Contained Use of Genetically Modified Micro-Organisms Regulations, 2002 (L.N. No. 169 of 2002)

L.N.169 of 2002 ENVIRONMENT PROTECTION ACT, 2001 (ACT NO. XX OF 2001 Contained use of Genetically Modified Micro-Organisms Regulations, 2002 BY virtue of the powers conferred by articles 9 and 11 of the Environment Protection Act, 2001, hereinafter referred to as 'the Act', the Minister for Home Affairs and the Environment has made the following regulations: B 2649 1. (1) The title of these regulations is Contained use of Citationand • . · commencement. genetically modified micro-orgamsms Regualbons, 2002. (2) (a) These regulations shall come into force on such date as the Minister responsible for the environment may by notice in the Gazette appoint and different dates may be so appointed for different provisions and different purposes of these regulations. (b) A notice under paragraph ( a) of this sub-regulation may make such transitional provisions as appear to the Minister to be necessary or expedient in connection with the provisions thereby brought into force. 2. The objective of these regulations is to lay down measures Objectives. for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment. 3. In these regulations, unless the context otherwise requires: Interpretation. "micro-organism" means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture; "genetically modified micro-organism" (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Within the terms of this definition: B 2650 Exemptions. (i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A; (ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification; "contained use" means any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment; "accident" means any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment; "user" means any natural or legal person responsible for the contained use of GMMs; "notification" means the presentation of the requisite information to the Authority; "Minister" means the Minister responsible for the environment "Authority" means the Malta Environment and Planning Authority as prescribed by the notice entitled Nomination of the Malta Environment and Planning authority as the competent authority, and such other body or person as the Minister responsible for the environment may by order in the Gazette prescribe and different bodies or persons may be designated as the competent authority for different provisions and different purposes of these regulations; 4. (1) Without prejudice to Article 6(1) these regualtions shall not apply: where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety to human health and the environment. These types of GMMs shall be listed in Annex II, Part C. B 2651 (2) Article 5(2), 5(5), 5(6), 5(7) and Articles 6 to 11 shall not apply to the transport of GMMs by rail, by road, sea or air. (3) To the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with the deliberate release into the environment of genetically modified organisms regulations, 2002 or pursuant to other relevant legislation, which provides for a specific environmental risk assessment similar to that laid down in the said regulations, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. 5. ( 1) In order to ensure that the contained use of GMMs does Assessment. not produce adverse effects on human health and the environment the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the elements of assessment and the procedure set out in Annex III, sections A and B. (2) The assessment referred to in sub-article ( 1) shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with sub-articles (6) and (7) : Class 1 : activities of no or negligible risk, for which level 1 containment is appropriate. Class 2 : activities of low risk, for which level 2 containment is appropriate. Class 3 : activities of moderate risk, for which level 3 containment is appropriate. Class.4: activities of high risk, for which level 4 containment is appropriate. (3) Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority ,justifies the application ofless stringent measures. (4) The assessment referred to in sub-article (1) shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment. B 2652 Premises used for the first time. Class 1 contained use. Class 2 contained use. (5) A record of the assessment referred to in sub-article (1) shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 6, 8 and 9 or on request. (6) The user shall apply, except to the extent that paragraph 2 of Annex IV allows other measures to be applied, the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured. (7) The assessment referred to in sub-article 5(1) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if: ( a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct, or (b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge. 6. When premises are to be used for the first time for contained uses, the user shall be required to submit to the competent authority, before commencing such use, a notification containing at least the information listed in Annex V, Part A. 7. Following the notification referred to in Article 6, subsequent class 1 contained use may proceed without further notification, and users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in sub-article 5(5), which shall be made available to competent authority on request. 