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					                      EUROPEAN COMMISSION
                      ENTERPRISE DIRECTORATE-GENERAL

                      Regulatory policy and standardisation, electronic commerce, telematics networks, environment
                      Standardization




                                                                           Brussels, 26 November 1999

                                                                      Committee on “Standards and
                                                                           Technical Regulations”
                                                                                   Doc. 80/99 – EN


                            Study on the legal aspects of standards

                               Concluding Remarks, Perspectives


15.        Concluding Remarks, Perspectives

The organisation of standardisation, and its regulation by public authorities, is in flux
throughout the European Economic Area. It is hard to overestimate the influence of
European integration and European standardisation policy on this state of affairs. It
should, however, not be forgotten that the European system itself is embedded in wider
developments. Economic globalisation erodes the regulatory capacity of nation-states
generally, and implies the need for transnational arrangements in ever wider geographi-
cal settings. The increased involvement of non-governmental actors in regulation is a
logical corollary to the State‟s withdrawal from many sectors of the economy, or priva-
tisation, and to the widespread movement towards deregulation.

We will first provide a bird‟s eye view of major differences, trends and developments in
national standardisation. We will conclude with an outlook and identify some issues that
merit further reflection in light of the ongoing Europeanisation of standardisation.

15.1       The Organisation and Regulation of Standards Bodies

But for the National Standards Bodies of a few smaller EC Member States, all standards
bodies are organised as non-profit associations where ultimate power is exercised by the
General Assembly of members from sectors of industry and other spheres of society.
The Danish and Dutch bodies, though formally not associations, function in much the
same way1.




1      See section 2.2.
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There is a widespread movement towards privatisation and centralisation of national
standardisation. Spain replaced an administrative body with a private association upon
entering the Community in 1986. Iceland has done the same in 1992 with a view to the
EEA Agreement. In Portugal in 1986 and in Ireland in 1996, the public standards bodies
were given considerably more autonomy by major new legislation. In Denmark in 1992,
and in Luxembourg in 1997, standards activity was merged into a single body. In Nor-
way, a major initiative to improve co-ordination between the various standards bodies
was launched and implemented in 1989. ELOT„s transformation in 1997 from an asso-
ciation to a State-owned joint-stock company should be seen in the same light, as an
effort to streamline standardisation and make it more efficient2.

Historically, standardisation in the electrotechnical field has been a separate activity and
national organisations reflect this tradition. However, truly separate, autonomous, and
equal organisations exist only in Austria, Belgium, Ireland, Italy, and the Netherlands.
The French and German electrotechnical committees are closely connected to the
central standards bodies; the BEC in the UK forms part of BSI. The Finnish, Norwe-
gian, Swedish, and Swiss electrotechnical committees form part of a wider sectorial
differentiation of standardisation in their countries and have their standards adopted by
the central bodies3. Several members of CENELEC do hence not have the competence
to adopt European standards as national standards.

Standardisation in the telecommunications sector is organised differently from other
sectors in most Member States as it is on European level. Usually, this is thought to be
due to the characteristics of the fast moving technology in the sector. Part of it, it is sub-
mitted, stems also from the absence of an associational tradition. Accordingly, ICT
standardisation is both more industry-led and, paradoxically, more directly influenced
by regulatory authorities than standardisation in other fields. In the federal systems of
standardisation, it is often the national Telecom Authority that acts as the standards
body in telecommunications. The designation of NSOs in ETSI testifies to this hybrid
nature: some countries designate their Telecom Authorities (Denmark, Finland, Nor-
way), some their central standards bodies (Belgium, France, Greece, Ireland, Portugal,
Spain, the United Kingdom) and some their electrotechnical standards bodies (the Neth-
erlands, Germany).

