Source: EURLEX
Language: en
Format: md

###### **COMMISSION OF THE EUROPEAN COMMUNITIES**

**Brussels, 27.01.1998**

COM(1998) 31 final

### Commission Working document RESEARCH AND STANDARDIZATION Greater consideration of the **prenormative dimension** in Community research programmes in order to foster the sustainable growth, competitiveness and interoperability of products and services to emerge from research

#### CONTENTS.

##### 1. Introduction 2. The need for standards 2.1 Economic and social usefulness 2.2 International trade 2.3 Economic impact of standards 3. Situation of prenormative research in the Commission's specific programmes 3.1 Information technologies and communications 3.2 Industrial technologies and materials 3.3 Standards, measurements and tests 3.4 Agriculture and fisheries 3.5 Biotechnology 3.6 Environment and climate 3.7 Prenormative activities of the J.R.C 4. Increasing the effectiveness of Community prenormative research 4.1 Coordination between the specific programmes of the 4th R&D framework programme 4.2 Research specifically geared to standards 4.3 Prenormative research and the environment 4.4 Prenormative research and intellectnal property rights 4.5 Prenonnative research and innovation 4.6 Transfer ofresults to standards bodies 4.7 International dimension of prenonnative research 4.8 Dedicated calls for proposals of the specific SMT programme 4.9 "Key actions" of the 5th Research and Development Framework Programme 5. Conclusions

1. INTRODUCTION

Being one of the tools of quality [12,3] in the same way as measurements, testing, management
techniques and quality assurance, standards are in a strategic position to promote the
competitiveness and interoperability of products and services [4] .
Standards thus provide a bridge between **the technical** **domain** **and the regulatory and**

economic framework.

The development of new standards and their implementation depend on preliminary research. Their
bridge function should thus be taken into account in the selection, direction and content of research
projects.

This bridge function is a two-way affair: one the one hand, prenormative research [5] promotes the
development of new standards while, on the other hand, the standards create the conditions for
better dissemination of the results of the research. In both cases a specific strategy is needed to
make the results usable by the standards bodies.

2. THE NEED FOR STANDARDS

2.1 Economic and social usefulness

The advantages of standards have led to them being adopted in many industrial areas. Standards are
indispensable tools in providing commerce with a platform for good working practices. They are
also the tool of choice for protecting consumers and the health, safety and environment of citizens.
They make for economies of scale and facilitate the interoperability of products and services.

General safety of products

The framework Directive 92/59/EEC leaves it to the European standards to
define the technical specifications applicable to the products in question. The
establishment of these specifications and the implementation of the standards
require prior research in numerous fields: ergonomics, construction,
engineering, toxicology, biomechanics, etc.

Quality is now recognized as being a strategic instrument/wr _excellence._ As such, it has become one of the key
factors in the competitiveness of companies and thus their capacity to innovate. Quality and innovation are
inseparable. Quality is also a guarantee of the competitiveness of services closely connected the health, safety
and environment of European citizens.

European quality promotion policy for improving European competitiveness (SEC (96) 2000).

Benchmarking the competitiveness of European industry (COM (96) 463 final, 9 October 1996).

Services: In this document this term covers all technical services: public or private services with the exception
of services in banking, insurance, distribution, education and training.

Prenormative research: All R&D activities including demonstration projects needed to establish a standard plus
the activities required for proper implementation.
Green Paper on Innovation (COM (95) 688 final, 20/12/95).

Although it is very difficult to quantify their economic impact, the significance of standards for industry
and services is undeniable. For example:

- the use of standardized techniques allows manufacturers to save time and money in developing their
own techniques;

- standardization offers a choice of many equally valid solutions which often exist side-by-side and, as a
result, it facilitates the design and production of equipment;

- the fact that products and components available on the market are consistent with standards gives
potential customers exact knowledge of their technical characteristics, thereby enabling them to make
the right choice in terms of quality and price;

- standardized specifications for appliances or components facilitate "'interoperability". i.e. they allow
consumers to use appliances and equipment from different sources.

In Europe standards have mainly been developed by the CEN, CENELEC and ETSI [1] l'.sing different
approaches:

- First and foremost, standards developed at the request of industry in order to establish a coherent
market and to define rules and a common framework conducive to trade. These standards enable

manufacturers to establish universally-recognized specifications for design. performance. composition.
tolerances and other characteristics.

_**Rational use**_ _**ofenersv**_ _**in**_ _**buildinss**_

_**Between**_ _**1986 and 1993**_ _**twelve national buildings rcsearch centres**_
_**joined forces in a**_ _**JOULE**_ _**project**_ _**(non-nuclear**_ _**energy) to**_ _**dewlop**_
_**a series of test**_ _**cells**_ _**for innovative building components (e.g.**_
_**super-insulating**_ _**or smart**_ _**glazing)**_ _**and a reliable and rapid**_
_**procedure ofmeasuring**_ _**the optical**_ _**and**_ _**thermal properties of these**_

_**components.**_

_**The**_ _**consortiuin**_ _**cooperated actively**_ _**throughout**_ _**the**_ _**entire**_ _**period**_
_**with the CEN's Technical Committee 89 in order to establish**_

_**standards**_ _**on the thermal performances**_ _**of buildings and**_
_**components. The cells are currently operational and managed by**_
_**an**_ _**EEIG.**_

_JOULE!_ _Joint_ _Opportumties_ _for_ _Unconventional_ _or_ _Long-term Energy Supp'iy_
_EEIG_ _European_ _Economic Jnterest_ _Groupmg_

Secondly, standards mandated by the Commission which have been developed to implement new
approach European Directives [2] .

