of the Council (5) and Directive 2001/83/EC of the European Parliament and of the Council (6). However the Commission should, at the latest two years after entry into force of this Directive, present a proposal to revise Directive 2009/54/EC, in order to align the control requirements for natural mineral waters to the requirements set out in this Directive and in Directive 98/83/EC. The monitoring of waters put into bottles or containers intended for sale, other than natural mineral waters, for the purpose of checking that the levels of radioactive substances comply with the parametric values laid down in this Directive should be done in accordance with the principles of hazard analysis and critical control points (HACCP) as required by Regulation (EC) No 852/2004 of the European Parliament and of the Council (7). [Am. 17]

(9) Each Member State should establish robust monitoring programmes to check on a regular basis that water intended for human consumption meets the requirements of this Directive. [Am. 18]

(10) The methods used to analyse the quality of water intended for human consumption should be such as to ensure that the results obtained are reliable and comparable. Such monitoring programmes should be appropriate to local needs and should meet the minimum monitoring requirements laid down in this Directive. [Am. 19]

(10a) There is a need for natural radiation levels and contamination from human activities to be managed in a differentiated manner, on the basis of distinct dosimetric criteria. Member States must ensure that nuclear activities do not lead to a contamination of drinking water. [Am. 20]

(11) Commission Recommendation 2001/928/Euratom (8) deals with the radiological quality of drinking water supplies regarding radon and long-lived radon decay products, and it is appropriate to include these radionuclides in the scope of this Directive.

(11a) In order to ensure the coherence of European Water policy, the parametric values, frequencies and methods for monitoring radioactive substances in this Directive need to be compatible with the Directive 2006/118/EC of the European Parliament and of the Council (9) and Council Directive 98/83/EC. Furthermore, the Commission should ensure that when a review of Directive 2000/60/EC of the European Parliament and of the Council (10) and Directive 2006/118/EC takes place, reference to this Directive should be made in order to fully protect all types of water against contamination of radioactive substances, [Am. 21]

HAVE ADOPTED THIS DIRECTIVE:

Article1

Subject matter

This Directive lays down concerns harmonised requirements for the protection of in respect of the quality of water intended for human consumption, with the aim of safeguarding the health of the general public with regard to radioactive substances in water intended for human consumption. It sets out parametric values, frequencies and methods for monitoring against the adverse effects of the contamination of such water by radioactive substances. [Am. 22]

Article 2

Definitions

For the purposes of this Directive, the definitions laid down in Article 2 of Directive 98/83/EC shall apply.

In addition to the definitions referred to in paragraph 1, the following definitions shall apply:

(1) ‘radioactive substance’ means any substance that contains one or more radionuclides, the activity or concentration of which cannot be disregarded as far as radiation protection is concerned;

(2) ‘total indicative dose’(TID) means the committed effective dose for one year of ingestion resulting from all the radionuclides whose presence in water supply has been detected, either of natural or of artificial origin, excluding potassium-40, radon and short-lived radon decay products;

(3) ‘parametric value’ means the value with which water intended for human consumption shall comply. If a parametric value is exceeded, Member States shall assess the level of risk associated with the presence of radioactive substances and, based on the results of this assessment, shall take immediate remedial action to ensure compliance with the requirements laid down in this Directive. [Am. 23]

Article 3

Scope

This Directive shall apply to water intended for human consumption, as defined in Article 2 of Directive 98/83/EC, with the exemptions set out in Article 3(1) of that Directive and laid down in accordance with Article 3(2) thereof. [Am. 24]

Article 4

General obligations

Without prejudice to the provisions laid down in Article 6(3)a of Directive 96/29/Euratom, Member States shall take all measures necessary to establish an appropriate monitoring programme to ensure that water intended for human consumption complies with the parametric values established in accordance with this Directive. A guide to best practices shall be provided by the Commission to the Member States.

