98/34/EC - - - I
1This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
DIRECTIVE 98/34/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 22 June 1998
aying down a procedure for the provision of information in the field of technical standards and
regulations and of rules on Information Society services;
(OJ No L 204, 21. 7. 1998, p. 37)
Amended by:
Official Journal
No page date
Directive 98/48/EC of the European Parliament and of the Council of 20 July
1998L 217 18 5. 8. 199898/48/EC
98/34/EC - - - I
IDIRECTIVE 98/34/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 22 June 1998
laying down a procedure for the provision of information in the field of technical standards and
regulations and of rules on Information Society services;
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,
Having regard to the T reaty establishing the European
Community, and in particular Articles 100a, 213 and 43
thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance with the procedure laid down in Ar-
ticle 189b of the T reaty (3),
(1) Whereas Council Directive 83/189/EEC of 28 March
1983 laying down a procedure for the provision of
information in the field of technical standards and re-
gulations (4) has been variously and substantially
amended; whereas for reasons of clarity and rational-
ity the said Directive should be consolidated;
(2) Whereas the internal market comprises an area with-
out internal frontiers in which the free movement of
goods, persons, services and capital is ensured; where-
as, therefore, the prohibition of quantitative restric-
tions on the movement of goods and of measures hav-
ing an equivalent effect is one of the basic principlesof the Community;
(3) Whereas in order to promote the smooth functioning
of the internal market, as much transparency as poss-
ible should be ensured as regards national initiatives
for the establishment of technical standards or regula-
tions;
(4) Whereas barriers to trade resulting from technical re-
gulations relating to products may be allowed only
where they are necessary in order to meet essential
requirements and have an objective in the public in-
terest of which they constitute the main guarantee;
(5) Whereas it is essential for the Commission to have
the necessary information at its disposal before the
adoption of technical provisions; whereas, consequent-
ly, the Member States which are required to facilitate
the achievement of its task pursuant to Article 5 of
the T reaty must notify it of their projects in the field
of technical regulations;
(1) OJ C 78, 12. 3. 1997, p. 4.
(2) OJ C 133, 28. 4. 1997, p. 5.
(3) Opinion of the European Parliament of 17 September
1997 (OJ C 304, 6. 10. 1997, p. 79), Council CommonPosition of 23 February 1998 (OJ C 110, 8. 4. 1998, p. 1)and Decision of the European Parliament of 30 April 1998(OJ C 152, 18. 5. 1998). Decision of the Council of 28May 1998.
(
4) OJ L 109, 26. 4. 1983, p. 8. Directive as last amended by
Commission Decision 96/139/EC (OJ L 32, 10. 2. 1996, p.31).98/48/EC
98/34/EC - - - I
II(6) Whereas all the Member States must also be in-
formed of the technical regulations contemplated by
any one Member State;
(7) Whereas the aim of the internal market is to create
an environment that is conducive to the competitive-
ness of undertakings; whereas increased provision of
information is one way of helping undertakings to
make more of the advantages inherent in this market;
whereas it is therefore necessary to enable economic
operators to give their assessment of the impact of
the national technical regulations proposed by other
Member States, by providing for the regular publica-
tion of the titles of notified drafts and by means of
the provisions relating to the confidentiality of such
drafts;
(8) Whereas it is appropriate, in the interests of legal cer-
tainty, that Member States publicly announce that anational technical regulation has been adopted in ac-
cordance with the formalities laid down in this Direc-
tive;
(9) Whereas, as far as technical regulations for products
are concerned, the measures designed to ensure the
proper functioning or the continued development of
the market include greater transparency of national
intentions and a broadening of the criteria and condi-
tions for assessing the potential effect of the proposed
regulations on the market;
(10) Whereas it is therefore necessary to assess all the re-
quirements laid down in respect of a product and to
take account of developments in national practices for
the regulation of products;
(11) Whereas requirements, other than technical specifica-
tions, referring to the life cycle of a product after it
has been placed on the market are liable to affect the
free movement of that product or to create obstacles
to the proper functioning of the internal market;
(12) Whereas it is necessary to clarify the concept of a de
facto technical regulation; whereas, in particular, the
provisions by which the public authority refers to
technical specifications or other requirements, or en-
courages the observance thereof, and the provisions
referring to products with which the public authority
is associated, in the public interest, have the effect of
conferring on such requirements or specifications a
more binding value than they would otherwise have
by virtue of their private origin;
(13) Whereas the Commission and the Member States
must also be allowed sufficient time in which to pro-
pose amendments to a contemplated measure, in
order to remove or reduce any barriers which it might
create to the free movement of goods;
(14) Whereas the Member State concerned must take ac-
count of these amendments when formulating the de-
finitive text of the measure envisaged;
98/34/EC - - - I
III(15) Whereas it is inherent in the internal market that, in
particular where the principle of mutual recognition
cannot be implemented by the Member States, the
Commission adopts or proposes the adoption of bind-
ing Community acts; whereas a specific temporary
