Proposal for a Council Decision on the signature on behalf of the Community of an Agreement between the European Community and Malta on Conformity Assessment and Acceptance of Industrial Products
Date: 2003-04-11
Institutions: European Commission
Subjects: Malta, accession to an agreement, agreement (EU), approval, industrial product, liberalisation of trade

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 11.4.2003
COM(2003) 182 final

2003/0065 (ACC)
2003/0066 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an Agreement between the European
Community and Malta on Conformity Assessment and Acceptance of Industrial
Products

Proposal for a

COUNCIL DECISION

on the conclusion of an Agreement between the European Community and Malta on
Conformity Assessment and Acceptance of Industrial Products - ACAA -

(presented by the Commission)

EXPLANATORY MEMORANDUM

I.

EXPLANATORY MEMORANDUM

On the basis of negotiating directives adopted by the Council on 21.9.92 as amended by the
decision  adopted  by  the  Council  on  19.07.2002,  and  of  the  specific  decision  issued  by  the
Council  in  June  1997  addressing  guidelines  to  the  Commission  for  the  negotiation  of
European Conformity Assessment Agreements with Central and Eastern European Countries,
the  Commission  has  negotiated  and  initialled  an  Agreement  on  Conformity  assessment  and
Acceptance of industrial products with Malta (hereinafter referred to as "ACAA").

The  text  of  this  Agreement  is  attached  to  this  Communication.  The  following  provides  an
assessment  of  the  Agreement  in  the  light  of  the  negotiating  directives  approved  by  the
Council, and proposes that the Council authorises the signature of the Agreement and decides
to approve its conclusion on behalf of the Community. This assessment and these proposals
are similar to the relevant documents for the PECAs concluded by the Council with Hungary,
the Czech Republic, Latvia and Lithuania.

I.1

ASSESSMENT OF THE AGREEMENT

This  sort  of  agreement  is  intended  to  work  only  during  the  pre-accession  period.  However,
since,  like  other  candidate  countries,  there  is  no  Europe  Agreement  to  offer  an  appropriate
legal  framework,  it  was  decided,  in  consultation  with  the  133  Committee,  to  adopt  this
agreement as a stand alone agreement.

The ACAA follows the general principles laid down in the Commission's communication on
Community External Trade Policy in the field of standards and conformity assessment1 under
its paragraph 49. The  ACAA  is  a transitional arrangement,  and thus will terminate  with  the
candidate country accession.

The  ACAA  provides  for  an  extension  of  certain  benefits  of  the  Internal  Market  in  sectors
already aligned. The ACAA thus facilitates market access by eliminating technical barriers to
trade  with  respect  to  industrial  products.  To  this  end,  the  ACAA  provides  for  two
mechanisms, a) for the mutual acceptance of industrial products which fulfil the requirements
to be lawfully placed on the market in one of the Parties, and b) the mutual recognition of the
results of conformity assessment of industrial products subject to Community law and to the
equivalent national law.

The first mechanism, i.e. the mutual acceptance of industrial products, provides that products
covered by the ACAA that are lawfully placed on the market of one of the Parties has access
on  the same terms  to the other Party’s market.  This  provision adds the predictability  that  is
necessary  to  manufacturers  and  exporters,  confirming  in  advance  that  industrial  products
under  this  mechanism  may  freely  move  between  the  Parties.  The  annexes  making  this
mechanism operational have still to be negotiated.

The second mechanism is a particular type of mutual recognition agreement (MRA) in which
the mutual recognition operates on the basis of the acquis communautaire. It allows industrial
products  certified  by  Notified  Bodies  in  the  European  Union  to  be  placed  on  the  Maltese
market  without  having  to  undergo  any  further  approval  procedures,  and  vice-versa.  The

1

COM(1996) 564 final. 13.11.1996.

2

                                                
following  sectors  are  covered:  electrical  safety,  electromagnetic  compatibility,  machinery,
lifts, personal  protective  equipment’s,  equipment  and  protective systems intended  for use  in
potentially  explosive  atmospheres,  safety  of 
toys,  and  radio  communication  and
telecommunication terminal equipment.

The draft ACAA with Malta is in line with the PECAs concluded by the Council with Latvia,
Lithuania2 , Hungary and the Czech Republic3. Malta has taken over the Community technical
legislation  in  the  sectors  covered  by  the  Agreement  and  participates  in  the  European
organisations in the field of standards, metrology, testing laboratories and accreditation.

The ACAA consists of a framework agreement and a series of annexes as referred to above. A
unilateral Community declaration inviting the Maltese representatives to experts meetings and
committees established under the Community law referred to in the annexes is attached to the
Final  Act,  making  it  clear  that  this  will  not  entail  any  participation  in  the  Community
decision-making process. An assessment of the ACAA is made in the next paragraphs.

I.1.1 FRAMEWORK AGREEMENT

An article-by-article assessment follows:

Pre-amble. This sets out the basic objective of the ACAA which is that, as the application for
membership of the European Union implies the implementation of the acquis communautaire
by the applicant country, it provides the opportunity to extend certain benefits of the Single
Market in certain sectors already aligned before.

Article 1: Purpose. This article establishes the purpose of the ACAA, namely the elimination
of  technical  barriers  to  trade  in  respect  to  industrial  products.  The  ACAA  provides  for  two
mechanisms, a) for the mutual acceptance of industrial products which fulfil the requirements
to be lawfully placed on the market in one of the Parties, and b) the mutual recognition of the
results of conformity assessment of industrial products subject to Community law and to the
equivalent national law.

Article  2:  Definitions.  This  is  self-explanatory.  Definitions  of  industrial  products,
Community  and  national 
legislation  and
implementation  measures  (administrative  provisions,  guidelines  and  other  means  of
/implementation of the legislation) are covered by the definitions of Community and national
law.

included.  All  pieces  of 

law  have  been 

Article  3:  Alignment  of  legislation.  This  contains  a  commitment  for  Malta  to  take
appropriate  measures  in  order  to  maintain  or  complete  the  take-over  of  Community  law,
namely in the field of technical legislation and for the purpose of the ACAA. Together with
the 4th whereas, it means that the alignment is an ongoing process and the Parties agree to iron
out any problems of transposition that could appear later.

2

3

Council  Decision  2002/608/EC  of  25  June  2002  on  the  conclusion  of  a  PECA  with  the  Republic  of
Latvia (OJ L 202, 31.07.2002, p.1) Council Decision 2002/609/EC of 25 June 2002 on the conclusion
of a PECA with the Republic of Lithuania (OJ L 202, 31.07.2002, p. 19)
Council Decision 2001/365/EC of 4 April 2001 on the conclusion of a PECA with the Czech Republic
(OJ  L  135,  17.05.2001,  p.1)  Council  Decision  2001/366/EC  of  4  April  2001  on  the  conclusion  of  a
PECA with Hungary (OJ L 135, 17.05.2001, p.35)

3

                                                
Article  4:  Mutual  acceptance  of  industrial  products.  The  principle  under  Article  1.1)  is
detailed in this article. It provides that listing industrial products in such annexes will confirm
that these products can freely circulate between the Parties. As already stated, no such annex
has been negotiated yet.

Article  5:  Mutual  recognition  of  the  results  of  conformity  assessment  procedures.  This
provision expands the principle under Article 1.2). This kind of recognition is similar to the
one  in  Mutual  Recognition  Agreements,  with  the  special  feature  that  all  legislation  and
standards  are  aligned.  The  sectoral  annexes  will  contain  the  references  to  the  relevant
Community and national legislation.

Article 6: Safeguard clause. This sets up the right of each Party to deny market access when
such Party is able to demonstrate that a product might endanger the legitimate concern which
is protected by legislation listed in the annexes (safety and/or public health of users or other
persons mainly). The annexes provide for the detailed procedures to be used in such cases.

Article  7:  Extension  of  coverage.  The  Parties  may  modify  the  scope  and  coverage  of  this
Agreement through an amendment of the annexes or by the addition of new annexes as soon
as all alignment conditions are met.

Article  8:  Origin.  The  provisions  of  this  Agreement  shall  apply  to  industrial  products
irrespective of their origin.

