Agreement between the European Community and Malta on conformity assessment and acceptance of industrial products (ACAA)
Date: 2003-12-19
Institutions: European Community, Malta
Subjects: Malta, agreement (EU), approval, industrial product, product safety

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between the European Community and Malta on conformity assessment and acceptance of
industrial products (ACAA)

AGREEMENT

THE EUROPEAN COMMUNITY (hereinafter ‘the Community’),

of the one part, and

MALTA,

of the other part,

hereinafter referred to as ‘the Parties’,

WHEREAS Malta has applied for membership of the European Union and such membership implies the effective imple-
mentation of the acquis of the Community,

RECOGNISING that the progressive adoption and implementation of Community law by Malta provides the opportunity
to extend certain benefits of the internal market and to ensure its effective operation in certain sectors before accession,

CONSIDERING that, in the sectors covered by this Agreement, Maltese national law substantially takes over Community
law,

CONSIDERING their shared commitment to the principles of free movement of goods and to promoting product
quality, so as to ensure the health and safety of their citizens and the protection of the environment, including through
technical assistance and other forms of cooperation between them,

CONSIDERING the Agreement of 5 December 1970 creating an association between the European Economic Com-
munity and Malta (1),

DESIRING to conclude an Agreement on conformity assessment and acceptance of industrial products (hereinafter ‘this
Agreement’) providing for the application of the mutual acceptance of industrial products which fulfil the requirements
for being lawfully placed on the market in one of the Parties and of the mutual recognition of the results of conformity
assessment of industrial products which are subject to Community or national law,

NOTING the close relationship between the Community and Iceland, Liechtenstein and Norway through the Agreement
on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel European Confor-
mity Assessment Agreement between Malta and these countries equivalent to this Agreement,

BEARING IN MIND the Parties' status as contracting parties to the Agreement establishing the World Trade Organisa-
tion, and conscious in particular of the Parties' obligations under the World Trade Organisation Agreement on Technical
Barriers to Trade,

HAVE AGREED AS FOLLOWS:

Article 1

Purpose

1.
The purpose of this Agreement is to facilitate the elimina-
tion by the Parties of technical barriers to trade in respect of
industrial products. The means to this end is the progressive
adoption and implementation by Malta of national law which
is equivalent to Community law.

2.

This Agreement provides for:

(a) the mutual acceptance of industrial products, listed in the
industrial products’,
Annexes on ‘Mutual acceptance of
which fulfil the requirements for being lawfully placed on
the market in one of the Parties;

(b) the mutual recognition of the results of conformity assess-
ment of industrial products subject to Community law and
to the equivalent Maltese national law, both listed in the
Annexes on ‘Mutual recognition of results of conformity
assessment’.

Article 2

Definitions

For the purpose of this Agreement:

(a) ‘industrial products’ means the products listed in Chapters

25 to 97 of the Combined Nomenclature;

(b) ‘Community law’ means any legal act and implementing
practice of the Community applicable to a particular situa-
tion, risk or category of industrial products, as interpreted
by the Court of Justice of the European Communities;

(c) ‘national law’ means any legal act and implementing prac-
tice by which Malta takes over the Community law applic-
able to a particular situation, risk or category of industrial
products.

(1) OJ L 61, 14.3.1971, p. 2.

The terms used in this Agreement shall have the meaning given
in Community law and national law.

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Article 3

Alignment of legislation

Article 8

Origin

For the purpose of this Agreement, Malta agrees to take appro-
priate measures, in consultation with the Commission of the
European Communities, to maintain or complete the takeover
of Community law, in particular in the fields of standardisation,
metrology,
assessment, market
surveillance, general safety of products and producer's liability.

accreditation,

conformity

This Agreement shall apply to industrial products irrespective
of their origin.

Article 9

Article 4

Obligation of Parties as regards their authorities and
bodies

Mutual acceptance of industrial products

The Parties agree that, for the purpose of mutual acceptance,
industrial products listed in the Annexes on ‘Mutual acceptance
of industrial products’, which fulfil the requirements for being
lawfully placed on the market in one of the Parties, may be
placed on the market of the other Party, without further restric-
tion.

