The health requirements for drinking water for public consumption and for packaged drinking water were regulated, respectively, by the Royal Decrees 1138/1990 of 14 September 1990 and 1164/1991 of 22 December 1990. July, as amended by Royal Decree 781/1998 of 30 April 1998, provisions which incorporated into Spanish law the corresponding Community Directives 80/7 7 8/EEC, 80 /777/EEC and 96 /70/EC.

The European Union, by means of Council Directive 98 /83/EC of 3 November 1998 on the quality of water intended for human consumption, has carried out an update of the legislation so far in force, given the Transcendent character that the health suitability of drinking water represents for human health. By pursuing the uniformity of criteria and requirements applicable to the two types of water referred to above, the Directive provides for the regulation, in a common area, of categories which have been the subject of both Community and Community legislation. at the national, independent treatment.

However, even assuming the convenience of public drinking water and the packaging being due to common health criteria, which is in any case guaranteed, it seems appropriate, given the particularities of each of them, to maintain the regulation of some and others by means of consistent but independent provisions, as has been carried out so far.

This Royal Decree incorporates into national law only those aspects of Directive 98 /83/EC which refer to packaged drinking water, as common requirements or as specific requirements, representing, by this, a partial transposition of the said Directive.

As a result, the recast has been carried out in a single text of Royal Decree 1164/1991 of 22 July 1991, amended by Royal Decree 781/1998 of 30 April 1998 and the provisions relating to drinking water. packaged in Directive 98 /83/EC.

This Royal Decree is of a basic nature, in accordance with the provisions of Article 149.1.16 of the Spanish Constitution and Article 40.2 of Law 14/1986 of 25 April, General of Health, except for Article 9, and the (b) of Articles 17 and 18 which are dictated by virtue of the exclusive competence of the State in the field of external trade and external health, pursuant to Article 149.1.10. and 16. of the Constitution.

the representatives of the affected sectors have been heard in their preparation, with the Inter-Ministerial Commission for Food Management having issued a mandatory report.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs; of Economy; of Agriculture, Fisheries and Food, and of Science and Technology, according to the Council of State and after deliberation of the Council of Ministers in its Meeting of 18 October 2002,

DISPONGO:

Article 1. Object and scope of application.

1. The purpose of this provision is to define, for legal purposes, what is meant by packaged drinking water and to fix, on a compulsory basis, the rules for handling and/or processing, circulation, marketing and, in general, the legal order of such products.

It will also apply to imported packaged drinking water.

This Royal Decree obliges all industrialists, traders and, where appropriate, importers of packaged drinking water.

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

(a) Those that are regulated by the corresponding specific regulations for their medicinal properties.

b) Those distributed through a public supply network.

Article 2. Denominations and definitions.

For the purposes of this Royal Decree, it shall be understood as:

A) Industrial drinking water: those natural or legal persons who, in the use of the authorizations granted by the competent official bodies, engage in their activity in the handling of the products defined in this Article.

B) Water-packed drinking water: the different waters listed below, which are marketed as packaged and meet all the specifications for each type of water set out in this provision:

(a) Natural mineral waters: those bacteriologically healthy which have their origin in a stratum or underground formation and which sprout from a spring into one or more points of light, natural or perforated.

These can be clearly distinguished from the remaining drinking water:

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

2. º For its original purity.

These characteristics have been preserved intact, given the underground origin of the water, by protecting the aquifer against any risk of contamination.

For the use of this name, the waters shall comply with the characteristics set out in Annex I and the recognition and authorisation requirements set out in Article 17 for this type of water.

b) Spring waters: are the potables of underground origin that emerge spontaneously on the surface of the earth or are captured by works practiced to the effect, with the natural characteristics of purity that allow their consumption.

For the use of this name, the waters shall comply with the characteristics set out in Annex I and the recognition and authorisation requirements set out in Article 18 for this type of water.

(c) Prepared waters: are those subject to the physico-chemical authorised treatments necessary to meet the characteristics set out in Annex I.

For the purposes of their name, the following types must be differentiated:

1. Potable Potables prepared: when they come from spring or pick up and have been subjected to treatment so that they can be potable, thus losing, if they have, the qualification of spring water or natural mineral water and passing to be called ready-made drinking water, not being able to again qualify for water from spring water or natural mineral water.

2. Prepared public procurement: In the case of having such a source.

d) Water for public consumption: these are the drinking water for public consumption, packaged together for home distribution, with the sole purpose of supplying absences or accidental inadequacies of the water public consumption distributed by the general network. They shall meet the characteristics set out in Annex I.

c) Normal water microbism: 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.

Article 3. Requirements of the industries.

The drinking water packaging industries will comply, without prejudice to the provisions of Royal Decree 2207/1995 of 28 December 1995 laying down the hygiene rules for the products of drinking water. food, the following requirements:

a) Relatives to installations and equipment:

1. The spring or water catchment and its protection perimeter, as well as water storage tanks, shall be maintained with appropriate preventive measures to avoid possible contamination.

2. All facilities and operating equipment, and especially the washing and packaging plant or plants, must be in perfect hygiene conditions.

3. The waters shall be driven by closed pipes which must be run in such a way as to avoid possible contamination or alteration. In addition, the joints and valves, ends or other derivations are limited to the necessarily essential ones, which must ensure the impossibility of mixing with other waters or returns to the conduction of the water intended for their packaging.

4. All the driving of the water destined to be packaged must be inspected, being continuously marked with a white band and with arrows indicating the direction of circulation of the liquid. The remainder of the water pipelines shall be identified in accordance with UNE.1063.

5. The facilities of the packaging circuit must be located in the nearest possible place to the point of capture, suitably arranged with respect to the rest of the dependencies and warehouses, and protected in order to avoid any possibility of contamination during the filling process.

6. All water-driving circuits to be packaged, and in particular tanks and filling machines, shall have devices which allow for efficient cleaning and periodic sterilisation, by means of water vapour or products Authorized microbiocides for use in this type of industries.

7. Industrial installations must comply with the general and specific precepts dictated, for this type of industry, by the Ministry of Science and Technology and/or any other government agencies. Public, in the field of their respective competences.

b) Relatives to locals:

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.

Article 4. Staff conditions.

