RESOLUTIONOn the Implementation of the Automated Information System “State Register of

Bottled Natural Mineral Water, Table Water and Soft Drinks”No. 934 of 15.08.2007

Official Gazette of the Republic of Moldova “Monitorul Oficial” no. 131-135/970 of 24.08.2007

* * *To improve the quality controls in respect of the bottled natural mineral water, table

water and soft drinks, the Government herebyRESOLVES:

1. To develop and implement the automated information system “State register of bottled natural mineral water, table water and soft drinks”.

2. The customer ordering the automated information system “State register of bottled natural mineral water, table water and soft drinks” shall be the Ministry of Health represented by the National Research and Implementation Center of Preventive Medicine, an organization within the Ministry’s jurisdiction; the Ministry of Informational Development jointly with certain organizations within its jurisdiction shall be the General Contractor.

3. To approve:- Sanitary norms for the use and distribution of natural mineral water - as per

Appendix 1;- Sanitary norms for the quality of table water - as per Appendix 2; - Regulations on soft drinks - as per Appendix 3;- Regulations on medicinal mineral water - as per Appendix 4;- Regulations on the procedures for the marking of bottled mineral water, table

water and soft drinks with the National Trademark stamps- as per Appendix 5.4. To make the Ministry of Informational Development and the National

Research and Implementation Center of Preventive Medicine responsible for the development and implementation by October 1, 2007 of the automated information system “State register of bottled natural mineral water, table water and soft drinks”, which system shall use the State Trademark stamps.

The Ministry of Informational Development and organizations within its jurisdiction shall ensure the production of the State Trademark stamps against contracted fees according to contract(s) concluded with the Main State Fiscal Inspectorate and the National Research and Implementation Center of Preventive Medicine.

The proceeds from sale of the State Trademark stamps shall be used to fund the development, implementation and operation of the automated information system “State register of bottled natural mineral water, table water and soft drinks”.

5. To decide that, starting on January 1, 2008 any bottled natural mineral water, table water or soft drink produced, imported and distributed in Moldova must be

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marked with the State Trademark stamps, which are made available against the established fee in compliance with the Regulations on the procedures for marking of bottled natural mineral water, table water and soft drinks with the State Trademark stamps.

6. To ban starting on January 1, 2008 the entrance of bottled natural mineral water, table water and soft drinks not marked with the State Trademark stamps in the customs territory of Moldova.

7. The National Research and Implementation Center of Preventive Medicine and the Ministry of informational development (jointly with organizations within its jurisdiction) shall develop and implement by October 1, 2007 the mechanism for quality monitoring of bottled natural mineral water, table water and soft drinks subject to marking with the State Trademark stamps, using for the purpose the web-page www.moldapa.md .

8. The National Research and Implementation Center of Preventive Medicine, the Main State Fiscal Inspectorate and the Ministry of informational development shall ensure the development and approval of technical specifications for the State Trademark stamps by October 1, 2007.

9. To make the National Research and Implementation Center of Preventive Medicine responsible for the following functions:

- Maintenance of the automated information system “State register of bottled natural mineral water, table water and soft drinks”;

- Administration of the web-page www.moldapa.md designed for the collection of information on the bottled natural mineral water, table water and soft drinks intended to be circulated at the Moldovan market;

- Ensuring of the development of the national databases with information on the registered natural mineral water springs and table water springs, circulation of the produced, exported and imported bottled natural mineral water, table water and soft drinks;

- gathering, accumulation, updates and analysis of data on the entities licensed to extract minerals and/or produce and bottle mineral and natural table water as well as holders of sanitary authorizations to operate as producers of bottled natural mineral water, table water and soft drinks (register of the relevant companies);

- Ensuring of the objectivity of reports on checks and inspections of mineral water springs, bottlers of natural mineral water and table water, producers and bottlers of soft drinks;

- Provision of comprehensive and veritable information to the public administration authorities in line with the basic principles for the implementation of the automated information system “State register of bottled natural mineral water, table water and soft drinks”;

- Collection of the information regarding the market circulation and turnover of bottled natural mineral water, table water and soft drinks from individuals and entities producing, importing, exporting and placing the above products at the market.

10. The Main State Fiscal Inspectorate shall ensure:

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- Transfer of the funds provided for in the 2008 cost estimate and required to produce the State Trademark stamps and to develop the automated information system “State register of bottled natural mineral water, table water and soft drinks” to the entity appointed by the Ministry of informational development in compliance with the law and recovery of the respective funds during 2008 from the proceeds from sale of the State Trademark stamps;

- Acceptance, reporting, distribution and sales in respect of the State Trademark stamps;

- Transfer of the information regarding the distribution and sales of the State Trademark stamps to the National Research and Implementation Center of Preventive Medicine, such information to be transferred in the established format and following the established procedures.

11. Individuals and entities producing or importing bottled water and soft drinks as well as individuals and entities acquiring bottled water and soft drinks from entities, which have no fiscal relationships with the state budget system of Moldova, and placing bottled natural mineral water, table water and soft drinks at the market shall submit the information regarding the turnover of bottled natural mineral water, table water and soft drinks to National Research and Implementation Center of Preventive Medicine, such information to be transferred within the terms established by the Center and in the established format.

12. The Main State Fiscal Inspectorate, the Ministry of informational development and the National Research and Implementation Center of Preventive Medicine shall develop the Action plan for the implementation of this Resolution and approve such plan by their joint order.

13. The Ministry of Health shall be responsible for monitoring of the implementation of this Resolution.

Prime Minister  Vasile TarlevCountersigned by:

The First Deputy Prime Minister Zinaida GrecianiMinister of Health Ion AbabiiMinister of Information Development Vladimir MolojonMinister of Finance Mihail PopChisinau, August 15, 2007No. 934.  

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Appendix 1To Government ResolutionNo. 934 of August 15, 2007

SANITARY NORMSregarding the Use and Distribution of Natural Mineral Water

I. General1. The Sanitary Norms for the Use and Distribution of Natural Mineral Water

(further ‘the Norms’) have been developed in compliance with STAN 108-1981 and based on the Council Directive 80/777/ЕС of 15 July 15 1980 on the approximation of the laws of the member states concerning the use and distribution of natural mineral water, as published in OJ L 229, 30.08.1980 (Directive as last amended by Directive 1.276/80/ЕС of 22 December 1980, published in OJ L 375, 31.12.1980), Directive 7/85/ЕС of 19 December 1984, as published in OJ L 2, 03.01.1985, Directive 70/96/ЕС of 28 October 1996, as published in OJ L 299, 23.11.1996 and Directive 40/2003/ЕС of 16 May 2003 concerning the list of admissible concentrations, criteria for labeling of the natural mineral water composition as well as conditions for the use of ozone-enriched air for treatment of natural mineral water and spring water, as published in OJ L 126, 22 .05.2003.

2. These Norms shall apply to domestically extracted or imported water, acknowledged by a competent authority as natural mineral water in compliance with the requirements of Schedule 1 hereto. The Norms shall specify the components (composition) of the natural mineral water, which can be potentially dangerous for human health, their maximum admissible concentrations, the deadline for the implementation of such maximum admissible values and the requirements regarding the labeling in respect of certain components. Such components shall be of natural origin rather than originating from the water-spring pollution.

 II. Scope

3. The objective of the NormsThese Norms shall apply to deposits of the subterranean water acknowledged to be

natural mineral water; they shall regulate the procedures for the acknowledgement and approval of natural mineral water and establish the requirements regarding such water quality with the objective to protect human health from any mineral water pollution. The Norms shall apply to any mineral water bottled for sale as foodstuffs intended for human consumption.

4. The requirements of the NormsThese Norms shall:a) require the official acknowledgement of natural mineral water;b) establish the required conditions for operation of a mineral water spring;c) regulate mineral water treatment;d) require certain measures to be taken in respect of the natural mineral water

microbiology;e) ban the sales of natural mineral water containing toxic compounds or with

non-compliances in terms of taste and appearance;f) require hermetic sealing of mineral water;

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g) require the specifics of natural mineral water to be indicated clearly on the label;

h) regulate trademarks used in respect of natural mineral water;i) specify the requirements and limitations concerning the development of

labels and advertisement;j) provide for periodic checks of the natural mineral water springs by the

duly empowered state authorities;k) substantiate the requirements regarding limitations, etc.5. These Norms shall apply to the table natural mineral water intended for

sale as a human consumption product and acknowledged as such by the competent Moldovan authorities.

6. These Norms shall not apply to the natural mineral water, which:a) has been acknowledged by the Ministry of Health to be medicinal natural

mineral water in compliance with the Regulations on medicinal mineral water;

b) is consumed directly from the water-spring for medicinal purposes in preventive health centers, geothermal and/or hydro-mineral treatment institutions;

c) is not intended for sale as a human consumption product. 

III. Acknowledgement and Use of Natural Mineral Water7. The acknowledgement of natural mineral water7.1. Under these Norms, no water produced in Moldova shall be deemed

natural mineral water except the water acknowledged as such in the opinions (certificates) issued by the competent authorities, such as: the Ministry of Health and the State Agency of Geology (AGeoM) (Schedule 1 hereto).

7.2. No imported natural mineral water may be distributed in Moldova where it has not been acknowledged as such by the duly empowered authorities in its country of origin and the acknowledgement confirmed by the competent authorities of Moldova.

7.3. Where, upon acknowledgement of the water as natural mineral water in compliance herewith, any water - originating from Moldova or imported – is found subsequently not in compliance with one or more requirements of Schedule 1 Part 1 hereto or Schedule 2 hereto regarding the operation of the water-spring, it shall be withdrawn the right to be categorized as natural mineral water until full compliance is ensured with the principal standards or requirements.

8. Requirements regarding the operation of natural mineral water springs The natural mineral water springs may be operated and their water may be bottled

solely in compliance with the requirements of Schedule 2 hereto.9. Authorized treatment9.1. Mineral water taken from the water spring may not undergo any treatment

or modifications, excepting the following:a) removal of unstable components, such as iron and sulfur compounds,

using sedimentation and/or filtration, which may be accelerated if necessary via enrichment with oxygen, in a way which does not result in any changes in the composition of the natural mineral water in terms of concentrations of its characteristic components giving the water its special properties;

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b) Removal of iron, manganese, sulfur and arsenic compounds from some types of mineral water, using their treatment with oxygen-enriched air, provided the following requirements are complied with:

Physical and chemical composition of the natural mineral water undergoes no changes during the treatment in terms of concentrations of its characteristic components;Compliance with the specific requirements established by the Ministry of Health;Due notification of the Ministry of Health and specialized monitoring performed by the Ministry;

c) Separation of unstable components other than those covered by Letters а) or b) hereof via water treatment, provided the following requirements are complied with:

The composition of the natural mineral water may not be modified in terms of concentrations of its characteristic components giving the water its special properties;Compliance with the specific requirements regarding its use established by the Ministry of Health; Due notification of the competent authorities and specialized monitoring performed by such authorities;

d) Full or partial removal of free carbon dioxide using solely physical methods.

9.2. Bottling or sales shall be prohibited in the case of the natural mineral water treated using any method other than those specified in Subparagraph 9.1 hereof.

9.3. The water must be bottled solely close to the water-spring and fed to the bottling facility from the water-spring via pipeline.

9.4. Natural mineral water may not be transported in bulk (in containers, tanks) for the purpose of bottling or for any other purpose - prior to bottling. Natural mineral water may be transported solely in retail consumer packaging, such as glass bottles or РЕТ bottles in a range of volumes.

9.5. Nothing may be added to the natural mineral water taken from the spring, except the carbon dioxide, in compliance with Schedule 1 Chapter III hereto.

9.6. Any disinfection shall be prohibited, irrespective of the products used for the purpose, excluding the treatment provided for in Subparagraph 9.5, as well as addition of bacteriostatic components or any other treatment for the purpose of changing the total concentration of microbes in the natural mineral water.

9.7. The provisions of Paragraph 9 shall not apply to natural mineral or spring water used in the production of soft drinks.

10. Microbiology10.1. The total count of viable microbe colonies in the water spring must be in

compliance with the normal levels and evidence convincingly the necessity of protecting the water-spring from any pollution. The total microbe count should be performed on agar-agar or agar-gelatin medium exposed to +20-22ºС for 72 hours and on agar-agar medium exposed to +37ºС for 24 hours.

10.2. The total microbe count after bottling shall not exceed 100 per 1 ml on agar-agar or agar-gelatin medium exposed to 20-22ºС for 72 hours and 20 per 1 ml on agar-agar medium exposed to 37ºС for 24 hours.

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10.3. The total microbe count must be determined within 12 hours after bottling: the water must be stored at 4ºС ± 1ºС during that period. Subsequently, including at the time of sales, the total microbe count must not exceed the count expected as result of the normal development of the bacteria present in the water taken from the water spring.

10.4. The water spring and the natural mineral water prior to its sales must be free of any:

a) pathogen microorganisms and parasites;b) Е. Coli, other coli forms and faecal streptococci in any tested sample of 250 ml; c) sporulated sulfite-reducing anaerobic bacteria in any tested sample of 50 ml;d) Pseudomonas aeruginosa in any tested water sample of 250 ml.11. Chemical composition11.1. It shall be prohibited to use or sell the natural mineral water containing any

of the substances listed in Schedule 1 hereto in concentrations exceeding the maximum admissible concentrations specified for each substance, or any other substance in concentrations making the water unfit for use.

11.2. Natural mineral water must contain the following in concentrations below the test method sensitivity threshold value: anion-active substances, pesticides and chlorodiphenyl, mineral oil, polycyclic aromatic hydrocarbons.

11.3. Where the natural mineral water contains fluorine in concentrations above 1 mg per liter, the label must state, ‘Contains fluorine.’ Where the natural mineral water contains fluorine in concentrations above 1.5 mp per liter, the label must state, ‘Warning! Contains fluorine above 1.5 mg per liter: This water is not recommended for babies or children aged below 7.’

12. Non-compliances in taste and appearanceNatural mineral water not complying in terms of its taste and appearance may not

be bottled or sold.13. PackagingNatural mineral water may be offered for sale solely in specialized hermetically

sealed containers, designed to prevent any spoilage or pollution of the product contained therein.

