# EUR-Lex - 52013PC0932 - EN

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# 52013PC0932

**Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (codification) /* COM/2013/0932 final - 2010/0095 (COD) */**

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EXPLANATORY MEMORANDUM

1.           On 23 April 2010, the Commission
presented a proposal for a Directive of the European Parliament and of the
Council codifying Directive 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[1].

2.           Having regard to the amendment
adopted[2]
in respect of the proposal referred to in point 1 and in view of the work already
carried out in the course of the legislative procedure, the Commission has
decided to present – in accordance with Article 293(2) of the TFEU – an
amended proposal for codification of the Directive in question.

This amended proposal also takes account of the
purely formal or editorial changes proposed by the Consultative Working Party
of the legal services, where these changes are considered justified[3].

3.           The changes made in this amended
proposal, compared with the proposal referred to in point 1, are the following:

(1)     in the title of the act, the words ‘standards
and’ are deleted;

(2)     in the preamble, the formula ‘After
transmission of the draft legislative act to the national Parliaments’ is
inserted after the first two citations, and the words ‘After transmission of
the proposal to the national Parliaments’ are deleted;

(3)     in recital 3, the words ‘standards
or’ are deleted;

(4)     recitals 18 to 25 are deleted;

(5)     recital 26 is renumbered 18 and its
text is replaced by the following:

‘It is necessary to envisage a Standing
Committee, the members of which are appointed by the Member States, with the
task of cooperating in the efforts of the Commission to lessen any adverse
effects on the free movement of goods.’;

(6)     recital 27 is deleted;

(7)     recital 28 is renumbered 19, and the
reference to ‘Annex V’ is replaced by a reference to ‘Annex III’;

(8)     in the last sentence of Article
1(1)(b), the reference to ‘Annex III’ is replaced by a reference to ‘Annex
I’;

(9)     in Article 1(1), points (f) to (j) are
deleted;

(10)   in Article 1(1), point (k) becomes point
(f); in that point, the reference to ‘Article 10’ is replaced by a
reference to ‘Article 7’, and the reference to ‘Article 5’ is
replaced by a reference to ‘Article 2’;

(11)   in Article 1(1), point (l) becomes point
(g);

(12)   in Article 1(2), point (b) is replaced
by the following text:

‘(b)    television broadcasting services
covered by point (e) of Article 1(1) of Directive 2010/13/EU of the European
Parliament and of the Council.’;

(13)   in Article 1(3), the word ‘defined’
is replaced by the word ‘covered’;

(14)   in Article 1(4), the reference to ‘Annex
IV’ is replaced by a reference to ‘Annex II’;

(15)   in Article 1(5), the reference to ‘Article
8’ is replaced by a reference to ‘Article 5’;

(16)   Articles 2, 3 and 4 are deleted;

(17)   Article 5 is renumbered 2;

(18)   Article 6 is renumbered 3; in the first
subparagraph of paragraph 1 of that Article, the final words ‘with the
representatives of the standards institutions referred to in Annexes I and II’
are deleted; in paragraph 3, point (a) is deleted and points (b), (c) and
(d) become respectively points (a), (b) and (c); in paragraph 4, points (a),
(b) and (e) are deleted and points (c) and (d) become respectively points (a)
and (b); in that point (b), the words ‘when reviewing the operation of the
system set up by this Directive’ are replaced by the words ‘when
reviewing the operation of the system provided for in this Directive’;

(19)   Article 7 is renumbered 4 and its text
is replaced by the following:

‘Member States shall communicate to the
Commission, in accordance with Article 5(1), all requests made to standards
institutions to draw up technical specifications or a standard for specific
products for the purpose of enacting a technical regulation for such products
as draft technical regulations, and shall state the grounds for their
enactment.’;

(20)   Article 8 is renumbered 5; in the first
subparagraph of paragraph 1 of that Article, the reference to ‘Article 10’
is replaced by a reference to ‘Article 7’; in the fifth
subparagraph of that paragraph, as well as in the second subparagraph of
paragraph 4, the reference to ‘Article 5’ is replaced by a reference to ‘Article 2’;
in the sixth subparagraph of paragraph 1, the words ‘point (k)’ are
replaced by ‘point (f)’;

