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Royal Decree 1798 / 2010, Of 30 December, Which Regulates The Exploitation And Marketing Of Natural Mineral Waters And Spring Waters That Are Packaged For Human Consumption.

Original Language Title: Real Decreto 1798/2010, de 30 de diciembre, por el que se regula la explotación y comercialización de aguas minerales naturales y aguas de manantial envasadas para consumo humano.

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TEXT

According to the current regulations, the waters currently being packaged for human consumption are natural mineral waters, spring waters, prepared waters, and packaged public drinking water. This provision is intended to regulate exclusively natural mineral waters and spring waters.

Royal Decree 1074/2002 of 18 October 2002 regulating the processing, circulation and trade of packaged drinking water, incorporated into Spanish law Council Directive 98 /83/EC of 3 November 2002 on the 1998 on the quality of water intended for human consumption in the case of packaged drinking water, as well as Council Directive 80 /777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to members on the exploitation and marketing of natural mineral waters, as amended by Directive 96 /70/EC of the European Parliament and of the Council of 28 October 1996 amending Council Directive 80 /777/EEC on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters.

Subsequently, Council Directive 80 /777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters has been recast and Repealed by Directive 2009 /54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters, incorporating minimum changes in administrative procedures at European level which do not affect the content of the previously integrated rule in the legal order national.

The European Union also, by way of Commission Directive 2003 /40/EC of 16 May 2003 fixing the list, concentration limits and labelling indications for the components of mineral waters In addition to the conditions for the use of ozone-enriched air for the treatment of natural mineral waters and spring waters, an update of the existing legislation was carried out, given the transcendent nature of the the health suitability of drinking water represents for human health. This rule was transposed into Spanish law by Royal Decree 1744/2003 of 19 December 2003 amending Royal Decree 1074/2002 of 18 October 2002 regulating the process of production, circulation and trade of packaged drinking water.

This royal decree does not incorporate any new Community directive into Spanish law, but is due to the desirability of separating in two independent rules, in the interests of greater legal certainty, the regulation of the waters natural minerals and spring waters, on the one hand, and of the waters prepared, on the other, regulations which until now were contained in a single provision, Royal Decree 1074/2002 of 18 October, for which the processing process is regulated, circulation and trade in packaged drinking water.

Several aspects of the previous legislation have been modified in the wording of this standard, taking into account the application of the new legislation on food hygiene and materials in contact with food, as reflected respectively in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs and in Regulation (EC) No 1935/2004 of the European Parliament and of the Council of the Council of 27 October 2004 on materials and articles intended to enter into contact with food and repealing Directives 80 /590/EEC and 89 /109/EEC, as well as Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Authority Food security and procedures relating to food security are laid down.

Moreover, it should be noted that Law 22/1973, of 21 July, of Minas remains in force and is applicable to mineral and thermal waters, regardless of the use to which they are intended. In order to clarify this aspect, a final provision amending Article 38.1 of the General Regulation for the Mining Regime, approved by Royal Decree 2857/1978 of 25 August

, is introduced in this royal decree.

This royal decree has been subject to the procedure of information in the field of technical norms and regulations and regulations concerning the services of the information society, regulated in Royal Decree 1337/1999, For the purposes of implementing Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998, as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998

Directive 98 /34/EC of the European Parliament and of the Council of 20 July 1998.

In its preparation have been consulted the autonomous communities and cities of Ceuta and Melilla, as well as the sectors affected, having issued its mandatory report the Inter-Ministerial Commission for Food Management.

In its virtue, on the proposal of the Minister of Health, Social Policy and Equality, of the Minister of Industry, Tourism and Trade, the Minister for the Environment, and the Rural and Marine Environment, and the Minister of Science and Innovation, with the prior approval of the First Vice-President of the Government and Minister of the Presidency, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 30 December 2010,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. The purpose of this provision is to define, for legal purposes, what is meant by natural mineral waters and spring waters and to lay down rules for the collection, handling, circulation, marketing and, in general, legal order of such products.

2. This royal decree will apply to the waters extracted from the subsoil of the territory of the Kingdom of Spain, defined as mineral waters for the purposes of applying the provisions relating to their use of the Law of Mines, and recognized by the competent authorities such as natural mineral waters or spring waters, which comply with the provisions laid down in Parts A or B respectively of Annex I.

3. This royal decree shall also apply to waters extracted from the subsoil of another Member State of the European Union and recognised by the competent authorities of that Member State as natural or spring mineral waters, which are in accordance with the provisions of Parts A or B of Annex I, as well as those imported into Spain from a third country not belonging to the European Union, irrespective of whether or not they have been recognised as natural or spring mineral waters by the competent authorities of another Member State of the European Union, provided that the authorities of the the country of extraction has certified that those waters comply with the provisions of Annex I, and that the application of the provisions of Annex II has been continuously monitored.

4. This royal decree obliges all operators of natural mineral waters and spring waters.

5. The following waters are expressly excluded from the scope of this provision:

(a) waters which, in accordance with Law 29/2006 of 26 July, guarantees for the rational use of medicinal products and medical devices, and their implementing rules, are considered to be medicinal products,

b) mineral-medicinal waters for therapeutic purposes,

c) the prepared waters and

d) the public drinking water packaged.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

(a) Natural mineral waters: those microbiologically sound which have their origin in a stratum or underground field and which sprout from a spring or can be artificially caught by means of a borehole, pit, ditch or gallery; or or the combination of any of them.

These can be clearly distinguished from the remaining ordinary drinking water:

1. º by its nature, characterized by its content in minerals, trace elements and other components, and sometimes for certain purposes,

2. º for its chemical constancy and

3. º for its original purity,

characteristics that have remained intact, given the underground water source that has protected it naturally from any risk of contamination.

For the use of this name, the waters shall comply with the characteristics set out in Part A of Annex I and the declaration and approval requirements laid down in Article 3 for this type of water, as well as the operating and marketing conditions laid down in Chapter II of this provision.

(b) Spring waters: are those of underground origin that emerge spontaneously on the surface of the earth or are captured by work performed to the effect, with the natural characteristics of purity that allow their consumption; characteristics that are preserved intact, given the underground origin of the water, by the natural protection of the aquifer against any risk of contamination.

For the use of this name, the waters shall comply with the characteristics set out in Part B of Annex I and the declaration and approval requirements laid down in Article 3 for this type of water, as well as the operating and marketing conditions laid down in Chapter II of this provision.

c) Normal water microbism: It is the perceptibly constant bacterial flora, existing in the spring prior to any manipulation thereof, and whose qualitative and quantitative composition, taken into account for the recognition of such water, be controlled periodically by relevant analyses.

