CELEX: 51987PC0444
Language: es
Date: 1987-10-19
Title: Propuesta de REGLAMENTO (CEE) DEL CONSEJO sobre un programa de investigación y desarrollo en el ámbito de la metrología aplicada y de los análisis químicos para la Comunidad Económica Europea 1988 - 1992 (Oficina Comunitaria de Referencias - BCR) (presentada por la Comisión)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (87) 444
Vol. 1987/0230
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 ---pagebreak---          COMISIÓN DE LAS COMUNIDADES EUROPEAS
VERSION REVISADA
                                                  COM(87 ) 444  final . /2
ESTE DOCUMENTO ANULA Y SUSTITUYE
EL DOCUMENTO C0MC87 ) 444 f inal .
                                                  Bruselas , 19 de octubre de 1987
AFECTA A TODAS LAS VERSIONES
                                    Propuesta de
                           REGLAMENTO ( CEE ) DEL CONSEJO
    sobre un programa de investigación y desarrollo en el ámbito de la
           metrologia aplicada y de los análisis químicos para la
                            Comunidad Económica Europea
                                    1988 - 1992
                  ( Oficina Comunitária de Referencias - BCR )
                          ( presentada por la Comisión )
                                        09  10
                               if            ^ ^
                              I
                              1
                                     ^     oc- ,      H
                                                     ig
C0M(87 ) 444  final . /2
 ---pagebreak---                                                2
     INTRODUCTION
     1 . For about 10 years the Community has , through the OCR programme , provided
     the laboratories of the Member States with a means of carrying out
     collaborative measurement studies in the fields of metrology ( physical
    measurements ) and chemical analyses . The objective has been to improve the
    methods of measurements , their accuracy and , thereby , their harmony throughout
    the Community .
    To understand the role of the programme , it is important to remember that
    common written standards are essential to achieve harmonization but not
    sufficient by themselves to avoid discrepancies . Even when applying a
    standardized method , laboratories can still find very different results .
    For that reason , almost fifty percent of all projects which were undertaken in
    the programme are related to existing written standards or Community
    Directives . Experts who have to apply them have realized that these norms or
    Directives would have little harmonization effect in the absence of suitable
    means by which the laboratories could verify that their methods of analyses or
    measurement have been correctly applied .
    The SCR programme doesnot produce any written standard ; it provides the
    technical support for the correct implementation of methods of measurements .
    It is necessary to ensure that it is technically possible for laboratories to
    obtain acceptable results . It is typically the task of the Community to
    encourage and support collaboration between Member States to improve common
    methods and to develop common means of calibration and verification of the
    methods of measurements .
    2 . Activities o i the programme in the field of metrology, tan be -i llustrated by
    the following examples .
    A project was undertaken follovTing disputes over measurement results
    concerning double-glazed windows , which had led to import restrictions between
    Member States . An intercomparison involving about fifteen laboratories showed
    that , if conditions of measurements .were better specified than they are at
    present in written standards , laboratories would obtain good- agreement .
- Also in the field of metrology , a project on the flow measurements        in .
    pipelines for natural gas detected_a systematic error of 0.2% in the results- _
    of one of the Mer.iber_ States and so put an end to dffficuU; disputes over the
    quantities of . gas exported .
  . Two pro-jects can illustrate the work in the field of chemical analysis :
                                             • *
    - the determination of lead and cadmium in blood , as required to monitor
    workers exposed to hostile industrial environments , has been the subject of
 . several successive intercomparisons which enventually led to the certification
    of samptes which are now used as reference material by many laboratories in
    the Community .
 ---pagebreak---                                            3
- the determination of aflatoxin M1 in milk , a dangerous toxin which is
subject to regulation imposing severe restrictions on the maximum content .
Here also , the intercomparisons were followed by the certification of
reference materials which are now used by laboratories to verify their
methods .
3 . The present SCR programme terminates on 31st December , 1987 and the
Commission proposes to the Council to approve the new programme which includes
the requirements which are considerably increased as a result of the goals of
Community policies and mainly those regarding the completion of the Internal
Market .
The present BCR programme
4 . The main feature of the BCR programme is that of bringing together
laboratories of the Member States to improve measurements for which there are
difficulties or disagreements . This collaboration implies exchange of results
and experience between the participants . The transfer of know-how is the
essence of the functioning of BCR programme .
In general , therefore , projects are carried out by several laboratories .
Before the start of a project , the detailed definition of the work is
discussed with experts of possibly all Member States . The members of the CGC
are normally informed before the meetings and invited to suggest appropriate
experts . In case of an intercomparison , the measurement programme to be - _
carried out by each participant is defined and discussed at the meeting .
The projects are then submitted for opinion to the CGC . At the end of each
project , the results are discussed with all participants , in order to discover
the causes of possible discrepancies .
If necessary , a second intercomparison is - organized to verify that adequate
agreement can be reached . Sometimes several intercomparisons are needed ,
mainly- in the field of chemical, analyses .                  *
In some rare projects , the actual work involves only one laboratory in its
initial phase . In such cases , the project includes special action to transfer
the results : workshops , secondment of specialists , intercomparisons .
                                                    v#
The results of the present programme are reviewed in Appendix. 3 .
5 .- The BCR programme has been evaluated by a group of independent experts
during the second half of 1936 . Their report states that the work of the
Commission has been of 'a consistent high quality 1 and that 'the BCR
programme has established a solid international reputation' .                   -
6 . Definition of the new programme
As the BCR programme nust provide a technical support to harmonization within
the Community , in particular , that which is necessary for the completion of
the Internal Market , the Commission has chosen to follow the requirements of
the 1'hite Paper . The implementation of the Community policy on the environment
and health also " requi res -considerable improvements in chemical analysis .