Article  9:  Obligations  of  Parties  as  regards  their  authorities  and  bodies.  This  article
obliges  the  Parties  to  ensure  that  their  respective  authorities  continuously  monitor  the
technical  competence  and  compliance  of  the  notified  bodies  and  have  the  necessary  power
and  expertise  for  designating,  suspending,  and  withdrawing  their  bodies.  In  addition,  it
obliges the Parties to ensure that their respective notified bodies continuously comply with the
requirements of Community or national law and maintain their technical competence to carry
out the tasks for which they have been notified.

Article  10:  Notified  bodies.  This  describes  the  procedure  for  the  notification  of  bodies  to
assess conformity in relation to the legal requirements specified in the corresponding annexes.
The procedure is simplified and similar to the one applied within the Community. The second
paragraph sets out the procedure for the removal of notified bodies.

Article 11: Verification of notified bodies. This article gives the right to one Party to request
a verification of a body notified by the other Party. The verification may be done either by the
authorities which  have designated the body or  together  by  the  authorities  of  both  Parties.  If
the  Parties  do  not  agree  on  appropriate  steps  to  take,  they  may  notify  the  Chair  of  the
Association  Council  of  their  dissent,  and  leave  to  the  Association  Council  to  decide  on
appropriate  action.  The  notified  body  would  then  be  suspended  from  the  notification  of  the
Association Council until a final decision is taken.

Article  12:  Exchange  of  information.  A  transparency  provision  to  ensure  a  correct  and
uniform application and interpretation of the Agreement. The Parties are advised to encourage
their bodies to co-operate in order to establish mutual recognition agreements in the voluntary
sphere.

Article  13:  Confidentiality.  A  classical  provision  to  avoid  disclosing  information  acquired
under this Agreement.

4

Article 14: Management of the Agreement. A Joint Committee consisting of representatives
of  the  two  Parties  is  established.  This  Joint  Committee  will  be  responsible  for  the  effective
functioning of the Agreement. It shall determine its own Rules of Procedure.

Article 15: Technical co-operation and assistance. This confirms the Community policy on
technical co-operation and assistance with a view to properly implementing this Agreement.

Article 16: Agreements with other countries. This confirms that, unless otherwise agreed,
the  ACAA  does  not  entail  any  obligation,  for  one  Party,  to  accept  conformity  assessments
carried  out  in  another  country,  even  if  there  is  an  agreement  on  recognition  of  conformity
assessment between the other Party and any other third country.

Article 17: Entry into force. This is a standard provision that provides the arrangement for
the entry into force.

I.1.2     THE ANNEXES TO THE AGREEMENT

I.1.2.1 ANNEXES ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

There  follows  an  assessment  of  the  content  of  the  annexes  in  terms  of  their  coverage,  and
other  implications  where  relevant.  In  making  this  assessment,  the  Commission  has  kept  in
mind the following elements:

a.

b.

the  overall  consistency  with  the  Community  policy  objectives  in  the  field  of
standardisation, certification and conformity assessment for the sectors and industrial
products covered;

the overall consistency with Community policy objectives in the field of the removal
of technical barriers to trade;

The sectoral assessment is followed in item  I.2 by an overall appreciation of the benefits of
the Agreement.

Annexes  on  electrical  safety,  electromagnetic  compatibility,  machinery,  lifts,  personal
protective  equipment’s,  equipment  and  protective  systems  intended  for  use  in
potentially  explosive  atmospheres,  safety  of  toys,  and  radio  communication  and
telecommunication terminal equipment

These  annexes  on  mutual  recognition  of  results  of  conformity  assessment  cover  a  range  of
industrial  products  subject  to  third  party  conformity  assessment  under  the  New  Approach
Directives in the relevant sectors All these annexes present the same structure.

Coverage is determined by the relevant Community or national law, listed under Section I of
each  annex.  Section  II,  on  notifying  authorities,  lists  the  authorities  responsible  for  the
designation of bodies in the Member Sates and Malta. Section III, on notified bodies, makes
reference  to  the  notification  of  all  Conformity  Assessment  Bodies  notified  by  the  Member
States  and  by  Malta.  Section  IV,  on  specific  arrangements,  fixes  the  two  procedures  for  the
safeguard clause, relating to industrial products and to harmonised standards.

I.1.2.2 ANNEXES ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS

No such annexes have been negotiated for the moment. The ACAA provides nevertheless the
basis for such acceptance of products, similar to the one which operates in the Community.

5

I.1.2.3 UNILATERAL DECLARATION

This is attached to the Final Act and is annexed to this Communication.

Unilateral Community Declaration relating to attendance of the Maltese representatives
to Committees. Through this declaration, Malta is invited to send observers to the meetings
of the Committees established or referred to under the Community legislation included in the
annexes.  This  declaration  follows  the  principles  of  the  Commission  Communication  on
"Participation of candidate countries in Community programmes, agencies and committees"4.

I.1.3 RELATIONS WITH EFTA /EEA MEMBER COUNTRIES

In  accordance  with  the  general  information  and  consultation  procedures  set  out  in  the
European Economic Area-Agreement and Agreement 12 of that Agreement, the Commission
kept  EFTA/EEA  Member  Countries  regularly  informed  on  the  progress  of  the  negotiations
and informed them on the final result thereof. The EFTA/EEA Member Countries are in the
initial stage of negotiating a parallel mutual recognition agreement with Malta.

I.2

OVERALL APPRECIATION

The Commission considers that the proposed ACAA creates an acceptable balance of benefits
for  all  parties  in  the  pre-accession  framework.  In  all  sectors  the  Community  has  secured
effective  market  access  -  in  terms  of  access  to  all  mandatory  procedures  of  the  other  party.
The ACAA confirms that Malta has taken over the Community legislation in certain sectors
before its accession. Both political and commercial benefits are achieved with the ACAA.

The Agreement will  allow Community  exporters,  if  they  so  choose,  to  test  and  certify  their
industrial  products  to  the  same  (aligned)  requirements  prior  to  export,  and  then  access  that
market without any further conformity assessment requirements. The certification procedures
will  only  need  to  be  carried  out  one  time  for  both  markets  and  against  the  same  aligned
requirements or standards. The recognition of certification will permit savings and stimulate
exports.  European  industry  federations  were  consulted  and  supported  unequivocally  the
Agreement.

Industrial groups, while supporting the Agreement, have not always been able to quantify the
costs or time taken to obtain conformity assessment of their industrial products in Malta. The
precise extent of savings in time, cost and market opportunity of this Agreement is therefore
not feasible  in every  case to determine.  This  may only  be possible once  the  Agreement  has
been in operation for some time. However, on the basis of a rough calculation, it is estimated5
that  this  Agreement  would  create  cost  saving  opportunities  for  the  European  exporting
industry of around € 5.25 million per year and about € 2.25 million per year in terms of cost
savings to Maltese exporters to the EC. Some of these savings will be passed on to European
importers and consumers.

Trade  figures  between  the  EC  and  Malta  are  attached  for  information.  In  2001  the  general
trade balance in sectors covered by this Agreement shows a trade surplus for EU of around €
225  million.  However,  the  trade  surplus  is  for  Malta  in  the  toys  sector  .  It  is  expected  that
trade will increase further when the ACAA is in force.

4

5

Point 4.2.b. COM(1999) 710 final 20.12.1999.
Working hypothesis that certification and other related costs amount to an average of 1.5 % of trade

6

                                                
In fact, most benefits are clearly not quantifiable, such as reduced time for accessing markets,
better  predictability,  less  protectionism,  and  harmonisation  of  systems.  What  can  be
ascertained  is  that  any  agreement  provides  reciprocal  levels  of  market  access,  in  terms  of
conformity assessment.

These advantages outweigh greatly the resources that the Commission will have to engage in
maintenance activities of the Agreement, evaluated at 0.8 person per year and some travel and
other expenses relating to meetings and other activities such as editing guides.

In terms of the benefits to Malta, the ACAA will facilitate access to the Community market
and will give political credit for having aligned its legislation. Malta regards the ACAA as a
means to develop closer industrial relations with the EU and fully to integrate certain sectors
with the Single Market before accession.