standstill period has been established in order to pre-
vent the introduction of national measures from com-
promising the adoption of binding Community acts by
t h eC o u n c i lo rt h eC o m m i s s i o ni nt h es a m ef i e l d ;
(16) Whereas the Member State in question must, pursu-
ant to the general obligations laid down in Article 5
of the T reaty, defer implementation of the contem-
plated measure for a period sufficient to allow either
a joint examination of the proposed amendments or
the preparation of a proposal for a binding act of the
Council or the adoption of a binding act of the Com-
mission; whereas the time limits laid down in theAgreement of the representatives of the Governments
of the Member States meeting within the Council of
28 May 1969 providing for standstill and notification
to the Commission (
1), as amended by the Agreement
of 5 March 1973 (2), have proved inadequate in the
cases concerned and should accordingly be extended;
(17) Whereas the procedure concerning the standstill ar-
rangement and notification of the Commission con-
tained in the abovementioned agreement of 28 May
1969 remains applicable to products subject to that
procedure which are not covered by this Directive;
(18) Whereas, with a view to facilitating the adoption of
Community measures by the Council, Member States
should refrain from adopting technical regulations
once the Council has adopted a common position on
a Commission proposal concerning that sector;
(19) Whereas, in practice, national technical standards may
have the same effects on the free movement of goods
as technical regulations;
(20) Whereas it would therefore appear necessary to in-
form the Commission of draft standards under similar
conditions to those which apply to technical regula-
tions; whereas, pursuant to Article 213 of the T reaty,
the Commission may, within the limits and under the
conditions laid down by the Council in accordance
with the provisions of the T reaty, collect any informa-
tion and carry out any checks required for the per-
formance of the tasks entrusted to it;
(21) Whereas it is also necessary for the Member States
and the standards institutions to be informed of stan-
dards contemplated by standards institutions in the
o t h e rM e m b e rS t a t e s ;
(1) OJ C 76, 17. 6. 1969, p. 9.
(2) OJ C 9, 15. 3. 1973, p. 3.
98/34/EC - - - I
IV(22) Whereas systematic notification is actually necessary
only in the case of new subjects for standardisation
and in so far as the treatment of these subjects at
national level may give rise to differences in national
s t a n d a r d sw h i c ha r el i a b l et od i s t u r bt h ef u n c t i o n i n g
of the market as a result; whereas any subsequent
notification or communication relating to the progress
of national activities must depend on the interest in
such activities expressed by those to whom this new
subject has already been communicated;
(23) Whereas the Commission must nevertheless be able
to request the communication of all or part of the
national standardisation programmes so that it can re-
view the development of standardisation activity in
particular economic sectors;
(24) Whereas the European standardisation system must
be organised by and for the parties concerned, on abasis of coherence, transparency, openness, consensus,
independence of special interests, efficiency and deci-
sion-making based on national representation;
(25) Whereas the functioning of standardisation in the
Community must be based on fundamental rights for
the national standardisation bodies, such as the possi-
bility of obtaining draft standards, being informed of
the action taken in response to comments submitted,
being associated with national standardisation acti-
vities or requesting the preparation of European stan-
dards in place of national standards; whereas it is for
the Member States to take the appropriate measures
in their power to ensure that their standardisation
bodies observe these rights;
(26) Whereas the provisions concerning the standstill ar-
rangements applicable to national standardisation
bodies when a European standard is in preparation
must be brought into line with the relevant provisions
adopted by the standardisation bodies within the
framework of the European standardisation bodies;
(27) Whereas it is necessary to set up a Standing Commit-
tee, the members of which will be appointed by the
Member States with the task of helping the Commis-
sion to examine draft national standards and cooper-
ating in its efforts to lessen any adverse effects there-
of on the free movement of goods;
(28) Whereas the Standing Committee should be consulted
on the draft standardisation requests referred to in
this Directive;
(29) Whereas this Directive must not affect the obligations
of the Member States concerning the deadlines for
transposition of the Directives set out in Annex III,
Part B,
HAVE ADOPTED THIS DIRECTIVE:
98/34/EC - - - I
1Article 1
For the purposes of this Directive, the following meanings
shall apply:
1. ‘product’, any industrially manufactured product and
any agricultural product, including fish products;
2. ‘service’, any Information Society service, that is to
say, any service normally provided for remuneration,
at a distance, by electronic means and at the individu-
al request of a recipient of services.
For the purposes of this definition:
— ‘at a distance’ means that the service is provided
without the parties being simultaneously present,
— ‘by electronic means’ means that the service is
sent initially and received at its destination by
means of electronic equipment for the processing
(including digital compression) and storage of
data, and entirely transmitted, conveyed and re-ceived by wire, by radio, by optical means or by
other electromagnetic means,
— ‘at the individual request of a recipient of ser-
vices’ means that the service is provided through
the transmission of data on individual request.
An indicative list of services not covered by this defi-
nition is set out in Annex V .