Article 5

Mutual recognition of the results of conformity assess-
ment procedures

The Parties agree to recognise the results of conformity assess-
ment procedures carried out in accordance with the Com-
munity or national law listed in the Annexes on ‘Mutual recog-
nition of the results of conformity assessment’. The Parties shall
not require procedures to be repeated, nor shall they impose
for the purposes of accepting that
additional requirements,
conformity.

Article 6

Safeguard clause

Where a Party finds that an industrial product placed on its
territory by virtue of this Agreement and used in accordance
with its intended use may compromise the safety or health of
users or other persons, or any other
legitimate concern
protected by legislation identified in the Annexes, it may take
appropriate measures to withdraw such a product from the
market, to prohibit its placing on the market and putting into
service or use or to restrict its free movement. The Annexes
shall set out the procedure to be applied in such cases.

Article 7

Extension of coverage

As Malta adopts and implements further national law taking
over Community law, the Parties may amend the Annexes or
in accordance with the procedure laid
conclude new ones,
down in Article 14.

The Parties shall ensure that authorities under their jurisdiction
which are responsible for the effective implementation of Com-
munity and national law shall continuously apply it. Further-
more, they shall ensure that these authorities are able, where
appropriate, to notify, suspend, remove suspension and with-
draw notification of bodies, to ensure the conformity of indus-
trial products with Community or national law or to require
their withdrawal from the market.

The Parties shall ensure that bodies, notified under their respec-
tive jurisdictions to assess conformity in relation to the require-
ments of Community or national law specified in the Annexes,
continuously comply with the requirements of Community or
national law. Furthermore, they shall take all necessary steps to
ensure that these bodies maintain the necessary competence to
carry out the tasks for which they are notified.

Article 10

Notified bodies

Before the entry into force of this Agreement, Malta and the
Community will agree on the lists of the bodies notified for the
purpose of this Agreement.

After the entry into force of this Agreement, the following
procedure shall apply for the notification of bodies to assess
conformity in relation to the requirements of Community or
national law specified in the Annexes:

(a) a Party shall forward its notification to the other Party in

writing;

(b) on the acknowledgement of

the other Party, given in
writing, the body will be considered as notified and as
competent to assess conformity in relation to the require-
ments specified in the Annexes from that date.

If a Party decides to withdraw a notified body under its juris-
diction, it shall inform the other Party in writing. The body will
cease to assess conformity in relation to the requirements speci-
fied in the Annexes from the date of its withdrawal at the
latest. Nevertheless, conformity assessment carried out before
that date shall remain valid, unless otherwise decided by the
Joint Committee set up by Article 14 (hereinafter ‘the Joint
Committee’).

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Article 11

Verification of notified bodies

kind covered by the obligation of professional secrecy. This
information may not be used for purposes other than those
envisaged by this Agreement.

Each Party may request the other Party to verify the technical
competence and compliance of a notified body under its juris-
diction. Such request will be justified in order to allow the
Party responsible for the notification to carry out the requested
verification and report speedily to the other Party. The Parties
may also jointly examine the body, with the participation of
the relevant authorities. To this end, the Parties shall ensure the
full cooperation of bodies under their jurisdiction. The Parties
shall take all appropriate steps, and use whatever available
means may be necessary, with a view to resolving any
problems which are detected.

If the problems cannot be resolved to the satisfaction of both
Parties, they may notify the chairman of the Joint Committee
of their dissent, giving their reasons. The Joint Committee may
decide on appropriate action.

Unless and until decided otherwise by the Joint Committee, the
notification of the body and the recognition of its competence
to assess conformity in relation to the requirements of Com-
munity or national
law specified in the Annexes shall be
suspended in part or totally from the date on which the
disagreement of the Parties has been notified to the chairman
of the Joint Committee.

Article 12

Exchange of information and cooperation

In order to ensure a correct and uniform application and inter-
pretation of this Agreement, the Parties, their authorities and
their notified bodies shall:

(a) exchange all relevant information concerning implementa-
tion of law and practice including, in particular, the proce-
dure to ensure compliance of notified bodies;

(b) take part, as appropriate,

in the relevant mechanisms of
information, coordination and other related activities of the
Parties;

(c) encourage their bodies to cooperate with a view to estab-
lishing mutual recognition arrangements in the voluntary
sphere.

