Decree of the Ministry of Health No. 423 / 2001 Coll.
Ordinance of the Ministry of Health laying down the manner and scope of evaluation of natural medical and mineral resources and other details of their use, requirements for the environment and equipment of natural medical baths and the need for expert advice on the usefulness of natural medical resources and climatic conditions for therapeutic purposes, natural mineral waters for the production of natural mineral waters and the state of the environment of natural medical baths (Decree on Resources and Spa)
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423
DECLARATION
Ministry of Health
of 20 November 2001
laying down the manner and scope of the evaluation of natural medical and mineral water resources and other details of their use, the requirements for the environment and the equipment of natural medical baths and the necessary expertise on the usefulness of natural medical and climatic conditions for therapeutic purposes, natural mineral waters for the production of natural mineral waters and the state of the environment of natural medical baths (Decree on Resources and Spa)
According to § 46 (1) (a) to (h), Act No. 164 / 2001 Coll., on Natural Medical Resources, Natural Mineral Water Resources, Natural Spa and Spa Points and on the amendment of certain related laws (Spa Act) (hereinafter referred to as "the Act"):
NATURAL ACTIVE RESOURCES AND SOURCES OF NATURAL MINERALS
Method and scope of assessment of natural medicinal and mineral water sources
[Paragraph 46 (1) (a) of the Law]
The method and scope of evaluation of natural medicinal and natural mineral water sources (hereinafter referred to as "the source ') shall be based on the determination of the type and type of mineral water, peloid or gas in the source, on the basis of an assessment of the source in terms of its physical characteristics, chemical composition and compliance with microbiological requirements. The purpose of the assessment of the source is to identify and verify the quality and stability of the resource for the purposes of its certification (Section 5 of the Act), to issue authorisation for the use of the resource (Section 12 of the Act) and to use the resource (Section 16 of the Act).
(1) The extent of the assessment of the source in terms of its physical characteristics and chemical composition is set out in Annex 1. The assessment of the source shall be carried out through a comprehensive analysis or control analysis.
(2) A comprehensive analysis is carried out by a Health Institute based in Ústí nad Labem or by a public research institution for the purposes of issuing a source certificate [Paragraph 6 (2) (c) of the Act] and the use of the source. A comprehensive analysis for the use of the resource shall be carried out every 5 years unless otherwise specified in the authorisation for use of the resource [Paragraph 12 (4) (h) of the Act]. The content of the comprehensive analysis of the source is set out in Annex 2.
(3) A control analysis for quality verification and stability of the source may be carried out by a health institution, a public research institution, another accredited laboratory or source user. Control analyses shall be carried out at the frequency specified in the authorisation for use of the resource [Paragraph 12 (4) (h) of the Act] and after any technical or other intervention in receipt of the resource prior to its re-use, to the extent specified in Annex 2, unless otherwise provided in the authorisation for use of the resource, depending on the nature of the resource, the type of intervention in receipt of the resource, on the basis of verified changes in natural factors, or in order to verify or exclude other effects.
(4) Evaluation of the yield from a natural medical source for the purpose of verifying the quality before its use for the provision of spa rehabilitation care (hereinafter referred to as "spa care") (6) is carried out by a staff member authorised by the source user,
(a) in the case of a natural mineral water source within the scope laid down in the authorisation to use the source;
(b) for a natural health source of peloid, by monitoring the consistency and homogeneity of the peloid temperature field ready for application and the monthly consumption of peloid in m3.
The staff member responsible for the user of the source shall keep a file on the results of the evaluation of the yield in order to verify the quality before using it.
(5) The conditions for sampling for comprehensive analysis and control analyses shall not differ significantly from those for previous comprehensive analysis or control analysis, or shall comply with newly approved conditions of use of the source.
(1) Mineral water and gas at the broth and peloid obtained from the bearing must be non-toxic. They shall not exhibit microbial signs of fecal or other types of pollution from the external environment and shall not contain micro-organisms which could pose health risks to humans.
(2) The microbiological requirements for sources of mineral water and peloids with regard to microbiological parameters are set out in Annex 3.