Member States shall ensure that the measures taken to implement this Directive do not, under any circumstances, have the effect of allowing, either directly or indirectly, any deterioration in the present quality of water intended for human consumption or any increase in the pollution of waters used for the production of drinking water. [Am. 25]

New technologies shall be developed which minimise the time needed to isolate nuclear waste from the environment following a natural disaster. [Am. 26]

Member States shall take all measures necessary to ensure that radioactive waste from filtered drinking water is disposed of according to the provisions in force. The Commission shall provide guidelines on this process to the Member States. [Am. 27]

Member States shall carry out risk assessments of radioactive waste deposits that could have an impact on ground water or other sources of drinking water or that could be endangered by natural disasters. [Am. 28]

The Commission shall carry out a study on the ‘cocktail effects’ of other chemical substances combined with radioactive substances in water intended for human consumption.Based on the results of that study the Commission shall update the relevant legislation. [Am. 29]

The Commission shall carry out an evaluation of the implementation of Directive 2000/60/EC in the Member States. [Am. 30]

Article 5

Parametric values

Member States shall set parametric values applicable for the monitoring of radioactive substances in water intended for human consumption in accordance with Annex I; for water put into bottles or containers intended for sale this shall be without prejudice to the principles of hazard analysis and critical control points (HACCP) as required by Regulation (EC) No 852/2004.

Article 6

Monitoring

Member States shall ensure regular and accurate monitoring of water intended for human consumption in accordance with Annex II in order to check that the concentrations of radioactive substances do not exceed the parametric values laid down in accordance with Article 5. Monitoring shall take account of the long-term cumulative exposure of the population and shall be conducted as part of the checks referred to in Article 7 of Directive 98/83/EC on the quality of drinking water intended for human consumption. It shall include reference analyses aimed at establishing the radioactive content of the water and optimising the analysis strategy and periodic analyses in accordance with the methods set out in Annex III. The monitoring frequency for periodic analyses may be adapted through a risk-based approach, based on the results of reference analyses which shall be mandatory in all cases. In such cases, Member States shall communicate both the grounds for their decision and the results of the reference analyses concerned to the Commission and make them available to the public. [Am. 31]

Article 7

Sampling locations

Member States may take samples:

(a) in the case of water supplied from a distribution network, at the point within the supply zone or at the treatment works if it can be demonstrated that such sampling gives the same or higher measured value of the parameters concerned;

(b) in the case of water supplied from a tanker, at the point at which it emerges from the tanker;

(c) in the case of water put into bottles or containers intended for sale, at the point at which the waer is put into the bottles or containers;

(d) in the case of water used in a food-production undertaking, at the point where the water is used in the undertaking.

Article 8

Sampling and analysis

1. Samples representative of the quality of the water consumed throughout the year shall be taken and analysed in accordance with the methods set out in Annex III.

2. Member States shall ensure that all laboratories analysing samples of water intended for human consumption have a system of analytical quality control. They shall ensure that that system is subject to occasional random checks , at least once a year, by an independent controller approved by the competent authority for that purpose. [Am. 32]

2a. The financing of the monitoring measures shall be effected in accordance with Chapter IV of Regulation (EC) No 882/2004 of the European Parliament and of the Council (11) . In the case of pollution arising from human activities, these costs shall be borne by the polluter. [Am. 33]

Article 9

Remedial action and notification of consumers

1. Member States shall ensure that any failure to comply with the parametric values laid down in accordance with Article 5 is immediately investigated in order to identify its cause.

1a. Information on the risk assessment of nuclear plants and the surrounding areas, as regards radioactive substances in the water shall be made available to the public. [Am. 34]

1b. Member States shall ensure that information regarding the presence of radioactive substances in water intended for human consumption is included in the triennial report on the quality of water referred to in Article 13(2) of Directive 98/83/EC. [Am. 35]

2. Where there is a failure to comply with the parametric values laid down in accordance with Article 5 occurs defined for radon and for the TID from natural sources , the Member State concerned shall immediately assess whether the failure poses a the level of the risk to human health. In the event that there is such a risk, and the possibilities for intervention, taking into account the local conditions. On the basis of these findings, the Member State shall take remedial action to restore ensure that the water supply complies with the quality of the water criteria laid down in this Directive .

