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Dir 98.83.ec

Official Journal of the European Communities COUNCIL DIRECTIVE 98/83/EC
of 3 November 1998
on the quality of water intended for human consumption
THE COUNCIL OF THE EUROPEAN UNION, leaving Member States free to add otherparameters if they see fit; Having regard to the Treaty establishing the European (3) Whereas, in accordance with the principle of Community and, in particular, Article 130s(1) thereof, subsidiarity, Community action must support andsupplement action by the competent authorities inthe Member States; Having regard to the proposal from the Commission (1), (4) Whereas, in accordance with the principle of Having regard to the opinion of the Economic and Social subsidiarity, the natural and socio-economic differences between the regions of the Unionrequire that most decisions on monitoring,analysis, and the measures to be taken to redress Having regard to the opinion of the Committee of the failures be taken at a local, regional or national level insofar as those differences do not detractfrom the establishment of the framework of laws,regulations and administrative provisions laid Acting in accordance with the procedure laid down in down in this Directive; Article 189c (4), Whereas Community standards for essential and Whereas it is necessary to adapt Council Directive preventive health-related quality parameters in 80/778/EEC of 15 July 1980 relating to the quality water intended for human consumption are of water intended for human consumption (5) to necessary if minimum environmental-quality goals scientific and technological progress; whereas to be achieved in connection with other experience gained from implementing that Community measures are to be defined so that the Directive shows that it is necessary to create an sustainable use of water intended for human appropriately flexible and transparent legal consumption may be safeguarded and promoted; framework for Member States to address failuresto meet the standards; whereas, furthermore, thatDirective should be re-examined in the light of theTreaty on European Union and in particular the Whereas, in view of the importance of the quality principle of subsidiarity; of water intended for human consumption forhuman health, it is necessary to lay down atCommunity level the essential quality standardswith which water intended for that purpose must Whereas in keeping with Article 3b of the Treaty, which provides that no Community action shouldgo beyond what is necessary to achieve theobjectives of the Treaty, it is necessary to reviseDirective 80/778/EEC so as to focus on compliance Whereas it is necessary to include water used in the with essential quality and health parameters, food industry unless it can be established that theuse of such water does not affect thewholesomeness of the finished product; (1) OJ C 131, 30.5.1995, p. 5 and OJ C 213, 15.7.1997, p. 8.
(2) OJ C 82, 19.3.1996, p. 64.
(3) OJ C 100, 2.4.1996, p. 134.
(8) Whereas to enable water-supply undertakings to (4) Opinion of the European Parliament of 12 December 1996 meet the quality standards for drinking water, (OJ C 20, 20.1.1997, p. 133), Council common position of appropriate water-protection measures should be 19 December 1997 (OJ C 91, 26.3.1998, p. 1) and Decisionof the European Parliament of 13 May 1998 (OJ C 167, applied to ensure that surface and groundwater is 1.6.1998, p. 92).
kept clean; whereas the same goal can be achieved (5) OJ L 229, 30.8.1980, p. 11. Directive as last amended by the by appropriate water-treatment measures to be 1994 Act of Accession.
applied before supply; Official Journal of the European Communities Whereas the coherence of European water policy (16) Whereas in particular the standards in Annex I are presupposes that a suitable water framework generally based on the World Health Directive will be adopted in due course; Organisation's ‘Guidelines for drinking waterquality', and the opinion of the Commission'sScientific Advisory Committee to examine the (10) Whereas it is necessary to exclude from the scope toxicity and ecotoxicity of chemical compounds; of this Directive natural mineral waters and waterswhich are medicinal products, since special rulesfor those types of water have been established; (17) Whereas Member States must set values for other additional parameters not included in Annex Iwhere that is necessary to protect human healthwithin their territories; (11) Whereas measures are required for all parameters directly relevant to health and for other parametersif a deterioration in quality has occurred; whereas, (18) Whereas Member States may set values for other furthermore, such measures should be carefully additional parameters not included in Annex I coordinated with the implementation of Council where that is deemed necessary for the purpose of Directive 91/414/EEC of 15 July 1991 concerning ensuring the quality of the production, distribution the placing of plant protection products on the and inspection of water intended for human market (1) and Directive 98/8/EC of the European Parliament and of the Council of 16 February1998 concerning the placing of biocidal productson the market (2); (19) Whereas, when Member States deem it necessary to adopt standards more stringent than those setout in Annex I, Parts A and B, or standards for (12) Whereas it is necessary to set individual parametric additional parameters not included in Annex I but values for substances which are important necessary to protect human health, they must throughout the Community at a level strict enough notify the Commission of those standards; to ensure that this Directive's purpose can beachieved; (20) Whereas Member States are bound, when introducing or maintaining more stringentprotection measures, to respect the principles and (13) Whereas the parametric values are based on the rules of the Treaty, as they are interpreted by the scientific knowledge available and the Court of Justice; precautionary principle has also been taken intoaccount; whereas those values have been selectedto ensure that water intended for human (21) Whereas the parametric values are to be complied consumption can be consumed safely on a life-long with at the point where water intended for human basis, and thus represent a high level of health consumption is made available to the appropriate (14) Whereas a balance should be struck to prevent (22) Whereas the quality of water intended for human both microbiological and chemical risks; whereas, consumption can be influenced by the domestic to that end, and in the light of a future review of distribution system; whereas, furthermore, it is the parametric values, the establishment of recognised that neither the domestic distribution parametric values applicable to water intended for system nor its maintenance may be the human consumption should be based on responsibility of the Member States; public-health considerations and on a method ofassessing risk; (23) Whereas each Member State should establish monitoring programmes to check that waterintended for human consumption meets the (15) Whereas there is at present insufficient evidence on requirements of this Directive; whereas such which to base parametric values for monitoring programmes should be appropriate to endocrine-disrupting chemicals at Community local needs and should meet the minimum level, yet there is increasing concern regarding the monitoring requirements laid down in this potential impact on humans and wildlife of the effects of substances harmful to health; (1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by (24) Whereas the methods used to analyse the quality Commission Directive 96/68/EC (OJ L 277, 30.10.1996, p.
