29. 7. 83 Official Journal of the European Communities No C 202/5 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive relating to the protection of dialysis patients by 
minimizing the exposure to aluminium 
(Submitted by the Commission to the Council on 29 June 1983) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Articles 100 and 235 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas at the Conference held in Paris in October 
1972 the Heads of State or of Government affirmed 
that the first aim of economic expansion, which is not 
an end in itself, should be to enable disparities in 
living conditions to be reduced and that it should 
result in an improvement in the quality of life as well 
as in standards of living; 
Whereas, in view of the growth in the number of 
renal dialysis patients in the Community, of their 
continued health problems and of the economic cost 
of renal dialysis treatment, it is necessary to lay down 
rules aimed at increasing the protection of the health 
of these patients; 
Whereas it is necessary that renal dialysis patients 
benefit from the same health protection when 
travelling within the Community; 
Whereas clinical observations and epidemiological 
studies have shown that aluminium accumulates in the 
body of dialysis patients; 
Whereas clinical observations have shown that with 
elevated body burdens of aluminium, severe health 
effects and in particular encephalopathy develops in 
two to three years; 
Whereas the determination of aluminium in plasma or 
serum provides an indication of the aluminium body 
burden and the reference levels help in the 
management of the dialysis patients; Whereas it is appropriate to consider a comprehensive 
approach and cover all types of renal dialysis methods 
and all sources of aluminium; 
Whereas the aluminium accumulating in the body of 
dialysis patients may arise from the dialysis fluids, 
including the water used for the dilution of the 
concentrates, the dialysis instrumentation, and the 
aluminium salts taken orally for phosphate binding; 
Whereas recent scientific data have shown that the 
aluminium body burden increases if the aluminium 
level in the renal dialysis fluids exceeds 10-20 ug/1; 
Whereas Council Directive 80/778/EEC of 15 July 
1980 relating to the qualitiy of water intended for 
human consumption (') does not consider aluminium 
as a toxic substance and sets a maximum admissible 
concentration for aluminium in water of 0,2 ng/1 and 
a guide level of 0,05 |ig/l; 
Whereas recent scientific data clearly demonstrated 
that, if aluminium concentrations in excess of 50 fig/1 
are present in the water intended for renal 
hemodialysis, there is the probability of 
encephalopathy developing in a significant number of 
patients; 
Whereas there may be considerable variability in the 
aluminium level in the mains water supply; 
Whereas the interconnection of water grid systems 
may render this variation unpredictable and there is 
therefore the need for close cooperation between the 
responsible authorities for water distribution and the 
renal dialysis units; 
Whereas the efficiency of various water treatment 
methods for the removal of aluminium depends on 
the concentration and chemical form of the 
aluminium present in water; 
Whereas at present demineralization and reverse 
osmosis appear to be the water treatment techniques 
most appropriate; 
(») OJ No L 229, 30. 8. 1980, p. 11. 
No C 202/6 Official Journal of the European Communities 29. 7. 83 
Whereas it is necessary to minimize the aluminium 
concentration in the dialysis concentrates, haemo-
filtration and peritoneal dialysis solutions; whereas it 
is, however, recognized that due to technical 
difficulties a stepwise approach is necessary; whereas 
Member States should be encouraged to achieve these 
low levels as soon as possible; 
Whereas these provisions supplement the general 
requirements laid down for medicinal preparations in 
Council Directives 65/65/EEC (1), 75/318/EEC (2) 
and 75/319(EEC (J); 
Whereas it is desirable to minimize the oral intake of 
aluminium and develop substitute treatment methods; 
Whereas it is recognized that at present the analytical 
methodology is deficient for the analysis of 
aluminium in water, dialysis fluids and body fluids at 
the concentration required for the protection of 
dialysis patients as set out in this Directive, and that 
the setting up of quality assurance procedures and the 
development of reference materials is urgently 
required, and that the Commission should be 
entrusted with the implementation of these measures, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
This Directive concerns the protection of renal 
dialysis patients from the toxic effects of aluminium 
absorption from all sources, by monitoring the 
aluminium levels in plasma and dialysis fluids and 
minimizing the absorption. 