7

II.        THE DRAFT COUNCIL DECISIONS

A  proposal  for  two  Council  decisions  is  attached.  Both  are  similar  to  the  Commission
proposals for the previous Council decisions on the signature on behalf of the Community and
conclusion  of  the  PECAs  with  Hungary  and  the  Czech  Republic6  and  with  Latvia  and
Lithuania7,  except  that  the  present  Agreement  stands  alone  rather  than  being  a  Protocol  to
Europe Agreement, which has not been negotiated with Malta.

The first one is concerned with the signature of the Agreement. Signature is required by Malta
for  the  adoption  of  this  Agreement.  It  is  accordingly  proposed  that  the  President  of  the
Council be authorised to designate the person empowered to sign the Agreement on behalf of
the  Community,  subject  to  conclusion  later,  on  the  basis  of  Articles  133  and  300  of  the
Treaty.

The  proposal  for  a  second  decision  is  concerned  with  the  adoption  of  the  ACAA.  In  this
context, the Council should, in line with the previous Council decisions on the conclusion of
PECAs  and mutual  recognition  agreements,  establish  the  appropriate  Community  procedure
for the implementation and management of the Agreement.

In particular, the Council should confer on the Commission, in consultation with the special
committee  appointed  by  the  Council,  the  necessary  powers  for  the  management  and
implementation of the Agreement. Moreover, the Council should delegate to the Commission,
acting  in  consultation  with  the  special  committee,  the  necessary  powers  to  determine  in
certain cases the Community position with regard to this Agreement in the Joint Committee
set up under the Agreement. The delegation of powers to the Commission includes delegation
of  the  power  to  add  new  Annexes,  since,  as  indicated  in  the  Preamble,  membership  of  the
European Union, for which Malta has applied, implies the effective implementation of all the
Community acquis.

The  Commission  therefore  proposes  that  the  Council  adopts  the  attached  decisions  on  the
signature and conclusion of the ACAA.

6

7

For the Czech Republic, Council decision 2001/365/EC of 4 April 2001 (OJ L 135, 17.05.2002, p.1).
For Hungary, Council decision 2001/366/EC of 4 April 2001 (OJ L 135, 17.05.2002, p.35).
Council  Decision  2002/608/EC  of  25  June  2002  on  the  conclusion  of  a  PECA  with  the  Republic  of
Latvia (OJ L 202, 31.07.2002, p.1) Council Decision 2002/609/EC of 25 June 2002 on the conclusion
of a PECA with the Republic of Lithuania (OJ L 202, 31.07.2002, p. 19).

8

                                                
EU-Malta Trade - Annex to the Explanatory Memorandum to the Council. (1000€)

1999

2000

2001

IMPORT

EXPORT

Balance

Total Trade IMPORT

EXPORT

Balance

Total Trade IMPORT

EXPORT

Balance

Total Trade

Electrical sector

52.518

92.476

39.958

144.994

63.906

122.185

58.279

186.091

63.360

150.624

87.263

213.984

Machinery

25.247

156.866

131.618

182.113

34.116

195.194

161.078

229.310

45.423

197.669

152.246

243.092

Lifts

Toys

0

2.101

2.101

2.101

26

2.852

2.827

2.878

0

2.559

2.559

2.559

40.166

7.835

-32.331

48.001

51.020

8.100

-42.920

59.120

42.012

8.840

-33.172

50.852

RTTE

205

10.369

10.163

10.574

827

15.323

14.496

16.150

1.208

19.182

17.975

20.390

Total sectors

118.136

269.647

151.509

387.783

149.895

343.654

193.760

493.549

152.003

378.874

226.871

530.877

Source: Comext/Eurostat. . Date extracted on 29/11/02 and elaborated by DG Trade-F2

9

2003/0065 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an Agreement between the European
Community and Malta on Conformity Assessment and Acceptance of Industrial
Products

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
133, in conjunction the first sentence of the first subparagraph of Article 300 (2) thereof,

Having regard to the proposal from the Commission8,

Whereas:

(1)

(2)

The  Agreement  on  Conformity  Assessment  and  Acceptance  of  Industrial  Products
between the European Community and Malta has been negotiated by the Commission
on behalf of the Community.

Subject  to  its  possible  conclusion  at  a  later  date,  the  Agreement  on  Conformity
Assessment and Acceptance of Industrial Products initialled in Brussels on 30th April
2002 should be signed.

HAS DECIDED AS FOLLOWS:

Sole Article

Subject  to  a  possible  conclusion  at  a  later  date,  the  President  of  the  Council  is  hereby
authorised  to  designate  the  person  empowered  to  sign,  on  behalf  of  the  Community,  the
Agreement with Malta on Conformity Assessment and Acceptance of Industrial Products.

Done at Brussels, […]

8

OJ C […], […], p. […].

For the Council
The President

10

                                                
2003/0066 (ACC)

Proposal for a

COUNCIL DECISION

on the conclusion of an Agreement between the European Community and Malta on
Conformity Assessment and Acceptance of Industrial Products.
- ACAA -

THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 133 thereof, in conjunction with the first sentence of the first subparagraph of Article
300(2), and the first sentence of the first subparagraph of Article 300(3) thereof,

Having regard to the proposal from the Commission9,

Whereas:

(1)
The draft Agreement on Conformity Assessment and Acceptance of Industrial
Products between the European Community and Malta, has been signed in Brussels on
[…2003], on behalf of the Community, and should be approved.

The appropriate internal procedures should be established to ensure the proper

(2)
functioning of the Agreement.

It  is  necessary  to  empower  the  Commission  to  make  certain  technical

(3)
amendments to this Agreement and to take certain decisions for its implementation,

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement with Malta on Conformity Assessment and Acceptance of Industrial Products
(hereinafter  referred to as "the Agreement"),  as  well as the declaration annexed  to the Final
Act thereto, are hereby approved on behalf of the European Community.

The text of the Agreement, and of the declaration annexed to the Final Act thereto, is attached
to this Decision.

9

OJ C […], […], p. […].

11

                                                
Article 2

The  President  of  the  Council  is  hereby  authorised  to  designate  the  person  empowered  to
transmit, on behalf of the Community, the diplomatic note provided for in  Article  17  of  the
Agreement.

1.

The  Commission,  after  consultation  with  the  special  committee  appointed  by  the
Council, shall:

Article 3

(a)

(b)

(c)

carry  into  effect  the  notifications,  acknowledgements,  suspensions  and
withdrawals of bodies, and appointments of joint team or teams of experts, in
accordance with Articles 10, 11 and 14 (3) (c) of the Agreement;

bring  about  the  consultations,  exchange  of  information,  the  requests  for
verifications and for participation in verifications, in accordance with Articles
3, 12 and 14 (d) (e), and Sections III and IV of the Annexes to the Agreement
concerning  Electrical  Safety,  Electromagnetic  Compatibility 
(EMC),
Machinery,  Lifts,  Personal  Protective  Equipment  (PPE),  Equipment  and
Protective  Systems  intended  for  use  in  Potentially  Explosive  Atmospheres
(ATEX),  Safety  of  toys  and  Radio  communication  and  telecommunication
terminal equipment

to 

the  Annexes 

if necessary, reply to requests in accordance with Article 11, Sections  III  and
IV  of 
the  Agreement  concerning  Electrical  Safety,
Electromagnetic  Compatibility  (EMC),  Machinery,  Lifts,  Personal  Protective
Equipment  (PPE),  Equipment  and  Protective  Systems  intended  for  use  in
Potentially  Explosive  Atmospheres  (ATEX),  Safety  of  toys  and  Radio
communication and telecommunication terminal equipment

2.

Following  consultation  of  the  special  committee  referred  to  in  paragraph  1  of  this
Article, the Commission shall determine the position to be taken by the Community
in  the  Association  Council  and,  where  applicable,  in  the  Association  Committee,
with regard to:

(a)

(b)

(c)

amendments  to  the  Annexes  in  accordance  with  Article  14,  point  (a)  of  the
Agreement;

addition  of  new  Annexes  in  accordance  with  Article  14,  point  (b)  of  the
Agreement;

any  decisions  regarding  disagreements  on  the  results  of  the  verifications  and
the suspensions, in part or totally, of any notified body in accordance with the
second and third subparagraphs of Article 11 of the Agreement;

12

(d)

any measures taken in the application of the safeguard clauses in Section IV of
the  Annexes  of  the  Agreement  concerning  Electrical  Safety,  Electromagnetic
Compatibility (EMC), Machinery, Lifts, Personal Protective Equipment (PPE),
Equipment  and  Protective  Systems  intended  for  use  in  Potentially  Explosive
toys  and  Radio  communication  and
Atmospheres  (ATEX),  Safety  of 
telecommunication terminal equipment

(e)

any  measures  concerning  the  verification,  suspension,  or  withdrawal  of
industrial  products  as  having  mutual  acceptance  under  Article  4  of  the
Agreement.

