Statutory Instruments of the Scottish Parliament

(a) the particulars in paragraph 1 of Part 3;

(b) any other information showing that the matters specified in paragraphs 2 and 3 of Part 3 are established; and

(c) such evidence as is satisfactory to show that the water contains no substance listed in Schedule 6 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule.

     3. In so far as particulars of any of the anions, cations, non-ionised compounds or trace elements specified in column 1 of Schedule 5 are required to be given pursuant to sub-paragraph (b) of paragraph 2, the concentration of each such anion, cation, non-ionised compound or trace element shall, in those particulars, be expressed in the unit of measurement specified opposite it in column 2 of that Schedule.

     4. Where such particulars have been given, the food authority shall assess them and shall recognise the water to which those particulars relate as natural mineral water if it is satisfied that–

(a) the water is natural mineral water which complies with paragraph 3 of Section I of Annex I; and

(b) the characteristics of the water have been assessed in accordance with–


(i) the points numbered 1 to 4 set out in paragraph 2(a) of Section I of Annex I,

(ii) the requirements and criteria listed in Part 3 of this Schedule, and

(iii) recognised scientific methods.

     5. The food authority shall, on recognising a natural mineral water in accordance with paragraph 4, publish an announcement of such recognition and the grounds on which it has been granted, in the Edinburgh Gazette.

(a) those specified in paragraph 1 of Part 3;

(b) any other information showing that the matters specified in paragraphs 2 and 3 of Part 3; are established; and

(c) such evidence as is satisfactory to show that the water contains no substance listed in Schedule 6 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule.

     3. In so far as particulars of any of the anions, cations, non-ionised compounds or trace elements specified in column 1 of Schedule 5 are required to be given pursuant to sub-paragraph (b) of paragraph 2, the concentration of each such anion, cation, non-ionised compound or trace element shall be expressed in those particulars in the unit of measurement specified opposite it in column 2 of that Schedule.

     4. The Agency shall not recognise such a water unless the responsible authority of the country in which the water is extracted has certified that–

(a) it is satisfied–


(i) that the requirements in paragraphs 2 and 3 of Part 3 are established; and

(ii) with the evidence given pursuant to sub-paragraph (c) of paragraph 2; and



(b) periodic checks are made to ascertain that–



(i) the water is natural mineral water which complies with paragraph 3 of Section I of Annex I;

(ii) the characteristics of the water are assessed in accordance with–


(aa) the points numbered 1 to 4 set out in paragraph 2(a) of Section I of Annex I;

(bb) the requirements and criteria listed in Part 3; and

(cc) recognised scientific methods; and



(iii) the provisions of Schedule 4 are being applied by the person exploiting the spring.

     5. Recognition of such water shall lapse after a period of five years unless the responsible authority of the country in which the water is extracted has renewed the certification required by paragraph 4.

     6. The Agency shall, on recognising water in accordance with this Part of this Schedule, publish an announcement of such recognition in the Edinburgh Gazette, the London Gazette and the Belfast Gazette.

(a) the exact site of the catchment with indication of its altitude, on a map with a scale of not more than 1:1,000;

(b) a detailed geological report on the origin and nature of the terrain;

(c) the stratigraphy of the hydrogeological layer;

(d) a description of the catchment operations; and

(e) the demarcation of the area or details of other measures protecting the spring against pollution.

     2. Physical, chemical and physico-chemical surveys must establish–

(a) the rate of flow of the spring;

(b) the temperature of the water at source and the ambient temperature;

(c) the relationship between the nature of the terrain and the nature and type of minerals in the water;

(d) the dry residues at 180°C and 260°C;

(e) the electrical conductivity or resistivity, with the measurement temperature being specified;

(f) the hydrogen ion concentration (pH);

(g) the anions and cations;

(h) the non-ionized elements;

(i) the trace elements;

(j) the radio-actinological properties at source;

(k) where appropriate, the relative isotope levels of the constituent elements of water, oxygen (¹⁶O — ¹⁸O) and hydrogen (protium, deuterium, tritium);

(l) the toxicity of certain constituent elements of the water, taking account of the limits laid down for each of them.