(d) Public consumption water packaged: those distributed through a public supply network and those from this origin, packaged in accordance with the regulations governing the materials in contact with food, For their home and free distribution, with the sole purpose of supplying absences or accidental inadequacies of the public network, they must comply with the Royal Decree 140/2003, of February 7, for which the criteria are established health care for the quality of water for human consumption.

In addition, they shall apply to the effects provided for in this royal decree, to the extent necessary, the rest of the definitions contained in the applicable regulations applicable and, in particular, those established in the Regulation (EC) No 178/2002 and Regulation (EC) No 852/2004.

CHAPTER II

Conditions for the exploitation and marketing of natural mineral waters and spring waters

Article 3. Declaration and authorization for the use of the spring of "Natural mineral water" and "Spring water".

For this type of water the following requirements are established, depending on the source of the extraction:

1. Nationals:

(a) For the entire procedure of declaration and authorization for the use of the spring, the requirements laid down in Law 22/1973 of 21 July of Minas.

b) To the above procedure, the requirements set out in this royal decree will be added, leaving the process as follows:

1. The applications for declaration of water as natural mineral water or spring water shall be submitted to the competent mining authority of the autonomous community to which the spring belongs. Such applications shall be accompanied by the documentation contained in the part corresponding to each type of water described in Annex II to this provision and shall be published in the Official Journal of the State and in the Official Journal of the European Union. corresponding stand-alone community.

For the extension of the recognition of a new spring or underground collection within the protection perimeter granted, it is sufficient to demonstrate that the water comes from the same aquifer and that its physico-chemical composition is According to the criterion of chemical constancy, to which the declaration already holds, by carrying out an analysis, according to the procedure laid down in the Law of Mines. In the event that the new collection or the re-deepening of the existing one would have the uptake of another aquifer other than the one in use, a new declaration dossier must be initiated in accordance with the procedure described in this case. decree.

2. The competent authority shall comply with the procedure laid down in Law 22/1973 of 21 July of Mines, requesting the reports to be obtained. In the light of the action taken, the water declaration shall be made out of the application as natural mineral water or spring water, as appropriate. Such a statement, duly substantiated, must be published in the "Official Gazette" and in the "Official Gazette" of the corresponding autonomous community, which may be revoked in the event of the failure to comply with the requirements. imposed in this provision on this type of water.

3. Once the water declaration has been published, the application for authorization to use the spring or underground collection shall be made to the competent mining authority of the corresponding autonomous community. any person who complies with the requirements of Title IV of that Law of Mines. This application must be published in the Official Gazette and in the Official Gazette of the autonomous community concerned, and must be accompanied by the documentation contained in the part corresponding to each type of water described in the Annex II to this provision.

The competent mining authority shall comply with the procedure laid down in Law 22/1973 of 21 July of Mines, requesting the reports to be obtained.

4. In case the perimeter of protection of the spring or underground collection is on the ground that affects more than one autonomous community or that, for any other cause, the file affects more than one community The competent body shall be the Ministry of Industry, Tourism and Trade, who shall grant or revoke the authorisation to use the same, which, if granted, shall be published in the "Official State Gazette" and in the " Bulletin Officer " of the corresponding Autonomous Community.

5. Once the authorization to use the spring or underground collection has been published in the "Official State Gazette", the operator may initiate the formalities for the application for registration in the Register General Sanitary Food of the corresponding water, according to the legislation on General Health Registration. Registration in the register will be a prerequisite for your marketing. In addition, and in the case of natural mineral waters, this registration in the register will also be a prerequisite for inclusion in the list of recognized mineral waters that the Spanish Agency for Food Safety and Nutrition draw up and communicate to the Commission and be published in the Official Journal of the European Union.

2. Countries outside the European Union:

(a) Waters from a third country may only be recognised directly by the Spanish State where the authority empowered for that purpose in the country of extraction has certified that those waters are in accordance with the the provisions of Annex I, and that the application of the provisions of Annex II has been permanently monitored.

(b) The validity of the certificate referred to in the preceding paragraph may not exceed five years. It shall not be necessary to proceed back to the above recognition if the certificate issued by the country of origin authority was renewed before the end of the said period.

(c) The corresponding recognition shall be carried out by the Spanish Food Safety and Nutrition Agency, which shall be duly motivated and published on the Agency's website, including at least the data of the country of origin and those of identification established for national waters. In the case of natural mineral waters, the Spanish Food Safety and Nutrition Agency shall bring it to the attention of the European Commission, in order to be published in the Official Journal of the European Union.

3. Other Member States of the European Union: The natural mineral waters included in the 'Official Journal of the European Union', as well as the spring waters recognised in other Member States of the Union, are recognised as natural mineral waters. European.

Article 4. Obligations of food business operators (packaging and distribution industries).

1. As a general rule, food business operators shall ensure that at all stages of production, processing and distribution of food under their control the relevant hygiene requirements referred to in paragraph 1 are met. this royal decree and the other implementing rules, in particular Regulations (EC) No 178/2002 and 852/2004.

If during the holding it is verified that natural mineral water or spring water is contaminated and does not possess the biological characteristics referred to in Annex I, the natural or legal person to exploit the spring must immediately stop the activity, in particular that of packaging until the cause of the contamination has been removed and the water is in accordance with the rules of Annex I.

2. On a specific basis, food business operators shall comply with the following obligations:

(a) General requirements for installations and equipment: Facilities and equipment for the operation of the underground spring or collection must be conditioned in such a way as to avoid any possibility of contamination and the preservation of the properties that the water possesses at the time of its declaration and which correspond to its rating.

b) Specific requirements for installations and equipment:

1. The waters will be driven by pipes constructed with suitable and closed materials, which must be run in such a way as to avoid possible contamination or alteration. In addition, the joints and valves, blind stubs or other derivations shall be limited to the necessary ones, which must ensure the impossibility of mixing with other waters or returns to the conduction of the water intended for their packaging.

2. The entire unburied driving of the water intended to be packaged shall be inspected, continuously marked with a white band and with arrows indicating the direction of circulation of the liquid.

3. Packaging circuit installations must be located in the nearest possible location to the point of collection, suitably arranged with respect to the rest of the premises and warehouses, and protected in such a way as to avoid any possibility of contamination during the filling process.

4. All water-conducting circuits intended to be packaged, and in particular the tanks and filling machines, shall have devices for efficient cleaning and periodic disinfection, by means of water vapour or products Authorised biocidal products in the food industry for the disinfection of surfaces which are in contact with food.