_CEN_ _European_ _Committee_ _for_ _Standardization_

_CENELEC_ _European Committee for_ _Electrotechnical_ _Standardization_

_ETSI_ _European Telecommunications_ _Standards_ _Institute_

**Council Resolution: "New approach to technical harmonization and standardization"** **(O.l No** **L** **1 "i<** 4.6.1985).

These standards, which are principally performance standards [1], enable manufacturers to demonstrate
that their products are consistent with the essential requirements set out in the directives. Many of
them have needed prior research or post-research work to solve implementing problems. Numerous
examples illustrate these activities throughout this document.

_Food_ _packasins_

_In_ _1992 some 28_ _million_ _tonnes ofplastics were_ _used in the EC_ _as packaging_ _for foodstuffs_
_which_ _hadto complywith_ _the_ _provisions ofDirective_ _89/109/EEC,_ _namely:_

_a) not_ _to containinatefoodstuffs through any transfer_ _ofconstituents;_
_b) not_ _to cause unacceptable changes_ _to the_ _composition_ _of the foodstuffs; and_
_c)_ _not_ _to rob_ _the foodstuffs of their_ _organoleptic_ _properties._
_The CEN is currently working on the standardization of 33_ _analytical_ _methods of_
_quantifying the_ _level_ _of_ _contaminants._ _These methods are being_ _developed_ _as part of a_
_research project in the Standards, Measurements and Testing Programme and are_
_supported via_ _the_ _preparation_ _of certified_ _reference_ _materials._

Thirdly, ISO/EN 9000 and EN 45000 standards to define the organization of quality and systems of
laboratory accreditation. These standards have made for procedures to evaluate the conformity of
products and services which are mutually recognized by the Member States. A similar approach was
adopted for the standard ISO 14001 which implements an environmental impact assessment procedure
for industrial activities and services.

ISO 9000 standards were first published in 1987. They have since become widely
recognized by the industry and the services sector and have been adopted by almost all
the members of the International Standards Organization (ISO).
A survey run by Mobile Europe Ltd showed that at the end of 1995 more than 127 000
certificates had been issued throughout the world and that the number was growing
constantly.
ISO 9000 certification is often required for major public works contracts and many of
the big manufacturing industries have introduced quality systems which are applicable
to all their suppliers. At present this certification of such systems is not limited solely
to big companies, it also includes small and medium-sized enterprises and is rapidly
being extended to the services sector.
Another survey run by the Manchester Business School in 1995 showed that ISO 9000certified companies had a higher turnover than the national average and a four times
better chance of surviving the current economic recession.

Finally, standards connected to the development of high-technology sectors [information society
(including satellites [2] ) or biotechnology]. These standards are very important to the competitiveness of
industry and services in that they give preference to the European approach at world level.

Standards which establish the general framework of a system arc called performance standards as
opposed to product standards which dcscribe in detail a product or a proccss. The flexibility of the
standards allows industry to producc compctitive products and services at world levcl while fostering an
innovative approach in continually evolving areas and inspiring confidence in users and consumcrs.
Preparatory document on "EU action plan : satellite communications in the Information Society" (COM(97) 91
final, 5/3/1997).

_**Mobile communications**_

_**In 1993 the**_ _**value**_ _**of**_ _**output**_ _**in the EC in telecommunications**_ _**equipment was**_
_**ECU1S**_ _**425m,**_ _**16% more than in the USA and 53% more than in**_ _**Japan.**_ _**This**_
_**reflects**_ _**the development**_ _**of standards**_ _**such**_ _**as**_ _**ISDN**_ _**(Integrated Services Digital**_
_**Network),**_ _**GSM**_ _**(Global**_ _**System**_ _**for Mobile Communications) and DECT (Digital**_
_**European**_ _**Cordless**_ _**Telecommunications),**_ _**allo/European**_ _**origin.**_

_**RACE and its**_ _**suecessor,**_ _**ACTS, are currently**_ _**working**_ _**on the development of**_
_**standards for the Universal Mobile Telecommunications System (VMTS).**_ _**These**_
_**should integrate**_ _**domestic and**_ _**prqfessional**_ _**services**_ _**whereby**_ _**individual pieces of**_
_**equipment**_ _**will**_ _**be**_ _**capable**_ _**ofproviding multimedia mobile services.**_

RACE Research in Advanced Communications in Europe
ACTS Advanced Communications Technologies and Services

**2.2** **IpternatiQnal frade**

The establishment of the big internal market in Europe, the ratification of agreements from the
Uruguay Round and the existence of the World Trade Organization (WTO) are accelerating the
removal of technical barriers to trade (TBT), [1] in particular by way of the code of good practice.
The Community has thus set two fundamental objectives:

   - firstly, to reduce or prevent the establishment of protectionist standards or technical barriers on
markets outside the Union;

   - secondly, to promote the development and adoption of standards and regulatory approaches
among its partners which are compatible with or even based on European practices.
These concerns of the Community are coming increasingly to the forefront, for example, in the
transatlantic dialogue within the Transatlantic Advisory Committee on Standards, Certification and
Regulatory Policy (TACS).