IV. Labeling and Advertisement14. Labeling14.1. Any natural mineral water bottled for sale must be labeled in compliance

with the Labeling Norms for Foodstuffs as approved by Government Resolution 996 of August 20, 2003 (Monitorul Oficial no. 189-190, 2003, page 1046), with account of the following specific requirements:

a) for still natural mineral water – the label must state ‘Natural mineral water’;b) for carbonated natural mineral water - the label must state ‘Natural mineral water

naturally enriched with carbon dioxide,’ ‘Natural mineral water with water-spring gas,’ or ‘Natural mineral water enriched with carbon dioxide’;

c) the name of the location where the water is obtained, including the name of the water-spring, artesian well, the producer and its address;

d) chemical composition as shown by the existing official tests (to include Test Protocol no. and the name of the testing authority, analytical composition and

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mineralization of the water, including the compounds characterizing the water composition);

e) shelf life;f) where a РЕТ container is used, the label must state, ‘Disposable container’;g) the label on bottles of the natural mineral water treated with ozone-enriched air

must contain an indication next to the chemical composition, ‘Water oxidized with ozone-enriched air in compliance with approved techniques.’

14.2. The above indications must be visible, clear, easy to read and resistant.14.3. Natural mineral water may not be sold where it does not comply with these

labeling requirements.15. Trademarks15.1. The name of any city, town or village may not be used as a trade name for

the natural mineral water where:a) it is not the location or operation place of the water-spring from which such

water is taken to be used;b) it may mislead the consumer as to the actual place of origin of such water.15.2. Natural mineral water may not be sold where its label or advertisement

bears any name non-complying with the requirements of Paragraph 14.1 hereof.15.3. No more than one natural mineral water trademark may be taken and sold

from one water-spring. However, it shall be admissible to bottle natural mineral water, which is the product of blending water from two or more water-springs, under one trademark, provided such water-springs are the acknowledged mineral water springs and the water taken from them complies with the requirements of Paragraph 4.1 hereof.

15.4. According to Paragraph 15.3 hereof, commercial labels differing from the others solely in the name of the product type, merchandise mark and presented name should be perceived as such, because the case in point is different merchandise marking.

16. Limitations in respect of labeling and advertisement16.1. No description, name, trademark, emblem, picture or other symbol

(symbolical or other) may be present on the label or in the advertisement of natural mineral water where it indicates the properties and qualities such water is lacking.

16.2. Any reference to preventive or medicinal properties of the natural mineral water must be prohibited for use on the label or in the advertisement, excepting the situations provided for in Schedule 3 hereto.

16.3. No description, indication, specific name, trademark, emblem, picture or other symbol (symbolical or other) may be present on the label or in the advertisement of bottled table water where it is not acknowledged to be mineral water or where it has been produced in a way which can result in its confusion with natural mineral water. The name of a certain settlement or location may be used as trademark solely provided the natural mineral water originates exactly from the place indicated in the trademark.

16.4. Any advertisement or sales of bottled mineral or spring water shall be prohibited where the product does not comply with the requirements of Paragraph 16 hereof.

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V. Compliance and Monitoring17. Periodical inspectionsThe competent state authorities (State Sanitary Epidemiologic Service and State

Agency of Geology) shall perform periodical inspections to ensure compliance of any water acknowledged to be natural mineral water with the requirements entitling to such acknowledgement and the operation of the spring from which it originates in compliance with the requirements of Schedule 2 hereto.

18. Limitations18.1. The respective competent state authorities shall be responsible for the

implementation hereof.18.2. Where any non-compliance with the requirements of Paragraph 3 hereof is

identified, the state authorities competent in the sphere of sanitary and food safety oversight shall apply administrative sanctions according to the Administrative Infringements Code.

19. The authority of duly empowered public officers19.1. To check compliance with the requirements hereof, the officer of the State

Sanitary Epidemiologic Service or any other authorized service (further ‘the authorized officer’) may require from the company provision of access at any time to:

a) any premises other than housing;b) any vehicle, including a ship or an aircraft, transporting bottled natural

mineral water.19.2. Where reasonable grounds exist to suspect infringements hereof, the

authorized officer shall have the authority to:a) request from the person in charge of the respective facility or the business

owner any original document or a copy thereof with regard to the issue in question;b) take samples of any water or subject matter having regard to the identified

infringements in order to define the infringement in more detail.20. ConfidentialityThe information obtained from the submitted documents may not be disclosed

without prior written consent of the party extracting and producing natural mineral water, except the disclosure in court proceedings.

21. Tests and laboratory examination 21.1. Where the authorized officer takes samples of any water and decides they

should be analyzed and tested, he/she must send them to the respective state institution or accredited laboratory.

21.2. The state institution or accredited laboratory analyzing or testing the submitted samples must issue the officer submitting the samples a special certificate regarding the analysis or test findings. This certificate shall be issued on a special statistical form developed according to these Norms and approved by the order of the Minister of Health. The costs of the natural mineral water tests or analysis shall be charged to the producer according to the Government-approved rates published in Monitorul Oficial – the Official Gazette of Moldova.

21.3. All certificates issued regarding the analysis or test findings must be signed by the person performing the tests and Head of Laboratory or CEO of the state institution where the tests were performed.

22. Samples for testing

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22.1. The authorized officer taking samples for tests or analysis must proceed in compliance herewith.

22.2. Such authorized officer must follow the below procedures:a) the sample must be divided into 3 parts, with each part marked and sealed

or closed to ensure the preservation of its initial characteristics;b) one part of the sample must be handled in compliance with Paragraphs

22.3-22.6 hereof;c) the other two parts of the sample must be handled in compliance with

Paragraph 22.7 hereof.22.3. Where the sample of water or subject matter is received from outside

Moldova and taken by the authorized officer prior to the delivery of the goods to their consignee, the officer must leave one part of the sample with the consignee.

22.4. Should it be impossible to apply the provisions of Paragraph 22.3 hereof, the authorized officer must transmit one part of the sample to the owner of the sampled water or subject matter.

22.5. In each of the situations referred to in Paragraphs 22.3 - 22.4 hereof the authorized officer must notify the party in respect of whom the samples were taken about the fact of taking samples for testing.

22.6. The authorized officer shall transmit one of the two remaining sample parts for testing of the indicators specified in accordance herewith whereas the other part is placed in safekeeping as reference matter.

22.7. The sampling shall be confirmed with the sampling protocol, which must be produced on the standardized statistical form approved by the Minister of Health, signed by the authorized officer and the representative of the mineral water producer. The sampling protocol shall be produced in two counterparts, one for each party.

23. State register of natural mineral water23.1. The respective State registers shall be established for the purposes of

correct reporting on the deposits of natural mineral water and bottled natural mineral water. The State Register of the natural mineral water deposits shall be kept by the National Agency of Geology, which agency shall – upon the approval of the mineral water by the State Committee on useful mineral resources and subject to the existence of the positive opinion from the Ministry of Health – shall maintain the Register, keep records and control the deposits of the natural mineral water approved for use. The Register shall be maintained both electronically and in hard copy, and any deposit of the natural mineral water may be entered in the Register or removed from it solely by the decision of the State Committee on useful mineral resources.

23.2. The records of the bottled natural mineral water shall be kept by the National Research and Implementation Center of Preventive Medicine, which maintains the State Register of natural mineral water, table water and bottled soft drinks. The Register shall be maintained both electronically and in hard copy, and any trademark of natural mineral water, table water and bottled soft drinks may be entered in the Register or removed from it solely by the decision of the Chief State Sanitary Officer of Moldova or his/her deputies.

24. Effective dateSchedules 1-5 shall form an integral part hereof.

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These norms shall come into effect upon their publication in Monitorul Oficial – the Official Gazette of Moldova.

Any instructions or guidelines conflicting with these norms shall be deemed ineffective immediately upon coming of these norms into effect.

The producers of mineral water must bring their operations in compliance with these norms within 6 months after their effective date and submit all the required documents for the acknowledgement of mineral water according to Schedule 1 hereto.

 Schedule 1

To Sanitary Normsregarding the Use and Distribution of Natural Mineral Water

Definition and Acknowledgement of the Natural Mineral Water1. Natural mineral water shall be understood as microbiologically pure water

as per Section 12 of these norms, which is extracted from underground deposits/water-bearing levels and taken from one or more natural water-springs or artificial water wells.

Natural mineral water differs from the normal table water in the following aspects:a) concentrations of minerals in certain proportion;b) direct extraction from natural water-springs or artificial water wells taking

water from underground water-bearing levels. In such cases maximum efforts are made to prevent the natural mineral water from pollution or external impact on their chemical and physical characteristics;

c) sustainability of chemical composition and concentrations of chemical compounds without any significant natural variations;

d) extraction and collection in the environment and ambient conditions ensuring its purity in terms of microbiology and sustainability of main chemical components and their concentrations;

e) water shall be filled in consumer-size containers directly close to the water spring in compliance with special hygienic requirements;

f) the natural composition must be ensured without any auxiliary purification, excepting the situations provided for herein.

The bottled mineral water enriched with carbon dioxide shall be subdivided into 3 categories:

a) naturally carbonated natural mineral water, in which the carbon dioxide concentrations after bottling are similar to its concentration at the water-spring outlet, or the water where carbon dioxide (of the origin similar to that in the water) was added if necessary in the amounts no to exceed its losses during bottling and re-bottling within the limits allowed by the respective specifications;

b) natural mineral water enriched with carbon dioxide from the spring, understood as the water in which the concentrations of carbon dioxide originating from the same water spring are higher after the enrichment and bottling than those at the water-spring outlet;

c) carbonated natural mineral water understood as the water enriched with (solely food quality) carbon dioxide originating elsewhere other than the water-spring/water-bearing level.

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2. The characteristics provided for in Paragraph 1 hereof, which may make the natural mineral water medicinal, must be assessed from the following perspectives:

geology and hydrogeology;physical, chemical and physical-chemical aspects;microbiology;if necessary - pharmacology, physiology and clinical data:1) in compliance with the requirements hereof;2) in compliance with the research methods approved by the competent

authorities.3. The composition, temperature and other characteristics of the natural

mineral water must remain stable within natural variances - irrespective of possible water debit variances in the spring.

For the purposes of Section 10 of these Norms, the normal microbiology of the natural mineral water shall be understood as the count of stable sensitive microorganism colonies in the respective water-spring prior to any conditioning, where the quality and count of microorganisms identified at the time of the water acknowledgement is monitored by means of periodical testing.

4. Any person desirous to obtain the acknowledgement in respect of the natural mineral water in compliance herewith shall submit an application to the Ministry of Health, attaching the following documents, information and data:

a) report on the hydrology survey performed by the State Agency of Geology, complete with the minutes of the State Committee on useful mineral resources regarding the examination and approval of such report, and on the capacity of the surveyed mineral water deposit, indicating the following:

1) the exact location of the water-spring, complete with the level, on the map scaled between 1:1000 and 1:25000;

2) water-spring hydrology, complete with the details regarding the deposit geology, water-bearing layers and their rocks;

3) description o the plant and equipment for water extraction;4) details regarding the water-spring location and measurements performed to

prevent possible pollution;b) physical and chemical characteristics of the water: 1) water debit of the spring or well and its seasonal variations; the highest water

debit;2) water temperature in the water-spring;3) correlation between individual rock layers and the data regarding concentrations

of inorganic components in water;4) solids at 180ºС;5) specific conductivity at moderate temperatures;6) hydrogen ion concentrations (pH);7) concentrations of the cations and anions listed in Schedule 4 to these Norms;8) concentrations of the substances listed in Schedule 4 to these Norms as ‘trace

elements’;9) a-type and b-type wave induced radioactivity of water in the spring;10)where the water is intended for sale as the water with special isotope ratios,

details should be provided regarding the compliance of levels or isotope ratios;

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c) microbiology test findings including:1) evidence regarding the absence of parasites and pathogenic microorganisms;2) faecal pollution levels including:

a) absence of Escherichia coli and other coli-forms in the tested water sample of 250 ml at 37ºС and 44.5ºС;

b) absence of faecal streptococci in the tested water sample of 250 ml;c) absence of sporulated sulfite-reducing anaerobic bacteria in the tested

water sample of 50 ml; d) absence of Pseudomonas aeruginosa in the tested water sample of 250 ml;

3) total count of viable microbe colonies in 1 ml of water:a) on agar-agar or agar-gelatin medium after 72 hours at 20-22ºС;b) on agar-agar medium after 24 hours at 37ºC;

d) Chemical composition:Water may not contain any of the components shown in Column I in concentrations

higher than the maximum admissible levels shown in the table below:Component Measurement unit Maximum admissible concentrations

Arsenic As, mcg/l 10Barium Ba, mg/l 0.7Boron B, mg/l 5Cadmium Cd, mcg/l 3Cyanides CN, mcg/l 70Chromium Cr, mcg/l 50Copper Cu, mg/l 1Manganese Mn, mg/l 0.5Mercury Hg, mcg/l 1Nickel Ni, mcg/l 20Nitrates NO3, mg/l 50Nitrites NO2, mg/l 0.5Antimony Sb, mcg/l 5Selenium Se, mcg/l 10Lead Pb, mcg/l 10Fluorine F, mg/l 5 (subject to compliance with 11.3)Total pesticides mcg/l 0.5

e) Freedom from pollutantsThe natural mineral water must be free from pollutants and comply with the

requirements of Schedule 2 to these Norms;f) StabilityThe submitted data must evidence the stability of the chemical composition,

temperature and other material characteristics of the natural mineral water within the natural variances;

g) Details of any clinical or pharmacological testsThe research performed according to the scientific methods must concern the

peculiarities of the natural mineral water and its impact on humans, e.g. in terms of its diuretic or laxative action, compensation for the deficit of trace elements.

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The acknowledged representative number of coordinated clinical observations can sometimes replace the research described in the previous paragraph. Such observations may replace clinical tests subject to the reproducibility of results based on the representative number of coordinated clinical observations.

5. The National Research and Implementation Center of Preventive Medicine duly empowered by the Government must examine the producer-provided information regarding the specifics of the water and issue an opinion regarding compliance or non-compliance of the natural mineral water with these Norms and arrange for such opinion to be published in the Center’s official bulletin or web-page.

Schedule 2

To Sanitary Normsfor the Use and Distribution of Natural Mineral Water

 Terms and Conditions for the Use of Natural Mineral Water Springs

1. The operation of the natural mineral water-spring must be approved by the State Sanitary Epidemiology Service where it is fount that the water complies with the criteria specified in Schedule 1 to these Norms.

2. The equipment for the water-spring operation must be designed to ensure the prevention of any possible pollution and preservation of the characteristics typical of the respective water at the water-spring outlet.

