CELEX: 51987PC0444
Language: en
Date: 1987-10-19
Title: Proposal for a COUNCIL REGULATION (EEC) on a Research and Development Programme in the field of Applied Metrology and Chemical Analyses in the European Economic Community 1988-1992 (the Community Bureau of Reference - BCR) (presented by the Commission)

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                                  Proposal for a
                            COUNCIL REGULATION ( EEC )
     on a Research and Development Programme in the field of Applied
         Metrology and Chemical Analyses in the European Economic
                                     Community
                                     1988-1992
                 ( the Community Bureau of Reference - BCR )
                    / i u (presented by the Commission )
 C0M(87 ) 444 final / 2
 ---pagebreak---                                          2
INTRODUCTION
1 . For about 10 years the Community has , through the BCR 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 BCR programme does not 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 of the programme in the field of metrology can be illustrated by
 the following examples .
 A project was undertaken following 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 Member States and so put an end to difficult disputes over the
 quantities of gas exported .
 Two projects 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 samples which are now used as reference material by many laboratories in
 the Community .
 ---pagebreak---                                           3
- \ f- e 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 BCR 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 §oals Q f
Community policies and mainly those regarding the completion of the Internal
Market .
The present BCR programme
A. 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 .
The results of the present programme are reviewed in Appendix 3 .
5 . The BCR programme has been evaluated by a croup 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' 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 White Paper . The implementation of the Community policy on the environment
and health also requires considerable improvements in chemical analysis .
 Finally it is recommended that the current work in the field of applied
metrology ( e.g. dimensional , electrical , optical measurements ) 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---                                         4
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 has 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 envi ronnement or
health care
- the number of countries interested
Financial support to projects
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 % 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
similar service to the new Member States . Limited intercomparisons will be
supported for them, as necessary , on subjects previously covered by the
programme . More generally , for Member States which do not have the possibility
of parti cipating in intercomparisons , 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 chemistry , 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 of reference materials can be used by any
 laboratory to verify its methods and improve them in order to become
 ---pagebreak---                                           6
compatible with those of other laboratories . The report , which is 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 . This 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
 coordination 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 .
ine 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
ECU .
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 SCR programme .
 ---pagebreak---                                            δ
                                     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 juices
            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 . ANALYSES RELATED TO THE ENVIRONMENT
    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 . ANALYSES RELATED TO HEALTH
    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 money ( 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 CSuality Control Schemes had
     a very favourable effect on analytical quality ( blood , serum ), but they
     are limited to a 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 collaboration 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 equivalent 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
    (" etalons ") , also known as transfer standards , which are necessary to
    calibrate or verify measuring instruments in the work place .
    Di^rnenslona l^_and mechanical metrology
    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 laboratories 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 ).
When 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 .
lemgerature
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 .
§i2£î£i£ii_!I!ÊÏ£2i22Z
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 ).
22£l£2i_î5Ë££2l2£Z
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 for 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
rnach i nes .
The effort undertaken to develop the ultrasonic measurements will be
continued with particular reference to the rapidly increasing medical
appl i cat i ons .
[leasurement_of _materi^a l_grogerties
Measurement of material properties have considerable technical
importance and are the subject of many written standards ( norms ). As
has been observed 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
Dissémination of information                       1
Coordination ( Head of Division )                  1
                                                  19                   38.2
Commission staffing needs
The experience of the two last BCR 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---                                   14
The total staff necessary is as follows :
         A Grade                            19
Auxiliary personnel
         G Grade                               3
         C Grade                            10
         Total                              32
Total funding
         Cont ract s                        38.2 Mio ECU
         Personnel                          12.5
         Administration Costs                  5.5
         Services of JRC                       3
         Total                              59 .2 Mio ECU
N.8 . : 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 well equipped , the opportunity
to confirm 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 natural
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
quantities of gas exported . Several projects in this field concern the
different methods of flow determination and while the accuracy of European
results increases , discrepancies appear with the American specifications
which had been adopted up to now . Many valuable fluids have to be metered
accurately . For liquid petroleum gas ( LPG ), 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 equipment .
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
 improvements 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 improved . European laboratories are now providing
calibrations for users throughout the world and European industry is 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 , lyophiliseci 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 be 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
biphenyls ( PCBs ), polycyclic aromatic 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 , several 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 one thousand . A BCR
project was therefore established , bringing together about 20 major
 laboratories of the Member States . After several intercompari sons , 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 request 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          80,900 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 :
Biomedical                 11
Food                       15
Environment                77
Metals and Ores            41
Coke and Coal               9
Fertilizers                 6
Physical Properties        17
Miscellaneous              18
Each sample is supplied with a detailed report where the user can find all
details on the work done and recommendations on how to make the
measurements .
It is to be noted that the high quality of the BCR reference materials is
acknowledged by the U.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 .
 ---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 completing the internal 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 this 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 formal collaboration of national measurement
 institutions , EUR0MET , 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 CGC 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
                                   Proposal for a
                              COUNCIL REGULATION ( EEC )
      adopting a research and development programme for the European Economic
         Community in the field of Applied Metrology and Chemical Analysis
                                      ( 1988-1992 )
                        ( The Community Bureau of Reference )
THE COUNCIL OF THE EUROPEAN COMMUNITIES :
Having regard to the Treaty establishing the European Economic Community and ,
in particular, article 130 Q ( 2 ) thereof.
Having regard to the proposal from the Commission , ( 1 )
In co-operation with the European Parliament , ( 2 )
Having regard to the opinion of the Economic and Social Committee , ( 3 ),
( 1 ) 0J
( 2 ) 0J
( 3 ) 0J
 ---pagebreak---                                           22
Whereas the Community has assigned itself the objective of completing the
internal market by 1992 for which it has the task of eliminating technical
trade barriers mainly through harmonisation of norms and technical
regulations ,
Whereas the Framework programme of Community Activities in the Field of
Research and Technological Development adopted by the Council for the period
1987-1991 includes support to the application of technical norms .
