Agreement between the European Community and the Republic of Malta laying down a procedure for the provision of information in the field of technical regulations and of rules on information society services
Date: 2004-04-24
Institutions: European Community, Malta
Subjects: European standard, Malta, agreement (EU), bilateral agreement, exchange of information, information society, service, technical regulations

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between the European Community and the Republic of Malta laying down a procedure for the
provision of information in the field of technical regulations and of rules on information society
services

AGREEMENT

THE EUROPEAN COMMUNITY,

hereinafter referred to as ‘the Community’,

on the one hand, and

THE REPUBLIC OF MALTA, hereinafter referred to as ‘Malta’,

on the other hand,

hereinafter referred to as ‘the Contracting Parties’,

HAVING REGARD to the Agreement establishing an Association between the European Economic Community, of the
one part, and the Republic of Malta, of the other part (1) and in particular to the aims set out in Article 2(1) thereof,

HAVING REGARD to the information procedure on technical regulations and rules on information society services
applied within the European Community (2),

CONSIDERING the commitment of the Contracting Parties to promote harmonious economic relations between them-
selves,

CONSIDERING the ongoing cooperation between the Contracting Parties in the field of technical barriers to trade and
the common understanding reached within the framework of that cooperation to extend this information procedure on
technical regulations and rules on information society services applied in the Community to Malta,

HAVE AGREED AS FOLLOWS:

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

Article 1

This Agreement shall not apply to:

— radio broadcasting services,

For the purpose of this Agreement, the following definitions
apply:

— television broadcasting services covered by point (a) of

Article 1 of Directive 89/552/EEC (3);

(a) ‘product’: any industrially manufactured product and any

agricultural product, including fish products;

(b) ‘service’: any information society service, by which is meant
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:

— ‘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 elec-
tronic equipment for the processing (including digital
compression) and storage of data, and entirely trans-
mitted, conveyed and received by wire, by radio, by
optical means or by other electromagnetic means,

— ‘at the individual request of a recipient of services’:
means that the service is provided through the trans-
mission of data on individual request.

(1) OJ L 61, 14.3.1971, p. 2.
(2) 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
rules on information society services (OJ L 204, 21.7.1998, p. 37);
Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998,
p. 18).

(c) ‘technical specification’: a specification contained in a docu-
ment 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,
testing and test methods,
packaging, marking or labelling and conformity assessment
procedures.

terminology,

symbols,

This definition also covers production methods and
processes used in respect of agricultural products as
referred to in Article 38(1) of the Treaty establishing the
European Community, products intended for human and
animal consumption, and medicinal products as defined in
Article 1 of Directive 2001/83/EC (4), as well as production
methods and processes relating to other products, where
these have an effect on their characteristics;

(3) Council Directive 89/552/EEC of 3 October 1989 on the coordina-
tion of certain provisions laid down by law, regulation or adminis-
trative action in Member States concerning the pursuit of television
broadcasting activities (OJ L 298, 17.10.1989, p. 23); Directive as
last amended by Directive 97/36/EC (OJ L 202, 30.7.1997, p. 60).
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).
Directive as amended by Directive 2002/98/EC (OJ L 33, 8.2.2003,
p. 30).

the European Parliament and of

(4) Directive 2001/83/EC of

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(d) ‘other requirements’: a requirement, other than a technical
imposed on a product for the purpose of
specification,
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;

(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 therein.

This Agreement shall not apply to rules relating to matters
which are covered by Community legislation in the field of
telecommunications services, as defined by Directive 90/
387/EEC (1).

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

With the exception of Article 11, this Agreement shall not
apply to rules enacted by or for regulated markets within
the meaning of Directive 93/22/EEC (2) or by or for other
markets or bodies carrying out clearing or settlement func-
tions for those markets.