     3. Microbiological analysis at source must show–

(a) the absence of parasites and pathogenic micro-organisms;

(b) quantitative determination of the revivable colony count indicative of faecal contamination, demonstrating–


(i) absence of Escherichia coli and other coliforms in 250 ml at 37°C and 44.5°C;

(ii) absence of faecal streptococci in 250 ml;

(iii) absence of sporulated sulphite-reducing anaerobes in 50 ml;

(iv) absence of Pseudomonas aeruginosa in 250 ml;



(c) the revivable total colony count per ml of water–



(i) at 20 to 22°C in 72 hours on agar-agar or an agar-gelatine mixture,

(ii) at 37°C in 24 hours on agar-agar.

     4. —(1) Subject to sub paragraph (2), clinical and pharmacological analyses must be carried out in accordance with scientifically recognised methods and should be suited to the particular characteristics of the natural mineral water and its effects on the human organism, such as diuresis, gastric and intestinal functions, compensation for mineral deficiencies.

    (2) Clinical analyses may, in appropriate cases, take the place of analyses referred to in sub paragraph (1) provided that the consistency and concordance of a substantial number of observations enable the same results to be obtained.

(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.

     7. —(1) After bottling, the total colony count at source may not exceed–

(a) 100 per ml at 20 to 22°C in 72 hours on agar agar or an agar gelatine mixture; and

(b) 20 per ml at 37°C in 24 hours on agar agar.

    (2) The total colony count shall be measured within the period of 12 hours following bottling, the water being maintained at 4°C +/− 1°C during that period.

     8. Water shall be free from–

(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; and

(d) Pseudomonas aeruginosa in any 250 ml sample examined.

(a) three times the relative standard deviation within a batch of a natural sample containing a low concentration of the constituent; or

(b) five times the relative standard deviation within a batch of a virgin sample.

     7. The method should make it possible to determine total cyanide in all its forms.

(a) 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 (O.J. No. L 229, 30.8.80, p.1) as last amended by Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (O.J. L 284, 31.10.2003, p.1);

(b) Commission Directive 2003/40/EC (O.J. No. L 126, 22.5.2003, p.34) establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters; and

(c) in relation to spring water and bottled drinking water, Council Directive 98/83/EC (O.J. No. L 330, 3.11.98, p.32) relating to the quality of water intended for human consumption.

The principal changes are that–

(a) it is specifically provided that the Regulations do not apply to packaged ice portions for use in cooling food;

(b) the requirements in the Regulations relating to marking and labelling of natural mineral water and spring water are extended to advertising of such water; and

(c) provision is made for retained parts of samples obtained by authorised officers of food authorities for the purpose of analysis to be submitted for analysis to the Government Chemist in specified circumstances.

The Regulations–

(a) provide for exemptions from the Regulations to apply in relation to specified types of water and for ice for cooling food (regulation 3);

(b) prescribe the conditions for recognition of natural mineral water, the procedures for withdrawal of such recognition and provide for review of decisions not to grant or to withdraw recognition where that is requested by the person affected by the decision (regulation 4);

(c) set out the conditions which must be satisfied for springs to be exploited with a view to marketing water from them as natural mineral water and prohibit exploitation of polluted springs until the cause of the pollution is eradicated (regulation 5);

(d) prohibit subjection of natural mineral water to treatments and additions other than specified ones, subject to an exception in the case of such water when used in the manufacture of soft drinks (regulation 6);

(e) prohibit bottling of natural mineral water containing specified substances above specified limits and prescribe the methods to be used for detection of such substances (regulation 7(1) and (2));

(f) prohibit bottling of natural mineral water where specified requirements relating to exploitation of the spring from which the water comes and to bottling of the water are not complied with (regulation 7(3));