Staff working on the collection, handling, driving, control and packaging of the waters covered by this provision must comply with the provisions of the Food Manipulation Regulation, approved by Royal Decree 202/2000 of 11 February 2000, applicable to it.

Article 5. Requirements for materials brought into contact with water at any stage of the packaging process.

1. The collection equipment, pipes, tanks, containers and other useful materials which come into contact with the packaging water at any time of the process shall be of materials suitable for use with the water, in order to avoid any chemical, physicochemical or microbiological alteration of that.

2. These materials must be unassailable by the compounds of the water, which is particularly important for the carbon water.

Article 6. Requirements for the packaging process and packaging.

Packaging and packaging must meet the following requirements:

a) Relating to the packaging process:

1. Both the packaging and closing operation itself, such as washing, rinsing and cleaning or pre-sterilisation of packaging, whether recoverable or not, will always be carried out by means of automatic systems, procedures in line with the 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 bacteriological and chemical characteristics of the waters.

3. º Recoverable and non-recoverable containers manufactured or stored outside the same water packaging industry and, in the other packaging assumptions, will have to undergo a treatment process that ensures their cleaning internal and external industrial sterilization or sterilization. Also, the closure devices shall be treated, where necessary, for the same purpose and in accordance with the hazard analysis and critical control points (HACCP) system established in each packaging plant and in accordance with the Royal Decree 2207/1995 of 28 December 1995 laying down the hygiene rules for foodstuffs.

4. The level of tolerance of the content volume shall be in accordance with the provisions of Royal Decree 723/1988 of 24 June 1988 on the general rule for the control of the effective content of foodstuffs packaged.

b) Relatives to packaging:

1. All containers used for the packaging of water must be fitted with a non-reusable closing device designed to prevent any possibility of falsification or contamination.

2. These containers must be free of cracks, breaks or defects that may alter water or present danger to consumers, and cannot be reused for successive filled ones considered as lost or not. retrievable.

3. The maximum authorised capacity of the packages shall be 10 litres, the volumes established for drinking water in paragraph 8.a) of Annex I to Royal Decree 1472/1989 shall be adopted for intermediate capacity. 1 December, for which the ranges of nominal quantities and nominal capacities for certain packaged products are regulated, in the wording given to that paragraph by Royal Decree 151/1994 of 4 February.

4. No prejudice to the foregoing, packages with capacities of more than 10 litres in the packaged drinking water may be used, by means of the appropriate dispensing apparatus, when they are intended exclusively for collectivities. Its content may not be redistributed in any case, either directly or by means of dispensers, in others of a lesser capacity intended for the final consumer, nor shall it be self-directed to fill or replace the content, be replaced exclusively by other integrals and complete ones.

(c) Types of packaging for the number of uses: in the case of the number of uses, the following types of packaging may be used:

1. Recoverable or return: they are susceptible to perfect industrial cleaning and sterilization before being used again.

2. No. Unrecoverable or lost: correspond to those manufactured for single use, depending on the specific characteristics of the materials used.

Article 7. Distribution and sale.

1. In the phases considered, including transport, the waters covered by this provision may be placed on the market only in packages intended for distribution to the final consumer, duly labelled and closed. In hospitality and/or catering premises, packaging must be opened in the presence of the consumer.

2. The transport or storage of packaged waters together with toxic substances, pesticides, biocidal products and polluting products shall be prohibited.

3. Disinfection of all types of warehouses and means of transport shall be compulsory and shall be carried out by appropriate staff, with the procedures approved by the relevant provisions.

4. Packaged public drinking water may only be distributed in an emergency and free of charge in cases of urgency, subject to the authorisation of the competent health authority.

Article 8. 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 this provision 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 Commission of the European Union shall be informed immediately, indicating the reasons for such a decision, and requesting, in accordance with Directive 96 /70/EC, the whole of the relevant information concerning the recognition of water, together with the results of the periodic checks.

Article 9. Imports from non-EU countries.

1. Natural mineral waters and spring waters shall, for their import, comply with the provisions laid down in 17.b) and 18.b) of this provision.

2. Moreover, the provisions of this provision are without prejudice to the provisions of the international treaties or conventions on the matter and which are applicable in Spain.

Article 10. Administrative records.

1. Concerning the industries: the industries engaged in the activity regulated by this provision, installed in the national territory, must comply with the provisions of Royal Decree 1712/1991 of 29 November, on the Sanitary Register 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, where natural mineral waters and spring waters from third countries have been recognised as such by another Member State, and such recognition has been published in the Official Journal of the European Union, the European Communities " shall be exempt from their registration in the General Health Register of Food.

(b) The recognition of the right to use certain water names, as set out in Articles 17 and 18, is a prerequisite for the registration of the register.

Article 11. Self-controls and analysis log.

1. Nature, periodicity and incidence of these:

(a) With the necessary periodicity estimated by the packer in attention to the characteristics of the industry, and whenever health anomalies are detected, the corresponding study of the possible risk points will be carried out cause of contamination, subject to periodic control the appropriate factors to avoid those.

(b) If during the holding it was found that the water was contaminated and did not possess the parameters and microbiological and chemical characteristics referred to in Annexes I and IV to this provision, the person (a) a natural or legal entity that exploits the spring or the industry must immediately discontinue the packaging activity until the cause of contamination has been eliminated and the water is in accordance with the above characteristics.

(c) The corresponding analytical controls shall include at least the following determinations at the above maximum periods:

1. For natural mineral waters, at least every five years, the water of the emergency points must be controlled by a complete physico-chemical analysis and possible contaminants, according to the Part B of Annex IV to this provision.

For prepared waters and spring waters, the sampling frequency and the analyses to be carried out shall be in accordance with the provisions of Tables A and B of Annex V, as well as Annex IV, Part B of this provision.

2. For natural mineral waters, water shall be monitored at least quarterly, and the analysis shall comprise at least all the microbiological determinations provided for in this provision and the physico-chemical substances. indicators of possible contamination, the conductivity, as provided for in Annex IV to this Royal Decree, as well as the majority components and those parameters that characterise such water.

For prepared waters and spring waters, it shall be in accordance with the provisions of Tables A and B of Annex V, as well as Annex IV to this provision.

3. On each working day, analyses must be carried out on finished product samples, which will comprise at least the parameters of microbiological contamination.