5. Industrial installations must comply with the general and specific precepts dictated for this type of industry by the Ministry of Industry, Tourism and Trade and/or any other organizations of the Public administrations, within the scope of their respective competences.

6. All elements of the dispensing apparatus ("water sources") must be cleaned and, where appropriate, disinfected by competent personnel with the frequency and method to be determined by the operator in his or her plans. self-control. Only those appliances whose design allows the cleaning and, where appropriate, disinfection, in an effective manner to prevent contamination of the water to be supplied, may be placed on the market.

c) Specific requirements for premises:

1. All premises intended for the manufacture, handling and packaging shall be isolated from any other persons other than their specific tasks.

2. Local or independent sites shall be available for storage of packaging and packaging, cleaning and sterilisation products, finished products and temporary storage of waste and wastes.

d) Specific requirements for the packaging process:

1. Both the packaging and closing operation itself, such as washing, rinsing and cleaning or pre-sterilisation of packaging, whether reusable or not, will always be carried out by means of automatic systems, procedures in accordance with good manufacturing practice and, where appropriate, with products authorised for the relevant purpose in the food industry.

2. In any case, the packaging shall be manufactured or treated in such a way as to avoid any alteration of the microbiological and physico-chemical characteristics of the waters.

3. Non-reusable and reusable packaging manufactured or stored outside the same water packaging company will have to undergo a treatment process that ensures compliance with hygiene requirements. laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.

e) Specific requirements for packaging:

1. All containers used for the packaging of water must be fitted with an airtight sealing device designed to prevent any possibility of falsification or contamination.

2. Packaging must be free of cracks, breakages or defects that may alter water or present danger to consumers, and cannot be reused for successive filled ones that are considered as non-reusable.

f) Types of packaging:

1. Reusable: They are the ones that can be perfectly cleaned and sterilized before being used again.

2. º Non-reusable: Corresponding to those manufactured for single use, depending on the specific characteristics of the materials used.

Article 5. Distribution and sale.

1. The products covered by this provision must be placed on the market in packages intended for distribution to the final consumer, to whom they must be duly labelled and hermetically sealed. In hospitality and/or catering premises, packaging must be opened in the presence of the consumer.

2. The transport or storage of natural mineral waters and spring waters together with toxic substances, plant protection products, biocidal products and other polluting products shall be prohibited.

Article 6. Specifications.

1. The waters described in Article 2 shall comply with the specifications set out in Annex I.

2. The carbon dioxide used to strengthen or to gasify the waters referred to in Article 2 shall comply with the purity criteria set out in Part C of Annex I.

Article 7. Manipulations allowed.

Natural mineral waters and spring waters, at their origin, may only be subjected to the following processes:

1. The separation of unstable natural elements, such as sulphur and iron compounds, by filtration or decantation, preceded, where appropriate, by oxygenation, is permitted provided they do not change the composition of those constituents of water which give you their essential properties.

2. The separation of iron, manganese and sulphur compounds, as well as arsenic, in certain natural mineral waters and ozone-enriched air springs, is permitted provided that the composition of the water is not altered in so far as (a) the components which give the essential properties thereof and provided that the operator takes all the necessary measures to ensure its efficacy and safety and is notified to enable it to be checked by the health authorities; competent.

In any case, the ozone-enriched air technique must meet the following conditions:

a) That the technique does not modify the analytical composition as regards its majority components and those that characterize the water.

(b) Where the water at source complies with the microbiological criteria defined in points 1, 2, 2 and 3 (b) of Annex I, Part A, paragraph 2.

(c) The technique does not originate by-products that may present a public health risk or a concentration exceeding the maximum limits set out in Annex VI.

3. The separation of fluorides by alumina, activated as laid down in Commission Regulation 115/2010 of 9 February 2010 laying down the conditions for the use of activated alumina for the disposal of fluorides, is permitted. fluorides in natural mineral waters and in spring waters.

4. The separation of other unwanted components other than those listed in paragraphs 1, 2 and 3 of this Article is permitted provided that such technique does not alter the composition of the water in respect of the essential components which confer on the is its properties and provided that:

a) The technique is evaluated and controlled by the competent health authorities of the autonomous communities and notified to the Spanish Food Safety and Nutrition Agency.

(b) The technique is carried out without any health risk to the consumer and is sufficiently technologically justified.

5. The total or partial elimination of free carbon dioxide is permitted by exclusively physical procedures.

6. The incorporation or reinstatement of carbon dioxide is permitted, provided that it complies with the specifications laid down in Article 6.

7. The use of nitrogen as a technological aid (packaging gas) in the natural mineral water and spring water is permitted to ensure the stability of the containers.

8. The use of these waters in the manufacture of alcoholic soft drinks is permitted.

Article 8. Prohibited manipulations.

The following manipulations are prohibited:

1. Transport the water from the catchment to the packaging plant by means other than the closed and continuous driving.

2. The distribution of water in containers other than those intended for the final consumer.

3. Perform manipulations other than those authorised specifically for each type of water.

4. Carry out disinfection treatments, as well as the addition of bacteriostatic elements or any other treatment whose purpose is disinfection or to modify the content of micro-organisms in these waters.

5. To market waters from the same source or underground collection under different trade names.

6. The content of the water sources ("cooler") may not be redistributed in any case, directly or by means of dispensers, in other less-capacity intended for the final consumer, nor shall it be authorised to fill or replace the content, and shall be renewed by means of substitution exclusively for other full and complete.

Article 9. Labelling and advertising.

The labelling of the waters covered by this provision will apply to the provisions of Royal Decree 1334/1999 of 31 July on the general rule of labelling, presentation and advertising of products food, with the following particularities:

1. Sales name:

(a) Natural mineral waters: The name of sale shall be "Natural mineral water" or those set out below for the assumptions provided for in Article 7 (5) and (6). The following names shall be used in such cases:

1. "Natural natural mineral water naturally gaseous" or "natural natural carbon mineral water", for which the content of carbon dioxide, once packaged, is equal to that in which it has been placed in it or the lighting points. The gas added to replace, where appropriate, the gas released during the packaging process shall be from the same source.

2. "Natural mineral water reinforced with gas from the same spring", for which the content of carbon dioxide, once packaged, is higher than the one in it or the lighting points. The added gas shall come from the same spring as the water in question.

3. "Natural mineral water with added carbon dioxide", for which carbon dioxide has been added, not from the same spring as the water in question.

4. "Fully degassed natural mineral water", for which free carbon dioxide has been removed by exclusively physical procedures.

