(a) waters which are medicinal products within the meaning of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human useOJ L 311, 28.11.2001, p. 67 .(b) natural mineral waters used at source for curative purposes in thermal or hydromineral establishments.
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 (Recast) (Text with EEA relevance)
(a) the separation of its unstable elements, such as iron and sulphur compounds, by filtration or decanting, possibly preceded by oxygenation, in so far as this treatment does not alter the composition of the water as regards the essential constituents which give it its properties; (b) the separation of iron, manganese and sulphur compounds and arsenic from certain natural mineral waters by treatment with ozone-enriched air in so far as such treatment does not alter the composition of the water as regards the essential constituents which give it its properties, and provided that: (i) the treatment complies with the conditions for use to be laid down by the Commission following consultation of the European Food Safety Authority, established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyOJ L 31, 1.2.2002, p. 1 .(ii) the treatment is notified to, and specifically controlled by, the competent authorities;
(c) the separation of undesirable constituents other than those specified in points (a) or (b), in so far as this treatment does not alter the composition of the water as regards the essential constituents which give it its properties, and provided that: (i) the treatment complies with the conditions for use to be laid down by the Commission following consultation of the European Food Safety Authority; (ii) the treatment is notified to, and specifically controlled by, the competent authorities;
(d) the total or partial elimination of free carbon dioxide by exclusively physical methods.
(a) parasites and pathogenic micro-organisms; (b) Escherichia coli and other coliforms and faecal streptococci in any 250 ml sample examined;(c) sporulated sulphite-reducing anaerobes in any 50 ml sample examined; (d) Pseudomonas aeruginosa in any 250 ml sample examined.
(a) the revivable total colony count of a natural mineral water may only be that resulting from the normal increase in the bacterial count which it had at source; (b) the natural mineral water may not contain any organoleptic defects.
(a) a statement of the analytical composition, giving its characteristic constituents; (b) the place where the spring is exploited and the name of the spring; (c) information on any treatments referred to in points (b) and (c) of the first subparagraph of Article 4(1).
(a) in the case of a natural mineral water, suggest a characteristic which the water does not possess, in particular as regards its origin, the date of the authorisation to exploit it, the results of analyses or any similar references to guarantees of authenticity; (b) in the case of drinking water packaged in containers, which does not satisfy the provisions of Annex I, Section I, are liable to cause confusion with a natural mineral water, in particular the description "mineral water".
(a) satisfies the conditions of exploitation laid down in Annex II, points 2 and 3, which shall be fully applicable to spring waters; (b) satisfies the microbiological requirements laid down in Article 5; (c) satisfies the labelling requirements of Article 7(2), points (b) and (c), and Article 8; (d) has not undergone any treatment other than those referred to in Article 4. Other treatments may be authorised by the Commission.
(a) limits for the concentrations of constituents of natural mineral waters; (b) any necessary provisions for the indication on the labelling of high levels of certain constituents; (c) the conditions of use of ozone-enriched air referred to in point (b) of the first subparagraph of Article 4(1); (d) the information on the treatments referred to in Article 7(2)(c); (e) methods of analysis, including limits of detection, to verify the absence of pollution of natural mineral waters; (f) the sampling procedures and the methods of analysis necessary for checking the microbiological characteristics of natural mineral waters.
(a) by its nature, which is characterised by its mineral content, trace elements or other constituents and, where appropriate, by certain effects; (b) by its original purity,
(a) from the following points of view: (i) geological and hydrological; (ii) physical, chemical and physico-chemical; (iii) microbiological; (iv) if necessary, pharmacological, physiological and clinical;
(b) according to the criteria listed in Section II; (c) according to scientific methods approved by the responsible authority.
1.1.1. the exact site of the catchment with indication of its altitude, on a map with a scale of not more than 1: 1000 ;1.1.2. a detailed geological report on the origin and nature of the terrain; 1.1.3. the stratigraphy of the hydrogeological layer; 1.1.4. a description of the catchment operations; 1.1.5. the demarcation of the area or details of other measures protecting the spring against pollution.