2a. Where there is a failure to comply with the parametric values defined for tritium and for the TID originating from human activities, the Member State concerned shall ensure that the investigation which is to be launched immediately establishes the nature, scale and dosimetric impact of the pollution. That investigation shall take into account all the environments liable to be affected and all exposure pathways. The Member State concerned shall ensure that the necessary corrective action is taken to ensure that the water again meets the parametric values. Solutions should be centred on tackling the pollution at source. The necessary remedial action may go as far as shutting down the facility concerned if the water quality requires such action. The Member State concerned shall ensure that the costs of remedial action are borne by the polluter. [Am. 36]

3. Member States shall ensure that the results of the analyses performed pursuant to Article 8 are published, made publicly available as soon as possible and included in the reports referred to in Article 13 of Directive 98/83/EC. Where the risk to human health cannot be regarded as trivial, the Member State , together with the responsible actor or actors, shall ensure that consumers are notified alerted immediately and given complete information related to the risk to human health and on how to cope with the problems encountered, which shall be published and made available on the internet as soon as possible. They shall also ensure that alternative uncontaminated water supplies are provided without delay . [Am. 37]

Article 9a

Amendments to Directive 98/83/EC

Directive 98/83/EC is amended as follows:

(1) The ‘Radioactivity’ section of Part C of Annex I is deleted.

(2) The last two sentences of paragraph 2, Table (A) of Annex II are deleted. [Am. 38]

Article 9b

Review of the Annexes

1. At least every five years, the Commission shall review the annexes in the light of scientific and technical progress. It shall be empowered to adopt delegated acts in accordance with Article 9c to adapt the annexes to reflect such progress.

2. The Commission shall make public its reasons for deciding whether or not to adapt the annexes, making reference to the scientific reports considered. [Am. 39]

Article 9c

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt the delegated acts referred to in Article 9b shall be conferred on the Commission for a period of five years from …. (12) The Commission shall draw up a report in respect of the delegated power, not later than nine months before the end of the five-year period. The delegation of powers shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of powers referred to in Article 9b may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. A delegated act adopted pursuant to Article 9b shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. [Am. 40]

Article 9d

Information and reporting

1. Member States shall take the measures necessary to ensure that adequate and up-to-date information on the quality of water intended for human consumption is available to consumers and not only when a risk to human health cannot be regarded as trivial.

2. Each Member State with water systems located in areas that have potential sources of radioactive contamination — man-made or natural — shall include information on the concentrations of radioactive substances in water intended for human consumption in their triennial report on the quality of water intended for human consumption, as referred to in Article 13 of Directive 98/83/EC.

3. The Commission shall include in its report on the quality of water intended for human consumption in the Community, as referred to in Article 13 of Directive 98/83/EC, the findings of the Member States on radioactive substances in water intended for human consumption. [Am. 41]

Article 10

Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [one year after the date referred to in Article 11- specific date to be inserted by the Publications Office] … (13) at the latest. They shall forthwith communicate to the Commission the text of those provisions. [Am. 42]

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.

Article 11

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 12

Addressees

This Directive is addressed to the Member States.

Done at, For the European Parliament The President For the Council The President

(1) OJ C , , p. OJ C 229, 31.7.2012, p. 145.

(2) Position of the European Parliament of 12 March 2013.

(3) Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 1).

(4) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).

(5) Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (OJ L 164, 26.6.2009, p. 45).

(6) 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).

(7) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

(8) Commission Recommendation 2001/928/Euratom of 20 December 2001 on the protection of the public against exposure to radon in drinking water supplies (OJ L 344, 28.12.2001, p. 85).

(9) Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19).

(10) 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).

(11) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

(12) Date of entry into force of this Directive.

(13) Two years after the entry into force of this directive.

ANNEX I Parametric values for radon and tritium and parametric values for Total Indicative Dose, for other radioactive substances, in water intended for human consumption Radioactivity Parameter Parametric value Unit Notes Radon 222 Rn 100 20 Bq/l Tritium 100 20 Bq/l Total indicative dose (from natural sources) 0,10 mSv/year (Note 1) Total indicative dose (from human activity sources) 0,01 mSv/year Note 1: Excluding tritium, potassium - 40, radon and short-lived radon decay products [Am. 43]