Done at Brussels, […]

For the Council
The President

13

Agreement between the European Community and Malta on Conformity
Assessment and Acceptance of Industrial Products
-ACAA-

The European Community and Malta, hereinafter referred to as “the Parties”,

Whereas  Malta  has  applied  for  membership  of  the  European  Union  and  such
membership  implies  the  effective  implementation  of  the  acquis  of  the  European
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,  the  Maltese  national  law
substantially takes over the 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 co-operation between them,

Considering  the  Agreement  of  5  December  1970  creating  an  Association  between  the
European Economic Community and Malta10,

Desiring  to  conclude  an  Agreement  on  Conformity  Assessment  and  Acceptance  of
industrial  products  (hereafter  “the  Agreement”)  providing  for  the  application  of  the
mutual  acceptance  of  industrial  products  which  fulfil  the  requirements  to  be  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  European  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 Conformity
Assessment Agreement between Malta and these countries equivalent to this Agreement,

Bearing  in  mind  their  status  as  Contracting  Parties  to  the  Agreement  establishing  the
World  Trade  Organisation,  and  conscious  in  particular  of  their  obligations  under  the
World Trade Organisation Agreement on Technical Barriers to Trade,

Have agreed as follows:

Article 1

Purpose

The purpose of this Agreement is to facilitate the elimination 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.

This Agreement provides for:

10

OJ L61 of 14.03.1971, p.2

14

                                                
1)  the  mutual  acceptance  of  industrial  products,  listed  in  the  annexes  on  “"mutual
acceptance  of  industrial  products”,  which  fulfil  the  requirements  to  be  lawfully  placed
on the market in one of the Parties;

2) the mutual recognition of the results of conformity assessment 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,

“Industrial  products”  means  products  listed  in  Chapters  25  to  97  of  the  Combined
Nomenclature.

“Community  law”  means  any  legal  act  and  implementing  practice  of  the  European
Community applicable to a particular situation, risk or category of industrial products, as
interpreted by the Court of Justice of the European Community.

“National  law”  means  any  legal  act  and  implementing  practice  by  which  Malta  takes
over  the  Community  law  applicable  to  a  particular  situation,  risk  or  category  of
industrial products.

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

Article 3

Alignment of legislation

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

Article 4

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
to be lawfully placed on the market of a Party, may be placed on the market of the other
Party, without further restriction.

Article 5

Mutual Recognition of the results of conformity assessment procedures

The Parties agree to recognize the  results  of  conformity assessment  procedures  carried
out in accordance with the Community or national law listed in the annexes on “mutual
recognition  of  the  results  of  conformity  assessment”.  The  Parties  shall  not  require
procedures  to  be  repeated,  nor  shall  they  impose  additional  requirements,  for  the
purposes of accepting that conformity.

15

Article 6

Safeguard clause

Where  a  Party  finds  that  an  industrial  product  placed  on  its  territory  by  virtue  of  the
present 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, putting into service or
use, or to restrict its free movement. The annexes shall provide for 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 conclude new ones, in accordance with the procedure
laid down in Article 14.

Article 8

Origin

The provisions of this Agreement shall apply to industrial products irrespective of their
origin.

Article 9

Obligation of Parties as regards their authorities and bodies

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

The Parties shall ensure that bodies, notified under their respective jurisdiction to assess
conformity  in  relation  to  requirements  of  Community  or  national  law  specified  in  the
annexes,  continuously  comply  with  the  requirements  of  Community  or  national  law.
Further,  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 European Community will
agree on the lists of the bodies notified for the purpose of the Agreement.

After the entry into force of the 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
requirements specified in the annexes from that date.

16

If a Party decides to withdraw a notified body under its jurisdiction, it shall inform the
other  Party  in  writing.  The  body  will  cease  to  assess  conformity  in  relation  to  the
requirements  specified  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 of this Agreement
(hereafter “the Joint Committee”).

Article 11

Verification of notified bodies

Each  Party  may  request  the  other  Party  to  verify  the  technical  competence  and
compliance  of  a  notified  body  under  its  jurisdiction.  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 co-operation 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 Community 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 Co-operation

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

a)  exchange  all  relevant  information  concerning  implementation  of  law  and  practice
including, in particular, on procedure to ensure compliance of notified bodies;

b)  take  part,  as  appropriate,  in  the  relevant  mechanisms  of  information,  co-ordination
and other related activities of the Parties.

c) encourage  their bodies to co-operate with a  view  to  establishing  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 kind covered by the obligation of professional secrecy. This information may not
be used for purposes other than those envisaged by this Agreement.

17

Article 14

Management of the Agreement

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

2. The Joint Committee shall 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 modifications 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 co-operation and assistance

The European Community may provide  technical co-operation and assistance  to  Malta
where necessary in order to support the effective 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 that third country, unless
there is an explicit agreement between the Parties in the Joint Committee.

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  agreement  of  the  Parties.
Amendments  or  additions  of  Sectoral  Annexes  will  be  made  through  the  Joint
Committee.

Either Party may terminate this Agreement by giving the other Party six months’

3.
notice in writing.

18

In case Malta has not become a Member of the European Union by 1 May 2004,
4.
both Parties will meet within a six-month period to review this Agreement in view of the
new situation.

Article 18

Final provisions

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.

Done at

, […]

19

ANNEXES ON MUTUAL ACCEPTANCE

OF INDUSTRIAL PRODUCTS

(For the record)

20

ANNEXES ON MUTUAL RECOGNITION

OF RESULTS OF CONFORMITY ASSESSMENT

Table of contents

Electrical Safety

Electromagnetic Compatibility (EMC)

Machinery

Lifts

Personal Protective Equipment (PPE)

Equipment  and  Protective  Systems  intended  for  use  in  Potentially  Explosive
Atmospheres (ATEX)

Safety of toys

Radio communication and telecommunication terminal equipment

1.

2.

3.

4.

5.

6.

7.

8.

21

Annex on Mutual Recognition of results of Conformity Assessment

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, 26.03.1973, p. 29), as last amended by Directive
93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p.1).

 National law:

 L.N. 23 of 1999: Low Voltage Electrical Equipment

Section II

NOTIFYING AUTHORITIES

European Community

- Belgium:

- Denmark:

- France:

- Germany:

- Greece:

- Spain:

- Ireland:

- Italy:

Ministère 
Economische Zaken.

des  Affaires 

Economiques/Ministerie 

van

Økonomi- og Erhvervsministeriet, Elektricitetsrådet

Ministère de l'économie, des finances et de l'industrie. Direction
Générale de l'Industrie, des Technologies de l'Information et des
Postes (DiGITIP) – SQUALPI.

Bundesministerium für Arbeit und Sozialordung

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.

Ministère du Travail (Inspection du Travail et des Mines).

- Netherlands:

Minister  van  Volksgezondheid,  Welzijn  en  Sport  (consumer
goods).

Minister van Sociale Zanken en Werkgelegenheid (others).

- Austria:

Bundesministerium für Wirtschaft und Arbeit .

22

- Portugal:

Under the authority of the Government of Portugal:

Instituto Português da Qualidade.

- Finland:

- Sweden:

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

 - Malta

Ministry or Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products:

1.

2.

3.

4.

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.

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

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

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 expertise carried out.

23

5.

(a)

(b)

Where the Joint Committee finds that the measure is:

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

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.

2.

3.

4.

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.

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
identified in this Annex.

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

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

24

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

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,  23.05.1989,  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. 24 of 1999: Electromagnetic Compatibility

Section II

NOTIFYING AUTHORITIES

European Community:

- Belgium:

- Denmark:

- France:

- Germany:

- Greece:

- Spain:

- Ireland:

- Italy:

Ministère 
Economische Zaken.

des  Affaires 

Telestyrelsen.