1.2.1. the rate of flow of the spring; 1.2.2. the temperature of the water at source and the ambient temperature; 1.2.3. the relationship between the nature of the terrain and the nature and type of minerals in the water; 1.2.4. the dry residues at 180 °C and 260 °C; 1.2.5. the electrical conductivity or resistivity, with the measurement temperature having to be specified; 1.2.6. the hydrogen ion concentration (pH); 1.2.7. the anions and cations; 1.2.8. the non-ionised elements; 1.2.9. the trace elements; 1.2.10. the radio-actinological properties at source; 1.2.11. where appropriate, the relative isotope levels of the constituent elements of water, oxygen ( 16 O —18 O) and hydrogen (protium, deuterium, tritium);1.2.12. the toxicity of certain constituent elements of the water, taking account of the limits laid down for each of them.
1.3.1. a demonstration of the absence of parasites and pathogenic micro-organisms; 1.3.2. a quantitative determination of the revivable colony count indicative of faecal contamination: (a) absence of Escherichia coli and other coliforms in 250 ml at 37 °C and 44,5 °C;(b) absence of faecal streptococci in 250 ml; (c) absence of sporulated sulphite-reducing anaerobes in 50 ml; (d) absence of Pseudomonas aeruginosa in 250 ml;
1.3.3. determination of the revivable total colony count per ml of water: (a) at 20 to 22 °C in 72 hours on agar-agar or an agar-gelatine mixture; (b) at 37 °C in 24 hours on agar-agar.
(a) "naturally carbonated natural mineral water" means water the carbon dioxide content of which from the spring after decanting, if any, and bottling is the same as at source, taking into account where appropriate the reintroduction of a quantity of carbon dioxide from the same water table or deposit equivalent to that released in the course of those operations and subject to the usual technical tolerances; (b) "natural mineral water fortified with gas from the spring" means water the carbon dioxide content of which from the same water table or the same deposit after decanting, if any, and bottling is greater than that established at source; (c) "carbonated natural mineral water" means water to which has been added carbon dioxide of an origin other than the water table or deposit from which the water comes.
(a) the spring or outlet shall be protected against the risks of pollution; (b) the catchment, pipes and reservoirs shall be of materials suitable for water and so built as to prevent any chemical, physico-chemical or microbiological alteration of the water; (c) the conditions of exploitation, particularly the washing and bottling equipment, shall meet hygiene requirements; in particular, the containers shall be so treated or manufactured as to avoid adverse effects on the microbiological and chemical characteristics of the natural mineral water; (d) the transport of natural mineral water in containers other than those authorised for distribution to the ultimate consumer shall be prohibited.
(a) the natural mineral water in respect of which exploitation of the spring has been authorised complies with the provisions of Annex I, Section I; (b) the provisions of points 2 and 3 are being applied by the person exploiting the spring.
| Indications | Criteria |
|---|---|
| Low mineral content | Mineral salt content, calculated as a fixed residue, not greater than 500 mg/l |
| Very low mineral content | Mineral salt content, calculated as a fixed residue, not greater than 50 mg/l |
| Rich in mineral salts | Mineral salt content, calculated as a fixed residue, greater than |
| Contains bicarbonate | Bicarbonate content greater than 600 mg/l |
| Contains sulphate | Sulphate content greater than 200 mg/l |
| Contains chloride | Chloride content greater than 200 mg/l |
| Contains calcium | Calcium content greater than 150 mg/l |
| Contains magnesium | Magnesium content greater than 50 mg/l |
| Contains fluoride | Fluoride content greater than 1 mg/l |
