EN    EN EN EN 1   EN DRAFT 
COMMISSION REGULATION (EC) No …/.. 
of […] 
laying down the conditions for use of activate d alumina for the removal of fluoride from 
natural mineral waters and spring waters  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Directive 2009/54/EC of the European Parliament and of the Council1, on 
the exploitation and marketing of natural mineral waters, and in particular Article 4(1)(c) and 
Article 12 (d) thereof, 
Having regard to the opinion of th e European Food Safety Authority, 
Whereas: (1) Commission Directive 2003/40/EC of 16 May 2003
2 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 sets a maximum limit for fluoride in natural mineral waters. As regards spring water, such a limit is fixed by Council Directive 98/83/EC of 
3 November 1998
3 on the quality of water intended for human consumption. 
(2) To allow operators to comply with those Directives, a treatment to remove fluoride 
from natural minerals waters and spring wate rs by using activated alumina (hereinafter 
‘the fluoride removal treatment’) should be authorised. 
(3) The fluoride removal treatment should not add residues to the treated water at 
concentrations which may pose a risk for public health.  
(4) The fluoride removal treatment should be notified to the competent authorities to 
allow those authorities to exercise the contro ls necessary to ensure correct application 
of the treatment. 
(5) The use of a fluoride removal treatment s hould be indicated on the label of treated 
water. 
                                                 
1 OJ L 164, 26.6.2009, p. 45. 
2 OJ L 126, 22.5.2003, p. 34 
3 OJ L 330, 05.12.1998, p. 32 EN 2   EN (6) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council has opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The treatment of natural mineral waters and spring waters with activated alumina in 
order to remove fluoride, he reinafter ‘the fluoride removal treatment’, shall be 
allowed.  
Natural mineral waters and spring waters together are referred to hereinafter as 
‘water’. 
2. The fluoride removal treatment shall be performed in accordance with the technical 
requirements as set out in the Annex.  
Article 2 
The release of residues into the water as a result of the fluoride removal treatment shall be as 
low as technically  feasible according to the  best practices and shall not pose a risk to public 
health. To ensure this, the operator shall implement  and monitor the criti cal processing steps 
set in the Annex.  
Article 3   
1. The application of a fluoride removal tr eatment shall be notified to the competent 
authorities at least three months prior to use.  
2. With the notification the operator shall communicate to the competent authorities 
relevant information, documentation and an alytical results on the treatment which 
show that it complies with the Annex.   
Article 4 
The label on water which has been the subject of a  fluoride removal treatment shall include, in 
proximity to the statement of the analytical co mposition, the indication "w ater subjected to an 
authorised activated alumina treatment". 
Article 5 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
Products which were placed on the market by [ Office of Publications please insert date 6 
months after publication ] and which do not comply with Ar ticle 4, may continue to be 
marketed until ( Office of Publications please insert date one year after date of publication ). EN 3   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission EN 4   EN ANNEX  
Technical requirements for the use of activated  alumina for the removal of fluoride from 
natural mineral waters and spring waters  
The following critical processing steps shall be implemented and monitored appropriately: 
1. Before the activated alumina is used for th e treatment of water it shall be subjected to 
an initialisation procedure which includes th e use of acidic or alkaline chemicals to 
remove any residues and a backwash tr eatment to remove fine particles. 
2. A regeneration procedure shall be applied at intervals ranging from one to four 
weeks depending on the water quality and th roughput. It shall include the use of 
appropriate chemicals to remove the adsorbed  ions in order to restore the adsorption 
capacity of the activated alumina, and to remove any possibly formed biofilms. This 
procedure shall be done in the following three stages: 
– Treatment with sodium hydroxide to re move fluoride ions and replace them 
with hydroxide ions. 
– Treatment with an acid to remove resi dual sodium hydroxide and activate the 
medium. 
– Rinsing with drinking or demineralise d water and condition ing with the water 
as the final step in order to ensure that  the filter has no impact on the overall 
mineral content of the treated water.  
3. The chemicals and reagents used for the initialisation and regeneration procedures 
shall comply with the relevant European standards4 or applicable national standards 
relating to the purity of the chemical reagen ts used for treatment of water intended 
for human consumption.  
4. The activated alumina shall comply with the European standard for leaching tests 
(EN 12902)5 to ensure that no residues are releas ed into the water in concentrations 
exceeding the limits set in Commission Dire ctive 2003/40/EC or in the absence of 
limits in that Directive, the restrictions  set in Council Directive 98/83/EC or in 
applicable national legislation. The total amount of aluminium ions in the treated 
water as it results after the release of al uminium, the main component of activated 
alumina, shall not exceed 200microg/L, as established in Council Directive 
98/83/EC. This amount shall be checked regularly in accordance with the Council 
Directive.  
5. The processing steps shall be subject to good manufacturing practices and HACCP 
principles set out in Regulation (EC) No 852/2004 of the European Parliament and of 
the Council on food hygiene6  
                                                 
4 European Standards developed by the European Committee for Standardisation (CEN).  
5 European Standard EN 12902 (2004): Products used for treatment of water intended for human 
consumption. Inorganic supporting and filtering materials. 
6 OJ L 139, 30.4.2004, p. 1-54  
 EN 5   EN 6. The operator shall establish a monitoring programme in order to  ensure the proper 
functioning of the processing st eps in particular as rega rds the maintenance of the 
essential characteristics of the water and its fluoride content.