4. For quality control purposes, the indicator parameters set out in Part C of Annex IV to this provision are set, with the exceptions set out therein, and the requirements shall be included in that control. minima set out in Annex V to this Royal Decree. The analysis of the parameters shall be in accordance with the specifications set out in Annex VI to this provision.

(d) 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 they determine in each case.

(e) The analyses may be carried out, in whole or in part, in a laboratory of their own, on the same packaging plant or in a laboratory other than the same, and in any event the appropriate technical competence of the the same and the quality of the analytical results.

(f) Furthermore, in cases where disinfection is carried out, in the process of drinking water prepared, the effectiveness of the disinfectant treatment should be verified, as well as any contamination generated by derived products. of disinfection.

2. Analysis log book:

(a) In each water packaging industry, a book of analysis shall be carried out in which the physico-chemical and microbiological results performed in accordance with this provision, as well as the control of the quality to be performed. The analysis record book shall comply with the content of the model adopted by Resolution of 25 January 1982, which approves the model of the book of analysis for the packaged drinking water industries.

(b) The book shall be completed by the competent health authority to carry out the relevant inspections.

Article 12. Inspections.

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 concerning the prevention of pollution are complied with, and in particular those relating to the self-checks provided for in Article 11.

(c) If the waters from the sources or springs, the holding of which has been authorised, comply with the provisions of Article 17 or 18, where applicable.

Article 13. Methods of analysis and sampling.

1. The corresponding official methods of analysis and sampling to be established for the determination of the different analytical parameters of the products referred to in this provision shall apply.

2. In particular, the analysis of the parameters shall conform to the specifications set out in Annex VI to this provision, as well as to the methods approved by the Order of 8 May 1987 approving the official methods of analysis. microbiological for the manufacture, circulation and trade of packaged drinking water which are not included in Annex VI to that Regulation.

3. In the absence of official sampling methods or for parameters for which no official methods of analysis exist, the corresponding methods approved by national and international bodies, recognised as recognised, may be used. solvency.

4. However, other methods other than those listed in Annex VI (1) may be used, provided that it can be demonstrated that the results obtained shall be at least as reliable as those produced by the methods specified. Where a method other than those identified is applied, all information of interest on that method and its equivalence should be provided to the competent authorities upon request.

5. For the parameters listed in paragraphs 2 and 3 of Annex VI, any method of analysis may be used provided that it complies with the requirements set out therein.

Article 14. Responsibilities.

Without prejudice to the provisions of Law 14/1986, of 25 April, General of Health, and Law 26/1984, of July 19, General for the Defense of Consumers and Users, the following responsibilities are established:

(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.

Article 15. Sanctioning regime.

1. It shall apply to the provisions of this Royal Decree on procedural matters, as laid down in Law No 30/1992 of 26 November 1992 on the Legal Regime of the General Administration and the Common Administrative Procedure, as amended by Law 4/1999, of 13 January, and in Royal Decree 1945/1983, of 22 June, regulating infringements and penalties in matters of consumer protection and agri-food production, as well as in their implementing rules.

2. Without prejudice to other rules which may be applicable, infringements committed against the provisions of this provision shall be the subject of administrative penalty upon the instruction of the appropriate administrative file, in accordance with the provisions of the provided for in Chapter VI of Title I of Law 14/1986, of 25 April, General of Health:

(a) Under Article 35 (b) (1) of Law 14/1986 of 25 April of 25 April, the failure to comply with the requirements laid down in Article 3 (2) (2) is deemed to be serious; Article 5 (1) (a) (1) and (2) (c) of Article 6 (1) (c) and Article 20 (d) of this provision, provided that they do not involve direct and serious risks to the health of consumers.

(b) Also, on the basis of the provisions of Article 35. C). 1. Law No 14/1986 of 25 April 1986, General Health, shall be deemed to be a very serious failure to comply with the requirements laid down in Article 3 (2) (a); Article 5 (1); paragraph 1 (a) and (a) (2). 6; Article 11 (1) (c) and Article 20 (d) of this Royal Decree, where they involve serious and direct risks to the health of consumers, as well as those relating to the provisions of Article 11 (1) (b).

Article 16. Specifications.

1. The packaged waters described in Article 2, which are the subject of this provision, shall comply with the specifications set out in Annex I.

2. The carbon dioxide used to reinforce or gasify the waters referred to in Article 2 shall comply with the purity criteria laid down in

I.

Article 17. Recognition of the right to use the name "Natural Mineral Water".

For this type of water the following requirements are set, depending on their extraction procedures:

a) Nationals:

1. The application for recognition shall be submitted to the competent authority of the Autonomous Community. In the event that the spring or collection is on land that affects more than one Autonomous Community, or that for any other reason the file affects more than one Autonomous Community, the competent body shall be the Ministry of Economy.

2. The application shall be accompanied by the documentation set out in Annex II to this provision.

3. 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 shall be recognised as natural mineral water. Such recognition, duly motivated, must be published in the "Official State Gazette". This recognition may be revoked in the event of a failure to comply with the requirements imposed in this provision on this type of water.

4. The publication, the authority responsible for the recognition shall inform the Ministry of Health and Consumer Affairs, which shall bring it to the attention of the Commission of the European Union for publication in the 'Official Journal of the European Communities'.

b) Non-European Union countries:

1. May be recognised directly by the Spanish State when the authority empowered for that purpose in the country of extraction has certified that those waters comply with the provisions of paragraph 1.4.1 of Annex II, and that the permanent monitoring of the application of the provisions referred to in paragraph 1.4.2 of Annex II has been carried out.

2. 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.

3. The corresponding recognition will be carried out by the Ministry of Health and Consumer Affairs, it will be duly motivated and must be published in the "Official State Gazette", including at least the data of the country of origin and the identification established for national waters. That Ministry shall bring it to the attention of the Commission of the European Union, in order to publish it in the Official Journal of the European Communities.

(c) Other Member States of the European Union: The natural mineral waters shall be recognised as natural mineral waters in the Official Journal of the European Communities.

Article 18. Recognition of the right to use the name "Manantial Water".