The expertise on the applicability of natural medical resources for medical purposes and natural mineral waters for the production of packaged natural mineral waters
[Paragraph 46 (1) (d) and (e) of the Act]
(1) The expert opinion on the usefulness of a natural medical resource for medical purposes (Section 6 (2) (d) of the Act) contains:
(a) a geological and hydrogeological assessment of the source; and
1. the technical documentation of the source, the assessment of its viability and stability in the extent of natural fluctuations in the conditions of the semi-operational hydrodynamic test, the assessment of the risks of possible contamination, or, where appropriate, the design of the extent of monitoring of potential health-risk indicators due to the vulnerability of the particular source structure, the design of the method and the degree of use of the source, including in relation to possible ambient sources, the evaluation of the results of a comprehensive mineral water analysis carried out in accordance with Article 2 before the end of the half-operational hydrodynamic test, the design of the source of the overhaul and the design of safety measures for potential eruptions, if any sources of mineral water or gas,
2. the qualitative characteristics of the bearing on the basis of a comprehensive analysis, broken down for use for baths, wraps or other applications, stock calculation, conditions of extraction, transport and storage and subsequent reclamation of the bearing, as well as the risk assessment of possible contamination, if any, if it is a source of peloid;
(b) identification of essential, characteristic and balneologically relevant components, an overview of the clinical trials of the source yield and their evaluation, and, where appropriate, an assessment of the extent of compliance of the source with other natural medicinal sources already used, an assessment of possible methods of therapeutic use of the source, including the necessary adjustments;
(c) an assessment of the suitability of filling in consumer packaging;
(d) the overall assessment, where appropriate for the therapeutic use of indication, contraindication and method and conditions of application.
(2) The expert opinion on the applicability of natural mineral water as food and for the production of packaged mineral waters (Section 6 (2) (d) of the Act) contains:
(a) the geological and hydrogeological assessment of the source, the technical documentation of the source, the assessment of its performance and stability in the extent of natural fluctuations in the conditions of the semi-operational hydrodynamic test, the design of the method and the rate of use, including in relation to possible ambient sources, the assessment of the risks of possible contamination, or, where appropriate, the design of the extent of monitoring of potential health-risk indicators due to the vulnerability of the particular base structure, the evaluation of the results of a comprehensive mineral water analysis carried out in accordance with Article 5 before the completion of the semi-operational hydrodynamic test, the design of the source of the system monitoring and the design of safety measures for potential eruptions;
(b) an assessment of the necessity and manner of treatment of mineral water;
(c) an assessment of the physiological importance of mineral water in terms of impact on human health and nutritional importance;
(d) an overall assessment of the source, including an assessment of the suitability of mineral water to be filled in consumer packaging in natural condition, after treatment or seasoning, as appropriate.
(3) Furthermore, the expert opinions referred to in paragraphs 1 and 2 shall include information on education, including post-graduate training and the professional practice of processors and their working relationship with the applicant, on the issue of a source certificate.
Modifications to the yield of natural medical resources and natural mineral water
[Paragraph 46 (1) (b) of the Law]
(1) The proceeds from a natural medical resource, which is mineral water used for medical purposes, can only be adjusted in the manner defined in the authorisation for the use of the resource (Section 12 (4) (f) of the Act) in order to preserve or enhance its medicinal properties.
(2) The proceeds from the natural mineral water source can be adjusted in the manner defined in the authorisation to use the resource [Paragraph 12 (4) (f) of the Act], only
(a) the removal of unstable substances such as iron and sulphur compounds, filtration or decanting, with any prior oxygenation,
(b) by the removal of arsenic, manganese, iron or sulphur compounds, by ozone-enriched air, filtration or decanting;
(c) by removing other undesirable components such as beryllium, nickel compounds;
(d) by saturation or saturation of carbon dioxide from a source or, where appropriate, by carbon dioxide from a non-natural source of quality laid down by a specific legislation; (2) carbon dioxide may also be removed from mineral water using exclusively physical methods.
(3) The use of the adaptations referred to in paragraph 2 shall not alter the composition of the essential components of the yield from the source of natural mineral water which confers on it its properties and shall not cause harmful substances. The yield cannot be disinfected or bacteriostatic substances can be added to it. Furthermore, other ingredients may not be added to the yield, except for carbon dioxide as referred to in paragraph 2 (d). This provision does not preclude the seasoning of mineral water in the production of soft drinks.
(4) The proceeds from a natural medical source which is a gas can only be adjusted in the manner defined in the authorisation for the use of the source [Paragraph 12 (4) (f) of the Act] in such a way as to remove moisture or traces of oil particles by using appropriate sorbents and filters.
(5) The proceeds from a natural medical resource, which is a peloid, can only be adjusted in the manner defined in the authorisation to use the resource [Paragraph 12 (4) (f) of the Act], which consists in particular of:
(a) removal of non-usable components for the preparation of the mixture;
(b) crushing, grinding, dilution of water to the necessary consistency according to the method of use for balneation;
(c) heating to the prescribed temperature or pasteurisation during the preparation of peloid swabs.