Economiques/Ministerie 

van

Ministère de l'économie, des finances et de l'industrie. Direction
Générale de l'Industrie, des Technologies de l'Information et des
Postes (DiGITIP) – SQUALPI.

Bundesministerium für Wirtschaft und Technologie.

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:

Ministerie van Verkeer en Waterstaat

- Austria:

- Portugal:

Bundesministerium für Wirtschaft und Arbeit .

Under the authority of the Government of Portugal:

Instituto Português da Qualidade.

ICP – Autoridade Nacional de Comunicações (ANACOM)

25

- Finland:

Kauppa-ja teollisuusministeriö / Handels- och industriministeriet.

For  EMC  aspects  of  telecommunications  and  radio  equipment:
Liikenne-javiestintäministeriö / Kommunikatiosministeriet.

- Sweden:

Under the authority of the Government of Sweden :

Styrelsen för ackreditering och teknisk kontrol (SWEDAC).

- United Kingdom:

Department of Trade and Industry

- Malta:

 Ministry for Economic Services

Section III

NOTIFIED AND COMPETENT BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products:

1.

2.

3.

4.

5.

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.

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

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

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 expertise carried out.

Where the Joint Committee finds that the measure is:

26

(a)

(b)

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

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.

2.

3.

4.

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.

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
identified in this Annex.

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

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

27

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

MACHINERY

Section I

COMMUNITY AND NATIONAL LAW

 Community law:

 European  Parliament  and  Council  Directive  98/37/EC  of  22  June
1998  on  the  approximation  of  the  laws  of  the  Member  States
relating to machinery (OJ L 207, 23.07.1998, p.1), as amended by
European  Parliament  and  Council  Directive  98/79/EC  of  27
October 1998 (OJ L 331, 07.12.1998, p.1).

 National law:

L.N. 250 of 2001: Machinery

Section II

NOTIFYING AUTHORITIES

European Community:

- Belgium:

Ministère  de  l’Emploi  et  du  Travail  /  Ministerie  voor  Arbeid  en
Tewerkstelling

- Denmark:

Arbejdsministeriet, Arbejdstilsynet.

- France:

Ministère  de  l'Emploi  et  de  la  Solidarité,  Direction  des  relations  du
travail, Bureau CT 5.

- Germany:

Bundesministerium für Arbeit und Sozialordnung.

- Greece:

- Spain:

- Ireland:

- Italy:

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 Zanken 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).

28

- U.K.

 Malta:

 Department of Trade and Industry.

 Ministry for Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products:

1.

2.

3.

4.

5.

(a)

(b)

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.

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

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

n case of disagreement on the outcome of such investigations the matter shall be
forwarded  to  the  Joint  Committee  who  may  decide  to  have  an  expertise  carried
out.

Where the Joint Committee finds that the measure is:

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

justified, the Parties shall take appropriate measures  to  ensure  that  such  products
are not placed on the market.

29

B. Safeguard clause relating to harmonised standards:

1.

2.

3.

4.

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.

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 identified in this Annex.

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

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

30

ANNEX ON MUTUAL RECOGNITION OF RESULS OF CONFORMITY ASSESSMENT

LIFTS

Section I

COMMUNITY AND NATIONAL LAW,

Community law:

European  Parliament  and  Council  Directive  95/16/EC  of  29
June 1995 on the approximation of the laws of  the Member
States relating to lifts (OJ L 213 , 07.09.1995, p.1).

National law:

L. N. 249 of 2001: Lifts

Section II

NOTIFYING AUTHORITIES

European Community:

- Belgium:

- Denmark:

- France:

- Germany:

- Greece:

- Spain:

- Ireland:

- Italy:

Ministère 
Economische Zaken.

des  Affaires 

Direktoratet for Arbejdstilsynet

Economiques/Ministerie 

van

Ministère  de  l'equipment,  des 
Direction  Générale  de  l'urbanisme,  de 
construction

transports  et  du 

l’habitat  et  de 

logement.
la

Bundesministerium für Arbeit und Sozialordnung

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 Zanken en Werkgelegenheid

- Austria:

- Portugal:

Bundesministerium für Wirtschaftliche und Arbeit .

Under the authority of the Government of Portugal:

Instituto Português da Qualidade

- Finland:

Kauppa-ja teollisuusministeriö/Handels-och industriministeriet

31

- Sweden:

Under the authority of the Government of Sweden :

Styrelsen för ackreditering och teknisk kontrol (SWEDAC).

- United Kingdom:

Department of Trade and Industry

 Malta:

 Ministry for Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

A. Safeguard clause relating to industrial products:

1.

2.

3.

4.

5.

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.

The  Parties  shall  consider  the  matter  and  the  evidence  brought  to  their
knowledge, and shall report to each other the results of its investigations.

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

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  expertise  carried
out.

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;

32

(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.

2.

3.

4.

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.

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 identified in this Annex.

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

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

33

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

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  Parliament  and  Council  Directive
96/58/EC of 3 September 1996 (OJ L 236, 18.09.1996, p.44).

National law:

L.N. 122 of 1998: Personal Protective Equipment

Section II

NOTIFYING AUTHORITIES

European Community

- Belgium:

Ministère de l’Emploi et du Travail/ Ministerie voor Arbeid en
Tewerkstelling

- Denmark:

Arbejdsministeriet, Arbejdstilsynet.

- France:

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 
technologies  de
l'information et des postes (DiGITIP) - SQUALPI.

l'industrie,  des 

- Germany:

Bundesministerium für Arbeit und Sozialordnung.

- Greece:

- Spain:

- Ireland:

- Italy:

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:

Ministerie van Volksgezondheid, Welzijn en Sport.

- Austria:

- Portugal:

Bundesministerium für Wirtschaft und Arbeit.

Under the authority of the Government of Portugal:

Instituto Português da Qualidade.

34

- Finland:

- Sweden:

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.

Malta:

Ministry for Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

Safeguard clauses

A. Safeguard clause relating to industrial products:

1.

2.

3.

4.

5.

(a)

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.

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

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

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  expertise  carried
out.

Where the Joint Committee finds that the measure is:

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

35

(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.

2.

3.

4.

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.

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 identified in this Annex.

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

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

36

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT

EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY
EXPLOSIVE ATMOSPHERES

Section I

COMMUNITY AND NATIONAL LAW

Community law:

European  Parliament  and  Council  Directive  94/9/EC  of  23
March 1994 on the approximation 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.  107  of  1999:  Equipment  and  Protective  Systems  in
Potentially Explosive Atmospheres

Section II

NOTIFYING AUTHORITIES

European Community

- Belgium:

Ministère 
Economische Zaken.

des  Affaires 

Economiques/Ministerie 

van

- Denmark:

For electrical aspects:

Økonomi- og Erhvervsministeriet, Elektricitetsrådet

For mechanical aspects:

Arbejdsministeriet, Arbejdstilsynet

- France:

- Germany:

- Greece:

- Spain:

- Ireland:

- Italy:

l'économie,  des 

Ministère  de 
l'industrie,
Direction de  l'Action  Régionale  et  de  la  Petite  et  Moyenne
Industrie (DARPMI), Sous-direction de la sécurité industrielle

finances  et  de 

Bundesministerium für Arbeit und Sozialordnung

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 Zanken en Werkgelegenheid

37

- 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

 Malta:

 Ministry for Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

1.

Transitional arrangements

The  certificates  issued  in  the  EC  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
applicable requirements referred to in this paragraph.

2.

Safeguard Clauses

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.

38

2.

3.

4.

5.

(a)

(b)

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

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

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  expertise  carried
out.

Where the Joint Committee finds that the measure is:

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

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.

2.

3.

4.

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.

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 identified in this Annex.

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

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

39

ANNEX ON MUTUAL RECOGNITION

OF RESULTS OF CONFORMITY ASSESSMENT:

SAFETY OF TOYS

Section I

Community law:

COMMUNITY AND NATIONAL LAW

Council Directive of 3 May 1988 on the approximation of
the  laws  of  the  Member  States  concerning  the  safety  of
toys  (88/378/EEC)  (OJ  L  187,  16.7.1988,  p.1),  as
amended by Council Directive 93/68/EEC of 22 July 1993
(OJ L 220, 30.08.1993, p.1).