(21)   Article 9 is renumbered 6; the
references to ‘Article 8’ in paragraphs 1 to 4 and 7 of that
Article are replaced by references to ‘Article 5’; in the first indent
of paragraph 2, the words ‘point (k)’ are replaced by ‘point (f)’;

(22)   Article 10 is renumbered 7, in
paragraph 1 of that Article, the initial words ‘Articles 8 and 9’ are
replaced by ‘Articles 5 and 6’; in point (f) of that paragraph, as well
as in paragraphs 3 and 4, the words ‘point (k)’ are replaced by ‘point
(f)’; and in paragraphs 2, 3 and 4, the initial references to ‘Article 9’
are replaced by references ‘Article 6’;

(23)   Article 11 is renumbered 8; and the
second paragraph of that Article is replaced by the following text:

‘The Commission shall publish annual
statistics on the notifications received in the Official Journal of the
European Union.’;

(24)   Article 12 is renumbered 9;

(25)   Article 13 is renumbered 10; in the
first paragraph of that Article, the references to ‘Annex V’ are
replaced by references to ‘Annex III’; and in the second paragraph, the
reference to ‘Annex VI’ is replaced by a reference to ‘Annex IV’;

(26)   Articles 14 and 15 are renumbered 11
and 12;

(27)   Annexes I and II are deleted;

(28)   Annex III is renumbered I; in point
3(a) of that Annex, the reference to ‘point (e) of Article 1 of
Directive 89/552/EEC’ is replaced by a reference to ‘point (e) of
Article 1(1) of Directive 2010/13/EU’;

(29)   Annex IV is renumbered II; in point (b)
of that Annex, the reference to ‘Directive 2006/48/CE of the European
Parliament and of the Council’ is replaced by a reference to ‘Directive
2013/36/EU of the European Parliament and of the Council’; and the text in
point (c) is replaced by the words ‘operations covered by the insurance and
reinsurance activities referred to in Directive 2009/138/EC of the European
Parliament and of the Council’;

(30)   Annex V is renumbered III; in Part A of
that Annex, the following entry is added:

‘Regulation (EU) No 1025/2012 of the
European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12) / Only
Article 26(2)’;

(31)   References to acts and to footnotes
have been adapted to take into account the new way of citing acts, applicable
since 1 July 2013; where relevant, the footnotes have been updated.

4.           The Correlation Table, in Annex VI
(renumbered IV), has been amended in accordance with the foregoing.

5.           To facilitate reading and
examination, the full text of the amended proposal for codification is
attached hereto.

ê 98/34/EC
(adapted)

è1 98/48/EC Art. 1 pt. 1

2010/0095 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

è1 laying down a procedure for the provision of
information in the field of technical regulations and of rules on Information
Society services ç (codification)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Articles Ö 114 Õ ,

Ö 337 Õ and 43
thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[4],

Acting in accordance with the ordinary
legislative procedure[5],

Whereas:

ê

(1)       Directive 98/34/EC of the European Parliament and of
the Council[6]
has been substantially amended several times[7].
In the interests of clarity and rationality the said Directive should be
codified.

ê 98/34/EC

(2)       The internal market
comprises an area without internal frontiers in which the free movement of
goods, persons, services and capital is ensured. Therefore, the prohibition of
quantitative restrictions on the movement of goods and of measures having an
equivalent effect is one of the basic principles of the Union.

ê 98/34/EC
(adapted)

(3)       In order to promote the
smooth functioning of the internal market, as much transparency as possible
should be ensured as regards national initiatives for the establishment of
technical regulations.

ê 98/34/EC

(4)       Barriers to trade
resulting from technical regulations relating to products may be allowed only
where they are necessary in order to meet essential requirements and have an
objective in the public interest of which they constitute the main guarantee.

(5)       It is essential for the
Commission to have the necessary information at its disposal before the
adoption of technical provisions. Consequently, the Member States which are
required to facilitate the achievement of its task pursuant to Article 4(3) of
the Treaty on European Union (TEU) must notify it of their projects in the
field of technical regulations.

(6)       All the Member States must
also be informed of the technical regulations contemplated by any one Member State.

(7)       The aim of the internal
market is to create an environment that is conducive to the competitiveness of
undertakings. Increased provision of information is one way of helping
undertakings to make more of the advantages inherent in this market. 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 publication of the titles of notified
drafts and by means of the provisions relating to the confidentiality of such
drafts.