(6) For the preparation of peloid mixtures, a regenerated peloid may be used with the pelloid used for the first time for balneation, not earlier than 5 years after its storage for regeneration. The regenerated peloid can be used in the mixture after complete analysis including verification of microbiological requirements. The proportion of regenerated peloid in the mixture shall not exceed one half of the total volume of pelloid used to prepare the peloid mixture.
Collection, transport, accumulation and storage of mineral water, gas and peloid from natural medical and natural mineral water sources
[Paragraph 46 (1) (c) of the Law]
(1) Proceeds from the natural medical resource:
(a) mineral water may only be transported and stored (stored) in such a way as to limit changes in the composition and loss of unstable active ingredients to the minimum possible and prevent contamination with harmful or undesirable substances;
(b) gas may be transported by pipeline or in pressure vessels and stored (stored) in pressure vessels.
(2) The yield from the source of natural mineral water can only be transported to the place of filling into consumer packaging by pipeline.
(3) The extraction of the extract from the natural health source of peloid, which includes the opening, extraction, method and procedure for the reclamation of the bearing, the handling of the pelloid used, the dislocation of sites for the storage of the hide not available for balneation or, where applicable, the storage of pelloid mixtures after use for balneation, must be carried out only in the manner laid down in the authorisation for use of the resource [Paragraph 12 (4) (d) of the Law], on the basis of the proposal set out in the application for authorisation for use of the source [Paragraph 10 (1) (e), (a) (a) (8) and (f) of the Law], so that the bearing and its surroundings are examined as far as possible. Mining, transport and storage shall be carried out in such a way as to avoid changes in the composition and physical characteristics of the peloid and to avoid contamination. When handling a used pelloid, it is preferable to return it to the extracted bearing.
Data on the packaging of the yield from the natural medical source
[Paragraph 46 (1) (f) of the Law]
The following information shall be indicated on the packaging of the yield from the natural medical source, which is mineral water, or on the package leaflet of the yield, which is peloid, [Paragraph 16 (1) (k) of the Act]:
(a) the designation and registered office of the manufacturer;
(b) designation of mineral water (e.g. name of mineral water),
(c) indication of volume or weight,
(d) the serial number of the production series;
(e) minimum storage life;
(f) the recommended storage method,
(g) the designation of the source, including its location;
(h) classification of the natural medical source;
(i) the date of the last comprehensive analysis carried out and the name of the laboratory which carried out the analysis, the modification (e.g. de-irrigation) carried out and the characteristic composition of the yield; If an adjustment has been made, the characteristic composition of the yield after that adjustment shall be reported,
(j) the recommended time of use and, where appropriate, the warning in relation to the use of the yield.
NATURAL MEDICINAL PRODUCTS
Environmental requirements in the internal territory of the spa site and equipment of natural spa treatments
[Paragraph 46 (1) (g) of the Law]
(1) The specific nature of the spa environment as an important factor in spa care is created and stored in the territory in which the natural spa was or should be established (Section 25 of the Act),
(a) respect for the bioclimatic bonita of the territory;
(b) by defining the optimal size of natural medical baths depending on the nature of the terrain and the capacity of the natural medical source;
(c) by increasing green value by selecting suitable crops in accordance with landscape conditions and treatment requirements; and
d) by harmonious segregation of architectural and urban solutions with surrounding landscape.
(2) Medical and other facilities for the provision of spa care must, to the extent possible, be separated from other parts of the municipality, displacing sources of air pollution and causing noise. The area of the green area in the inner territory of the spa area must be at least 4 hectares per 100 beds intended for patients and visitors to the natural spa, with additional at least 4 hectares of greenery per 100 beds over the border of that area. Green in the inner territory of the spa area as well as in the surrounding countryside must be species-diverse, excluding planting of species causing more frequent allergic reactions.
(3) The territory used in connection with providing spa care within a distance of 4 to 8 km around the natural therapeutic spa (spa landscape) must provide conditions for field treatment, or other controlled physical burden, and allow for the choice of climatic contrasts, which are the alternating of latent sections with paths in the open landscape and shady places with sun positions, the rotation of landscape parts (e.g. meadows, tree groups).
(4) The spa facilities must be addressed without barriers (3) and in such a way that there is no excessive thermo-regulatory burden on patients moving from the internal to the outdoor environment. The installation also includes elements providing protection against rain and wind and allowing outdoor and weather movement (colonnades, arches).