For this type of water the following requirements must be met, according to their extraction procedures:

a) Nationals:

1. The application for recognition shall be submitted to the competent authority of the Autonomous Community, accompanied by at least the analyses and studies referred to in paragraph 2 of Annex II. In the event that the spring or collection is on land that affects more than one Autonomous Community, or that for any other reason the file affects more than one Autonomous Community, the competent body shall be the Ministry of Economy.

2. The estimated checks necessary to verify compliance with the requirements of these waters, the competent authority of the corresponding Autonomous Community shall follow the procedure laid down in the Article 17 (3) (a) and shall, where appropriate, give due recognition to the water in which the application is made as spring water. Such recognition must be published in the "Official Gazette of the State", which may be revoked if the non-compliance with the requirements imposed by this provision on this type of water is verified.

3. The publication, the authority responsible for the recognition shall inform the Ministry of Health and Consumer Affairs.

b) Non-European Union countries:

1. The spring waters originating in these countries may be recognized by the Spanish State when they have the same qualification in the country of origin. The authority empowered to do so shall certify that its characteristics are in accordance with the provisions of this provision.

2. This certification shall be valid for a maximum of five years, requiring periodic renewal.

3. Regarding the procedure for processing the recognition, it shall apply to it as set out in Article 17.

(c) Other Member States of the European Union: the waters of spring waters which are legally placed on the market in the country of extraction, with their own name.

Article 19. Manipulations allowed.

The following manipulations will be allowed:

A) Natural mineral waters and spring waters:

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 that such treatment does not have the effect of modifying the composition of those constituents of water that give it its essential properties.

2. The separation of the compounds of iron, manganese and sulphur, as well as arsenic, in certain natural mineral waters and springs, by ozone-enriched air, is permitted provided that such treatment does not alter the composition of the water in respect of those essential components which confer on it its properties and provided that:

(a) The treatment is notified to the competent health authorities and is subject to specific control by the competent health authorities.

(b) The conditions to be established for the use of ozone-enriched air treatment shall be taken into account. As long as these conditions are not regulated, the undertaking which uses the same, whether natural or legal person, shall be responsible for the conduct of such conditions without any health risk, limiting, in any event, the maximum possible by-products, as well as the levels of residual ozone in the treated water.

3. The separation of other unwanted components other than those listed in paragraphs (A) .1 and (A) .2 of this Article is permitted provided that such treatment does not alter the composition of the water in respect of the essential components which Give this their properties and provided that:

(a) The treatment is notified to the competent health authorities and is subject to specific control by the competent health authorities.

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

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

5. The incorporation or reinstatement of carbon dioxide is permitted, provided that it comes from the same water table or from the same field or meets the specifications laid down in Article 16.

6. The effects derived from the normal evolution of water during driving and packaging, such as temperature variation, radioactivity, dissolved gases and others, are supported.

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

B) Prepared water:

1. The necessary physico-chemical treatments, such as decantation, filtration, chlorination, ozonization and disinfection, are permitted, provided that the impurities associated with the substances and materials used do not remain in the water intended for consumption in concentrations above what is necessary to comply with the provisions of Annex IV, provided that it does not directly or indirectly result in a detriment to human health.

2. The substances which need to be used in the various water treatment processes must be authorised for the purposes and in the proportions indicated in the list of additives approved for treatment of drinking water public.

C) Public consumption water packaged: authorised treatments for water distributed through a public supply network are permitted.

Article 20. Prohibited manipulations.

The following manipulations are prohibited:

(a) Markup waters from the same spring or collection under different trade marks or designations.

b) Transporting water for packaging by means other than closed and continuous driving.

c) Carry out manipulations other than those authorised respectively for each type of water.

(d) Specifically, in natural mineral waters and spring waters, disinfection treatments, as well as the addition of bacteriostatic elements or any other treatment whose purpose is to be used, are prohibited. disinfection or modification of the content of micro-organisms in these waters.

e) Natural mineral waters, as well as spring waters, may not be added to products other than carbon dioxide incorporated or incorporated, in accordance with Article 19 (A) (5).

Article 21. Labelling and advertising.

The labelling of packaged drinking water containers will apply to the General Standard of Labelling, Presentation and Advertising of Packaged Food Products, approved by Royal Decree 1334/1999. July 31, and its amendment to Royal Decree 238/2000 of 18 February, with the following particularities:

A) Natural mineral waters:

1. Name of sale. The name of sale shall be either Natural Mineral Water or those set out below for the assumptions provided for in Article 19 (4) and (5) (5). The following names shall be used in such cases:

(a) "Natural mineral water naturally gaseous" or "natural natural carbon natural 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.

(b) "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 which it has been placed in it or the lighting points. The added gas shall come from the same spring as the water in question.

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

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

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

2. The name of the spring or collection and the place of operation 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 is located.

3. The terms referred to in the preceding paragraph may be added to a distinctive mark or mark, in which the name of a town, village or place may be given, provided that the name relates to a natural mineral water whose spring or the catchment area is operated at the place indicated by that commercial designation and provided that it does not mislead the place of exploitation of the spring or catch or enter into competition with the original name of the water.

In the case of not matching the chosen mark or sign with the name of the spring or collection, or with the place of exploitation, the largest size of the characters used in the commercial designation must be one and a half times. less than those with which the spring or collection or the place of exploitation appears, both on the labelling and on the packaging of the packaging.

4. The placing on the market with various commercial designations of natural mineral water from the same source is prohibited.

5. An indication of the analytical composition listing its characteristic components shall be mandatory.

6. Information on the treatments listed in Article 19 (2) (a) (2) and (3) (3) should be included in the case where they have been carried out.

7. The competent health authorities shall determine the obligation to include in labels and in advertising warnings concerning contraindications for certain sectors of the population.

8. The temperature of the temperature at the point of emergency can be measured by means of the temperature measurement. If the water is thermal, the date of the declaration as a natural mineral or a public utility can also be a short relative text. the characteristics of the water, among those detailed in Annex III.

9. In the field of advertising, the criteria laid down in paragraphs (A) (2) and (3) of this Article, as well as the provisions of Royal Decree 1907/1996 of 2 August 1996 on advertising and commercial promotion of products, shall apply. activities or services with intended health purpose.

