9. 2. 84 Official Journal of the European Communities No C 35/1 
II 
(Preparatory Acts) 
ECONOMIC AND SOCIAL COMMITTEE 
Opinion on the proposal for a Council Directive relating to the protection of dialysis 
patients by minimizing the exposure to aluminium 
(84/C 35/01) 
The text referred to the Committee has been published in Official Journal of the Euro­
pean Communities No C 202 of 29 July 1983, page 5. 
A. LEGAL BASIS FOR THE OPINION 
On 13 July 1983 the Council referred the abovementioned proposal to the Economic 
and Social Committee in accordance with Articles 100 and 235 of the Treaty establish­
ing the European Economic Community. 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Economic and Social Committee prepared its opinion on the above matter at its 
213th plenary session held in Brussels on 14 and 15 December 1983. 
The full text of the opinion is as follows: 
THE ECONOMIC AND SOCIAL COMMITTEE, 
Having regard to the Treaty establishing the Euro­
pean Economic Community, and in particular 
Articles 100 and 235 thereof, 
Having regard to the request from the Council on 13 
July 1983 for an opinion on the proposal for a 
Council Directive relating to the protection of 
dialysis patients by minimizing the exposure to alu­
minium, 
Having regard to the decision taken by its Bureau 
on 5 July 1983, in anticipation of an imminent for­
mal request, to refer this matter to the Section for 
Protection of the Environment, Public Health and 
Consumer Affairs, 
Having regard to the oral report of the rapporteur, 
Mr Monier, 
Having regard to the opinion adopted by the above-
mentioned Section at its 78th meeting held on 16 
November 1983, Having regard to to the discussions at its meeting on 
14 December 1983 (213th plenary session of 14 and 
15 December 1983), 
HAS ADOPTED THE FOLLOWING OPINION 
by a unanimous vote: 
1. General comments 
1.1. The Committee welcomes the Commission's 
initiative aimed at reducing the exposure of dialysis 
patients to aluminium, especially in view of the big 
rise in the number of such patients in the Com­
munity. 
1.2. The Committee notes, nevertheless, that the 
percentage of dialysis patients currently varies from 
one Member State to another, as does the trend in 
the number of dialysis centres built between 1971 
and 1981. 
No C 35/2 Official Journal of the European Communities 9. 2. 84 
1.3. The Committee thinks that this area of health 
care should be given much greater attention if needs 
are to be satisfactorily met now and in the future. In 
particular, thought should be given to the possibili­
ties of providing haemodialysis treatment for new 
categories of persons suffering from renal insuffi­
ciency. 
1.4. The Committee is aware that the cost of hae­
modialysis treatment is already very high and that 
there are grounds for fearing that the proposed 
Directive might push them higher, because of the 
limits it lays down. The Committee agrees with the 
Commission that such an increase would be very 
small; however, failure to adopt the measures 
recommended in the proposed Directive would con­
siderably increase the risk of dialysis patients con­
tracting encephalopathy and osteomalacia, which 
would in turn lead to a much greater rise in hospital­
ization costs. 
1.5. The Committee therefore feels it should 
emphasize once more all the preventive measures in 
the proposed Directive, whether they involve the 
health of dialysis patients or the costs to be borne by 
the social security system. 
1.6. Finally, the Committee is pleased that a work­
ing party on health has been set up at the Council to 
examine the proposed Directive. The Committee 
hopes that this working party will be given institu­
tional status, that it will have access to the expert 
counsel necessary and that it will be responsible for 
examining other proposals that the Commission 
should be presenting on health matters, and particu­
larly on patient protection. 
2. Specific comments 
Article 2(1) 
In view of the comments above, the Committee pro­
poses that the word 'desirable' be replaced by 'indis­
pensable'. 
Article 3(1) 
Similarly, the Committee suggests that this point be 
worded as follows: 
Done at Brussels, 16 November 1983. 'From 1 January 1986, Member States shall 
ensure that the aluminium level in the dialysis 
fluids never exceeds 30 u.g/1; it is recommended 
that this level does not exceed 10 u.g/1.' 
Article 3 (6) 
Although the Committee understands the technical 
difficulties of imposing a deadline for achieving 10 
u.g/1, it calls upon the Commission to keep a close 
eye on technical developments and on how they are 
applied in this area. 
Article 7 
The Committee notes that the Commission plans to 
provide reference samples and set up a quality mon­
itoring programme to help laboratories improve the 
standard of aluminium analyses. 
The Committee feels that such action is all the more 
necessary because there are considerable differences 
between the results of analysis by different laborato­
ries on identical samples. 
Annex 1 
First paragraph 
The Committee proposes that the monitoring fre­
quency of the aluminium in plasma or serum be 
re-examined in the light of experience. 
Third paragraph 
The Committee proposes the following wording: 
'If the aluminium level in plasma or serum 
exceeds 100u,g/l, there should be increased 
monitoring frequency and health surveillance of 
the patient, and steps must be taken to reduce 
exposure to aluminium.' 
Fourth paragraph 
The Committee proposes that 'should' be replaced 
by 'must'. 
The Chairman 
of the Economic and Social Committee 
Francois CEYRAC