(5) The transit sections of the roads must be kept outside the inner territory of the spa area.
(6) Allowed noise levels in natural treatment spas are laid down in specific legislation. (4)
(7) It is inappropriate to place medical facilities providing spa care in the vicinity of the facility (e.g. cemeteries, crematorium, prisons) which could have a negative effect on the psyche of persons receiving spa care. 5)
Air quality in natural spa treatments is set limits:
(a) the mean value of dusty aerosol does not exceed 150 μg / m3 in 24 hours and 500 μg / m3 in 30 min. in the case of aerosol which does not contain more than 20% of free SiO2;
(b) the mean sulphur dioxide value does not exceed 50 μg / m3 in 24 hours and 200 μg / m3 in 30 minutes;
(c) the mean value of NOx oxides does not exceed 100 μg / m3 per 24 hours, 200 μg / m3 per 30 min and 50 μg / m3 per year;
(d) in the long-term average, no more than 50 days of fog in the months of October to March, no more than 15 days of fog in April to September;
(e) the average length of sunlight shall be at least 1500 hours per year, and shall not be less than 1300 hours per year when the horizon is orographed.
(1) The internal territory of the spa area of the climatic baths must show the following climatic factors:
(a) irritating factors (position at altitude above 800 m above sea level with reduced barometric pressure, rich sunlight, intense sunlight, intense ventilation with a significant and strongly fluctuating cooling level); and
(b) saving factors (presence of a sufficient number of shady places, protection against strong winds but without stagnation of air, adequate cooling, relative weather stability, poor air on dusty ingredients and allergens).
(2) The internal territory of the spa site of the climate baths shall not be polluted by temporary exhaust gases, industrial exhalation and smoke from local space heaters.
In particular, due to their nature, natural spa facilities providing spa care (5) include:
(a) facilities for the therapeutic use of natural medical resources not incorporated into a spa care facility (drinking pavilions, colonnades);
(b) facilities for the use of the spa environment and surrounding landscape for field and climate treatment (parks and forest parks with marked roads for field treatments, outdoor lounges with sun and shade positions);
(c) accommodation and catering facilities (including dietetic) for persons using spa care and other visitors to natural spa treatments, which are not or are not part of health facilities (e.g. spa hotels and guesthouses),
(d) leisure facilities (such as clubhouses, reading rooms, social halls, sports grounds);
(e) public transport facilities without negative environmental impact (e.g. trolleybuses, electric vehicles);
f) parking houses and parking lots connected to public transport stations on the edge of the inner territory of the spa site,
(g) facilities to monitor climatic conditions in the internal territory of the spa site.
In natural spa treatments which have been established in accordance with the legislation previously in force and which do not comply with the requirements laid down in Sections 8 to 11, the environmental development and the provision of their equipment shall be carried out in such a way that these requirements are respected as far as possible. If non-compliance pursuant to § 8 to 11 distorts the purpose for which the natural spa has been established, the procedure laid down in § 25 (4) of the Act shall be followed.
Forms of expert opinion on the state of the environment of natural spa treatments
[Paragraph 46 (1) (h) of the Law]
(1) The expert opinion on the state of the environment of the natural health spa always contains the following elements:
(a) the reason for the location of the natural spa in the location and for the establishment of the spa site;
(b) description of the overall landscape including assessment
1. horizontal and vertical landscape breakdown,
2. the crops at and around the site of the proposed natural spa,
3. soil characteristics;
4. the overall natural framework of the surrounding landscape;
(c) solutions to the supply of drinking water, the disposal of waste water, the disposal and disposal of solid and liquid waste materials;
(d) solutions to public transport traffic of proposed natural medical baths, a proposal for measures limiting the threat to visitors by means of transport;
(e) the bioclimatic conditions of the proposed natural treatment spa, supported by data on:
1. the altitude of the territory and the prevailing wind directions;
2. air temperature (annual average and highest average daily amplitude in months),
3. rainfall rates (average relative humidity, minimum and maximum with indication of months, average precipitation total in April to September and October to March),
4. sunlight (average number of hours of sunshine in the year, number of days of sunshine in the months),
5. air purity (in the scope of Section 9),
6. leeward and windward areas, sunny and shady areas and areas;
f) the effect of the environment of the proposed natural healing spa on the psyche of visitors in terms of
1. the separation of the landscape from urban activity;
2. Sound background and noise including airplanes and possibilities for elimination of noise sources,
3. harmony of surrounding landscape,
4. the possibility of removing aesthetically disruptive elements in the landscape,
5. the possibility of setting up new green areas, forests, orchards, parks, sightseeing sites,
6. other effects (§ 8 (7));
(g) a description of other factors at the site and surrounding the proposed natural treatment baths, in particular:
1. water flows and areas;
2. the possibility of setting up routes for field treatment with different length and climb,
3. the possibility of improving the bioclimate by planting and maintaining green, removing sources of pollution by dust and exhalation;
(h) a comprehensive assessment of the quality of the territory of the natural health spa and the location in which they are or are to be determined in terms of bioclimatology and ecology in relation to the needs of spa care for the relevant therapeutic indications;
(i) compliance of the zoning documentation with the needs of spa care, including any proposal to limit the housing around the natural therapeutic spa by capacity building of livestock production (mainly for pig farming) or other production.