5. "Partially degassed natural mineral water", for which free carbon dioxide has been partially removed by exclusively physical procedures.

b) Spring waters: The sales denomination shall be "Spring Water", prominently. In the cases referred to in Article 7 (5) and (6), the words 'Gasified' or 'settled case' shall also be included, as appropriate.

2. Mandatory information:

(a) The name of the spring or underground collection and the place of exploitation shall be included. In the case where the source of the water is national, it should also be added to the municipality and province in which the spring or underground collection is located.

(b) In the case of natural mineral waters, the quantitative analytical composition listing its characteristic components shall be obligatory.

(c) Information on the treatments listed in Article 7 (2) and (3) shall be included in the case where they have been carried out.

Waters which have been the subject of an ozone-enriched air treatment must carry close to the analytical composition of characteristic components the indication " water subjected to an oxidation technique authorised with Ozonized air. "

In the same way, waters which have been subjected to an activated alumina technique must carry close to the analytical composition of characteristic components the indication "water subjected to an adsorption technique". authorized ".

(d) Natural mineral waters where the concentration of fluorine is greater than 1,5 mg/l shall include in the labelling the indication " contains more than 1,5 mg/l of fluoride: not suitable for the regular consumption of infants and children less than seven years. " This indication must be immediately on the side of the sales denomination and in clearly visible characters.

Also, natural mineral waters which, in accordance with the above, should bear an indication on the labelling, must indicate the final content of fluoride in the analytical composition of its characteristic components, such as as referred to in paragraph 2.b).

3. Trade name:

(a) A trade name may be added to the terms referred to in paragraph 2 (a), in the text of which the name of a town, village or place may appear, provided that the name relates to a water whose spring or Underground collection is operated at the site indicated by that commercial designation and provided that this does not mislead the place of operation of the underground spring or collection.

In the case of not matching the chosen mark or distinctive sign with the name of the spring or underground collection, or with the place of exploitation, such mark or distinctive sign must appear in minor characters (one and a half times less in height and width) than those with which the name of the spring or underground collection or the place of exploitation is indicated. Also, in order to prevent the distinctive mark or sign added between in competition with the name of the spring or underground collection or the place of exploitation, the characters with which the said mark appears must be, at most, equal to pronounced (colour and intensity of the same) as those with which the name of the spring or underground collection or the place of operation is indicated, both on the labelling and on the packaging of the packaging.

(b) Waters coming from the same source or underground collection must be marketed under a single commercial name within the meaning of Article 8 (5), in which the words may be included referred to in paragraph 3 (a) in the form provided for therein.

(c) Waters coming from different springs or underground fetches may only be placed on the market under a trade name if the requirements laid down in paragraph 3 (a) are met.

4. Optional information: Optatively, its temperature can be quoted by the words "temperature at the point of emergency ... ° C" if the water is thermal, and its date of declaration as natural mineral, mineral-medicinal or public utility.

5. Advertising: In any form of advertising the waters shall be applicable, mutatis mutandis and for the same purpose, points (a), (b) and (c) of paragraph 3 of this Article, concerning the importance given to the name of the spring or the place of its exploitation in respect of the indication of the trade name, as well as the provisions of Royal Decree 1907/1996 of 2 August 1996 concerning the advertising and commercial promotion of products, activities or services with a intended health purpose.

Article 10. General prohibitions on labelling and packaging.

It is prohibited:

(a) Register the mandatory data only on seals, capsules, plugs and other parts that are used when opening the package.

b) The use of indications, denominations, marks, images or other signs, figurative or not, that:

1. No. Be expressly prohibited in accordance with the provisions of Law 17/2001 of 7 December of Marks.

2. º In the case of natural mineral waters, evades characteristics which they do not possess, especially as regards their origin, the date of the authorization of exploitation, the results of the analyses or other references analogous to the guarantees of authenticity.

3. º Atribuyan to any water properties of prevention, treatment or cure of a human disease. However, in the case of natural mineral waters, the entries set out in Annex III are authorised.

4. Inlead to error with respect to its source.

c) The inclusion of analytical data in the labelling of spring water, in the event that the composition is not constant.

CHAPTER III

Intra-Community trade and imports of natural mineral waters and spring waters

Article 11. Intra-Community trade in natural mineral waters and spring waters.

In the event that natural mineral water or spring water does not comply with the provisions of Community legislation or poses a risk to public health, in spite of circulating freely in one or more of the Member States of the The placing on the market of such a product on national territory may be suspended or temporarily limited.

The other Member States and the European Commission shall be informed immediately, indicating the reasons for such a decision, and requesting the Member State which has recognised the water all relevant information. on the recognition of water, together with the results of regular checks.

Article 12. Imports from non-EU countries.

1. Natural mineral waters and spring waters shall, in advance of their importation, comply with the provisions of Article 3 (2) of this provision.

2. The products referred to in this provision and coming from third countries must comply with the requirements laid down in this royal decree for marketing in Spain.

CHAPTER IV

Autocontrols, records, and official controls

Article 13. Administrative records.

1. Concerning industries: the industries engaged in the activity regulated by this provision, installed in the national territory, must comply with the provisions of the legislation on the General Health Registry of Food.

2. Concerning products:

(a) The natural mineral waters and spring waters, as defined in Article 2, when their extraction is carried out in the territory, are subject to the requirement of registration in the General Health Register of Food national or in that of non-EU countries.

However, when natural mineral waters and spring waters from third countries have been recognised as such by another Member State and, in the case of natural mineral waters, the said waters have been published recognition in the Official Journal of the European Union, shall be exempt from registration in the General Health Register of Food.

(b) The declaration of water and the authorisation of the use of natural and spring mineral waters are a prerequisite for the registration of the natural mineral waters.

Article 14. Self-controls.

1. If during the holding the water is found to be contaminated and does not comply with the microbiological and chemical parameters and characteristics referred to in Annexes I and IV to this provision, the natural or legal person who The spring or industry shall immediately interrupt the packaging activity until the cause of contamination has been removed and the water is in accordance with the above characteristics.

2. The corresponding analytical controls shall include at least the following determinations in the maximum periods quoted for each type of water, as follows:

a) Natural mineral waters:

1. Each working day shall be carried out analyses on samples of finished product which shall comprise at least the parameters of microbiological contamination (Part A of Annex IV, Part A), and measures of Electrical conductivity and pH.

2. Water shall be controlled on samples of finished product, at least quarterly, and its analysis shall comprise at least all microbiological determinations provided for in this royal decree, the components majority (cations and anions) and those components that characterise such water, as well as nitrites, nitrates, pH and electrical conductivity.