_**EXTRACT FROM THE TACS REPORT OF**_ _**JUNE1996**_

_**The establishment**_ _**ofa**_ _**transatlantic market needs the adoption**_ _**ofa**_ _**multiple strategy,**_
_**including, in addition to the**_ _**mutual**_ _**recognition of agreements, greater use of**_
_**international**_ _**standards, the elimination of certification procedures and double**_
_**verification,**_ _**the development and use of**_ _**common**_ _**industrial standards, the use of**_
_**functional**_ _**standards in regulations and directives and greater transparency,**_
_**participation and cooperation in**_ _**theprocess ofdrafting**_ _**standards.**_
_**To sum up,**_ _**theprinciple**_ _**to be adopted should be**_ _**"once**_ _**verified accepted by**_ _**all".**_

Community external trade policy in the field of standards and conformity assessment (COM (96) 564 final).

International standards make for economies of scale not only for nultinational coinpanies but also for
SMEs which export or supply parts incorporated in units for export.
In short, **standards reduce barriers to trade and assist the** **development** **of** **markets** **in the**
**economic areas** **where** **they are applied.**

**2.3** **Economic** **impact** **of standards**

The first figure shows the importance that European organizations attach to international
standardization. [1] This is reflected by the number of secretariats within the ISO.
The other three figures show the progression in the annual production of standards by the three
European standards organizations to meet the needs of industry.

Secretariat of international technical groups CEN - Annual prod. of standards
by region (end of 1994)

Tapan

_**Europe**_ _**\**_ _**^\^**_
_64%_ _\_

Others

7%

North

/ America

_J_ 26%

**800**

**700**

**600**

**500**

**400**

**300**

**200**

**100**

**0**

CENELEC - Annual prod. of standards ETSI-Annual prod.of standards

##### **_m m_**

_mm_

The economic impact of adopting a standard can be illustrated by numerous examples, one of them
being the mobile telephones now seen everywhere (see box on previous page).
In a similar area connected with data transmission Japan has also had success with the vehicle
guidance system. Since the display panels have been standardized some 400 000 vehicles have been
fitted with the system.

The ISO secretariat conducted a study using the PERINORM database (produced by AFNOR, DIN
and BSI) on the significance of normative work in certain technical areas. [2] This study compares the
number of standards produced between 1965 and 1994 in a given economic sector and the import and
export volume in US dollars. The results, as presented in the following examples, suggest that in some
sectors the normative effort is limited, in particular in the construction industry.

1 Report on the progress of European standardization (SEC (95) 2104).
2 R. Weissinger: ISO standards and international markets; a preliminary analysis of their correlative development.
May 1995, ISO, Geneva.

In contrast, in the services sector such as health and medicine where significant normative work would
not normally be expected the effort is proportional to or greater than the increase in trade.

Construction Health and Safety

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**32**

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Packaging and Distribution Mechanical Engineering.

3000 T

In Europe the 25 000 standards (adopted or in preparation - i.e. five new standards per working day) from
the CEN, CENELEC and ETSI are a clear sign of harmonization and economic integration.
This effort also has an effect on harmonization at world level, given the agreements concluded by the
European standards bodies with the ISO. The final two graphs show the degree of transposition between
ISO/CEN and ISO/CENELEC.

**CENELEC**
**CEN**

In conclusion, it can be said that the European strategy consists of combating protectionist standards
and promoting the adoption of international rules and standards, thereby providing European
manufacturers with access to the world market without barriers. The production of new, specific
standards requires prior research which the Community must support.

**3.** **SITUATION OF PRENORMATIVE RESEARCH** **IN** **THE COMMISSION'S SPECIFIC**

**PROGRAMMES**

One of the principal objectives of these specific programmes is to strengthen the scientific and
technological bases of European industry, as enshrined in the Treaty on European Union.
The first area of activity of the 4th Research and Development Framework Programme (1994-98)
comprises 15 specific programmes. All the specific programmes refer to prenormative research. That
said, the way in which this research is carried out and the importance actually attached to it vary
considerably from one programme to another.

**3.1** **Information technologies and communications**

This specific programme fully integrates prenonnative research in its strategy, thus making for
complete interoperability of products and services. A series of consultation and exchange mechanisms
witli the European standards bodies (CEN. CENELEC, ETSI) have been set up.