| Contains iron | Bivalent iron content greater than 1 mg/l |
| Acidic | Free carbon dioxide content greater than 250 mg/l |
| Contains sodium | Sodium content greater than 200 mg/l |
| Suitable for the preparation of infant food | — |
| Suitable for a low-sodium diet | Sodium content less than 20 mg/l |
| May be laxative | — |
| May be diuretic | — |
| Article 1, third indent only | |
| Article 1, point 10 only | |
| Annex III, point 4 only |
| Directive | Time-limit for transposition | Permission of trade in products complying with this Directive | Prohibition of trade in products not complying with this Directive |
|---|---|---|---|
| 80/777/EEC | — | ||
| 80/1276/EEC | — | — | — |
| 85/7/EEC | — | — | — |
| 96/70/EC | — |
| Directive 80/777/EEC | This Directive |
|---|---|
| Article 1(1) | Article 1(1) |
| Article 1(2) | Article 1(2) |
| Article 1(3), first and second indents | Article 1(3), points (a) and (b) |
| Article 1(4) | Article 1(4) |
| Article 1(5) | Article 1(5) |
| Article 2 | Article 2 |
| Article 3 | Article 3 |
| Article 4(1), point (a) | Article 4(1), first subparagraph, point (a) |
| Article 4(1), point (b), first and second indents | Article 4(1), first subparagraph, points (b)(i) and (ii) |
| Article 4(1), point (c), first and second indents | Article 4(1), first subparagraph, points (c)(i) and (ii) |
| Article 4(1), point (d) | Article 4(1), first subparagraph, point (d) |
| — | Article 4(1), second subparagraph |
| Article 4(2) | Article 4(2) |
| Article 4(3) | Article 4(3) |
| Article 4(4) | Article 4(1), third subparagraph |
| Article 5(1) | Article 5(1) |
| Article 5(2) | Article 5(2) |
| Article 5(3), first and second indents | Article 5(3), points (a) and (b) |
| Article 6 | Article 6 |
| Article 7(1) | Article 7(1) |
| Article 7(2) | Article 7(2) |
| Article 7(2a) | Article 7(3) |
| Article 8 | Article 8 |
| Article 9(1) | Article 9(1) |
| Article 9(2), points (a), (b) and (c) | Article 9(2), first, second and third subparagraphs |
| Article 9(3) | Article 9(3) |
| Article 9(4) | — |
| Article 9(4a), first subparagraph, first to fourth indents | Article 9(4), first subparagraph, points (a) to (d) |
| Article 9(4a), second subparagraph | Article 9(4), second subparagraph |
| Article 9(4b) | Article 9(5) |
| Article 10(1) | Article 10 |
| Article 10a | Article 11 |
| Article 11(1), first to fourth indents | Article 12, points (a) to (d) |
| Article 11(2), first and second indents | Article 12, points (e) and (f) |
| Article 11a | Article 13 |
| Article 12(1) | Article 14(1) |
| Article 12(2) | Article 14(2) and (3) |
| Article 12(3) | — |
| Article 13 | — |
| Article 14 | Article 15 |
| Article 15 | — |
| Article 16 | — |
| — | Article 16 |
| — | Article 17 |
| Article 17 | Article 18 |
| Annex I, part I, point 1 | Annex I, part I, point 1 |
| Annex I, part I, point 2, first paragraph, points (a)(1) to (4) | Annex I, part I, point 2, first paragraph, points (a)(i) to (iv) |
| Annex I, part I, point 2, first paragraph, point (b) | Annex I, part I, point 2, first paragraph, point (b) |
| Annex I, part I, point 2, first paragraph, point (c) | Annex I, part I, point 2, first paragraph, point (c) |
| Annex I, part I, point 2, second paragraph | Annex I, part I, point 2, second paragraph |
| Annex I, part I, point 3 | Annex I, part I, point 3 |
| Annex I, part II, point 1.1 | Annex I, part II, point 1.1 |
| Annex I, part II, point 1.2 | Annex I, part II, point 1.2 |
| Annex I, part II, point 1.3 | Annex I, part II, point 1.3 |
| Annex I, part II, point 1.3.1 | Annex I, part II, point 1.3.1 |
| Annex I, part II, point 1.3.2 | Annex I, part II, point 1.3.2 |
| Annex I, part II, point 1.3.3, points (i) and (ii) | Annex I, part II, point 1.3.3, points (a) and (b) |
| Annex I, part II, point 1.4 | Annex I, part II, point 1.4 |
| Annex I, part III | Annex I, part III |
| Annex II | Annex II |
| Annex III | Annex III |
| — | Annex IV |
| — | Annex V |