B) Spring water:

1. Name of sale. The sales denomination will be "Spring Water", in outstanding form. In the cases referred to in Article 19 (A) (4) and (5) (5), the words 'Gasified' or 'settled case' shall also be included, as appropriate.

2. The criteria set out in paragraphs (A) .2, A) .3, A) .4, A) .6 and A) .9 of this Article shall also apply.

3. For the waters of national origin, the municipality and province in which the spring is located shall be included.

4. In any form of advertising of spring waters, the provisions of paragraph B (2) of this Article shall apply mutatis mutandis and for the same purpose in relation to the importance given to the name of the spring or the collection, or to the place of holding with respect to the indication of the mark or distinguishing sign.

C) Ready drinking water:

1. Prepared drinking water from spring or fetch:

a) Denomination of sale. The sales denomination will be "Potable Water prepared", in outstanding form. If carbon dioxide has been added or removed, the words 'Gasified' or 'Asified' shall also be included, as appropriate.

b) A distinctive mark or sign may be added which, in such a case, must appear in characters whose height and width are equal to or less than the smallest of the characters used for the sales denomination.

2. Prepared public water supply:

a) Denomination of sale. The sales denomination will be "Water of public supply prepared", in outstanding form. If carbon dioxide has been added, the words 'Gasified' shall be included.

b) A distinctive mark or sign may be added which, in such a case, must appear in characters whose height and width are equal to or less than the smallest of the characters used for the sales denomination.

Article 22. General prohibitions in relation to labelling and labelling.

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. In the case of other packaged waters, they may create confusion with natural mineral water, and in particular the mention "mineral water", the word "mineral", or the words derived therefrom.

c) Any indication, denomination, brand, image or symbol, figurative or not, that ascribes to any water properties of prevention, treatment or cure of a human disease.

d) In the case of spring water, prepared drinking water, prepared public supply or packaged public consumption, any indication, denomination, brand, image or symbol, figurative or not, that suggests physiological actions specific or misleading about its origin.

e) The inclusion of analytical data in the labelling of spring water, prepared drinking water, prepared public supply and packaged public consumption.

TRANSIENT DISPOSITION

Unica. Marketing extension.

Ready 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 placed on the market until 1 January 2004, even if they do not comply to the provisions of the same.

For natural mineral waters, marketed or labelled in accordance with the legislation in force prior to the entry into force of this Royal Decree, the parameters set out in Part B of Annex IV shall not be required. until 1 January 2004, except for new Community provision to the contrary.

REPEAL PROVISION

Unica. Regulatory repeal.

As many provisions of equal or lower rank are repealed as set out in this Royal Decree and, in particular, the Royal Decree 1164/1991 of 22 July, approving the Regulations Technical-Health for the elaboration, circulation and trade of packaged drinking water, and its modification by Royal Decree 781/1998, of April 30.

FINAL PROVISIONS

First. Competence title.

This Royal Decree is of a basic nature, in accordance with the provisions of Article 149.1.16. of the Spanish Constitution and in Article 40.2 of Law 14/1986 of 25 April, General of Health, with the exception of Article 9 and the (b) of Articles 17 and 18 which are dictated by virtue of the exclusive competence of the State in the field of external trade and external health, pursuant to Article 149.1.10. and 16. of the Constitution.

Second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to October 18, 2002.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIANO RAJOY BREY

ANNEX I

Characteristics required for different types of water

The waters referred to in this Annex shall comply with the specifications set out below:

1. Natural mineral waters.

1.1 General features.

1.1.1 In addition to the characteristics referred to in Article 2 (B) (a) of this provision, the composition, temperature and other essential characteristics of natural mineral water shall be maintained. constant, within the limits imposed by natural fluctuations. In particular, they should not be affected by possible variations in the flow of the spring.

1.1.2 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.

1.2 Specifications of different nature.

1.2.1 Organoleptic: must not present any defects from the point of view considered, smell, taste, color, turbidity or sediment, other than the characteristics of each water.

1.2.2 Microbiological and parasitological:

1. At the point of delivery, the total content of the micro-organisms to be revived from a natural mineral water shall be adjusted to its normal microbism and provide effective protection of the spring against any contamination. The total content of revivifiable micro-organisms should not normally exceed 20 colonies per milliliter after incubation at 20-22 ^orC for seventy-two hours and 5 colonies per millilitre after incubation at 37 ^orC for twenty-four hours, assuming that these values should be considered as data and not as maximum concentrations.

2. After packaging, this content may not pass from 100 colonies per millilitre after incubation to 20-22 ^orC for seventy-two hours on agar-plate or agar-gelatin-mix plates, and 20 colonies per milliliter after incubation at 37 ^orC for twenty-four hours on agar plates. The count must be performed within twelve hours of packaging; during this time, the water must be kept at a temperature between 4 ^orC and 1 ^orC.

3. Natural mineral water must be exempt from:

both at the point of delivery and during its placing on the market:

a) Pathogenic parasites and microorganisms.

(b) "Escherichia coli" and other coliforms and fecal streptococci in 250 millilitres of the sample examined.

c) Sulfito reductors, in 50 millilitres of the sample examined.

d) Pseudomonas aeruginosa, in 250 millilitres of the sample examined.

4. Without prejudice to the provisions of the above paragraphs, the total content of viable micro-organisms of natural mineral water may only result from the normal evolution of the germ content at the point of delivery.

1.2.3 Chemical:

1. They shall, at least, comply with the specifications relating to the chemical parameters set out in Part B of Annex IV to this provision, with the exceptions provided for therein.

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 force the warning on the labelling as provided for in Annex III.

1.2.4 Purity: the following substances shall not exceed the detection limits: residual chlorine, phenolic compounds, surfactants, chlorinated diphenyl, oils, fats and any other products not covered by the Part B of Annex IV to this provision as soon as they are indicators of possible contamination.

2. Spring waters.

1. General characteristics. In addition to the basic aspects referred to in Article 2 (B) (b) of this provision, their composition and other essential characteristics shall be kept constant within the limits imposed by the fluctuations. natural.

2. Specifications of different nature:

(a) Microbiological and parasitological: shall meet the criteria set for natural mineral waters in paragraph 1.2.2 of this Annex.

(b) Remaining specifications: they shall be applicable to at least those set out in Annex IV to this provision.