Whereas the elimination of supplementary technical barriers requires that the
laboratories of the Member States have the technical means necessary to ensure
the uniform application of norms, technical regulations and directives .
Whereas to achieve this aim it is important that the Community supports
collaborative activities having as objective the harmonisation of the
measurements and chemical analyses in the Member States so as to ensure
concordance of the results of tests and controls ,
Whereas work on metrology and chemical analysis in progress in some EFTA
States could usefully be coordinated with Community work under the present
programme ,
Whereas CREST has expressed its opinion ,
HAS ADOPTED THIS REGULATION :
Article 1
1 . A research and development programme for the European Economic Community
       in the field of applied metrology and chemical analyses as defined in the
       Annex , is hereby adopted for a period of five years with effect from 1
       January 1988 .
2.     Experimental work will be carried out under contract .
       The participants may be industrial organisations , research institutes and
       universities established in the Community .
Article 2
The funds estimated as necessary for the execution of the programme ( 1988-
1992 ) amount to 59,2MioECU which includes expenditure on a staff of 32 .
Article 3
The Commission shall be responsible for the execution of the programme . It
will be assisted in its function of programme management by the Management and
Coordination Advisory Committee ( CGC ) ( Scientific and Technological Standards )
created by Council Decision 84 / 338 / Euratom , ECSC , CEE ( 1 ).
  ( 1 ) OJ No L 177 , 4.7.1984 , p. 25 .
 ---pagebreak--- Article 4
During the third year the programme shall be reviewed . The results of this
review shall be communicated to the Council and the European Parliament .
This review may lead to the submission by the Commission of a proposal for
a revision of the programme in accordance with the appropriate procedures .
Article 5
The Commission is hereby authorized to negotiate agreements for cooperation
in the fields of operation of this programme with third countries , in
particular those European non-member States which have concluded framework
agreements for scientific and technical cooperation with the Community .
Article 6
This Regulation shall enter into force on 1 January 1988 .
This Regulation shall be binding in its entirety and directly applicable in
all Member States .
Done at                                                    For the Counci l
 ---pagebreak---                                         24
                                        ANNEX
    Research and development programme in the field of Applied metrology and
                                 Chemical analyses
                       ( Community Bureau of Reference-BCR )
The objective of the programme is to improve the reliability of chemical
analyses and physical measurements ( applied metrology ) so as to achieve
agreement of results in all Member States .
The projects will be chosen from those fields which are of priority importance
for the Community as judged from an economic , environmental or public health
view point .
The priority areas will be in particular , the following :
-analysis of food and agricultural products
-environmental analysis
-biomedical analysis
-analysis of metals , including surface analysis
-physical measurements ( Applied metrology )
The activities include in particular :
-execution of measurement programmes on a collaborative basis
( intercomparisons )
- improvement of methods of analysis and measurement
- improvement of instruments necessary for high precision measurements
-development of transfer standards
-preparation and certification of reference materials
- storage and distribution of reference materials
-scholarships for young scientists in subjects covered by the programme
-exchange of scientists in subjects covered by the programme
 ---pagebreak---                                        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---                                                     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 Multianriual timetable for appropriations
                              APPROPRIATIONS FOR COMMITMENT ( MioECU )
                   r_          T         1           y-y-y-y-                            π-
                       1988    I   1989   I   1990    I 1991   I  1992   I  1993  I 1994  II  TOTAL
                               I          I           I        I         I        I       II
                   T           I          I        _ r        'T'        I        I      ΤΤ
Personnel          | " 1.846   I   2.100  I   2.700 I   2.900  I  3.000  I        I         | 12.546
                   I           I          I           1        1
                                                               1         I        1
                                                                                  1         I
Admi ni st rat ion I    . 704  I   1.200  I   1.200 I   1.200  1  1.196  I        1         |  5.500
                   I           I          I           1        1
                                                               1         I
                                                                         I        1
                                                                                  1         I
Contracts          |   3.450   I   9.800  I 11.800 I 10.300 1 5.804 I             1         | 41.154
                               I          I           I        1         I        1         I
                   T           I          I -         r       "Τ'       "T ”   ■' T "    ΤΤ
TOTAL·             I   6.000   I  13.100  I 15.700 I 14.400 1 10.000 I             1      ||  59.200
                                I         I           I         1         I        1
                                                                                                  %
 ---pagebreak---                                                    VIII
                      APPROPRIATIONS FOR PAYMENTS ( MioECU )
                  Γ             Ί"        T        T         T        'T'        T        ΤΓ             1
                         1988    I  1989  I  1990   I  1991  I  1992   I   1993  I 1994 + II     TOTAL    1
                   1             I        I         I        I         I         I        II              1
                  Γ             T         T        T         T         I         I        II              1
Personnel          I 1.846 I        2.100 I  2.700 I   2.900 I  3.000  I         I        II      12.546  1
                    1            II       I         I        I         I         I        II II           ;1
Admi ni st rat ioni       . 704   I 1.200 I  1.200  I  1.200 I  1.196  I         I         II      5.500
                   11             I
                                  I       I         I        I         I         I         II II
Contracts           I     . 650   I 3.200 I  6.100  I  5.900 I  5.804  I  10.000 I 9.500    Μ     41.154
                    1             I       I         I        I         I         I          II
                  T               I       I         I        I         I         I          II
TOTAL               1    3.200    I 6.500 I 10.000  I 10.000 I 10.000  I 10.000  I 9.500    II    59.200
                                  I       I         I                  I         I          II
                                                                                                     n
 ---pagebreak---                                        IX
                          SME 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 .