Finally it is recommended that the current work in the field of applied
metrology ( e.g. dimensional , electrical , optical measui eraents ) continue . The
effect of the programme in this respect is to ensure that calibrations
furnished by the Rational metrology laboratories are equivalent throughout the
Community . This is considered vital to the development of a perfectly coherent
basic infrastructure .
 ---pagebreak---                                         A
7 . The Commission has therefore selected 5 priority areas for the proposed BCR
programme :
- analyses related to foodstuffs and agricultural produce
- analyses related to the environment
- analyses related to health
- the analysis of metals
- physical measurements for trade and industry ( i.e. applied metrology )
8 . For each priority area the Commission lias consulted industry , government
laboratories and its own services in order to restrict the themes to those of
the highest priority .
The statement of the programme , given in Annex I , contributes to the proposed
workplan , it being understood that it is necessary to retain sufficient
flexibility to take into account changes in circumstances which may arise
during the course of the programme . The exercise of such flexibility will be
in strict collaboration with the CGC .
 ---pagebreak---                                             5
 Programme implémentation
 9 . The proposed programme will be implemented in 3 types of activities :
 - intercomparisons
 - the development of means of calibration ( transfer standards or etalons and
 reference materials ) which are necessary for laboratories to verify their
performance and maintain agreement with the results of others
- the development of new methods of measurements .
 In addition , the Commission will offer scholarships for doctorate and
post-doctorate work in the content of the programme defined in Annex I. The
Commission will also give special attention to supporting the secondment of
scientific personnel , particularly from Spain , Portugal and Greece , in order
to accelerate the training . of specialists .
10 . Projects will be selected according to the following criteria :
- technical objective , this having to correspond to one of the priority themes
of the programme
- economic importance or their importance with respect to the environnement or
health care
- the number of countries interested
Financial support to projects'     .      T   _ '
11 . For projects involving a succession of intercomparisons , the Community
will cover the costs necessary for the collaboration ( meetings , samples ,
evaluation of results , etc ), the costs of the measurements being borne by the
participants .
For projects which- include a substantial amount of research and development ,
the financial contribution of the Commission could be upto 50% of the cost of
the work .                                     .             \
Projects or parts of projects which are pure services ( e.g. the development of
appropriate samples for analysis ) will be financed 100 V, by the Community .
Dissémination of results
12 . The dissemination of results ,will be. made along the following lines :
In the field of metrology , the results and consequences of intercomparisons
are automatically disseminated through the participating laboratories which
are responsible for providing calibrations to -all users in their respective
countries . However , as the laboratories who have participated in such
intercomparisons had considerable benefit , there is now a need to provide a
sinilar service to the new Member States , limited - intercomparisons will be
supported for then, as necessary , on subjects previously covered by the
programme . More generally , for Member States which c'o not have the possibility
of part i cipat inn in interconparisons , the programme will provide support for
the secondment of personnel in laboratories of the Community for periods of up
to three months .                  –                    •
In the field of analytical chenistry , the benefits are not transferred to the
users through a central national laboratory . Therefore , projects often include
the preparation of reference materials to allow dissemination of the results
to other laboratories . Samples cf reference materials can be used by any
laboratory to verify its methods anc! improve them in order to become
 ---pagebreak---                                             6
  compatible with those of other laboratories . The report , which i s, disseminated
  with the sample , gives an account of all the work done by those who have
  participated in the project and the recommendations that were drawn from the
  collaboration .
  The Commission shares the opinion of the evaluation panel for centralised
  information on reference materials . The Commission had already provided •
  financial support to the creation of a data bank , which will be managed by a
  national organisation and will be accessible to users throughout the world .
  Already in 1973 , the BCR programme , in collaboration with the JRC , produced
  the first guide to reference materials then available in the world .
  Collaboration with the JRC
  13 . The JRC has provided , in the past , indispensable support to BCR for the
 conditioning of reference materials and the storage and the distribution of
 samples to customers . The CBNM has a long experience in the preparation of
 special samples of nuclear materials ; this experience could be of benefit for
 the execution of the BCR programme .
  From 1988 onwards , the contribution of the JRC will be increased and will be
 financied by an amount of about 3 mioECU by the BCR programme for the period
 1988-1992 .
 Moreover , the JRC will continue to have the possibility to participate with
-other laboratories in BCR intercomparisons .                         ..
 The Commission has taken note of the comments of-the evaluation panel on the
 administration of the reference materials and will look into the possibility
 of a further streamlining of the administrative procedure .
 International collaboration
 14 . It is proposed to extend participation in the BCR programme to the EFTA
 countries , which are already cooperating with the Community in many relevant
 organisations and , in particular , through CEN /CENELEC . Tfcis participation
 should take the form of a participation as full members with an appropriate
 financial input .
 15 For several years , the European metrology institutes have been meeting in
 the context of the 17 member West European Metrology Club ( WEMC ) with the aim
 of exchanging information and improving coordination of national activities ,
 where necessary and possible . It is now under discussion to give the WEMC a
 more formal organisational form under the name of EUROMET . The- Commission
 supports this initiative which can improve the exchange of information and
 ccordination of national activities .
 Estimated budgetary requirement
 16 . The objectives of technical harmonization that the Community has set for
 the achievement of the Internal Market call for a corresponding effort-in the ~
 field of measurements and chemical analysis . The Commission reviewed the main
 problems to be faced and , far from presenting an exhaustive programme , it has
 limited it to the themes with the highest priority .
 The number of intercomparisons to undertake is more than double of what could
 be achieved in the present programme . A similar effort is necessary for
 applied metrology . The details of the estimated costs are given in Annex 2
 and result in a total budget of 59.2 MioECU . This includes the expenditure for
 a staff of 32 ( including one official for dissemination of information ).
 ---pagebreak---                                         7
The present programme had a budget of 25 MioECU and a staff of 16 .
The work needed for repeated intercomparisons in the field of Chemical
Analyses cost little money but require more personnel than in other
programmes . The Commission should keep the indispensable role of honest broker
to stimulate and develop collaboration and mutual confidence between national
laboratories .