8. ( 1) For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part B shall be submitted to the competent authority. (2) If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. B 2653 Provided that the applicant can, however, himself request a decision on a formal authorisation from the authority. The decision must be made within a maximum of 45 days from the notification. (3) If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in sub-article (1), or earlier with the agreement of the competent authority. 9. ( 1) For first and subsequent class 3 or class 4 contained uses Class 3 and class 4 b · d · · 'fj d · d · h A · 1 7 contained use to e came out m premises not! 1e m accor ance wit rt1c e , a. · notification containing the information listed in Annex V, Part C shall be submitted. (2) A class 3 or higher class of contained use may not proceed without the prior consent of the authority which shall communicate its decision in writing: (a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed; (b) at the latest 90 days after submission of the notification, in other cases. 10. (1) The competent authority shall examine the conformity Notifications to the of the notifications with the requirements of this Directive, the accuracy ~~::~t and completeness of the information given, the correctness of the assessment referred to in Article 5( 1) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures. (2) If necessary, the Authority may: (a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). Provided that in this case the Authority may require that the contained use, if proposed, does not begin, or, if in progress, is suspended B 2654 New information on risks of contained use. or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use; (b) limit the time for which the contained use should be permitted or subject it to certain specific conditions. (3) For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time during which the Authority: is awaiting any further information which it may have requested from the notifier in accordance with sub-article 2(a), or is carrying out a public inquiry or consultation in accordance with Article 12 shall not be taken into account. 11. If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the Authority shall be informed as soon as possible and the notification pursuant to Articles 6, 8 and 9 shall be modified. Provided that if information subsequently becomes available to the competent authority which could have significant consequences for the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use. Public consultation. 12. Where the competent authority considers it appropriate, it may hold public consultations on aspects of the proposed contained use, without prejudice to Article 18. Emergency plans. 13. The competent authority shall ensure that before a contained use commences: ( a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other relevant legislation; (b) information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information B 2655 shall be updated at appropriate intervals. It shall also be made publicly available. The authority shall at the same time make available to other States concerned, the same information as that which is disseminated to their nationals. 14. (1) In the event of an accident, the user shall be required to Occurrences of inform immediately the competent authority and provide the following accidents. information: the circumstances of the accident, the identity and quantities of the GMMs concerned, any information necessary to assess the effects of the accident on the health of the general population and the environment, the measures taken. 2. Where information is given pursuant to sub-article (1), the competent authority shall be required to: ensure that any measures necessary are taken, and immediately alert other States which could be affected by the accident, collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof. 15. The compelenl aulhurily shall cunsull wilh olher Stales, likely Communication to be affected in the event of an accident, on the proposed wi th 0th er st ates. implementation of emergency plans. 