No C 150/6 Official Journal of the European Communities 20.6.85 
II 
(Preparatory Acts) 
COMMISSION 
Amended proposal for a Council Directive relating to the protection of dialysis patients by 
minimizing the exposure to aluminium 
COM(85) 263 final 
(Submitted by the Commission to the Council pursuant to the second paragraph of Article 149 of 
the EEC Treaty on 3 June 1985) 
(85/C 150/04) 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Having regard to the Treaty establishing the European Having regard to the Treaty establishing the European 
Economic Community, and in particular Articles 100 and Economic Community, and in particular Article 100 (two 
235 thereof, words deleted) thereof, 
Last three citations unchanged 
Recital 1 
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; Deleted 
Recital 2 
Whereas, in view of the growth in the number of renal Whereas the number of persons in the Community having 
dialysis patients in the Community, of their continued to resort to dialysis in order to preserve normal living 
health problems and of the economic cost of renal conditions is rising considerably; 
dialysis treatment, it is necessary to lay down rules aimed 
at increasing the protection of the health of these 
patients; 
Recital 3 
Whereas it is necessary that renal dialysis patients benefit 
from the same health protection when travelling within 
the Community; Deleted 
Recital 3 (a) (new) 
Whereas the protection of persons undergoing dialysis 
requires that standards of purity be laid down, to be met 
on the one hand by dialysis concentrates and prepared 
dialysis fluids and on the other hand by the water used 
for the dilution of the concentrates to prepare dialysis 
fluids; 
Recital-4 
Whereas clinical observations and epidemiological 
studies have shown that aluminium accumulates in the 
body of dialysis patients; Deleted 
20. 6. 85 Official Journal of the European Communities No C 150/7 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Recital 4 (a) (new) 
Whereas these measures should relate in particular to the 
aluminium content of dialysis concentrates and fluids and 
diluting water; 
Recital 5 
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; (Incorporated in new Recital 8 (a)) 
Recital 5 (a) (new) 
Whereas a disparity between the provisions applicable or 
in the process of being drawn up in the Member States, 
relating to the aluminium content of dialysis concentrates, 
prepared dialysis fluids and the diluting water, is likely on 
the one hand to constitute a barrier to the free movement 
of such concentrates and fluids within the Community 
and, on the other, to bring about differences in the 
standard of dialysis treatment which may constitute a 
barrier to the free movement of persons undergoing 
dialysis in the Community; whereas as a consequence 
such a disparity will directly affect the functioning of the 
common market and steps should be taken in this field 
for the approximation of such provisions in accordance 
with Article 100 of the Treaty; 
Recital 6 
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; (Incorporated in new Recitals 8 (a) and 10 (a)) 
Recital 6 (a) (new) 
Whereas, although Council Directives 65/65/EEC (') 
75/318/EEC(2) and 75/319/EEC (3) lay down the 
general conditions governing the placing on the market 
of proprietary medicinal products, specific limit values 
should in addition be set for aluminium dialysis 
concentrates and prepared dialysis fluids, account being 
taken of the work of the European Pharmacopoeia, and 
the labels of such products should indicate their 
aluminium content; 
Recital 7 
Whereas it is appropriate to consider a comprehensive 
approach and cover all types of renal dialysis methods 
and all sources of aluminium; Deleted 
0) OJ No 22, 9. 2. 1965, p. 369/65. 
(2) OJNoL 147,9.6. 1975, p. 1. 
(3) OJ No L 147, 9. 6. 1975, p. 13. 