Evaluation
17 . After the third year the programme will be evaluated by an indipendent
group of experts . The cost of this evaluation will be approximately 80.000
icu .
Conclusion
18 . It is asked that the Council approve the present proposal before the 31
December 1987 to avoid discontinuity in the activities of the 3CR programme .
 ---pagebreak---                                             8
                                      APPENDIX 1
                             THE CONTENT OF THE PROGRAMME
In addition to the internal consultations within the Commission Services ,
fifteen meetings of experts from industry , research institutes and government
services were organized to review each one of the areas to be covered and
select the priority themes . The programme has been defined in great detail .
While the Commission will make full use of this extensive preparation to
conduct the programme during the next five years , a sufficient degree of
flexibility must be maintained to allow new and urgent topics to be dealt with
as they occur and to review periodically the priority themes in collaboration
with the CGC .
1 . ANALYSES FOR FOOD AND AGRICULTURE
    Agriculture employs 10 million people in the Community . About
    three-quarters of agricultural produce , worth some 200.000 Mio ECU , is
    consumed by the food processing industry which employs about 3 million
    people , i.e. 7 % of the total employment in industry . The turnover of  ~_
    agrofood industry” in the Community is about 300.000 Mio ECU .
    Because of the economic importance of this sector and the sensitivity of
    the consumer to all quality aspects , it is not surprising that a large
    effort is planned in the White Paper in particular in the following fields .
         Veterinary and phytosani tary controls
             quality of milk and meat , hormone growth promoters ,        -
             antibiotics and other residues , animal feedstuffs ,
           . pesticides in animal feedstuff , in . fruit and vegetables ,
             shellfish
         Processed food
             additives , preservatives and flavourings
             nutritional properties ( labelling )
             infant formulae and dietetic food
             fruit j ui ces
         - bacterial contaminations ( microbiology ).
    Work on all these subjects is included in the BCR programme because
    experience shows considerable differences between results of various
    laboratories . Variations by factors of 10 or 100 have been-observed ;
    these are of course unacceptable for the correct implementation of
    harmonized regulations .
    The details of the work to be undertaken were discussed with the General
    Directorates concerned and with experts from the Member States and
    industry .
 ---pagebreak---                                       9
 2 • ^^LYSES_R6yTED_T0_THE_ENVIR0rJME N'T
      The monitoring of the environment poses acute analytical problems' of
      great concern for the Member States , the national laboratories and
      industry .
      Analytical methods must detect minute traces of toxic metals or of
      dangerous organic compounds ( dioxins , pesticides , etc .) where the
      results of laboratories are known to differ by as much as a factor of
      100 .
      The major priorities are :
     - determination of pollutants in fresh water and the analyses of
        bacterial contamination ;
     - determination of pollutants in seawater , in living marine organisms
        ( plants , fish );
     - analysis required for monitoring damage caused by acid rain to
        forests ;              –    _
     - improvement of methods for the determination of the-most dangerous ,
        organic compounds such as : carcinogens , dioxins ,
        polychlorobi phenyls ;
     - analysis related to the exposure of workers to dangerous industrial
        atmospheres ;
     - tests related to the Directive on Chemicals , in particular
        mutagenicity test .
                                                         %  _
3 . ANALYSESJ^ELATED_TO_HEALTM
     Member States have recognized during the past few years that - the      _
     quality of medical analysis was not satisfactory and that this had led
     to considerable wastage of time and mon£y ( through the need to repeat
     measurements ) and was even a threat to the health of patients .     Several
     Member States have created systems of periodic . circulation of samples
     that all laboratories must analyse . These Quality Control Schemes had
     a very favourable effect on analytical quality Cbloori , serum ), but they
     are limited to u small number of parameters such as glucose , -urea ,
     cholesterol , sodium, potassium , calcium , etc
    Many other parameters are not covered partly because of the lack of
     reference data . In routine work , these parameters are determined by
    commercial diagnostic kits or automatic equipment . The results
    essentially depend of the supplier of the kit or of the equipment . It
     is widely accepted that there is an urgent need to improve the
 – situation through -intensive , col laborat ion and to establish-reference
    materials that would be recognized throughout the Community . They
    would , for the first time make it possibly for industry to produce
    diagnostic products based on a common reference point . The usefulness
    of reference materials in this field is illustrated by two examples in
    Appendix 3 ( thromboplastins , cortisol ).
 ---pagebreak---                                                    10
     Consultation with the national health authorities and with industry
     resulted in the selection of the following priority themes : the
    determination of enzymes and hormones ( in human serum ), haematological
     tests ( e.g. blood coagulation ), analyses related to cardiovascular
    diseases , tumor markers and drugs in the human body .
4 . ANALYSES OF METALS
     For many years the non-ferrous metals industry has collaborated within the
    BCR programme to solve some of its most difficult analytical problems .
    The work now planned will concern the need for reference materials in the
    field of copper, zinc and their alloys , determination of noble metals in
    various metals and ores , and the analysis of high purity metals required in
    the semiconductors industry . It also covers the new techniques of surface
    analysis which are of increasing importance for semiconductors ,
    microelectronics , catalysts and corrosion studies . The work will consist
    primarily in establishing the reference materials and calibration methods
    which are essential if agreement of the results of different laboratories
    is to be achieved .
    Particular attention will be given to–the reference materials needed to -
    determine the thickness of dopant, in semiconductors .
5 - APPLIED_METROLOGY
    Each Member State has , in some form , a central metrology organisation which
    provides industry and other users with the calibrations that they need . In .
    order to ensure harmony of measurement in the Community , it is important
_ that these institutes provide equi valent~calibration . Comparisons were
    made in the previous programmes and -led to very useful collaboration “and to
    improvements in many areas . ...                             *
    In the proposed programme , the projects will continue to be developed in
    the same-spirit but moving closer to direct industrial applications . The
    work will consist for a large part in intercomparisons involving institutes
    and industry laboratories from possibly all Member States . It will also
    include where necessary the development of the measurement standards
    ( "eta Ions "), also known as transfer standards , which are necessary to.
    calibrate or verify measuring instruments in the work place .