of water intended for human consumption should be such as to ensure that the results obtained are (2) OJ L 123, 24.4.1998, p. 1.
reliable and comparable; Official Journal of the European Communities (25) Whereas, in the event of non-compliance with the intended for human consumption, of any standards imposed by this Directive the Member derogations granted by the Member States and of State concerned should investigate the cause and any remedial action taken by the competent ensure that the necessary remedial action is taken authorities; whereas, furthermore, consideration as soon as possible to restore the quality of the should be given both to the technical and statistical needs of the Commission, and to the rights of theindividual to obtain adequate informationconcerning the quality of water intended for (26) Whereas it is important to prevent contaminated human consumption; water causing a potential danger to human health;whereas the supply of such water should beprohibited or its use restricted; (33) Whereas, in exceptional circumstances and for geographically defined areas, it may be necessaryto allow Member States a more extensive timescale (27) Whereas, in the event of non-compliance with a for compliance with certain provisions of this parameter that has an indicator function, the Member State concerned must consider whetherthat non-compliance poses any risk to humanhealth; whereas it should take remedial action to (34) Whereas this Directive should not affect the restore the quality of the water where that is obligations of the Member States as to the time necessary to protect human health; limit for transposition into national law, or as toapplication, as shown in Annex IV, (28) Whereas, should such remedial action be necessary to restore the quality of water intended for humanconsumption, in accordance with Article 130r(2) of HAS ADOPTED THIS DIRECTIVE: the Treaty, priority should be given to actionwhich rectifies the problem at source; (29) Whereas Member States should be authorised, under certain conditions, to grant derogations from this Directive; whereas, furthermore, it is necessaryto establish a proper framework for suchderogations, provided that they must not constitute 1. This Directive concerns the quality of water intended a potential danger to human health and provided for human consumption.
that the supply of water intended for humanconsumption in the area concerned cannototherwise be maintained by any other reasonable 2. The objective of this Directive shall be to protect human health from the adverse effects of anycontamination of water intended for human consumptionby ensuring that it is wholesome and clean.
(30) Whereas, since the preparation or distribution of water intended for human consumption mayinvolve the use of certain substances or materials, rules are required to govern the use thereof inorder to avoid possible harmful effects on human For the purposes of this Directive: (31) Whereas scientific and technical progress may necessitate rapid adaptation of the technical 1. ‘water intended for human consumption' shall mean: requirements laid down in Annexes II and III; (a) all water either in its original state or after whereas, furthermore, in order to facilitate treatment, intended for drinking, cooking, food application of the measures required for that preparation or other domestic purposes, regardless purpose, provision should be made for a procedure of its origin and whether it is supplied from a under which the Commission can adopt such distribution network, from a tanker, or in bottles adaptations with the assistance of a committee composed of representatives of the MemberStates; (b) all water used in any food-production undertaking for the manufacture, processing, preservation ormarketing of products or substances intended for (32) Whereas consumers should be adequately and human consumption unless the competent appropriately informed of the quality of water national authorities are satisfied that the quality Official Journal of the European Communities of the water cannot affect the wholesomeness of when a potential danger to human health arising out of the foodstuff in its finished form; the quality of such water is apparent, the populationconcerned shall promptly be given appropriate advice.
2. ‘domestic distribution system' shall mean the pipework, fittings and appliances which are installedbetween the taps that are normally used for humanconsumption and the distribution network but only if they are not the responsibility of the water supplier,in its capacity as a water supplier, according to the relevant national law.