_INFORMATION TECHNOLOGIES AND_ _COMMUNICATIONS_

_Advanced Informatics in Medicine_ _(AIM)_

_By setting up technical committees and_ _working_ _parties with the CEN and EJVOS, AIM has_
_prepared a_ _work_ _programme and initiated the development of_ _specifications_ _for a_ _broadfield_
_ofactivities relating_ _to the establishment, protection and exchange_ _ofpatents._

_Technology Initiative for the Disabled_ _andElderly (TIDE)_

_Preliminary studies have been undertaken to develop TIDE and these have_ _led_ _to_ _mandates_
_for the_ _ETSI,_ _CEN and CENELEC and concerted action projects as part of the COST_
_organization._

_Advanced Transport_ _Telematics_ _(ATT/DRIl_ _[/]_ _EII)_
_Ten working parties have been set up to identify the subjects relating to this programme and_
_these working parties have prepared the requisite documents for the technical committees of_
_CEN and CENELEC_

_ESPRIT_

_The scientific managers responsible for this specific programme are asked_
_to identify the possible_ _links_ _between existing projects and standards in_
_order to improve the utilization of resulis or the development of_ _ne>v_
_technologies._ _Studies are therefore undertaken under the "Accompanying_
_measures"_ _section which_ _could lead_ _to the_ _defmition of_ _new priorities for_
_research, changes in activities for the standards organizations or, via the_
_technological_ _coordination_ _groups consisting of representatives from the_
_Member_ _States, the issue of new standardization remits. In the STEP_
_(Standard for the Exchange and Representation of Product_ _Model_ _Data)_
_and CNMA (Communications Network for Manufacturing_ _Applications)_
_programmes_ _these activities_ _apply_ _to_ _both_ _research and_ _demonstration_
_projects._

**3.2** **Industrial** **materials** **and technologies**

The specific BRITE-EURAM III programme covers broad technological and industrial sectors. It
does not specifically finance prenormative projects, but it includes prenormative aspects in the criteria
for evaluating projects for selection (optimization and dissemination). During the research phase the
Commission's scientific follow-up calls for a check of the possible impact of the work in progress,
either on the creation of new standards or on the use and development of existing ones. All in all,
some 26% of the projects financed are of great to very great benefit to the standards needed by
industry, a quarter of them accounting for the specific programme's success stories.

**• ~ i**

_**BRITE-EURAM**_ _**III:**_ _**Technical inspection**_ _**ofaircraft**_

_**In 1992 the cost of servicing the**_ _**undercarriages ofthe**_ _**European**_ _**fleet**_ _**exceeded**_ _**ECU15**_ _**000m,**_
_**Thisfigure will**_ _**probably be over ECU 24 000m in**_ _**theyear**_ _**2000.**_
_**The**_ _**standardized**_ _**inspection procedures (for big as**_ _**well**_ _**as**_ _**small**_ _**aircraft) recently**_ _**developed**_
_**under the**_ _**BRITEprogramme**_ _**will minimize**_ _**human**_ _**error and maximize reliability. At the**_ _**same**_
_**time**_ _**they will make for**_ _**more**_ _**efficient use of resources**_ _**and,**_ _**consequently,**_ _**more profiiable**_
_**operating ofthe**_ _**air fleet. As inspection is a**_ _**keypart ofthe**_ _**cost of servicing aircraft**_ _**andthus**_ _**an**_
_**important aspect**_ _**on**_ _**purchase,**_ _**thefact ofhaving**_ _**a standardized and more competitive**_ _**systemfor**_
_**European aircraft should**_ _**lead airlines**_ _**to purchase entirely**_ _**European**_ _**fleets.**_

_**BRITE-EURAM**_ _**III:**_ _**Manufacture**_ _**ofcar seats**_

The aim of the project initially was to reduce the design and
development time of seats using a concurrent engineering method. The
specifications for seats developed in this project now form the basis for
standards used for the comfort and safety of passengers. The success of
this new process is such that it is already being used by Lear
Corporation to the benefit of several car manufacturers.

3.3 Standards, Measurements **and** Testing

The specific "Standards, Measurements and Testing" (SMT) programme is the only one designed to
develop tools to support the Commission's quality promotion policy. Being horizontal in nature, it is
involved in all physical, chemical and biological sectors where measurement and test methods need to
be developed. It promotes activities linked to prenormative research and has also helped to improve
standards in various important areas and, as such, the smooth operating ofthe internal market, e.g. in
the control of raw materials (break resistance of metals), the characterization of manufactured
products (sound insulation of windows) and better quality of services (control of the microbiological
quality of bathing water). This programme is also responsible for research into and production of
Certified Reference Materials (CRMs). The aim of developing numerous CRMs is to guarantee the
implementation of standards and directives (see box).