3. Prepared waters.

1. Microbiological and parasitological specifications:

(a) At the delivery points, they must comply with the requirements laid down for water intended for the production of drinking water for public consumption, before processing, in accordance with the provisions of the Order of 11 May 1988 on basic quality characteristics to be maintained in surface water streams when they are intended for the production of drinking water.

(b) The preparation shall comply with the requirements laid down for natural mineral waters in paragraph 1.2.2 of this Annex, applying to the treatment completion stage the criteria set out in the heading 1 of that paragraph.

2. Other specifications. It shall apply to them at least those laid down for drinking water for public consumption in Annex IV to this provision.

4. Public drinking water packaged.

In all of its specifications, it shall at least comply with the requirements laid down for drinking water for public consumption in Annexes IV, V and VI to this provision.

5. Criteria for purity of carbon dioxide.

The carbon dioxide used to strengthen or to gasify the waters which are placed on the market must meet the conditions laid down in Royal Decree 1917/1997 of 19 December 1997 laying down the Identity and Purity of Food Additives other than Colorants and Sweeteners used in foodstuffs.

ANNEX II

Rules and criteria for the recognition of the right to the use of the designations provided for in Articles 17 and 18 of this Royal Decree

In order to carry out the recognition of the right to the use of the names, the analyses and studies indicated below for each type of water must be carried out, taking into account the respective criteria of interpretation concerning compliance with the required characteristics:

1. Natural mineral waters.

1.1 The basic characteristics of these waters, as defined in Article 2 (B) (a) and specified in Article 17, both of this provision, which confer on natural mineral water their properties Saluterae must be appreciated:

1.1.1 From the views:

a) Geological and hydrological.

b) Physical, chemical, and physicochemical.

c) Microbiological.

d) Pharmacologic, physiological and clinical, if any.

1.1.2 According to the criteria set out in section 1.2 below.

1.1.3 According to scientific methods recognised by the competent authorities.

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

1.2.1 Rules applicable to geological and hydrological studies. They shall be required in particular:

(a) The exact location of the catchment, with an indication of its altitude, on a map of scale not exceeding 1/1,000.

b) A detailed geological report on the origin and nature of the land.

c) The stratigraphy of the hydrological field.

d) A description of the collection works and facilities.

e) Measures to protect the spring and surrounding area against pollution.

1.2.2 Rules applicable to physical, chemical and physical analysis and studies. They shall be determined by:

a) The flow of the spring.

b) The water temperature at the lighting points and room temperature.

c) The relationship between the nature of the land and the nature and type of mineralisation.

d) The dry residue at 180 ° C and 260 ° C.

e) The electrical conductivity or resistivity, specifying the temperature at which the measurement was carried out.

f) The concentration of hydrogen ions (pH).

g) The anions and cations.

h) The non-ionized elements.

i) The trace elements.

j) The radioactivity at the delivery points.

k) The relative isotope levels of the water, oxygen components (16_or-18_or) and hydrogen (protium, deuterium, tritium), if any.

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

1.2.3 Rules applicable to the microbiological analysis of water at points of delivery. Such analyses shall include the following:

a) Demonstration of the absence of parasites and pathogenic microorganisms.

b) Total count of revificable micro-organisms indicative of faecal contamination:

b.1) Absence of "Escherichia coli" and other coliforms in 250 millilitres at 37 ° C and 44.5 ° C.

b.2) Absence of fecal streptococci in 250 millilitres.

b.3) Absence of sulphite-reducing clostrides in 50 millilitres.

b.4) Absence of pseudomonas aeruginosa in 250 millilitres.

c) Total count of microorganism relivable per milliliter of water:

c.1) Incubated between 20 ° C and 22 ° C for seventy-two hours in agar plates or agalgeratin mixture.

c.2) Incubated at 37 ° C for twenty-four hours in agar plates.

1.2.4 Rules applicable to clinical and pharmacological analyses:

(a) 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 body (diuresis, gastrointestinal functions, compensation for lack of mineral substances).

(b) The verification of the constancy and the concordance in a large number of clinical observations may replace, where appropriate, the analyses referred to in paragraph 1.2.4.a. above. 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.

1.3 A comprehensive table of data relating to the flow, temperature, chemical composition and microbiological characteristics of the water, referring to each of the twelve months preceding the presentation of the request.

1.4 The certifications provided for in Article 17 (b) .1. of this provision for waters from non-EU countries shall be required to record compliance with the following: requirements:

1.4.1 The compliance of those waters with the provisions of paragraphs 1.1 of Annex I and 1.1 of Annex II.

1.4.2 That the application of the provisions of Article 3 (1) (a) (a) (a), (a), (a) (1) and (a) (2) (a) and (2) of Article 6 (1) and Article 7 (1) have been permanently checked. of this Royal Decree.

2. Spring waters.

In order to verify compliance with the requirements imposed on this type of water, and in particular those established in Article 18 of this Royal Decree, it will be required, in order to carry out the surveys, to carry out the studies and analyses referred to in the rules laid down in paragraphs 1.2.1, 1.2.2, 1.2.3 and 1.3 of this Annex, applying the corresponding interpretation criteria to their nature.

ANNEX III

Specific requirements for the labelling of natural mineral waters complementary to the general rules set out in Article 2. of this Royal Decree

The use of the following entries is authorised provided that they respect the relevant criteria laid down and provided that they are established on the basis of physico-chemical analysis and, if necessary, 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	Criteria for performing Content-based
weak mineralization	Up to 50 mg/l of dry residue.
Up to 500 mg/l dry residue
	mineralization	Over 1,500 mg/l of dry residue
More than 600 mg/l bicarbonate
Sulfatada	Over 200 Sulfate mg/l
	Chlorurated	More than 200 mg/l chloride.
Calcica	More than 150 mg/l of calcium.
Magnesica	More than 50 mg/l magnesium.
Fluorated, or containing fluorides	More than 1 mg/l of fluorides.
Ferruginosa or containing iron	More than 1 mg/l of bivalent iron.
Acidulada	More than 250 mg/l of CO2 free.
Sodica	More than 200 mg/l of sodium.
Indicated for preparation child foods.
Indicated for poor sodium diets	Up to 20 mg/l of sodium.
can have laxative effects.
be diuretic.