This Directive shall not apply to:
— radio broadcasting services,
— television broadcasting services covered by point
(a) of Article 1 of Directive 89/552/EEC (
1)
3. ‘technical specification’, a specification contained in a
document which lays down the characteristics required
of a product such as levels of quality, performance,
safety or dimensions, including the requirements ap-
plicable to the product as regards the name under
which the product is sold, terminology, symbols, test-
ing and test methods, packaging, marking or labelling
and conformity assessment procedures.
(1) OJ L 298, 17. 10. 1989, p. 23. Directive as last amended
by Directive 97/36/EC (OJ L 202, 30. 7. 1997, p. 1).98/34/EC
98/48/EC
98/34/EC - - - 98/48/EC
98/34/EC - - - I
2The term ‘technical specification’ also covers produc-
tion methods and processes used in respect of agricul-
tural products as referred to Article 38(1) of the
T reaty, products intended for human and animal con-
sumption, and medicinal products as defined in Ar-
ticle 1 of Directive 65/65/EEC (1), as well as produc-
tion methods and processes relating to other products,
where these have an effect on their characteristics;
4. ‘other requirements’, a requirement, other than a
technical specification, imposed on a product for the
purpose of protecting, in particular, consumers or the
environment, and which affects its life cycle after it
has been placed on the market, such as conditions of
use, recycling, reuse or disposal, where such condi-
tions can significantly influence the composition or
nature of the product or its marketing;
5. ‘rule on services’, requirement of a general nature re-
lating to the taking-up and pursuit of service activities
within the meaning of point 2, in particular provisions
concerning the service provider, the services and the
recipient of services, excluding any rules which are
not specifically aimed at the services defined in that
point.
This Directive shall not apply to rules relating to mat-
ters which are covered by Community legislation in
the field of telecommunications services, as defined by
Directive 90/387/EEC (2).
This Directive shall not apply to rules relating to mat-
ters which are covered by Community legislation in
the field of financial services, as listed non-exhaustive-
ly in Annex VI to this Directive.
With the exception of Article 8(3), this Directive shall
not apply to rules enacted by or for regulated markets
within the meaning of Directive 93/22/EEC or by or
for other markets or bodies carrying out clearing or
settlement functions for those markets.
For the purposes of this definition:
(1) Council Directive 65/65/EEC of 26 January 1965 on the
approximation of provisions laid down by law, regulationor administrative action relating to medicinal products (OJ22, 9. 2. 1965, p. 369/65), Directive as last amended byDirective 93/39/EEC (OJ L 214, 24. 8. 1993, p. 22).
(2) OJ L 192, 24. 7. 1990, p. 1. Directive as amended by Di-
rective 97/51/EC (OJ L 295, 29. 10. 1997, p. 23).98/34/EC
98/48/EC
98/48/EC
98/34/EC - - - I
3— a rule shall be considered to be specifically
aimed at Information Society services where,
having regard to its statement of reasons and its
operative part, the specific aim and object of all
or some of its individual provisions is to regulate
such services in an explicit and targeted manner,
— a rule shall not be considered to be specifically
aimed at Information Society services if it affects
such services only in an implicit or incidental
manner.
6. ‘standard’, a technical specification approved by a re-
cognised standardisation body for repeated or contin-
uous application, with which compliance is not com-
pulsory and which is one of the following:
— international standard: a standard adopted by an
international standardisation organisation and
made available to the public,
— European standard: a standard adopted by a
European standardisation body and made avail-
able to the public,
— national standard: a standard adopted by a
national standardisation body and made available
to the public;
7. ‘standards programme’, a work programme of a recog-
nised standardisation body listing the subjects on
which standardisation work is being carried out;
8. ‘draft standard’, document containing the text of the
technical specifications concerning a given subject,
which is being considered for adoption in accordance
with the national standards procedure, as that docu-
ment stands after the preparatory work and as circu-
lated for public comment or scrutiny;
9. ‘European standardisation body’, a body referred to in
Annex I;
10. ‘national standardisation body’, a body referred to in
Annex II;
11. ‘technical regulation’, technical specifications and oth-
er requirements or rules on services, including the
relevant administrative provisions, the observance of
w h i c hi sc o m p u l s o r y ,d ej u r eo rd ef a c t o ,i nt h ec a s e
of marketing, provision of a service, establishment of
a service operator or use in a Member State or a ma-
jor part thereof, as well as laws, regulations or admin-
istrative provisions of Member States, except those
provided for in Article 10, prohibiting the manufac-
ture, importation, marketing or use of a product orprohibiting the provision or use of a service, or estab-
lishment as a service provider.
De facto technical regulations include:98/48/EC
98/34/EC - - - 98/48/EC
98/48/EC
98/48/EC
98/48/EC
98/48/EC
98/48/EC
98/34/EC - - - I
4— laws, regulations or administrative provisions of a
Member State which refer either to technical
specifications or to other requirements or to
rules on services, or to professional codes or
codes of practice which in turn refer to technical
specifications or to other requirements or to
rules on services, compliance with which confers
a presumption of conformity with the obligations
imposed by the aforementioned laws, regulations
or administrative provisions,
— voluntary agreements to which a public authority
is a contracting party and which provide, in the
general interest, for compliance with technical
specifications or other requirements or rules on
services, excluding public procurement tender
specifications,
— technical specifications or other requirements or
rules on services which are linked to fiscal or fi-
nancial measures affecting the consumption of
products or services by encouraging compliance
with such technical specifications or other re-
quirements or rules on services; technical specifi-
cations or other requirements or rules on ser-
vices linked to national social security systems
are not included.