It is easy to overstate the case of standardisation as a “private” activity. The Irish,
Luxembourg and Portuguese standards bodies are public agencies, Greek ELOT is a
public corporation. Standardisation is heavily regulated by standards laws in Austria,
Belgium, France, Iceland and Spain. Standards bodies in the United Kingdom and Ger-
many have explicitly taken up public interest duties in contractual relations with the
State. While standards bodies in the other countries are formally autonomous private
organisations, one should be careful not to overstate the formal differences in State
involvement. Functional equivalents for legislative and administrative control are rela-
tively easily found in those countries where standardisation is formally an unregulated
private activity. These are constituted, for example, by the Government‟s power of ap-
proval of the statutes and/or bye-laws of standards associations (as for example in Fin-
land), by strong representation of public authorities in governing bodies (as for example
in Italy), or by the targeting and conditioning of financial support (as for example in

2   See section 2.3.
3   See section 2.2.1.
                                              2
Denmark)4.

More importantly, supported by long traditions and a common culture that extends well
beyond Europe alone, standardisation bodies show remarkable similarities in the way
they organise and carry out the technical work. A hard core of principles of standards
work – elaboration of drafts by technical committees composed of experts, extensive
consultation by means of public enquiry, adoption by consensus – is almost universally
adhered to and safeguarded in statutes and rules of procedure.

15. 2    The Legal Status of Standards in Regulation5

Standards are adopted by Royal Decision in Belgium, need the Minister‟s “consent” in
Ireland, and are subject to a government veto in France. In other countries, standards
are, formally, private recommendations emanating from autonomous private associa-
tions. Still, standards everywhere are of voluntary application unless they are rendered
mandatory by a regulatory act. Austrian, Belgian, French and Irish standards law con-
tain explicit provisions allowing for this. Spanish standards law has abolished the cate-
gory of “official” standards in 1995. Mandatory standards can raise problems under
Community law; they need to be notified as technical regulations under the Information
Directive, and will generally have to be accompanied by mutual recognition clauses, as
recognised by French and Irish standards law. Generally, the trend is clearly away from
mandatory standards.

Reference to standards is on the rise. By law, resolutions or circulars, regulators are
encouraged to use standards rather than draw up technical specifications themselves.
Different techniques are in vogue, however. Two aspects should be distinguished. First,
the strength and precision of the reference itself can differ. Exclusive general references
render standards mandatory without identifying which standards are involved. At the
other extreme, indicative dated references identify exact versions of specific standards
compliance with which is but one of the ways of satisfying legal requirements. While a
general trend can be identified towards the use of the latter technique, the former is still
widely used in for example Belgium, France and Greece. The technique is regarded as
unconstitutional in Austria, Germany and Switzerland. These examples quickly bear out
the second aspect. Regulators use exclusive references more easily when other instru-
ments of control are available. In those countries where standards bodies are either pub-
lic bodies or heavily regulated private bodies, concerns about delegation of regulatory
competences will be less pronounced.

Increased reference to standards in regulation can have far-reaching consequences for
the financial structure of standardisation. Courts in Italy and Germany and the Copy-
right Council in Finland have indicated their unwillingness to give copyright protection
to standards where reference in legislation attaches legal consequences to them.
Although the extent of this trend is not easily evaluated as of yet, the refusal of espe-
cially the Bundesverfassungsgsericht to extend copyright protection to standards that
were referred to in binding regulations should be regarded as an invitation to the stan-

4   See section 2.3.
5   See chapter 9.
                                             3
dardisation community and regulators alike to reconsider the financial basis of stan-
dardisation6.

15.3        The Legal Status of Standards in Private Law

Standards serve a vital economic function in lowering transaction costs, creating market
transparency and stabilising reciprocal expectations. Standards can lay down baseline
requirements of quality, care and skill. As such, they can be vital resources for private
contracts. However, it seems that the potential of standards is still largely to be discov-
ered in this area at least in some countries and sectors7.

Moreover, standards can play an important role in the establishment of civil liability.
Generalising beyond important nuances, the status of standards in private law is strik-
ingly similar throughout the European Economic Area. Compliance with standards will
be interpreted by courts as an indication, but no more than that, that legal requirements
of skill and care have been fulfilled. Non-compliance with standards will lead to a pre-
sumption, and often more than that, that these requirements have not been met. Both
statements are subject to important qualifications, however.

