CELEX: 51983PC0368
Language: en
Date: 1983-06-17
Title: PROPOSAL FOR A COUNCIL DIRECTIVE RELATING TO THE PROTECTION OD DIALYSIS PATIENTS BY MINIMISING THE EXPOSURE TO ALUMINIUM

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