(g) prohibit bottling of natural mineral water in containers not satisfying specified requirements (regulation 7(4));

(h) restrict the marking and labelling that may be applied to bottled natural mineral water (including effervescent natural mineral water), require such water to be marked or labelled with specified information and in two respects regulate advertising of such water in addition to its marking and labelling (regulation 8);

(i) prohibit sale of water–


(i) marked or labelled as natural mineral water unless it is such water,

(ii) containing certain substances or organoleptic defects,

(iii) where the total colony count of the water does not comply with paragraph 7(a) of Schedule 4, and

(iv) if the requirements as regards exploitation of the spring from which the water comes, treatment and additions and labelling contained in regulations 5, 6 and 8 respectively are not satisfied (regulation 9);



(j) prohibit bottling of water in a bottle marked or labelled "spring water" unless the water satisfies specified requirements, prohibit such bottling where the water has been treated with ozone enriched air unless the treatment is an authorised one and prohibit exploitation of polluted springs until the cause of the pollution is eradicated (regulation 10);

(k) restrict the marking and labelling that may be applied to spring water, require such water to be marked or labelled with specified information and in one respect regulate advertising of such water in addition to its marking and labelling (regulation 11);

(l) prohibit sale of water marked or labelled "spring water" if the water does not comply with the requirements as regards bottling and as regards labelling and advertisement in regulations 10 and 11 respectively, and prohibit sale of such water from one spring under more than one trade description (regulation 12);

(m) prohibit bottling of drinking water unless it satisfies the requirements of Schedule 2 (regulation 13);

(n) impose restrictions on the marking, labelling and advertising of bottled drinking water with specified information (regulation 14);

(o) prohibit sale of bottled drinking water not bottled in accordance with regulation 13 or not marked or labelled in accordance with regulation 14 (regulation 15);

(p) allocate responsibility for the enforcement and execution of the Regulations, including the carrying out of specified checks for the purpose of ensuring that specified requirements relating to natural mineral water and the requirements as regards ozone enriched air oxidation techniques applicable to natural mineral water and spring water are satisfied (regulation 16);

(q) prescribe the arrangements for handling samples of water taken for analysis for the purposes of the Regulations, provide for submission of a part of the sample for the Government Chemist in specified circumstances and require that, for the purpose of determining whether water complies with Schedule 2, methods of analysis according with Article 7.5 of Directive 98/83/EC must be used (regulations 17 to 19 respectively);

(r) provide that contravention of specified provisions of the Regulations is an offence and prescribe the penalty applicable in the event of conviction (regulation 20);

(s) provide defences in relation to water bottled, marked and labelled before the Regulations come into force and water bottled or sold in an EEA State other than the UK (regulation 21);

(t) apply for the purposes of the Regulations certain provisions of the Food Safety Act 1990 and the Food Labelling Regulations 1996 (S.I. 1996/1499) as amended (regulation 22(1) and (2));

(u) prohibit sale of water not marked in accordance with regulation 38 (intelligibility) of those Regulations (regulation 22(3)); and

(v) revoke the Natural Mineral Water Spring Water and Bottled Drinking Water Regulations 1999 (S.I. 1999/1540) as amended (regulation 23).

These Regulations also revoke the Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) Regulations 2007 (S.S.I. 2007/435) which contain a minor defect at regulation 12(1)(b).

The requirement contained in paragraph 1(d) of Part 1 of Schedule 2 to these Regulations has been notified to the European Commission in accordance with the requirements of Article 8 of Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations (O.J. No. L 204, 21.7.98, p.37) as amended by Directive 98/48/EC of the European Parliament and of the Council (O.J. No. L 217, 5.8.98, p.18).

A full regulatory impact assessment, which includes a compliance cost assessment of the effect which these Regulations will have on business costs has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency (Scotland), 6th Floor, St Magnus House, 25 Guild Street, Aberdeen, AB11 6NJ.