Article 13

Confidentiality

Representatives, experts and other agents of the Parties shall be
required, even after their duties have ceased, not to disclose
information acquired under this Agreement which is of the

Article 14

Management of the Agreement

1.
A Joint Committee consisting of representatives of the
Parties shall be established. The Joint Committee will be respon-
sible for the effective functioning of this Agreement.

The Joint Committee shall

2.
take decisions and adopt
recommendations by consensus. It shall meet at the request of
either Party under the co-chairmanship of both Parties. It shall
determine its own Rules of Procedure.

3.
The Joint Committee may consider any matter related to
the operation of this Agreement. In particular, it shall have the
power to take decisions regarding:

(a) amending the Annexes;

(b) adding new Annexes;

(c) appointing a joint team or teams of experts to verify the
technical competence of a notified body and its compliance
with the requirements;

(d) exchanging information on proposed and actual modifica-
tions of the Community and national law referred to in the
Annexes;

(e) considering new or additional

conformity assessment

procedures affecting a sector covered by an Annex;

(f) resolving any questions relating to the application of this

Agreement.

Article 15

Technical cooperation and assistance

The Community may provide technical cooperation and assis-
tance to Malta where necessary, in order to support the effec-
tive implementation and application of this Agreement.

Article 16

Agreements with other countries

Agreements on conformity assessment concluded by either
Party with a country which is not a Party to this Agreement
shall not entail an obligation upon the other Party to accept
the results of conformity assessment procedures carried out in
third country, unless there is an explicit agreement
that
between the Parties in the Joint Committee.

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Article 17

Entry into force, modification and duration

1.
This Agreement shall enter into force on the first day of
the second month following the date on which the Parties have
exchanged diplomatic notes confirming the completion of their
respective procedures for entry into force of this Agreement.

2.
This Agreement may be amended by the written agree-
ment of the Parties. Amendments to or additions of Annexes
will be made through the Joint Committee.

Either Party may terminate this Agreement by giving the

3.
other Party six months' notice in writing.

Article 18

Final provisions

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

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 zweitausenddrei.
Έγινε στις Βρυξέλλες, στις δεκαεννέα ∆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.

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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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ANNEXES

ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS

(For the record)

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ANNEXES

ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

CONTENTS

1.

2.

Electrical safety

Electromagnetic compatibility (EMC)

3. Machinery

4.

5.

6.

7.

Lifts

Personal protective equipment (PPE)

Equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)

Safety of toys

8. Radio communication and telecommunication terminal equipment (RTTE)

ELECTRICAL SAFETY

SECTION I

Community and national law

Community law: Council Directive 73/23/EEC of 19 February 1973 on the approximation of the laws of the Member
States relating to electrical equipment designed for use within certain voltage limits (OJ L 77,
26.3.1973, p. 29), as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1)

National law:

L.N. 367 of 2002: Low Voltage Electrical Equipment Regulations, 2002

SECTION II

Notifying authorities

E u rope an Community:

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Luxembourg:

Netherlands:

Austria:

Portugal:

Finland:

Sweden:

Service Public Fédéral Economie, P.M.E., Classes Moyennes & Energie/Federale Overheidsdienst
Economie, K.M.O., Middenstand & Energie

Økonomi- og Erhvervsministeriet, Elektricitetsrådet

Ministère de l'économie, des finances et de l'industrie. Direction générale de l'industrie, des technolo-
gies de l'information et des postes (DiGITIP) — SQUALPI

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας (Ministry of Development. General Secretariat of
Industry)

Ministerio de Ciencia y Tecnología

Department of Enterprise and Employment

Ministero delle Attività Produttive

Ministère de l'économie — Service de l'energie de l'Etat.
Ministère du travail (Inspection du travail et des mines)

Minister van Volksgezondheid, Welzijn en Sport (consumer goods)
Minister van Sociale Zaken en Werkgelegenheid (others)

Bundesministerium für Wirtschaft und Arbeit

Under the authority of the Government of Portugal:
Instituto Português da Qualidade

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

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SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been authorised by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

S a fe g u a rd c l a u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its decision
and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge and shall report to each other

the results of their investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed on

the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this Annex
does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving the
reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance with

the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

ELECTROMAGNETIC COMPATIBILITY

SECTION I

Community and national law

Community law: Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member
States relating to electromagnetic compatibility (OJ L 139, 23.5.1989, p. 19), as last amended by
Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1).

