Proposal for a Council Decision on the signature on behalf of the Community of an additional Protocol to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and Romania, of the other part, on Conformity Assessment and Acceptance of Industrial Products
Date: 2006-07-26
Institutions: European Commission
Subjects: European Community, Romania, approval, association agreement, industrial product, signature of an agreement

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.7.2006 
COM(2006)420 final 

2006/0137(ACC) 
2006/0138(ACC) 

Proposal for a 

COUNCIL DECISION 

on the signature on behalf of the Community of an additional Protocol to the Europe 
Agreement establishing an Association between the European Communities and their 
Member States, of the one part, and Romania, of the other part, on Conformity 
Assessment and Acceptance of Industrial Products 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an additional Protocol to the Europe Agreement establishing an 
Association between the European Communities and their Member States, of the one 
part, and Romania, of the other part, on Conformity Assessment and Acceptance of 
Industrial Products 
- PECA - 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

I. EXPLANATORY MEMORANDUM 

On the basis of negotiating directives adopted by the Council on 21 September 1992 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 
additional  protocol  to  the  Europe  Agreement  with  Romania  (Protocol  to  the  Europe 
Agreement  on  Conformity  assessment  and  Acceptance  of  industrial  products,  hereinafter 
referred to as "PECA").  

The  text  of  this  Protocol  is  attached  to  this  Communication.  The  following  provides  an 
assessment of the Protocol in the light of the negotiating directives approved by the Council, 
and proposes that the Council authorises the signature of the additional Protocol to the Europe 
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  the  Czech  Republic,  Hungary,  Slovenia,  Slovakia,  Estonia, 
Latvia and Lithuania before their accession to the European Union. 

I.1 ASSESSMENT OF THE AGREEMENT 

Considering that this agreement is intended to work only during the pre-accession period, and 
that an appropriate legal framework was offered by the Europe Agreement, it was decided, in 
consultation  with  the  133  Committee,  to  adopt  this  agreement  as  a  Protocol  to  the  Europe 
Agreement. 

The draft PECA 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 PECA is a transitional arrangement, and thus will terminate with 
the candidate country’s accession. 

The  PECA  provides  for  an  extension  of  certain  benefits  of  the  Internal  Market  in  sectors 
already aligned. The PECA thus facilitates market access by eliminating technical barriers to 
trade with respect to industrial products. To this end, the PECA 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, confirms that Articles 
10.3  and  11.4  of  the  Europe  Agreement  with  Romania  apply  without  other  restriction  as 
referred to in Article 36 of the Europe Agreement. 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. Annexes making this mechanism 
operational remain to be negotiated. 

1 

COM(1996) 564 final, 13.11.1996. 

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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 Romanian 
market without having to undergo any further approval procedures, and vice-versa. Initially, 
only the following sector is covered: pressure equipment. 

Romania  has  taken  over  the  Community  technical  legislation  in  the  sector  covered  by  the 
Protocol and participates in the European organisations in the field of standards, metrology, 
testing laboratories and accreditation. 

The PECA consists of a framework agreement and annexes as referred to above. A unilateral 
Community  declaration  inviting  the  Romanian  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 PECA is made in the next paragraphs. 

I.1.1 Framework Agreement 

An article-by-article assessment follows: 

Preamble. This sets out the basic objective of the PECA 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 PECA, namely the elimination 
of  technical  barriers  to  trade  in  respect  to  industrial  products.  The  PECA  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  Romania  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 PECA. 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. 

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.  

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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 
Protocol 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 Protocol 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 Protocol. 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 Protocol. 

Article 14: Management of the Protocol. The Association Council will be responsible for its 
effective functioning and may delegate its duties in conformity with the relevant Articles of 
the Europe Agreement.  

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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 Protocol. 

Article 16: Agreements with other countries. This confirms that, unless otherwise agreed, 
the  PECA  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.  

Article 18: Status of the Protocol. This establishes the fact that the PECA is an integral part 
of the Europe Agreement. 

I.1.2 The Annexes to the Protocol 

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 Protocol. 

Annexe on Pressure Equipment. 

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 
the  annex.  Section  II,  on  notifying  authorities,  lists  the  authorities  responsible  for  the 
designation  of  bodies  in  the  Member  Sates  and  Romania.  Section  III,  on  notified  bodies, 
makes  reference  to  the  notification  of  all  Conformity  Assessment  Bodies  notified  by  the 
Member  States  and  by  Romania.  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 PECA, in line with the Europe 
Agreement, provides nevertheless the basis for such acceptance of products, similar to the one 
which operates in the Community. 