National law:

L.N. 16 of 1996: Safety of Toys

Section II

NOTIFYING AUTHORITIES

European Community:

- Belgium:

- Denmark:

- France:

- Germany:

- Greece:

Ministère 
Economische Zaken.

des  Affaires 

Economiques/Ministerie 

van

Økonomi- og Erhvervsministeriet, Forbrugerstyrelsen

Ministère de l'Economie et des Finances

Bundesministerium für Arbeit und Sozialordnung

Υπουργείο  Ανάπτυξης.  Γενική  Γραµµατεία  Βιοµηχανίας
(Ministry of Development. General Secretariat of Industry).

- Spain:

Ministerio de Ciencia y Tecnología

Instituto Nacional del Consumo

- Ireland:

- Italy:

Department of Enterprise and Employment

Ministero delle Attività Produttive

- Luxembourg:

Ministère du Travail et de l’emploi

- Netherlands:

General Inspectorate for Health Protection

- Austria:

- Portugal:

- Finland:

- Sweden:

Bundesministerium für Wirtschaftliche und Arbeit .

Divisao 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).

40

- United Kingdom:

Department of Trade and Industry

- Malta:

 Ministry for Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

1.

Information concerning the certificate and the technical file

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 examinations and tests carried out.

2.

Notification of grounds for refusal by approved bodies

In  accordance  with  Article  10(5)  of  Directive  88/378/EEC,  Maltese  bodies  shall  inform  the
Notifying Authority when refusing to issue an EC type-examination certificate. The Notifying
Authority shall likewise notify the Commission of the European Community thereof.

3.

Safeguard Clauses

A. Safeguard clause relating to products

1.

2.

3.

4.

5.

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.

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

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

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 expertise carried out.

Where the Joint Committee finds that the measure is:

41

(a)

(b)

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

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.

2.

3.

4.

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

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
identified in this Annex.

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

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

42

ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

RADIO COMMUNICATION AND TELECOMMUNICATION TERMINAL EQUIPMENT

Section I

COMMUNITY AND NATIONAL LAW

Community law:

European  Parliament  and  Council  Directive  1999/5/EC  of  9th
March  1999  on  the  approximation  of  the  laws  of  the  Member
States  relating  to  radio  communication  and  telecommunication
terminal  equipment  and 
their
conformity (OJ L 91, 7.4.1999, p. 10).

the  mutual  recognition  of 

Maltese 
law:

national

L.N.  329  of  2001:  Radio  Equipment  and  Telecommunications
Terminal Equipment and mutual recognition of their conformity

Section II

NOTIFYING AUTHORITIES

European Community:

- Belgium:

Ministère des Affaires Economiques

- Denmark:

- France:

Ministerie van Economische Zaken.

National Telecom Agency (Telestyrelsen)

Ministère  de  l'Economie,  des  Finances  et  de  l'Industrie  –
Direction  Général  de 
l'Industrie,  des  Technologies  de
l’Information et des Postes

- Germany:

Bunderministerium für Wirtschaft und Technologie

- Greece:

- Spain:

- Ireland:

- Italy:

Ministry of Development

Ministerio de Ciencia y Technogía

Department of Public Enterprise, Communication Division

Ministero delle Comunicazioni

- Luxembourg:

Ministère des Transports

- Netherlands:

Ministry of Economic Affairs, Radiocommunications Agency

- Austria:

- Portugal:

Bundesministerium für Verkehr, Innovatioon und Technologie

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

For  EMC  aspects  of  telecommunications  and  radio  equipment:
Ministerio  de  Fomento.  Subdirección  General  de  Promoción  y
Normalización de Servicios de Telecomunicaciones

- Finland:

Kauppa-ja teollisuusministeriö/Handels-och industriministeriet

43

- Sweden:

Under the authority of the Government of Sweden :

Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

- United Kingdom:

Department of Trade and Industry

 - Malta:

 Ministry for Economic Services

Section III

NOTIFIED BODIES

European Community

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

Malta

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

Section IV

SPECIFIC ARRANGEMENTS

1.

Market Surveillance authorities

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

2.

Notification of interface regulations

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.

Application of essential requirements

Where  the  Commission  considers  adopting  a  Decision  to  apply  a  requirement  contained  in
article  3.3  of  Directive  99/5/EC  Malta  shall  give  its  opinion  on  the  issue  in  its  capacity  of
observer in the TCAM before the formal opinion of the Committee is requested.

4.

Notification of apparatus causing damage

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,
disconnect  or  to  withdraw  it  from  service  the  Party  shall  inform  such  authorisation  to  the
other Party.

44

5.

Safeguard Clauses

A. Safeguard clause relating to industrial products

1.

2.

3.

4.

5.

(a)

(b)

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

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

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

In  case  of  disagreement  on  the  outcome  of  such  investigations  the  matter  shall  be
forwarded  to the  Association Council who may decide to have an  expertise  carried
out.

Where the Association Council finds that the measure is:

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

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.

2.

3.

4.

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

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 identified in the present annex.

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

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

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

Where a Member State  or  Malta  takes  a  measure  to  adopt  any  appropriate  measures  with  a
view to: prohibiting or restricting the placing on its market, and/or requiring the withdrawal
from its market,

of  radio  equipment,  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.

45

1.

2.

(a)

(b)

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

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

justified,  it  shall  immediately  so  inform  the  Party  who  took  the  initiative  and  the
other Party.

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

46

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  communautaire,  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 electromagnetic compatibility, electrical safety, machinery and gas appliances.

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  implementation  or  management  powers  delegated  to  the  Commission  by  the
Council.

This invitation may be extended, on a case-by-case basis, to  groups of  experts convened  by
the Commission.

47

LEGISLATIVE FINANCIAL STATEMENT

Policy  area(s):  External  trade  relations,  including  access  to  the  markets  of  non-
Community countries

Activit(y/ies):  Conformity  Assessment  Procedures  and  Acceptance  of  Industrial
Products

TITLE OF ACTION:

Agreement establishing an Association between the European Community and
their  Member  States,  of  the  one  part,  and  Malta,  of  the  other  part,  on
Conformity Assessment and Acceptance of Industrial Products (ACAA)

1.

BUDGET LINE(S) + HEADING(S):

B7-8500

A-7010

2.

2.1.

2.2.

OVERALL FIGURES

Total allocation for action (Part B): €72380

Period of application:

The  general  action  undertaken  will  be  of  a  definite  duration.  The  ACAA  has  a
lifetime limited to the pre-accession period of Malta. The initial period of confidence
building  will  require  a  more  intensive  effort  but  the  expenditure  should  be
substantially  less  after  1  year.  However,  during  the  life  of  the  ACAA  a  continued
effort will be needed to ensure management and maintenance of confidence.

2.3.

Overall multiannual estimate of expenditure:

Schedule  of  commitment  appropriations/payment  appropriations  (financial

(a)
intervention) (see point 6.1.1)€

Year

2003
 14550

Commitments

2004
12270

2005
8520

2006
8520

2007
8520

52380

Total

Payments

 14550

12770

8520

8520

8520

52380

48

Technical 
(b)
(see point 6.1.2)

and 

administrative 

assistance 

and 

support 

expenditure

Commitments

10000

5000

5000

Payments

10000

5000

5000

Subtotal a+b

2003

2004

2005

2006

Commitments

24550

17270

13520

8520

Payments

25550

17270

13520

8520

2007

8520

8520

20000

20000

Total

72380

72380

(c) Overall  financial  impact  of  human  resources  and  other  administrative
expenditure (see points 7.2 and 7.3)

2003

2004

2005

2006

2007

Total

Commitments

96310

94300

94300

94300

94300

473510

Payments

96310

94300

94300

94300

94300

473510

TOTAL
a+b+c

2003

2004

2005

2006

2007

Total

Commitments

120860

111570

107820

102820

102820

545890

Payments

120860

111570

107820

102820

102820

545890

2.4.

Compatibility with financial programming and financial perspective

Proposal is compatible with existing financial programming.

2.5.

Financial impact on revenue:

Proposal does not involve any type of revenue.

3.

BUDGET CHARACTERISTICS

Type of
expenditure

New

EFTA
contribution

Contributions
form applicant
countries

Heading in
financial
perspective

Non-comp

Diff

NO

NO

NO

No 4

49

4.