3. At least every five years, the water in the emergency points shall be controlled by an analysis covering the parameters referred to in the quarterly analysis and those set out in Part B of paragraph 1 of the Annex. IV.

b) Spring water:

1. Each working day shall be carried out analyses on samples of finished product which shall comprise at least the parameters of microbiological contamination (Part A of Annex IV, Part A) and measures of pH and electrical conductivity.

2. Water shall be monitored at least quarterly on samples of finished product, and its analysis shall comprise at least all microbiological determinations provided for in this royal decree, the components majority (cations and anions) and those that characterise such water, as well as nitrites, nitrates, pH and electrical conductivity.

3. at least every five years, the water in the emergency points shall be controlled by an analysis covering the parameters referred to in the quarterly analysis and those indicated in Parts B and C of paragraph 2 of the Annex IV.

3. In the face of health risks by water transmission, the competent health authority may require the drinking water packaging companies to carry out the tests and controls which, in each case, the competent health authority determines.

4. The analysis may be carried out, in whole or in part, in a laboratory of its own, on the same packaging plant or in a laboratory other than that, and in any case must be ensured the proper technical competence of the same and the quality of the analytical results, as well as compliance with the requirements of Annex V.

Article 15. Official control.

The competent authorities in this field shall establish regular checks to ensure compliance with the provisions of this provision, in particular those relating to the verification:

(a) If the waters comply with the provisions of the Annexes to this provision.

(b) If the provisions relating to the prevention of pollution are complied with, and in particular those relating to the self-checks provided for in Article 14.

(c) If the waters from the underground fetches, the holding of which has been authorised, comply with the provisions of Article 3.

Article 16. Methods of analysis and sampling.

1. Without prejudice to Chapter III of Regulation (EC) No 882/2004 of 29 April 2004 on official controls carried out to ensure the verification of compliance with the legislation on feed and food and the animal health and animal welfare rules, the parameters analysed shall comply with the specifications set out in Annex V to this provision.

2. The taking of samples by the official control services will follow the provisions of the Royal Decree 1945/1983 of 22 June, which regulates the infringements and penalties in the field of consumer and consumer protection. agri-food production.

CHAPTER V

Sanctioning Regime

Article 17. Responsibilities.

Without prejudice to the provisions of Law 14/1986, of 25 April, General of Health, in the recast text of the General Law for the Defense of Consumers and Users, approved by Royal Legislative Decree 1/2007, of 16 In November and in Law 22/1973 of 21 July, the following responsibilities are laid down:

(a) The packaging company shall be responsible for the water that is delivered for distribution to be in accordance with the characteristics of the Sanitary Record file and the provisions of this provision.

(b) It is also the responsibility of the packaging company, with the exception of proof to the contrary, the responsibility inherent in the identity, integrity, quality and composition of the product contained in closed and undamaged packaging.

c) Corresponds to the product holder, once the container is opened, the responsibility inherent in the identity and possible deterioration that its contents may experience.

d) It is also up to the holder of the product to bear the responsibility for the deterioration suffered by the contents of the sealed packages as a result of their defective preservation or tampering.

e) In water dispensers (water sources), responsibility for the control and maintenance of such dispensers shall be borne by the owner.

Article 18. Sanctioning regime.

1. Without prejudice to other provisions which may be applicable, failure to comply with the provisions of this royal decree may be the subject of an administrative penalty, subject to the instruction of the appropriate administrative file, in accordance with Article 1 (2) of Regulation (EU) No as provided for in Chapter VI of Title I of Law 14/1986 of 25 April, General of Health.

In particular, failure to comply with the provisions concerning hygiene, self-control and treatment of products covered by this technical-health regulation will be considered a serious infringement, according to the Article 35 (B) (b) of Law 14/1986 of 25 April 1986.

Also, failure to comply with the provisions relating to the exploitation and marketing of the products covered by this Regulation, which do not follow the criteria of composition specified in Chapter II, in relation to the Annexes I, II and III shall be considered to be a very serious infringement, in accordance with Article 35 (C) (1) of Law 14/1986 of 25 April.

2. It shall apply to the provisions of this royal decree on procedural matters, as laid down in Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, as amended by the Law 4/1999, of 13 January, and in Royal Decree 1945/1983 of 22 June 1983 on the regulation of infringements and penalties in respect of the defence of the consumer and of agri-food production, as well as their implementing rules.

First transient disposition. Marketing extension.

Natural mineral waters and spring waters, marketed or labelled in accordance with the legislation in force prior to the entry into force of this royal decree, may be marketed until stocks are exhausted, although not conform to the provisions of the same.

Second transient disposition. Processing of the procedures for the declaration and authorization.

The procedures for the declaration and authorisation of the waters provided for in paragraphs 2 and 3 of Annex II to this royal decree already initiated under Royal Decree 1074/2002 of 18 October 2002 regulating the process of Development, circulation and trade in packaged drinking water, which is now repealed, will continue to be processed in accordance with the provisions of this Regulation.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, they oppose the provisions of this royal decree and, in particular, the Royal Decree 1074/2002 of 18 October, which regulates the process of elaboration, circulation and trade in packaged drinking water, except for the provisions relating to prepared waters.

Final disposition first. Amendment of the General Regulation for the Mining Regime, approved by Royal Decree 2857/1978 of 25 August.

Article 38.1 of the General Regulation for the Mining Regime, approved by Royal Decree 2857/1978 of 25 August, is amended as follows:

" 38.1 For the purposes of this Regulation, mineral waters are classified as:

a) Minero-medicinal: the natural or artificially lit ones which, due to their characteristics and qualities, are declared to be of public use. Depending on the use or destination, these are classified in mineral-medicinal waters for therapeutic purposes, natural mineral waters and spring waters.

(b) Minero-industrial: those that allow the rational use of the substances they contain. "

Final disposition second. Competence title.

This royal decree is dictated by the provisions of article 149.1.16. of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health. Articles 3.2 and 12, which are issued under the jurisdiction of the State in respect of external health, are exempted from Article 149.1.16 of the Constitution, and Article 3.1 and the first provision of the Constitution, which are issued under the terms of the established in Article 149.1.25. of the Constitution, which attributes exclusive competence to the State on the basis of the mining and energy regime.

Final disposition third. Regulatory enablement.

The person holding the Ministry of Health, Social Policy and Equality is hereby authorized to make, in the field of his or her competence, the necessary provisions for updating and amending the annexes to this royal decree. to adapt them to scientific and technical knowledge and, in particular, to the changes introduced by Community legislation.

Final disposition fourth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 30 December 2010.

JOHN CARLOS R.