1. Without prejudice to their obligations under otherCommunity provisions, Member States shall take themeasures necessary to ensure that water intended for human consumption is wholesome and clean. For thepurposes of the minimum requirements of this Directive,water intended for human consumption shall be wholesome and clean if it: (a) is free from any micro-organisms and parasites and 1. This Directive shall not apply to: from any substances which, in numbers orconcentrations, constitute a potential danger to (a) natural mineral waters recognised as such by the human health, and competent national authorities, in accordance withCouncil Directive 80/777/EEC of 15 July 1980 on the (b) meets the minimum requirements set out in Annex I, approximation of the laws of the Member States relating to the exploitation and marketing of naturalmineral waters (1); and if, in accordance with the relevant provisions ofArticles 5 to 8 and 10 and in accordance with the Treaty, (b) waters which are medicinal products within the Member States take all other measures necessary to meaning of Council Directive 65/65/EEC of 26 ensure that water intended for human consumption January 1965 on the approximation of provisions laid complies with the requirements of this Directive.
down by law, regulation or administrative actionrelating to medicinal products (2).
2. Member States shall ensure that the measures takento implement this Directive in no circumstances have the 2. Member States may exempt from the provisions of effect of allowing, directly or indirectly, either any deterioration of the present quality of water intended forhuman consumption so far as that is relevant for theprotection of human health or any increase in the (a) water intended exclusively for those purposes for pollution of waters used for the production of drinking which the competent authorities are satisfied that the quality of the water has no influence, either directlyor indirectly, on the health of the consumersconcerned; (b) water intended for human consumption from an individual supply providing less than 10 m³ a day as an average or serving fewer than 50 persons, unlessthe water is supplied as part of a commercial orpublic activity.
1. Member States shall set values applicable to waterintended for human consumption for the parameters setout in Annex I.
3. Member States that have recourse to the exemptionsprovided for in paragraph 2(b) shall ensure that the 2. The values set in accordance with paragraph 1 shall population concerned is informed thereof and of any not be less stringent than those set out in Annex I. As action that can be taken to protect human health from regards the parameters set out in Annex I, Part C, the the adverse effects resulting from any contamination of values need be fixed only for monitoring purposes and water intended for human consumption. In addition, for the fulfilment of the obligations imposed in Article8.
(1) OJ L 229, 30.8.1980, p. 1. Directive as last amended by Directive 96/70/EC (OJ L 299, 23.11.1996, p. 26).
(2) OJ 22 9.2.1965, p. 369. Directive as last amended by 3. A Member State shall set values for additional Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
parameters not included in Annex I where the protection Official Journal of the European Communities of human health within its national territory or part of it so requires. The values set should, as a minimum, satisfythe requirements of Article 4(1)(a).
1. Member States shall take all measures necessary toensure that regular monitoring of the quality of water intended for human consumption is carried out, in orderto check that the water available to consumers meets the Point of compliance
requirements of this Directive and in particular theparametric values set in accordance with Article 5.
Samples should be taken so that they are representative 1. The parametric values set in accordance with Article of the quality of the water consumed throughout the 5 shall be complied with: year. In addition, Member States shall take all measuresnecessary to ensure that, where disinfection forms part of (a) in the case of water supplied from a distribution the preparation or distribution of water intended for network, at the point, within premises or an human consumption, the efficiency of the disinfection establishment, at which it emerges from the taps that treatment applied is verified, and that any contamination are normally used for human consumption; from disinfection by-products is kept as low as possiblewithout compromising the disinfection.
(b) in the case of water supplied from a tanker, at the point at which it emerges from the tanker; 2. To meet the obligations imposed in paragraph 1, (c) in the case of water put into bottles or containers appropriate monitoring programmes shall be established intended for sale, at the point at which the water is by the competent authorities for all water intended for put into the bottles or containers; human consumption. Those monitoring programmesshall meet the minimum requirements set out in AnnexII.
(d) in the case of water used in a food-production undertaking, at the point where the water is used inthe undertaking.
3. The sampling points shall be determined by thecompetent authorities and shall meet the relevantrequirements set out in Annex II.
2. In the case of water covered by paragraph 1(a),Member States shall be deemed to have fulfilled theirobligations under this Article and under Articles 4 and 4. Community guidelines for the monitoring prescribed 8(2) where it can be established that non-compliance in this Article may be drawn up in accordance with the with the parametric values set in accordance with Article procedure laid down in Article 12.
5 is due to the domestic distribution system or themaintenance thereof except in premises andestablishments where water is supplied to the public, suchas schools, hospitals and restaurants.
Member States shall comply with thespecifications for the analyses of parameters setout in Annex III.
3. Where paragraph 2 applies and there is a risk that (b) Methods other than those specified in Annex III, water covered by paragraph 1(a) would not comply with Part 1, may be used, providing it can be the parametric values established in accordance with demonstrated that the results obtained are at least Article 5, Member States shall nevertheless ensure that: as reliable as those produced by the methodsspecified. Member States which have recourse to (a) appropriate measures are taken to reduce or eliminate alternative methods shall provide the Commission the risk of non-compliance with the parametric with all relevant information concerning such values, such as advising property owners of any methods and their equivalence.
possible remedial action they could take, and/or (c) For those parameters listed in Annex III, Parts 2 other measures, such as appropriate treatment and 3, any method of analysis may be used techniques, are taken to change the nature or provided that it meets the requirements set out properties of the water before it is supplied so as to reduce or eliminate the risk of the water notcomplying with the parametric values after supply; 6. Member States shall ensure that additionalmonitoring is carried out on a case-by-case basis of (b) the consumers concerned are duly informed and substances and micro-organisms for which no parametric advised of any possible additional remedial action value has been set in accordance with Article 5, if there is that they should take.