LEGAL BASIS

Article 133 of the Treaty establishing the European Community.

Council  Decision  98/552/EC  of  24  September  1998  on  the  implementation  by  the
Commission  of  activities  relating  to  the  Community  market  access  strategy
(OJ L 265, 30.9.1998, p. 31).

Proposal for a Council decision N°.... on the conclusion by the European Community
of  an  additional  Agreement  establishing  an  Association  between  the  European
Community and their Member States, of the one part, and Malta, of the other part, on
Conformity Assessment and Acceptance of Industrial Products (ACAA).

5.

DESCRIPTION AND GROUNDS

5.1.

Need for Community intervention

5.1.1. Objectives pursued

Community trade objectives in the field of standards and conformity assessment can
be summarised. First, to reduce technical barriers to trade in external markets and to
prevent the emergence of new ones; and second, to encourage our trading partners to
adopt standards and regulatory approaches based on, or compatible with international
or European practice.

These  Community's  trade  objectives  have  so  far  been  pursued  through  a  four-fold
strategy. One of them is the negotiation of Mutual Recognition Agreements (MRAs).
ACAAs are mutual recognition agreements in which the mutual recognition operates
on  the  basis  of  the  acquis  communautaire.  They  are  trade  agreements  with  the
applicant countries, and are an important element of the pre-accession strategy.

The main objective of the ACAA is to facilitate trade by means of the elimination of
technical  barriers  in  respect  of  industrial  products  in  certain  sectors  in  which  the
candidate country has aligned its legislation on the acquis communautaire.

The  purpose  of  this  ACAA  is  to  establish  the  mutual  acceptance  of  industrial
products  which fulfil the  requirements  to be lawfully  placed  on  the  market  and  the
mutual  recognition  of  the  results  of  conformity  assessment  of  industrial  products
subject  to  the  Community  technical  regulations  and  to  the  equivalent  Maltese
national legislation.

5.1.2. Measures taken in connection with ex ante evaluation

The  Agreements  on  Conformity  Assessment  and  Acceptance  of  Industrial  products
(ACAAs) are to be considered in the context of Enlargement policy of the European
Union.

The  Europe  Agreements  recognise  that  a  major  precondition  for  the  Associated
Countries’  economic  integration  into  the  Community  is  the  integration  into  the
internal market via the approximation of their legislation to the Community.

50

The  Article  76  of  the  Europe  Agreement  establishing  an  Association  between  the
European Community and their Member States, of one part, and Malta, of the other
part,  promotes  the  conclusion  of  agreements  on  mutual  recognition  in  the  field  of
industrial standards and conformity assessment.

5.1.3. Measures taken following ex post evaluation

The major actions, which will be pursued by the Commission under this budget line,
will be the following:

-Confidence-building activities to facilitate the proper implementation of the ACAA.

-Management of the ACAA and maintenance of the necessary degree of confidence.

-Extension of the ACAA to new sectors.

The  Commission  will  be  assisted  by  experts,  particularly  in  regard  to  sectoral
activities. It will however remain the final arbiter in the management of this ACAA.

5.2.

Action envisaged and budget intervention arrangements

-the target population

The target population are the exporting companies, business associations, chambers
of  commerce  and  public  institutions  of  the  European  Union  and  the  general
consumer  which  will  benefit,  or  have  an  interest  in,  the  mutual  acceptance  of
industrial products and recognition of results of conformity assessment certification.

The  specific  objectives  of  ACAAs  (Agreements  on  Conformity  Assessment  and
Acceptance of Industrial Products) are:

-to avoid duplication of certification by economic operators

-to promote exports, employment, competitivity and investment

-to reduce costs, in particular for small and medium-sized enterprises and ultimately
for the consumer,

-to extend certain benefits of the Internal Market to Malta

-to  ensure  the  effective  operation  of  the  Internal  Market  in  certain  sectors  before
accession of Malta

-the concrete measures to be taken to implement the action are:

A.
Attendance  at  the  Association  Council,  the  Association  Committee  or  any
special subcommittee or group to which has been delegated the management of the
ACAA.

This will be attended  by  Commission  officials  and  some  experts  from  the  Member
States. Travel and per diem expenses should be foreseen within the normal range of
such expenses. The travel expenditure for officials will be covered by the  "Mission
budget" (A-7010). The reimbursement of travel and related expenses for experts will
be made on line B7-8500.

51

B. Workshops and Seminars

These will be held to familiarise economic and other operators with the requirements
of the ACAA. The cost of  these seminars  will vary  according  to  the  subject matter
and location, and will include travel and organisational costs (when in  the EC)  and
substantial  travel  costs  when  in  Malta.  Organisational  costs  will  cost  c.  3000  Euro
each.  The  number  of  seminars  will  vary  depending  on  the  individual  industrial
sectors covered by the ACAA.

C.

Verification actions

The competence of the notified bodies will in some cases have to be checked, more
so in the initial period of the ACAA, but as a matter of course throughout the life of
the ACAA to maintain confidence in the system.

This  will  involve  on-site  assessment  by  teams  of  experts  of  notified  bodies  in  the
partner  country  in  the  initial  stages,  and  subsequently  investigation  of  complaints.
This  expenditure  will  cover  all  sectors  of  the  ACAA  and  may  involve  several
notified bodies in each sector.

D.

Production and dissemination of information

Certain costs may need to be incurred for the dissemination of information. Guides to
regulations and assessment procedures  may be needed typically at a  cost of 10,000
Euro.

5.3.

Methods of implementation

Under  Article  133  of  the  Treaty,  the  Community  has  exclusive  competence  for
commercial  policy  and  this  agreement  have  been  negotiated  in  accordance  with  a
mandate  of  the  Council  of  Ministers  and  in  consultation  with  the  133  Committee.
The  Commission  will  be  responsible  for  implementation  and  management  of  this
Agreement.

The  choice  of  management  method  (Association  Council)  has  been  set  out  in  the
ACAA and constitute a minimum necessary for the proper functioning of the ACAA.
The  use  of  seminars  in  the  initial  phases  will  allow  ensuring  familiarity  with  other
systems.

These  seminars  and  verifications  are  also  designed  to  build  mutual  confidence;
verifications will also be required to ensure this confidence is maintained throughout
the  life  of  the  ACAA.  Confidence  and  its  maintenance  are  keys  to  the  successful
operation of the ACAA.

The  importance  of  this  budget  is  justified  when  put  in  perspective  with  the  trade
involved in this ACAA and the yearly savings for EU exporters which are expected
(estimated on a yearly basis at € 26 million for EU exporters to Malta).

There is no main factors of uncertainty which could affect the specific results of the
operation.

52

6.

FINANCIAL IMPACT

6.1.

Total financial impact on Part B - (over the entire programming period)

(The  method  of  calculating  the  total  amounts  set  out  in  the  table  below  must  be
explained by the breakdown in Table 6.2.)

6.1.1.

Financial intervention

Commitments (in € )

Breakdown

Committees

Seminars

Verifications

Year

2003

5360

6030

3160

5360

3750

3160

2004

2005

2006

2007

Total

5360

5360

5360

26800

3160

3160

8520

3160

8520

9780

15800

52380

TOTAL 14550

12270

8520

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

Year

2003

2004

2005

2006

2007

Total

1) 
Technical 
administrative assistance

and

a)  Technical 
offices

assistance

b)  Other 
administrative assistance:

technical  and

- intra muros:

- extra muros:

of  which  for  construction
and 
of
maintenance 
computerised  management
systems

Subtotal 1

2) Support expenditure

a) Studies

b) Meetings of experts

Information 

c) 
publications

Subtotal 2

TOTAL

and

10000

5000

5000

10000

10000

5000

5000

5000

5000

53

20000

20000

20000

6.2.

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire
programming period)11

(Where there is more than one action, give sufficient detail of the specific measures
to  be  taken  for  each  one  to  allow  the  volume  and  costs  of  the  outputs  to  be
estimated.)

Commitments (in € )

Breakdown

Meetings/year

Number of
outputs

Average unit
cost

(total for years
1…n)

Total cost

(total for years
1…n)

Action 1: Committees (B7-8500)

-Meetings in Bxl

- Meetings in Malta

Action 2 : Seminars (B7-8500)

- In Bxl

- In Malta

Action 3: Verifications (B7-8500)

-In Malta

1

1

.