(8)       It is appropriate, in the
interests of legal certainty, that Member States publicly announce that a national
technical regulation has been adopted in accordance with the formalities laid
down in this Directive.

(9)       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
conditions for assessing the potential effect of the proposed regulations on
the market.

(10)     It is therefore necessary
to assess all the requirements laid down in respect of a product and to take
account of developments in national practices for the regulation of products.

(11)     Requirements, other than
technical specifications, 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)     It is necessary to clarify
the concept of a de facto technical regulation. In particular, the
provisions by which the public authority refers to technical specifications or
other requirements, or encourages 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)     The Commission and the Member States must also be allowed sufficient time in which to propose amendments to a
contemplated measure, in order to remove or reduce any barriers which it might
create to the free movement of goods.

(14)     The Member State concerned must take account of these amendments when formulating the definitive text of
the measure envisaged.

ê 98/34/EC
(adapted)

(15)     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 binding acts. A specific temporary standstill period has been
established in order to prevent the introduction of national measures from
compromising the adoption of binding acts by Ö the
European Parliament and Õ the Council or
Ö by Õ the Commission
in the same field.

(16)     The Member State in
question must, pursuant to the general obligations laid down in
Article 4(3) of the TEU, defer implementation of the contemplated measure
for a period sufficient to allow either a joint examination of the proposed
amendments or the preparation of a proposal for a Ö legislative Õ act or the
adoption of a binding act of the Commission.

ê 98/34/EC
recital 18 (adapted)

(17)     With a view to facilitating
the adoption of measures Ö by the
European Parliament and the Council Õ , Member
States should refrain from adopting technical regulations once the Council has
adopted a position Ö at first
reading Õ on a
Commission proposal concerning that sector.

ê 98/34/EC
recital 27 (adapted)

(18)     It is necessary to Ö envisage Õ a Standing
Committee, the members of which Ö are Õ appointed by
the Member States, with the task of cooperating in Ö the Õ efforts Ö of the
Commission Õ to lessen any
adverse effects on the free movement of goods.

ê 98/34/EC
recital 29 (adapted)

(19)     This Directive Ö should be
without prejudice to Õ the
obligations of the Member States Ö relating
to the time-limits Õ for Ö the Õ transposition Ö into Õ national law
of the directives set out in Annex III, Part B,

ê 98/34/EC

HAVE ADOPTED THIS DIRECTIVE:

Article 1

1. For the purposes of this Directive, the
following meanings shall apply:

(a)          ‘product’, any industrially
manufactured product and any agricultural product, including fish products;

ê 98/48/EC
Art. 1 pt. 2(a)

(b)          ‘service’, any Information
Society service, that is to say, any service normally provided for
remuneration, at a distance, by electronic means and at the individual request
of a recipient of services.

For the purposes of this definition:

(i)      ‘at a distance’ means that the
service is provided without the parties being simultaneously present,

(ii)     ‘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 received by wire, by
radio, by optical means or by other electromagnetic means,

(iii)    ‘at the individual request of a
recipient of services’ means that the service is provided through the
transmission of data on individual request.

An indicative list of services not covered by
this definition is set out in Annex I;

ê 98/34/EC
(adapted)

è1 98/48/EC Art. 1 pt. 2(b)

è1 (c) ç        ‘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 applicable to the product as
regards the name under which the product is sold, terminology, symbols, testing
and test methods, packaging, marking or labelling and conformity assessment
procedures.

The term ‘technical specification’ also covers
production methods and processes used in respect of agricultural products as
referred to Article 38(1), second subparagraph of the TFEU, products intended
for human and animal consumption, and medicinal products as defined in Article
1 of Directive Ö 2001/83/EC
of the European Parliament and of the Council[8] Õ, as well as
production methods and processes relating to other products, where these have
an effect on their characteristics;

è1 (d) ç        ‘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
conditions can significantly influence the composition or nature of the product
or its marketing;

ê 98/48/EC
Art. 1 pt. 2(c)

(e)          ‘rule on services’, requirement of
a general nature relating to the taking-up and pursuit of service activities
within the meaning of point (b), 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.