reason to suspect that they may be present in amounts or Official Journal of the European Communities numbers which constitute a potential danger to human 1. Member States may provide for derogations from the parametric values set out in Annex I, Part B, or set inaccordance with Article 5(3), up to a maximum value to Remedial action and restrictions in use
be determined by them, provided no derogationconstitutes a potential danger to human health andprovided that the supply of water intended for human 1. Member States shall ensure that any failure to meet consumption in the area concerned cannot otherwise be the parametric values set in accordance with Article 5 is maintained by any other reasonable means. Derogations immediately investigated in order to identify the cause.
shall be limited to as short a time as possible and shallnot exceed three years, towards the end of which areview shall be conducted to determine whether sufficient 2. If, despite the measures taken to meet the obligations progress has been made. Where a Member State intends imposed in Article 4(1), water intended for human to grant a second derogation, it shall communicate the consumption does not meet the parametric values set in review, along with the grounds for its decision on the accordance with Article 5, and subject to Article 6(2), the second derogation, to the Commission. No such second Member State concerned shall ensure that the necessary derogation shall exceed three years.
remedial action is taken as soon as possible to restore itsquality and shall give priority to their enforcement action,having regard inter alia to the extent to which the 2. In exceptional circumstances, a Member State may relevant parametric value has been exceeded and to the ask the Commission for a third derogation for a period potential danger to human health.
not exceeding three years. The Commission shall take adecision on any such request within three months.
3. Whether or not any failure to meet the parametricvalues has occurred, Member States shall ensure that any 3. Any derogation granted in accordance with supply of water intended for human consumption which paragraphs 1 or 2 shall specify the following: constitutes a potential danger to human health isprohibited or its use restricted or such other action is (a) the grounds for the derogation; taken as is necessary to protect human health. In suchcases consumers shall be informed promptly thereof and the parameter concerned, previous relevant given the necessary advice.
monitoring results, and the maximum permissiblevalue under the derogation; 4. The competent authorities or other relevant bodies (c) the geographical area, the quantity of water supplied shall decide what action under paragraph 3 should be each day, the population concerned and whether or taken, bearing in mind the risks to human health which not any relevant food-production undertaking would would be caused by an interruption of the supply or a restriction in the use of water intended for humanconsumption.
(d) an appropriate monitoring scheme, with an increased monitoring frequency where necessary; (e) a summary of the plan for the necessary remedial 5. Member States may establish guidelines to assist the action, including a timetable for the work and an competent authorities to fulfil their obligations under estimate of the cost and provisions for reviewing; paragraph 4.
(f) the required duration of the derogation.
6. In the event of non-compliance with the parametricvalues or with the specifications set out in Annex I, Part 4. If the competent authorities consider the C, Member States shall consider whether that non-compliance with the parametric value to be trivial, non-compliance poses any risk to human health. They and if action taken in accordance with Article 8(2) is shall take remedial action to restore the quality of the sufficient to remedy the problem within 30 days, the water where that is necessary to protect human health.
requirements of paragraph 3 need not be applied.
7. Member States shall ensure that, where remedial In that event, only the maximum permissible value for action is taken, consumers are notified except where the the parameter concerned and the time allowed to remedy competent authorities consider the non-compliance with the problem shall be set by the competent authorities or the parametric value to be trivial.
other relevant bodies.
Official Journal of the European Communities 5. Recourse may no longer be had to paragraph 4 if Article 11 failure to comply with any one parametric value for agiven water supply has occurred on more than 30 days Review of Annexes
on aggregate during the previous 12 months.
1. At least every five years, the Commission shall reviewAnnex I in the light of scientific and technical progress 6. Any Member State which has recourse to the and shall make proposals for amendments, where derogations provided for in this Article shall ensure that necessary, under the procedure laid down in Article 189c the population affected by any such derogation is of the Treaty.
promptly informed in an appropriate manner of thederogation and of the conditions governing it. In additionthe Member State shall, where necessary, ensure that 2. At least every five years, the Commission shall adapt advice is given to particular population groups for which Annexes II and III to scientific and technical progress.
the derogation could present a special risk.
Such changes as are necessary shall be adopted inaccordance with the procedure laid down in Article 12.
These obligations shall not apply in the circumstancesdescribed in paragraph 4 unless the competent authoritiesdecide otherwise.
Article 12 7. With the exception of derogations granted inaccordance with paragraph 4 a Member State shall 1. The Commission shall be assisted by a committee inform the Commission within two months of any composed of representatives of the Member States and derogation concerning an individual supply of water chaired by a Commission representative.
exceeding 1 000 m³ a day as an average or serving morethan 5 000 persons, including the information specified inparagraph 3.
2. The Commission representative shall submit to thecommittee a draft of the measures to be taken. Thecommittee shall deliver its opinion on the draft within atime limit which the chairman may lay down according 8. This Article shall not apply to water intended for to the urgency of the matter. The opinion shall be human consumption offered for sale in bottles or delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council isrequired to adopt on a proposal from the Commission.