This comprises technical regulations imposed by
the authorities designated by the Member States
and appearing on a list to be drawn up by the
Commission before 5 August 1999 (*), in the
framework of the Committee referred to in Ar-
ticle 5.
T h es a m ep r o c e d u r es h a l lb eu s e df o ra m e n d i n g
this list;
12. ‘draft technical regulation’, the text of a technical
specification or other requirement or of a rule on ser-
vices, including administrative provisions, formulated
with the aim of enacting it or of ultimately having it
enacted as a technical regulation, the text being at a
stage of preparation at which substantial amendments
can still be made;
This Directive shall not apply to those measures MemberStates consider necessary under the T reaty for the protec-
tion of persons, in particular workers, when products are
used, provided that such measures do not affect the prod-
ucts.98/48/EC
98/34/EC
98/34/EC - - - I
5Article 2
1. The Commission and the standardisation bodies re-
ferred to in Annexes I and II shall be informed of the new
subjects for which the national bodies referred to in Annex
II have decided, by including them in their standards pro-
gramme, to prepare or amend a standard, unless it is an
identical or equivalent transposition of an international or
European standard.
2. The information referred to in paragraph 1 shall indi-
cate, in particular, whether the standard concerned:
— will transpose an international standard without being
the equivalent,
— will be a new national standard, or
— will amend a national standard.
After consulting the Committee referred to in Article 5,
the Commission may draw up rules for the consolidated
presentation of this information and a plan and criteriagoverning the presentation of this information in order to
facilitate its evaluation.
3. The Commission may ask for all or part of the stan-
dards programmes to be communicated to it.
It shall make this information available to the Member
States in a form which allows the different programmes to
be assessed and compared.
4. Where appropriate, the Commission shall amend
Annex II on the basis of communications from the
Member States.
5. The Council shall decide, on the basis of a proposal
from the Commission, on any amendment to Annex I.
Article 3
The standardisation bodies referred to in Annexes I and II,
and the Commission, shall be sent all draft standards on
request; they shall be kept informed by the body con-
cerned of the action taken on any comments they have
made relating to drafts.
Article 4
1. Member States shall take all necessary steps to ensure
that their standardisation bodies:
— communicate information in accordance with Articles
2a n d3 ,
— publish the draft standards in such a way that com-
ments may also be obtained from parties established
i no t h e rM e m b e rS t a t e s ,
— grant the other bodies referred to in Annex II the
right to be involved passively or actively (by sending
an observer) in the planned activities,98/34/EC
98/34/EC - - - I
6— do not object to a subject for standardisation in their
work programme being discussed at European level in
accordance with the rules laid down by the European
standardisation bodies and undertake no action which
may prejudice a decision in this regard.
2. Member States shall refrain in particular from any act
of recognition, approval or use by reference to a national
standard adopted in breach of Articles 2 and 3 and of
paragraph 1 of this Article.
Article 5
A Standing Committee shall be set up consisting of repre-
sentatives appointed by the Member States who may call
on the assistance of experts or advisers; its chairman shall
be a representative of the Commission.
The Committee shall draw up its own rules of procedure.
Article 6
1. The Committee shall meet at least twice a year with
the representatives of the standards institutions referred to
in Annexes I and II.
The Committee shall meet in a specific composition toexamine questions concerning Information Society services.
2. The Commission shall submit to the Committee a re-port on the implementation and application of the pro-
cedures set out in this Directive, and shall present propo-
sals aimed at eliminating existing or foreseeable barriers totrade.
3. The Committee shall express its opinion on the com-
munications and proposals referred to in paragraph 2 and
may in this connection propose, in particular, that the
Commission:
— request the European standards institutions to draw
up a European standard within a given time limit,
— ensure where necessary, in order to avoid the risk of
barriers to trade, that initially the Member States con-
cerned decide amongst themselves on appropriate
measures,
— take all appropriate measures,
— identify the areas where harmonisation appears
necessary, and, should the case arise, undertake ap-
propriate harmonisation in a given sector.
4 . T h eC o m m i t t e em u s tb ec o n s u l t e db yt h eC o m m i s -
sion:
(a) before any amendment is made to the lists in An-
nexes I and II (Article 2(1));98/34/EC
98/48/EC
98/34/EC
98/34/EC - - - I
7(b) when drawing up the rules for the consolidated pres-
entation of information and the plan and criteria for
the presentation of standards programmes (Article
2(2));
(c) when deciding on the actual system whereby the ex-
change of information provided for in this Directive is
to be effected and on any change to it;
(d) when reviewing the operation of the system set up by
this Directive;
(e) on the requests to the standards institutions referred
to in the first indent of paragraph 3.