**10**

_**SMTJ**_ _**CettiteàR*ferenùeM<*e*m (CRMs)**_

_**Ihe**_ _**Standards,**_ _**Measurements and**_ _**Testing**_ _**programme**_ _**r**_ _**m**_ _**conjunction with the JRC>**_ _**has**_
_**dëvetaped**_ _**ctose**_ _**to**_ _**400**_ _**CRMs**_ _**in the**_ _**sectors ofthe**_ _**environment,**_ _**health**_ _**and**_ _**safety at**_ _**work,**_ _**agri~**_
_**fiHtfMffi,**_ _**mkwbiafygy***_ _**ttomtdtefae,**_ _**properfiefùftmtria&**_ _**ete,**_ _**Mwe thm 90 àthet ÇMMs are**_

_**cttrrentïyBewgprepareÂ**_

_**These**_ _**CRMs,**_ _**i&ongwith**_ _**tkose produced by the**_ _**JRC**_ _**m**_ _**tkenuctear $ectar>**_ _**are**_ _**sold/distiiouied**_ _**By**_
_**thelRClRMMaskeyetementsfor:**_
_**thecomparabtiuy ofthe results oftaboratory**_ _**measurements;**_
_**th»**_ _**appUcatwn4>fnumetvusstandards;**_
_**the**_ _**imptmenta&ttn àfÇùmmtmty îmvm health**_ _**mdmvirmmentalprûtêction;**_

_**the**_ _**mutuat recognuwn af results**_ _**and the**_ _**applxcaûon**_ _**of**_ _**quality**_ _**assurance and**_ _**laboratory**_
_**açûTtditaÛûn**_ _**systems.**_

SMT: Oualitv of bathing water

The microbiological quality of water is the
most important parameter taken into account
by the EC Directive on Bathing Water to
determine the quality of bathing zones
throughout Europe. A prqject launched by the
specific SMT programme in 1992 has
improved the methods of measuring the
microbiological quality of water and made
recommendations in conjunction with DGXI
to improve the comparability of measurements.
The results of the prqject will be used to
develop a European standard on the
performance of methods of measuring the
microbiological quality of water.

SMT: Fire safety of upholstered seats

Fires in homes involving upholstered seats such
as settees are particularly dangerous and cause
numerous deaths every year. At the request of
DGIII (industry) the specific SMT programme
began a prqject in 1993 designed to develop test
methods for measuring the fire performance of
upholstered seats. The prqject was successfully
terminated at the end of 1995, and DGIII
believes that the results will help to develop
European standards on the fire performance of
upholstered seats, thereby helping to improve
the safety of consumers in Europe.

The specific SMT programme aecepts prenormative research projects in its annual calls for proposals.
For the 4th FWP it has also developed a svstem of dedicated calls for proposals. This will help to
meet the R&D needs required to implement European regulations and directives as well as to develop
standards. The subjects to aid standardization are selected in conjunction with the standards bodies
(CEN, CENELEC and ETSI). To this end, the CEN has set up a consultation structure of its
technical committees (CEN-STAR) which will enable it to make an inventory and draw up a list of
priority RTD subjects.

**n**

_CEN-STAR_

_The CEN/BT WG 70_ _[ t(]_ _STAndardization_ _andResearch_ _(STAR)"_ _was set up in 1992 in order to:_

_• prepare guidelines to develop a_ _more_ _efficient_ _link_ _between cooperative_ _R&D_ _and European_
_standardization, the ultimate_ _aim_ _being to improve the speed and quality of the standardization_

_process;_

_• promote these guidelines by participating in_ _thepreliminary_ _consultations of_ _R&D_ _programmes._

_The CEN-STAR committee is_ _made_ _up_ _ofthe_ _chairman of the sectoral committees_ _ofthe_ _CEN and of_
_theplanning_ _committees, assisted by the secretariats_ _ofEFTA,_ _EUREKA, EUROLAB and Commission_
_representatives (DGs III_ _and_ _XII, JRC) and any_ _otherparties_ _involved in standardization._

_Dedicated_ _call:_ _Sample of subjects_ _proposed by the CEN and the General Directorates_
_ofthe_ _Commission for the dedicated call of 27.11.1997:_

_Test_ _method_ _to determine the action of disinfectants on organic materials in contact with_

_drinkingwater._
_Bite_ _test_ _for_ _cltildren_ _'sproducts,_ _in particular_ _toys._
_Fatigue crack_ _growth_ _rate qualifying criteria_ _ofrails_ _for_ _railways_ _: test conditions to be_

_optimised_
_Assessment_ _ofexotic quarantine_ _pest risk to the European_ _Union plant_ _health : analytical_

_methods_

3.4 Agriculture and fisheries

A certain number of prenormative activities can be found in the specific "Agriculture and Fisheries"
programme. These cover in particular the areas of foodstuffs, use of agricultural products for nonfood purposes, and determination of acceptable levels of impurities in food.
Tlie increase in the number of standards for analytical methods clearly illustrates a need and can be
taken as a sign of progress. Alternative solutions are nonetheless necessary to establish performance
criteria in place of reference methods.