The votes of the representatives of the Member Stateswithin the committee shall be weighted in the manner setout in that Article. The chairman shall not vote.
Article 10 Quality assurance of treatment, equipment and materials
3. The Commission shall adopt measures which shallapply immediately. However, if those measures are not inaccordance with the committee's opinion, the Member States shall take all measures necessary to ensure Commission shall communicate them to the Council that no substances or materials for new installations used forthwith. In that event: in the preparation or distribution of water intended forhuman consumption or impurities associated with such the Commission shall defer application of the substances or materials for new installations remain in measures which it has adopted for a period of three water intended for human consumption in concentrations months from the date of communication; higher than is necessary for the purpose of their use anddo not, either directly or indirectly, reduce the protection (b) the Council, acting by a qualified majority, may take of human health provided for in this Directive; the a different decision within the time limit referred to in interpretative document and technical specifications pursuant to Article 3 and Article 4 (1) of CouncilDirective 89/106/EEC of 21 December 1988 on theapproximation of laws, regulations and administrativeprovisions of the Member States relating to construction Article 13 products (1) shall respect the requirements of thisDirective.
Information and reporting
(1) OJ L 40, 11.2.1989, p. 12. Directive as last amended by 1. Member States shall take the measures necessary to Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).
ensure that adequate and up-to-date information on the Official Journal of the European Communities quality of water intended for human consumption is Article 15 available to consumers.
2. Without prejudice to Council Directive 90/313/EECof 7 June 1990 on the freedom of access to information 1. A Member State may, in exceptional circumstances on the environment (1), each Member State shall publish and for geographically defined areas, submit a special a report every three years on the quality of water request to the Commission for a period longer than that intended for human consumption with the objective of laid down in Article 14. The additional period shall not informing consumers. The first report shall cover the exceed three years, towards the end of which a review years 2002, 2003 and 2004. Each report shall include, as shall be carried out and forwarded to the Commission a minimum, all individual supplies of water exceeding which may, on the basis of that review, permit a second 1 000 m³ a day as an average or serving more than 5 000 additional period of up to three years. This provision persons and it shall cover three calendar years and be shall not apply to water intended for human published within one calendar year of the end of the consumption offered for sale in bottles or containers.
reporting period.
2. Any such request, grounds for which shall be given, 3. Member States shall send their reports to the shall set out the difficulties experienced and include, as a Commission within two months of their publication.
minimum, all the information specified in Article 9(3).
4. The formats and the minimum information for the 3. The Commission shall examine that request in reports provided for in paragraph 2 shall be determined accordance with the procedure laid down in Article 12.
having special regard to the measures referred to inArticle 3(2), Article 5(2) and (3), Article 7(2), Article 8,Article 9(6) and (7) and 15(1), and shall if necessary beamended in accordance with the procedure laid down in 4. Any Member State which has recourse to this Article shall ensure that the population affected by its request ispromptly informed in an appropriate manner of theoutcome of that request. In addition, the Member Stateshall, where necessary, ensure that advice is given to 5. The Commission shall examine the Member States' particular population groups for which the request could reports and, every three years, publish a synthesis report present a special risk.
on the quality of water intended for human consumptionin the Community. That report shall be published withinnine months of the receipt of the Member States'reports.
Article 16 6. Together with the first report on this Directive as mentioned in paragraph 2, Member States shall alsoproduce a report to be forwarded to the Commission onthe measures they have taken or plan to take to fultil 1. Directive 80/778/EEC is hereby repealed with effect their obligations pursuant to Article 6(3) and Annex I, from five years after the entry into force of this Directive.
Part B, note 10. The Commission shall submit, as Subject to paragraph 2, this repeal shall be without appropriate, a proposal on the format of this report in prejudice to Member States' obligations regarding accordance with the procedure laid down in Article 12.
deadlines for transposition into national law and forapplication as shown in Annex IV.
Article 14 Any reference to the Directive repealed shall be construedas a reference to this Directive and shall be read in Timescale for compliance
accordance with the correlation table set out in AnnexV.
Member States shall take the measures necessary toensure that the quality of water intended for humanconsumption complies with this Directive within five 2. As soon as a Member State has brought into force the years of its entry into force, without prejudice to Notes laws, regulations and administrative provisions necessary 2, 4 and 10 in Annex I, Part B.
to comply with this Directive and has taken the measuresprovided for in Article 14, this Directive, not Directive80/778/EEC, shall apply to the quality of water intended (1) OJ L 158, 23.6.1990, p. 56.
for human consumption in that Member State.
Official Journal of the European Communities Article 17 Article 18 Transposition into national law
Entry into force
This Directive shall enter into force on the 20th day 1. Member States shall bring into force the laws, following its publication in the Official Journal of the regulations and administrative provisions necessary to comply with this Directive within two years of its entryinto force. They shall forthwith inform the Commissionthereof.