3. For the purpose of achieving the above objective:a) the water-spring must be protected from the threat of pollution;b) the equipment for the extraction of water, the piping and the water tanks

must be designed and manufactured to minimize the possibility of any chemical, physical-chemical or microbial changes in the water;

c) the water-tanks must be designed and manufactured to prevent any impact on the microbiology and chemical composition of the water;

d) the equipment for washing of bottles and bottling of water as well as all other operational processes must comply with the applicant hygiene requirements;

e) the natural mineral water may be transported solely in the final consumer-size packaging.

4. Should it be found during the operation of the water-spring that the natural mineral water originating from such springs is polluted and does not comply with the microbiology requirements specified in Paragraph 10 of these Norms, the entity in charge of the water-spring operation must suspend any processes relating to water extraction, and in particular the bottling process, till the pollution and its root causes are eliminated and the water is re-confirmed to comply with the applicable requirements.

5. The duly empowered authorities shall perform periodical compliance checks to monitor compliance of the water from the spring with the requirements of Schedule 1 and compliance of the parties in charge of water-spring operation with the requirements of Schedule 2, Paragraphs 2 and 3 to these norms.

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Schedule 3To Sanitary Norms

for the Use and Distribution of Natural Mineral Water

Water CompositionWater Type Threshold Values

Low in mineral salts The mineral salts concentrations calculated as solid residue: not above 500 mg/lVery low in mineral salts The mineral salts concentrations calculated as solid residue: not above 50 mg/lRich in mineral salts The mineral salts concentrations calculated as solid residue: not above 1500 mg/lContaining bicarbonate Bicarbonate concentrations: above 600 mg/lContaining sulfate Sulfate concentrations: above 200 mg/lContaining chloride Chloride concentrations: above 200 mg/lContaining calcium Calcium concentrations: above 150 mg/lContaining magnesium Magnesium concentrations: above 50 mg/lContaining fluoride Fluoride concentrations: above 1 mg/l – subject to compliance with the labeling

requirements of the Norms (Paragraph 11.3)Containing iron Ferrous iron concentrations: above 1 mg/lAcid Carbonic acid concentrations: above 250 mg/lContaining sodium Sodium concentrations: above 200 mg/lMay be used in diets low in sodium Sodium concentrations: below 20 mg/lMay be used to make food for babies Solid residue concentrations: below 1000 mg/l; nitrites: 0.02 mg/l; nitrates: 5 mg/lMay produce laxative action Based on the results of clinical tests according to Schedule 1 (Paragraph 5 Letter g) to

these NormsMay produce diuretic action Based on the results of clinical tests according to Schedule 1 (Paragraph 5 Letter g) to

these Norms

Schedule 4To Sanitary Norms

for the Use and Distribution of Natural Mineral Water 

Chemical Composition of the Natural Mineral Water1. The test protocol must provide findings regarding the concentrations of the following chemical substances:а) cations and anions:

Cations Unit Anions UnitAluminum Al mg/l Borates BO3 mg/lAmmonium NH4 mg/l Carbonates CO3 mg/lCalcium Ca mg/l Chlorides Cl mg/lMagnesium Mg mg/l Fluorides F mg/lPotassium K mg/l Hydrogen carbonate ions HCO3 mg/lSodium Na mg/l Nitrates NO3 mg/l

Nitrites NO2 mg/lPhosphates P2O5 mg/lSilicates SiO2 mg/lSulfates SO4

mg/lSulfides S-2 mg/l

 b) non-ionizing compounds:

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Non-ionizing compounds UnitOrganic carbon C mg/lFree carbon dioxide CO2 mg/lSilicon oxide SiO2 mg/l 

с) trace elementsElement Unit Element Unit

Barium Ba mg/l Lithium Li mg/lBoron, total Br mg/l Manganese Mn mg/lCobalt Co mg/l Molybdenum Mo mg/lCopper Cu mg/l Strontium Sr mg/lIodine (total) I mg/l Zinc Zn mg/lIron Fe mg/l 

2. Where the hydrology report as per Schedule 1 Paragraph 2 Letter а) to the Norms indicates the presence in water of specific cations, anions, non-ionizing compounds or trace elements not listed in Paragraph 1 hereof, their concentrations (if determinable) must be determined and described in detail.

Schedule 5To Sanitary Norms

for the Use and Distribution of Natural Mineral Water

Monitoring of Natural Mineral Water SpringsMonitoring Frequency

Daily Weekly Monthly Quarterly Once in 6 months

Annually Upon necessity

Temperature CO2 Nitrates Escherichia coli Anions and cations as per Schedule 2 Paragraph 1 Letter а) to the Norms

All regulated parameters

Upon identification of emergency pollution. The test frequency and types will be determined depending on the circumstances. The tests shall be performed till the parameters are found to be in compliance with the requirements regarding the concentration norms and water characteristics

Conductivity HCO3 Nitrites EnterococciрН O2 dissolved Ammonium Ps.aeruginosa

Iron Sulfite reducing anaerobic bacteriaTotal colony count at 22ºС and 37ºС

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Appendix 2To Government ResolutionNo. 934 of August 15, 2007

SANITARY NORMSregarding the quality of table water

I. General1. These norms shall regulate the quality of table water with the objective to

protect human health by preventing any pollution or infection of table water and ensuring its quality as clean and useful water.

2. The terms used herein shall have the following definitions:2.1. Table water shall be understood to mean the water intended for human

consumption, and in particular:а) any type of water - natural or treated – used for drinking, making meals or

other household purposes, irrespective of its origin or source (such as distribution network, water spring, water tank, water filled into consumer size bottles or other containers);

b) any type of water used in food industry to produce, treat, preserve (can) or distribution of food or substances intended for human consumption, except where the Ministry of Health and the Ministry of agriculture and food industry allow the use of technical water provided it has been proven that the used water does not affect the quality and purity of the resulting final food;

с) water originating from the local sources, such as water wells, water springs, etc. used for drinking, making meals or other household purposes. The Ministry of Health may allow deviations from the required quality values where such deviations hold no threat for human life.

2.2. The distribution system or in-house installations shall mean the aggregate of piping, fittings and equipment installed between the taps for water normally used for human consumption and the external distribution network; however, solely where they do not form part of the water supplier’s responsibility as the producer and/or water supplier under the applicable law.

3. These norms shall not apply to:а) natural mineral water acknowledged as such by the duly empowered authorities

according to the applicable legislation;b) medicinal table water with stated medicinal properties according to the laws,

regulations and administrative decisions applicable to pharmaceutical products.3.1. The scope hereof shall not include:а) water intended solely for special use – where the Ministry of Health

approves its use and quality – which does not affect directly or indirectly the health of the consumers for whom it is produced;

b) table water coming from an individual water producer who supplies on the average less than 5 cubic meters per day or to less than 50 persons – except where the production of water is a part of business or state operations.

3.2. In the above cases territorial offices of the state sanitary epidemiology service shall inform the public about such exceptions and the measures to protect human health, which should be taken in case pollutions are found in the water intended for

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human consumption. Where the quality of water is found to present potential threat for public health, the public shall be given the appropriate recommendations according to the Sanitary norms and rules for control and monitoring of the table water quality.

 II. Quality requirements in respect of table water

4. Table water must be useful, pure and complying with the following requirements:

а) be free from microorganisms, parasites or substances presenting potential threat for human health, considering their number or concentration;

b) comply with the minimum requirements specified in Schedule 1 hereto in Tables 1А, 1В and 2;

c) comply with the requirements of Paragraphs 5-8 and 10 hereof.5. The application hereof shall not cause any direct or indirect decrease in the

actual table water quality, which might affect human health, or any increase in pollution levels in the water used for the production of table water.

6. The quality of table water intended for human consumption must comply with the maximum admissible values for the parameters listed in Schedule 1 hereto. As regards the parameters listed in Schedule 1 Table 3, their values shall be deemed recommended for the purposes of assessing table water quality in monitoring programs and to comply with the obligations specified in Paragraph 8 hereof.

7. The Ministry of Health shall approve values for additional indicators not listed in Schedule 1 where such are required to protect human health. Such values should comply with the requirements of Paragraph 4 Letter а) hereof.

8. Table water quality shall be deemed adequate where the values for the quality indicators are in compliance with the requirements of Schedule 1 hereto for the samples taken in the following locations:

а) at the outlet of the consumer’s water tap, at the inlet to the building and at the outdoor distribution water-pumps – for water sourced from the distribution system;

b) at the tank outlet – for table water supplied in tanks;c) at the outlet filling water into bottles or containers – for bottled table

water;d) at the outlet from which water is taken to be used in the industrial process

at food industry facilities producing foodstuffs.9. Where non-compliances with the maximum admissible values provided in

Schedule 1 hereto are identified in situations provided for in Paragraph 4 Letter а) and such non-compliances are caused by the internal distribution system or its contents, the producer’s/supplier’s obligations shall be deemed to be fulfilled – except where water is supplied directly to consumers and the producer/supplier is also responsible for the maintenance of internal distribution systems.

10. Situations provided for in Paragraph 9 shall be handled as follows:а) the producers and suppliers of table water shall notify the local public

authorities and/or owners of the scheduled actions to restore and maintain the distribution network or water treatment equipment, which must be taken to control or eliminate the risk of non-compliance with the admissible values of table water quality indicators, and simultaneously notify accordingly the respective territorial office(s) of the State Sanitary Epidemiology Service (further ‘SSES’);

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b) the SSES territorial offices shall notify consumers of the additional measures which should be taken, if necessary, to prevent diseases.

 III. Supervision and Monitoring

11. Monitoring of the table water quality shall be ensured by the producer, supplier and SSES offices.

12. The producers and supplies of table water shall ensure compliance with the quality requirements, funding of the audit monitoring and table water quality control.

13. The SSES territorial offices shall ensure supervision and table water quality monitoring with the objective to ensure that the water delivered to the final consumer complies with the applicable quality requirements and holds no potential threat for human health.

14. The Ministry of Health must develop - within 6 months after the day of which these Norms are published in the Official Gazette of Moldova ‘Monitorul Oficial’ - the Sanitary Epidemiology Rules and Norms for the Supervision and Monitoring of Table Water Quality in compliance with the minimum requirements specified in Schedule 2 hereto.

15. Producers, suppliers or users of the table water deriving from the public collective or individual system, filled into bottles or other food quality containers shall ensure the current monitoring of the table water quality according to the Program, which must include control of the treatment method effectiveness and in particular disinfection and the quality of the manufactured, supplied and used table water.

16. The monitoring procedures provided for in Paragraph 15 hereof shall be determined in compliance with the Sanitary Epidemiology Rules and Norms for the Supervision and Monitoring of Table Water Quality, and the monitoring program must be approved by the SSES territorial offices.

17. The laboratories monitoring table water must comply with the requirements of Schedule 3 hereto regarding the testing methods for the specified parameters.

18. The list of the registered laboratories authorized to monitor the table water quality shall be published by the Ministry of Health.

19. Other testing methods may be used in addition to those specified in Schedule 3 hereto where it is obvious that the test findings are comparable. The laboratories using alternative testing methods shall provide the information confirming the appropriateness of such methods as per Schedule 3 hereto.

20. The SSES national/territorial offices may decide to perform additional monitoring where it is found that water contains certain substances or microorganisms, for which no maximum admissible concentrations are specified by Paragraph 4 hereof, but which might present potential threat for human health. Additional monitoring shall be performed separately for each individual substance or microorganism.

 IV. Corrective actions and restrictions regarding water use

21. Non-compliance with the requirements of Paragraphs 6 and 7 hereof shall be treated as an emergency and examined without delay by the respective SSES office in charge of the supervision and control of the table water quality as well as the producers, suppliers and users for the purpose of identifying the root cause for such non-compliance.

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22. Where table water is still in non-compliance with the maximum admissible concentrations as per Schedule 1, notwithstanding the corrective measures taken to bring it back in compliance with the requirements of Paragraph 4, the provisions of Paragraph 9 hereof shall apply, and the respective SSES territorial office shall decide on the urgent measures to be taken to restore the required water quality. Preference shall be given to the measures intended to bring down the concentrations of the substances, which present a threat for human health, if present in high concentrations.

23. The respective SSES territorial office must issue an order prohibiting or limiting the use of table water – irrespective of the fact whether non-compliance was or was not registered with the maximum admissible concentrations - where table water presents a danger for human health, and check if all the required measures are taken to protect human health. In such situations water consumers must be notified and given appropriate instructions without delay.

24. The respective SSES territorial office must decide jointly with the other competent authorities and public services, which measures should be taken out of the measures provided for in Paragraph 23 hereof in view of the threat for human health resulting from interruptions in table water supply or restrictions on its use.

25. Where any non-compliance is identified with the maximum admissible concentrations or values listed in Schedule 1 Table 3 hereto, the respective SSES territorial office should assess such non-compliances for their potential threat to human health and, if necessary, order the appropriate measures to be taken with the objective to restore water quality and to protect human health.

26. The respective SSES territorial office shall notify the consumer of any case where corrective measures are taken, excepting the cases where the identified non-compliance with the maximum admissible values is deemed to have an insignificant impact on their health.

V. Deviations27. Acting upon request of the respective SSES territorial office, the Ministry

of Health may allow deviations for a certain period of time from the maximum admissible concentrations as per Paragraph 7 or Schedule 1 Table 2 hereof within the limits specified and approved by the Ministry of Health in view of the threat for human health and the alternatives available in the respective area to supply the community with table water. Deviations from the norms must be of limited duration, which duration may not exceed 3 years. Where the respective SSES territorial office applies for prolongation of the deviation period, it must submit to the Ministry of Health their analysis of the existing situation and substantiations for their decision to apply for a repeated deviation period, which period may not exceed 3 years.

28. In exceptional situations the Ministry of Health may approve a third deviation period – also not to exceed 3 years. The Ministry of Health should make a decision regarding such application within 3 months after its filing date.

29. For any requested deviation approved according to Paragraphs 27 and 28 hereof, the application shall specify:

а) reasons for seeking such deviation;b) respective indicator, the latest monitoring results and the maximum

admissible limit for the deviation;

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c) geographical region, water quantity, population affected, possible consequences for producers of food and foodstuffs;

d) schedule of the increased frequency monitoring – where applicable;е) summary of the scheduled corrective measures, including the work

schedule, estimated value and actions to ensure control;f) duration of the deviation allied for.30. The provisions of Paragraph 29 hereof shall not apply where the respective

SSES territorial office believes that the non-compliance with the requirements does not present a threat for human health or where the measures taken according to Paragraph 22 hereof are sufficient to remedy the non-compliance within 30 days. In such situations the Ministry of Health shall set jointly with the involved authorities the maximum admissible limit for the indicator under scrutiny and the time to remedy the non-compliance.