16. The competent authority shall organise inspections and other Inspection and control measures to ensure user compliance with these regulations. control measures 17. (1) following: Where disclosure of data affects one or more of the Disclosure of confidential data. the confidentiality of the proceedings of public authorities, international relations and national defence, B 2656 public security, matters which are, or have been, sub judice, or under enquiry (including disciplinary enquiries), or which are the subject of preliminary investigation proceedings, commercial and industrial confidentiality, including intellectual property, the confidentiality of personal data and/or files, material supplied by a third party without that party being under a legal obligation to do so, material, the disclosure of which would make it more likely that the environment to which such material related would be damaged, the notifier may indicate the information in the notifications submitted pursuant to these regulations that should be treated as confidential. Provided that a verifiable justification must be given in such cases. (2) The Authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. (3) In no case may the following information, when submitted according to Articles 6, 8 or 9, be kept confidential: the general characteristics of the GMMs, name and address of the notifier, and location of use, class of contained use and measures of containment, the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. ( 4) The competent authority shall not divulge to third parties any information decided to be confidential according to sub-article 2 and notified or otherwise provided pursuant to these regulations, and shall protect intellectual property rights relating to the data received. (5) If, for whatever reasons, the notifier withdraws the notification, the Authority must respect the confidentiality of the information supplied. B 2657 18. Any person shall be guilty of an offence under these Offences. regulations if: (a) he fails to comply with any provision of these regulations or fails to comply with permit conditions or with any order lawfully given in terms of any provision of these regulations; or (b) he contravenes any restriction, prohibition or requirement imposed by or under these regulations; or (c) he acts in contravention of any of the provisions of these regulations; or (d) he conspires or attempts, or aids, or abets, any other person by whatever means, including advertising, counselling or procurement to contravene the provisions of these regulations or to fail to comply with any such provisions, including any order lawfully given in terms of any of the provision of these regulations, or to contravene any restriction, prohibition or requirement imposed by or under the said regulations. 19. Any person who commits an offence against these regulations Penalties. shall, on conviction, be liable: (a) on a first conviction to a fine (multa) of not less than five hundred Maltese liri but not exceeding one thousand Maltese liri; (b) on a second or subsequent convictions, to a fine (multa) of not less than one thousand Maltese liri, but not exceeding two thousand Maltese liri or to imprisonment for a term not exceeding two years, or to both such fine and imprisonment: Provided that the court shall order any person who has been found guilty of committing an offence against these regulations to pay for the expenses incurred by the competent authority as a result of the said offence, the revocation of the permit issued by the competent authority and the confiscation of the corpus delicti. 20. (1) The provisions of articles 23 and 30 of the Criminal Code shall, mutatis mutandis, apply to proceedings in respect of offences against these regulations, so however that the disqualification from holding or obtaining a licence, permit or authority shall in no case be for less than one year. (2) Notwithstanding the provisions of article 370 of the Criminal Code, proceedings for an offence against these regulations Applicability of the Criminal Code Cap.9. B 2658 Language of schedules. shall be held before the Court of Magistrates (Malta) or the Court of Magistrates (Gozo), as the case may be, and shall be in accordance with the provisions of the Criminal Code regulating the procedure before the said courts as courts of criminal judicature. (3) Notwithstanding the provisions of the Criminal Code, the Attorney General shall always have a right of appeal to the Court of Criminal Appeal from any judgement given by the Court of Magistrates (Malta) or the Court of Magistrates (Gozo) in respect of proceedings for any offence against these regulations. 