MINISTRY OF HEALTH
SPREME DECREE No. 106
Published in the Official Gazette on June 14, 1997
APPROVES REGULATIONS ON MINERAL WATER
Number 106 – Santiago, January 22, 1997
Having had before me
The provisions contained in Decree with Force of Law No. 237 of 1931, under articles 3, 68, 76, 77d), and 129 of the Health Code, approved under Decree with Force of Law No. 726, of 1967, issued by the Ministry of Health: under articles 4, 6, 16, and 20 of Decree Law No. 2,763, of 1979, and bearing in mind the authority granted to me under article 32 item 8 of the Constitution, and
There is a need to regulate the activities associated to mineral waters, in order to safeguard the health of the population,
I hereby decree;
The following regulations on mineral water is hereby approved:
MINERAL WATER AND THE PROTECTED PERIMETER THEREOF
Article 1 – For the purposes hereunder, the term “mineral water” is understood to mean natural water rising from the ground not originating in superficial watercourses or tables, of known analysis, whose constitution or physico-chemical or biological properties make it suitable for applications beneficial to health.
For the purposes hereunder, mineral water shall be classified as follows:
1. Thermal mineral water: when water temperature, measured at the point where the spring rises, is equal to or higher than 18º Celsius;
2. Non-thermal mineral water: when water temperature, measured at the point where the spring rises, is less than 18º Celsius.
Article 2 – Only springs of thermal mineral water that have been declared by the President of the Republic to be curative springs, under a supreme decree issued by the Ministry of Health, titled “By order of the President of the Republic”, may be opened to the public or exploited as thermal springs.
Article 3 – For a spring to be declared curative, the interested party shall submit an application to the Health Agency with jurisdiction over the territory where such spring is located, supported by the following documents:
(a) Name of spring and geographic location thereof;
(b) Applicant information, copies of public organization deed in the case of a juristic person and power of attorney of the individual representing it;
(c) Documents proving that applicant is entitled to utilize the water, in accordance with the provisions contained in the Water Code, and the protection area as set by the Water Department;
(d) Map in triplicate of the geographic basin where the mineral water spring is located, signed by applicant and by author of such map;
(e) Certificates of physico-chemical, bacteriological, and temperature analyses at the water spring, performed for one year at least by the Health Agency, Chilean Institute of Public Health, or a laboratory duly authorized for the purpose:
(f) A geological report on the terrain occupied by such mineral water régime, with specifications of the feed perimeter thereof, performed by a qualified geologist;
(g) Map of location, in triplicate, showing the area, including spring area, ways of access, and nearest towns;
(h) Statement by applicant engaging, once the spring is declared a ”curative spring”, to refrain from executing any work or construction liable to pollute or alter the analysis of such mineral water.
Article 4 – The Director of the Health Agency, based on the information submitted and the physico-chemical characteristics of the water, will determine the conditions thereof and the use that may be made thereof so that it may be utilized in applications beneficial to health, whether for drinking or baths, or both, and thus qualified to be declared a curative spring The above will be contained in the report to be submitted with all supporting documents to the Ministry of Health for the necessary supreme decree to be issued.
Rejection of such application shall be made under a grounded resolution.
Article 5 – The supreme decree declaring such spring to be a curative spring shall state the sanitary uses to which such water may be put, i.e. for drinking, baths, or other uses.
Article 6 – The spring protection area, intended to prevent works or underground construction from being undertaken in the vicinity thereof liable to alter, reduce, or extinguish such spring shall be set by the General Water Department pursuant to the provisions contained in the Water Code.
Article 7 – A supreme decree issued by the Ministry of Health shall void the declaration that such spring is a curative spring in the event that such spring no longer complies with any of the requirements that were considered to issue such declaration, based on a report from the Health Agency concerned, supported by a summary proceeding.
EXPLOITATION OF MINERAL WATER
Article 8 – A crenotherapy establishment is one devoted to exploiting mineral water for medical purposes.
A mineral water bottling establishment is one devoted to exploiting mineral water for consumption thereof, by bottling or otherwise putting the water in containers for distribution and sale thereof.
