T.C.
TARIM ve KÖYİŞLERİ BAKANLIĞI
Koruma ve Kontrol Genel Müdürlüğü
Section One
General Provisions
Part One
Objective, Scope, Legal Basis and Definitions
Objective
Article 1- The aim of this regulation is; to provide the technical and hygienic conditions and ensure the quality standards of the waters for human consumption and; to organize the basics and procedures regarding the production, packaging, labeling, marketing and auditing of the spring and drinking waters.
Scope
Article 2- This regulation constitutes provisions about spring waters, drinking waters and waters for drinking-using purpose. However, it does not apply to natural mineral waters, thermal and drinking waters, and waters for medicinal purposes.
Exemptions
Article 3- The provisions mentioned below will not be applied;
a) water intended exclusively for those purposes for which the competent authorities are satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the consumers concerned;
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, unless the water is supplied as part of a commercial or public activity.
The exemptions provided for in paragraph (b) of this article shall ensure that the population concerned is informed thereof and of any action that can be taken to protect human health from the adverse effects resulting from any contamination of water intended for human consumption. In addition, when a potential danger to human health arising out of the quality of such water is apparent, the population concerned shall promptly be given appropriate advice and the necessary measures shall be taken.
Legal Basis
Article 4- This regulation is prepared according to; Article 235 and 242 of the 24/4/1930 dated and 1593 numbered General Hygiene Law and Article 26 of the 27/5/2004 dated and 5179 numbered law regarding the approval of the amended statutory decree concerning the Protection, Consumption and Inspection of Food and; Article 43 of the 13/12/1983 dated and 181 numbered Statutory decree Concerning the Organization and Tasks of the Ministry of Health,
Also, the 98/83/EC numbered Council Directive on the Quality of Water Intended for Human Consumption, the 15/7/87 dated and 80/777/EEC numbered Council Directive about the Approximation of the Laws of the Member States Relating to the Exploitation and Marketing of Natural Mineral Waters and the 16/5/2003 dated 2003/40/EC numbered Council Directive, Establishing the List, Concentration Limits and Labeling Requirements for the Constituents of Natural Mineral Waters and the Conditions for Using Ozone-Enriched Air for the Treatment of Natural Mineral Waters.
Definitions
Article 5- The following concepts are used to mean the following;
a) Ministry: The Health Ministry,
b) Commission: The European Commission
c) Deputy Under secretariat: Office of the Prime Minister, Under-secretariat of Foreign Trade,
d) Directorship: Local Health Authority,
e) Water intended for Human Consumption: all water either in its original state or after treatment, intended for drinking, cooking, food preparation or other purposes, supplied from a distribution network, from a tanker, or in bottles or containers and; all water used in any food-production undertaking for the manufacture, processing, preservation or marketing of products or substances intended for human consumption unless the water does not affect the wholesomeness of the foodstuff in its finished form,
f) Spring Water constitutes: the water naturally formed under appropriate geological conditions within geological units, emerging from a spring tapped at one or more natural exits or/either extracted by technical means; water without undergoing any treatment apart from the ones permitted in Article 36 and carrying the characteristics indicated in Annex-1; meeting the labeling requirements and; the underground water packaged in order to be supplied to the market,
g) Drinking Water constitutes: the water naturally formed under appropriate geological conditions within geological units, emerging from a spring tapped at one natural exit or/either extracted by technical means; the applicability of the disinfection, filtration, precipitation, purification and similar procedures permitted by the Ministry; reaching the parameter values enlisted in Annex-I by increasing or decreasing the parameter values; the water meeting the labeling requirements and; the underground water bottled in order to be supplied to the market,
h) Drinking-Using Water constitutes: all water regardless of its origin or in its original state or after refinement supplied from source or distribution network intended for drinking and cooking; used in preparation, marketing, processing and preservation of food or other products offered to human consumption and; the water fulfilling the parameters indicated in Annex-1,
i) External Distribution System: the pipe work, fittings and appliances which are installed until the domestic distribution system and used for supplying water for human consumption,
j) Domestic Distribution system: the pipe work, fittings and appliances which are installed between the taps that are normally used for human consumption 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,
k) Committee: is the Committee established (i.e. with the proposal of the local health director and the acceptance of the Governorship) in each province to analyze the spring and drinking waters,
l) Facility license: is the permission given to construct spring and drinking waters installations in accordance with this Regulation,
m) Manufacturing license: is the certificate given to spring and drinking waters manufactures,
n) Automatic Machines: refers to the machine used in the bottling plant to do the washing, filling and capping process automatically without being touched by human hand,
o) Automatic system: is the system used in the business to automatically clean the containers produced and do the filling and capping process without being touched by human hand,
p) Recyclable containers: constitutes water non-interactive glass, metal, chrome-nickel and similar containers which are not used more than once,
q) Un-recyclable containers: are defined as the pet, glass, metal, chrome-nickel and similar containers that cannot be used more than once,
r) The Preliminary Report of the Committee: is the first report prepared (i.e. according to the basis and procedure of this Regulation) by the committee about the source of the water, exit point and the place of installation,
s) The Final Report of the Committee: it is the final report prepared by the committee indicating that the construction of the spring and drinking waters installation is in line with the procedures and basis of this Regulation and the projects presented during the stage of facility license.
t) Member States: Member states of the European Union,
u) Third countries: Those countries that are not members of the European Union.
PART TWO
General Characteristics, Quality Standards and Timescale for Compliance of the Regulation
General Characteristics
Article 6- It is compulsory that the water intended for human consumption is wholesome and clean.
According to the minimum requirements of this regulation, water intended for human consumption shall be wholesome and clean if it;
a) is free from any micro-organisms and parasites and from any substances which, in numbers or concentrations, constitute a potential danger to human health, and
b) meets the minimum requirements set out in Annex I and if it is in line with Article 7, 8, 10, 11 and 13 of this regulation;
The measures taken to protect human health during the implementation of this regulation in no circumstances have the effect of; exceeding the physical, chemical, radioactive and microbiological parameters indicated in this regulation; any deterioration of the present quality of water intended for human consumption or any increase in the pollution of waters.
Quality Standards
Article 7- The quality standards of the water constitutes the parameter values set out in Annex- I
The values of parameters set out in Annex I (c) and (d) are used for monitoring water and remedial action, and for the fulfillment of the obligations imposed in Article 11.
In situations where the protection of human health is necessary, the parameters not constituted within Annex I can be included. The parameters added should at least should ensure that the water is free from any micro-organisms and parasites and from any substances which, in numbers or concentrations, constitute a potential danger to human health.
The Points Compliance
Article 8- The parametric values set out in Article 7 shall be complied with:
a) in the case of water supplied from a distribution network, at the point, within premises or an establishment, at which it emerges from the taps that are normally used for human consumption;
b) in the case of water supplied from a tanker, at the point at which it emerges from the tanker;
c) in the case of water put into bottles or containers intended for sale, at the point at which the water is put into the bottles or containers;
d) in the case of water used in a food-production undertaking, at the point where the water is used in the undertaking.
When non-compliance in quality standards is detected-except in establishments where water is supplied to and water outside collective use-due to repair of domestic distribution system, then it shall be considered that the water complies with the provisions this Regulation.
In cases where paragraph 2 of this article applies for waters maintained from domestic distribution systems, the competent authorities shall take appropriate measures to reduce or eliminate the risk of non-compliance with the parametric values and advise property owners of any possible remedial action they could take. Apart from these, other measures such as appropriate treatment techniques shall be taken by the competent authorities to change the nature or properties of the water before it is supplied so as to reduce or eliminate the risk of the water not complying with the parametric values after supply. Thus the consumers concerned will be duly informed and advised of any possible additional remedial action that they should take.
Time Scale for Complying with the Provisions of the Regulation
Article 9-The measures necessary to ensure that the quality of water complies with this regulation shall be taken within three years after the entry into force of this Regulation.
However;
a) when possible (without making any concessions on disinfection) a lower value of Bromat than the one referred to in Annex-1(b) shall be targeted. For waters referred to in Article 8 paragraphs (a), (b) and (c), the parametric value of Bromat in Annex-1 (b) shall be maintained within 5 years after the entry into force of this Regulation (at the latest). The parametric value of Bromat for the first three years after the entry into force of this Regulation is 25µg/L.
b) For waters referred to in Article 8 paragraphs (a), (b) and (c), the parametric value for Lead mentioned in Annex-1
(b) shall be maintained at the latest within 15 years after the entry into force of this Regulation. The parametric value of Lead for the first eight years after the entry into force of this Regulation is 25µg/L.