The Minister of the Presidency,

RAMON JAUREGUI STUNNED

ANNEX I

Characteristics required for different types of water

The waters referred to in this Annex shall comply with the following specifications:

Part A. Natural mineral waters

1. General features:

(a) In addition to the characteristics referred to in Article 2 (a) of this provision, the composition, temperature and other essential characteristics of natural mineral water shall be kept constant, within the limits imposed by natural fluctuations.

(b) For the purposes of this provision, constant composition shall mean the permanence of the type of mineralisation, characteristic determined by the majority components and, where appropriate, by those other parameters which Characterize the water.

c) Likewise, the effects derived from normal water evolution, such as temperature variation, radioactivity, dissolved gases and salt precipitates, are allowed.

2. Specifications of different nature:

(a) Organoleptic: must not present any anomaly from the point of view considered, smell, taste, colour, turbidity or sediment, other than the characteristics of each water.

b) Microbiological and parasitological:

1. In the lighting points, the total content of the revilable micro-organisms of a natural mineral water shall be adjusted to its normal microbism and demonstrate effective protection of the spring against any contamination. The total content of relivable micro-organisms should not normally exceed 20 colonies per milliliter after incubation at 20-22 ° C for seventy-two hours and 5 colonies per millilitre after incubation at 37 ° C during 24 hours, assuming that these values should be considered as data rather than as maximum concentrations. The count must be carried out within 12 hours of packaging; during this time, the water must be maintained at a temperature between 4 ° C and 1 ° C.

2. ° After packaging, the total content of micro-organisms must not exceed the content at the point of delivery in 100 colonies per millilitre after incubation at 20-22 ° C for seventy-two hours in agar plates and in 20 colonies per millilitre after incubation at 37 ° C for twenty-four hours in agar plates. The count must be carried out within 12 hours of packaging; during this time, the water must be maintained at a temperature between 4 ° C and 1 ° C.

3. º In the lighting points and during the placing on the market, natural mineral water must be exempt from:

Pathogens and pathogenic microorganisms,

"Escherichia coli" and other coliforms, and fecal streptococci, in 250 millilitres of the sample examined,

Anaerobes sulfito reducers sporuulated, in 50 millilitres of the sample examined and

"Pseudomonas aeruginosa", in 250 millilitres of the sample examined.

4. No prejudice to the above paragraphs and in Article 4, during the marketing stage the total content of viable micro-organisms of natural mineral water may only result from evolution. normal of the germ content you had at the delivery points.

c) Chemical:

1. The specifications concerning the chemical parameters set out in Part B of paragraph 1 of Annex IV to this provision shall at least be complied with.

2. Where the competent health authority considers that some of the particularities of a given water may be contraindicated for a sector of the population, it may refuse to authorise the packaging or to oblige the warning on the labelling provided for in Annex III.

(d) Of purity: Do not exceed the limits of detection of the following substances: residual chlorine, phenolic compounds, surfactants, chlorates, oils, fats and any other products not covered by Part B Paragraph 1 of Annex IV to this provision, as soon as they are indicators of possible exogenous contamination of non-subsurface origin.

Part B. Spring Waters

1. General characteristics: In addition to the basic aspects referred to in Article 2 (b) of this provision, their composition and other essential characteristics may or may not remain constant within the limits imposed by the natural fluctuations, as set out in point (b) of Part A of this Annex.

2. Specifications of different nature:

(a) Microbiological and parasitological: shall meet the criteria laid down for natural mineral waters in paragraph 2 (b) of Part A of this Annex.

(b) Remaining specifications: they shall be applicable to at least those set out in Parts B and C of paragraph 2 of Annex IV to this provision.

Part C. Carbon dioxide purity criteria

The carbon dioxide used to strengthen or to gasify the waters that are placed on the market must meet the conditions laid down in Royal Decree 1466/2009 of 18 September 2009 laying down the rules of Identity and Purity of Food Additives other than Colorants and Sweeteners used in foodstuffs.

ANNEX II

Standards and criteria for requesting the declaration and authorization of the use of natural mineral waters and spring waters, as provided for in Article 3 of this royal decree

To proceed with the application for declaration and subsequent authorization of the use of natural and spring mineral waters, the analyses and studies indicated below shall be carried out for each type of water, taking into account the respective interpretation criteria for compliance with the required characteristics:

1. General features:

1.1 The basic characteristics of these waters, as defined in points (a) and (b) respectively of Article 2 and specified in Article 3, shall be assessed:

a) From the views:

1. geologic and hydrogeological,

2. physical, chemical, and physicochemical,

3. microbiological and

4. pharmacological, physiological and clinical, if any, and only for natural mineral waters.

(b) In accordance with the criteria set out in paragraph 1.2 below.

c) According to scientific methods recognized by the competent authorities.

1.2 Standards and criteria for verification of compliance with the required characteristics, for the purposes of recognition:

(a) Rules applicable to geological surveys: A detailed geological report on the origin and nature of the land shall be required to contain:

1. the exact situation of the capture with UTM coordinates with indication of its altitude, on a map of scale not exceeding 1/1,000,

2. º the stratigraphy of the hydrogeological field,

3. th geological map of detail at the appropriate scale,

4. description of the lithologies of different formations and their potency,

5. structure of geological formations and formations and

6. th fracturing analysis.

(b) Rules applicable to hydrogeological studies: It shall be required in particular:

1. a description of the collection works and facilities,

2. a study that sufficiently credits the source of water and the natural protection of the aquifer in the face of pollution,

3. the flow of the spring or the underground collection,

4. º water temperature at the point of lighting and room temperature,

5. º in underground fetches, conducting a pumping test to determine the optimum flow rate,

6. Inventory of existing water points in the area,

7. hydrodynamic aquifer parameters,

8. map of isopieces with direction and direction of flow,

9. º inventories of potential contamination foci,

10. study of the vulnerability of the aquifer assessing the self-scavenging power of the lands crossed,

11. study of recharging zones by performing isotope analyses (O18 and deuterium),

12. º determination of the water residence time in the aquifer by isotopic analysis (tritium or the most suitable tracer),

13. º the relationship between the nature of the terrain and the nature and type of mineralization and

14. the measures to protect the spring and the surrounding area against pollution, which are necessary for the correct quantitative and qualitative protection of the spring or underground collection. In particular, the polygonal that defines the protection perimeter by means of UTM coordinates must be delimited.

