CELEX: 51988PC0278
Language: en
Date: 1988-05-20
Title: Proposal for a COUNCIL DECISION approving the amendments to the Protocol to European Agreement No 39 on the Exchange of Blood-grouping Reagents (presented by the Commission)

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COM (88) 278
Vol. 1988/0087
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                               COM(88 ) 278 final .
                                               Brussels , 20 May 1988
                               Proposai for a
                              COUNCIL DECISION
 approving the amendments to the Protocol to European Agreement No 39
               on the Exchange of Blood-grouping Reagents
                      ( presented by the Commission )
 ---pagebreak---                                                                         Сппп
                                 EXPLANATORY MEMORANDUM
1.    European Agreement No 39 on the Exchange of Blood-grouping Reagents was
      signed and ratified by the European Economic Community on 30 March 1987
      and entered into force on 1 April 1987 . The Agreement includes a Protocol
      and an annex ( 1 ).
2.    The Council of Europe Committee of Experts on blood transfusion and
      immunohaematology has drawn up amendments to the Protocol introducing
      specific provisions to bring it into line with technical progress on
      reagents and the methods used .
3.    At its 22nd meeting in November 1987 the European Public Health Committee
      approved the amendments to the Protocol to the Agreement , the text of
      which is attached .
4.    The amendments are to be submitted for adoption by the Committee of
      Ministers , which will be restricted to the Contracting Parties to the
      Agreement in accordance with the procedure laid down in Article 4 thereof ,
      which provides that :
      M
      The Protocol and its Annex constitute an administrative arrangement and
      may be amended or supplemented by the Governments of the Parties to this
      Agreement ."
( 1 ) The text of the Agreement , the Protocol and the Annex is given in OJEC L
      37 of 7 February 1987 , p. 31 .
 ---pagebreak--- 5. Because the European Community has only observer status at meetings of the
   various bodies of the Council of Europe , which it attends at the
   invitation of the Secretariat , it has not played a full part in drawing up
   and approving the amendments .
   It must therefore now give its opinion on the results of the negotiations
   and assess whether the amendments are justified before the meeting of the
   restricted Committee of Ministers at which it must define its position as
   a contracting party to the Agreement .
6. The Commission considers that the amendments to the Protocol are in line
   with the technical developments which have occurred in the blood-grouping
   reagents field and the methods used since the Agreement was concluded . It
   considers the amendments to be acceptable for the Community .
7. The Commission therefore recommends that the Council decide that :
   a)   the amendments to the Protocol to Agreement No 39 as approved by the
        European Public Health Committee are acceptable for the Community ;
   b)   at the meeting of the restricted Committee of Ministers , the
        Commission is authorized to approve the amendments on behalf of the
        Community as a contracting party to the Agreement ;
   c)   the Commission shall introduce any adaptations necessary with respect
        to future amendments to the Protocol and its Annex , which constitute
        an administrative arrangement having no effect on the main elements
        of the Agreement .
        The Commission shall be assisted by an Advisory Committee comprising
        representatives of the Member States and chaired by the
        representative of the Commission .
        The representative of the Commission shall submit draft measures to
        the Committee , which shall give its opinion within a period to be
        determined by the chairman depending on the urgency of the matter in
        question ; where appropriate , a vote shall ho taken .
 ---pagebreak--- The opinion shall be noted in the minutes ; in addition each Member
State shall be entitled to request that its views be noted in the
minutes .
The Commission shall take account as far as possible of the
Committee 's opinion and shall inform the Committee of how it
presented that opinion to the Council of Europe authorities .