ANNEX II Monitoring of radioactive substances 1. General principles and monitoring frequencies A Member State is not required to monitor drinking water for tritium or radioactivity to establish and radon with a view to establishing the total indicative dose (TID) where it is satisfied on the basis of other monitoring that the levels of both tritium and of the calculated total indicative dose are well below the parametric value. Monitoring drinking water for radon is not required where a Member State is satisfied on the basis of other monitoring that the levels of radon are well below the parametric value. In these cases, it shall communicate the grounds for its decision to the Commission, including the results of the other monitoring carried out for natural radioactivity and radioactivity attributable to human activities . Monitoring shall include reference analyses and periodic analyses. The reference analyses must be conducted as part of the examination of the application for authorisation to distribute drinking water. In the case of already-operating distribution networks, Member States shall set the deadlines within which the analyses must be conducted, on the basis of the volumes of water distributed and the level of potential risk, both for natural radioactivity and the radiological impact of human activities. The reference analyses must enable all the relevant natural and artificial radionuclides to be investigated and quantified. In the case of natural radiation, the activity of at least the following 9 radionuclides must be quantified: uranium 238, uranium 234, radium 226, radon 222, lead 210, polonium 210, radium 228 (if necessary via its immediate descendant direct, actinium 228), actinium 227 (if necessary via its immediate descendant thorium 227). In the case of the impact of human activities, potential sources of contamination must be investigated, and a list drawn up of the radionuclides to be checked on the basis of that research. Besides the specific checks arising from the investigations, all reference analyses must include measurement of tritium, carbon 14, strontium 90 and plutonium isotope levels, as well as a gamma spectrometry test to assess the activity levels of the main artificial radionuclides emitting gamma rays (including cobalt 60, iodine 131, caesium 134, caesium 137 and americium 241). The result of the reference analyses should be used to establish the analysis strategy to be implemented during monitoring periods. Subject to the outcome of the reference analyses, as a result of which the system may be reinforced, the periodic checks shall be conducted at the audit frequency indicated in point 4. [Am. 44] 2. Radon and Tritium Monitoring of drinking water for radon or tritium shall be carried out where a source of radon or tritium is present within the catchment and it cannot be shown on the basis of other surveillance programmes or investigations that the level of radon or tritium is well below its parametric indicator value 100 Bq/l. Where monitoring for radon or tritium is required, it shall be carried out at the audit frequency. 3. Total Indicative Dose Monitoring of drinking water for Total Indicative Dose (TID) shall be carried out where a source of artificial or enhanced natural radioactivity is present within the catchment and it cannot be shown on basis of other surveillance programmes or investigations that the level of TID is well below its parametric indicator value 0,1 mSv/year. Where monitoring for artificial radionuclide levels is required, it shall be carried out at the audit frequency indicated in the table. Where monitoring for natural radionuclide levels is required, Member States shall define the frequency of the monitoring having regard to all relevant information available on temporal variations of natural radionuclide levels in different types of waters. Depending on the expected variations, monitoring frequency may vary from a single check measurement to the audit frequency. Where only a single check for natural radioactivity is required, a re-check shall be required at least where any change occurs in relation to the supply likely to influence the concentrations of radionuclides in the drinking water. Where methods for removing radionuclides from drinking water have been applied in order to ensure that a parametric value is not exceeded, monitoring shall be carried out at the audit frequency. Where results of other surveillance programmes or investigations than those required as provided in the first paragraph of this point are used to ensure compliance with this Directive, the Member State shall communicate the grounds for its decision to the Commission, including the relevant results of these monitoring programmes or investigations. [Am. 45] 4. The audit frequency of monitoring shall be as set out in the following table: TABLE Audit frequency of monitoring for water intended for human consumption supplied from a distribution network Volume of water distributed or produced each day within a supply zone (Notes 1 and 2) m3 Number of samples per year (Notes 3) ≤ 100 (Note 4) > 100 ≤ 1 000 1 > 1 000 ≤ 10 000 1 + 1 for each 3 300 m3/d and part thereof of the total volume > 10 000 ≤ 100 000 3 + 1 for each 10 000 m3/d and part thereof of the total volume > 100 000 10 + 1 for each 25 000 m3/d and part thereof of the total volume Note 1: A supply zone is a geographically defined area within which water intended for human consumption comes from one or more sources and within which water quality may be considered as being approximately uniform. Note 2: The volumes are calculated as averages taken over a calendar year. A Member State may use the number of inhabitants in a supply zone instead of the volume of water to determine the minimum frequency, assuming a water consumption of 200 l/day/capita provided that the water in question is not sold or distributed outside the zone concerned . [Am. 46] Note 3: As far as possible, the number of samples should be distributed equally in time and location. Note 4: The frequency is to be decided by the Member State concerned.