(c) Rules applicable to physical, chemical and physico-chemical analyses and studies: To be determined:

1. th the flow of the spring,

2. º water temperature at lighting points and room temperature,

3. º the relationship between the nature of the terrain and the nature and type of mineralization,

4. the dry residue at 180 ° C and 260 ° C,

5. º conductivity or electrical resistivity, specifying the temperature at which the measurement was carried out,

6. the concentration of hydrogen ions (pH),

7. the anions and cations,

8. º non-ionized elements,

9. the trace elements,

10. º radioactivity in the delivery points and

11. the toxicity of certain water components, taking into account the limits set in this respect for each of them.

(d) Rules applicable to microbiological analysis of water at points of delivery: Such analyses shall include the following:

1. demonstration of the absence of parasites and pathogenic microorganisms,

2. Total count of reliving microorganisms indicative of fecal contamination:

absence of "Escherichia coli" and other coliforms in 250 millilitres at 37 ° C and 44.5 ° C,

absence of fecal streptococci in 250 millilitres,

absence of anaerobic sulphite reducers sporulated in 50 millilitres and

absence of "pseudomonas aeruginosa" in 250 millilitres.

3. Total count of relivable microorganisms per milliliter of water:

incubated between 20 ° C and 22 ° C for seventy-two hours on agar plates and

incubated at 37 ° C for twenty-four hours in agar plates.

e) Rules applicable to clinical and pharmacological analyses:

1. These analyses shall be carried out with scientifically recognised methods and shall be adapted to the characteristics of natural mineral water and its effects on the human organism (diuresis, gastrointestinal functions, compensation for lack of mineral substances, etc.).

2. The verification of the constancy and the concordance in a large number of clinical observations may replace, where appropriate, the analyses referred to in the previous point. These same tests may be replaced by clinical examinations when the constancy and agreement of a large number of observations allow the same results to be obtained.

2. Specific characteristics of Natural Mineral Water: To proceed with the application for declaration and authorization to use water as a "natural mineral", it must be submitted to the competent mining authority, in addition to the Law 22/1973, of 21 July of Mines, the following requirements:

(a) Declaration of natural mineral water: The requirements of point 1 (a) and point 2 (b) of paragraph 1.2 of this Annex shall be submitted. Once the application for a declaration has been submitted, the competent mining authority shall take samples corresponding to 12 consecutive months for the complete physico-chemical and microbiological analysis as set out in point 3. point (a), Article 14 (2). Studies based on clinical and pharmacological analyses as laid down in point (e) of paragraph 1.2 of this Annex shall also be presented in their case.

(b) Authorisation for the use of natural mineral water: For the application for authorisation to use water as a natural mineral, a documentation shall be submitted to the competent mining authority. meets the requirements set out in paragraph 1.2 of this Annex.

3. Specific characteristics of the Manantial Water: To proceed to the application for declaration and authorization to use a water as a "spring" must be submitted to the competent mining authority, in addition to what is established in the Law 22/1973, of July 21, Mines, the following requirements:

(a) Declaration of spring water: The requirements of point 1 (a) and point 2 (b) of paragraph 1.2 of this Annex shall be submitted. Once the application for a declaration has been submitted, the competent mining authority shall take samples corresponding to 12 consecutive months for the complete physico-chemical and microbiological analysis as set out in point 3. point (b), Article 14 (2).

(b) Authorisation for the use of spring water: In order to proceed with the application for authorisation to use spring waters, a documentation meeting the requirements shall be submitted to the competent mining authority. requirements set out in points (a), (b), (c) and (d) of paragraph 1.2 of this Annex.

4. Waters originating in other countries outside the European Union: The certifications provided for in Article 3 (2) (a) of this provision for these waters shall be consistent with the following requirements: requirements:

(a) The conformity of natural mineral waters with the provisions of Part A of Annex I, and the conformity of spring waters with Part B of Annex I.

(b) That the application of the provisions of Annex II has been continuously monitored.

c) That the labelling aspects as well as the sales denomination of the existing national legislation have been respected.

ANNEX III

Specific requirements for the labelling of natural mineral waters complementary to the generals set out in Article 2 of this royal decree

The use of the following entries is authorised provided that they comply with the relevant criteria laid down and provided that they are established on the basis of physico-chemical analysis and, if necessary, for pharmacological, physiological and clinical examinations carried out in accordance with scientifically recognised methods, in accordance with the provisions of paragraph 1 of Annex II.

Mentions

Sodica.

Criteria for making the mentions
based on contents

weak mineralization.

Up to 50 mg/l of dry residue

Up to 500 mg/l of dry residue

medium mineralization.

From 500 mg/l to 1,500 mg/l dry residue.

Strong mineralization.

More than 1,500 mg/l of dry residue

Bicarbonated.

More than 600 mg/l bicarbonate.

Sulfatada.

More than 200 mg/l of sulfates.

chlorinated.

More than 200 mg/l chloride.

More than 150 mg/l of calcium

Magnesica.

More than 50 mg/l magnesium.

Fluorated, or containing fluoride.

More than 1 mg/l of fluoride.

Ferruginosa, or containing iron.

More than 1 mg/l of bivalent iron

sweetened.

More than 250 mg/l of CO2 free

More than 200 mg/l sodium.

Indicated for child food preparation.

Indicated for poor sodium diets.

Up to 20 mg/l sodium.

can have laxative effects.

be diuretic.

ANNEX IV

Parameters and parametric values

1. Natural mineral waters:

Part A

Microbiological parameters

Pseudomonas aeruginosa

Parameter

Value
parametric (UFC)

Escherichia coli (E-coli)

0/250 ml.

0/250 ml.

0/250 ml.

Colony Count to 22 ° C/Incubation 72 hours

100 ml.

colony count at 37 ° C/Incubation 24 Hours

20 ml.

Sulfito Anaerobes sporered reducers

0/50 ml.

Part B

Physical-chemical parameters

Parameter

parametric value

Unit

Antimony

5.0

µ g/l

Arsenic

10

µ g/l

Barium

1.0

mg/l

benzene

1.0

µ g/l

Benzo (a) pyrene

0.010

µ g/l

Cadmium

3.0

µ g/l

50

1.0

1.0

70

70

µ g/l

Fluoride

5.0

mg/l

10

µ g/l

Mantime

0.5

mg/l

Mercury

1.0

µ g/l

20

µ g/l

Nitrate

50

Nitrite

0.1

Selenium

10

0.10

µ g/l

Notes 1 and 2.

0.50

0.50

Notes 1 and 3

Aromatic Polycyclic Hydrocarbons

0.10

µ g/l

Sum of specified compound concentrations (note 4)

Note 2: the parametric value is applied to each of the pesticides. In the case of aldrin, dieldrin, heptacloro and heptachloroepoxide, the parametric value is 0.030 µ g/l.
Note 3: "Total pesticides" means the sum of all pesticides detected and quantified in the control procedure.
Note 4: The specified compounds are: Benzo (b) fluoranthene, benzo (k) fluoranthene, benzo (ghi) perylene and indeno (1,2,3-cd) pyrene.