For the purposes of this definition:

(i)      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,

(ii)     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;

ê 98/48/EC
Art. 1 pt. 2(e)

(f)          ‘technical regulation’, technical
specifications and other requirements or rules on services, including the
relevant administrative provisions, the observance of which is compulsory, de
jure or de facto, in the case of marketing, provision of a service,
establishment of a service operator or use in a Member State or a major part
thereof, as well as laws, regulations or administrative provisions of Member
States, except those provided for in Article 7, prohibiting the manufacture,
importation, marketing or use of a product or prohibiting the provision or use
of a service, or establishment as a service provider.

De facto
technical regulations include:

(i)      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,

(ii)     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,

(iii)    technical specifications or other
requirements or rules on services which are linked to fiscal or financial
measures affecting the consumption of products or services by encouraging
compliance with such technical specifications or other requirements or rules on
services; technical specifications or other requirements or rules on services
linked to national social security systems are not included.

ê 98/48/EC
Art. 1 pt. 2(e) (adapted)

This comprises technical regulations imposed by
the authorities designated by the Member States and appearing on a list Ö drawn up
and updated, where appropriate Õ by the
Commission before, in the framework of the Committee referred to in Article 2.

ê 98/48/EC
Art. 1 pt. 2(e)

The same procedure shall be used for amending
this list;

ê 98/48/EC
Art. 1 pt. 2(f)

(g)          ‘draft technical regulation’, the
text of a technical specification or other requirement or of a rule on
services, 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.

ê 98/48/EC
Art. 1 pt. 2(a) (adapted)

2. This Directive shall not apply to:

(a)          radio broadcasting services;

(b)          television broadcasting services
covered Ö by point
(e) of Article 1(1) of Directive 2010/13/EU of the European Parliament and
of the Council[9] Õ.

ê 98/48/EC
Art. 1 pt. 2(c) (adapted)

3. This Directive shall not apply to rules
relating to matters which are covered by Union legislation in the field of
telecommunications services, as Ö covered Õ by
Directive Ö 2002/21/EC
of the European Parliament and of the Council[10] Õ.

4. This Directive shall not apply to rules
relating to matters which are covered by Union legislation in the field of
financial services, as listed non-exhaustively in Annex II to this Directive.

5. With the exception of Article 5(3), this
Directive shall not apply to rules enacted by or for regulated markets
within the meaning of Directive Ö 2004/39/EC
of the European Parliament and of the Council[11] Õ or by or for
other markets or bodies carrying out clearing or settlement functions for those
markets.

ê 98/34/EC
(adapted)

6. This Directive shall not apply to those
measures Member States consider necessary under the Ö Treaties Õ for the
protection of persons, in particular workers, when products are used, provided
that such measures do not affect the products.

ê 98/34/EC

Article 2

A Standing Committee shall be set up
consisting of representatives 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 3

1. The Committee shall meet at least twice
a year.

ê 98/48/EC
Art. 1 pt. 3(a)

The Committee shall meet in a specific
composition to examine questions concerning Information Society services.

ê 98/34/EC

2. The Commission shall submit to the
Committee a report on the implementation and application of the procedures set
out in this Directive, and shall present proposals aimed at eliminating
existing or foreseeable barriers to trade.

3. The Committee shall express its opinion
on the communications and proposals referred to in paragraph 2 and may in this
connection propose, in particular, that the Commission:

(a)          ensure where necessary, in order
to avoid the risk of barriers to trade, that initially the Member States
concerned decide amongst themselves on appropriate measures;

(b)          take all appropriate measures;

(c)          identify the areas where harmonisation
appears necessary, and, should the case arise, undertake appropriate
harmonisation in a given sector.

4. The
Committee must be consulted by the Commission:

(a)          when deciding on the actual
system whereby the exchange of information provided for in this Directive is to
be effected and on any change to it;

ê 98/48/EC
(adapted)

(b)          when reviewing the operation of
the system Ö provided
for in Õ this Directive.

ê 98/48/EC

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
request of its chairman or of a Member State.

7. The proceedings of the Committee and the
information 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.

ê 98/48/EC
Art. 1 pt. 3(b)

8. With respect to rules on services, the
Commission and the Committee may consult natural or legal persons from industry
or academia, and where possible representative bodies, capable of delivering an
expert opinion on the social and societal aims and consequences of any draft
rule on services, and take notice of their advice whenever requested to do so.