National law:

L.N. 368 of 2002: Electromagnetic Compatibility Regulations, 2002

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SECTION II

Notifying authorities

E u rope an Community:

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Economie, P.M.E., Classes Moyennes & Energie/Federale Overheidsdienst
Economie, K.M.O., Middenstand & Energie

IT- og Telestyrelsen

Ministère de l'économie, des finances et de l'industrie. Direction générale de l'industrie, des technolo-
gies de l'information et des postes (DiGITIP) — SQUALPI

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας (Ministry of Development. General Secretariat of
Industry)

Ministerio de Ciencia y Tecnología

Department of Enterprise and Employment

Ministero delle Attività Produttive

Luxembourg:

Ministère de l'Economie — Service de l'Energie de l'Etat

Netherlands:

Minister van Verkeer en Waterstaat

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Wirtschaft und Arbeit

Under the authority of the Government of Portugal:
Instituto Português da Qualidade
ICP — Autoridade Nacional de Comunicações (ANACOM)

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet.
For EMC aspects of telecommunications and radio equipment:
Liikenne-javiestintäministeriö/Kommunikatiosministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

SECTION III

Notified and competent bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been authorised by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

S a fe g u a rd c l a u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its decision
and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each other

the results of their investigations.

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3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed on

the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this Annex
does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving the
reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance with

the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

MACHINERY

SECTION I

Community and national law

Community law: Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approxi-
mation of the laws of the Member States relating to machinery (OJ L 207, 23.7.1998, p. 1), as
amended by Directive 98/79/EC (OJ L 331, 7.12.1998, p. 1)

National law:

L.N. 369 of 2002: Machinery Regulations, 2002

SECTION II

Notifying authorities

E u rope an Community:

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Emploi, Travail et Concertation Sociale/Federale Overheidsdienst Werkgelegen-
heid, Arbeid en Sociaal Overleg

Beskæftigelsesministeriet, Arbejdstilsynet

Ministère de l'emploi et de la solidarité, direction des relations du travail, Bureau CT 5

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας Ministry of Development. General Secretariat of
Industry

Ministerio de Ciencia y Tecnología

Department of Enterprise and Employment

Ministero delle Attività Produttive

Luxembourg:

Ministère du travail (Inspection du travail et des mines)

Netherlands:

Minister van Sociale Zaken en Werkgelegenheid

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Wirtschaft und Arbeit

Under the authority of the Government of Portugal:
Instituto Português da Qualidade

Sosiaali- ja terveysministeriö/Social- och hälsovårdsministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontroll (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

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SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been designated by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

S a fe g u a rd c l a u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its decision
and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each other

the results of their investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed on

the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this Annex
does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving the
reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance with

the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

LIFTS

SECTION I

Community and national law

Community law: Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approxi-
mation of the laws of the Member States relating to lifts (OJ L 213, 7.9.1995, p. 1)

National law:

L. N. 370 of 2002: Lifts Regulations, 2002

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SECTION II

Notifying authorities

E u rope an Community:

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Economie, P.M.E., Classes Moyennes & Energie/Federale Overheidsdienst
Economie, K.M.O., Middenstand & Energie

Arbejdstilsynet

Ministère de l'equipment, des transports et du logement. Direction Générale de l'urbanisme, de
l'habitat et de la construction

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας (Ministry of Development. General Secretariat of
Industry)

Ministerio de Ciencia y Tecnología

Department of Enterprise and Employment

Ministero delle Attività Produttive

Luxembourg:

Ministère du travail (Inspection du travail et des mines)

Netherlands:

Minister van Sociale Zaken en Werkgelegenheid

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Wirtschaft und Arbeit

Under the authority of the Government of Portugal:
Instituto Português da Qualidade

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been designated by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

S a fe g u a rd c l a u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its decision
and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each other

the results of its investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed on

the market.