In contract law, the existence of standards does not discharge professionals of the duty
to deliver work up to the general levels of quality in the sector concerned or to be up to
date as regards new methods and techniques. Compliance with obsolete standards will
generally not serve the purpose of avoiding contractual liability, unless it can not be
expected of the professional concerned in the given circumstances to be aware of the
technical obsolescence of the standard. On the other hand, non-compliance will likely
have no consequences if the standards concerned are not widely known and used, obso-
lete, or so complex that compliance cannot be expected in the given circumstances of
the professional concerned.

In tort, compliance with standards is widely interpreted as a necessary but insufficient
condition to avoid liability. Of particular importance in this regard is the fact that stan-
dards are generally written for normal use of products and methods: they cannot be
expected to cover every foreseeable contingency and hence cannot be relied upon in all
circumstances. Non-compliance with standards will often lead to a reversal of the bur-
den of proof, in that the defendant will have to offer proof that he has honoured his obli-
gations of care in some other way.

In the harmonised field of product liability, standards are explicitly left out of the
definition of a defectless product lest manufacturers be made into the “masters of their
own liability”. Nor can compliance with standards be deemed automatically to liberate
manufacturers from liability under the “development risk” clause which excludes liabil-
ity in case “the state of scientific and technical knowledge” at the time the product was
put into circulation was not such as to enable the existence of the defect to be discov-
ered.



6      See section 7.2.
7      See chapter 12.
                                             4
15. 4       Legislative and Judicial Requirements on Standardisation

The formulation of legal requirements as to the technical sophistication and updatedness
of standards differs slightly in the EEA. German law, and the State„s contract with DIN,
uses “anerkannte Regeln der Technik”, or “acknowledged rules of technology”. As
defined by EN 45020, acknowledged rules of technology are “technical provisions
acknowledged by a majority of representative experts as reflecting the state of the art”.
The French “règles de l‘art”, and the Italian “a regola d‘arte”, for example, seem to
lack this subjective element and are more akin to the objective “state of the art”.

These definitions bring out the two accumulative elements of requirements placed on
standards. They need to be up to date and technically valid, reflecting expert knowledge.
It might be useful to recall the statement of the Cour d‘Appel de Bruxelles to the effect
that a standard establishes a minimum requirement which is not admissible if the state
of knowledge at the time permitted better performances8. Standards also need to be
elaborated according to procedures that ensure wide representation and consensus, tak-
ing into account the “public interest”. To recall a statement from the German Bundes-
verwaltungsgericht this time, one must not overlook that standards are agreements
between interested parties which have the aim to influence market events in a certain
way9. The point is well made in BS 0-210:

“The quality of standards and their acceptance, particularly by the courts, depends
largely upon the widest and most authoritative representation available. Any imbalance
in the constitution of committees could result in the production of an inadequate stan-
dard which, if discredited by a court decision, might jeopardise the status of standards
generally.”

The precarious, and sometimes even deteriorating, position of public interest groups in
standards bodies is therefore not only to be lamented from a general standpoint of
associational democracy11, but could also hurt courts„ acceptance of standards.

Especially in the light of increased privatisation and centralisation of standardisation,
standards bodies should take up their increased responsibility and step up their efforts to
provide for vigorous procedures and mechanisms that ensure, on the one hand, that the
public interest be taken into account, and, on the other hand, that technical coherence
not be sacrificed to political or economic compromise. Public financial support for the
participation of public interest groups in standardisation, under pressure in several coun-
tries, is vital in this respect.

15.5        The Europeanisation of Standardisation
            and its Impact on National Standardisation


8      See section 14.2.1.
9      See section 4.5.
10     See section 4.1.
11     See section 4.2.
                                            5
European standardisation has an enormous impact on regulatory arrangements at
national level. On the one hand, European standards law and policy has led to explicit
recognition of public interest duties to standards bodies in those countries where no
such regulatory tradition existed. The duties imposed by the Information Directive as
regards standardisation have given rise to a Luxembourg standards body in the first
place; in countries such as Italy and the Netherlands the Directive has led the
government, whether by legislation or by contract, to clarify relations between public
authorities and standards bodies. On the other hand, it has led to greater autonomy and
privatisation of standards bodies in those countries with strong regulatory traditions of
administrative oversight.