_**AIR:**_ _**Biodiesel -**_ _**atiernative renewable fuel without**_ _**risk**_

_**Biodiesel is made up of**_ _**vegetable oils**_ _**and products derived therefrom,**_
_**extracts of non-food**_ _**agricultural**_ _**products.**_ _**It may**_ _**be used as such or**_
_**mixed with**_ _**conventional**_ _**diesel to provide a cleaner renewable**_ _**source**_ _**of**_
_**energy.**_ _**Despite thefact that**_ _**in 1994**_ _**only**_ _**65 000 tonnes were produced**_
_**the AIR demonstration project**_ _**aints**_ _**at**_ _**establishing platfornts**_ _**for the**_
_**future exploration**_ _**ofthe**_ _**market.**_ _**It is in this context that it**_ _**also**_ _**sets out**_
_**to define**_ _**physico-chemical**_ _**parameters for mixtures of**_ _**fuels**_ _**as a**_
_**contribution to future European standards, to**_ _**runfield**_ _**tests for a range**_
_**of cars, to study the**_ _**impact**_ _**on the environment and to define a**_
_**European**_ _**strategyfor large-scale**_ _**production**_ _**instdllations.**_

**12**

3.5 Biotechnology

The specific "Biotechnology" programme includes a sector on prenormative research in bio-safety to
assist the regulation of biotechnology at European level (managed by the Directorates-General for
Industry, Agriculture and the Environment). The regulation of biotechnology is generally considered
to be one of the most important factors for the competitiveness of the biotechnology industry in Europe
in the spirit of the precautionary principle.

_**Biotechnoloev**_

_**Prenormative research**_ _**also**_ _**involves the development of new in vitro**_
_**approaches in pharmacotoxicoloev**_ _**which**_ _**avoid**_ _**animal**_ _**experiments.**_
_**This research is carried out in conjunction with the European centres for**_
_**the validation of new methods (ECVAM:**_ _**European Centres for the**_
_**Validation of**_ _**Alternative**_ _**Methods) of the JRC in**_ _**Ispra**_ _**and the in vitro**_
_**testing industrial platform**_ _**(IVTIP)**_ _**with about 20 companies in the**_
_**toxicology sector.**_

3.6 Environment and climate

The specific "Environrnent and climate" (E&C) programme sets out to foster the development of
environmentally friendly products, technologies and services and to promote the definition of
environmental quality criteria. Its research activities fall Vvithin the spirit of the Commission's 5th
programme of action for the environment and sustainable development and also in a more general
framework in connection with certain activities of the OECD (tests on chemical products). Several
fields of activity are concemed, in particular the protection and improvement of the quality of water
and air and the risk management of industrial activities. Prenormative research in the E&C programme
is closely coordinated with the activities of the JRC and the specific SMT programme.

_Incineration_ _ofhazardous_ _waste:_

_The European_ _directive_ _on the incineration of hazardous waste (94/67/EC) sets_
_maximum emission limits for several toxic substances and,_ _among_ _other things,_
_obliges the_ _Member_ _States to control the rate of emission of dioxins_ _from_
_incinerators._ _Three standards prepared by CEN_ _lay_ _down the procedures for_
_sampling and measuring dioxins and a set_ _ofnine_ _certified reference materials is in_
_the_ _process_ _ofbeing_ _produced in conjunction with the specific SMT programme._

_E&C:_ _air_ _pualitv_

_The results_ _ofthe_ _APHEA and_ _PEACEprojects concerning limit_ _values for_ _S0_ _2_ _,_ _No_ _x_
_and suspended particulates in air indicate a correlation between the_ _level_ _of these_
_pollutants in the atmosphere_ _oftowns_ _and cities and respiratory and cardio-vascular_
_diseases. These limits_ _could_ _be used to revise the values adopted by the_ _Commission_
_(Directives 80/779/EEC and 85/203/EEC) and the WHO._

**13**

3.7 **Prenormative activities** of **the** **JRC**

The Commission undertakes direct R&D activities by way of its Joint Research Centre. The latter
contributes to the activities of normative research in several fields, including advanced materials (in
conjunction with the specific Industrial Materials and Technologies programme), structure stability
and the environment. The JRC has opened a dialogue with the CEN-STAR to improve the utilization
of the results of its research through standardization.

JRC: Seismic protection

Collapsing buildings, bridges and other structures due
to earthquakes result in economic and human loss.
The JRC's test laboratory ELSA is working together
with 18 European laboratories, as part of the
networks established by the specific mobility and
training of researchers programme, to test buildings
(mock-ups or full-scale models) or other constructions.
The aim is to develop and validate improvements
concerning "Eurocodes" (Directive on construction
products). This installation is unique in Europe.

4. INCREASING THE EFFECTIVENESS OF COMMUNITY PRENORMATIVE RESEARCH

4.1 Coordination between the specific programmes of the **4th** FWP

The various specific programmes of the FWP do not have a coordinated policy where standards bodies
are concerned. If all the normative needs required to develop a European quality promotion policy for
products and services are to be taken into account, all the specific programmes and JRC should have
some form of communication structure with the standard bodies and the users of standards. This

would guarantee the harmonious and effective inclusion of the normative dimension in research
projects.