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4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this Annex
does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving the
reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance with

the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

PERSONAL PROTECTIVE EQUIPMENT

SECTION I

Community and national law

Community law: Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the
Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18), as last
amended by Directive 96/58/EC of
(OJ L 236,
18.9.1996, p. 44)

the European Parliament and of

the Council

National law:

L.N. 371 of 2002: Personal Protective Equipment Regulations, 2002

SECTION II

Notifying authorities

E u rope an Community:

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Emploi, Travail et Concertation Sociale/Federale Overheidsdienst Werkgelegen-
heid, Arbeid en Sociaal Overleg

Beskæftigelsesministeriet, Arbejdstilsynet

Ministère de l'emploi et de la solidarité, Direction des relations du travail, Bureau CT 5
Ministère de l'économie, des finances et de l'industrie, Direction générale de l'industrie, des technolo-
gies de l'information et des postes (DiGITIP) — SQUALPI

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας Ministry of Development. General Secretariat of
Industry

Ministerio de Ciencia y Tecnología

Department of Enterprise, Trade and Employment

Ministero delle attività produttive

Luxembourg:

Ministère du travail (Inspection du travail et des mines)

Netherlands:

Minister van Volksgezondheid, Welzijn en Sport

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Wirtschaft und Arbeit

Under the authority of the Government of Portugal:
Instituto Português da Qualidade

Sosiaali- ja terveyministeriö/Social- och hälsovårdsministeriet

Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll
(SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

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SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been authorised by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

S a fe g u a rd c l a u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its decision
and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each other

the results of their investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed on

the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this Annex
does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving the
reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance with

the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE
ATMOSPHERES

SECTION I

Community and national law

Community law: Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approxi-
mation of the laws of the Member States relating to equipment and protective systems intended for
use in potentially explosive atmospheres (OJ L 100, 19.4.1994, p. 1)

National law:

L.N. 372 of 2002: Equipment and Protective Systems intended for use in Potentially Explosive Atmo-
spheres Regulations, 2002

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E u rope an Community:

SECTION II

Notifying authorities

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Economie, P.M.E., Classes Moyennes & Energie/Federale Overheidsdienst
Economie, K.M.O., Middenstand & Energie

For electrical aspects:
Økonomi- og Erhvervsministeriet, Elektricitetsrådet

For mechanical aspects:
Beskæftigelsesministeriet, Arbejdstilsynet

Ministère de l'économie, des finances et de l'industrie, Direction de l'action régionale et de la petite et
moyenne industrie (DARPMI), Sous-direction de la sécurité industrielle

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας (Ministry of Development. General Secretariat of
Industry)

Ministerio de Ciencia y Tecnología

Department of Enterprise and Employment

Ministero delle Attività Produttive

Luxembourg:

Ministère de l'economie — Service de l'Energie de l'Etat

Netherlands:

Minister van Sociale Zaken en Werkgelegenheid

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Wirtschaft und Arbeit

Under the authority of the Government of Portugal:
Instituto Português da Qualidade

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been authorised by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

1. Tr ansiti onal a rr a nge me nts

The certificates issued in the Community Member States in conformity with Directives 76/117/EEC, 79/196/EEC and
82/130/EEC will be recognised as a proof of conformity assessment under the Maltese Act. Based on these certificates,
the importer of these products in Malta will issue a declaration of conformity of the relevant product to the applic-
able requirements referred to in this paragraph.

2. S a f eg u a r d c la u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its deci-
sion and how non-compliance has been assessed.

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2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of their investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed

on the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this
Annex does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving
the reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance with

the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

SAFETY OF TOYS

SECTION I

Community and national law

Community law: Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member
States concerning the safety of toys (OJ L 187, 16.7.1988, p. 1), as amended by Directive 93/68/EEC
of 22 July 1993 (OJ L 220, 30.8.1993, p. 1)

National law:

L.N. 373 of 2002: Safety of Toys Regulations, 2002

E u rope an Community:

SECTION II

Notifying authorities

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Economie, P.M.E., Classes Moyennes & Energie/Federale Overheidsdienst
Economie, K.M.O., Middenstand & Energie

Økonomi- og Erhvervsministeriet, Forbrugerstyrelsen

Ministère de l'économie, des finances et de l'industrie, Direction générale de l'industrie, des technolo-
gies de l'information et des postes (DiGITIP) — SQUALPI