Within the timescale given for complying with the parametric value of Lead all measures shall be taken to ensure that the amount of Lead in waters intended for human consumptions is at the lowest possible level.
During the measures taken to ensure the compliance with this value, the Ministry shall give priority to places where the amount of lead is high in waters intended for human consumption.
c) When possible(without making concessions on disinfection) a lower value for trihalometans than the one referred to in Annex-1(b) shall be targeted. For waters referred to in Article 8 paragraphs (a), (b) and (c), the parametric value for trihalometans mentioned in Annex-1 (b) shall be maintained within 10 years after the entry into force of this Regulation (at the latest). The parametric value of total trihalometans for the first eight years after the entry into force of this Regulation is 150µg/L.
SECTION TWO
Drinking-Using Water
PART ONE
Provisions Regarding Drinking-Using Waters
Monitoring, Disinfection and Analysis Characteristics
Article 10- The drinking-using waters offered to consumption are subject to audit and check monitoring in the minimum frequency laid down Annex-2 Table B1. Monitoring programs shall be prepared according to the minimum requirements mentioned in Annex-2 Table 1. The points of sampling shall be determined by the competent authorities so as to meet the requirements mentioned in Annex-2. The samples shall be taken so that it can reflect the quality of the water throughout the year. However, in circumstances where non-compliance with the parametric values laid down in Annex-1 (a) and (b) and Article 7 paragraph 2 is detected, to determine the volume of pollution and effectiveness of measures, additional audit monitoring outside the audit programme in Article 11 may be demanded.
The purpose of audit monitoring is to provide the information necessary to determine whether or not all of the Regulation's parametric values in Annex-1(a) and (b) are being complied with. All parameters set in accordance with Annex-1 (a) and (b) and Article 7 paragraph 2 must be subject to audit monitoring. If seen necessary by the Ministry the parameter values in Annex-1(c) and (d) can be included audit 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 drinking-using water parametric values laid down in Annex-2 Table A complies with the parametric values in Annex-1.
In circumstances where the disinfection of drinking-using waters is necessary, the effectiveness of the disinfection shall be confirmed. In order to avoid pollution arising from by-products; (without making concessions on disinfection) the doses of disinfection are kept at low levels and all necessary measures shall be taken.
When chlorine is used in the disinfection of drinking-using waters, the amount of free balance chlorine -samples taken from the edge points-can be 0.5 mg/L at the most.
The sampling points of drinking-using waters are the points indicated in Article 8. The samples and analysis taken from these points, analysis of parameters, sampling and analysis frequency shall be carried out according to Annex-2 Table B1.
For the parameter’s analysis specifications the requirements set out in Annex-3 shall be met.
When different methods are used apart from the ones in Annex-3(1), the results of the methods used must be credible. The Ministry must approve and be informed of methods used thus the methods used must equitable to Annex-3. The Commission must be informed of the different methods used.
Any method may used as long as the conditions in Annex-3 are fulfilled. The analysis performance specifications used for the analysis of the parameters in Annex-3(2) must be in accordance with the performance characteristics set out in this part.
If the drinking-using waters are polluted due to the parameters not included in this regulation and if the nature of this pollution poses a potential threat to human health, a separate monitoring will be carried out for substances and micro-organisms that do not exist within this Regulation and according to the monitoring results necessary measures will be taken.
Remedial Action and Restrictions in Use
Article 11-In situations where failure to meet the parametric values set in Annex-1(a), (b) and Article 7 of this Regulation exists, investigation will be carried out in order to identify the cause of non-compliance.
If the waters provided by distribution network do not comply with the parametric values set in Annnex-1(a) and Article 7(2) despite the measures taken, and if this situation is caused by repair of the distribution network, then the competent authorities shall take remedial action as soon as possible to restore the quality of the water, having regard inter-alia to the extent to which the relevant parametric value has been exceeded and to the potential danger to human health.
In situations where there is a failure to meet any of the parametric values, if seen necessary the waters may be subject to additional audit monitoring outside the monitoring programme. Whether or not any failure to meet the parametric values has occurred, it shall be ensured that any supply of water intended for human consumption which constitutes a potential danger to human health is prohibited or its use restricted or such other action is taken as is necessary to protect human health. What sorts of action should be taken, is decided bearing in mind the risks to human health which would be caused by an interruption of the supply or a restriction in the use of water intended for human consumption. In such cases consumers shall be informed promptly thereof and given the necessary advice. The competent authorities may prepare guidelines about the measures taken.
In the audit monitoring, when there is non-compliance with the parametric values or with the requirements set out in Annex I (c) and (d), then it shall be considered whether the non-compliance poses any risk to human health. Remedial action shall be taken to restore the quality of the water where it is necessary to protect human health.
Consumers are notified if non-compliance is at serious levels and if it requires remedial action.
Derogations
Article 12- No derogation shall constitute a potential danger to human health. However in circumstances where the supply of water intended for human consumption in the area concerned cannot otherwise be maintained by any other reasonable means, derogations may be given from the parametric values in Annex-1 and Article 7(2) to the maximum limits determined by the competent authorities. Derogations shall be limited to a short time and shall not exceed three years. Towards the end of this time period a review shall be conducted to determine whether sufficient progress has been made. In circumstances where a second derogation is granted, the reasons for taking derogation shall be forwarded to the Commission. The second derogative shall not exceed three years. However in exceptional circumstances, a third derogation for a period not exceeding three years may be demanded from the Commission.
Any derogation granted shall specify the following:
(a) the grounds for the derogation;
(b) the parameter concerned, previous relevant monitoring results, and the maximum permissible value under the derogation;
(c) the geographical area, the quantity of water supplied each day, the population concerned and whether or not any relevant food-production undertaking would be affected;
(d) an appropriate monitoring scheme, with an increased monitoring frequency where necessary;
(e) a summary of the plan for the necessary remedial action, including a timetable for the work and an estimate of the cost and provisions for reviewing;
(f) the required duration of the derogation.
If the competent authorities consider the non-compliance with the parametric value to be trivial, and if action taken in accordance with Article 11(2) is sufficient to remedy the problem within 30 days, the requirements of paragraph 2 need not be applied. In that event, only the maximum permissible value for the parameter concerned and the time allowed to remedy the problem shall be set.
Recourse may no longer be had to the previous paragraph if failure to comply with any one parametric value for a given water supply has occurred on more than 30 days on aggregate during the previous 12 months.
Recourse to the derogations provided for in this Article shall ensure that the population affected by any such derogation is promptly informed. In addition to this, where necessary, advice is given to particular population groups for which the derogation could present a special risk. These obligations shall not apply in the circumstances described in paragraph 3 unless the competent authorities decide otherwise.
With the exception of derogations granted in accordance with paragraph 3, the Commission shall be informed within two months of any derogation concerning an individual supply of water exceeding 1 000 m³ a day as an average or serving more than 5 000 persons, including the information specified in paragraph 2.
This Article shall not apply to water intended for human consumption offered for sale in bottles or containers.
Quality Assurance of Treatment, Equipment and Materials
Article 13-All necessary measures shall be taken to ensure that no substances or materials for new installations used in the preparation or distribution of drinking-using waters or impurities associated with such substances or materials for new installations remain in water intended for human consumption in concentrations higher than is necessary for the purpose of their use and do not, either directly or indirectly pose a risk to human health. All surface and toolsa nad devices contacting or having the possibility of contacting with water till the final point where the water is offered to consumption shall be made of materials which will not affect the characteristics of water or harmful to human health.
Information and Reporting
Article 14-The competent authorities shall provide the consumers adequate and up-to-date information on the drinking-using water thus the Ministry will be informed in this direction.
A report will be published every three years about the quality of the water to provide consumers with information. The report shall include, as a minimum, information about all individual supplies of water exceeding 1 000 m³ a day as an average or serving more than 5000 persons. It shall cover three calendar years and be published within one calendar year of the end of the reporting period. These reports shall be forwarded to the Commission within three months of their publication. The reports shall be prepared having regard to the provisions in Article 3 paragraph 1(b), Article 7 paragraph 1 and 2, Article 10 paragraph, Article 11, Article 12 paragraph 5 and 6, and Article 15 paragraph 1.