For the purposes of this definition:

— 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 provi-
sions 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;

(f) ‘technical

regulation’:

technical specifications and other
including the relevant
requirements or rules on services,
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 one of the Member States of the European Com-
munity, hereinafter referred to as ‘Member States’, or a
major part thereof, or in Malta or a major part thereof, as
well as laws, regulations or administrative provisions of the
Member States or of Malta, except those provided for in
importation,
Article 12, prohibiting the manufacture,
marketing or use of a product or prohibiting the provision
or use of a service, or establishment as a service provider.

the internal market

(1) Council Directive 90/387/EEC of 28 June 1990 on the establish-
services
ment of
through the implementation of open network provision (OJ L 192,
24.7.1990, p. 1); Directive as amended by Directive 97/51/EC (OJ L
295, 29.10.1997, p. 23).

telecommunications

for

(2) Council Directive 93/22/EEC of 10 May 1993 on investment
services in the securities field (OJ L 141, 11.6.1993, p. 27); Direc-
tive as last amended by Directive 2002/87/EC (OJ L 35, 11.2.2003,
p. 1).

De facto technical regulations include:

— laws,

regulations or administrative provisions of a
Member State or Malta 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
rules on services, excluding
public procurement tender specifications,

requirements or

— 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
rules on
services; technical specifications or other requirements
or rules on services linked to national social security
systems are not included.

requirements or

This comprises technical regulations imposed by the autho-
rities designated by the Member States and appearing on a
list (3) drawn up by the Commission of
the European
Communities, thereinafter called ‘the Commission’, in the
framework of the Committee referred to in Article 5 of
Directive 98/34/EC. Malta shall draw up such a list and
forward it to the Commission on the first day of the first
month following the entry into force of this Agreement.

The same procedure shall be used for amending this list;

(g) ‘draft technical regulation’: the text of a technical specifica-
tion 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.

Article 2

This Agreement shall not apply to those measures the Member
States consider necessary under the Treaty establishing the
European Community or Malta considers necessary for the
protection of persons, in particular workers, when products are
used, provided that such measures do not affect the products.

(3) OJ C 23, 27.1.2000, p. 3.

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Article 3

1.
Subject to Article 12, the Community shall notify Malta
of the draft technical regulations notified to it by its Member
States. Where these technical regulations merely transpose the
full text of an international or European standard, information
regarding the relevant standard shall suffice. It shall also let
Malta have a statement of the grounds which make the enact-
ment of such a technical regulation necessary, where these
have not already been made clear in the draft.

2.
Subject to Article 12, Malta shall likewise notify the Com-
munity of its draft technical regulations. Where these technical
regulations merely transpose the full text of an international or
European standard, information regarding the relevant standard
shall suffice. It shall also let the Community 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.

Article 4

A full text of the draft technical regulation notified shall be
language as well as in a full
made available in the original
translation into one of
the Com-
munity.

languages of

the official

Article 5

1. Where appropriate, and unless it has already been sent
with a prior communication, a full text in the original language
of the basic legislative or regulatory provisions principally and
directly concerned shall also be simultaneously communicated,
should knowledge of such text be necessary in order to assess
the implications of the draft technical regulation notified.

seeks

to limit

the draft

in particular,

the
2. Where,
marketing or use of a chemical substance, preparation or
product on grounds of public health or of the protection of
consumers or the environment, the Member States and Malta
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
general principles for the risk evaluation of chemical substances
as referred to in Article 10(4) of Regulation (EEC) No 793/
93 (1) in the case of an existing substance, or in Article 3(2) of
Directive 67/548/EEC (2), in the case of a new substance.

its scope, shortening the timetable originally envisaged for
requirements, or
implementation, adding specifications or
making the latter more restrictive. Transmission of
these
communications shall take place in accordance with the provi-
sions set out in Article 3.

Article 7

Each Contracting Party may ask for further information on a
draft
technical regulation notified in accordance with this
Agreement.

Article 8

The Community and Malta may make comments upon
1.
the draft technical regulations communicated. The comments
of Malta shall be forwarded to the Commission and the
comments of
the Community shall be forwarded by the
Commission to Malta.

2.
The Member States and Malta shall take such comments
into account as far as possible in the subsequent preparation of
the technical regulation.

the second subparagraph of point

3. With respect
to the technical specifications or other
requirements or rules on services referred to in the third indent
of
the
comments of the Contracting Parties 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.

(f) of Article 1,

The Commission shall, when a six-month standstill

4.
is
invoked according to the rules set out in Directive 98/34/EC,
inform Malta thereof.

Article 9

The competent authorities of the Member States and Malta
shall postpone the adoption of a draft technical regulation noti-
fied for three months from the date of receipt by the Commis-
sion of the text thereof.