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Γενική Γραµµατεία Βιοµηχανίας (Ministry of Development. General Secretariat of
Industry)

Ministerio de Ciencia y Tecnología
Instituto Nacional del Consumo

Department of Enterprise and Employment

Ministero delle Attività Produttive

Luxembourg:

Ministère du travail et de l'emploi

Netherlands:

Minister van Volksgezondheid, Welzijn en Sport. Inspectie voor de Gezondheidszorg (IGZ)

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Wirtschaft und Arbeit

Divisão de Estudos de Produtos do Instituto do Consumidor

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

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SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been authorised by Malta in accordance with the Maltese national law referred to in Section I and
notified to the Community in accordance with Article 10 of this Agreement.

SECTION IV

Specific arrangements

1. Infor ma ti on c on ce r ni ng the c er ti fi ca te a nd the tec hn i c a l fi le

In accordance with Article 10(4) of Directive 88/378/EEC, the notifying authorities listed in Section II may obtain on
request a copy of the certificate and, on reasoned request, a copy of the technical file and the reports on the exami-
nations and tests carried out.

2. Notific a ti on of g r ou n ds for re fu sal by a ppr ove d b odi es

In accordance with Article 10(5) of Directive 88/378/EEC, Maltese bodies shall inform the notifying authority when
refusing to issue a certificate. The notifying authority shall likewise notify the Commission thereof.

3. Sa fe g u a r d cla u se s

A. Safeguard clause relating to products

1. Where a Party has taken a measure to deny free access to its market for products bearing the CE marking,
subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its decision and
how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of their investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed

on the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation listed in Section I of this
Annex does not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving
the reasons therefor.

2. The Joint Committee shall consider the matter and may request the Community to proceed in accordance

with the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

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RADIO COMMUNICATION AND TELECOMMUNICATION TERMINAL EQUIPMENT

SECTION I

Community and national law

Community law: Directive 1999/5/EC of the European Parliament and of the Council of 9March 1999 on the approxi-
mation of the laws of the Member States relating to radio communication and telecommunication
terminal equipment and the mutual recognition of their conformity (OJ L 91, 7.4.1999, p. 10)

National law:

L.N. 374 of 2002: Radio Equipment and Telecommunications Terminal Equipment and mutual
recognition of their conformity Regulations, 2002

SECTION II

Notifying authorities

E u rope an Community:

Belgium:

Denmark:

France:

Germany:

Greece:

Spain:

Ireland:

Italy:

Service Public Fédéral Economie, P.M.E., Classes Moyennes & Energie/Federale Overheidsdienst
Economie, K.M.O., Middenstand & Energie

IT- og Telestyrelsen

Ministère de l'économie, des finances et de l'industrie — Direction générale de l'industrie, des tech-
nologies de l'information et des postes (DiGITIP) — SQUALPI

Bundesministerium für Wirtschaft und Arbeit
Υπουργείο Ανάπτυξης. Ministry of Development
Ministerio de Ciencia y Tecnología

Department of Public Enterprise, Communication Division

Ministero delle Comunicazioni

Luxembourg:

Ministère des transports

Netherlands:

Minister van Economische Zaken, Agentschap Telecom

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für Verkehr, Innovation und Technologie

Under the authority of the Government of Portugal:
Instituto Português da Qualidade

For EMC aspects of telecommunications and radio equipment:
ICP — Autoridade Nacional de Comunicações (ANACOM)

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet

Under the authority of the Government of Sweden:
Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

United Kingdom: Department of Trade and Industry

M a lta :

Under the authority of the Government of Malta:
Consumer and Industrial Goods Directorate of the Malta Standards Authority

SECTION III

Notified bodies

E u rope a n Com mun i ty

Bodies which have been notified by the Member States of the Community in accordance with the Community law
referred to in Section I and notified to Malta in accordance with Article 10 of this Agreement.

M a lta

Bodies which have been authorised by Malta in accordance with the Maltese national law referred to in Section I and
notified to the European Community in accordance with Article 10 of this Agreement.

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SECTION IV

Specific arrangements

1. Ma rke t su r v e i lla nc e a u th ori ti es

In accordance with the general provisions of this Agreement, each Party shall notify to the other Party the authorities
established within its territory which are to carry out the surveillance tasks related to the operation of the respective
legislation listed in Section I.