31. The provisions of Paragraph 30 hereof shall not apply where non-compliance in the water supply system with the maximum admissible value for the indicator under scrutiny during more than 30 consecutive days in the last 12 months.

32. The respective SSES territorial office and the public administration authorities in the respective area covered by the approved deviation according to this section shall notify the local community within 48 hours after the information is confirmed regarding the deviation and terms and conditions for the remedy of the non-compliance. The respective SSES territorial office and the public administration authorities in the respective area must ensure assistance to the disadvantaged social groups, for which the deviation can present a particular exposure to the existing threat. These provisions shall not apply in situations covered by Paragraph 30 hereof, unless the competent authorities decide otherwise.

33. The respective SSES territorial office shall notify the Ministry of Health within 60 days of any deviation, except the deviations according to Paragraph 30 hereof, in respect of individual water supply systems supplying on the average 1000 cubic meters of water daily or servicing above 5000 persons, including the information specified in Paragraph 28 hereof.

34. The provisions of Paragraphs 27-33 hereof shall not apply to table water filled into bottles or other containers.

 VI. Quality assurance in respect of purification methods, equipment, substances and

materials coming in contact with table water35. No substance or material (such as coagulating agents, precipitators,

filtering substances, disinfectants) used in the plant and equipment for the production, distribution, bottling, transportation or storage of table water may be present in concentrations higher than those required for their use; no compounds or pollutant may remain in the water directly or indirectly, where they impact the protection of human health. Only substances and materials approved by the Ministry of Health may be used for the above purposes.

36. The Ministry of Health and the Agency of Construction and territorial development shall develop - within 1 year after the day on which these norms are published in ‘Monitorul Oficial’ - regulations for testing, sanitary authorization, registration and use of filters, substances and materials coming in contact with table water.

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37. Within 6 months after the publication of these norms in ‘Monitorul Oficial’ the Ministry of Health shall develop the procedures for sanitary authorization of the production processes and plant and equipment for filling of table water in bottles or other containers.

38. The trade circulation of the table water filled in bottles or other containers shall be allowed in compliance with the requirements of the applicable laws and regulations regarding the packaging and labeling of foodstuffs.

 VII. Information and reporting

39. The respective SSES territorial offices must ensure the availability of information regarding the quality of table water, dissemination of consumer information regarding the possible impact on human health and corrective measures taken or scheduled to be taken by the competent authorities or consumers. The information must be true, clear, available on timely basis and recent.

40. To inform the public, the Ministry of Health (acting through the National Research and Implementation Center of Preventive Medicine) shall produce and publish once in 3 years the National report on the quality of table water, which - according to the monitoring program - must include at least the information on:

а) individual or collective table water supply systems with the average daily output of above 1000 cubic meters of water or servicing above 5000 persons;

b) the existing situation for the 3 consecutive years (to be published before the end of Year 3);

с) the aspects covered by the provisions of Paragraph 3.1, Paragraphs 21-26 and 32-33 hereof.

41. The information required to produce the National report on the quality of table water shall be submitted to the National Research and Implementation Center of Preventive Medicine in compliance with the Sanitary Norms regarding the supervision and monitoring of table water quality.

42. Table water producers and consumers shall submit the information required to produce the National report on the quality of table water to the respective SSES territorial offices.

43. Table water producers and consumers shall record and file the information on the quality of the produced, distributed and used table water in compliance with the Sanitary Norms regarding the supervision and monitoring of table water quality.

44. Producers of the table water supplied via public systems shall ensure the public access to the information on the quality of the table water produced by them and allow public inspections at any convenient time. The producers must have a PR office and make widely known its work hours and the contact phone where the public can obtain the information regarding the table water manufactured and distributed by them.

45. Table water producers and suppliers must provide the information on table water quality free of charge to the concerned community. A fee may be charged for the information on table water quality provided to individuals and entities outside the area serviced by the producer and distribution company.

46. The respective SSES territorial offices shall annually produce and publish jointly with the producer and the supplier of table water the Municipal Report and

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respectively the Regional Report on the quality of table water, which must include the information on:

а) individual or collective table water supply systems, including those with the average daily output below 10 cubic meters of water or servicing less than 50 persons;

b) the aspects covered by the provisions of Paragraph 3.1, Paragraphs 7, 21-26 and 32-33 hereof;

c) the existing situation for the year (to be published before the end of the respective year).

 VIII. Infringements and sanctions

47. Non-compliance with the requirements hereof shall result in financial, civil, disciplinary, administrative or penal responsibility according to the Code on administrative infringements.

48. During the implementation period hereof, non-compliance with any table water quality indicator on the part of individual producers or distributors of table water via public systems shall not be persecuted according to the Code on administrative infringement in respect of the responsibility for non-compliance with the sanitary norms, excluding the cases where the producer or the supplier of water does not comply with the action plan or schedule to ensure compliance. Non-compliance with the respective indicators must not present a threat to the health of consumers.

 IX. Miscellaneous

49. The local public administration authorities shall coordinate the development of Action plans to ensure compliance, including the time schedule and cost estimate of the actions to ensure compliance on the part of the table water producers and suppliers to the requirements hereof. Action plans to ensure compliance shall be produced by the table water producers and suppliers within 90 days after the publication hereof in ‘Monitorul Oficial’.

50. The Ministry of Local Public Administration shall systematize jointly with the Agency for Construction and Territorial Development Action plans to ensure compliance, including the time schedule and cost estimate of the actions to ensure compliance, within 180 days after the publication hereof in ‘Monitorul Oficial’.

51. The Ministry of Health shall monitor and control the implementation of the Action plans to ensure compliance.

52. The Ministry of Health shall take actions by December 31, 2012 to ensure the possibility to perform audits of table water quality with the objective to prevent the potential threat for human health.

53. The Ministry of Health shall produce the action plan and time schedule and estimate the costs of the actions to perform table water quality audits within 1 year after the publication hereof in ‘Monitorul Oficial’.

54. Producers and suppliers (consumers) of water from individual systems must take actions to ensure compliance with the quality requirements hereof by 2015.

55. Producers of bottled water must take the respective actions to ensure compliance with the quality requirements hereof starting on the day they are published in ‘Monitorul Oficial’.

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56. Water producers and food industry consumers, which have their own water springs, must take the respective actions to ensure compliance with the quality requirements hereof within 1 year after the day they are published in ‘Monitorul Oficial’.

57. The Ministry of agriculture and food industry shall produce and consolidate the action plan and time schedule of the actions to ensure compliance with the requirements hereof on the part of table water producers and food industry consumers within 6 months after the day the norms are published in ‘Monitorul Oficial’.

58. It shall be allowed in emergency situations and for geographically locked regions to submit special requests to the National Research and Implementation Center of Preventive Medicine, Applying for the extension of the period allocated to ensure compliance. The additional extension period shall not be longer than 3 years. A reconciliation of the current status shall be performed in the end of that period, and the results shall be submitted to the National Research and Implementation Center of Preventive Medicine, which may provide a second additional extension period, not to exceed 3 years, based on the scrutiny of the submitted information.

59. The requirements of Paragraph 58 hereof shall not apply to table water filled into bottles or other containers.

60. The control of water sources located in the rural area, such as water wells, low-depth artesian wells and water outlets operated in the local systems shall be performed every 2 years by way of taking water samples and performing the respective laboratory tests.

61. The condition of table or non-table water determined by the findings of the tests performed by an accredited laboratory shall be indicated on a datasheet located in an easy to see place above the water spring or near it.

62. Where the laboratory tests demonstrate that the quality of water is not in compliance with the requirements for table water, its use shall be prohibited for the consumption by humans and animals or for irrigation purposes.

63. Owners and users of water sources provided for in Paragraphs 60-62 hereof must ensure the controlling authorities access to the water springs for taking of samples and make every reasonable effort to ensure safekeeping of such water springs and their protection from any possible pollution.

64. The costs of water sampling and sample tests shall be charged to the owner of the water spring.

65. Schedules 1-3 shall form an integral part hereof.66. Schedules 1-3 shall be updated from time to time by the respective

government resolutions.67. These Norms shall come into effect upon their publication in the Official

Gazette of Moldova ‘Monitorul Oficial’.68. Any conflicting resolutions shall be deemed ineffective as soon as these

Norms come into effect.

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 Schedule 1

To Sanitary Norms regarding the quality of table water Table water quality parameters

 1. Table water quality parametersThere are microbiological, chemical and indicative quality parameters. 2. Maximum admissible concentrations for the table water quality parameters are shown in Tables 1А, 1В, 2 and 3

of this Schedule.Table 1А

MicrobiologySubstance Maximum admissible concentration (count per 100 ml)

Esсherichia coli (E.coli) 0Enterococci  (Streptococci fecali) 0

Table 1В Microbiology for table water filled into bottles or other containers 

Параметр Maximum admissible valueEsсherichia coli (E.coli) 0/250 mlEnterococi(Streptococi fecali) 0/250 mlPseudomonas aeruginosa 0/250 mlColony count at 22°С 100/1 mlColony count at 37°С 20/1 ml

Table 2 Chemical composition

Substance Maximum admissible concentration

Unit Notes

Acrylamide 0.1 mcg/l Note 1Arsenic 10 mcg/lBenzene 1 mcg/lBenzpyrene 0.01 mcg/lBoron 0.5 mg/l Note 2Bromates 10 mcg/lCadmium 3 mcg/lVinylchloride 0.30 mcg/l Note 1Total cyanides 50 mcg/lFree cyanides 10 mcg/lTotal chromium 50 mcg/lCopper 1 мг/л Notes 3 and 41.2-dichloroethane 3 mcg/lEpichlorhydrine 0.1 mcg/l Note1Fluoride 1.5 mg/l Note 5Polycyclic aromatic hydrocarbons 0.1 mcg/l Note 6

The aggregate concentration of the specified substances

Mercury 1 mcg/lMicrocystin LR 1 mcg/l Note 7Nickel 20 mcg/l Note 4Nitrate 50 mg/l Notes 8 and 9Nitrite 0.5 mg/l Notes 8 and 9

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Pesticides 0.1 mcg/l Notes 10 and 11Pesticides, total 0.5 mcg/l Notes 8 and 12Lead 10 mcg/l Notes 4 and 13Selenium 10 mcg/lAntimony 5 mcg/lTetrachlorethylene and trichlorethylene

10 mcg/l The aggregate concentration of the specified substances

Trihalomethanes, total 100 mcg/l Note 14 The aggregate concentration of the specified substances

 Notes:1. The value shows the residual monomer concentrations in water, which are calculated from the maximum emission by

the respective polymer in contact with water. The waste water treatment facility shall notify the respective SSES territorial office of the use of this substance in water treatment processes.

2. Exceptional maximum admissible concentrations of up to 1.0 mg/l shall be allowed for public water supply systems till 2015.

3. The value shall be derived from the water sample taken using the respective methods from the consumer’s water tap and it shall show the average weekly concentrations consumed by the consumer. The monitoring method shall take into account the peak levels able to produce negative impact on human health.

4. The value for copper shall be 2.0 mg/l where the water pipeline is made of copper compounds, subject to compliance with the requirements of Note 3.

5. The maximum admissible fluoride concentrations in bottled water intended for consumtion by babies shall be 1.0 mg/l.6. The specified substances shall be understood to include:benz(b)phthorantrene,benz(k) phthorantrene, benz(ghi)perylene,indene-(1,2,3-сd)pyrene. 7. The tests to determine the concentrations of Microcystin LR shall be limited to the situations where there is a threat for

human health and where the water-basin surface with threat of cyanobacteriae reproduction is used as water outlet.8. The following requirement must be complied with:{nitrate}/50 + {nitrite}/3 ≤ 1; the values in the parenthesis shall mean nitrate (NО 3) and nitrite (NО2) concentrations in

mg/l. 9. The maximum admissible fluoride concentrations in bottled water intended for consumption by babies shall be 5 mg/l

for nitrates and 0.02 mg/l for nitrites.10. Pesticides shall be understood to include:Organic insecticides,Organic herbicides,Organic fungicides,Organic nematocides, Organic acaricides, Organic algicides, Organic rodenticides,Organic slimicides, Related products (including growth control ones) and their metabolites, reaction or decomposition products. Only the pesticides which might be present in the respective water supply source shall be the subject matter of monitoring. 11. Concentrations shall be determined separately for each compound. The maximum admissible concentrations shall be

0.030 mcg/l for aldrine, dieldrine, heptachlorine and heptachlorepoxy.12. The term ‘total pesticide concentration’ shall mean the sum of the individual pesticide concentrations determined and

calculated during the monitoring process.13. Water covered with the provisions of Paragraph 8 Letters а), b) and d) must actually comply with the approved

requirements for no longer than 10 calendar years after the effective date of these Norms. Lead concentrations of 25 mcg/l are admissible during that period.

14. The total THM concentrations must be as low as possible without any decrease in the disinfection effectiveness.

26

The specified substances shall be understood to include:chlorophorm, bromoform, dibromochlormethane, bromodichlormethane. Water covered with the provisions of Paragraph 8 Letters а), b) and d) must actually comply with the approved

requirements for no longer than 10 calendar years after the effective date of these Norms. The total THM concentrations of 150 mcg/l are admissible during the first 5 years.

 Table 3

Indicative valuesSubstance Maximum admissible

concentrationUnit Notes

Aluminum 200 mcg/lAmmonium 0,5 mg/lColi forms 0 count/100 ml Note 1Total organic carbon Without any abnormal changes Note 2Chlorides 250 mg/l Note 3Clostridium perfrigens (incl. Spores) 0 count/100 ml Note 4Free residual chlorine 0.5 mg/l Note 5Conductivity 2500 mcCmcm-1 at 20°С Note 3Color Acceptable for consumer, Without

any abnormal changesTotal solid residue, dissolved 1500 mg/lTotal hardness, minimum 5 German degreesIron 0.3 mg/lTaste Acceptable for consumer, Without

any abnormal changesManganese 50 mg/lSmell Acceptable for consumer, Without

any abnormal changesColony count at 22°С Without any abnormal changesColony count at 37°С Without any abnormal changesOxidability 5 mg О2/l Note 6Hydrogene ion concentration ≥6.5 and ≤9,5 pН units Notes 3, 7Sodium 200 mg/lSulfate 250 mg/l Notes 3,8Sulfites and hydrogen sulfide 100 mcg/lTurbidity ≤5 NTU Note 9Zinc 3 mg/lTritium 100 Bq/l Notes 10 and 11Total indicative dosis 0.1 mЗ annually Notes 11 and 12Global alpha-activity 0.1 Bq/l Note 13Global beta-activity 1 Bq/l Note 13 

Notes:1. The values for bottled water shall be expressed as count/250 ml.2. This parameter shall be tested solely for water supply systems supplying above 10000 cubic meters of water daily.3. The water must not be aggressive.4. This parameter must be tested where the water is sourced from the surface of a water-basin or where it contacts with the

surface water. In case of non-compliance with the maximum admissible value for this parameter the water should be tested for the presence of other pathogen microorganisms, such as cryptosporidium.