Together with the report, a report shall be prepared and forwarded to the Commission about the measures taken or planned to be taken to fulfill their obligations under Article 11 paragraph (1) and (3) and Article 9 paragraph (c) 10.
Timescale for Compliance and Exceptional Circumstances
Article 15- To comply with the provisions in Article 9 regarding the timescale for compliance, in exceptional circumstances and for geographically defined areas, a special request may be submitted to the Commission to extend the period longer than that laid down in Article 9. This additional period cannot exceed three years and towards the end of the period a review shall be forwarded to the Commission. On the basis of the review a second additional period of up to three years may be demanded from Commission. This provision shall not apply to water intended for human consumption offered for sale in bottles or containers.
Any such request, grounds for which shall be given, shall set out the difficulties experienced and include, as a minimum, all the information specified in Article 12 (2).
The competent authority shall ensure that the population affected by the request is promptly informed in an appropriate manner about the outcome of the request and where necessary, ensure that advice is given to particular population groups for which the request could present a special risk.
SECTION THREE
Spring Waters and Drinking Waters
Part One
Provisions Concerning the Permission of Spring and Drinking Waters
Prohibiting the Sale of Unpermitted Spring and Drinking Waters
Article 16- The provisions concerning the prohibition of the sale of unpermitted Sring and Drinking waters are as follows:
a) Even if the waters comply with the definition and characteristics specified in this Regulation, the spring and drinking waters which haven’t acquired permission in accordance with the provisions of this Regulation are prohibited to be sold, supplied to market or offered to consumption.
b) It is forbidden to sell surface waters such as stream, river and lake waters.
c) The spring and drinking waters coming from one source cannot be used more than one real or artificial persons.
d) It is prohibited to sell licensed waters under a different name from that of the manufacturing License. However, with the special permission of the Ministry the licensed waters may be bottled for own company or in lieu of a different company with a different commercial name with the objective of exporting spring and drinking waters to third countries. It is essential that producers doing bottling according to this Article inform the Ministry and take permission according to Annex-6.
e) The spring and drinking waters permitted according to this Regulation shall be transported and deposited to areas of consumption through vehicles, tanks and depots in accordance with the hygienic conditions. Thus in accordance with the framework of these procedures and with the permission of the Ministry, water shall be supplied to establishments or businesses preferring the spring and drinking waters fulfilling the requirements in Annex-2 and in need of water over 500 Liters per day for the preparation of food or foodstuffs or meeting the water needs of the employed and service staff or producing any material within the industry.
f) According to paragraph (e) of this Article, water shall be supplied to groups of people living outside municipality which are in need of water more than 500 liters per day and do not posses a hygienic water network or sufficient amount of drinking-using water. These waters cannot be sold to others.
Obligation to take Permission
Article 17- According to the basis of this regulation, those who wants to operate spring and drinking waters must receive facility license and manufacturing license from the Ministry.
The permission given according to this Regulation does not eliminate the obligations required by the legislation in force to take permission from other institutions.
First Application, the Examination of Water and Analyses
Article 18- The real and artificial persons wanting to operate the spring and drinking waters (stated in this regulation) prior to commencing any treatment to the source, should apply to the governorship with a plan and croquis indicating the place of the source and the land where the plant will be constructed on, without leaving any points for hesitation.
Upon the receival of the application by the directorship, the source or exit point of the water shall be transformed so that the personnel from the directory can take samples from the source. The Committee will analyze the source or exit points and the facility place at site. If the directorship, at the end of the inspection arrives to a conclusion that the source is in accordance with its identification, technically appropriate samples shall be taken to carry out measurements like the inflow rate and temperature at the source and latter prepares a detailed preliminary report about the catchment area and the protected area surrounding the source or exit points and other aspects.
The samples taken will be analyzed preferably by accredited laboratories with analytical control systems, selected among the laboratories that are inspected by certain institution or individuals whose inspection authority is approved but empowered institutions, analyzed by laboratories given authority by the Ministry.
According to the legislation in force, the costs of the analysis made for the manufacturing license and facility license, the transportation costs of the members of the Committee should be covered by the manufacturer.
Committee
Article 19- Committee; is formed under the leadership of the Local Health Authority or the assigned Vice Health Authority and there under the following members:
a) Head of Food and Environmental Control Division,
b) Chemical Engineer or Chemist or Food Engineer or biologist,
c) Geology Engineer or Hydro-Geology Engineer,
d) Mechanical Engineer,
e) Construction Engineer,
f) Medical technology or Health official or Environmental Health Technician,
g) An interested authority from the Public Works Director.
In the stage of facility license, the Committee will be gathered with at least one representative from the groups mentioned in the first section of this article (a, c, e, f and g).
In the Manufacturing License stage, the Committee will gather with at least one representative from the groups mentioned in the first section of this article (a, b, d, e ve f).
If it is seen necessary other relative technical staff will be included in the Committee. Also, a representative from the civil society organizations may attend the Committee as an observer. The representative does not have to attend the Committee.
If there is a conflict among the Committee members, the Ministry may take into consideration the opinion of a specialist or reorganize another group.
The Preparations of Projects
Article 20- Following the positive report of the Committee, the manufacturer appoints a responsible engineer to prepare projects constituting the source (exit point) that belongs to the company, catchment area, pipeline, accumulation room, depository, bottling plant and other units belonging to the social facilities. The projects will be prepared at the following scale:
a) Plans showing the source area (indicating the preservation area) on a 1/100 or 1/1000 scale,
b)1/20 - 1/50 scale catchment area project,
c) 1/200-1/2000 scale, pipeline plan and profile indicating the connections of the source, the accumulation room, trough and other similar units,
d) 1/20 - 1/50 phoseptic project and explanation report on areas with no canalization,
e) If a depository is to be used, a 1/50 - 1/100 scale depository projects,
f) 1/50 –1/500 scale bottling Project (With regard to the process applied, showing the production place for non-recyclable containers, the unwashed and filled containers waiting place, washing, bottling, capping and other similar units),
g) The machine construction and work line scheme and explanation reports,
h) 1/50-1/500 scale Project showing the social facility and other supplementary units,
i) General plan showing all the units, including the protection area of source.
The Preparation of Files
Article 21-For the Facility License, the submitted file will contain three copies of the following information and documents:
a) Petition,
b) Projects mentioned in Article 20,
c) A full analysis reports of the samples taken from the source/sources or exit point/points of the waters according to the parameters indicated in Annex I (),
d) The Committee’s preliminary report about the water,
e) The Evaluation Form for Spring and Drinking Water Facility License in Annex 4,
f) The Approval of the Governorship,
g) An explanatory report about the bottling of water,
h) Hydro geological analysis report,
i) The land registry of the spring water including the protected area defined by the committee, if the place belongs to other real or artificial persons a copy of an agreement approved by the notary. In shared title deeds a notary approval of the shareholders consent or the relative courts decision,
j) Information and documents about the process applied on the water,
k) For underground waters extracted by technical means and drinking waters exiting from wells, the Underground Water Intended for Drinking Use Document shall be taken from the General Directorate of State Water Affairs,
l) For underground drinking waters extracted by technical means a contract stating that water is rented from the Provincial Administration in accordance with the relative legislation,
m) Information and documents about the materials that will be used for the pipeline project,
n) If present, written opinion taken from other establishments (in accordance with this regulation).
The prepared files and projects will be analyzed by the directorship and if seen appropriate it shall be approved. The documents and files seen appropriate and approved by the Directorship (that is, the form in Annex-4) prepared in accordance with the information in file, Governorship Approval, Committee Report and Analysis Reports will be sent to the Ministry. A copy of the files will be preserved in the Directorship and the other copy will be preserved by the Manufacturer.
Facility License
Article 22- The information and documents transmitted to the Ministry will be examined and if necessary inspected at site. If appropriate, the governorship is writtenly informed that the organization is awarded the facility license. One copy of the files approved by the Directorate shall remain at the Directorate; the other shall be preserved by the manufacturer.
The water owners or manufacturers cannot have any rights over constructions and facilities they have established without obtaining facility license from the Ministry.
The Facility License shall be valid for three years. If the facility cannot be constructed within this period of time and if the owner of the establishment applies to the Ministry for additional time before the end of the three year period, the Ministry can extend this time period for 2 years at the most.