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I.1.2.3 Unilateral Declaration 

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

Unilateral  Community  Declaration  relating 
the  Romanian 
representatives  to  Committees.  Through  this  declaration,  Romania  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"2. 

to  attendance  of 

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  Protocol  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 Romania. 

I.2 OVERALL APPRECIATION 

The Commission considers that the proposed PECA 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 PECA confirms that Romania has taken over the Community legislation in certain sectors 
before its accession. Both political and commercial benefits are achieved with the PECA. 

The  Protocol  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 
Protocol. 

It  has  not  been  able  to  quantify  the  costs  or  time  taken  to  obtain  conformity  assessment  of 
industrial  products  in  Romania.  The  precise  extent  of  savings  in  time,  cost  and  market 
opportunity of this Protocol is therefore not feasible in every case to determine. However, on 
the  basis  of  a  rough  calculation,  it  is  estimated3  that  this  Protocol  would  create  cost  saving 
opportunities  of  around  €8  millions  per  year  for  the  European  exporting  industry  and  to 
Romanian  exporters  to  the  EC.  Some  of  these  savings  will  be  passed  on  to  European 
importers and consumers. 

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.  

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

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

I.3 FINANCIAL IMPACT 

There are no financial implications to this proposal. Maintenance activities of the Protocol are 
expected  to  be  minimal,  and  are  already  covered  by  funding  already  established  for  the 
maintenance of the Europe Agreement to which this is a Protocol. 

I.4 IMPACT ON BUSINESS 

Exporting companies, business associations, chambers of commerce and public institutions of 
the European Union and the general consumer 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  the  PECA  are  to  avoid  duplication  of  certification  by  economic 
operators.  The  PECA  will  promote  exports,  employment,  competitiveness  and  investment, 
and  to  reduce  costs,  in  particular  for  small and  medium-sized  enterprises  and  ultimately  for 
the  consumer,  by  extending  certain  benefits  of  the  Internal  Market  to  Romania,  and  by 
ensuring  the  effective  operation  of  the  Internal  Market  in  Romania  in  the  sectors  that  it 
covers, before Romanian accession. 

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 the former acceding countries. 

The  first  one  is  concerned  with  the  signature  of  the  Protocol.  Signature  is  required  by 
Romania for the adoption of this Protocol. It is accordingly proposed that the President of the 
Council be authorised to designate the person empowered to sign the Protocol 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  PECA.  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 Protocol. 

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  Protocol.  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 Protocol in the Association Council, 
or where applicable the Association Committee. 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  Romania  has  applied,  implies  the  effective 
implementation of all the Community acquis. 

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In all other cases the Community position with respect to the Protocol shall be determined by 
the Council, acting by qualified majority, on a proposal from the Commission. 

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

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2006/0137(ACC) 

Proposal for a 

COUNCIL DECISION 

on the signature on behalf of the Community of an additional Protocol to the Europe 
Agreement establishing an Association between the European Communities and their 
Member States, of the one part, and Romania, of the other part, 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 Commission4, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

The  Europe  Agreement  establishing  an  association  between 
the  European 
Communities and their Member States, of the one part, and Romania of the other part,5 
entered into force on 1st February 1995. 

Article  75  of  the  Europe  Agreement  provides  that  co-operation  in  the  fields  of 
standardisation  and  conformity  assessment  shall  seek  to  achieve  the  conclusion  of 
agreements on mutual recognition. 

The Protocol to the Europe Agreement on Conformity Assessment and Acceptance of 
Industrial  Products  has  been  negotiated  by  the  Commission  on  behalf  of  the 
Community. 

Subject to its possible conclusion at a later date, the Protocol to the Europe Agreement 
on  Conformity  Assessment  and  Acceptance  of  Industrial  Products  initialled  in 
Brussels on 18 April 2006 should be signed. 

4 
5 

OJ C …, …, p. … 
OJ L 357, 31.12.1994, p. 2. 

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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 
Protocol to the Europe Agreement with Romania on Conformity Assessment and Acceptance 
of Industrial Products. 