Article 6

Article 10

The Member States and Malta shall communicate the draft tech-
nical regulation again under the above conditions if they make
changes to the draft that have the effect of significantly altering

(1) Council Regulation (EEC) No 793/93 of 23 March 1993 on the
evaluation and control of the risks of existing substances (OJ L 84,
5.4.1993, p. 1).

(2) Council Directive 67/548/EEC of 27 June 1967 on the approxima-
tion of the laws, regulations and administrative provisions relating
to the
and labelling of dangerous
substances (OJ 196, 16.8.1967, p. 1); Directive as last amended by
Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

classification, packaging

The standstill period referred to in Article 9 shall not apply in
those cases where:

— 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, the competent authorities
are obliged to prepare technical regulations in a very short
space of time in order to enact and introduce them immedi-
ately without any consultations being possible or

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— 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, the competent authorities
are obliged to enact and implement rules on financial
services immediately.

The reasons which warrant the urgency of the measures taken
shall be given. The justification for urgent measures shall be
detailed and clearly explained with particular emphasis on the
unpredictability and the seriousness of the danger confronting
the concerned authorities as well as the absolute necessity for
immediate action to remedy it.

Article 9 and 10 shall not apply to the technical specifica-
3.
tions or other requirements or the rules on services referred to
in the third indent of the second subparagraph of point (f) of
Article 1.

Article 13

Information supplied under this Agreement shall be considered
as confidential upon request. However, both the Community
and Malta may, provided that the necessary precautions are
taken, consult for an expert opinion natural or legal persons,
including persons in the private sector.

Article 11

Article 14

The final text in the original language of a technical regu-

1.
lation shall also be communicated.

2.
The administrative arrangements for the abovementioned
notifications and communications are set out in Annex III to
this Agreement.

Article 12

1.
Articles 3 to 10 shall not apply to those laws, regulations
and administrative provisions of the Member States and Malta
or voluntary agreements by means of which Member States or
Malta:

— comply as far as the Member States are concerned with
binding Community acts which result in the adoption of
technical specifications or rules on services, and as far as
Malta is concerned transpose into national law Community
acts which result in the adoption of technical specifications
or rules on services,

— fulfil as far as the Member States are concerned the obliga-
tions arising out of international agreements which result in
the adoption of common technical specifications or rules
on services in the Community,

— fulfil as far as Malta is concerned the obligations arising out
of international agreements which result in the adoption of
common technical specifications or rules on services in
Malta and the Community,

— make use of safeguard clauses provided for in binding Com-

munity 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 (f) of Article 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.

Articles 9 and 10 shall not apply to the laws, regulations
2.
and administrative provisions of the Member States and of
Malta prohibiting manufacture in so far as they do not impede
the free movement of products.

1.
The Contracting Parties shall, within the framework of
the established cooperation between experts of the Community
and Malta in the field of
technical barriers to trade, hold
regular consultations both to ensure the satisfactory func-
tioning of the procedure laid down in this Agreement and to
exchange views on the comments which have been submitted
by a Contracting Party concerning a draft technical regulation
notified in accordance with this Agreement. Furthermore, by
common consent, the Contracting Parties may hold additional
ad hoc meetings to deal with specific cases of particular interest
to either Contracting Party.

2. Malta shall appoint an expert to represent it in meetings
of the Committee established under Article 5 of Directive 98/
34/EC, part ‘information society services’ and ‘technical regula-
the Government
tions’. The expert must be a member of
services of Malta. The expert shall not be entitled to vote.

3.
The Commission shall, in good time, inform the expert of
the dates of the meetings, and of the items on the agenda of
the Committee. The Commission shall forward relevant infor-
mation to the expert.

4.
On the initiative of its chairman, the Committee may
meet without the expert representing Malta being present. In
that case, Malta shall be informed.

Article 15

This Agreement shall apply, on the one hand, to the territories
in which the Treaty establishing the European Community is
applied and under the conditions laid down in that Treaty and,
on the other hand, to the territory of Malta.

Article 16

This Agreement shall enter into force on the first day of the
first month following the date on which the Contracting Parties
have exchanged Notes confirming the completion of
their
respective procedures for the entry into force of this Agree-
ment.

Article 17

(1) Council Directive 92/59/EEC of 29 June 1992 on general product

safety (OJ L 228, 11.8.1992, p. 24).