5. The Committee may be consulted by the Commission
on any preliminary draft technical regulation received by
the latter.
6. Any question regarding the implementation of this
Directive may be submitted to the Committee at the re-
quest of its chairman or of a Member State.
7. The proceedings of the Committee and the informa-
tion to be submitted to it shall be confidential.
However, the Committee and the national authorities may,
provided that the necessary precautions are taken, consult,
for an expert opinion, natural or legal persons, including
persons in the private sector.
8. With respect to rules on services, the Commission andthe Committee may consult natural or legal persons from
industry or academia, and where possible representative
bodies, capable of delivering an expert opinion on the so-
cial and societal aims and consequences of any draft rule
on services, and take notice of their advice whenever re-
q u e s t e dt od os o .
Article 7
1. Member States shall take all appropriate measures to
ensure that, during the preparation of a European stan-dard referred to in the first indent of Article 6(3) or after
its approval, their standardisation bodies do not take any
action which could prejudice the harmonisation intended
and, in particular, that they do not publish in the field in
question a new or revised national standard which is not
completely in line with an existing European standard.
2. Paragraph 1 shall not apply to the work of standards
institutions undertaken at the request of the public author-
ities to draw up technical specifications or a standard for
specific products for the purpose of enacting a technical
regulation for such products.98/34/EC
98/48/EC
98/34/EC
98/34/EC - - - I
8Member States shall communicate all requests of the kind
referred to in the preceding subparagraph to the Commis-
sion as draft technical regulations, in accordance with Ar-
ticle 8(1), and shall state the grounds for their enactment.
Article 8
1. Subject to Article 10, Member States shall immediate-
ly communicate to the Commission any draft technical re-
gulation, except where it merely transposes the full text of
an international or European standard, in which case in-
formation regarding the relevant standard shall suffice;
they shall also let the Commission have a statement of the
grounds which make the enactment of such a technical re-
gulation necessary, where these have not already been
made clear in the draft.
Where appropriate, and unless it has already been sent
with a prior communication, Member States shall simulta-
neously communicate the text of the basic legislative or
regulatory provisions principally and directly concerned,
should knowledge of such text be necessary to assess the
implications of the draft technical regulation.
Member States shall communicate the draft again under
the above conditions if they make changes to the draft thathave the effect of significantly altering its scope, shortening
the timetable originally envisaged for implementation, ad-
ding specifications or requirements, or making the latter
more restrictive.98/34/EC
98/34/EC - - - I
9Where, in particular, the draft seeks to limit the marketing
or use of a chemical substance, preparation or product on
grounds of public health or of the protection of consumers
or the environment, Member States shall also forward
either a summary or the references of all relevant data re-
lating to the substance, preparation or product concerned
and to known and available substitutes, where such in-
formation may be available, and communicate the antici-
pated effects of the measure on public health and the
protection of the consumer and the environment, together
with an analysis of the risk carried out as appropriate in
accordance with the general principles for the risk evalu-
ation of chemical substances as referred to in Article 10(4)
of Regulation (EEC) No 793/93 (1)i nt h ec a s eo fa ne x i s t -
ing substance or in Article 3(2) of Directive
67/548/EEC (2) ,i nt h ec a s eo fan e ws u b s t a n c e .
The Commission shall immediately notify the other
Member States of the draft and all documents which have
been forwarded to it; it may also refer this draft, for an
opinion, to the Committee referred to in Article 5 and,
where appropriate, to the committee responsible for the
field in question.
With respect to the technical specifications or other re-quirements or rules on services referred to in the third in-
dent of the second subparagraph of point 11 of Article 1,
the comments or detailed opinions of the Commission or
Member States may concern only aspects which may hin-
der trade or, in respect of rules on services, the free move-
ment of services or the freedom of establishment of service
operators and not the fiscal or financial aspects of the
measure.
2. The Commission and the Member States may makecomments to the Member State which has forwarded a
draft technical regulation; that Member State shall take
such comments into account as far as possible in the
subsequent preparation of the technical regulation.
3. Member States shall communicate the definitive text
of a technical regulation to the Commission without delay.
4. Information supplied under this Article shall not be
confidential except at the express request of the notifying
Member State. Any such request shall be supported by
reasons.
(1) Council Regulation (EEC) No 793/93 of 23 March 1993
on the evaluation and control of the risks of existing sub-stances (OJ L 84, 5. 4. 1993, p. 1).
(2) Council Directive 67/548/EEC of 27 June 1967 on the ap-
proximation of the laws, regulations and administrativeprovisions relating to the classification, packaging and la-belling of dangerous substances (OJ L 196, 16. 8. 1967,p. 1). Directive, as amended by Directive 92/32/EEC, (OJL 154, 5. 6. 1992, p. 1).98/34/EC
98/48/EC
98/34/EC
98/34/EC - - - I
10I nc a s e so ft h i sk i n d ,i fn e c e s s a r yp r e c a u t i o n sa r et a k e n ,
the Committee referred to in Article 5 and the national
authorities may seek expert advice from physical or legal
persons in the private sector.