    D i^men s lona t^_and_mec h an i cal metrolog^
    The most frequent measurements in manufacturing industry are those related -
    to size , shape and surface finish . When automated , these measurements are
    made by sophisticated equipment which should be verified ; the measurements
    are often at the limit of present technology and it is important to pool
    efforts to arrive at harmonized solutions .       Initial work was done in the
    current programme for the so called three coordinate measuring machines .
    It consisted, in comparing the performance of laboratorfes and the software -
    used on various machines .                 ~              -         -
 ---pagebreak---                                    11
   This work has now to be extended to other types of machinery , for
   example for the verification of robots used for high precision work and
   in automated work-shops ( flexible manufacturing ).
  VJhen measuring equipment includes computers , it is important to verify
   that the software used to evaluate the data and to calculate the final
   results is not a cause of errors . This requires appropriate testing of
  the software itself and it is useful to develop harmonized test methods
  based on broad Community collaboration .
  Jennerature
  Temperature is a parameter of high importance for process industry .
  There is now a variety of new devices for which calibration methods
  will have to be developed , preferably in collaborative exercises .
  Ej. ec t r_i c a]._me t ro
  The requirements identified in this field concern measurements such as
  power , resistance and capacitance at very high frequencies . In
–addition , work will continue on methods of measurement for       _ .
" electromagnetic interferences especially as applied to measuring
  instruments ( legal metrology ).              ~
  9Gii£§i_!5£i£2i2£^
  In addition to the practical work on measurements related to lamps and
  illumination , a number of topics , such as ultra-violet , infra-red ,
  laser measurements need closer attention . This activity is connected
  to the rapid development of optics for many industrial ‘applications .
  Flow measurements                                   *
  The metering of liquids and gases for sale to the public and for the
  imposition of tax is governed by national regulations ( legal
 metrology ). This field has been covered for many years by Community
  Directives .                            '
  However , in recent times a large number of new meters with special
  advantages in specific applications have been developed and it becomes
 necessary to investigate their properties for metrology purposes ( e.g.
 measurement of liquified gases ).
 Besides legal aspects ^ the commercial importance of accurate metering
 of gas or oil is very considerable ( see section 2 ). The work planned
  consists of :                              -                           -
 - increasing our understanding of the behaviour of orifice plates
     widely used ior metering in pipelines ;
 - studying the effect of installation conditions on the readings of
     different meters ;
 - studying the effect of fluid properties on the different meters .
 ---pagebreak---                                             12
 Acoustics and ultrasonics
Noise measurements have taken on considerable importance because of the
number of regulations which have been adopted for noise abatement both
 indoors and outdoors . They are the cause of difficulties in trade
because of differences between laboratories and between national
standard methods . In addition , precision requirements in the
regulations are sometimes beyond the capabilities of the best
 laboratories . It is therefore planned to improve the basic methods of
acoustic measurements and to work on specific practical problems such
as windows , insulation material and noise emission of various types of
machines .
The effort undertaken to develop the ultrasonic measurements will be
continued with particular reference to the rapidly increasing medical
applications .
[lea surernen t _o f _ma t e ria L^_o rooe r t
Measurement of material properties have considerable technical
importance and are the subject of many written standards ( norms ).  As
has been’ohserved in many cases , these norms are not sufficient and’
laboratories need transfer standards on reference materials to verify
or to calibrate their instruments .
A list of priority requirements were defined ( see Appendix ) in the
field of small particles measurements , physical properties such as
viscosity , thermal conductivity of insulating materials and methods of
testing of engineering- materials to determine their mechanical
properties . The programme will not generate data to characterize
particular materials but will study in considerable depth the. methods
used to measure the properties .                  *
 ---pagebreak---                                      13
                                  APPENDIX 2
                  FUNDING OF THE PROGRAMME AND STAFFING NEEDS
 The funding estimates result from the discussions at the expert meetings
 that were held to prepare the programme < cf . Section 3.2 ). For
 intercomparisons , it is known from experience that the expenditure for the
 Community vary from 80 to 150.000 ECU per collaborative project . In the
 area of metrology there will be some projects involving research and
development which will cost up to 300.000 ECU and for which Community
 funding would be 50% .
 The amounts necessary for each area of the programme together with the
number of A grade personnel , are given in the following table .
                                                   Resources necessary
                                           - A Grade personnel       Mio ECU
Analyses . for food-and agriculture                4                    5.8
'Analyses for environment                          4                    5.8
Analyses related to health                         3                    4.8
Analyses for metals                                2                    3.0
Applied metrology                                  4                   18.8
Dissemination of information                       1
Coordination ( Head of Division )                  1
                                                  19                   38.2
Commission staffing needs                   ^
The experience of the two last SCR programmes has shown that because the
projects involve, a large degree of collaboration they also require
considerable work from Commission personnel even when the expenditure in
contracts is very small . The role of Commission -experts is of crucial
importance to bring laboratories together and stimulate collaboration .
In the field of chemical analysis , intercomparisons are often repeated
several times and one A official cannot manage more than ten such projects
simultaneously or terminate more than 2 per year . In the field of
metrology , intercomparisons are easier and therefore require fewer
Commission Staff .
The details on A staff required are shown in the table above .
 ---pagebreak---                                  K
The total staff necessary is as follows :
        A Grade                             19
Auxiliary personnel
        8 Grade                               3
        C Grade                             10
        Total                               32
Total funding
        Contracts                          38.2 Mio ECU
        Personnel                          12.5
        Administration Costs                  5.5
        Services of JRC                       3
        Total                              59 .2 Mio ECU
N.B. : 60% of the Administration costs are absorbed by the expenses for
       meetings of experts and of contractors which are essential to
       implement contacts and collaboration .                     –
 ---pagebreak---                                      15
                                    APPENDIX 3
                       RESULTS FROM THE PREVIOUS PROGRAMME
 A total of 300 measurement projects have been undertaken by the programme
 since it began in 1973 , 115 of them being started in the last programme
 ( 1983-1987 ).