Article 19 When the Member States adopt those measures, these This Directive is addressed to the Member States.
shall contain references to this Directive or shall beaccompanied by such references on the occasion of theirofficial publication. The methods of making suchreferences shall be laid down by the Member States.
Done at Brussels, 3 November 1998.
For the Council 2. The Member States shall communicate to the The President Commission the texts of the provisions of national lawwhich they adopt in the field covered by this Directive.
Official Journal of the European Communities PARAMETERS AND PARAMETRIC VALUES
Escherichia coli (E. coli) The following applies to water offered for sale in bottles or containers: Escherichia coli (E. coli) Colony count 22 °C Colony count 37 °C Official Journal of the European Communities Pesticides — Total Polycyclic aromatic hydrocarbons Sum of concentrations ofspecified compounds;Note 9 Tetrachloroethene and Sum of concentrations of specified parameters Trihalomethanes — Total Sum of concentrations ofspecified compounds;Note 10 Official Journal of the European Communities The parametric value refers to the residual monomer concentration in the water as calculated according tospecifications of the maximum release from the corresponding polymer in contact with the water.
Where possible, without compromising disinfection, Member States should strive for a lower value.
For the water referred to in Article 6(1)(a), (b) and (d), the value must be met, at the latest, 10 calendaryears after the entry into force of the Directive. The parametric value for bromate from five years after theentry into force of this Directive until 10 years after its entry into force is 25 µg/l.
The value applies to a sample of water intended for human consumption obtained by an adequatesampling method (1) at the tap and taken so as to be representative of a weekly average value ingested byconsumers. Where appropriate the sampling and monitoring methods must be applied in a harmonisedfashion to be drawn up in accordance with Article 7(4). Member States must take account of theoccurrence of peak levels that may cause adverse effects on human health.
For water referred to in Article 6(1)(a), (b) and (d), the value must be met, at the latest, 15 calendar yearsafter the entry into force of this Directive. The parametric value for lead from five years after the entryinto force of this Directive until 15 years after its entry into force is 25 µg/l.
Member States must ensure that all appropriate measures are taken to reduce the concentration of lead inwater intended for human consumption as much as possible during the period needed to achievecompliance with the parametric value.
When implementing the measures to achieve compliance with that value Member States must progressivelygive priority where lead concentrations in water intended for human consumption are highest.
Member States must ensure that the condition that [nitrate]/50 + [nitrite]/3 # 1, the square bracketssignifying the concentrations in mg/l for nitrate (NO3) and nitrite (NO2), is complied with and that thevalue of 0,10 mg/l for nitrites is complied with ex water treatment works.
‘Pesticides' means: — organic insecticides, — organic herbicides, — organic fungicides, — organic nematocides, — organic acaricides, — organic algicides, — organic rodenticides — organic slimicides, — related products (inter alia, growth regulators) and their relevant metabolites, degradation and reaction products.
Only those pesticides which are likely to be present in a given supply need be monitored.
The parametric value applies to each individual pesticide. In the case of aldrin, dieldrin, heptachlor andheptachlor epoxide the parametric value is 0,030 µg/l.
‘Pesticides — Total' means the sum of all individual pesticides detected and quantified in the monitoringprocedure.
The specified compounds are: — benzo(ghi)perylene, Where possible, without compromising disinfection, Member States should strive for a lower value.
The specified compounds are: chloroform, bromoform, dibromochloromethane, bromodichlorome-thane.
For the water referred to in Article 6(1)(a), (b) and (d), the value must be met, at the latest, 10 calendaryears after the entry into force of this Directive. The parametric value for total THMs from five years afterthe entry into force of this Directive until 10 years after its entry into force is 150 µg/l.
(1) To be added following the outcome of the study currently being carried out.
Official Journal of the European Communities Member States must ensure that all appropriate measures are taken to reduce the concentration of THMsin water intended for human consumption as much as possible during the period needed to achievecompliance with the parametric value.
When implementing the measures to achieve this value, Member States must progressively give priority tothose areas where THM concentrations in water intended for human consumption are highest.
(including spores) Acceptable toconsumers and noabnormal change µS cm-1 at Hydrogen ion concentration Acceptable toconsumers and noabnormal change Acceptable toconsumers and noabnormal change Colony count 22° No abnormal change Coliform bacteria Total organic carbon (TOC) No abnormal change consumers and noabnormal change Official Journal of the European Communities Total indicative dose The water should not be aggressive.
This parameter need not be measured unless the water originates from or is influenced by surface water. Inthe event of non-compliance with this parametric value, the Member State concerned must investigate thesupply to ensure that there is no potential danger to human health arising from the presence of pathogenicmicro-organisms, e.g. cryptosporidium. Member States must include the results of all such investigations inthe reports they must submit under Article 13(2).
For still water put into bottles or containers, the minimum value may be reduced to 4,5 pH units.
For water put into bottles or containers which is naturally rich in or artificially enriched with carbondioxide, the minimum value may be lower.
This parameter need not be measured if the parameter TOC is analysed.
For water put into bottles or containers the unit is number/250 ml.
This parameter need not be measured for supplies of less than 10 000 m³ a day.