No C 150/8 Official Journal of the European Communities 20.6.85 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Recital 7 (a) (new) 
Whereas by means of Directive 80/778/EEC (') the 
Council has already laid down a series of standards 
relating to the quality of water intended for human 
consumption; 
Recital 8 
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 bindings; (Incorporated in new Recitals 8 (a) and 10 (a)) 
Recital 8 (a) (new) 
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 dialysis fluids, a maximum value should be 
set for aluminium not only in dialysis concentrates but 
also in the diluting water, and whereas this value should 
be lower than that laid down in Directive 80/778/EEC 
where this water is used for purposes of dialysis; 
Recital 9 
Whereas recent scientific data have shown that the 
aluminium body burden increases if the aluminium level 
in the renal dialysis fluids exceeds 10-20 (ig/1; Deleted 
Recital 9 (a) (new) 
Whereas, in order to ensure that the maximum values are 
respected, provision should be made for Member States 
to take the necessary steps to ensure that appropriate 
monitoring is performed of aluminium concentration in 
dialysis fluids; 
Recital 10 
Whereas Council Directive 80/778/EEC of 15 July 1980 
relating to the quality 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 jxg/l and a guide level of 
0,05 H-g/1; (Incorporated in new Recital 7 (a)) 
Recital 10 (a) (new) 
Whereas, in order to ensure the effectiveness of harmo­
nization, the oral intake of aluminium should be reduced 
as far as possible and provision should be made to ensure 
that the authorities responsible for dialysis treatment are 
fully informed of the risk of the toxic effects of 
aluminium for dialysis patients; whereas in addition it 
(') OJL229, 30. 8. 1980, p. 11. 
20. 6. 85 Official Journal of the European Communities No C 150/9 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
seems advisable, with a view to evaluating the 
effectiveness of harmonization, to measure on a regular 
basis the aluminium levels in plasma, which measurements 
constitute a very useful indication of the body burdens of 
aluminium of dialysis patients; 
Recital 11 
Whereas recent scientific data clearly demonstrated that 
if aluminium concentrations in excess of 50 jig/1 are 
present in the water intended for renal haemodialysis 
there is the probability of encephalopathy developing in 
a significant number of patients; (Incorporated in new Recital 8 (a)) 
Recital 11 (a) (new) 
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; 
Recital 12 
Whereas there may be considerable variability in the 
aluminium level in the mains water supply; Deleted 
Recital 12 (a) (new) 
Whereas scientific and technical progress requires a rapid 
adaptation of the reference methods of analysis 
mentioned in this Directive; whereas, in order to facilitate 
the implementation of measures required to this end, 
provision should be made for a procedure involving close 
cooperation between the Member States and the 
Commission within a Committee on the adaptation to 
scientific and technical progress; 
Recital 13 
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; Deleted 
Recital 13 (a) (new) 
Whereas the cost of applying the standards laid down in 
this Directive is significantly lower than the additional 
costs presently involved in the treatment of dialysis 
patients suffering from encephalopathy and osteomalacia 
caused by the excessive intake of aluminium; whereas the 
result will be a significant reduction in the costs of 
dialysis; 
Recital 14 
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; Deleted 
No C 150/10 Official Journal of the European Communities 20. 6. 85 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Recital 15 
Whereas at present demineralization and reverse osmosis 
appear to be the water treatment techniques most appro­
priate; Deleted 
Recital 16 
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; (Incorporated in new Recital 8 (a)) 
Recital 17 
Whereas these provisions supplement the general 
requirements laid down for medicinal preparations in 
Council Directives 65/65/EEC (*), 75/318/EEC (2) and 
75/319/EEC (3). (Incorporated in new Recital 6 (a)) 
Recital 18 
Whereas it is desirable to minimize the oral intake of 
aluminium and develop substitute treatment methods; (Incorporated in new Recital 10 (a)) 
Recital 19 
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, (Incorporated in new Recital 11 (a)) 
Article 1 
This Directive concerns the protection of renal dialysis 1. The purpose of this Directive is to establish 
patients from the toxic effects of aluminium absorption common rules for the maximum permissible aluminium 
from all sources, by monitoring the aluminium levels in content of dialysis fluids, in order: 
plasma and dialysis fluids and minimizing the absorption. 