ANNEX IV

Parameters and parametric values

PART A

Microbiological parameters

0/250 ml

Parameter	parametric
Escherichia coli (E-coli)	0/250 ml
Enterecocos	0/250 ml
0/250 ml
Colony Count to 22 ° C/Incubation 72 hours	100 /ml
Count at 37 ° C/Incubation 24 Hours	20 /ml
Sulfito reductors *	0/50 ml

* For natural mineral waters and spring waters.

PART B

Chemical parameters

Parameter	parametric value	Unit	Notes
Acrilamide	0.10	µ g/l	Note 1
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
		10	10	µ g/l	Note 2
Cadmium	5.0
		50	50	50 Centro_table_body"> µ g/l	Note 3
	2.0	mg/l	Note 3
Cianuro	50	µ g/l
1,2-dichloroethane	3.0	µ g/l
	Epiclorhydrin	0.10	µ g/l	Note 1
1.5	1.5	mg/l
			10	µ g/l	Note
	Mercury	1.0	µ g/l	Niquel
20	µ g/l	Note 3
Nitrate	50	mg/l	Note 4
Nitrite	0.50	mg/l	Note 4
	0.10	µ g/l	Notes 5 and
Total Pesticides	0.50	µ g/l	Notes 5 and 7
aromatic polycyclic hydrocarbons	0.10	µ g/l	Sum of Specified compound concentrations; note 8.
Selenium	10	µ g/l
Tetrachloroetene and trichloroetene	10	µ g/l	Sum of specified parameter concentrations
Total trihalomethanes	100	µ g/l	Sum of compound concentrations specified; note 9
chloride	0.50	µ g/l	Note 1

* Except in Natural Mineral Waters. The provisions of Annex III shall be taken into account for the labelling of the Fluoride.

Note 1: The value of the parameter refers to the residual monomeric concentration in the water, calculated according to the characteristics of the maximum migration of the corresponding polymer in contact with the water.

Note 2: When possible without affecting disinfection, care must be taken to ensure that the value is lower.

Note 3: 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 4: On the way out of the facility, the value of the nitrites must be ≤ 0,10 mg/l, in addition to the condition that [nitrate] /50 + [nitrite] /3 ≤ 1. The brackets mean concentrations in mg/l for nitrate (NO₃) and for nitrite (NO₂).

Note 5: "Pesticides" means organic insecticides, organic herbicides, organic fungicides, organic nematocides, organic acaricides, organic algicides, organic rodenticides, organic molluscicides, products related (among others, 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 6: The parametric value applies to each of the pesticides. In the case of aldrin, dieldrin, heptacloro and heptaclorepoxide, the parametric value is 0.030 µ g/l.

Note 7: "Total pesticide" means the sum of all pesticides detected and quantified in the control procedure.

Note 8: The specified compounds are:

Benzo (b) fluoranthene.

Benzo (k) fluoranthene.

Benzo (ghi) perylene.

Indene (1,2,3-cd) pyrene.

Note 9: When possible without affecting disinfection, a lower value must be obtained. The compounds specified are: Chloroform, bromoform, dibromochloromethane, bromodichloromethane.

PART C

Indicator parameters

ammonium

Color

Olor

Parameter	parametric value	Unit
		200	µ g/l
	0.50	mg/l
*	250	mg/l	Note 1
Clostridium perfringens (including spores)	0	n. º/100 ml	Note 2
Acceptable for consumers and no abnormal changes.
	2,500	1
Note 1
Note 1
	≥ 6.5 and ≤ 9.5		pH Units	Notes 1 and 3
*	200	µ g/l
Manage	50
Acceptable for Consumers and Unchanged failed.
Oxidability	5.0	mg/l O2	Note 4
Sulphate *	250	mg/l	Note 1
Sodio *	200	mg/l
Sabor	Acceptable for Consumers and Unchanged failed.
count at 22 °C and at 37th
	coliform Bacteria			0	n. º/250 ml
Organic Carbon (COT)	No changes failed.
turbidity	Acceptable to consumers and no abnormal changes.

* Except in Natural Mineral Waters.

** It will not apply to natural mineral waters and carbon spring waters at source.

RADIACTIVITY *

Parameter	parametric value	Unit
	Tritio	100	Bq/l	Notes 5 and 7
Indicative Dose	0.10	msv/year	Notes 6 and 7

* Not applicable to Natural Mineral Waters.

Note 1: Water must not contain corrosive materials.

Note 2: This parameter must be measured only if the water is wholly or partially derived from surface water. In the event of non-compliance with this parametric value, the supply shall be investigated to ensure that the presence of pathogenic micro-organisms such as cryptosporidium does not result in any potential danger to human health. The results of all these investigations should be included in the log book.

Note 3: For water without packaged gas, the minimum value may be reduced to 4.5 units of pH.

For water packed in bottles or other containers that are naturally rich in carbon dioxide or with artificial addition of carbon dioxide, the minimum value may be lower.

Note 4: You do not need to measure this parameter if the COT parameter is parsed.

Note 5: the periodicity of the control shall be indicated later in Annex V.

Note 6: excluding tritium, potasium-40, radon and radon decay products. The periodicity of the control, the control methods and the most suitable places for sampling shall be

in Annex V.

Note 7: It will not be necessary to control drinking water in respect of tritium or radioactivity to establish the total indicative dose when it is considered that on the basis of other controls carried out the tritium or the Total indicative dose of water is well below the parametric value.

ANNEX V

Control

In the framework of the Self-Control Plan based on the system of hazard analysis and critical control points (HACCP) that must be carried out by each company, according to the Royal Decree 2207/1995, 28 The following controls shall be carried out, without prejudice to other actions integrated in that programme, without prejudice to other actions included in that programme:

TABLE A

Parameters to be parsed

1. Check control.

It is intended to obtain periodic information on the organoleptic and microbiological quality of the waters covered by this Regulation, as well as for the drinking water prepared near the effectiveness of the treatment applied, particularly in cases of disinfection treatment, in order to determine the conformity of these waters with the following parametric values:

(a) From the microbiological parameters of Part A of Annex IV:

Escherichia coli (E-coli).

Pseudomonas aeruginosa.

(b) The indicator parameters in Part C of Annex IV:

Aluminium (note 1).