These establishments may also exploit the byproducts of such water for medical, hygienic, or other purposes.
A mineral water establishment for tourists or recreational purposes is one that exploits mineral waters for other than medical purposes, i.e. merely for user leisure and relaxation
Article 9 – Permission to install and operate crenotherapy, mineral water bottling, and by-product exploitation establishments will be granted by the Health Agency with jurisdiction over the place where the spring is located, pursuant to the provisions hereunder.
Permission for establishments intended for tourism and recreational purposes will be granted by the competent Health Agency, pursuant to applicable standards in accordance with the facilities offered, that is, swimming pool regulations, camping or camp grounds for tourism, regulations governing hotels and similar establishments, and other applicable regulations.
PERMISSION FOR CRENOTHERAPY ESTABLISHMENTS AND OPERATION THEREOF
Article 10 – To obtain permission to install a crenotherapy establishment, the interested party shall submit an application to the Health Agency for the location thereof, supported by the following documents:
(a) Identification of spring and documents proving that is has been declared a curative spring;
(b) Identification of applicant and documents proving entitlement to use the water in question, pursuant to the Water Code;
(c) Map of the area in triplicate, including the establishment, ways of access, and nearest towns;
(d) Drawing in triplicate showing mineral water catchment, storage, adduction, and distribution within the establishment where it is to be used;
(e) Drawing in triplicate of the establishment.
Article 11 – Having verified compliance with requirements, the Health Agency will issue a resolution authorizing installation of such establishment. Rejection of such application shall be issued in a grounded resolution.
Article 12 – To obtain permission to operate the establishment, the interested party shall submit to the appropriate Health Agency the following:
(a) Permission for installation granted by the appropriate Health Agency;
(b) Identification of the technical director thereof stating his/her profession and hours when he/she will be present at the establishment;
(c) List of staff who will operate the establishment;
(d) Book of suggestions and complaints with numbered pages for use by the public, which will require stamping by the Health Agency; and
(e) Drawing of emergency exits
Article 13 – Having verified compliance with the requirements hereunder, the Health Agency will grant permission to operate under a resolution stating the type of services to be provided and conditions thereof.
Such permission shall lapse after three years and shall be automatically and successively renewed for equal periods unless specifically revoked.
Rejection of such application shall be issued in a grounded resolution.
Article 14 – The mineral water catchment, storage, and distribution tanks shall be ventilated, enclosed, and protected against all possible pollution and access of strangers or animals to the facilities.
Article 15 – Supply and distribution pipelines, storage tanks, and heat exchangers, if any, shall be made of materials that are impervious to mineral water and do not alter the composition thereof.
There shall be no leaks in pipelines, to avoid any possible pollution from sewage or surface water.
>Article 16 – For purposes of permission and operation, pavilions or buildings intended to accommodate guests or patients shall comply with the regulations governing them according to the nature thereof.
Article 17 – The hydrotherapy sections or bath houses of crenotherapy establishments shall comply with the following requirements:
1. Buildings shall ensure thermal insulation from the weather and shall be easily cleaned.
2. Hydrotherapy rooms shall be built of appropriate materials with waterproof floors and baseboard. Floors shall be equipped with appropriate drainage and run-off fittings.
3. Bathtubs shall be made of appropriate materials, smooth, waterproof, strong, and suitable for the object thereof.
4. Mud bath sections shall be equipped with tubs or showers for washing off mud with mineral or potable water.
5. Sheets, towels, and personal utensils used in baths and resting rooms shall be changed after each use, Such items shall be sanitized before reuse.
6. Toilets shall be available in sufficient number, as required by the General Construction and Urban Development Ordinance, and shall be kept in perfect condition as regards cleanliness and conservation.
Article 18 – Ancillary facilities annexed to hydrotherapy sections, baths, or equipment for medical treatment or therapy installed therein shall comply with the provisions contained in the regulations governing them and shall be approved by the Health Agency.
