S.I. No. 79/2005 - European Communities (Natural Mineral Waters, Spring Waters and Other Waters in Bottles Or Containers) Regulations 2005

The following principles for methods of microbiological parameters are given either for reference whenever a CEN/ISO method is given or for guidance, pending the possible future adoption, in accordance with the procedure laid down in Article 12 of Council Directive 98/83/EC³, of further CEN/ISO international methods for these parameters. Member States may use alternative methods, providing the provisions of Article 7(5) of Council Directive 98/83/EC³ are met.

Coliform bacteria and Escherichia coli (E. coli) (ISO 9308-1)

Enterococci (ISO 7899-2)

Pseudomonas aeruginosa (prEN ISO 12780)

Enumeration of culturable microorganisms — Colony count 22 °C (prEN ISO 6222)

Enumeration of culturable microorganisms — Colony count 37 °C (prEN ISO 6222)

Clostridium perfringens (including spores)

Membrane filtration followed by anaerobic incubation of the membrane on m-CP agar (Note 1) at 44 ± 1 °C for 21 ± 3 hours. Count opaque yellow colonies that turn pink or red after exposure to ammonium hydroxide vapours for 20 to 30 seconds.

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

Dissolve the ingredients of the basal medium, adjust pH to 7.6 and autoclave at 121 °C for 15 minutes. Allow the medium to cool and add:

PART 2 - PARAMETERS FOR WHICH PERFORMANCE CHARACTERISTICS ARE SPECIFIED

2.1. For the following parameters, the specified performance characteristics are that the method of analysis used must, as a minimum, be capable of measuring concentrations equal to the parametric value with a trueness, precision and limit of detection specified. Whatever the sensitivity of the method of analysis used, the result must be expressed using at least the same number of decimals as for the parametric value considered in Schedule 5 Parts B and C.

2.2 For hydrogen ion concentration the specified performance characteristics are that the method of analysis used must be capable of measuring concentrations equal to the parametric value with a trueness of 0.2 pH unit and a precision of 0.2 pH unit.

Note 1: Trueness is the systematic error and is the difference between the mean value of the large number of repeated measurements and the true value. This term is further defined in ISO 5725.

Note 2: Precision is the random error and is usually expressed as the standard deviation (within and between batch) of the spread of results about the mean. Acceptable precision is twice the relative standard deviation. This term is further defined in ISO 5725.

Note 3: Limit of detection is either:

— three times the relative within batch standard deviation of a natural sample containing a low concentration of the parameter, or

— five times the relative within batch standard deviation of a blank sample.

Note 4: The method should determine total cyanide in all forms.

Note 5: Oxidation should be carried out for 10 minutes at 100 °C under acid conditions using permanganate.

Note 6: The performance characteristics apply to each individual pesticide and will depend on the pesticide concerned. The limit of detection may not be achievable for all pesticides at present, but Member States should strive to achieve this standard.

Note 7: The performance characteristics apply to the individual substances specified at 25 % of the parametric value in Schedule 5.

Note 8: The performance characteristics apply to the individual substances specified at 50 % of the parametric value in Schedule 5.

PART 3 - PARAMETERS FOR WHICH NO METHOD OF ANALYSIS IS SPECIFIED

Colour

Odour

Taste

Total organic carbon

Turbidity (Note 1)

Note 1: For turbidity monitoring in treated surface water the specified performance characteristics are that the method of analysis used must, as a minimum, be capable of measuring concentrations equal to the parametric value with a trueness of 25 % precision of 25 % and a 25 % limit of detection.

Schedule 8 CONSTITUENTS NATURALLY PRESENT IN NATURAL MINERAL WATERS AND MAXIMUM LIMITS WHICH, IF EXCEEDED, MAY POSE A RISK TO PUBLIC HEALTH

• The maximum limit for boron will be fixed, where necessary, following an opinion of the European Food Safety Authority and on a proposal from the Comission by 1 January 2006.

Schedule 9 PERFORMANCE CHARACTERISTICS* FOR ANALYSING THE CONSTITUENTS IN SCHEDULE 8

• Analytical methods for measuring concentrations of the constituents listed in Schedule 8 must be able to measure, as a minimum, concentrations equal to the parametric value with a specified accuracy, precision and detection limit. Whatever the sensitivity of the method of analysis used, the result will be expressed using at least the same number of decimal places as for the maximum limit laid down in Schedule 8.

Note 1: accuracy is the systematic error and is the difference between the average value of a large number of repeated measurements and the exact value.

Note 2: precision is the random error and is expressed in general as the standard deviation (within a batch and between batches) of a sample of results from the average. Acceptable precision is equal to twice the relative standard deviation.

Note 3: the detection limit is:

— either three times the relative standard deviation within a batch of a natural sample containing a low concentration of the parameter,

— or five times the relative standard deviation within a batch of a virgin sample.

Note 4: the method should make it possible to determine total cyanide in all its forms.

Schedule 10 MAXIMUM LIMITS FOR RESIDUES FROM TREATMENT OF NATURAL MINERAL WATERS AND SPRING WATERS BY OZONE-ENRICHED AIR

• compliance with the maximum limits is monitored by the competent authorities in the Member States at the time of bottling or other form of packaging intended for the final consumer.

Schedule 11 Form of official certificate to be given by an approved examiner to an authorised officer.

European Communities (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) Regulations 2005

Certificate of Analysis

To ^(1) .................................

I, the undersigned ^(2) .................................

being an Approved Examiner for the purpose of the above Regulations certify that on

the .................................day of ................................. 20......

a sample marked ^(3) .................................

Date .................................

Number .................................

Weight or Measure .................................

was submitted to me by you and I certify that the sample was prepared and analysed/examined by me or under my direction^(4)

and as a result I am of the opinion that ^(5)

Observations:^(6)

I further certify that the sample has undergone no change which would affect my opinion/observations expressed above.

Certified by me this ..................... day of ........................... 20.....

at ^(7) .................................

Name in BLOCK LETTERS .......................................................

Status .................................

Signature .................................

Official Stamp

NOTES

• (1) Insert the name and address of the person submitting the sample for analysis.

• (2) Insert description (e.g. Executive Analytical Chemist located at a Public Analyst Laboratory).

• (3) Insert particulars of marking (e.g. name, date etc.) and the weight or measure (this may be left unanswered if the sample cannot be conveniently weighed or measured or if the weight or measurement is not material to the result of analysis).

• (4) Indicate whether the approved examiner carried out the analysis himself or herself or whether it was carried out by another under the direction of the approved examiner.

• (5) Here the approved examiner should specify the result of the analysis having regard to the provisions of the relevant legislation.

• (6) Here the approved examiner may insert, at his or her discretion, his or her opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he or she may add any other observations as he or she may consider relevant.

• (7) Insert the name and address of the laboratory carrying out the analysis/examination.

Explanatory Note

(This note is not part of the instrument and does not purport to be a legal interpretation.)

These Regulations, which may be cited as the European Communities (Natural Mineral Waters Spring Waters and Other Waters in Bottles or Containers) Regulations 2005, give further effect to Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters, as amended by Directive 96/70/EC of the European Parliament and of the Council of 28 October 1996. They also give further effect to Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption and to Commission Directive 2003/40/EC of 16 May 2003 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.

These Regulations set certain requirements in respect of the exploitation, treatment, packaging and marketing of bottled waters and also include requirements in relation to labelling and various parametric values.

These Regulations revoke the European Communities (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) Regulations 2004 ( S.I. No. 6 of 2004 ).

DEPARTMENT OF HEALTH AND CHILDREN

FEBRUARY 2005

Footnotes