Ammonium.

Clostridium perfrigens (including spores) (note 2).

Color.

Conductivity.

Hydrogen ion concentration.

Iron (note 1).

Nitrite (note 3).

Odor.

Flavor.

Colony count at 22 ° C and 37 ° C.

Coliform Bacteria.

Turbidity.

The check shall be carried out at least with the frequency set for that purpose in this Annex, without prejudice to the provisions of Article 11 of this provision for natural mineral waters.

2. Global or audit control.

It is intended to check all the parameters set out in this Regulation, with the exception of those relating to radioactivity, which shall be checked in accordance with the requirements laid down in this Regulation. regulentarily.

The Ministry of Health and Consumer Affairs, at the request of the competent authorities of the Autonomous Communities, may also establish the possibility of excluding systematic audit control during the period of determine, and for a given supply, source or collection, any of the parameters included in it, where it has been established on a regular basis that it complies with the limits laid down and no circumstances may arise which may affect such parameters up to the transgression of those limits.

The overall audit or audit shall be carried out at least with the frequency set out in Table B of this Annex, and as long as it is necessary in the light of the results of the verification or verification checks. Detection of any incidence that may affect the potability of the waters.

Note 1: Required only if used as flocculant (*).

Note 2: necessary only if the water is wholly or partially derived from surface water (*).

Note 3: Required only if chloramination (*) is used as a disinfectant.

(*) In all other cases, the parameters are listed in the global or audit control list.

TABLE B

Minimum frequency of sampling and analysis for water packaged in bottles or other containers and intended for sale

Volume of water produced per day for sale in bottles or other containers (1) m³

Control checking/number of samples per year (Minimum sampling rate)	Audit control/number of samples per year
≤10	1	1
> 10 ≤ 60	12	1
> 60	1 for every 5 m3 and fraction of the total volume.	1 for every 100 m3 and fraction of the total volume.

(1) Volumes are calculated as averages over a calendar year.

ANNEX VI

Specifications for parameter analysis

The laboratories in which the samples are analysed must have a quality control system for the analyses which will be periodically checked by a person independent of the laboratory who has been authorised for this purpose. competent authority.

1. Parameters for which analysis methods are specified. The methods of analysis for the following parameters set out in the UNE/CEN/ISO standards may be used as a guide, pending the possible future adoption of new national and international methods UNE/CEN/ISO for these parameters.

Parameters	Analysis
Coliform Bacteria and Escherichia coli (E. Coli).	ISO 9308-1
Enterecocos	ISO 7899-2
EN ISO 12780
enumeration of Cultivable Microorganisms Count to 22 ° C	pr EN ISO 6222
numbering cultivable Colony Count to 37 ° C	pr EN ISO 6222
Clostridium perfringens (including spores)	Filtering on membranes and anaerobic incubation of the membrane on m-CP agar (note 1) at 44 ± 1 ° C for 21 ± 3 hours. Count of opaque yellow colonies that change in pink or red in colour after 20 to 30 seconds of exposure to ammonium hydroxide vapours

Note 1: The composition of the m-CP agar is:

Base Medium:

Tryptose: 30 g.

yeast extract: 20 g.

Sucrose: 5 g.

L-cysteine hydrochloride: 1 g.

MgSO₄ -7H₂O: 0.1 g.

Bromoresol purple: 40 mg.

Agar: 15 g.

Water: 1,000 ml.

Dissolve the ingredients in the base medium, adjust the pH to 7.6 and keep the autoclave at 121 ° C for fifteen minutes. Let the media cool and add:

D-cicloserin: 400 mg.

B-polymyxin sulfate: 25 mg.

(β-D-indoxyl glucoside: 60 mg.

(To be dissolved in 8 ml sterile distilled water before added).

Phenolphthalein diphosphate solution at 0.5 per 100 sterilized by filtration: 20 ml.

FeCl₃ -6H₂Or 4.5 per 100 sterilized by filtration: 2 ml.

2. Parameters for which Feature Results are specified.

2.1 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 specified accuracy, 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 in Parts B and C of Annex IV.

Mercury

Parameters	Exattitude% of the parametric value (note 1)	Precision% of the parametric value (note 2)	Detection limit% of parametric value (note 3)	Conditions	Notes
Acrilamide				Control according to the product specification.
	10	10	10
		10	10	10
Antimony	25	25	25
Arsenic	10	10
	Benzo (a) pyrene	25	25	25
benzene	25	25	25
		10	10	10
Bromate	25	25	25
Cadmium	10	10	10
		10	10
Chromium	10	10	10
Conductivity	10	10	10
Copper	10	10	10
	Cianuro	10	10	10
	1,2-dichloroethane	25	25	10		Note 4
	Epiclorhydrin				Control by product specification.
Floride	10	10	10
Iron	10	10	10
	10		10	10
Manang................. ... .	10	10	10
20	10	20
	10	10	10
Nitrate	10	10	10
Nitrite	10	10
	Oxidability	25	25	10		Note 5
	Pesticides	25	25	25		Note 6
aromatic polylinic hydrocarbons.	25	25	25		Note 7
		10	10
	10	10	10
Sulphate	10	10	10
	25		10	25	25		Note 8
		25	10		Note 8
Total THM	25	25	10		Note 7
chloride				Control according to the product specification.

2.2 With respect to hydrogen ion concentration, the characteristics specified for the results assume that the applied analysis method can measure concentrations equal to the value of the parameter with an accuracy of 0,2 units pH and a precision of 0,2 units pH.

Note 1 (*): 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 acceptable accuracy.

(*) These terms are defined in greater detail in ISO 5725.

Note 3: The limit of detection is either triple 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 blank sample.

Note 4: The method must determine 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 per 100 of the parametric value in Annex IV.

Note 8: The characteristic results apply to each of the specified substances at 50 per 100 of the parametric value in Annex IV.

3. Parameters for which no analysis method is specified.

Color.

Odor.

Flavor.

Total organic carbon.

Turbidity (note 1).

Note 1: For the control of turbidity in treated surface water, the specified characteristic results are that the method of analysis used must be able to measure at least the concentrations equal to the parametric value with an accuracy of 25 per 100, an accuracy of 25 per 100 and a detection limit of 25 per 100.