 Applied Metrology
 For metrology , the projects generally associate all the national metrology
 laboratories and allow them to improve and harmonize their methods thus
 ensuring that a common level of calibration is available to industry
 throughout the Community . Many physical quantities were dealt with such
 as electric power , high voltage , high frequence voltage and power ,
 resistance , capacitance , mass , length , force , pressure , etc .
 As the topics are selected where difficulties are known to exist , each
 project has given the possibility for at least one laboratory to discover
weaknesses in the measurement procedure and to correct them . The projects
also gave to the laboratories who are less_wetl equipped , the opportunity
 to conftrm the accuracy of the calibrations- that they provide to industry_
 in their respective countries .
 Important results were also obtained in projects closely related to
practical applications where industry laboratories had participated .
A project on the flow measurements which are made in pipelines "for natura-l
gas , detected a systematic error- of 0.2 % in the results of one of the
Member States and thereby put an end to_ severe disputes over the           j
quantities of gas exported . Several projects in.thi*s field concern the .
different methods of flow determination and wh'ile the accuracy of Eurooean
results increases , discrepancies appear with the American specifications
which had been adopted, up to now . Many valuable- fluids tfave to be metered
accurately . For liquid petroleum gas ( LPGJ , the programme gave an
opportunity to the Member States to compare their methods of controlling
road-side service stations :- several Member States used the conclusions of
the project to select the most reliable measurement eo^uipment .
Among many subjects of dimensional metrology , surface roughness
measurements which are of - considerable industrial importance have been
substantially improved . Discrepancies were as high as 60 % , even between
laboratories applying standard methods . Improving the methodology reduced
the scatter to 15 % .
Several projects concerning double glazed windows ( noise attenuation and
heat losses ) were undertaken , because severe disputes over measurement
results were the cause of trade barriers . The first intercomparison
organized on noise attenuation produced results in very good- agreement , .
because the details of the measurement conditions had been carefully
prepared . It showed that when adhering to a well defined measurement
procedure , the laboratories can avoid many difficulties . The method
- mprovements will probably be incorporated into the existing standards .
 ---pagebreak---                                       16
   Measurements of the luminous flux of lamps for domestic or street lighting
   were undertaken with the participation of industry , because differences
   between laboratories were initially as high as 7 % . These differences
   were reduced to 1 % in one single carefully planned intercomparison .
   Thermal conductivity measurements of insulating materials used in building
   construction , were also undertaken to solve discrepancies which arose
  because the measuring equipment described in the written standards was not
  accurate . This problem is now solved and the standard has been improved .
   For measurement of thermal conductivity of industrial refractory materials
  at high temperature , errors of up to 30 % are common and make it
   impossible to accurately design large industrial furnaces . Work in
  progress should be able to reduce such discrepancies to only a few
  percent .
  The programme has contributed to the acceleration of the development of
  the metrology of ultrasonics . The medical applications of ultrasonic
  equipment ( e.g. diagnostics in gynaecology ) require very careful control
  of the instrument , because overexposure of the patients is dangerous . Yet
  the uncertainty in the ultrasonic power measurement can reach 30 % . With
  the support of the BCR programme , measurements in the Community have been
  considerably iriprovedT European laboratories are now providing
- calibrations for users throughout the world and European industry i_s in a
  favourable position to demonstrate the quality of their equipment .
  Chemical Analyses
  In the field of chemical analyses , the BCR programme has responded to many
  requests related to the most difficult analyses . During the seventies , an
  enthusiastic group of university and industry laboratories achieved
  considerable improvements in the determination of traces of oxygen ,
  nitrogen and carbon at levels of 1 ppm or below in a*variety of metals .
  Considerable progress has also been made in the Community for the
  determination of traces of heavy elements ( lead ,- cadmium , etc .) in the
  environment . The need for improvement was very great . Early
  intercomparisons showed differences of a factor of 100 for contents of the
  order of 1 part per million ( ppm ). Below 1 ppm differences were even -
  greater and around 1 part per billion ( ppb ) - results differing by a factor
  of 10,000 were observed . As a consequence of the many intercomparisons ,
  many experienced laboratories can now agree to within 10-20% on the
  results for elemental contents of 1 ppm and less . About thirty reference
  materials have been issued in this field .
  Particular mention should be made of the reference materials for the
  determination of lead and cadmium in blood , which are very important in
  the monitoring of workers exposed to hostile industrial environments .
  Considerable effort was devoted to the field of medical analysis .
  Successful completion of some projects was delayed by the need to
  thoroughly investigate the stability and suitability of the material e.g.
  to show that , after reconstitution , lyophilised human serum behaves in the
  sane way as fresh serum in routine analysis . In addition methods having
  the accuracy required for certification were in general not available and
  scientific developments were required before the actual certification
  could he achieved .
 ---pagebreak---                                       17
  The BCR cortisol reference material allows resolution of the differences
  of up to 25% that had been observed in the results of the more commonly
  used methods -   The most successful reference materials up to now concern
  the determination of the coagulation time of the blood of persons subject ■
  to thrombosis . Most major firms producing diagnostic products or
  instruments for this type of measurement are now using the BCR reference
 materials both in the USA and in Europe .     This has led to a very wide
 harmonization , the absence of which some years ago was still a cause of
 death in some cases .
 The programme has produced the basis for considerable improvements in the
 determination of dangerous organic compounds in the environment
  ( pesticides , carcinogenic polyaromatic hydrocarbons , polychlorobiphenyls ,
 dioxins ) .
