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
This Directive establishes the list of constituents of natural mineral waters which may present a risk to public health, the limits for admissible levels of these constituents, the deadlines for application of these limits and the labelling requirements for certain constituents. These constituents must be present in the water naturally and may not result from contamination at source.
It also defines the conditions for using ozone-enriched air for separating compounds of iron, manganese, sulphur and arsenic from natural mineral waters or spring waters, and the labelling requirements for waters which have undergone such treatment.
1. By 1 January 2006 at the latest, natural mineral waters shall, at the time of packaging, comply with the maximum concentration limits set out in Annex I for the constituents listed in that Annex.
2. However, in the case of fluorides and nickel, the deadline referred to above is extended until 1 January 2008.
3. By way of derogation from paragraph 1, during the procedure for official recognition of natural mineral waters collected within their territory, the competent authorities of the Member States may take a lower reference value for nitrates and nitrites, provided that the same reference value is applied to all applications made to them.
For the purposes of official controls, the Member States shall comply with the specifications listed in Annex II for analysing the constituents listed in Annex I.
1. Natural mineral waters with a fluoride concentration exceeding 1,5 mg/l shall bear on the label the words "contains more than 1,5 mg/l of fluoride: not suitable for regular consumption by infants and children under 7 years of age".
2. The label information laid down in paragraph 1 of this Article shall be placed in immediate proximity to the trade name and in clearly visible characters.
3. Natural mineral waters which, under the terms of paragraph 1 of this Article, bear label information, shall indicate the actual fluoride content in relation to the physico-chemical composition in terms of essential constituents, as laid down in Article 7(2)(a) of Directive 80/777/EEC.
1. Without prejudice to the provisions of Article 4(1)(b) of Directive 80/777/EEC, application of the treatment of natural mineral waters with ozone-enriched air must be notified in advance to the competent authorities, who shall ensure that:
(a) use of such treatment is justified by the composition of the water in terms of compounds of iron, manganese, sulphur and arsenic;
(b) the operator takes all measures necessary to guarantee that the treatment is effective and safe and to allow it to be checked by the competent authorities.
2. Ozone-enriched air treatment of natural mineral waters must comply with all the following conditions:
(a) the physico-chemical composition of the natural mineral waters in terms of essential constituents shall not be modified by the treatment;
(b) the natural mineral water before treatment must comply with the microbiological criteria laid down in Article 5(1) and (2) of Directive 80/777/EEC;
(c) the treatment shall not lead to the formation of residues with a concentration exceeding the maximum limits laid down in Annex III or residues which could pose a risk to public health.
Pursuant to Article 7(2)(c) of Directive 80/777/EEC, the labelling of natural mineral waters which have been treated with ozone-enriched air shall bear, in proximity to the analytical composition of characteristic constituents, the words "water subjected to an authorised ozone-enriched air oxidation technique".
Without prejudice to the provisions of Article 9(4)(b) of Directive 80/777/EEC, the provisions of Articles 5 and 6 of this Directive shall apply to spring waters.
1. The Member States shall take the necessary measures to permit the marketing of products complying with the present Directive by 1 January 2004 at the latest.
2. Without prejudice to the deadlines set out in Article 2(1) and (2), the Member States shall prohibit the marketing of products not complying with the present Directive from 1 July 2004. However, products packaged and labelled prior to 1 July 2004 may be sold until stocks are exhausted.
The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2003 at the latest. They shall forthwith inform the Commission thereof.
The provisions adopted pursuant to this paragraph shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall determine how such reference is to be made.
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 16 May 2003.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 229, 30.8.1980, p. 1.
(2) OJ L 299, 23.11.1996, p. 26.
(3) Opinion of 13 December 1996 on arsenic, barium, fluoride, boron and manganese in natural mineral waters.
(4) Codex standard 108-1981, Rev 1-1997, revised during the 7th session of the CCNMW (October 2000).
(5) WHO (1996): guidelines on the quality of drinking water, second edition, volume 2.
(6) Council Directive 98/83/EC (OJ L 330 of 5.12.1998, p. 32).
(7) Opinion of the Scientific Committee for Food of 7 June 1996 on the use of ozone for separating unstable elements such as iron, manganese and arsenic from natural mineral waters.
Supplementary provisions
ANNEX ISupplementary provisions
Constituents naturally present in natural mineral waters and maximum limits which, if exceeded, may pose a risk to public health
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ANNEX II
Performance characteristics((Analytical methods for measuring concentrations of the constituents listed in Annex I 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 Annex I.)) for analysing the constituents in Annex I
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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.
ANNEX III
Maximum limits for residues from treatment of natural mineral waters and spring waters by ozone-enriched air
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