5. When draft technical regulations form part of
measures which are required to be communicated to the
Commission at the draft stage under another Community
act, Member States may make a communication within the
meaning of paragraph 1 under that other act, provided
that they formally indicate that the said communication
also constitutes a communication for the purposes of this
Directive.
The absence of a reaction from the Commission under this
Directive to a draft technical regulation shall not prejudice
any decision which might be taken under other Community
acts.
Article 9
1. Member States shall postpone the adoption of a draft
technical regulation for three months from the date of re-
ceipt by the Commission of the communication referred to
in Article 8(1).
2. Member States shall postpone:
— for four months the adoption of a draft technical re-
gulation in the form of a voluntary agreement within
the meaning of the second indent of the second sub-
paragraph of point 11 of Article 1,
— without prejudice to paragraphs 3, 4 and 5, for six
months the adoption of any other draft technical re-
gulation (except for draft rules on services),
from the date of receipt by the Commission of the com-
munication referred to in Article 8(1) if the Commission
or another Member State delivers a detailed opinion, with-
in three months of that date, to the effect that the mea-
sure envisaged may create obstacles to the free movement
of goods within the internal market;
— without prejudice to paragraphs 4 and 5, for four
months the adoption of any draft rule on services,
from the date of receipt by the Commission of the
communication referred to in Article 8(1) if the Com-
mission or another Member State delivers a detailed
opinion, within three months of that date, to the ef-
fect that the measure envisaged may create obstacles
to the free movement of services or to the freedom of
establishment of service operators within the internal
market.98/34/EC
98/48/EC
98/34/EC - - - I
11With regard to draft rules on services, detailed opinions
from the Commission or Member States may not affect
any cultural policy measures, in particular in the audiovi-
sual sphere, which Member States might adopt in accord-
ance with Community law, taking account of their linguistic
diversity, their specific national and regional characteristics
and their cultural heritage.
The Member State concerned shall report to the Commis-
sion on the action it proposes to take on such detailed
opinions. The Commission shall comment on this reaction.
With respect to rules on services, the Member State con-
cerned shall indicate, where appropriate, the reasons why
the detailed opinions cannot be taken into account.
3. With the exclusion of draft rules relating to services,
Member States shall postpone the adoption of a draft
technical regulation for twelve months from the date of
receipt by the Commission of the communication referredto in Article 8(1) if, within three months of that date, the
Commission announces its intention of proposing or adopt-
ing a directive, regulation or decision on the matter in ac-
cordance with Article 189 of the T reaty.
4. Member States shall postpone the adoption of a drafttechnical regulation for 12 months from the date of receipt
by the Commission of the communication referred to in
Article 8(1) if, within the three months following that date,
the Commission announces its finding that the draft
technical regulation concerns a matter which is covered by
a proposal for a directive, regulation or decision presented
to the Council in accordance with Article 189 of the
Tr e a t y .
5. If the Council adopts a common position during the
standstill period referred to in paragraphs 3 and 4, that
period shall, subject to paragraph 6, be extended to 18
months.
6. The obligations referred to in paragraphs 3, 4 and 5
shall lapse:
— when the Commission informs the Member States
that it no longer intends to propose or adopt a bind-
ing Community act,
— when the Commission informs the Member States of
the withdrawal of its draft or proposal,
— when the Commission or the Council has adopted a
binding Community act.
7. Paragraphs 1 to 5 shall not apply in cases where:98/48/EC
98/34/EC
98/48/EC
98/34/EC - - - I
12— for urgent reasons, occasioned by serious and unfore-
seeable circumstances relating to the protection of
public health or safety, the protection of animals or
the preservation of plants, and for rules on services,
also for public policy, notably the protection of mi-
nors, a Member State is obliged to prepare technical
regulations in a very short space of time in order to
enact and introduce them immediately without any
consultations being possible or
— for urgent reasons occasioned by serious circum-
stances relating to the protection of the security and
the integrity of the financial system, notably the
protection of depositors, investors and insured per-
sons, a Member State is obliged to enact and imple-
ment rules on financial services immediately.
In the communication referred to in Article 8, the Member
State shall give reasons for the urgency of the measurestaken. The Commission shall give its views on the com-
munication as soon as possible. It shall take appropriate
action in cases where improper use is made of this pro-
cedure. The European Parliament shall be kept informed
by the Commission.
Article 10
1. Articles 8 and 9 shall not apply to those laws, regula-
tions and administrative provisions of the Member States
or voluntary agreements by means of which Member
States:
— comply with binding Community acts which result in
the adoption of technical specifications or rules on
services,
— fulfil the obligations arising out of international agree-
ments which result in the adoption of common techni-
cal specifications or rules on services in the Commun-ity,
— make use of safeguard clauses provided for in binding
Community acts,
— apply Article 8(1) of Directive 92/59/EEC (1),
— restrict themselves to implementing a judgment of the
Court of Justice of the European Communities,
— restrict themselves to amending a technical regulation
within the meaning of point 11 of Article 1, in ac-
cordance with a Commission request, with a view to
removing an obstacle to trade or, in the case of rules
on services, to the free movement of services or the
freedom of establishment of service operators.
