L 126/34 Official Journal of the European Union 22.5.2003 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 (), 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 (), 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 hydrogeo- logical 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 consti- tuents of natural mineral waters after consulting the Scientific Committee for Food, and for labelling require- ments to indicate, where applicable, the presence of certain constituents at high concentrations. (3)  The Scientific Committee for Food issued an opinion (¥), on arsenic, barium, fluoride, boron and manganese and, for other constituents of natural mineral waters, vali- dated the limits recommended by the WHO for drinking water. (4 The revised Codex standard for ‘natural mineral waters’ (*), gives, for health purposes, a list of constitu- ents and maximum limits for these constituents. It was adopted on the basis of the most recent international scientific data and affords sufficient public health protec- tion. (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 () OJ L 229, 30.8.1980, p. 1. () OJ L 299, 23.11.1996, p. 26. (*) Opinion of 13 December 1996 on arsenic, barium, fluoride, boron and manganese in natural mineral waters. (*) Codex standard 108-1981, Rev 1-1997, revised during the 7th session of the CCNMW (October 2000). 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 (°), 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 avail- able 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, manga- nese 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 (%). (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 consti- tuents exceeds the maximum limits for these constitu- ents 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, suffi- cient 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. () WHO (1996): guidelines on the quality of drinking water, second edition, volume 2. (®) Council Directive 98/83/EC (O] L 330 of 5.12.1998, p. 32).