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5. Where rectified surface water is used for human consumption, to prevent the threat for human health the minimum concentrations of free residual chlorine at the consumer’s water tap should be no less than 0.1-0.2 mg/l. The maximum concentrations of 1 mg/l are admissible for water with high chlorine demand.

6. This parameter shall be tested in situations where the determination of the total organic carbon concentrations is impossible or not provided for.

7. The maximum admissible value may be decreased to 4.5 pH units for non-running bottled water.The maximum admissible pH value may be lower for the naturally or artificially carbonated bottled water.8. Concentrations of 500 mg/l for sulfates may be allowed till 2015 - subject to compliance with the requirements of Note

3.9. In case of treated surface water, the turbidity may not exceed 1.0 NTU (nephelometric turbidity unit) in water prior to

disinfection. 10. The monitoring frequency and methods as well as locations for the monitoring points shall be determined in

compliance with Schedule 2 Paragraph 3 to these Norms.11. The total indicative consumption value admissible for an adult human corresponds to daily consumption of 2 l of table

water during the year. The monitoring of tritium concentrations and radioactivity in table water shall be performed where the required data is lacking to calculate the total indicative consumption. Where the tests performed at an earlier stage show that the tritium concentrations in the total indicative concentration are much lower than the maximum admissible level, it is allowed to skip the tritium concentration monitoring.

12. Excepting tritium, potassium-40, radon and radon disintegration products. The monitoring frequency and methods as well as locations for the monitoring points shall be determined in compliance with Schedule 2 to these Norms.

13. The table water quality shall be assessed in terms of the radioactivity levels in the determination of the global alpha and beta activity. If the determined levels are higher than the maximum admissible levels, the concentrations of radioactive nucleids must be tested in compliance with the Sanitary Norms regarding the supervision and monitoring of table water quality.

Schedule 2To Sanitary Norms regarding the quality of table water

 Monitoring by way of checks and audits

 I. Monitoring by way of checks

1. The objective of monitoring by way of checks shall be to obtain information regarding the water quality in terms of taste and appearance as well as microbiology for the water produced and supplied to consumers and also the information regarding the effectiveness of water treatment methods with special focus on the disinfection methods to check the compliance of table water with the requirements of these Norms.

2. Monitoring by way of checks must be performed in respect of the following parameters:

Aluminum Note 1AmmoniumColi formsColorHydrogen ion concentrations (pH)ConductivityFree residual chlorine Note 2Сlоstridium perfringens Note 3Escherichia coli (E.coli)IronTasteSmell

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Nitrites Note 4Oxidability Note 5Pseudomonas aeruginosa Note 6 Sulfites and hydrogen sulfide Note 7TurbidityDeveloped colony count at 22ºС and 37ºС Note 6 

Notes: 1. Solely where it is used as coagulant.2. Free residual chlorine must account for at least 80% of the total residual chlorine.3. This parameter is tested solely where the water is surface-sourced or mixed. Where they are identified,

further tests should be made to determine concentrations of other pathogen microorganisms and in particular cryptosporidium.

4. The tests are performed solely where chlorine or chlorine-containing products are used for disinfection purposes.

5. The tests shall be performed solely where the available testing equipment is inadequate for testing of the total organic carbon concentrations.

6. Applicable solely to bottled water.7. The tests shall be performed solely where sulfur is removed from water.

3. The Ministry of Health and the Agency for construction and territorial development shall lay down within 6 months after the publication of these Norms in ‘Monitorul Oficial’ the frequency methods and locations of the sampling points vital for the purposes monitoring as per Schedule 2, with account of the most important provisions of the applicable law in this sphere or the findings of the respective monitoring programs.

4. The respective SSES territorial offices may expand the list shown in Paragraph 2 hereof by adding other parameters in view of the local specifics and/or used water purification methods.

 II. Monitoring by way of audits

5. The objective of monitoring by way of audits shall be to obtain the required information for the purpose of assessing compliance or non-compliance in terms of the total monitored parameters listed in these Norms.

6. All parameters listed in Paragraph 6 of these Norms must be tested in the process of Monitoring by way of audits.

7. Monitoring by way of audits shall be performed by the respective SSES territorial offices in compliance with the sanitary norms for supervision and monitoring of table water quality.

8. The minimum frequency for taking of samples and performing tests of the samples of table water, which is supplied through the public distribution network or in mobile tanks or used in production of food shall be laid down in compliance with Table 1A hereto.

9. Samples must be taken in the compliance control points as per Paragraph 8 of these Norms to test the table water for compliance with these Norms. Samples should be taken from the distribution network in any water supply area or water treatment facility to test individual parameters solely where it is shown that the sampling does not cause an aggravation in the respective parametrical values.

Table 1А

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 Daily table water output or distribution volume in the supplied area (Notes 1 and

2), m3

Number of samples taken annually for monitoring by way of checks (Notes 3, 4

and 5)

Number of samples taken annually for monitoring by way of audits (Notes 3

and 5)≤100 Note 6 Note 6>100 ≤1000 4 1>1000 ≤10000 4+3 for each 1000 m3 in a day and this

portion in the total output1+1 for each 3300 m3 in a day and this portion in the total output

>10000 ≤100000 3+1 for each 10000 m3 in a day and this portion in the total output

>100000 10+1 for each 25000 m3 in a day and this portion in the total output

 Notes:1. The supplied area shall be understood as the geographical area where water intended for human consumption is sourced

from one or several water springs and in which the quality of water can be considered approximately similar.2. The volumes shall be calculated as the average for the calendar year. The number of consumers in the supplied area

rather than water output may be used to calculate the minimum frequency of sampling and table water sample tests, assuming daily per capita water consumption as 200 l.

3. The required sampling frequency shall be laid down by the respective SSES territorial office in case of short interruptions in the supply of water distributed from tanks.

4. The respective SSES territorial office may reduce the number of parameters and tests specified in Schedule 1 to these Norms where:

а) the results of sample testing remain during no less than 2 consecutive years stable and considerably better than the maximum admissible levels provided for in Schedule 1 to these Norms;

b) the re are no factors causing aggravations in water quality.The applied minimum frequency may not be below 50% of the total number of samples specified in the Table, except in

special situations provided for in Paragraphs 8 and 9 of these Norms.5. The number of samples taken and the sampling frequency should be distributed as evenly as possible in terms of time

and space. 6. The number of samples taken and the sampling frequency shall be laid down by the respective SSES territorial offices.

10. The minimum frequency of sampling and the number of samples in respect of bottled water intended for sale shall be determined as per Table 1В.

Table 1В  

Water volumes filled daily (calculated as the average for the year), m3

Number of samples taken annually for monitoring by way of checks

Number of samples taken annually for monitoring by way of audits

<10 1 1>10 ≤60 12 1>60 1 for each 5 m3 in a day and this portion

in the total volume1 for each 100 m3 in a day and this portion in the total volume

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Schedule 3 To Sanitary Norms regarding the quality of table water

Parameter testing conditionsThe laboratories, which perform tests of water samples for monitoring purposes,

must have an analytical quality control system periodically checked by a certified authority, desirably a member of an European certification body.

1. The parameters for which specific test methods are required:Bacteria of coli-forms and Esсherichia coli (E.coli) (ISО 9308-1);Enterococci (ISО 7899-2);Рsеudomon аеruginоsа (ЕN ISО 12780);Colony count at 22°С (ЕN ISО 6222);Colony count at 37°С (ЕN ISО 6222);Сlоstridium рerfrigens (including spores);Membrane filtration with subsequent anaerobic incubation of the membrane on m-

РС agar (Note 1) at 44 ± 1оС during 21 ± 3 hours. The count must cover non-transparent yellow colonies, which become pink or red under influence of ammonium hydroxide vapors during 20-30 seconds.

Note:Composition of m-РС agar:Basic medium:Triptose - 30 gYeast extract - 20 gSucrose - 5 gL-cystine hydrochloride - 1 gМgSО4 х 7Н20 - 0.1 gMonobromated cresol red - 40 mgAgar - 15 gWater - 1000 mlThe basic medium components are dissolved; рН is set to 7.6 and the medium is

autoclaved at 121°С for 15 minutes. When the medium cools down, the following should be added:

D-cycloserine - 400 mgВ-polymyxin sulphate - 25 mgIndoxyl-b-D-glucoside (dissolved in sterile water) - 60 mg in 8 mlPhenolphtaleine diphosphate solution 0.5%, filtration sterilized

- 20 ml

FеСl3 х 6H2O 4.5%, filtration sterilized - 2 mlNote:It is allowed to use other nutrient media with similar characteristics, registered in Moldova and

approved by the Ministry of Health. 2. The parameters for which specific working characteristics have been

approved:2.1. The test method must determine at least one concentration allowing to

assess compliance with a parametrical (maximum admissible) value. The working

31

characteristics shall be reliability, accuracy and detection limit in respect of the following parameters:

 Parameter Reliability, % of

the maximum admissible value

(Note 1)

Accuracy, % of the maximum

admissible value (Note 2)

Detection limit, % of the

maximum admissible

value (Note 3)

Notes

Acrylamide Concentration control as per product specificationsAluminum 10 10 10Ammonium 10 10 10Arsenic 10 10 10Benzene 25 25 25Benz(a)pyrene 25 25 25Boron 10 10 10Bromates 25 25 25Cadmium 10 10 10Chlorides 10 10 10Vinylchloride Concentration control as per product specificationsConductivity 10 10 10Chromium 10 10 10Total cyanides 10 10 10 Note 4Free cyanides 10 10 10Copper 10 10 101.2-dichlorethane 25 25 10Epichlorohydrine Concentration control as per product specificationsFluorine 10 10 10Polycyclic aromatic hydrocarbon 25 25 25 Note 5Manganese 10 10 1.0Mercury 20 10 20Nickel 10 10 10Nitrates 10 10 10Nitrites 10 10 10Oxidability 25 25 10 Note 6Pesticides 25 25 25 Note 7Lead 10 10 10Selenium 10 10 10Sodium 10 10 10Antimony 25 25 25Sulfate 10 10 10Tetrachlorethane 25 25 10 Note 8Trichlorethylene 25 25 10 Note 8Trihalomethanes, total 25 25 10 Note 5 

Notes:1. Reliability shall mean the systematic mistake equal to the difference between the average value determined in a large

number of repeated measurements and the true value (understood as per ISО 5725). 2. Accuracy shall mean an accidental mistake expressed normally as the standard deviation of the results (in the series

32

and among them). The acceptable accuracy shall be equal to double of the relative standard deviation (understood as per ISО 5725).

3. The detection limit shall be equal to:а) triple of the relative standard deviation in the series for the natural sample with low parametrical value;b) five-fold of the relative standard deviation in the series for the blank.4. The method shall determine the total cyanide concentrations in any form.5. Working characteristics shall be applied to individual substances determined at 25% of the maximum admissible

value as per Schedule 1 to these Norms.6. Oxidation shall be performed using potassium permanganate in acid medium during 10 minutes at 1000С.7. The working characteristics shall apply to each individual pesticide and depend on the specific pesticide. The

detection limits are not yet reached currently in respect of all pesticides, but the goal should be achievable.8. The working characteristics shall apply to each individual sample determined as 50% of the maximum admissible

value as per Schedule 1 to these Norms. 2.2. The test method used to determine concentrations of hydrogen ions must

ensure the possibility of finding the concentrations equal to the maximum admissible value with the reliability and accuracy of 0.2 рН units.

3. The parameters for which there are no approved specific working characteristics:

Total organic carbonColorTasteSmellTurbidity (The applicable testing method to monitor the turbidity of treated

(purified) surface water must be able to measure at least the concentrations equal to the maximum admissible values with the reliability and accuracy of 25%.

33

Appendix 3To Government ResolutionNo. 934 of August 15, 2007

REGULATIONSRegarding Soft Drinks

I. General1. The Regulations regarding soft drinks (further ‘the Regulations’) shall lay

down the requirements regarding the quality and safety of soft drinks as well as additional requirements regarding the labeling and market placement of soft drinks.

2. For the purposes of these Regulations, the following terms shall have the following definitions:

soft drinks shall mean the drinks with ethyl alcohol concentrations of no more than 0.5% by volume (measured at 20оС), made of table water with food additives, fruit and/or vegetable juices, including juice concentrates, syrups from fruits, berries and/or aromatic vegetable material, aromas and/or aromatic substances, natural sugars (sugar, sucrose, glucose), sweeteners, honey, filled, saturated or not saturated with carbon dioxide. Fermented drinks with ethyl alcohol concentrations of no more than 1.2% by volume shall be categorized as soft drinks;

drinks with fruit and/or vegetable juice shall mean soft drinks where the content of fruit and/or vegetable juice is no less than 4%;

low energy value drinks shall mean soft drinks containing sweeteners, in which the energy value is at least 30% lower than that of the original drink made with addition of sugar and without sweeteners;

aromatized soft drinks shall mean soft drinks based on table water with additions of aromas and/or aromatic substances, with or without additions of other raw materials listed in the definition of soft drinks, mainly saturated with carbon dioxide;

instant (powder) drinks shall mean a mixture of various raw materials listed in the definition of soft drinks in the form of powder, granules or tablets, intended for the production of soft drinks via their recovery;

refreshing soft drinks shall mean aromatized soft drinks based on table water, concentrates for soft drinks or raw materials for the production thereof, mainly saturated with carbon dioxide;

concentrates for the production of soft drinks shall mean the products with ethyl alcohol concentrations of no more than 0.5% by volume (measured at 20оС) and the raw materials listed in the definition of soft drinks, intended for the production of soft drinks via dissolution in the producer- recommended proportion;

concentrates for soft drinks shall mean the condensed mixture of the diverse raw materials used for the production of soft drinks, which is intended for the production of soft drinks via dissolution;

kvas shall mean a soft drink with ethyl alcohol concentrations of no more than 1.2% by volume, which is produced via alcohol fermentation or alcohol and interrupted lactic acid fermentation of grain extracts as well as vegetable, fruit and berry extracts and other raw materials of vegetable origin and products containing natural sugar with or without subsequent addition of aromas and flavors;

34

syrup shall mean concentrate with concentrations of natural sugars of above 50% by weight.