Article 19 – Mineral water cooling and heating shall be performed by indirect means (coil, cold or hot water jets playing on mineral water pipeline, ice, etc.); mixing mineral water with other water is prohibited.
Article 20 – Pools belonging to establishments hereunder shall be governed by the general provisions contained in the Swimming Pool Regulations.
Supply of mineral water for pools shall be direct through closed pipelines made of appropriate materials, from the springs or from storage tanks.
Article 21 – Places containing mineral-medicinal mud shall be perfectly closed; access of strangers thereto shall be prevented.
If mud is brought from locations not adjacent to the establishment, it shall remain in contact with the appropriate mineral water for at least one year.
Crenotherapy establishments utilizing mineral mud for medicinal purposes shall operate a section designed specially for the purpose. Treatment shall be applied in individual tubs and the same mineral mud shall not be used for more than one person.
Mud bath houses shall meet the same requirements as water bath houses and shall be suitably equipped to remove the mud.. Waste mud disposal shall not be performed in the same location where mud is collected for use and application.
Article 22 – Sections intended for treatment using gas or vapor from the thermal springs shall be made of appropriate materials, compatible with the nature thereof.
Article 23 – Sections intended for baths shall be fitted with thermometers wherever needed. They shall further be equipped with appropriate means for cleaning, disinfecting, and possibly sterilizing utensils and mineral-water bath systems utilized.
Article 24 – Facilities shall be fitted with a sewer system to collect sewage and waste material in compliance with prevailing standards.
Article 25 – All crenotherapy establishments shall have a medicine cabinet for internal use thereof, in compliance with the relevant constitution and operation standards contained in the Regulations for Pharmacies, Drugstores, and Similar Establishments.
Article 26 – Crenotherapy establishments shall be managed by a technical director, who shall perform tests on, and prescribe treatment for, patients coming to the establishment and so requiring. Diagnoses and treatment shall be noted on patients’ records, which shall be kept in a clinical file at the establishment. In addition to such file, the establishment shall carry a Register of medical staff.
TECHBNICAL AND AUXILIARY STAFF AT CRENOTHERAPY ESTABLISHMENTS
Article 27 – The technical management of a crenotherapy establishment shall be performed by a qualified physician.
Article 28 – When the medical director is absent from his duties for more than fifteen days, he shall be replaced by another physician, this fact being entered in the Register..
Article 29 – The medical director shall have the following duties and authority:
(a) Treat any patients and guests who require it.
(b) Direct and supervise the staff working in the establishment as regards treatment and care of patients and guests.
(c) Keep a clinical file of individuals receiving treatment prescriptions or complying therewith within the establishment, and supply the relevant statistics to the Health Agency concerned.
Article 30 – Any physician may care, inside the establishment, for any patient referred by him/her. In any event, he/she shall report this to the medical director.
Article 31 – Staff in charge of assistance at the baths shall meet the following requirements:
1- Be more than 18 years old.
2- Have completed full primary schooling.
Auxiliary staff, nurses, masseurs, etc. at the crenotherapy establishment shall be appointed by the management thereof with the approval of the medical director.
MINERAL WATER INTENDED FOR CONSUMPTION OR SALE
Article 32 – Bottled mineral waters intended for consumption or sale shall come from officially recognized natural springs, comply with bacteriological requirements applicable to potable water, contain less than one and one-half grams of minerals per liter, and not exceed the limits listed below for the following substances:
Arsenic 0.05 mg/l
Barium 1 mg/l
Borate 30 mg/l calculated as H3BO3
Cadmium 0.01 mg/l
Cyanide 0.01 mg/l calculated as CN
Zinc 5 mg/l
Copper 1 mg/l
Chrome (hexavalent) 0.05 mg/l
Fluoride 2 mg/l calculated as F
Manganese 2 ng/l
Organic matter 30 mg/l calculated as O2
Mercury 0.001 mg/l
Nitrate 45 mg/l calculated as NO3-
Nitrite 0.005 mg/l calculated as NO2-
Lead 0.05 mg/l
Selenium 0.01 mg/l
Sulphur 0.05 mg/l calculated as HsS
In addition, the following contaminants shall not be present in detectable amounts in mineral water intended for drinking: phenol compounds, tensoactive agents, pesticides, polychlorinated biphenyls, mineral oils or polynuclear hydrocarbons.