Much more important is the factual deplacement of national standards by European
standards with the enormous increase in the production of the European standards bod-
ies. Luxembourg„s SÉÉ does nothing but implement European standards. To a lesser but
significant extent, the same can be said of other smaller countries; at the end of 1997 in
Austria, Belgium, Iceland, the Netherlands, Norway and Switzerland more than 40 % of
the national standards repository in the non-electrotechnical field were already based on
European standards, adopted by CEN. Even in the big standardisation countries France,
Germany, Italy, Spain and the United Kingdom, far more European standards are im-
plemented every year now than purely national standards adopted12. Moreover, also
under pressure of the WTO Agreement on Technical Barriers to Trade13 and according
to agreements between the European and the international standards bodies14, more and
more European and national standards will be based on international standards.

This Europeanisation of standardisation implies a shift in functions and roles for
national standards bodies. Regulatory and organisational arrangements at national level,
however, are hardly being adapted to this new reality. While most standards bodies are
conceived of as fora for discussion and standards-writing, their new role implies a
monopoly of representation in European and international standards bodies and limited
influence in the final drafting of standards. Where standards are conceptualised as docu-
ments established with the consensus of all interested parties, standards bodies that are
outvoted at European level are obliged to transpose European standards nonetheless.

Inevitably, consensus building at national level comes under pressure in case of Euro-
pean standards, if only because of the time limits imposed by the European bodies„ rules
of procedure. Moreover, ICT standardisation and the associated need for efficiency,
flexibility and sheer speed puts further pressure on well established standardisation pro-
cedures and the concept of “consensus” itself.

These developments should not obscure the national standards bodies„ duties to take up
the responsibility that their monopoly of representation in the European standards
bodies brings. They should be creative and vigorous in adapting their procedures and
mechanisms for consensus-building to the realities and time pressures associated with
European standardisation.

12   See section 1.5.
13   See section 1.4.2.
14   See section 1.4.1.
                                            6
15.6     European Standardisation – Problems and Prospects

European standards have no autonomous status; they need to be transposed as national
standards. Under the Internal Regulations of the European Standards Bodies, National
Standards Bodies are obliged to do so. However, Belgian, French and Irish standards
law require government approval for the adoption of standards, including European
standards. This makes the fulfilment by AFNOR, IBN/ BNI and NSAI of their contrac-
tual duties towards the European standards bodies dependent on government discretion.
While it is relatively easy to argue that the clauses concerned should be modified in the
light of the principle of Community loyalty enshrined in Article 5 EC, this should not
obscure the deeper and very real problems and concerns involved. Member States have
legitimate concerns and interests which national and European Standards Bodies alike
should take into account through appropriate mechanisms and procedures. One such
mechanism is found in several national arrangements and seems relatively easy to trans-
plant to the European level: one could envisage a non-intrusive mechanism whereby
national delegations in European Technical Committees are obliged to present com-
ments received from their respective public authorities during public enquiry; con-
sequently, if it is decided not to incorporate these comments, European Technical Com-
mittees could be obliged to state their reasons in written form for not doing so.

However, not only regulatory instruments stand in the way of automatic transposition of
European standards. BSI„s duty of care under liability law, for example, is claimed to
stand in the way of “blind” transposition of European standards as well. As noted
before, courts„ acceptance of standards depends widely on both demonstrable expertise
and wide representation of interested circles. The need for efficiency at European level
should not sacrifice these principles lest European standards be discredited by national
courts. Further development of the involvement of European public interest groups in
European standardisation seems, in this regard, a necessary condition.

The European standardisation system is firmly based on established principles of
national representation, transparency, openness, consensus, independence and wide-
spread and authoritative representation. However, absent clear Community rules codi-
fying these principles, national regulators and public interest groups will continue to
raise concerns as regards the legitimacy of the system. Moreover, these principles are
coming under pressure from both developments in ICT standardisation with its empha-
sis on speed and flexibility and from developments in the WTO where the TBT„s
definition of “international standards” seems more and more to be interpreted as to
include de facto international standards not necessarily adopted by consensus, and not
necessarily including representation of all national standards bodies that wish to partici-
pate. An initiative to enshrine these principles clearly and unambiguously in Commu-
nity rules would clearly invigorate the Community„s defence of them in international
fora.




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