ê 1025/2012
Art. 26(2), pt. (f)

Article 4

Member States shall communicate to the
Commission, in accordance with Article 5(1), all requests made to standards
institutions to draw up technical specifications or a standard for specific
products for the purpose of enacting a technical regulation for such products
as draft technical regulations, and shall state the grounds for their
enactment.

ê 98/34/EC

Article 5

1. Subject to Article 7, Member States
shall immediately communicate to the Commission any draft technical regulation,
except where it merely transposes the full text of an international or European
standard, in which case information 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 regulation 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
simultaneously 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.

ê 98/34/EC
(adapted)

Member States shall communicate the draft
again under the conditions Ö set out
in the first and second subparagraphs of this paragraph Õ if they make
changes to the draft that have the effect of significantly altering its scope,
shortening the timetable originally envisaged for implementation, adding
specifications or requirements, or making the latter more restrictive.

Ö Without
prejudice to the provisions of Title VIII of Regulation (EC) No 1907/2006
of the European Parliament and of the Council[12], Õ where, 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 relating to the
substance, preparation or product concerned and to known and available
substitutes, where such information may be available, and communicate the
anticipated 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 principles Ö provided
for in the relevant part of Section II.3 of Annex XV to Regulation (EC)
No 1907/2006 Õ.

ê 98/34/EC

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 2 and, where appropriate, to the committee responsible for the field
in question.

ê 98/48/EC
Art. 1 pt. 4

With respect to the technical
specifications or other requirements or rules on services referred to in point
(iii) of the second subparagraph of point (f) of Article 1(1), the comments or
detailed opinions of the Commission or Member States may concern only aspects
which may hinder trade or, in respect of rules on services, the free movement
of services or the freedom of establishment of service operators and not the
fiscal or financial aspects of the measure.

ê 98/34/EC

2. The Commission and the Member States may make comments 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.

In cases of this kind, if necessary
precautions are taken, the Committee referred to in Article 2 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 Union 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 Union acts.

Article 6

1. Member States shall postpone the
adoption of a draft technical regulation for three months from the date of receipt
by the Commission of the communication referred to in Article 5(1).

ê 98/48/EC
Art. 1 pt. 5(a)

2. Member
States shall postpone:

–
for four months the adoption of a draft
technical regulation in the form of a voluntary agreement within the meaning of
point (ii) of the second subparagraph of point (f ) of Article 1(1),

–
without prejudice to paragraphs 3, 4 and 5, for
six months the adoption of any other draft technical regulation (except for
draft rules on services),

from the date of receipt by the Commission
of the communication referred to in Article 5(1) if the Commission or another
Member State delivers a detailed opinion, within three months of that date, to
the effect that the measure 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 5(1) if
the Commission or another Member State delivers a detailed opinion, within
three months of that date, to the effect 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.

With 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 audiovisual sphere, which Member
States might adopt in accordance with the law of the Union, taking account of
their linguistic diversity, their specific national and regional
characteristics and their cultural heritage.

The Member State concerned shall report to
the Commission 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 concerned 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 referred to in Article 5(1) if, within three
months of that date, the Commission announces its intention of proposing or
adopting a directive, regulation or decision on the matter in accordance with
Article 288 of the TFEU.

ê 98/34/EC
(adapted)

4. Member States shall postpone the
adoption of a draft technical regulation for 12 months from the date of
receipt by the Commission of the communication referred to in Article 5(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 Ö European
Parliament and the Õ Council in
accordance with Article 288 of the TFEU.

5. If the Council adopts a position Ö at first
reading Õ 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:

(a)          when the Commission informs the
Member States that it no longer intends to propose or adopt a binding act;

(b)          when the Commission informs the
Member States of the withdrawal of its draft or proposal;

(c)          when Ö a binding
act has been adopted by Õ the Commission
or Ö by Õ the Ö European
Parliament and the Õ Council.

ê 98/48/EC
Art. 1 pt. 5(b)

7. Paragraphs 1 to 5 shall not apply in
cases where:

(a)          for urgent reasons, occasioned by
serious and unforeseeable 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
minors, 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

(b)          for urgent reasons occasioned by
serious circumstances relating to the protection of the security and the integrity
of the financial system, notably the protection of depositors, investors and
insured persons, a Member State is obliged to enact and implement rules on
financial services immediately.

