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

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
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 80/777/EEC(1), 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 last amended by Directive 96/70/EC of the European Parliament and of the Council(2), and in particular Article 11(1) thereof,
Whereas:
(1) Constituents may be present in the natural state in certain natural mineral waters because of their hydrogeological origin and may present a risk to public health above a certain concentration. It is therefore deemed necessary to establish concentration limits for these constituents in natural mineral waters.
(2) Article 11 of Directive 80/777/EEC makes provision for adopting harmonised concentration limits for the constituents of natural mineral waters after consulting the Scientific Committee for Food, and for labelling requirements to indicate, where applicable, the presence of certain constituents at high concentrations.
(3) The Scientific Committee for Food issued an opinion(3), on arsenic, barium, fluoride, boron and manganese and, for other constituents of natural mineral waters, validated the limits recommended by the WHO for drinking water.
(4) The revised Codex standard for "natural mineral waters"(4), gives, for health purposes, a list of constituents and maximum limits for these constituents. It was adopted on the basis of the most recent international scientific data and affords sufficient public health protection.
(5) It is generally acknowledged that a low-level fluoride intake can have a beneficial effect on teeth. By contrast, excessive fluoride intake across the board can have harmful effects on public health. Thus, it is necessary to lay down a harmonised maximum limit for fluoride in natural mineral waters affording sufficient protection for the population as a whole.
(6) The World Health Organisation recommended a guide value of 1,5 mg/l for fluoride for drinking water, which was validated for natural mineral waters by the Scientific Committee for Food in the abovementioned opinion. In order to protect infants and young children, who are the most sensitive to the risk of fluorosis, where the fluoride content of a natural mineral water exceeds this guide value, a reference to this fact, which can be seen easily by the consumer, also needs to be made on the label.
(7) The Scientific Committee for Food indicated a guide value for boron in natural mineral waters based on the WHO(5), recommendations of 1996. However, the WHO and other internationally recognised scientific organisations have since then made new appraisals of boron's effect on public health and have recommended higher values. The European Food Safety Authority should therefore be consulted about boron in natural mineral waters so that the new scientific appraisals available can be taken into account and a maximum limit for boron should not be set at this stage.
(8) The Scientific Committee for Food also indicated in the above opinion the acceptable level for barium, manganese and arsenic in natural mineral waters. For the other undesirable constituents of natural mineral waters which may have a harmful effect on public health, the revised Codex standard lays down maximum limits that afford sufficient protection for public health. However, the limit for nitrates is deemed to be too low in the light of the available data and should be brought into line with that for drinking water(6).
(9) The maximum limit for nitrates laid down in the Codex standard affords sufficient protection for public health and should serve as a reference for Community and international trade in natural mineral waters. However, during the procedure for official recognition of natural mineral water sources referred to in Article 1 of the aforementioned Directive, the Member States' competent authorities must be able to take a lower guide value for nitrates in natural mineral waters collected within their territory.
(10) Natural mineral waters whose content in certain constituents exceeds the maximum limits for these constituents shall, for public health purposes, be subjected to the separation treatments for these constituents. In order to enable the operators concerned to make the necessary investment to comply with these new standards, sufficient periods should be allowed before the maximum concentration limits for such constituents come into force, in particular with regard to fluoride and nickel for which no separation treatment has yet been assessed or authorised at Community level.
(11) For the purposes of official checks on these constituents, a fluctuation margin around the maximum concentration limits is required corresponding to measurement uncertainties.
(12) Article 4(1)(b) of Directive 80/777/EEC (as amended) provides for the separation of iron, manganese, sulphur and arsenic from certain natural mineral waters, using ozone-enriched air treatment, subject to an assessment of this treatment by the Scientific Committee for Food and adoption of the conditions for use of this treatment by the Standing Committee on the Food Chain and Animal Health.
(13) The Scientific Committee for Food issued an opinion(7), on this treatment which provides for both given methods and results. However, it is deemed appropriate to stipulate only given results, in order to take account of developments in ozone-enriched air treatment techniques and treatment variability depending on the physico-chemical composition of the water to be treated.
(14) Moreover, treatment with ozone-enriched air should not modify the composition in terms of characteristic constituents within the meaning of Article 7(2)(a) of Directive 80/777/EEC, or have a disinfectant action within the meaning of Article 4(3) or generate the formation of treatment residues which may have a harmful effect on public health.
(15) Pursuant to Article 7(2)(c) of the above Directive, natural mineral waters treated with ozone-enriched air must bear a reference on the label giving customers sufficient information about the treatment carried out.
(16) In accordance with the provisions of Article 9(4)(a) fourth indent of Directive 80/777/EEC, the provisions concerning the treatments provided for in Article 4 of the Directive, and in particular treatment with ozone-enriched air, are applicable to spring waters.
(17) The measures laid down in this Directive are in accordance with the opinion of the Scientific Committee on the Food Chain and Animal Health,