(1) Council Directive 92/59/EEC of 29 June 1992 on general
product safety (OJ L 228, 11. 8. 1992, p. 24).98/48/EC
98/34/EC
98/48/EC
98/34/EC
98/48/EC
98/34/EC - - - I
132. Article 9 shall not apply to the laws, regulations and
administrative provisions of the Member States prohibiting
manufacture insofar as they do not impede the free move-
ment of products.
3. Paragraphs 3 to 6 of Article 9 shall not apply to thevoluntary agreements referred to in the second indent of
the second subparagraph of point 11 of Article 1.
4. Article 9 shall not apply to the technical specifications
or other requirements or the rules on services referred to
in the third indent of the second subparagraph of point 11
of Article 1.
Article 11
The Commission shall report every two years to the Euro-
pean Parliament, the Council and the Economic and Social
Committee on the results of the application of this Direc-
tive. Lists of standardisation work entrusted to the Euro-
pean standardisation organisations pursuant to this Direc-
tive, as well as statistics on the notifications received, shall
be published on an annual basis in the Official Journal of
the European Communities.
Article 12
When Member States adopt a technical regulation, it shall
contain a reference to this Directive or shall be accompa-
nied by such reference on the occasion of its official publi-
cation. The methods of making such reference shall be laid
down by Member States.
Article 13
1. The Directives and Decisions listed in Annex III, Part
A are hereby repealed without prejudice to the obligations
of the Member States concerning the deadlines for trans-
position of the said Directives, set out in Annex III, Part
B.
2. References to the repealed directives and decisions
shall be construed as references to this Directive and shall
be read in accordance with the correlation table set out in
Annex IV .
Article 14
This Directive shall enter into force on the 20th day fol-
lowing that of its publication in the Official Journal of the
European Communities .
Article 15
This Directive is addressed to the Member States.98/34/EC
98/48/EC
98/34/EC
98/34/EC - - - I
14ANNEX I
EUROPEAN STANDARDISATION BODIES
CEN
European Committee for Standardisation
Cenelec
European Committee for Electrotechnical Standardisation
ETSI
European Telecommunications Standards Institute98/34/EC
98/34/EC - - - I
15ANNEX II
NATIONAL STANDARDISATION BODIES
1. BELGIUM
IBN/BIN
I n s t i t u tb e l g ed en o r m a l i s a t i o nBelgisch Instituut voor Normalisatie
CEB/BEC
Comité électrotechnique belge
Belgisch Elektrotechnisch Comité
2. DENMARK
DS
Dansk Standard
NTA
T elestyrelsen, National T elecom Agency
3. GERMANY
DIN
Deutsches Institut für Normung e.V .
DKE
Deutsche Elektrotechnische Kommission im DIN und VDE
4. GREECE
ΕΛΟΤ
Ε λ λ η ν ι κ ό ςΟ ρ γ α ν ι σ μ ό ςΤ υ π ο π ο ί η σ η ς
5. SPAIN
AENOR
Asociación Española de Normalización y Certificación
6. FRANCE
AFNOR
Association française de normalisation
UTE
U n i o nt e c h n i q u ed el ’ é l e c t r i c i t é—B u r e a ud en o r m a l i s a t i o n
auprès de l’AFNOR
7. IRELAND
NSAI
National Standards Authority of Ireland
ETCI
Electrotechnical Council of Ireland
8. ITAL Y
UNI (
1)
(1) UNI and CEI, in cooperation with the Istituto superiore delle
Poste e T elecommunicazioni and the ministero dell’Industria, have
allocated the work within ETSI to CONCIT, Comitato nazionale di
coordinamento per le tecnologie dell’informazione.98/34/EC
98/34/EC - - - I
16Ente nazionale italiano di unificazione
CEI (1)
Comitato elettrotecnico italiano
9. LUXEMBOURG
ITM
Inspection du travail et des mines
SEE
S e r v i c ed el ’ é n e r g i ed el ’ É t a t
10. NETHERLANDS
NNI
Nederlands Normalisatie Instituut
NEC
Nederlands Elektrotechnisch Comité
11. AUSTRIA
ON
Österreichisches Normungsinstitut
ÖVE
Österreichischer Verband für Elektrotechnik
12. PORTUGAL
IPQ
Instituto Português da Qualidade
13. UNITED KINGDOM
BSI
British Standards Institution
BEC
British Electrotechnical Committee
14. FINLAND
SFS
Suomen Standardisoimisliitto SFS ry
Finlands Standardiseringsförbund SFS rf
THK/TFC
T elehallintokeskus
T eleförvaltningscentralenSESKO
Suomen Sähköteknillinen Standardisoimisyhdistys SESKO ry
Finlands Elektrotekniska Standardiseringsförening SESKO
rf
(1) UNI and CEI, in cooperation with the Istituto superiore delle
Poste e T elecommunicazioni and the ministero dell’Industria, have
allocated the work within ETSI to CONCIT, Comitato nazionale di
coordinamento per le tecnologie dell’informazione.98/34/EC
98/34/EC - - - I
1715. SWEDEN
SIS
Standardiseringen i Sverige
SEKSvenska elektriska kommissionen
ITS
Informationstekniska standardiseringen98/34/EC
98/34/EC - - - I
18ANNEX III
PART A
Repealed Directives and Decisions
(referred to by Article 13)
Directive 83/189/EEC and its following amendments
Council Directive 88/182/EEC
Commission Decision 90/230/EECCommission Decision 92/400/EEC
Directive 94/10/EC of the European Parliament and Council
Commission Decision 96/139/EC
PART B
List of deadlines for transposition into national law
( r e f e r r e dt oi nA r t i c l e1 3 )
Directive
Deadline for transposition
83/189/EEC (OJ L 109, 26. 4. 1983,
p. 8)3 1 .3 .1 9 8 4
88/182/EEC (OJ L 81, 26. 3. 1988, p.75)1. 1. 1989
94/10/EC (OJ L 100, 19. 4. 1994, p.