RECOMMENDATION

_A mechanism to improve communication and coordination between the specific research and_
_innovation programmes, the JRC and the economic operators involved in standardization._

4.2 Research specifically geared to standards

Many prenormative research projects in Europe are never submitted for the various programmes of the
4th FWP. This is because the parties in question do not know that these projects are eligible since
there is not sufficient information about the various programmes. Only the specific SMT programme
is very active in the prenormative sector. However, it does not cover all needs since it is limited to
measurements and testing. This situation will only get worse if Community research does not give
wholehearted support to a quality policy where standards are an essential tool. The areas of
prenormative research eligible in the various programmes should therefore be stressed.

14

**RECOMMENDATIONS**

_**Make programme participants not or barely active in**_ _**tlte**_ _**field of standardization aware of the**_
_**potential**_ _**ofstandards where**_ _**utilization**_ _**ofresults**_ _**is**_ _**concerned**_

_**Make proposers aware, at the preliminary evaluation stages,**_ _**ofthe importance**_ _**of the normative**_
_**dimension (especially**_ _**inprojects with**_ _**quality objectives) for utilization**_ _**ofresults.**_

**4.3** **Prenormative research and the environment**

According to the objectives ofthe 5th programme of action for the environment "For a sustainable
development", prenormative research should be promoted in the field of environmental protection.
This applies in particular to research projects on industrial materials and technologies. Concern for
the environment involves both the scientific and technical aspects and the socio-economic impact of
projects.

**RECOMMENDATION**

_**The parties and participants involved in**_ _specific_ _**programmes**_ _**need**_ _**to be**_ _**made**_ _**aware**_ _**ofthe**_ _**need**_
_**to take account**_ _**ofthe**_ _**environmental dimension**_ _**ofthe**_ _**results of**_ _research projects._

**4.4** **Prenormative research and intellectual property rights**

For the normative dimension to be integrated in specific R&D programmes the fact has to be taken
on board that prenormative research is not by definition an obstacle to the protection of intellectual
property rights. Early dialogue and cooperation between researchers and standards bodies can
remove any problems of intellectual property. The implication of this research on the property of
results and their dissemination needs to be spelt out during the negotiation of research contracts and
agreements between partners. Conflicts rarely arise for performance standards or standards
providing a basis for the interoperability of new technologies.

This aspect of relations between research and standardization was covered by a memorandum
published by CEN/CENELEC in 1992 (CEN/CENELEC Memorandum No 8, 1992/03). A major
conclusion of this memorandum was that potential conflicts are rare, given the areas and objectives
of standards. A procedure guaranteeing copyright was drawn up.

**RECOMMENDATIONS**

_**Improve communication between researchers and standards bodies to**_ _fdcilitate_ _**the protection**_ _of_
_**intellectual property rights**_ _**when**_ _**the results of research are transferred**_ _to standards bodies_ _[1]_ _._

The First Action Plan for Innovation in Europe (COM(96)589 final, 20/11/1996).

**15**

**4.5** **Prenormative** **research and innovation** **[1 ]**

Rather than acting as a brake, creating an environment which is conducive to innovation will promote
performance standards and voluntary agreements, improve the juxtaposition between tlie establishment
of standards and scientific and technical development and increase the awareness of the authors and
users of standards, especially SMEs.

**RECOMMENDATION**

_Member_ _States are asked to encourage the adoption of voluntary standards_ _between_
_manufacturers and suppliers_ _andto_ _opt, wherever possible, for performance standards._

4.6 Transfer of results **to** standards bodies

The results of Community research projects (direct action by the JRC or indirect) can be optimized
through standardization. This will depend both on the transfer of the results to the standards bodies
(authors and users) and on the phasing of research with the various preparatory stages.
Presentation of results and the method of transfer must be set out at the project design stage.
Experience with the specific SMT programme has shown that researchers rarely make this
presentation effort, either as regards the content, the form of information, the identification of CEN,
CENELEC or ETSI committees, the inclusion of these committees in identification or the utilization of

research results.

To remedy these shortcomings, proponents have been asked to include, at the proposal stage
(evaluation criterion), all the requisite information and all the means to be used. A clause has also been
added to contracts to guarantee communication between researchers anti standards bodies.

**RECOMMENDATIONS**

_Guarantee that when projects are evaluated relations with the standards bodies and an expression_
_oftheir_ _needs are recognized_

_Guarantee that the conditions are included in RTD project contracts for the transfer of results to_
_standards bodies._

_Guarantee that as projects unfold purely normative activities are carried out in parallel with the_
_research._

_TJie_ _JRC must guarantee transfer_ _ofthe_ _results_ _ofits_ _research to the standards bodies._

4.7 International dimension of prenormative research

Being a tool to improve the quality of products and services, standardization, as mentioned above,
comes witliin the framework of world trade rather than the Community. This is especially so of
emerging and enabling technologies. In this case it is essential for prenormative research to be part of
a supra-Community context. There should thus be collaboration with participants from third countries
in order to guarantee the acceptability of standards to emerge from this research. In this way,
standardization, while taking account of the economic and socio-cultural needs of the partners, can
make for a European approach at world level.