(a) to remove obstacles to trade in dialysis concentrates 
and prepared dialysis fluids; 
(b) to remove obstacles to the free movement in the 
Community of persons undergoing dialysis for renal 
insufficiency; 
while at the same time ensuring the protection of 
such persons. 
0) OJ No 22, 9. 2. 1965, p. 369/65. 
(2) OJ No No L 147, 9. 6. 1975, p. 1. 
C) OJ No L 147, 9. 6. 1975, p. 43. 
20.6.85 Official Journal of the European Communities No C 150/11 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
In this Directive: 
dialysis concentrate means any solution which can be 
diluted with water for the purpose of making up a 
dialysis fluid; 
dialysis fluid means any solution, whether a prepared 
dialysis fluid or a fluid made up from dialysis 
concentrate diluted with water, used for the purpose 
of human dialysis; 
diluting water means any water which is added to a 
dialysis concentrate in order to prepare a dialysis 
fluid; 
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, including the 
solutions known as IPD, CAPD and CCPD; 
prepared dialysis fluid means any fluid supplied in 
such a form as to be ready for use without the 
addition of diluting water. 
Article 2, paragraph 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 provided 
recommended reference levels for aluminium in serum or 
plasma. (Modified and moved to new Article 6 (a), paragraph 1) 
Article 2, paragraph 2 
Recommended reference levels of aluminium in plasma 
or serum, monitoring frequency and analytical methods 
are given in Annex 1. (Unchanged and moved to new Article 6 (a), paragraph 2) 
Article 2 (a) (new) 
1. When the competent authorities in the Member 
States authorize the marketing of prepared dialysis 
solutions and dialysis concentrates in accordance with the 
provisions of Directives 65/65/EEC, 75/318/EEC and 
75/319/EEC, they must ensure that: 
— the total amount of aluminium present in the dialysis 
concentrates shall not contribute more than 10 |ig/l 
to the aluminium concentration of the dialysis fluid 
when made up; 
— the aluminium concentration in the prepared dialysis 
fluid supplied for peritoneal dialysis solution does not 
exceed 15 ug/1 as from 1 January 1986 and 10 jig/1 as 
from 1 January 1988; 
No C 150/12 Official Journal of the European Communities 20.6.85 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
— the aluminium concentration in the prepared heamo-
filtration and peritoneal dialysis solutions and 
concentrated saline solutions for heamodialysis does 
not exceed 10 (ig/1. 
2. In addition they must ensure that all dialysis 
solutions and concentrates put on the market shall bear a 
label showing the maximum concentration of aluminium 
they are likely to contain (after dilution in the case of 
dialysis concentrates). 
Article 3, paragraph 1 
From 1 January 1986 Member States shall ensure that From 1 January 1986 Member States shall ensure that 
the aluminium level in the dialysis fluids does not exceed the aluminium level in the dialysis fluids does not exceed 
30 |ig/l; it is recommended however that these levels do 30 u.g/1; however, this aluminium level must be restricted 
not exceed 10 Hg/1. to a maximum of 10 ug/1 as from 1 January 1988. 
Article 3, paragraph 2 
For the purpose of this Directive dialysis fluids shall 
mean all the solutions used for the purpose of haemo-
dialysis. Deleted 
Article 3, paragraph 2 (new) 
Member States shall take all necessary measures to 
ensure regular monitoring of the aluminium concen­
tration in the dialysis fluid. 
Guidance regarding the sampling methods, the frequency 
of monitoring and the analytical methods is given in 
Annex 1. 