                                                                 V
 ---pagebreak---                                       Proposai for a
                                     Council Decision
                      approving the amendments to the Protocol to
                                 European Agreement No 39
                       on the Exchange of Blood-grouping Reagents
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community , and
 in particular Article 28 thereof ,
Having regard to the proposal from          the Commission ,
Whereas the amendments to the Protocol to Agreement No 39 have been negotiated
 in the European Public Health Committee of the Council of Europe with a view
to their approval by the Committee of Ministers of that organization ,
restricted to the Contracting Parties to the Agreement ;
Whereas the Community , by virtue of Council Decision 87/68/EEC ( 1 ), is a contracting party to
 Agreement No 39;
Whereas the amendments are acceptable for the Community and should be approved
as such ;
Whereas the Commission must be given power of execution to adopt future
amendments to the Protocol , where these constitute an acininist rat ive arrangement,
HAS DECIDED AS FOLLOWS :
                                        Article 1
The amendments to the Protocol to European Agreement No 39 on the Exchange of
Blood-grouping Reagents are hereby approved on behalf of the
Community .
The amendments are set out in the Annex .
( 1 ) OJ No L 37 , 7.2.1987 , p.30 .
                                                                                   Г
 ---pagebreak---                                          Article 2
 The Commission is hereby authorized to approve the  amendments at the meeting of the
 Committee of Ministers of the Council of Europe .
                                         Article 3
The Commission is hereby authorized to introduce adaptations to the  Protocol in the
future following the opinion of a committee set up under             Council Decision
87/ 373 / EEC ( 2 ) and in particular Article 2 , procedure I thereof .
Done at                                                      For the Council
 ( 2 ) OJ NOL 197 , 18.7.1987, p.33 .
                                                                                c
 ---pagebreak--- 7                         ON THE EXCHANGE OF BLOOD - GROUPING REAGENTS
                                                                         ANNEX
                                   ( European Agreement No 39 )
                                        SPECIFIC PROVISIONS
  A.    BLOOD-GROUPING REAGENTS OF HUMAN ORIGIN
  B.    REAGENTS OF NON-HUMAN ORIGIN
        a ) Sera of animal origin
  iii )    Anti -human- globulin serum ( animai ) ( 1 )
           Anti -human-globulin serum for use in blood group serology must contain
           antibodies against IgG globulin and antibodies against C3c and C3d or
           C3g complement factors .
           Polyspecific anti-globulin reagents of this type are usually a
           combination of anti-IgG serum and anti-complement reagents . All the
           components of the reagents may be polyclonal , i.e. may originate from
           immunized animals or be a combination of polyclonal anti-IgG and
           monoclonal murine anti-C3c and anti-C3d or anti-C3g .
  Specif icity
           The reagent must not agglutinate insensitized red corpuscles from any
           ABO blood group preserved for 28-35 days in ACD or CPD blood and
           incubated as for the direct compatibility test using compatible normal
           human serum .
  Potency
           In a " rotating " anti-globulin test , the reagent supplied must
           agglutinate a 3% suspension of R^r red corpuscles sensitized with
           anti-D IgG using a serum containing 75 ui IgG per ml , having a titre of
           between 512-10 24 ( maximum potency ) and 256 ( minimum potency ) . It must
           also agglutinate red corpuscles sensitized with known weak anti-IgG
           antibodies of any specificity . To produce weakly sensitized red
           corpuscles , successive two-fold dilutions of exythrocyte allo-antisera
           may be used to sensitize red corpuscles from heterozygote subjects for
           the corresponding antigens .
           The reagent must also agglutinate red corpuscles coated with a 16-32
           dilution of C3b OE iC3b and corpuscles coated with a 2-4 titre of C3d .
  NOTE
           The following method is proposed for producing weakly sensitized
           corpuscles : eight dilutions ( or more , depending on the anti-serum used )
           of an erythrocyte anti-serum containing only incomplete antibodies
           should be prepared using successive two-fold dilutions . It is
           recommended to use anti-sera of different specificities , such as anti-D ,
           anti-K and anti-Fya .
           Erythrocyte samples from a heterozygote subject for the corresponding
           antigen should be sensitized with the anti-erythrocyte anti-serum ,
           diluted or undiluted . The red corpuscles from each sample sensitized
           should then be tested using undiluted anti-globulin reagents and
           two-fold dilutions thereof .
  ( 1 ) Coombs R.R.A. , Mourant A.E. and Race R.R. ( 1945 ) Lancet iii 5
        Coombs R.R.A. , Mourant A.E. and Race R. R. ( 1945 ) Rrit . J. Exp . Path . 26,255