(2) The expert opinion also includes information on education, including post-graduate and other training and on the professional practice of the processor and on his professional or other relationship with the promoter of the proposal for the establishment of a natural hospital (Section 25 (3) of the Act).
Requirements for expert opinion on the applicability of climate conditions for medical purposes
[Paragraph 46 (1) (d) of the Law]
(1) The expert opinion on the applicability of climate conditions for medical purposes contains:
(a) the justification for the location of the climate spa in the site and, where appropriate, for the establishment of a spa site;
(b) a description of the overall landscape including data on:
1. altitude;
2. horizontal and vertical landscape breakdown,
3. the crops at the site of and around the proposed development of climatic baths,
4. the separation of the landscape from urban activity,
5. soil properties,
(c) an assessment of the climate characteristics in relation to the proposed indications for treatment, including the specification which components of the bioclimate including aerosols are essential for the applied climate treatment;
(d) documentation on the effects of climatic factors over at least a five-year closed period;
(e) a description of the climatic treatment and a list of the facilities that allow it to be carried out;
(f) solutions for drinking water supply, waste water disposal, disposal and disposal of solid and liquid waste materials; and
(g) a solution to the transport connection of the internal territory of the spa site proposed by the public public health spa, including a proposal for measures restricting transport within the internal territory of the spa site proposed by the climate spa.
(2) The expert opinion also includes information on education, including post-graduate training and the professional practice of the processor and on his working relationship with the promoter of the proposal for the establishment of natural spa treatments.
Decree No. 26 / 1972 Coll., on the protection and development of natural medical baths and natural medical resources is hereby repealed.
EFFECTIVE
This Decree shall take effect on 1 January 2002.
Minister:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No 1 to Decree No 423 / 2001 Coll.
Criteria for assessing mineral water, gas and pelloid sources
A. Natural mineral waters are evaluated:
(a) according to total mineralisation as mineral water:
1. very weakly mineralized with dissolved solids up to 50 mg / l,
2. slightly mineralized with dissolved solids 50 to 500 mg / l,
3. Medium mineralized with dissolved solids 500 mg / l to 1500 mg / l,
4. strongly mineralized with a dissolved solid content of 1500 mg / l to 5 g / l;
5. very strongly mineralized with a dissolved solid content exceeding 5 g / l;
(b) depending on the content of the gases dissolved and the content of the major components such as water:
1. carbon above 1 g of carbon dioxide / l of water,
2. Sulphur above 2 mg of Titrate Sulphur (Sulfan dissociated at varying degrees and thiosulphates) / l of Water,
3. iodine above 5 mg iodide / l water,
4. with an increased content of: silica acid (above 70 mg / l water), fluoride (above 2 mg / l water), lithium (above 3 mg / l), barium (above 1 mg / l), strontium (above 5 mg / l), bromide (above 5 mg / l), iodide (1-5 mg / l), boric acid (above 17 mg / l; 4 mg B / l), sulphate (1-2 mg / l), arsenic (above 0,4 mg / l);
(c) according to the actual reaction expressed by the pH value, the water is distributed only if the water is:
1. strongly acidic - pH below 3,5,
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Regulation Information
| Citation | Decree of the Ministry of Health No. 423 / 2001 Coll., establishing the manner and extent of evaluation of natural medical and mineral resources and other details of their use, requirements for the environment and equipment of natural medical baths and the need for expert advice on the usefulness of natural medical resources and climatic conditions for medical purposes, natural mineral waters for the production of natural mineral waters and the state of the environment of natural medical baths (Decree on Resources and Spa) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.12.2001 |
|---|---|
| Effective from | 01.01.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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