Manufacturing License
Article 23- The manufacturers granted with the facility license upon fully complying with the requirements of the regulation and completing the construction of the facility can apply to Governorship with their approved project by submitting a petition requesting the manufacturing license.
The Committee will ensure the inspection of the facility locally and upon approval of the project’s accordance to the provisions of the regulation, the analysis of the samples (according to the basis of the License) of the water taken from the exit point where the water will be presented for consumption, in accordance with the parameters in Annex-1. The result of the analysis shall take place on the label information of the water.
The Committee Final Report, full analysis report of the water, approval of the Governorship, three label samples containing company’s stamp and signature, and the Evaluation Form for the Spring and Drinking Waters Manufacturing License in Annex-5 will be sent to the Ministry.
The manufacturing license will be granted by the ministry upon local inspection of the facility and inspection of the file, if seen necessary.
In the event constructing facilities in accordance with their project before, the facility will be evaluated by Local Health Authorities according to Annex 4 and Annex 5 and if there is no deficiency the necessary information and documents will be sent to the Ministry. If it is seen appropriate by the Ministry the Manufacturing License and Facility License may be given at the same time.
SECTION TWO
The Provisions About the Facility
Protected Source Area
Article 24- The protected source area, is determined by the Committee by taking into consideration the geological formation, topographic and hydro geologic conditions.
The points about the protection area will be indicated in the projects and the reasons shall be clarified in Preliminary reports of the Committee.
In the protected area the entrance of humans, animals, flood and other waters must be avoided and all the necessary precautions must be taken against pollution. In this area it is not permitted to do any activity that will affect the characteristics of the water.
Catchment Area
Article 25- It is essential to collect waters emerging from natural exits (by not using technical means) in the catchment area. The catchment area shall be constructed in such a way that; the water gets prepared for bottling and all sorts of pollution and leeks inside the catchment area prevented. The catchement area is situated in the outflow point of the source.
The catchment area, constituting of the maneuvering room and the room where the water is collected, will be made by glass or other materials that will not affect the natural characteristics of water and separated in such a way that it can be opened and closed.
In the maneuvering room constitutes; the area where the water is collected, extracted, sampled and the inflow rate measured thus; the devices necessary to release the waters into the maneuvering room. Also, an arrangement shall be made to air both rooms either separately or together, without the water being polluted from external effects. These characteristics will be taken into consideration in the room where the water is collected and similar structures, thus in such units the necessary devices will be placed in the releasing points.
For the waters collected in separate catchment areas constituting the same characteristics, one maneuvering room may be constructed.
The Production
Article 26- The pipeline for releasing water from the catchment area to the depository should be made by material that will not affect the physical, chemical and microbiological characteristics of the water.
The pipeline project shall be constructed in such a way that the pipeline continuously has pressurized water.
The water will be released from the catchment area to the depository under hygienic and technical conditions. If this is not possible topographically, then the production of water will be maintained by increasing the level of water and using a pump.
Water Deposits
Article 27- The water deposits should carry the following characteristics:
a) The internal surface of the depository can be either inlaid with tiles or covered with materials which do not affect the characteristics of the water. The deposits will constitute the maneuvering room and two divisions.
b) The entrance into the deposit divisions will be made through the maneuvering room or valve groups which allow maneuvering. It is not allowed to have fixed ladders inside the deposits.
c) A system should be found for sampling the waters entering and exiting the deposits and measuring the inflow rate of the water.
d) The deposits cannot be made next to any other building or have a roof; however if it is necessary it can be next to the bottling plant.
e) An appropriate ventilator could be found for airing the divisions of the deposits and avoiding the entrance of other substances from the outside.
f) The pipes that enter the depository (used for releasing water) shall be organized so that it does not contact with water.
g) A visible scheme indicating the pipes entering and exiting the deposit and the connections between the pipes should be hanged in the maneuvering room of the deposit.
h) Also, in deposits made from stainless steel or similar substances (which will not affect the characteristics of the water) steel tanks covered with epoxy substance can be used on surfaces contact with water.
Bottling Plant
Article 28- The bottling plant constitutes the following sections:
a) For the filling of recyclable glass and other containers permitted;
1) A depository for empty bottles,
2) A section for the filled containers.
b) For filling the containers produced in the facility;
1) A section where the raw materials stored,
2) A section for the filled containers
The floors of bottling plant shall be inlaid with stainless and washable tiles and the floors of each section must have drains, if drains are not present, then a siphon and grill apparatus connects with the septic tank will be found. The floors of all units will be made so that the water will run quickly and easily towards the siphon apparatus.
The septic hole should be separate from the sewage (toilette) hole and should be built in a separate place where it will not pollute the waters. It should be in accordance with the 19/3/1971 dated and 13783 numbered regulation (i.e. published in the official gazette) about the Places where Building Sewage Course is not allowed.
The walls (at least 2 meters long) of the bottling plant will be inlaid with tiles from top to bottom, which are easily washed and hygienic.
The division walls of the bottling plant can be inlaid with tiles or stainless steel or glass. It is essential that these walls are at the minimum 2 meters long.
The bottling plant shall be constructed in such a way that the plant remains clean and daylight could enter (having sufficient size) the plant. Cleaning shall be made by technical and hygienic means.
The tools and devices in the bottling plant should be made by material which can easily be cleaned. The dust bins and other equipments used for cleaning should be preserved in a place that would not affect the natural mineral water. General cleaning will be made outside the working hours. If working hours is non-stop, then cleaning will be done by temporarily stopping work.
All sorts of scientific and hygienic precautions will be taken to avoid insects and rodents entering the bottling plant. If necessary, the authorized personnel will conduct chemical combat according to the techniques and procedure in the plant. During the combat only products (chemicals) that are authorized by authorities will be used and these products should not be present (during production) in the plants.
In the bottling plant it is prohibited; for the staff to do their personal cleaning; to store containers, caps and other materials in private sections and; to have cats, dogs, poultry and similar pets.
In the bottling plant, the same machines and filling devices may be used to manufacture other water and drinks with the permission of the relevant institutions.
Social Facilities
Article 29- In order to meet the social demands of the workers, hygienic and appropriate numbers of dining halls, dressing rooms, resting place, showers, toilets, sinks and if necessary dormitories should be built.
The Surface in Contact with Water
Article 30- From the source to the filling, all surfaces and potential surfaces contacting waters (i.e. thus the tools and devices used) must be made by materials that are will not be effective on the characteristics of the water or harmful to health.
Part Three
Containers, Caps and Labels
Containers
Article 31- The containers used for filling the waters must be permitted by the relative Ministry. These containers shall be made by substances (which are permitted) which does not contact with water or affect the characteristics of the water.
In situations where material other than glass is used, information and documents about the use and production of containers and containers not being harmful to health will be submitted to the Ministry and then permission will be given.
The containers used for the filling waters are divided into two groups, namely recyclable and non-recyclable containers:
a) Recyclable Containers: must be washable at least at 55-70 C temperature; can be washed by automatic machines (i.e. with appropriate cleaning substance) without being touched by human hand and; must not be deformed after being washed. The containers must be controlled by detectors or similar systems.
b) Non-Recyclable Containers: In the usage of containers other than glass and metal for filling waters, these containers will be produced in the relative section by raw materials and performs actions in the relevant section. Prior to filling, the containers will be washed by pressurized water and air without being touched by human hand and then taken to filling.
Apart from non-recyclable containers such as PET polyethylene or PVC (polyvinyl chlorine) automatically produced aluminum foil containers (non-recyclable) may be used.
Caps/Lids
Article 32- The caps used on the water containers are dependent on the permission the Ministry, thus must possess the following characteristics:
a) The caps will be made of metal or plastic which are non-interactive with water and are not harmful to human health. However, the lids will be firmly closed without being ripped or deformed by the automatic capping machine in the bottling plant.
b) In the filling of containers that is in the shape of glass (cup the top of the glass will be sealed completely-according to its technique- without using glue. In order to open the lids easily there should be an opening extension. The caps will be preserved in the bottling plant under hygienic conditions.
The usage of the deformed and used caps/lids is prohibited.
The Washing, Filling and Capping of Containers
Article 33-The washing, filling and capping of the containers is done with automatic machines and systems without being touched by human hand. The recyclable containers are washed before the filling process. In the automatic washing units, the washing process is done with the appropriate technology and equipment.
The products used for washing must continuously activate.