 Here too differences between laboratories can reach a factor of 100 , if
 not more .    The first step was to produce for calibration purposes the
 compounds of interest in a pure form when they were not commercially
 available .    Some fifty reference materials of this type have now been
prepared and are used worldwide , mainly for the analysis of water and
 automobile exhaust gases . New and improved methods are being developed in
 collaborative projects for the determination of traces of polychlorinated
binjienyls ( PCBs ), polycyclic aromatjc hydrocarbons ( PAHs ) and pesticides .
 Reference materials will be issued within a few years with certified
amounts of PCB and PAH in various matrices such as fats , oils and other
 food products .
BCR reference materials have been used in intercomparison campaigns
organized by official bodies in several Member States e.g. determination
of PCBs in human blood serum .                                               _
In the area of food and agricultural products , - severot projects were -
conducted in close collaboration with the responsable Commission services
 ( DG VI ). While results for heavy metals ( e.g. lead and cadmium ) differed
by factors of ten or more , work done in the BCR programme succeeded in
reducing these differences to 20% and led to the preparation of three
reference materials . Similar improvements! were achieved for these
analysis in cereal products .
Regulations impose severe restrictions on the levels of the dangerous
toxin aflatoxin        which occurs in milk as a result of fungal activity in
certain animal feed-stuffs . 'The implementation of these regulations was
initially the cause of many disputes because the results from different
laboratories could differ by factor as high as cne thousand . A BCR
project was therefore established , bringing together about 20 major
laboratories of the Member States . After several intercomparisons , the
difference between the results was reduced to as little as a few per cent
and milk-powder reference materials are now available to any laboratory
wishing to avoid errors .     Work for DG VI on the determination of a related
toxin in animal feed itself is now leading to excellent results .
Intercomparisons organized at the reo.uest of industry to investigate the
state of the art in the analyses of fruit juices ( according to the
Community Directive 75 / 726/ EEC ) has been of considerable help in reducing
disputes that had been going on for many years .
 ---pagebreak---                                       18
 Reference Materials
 At the end of most projects concerned with chemical analysis or material
 properties , one or several reference materials are issued . Any user of
 such a reference material is then able to compare his own results with the
value certified as being correct .      If the difference between his results
 and the certified value is too great , he must conclude that his method
needs to be improved . For this purpose he can consult the report which
accompanies the reference material and gives advice on avoidance of
errors . When the user can show that his measurements agree sufficiently
closely with the certified value , he knows that the accuracy of his
 results cannot be challanged .
In 1986 , the BCR programme could offer 175 different reference materials
and the number of samples sold amounted to 4,665 . In total more than
13,000 samples were sold during the last four years and several thousand
copies of reports were distributed with them . The details are shown in
the following table :
                   Number of Reference           Number of
                                                                            *
                   Materials available         samples sold        Receipts
1983                   –   105    ‘ -    _         1,466         ' 80,90CT ECU
1984                       126                     2,866         124,550 ECU
1985                       144                     3,471         105,300 ECU
1986                       175                     4,665         141,000 ECU
Receipts are returned to the budget of the programme .
At the end of* 1986 , 19 additional reference materials became available-.
The total- inventory can be classified as follows :
                                                         »
B i omed i c a l             11                                     ‘
Food                         15
Envj ronment                 77 -
Metals and Ores              41
Coke and Coal                  9
Ferti lizers                   6
Physical' Properties        -1 7
Miscellaneous                18
Each sample is supplied with a detailed report where the user can find all
details on the work dong and recommendat ions- on how to make the -
measurements .
It is to be noted that the high quality of the SCR reference materials is
acknowledged by the IJ.S. National Bureau of Standards who are recommending
them to American users .
*
- Prices are calculated on the basis of the expenditure in the projects
    corresponding to the respective reference materials
 ---pagebreak---                                         19
Utilisation of the budget
The programme 1983-1987 has a budget of 25 million ECU . The sums committed
for each of the first four years were as follows :
    1983       3,500 Mio  ECU
    1984       4,021 Mio  ECU
    1985       4,668 Mio  ECU
    1986       7,224 Mio  ECU
              19,413 Mio  ECU
The balance to be committed in 1987 is 5,6 Mio ECU .
                                                Ï
 ---pagebreak---                                       20
                                  APPENDIX       4
                                  OPINION OF THE CGC
   The CGC S&T Standards has examined the proposal entitled " Research and
  Development Programme in the Field of Metrology & Chemical Analyses
   1988-1992” .  The CGC has noted the advances made during the present BCR
  programme in improving the competence in measurement in many fields throughout
  the Community . This has resulted in improved agreements between the services
  to customers provided by the metrological services of the Members States .
  Reference materials have been produced successfully by collaboration between
  laboratories . Sales of some 15,000 samples have been achieved which will lead
  to improved chemical analyses by a large number of laboratories in particular
  in relation to health and environment .
  In considering the management of the programme the CGC concluded that the
  means of implementation of individual projects achieved a very effective
  optimization and dissemination of benefit to Member States . The CGC is of the
  opinion however that to further improve the dissemination of the benefit of
  the programme , an increase in publicity will be necessary .
  With the acceleration towards completjng t_he interna-l .market and the inclusion
  of new Member States the CGC believes that there is a need for- increasing
  activity in these fields . Increased participation in thi-s new programme will
  facilitate the extension of harmonization of measurement throughout the
  Community . The new programme contains the elements necessary to improve
  agreement in the implementation of directives and to the preparation of the
  technical infrastructure needed for the mutual recognition of test results as
  well as for the reduction of technical barriers to trade .
  The CGC thoroughly discussed and agreed the proposed programme- priorities-
- taking into account - detailed technical objectives . ‘It concluded that these
  are consistent with the objectives of the White Paper . Although the programme
  is defined in considerable technical detail , the CGC stresses the need to keep
  sufficient flexibility to adapt to changing situations and needs . It believes
  that the proposed programme is consistent with the need for an expenditure of
  about 50 M ECU and that any significant variation would require a revision of
  the programme and its staffing . Experience has shown that work on reference
  materials requires a. high number of staff . assigned to the programme .