2. Spring waters:

Part A

Microbiological parameters

Pseudomonas aeruginosa

Parameter

Value
parametric (UFC)

Escherichia coli (E-coli)

0/250 ml.

0/250 ml.

0/250 ml.

Colony Count to 22 ° C/Incubation 72 hours

100 ml.

colony count at 37 ° C/Incubation 24 Hours

20 ml.

Sulfito Anaerobes sporered reducers

0/50 ml.

Part B

Chemical parameters

Cianuro

Parameter

parametric value

Unit

Antimony

5.0

µ g/l

Arsenic

10

µ g/l

benzene

1.0

µ g/l

Benzo (a) pyrene

0.010

µ g/l

Boro

1.0

mg/l

cadmium

5.0

µ g/l

50

µ g/l

Note 1.

2.0

mg/l

Note 1

50

mg/l

10

Note 1.

Mercury

1.0

µ g/l

20

µ g/l

Note 1.

Nitrate

50

mg/l

Nitrite

0.5

mg/l

pesticides

Pesticides

0.1

µ g/l

Notes 2 and 3

Total Pesticides

0.5

µ g/l

0.10

0.10

0.10

0.10

0.10

0.10

0.10

0.10

µ g/l

Sum of specified compound concentrations (note 5)

Selenium

10

µ g/l

Note 1: the value is applied to a sample of water intended for human consumption, obtained by an appropriate method of sampling, provided that it is representative of a weekly average value ingested by consumers.
Note 2: "Pesticides" means: Organic insecticides, organic herbicides, organic fungicides, organic nematocides, organic acaricides, organic algicides, organic rodenticides, organic molluscicides, related products (between other, growth regulators) and their relevant metabolites and degradation and reaction products. Only those pesticides that are likely to be present in a given supply need to be controlled.
Note 3: the parametric value is applied to each of the pesticides. In the case of aldrin, dieldrin, heptacloro and heptachloroepoxide, the parametric value is 0.030 µ g/l.
Note 4: 'Total pesticide' means the sum of all pesticides detected and quantified in the control procedure.
Note 5: The specified compounds are: Benzo (b) fluoranthene, benzo (k) fluoranthene, benzo (ghi) perylene and indeno (1,2,3-cd) pyrene.

Part C

Indicator parameters

2,500.

.

Parameter

parametric value

Unit

.

200.

µ g/l.

ammonium.

mg/l.

.

250.

mg/l.

Color.

Acceptable for consumers and no abnormal changes.

µ S cm-1 a20 ° C

Note 1.

Concentration on hydrogen ions.

≥ 4.5 and ≤ 9.5.

pH Units.

Note 2.

200.

200.

0.05.

mg/l.

Olor.

Acceptable for consumers and no abnormal changes.

Sulphate.

250.

200.

200.

Acceptable for consumers and no abnormal changes.

Acceptable for consumers and no abnormal changes.

 

Oxidability.

5.

mg/l O2.

coliform bacteria.

0.

# 250 ml.

Note 1: will not apply to spring waters Carbon dioxide (carbon dioxide)
Note 2: For water with packaged gas, the minimum value may be lower

Part D

Radioactivity

Parameter

parametric value

Unit

Tritio

100

Bq/l.

Note 1.

Indicative Dose

0.10

mSv/year.

Note 2

Note 1: the periodicity of the control is indicated in Article 14 (2) (b).

Note 2: excluding tritium, potassium-40, radon and radon decay products. The periodicity of the control, the control methods and the most appropriate places for sampling are indicated in Article 14 (2) (b).

ANNEX V

Specifications for parameter analysis

The laboratories in which the samples are analyzed must have a quality control system for the analysis, for which the applicable regulations that correspond to each case will be applicable, and that will be verified periodically by a person independent of the laboratory which has been authorised for that purpose by the competent authority.

In relation to the following parameters, the characteristic results specified assume that the method of analysis used shall be capable, at least, of measuring concentrations equal to the value of the parameter with the accuracy, specified precision and detection limit. Whatever the sensitivity of the method of analysis used, the result shall be expressed using at least the same number of decimal places as for the parametric value referred to in Part B of paragraph 1 and in Parts B and C of paragraph 2 of this Regulation. Annex IV.

Nitrate

Parameters

Exattitude
Percentage in the parametric value
(note 1)

Precision
Percentage in parametric value
(note 2)

Limit
Detection Percentage of the parametric value
(note 3)

Conditions

Notes

Aluminium

10

10

10

ammonium

10

10

10

25

25

25

arsenic

10

10

10

Barium *

25

25

25

25

25

25

25

25

 

benzene

25

25

25

10

10

10

10

10

Cromo

10

10

10

10

10

10

10

10

10

Cianuro

10

10

10

Note 4.

10

10

10

10

10

10

10

10

10

10

10

10

20

10

20

10

10

Nitrate

10

10

10

Nitrite

10

10

10

25

25

25

5

pesticides

25

25

25

Note 6.

aromatic polycyclic hydrocarbons

25

25

25

Note 7.

Selenium

10

10

10

10

10

Sulphate

10

10

10

 

* Only for natural mineral waters:
Note 1 (*): the accuracy is the systematic error and represents the difference between the mean value of the large number of repeated measurements and the exact value.
Note 2 (*): accuracy is the random error and is usually expressed as the standard deviation (within each batch and between lots) of the dispersion of results around the mean. Double the relative standard deviation is considered to be acceptable.
(*) These terms are defined in greater detail in ISO 5725:
Note 3: the limit of detection is either the triple of the relative standard deviation within the batch of a natural sample containing a low concentration of the parameter, or the five-fold of the relative standard deviation within the batch of a shows blank.
Note 4: the method must determine the total cyanide in all forms.
Note 5: oxidation shall be carried out for ten minutes at 100 ° C in acidity using permanganate.
Note 6: the characteristic results apply to each of the pesticides and will depend on the pesticide in question.
Note 7: the characteristic results apply to each of the specified substances at 25% of the parametric value in Annex IV.

ANNEX VI

Maximum limits for the by-products of the authorised techniques for natural mineral waters and spring waters

Ozone-enriched air technique:

Subproducts of the Technique

Maximum
Limits * (µ g/l)

3

1

* The competent authorities shall monitor compliance with the maximum limits for bottling or other packaging for the final consumer.