The cleaning products permitted by the Ministry will be used. Information about the cleaner will exist in the process file.
The washing water of the facility should be changed every day and when it becomes unhygienic.
It is prohibited to have water in the filling room other than the water used for filling and the water used for washing.
Label Information
Article 34- The label of the water shall include: the name of the water, type, the place/address where the water is exploited, the authorization date and number given by the Ministry, the precautions seen as necessary by the Ministry, the separation of elements permitted by the Ministry, the information on any treatments and the parameter values of water. The production and expiry date, party and series number shall be written clearly on the label, lid or container. If the labels or inscriptions on the containers of spring waters include a trade description different from the name of the water or the place of its exploitation, the place or the name of the water shall be indicated in letters at least one and a half times the height and the width of the letters used for that trade description. The type of the water must be written clearly underneath the name of the water; the inscription cannot be hidden by symbols. The information required on the label may be ovened, inscribed or printed, as well as being in the form of paper label.
All preventive measures must be taken by the manufacturer to ensure that the paper label stays on the package and does not drop or become deformed until it reaches the consumer. The name of the water must be written on the lid.
The containers, caps, packages, labels and advertisements cannot contain symbols or information that would mislead the consumer. In order to ensure the security of the product and avoiding the consumer to be misled; the manufacturers shall apply shiring on containers such as polycarbonate damicana and the lids and containers without air leaking. The name and type of the water will be clearly written on the shiring.
In the organization of the labels;
a) the surface of the label- constituting the parameters in Annex-1(c) - may be blue ( its tones) for natural spring waters, brown(and its tones) for drinking water or exactly the same as the identified color,
b) According to the type of water a band will be placed on the top and bottom corners, any color may be used in the rest of the label as long as the color requirements mentioned above are satisfied. By satisfying the color labels of this paragraph the following measurements shall be applied,
1) In 8 liters or over containers at least 1.5 cm band width will be applied and within the band the type of the water will be written with at least 18 font size letters.
2) Apart from 1 liters, to the containers between 1 and 8 liters at least 1 cm band width will be applied and within the band the type of the water will be written with at least 14 font size letters.
3) On one liter and under containers minimum 0.5 cm band width will be applied and the type of the water will be indicated in 12 font size letters. The labels prepared shall be approved by the Ministry during the stage of manufacturing license.
On the surface of the label the chemical parameters within the indicator parameters shall be written clearly.
The provisions of this regulation shall not be applied to the labels of the waters bottled to be exported to third countries.
Treatments such as adverse osmosis, disinfection, precipitation, filtration which changes the physical and chemical characteristics of the drinking waters and ozone-enriched air treatment applied to the spring waters shall be indicated on the label.
In the event of producing waters which shall be used for offering purposes by persons and establishments, in addition to the label information mentioned above the logo, name or title of the persons or establishments for which the water is produced for can be indicated on the label. The establishments and persons cannot sell these products. The Ministry shall be informed about the name and title persons and establishments for which the water is produced thus the label example and the amount of such productions.
Part Four
Various Provisions Concerning Spring and Drinking Waters
Responsible Director
Article 35- It is essential to have a responsible manager in the water facility. The information and documents about the responsible manager will be sent to the Local Health Authority. If it is seen appropriate by the authority, responsible authority document will be arranged.
The responsible authority may be a graduate or undergraduate of health, food, biology, chemistry or environment.
The assigning of the authority does not eliminate the responsibility of the manufacturer.
Disinfection, Separation and Filtration
Article 36- It is essential that spring and drinking waters are microbiologically clean from the point of reaching the earth surface to the point that it is offered to consumption. The water may not be subject to treatments other than: the separation of unstable elements, such as iron and sulfuret compounds, by filtration or decanting, possibly preceded by oxygenation, in so far as this treatment does not alter the composition of the water as regards the essential constituents which give its properties; separation of iron, manganese and sulfuret compounds and arsenic from certain natural minerals by treatments with ozone-enriched air so far as such the treatment does not alter the composition of water; the total or partial elimination of free carbon dioxide exclusively by physical methods and; removing the particulars undisolved and hanging in water through filtration without changing spring waters chemical and microbiological characteristics. However, in the circumstances of war and natural calamities such as earthquake and flood, other procedures may be applied with the permission of the Ministry.
In conditions where ozone-enriched air treatment is used;
a) The Ministry should be acknowledged,
b) In the separation process, it is essential that the separation is effective, all measures taken to avoid harmful effects and that the physical and chemical aspects of the water do not change.
c) Prior to the separation process, the microbiological criteria indicated in Article 7 will be fulfilled. In the usage of ozone-enriched air treatment, ozone, bromat and broform will be included in the control observation of the processed waters, and the maximum limit for ozone is 50 m g/L, for bromat is 3.0 m g/L and for bromoform is 1.0 m g/L. If these elements exceed the constituting limits or if the element under the maximum limits constitutes a threat to public health then precautions will be taken by the Ministry in accordance with Article 40.
Preparation treatments such as disinfection, precipitation, and filtration may be applied to drinking waters. Also, to these waters deionization, adverse osmosis, electro dialysis and similar treatments may be applied.
In drinking waters disinfection is done through ozone, ultraviolet and similar methods.
The Outfits Belonging to the Personnel
Article 37- The personnel working in the bottling plant should wear appropriate outfits and caps. The personnel operating the filling machine will have to wear masks which veil the mouth and nose.
Attention is given to the personnel’s cleaning conditions. According to Article 126 of the 1593 numbered Sanitation Law, the workers health control and porter examinations will be registered to their Health Report. The director in charge is responsible of this process.
The Analysis that Must Made by the Manufacturer
Article 38- The manufacturers are responsible of enabling the analysis of samples in the laboratories mentioned in Article 18, keep the annual reports of the analysis in separate files and inform the ministry through the Directorate’s channel.
The Files that will be kept in the Businesses
Article 39- The files that will be kept in the business constitutes; the facility license given by the Ministry, a document (i.e. consisting a photo of manufacturer) belonging to the manufacturers which is approved by the Governorship, an auditing notebook with page numbers, the last page being approved by the Health authority, the Health reports and porter examinations of the workers and the reports of the analysis made by the manufacturer according to Article 38. Also, if there is a permission document given by the Ministry (in accordance with Article 16) to export waters to third countries, the document shall be preserved in the facility.
The Validity of the Facility License, the Lost Permission Documents or Damaged Documents
Article 40 - The permissions taken for the waters and the persons; are only valid for the water or the real or artificial persons in concern. The matters indicated in the permission document are valid until; any changes in these matters or when the facility license is lost and; when the permission document becomes unreadable or indicates wrong information. In these circumstances the owner of water applies to the Governorship with a petition. The document about the changes or the notice of loss published in the newspaper or the damaged original file will be attached to the petition.
Upon the application of the manufacturer, the staff in the directorship will make the necessary analysis and if it determines that the conditions remain to be unchanged, then, a report prepared by the Directorship with the opinion of the Governorship will be submitted to the Ministry. Aftermath, the inspection made by the Ministry, upon the approval of the demand made the manufacturer the necessary corrections will be made or a new license with the old date number will given and approved with the necessary clarifications.
If the license issued to the to the manufacturer during the stage of permission/License have been detected of losing (according to Article 46) their characteristics or if at any stage the documents submitted are fake or misleading, the permission organized in the name of manufacturers will be canceled. In addition to this, the license’s given in the name of manufacturers will be cancelled, if the facility is detected of not operating or if the facility does not operate within one year from the date of detection.
The Changes and Additions Made to the Facility
Article 41- In line with Article 22 and 23 of this regulation, those manufacturers wanting to include a new source or make changes or other inclusions that would change the physical structure of the water must take permission from the Ministry.
In circumstances where the water changes its characteristics as a result of the inclusion of a new source, the present permission will be canceled and a new dated and numbered permission document will be submitted.
Import and Export Permission
Article 42- The exportation and importation of the spring and drinking waters must be done according to the provisions and conditions of this regulation. However, it will be prohibited to export or market internally those waters which are contrary with this regulation.
According to Article 16, it is forbidden to use more than one trade name when bottling from the same source. However, with the special permission of the Ministry, waters exported to third countries may be bottled by own company or in lieu by a different company with a different commercial name. The producers which will do the bottling according to this article will have to receive permission in line with the form in Annex-6.