Done at Brussels, 

For the Council 
The President 

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2006/0138(ACC) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an additional Protocol to the Europe Agreement establishing an 
Association between the European Communities and their Member States, of the one 
part, and Romania, of the other part, on Conformity Assessment and Acceptance of 
Industrial Products 
- PECA - 

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), the first sentence of the first subparagraph of Article 300(3) and Article 300(4) 
thereof, 

Having regard to the proposal from the Commission6, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

the  European 
The  Europe  Agreement  establishing  an  association  between 
Communities and their Member States, of the one part, and Romania of the other part,7 
entered into force on 1st February 1995. 

Article  75(2)  of  the  Europe  Agreement  provides  that  co-operation  in  the  fields  of 
standardisation  and  conformity  assessment  shall  seek  to  achieve  the  conclusion  of 
agreements on mutual recognition. 

Article  110  of  the  Europe  Agreement  provides  that  the  Association  Council  may 
delegate to the Association Committee any of its powers. 

Article 2 of Decision 94/907/EC, ECSC, Euratom of the Council and the Commission 
of  19  December  1994  on  the  conclusion  of  the  Europe  Agreement  between  the 
European Communities and their Member States, of the one part, and Romania, of the 
other  part,8  provides  for  the  Community  decision-making  procedures  and  for  the 
presentation  of  the  Community  position  in  the  Association  Council  and  in  the 
Association Committee. 

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OJ C …, …, p. … 
OJ L 357, 31.12.1994, p. 2. 
OJ L 357, 31.12.1994, p. 1. 

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(5) 

(6) 

(7) 

The  draft  Protocol  to  the  Europe  Agreement  on  Conformity  Assessment  and 
Acceptance of Industrial Products, has been signed in Brussels on […], on behalf of 
the Community, and should be approved. 

The  appropriate  internal  procedures  should  be  established  to  ensure  the  proper 
functioning of the Protocol. 

It is necessary to empower the Commission to make certain technical amendments to 
this Protocol and to take certain decisions for its implementation, 

HAS DECIDED AS FOLLOWS:  

Article 1 

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

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

The President of the Council shall, on behalf of the Community, transmit the diplomatic note 
provided for in Article 17 of the Protocol9. 

Article 2 

1. 

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

Article 3 

(a) 

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, indent c) of the Protocol; 

(b)  bring  about  the  consultations,  exchange  of  information,  the  requests  for 
verifications and for participation in verifications, in accordance with Articles 
3, 12 and 14, indents d) and e), and Sections III and IV of the Annexes to the 
Protocol; 

(c) 

if necessary, reply to requests in accordance with Article 11, Sections III and 
IV of the Annexes to the Protocol; 

9 

The date of entry into force of the Protocol will be published in the Official Journal of the European 
Communities by the General Secretariat of the Council. 

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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) 

(d) 

(e) 

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

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

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 Protocol; 

any measures taken in the application of the safeguard clauses in Section IV of 
the Annexes of the Protocol; 

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

3. 

In  all  other  cases  the  position  to  be  taken  by  the  Community  in  the  Association 
Council  and,  where  applicable,  in  the  Association  Committee,  with  regard  to  this 
Protocol  shall  be  determined  by  the  Council,  acting  by  qualified  majority  on  a 
proposal from the Commission. 

Done at Brussels,  

For the Council 
The President

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DRAFT 

PROTOCOL 

TO THE EUROPE AGREEMENT ESTABLISHING AN ASSOCIATION BETWEEN THE 
EUROPEAN COMMUNITIES AND THEIR MEMBER STATES, OF THE ONE PART, 
AND ROMANIA, OF THE OTHER PART, 
ON CONFORMITY ASSESSMENT ANDACCEPTANCE OF INDUSTRIAL PRODUCTS 
(PECA) 

THE EUROPEAN COMMUNITY AND ROMANIA, 

hereinafter referred to as “the Parties”, 

WHEREAS  Romania  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 Romania 
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 Protocol, Romanian national law substantially 
takes over Community law, 

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

DESIRING  to  conclude  a  Protocol  to  the  Europe  Agreement  on  Conformity  Assessment  and 
Acceptance  of  Industrial  Products  (hereafter  referred  to  as  "this  Protocol")  providing  for  the 
application of the mutual acceptance of industrial products which fulfil the requirements for being 
lawfully placed on the market in one of the Parties and of the mutual recognition of the results of 
conformity  assessment  of  industrial  products  which  are  subject  to  Community  or  national  law, 
noting that Article 75 of the Europe Agreement provides, where appropriate, for the conclusion of 
an agreement on mutual recognition, 

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 
Romania and these countries equivalent to this Protocol, 

BEARING  IN  MIND  the  Parties'  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, 

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HAVE AGREED AS FOLLOWS: 

ARTICLE 1 

Purpose 

The  purpose  of  this  Protocol  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 Romania of national law, which is equivalent to Community law. 