21. The Schedules I to IV to these regulations are being published in the English language with the English text of these regulations. Escherichitl coli (E. coli) [nrerococci ANXEX I PARAMETERS AND PARAMETRIC VALUES PART A Microbiological parameters Parameter The following applies to water offered for sale in bottles or containers: Parameter Escherichia coli (E. coli) Emerococci Pscudomonas aerug111osa Colu11y c<>u11l 22 °C Colony count 37 °C B 2659 Parametric value lnumber/100 ml) 0 0 Parametric value 0/250 ml 0/250 ml 0/250 ml 1001ml 20/rnl B 2660 Parameter Acrylamide Antimony Arsenic Benzene Benzo(a)pyrene Boron Bromate Cadmium Chromium Copper Cyanide 1,2-dicbloroethane ~------ ~ - -- . ., .... --. Epichlorohydrin Fluoride Lead Mercury Nickel Nitrate Nitrite Pesticides Pesticides - Total Polycyclic aromatic hydrocarbons Selenium Tetrachloroethene and T richloroethene Trihalomethanes - Total Vinyl chloride > PART B Chemical parameters Parametric value 0,10 5,0 10 1,0 0,010 1,0 10 5,0. 50 2,0 50 3,0 ~------- -- - 0,10 1,5 10 1,0 20 . 50 0,50 0,10 0,50 0,10 10 10 100 0,50 Unit Notes Jlg/1 Note 1 ,ug/1 µg/1 µg/1 µg/1 mg/I µg/1 Note 2 µg/1 µg/1 mg/I Note 3 µg/1 µg/1 --- --- -- ~ ··---- ----· --~ ·--~ µg/1 Note 1 mg/) µg/1 Notes 3 and 4 µg/1 µg/1 Note 3 mg/I Note 5 mg/) Note 5 µg/1 Notes 6 and 7 µg/1 Notes 6 and 8 µg/1 Sum of concentrations of specified cumpounds; Note 9 µg/] ,ltg/1 Sum of concentrations of specified parameters µg/1 Sum of concentrations of specified compounds; Note 10 µg/1 Note 1 Note 1: Note 2, Note 3: Note 4: Note 5: Note 6: Note 7: Note 8: Note 9: Note 10: B 2661 The paramecric \·alue rrft:r~ tu d1t: rt:~itlual rnu11umt:r c.:uncencrarion in cht \VaitT as cai<.:ubtt:U au::orc.ling: co specifications of the maximum release from the corresponding polymer in contact with the water. \'Uhere ·possible, without C:'ompromising disinfection, Nlember States should strive for a lower value. For rhe water reierred ro in Article 6il)(a), 161 and id), the value must be mer, at the latest, 10 calendar years after the entr)' into force of rhe Direcri1·e. The parametric value for bromate from iive years airer the entry into force of this Directive until 10 years airer its entry into force is 25 11gll. The value applies to a sample of water intended for human consumption obtained by an adequate sampling method 11) at the tap and taken so as to be representative of a weekly average value ingested by consumers. Where appropriate the sampling and monitoring methods must be applied in a harmonised fashion to be drawn up in accordance with Article 714 l. Member States must take account of the occurrence of peak levels that may cause adverse effects on human health. For water referred tom Arttcle 6(1)(a), (b) and (d), the value must be met, at the latest, 15 calendar years after the entry into force of this Directive. The parametric value for lead from five years after the entry into force of this Directive until 15 years after its entry into force is 25 µg/1. Member Stares must ensure that all appropriate measures are taken to reduce the concentration of lead 1n water intended for human consumption as much as possible during the period needed to achieve compliance with the parametric value. When implementing the 1m::a~ures co achieve compliance with char value .i\/lember States must progressively give priority where lead concentrations in water intended ior human consumption are highest. Member States must ensure that the condition that [nitrate]/50 + [nitrite]/3 s 1, the square brackets signifying the concentrations in mg/l for nitrate {N03) and nitrite (N02), i~ complied wirh and rhor the value of OJ O mg/I ior 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 linter 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 paramerrk value applies to each individual pesticide. In the case of aldrin, dieldrin, heptachlor and heptachlor epoxide the parametric value is 0,030 µg/1. 