In the communication referred to in Article
5, the Member State shall give reasons for the urgency of the measures taken.
The Commission shall give its views on the communication as soon as possible.
It shall take appropriate action in cases where improper use is made of this
procedure. The European Parliament shall be kept informed by the Commission.

ê 98/34/EC

Article 7

1. Articles 5 and 6 shall not apply to
those laws, regulations and administrative provisions of the Member States or voluntary agreements by means of which Member States:

ê 98/48/EC
Art. 1 pt. 6(a)

(a)          comply with binding Union acts
which result in the adoption of technical specifications or rules on services;

(b)          fulfil the obligations arising
out of international agreements which result in the adoption of common technical
specifications or rules on services in the Union;

ê 98/34/EC
(adapted)

(c)          make use of safeguard clauses
provided for in binding Union acts;

(d)          apply Ö Article
12(1) of Directive 2001/95/EC of the European Parliament and of the Council[13] Õ;

(e)          restrict themselves to
implementing a judgment of the Court of Justice of the European Union;

ê 98/48/EC
Art. 1 pt. 6(b)

(f)          restrict themselves to amending a
technical regulation within the meaning of point (f) of Article 1(1), in
accordance 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.

ê 98/34/EC

2. Article 6 shall not apply to the laws,
regulations and administrative provisions of the Member States prohibiting
manufacture insofar as they do not impede the free movement of products.

ê 98/48/EC
Art. 1 pt. 6(c) (adapted)

3. Paragraphs 3 to 6 of Article 6 shall not
apply to the voluntary agreements referred to in point (ii) of the second
subparagraph of point (f) of Article 1(1).

4. Article 6 shall not apply to the
technical specifications or other requirements or the rules on services
referred to in point (iii) of the second subparagraph of point (f) of Article
1(1).

ê 98/34/EC
(adapted)

Article 8

The Commission shall report every two years
to the European Parliament, the Council and the Ö European Õ Economic and
Social Committee on the results of the application of this Directive.

ê 1025/2012
Art. 26(2), pt. (g)

The Commission shall publish annual
statistics on the notifications received in the Official Journal of the
European Union.

ê 98/34/EC

Article 9

When Member States adopt a technical
regulation, it shall contain a reference to this Directive or shall be
accompanied by such reference on the occasion of its official publication. The
methods of making such reference shall be laid down by Member States.

ê

Article 10

Directive 98/34/EC, as amended by the acts
listed in Annex III, Part A, is repealed, without prejudice to the obligations
of the Member States relating to the time-limits for the transposition into
national law of the Directives set out in Annex III, Part B of the repealed
Directive and in Annex III, Part B of this Directive.

References to the repealed Directive shall
be construed as references to this Directive and shall be read in accordance
with the correlation table in Annex IV.

ê 98/34/EC

Article 11

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Article 12

This Directive is addressed to the Member
States.

Done at Brussels,

For the European Parliament                        For
the Council

The President                                                 The
President

[1]               COM(2010) 179 final of 23.4.2010.

[2]               OJ L 316, 14.11.2012, p. 12.

[3]               Cf. the opinion of the Consultative Working Party of
7.7.2010.

[4]               OJ C [...], [...], p. [...].

[5]               OJ C [...], [...], p. [...].

[6]               Directive 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 (OJ L 204, 21.7.1998, p. 37).

[7]               See Annex III, Part A.

[8]               Ö Directive
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on
the Community code relating to medicinal products for human use (OJ L 311,
28.11.2001, p. 67) Õ.

[9]               Ö Directive
2010/13/EU of the European Parliament and of the Council of 10 March 2010 on
the coordination of certain provisions laid down by law, regulation or
administrative action in Member States concerning the provision of audiovisual
media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p.
1) Õ.

[10]             Ö Directive
2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a
common regulatory framework for electronic communications networks and services
(Framework Directive) (OJ L 108, 24.4.2002, p. 33) Õ.

[11]             Ö Directive
2004/39/EC of the European Parliament and of the Council of 21 April 2004 on
markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC
and Directive 2000/12/EC of the European Parliament and of the Council and
repealing Council Directive 93/22/EEC (OJ L 145, 30.4.2004, p. 1) Õ.