In the case of surface water treatment, Member States should strive for a parametric value not exceeding1,0 NTU (nephelometric turbidity units) in the water ex treatment works.
Monitoring frequencies to be set later in Annex II.
Excluding tritium, potassium -40, radon and radon decay products; monitoring frequencies, monitoringmethods and the most relevant locations for monitoring points to be set later in Annex II.
1. The proposals required by Note 8 on monitoring frequencies, and Note 9 on monitoring frequencies, monitoring methods and the most relevant locations for monitoring points in Annex II shall beadopted in accordance with the procedure laid down in Article 12. When elaborating these proposalsthe Commission shall take into account inter alia the relevant provisions under existing legislation orappropriate monitoring programmes including monitoring results as derived from them. TheCommission shall submit these proposals at the latest within 18 months following the date referred toin Article 18 of the Directive.
2. A Member State is not required to monitor drinking water for tritium or radioactivity to establish total indicative dose where it is satisfied that, on the basis of other monitoring carried out, the levels oftritium of the calculated total indicative dose are well below the parametric value. In that case, it shallcommunicate the grounds for its decision to the Commission, including the results of this othermonitoring carried out.
Official Journal of the European Communities Parameters to be analysed
1. Check monitoring The purpose of check monitoring is regularly to provide information on the organoleptic andmicrobiological quality of the water supplied for human consumption as well as information on theeffectiveness of drinking-water treatment (particularly of disinfection) where it is used, in order todetermine whether or not water intended for human consumption complies with the relevant parametricvalues laid down in this Directive.
The following parameters must be subject to check monitoring. Member States may add otherparameters to this list if they deem it appropriate.
Aluminium (Note 1) Clostridium perfringens (including spores) (Note 2) Escherichia coli (E. coli) Hydrogen ion concentration Pseudomonas aeruginosa (Note 4) Colony count 22 °C and 37 °C (Note 4) Coliform bacteria Necessary only when used as flocculant (*).
Necessary only if the water originates from or is influenced by surface water (*).
Necessary only when chloramination is used as a disinfectant (*).
Necessary only in the case of water offered for sale in bottles or containers.
(*) In all other cases, the parameters are in the list for audit monitoring.
2. Audit monitoring The purpose of audit monitoring is to provide the information necessary to determine whether or not allof the Directive's parametric values are being complied with. All parameters set in accordance withArticle 5(2) and (3) must be subject to audit monitoring unless it can be established by the competentauthorities, for a period of time to be determined by them, that a parameter is not likely to be present ina given supply in concentrations which could lead to the risk of a breach of the relevant parametricvalue. This paragraph does not apply to the parameters for radioactivity, which, subject to Notes 8, 9and 10 in Annex I, Part C, will be monitored in accordance with monitoring requirements adoptedunder Article 12.
Official Journal of the European Communities Minimum frequency of sampling and analyses for water intended for human consumption supplied from a
distribution network or from a tanker or used in a food-production undertaking
Member States must take samples at the points of compliance as defined in Article 6(1) to ensure that waterintended for human consumption meets the requirements of the Directive. However, in the case of adistribution network, a Member State may take samples within the supply zone or at the treatment worksfor particular parameters if it can be demonstrated that there would be no adverse change to the measuredvalue of the parameters concerned.
Volume of water distributed or produced each day within a supply Check monitoring number of samples Audit monitoring number of samples (Notes 3, 4 and 5) + 1 for each 3 300 m³/d and part thereof of the total volume + 3 for each 1 000 m³/d and + 1 for each 10 000 m³/d and part thereof of the total volume part thereof of the total volume + 1 for each 25 000 m³/d and part thereof of the total volume A supply zone is a geographically defined area within which water intended for human consumptioncomes from one or more sources and within which water quality may be considered as beingapproximately uniform.
The volumes are calculated as averages taken over a calendar year. A Member State may use the numberof 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.
In the event of intermittent short-term supply the monitoring frequency of water distributed by tankers isto be decided by the Member State concerned.
For the different parameters in Annex I, a Member State may reduce the number of samples specified inthe table if: (a) the values of the results obtained from samples taken during a period of at least two successive years are constant and significantly better than the limits laid down in Annex I, and (b) no factor is likely to cause a deterioration of the quality of the water.
The lowest frequency applied must not be less than 50 % of the number of samples specified in the tableexcept in the particular case of note 6.
As far as possible, the number of samples should be distributed equally in time and location.
The frequency is to be decided by the Member State concerned.
Official Journal of the European Communities Minimum frequency of sampling and analysis for water put into bottles or containers intended for sale
Volume of water produced for offering for sale in bottles or Check monitoring number of samples Audit monitoring number of samples containers each day (1) 1 for each 5 m³ and part thereof 1 for each 100 m³ and part of the total volume thereof of the total volume (1) The volumes are calculated as averages taken over a calendar year.
Official Journal of the European Communities SPECIFICATIONS FOR THE ANALYSIS OF PARAMETERS
Each Member State must ensure that any laboratory at which samples are analysed has a system ofanalytical quality control that is subject from time to time to checking by a person who is not under thecontrol of the laboratory and who is approved by the competent authority for that purpose.