Article 3, paragraph 3 
Member States shall take all necessary measures to 
ensure regular monitoring of the aluminium concen­
tration in the dialysis fluid. (Moved to Article 3, paragraph 2) 
Article 3, paragraph 4 
When the results of analysis show that the level of 
30 u.g/1 is exceeded, Member States shall ensure that 
appropriate remedial action is taken. Deleted 
Article 3, paragraph 5 
Guidance regarding the sampling methods, the frequency 
of monitoring and the analytical methods is given in 
Annex 1. (Moved to Article 3, paragraph 2) 
Article 3, paragraph 6 
The level of 30 u,g/l shall be regularly reviewed by the 
Commission, and proposals made in order to achieve the 
recommended level of 10 |Xg/l as soon as possible. Deleted 
20.6.85 Official Journal of the European Communities No C 150/13 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 4, paragraph 1 unchanged 
Article 4, paragraph 2 
For the purpose of this Directive diluting water shall 
mean that water which is added to dialysis concentrate 
to prepare dialysis fluid. Deleted 
Article 4, paragraph 2 (new) 
Member States shall ensure that diluting water is appro­
priately treated for the removal of aluminium if the 
aluminium level exceeds 30 jig/1 as from 1 January 1986 
and 10 jig/1 as from 1 January 1988. 
Article 4, paragraph 3 
Member States shall ensure that diluting water is appro­
priately 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 ji.g/1 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). (Modified and moved to Article 4, paragraph 2 (new)) 
Article 4, paragraph 3 (new) 
Guidance regarding the water treatment methods com­
patible with its use in haemodialysis is given in Annex 3. 
Article 4, paragraph 4 
Guidance regarding the water treatment methods is (Modified and moved to Article 4, paragraph 3 (new) 
given in Annex 3. 
Article 5, paragraph 1 
Member States shall ensure that the authorities Member States shall ensure that the authorities 
responsible for water distribution are informed of all the responsible for water distribution are informed of all the 
renal dialysis units and haemodialysis patients using the dialysis centres using the water distributed by these auth-
water distributed by these authorities. orities. 
Article 5, paragraph 2 
The authorities responsible for water distribution shall The authorities responsible for water distribution shall 
inform, if possible in advance, all renal dialysis units of inform, if possible in advance, all renal dialysis centres of 
any important change in the water treatment procedures any important changes in the water treatment procedures 
which may increase the aluminium concentration in the which may increase the aluminium concentration in the 
water. water and shall urge the renal dialysis centres to inform 
the patients in their care accordingly. 
Article 5, paragraph 3 unchanged 
No C 150/14 Official Journal of the European Communities 20.6. 85 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 6, paragraph 1 
For the purposes of this Directive: 
— Dialysis concentrate shall mean all the solutions used 
in the Community for the purpose of preparing 
dialysis fluids; 
— Peritoneal dialysis solution shall mean all solutions 
used in the Community for the purpose of peritoneal 
dialysis (i.e. IPD, CAPD, CCPD); 
— Haemofiltration solution shall mean all solutions used 
in the Community for the purpose of replacement 
fluids in heamofiltration. (Unchanged and moved to Article 1, paragraph 2) 
Article 6, paragraph 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 u.g/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 solution 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 haemofiltration 
solutions does not exceed 10 jxg/1. (Modified and moved to Article 2 (a) (new)) 
Article 6 (a) (new) 
1. In order to protect all individuals suffering from 
renal insufficiency and undergoing dialysis from the toxic 
effects of aluminium, Member States shall provide to all 
persons in charge of dialysis centres, information 
regarding the toxicity of aluminium and shall indicate the 
desirability of monitoring regularly the aluminium level in 
the plasma of these individuals. 
2. Recommended reference levels of aluminium in 
plasma or serum, monitoring frequency and analytical 
methods are given in Annexes 1 and 2. 
20.6. 85 Official Journal of the European Communities No C 150/15 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Articles 7, 8, 9, 10, 11 and 12 unchanged 
Annex 1 unchanged 
Annex 2, paragraph 1 unchanged 
Annex 2, paragraphs 2 and 3 — Deleted 
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. With the exception of water softening techniques, both deminer­
alization techniques and reversed osmosis may be used for this 
treatment. The choice will depend on the local circumstances.