'Pesticides - Total" means the sum of all individual pesticides detected and quantified in the monitoring procedure. The specified compounds are: benzo(b)tluoramhene, benzo(k)fluoranthene, benzo(ghi)perylene, indeno(l,2,3-cdip1·rene. Where possible, without compromising disinfection, Member States should strive for a lower value. The specified compounds are: chloroforrri, bromoform. dibromochloromethane, bromodichlorome­ thane. For the water referred ro in Article 6(1 )(a), (b) and (d), rhe rnlue must be met, at the latest, 10 calendar years a~er the entry into torce of this Directive. The parametric value for total THMs from five vears after the entry into force of this Directive until 10 years afrer irs ,n,rr in,o force is 150 ,,.g11. · ( 1 ) To be added following the outcome of the study currently being carried out. B 2662 Nlember States must ensure that all appropriate measures are rnken ro reduce the concentration oi THMs in water intended ior human consumption as much as possible during rhe period needed to achie1·e compliance with the parametric l'alue. \'('hen implementing the measures to achieve this l'alue, Member States must progressiveh· gi,·e priority to those areas where IBM concentrations in water inrended·ior human consumption are highest. PART C Indicator parameters Parameter Parametric value Unit Notes Aluminium 200 ,ug/1 Ammonium 0,50 mg/I Chloride 250 mg/I Note 1 Clostridium perfringens 0 numher/100 ml Note 2 (including spores) 6,lour Acceptable to consumers and no abnormal change Conductivity 2 500 ,uS cm·1 at Note 1 20 ·c Hydrogen ion concentration ~ 6,5 and :S 9,5 pH units Notes 1 and 3 Iron 200 ,ug/1 Manganese 50 ,ug/1 Odour Acc~ptable to consumers and no a~normal change Oxidisability 5,0 mg/I 02 Note 4 Sulphate 250 mg/I Note 1 Sodium 200 mg/I Taste Acceptable to consumers and no abnormal change Colony count 22° No abnormal change Coliform bacteria 0 nurriber/100 ml Note 5 Total ·organic carbon (TOC) No abnormal change Note 6 Turbidiry Acceptable to Nore 7 consumers and no abnormal change B 2663 RADIOACTIVITY Parameter Parametric value Unit Notes Tritium 100 Bq/1 Notes 8 and 10 Total indicative dose 0,10 mSv/year Notes 9 and 10 Note 1: Note 2: Nott(]: Note 4: Note 5: Note 6: Note 7: Note 8: Note 9: Note 10: The water should not be aggressive. This parameter need not be measured unless the water originates from or is influenced by surface water. In the event of non-compliance with this parametric value, the Member State concerned must investigate the supply to ensure that there is no potential danger to human health arising from the presence of pathogenic micro-organisms, e.g. cryptosporidium. Member States must include the results of all such investigations in the 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 carbon dioxide, 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 s;urface water treatment, Member States should strive for a para1m:ui~ valm: nut t:xceeding 1,0 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, monitoring methods 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 be adopted in accordance with the procedure laid down in Article 12. When elaborating these proposals the Commission shall take into account inter alia the relevant provisions Wlder existing legislation or appropriate monitoring programmes including momtormg results as derived trom them. The Commission shall submit these proposals at the latest within 18 months following the date referred to in Article 18 of the Directive. 2. A Member State is not required to monitor drinking water for rririum or radioacriviry ro establish total indicative dose where it is satisfied that, on the basis of other monitoring carried out, the levels of tritium of the calculated total indicative dose are well below the parametric value. In that case, it shall communicate the grounds for its decision to the Commission, including the results of this other monitoring carried out. B 2664 ANNEX II MONITORING TABLE A Parameters to be analysed 1. Check monitoring The purpose of check monitoring is regularly to provide information on the organoleptic and microbiological quality of the water supplied for human consumption as well as information on the effectiveness of drinking-water treatment (particularly of disinfection) where it is used, in order to determine whether or not water intended for human consumption complies with the relevant parametric values laid down in this Directive. The following parameters must be subject to check monitoring. Member States may add other parameters to this list if they deem it appropriate. Aluminium (Nore 1) Ammonium Colour Conductivity Clostridium perfringens (including spores) (Note 2) Escherichia coli (E. coli) Hydrogen ion concentration Iron (Note 1) Nitrite (Note 3) Odour Pseudomonas aeruginosa (Note 4) Taste Colony count 22 •c and 37 •e (Note 4) Coliform bacteria Turbidity Note 1: Necessary only when used ;is floccul:int (•). Note 2: Necessary only if the water originates from or is influenced by surface water ( • ). Note 3, Necessary only when chlorami.nation is used as a di5infcctant {-=-}. Note 4: 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 all of the Directive's parametric values are being complied with. All parameters set in accordance with Article 5(2) and (3) must be subject ro audit monitoring unless it can be established by the competent authorities, for