Avoiding Name Confusion
Article 43-In order to avoid confusion in auditing of spring and drinking waters or to avoid consumers to be deceived or misled, the waters produced by different companies cannot have the same name with another manufacturing company. However, if a manufacturer producing waters in a separate place, demands to use the same trade name and sales authorization, then the name of water, name of source, or the place of source will be included in the label information or in accordance with Article 34 the name of the spring or the place of its exploitation, the place or the name of the spring shall be indicated in letters at least one and a half times the height and the width of the largest of the letters used for that trade description or the included trade name.
In order to avoid name confusion, a trademark certificate of the water or if there isn’t a trademark certificate, then a copy of the application (i.e. notary approved) document to the Turkish Patent Institute must be submitted.
The Disinfection of the Facility
Article 44- It is essential that the water facilities are in accordance with the hygienic conditions. The manufacturers must use the disinfections permitted by the Ministry. If it is seen necessary, the waters will be disinfected under the supervision of the local health organization.
Packaging Wastes
Article 45- The wastes of the containers and caps used in the bottling plant will be kept in an independent unit
Plastic and other similar non-recyclable containers cannot be kept or stored in the bottling plants.
What ever the reason, the used caps cannot be found in the bottling plant.
Audit and Monitoring
Article 46-The spring and drinking waters belonging to the installations shall be audited annually by the Ministry and every three months by the Directorate. If deficiency is detected in the installations by the Ministry, the installation must overcome these deficiencies in at least 15 days. At the end of this period, legal action shall be taken against the installations which cannot fulfill the required conditions. The drinking-using waters offered to consumption shall be subject to audit monitoring, check monitoring and market control.
The samples will be taken at the final filling point. However, if there is contamination, samples will be taken outside the bottling plant by taking the necessary precautions.
The waters supplied to the market cannot be distributed or sold with gas, petrol and petrol products.
The manufacturers must inform the Ministry through the channel of the Local Health Directorate about the annual amount of production, in the first month of the following year. The audit and check monitoring of waters shall be programmed by the Ministry according to Annex-2, Table 3.
The purpose of audit monitoring is to provide the information necessary to determine whether or not all of the Regulation’s parametric values in Annex-1 (a) and (b) are being complied with. All waters are subject to audit monitoring in accordance with parameters set in Annex-1 (a) and (b) and Article 7 (2). If seen necessary, the Ministry may include into audit monitoring the parametric values in Annex-1 (c) and (d).
In accordance with the programme for audit monitoring, the samples taken from the Directorate shall be sent to the Laboratories mentioned in Article 18 for analysis. According to Article 38, the costs of the analysis shall be covered by the manufacturer.
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 parametric values laid down in Annex-2, Table A of this Regulation. In accordance with the programme for check monitoring the samples will be taken at the final point where the water is offered to consumption by the Directorate shall be analyzed according to the parameters in Annex-2 Table A and the results shall be sent to the Ministry.
In accordance with the programme for check monitoring, the samples taken from the Directorate shall be sent to the Laboratories mentioned in Article 18 for analysis. According to Article 38, the costs of the analysis shall be covered by the manufacturer.
The samples shall be taken so that it can reflect the quality of the water throughout the year. However, in circumstances where non-compliance with the parametric values laid down in Annex-1 (a) and (b) and Article 7 paragraph 2 is detected, to determine the volume of pollution and effectiveness of measures, additional audit monitoring outside the audit programme in Article 11 may be demanded. The waters not complying with this article shall be detected according to Article 48.
If the drinking-using waters are polluted due to the parameters not included in this regulation and if the nature of this pollution poses a potential threat to human health, a separate monitoring will be carried out for substances and micro-organisms that do not exist within this Regulation and according to the monitoring results necessary measures will be taken.
If seen necessary market control shall be applied by taking the samples of spring and drinking waters supplied to market. The necessary parameters shall be analyzed according to the parameters in Annex-1.
In circumstances where the disinfection of drinking-using waters is necessary, the effectiveness of the disinfection shall be confirmed. In order to avoid pollution arising from by-products; (without making concessions on disinfection) the doses of disinfection are kept at low levels and all necessary measures shall be taken.
For the parameters analysis characteristics the conditions in Annex-3 shall be applied.
When different methods are used apart from the ones in Annex-3(1), the results of the methods used must be credible. The Ministry must approve and be informed of methods used thus the methods used must equitable to Annex-3. According to this Article the Commission must be informed of the different methods used.
Any method may used as long as the conditions in Annex-3 (2) or (3) are fulfilled. The analysis performance specifications used for the analysis of the parameters in Annex-3(2) must be in accordance with the performance characteristics set out in this part.
What ever the reason, the waters permitted to be produced under a certain name cannot be included other waters not constituting the characteristics, in the event of the detection of these waters the license shall be taken back.
Laboratory
Article 47- The daily samples of the drinking and spring waters, which constitutes the F. coli form, total germ, E. coli, nitrate, nitrite parameters, will be analyzed in the Laboratory (i.e. in the plant) under the responsibility of a Laboratory technician or by personnel educated (i.e. undergraduate or graduate) about Laboratory. The manufacturers must keep the analysis reports for each party in a file. The manufacturers will keep a record about the amount of party produced.
In order keep a record of the daily analysis a sealed and approved notebook given by the Directorship will be found.
In the inspections made, this notebook will be analyzed and compared with the analysis results in the license.
The Auditing of Non-Conforming Waters
Article 48- If the violation of the parametric values or requirements in Annex-1(a) and (b) are detected in audit monitoring all remedial action shall be taken by the manufacturer.
In the violation of the parameters in Annex-1(c), the “total indication doses” and the parametric value of tritium in Annex-1 (d) or the violation of requirements it shall be evaluated whether or not this violation causes a potential risk to human health. If seen necessary for the protection of human health, all necessary measures shall be taken by the manufacturer to improve the quality of water.
In accordance with Article 18 the company will be warned, if the result of the analyses of audit and check monitoring of waters made in the laboratory exceeds the parameters indicated in this Regulation. Within a week the samples will be taken again. If the analyses of the samples are in contrary with the parameters, then the activities of the installation will be temporarily stopped and the necessary precautions will be taken. After the precautions taken, if the sample is appropriate with this Regulation the company will be permitted to produce and will be observed weekly during a month. If the analyses are appropriate after four times of inspection, then the company will return to the routine monitoring period.
If the water Licensed according to this Regulation has been detected of continuously losing their chemical, physical and micro-biological characteristics by laboratory reports mentioned in Article 18, then the license will be taken back and the facility will be closed.
The owners of the installation are obliged to collect the party and serial numbers of waters which are detected of being in contrary with this Regulation and destroy them under the control of the Health institution.
Part Four
Regulation Authority, Sanctions and Final Provisions
Regulation Authority
Article 49- Other secondary arrangements for the application of the provisions of this Regulation may be made by the Ministry by taking into consideration the scientific developments and studies.
Sanctions
Article 50- The provisions of the 5179 law regarding the approval of the amended statutory decree of protection, Consumption and Inspection of Food, the 1593 numbered General Sanitation Law and the 4703 numbered law concerning the preparation and Application of the Technical Law Products will be applied to those providing drinking-using water not complying with the provisions of this Regulation and companies, their owners and the responsible directors whom violate the provisions of this Regulation.
The Provisions Abolished
Article 51-The 18/10/1997 dated and 23144 numbered Regulation Concerning the Production, Packaging, Marketing and Inspection of Drinkable Waters (i.e. enforced on the same day published) has been abolished.
Temporary Article 1-according to the 18/10/1997 dated and 23144 numbered Regulation Concerning the Production, Packaging, Marketing and Inspection of the Drinkable Waters (enforced on the same day of the publication in the official gazette), sub-contractor filling permit given to natural spring waters and drinking waters have been abolished one year later.
Temporary Article 2 – The compliance period for the parameters done according to the 98/83/EC numbered Council Directive on the Quality of Water Intended for Human Consumption, the 15/7/87 dated and the 16/5/2003 dated 2003/40/EC numbered Council Directive, Establishing the List, Concentration Limits and Labeling Requirements for the Constituents of Natural Mineral Waters and the Conditions for Using Ozone-Enriched Air for the Treatment of Natural Mineral Waters, has been extended for another year.
Temporary Article 3-The manufacturers, given permission according to the 18/10/1997 dated and 23144 numbered Regulation Concerning the Production, Packaging, Marketing and Inspection of the Drinkable Waters, must harmonize their permits until 31/12/2007.