  The CGC reviewed the proposed programme in the light of national activities
  and the ‘initiative for a proposed formaj. col laborat iorr of national measurement
  institutions , EUROMET , and concluded that the programme complements them . –
  The CGC welcomes and encourages the proposal to include participation of EFTA
  countries in view of the common problems in harmonization of measurement in
  many fields .
  In response to the Evaluation Report on the BCR programme the CGC was pleased
  to note the increased involvement of other Commission" services' in the
  definition of BCR activities and in the use of the results . The GGC is also
  pleased to note that the Commission has agreed to provide forward working
  plans during the course of the programme to aid monitoring of the programme by
  the CGC and to provide the opportunity for incorporation of any necessary
  changes .
 ---pagebreak---                                         - 21-
                                                                 XII /266/87-ES
                  PROYECTO REGLAMENTO DEL CONSEJO
Por el que se adopta un programa de investigación y desarrollo para la Comunidad
Económica Europea en el ámbito de la metrología aplicada y del análisis quimico
                             ( 1988-1992 )
                    ( Oficina Comunitária de Referencias - BCR )
EL CONSEJO DE LAS COMUNIDADES EUROPEAS ,
Visto el Tratado constitutivo de la Comunidad Económica Europea y , en particular ,
el apartado 2 de su articulo 130 0,
Vista la propuesta de la Comisión ( 1 ) ,
En cooperación con el Parlamento Europeo      ( 2 ),
Visto el dictamen del Comité Económico y Social (3 ),
 (1 ) D0
 (2)  D0
 ( 3) D0
 ---pagebreak---                                           - 22-
 Considerando que La Comunidad se ha fiiado a si misma el objetivo de La consecución
deL mercado interior en 1992 , para Lo cuaL deberá eLiminar Los obstácuLos técnicos
aL comercio , principaLmente mediante La armonización de normas y de regLamentos
técnicos ;
Considerando que eL Programa Marco de Actividades Comunitarias en eL campo
de La Investigación y deL DesarroLLo TecnoLógico , adoptado por eL Consejo para
eL periodo de 1987 a 1991 , incLuye eL apoyo a La apLicaciqn de normas técnicas ;
Considerando que La eLiminación de otros obstácuLos técnicos exige que Los Labora ¬
torios de Los Estados miembros posean Los medios técnicos necesarios para garantizar
 La apLicación uniforme de normas , regLamentos técnicos y Directivas ,
Considerando que resuLta importante para conseguir este objetivo que La Comunidad
apoye actividades de coLaboración que tengan por objetivo La armonización de Las
mediciones y de Los anáLisis químicos en Los Estados miembros , para garantizar
La concordancia de Los resuLtados de pruebas y controLes ;
Considerando que Los trabajos sobre metroLogia y anáLisis químicos que se están
efectuando en aLgunos Estados de La AELC podrían coordinarse útiLmente con Los
trabajos comunitarios efectuados de conformidad con eL programa actuaL ;
Considerando que et CREST ha emitido su dictamen .
HA ADOPTADO ESTE REGLAMENTO :
ArtícuLo 1
1.    Por eL presente RegLamento    se adopta un programa de investigación y desarroLLo
      para La Comunidad- Económi ca Europea en'eL campo  de La metroLogia apLicada y
      de Los anáLisis quimicos , de acuerdo con Lo definido en el Anexo, por un pe¬
      riodo de 5 años y con efectos desde eL 1 de enero de . 1988 .
2.    EL trabajo experimentaL se LLevará a cabo bajo contrato . Los participantes
      podrán ser organizaciones industriaLes , institutos de investigación y univer¬
      sidades estabLecidas en La Comunidad .
ArtícuLo 2
Los fondos que se estiman necesarios para La ejecución deL programa ( de 1988 a
1992 ) ascienden a 59*2 miLLonesde ECUs , incLuyendo Los gastos de una pLantiLLa
de .32 coLaboradores .
ArtícuLo 3
La-Comisión será responsabLe de La ejecución deL programa . Será asistida en su función de
gestión deL Programa por eL Comité consuLtivo de gestión y coordinación ( CGC ) ( Normas
Científicas y TecnoLógi cas ) , creado por La Decisión 84 / 338 / Euratom , CECA , CEE deL
Consejo ( 1 ).
( 1 ) DO L 177    de 4.7.84 , p. 25
 ---pagebreak--- Artículo 4
Durante el tercer ano , se procederá a la revisión del programa . Los resultados
de dicha revisión deberán comunicarse al Consejo y al Parlamento Europeo . Como
consecuencia de la misma , La Comisión podrá presentar una propuesta de revi ¬
sión del programa según los procedimientos adecuados .
Articulo 5
La Comisión queda autorizada a negociar acuerdos de cooperación con terceros
países , en los ámbitos a los que se refiere el programa y, en particular, con
aquellos Estados europeos no miembros, que hayan concluido con la Comunidad
a acuerdos marco sobre cooperación científica y técnica .
 \
Articulo 6
El presente Reglamento entrará en vigor el 1 de enero de 1988 .
El presente Reglamento será obligatorio en todos sus elementos y directamente
aplicable en cada Estado miembro .
 ---pagebreak---                                           - 24-
                                      ΑΝΕΧΟ
 Programa de investigación y desarrollo en el campo de la metrología aplicada y de los
                                análisis químicos
                      ( Oficina Comunitária de Referencia - BCR )
 El objetivo de este programa consiste en mejorar la fiabilidad de los análisis
 químicos y de las mediciones físicas ( metrología aplicada ) de forma que se consiga
 una concordancia de resultados en todos los Estados miembros .