2. Notific a ti on of i nte r fac e r eg u lations

Each Party shall notify to the other Party the interfaces which they have regulated in their respective territory. When
classifying equipment the Community shall take due account of the interfaces regulated in Malta.

3. A pp li c a ti on of esse nti a l r eq u i r e me nts

Where the Commission considers adopting a decision to apply a requirement contained in Article 3(3) of Directive
1999/5/EC Malta shall give its opinion on the issue in its capacity as observer in the TCAM before the formal
opinion of the Committee is requested.

4. Notific a ti on of a ppa ra tus ca u si ng dama ge

Where a Party considers that apparatus declared to be compliant with the respective legislation causes serious
damage to a network or harmful radio interference or harm to the network or its functioning and has granted the
operator the right to refuse its connection, to disconnect it or to withdraw it from service, the Party shall notify such
authorisation to the other Party.

5. Sa fe g u a r d cla u se s

A. Safeguard clause relating to industrial products

1. Where a Party has taken a measure to deny free access to its market for industrial products bearing the CE
marking, subject to this Annex, it shall immediately inform the other Party, indicating the reasons for its deci-
sion and how non-compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each

other the results of their investigations.

3. In case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed

on the market.

4. In case of disagreement on the outcome of such investigations, the matter shall be forwarded to the Joint

Committee, who may decide to have an evaluation carried out.

5. Where the Joint Committee finds that the measure is:

(a) unjustified, the national authority of the Party who has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the

market.

B. Safeguard clause relating to harmonised standards

1. Where Malta considers that a harmonised standard referred to in the legislation defined in this Annex does
not meet the essential requirements of such legislation, it shall inform the Joint Committee, giving the reasons
therefor.

2. The Joint Committee shall consider the matter and may request the European Community to proceed in
accordance with the procedure provided for in the Community legislation listed in Section I of this Annex.

3. The Community shall keep the Joint Committee and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

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C. Safeguard clause relating to compliant radio products not intended for use in a spectrum of one of the Parties

1. Where a Member State or Malta takes a measure to adopt any appropriate measures with a view to prohi-
biting or restricting the placing on its market, and/or requiring the withdrawal from its market, of radio equip-
ment, including types of radio equipment, which has caused, or which it reasonably considers will cause,
harmful interference, including interference with existing or planned services on nationally allocated frequency
bands, the Party shall inform the other Party, giving the reasons therefor.

2. Where, after such information, the other Party considers that the measure may be unjustified, and when the
problems cannot be resolved to the satisfaction of both Parties, they may consult the Joint Committee on the
measure, giving their reasons.

3. Where, after such consultation, the Joint Committee finds that the measure is:

(a) justified, it shall immediately inform the Party who took the initiative and the other Party;

(b) unjustified, it shall immediately inform the Party who took the measure and request it to withdraw it.

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DECLARATION BY THE COMMUNITY ON THE ATTENDANCE OF MALTESE REPRESENTATIVES AT
COMMITTEE MEETINGS

In order to ensure a better understanding of the practical aspects of the application of the acquis of the
Community, the Community declares that Malta is invited, under the following conditions, to the meetings
of the committees established or referred to under the Community law on electrical safety, electromagnetic
compatibility, machinery, lifts, ATEX, toys, PPE and RTTE.

This participation shall be limited to meetings or parts thereof during which the application of the acquis is
discussed; it shall not entail attendance at meetings intended to prepare and issue opinions on implementa-
tion or management powers delegated to the Commission by the Council.

This invitation may be extended, on a case-by-case basis,
Commission.

to groups of experts convened by the

DECLARATION BY MALTA ON THE PLACING ON THE MARKET OF PRODUCTS SUBJECT TO MALTESE
LEGISLATION TRANSPOSING COMMUNITY LEGISLATION

1. Malta will specifically define, through legal notices, for all those sectors covered by the Agreement on
conformity assessment and acceptance of industrial products (ACAA) in Maltese national legislation
transposing Community legislation relating to the placing on the market of products, that reference to
placing on the market is intended to cover also the placing of products on the market anywhere on the
territory of the Community or that of Malta.

2. The legal notices shall be effective from the date of the coming into force of the ACAA.