a period of time to be determined by them, that a parameter is not likely to be present in a given supply in concentrations which could lead to the risk of a hreach of the relevant parametric value. This paragraph does not apply to the parameters for radioactivity, which, subject to Notes 8, 9 and 10 in Annex I, Part C, will be monitored in accordance with monitoring requirements adopted under Article 12. B 2665 TABLE Bl 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 water intended for human consumption meets the requirements of the Directive. However, in the case of a distribution network, a Member State may take samples within the supply zone or at the treatment works for particular parameters if it can be demonstrated that there would be no adverse change to the measured value 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 > 100 > 1 000 > 10 000 > 100 000 Note 1: Note 2: Note 3: Note 4: Note 5: Note 6: zone per year per year (Notes 1 and 2) (Notes 3, 4 and 5) (Notes 3 and 5) m' s: 100 (Note 6) (Note 6) :5 1 000 4 1 $ 10 000 1 + 1 for each 3 300 m3/d and part thereof of the total volume ··--~-- ·---- ::s 100 000 4 3 , 3 for each 1 000 m3/d and + 1 for each 10 000 m3/d and part thereof of the totai volume part thereof of the total volume 10 r 1 for each 25 000 m3/d and part tlu::n::uf of the tulal volume 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. 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 !/day/capita. In the event of intermittent short-term supply the monitoring frequency of warer distributed by cankers is to be decided by the Member State concerned. For the different parameters in Annex I, a Member State may reduce the number of samples specified in the 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 qualiry of the water. The lowest frequency applied must nor be less than 50 % of the number of samples specified in the table except 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. B 2666. TABLE BZ Minimum frequency of sampling and analysis for water put into botth:s 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 cuntaincrs each day 11 i per year per year m~ s 10 1 1 > 10 :s; 60 12 1 >60 1 for each 5 ml and part thereof 1 for each 100 ml and part of the total volume thereof'of the total volume (1) The volumes are calculated as averages taken over a calendar year. B 2667 ANNEX III SPECIFICATIONS FOR THE ANALYSIS OF PARAMETERS Each Member State must ensure that any laboratory at which samples are analysed has a system of analytical quality control that is subject from time to time to checking by a person who is not under the control 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 reference whenever a CEN/ISO method is given or for guidance, pending the possible future adoption, in accordance with the procedure laid down in Article 12, of further CEN/ISO international methods for these 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) Membraue fihraLiun fulluwed by anaerobic incubation of the membrane on m-CP agar (Note 1) at 44 ± 1 °C for 21 ± 3 hours. Count opaque yellow colonies that turn pink or red after exposure to ammonium hydroxide vapours for 20 to 30 seconds. Note 1: The composition of m-CP agar is: Basal medium Tryprose 30 g Yeast extract 20 g Sucrose 5 g L-cysteine hydrochloride 1 g Mgso •. 7H20 0,1 g Bromocresol purple 40 mg Agar 15 g Water 1 000 ml Dissolve the ingredients of the basal medium, adjust pH to 7,6 and autoclave at 121 •c for 15 minutes. Allow the medium tO cool and add: D-cycloserine Polymyxine-B sulphate Indoxyl-~-D-glucoside ro be dissolved m 8 ml sterile water before addition Filter - sterilised 0,5% phenolphthalein diphosphate solution Filter - sterilised 4,5 % FeCh · 6H20 400 mg 25 mg 60 mg 20 ml 2 ml 2. 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 a rrueness, precision and limit of detection specified. Whatever the sensitivity of the method of analysis used, the result must be expressed using at least the same number of decimals as for the parametric value considered in Annex I, Parts B and C. B 2668 Trueness % o{ Precision % of Limit of Parameters parametric value parametric value detection % of Conditions Notes parametric value (Nore l l (Nore 2) (Note 3) Acrylamide To be controlled by product specification Aluminium 10 10 10 Ammonium 10 10 10 Antimony 25 25 25 Arsenic 10 10 10 Benzo(a)pyrene 25 25 25 Benzene 25 25 25 Boron 10 10 10 Bromate 25 25 25 Cadmium 10 10 10 Chloride 10 10 10 Chromium 10 10 10 C~mductivity 10 10 10 Copper 10 10 10 Cyanide 10 10 10 Note 4 1,2-dichloroethane 25 25 10 ~~ Epichlorohydrin To be controlled by product specification Fluoride 10 10 10 Iron 10 10 10 Lead 10 10 10 Manganese 10 10 10 Mercury 