Article 2 
1. Member States shall inform all persons in charge 
of the management of renal dialysis patients that the 
regular monitoring of aluminium in the plasma or 
serum of these patients is desirable for attempting to 
protect them against the toxic effects of aluminium, 
and shall provide recommended reference levels for 
aluminium in serum or plasma. 
2. Recommended reference levels of aluminium in 
plasma or serum, monitoring frequency and analytical 
methods are given in Annex 1. 
(') OJ No 22, 9. 2. 1965, p. 369/65. 
(2) OJ No L 147, 9. 6. 1975, p. 1. 
O OJ No L 147, 9. 6. 1975, p. 13. Article 3 
1. From 1 January 1986, Member States shall 
ensure that the aluminium level in the dialysis fluids 
does not exceed 30 Hg/1; it is recommended, 
however, that these levels do not exceed 10 p.g/1. 
2. For the purpose of this Directive, dialysis fluids 
shall mean all the solutions used for the purpose of 
haemodialysis. 
3. Member States shall take all necessary measures 
to ensure regular monitoring of the aluminium 
concentration in the dialysis fluid. 
4. When the results of analysis show that the level 
of 30 jig/1 is exceeded, Member States shall ensure 
that appropriate remedial action is taken. 
5. Guidance regarding the sampling methods, the 
frequency of monitoring and the analytical methods is 
given in Annex 2. 
6. The level of 30 ug/1 shall be regularly reviewed 
by the Commission, and proposals made in order to 
achieve the recommended level of 10 (xg/1 as soon as 
possible. 
Article 4 
1. Member States shall ensure that diluting water is 
prepared only from water which complies with all the 
requirements of Directive 80/778/EEC, except those 
related to aluminium. 
2. For the purpose of this Directive, 'diluting 
water' shall mean that water which is added to 
dialysis concentrate to prepare dialysis fluid. 
3. Member States shall ensure that diluting water is 
appropriately treated for the removal of aluminium if 
the aluminium level exceeds 30 u,g/l. 
Even if the levels of aluminium in the diluting water 
are below 30 u,g/l, treatment of the water may be 
desirable in view of possible contributions of dialysis 
concentrates and of the instrumentation and in order 
to achieve the recommended levels set in Article 3 (1). 
4. Guidance regarding the water treatment 
methods is given in Annex 3. 
Article 5 
1. Member States shall ensure that the authorities 
responsible for water distribution are informed of all 
the renal dialysis units and haemodialysis patients 
using the water distributed by these authorities. 
2. The authorities responsible for water distri­
bution shall inform, if possible in advance, all renal 
29. 7. 83 Official Journal of the European Communities No C 202/7 
dialysis units of any important change in the water 
treatment procedures which may increase the 
aluminium concentration in the water. 
3. The authorities responsible for water distri­
bution should attempt to minimize the use of 
aluminium salts during the treatment of water 
intended for human consumption to the extent 
compatible with such treatment as set out in Directive 
80/778/EEC. 
Article 6 
1. For the purpose of this Directive: 
— 'dialysis concentrate' shall mean all the solutions 
used in the European Community for the purpose 
of preparing dialysis fluids, 
— 'peritoneal dialysis solution' shall mean all 
solutions used in the European Community for 
the purpose of peritoneal dialysis (i.e. IPD, 
CAPD, CCPD), 
— 'haemofiltration solutions' shall mean all solutions 
used in the European Community for the purpose 
of replacement fluids in haemofiltration. 
2. Member States shall take the appropriate 
measures to ensure that: 
— the total amount of aluminium present in the 
dialysis concentrate supplied for the purpose of 
preparing dialysis fluids shall not contribute more 
than 10 ng/1 to the aluminium concentration of 
the dialysis solution. Attempts should, however, be 
made to further reduce the aluminium 
concentration to as low a level as possible, 
— the aluminium concentration in the dialysis fluid 
supplied for peritoneal dialysis solutions does not 
exceed 15 jxg/1. Attempts should be made to 
further reduce the aluminium concentration to as 
low a level as possible, 
— the aluminium concentration in the haemo­
filtration solutions does not exceed 10 ug/1. 