30)1. 7. 199598/34/EC
98/34/EC - - - I
19ANNEX IV
CORRELATION TABLE
Directive 83/189/EEC This Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article 5
Article 6 Article 6
Article 7 Article 7
Article 8 Article 8
Article 9 Article 9
Article 10 Article 10
Article 11 Article 11
Article 12 Article 12
— Article 13
— Article 14
— Article 15
Annex I Annex I
Annex II Annex II
— Annex III
— Annex IV98/34/EC
98/34/EC - - - I
20ANNEX V
Indicative list of services not covered by the second subpara-
g r a p ho fp o i n t2o fA r t i c l e1
1. Services not provided ‘at a distance’
Services provided in the physical presence of the provider
and the recipient, even if they involve the use of electronic
devices
(a) medical examinations or treatment at a doctor’s sur-
gery using electronic equipment where the patient is
physically present;
(b) consultation of an electronic catalogue in a shop with
the customer on site;
(c) plane ticket reservation at a travel agency in the physi-
cal presence of the customer by means of a network of
computers;
(d) electronic games made available in a video-arcade
where the customer is physically present.
2. Services not provided ‘by electronic means’
— Services having material content even though provided
via electronic devices:
(a) automatic cash or ticket dispensing machines
(banknotes, rail tickets);
(b) access to road networks, car parks, etc., charging
for use, even if there are electronic devices at theentrance/exit controlling access and/or ensuring
correct payment is made,
— Off-line services: distribution of CD roms or software
on diskettes,
— Services which are not provided via electronic proces-
sing/inventory systems:
(a) voice telephony services;
(b) telefax/telex services;
(c) services provided via voice telephony or fax;(d) telephone/telefax consultation of a doctor;
(e) telephone/telefax consultation of a lawyer;
(f) telephone/telefax direct marketing.
3. Services not supplied ‘at the individual request of a recipi-
ent of services’
Services provided by transmitting data without individual
demand for simultaneous reception by an unlimited number
of individual receivers (point to multipoint transmission):
(a) television broadcasting services (including near-video
on-demand services), covered by point (a) of Article 1
of Directive 89/552/EEC;
(b) radio broadcasting services;
(c) (televised) teletext.98/48/EC
98/34/EC - - - I
21ANNEX VI
Indicative list of the financial services covered by the third sub-
p a r a g r a p ho fp o i n t5o fA r t i c l e1
— Investment services— Insurance and reinsurance operations
—B a n k i n g s e r v i c e s
— Operations relating to pension funds— Services relating to dealings in futures or options
Such services include in particular:
(a) investment services referred to in the Annex to Directive
93/22/EEC (
2); services of collective investment undertak-
ings,
(b) services covered by the activities subject to mutual recogni-
tion referred to in the Annex to Directive 89/646/EEC (3),
(c) operations covered by the insurance and reinsurance acti-
vities referred to in:
— Article 1 of Directive 73/239/EEC (4),
— the Annex to Directive 79/267/EEC (5),
— Directive 64/225/EEC (6),
— Directives 92/49/EEC (7) and 92/96/EEC (8).
(2) OJ L 141, 11. 6. 1993, p. 27.
(3) OJ L 386, 30. 12. 1989, p. 1. Directive as amended by
Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p. 52).
(4) OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by
Directive 92/49/EEC (OJ L 228, 11. 8. 1992, p. 1).
(5) OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by
Directive 90/619/EEC (OJ L 330, 29. 11. 1990, p. 50).
(6) OJ 56, 4. 4. 1964, p. 878/64. Directive as amended by the
1973 Act of Accession.
(7) OJ L 228, 11. 8. 1992, p. 1.
(8) OJ L 360, 9. 12. 1992, p. 1.98/48/EC