 Los proyectos se seleccionarán de entre los campos que sean de importancia prioritaria
 para la Comunidad teniendo en cuenta factores económicos , ambientales o de sanidad
 pública .
 En particular , los campos prioritarios serán los siguientes :
 - análisis de alimentos y de productos agrarios
 - análisis ambiental
 - análisis biomédico
 - análisis de metales , incluyendo análisis de superficies
 - mediciones físicas ( metrología aplicada )
 Las actividades incluirán en particular :
 - ejecución de programas de medición en colaboración- ( intercomparaciones )
 - mejora de los métodos de análisis y medición
 - mejora de los instrumentos necesarios para las mediciones de alta precisión
 - desarrollo de normas de transferencia
_r preparación y certificación de materiales de referencia
 - almacenamiento y distribución de materiales de referencia
 - becas para jóvenes científicos en temas incluidos en el programa
 - intercambio de cientificos en temas incluidos en el programa
 ---pagebreak---                                        - 25-
                                       VI
                                  FINANCIAL RECORD
   R & D Programme in the field of Applied Metrology and Chemical
   Analyses .
1 . Relevant budget heading
     Chapter 73 - Item 7350 -
2 . Legal basis
EEC Treaty Art . 130 Q §2
Council Regulation of
3 . Description and justification of the programme
     This programme is one of the components of the Framework
     programme for Community Research and Development activities ,
     and is included in it under the heading Technical Standards .
     The objective of the programme is to improve measurements and
     chemical analyses in the following priority areas
     - analysis of food and agriculture products
     - analysis related to environment
     - analysis related to health
     - analysis of materials
     - applied metrology
     The programme is addressed to industrial firms , to research
     centres and to universities .
4 . Type of expenditure
     The major part of the expenditure will be committed through
     shared cost  contracts .
     The programme will also require service work under contract in
     particular , for preparation of batches of reference material
     samples , for storage and distribution of samples . It will also
     include contracts for coordination , in particular when one
     laboratory is in charge of providing samples to be studied by
     a group of participants    and to collect and interpret results .
 ---pagebreak---                                              - 26-
                                              VII
     5 . Financial implications
         5.1 . Method of calculation
         5.1.1 . Personnel
         The staff required for the programme is 19 A, 3 B and 10 C.
         For the year 1988, the following tables include only 12 A, 1
         B and 6 C.
         5.1.2 . Administration costs
         Sixty per cent of the administration expenditure are absorbed
         by costs for meetings of participants to projects . These
         meetings are essential for the discussion of results and
         exchange of experience .
         5.1.3 . Contracts      See §4
         5.2 Multiannual timetable for appropriations
                           APPROPRIATIONS FOR COMMITMENT ( MioECU )
                  I 1988    1  1989  I  1990    I  1991   I  1992  I 1993   I 1994 II  TOTAL
                  I         1        t          I         I        I        I      II
                 I-         1        I          I         I        I        I      II
Personnel        |  1.846   1  2.100 I  2.700 I    2.900  I  3.000 I        I      1 1 12.546
                 I          1        I          I         I        I        I      II
Administration |     . 704  1  1.200 I  1.200 I    1.200  I  1.196 I        I      II   5.500
                 I          1        I          I         I        I        I      1 1
Contracts        |  3.450   1  9.800 I 11.800 I   10.300  I 5.804 I         I      1 1 41.154
                 I          1        I          I         I        I        I      1 1
                 T          1        I          r        'T'      7     " _ r __.  II
TOTAL            I  6.000   1 13.100 I 15.700 I 14.400    I 10.000 I        I      II  59.200
                 I          1        I          I         I        I        I      II
 ---pagebreak---                                              - 27-
                                           VIII
               APPROPRIATIONS FOR PAYMENTS ( MioECU )
                                 T                   T       T        T         7Г           7
                  1988     1989     1990        1991  | 1992  |  1993  I 1994 +      TOTAL
                                                      I       I        !
               Г                                -T-T-T- n-!
Personnel         1 . 846  2.100    2.700       2.900 | 3.000 |        |         ||   12.546  |
Administration      . 704  1.200    1.200       1.200 | 1.196 |        |         ||    5.500
                                                      I       I        I         II
Contracts           . 650  3.200    6.100       5.900 | 5.804 | 10.000 | 9.500   Il  41.154
                                                                                 II
               Г                 T        _T-T-J-J- 17-
TOTAL            3.200     6.500   10.000   | 10.000 | 10.000 | 10.000 | 9.500   Il   59.200
                                                                                   I
 ---pagebreak---                                         - 28-
                                       IX
                         SHE IMPACT ASSESSMENT STATEMENT
    1 . Reasons for the programme proposed
    Many analyses or tests carried out in many fields of chemical
    analyses or technology provide inadequate results which are
    causes of disagreements between the supplier and its customers
    and more generally of difficulties in trade .
    The objective of the programme is to improve measurements in a
    certain number of priority topics . In particular , those listed
    in the White Paper on the completion of the Internal Market .
2 . Type of industry involved
    The programme does not concern a particular type of business
    but a very large variety of industrial activities . Similarly
    it does not concern specifically large industrial companies or
    small firms , they are all concerned . In summary , what is
     involved is in particular , the quality of the products and the
    pollution that they could be produced .
3 . Conséquences for SMEs
     The programme will produce reports showing how measurement
    problems can be solved accurately and reference materials
    which can be used by any laboratory to verify its performance .
     The advantage for SMEs could be considerable because they will
     receive at very low cost the results and know-how from the
     work of others .
     Those SMEs who will be conscious of the need to maintain high
     quality of their products and for this to have adequate
    measurements will have better competitiveness and better
     security for the employment . The programme will not generate
     jobs directly .
     The proposal will not produce any new requirements of SMEs .
4 . Consultation of social partners
     The Communication will be submitted to the Economic and Social
     Committee for Opinion . On previous occasions the ESC was very
     favourable to this type of action because of its positive
     effect in eliminating some trade barriers .