Article 7 
In order to assist Member States to ensure the 
analytical precision for the aluminium determinations 
indicated in Annexes 1 and 2, the Commission shall 
set up a quality assurance programme for this purpose 
and shall develop reference methods. 
Article 8 
The adaptation of Annexes 1, 2 and 3 to scientific 
and technical progress, the development of the 
reference methods, their adaptation to scientific and technical progress, and the application of the quality 
assurance programme shall be carried out in 
accordance with the procedure laid down in Article 10. 
Article 9 
1. A Committee on Adaptation to Scientific and 
Technical Progress, hereinafter called 'the 
Committee', is hereby set up; it shall consist 
of representatives of the Member States with a 
representative of the Commission as chairman. 
2. The Committee shall adopt its own rules of 
procedure. 
Article 10 
1. Where the procedure laid down in this Article is 
to be followed, the matter shall be referred to the 
Committee by its chairman, either on his own 
initiative or at the request of a representative of a 
Member State. 
2. The representative of the Commission shall 
submit to the Committee a draft of the measures to 
be taken. The Committee shall give its opinion on 
that draft within a time limit set by the chairman 
having regard to the urgency of the matter. Opinions 
shall be adopted by a majority of 45 votes, the votes 
of the Member States being weighted as provided in 
Article 148 (2) of the Treaty. The chairman shall not 
vote. 
3. (a) Where the measures envisaged are in 
accordance with the opinion of the 
Committee, the Commission shall adopt them. 
(b) Where the measures envisaged are not in 
accordance with the opinion of the 
Committee, or if no opinion is delivered, the 
Commission shall without delay submit to the 
Council a proposal on the measures to be 
taken. The Council shall act by a qualified 
majority. 
(c) If, within three months of the proposal being 
submitted to it, the Council has not acted, the 
proposed measures shall be adopted by the 
Commission. 
Article 11 
The Member States shall bring into force the laws, 
regulations and administrative provisions necessary to 
comply with this Directive not later than 1 January 
1986. They shall forthwith inform the Commission 
thereof. 
Article 12 
This Directive is addressed to the Member States. 
No C 202/8 Official Journal of the European Communities 29.7.83 
ANNEX 1 
The monitoring of the aluminium levels in plasma or serum and the subsequent management of the 
patient is a matter for the doctor in charge of the patient. It is recommended that the basic 
monitoring frequency of the aluminium in plasma or serum be quarterly. 
When the aluminium level in the plasma or serum exceeds 60 ug/1, it may be considered that there 
is an excessive buildup of the aluminium body burden. 
If the aluminium in plasma or serum level exceeds 100 ug/1, increased monitoring frequency and 
health surveillance of the patient would be appropriate. 
All measures should be taken to ensure that the level of 200 ugAl/1 of plasma or serum is never 
exceeded in individual patients. 
As far as practicable, analytical methods with a detection limit of 10 |igAl/l of plasma or serum 
should be used for these analyses. 
ANNEX 2 
1. As far as practicable, analytical methods with a detection limit of at least 10, jtgAl/1 should be 
used for the analysis of water, dialysis fluid and dialysis concentrate; for peritoneal dialysis 
solutions and haemofiltration solutions the detection limit should be of 5 ugAl/1. 
2. When sampling the dialysis fluid, it is most appropriate to sample it as close as practicable to the 
membrane. 
3. The most appropriate frequency for the monitoring of the aluminium level in water and dialysis 
fluids is quarterly. However, the doctor in charge of the dialysis patients concerned may consider 
that more frequent monitoring is desirable. 
ANNEX 3 
In general at present both demineralization techniques and reversed osmosis may be used for this 
treatment. The choice will depend on the local circumstances.