II. The requirements regarding the basic raw materials and auxiliary materials3. Water used for the production of soft drinks must comply with the

requirements of the applicable regulations for table water in terms of quality and safety.4. Other raw materials for the production of soft drinks may include:sugar, glucose and sucrose;fruit and/or vegetable juices, including concentrates;syrups from fruits, berries and/or aromatic vegetable material, approved as safe for

human consumption;natural aromas (including macerates and oils), nature-identical or artificial aromas,

aromatic substances;honey;raw grain or its procession products;bakery yeast or pure yeast cultures;carbon dioxide.5. Food additives must be used in compliance with the requirements of

Sanitary Rules and Norms regarding the use of food additives 06.10.3.46 of December 17, 2001 (‘Monitorul Oficial’ 2002, no. 50-52, Page 123; ‘Monitorul Oficial’ 2006, no. 5-8, Page 12).

6. The quality and safety of raw materials and auxiliary materials used for the production of soft drinks must comply with the requirements of the applicable laws and regulations.

7. The purity and safety of food additives must comply with the requirements of the applicable national laws and regulations, and where such are missing – with the specifications of FAO/WHO Joint Expert Committee on Food Additives (JECFA).

III. Allowed Treatment Methods8. Soft drinks may be produced pasteurized (without addition of

preservatives) and un-pasteurized (with or without addition of preservatives). 

IV. Classification of soft drinks and concentrates for the production thereof; quality and safety requirements

9. Soft drinks are classified into groups and subgroups, which must have taste and appearance characteristics as shown in the table below:

 Classification Taste and appearance

Type Group Subgroup Appearance Taste and aromaSoft drinks Aromatized soft

drinksDrinks containing fruit or vegetable juice

Clear to turbid; insignificant sediment allowed; without alien admixtures

Corresponds to the ingredients used; without any off-taste or off-smell

Refreshing soft drinksFermented drinks (kvas)

Concentrates for the Fruit or vegetable Opalescent to turbid, with

35

production of soft drinks

concentrates sediment; without alien admixtures

Concentrates for soft drinks

Syrup Clear to turbid; insignificant sediment allowed; without alien admixtures

Instant (powdered) drinks

Powder, granules or tablets, without alien admixtures

  10. The concentrations of toxic substances in soft drinks may not exceed the

following maximum admissible values (mg/dcm3); Lead 0.3 Arsenic 0.1 Cadmium 0.03 Mercury 0.005 11. In their microbiology, soft drinks must comply with the following

requirements:Product Count of mesophilic

aerobic and facultative anaerobic

microorganisms, colony units per gram, not

above

Free from Colibacillus

group bacteria (coli-forms), count in cm3

Free from pathogen microorganisms,

including salmonella, count in cm3

Yeast and mold,

count/cm3, not above

Notes

Soft drinks un-pasteurized and without preservatives, with shelf life less than 30 days

30 333 25 100

Soft drinks, including juice-containing drinks, with shelf life above 30 days:With addition of natural sugars

- 100 100 15* *Count in 100 cm3, not above

With addition of sweeteners

100* 100 100 - * Count of mesophilic aerobic microorganisms

With addition of juice

- 100 100 40* * Volume (in cm3), which must be free therefrom

Concentrates (liquid, paste, powder, granules, tablets) for bottled soft drinks

5·104* 1,0 25 10** * Except concentrates containing sodium bicarbonate**. Volume (cm3) or weight (g) which must be free therefrom

Unpasteurized syrups

- 1,0 25 50* *Count in 10 cm3, not above

Pasteurized syrups filled hot

- 10 25 40* * Volume (cm3) which must be free therefrom

Fermented drinks:Filtered un-pasteurized kvas in PET bottles

- 10 25 -

36

Filtered pasteurized kvas

10 10 25 100

  12. Caffeine concentrations may not exceed 150 mg/dcm3 in caffeine-

containing soft drinks and 400 mg/dcm3 in special caffeine-containing soft drinks.13. Quinine concentration in soft drinks may not be above 85 mg/dcm3.14. The quality and safety parameters of soft drinks, including weight and

volume, must be measured with adequate measuring devices, which must be authorized and metrologically tested.

 V. Labeling

15. Soft drinks must be labeled in compliance with the Regulations regarding the labeling of food, as approved by Government Resolution 996 of August 20, 2003 (‘Monitorul Oficial’ 2003, no. 198-199, Page 1046), Sanitary Regulations regarding the labeling of energy value, labeling of food intended for special diets, labeling of food genetically modified or obtained from GMO products no. 01-04 of May 31, 2004 (‘Monitorul Oficial’ 2004, no. 138-146, Page 281), with subsequent amendments, modifications and clarifications thereto:

The term ‘syrup’ may be used for drink concentrates with sugar concentrations above 50% by weight;

The label must state the energy value in Ccal/100 cm3;The information on powdered drinks must be provided in respect of the final

product ready for consumption;Where carbon dioxide concentrations are no less than 2 g per liter, the label must

state that the drink is saturated with carbon dioxide;Where carbon dioxide concentrations are below 2 g per liter, the label must state

that the drink is not saturated with carbon dioxide;The label on drinks with low energy value must state concentrations of the used

natural sugars and sweeteners;Where sugar is not added, the label on the drink must state, ‘Without addition of

sugar’;Where the energy value of the drink is 30% lower than that of the original drink

produced with addition of sugar, the label must state ‘Low-calorie’;Where the soft drink contains aspartame, the label must contain a warning ‘A

source of phenilalanine’.16. Quinine and caffeine used as aromas for the production of soft drinks must

be included in the list of the ingredients directly after the word ‘aromas’.17. The labels of the soft drinks containing caffeine of any origin in

concentrations of no less than 150 mg/dcm3 must state ‘High in caffeine’ followed with the information on caffeine concentration in mg/100 cm3 and placed in the same vision fild with the trade name under which the product is distributed.

18. The soft drinks containing ingredients obtained from GMOs or genetically modified food additives must be labeled in compliance with Sanitary Regulations regarding the labeling of energy value, labeling of food intended for special diets, labeling of food genetically modified or obtained from GMO products no. 01-04 of May 31, 2004.

19. Soft drink labels may not contain any statements regarding healthiness.

37

20. Negative tolerances for weight and volume values are specified in the appendix to these Regulations.

 VI. Storage and transport

21. Soft drinks in transparent packaging must be stored and transported in the conditions protected from direct sunrays.

22. Soft drinks must be stored and distributed at 0-20оC and fermented drinks - at 0-12оC.

VII. Control of compliance with these Regulations23. Duly empowered authorities shall be responsible for control of compliance

with these Regulations.24. Persons guilty of non-compliance with these Regulations, including the

officers of the controlling authorities, shall be held responsible according to the applicable law.

Schedule To the Regulations regarding Soft Drinks

Admissible negative tolerances for weight and volumeConsumer packaging (bottle, box, bag, etc.) size Tolerance

Below 50 g or 50 ml 9%Above 50 g or 50 ml and below 100 g or 100 ml 4.5 g or 4.5 mlAbove 100 g or 100 ml and below 200 g or 200 ml 4.5%Above 200 g or 200 ml and below 300 g or 300 ml 9 g or 9 mlAbove 300 g or 300 ml and below 500 g or 500 ml 3%Above 500 g or 500 ml and below 1000 g or 1000 ml 15 g or 15 mlAbove 1.0 kg or 1.0 l 1.5%

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Appendix 4To Government ResolutionNo. 934 of August 15, 2007

REGULATIONSRegarding Medicinal Mineral Water

I. General1. The Regulations regarding medicinal mineral water (further ‘the

Regulations’) were developed based on Law 1456-XII of May 25, 1993 on pharmaceutical activity and in compliance with EC Directive 2001/83/ЕС for the EC Code on medical goods for human consumption, with account of the provisions of EC Directive 80/777/ЕС on the harmonization on member country legislations regarding the use and distribution of natural mineral water.

2. The Objective of the RegulationsThese Regulations shall apply to deposits of the subterranean water acknowledged

to be medicinal mineral water; they shall regulate the acknowledgement and approval procedures in respect of medicinal mineral water, lay down the requirements regarding their quality with the objective to protect human health from any mineral water pollution. The Regulations shall apply to any medicinal mineral water acknowledged as such, bottled for distribution as a pharmaceutical product or intended for consumption and external application in the conditions of balneology resorts or medical health centers.

3. The requirements of the RegulationsThese Regulations:a) require that medicinal mineral water be formally identified and

acknowledged as such;b) prescribe the conditions for operation of a medicinal mineral water spring;c) lay down the microbiology and chemical criteria for medicinal mineral

water;d) regulate the distribution of bottled medicinal mineral water and prescribe

the statutory labeling of its specifics;e) regulate the use of medicinal mineral water deposits in the conditions of

balneology resorts;f) authorize the trademarks to be used in respect of bottled medicinal mineral

water;g) lay down the requirements and restrictions regarding the contents of the

label and advertisement;h) provide for periodical checks of medicinal mineral water springs by duly

empowered state authorities;i) argument the status for the restrictions, etc.4. Terms and definitionsFor the purposes of these Regulations, the following terms shall have the following

meaning:medicinal mineral water shall mean the water obtained from a natural source such

as water spring, lake or artesian well, with specific geographical and hydrological borders and satisfying at least one of the following requirements:

а) concentration of dissolved mineral salts above 1 g/l;

39

b) presence of certain chemical elements with known pharmacological effect in the required minimum proportion;

c) presence of certain dissolved biologically active gases in the required concentrations (1000 mg/l for СО2, 1 mg/l for Н2S);

d) temperature above 20°С irrespective of the mineral composition, which temperature shall form a statutory characteristics of thermal water;

е) presence of the scientifically confirmed curative effect, which factor gives such mineral water its status of a medicine and prohibits any modification or treatment via addition or removal of any substance, excluding carbon dioxide;

thermal water shall mean the water extracted from subterranean water elevations or self-emitting to the surface, with temperatures above 20°С;

balneology resort shall mean a facility located close to a spring of thermal or medicinal mineral water and offering medical services and favorable conditions for the use of hydrotherapy;

hydrotherapy shall mean the diverse water treatment methods (baths, showers, hydro-massage) for various diseases;

trademark shall mean the name under which bottled medicinal mineral water is distributed and which contains an indication as to certain quality class, trademark or empiric name.

Medicinal mineral water differs from any other water by its:a) specific mineral or microbial composition, which renders the water its specific

medicinal qualities;b) extraction directly from self-emitting natural springs or wells using the

subterranean water-bearing layers. In such situations measures should be taken to prevent any pollution or external impact on the chemical or physical characteristics of medicinal mineral water;

c) sustainable chemical composition without any significant natural variations;d) collection and extraction in the conditions ensuring the microbial purity and

stability of its main chemical components;e) filling in consumer size packaging directly at the water spring subject to

compliance with special hygienic requirements;f) maintained natural composition without any additional treatment, excluding the

treatment provided for in these Regulations. 

II. Scope5. These Regulations shall apply solely to the medicinal mineral water

acknowledged as such by a competent authority, with a specific microbial and chemical composition rich in mineral salts which contain certain biologically active substances in curative concentrations and hydrogen sulfide, have specific radioactivity levels, temperature and рН level.

Medicinal mineral water which produces a curative effect on humans owing to its specific composition must be acknowledged as the medicinal water by the Ministry of Health based on the criteria listed in Schedule 1 hereto and the findings of special medical research. The curative effect shall be confirmed by the duly authorized institution subordinated to the Ministry of Health – the Agency for Drugs jointly with the National Research and Implementation Center of Preventive Medicine – based on the

40

findings of special medical research or by analogy with other medicinal mineral waters with similar composition and properties.

6. Medicinal mineral water shall be classified into the following categories:1) depending on the intended use:a) internal – as curative drink – crenotherapy (for swallowing), aerosols and

inhalations;b) parentheral introduction via injections;c) external treatment as baths in individual bath-tubs, balneology ponds,

kinetotherapy pools, swimming pools and solaria as well as curative irrigation;2) depending on the mineralization level:a) mineral water with mineralization above 1 g/l of dissolved solids, which can be

further categorized into: mineral water with medium mineralization levels of 1-5 g/l; concentrated mineral water with mineralization levels of 15-35 g/l; highly concentrated mineral water with mineralization levels of 35-150 g/l; extremely highly concentrated mineral water with mineralization levels of above 150 g/l;

b) mineral water with mineralization below 1 г/л g/l of dissolved solids – olygo-minerals containing biologically active substances, which render the water its specifics and which are categorized into: olygo-mineral sulfurous water; olygo-mineral ferriferous water; olygo-mineral carbonated water and other similar water types as well as olygo-mineral thermal water – depending on the temperature;

3) depending on physical and chemical composition:a) olygometallic - acratic;b) alkaline and alkaline earth - bicarbonate, sodium, calcium, magnesium;c) sodium – chlorinated salty; d) sulfate (with sulfate concentrations of above 600 mg/l);e) carbonic (with natural dissolved СО2 concentrations of above 1000 mg/l);f) ferriferous (with natural Fe concentrations of above 10 mg/l);g) bromine (with natural Br concentrations of above 25 mg/l); h) iodine (with natural I concentrations of above 5 mg/l); i) arsenious (with natural As concentrations of above 0.7 mg/l); j) radioactive (with natural radium levels of above 2 Bq/l); k) boroneous (with natural H3BO3 concentrations of above 35 mg/l); l) siliceous (with natural H2SiO3 concentrations of above 50 mg/l); m) sulfurous (with natural hydrogen sulfide concentrations of above 1 mg/l); n) containing organic substances (with concentrations – recalculated as carbon – of

above 5 mg/l);4) depending on the water temperature:a) cold: Т < 20°C; b) hypothermal: Т = 20-30°С;c) thermal: Т = 31-38°С;d) hyper-thermal: Т > 38°С;5) depending on рН value:a) super acid: рН < 3.5;b) acid: рН = 3.5-5.5;c) acidulous: рН = 5.5-6.8;d) neutral: рН = 6.9-7.1;

41

e) alkalescent: рН = 7.2-8.5;f) alkali: рН > 8.5. 