This Agreement shall expire on the date of accession of Malta
to the European Union.

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This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French, German,
Greek, Italian, Portuguese, Spanish, Swedish and Maltese languages, each text being equally authentic.

Article 18

Hecho en Bruselas, el diecinueve de diciembre de dos mil tres.

Udfærdiget i Bruxelles den nittende december to tusind og tre.

Geschehen zu Brüssel am neunzehnten Dezember zweitausendunddrei.
Έγινε στις Βρυξέλλες, στις δέκα εννέα ∆εκεµβρίου δύο χιλιάδες τρία.
Done at Brussels on the nineteenth day of December in the year two thousand and three.

Fait à Bruxelles, le dix-neuf décembre deux mille trois.

Fatto a Bruxelles, addì diciannove dicembre duemilatre.

Gedaan te Brussel, de negentiende december tweeduizenddrie.

Feito em Bruxelas, em dezanove de Dezembro de dois mil e três.

Tehty Brysselissä yhdeksäntenätoista päivänä joulukuuta vuonna kaksituhattakolme.

Som skedde i Bryssel den nittonde december tjugohundratre.
Magħmul fi Brussel fid-dsatax-il jum ta' Dic˙embru tas-sena elfejn u tlieta

Por la Comunidad Europea

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft
Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Għal Malta

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ANNEX I

Indicative list of services not covered by the definition in point (b) of Article 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 physi-

cally 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) fax/telex services;

(c) services provided via voice telephony or fax;

(d) telephone/fax consultation of a doctor;

(e) telephone/fax consultation of a lawyer;

(f) telephone/fax 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):

(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.

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Indicative list of the financial services covered by the definition in point (e) of Article 1

ANNEX II

— 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:

(a) investment services referred to in the Annex to Directive 93/22/EEC; services of collective investment undertakings,

(b) services covered by the activities subject to mutual recognition referred to in Annex I to Directive 2000/12/EC (1),

(c) operations covered by the insurance and reinsurance activities referred to in:

— Article 1 of Directive 73/239/EEC (2),
— the Annex to Directive 79/267/EEC (3),
— Directive 64/225/EEC (4),
— Directives 92/49/EEC (5) and 92/96/EEC (6).

(1) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking-up and pursuit of the

business of credit institutions (OJ L 126, 25.6.2000, p. 1); Directive as amended by Directive 2002/87/EC.

(2) First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to
the taking-up and pursuit of the business of direct insurance other than life assurance (OJ L 228, 16.8.1973, p. 3); Directive as last
amended by Directive 2002/87/EC.

(3) First Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating
to the taking-up and pursuit of the business of direct life assurance (OJ L 63, 13.3.1979, p. 1); Directive as last amended by Directive
2002/87/EC.

(4) Council Directive 64/225/EEC of 25 February 1964 on the abolition of restrictions on freedom of establishment and freedom to
provide services in respect of reinsurance and retrocession (OJ 56, 4.4.1964, p. 878/64); Directive as amended by the 1973 Act of
Accession.

(5) Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct

insurance other than life assurance (OJ L 228, 11.8.1992, p. 1); Directive as last amended by Directive 2002/87/EC.

(6) Council Directive 92/96/EEC of 10 November 1992 on the coordination of laws, regulations and administrative provisions relating to

direct life assurance (OJ L 360, 9.12.1992, p. 1); Directive as last amended by Directive 2002/87/EC.

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ANNEX III

Pursuant to Article 11 (2) of the Agreement, the following communications by electronic means are considered neces-
sary:

1. notification slips. They may be communicated before or together with the transmission of the full text;

2. the full text of the draft technical regulation notified;

3. acknowledgement of receipt of the draft text containing, inter alia, the relevant expiry date of the standstill period;

4. messages requesting supplementary information;

5. answers to request for supplementary information;

6. comments;

7. requests for ad hoc meetings;

8. answers to requests for ad hoc meetings;

9. requests for final texts;

10.

information that a six-month standstill referred to in Article 8(4) has been called.

The following communications may, for the time being, be transmitted by fax, even though electronic means are prefer-
able:

11. basic legal texts or regulatory provisions;

12. the final text;

The details of the administrative arrangements concerning the communications shall be jointly agreed on by the
Contracting Parties.