Entry into Force
Article 52 – This Regulation will enter into force on the day it is published.
Enforcement
Article 53 – the Ministry of Health will enforce the provisions of this Regulation.
Annex-1
Parameters and Parametric values
a) Microbiological Parameters
For Drinking-Using Waters:
| Parameter | Parametric value number/100 ml |
Escherichia Coli(E.Coli) |
0/100 ml |
Entrococci |
0/100 ml |
Coli form Bacteria |
0/100 ml |
For Drinking Waters (in the Bottling Plant):
| Parameter | Parametric value number/ml |
Escherichia Coli(E. Coli) |
0/250 ml |
Entrococci |
0/250 ml |
Coli form Bacteria |
0/250 ml |
P.aeruginosa |
0/250 ml |
Feacal Coli form Bacteria |
0/250 ml |
Salmonella |
0/100 ml |
Clostridium Perfiringens |
0/50 ml |
Pathogen Staphylococcus |
0/100 ml |
In 22 oC total colony |
100/ ml |
Parasite |
0/100 ml |
Other microscopic living things |
0/100 ml |
For Spring Waters:
| Parameter | Parameter value number/ ml |
Escherichia Coli(E. Coli) |
0/250 ml |
Entrococci |
0/250 ml |
Coli form Bacteria |
0/250 ml |
P.aeruginosa |
0/250 ml |
Feacal Coli form Bacteria |
0/250 ml |
Pathogen Micro-organisms |
0/100 ml |
Sporulated supplied-reducing anaerobes bacteria |
0/50 ml |
The maximum amount that could be found in the source sample: at 37 oC in 24 hours on agar-agar total colony count |
20/ ml 5/ ml |
The bottled water, the maximum amount that could be found after the bottling: (the sample will be taken 12 hours following bottling, the water being maintained at 4oC ± 1 oC ) at 37 oC in 24 hours on agar-agar total colony count |
100/ml |
Parasites |
0/100 ml |
Other microscopic living things |
0/100 ml |
b) Chemical Parameters
Parameter |
Parameter value |
Unit |
Notes |
Akrilamid |
0.1 |
µg/L |
Note-1 |
Antimony |
5.0 |
µg/L |
|
Arsenic |
10 |
µg/L |
|
Benzene |
1.0 |
µg/L |
|
Benzo(a)piren |
0.010 |
µg/L |
|
Boron |
1 |
µg/L |
|
Bromat |
10 (For drinking-using waters 25 µg/L will be used until 31/12/2007) |
µg/L |
Note 2 |
Cadmium |
5.0 |
µg/L |
|
Chromium |
50 |
µg/L |
|
Copper |
2 |
mg/L |
Note 3 |
Cyanides |
50 |
µg/L |
|
1.2-dikloretan |
3.0 |
µg/L |
|
Epikloridin |
0.10 |
µg/L |
Note 1 |
Fluorides |
1.5 |
mg/L |
|
Lead |
10 (For drinking-using waters 25 µg/L will be used until 31/12/2012) |
µg/L |
Note 3 and 4 |
Mercury |
1.0 |
µg/L |
|
Nickel |
20 |
µg/L |
Note 3 |
Nitrates |
50 |
mg/L |
Note 5 |
Nitrites |
0.50 |
mg/L |
Note 5 |
Pesticides |
0.10 |
µg/L |
Note 6 and 7 |
Total Pesticides |
0.50 |
µg/L |
Note 6 and 8 |
|
|
|
|
Polysic aromatic hydrocarbons |
0.10 |
µg/L |
Total combination of certain concentrations:Note9 |
Selenium |
10 |
µg/L |
Total combination of certain concentrations |
Tetrakloreten and trikloreten |
10 |
µg/L |
Total combination of certain concentrations |
Trihalometans-total |
100(For drinking-using waters 150 µg/L will be used until 31/12/2012) |
µg/L |
Total combination of certain concentrations: Note 10 |
Vinyl Chloride |
0.50 |
µg/L |
Note 1 |
Note 1: This parametric value indicates traces of monomer concentration due to polymer contacting with water.
Note 2: As mentioned in paragraph (a) of Article 9, when possible (without making any concessions on disinfection) a lower value of Bromat than the one referred to in Annex-1(b) shall be targeted. For waters referred to in Article 8 paragraphs (a), (b) and (c), the parametric value of Bromat in Annex-1 (b) shall be maintained within 5 years after the entry into force of this Regulation (at the latest). The parametric value of Bromated for the first three years after the entry into force of this Regulation is 25µg/L.
Note 3: The value shall be applied to; the samples taken from the taps- through sufficient illustration methods- of waters intended for human consumption and; the samples taken from waters intended to human consumption representing the weekly average value. The illustration and audit methods shall be applied in accordance with Article 10 (4). The Ministry, having regard to this value, shall take into consideration the periods where the monitoring and analysis periods are at the highest level (that may have a negative effect on human health).
Note 4: As mentioned in paragraph (b) of Article 9; for waters referred to in Article 8 paragraphs (a), (b) and (c), the parametric value for Lead mentioned in Annex-1 (b) shall be maintained at the latest within 15 years after the entry into force of this Regulation. The parametric value of Lead for the first eight years after the entry into force of this Regulation is 25µg/L.
Within the timescale given for complying with the parametric value of Lead, all measures shall be taken to ensure that the amount of Lead in waters intended for human consumptions is at the lowest possible level.
During the measures taken to ensure the compliance with this value, the Ministry shall give priority to places where the amount of lead is high in waters intended for human consumption.
Note 5: The Ministry shall take (nitrate)/50+ (nitrite)/3?1 formula as the basis for the process filtering water and for the amount of Nitrate and Nitrite mg/L unit shall be used. For Nitrites 0.10 mg/L value shall be applied.
Note 6: Pesticides constitutes:
Organic insecticides
Organic herbicides
Organic fungicides
Organic nematocysts
Organic acarisites
Organic algisites
Organic rodenticides
Organic slimisites
Other related products (apart from others, development controllers) and in relation to these metabolites, particles or reactive products.
The pesticides the water may include shall be monitored.
Note 7: The parametric value shall be applied to each pesticide. The parametric value for aldrin, dieldrin, and hetachlorine and heptachlorine epoksit is 0.030µg/L.
Note 8: Total pesticides constitute the total amount of each pesticide detected in the monitoring period.
Note 9: The compounds indicated are as follows:
Benzo (b) floranten,
Benzo (k) floranten,
Benzo (ghi) perilen,
Indeno (1.2.3-cd) piren.
Note 10: The compounds mentioned are: coli form, bromoform, dibromoklorametan, bromodiklorometan.
As mentioned in paragraph (c) of Article 9; when possible (without making concessions on disinfection) a lower value for trihalometans than the one referred to in Annex-1(b) shall be targeted. For waters referred to in Article 8 paragraphs (a), (b) and (c), the parametric value for trihalometans mentioned in Annex-1 (b) shall be maintained within 10 years after the entry into force of this Regulation (at the latest). The parametric value of total trihalometans for the first eight years after the entry into force of this Regulation is 150µg/L.
c) Indicator parameters
| Parameter | Parametric value | Units | Notes
|
Aluminum |
200 |
µg/L |
|
Ammonium |
0.50 |
mg/L |
|
Chloride |
250 |
mg/L |
Note 1 |
C.perfingens (including spores) |
0 |
Number/100 ml |
Note 2 |
Colour |
It may be accepted by consumers and no abnormal changes |
|
|
Conductivity |
2500 |
At 20 oC µS/cm |
Note 1 |
PH |
> 6.5 and <9.5 |
pH units |
Note 1 and 3 |
Iron |
200 |
µg/L |
|
Manganese |
50 |
µg/L |
|
Odour |
It may be accepted by consumers and no abnormal changes |
|
|
Oxidization |
5.0 |
mg/L Oxygen |
Note 4 |
Sulfate |
250 |
mg/L |
Note 1 |
Sodium |
200 |
mg/L |
|
Taste |
It may be accepted by consumers and no abnormal changes |
|
|
at 22 oC Colony Count |
No abnormal changes |
|
|
Coli form Bacteria |
0 |
number/100ml |
Note 5 |
Total Organic Carbon (TOC) |
No abnormal changes |
|
Note 6 |
Turbity |
It may accepted by consumers and no abnormal changes |
|
Note 7 |
d)Radioactivity
| Parameters | Parametric value |
Units |
Notes
|
Tritium |
100 |
Bq/L |
Notes 8 and 10 |
Total indication doses |
0.10 |
mSv/year |
Notes 9 and 10 |
Alpha convectors |
0.1 |
Bq/L |
|
Beta convectors |
1 |
Bq/L |
|
Note 1: the water should not abrade.
