RESOLUTIONof the Council and the representatives of the Member States, meeting within the Council,of 16 June 1986concerning the protection of dialysis patients by minimizing the exposure to aluminium(86/C 184/04)

THE COUNCIL OF THE EUROPEAN COMMUNITIES AND THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES, MEETING WITHIN THE COUNCIL, Having regard to the Treaty establishing the European Economic Community, Having regard to the proposal from the Commission (1) , Having regard to the opinion of the European Parliament (2) , Having regard to the opinion of the Economic and Social Committee (3) , Whereas the number of people in the Community having to resort to dialysis in order to lead normal lives is rising considerably; Whereas it is advisable, in order to protect dialysis patients, to lay down recommendations concerning the purity standards to be met, on the one hand, by concentrated solutions and dilute solutions for haemodialysis and, on the other, by the water used for the dilution of concentrated solutions and solutions used for the preparation of dilute solutions; Whereas, by means of Directive 80/778/EEC (4) , the Council has already laid down a series of standards relating to the quality of water intended for human consumption; Whereas the recommendations should relate in particular to the aluminium content of concentrated solutions and dilute solutions and diluting water; Whereas, in order to limit the risks of osteomalacia due to aluminium and to eliminate the risks to dialysis patients of encephalopathy caused by the presence of aluminium in dilute solutions, a maximum value should be set for aluminium not only in concentrated solutions but also in the diluting water and whereas this value should, where it is used for the purposes of dialysis, be lower than that laid down in Directive 80/778/EEC; Whereas, in order to ensure the effectiveness of the recommendations made, the oral intake of aluminium should be reduced as far as possible; whereas the authorities responsible for dialysis treatment should be informed of the risk of the toxic effects of aluminium for dialysis patients; whereas in addition it seems advisable, with a view to evaluating the effectiveness of the measures taken, to determine on a regular basis the aluminium levels in plasma, which constitutes a very useful indication of the body burdens of aluminium of dialysis patients; Whereas the accuracy required in the assessment of aluminium levels will be more easily and harmoniously achieved by the Member States within the framework of a Community programme to enhance the quality of methods of analysis and establish reference methods, HAVE ADOPTED THIS RESOLUTION: A. Aims This resolution concerns the monitoring of aluminium levels in dilute solutions for haemodialysis and in plasma and reducing the absorption of aluminium by persons undergoing dialysis. B. Definitions For the purposes of this resolution: - 'concentrated solution for haemodialysis' means any solution used for the preparation of a dilute solution for haemodialysis; -'diluting water' means the water added to a concentrated solution for haemodialysis; -'dilute solution for haemodialysis' means any solution used directly for haemodialysis; -'haemofiltration solution' means any solution used as a replacement fluid in haemofiltration; -'peritoneal dialysis solution' means any solution used for the purpose of peritoneal dialysis, i. e. IPD (intermittent peritoneal dialysis) , CAPD (continuous ambulatory peritoneal dialysis) and CCPD (continuous cyclical peritoneal dialysis) . C. Measures to be taken by Member States 1. Aluminium levels Member States should take the appropriate measures to ensure that: - the total amount of aluminium present in the concentrated solution for haemodialysis supplied for the purpose of preparing dilute solutions for haemodialysis does not contribute more than 10 mg/l to the concentration of aluminium in the dilute solution for haemodialysis; -the concentration of aluminium in the peritoneal dialysis solution does not exceed 15 mg/l; -the concentration of aluminium in the haemofiltration solution does not exceed 10 mg/l; -the level of aluminium in the dilute solution for haemodialysis does not exceed 30 mg/l; -diluting water complies at least with all the requirements of Directive 80/778/EEC, with the possible exception of those in Table F of Annex I thereto; -diluting water is appropriately treated to reduce the aluminium level if the latter exceeds 30 mg/l; -treatment of the water is also envisaged depending on the amount of aluminium introduced by the concentrate and the equipment. Member States should establish appropriate monitoring of these levels, taking account of the suggestions in Annex I. 2. Water distribution authorities and renal dialysis Member States should ensure as far as possible that the authorities responsible for water distribution: -inform all renal dialysis units, if possible in advance, of any important change in the treatment of water which might increase the aluminium level in the water distributed, and also of any accidental pollution of the water distributed; -take all necessary measures during treatment to ensure that water intended for human consumption meets at least the requirements of Directive 80/778/EEC; -study the possibility of replacing aluminium salts in the treatment of water. 3. Persons in charge of renal dialysis Member States should inform all persons in charge of the treatment of renal dialysis patients that the regular monitoring of aluminium in the plasma or serum of these patients is desirable in order to attempt to protect them against the toxic effects of aluminium (resulting from dilute solutions for haemodialysis and binders, in particular phosphate binders) . The reference levels and the analysis frequencies suggested in Annex II could serve as a guide for the doctor in charge. D. Analytical quality assurance scheme The Commission is requested to draw up a scheme to ensure quality, covering all types of analysis, and to make this available to the laboratories of the Member States, in cooperation with the European Pharmacopoeia Commission in so far as the latter draws up such a scheme or programme. E. Final provisions At the request of the Commission, the Member States shall inform it of progress made in implementing this resolution. The Commission is called upon to draw up regular reports for the Council and the European Parliament. (1) OJ No C 202, 29. 7. 1983, p. 5.

(2) OJ No C 172, 2. 7. 1984, p. 89.

(3) OJ No C 35, 9. 2. 1984, p. 1.

(4) OJ No L 229, 30. 8. 1980, p. 11.