.

.

.

1

TOTAL COST

5

5

.

1

1

.

5

2200

3160

.

3750

6030

.

3160

11000

15800

.

3750

6030

.

15800

52380

If necessary explain the method of calculation (See table annexed)

7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources

Types of post

to 

be 

assigned 

to
Staff 
management of the action using
existing 
additional
and/or 
resources

Description of tasks deriving
from the action

Total

Number of
permanent posts

Number of
temporary posts

None

Officials 
temporary staff

or

A

B

C

0,6

.

0,2

Other human resources None

Total

0,8

0,6

.

0,2

0,8

If necessary, a fuller
description of the tasks may
be annexed.

These  resources  are  expected  to  be  met  from  efficiency  savings  in  the  services
involved

11

For further information, see separate explanatory note.

54

                                                
7.2.

Overall financial impact of human resources

Type of human resources

Amount (€)

Method of calculation *

Officials

Temporary staff

Other human resources

86.400

0,8 staff ( 108.000 € per staff
member per year

(specify budget line)

Total

86.400

The amounts are total expenditure for twelve months.

7.3.

Other administrative expenditure deriving from the action

Budget line

2003

2004

2005

2006

2007

Total 2003-2007

A0701- Missions (Committee)

5800

5800

5800

5800

5800

29000

A0701- Seminars in Malta

1750

0

1750

A0701-Verifications in Malta

1450

1450

TOTAL

9000

7250

1450

7250

1450

7250

1450

7250

7250

38000

Budget 
heading)

line 

(number 

and

Amount €

Method of calculation

Overall allocation (Title A7)

A0701 – Missions (Committee)

.

A0701 – Seminars in Malta

.

A0701- Verifications in Malta

Total

.

29000

.

1750

.

7250

38000

2 days meeting in Malta:Travel €1150, per diem
€  150,  4  Commission  officials;  1  meeting  a
year, 5 years

4  days  seminar  in  Malta;  Travel  €1150;  per
diem  €150;  1  Commission  official;  1  meeting
year 2003

2  days  meeting  in  Malta;  Travel  €1150;  per
diem €150; 1 Commission official; 1 meeting a
year; 5 years

The amounts are total expenditure for the period 2003-2007

55

Specify the type of committee and the group to which it belongs.

I.

Annual total (7.2 + 7.3)

2003

–  2004-2007

II.

Total cost of action (2003-2007)

€

95400

374600

€ 470000

(In  the  estimate  of  human  and  administrative  resources  required  for  the  action,
DGs/Services  must  take  into  account  the  decisions  taken  by  the  Commission  in  its
orientation/APS debate and when adopting the preliminary draft budget (PDB). This
means  that  DGs  must  show  that  human  resources  can  be  covered  by  the  indicative
pre-allocation made when the PDB was adopted.

Exceptional cases (i.e. those where the action concerned could not be foreseen when
the  PDB  was  being  prepared)  will  have  to  be  referred  to  the  Commission  for  a
decision  on  whether  and  how  (by  means  of  an  amendment  of  the  indicative  pre-
allocation, an ad hoc redeployment exercise, a supplementary/amending budget or a
letter of amendment to the draft budget) implementation of the proposed action can
be accommodated.)

8.

FOLLOW-UP AND EVALUATION

8.1.

Follow-up arrangements

The success of this ACAA can be quantified by trade facilitation through avoidance
of duplication of testing and certification and costs. It is estimated on a yearly basis
at € 26 million for EU exporters to Malta.

Success can also be measured by increased EU and Maltese exports and this factor
will  be  taken  into  consideration  although  export  performance  is  subject  to  such  a
wide  range  of  variables  (e.g.  changes  in  exchange  rates,  general  economic  trends)
that this can never been the sole factor for evaluation. In addition, official trade data
are  not  always  available  for  all  types  of  specific  products  covered  by  the  sectoral
annexes to the ACAA.

Success  can  also  be  measured  increased  certificates  delivered  to  companies  in
accordance  with  the  ACAA.  This  could  be  put  into  relation  to  the  number  of
certificates  delivered  under  the  domestic  systems  before  the  ACAA  entered  into
force.

56

8.2.

Arrangements and schedule for the planned evaluation

Progress  in  the  attainment  of  the  ACAA  objectives  will  be  monitored  by
Commission  officials,  the  Association  Council  and  by  the  economic  operators
concerned.

The  evaluation  of  the  effectiveness  and  usefulness  of  the  ACAA  will  be  regularly
monitored by the Commission, by the Association Council at its annual meeting, by
the Association Committee at its annual meeting, or by any special subcommittee or
group  to  which  the  Association  Council  has  delegated  the  management  of  the
ACAA.  At  least,  the  first  major  evaluation  will  be  two  years  after  the  entry  into
force.

9.

ANTI-FRAUD MEASURES

Methods of control (submission of reports, etc.) will be included in all  contracts or
grant agreements between the Commission and beneficiaries.

A close co-operation with the delegations of the Commission and the participation of
a representative of the Commission at events in third countries will check on the spot
the work to ensure that it corresponds with the terms of reference, contract provisions
and required professionalism.

The  checks  take  place  before  the  final  payment.  The  same  rule  applies  to  the
financial incentives paid to participating companies. Where appropriate, agreements
also require organisations to submit financial accounts certified by their auditors.

57

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS
with special reference to small and medium-sized enterprises

Title of proposal

Proposal for Council Decisions on the signature and conclusion of an additional Agreement
between the European Community and Malta on Conformity Assessment and Acceptance of
Industrial Products (ACAA).

Reference number

The proposal

These  decisions  are  necessary  to  conclude  the  Agreement  between  the  European
Community  and  Malta  on  Conformity  Assessment  and  Acceptance  of  Industrial  Products.
The  Commission  negotiated  the  draft  Agreement  in  accordance  with  the  negotiating
guidelines  for  the  negotiation  of  European  Conformity  Assessment  Agreement  with  the
Central Eastern European Countries, adopted by the Council in June 1997.

The impact on business

The business sectors affected are electrical safety, electromagnetic compatibility, machinery
and gas appliances.

The ACAA provides to extend  certain benefits of the  Internal Market in industrial  sectors
already  aligned.  The  ACAA  permits  certification  of  conformity  with  technical  regulations
on product safety, etc, to be conducted in the European Union  for  exports destined Malta.
This  avoids  the  need  for  further  certification  by  Maltese  conformity  assessment  bodies
before  putting  them  on  Maltese  market.  The  certification  procedure  and  the  technical
regulations are the same as the Community one.

The ACAA also envisages acceptance of industrial products that fulfil the requirements to
be legally placed on the EU market by Malta without subject further requirement. Annexes
under this mechanism have still to be negotiated.

The ACAA therefore presents important advantages from the point of view of transparency,
market  access,  avoidance  of  duplication  especially  of  cost,  effective  operation  in  certain
sectors before accession and general facilitation of trade. This is of particular importance for
small  and  medium-sized  enterprises.  The  ACAA  covers  a  wide  range  of  sectors  and
therefore affects an extensive range of firms both large and  small. The  advantages  are not
limited to specific geographical areas in the Community.

58

Businesses  will  have  to  apply  Maltese  regulations  and  procedures.  However,  these  are
aligned  on  the  EC  ones  in  sectors  covered  by  the  ACAA.  Furthermore,  certification,  as
stated  above,  will  be  conducted  by  conformity  assessment  bodies  located  and  already
designated  by  the  Member  States  in  the  Community,  and  not  in  Malta.  The  ACAA  will
substantially  reduce  certification  costs  and  improve  prospects  for  exports,  employment,
investment and competitiveness by Community firms.

The ACAA does not contain measures to take account of the specific situation of small and
medium-sized firms, but by its nature and by reducing certification costs which are the same
for  all  firms,  the  agreement  will  benefit  small  and  medium  sized  enterprises  to  a  greater
extent proportionately than larger firms.

Consultation

The  main  industry  organisations  (e.g.  EFPIA,  Eurobit,  Unice  and  Orgalime)  have  been
consulted and have declared their support for this Agreement.

59