The First Action Plan for Innovation in Europe (COM(96)589 final, 20/11/1996).

**16**

RECOMMENDATION

_Examine the possibility, in conjunction with the economic operators_ _(IRDAC,_ _CEN, CENELEC,_
_ETSI,_ _etc), of opening up prenormative projects to non-European partners to guarantee_ _their_
_adaptation and acceptance, as_ _well_ _as the transfer_ _ofresults,_ _at international_ _level_

4.8 Dedicated calls for proposals of the specific SMT programme

Promoters and producers are rarely enthusiastic about normative research. Furthermore, in the
Commission's conventional mechanism for calls for proposals the rate of success is poor, and thus
researchers are not encouraged to build projects along these lines. The pilot project for dedicated calls
in the specific SMT programme, on the other hand, meets the specific needs of prenormative research.
The introduction of this system of calls has required standards bodies to set up a selection process for
their topics and priorities with every guarantee of fairness and transparency. The criteria and
mechanisms for selecting topics are specific to each body, depending on their structures and rules of
operation. The Commission, for its part, organizes an evaluation independent of the topic submitted
and the technical documents that accompany them. In addition to the specific nature of the topics, this
system could apply to the "urgencv" of problems to be tackled, with a shortening of the time span
between the selection of the topic and the commencement of research work.
Being entirely horizontal in function, the specific SMT programme could assist the other research
programmes and provide a coordinating function for prenormative activities.

RECOMMENDATIONS

_Identify prenormative research needs in the specific programmes which have been identified_
_during the implementation_ _ofthe_ _4th_ _FWPand_ _at JRC, indicating the urgency of the problems._

_Adapt selection procedures for the topics and projects_ _ofthe_ _dedicated calls, especially in urgent_

_cases._

4.9 Kev actions [1] ofthe 5th Research and Development Framework Programme

Since standardization is of strategic interest at the European level, prenormative research has obvious
added value. Consequently, the results of a prenormative research project in one of the thematic
programmes ofthe 5th FWP could be of interest to other projects or other programmes or structures.
Similarly, other quality tools developed in the thematic programmes or at the JRC (e.g. new measuring
instruments, new methods of measurement and control of production, results of impact studies on
processes or products, etc.) should, together with prenormative research projects, form part of a
coherent whole which should be coordinated.

Optimisation of approaches and investments needs global coordination of resources and research
projects in support of standardisation. Given the wide subject matter of standards, this coordination
must transcend the structures of RTD programmes and integrate them in projects geared to regulations
(directives, etc).

**l** Commission working paper "Towards the Fifth Framework programme: scientific and technological objectives"',
COM(97) 47 final, 12/02/97.

**17**

**A strategy of this** **kind** **should, for example, be** put in **place** in **each thematic** programme of **the 5th**
**FWP, backed up** if needed at **the** **level** of "key actions", so as to take account of the needs of
prenormative research.

**RECOMMENDATIONS**

_**A capability should be provided for in each thematic programme**_ _**ofthe**_ _**5th FWP, backed up if**_
_**needed at the level of**_ _**"key**_ _**actions",**_ _**which**_ _**ensures the monitoring of prenormative projects and**_
_**other projects developing**_ _**tools**_ _**in support of quality**_ _**such**_ _**as : measurements, tests, management**_
_**and quality assurance techniques...;**_

_**Member**_ _**States should be prompted to step up tlteir information activities to**_ _**make**_ _**the economic**_
_**operators involved in**_ _**standardisation,**_ _**including SMEs, aware**_ _**ofthe role**_ _**played by standards**_ _**in**_
_**optimising and disseminating results.**_

**5.** **CONCLUSIONS**

The approach to and investment in community RTD need to be optimized and coordinated in order
to promote the normative impact. The measures proposed above should be seen as priorities for
improving prenormative research and the quality of structures and standards. Some of these
recommendations require fairly significant changes whereas others could be put into effect quite
quickly.

In order of priority, these are as follows:

   - To set up a mechanism to improve communication and coordination between research and
innovation programmes, the JRC, and the economic operators involved in standardization;

   - A capability should be provided for in each thematic programme of the 5th FWP, backed up if
needed at the level of "key actions", which ensures the monitoring of prenormative prqjects and
other prqjects developing tools in support of quality such as: measurements. tests, management
and quality assurance techniques...;

     - Member States should be prompted to step up their information activities to make the economic
operators involved in standardisation, including SMEs, aware ofthe role played by standards in
optimising and disseminating results.

**18**

##### ISSN 0254-1475

## COM(98) 31 final

# **DOCUMENTS**

#### EN 15 01 10 Catalogue number : CB-CO-98-024-EN-C ISBN 92-78-30235-X

Office for Official Publications of the European Communities

L-2985 Luxembourg

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