20 10 20 Nickel 10 10 10 Nitrate 10 10 10 Nitrite 10 10 10 Oxidisabiliry 25 25 10 Note 5 Pesticides 25 25 25 Note 6 Polycyclic aromatic 25 25 25 Note 7 hydrocarbons B 2669 Trueness % of Precision % of Limit of Parameters parametric value parametric value detection % of Conditions Notes parametric value (Note 1) (Note 2) (Nore 3) Selenium 10 10 10 Sodium 10 10 10 Sulphate 10 10 10 Tetrachloroethene 25 25 10 Note 8 T richloroethene 25 25 10 Note 8 T rihalomethanes - 25 25 10 Note 7 Total Vinyl chloride To be controlled by product specification 2.2. For hydrogen ion concentration the specified performance characrerisarics are that the method of analysis used must be capable of measuring concentrations equal to the parametric value with a trueness of 0,2 pH unit and a precision of 0,2 pH unit. Note 1 (*): Note 2 (•): Note 3: Note 4: Note 5: Note 6: Note 7: Nnte 8: Trueness is the systematic error and is the difference between the mean value of the large number of repeated measurements and the true value. Precision is the random error and is usually expressed as the standard deviation (within and between batch) of the spread of results about the mean. Acceptable precision is twice the relative standard deviation. (•) These cerms are further defined in ISO 5725. Limit of detection is either: three rimes the relative within batch standard deviation of a natural sample containing a low concentration of the parameter, or five times the relative within barch standard deviation of a blank sample. The method should determine total cyanide in all forms. Oxidation should be carried our for 10 minutes at 100 •c under acid conditions using permanganate. The performance characteristics apply to each individual pesticide and will depend on the pesticide concerned. The limit of detection may not be achievable for all pesticides at present, but Member States should strive to achieve this standard. The performance characteristics apply to the individual substances specified at 25 % of the parametric value in Annex I. The performance characteristics apply to the individual :,ub:,cances specified ar 50 % of rhe parametric value in Annex I. 3. PARAMETERS FOR WHICH NO METHOD OF ANALYSIS IS SPECIFIED Colour Odour Taste Total organic carbon Turbidity (Note 1) Note 1: For turbidiry monitoring in treated surface water 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 a trueness of 25 %, precision of 25 % and a 25 % limit of detection. Directive 801778/EEC Transposition 17.7.1982 Application 17.7.1985 All Member States except Spain, Port11gal and new Liinder of Germany Articles I to 14 Article 15 Article 16 Article 17 Article 18 Article 19 Article 20 Article 21 ANNEXlV DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW AND FOR APPLICATION Directive 81/858/EEC Act of Accession of Spain and Directive 90/656/EEC for new Act of Accession of Austria, Portugal Liinde.- of Germany Finland and Sweden (Adaptation due to acces1ion of Spain: transposition 1.1.1986 Austria: transposition 1.1.1995 Greece) applicatio n 1.1.1986 application 1.1.1995 Portugal: transposiiion l.l.1986 Finland: transposition 1.1.1995 application 1.1.1989 application 1.1.1995 Sweden: transpositi,m 1.1.1995 application 1.1.1995 Application 31.12.1995 Amended with effect from Amended with effect from Amended with effect from 1.1.1981 1.1.1986 1.1.1995 Amended Amended Directive 91/692/EEC Article 1 ?(a) inserted tD N 0\ .J 0 B 2671 ANNEX V CORRELATION TABLE This Directive Directive 80/778/EEC Article 1 ( 1 I Article 1 ( 1) Article 1(2) Article 2( 1) Article 2 (a) and (b) Article 2(2) Article 3 ( 1) Article 4(1) (a) and (b) Article 3(2) (a) and (b) Article 3(3) Article 4 ( 1) Article 7(6) Article 4(2) Article 11 Article 5(1) Article 7(1) Article 5(2) first senrence Article 7 ( 3) Article 5(2) second sentence Article 5(3) Article 6(1) Article 12(2) Article 6(2) to (3) Article 7( 1) Article 12(1) Article 7(2) Article 7(3) Article 12(3) Article 7(4) Article 7(5) Article 12(5) Article 7(6) Article 8 Article 9(1) Article 9(1) and Article 10(1) Article 9(2) to (6) Article 9 ( 7) Article 9(2) and Article 10(3) Article 9(8) Article 10 Article 8 B 2672 This Directive Directive 80/778/EEC Arricle 11(1) Arricle 11(2) Article 13 Article 12(1) Article 14 Arrirle 12.()) and (3) Artide 15 Article 13(1) Article 13(2) to (5) Article 17(a) (inserted by Directive 91/692/EEC) Article 14 Article 19 Article 15 Article 20 Article 16 Article 17 Article 18 Article 18 Arrid,. 19 Article 21 lppubblikat mid-Dipartiment ta' 1-lnformazzjoni- 3, Pjazza Kastilja- Published by the Department of Information -3, Castille Place Mitbugh fl-Istamperija tal-Gvem - Printed at the Government Printing Press Prezz 34c - Price 34c