Note 2: This parameter is not required when water is not taken or affected by the surface. In circumstances of non-compliance with the parametric value, the Ministry must carry out research to determine whether the pathogenic micro-organisms (e.g. cryptosporidium) pose a potential threat to human health.
Note 3: The pH value for waters in bottles or containers is 4.5.
Note 4: If the TOC parameter is analyzed it is not necessary to measures this parameter.
Note 5: For waters in bottles or containers the unit number/ 250ml.
Note 6: When water is supplied less than 1000m³, this parameter does not have to be measured.
Note 7: when surface water is filtrated the Ministry shall ensure that the amount of Turbity does not exceed 1.0 NTU after filtration.
Note 8: The auditing frequency shall be determined in Annex-2.
Note 9: Apart from the products formed as a result of tritium, potassium -40, radon spoil; the precise places for monitoring frequency, monitoring methods and monitoring points will be determined in Annex-2.
Note 10:
1- The appropriate places for the monitoring frequency proposals in Note 8 and Annex-2 and for the monitoring frequency, monitoring methods and monitoring points will be determined according to the Union’s regulations regarding this subject matter.
2- If the Ministry based on other monitoring determines that the level of tritium (calculated as the total indication doses) is well below the parametric value, it may not monitor tritium or radioactivity to determine the total indication doses in drinking-using waters. In situations like this the Commission shall be informed about the reasons for this decision and other monitoring results.
Annex-2
Monitoring
Table A
Parameters to be analyzed
1) 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 regulation.
The following parameters must be subject to check monitoring. The Ministry may add other parameters to this list if they deem it appropriate.
Drinking-Using Waters |
Drinking Waters |
Spring Waters |
Notes |
Color |
Color |
Color |
|
Turbity |
Turbity |
Turbity |
|
Odour |
Odour |
Odour |
|
Taste |
Taste |
Taste |
|
Conductivity |
Conductivity |
Conductivity |
|
Hydrogen ion concentration(pH) |
Hydrogen ion concentration(pH) |
Hydrogen ion concentration(pH) |
|
Nitrate |
|
|
Note 3 |
Ammonium |
Ammonium |
Ammonium |
|
Aluminum |
Aluminum |
|
Note 1 |
Iron |
Iron |
|
Note 1 |
Clostridium perfringens (including spores)(Note 2) |
Clostridium perfringens (including spores)(Note 2) |
Clostridium perfringens (including spores)(Note 2) |
Note 2 |
Escherichia coli (E. Coli) |
Escherichia coli (E. coli) |
Escherichia coli (E. coli) |
|
Coli form bacteria |
Coli form bacteria |
Coli form bacteria |
|
|
Pseudomonas aeruginosa (Note 4) |
Pseudomonas aeruginosa (Note 4) |
Note 4 |
|
At 22 oC and 37 oC total colony count(Note 4) |
At 22 oC and 37 oC total colony count(Note 4) |
|
In the separation of iron, manganese and sulfur and arsenic from spring water by treatments with ozone-enriched air, the parameters of ozone, bromat and broform will be used in accordance with Article 42.
Note 1: Necessary only when used for refinement. In other situations, it will be included in the parameter monitoring.
Note 2: Necessary only if the water originates from or is influenced by surface water. In other situations, it will be included in the parameter monitoring.
Note 3: Necessary only when chloramination is used as a disinfectant. In other situations, it will be included in the parameter monitoring.
Note 4: Necessary only in the case of water offered for sale in bottles or containers.
2. Audit monitoring: The purpose of audit monitoring is to provide the information necessary to determine whether or not all of the Regulation’s parametric values are being complied with. All parameters set in accordance with Annex (1) and Article 7 (2) must be subject to 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 breach of the relevant parametric value. This paragraph does not apply to the parameters for radioactivity, which is, subject to Notes 8, 9 and 10 in Annex I (d).
TABLE B1
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
The amount of water produced or distributed from a distribution network(Note 1and 2) m³ |
The number of check monitoring per annum (Notes 3, 4 and 5) |
The number of audit monitoring per annum (Notes 3 and 5) |
<100 |
2 |
1 |
>100 <1000 |
4 |
1 |
>1000 <10 000 |
4 |
1 |
>10000 <100 000 |
31 |
3 |
>100 000 |
301 |
10 |
Note 1: A supply zone is a geographically defined area within which water intended for human consumption comes from one or more sources and within which water quality may be considered as being approximately uniform.
Note 2: The volumes are calculated as averages taken over a calendar year. The Ministry may use the number of inhabitants in a supply zone instead of the volume of water to determine the minimum frequency, assuming a water consumption of 200 l/day/capita.
Note 3: The intermittent short-term supply the monitoring frequency of water distributed by tankers will be decided by the Member State concerned.
Note 4: For the parameters in Annex I, the Ministry 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 quality of the water.
The lowest frequency applied must not be less than 50 % of the number of samples specified in the table.
Note 5: As far as possible, the number of samples should be distributed equally in time and location.
TABLE B2
Minimum frequency of sampling and analysis for water put into bottles or containers intended for sale
| The amount of water per day m³ | The number of check monitoring per annum |
The number of audit monitoring per annum |
<10 |
1 |
1 |
>10 <60 |
12 |
1 |
>60 |
12 |
1 |
Annex-3
Specifications for the Analysis of Parameters
In the analysis of samples the Ministry prefers laboratories which have 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 laboratories empowered by the Ministry.
1. Parameters for which Methods of Analysis are specified
The following principles for methods of microbiological parameters can be adapted to the analysis methods mentioned below or as an alternative methods, providing the provisions of Article 9(5) are met.
Coli form bacteria and Escherichia coli (E. coli) (ISO 9308-1)
Enterococci (ISO 7899-2)
Pseudomonas aeruginosa (prEN ISO 12780)
Total Germ Count - Colony count 22 °C (prEN ISO 6222)
Total Germ Count- Colony count 37 °C (prEN ISO 6222)
C. perfringers (including spores)
The water which will be analyzed will be subject to membrane filtration followed by anaerobic incubation of the membrane on m-CP agar at 44 ± 1 °C for 21 ± 3 hours. After incubation, count opaque yellow colonies that turn pink or red after exposure to ammonium hydroxide vapors for 20 to 30 seconds.
The composition of m-CP agar is:
Triptoz 30g2. PARAMETERS FOR WHICH PERFORMANCE CHARACTERISTICS ARE SPECIFIED
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 trueness, 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).
Parameters |
Accuracy of parametric value in % |
Precision of parametric value in % |
Detection limit in % of parametric value |
Conditions |
Notes |
Akrilamid |
|
|
|
It shall be controlled with the determined product. |
|
Aluminum |
10 |
10 |
10 |
|
|
Ammonium |
10 |
10 |
10 |
|
|
Antimony |
25 |
25 |
25 |
|
|
Arsenic |
10 |
10 |
10 |
|
|
Benzoprin |
25 |
25 |
25 |
|
|
Benzene |
25 |
25 |
25 |
|
|
Bor |
10 |
10 |
10 |
|
|
Bromat |
25 |
25 |
25 |
|
|
Cadmium |
10 |
10 |
10 |
|
|
Chloride |
10 |
10 |
10 |
|
|
Chrome |
10 |
10 |
10 |
|
|
Conductivity |
10 |
10 |
10 |
|
|
Copper |
10 |
10 |
10 |
|
|
Cyanides |
10 |
10 |
10 |
|
Note 4 |
1.2dikloretan |
25 |
25 |
10 |
|
|
Epikloridin |
|
|
|
It shall be controlled with the determined product. |
|
Floride |
10 |
10 |
10 |
|
|
Iron |
10 |
10 |
10 |
|
|
Lead |
10 |
10 |
10 |
|
|
Manganese |
20 |
10 |
20 |
|
|
Mercury |
20 |
10 |
20 |
|
|
Nickel |
10 |
10 |
10 |
|
|
Nitrates |