1. PARAMETERS FOR WHICH METHODS OF ANALYSIS ARE SPECIFIED The following principles for methods of microbiological parameters are given either for referencewhenever a CEN/ISO method is given or for guidance, pending the possible future adoption, inaccordance with the procedure laid down in Article 12, of further CEN/ISO international methods forthese parameters. Member States may use alternative methods, providing the provisions of Article 7(5)are met.
Coliform bacteria and Escherichia coli (E. coli) (ISO 9308-1) Enterococci (ISO 7899-2) Pseudomonas aeruginosa (prEN ISO 12780) Enumeration of culturable microorganisms — Colony count 22 °C (prEN ISO 6222) Enumeration of culturable microorganisms — Colony count 37 °C (prEN ISO 6222) Clostridium perfringens (including spores) Membrane filtration followed by anaerobic incubation of the membrane on m-CP agar (Note 1) at 44 6 1 °C for 21 6 3 hours. Count opaque yellow colonies that turn pink or red after exposure toammonium hydroxide vapours for 20 to 30 seconds.
The composition of m-CP agar is: L-cysteine hydrochloride Bromocresol purple Dissolve the ingredients of the basal medium, adjust pH to 7,6 and autoclave at 121 °C for 15minutes. Allow the medium to cool and add: Polymyxine-B sulphate to be dissolved in 8 ml sterile water before addition Filter — sterilised 0,5% phenolphthalein diphosphate solution Filter — sterilised 4,5 % FeCl3 · 6H2O PARAMETERS FOR WHICH PERFORMANCE CHARACTERISTICS ARE SPECIFIED 2.1. For the following parameters, the specified performance characteristics are that the method of analysis used must, as a minimum, be capable of measuring concentrations equal to the parametric value with atrueness, precision and limit of detection specified. Whatever the sensitivity of the method of analysisused, the result must be expressed using at least the same number of decimals as for the parametricvalue considered in Annex I, Parts B and C.
Official Journal of the European Communities parametric value parametric value To be controlled byproductspecification To be controlled byproductspecification Polycyclic aromatic Official Journal of the European Communities parametric value parametric value Trihalomethanes — To be controlled byproductspecification 2.2. For hydrogen ion concentration the specified performance characterisatics are that the method of analysis used must be capable of measuring concentrations equal to the parametric value with atrueness of 0,2 pH unit and a precision of 0,2 pH unit.
Note 1 (*): Trueness is the systematic error and is the difference between the mean value of the large numberof repeated measurements and the true value.
Note 2 (*): Precision is the random error and is usually expressed as the standard deviation (within andbetween batch) of the spread of results about the mean. Acceptable precision is twice the relativestandard deviation.
(*) These terms are further defined in ISO 5725.
Limit of detection is either: — three times the relative within batch standard deviation of a natural sample containing a low concentration of the parameter, — five times the relative within batch standard deviation of a blank sample.
The method should determine total cyanide in all forms.
Oxidation should be carried out for 10 minutes at 100 °C under acid conditions usingpermanganate.
The performance characteristics apply to each individual pesticide and will depend on the pesticideconcerned. The limit of detection may not be achievable for all pesticides at present, but MemberStates should strive to achieve this standard.
The performance characteristics apply to the individual substances specified at 25 % of theparametric value in Annex I.
The performance characteristics apply to the individual substances specified at 50 % of theparametric value in Annex I.
3. PARAMETERS FOR WHICH NO METHOD OF ANALYSIS IS SPECIFIED ColourOdourTasteTotal organic carbonTurbidity (Note 1) For turbidity monitoring in treated surface water the specified performance characteristics are thatthe method of analysis used must, as a minimum, be capable of measuring concentrations equal tothe parametric value with a trueness of 25 %, precision of 25 % and a 25 % limit of detection.
DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW AND FOR APPLICATION
Directive 80/778/EEC Directive 81/858/EEC Act of Accession of Spain and Directive 90/656/EEC for new Act of Accession of Austria, Länder of Germany Finland and Sweden Transposition 17.7.1982 (Adaptation due to accession of Spain: transposition Austria: transposition Application 17.7.1985 application 1.1.1986 application 1.1.1995 Portugal: transposition 1.1.1986 Finland: transposition All Member States except Spain, application 1.1.1989 application 1.1.1995 Portugal and new Länder of Sweden: transposition Official Journal of the European Communities Application 31.12.1995 Amended with effect from Amended with effect from Amended with effect from Article 17(a)inserted Official Journal of the European Communities Directive 80/778/EEC Article 5(2) first sentence Article 5(2) second sentence Article 6(2) to (3) Article 9(1) and Article 10(1) Article 9(2) to (6) Article 9(2) and Article 10(3) Official Journal of the European Communities Directive 80/778/EEC Article 12(2) and (3) Article 13(2) to (5) Article 17(a) (inserted by Directive 91/692/EEC)

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Children's apparel & accessories product safety guidelines

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