III. Filling and distribution of bottled medicinal mineral water7. Filling of medicinal mineral water 7.1. Medicinal table mineral water intended for distribution as a human

consumption therapeutic product must be filled in the facilities certified accordingly by the State Sanitary Epidemiology service and the Drugs Agency.

7.2. Certificates to produce bottled medicinal mineral water shall be issued by the National Research and Implementation Center of Preventive Medicine upon examination of the information regarding the properties of the water according to Schedule 1 hereto, jointly with the Drugs Agency, following the procedures laid down for the certification pf medicine production facilities.

7.3. Medicinal mineral water shall be treated similar to medicines in terms of the requirements regarding its production and distribution. The names of medicinal mineral water shall be entered in the State Register of Drugs and Medicines. The National Drugs Agency shall issue a registration certificate for bottled medicinal mineral water.

7.4. Bottled medicinal mineral water shall be produced by the certified facilities holding a respective license, using a special filling technology in compliance with the applicable special norms.

7.5. Bottled medicinal mineral water shall be used in health care industry according to medical recommendations issued by a doctor or/and a pharmaceutist and distributed via community pharmacy/drugstore networks; the distribution of such water shall be allowed without a medical prescription (similar to general therapy medicines).

7.6. Bottled medicinal mineral water shall be stored in the respective conditions ensuring adequate protection from the impact of light and low temperatures; its shelf life may not exceed 3 months.

7.7. Bottled medicinal mineral water of foreign origin may not be distributed in Moldova without its acknowledgement as such and certification by the national competent authorities in compliance with these Regulations.

8. Conditions for the operation of medicinal mineral water springs8.1. Medicinal mineral water springs shall be deemed public patrimony and

therefore they must be operated and guarded accordingly.8.2. Based on the findings of the hydrogeology survey performed by the

National Agency of Geology (АGeoM), technology procedures shall be developed for the operation of the medicinal mineral water source; such procedures shall be subject to approval by the national expert committee on hygiene and environment in compliance with the applicable law.

8.3. The operation of any medicinal mineral water spring is subject to authorization by the State sanitary epidemiology service where the water is found to be in compliance with the requirements hereof.

8.4. Acceptance and commissioning of balneology-climatic resorts and facilities operating the deposits and individual springs of medicinal mineral water shall be performed upon approval by the national authorities in charge of sanitary epidemiology supervision as well as the national geology and environment protection services,

42

complete with the production of the formal documentation required by the applicable law.

8.5. To prevent the depletion of the natural reserves, entities must operate mineral water fields and springs in compliance with the field operation production programs developed with consideration of the available field resources, special water use conditions, capping structure appropriate for the project, subject to systematical monitoring of the mineral water discharge, level, chemical composition and physical properties.

8.6. Water springs must be capped (captated) in order to preserve the total natural properties of medicinal mineral water and to prevent its pollution and demineralization. The capping shall be performed with consideration of the data collected as result of the hydrogeology survey.

The capping methods and the capping structure type to be used shall be specified and substantiated in detail in the development projects (schemes) depending on the specifics of each medicinal mineral water field.

The capping shall:а) ensure the comprehensive collection of the mineral water at the depth best

corresponding to its optimum composition, discharge and temperature;b) prevent the mineral water from any contact with the surface water (which is

often polluted) and from the negative impact of other natural factors or mixing with other sweet water types;

с) prevent the losses of mineral water and gas;d) ensure the possibility to perform the required operation monitoring.8.7. A capping superstructure in the form of a pavilion shall be constructed for

each water spring to protect the head of the structure from the impact of atmospheric conditions and to prevent outsiders from access to the water-spring mouth.

8.8. To prevent the mineral water from spoilage and to preserve its properties (suich as temperature, radioactivity level, dissolved gas concentrations, etc.) in their integrity, the water well setting, pumps, pipelines for feeding of water from the spring to its consumption place, collectors for the accumulation of mineral water and heating water vats shall be made of corrosion-resistant materials authorized for use by the Ministry of Health.

8.9. The design of the equipment for water extraction must prevent any possibility of water pollution and ensure preservation of the water properties in the spring:

а) the water spring must be protected from any pollution threat;b) the equipment for water extraction, pipes and tanks must be designed and

assembled to minimize any chemical, physical-chemical or microbial changes in the water as much as possible;

с) the packaging must be designed or treated to prevent any impact on the microbial and chemical properties of water;

d) the container-washing and filling equipment as well as all other operational aspects must comply with the hygiene requirements;

е) as per Paragraph 8.3 of these Regulations, bottled medicinal mineral water may be transported solely in consumer size packaging intended for sale to final consumers.

43

8.10. Should it be found during the water-spring operation that the medicinal mineral water in the spring is polluted and does not comply with the microbiology requirements hereof, the entity in charge of the water spring operation must suspend any operations relating to water extraction, and in particular filling, till the pollution and its root causes are eliminated and the water is brought back in compliance with the applicable requirements.

8.11. The competent authorities shall perform periodical checks of the spring water quality for compliance with the requirements hereof. Each spring must have a sign with its name and details regarding the chemical composition of the extracted mineral water.

8.12. The tests to monitor the quality of medicinal mineral water from the water spring shall be similar to those required in the case of natural mineral water springs and regulated with the sanitary norms regarding the use and distribution of natural mineral water.

8.13. Operation of water fields and operational monitoring of the medicinal mineral water shall be performed by the hydrogeology services of the respective balneology resorts in compliance with Government Resolution 632 of May 18, 2002 “On the survey, use and protection of mineral water’.

9. Quality requirements for medicinal mineral waterА. Microbiology 9.1. The total viable colony count in the medicinal mineral water in the spring

must correspond to the normal microbial population in water and prove that the water spring is protected reliably from any pollution threat. The total colony count shall be determined in compliance with Schedule 1 Paragraph 2 Letter 3) hereto.

9.2. The total colony count after filling may not exceed 100 per ml, when incubated for 72 hours at 20-22°С on agar-agar or mixed agar-gelatin medium and 20 per ml, when incubated for 24 hours at 37°С on agar-agar medium. The total colony count shall be monitored during 12 hours after bottling, and the water must be stored all that time at 4°С +/- 1°С.

9.3. Normally these values may not exceed 20 colonies in 1 ml for the spring water held at the temperature of 20-22°С during 72 hours and respectively 5 colonies in 1 ml for the spring water held at the temperature of 37°С during 24 hours, provided those values are deemed initial levels rather than maximum admissible levels.

9.4. The medicinal mineral water in the spring and during distribution may not contain any:

a) parasites or pathogen microorganisms;b) Escherichia coli or other coli-bacillae or faecal streptococci in 250 ml of the

tested sample;c) sporulate sulfite-reducing anaerobic bacteria in 50 ml of the tested sample;d) Pseudomonas aeruginosa in 250 ml of the tested sample.9.5. The total count of regenerated bacteria in the medicinal mineral water

must correspond to the normal result of the growth in the normal bacteria count initially present in the water spring.

В. Chemical parameters of medicinal mineral water shall be tested according to the list in Schedule 2 hereto, and the admissible maximum values shall be laid down in compliance with Schedule 1 Paragraph 5 hereto.

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9.6. It shall be prohibited to use or fill the medicinal mineral water containing any of the substances listed in Schedule 1 hereto in concentrations in excess of the maximum admissible values laid down for each substance, or any other substance in concentrations making the water unfit for use.

9.7. The natural mineral water must contain the following admixtures in concentrations below the detection threshold of the respective testing methods: anion-active substances, pesticides and chlorodiphenyl, mineral oils, polycyclic aromatic carbohydrates.

10. Quality control of the medicinal mineral water10.1. The balneology resort operating the water field or the producer of bottled

medicinal mineral water shall be responsible for the quality control of the medicinal mineral water. The control shall be performed in compliance with Schedule 2 hereto based on the program included in the producer’s statutory specifications coordinated with and approved by the National Research and Implementation Center of Preventive Medicine.

10.2. The National Research and Implementation Center of Preventive Medicine shall perform state quality control of the medicinal mineral water in compliance with the analytical and regulatory documents approved during the registration process in Moldova.

10.3. The expense in relation to the laboratory tests to control the quality of the medicinal mineral water shall be charged to the entities operating the respective water fields, importing, producing or distributing the respective medicinal mineral water.

10.4. The average samples of the medicinal mineral water shall be taken for the quality control purposes by the State Sanitary Epidemiology Service officer in the presence of the producer’s/importer’s quality assurance officer.

10.5. Domestic producers shall submit an application for sampling and state quality control to the National Research and Implementation Center of Preventive Medicine within 5 days after the production of the water.

10.6. The importers shall submit an application for sampling and state quality control to the National Research and Implementation Center of Preventive Medicine within 5 days after the imports, attaching a copy of the import license, including the technical specifications forming an annex to the respective contract and certified with an original stamp of the National Drugs Agency (for the first imported lot) and 2 copies of the customs invoice. Only 2 copies of the customs invoice and a reference to of the import license number in the submitted application shall be required in respect of the other lots of medicinal mineral water imported subsequently on the force of the same import license and technical specifications.

The importing company must perform the obligatory acceptance control in respect of the water in compliance with the applicable requirements and preliminary sorting of the goods by name and by line (lot).

10.7. An officer of the National Research and Implementation Center of Preventive Medicine shall visit the applicant company within 5 days after the filing date of the application and have the tests performed within 30 working days after the sample acceptance day.

10.8. A hygienic certificate after the standard form laid down by the applicable legislation and regulations shall be issued for the lots of the domestic or imported

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medicinal mineral water, the quality of which is found to be in compliance with the requirements hereof. The certificate confirming the quality compliance of an individual lot of the goods produced/imported by the holder shall apply solely to the lot, from which the average samples have been taken.

10.9. Only a testing protocol shall be issued in respect of the lots of medicinal mineral water, the quality of which is found to be not in compliance with the requirements hereof. Such lots shall be prohibited for distribution and sale in Moldova. In such case the producer/importer of the respective lot of water shall make a claim to the producer/supplier along the lines prescribed for that purpose. The non-complying lots must be returned to the producer/supplier to be placed on quarantine or destroyed according to the applicable law within no more than 2 months from the issue date of the testing protocol. The domestic producer of medicinal mineral water shall follow the procedures similar to those applicable to the imported water. The counterfeit bottled medicinal mineral water must be destroyed in compliance with the procedures established for the purpose.

11. Imports, exports and re-exports of medicinal mineral water11.1. The medicinal mineral water may be imported based on the import license

issued by the National Drugs Agency following the procedures established by the Ministry of Health.

11.2. Only the medicinal mineral water authorized in Moldova may be imported to Moldova. The exports and re-exports of the medicinal mineral water shall be performed in compliance with the applicable law.

 IV. Marking and Labeling. Promotion and Advertisement

12. Marking and Labeling12.1. The labels of bottled medicinal mineral water must contain the following

information:a) the place where the water is extracted and the name of the water spring or

artesian well; the producer and its address;b) water composition as confirmed by the performed official tests (the information

must include the testing protocol number and the name of the testing laboratory as well as the analytical water composition, including the substances determining its specific nature);

c) water trademark;d) shelf life and special storage requirements and precautions;e) words ‘disposable packaging’ where РЕТ packaging is used;f) number of the authorization allowing the distribution of the medicinal mineral

water;g) instructions regarding the intended use;h) all details must be made easily visible, clear, discernable and stable.12.2. The distribution shall not be permitted in respect of the medicinal mineral

water labeled not in compliance with the requirements hereof.13. Information dissemination and advertisement13.1. The information dissemination and advertisement shall be permitted solely

in respect of the medicinal mineral water registered in Moldova.

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13.2. The information disseminated regarding the medicinal mineral water must comply with the following requirements:

а) it must be true, objective and based on official documents;b) it may not address the public with an appeal to consume medicinal mineral

water;с) it may not produce the exaggerated (misleading) impression regarding the

composition and origin as well as curative properties of the medicinal mineral water;d) it may not suggest to the consumer that the consumption of medicinal mineral

water would improve his/her health state whereas the refusal to consume such water would result in aggravations for the health;

е) the promo spots advertising medicinal mineral water may not encourage excessive consumption of such water;

f) any advertisement must contain a reference to the registration no. in Moldova.13.3. The advertising entities must submit their advertisement and promotion

materials to the National Research and Implementation Center of Preventive Medicine for approval, where such materials shall be accepted and examined and an opinion shall be issued thereon. Any amendments or modifications in the contents of the advertisement and promotion materials shall be subject to approval following similar procedures. The approvals issued in respect of the advertisement and promotion materials shall be valid for 6 months.

14. Restrictions regarding the labeling and advertisement14.1. The label or advertisement of the medicinal mineral water may not contain

any description, name, trademark, emblem, picture or any other component with or without symbolical meaning, which are attributing the water any properties not characteristic for it.

14.2. The label or advertisement of the medicinal mineral water may not contain any statements regarding its preventive or curative effect for human health, where they are not confirmed with the findings of medical research performed in compliance with Annex 1 to these Regulations.

 V. Effectiveness of the Regulations

15. Implementation15.1. The implementation of these Regulations shall be the responsibility of the

respective duly empowered state authorities.15.2. In case of finding any non-compliance with the requirements hereof, the

state authorities in charge of sanitary epidemiology control and pharmaceutical supervision must apply administrative sanctions as per Administrative Infringements Code.

16. Implementation terms16.1. Schedules 1-2 shall form an integral part hereof.16.2. These Regulations shall become effective on the day they are published in

‘Monitorul Oficial’.16.3. Any resolutions or regulations conflicting with these Regulations shall be

deemed cancelled as soon as these Regulations become effective.

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16.4. The entities producing or using medicinal mineral water must ensure compliance with the requirements hereof within 6 months after the day these Regulations become effective.

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Schedule 1to the Regulations regarding medicinal mineral water

 Requirements regarding the use of medicinal mineral water

1. Requirements regarding geological survey: The geological and hydrogeology survey to explore and record the reserves of medicinal mineral water must be described in detail in the geology report on hydrogeology conditions for the field development, such report to be produced based on the criteria similar to those for natural mineral water as laid down in the Sanitary Regulations regarding the use and distribution of natural mineral water.