[12]             Ö Regulation
(EC) No 1907/2006 of the European Parliament and of the Council
of 18 December 2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94
as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1) Õ.

[13]             Ö Directive
2001/95/EC of the European Parliament and of the Council of 3 December 2001 on
general product safety (OJ L 11, 15.1.2002, p. 4) Õ.

ê 98/48/EC
Art. 1 pt. 7

ANNEX I

Indicative list of services not
covered by the second subparagraph of point (b)
of Article 1(1)

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 surgery 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 physical 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 the
entrance/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
processing/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
recipient of services’

Services
provided by transmitting data without individual demand for simultaneous
reception by an unlimited number of individual receivers (point to multipoint
transmission):

ê 98/48/EC
Art. 1 pt. 7 (adapted)

(a)     television broadcasting services
(including near-video on-demand services), covered Ö by point
(e) of Article 1(1) of Directive 2010/13/EU Õ;

ê 98/48/EC
Art. 1 pt. 7

(b)     radio broadcasting services;

(c)     (televised) teletext.

_____________

ANNEX II

Indicative list of the financial
services covered by Article 1(4)

–
Investment services,

–
Insurance and reinsurance operations,

–
Banking services,

–
Operations relating to pension funds,

–
Services relating to dealings in futures or
options.

Such services include in particular:

ê 98/48/EC
Art. 1 pt. 7 (adapted)

(a)          investment services referred to
in the Annex to Directive Ö 2004/39/EC Õ ;
services of collective investment undertakings;

(b)          services covered by the
activities subject to mutual recognition referred to in Ö Annex I
to Directive 2013/36/EU of the European Parliament and of the Council[1]Õ ;

(c)          operations covered by the
insurance and reinsurance activities referred to in Ö Directive
2009/138/EC of the European Parliament and of the Council[2] Õ.

_____________

é

ANNEX III

Part A

Repealed Directive with list of the
successive amendments thereto
(referred to in Article 10)

Directive 98/34/EC of the European Parliament and of the Council (OJ L 204, 21.7.1998, p. 37) || ||

|| Directive 98/48/EC of the European Parliament and of the Council (OJ L 217, 5.8.1998, p. 18) ||

|| Part 1, Title H of Annex II to Act of Accession 2004 (OJ L 236, 23.9.2003, p. 68) || Only as regards the reference to point 2 of Directive 98/34/EC

|| Council Directive 2006/96/EC (OJ L 363 of 20.12.2006, p. 81) || Only as regards the reference to Article 1 of Directive 98/34/EC

|| Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12) || Only Article 26(2)

Part B

List of time-limits for
transposition into national law
(referred to in Article 10)

Directive || Time-limit for transposition

98/34/EC || -

98/48/EC || 5 August 1999

2006/96/EC || 1 January 2007

_____________

ANNEX IV

Correlation Table

Directive 98/34/EC || This Directive

Article 1, first subparagraph, introductory wording || Article 1(1), introductory wording

Article 1, first subparagraph, point (1) || Article 1(1), point (a)

Article 1, first subparagraph, point (2), first subparagraph || Article 1(1), point (b), first subparagraph

Article 1, first subparagraph, point (2), second subparagraph, first indent || Article 1(1), point (b), second subparagraph, point (i)

Article 1, first subparagraph, point (2), second subparagraph, second indent || Article 1(1), point (b), second subparagraph, point (ii)

Article 1, first subparagraph, point (2), second subparagraph, third indent || Article 1(1), point (b), second subparagraph, point (iii)

Article 1, first subparagraph, point (2), third subparagraph || Article 1(1), point (b), third subparagraph

Article 1, first subparagraph, point (2), fourth subparagraph, introductory wording || Article 1(2), introductory wording

Article 1, first subparagraph, point (2), fourth subparagraph, first indent || Article 1(2), point (a)

Article 1, first subparagraph, point (2), fourth subparagraph, second indent || Article 1(2), point (b)

Article 1, first subparagraph, point (3) || Article 1(1), point (c)

Article 1, first subparagraph, point (4) || Article 1(1), point (d)

Article 1, first subparagraph, point (5), first subparagraph || Article 1(1), point (e), first subparagraph

Article 1, first subparagraph, point (5), second subparagraph || Article 1(3)