Article 33 – Addition of carbonic gas under pressure is permitted for preparing gas-containing mineral water, in compliance with the quality requirements established under the Sanitary Regulations on Food.
The denomination “gaseous mineral water” is permitted only for natural effervescent water, containing carbon gas rising from the same spring, a fact that shall be proved in situ by means of reiterated tests or technical inspections.
Article 34 – Industrial production, import, export, bottling, sale, or distribution of mineral water as discussed hereunder shall be governed by the provisions contained in the Sanitary Regulations on Food.
Article 35 – It is hereby forbidden to subject mineral waters to processes other than the following: deironizing, ozonizing, ultraviolet radiation, filtering, gasifying, and settling.
ESTABLISHMENTS DESIGNED TO BOTTLE MINERAL WATER
Article 36 – Establishments designed to bottle mineral water referred to under article 32 above, shall require a permit for installation and operation granted by the Health Agency concerned, in compliance with the requirements and conditions stated in the Sanitary Regulations on Food.
Article 37 – Mineral water and byproducts may be bottled at the original spring only, unless such water is piped from catchment to bottling plant.
The owner shall be responsible for operating a bacteriological quality control system of the spring and the bottled water, accepted by the health authority, together with a twice-yearly check of the physico-chemical analysis of the mineral water under exploitation, which shall be reported at like periods to the Health Agency concerned.
REQUIREMENTS FOR EXPLOITING MINERAL WATER BYPRODUCTS
Article 38 – For the purposes hereunder, mineral water byproducts shall mean solid or gaseous substances contained therein and collected by spontaneous settling or other means.
Such processes duly authorized by the Health Agency with jurisdiction over the place where the spring is located, may be conducted at establishments designed to bottle mineral water.
Article 39 – Import and sale in Chile of mineral water byproducts shall require authorization from the Health Agency concerned.
CONTAINERS, LABELS, AND ADVERTISING FOR MINERAL WATER AND BYPRODUCTS THEREOF
Article 40 – Mineral water and byproducts thereof, whether domestic or imported, as regards associated denomination, containers, labels, and advertising, shall comply with the requirements contained in the Sanitary Regulations on Food and other supplementary standards in effect.
Article 41 – No mention shall be made of any water qualities or attributes that fail to subsist after the water leaves the point of origin.
Article 42 – Brand names designed to distinguish bottled mineral water and byproducts thereof shall have the same denomination as the spring or springs thereof, registered with the Ministry of Health and shall not be used to market other products.
Article 43 – Mineral water bottled in its natural state without adding to the gas with which such water comes from the spring thereof, shall carry the word “natural” visibly printed on the label or the cap thereof. Water to which carbon gas has been added under pressure shall carry the word “gasified” or “gas-containing” printed on the label or cap thereof.
INSPECTION OF . . . ESTABLISHMENTS AND FACILITIES DESIGNED TO BOTTLE OR PROCESS MINERAL WATER AND BYPRODUCTS THEREOF
Article 44 – The Health Agency for the location where the spring rises shall perform sanitary control of spring, establishments, and end products.
Article 45 – Breaches of any of the provisions hereunder shall be penalized by the Health Agency for the location of the spring is pursuant to the provisions contained in Book Ten of the Health Code.
Article 46 – Decree No. 2.075, of 1953, issued by the Ministry of Health is hereby revoked as from the effective date hereof.
Article 47 – The present regulations shall take effect sixty days after publication thereof in the Official Gazette.
To be noted, registered, published, and entered in the Official Compilation kept by the Office of the Comptroller-General of the Republic. EDUARDO FREI RUIZ TAGLE, President of the Republic. Alex Figueroa Muñoz, Minister of Health.
Which I hereby transcribe for your information. Yours truly, Dr. Fernando Muñoz Porras, Under Secretary for Health.