2. The requirements for physical, chemical and physical-chemical survey shall include the tests of:

1) water spring discharge;2) water temperature in the spring and the ambient temperature;3) relationships between the nature of the rock and the properties/type of minerals

in the water;4) solid residue at the temperatures of 180°С and 260°С;5) electric conductivity or resistance, indicating the temperature at the time of

testing;6) hydrogen ion concentration levels (рН);7) cation and anion concentrations;8) concentrations of not disintegrated substances;9) concentrations of residue elements;10) water radioactivity levels in the spring;11) if necessary, testing of concentrations in water in respect of the isotopes for

oxygen (О16 - О18) and hydrogen (protons, heavy hydrogen, tritium);12) toxicity levels of certain individual water components with consideration of

maximum admissible values for each of them.3. Requirements regarding microbiology tests of water in the spring:1) evidence of freedom from parasites and pathogen microorganisms;2) tests of microbe counts indicating the nature of faecal pollution:а) absence of Escherichia coli and other coli bacilli in 250 ml of the tested sample

at 37°С and 44°С;b) absence of faecal streptococci in 250 ml of the tested sample;с) absence of sporulated sulfite reducing anaerobic bacteria in 50 ml of the tested

sample;d) absence of Pseudomonas aeruginosa in 250 ml of the tested sample;3) zero total microbe colony count in 1 ml of water:a) incubated on agar-agar or mixed agar-gelatin medium for 72 hours at 20°С and

22°С;b) ) incubated on agar-agar medium for 24 hours at 37°С.4. Requirements regarding clinical and pharmacologic researchThe type of the research, which was performed using scientifically acknowledged

methods, must be appropriate for the specific characteristics of the medicinal mineral water and its effect on human organism, such as: diuretic, digestive, laxative, compensating for the deficit in minerals, improving the sustainability of metabolism and

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endocrine gland secretion, improving the performance of locomotorium and peripheral nervous system.

5. Chemical characteristicsThe medicinal mineral water may not contain any of the elements listed in the table

below in concentrations exceeding the respective maximum admissible concentrations:

Element Unit Maximum admissible concentration1 2 3

Arsenic As, mg/l 2Barium Ba, mg/l 0.7Cadmium Cd, mcg/l 3Total organic carbon C, mg/l 15Cyanides CN, mcg/l 70Chromium Cr, mcg/l 50Copper Cu, mg/l 1Manganese Mn, mg/l 0.5Mercury Hg, mcg/l 1Nickel Ni, mcg/l 20Nitrates NO3, mg/l 50Nitrites NO2, mg/l 0,5Antimony Sb, mcg/l 5Strontium Sr, mg/l 25Selenium Se, mcg/l 50Lead Pb, mcg/l 10Phenols mcg/l 1Fluorine F, mg/l 10Radium Ra, Bq/l 18.5Pesticides, total mcg/l 0,5

6. Stability requirementsThe composition, temperature and other essential characteristics of the medicinal

mineral water must remain stable within the limits of natural variations.7. The National Research and Implementation Center of Preventive

Medicine and the National Drugs Agency shall, upon issuance of an opinion approving the registration of the medicinal mineral water, publish the information on the respective registration and the argumentation supporting such approval in the official bulletins or on the web sites of the respective authorities, specifying the name of the water as per National Register of Drugs and National Register of medicinal mineral water.

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Schedule 2To the Regulations regarding medicinal mineral water

Chemical characteristics of the medicinal mineral water 1. The testing protocol must include the findings of tests regarding the

concentrations of the following chemical substances and groups:a) anions and cations

Cations Unit Anions UnitAluminum Al mg/l Borates BO3 mg/lAmmonium NH4 mg/l Carbonates CO3 mg/lCalcium Ca mg/l Chlorides Cl mg/lMagnesium Mg mg/l Fluorine F mg/lPotassium К mg/l Hydro-carbonates HCO3 mg/lSodium Nа mg/l Nitrates NO3 mg/l

Nitrites NO2 mg/lPhosphates P2O5 mg/lSilicon SiO2 mg/lSulfates SO4 mg/lSulfites S-²

 b) non-ionized compounds

Non-ionized compounds UnitOrganic carbon C mg/lFree carbon dioxide CO2 mg/lSilicon oxides SiO2 mg/l

с) other elementsElement Unit Element Unit

Barium Ва mg/l Lithium Li mg/lBromates (total) Вr mg/l Manganese Mn mg/lCobalt Co mg/l Molybdenum Mo mg/lCopper Cu mg/l Strontium Sr mg/lIodine (total) I mg/l Copper Zn mg/lIron Fe mg/l

2. Where the geology report produced in compliance with Schedule 1 Paragraph 1 hereto indicates the presence of cations, anions, non-ionized compounds or trace elements listed in this Schedule above, their concentrations must be determined and described in detail.

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Appendix 5To Government ResolutionNo. 934 of August 15, 2007

REGULATIONSon the procedures for the marking of bottled mineral water, table water and soft

drinks with the National Trademark stamps

I. General1. These Regulations shall regulate the procedures for sale of the State

Trademark stamps and marking with them of bottled natural mineral water, table water and soft drinks (further ‘bottled water and soft drinks’).

2. The stamps shall be sold to entities for a fee and applied to bottled natural mineral water, table water and soft drinks produced or imported in Moldova.

3. The compliance with the procedures for the purchase of State Trademark stamps, as described herein, and their use for the marking of the water and soft drinks originating in Moldova or imported thereto shall be deemed an obligatory prerequisite for their distribution in Moldova.

4. The purchased State Trademark stamps may not be re-sold, transferred to a third party or transferred in any other form, excluding their return to the Main State Fiscal Inspectorate.

 II. The procedures for the distribution of the State Trademarks. Responsibility for

marking5. The party directly responsible for the distribution of the State Trademark

stamps to producers based on their applications shall be the Main State Fiscal Inspectorate.

6. The distribution of the State Trademark stamps to importers and entities acquiring bottled water and soft drinks from the resident entities, which have no fiscal relationships with Moldova’s National budget system, shall be performed by the Customs offices based on orders (applications) in the standard form provided as Schedule 1 hereto.

7. The distribution of State Trademark stamps for the marking of confiscated or waif bottled water and soft drinks shall be performed in compliance with the procedures laid down by the Main State Fiscal Inspectorate.

8. The producer must pay the price of the ordered stamps the Main State Fiscal Inspectorate as at the filing date of the order (application). The payment order column ‘payment purpose’ shall indicate ‘payment for the State Trademark stamps’.

9. The State Trademark stamps required for the distribution of bottled water and soft drinks sequestered under a civil claim with the possible subsequent confiscation shall be issued by the respective territorial office of the Main State Fiscal Inspectorate upon request of the authority duly authorized and empowered to sell the products in question. The price of the State Trademark stamps shall be paid from the proceeds from the distribution of marked products, and the respective amounts shall be remitted to the Main State Fiscal Inspectorate.

10. The importer and/or the entity acquiring bottled water and soft drinks from the resident entities, which have no fiscal relationships with Moldova’s National budget system, must pay the price of the ordered stamps to the respective Customs office a

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payment order for the bank, and fill the payment order form where the column ‘payment purpose’ indicates ‘payment for the State Trademark stamps’, as at the filing date of the order (application).

11. The responsibility for the marking of the bottled water and soft drinks intended for distribution shall lie with the domestic producers, importers or entities acquiring bottled water and soft drinks from the resident entities, which have no fiscal relationships with Moldova’s National budget system during the production process.

12. The required quantities of the State Trademark stamps shall be determined based on the volumes and measurement units of the goods, for the marking of which such stamps are acquired. To that end the buyer shall submit the following documentation to the Main State Fiscal Inspectorate or the Customs Service, as the case may be:

a) order (application) for the purchase of the stamps, specifying the quantities of the goods, for the marking of which such stamps are acquired;

b) contract between the importer and the foreign producer in the original and in copy (where bottled water and soft drinks are imported). An officer in charge of issuance of the State Trademark stamps shall verify the submitted copy of the contract with the original counterpart thereof and return the original to the buyer of the State Trademark stamps;

c) direct contract (an original and a copy) between the entity buying (acquiring) bottled water and soft drinks from the Moldovan resident entities, which have no fiscal relationships with Moldova’s National budget system. An officer in charge of issuance of the State Trademark stamps shall verify the submitted copy of the contract with the original counterpart thereof and return the original to the buyer of the State Trademark stamps;

d) payment documents (in the original) evidencing the performed payment for the State Trademark stamps acquired for the marking of bottled water and soft drinks as well as a bank account statement as at the day of payment;

e) ID and power of attorney (if applicable) to collect the stamps;f) the respective license in the original and in copy. An officer in charge of issuance

of the State Trademark stamps shall verify the submitted copy of the license with the original thereof and return the original to the buyer of the State Trademark stamps.

13. The producer must submit the documents listed in Paragraph 12 hereof under Letters a), d), e), f); the importer must submit the documents listed in Paragraph 12 under Letters a), b), d), e); the entity acquiring (obtaining) the products from the Moldovan resident entities, which have no fiscal relationships with Moldova’s National budget system, must submit the documents listed in Paragraph 12 under Letters a), с), d), e).

14. Copies of the documents listed in Paragraph 12 hereof shall be included by the Main State Fiscal Inspectorate or by the respective Customs office, as the case may be, in the personal file specially started in respect of the entity buying the State Trademark stamps.

15. An officer of the respective Customs office or the Main State Fiscal Inspectorate shall verify the arrival of the payment and examine the submitted documents.

16. The buyer of the State Trademark stamps is issued a bill for the stamps.17. The counterparts of the bill shall be used as follows:

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a) Counterpart 1 shall be attached (jointly with the power of attorney and the application) to the submitted payment evidence and included in the personal file started by the respective office for the buyer of the State Trademark stamps;

b) Counterpart 2 shall be issued to the buyer of the State Trademark stamps.18. The Main State Fiscal Inspectorate and the Customs Service shall maintain

a register of the issued State Trademark stamps received by the buyers.19. The State Trademark stamps shall be printed on the order of the Main

State Fiscal Inspectorate, which shall be responsible for their safekeeping and subsequent transfer to the Customs Service (for the subsequent allocation to its offices) as well as their distribution to the applicant entities based on the received orders.

20. The Customs Service shall give its orders for State Trademark stamps to the Main State Fiscal Inspectorate, where they are stored in compliance with the storage procedures for the sequentially numbered forms subject to registration.

 III. Procedures for the production of customs documents when State Trademark

stamps are shipped to a foreign producer21. The State Trademark stamps may be shipped to a foreign producer in

compliance with the Customs law. 

IV. Procedures for the marking of goods with the State Trademark stamps22. The bottled water and soft drinks shall be marked with the State

Trademark stamps during their production.23. The domestic producer or importer must attach the stamps to the

packaging of the goods in places specially envisaged for that purpose according to Schedule 2 hereto.

24. The imports to Moldova of the bottled water and soft drinks subject to the marking with such stamps or their entrance to the Moldovan territory via internal customs offices shall be allowed by the Customs service solely where the goods have been marked with the State Trademark stamp during their production.

 V. The return of unused or damaged State Trademark stamps

25. The return of unused or damaged State Trademark stamps shall be performed where the stamps have not been used or where they have been damaged during the production of the goods.

26. All damaged State Trademark shall be attached at the end of the day to a special stamp return form as per Schedule 3 hereto.

27. The damaged or subject to return State Trademark stamps shall be returned by the entities for destruction to the Main State Fiscal Inspectorate upon expiry of the 6-months period prior to the 15th day of the next month.

28. Upon verification of the submitted documents and agreement of the numbers and series of the returned State Trademark stamps with the numbers and series recorded on the entity’s file, an officer of the Main State Fiscal Inspectorate shall make a note ‘stamps duly returned’ on the entity’s application and indicate the respective stamp numbers and series.

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29. The destruction of the damaged State Trademark stamps shall be performed monthly by a special committee comprised of the representatives of the Main State Fiscal Inspectorate and the Customs Service.

A statement regarding the destruction of the damaged stamps shall be produced in 2 counterparts and signed by all committee members upon destruction of the respective stamps.

30. No refund shall be performed in respect of the cash paid for the State Trademark stamps, which are subsequently returned.

 VI. Production of a database on the quality of bottled water and soft drinks in

circulation at the Moldovan market and information sharing among the authorities31. The National Research and Implementation Center of Preventive Medicine

shall ensure the production of a database on the quality of bottled water and soft drinks in circulation at the Moldovan market.

32. The National Research and Implementation Center of Preventive Medicine shall submit weekly a list (after the standard format) of the respective license holders to the Main State Fiscal Inspectorate.

33. The Main State Fiscal Inspectorate shall submit weekly the data regarding the sales of the State Trademark stamps to the National Research and Implementation Center of Preventive Medicine.

 VII. Control over the purchase and use of the State Trademark stamps

34. The control over the marking with State Trademark stamps of the goods covered with these Regulations shall be performed by the duly empowered authorities.

35. Persons guilty of non-compliance with the requirements of these Regulations shall be held responsible according to the applicable law of Moldova.

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 Schedule 1

To the Regulations regarding the rules for marking of bottled natural mineral table waterand soft drinks with the State Trademark stamps»

To _______________________________________________ (The authority to which an application is submitted to obtain State Trademark stamps)

ORDER (APPLICATION)

Company ________________________________________________________________________________________ (Name, Fiscal code and Registered office)

_________________________________________________________________________________________________

Hereby applies for the State Trademark stamps as follows: 

Goods subject to marking with stamps

Unit of the goods (products)

The required quantity of stamps (pieces)

Price of one stamp (MDL)

Total value of the stamps (MDL)

Total amount to be paid (MDL)

1 2 3 4 5 6 

I have been made aware of the requirements laid down in the Regulations and I confirm that the requested stamps would be used solely in respect of the goods and volumes thereof specified in this application.

Date: __________________ 200___________________________________

(CEO’s name and signature)

Stamp HereSchedule 2

To the Regulations regarding the rules for marking of bottled natural mineral table waterand soft drinks with the State Trademark stamps»

 The rules for marking of bottled natural mineral table water and soft drinks

 The State Trademark stamp shall be attached to the bottle above the producer’s label.

   

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 Schedule 3

To the Regulations regarding the rules for marking of bottled natural mineral table waterand soft drinks with the State Trademark stamps 

Special FormFor the return of damaged State Trademark stamps

Entity __________________________________________________________________________________________

Date of filling the form _____________________________________________________________________________

The damaged stamps being returned: 

                    

Notes: 1. The stamps must be attached evenly and have no creases.2. The stamps must be attached in a way that ensures the visibility of the stamp number and series as well as central part.3. The parts of the stamps torn in several pieces must be glued together. Signature of the entity’s CEO_____________________________

Government Resolutions934/15.08.2007 Resolution on the implementation of the automated information system “State register of bottled natural mineral water, table water and soft drinks” /Monitorul Oficial no. 131-135/970, 24.08.2007

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