Article 1, first subparagraph, point (5), third subparagraph || Article 1(4)

Article 1, first subparagraph, point (5), fourth subparagraph || Article 1(5)

Article 1, first subparagraph, point (5), fifth subparagraph, introductory sentence || Article 1(1), point (e), second subparagraph, introductory sentence

Article 1, first subparagraph, point (5), fifth subparagraph, first indent || Article 1(1), point (e), second subparagraph, point (i)

Article 1, first subparagraph, point (5), fifth subparagraph, second indent || Article 1(1), point (e), second subparagraph, point (ii)

Article 1, first subparagraph, point (11), first subparagraph || Article 1(1), point (f), first subparagraph

Article 1, first subparagraph, point (11), second subparagraph, introductory sentence || Article 1(1), point (f), second subparagraph, introductory sentence

Article 1, first subparagraph, point (11) second subparagraph, first indent || Article 1(1), point (f), second subparagraph, point (i)

Article 1, first subparagraph, point (11), second subparagraph, second indent || Article 1(1), point (f), second subparagraph, point (ii)

Article 1, first subparagraph, point (11), second subparagraph, third indent || Article 1(1), point (f), second subparagraph, point (iii)

Article 1, first subparagraph, point (11), third subparagraph || Article 1(1), point (f), third subparagraph

Article 1, first subparagraph, point (11), fourth subparagraph || Article 1(1), point (f), fourth subparagraph

Article 1, first subparagraph, point (12) || Article 1(1), point (g)

Article 1, second subparagraph || Article 1(6)

Article 5 || Article 2

Article 6(1) and (2) || Article 3(1) and (2)

Article 6(3), introductory wording || Article 3(3), introductory wording

Article 6(3), second indent || Article 3(3), point (a)

Article 6(3), third indent || Article 3(3), point (b)

Article 6(3), fourth indent || Article 3(3), point (c)

Article 6(4), introductory wording || Article 3(4), introductory wording

Article 6(4), point (c) || Article 3(4), point (a)

Article 6(4), point (d) || Article 3(4), point (b)

Article 6(5) to (8) || Article 3(5) to (8)

Article 7 || Article 4

Article 8 || Article 5

Article 9(1) to (5) || Article 6(1) to (5)

Article 9(6), introductory wording || Article 6(6), introductory wording

Article 9(6), first indent || Article 6(6), point (a)

Article 9(6), second indent || Article 6(6), point (b)

Article 9(6), third indent || Article 6(6), point (c)

Article 9(7), first subparagraph, introductory wording || Article 6(7), first subparagraph, introductory wording

Article 9(7), first subparagraph, first indent || Article 6(7), first subparagraph, point (a)

Article 9(7), first subparagraph, second indent || Article 6(7), first subparagraph, point (b)

Article 9(7), second subparagraph || Article 6(7), second subparagraph

Article 10(1), introductory wording || Article 7(1), introductory wording

Article 10(1), first indent || Article 7(1), point (a)

Article 10(1), second indent || Article 7(1), point (b)

Article 10(1), third indent || Article 7(1), point (c)

Article 10(1), fourth indent || Article 7(1), point (d)

Article 10(1), fifth indent || Article 7(1), point (e)

Article 10(1), sixth indent || Article 7(1), point (f)

Article 10(2), (3) and (4) || Article 7(2), (3) and (4)

Article 11, first sentence || Article 8, first subparagraph

Article 11, second sentence || Article 8, second subparagraph

Article 12 || Article 9

Article 13 || -

- || Article 10

Article 14 || Article 11

Article 15 || Article 12

Annexe III || -

Annexe IV || -

Annexe V || Annexe I

Annexe VI || Annexe II

- || Annexe III

- || Annexe IV

_____________

[1]               Ö Directive
2013/36/EU of the European Parliament and of the Council of 26 June 2013
on access to the activity of credit institutions and the prudential supervision
of credit institutions and investment firms, amending Directive 2002/87/EC and
repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013,
p. 338) Õ.

[2]               Ö Directive
2009/138/EC of the European Parliament and of the Council of 25 November 2009
on the taking-up and pursuit of the business of Insurance and Reinsurance
(Solvency II)
(OJ L 335, 17.12.2009, p. 1) Õ.