This Protocol provides for: 

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

(b) 
the mutual recognition of the results of conformity assessment of industrial products subject 
to  Community  law  and  to  the  equivalent  Romanian  national  law,  both  listed  in  the  Annexes  on 
mutual recognition of results of conformity assessment. 

ARTICLE 2 

Definitions 

For the purpose of this Protocol,  

"industrial products" means products as specified in Article 9 of the Europe Agreement and 

(a) 
in Protocol 2 thereto; 

(b) 
"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 Communities; 

"national law" means any legal act and implementing practice by which Romania takes over 

(c) 
Community law applicable to a particular situation, risk or category of industrial products. 

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

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ARTICLE 3 

Alignment of legislation 

For the purpose of this Protocol, Romania agrees to take appropriate measures, in consultation with 
the  Commission  of  the  European  Communities,  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 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  for  being 
lawfully placed on the market of a Party, may be placed on the market of the other Party, without 
further restriction. This shall be without prejudice to Article 36 of the Europe Agreement. 

ARTICLE 5 

Mutual recognition of the results 
of conformity assessment procedures 

The  Parties  agree  to  recognise  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. 

ARTICLE 6 

Safeguard clause 

Where a Party finds that an industrial product placed on the market on its territory by virtue of this 
Protocol,  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  Romania  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.  

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ARTICLE 8 

Origin 

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

ARTICLE 9 

Obligations 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 

Initially,  the  bodies  notified  for  the  purpose  of  this  Protocol  shall  be  those  included  in  the  lists 
which  Romania  and  the  Community  have  exchanged  before  the  completion  of  the  procedures  for 
entry into force 

Afterwards, 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 shall be considered as 
notified and as competent to assess conformity in relation to the said requirements specified in the 
Annexes from that date; 

If a Party decides to withdraw the notification of a body under its jurisdiction, it shall inform the 
other Party in writing. The body will cease to assess conformity in relation to the said 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 
Association Council. 

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

If the problems cannot be resolved to the satisfaction of both Parties, they may notify the Chairman 
of  the  Association  Council  of  their  disagreement,  giving  their  reasons.  The  Association  Council 
may decide on appropriate action. 

Unless and until decided otherwise by the Association Council, 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 Association Council. 

ARTICLE 12 

Exchange of information and cooperation 

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

exchange all relevant information concerning implementation of law and practice including, 

(a) 
in particular, on procedure to ensure compliance of notified bodies; 

take part, as appropriate, in the relevant mechanisms of information, coordination and other 

(b) 
related activities of the Parties; 

encourage  their  bodies  to  cooperate  with  a  view  to  establishing  mutual  recognition 

(c) 
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 Protocol 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 Protocol. 

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ARTICLE 14 

Management of the Protocol 

Responsibility  for  the  effective  functioning  of  this  Protocol  shall  be  borne  by  the  Association 
Council  in  accordance  with  Article  106  of  the  Europe  Agreement.  In  particular,  it  shall  have  the 
power to take decisions regarding: 

(a) 

amending the Annexes; 

(b) 

adding new Annexes; 

appointing a joint team or teams of experts to verify the technical competence of a notified 

(c) 
body and its compliance with the requirements; 

exchanging information on proposed and actual amendments to the Community and national 

(d) 
law referred to in the Annexes;  

considering new or additional conformity assessment procedures affecting a sector covered 

(e) 
by an Annex; 

(f) 

resolving any questions relating to the application of this Protocol. 

The  Association  Council  may  delegate  the  above  responsibilities  set  out  under  this  Protocol,  in 
accordance with Article 110(2) of the Europe Agreement. 

ARTICLE 15 

Technical cooperation and assistance 

The  European  Community  may  provide  technical  cooperation  and  assistance  to  Romania  where 
necessary in order to support the effective implementation and application of this Protocol. 

ARTICLE 16 

Agreements with other countries 

Agreements  on  conformity  assessment  concluded  by  either  Party  with  a  country  which  is  not  a 
Party  to  this  Protocol  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 Association Council. 

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ARTICLE 17 

Entry into force 

This Protocol 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 Protocol. 

ARTICLE 18 

Status of the Protocol 

This Protocol shall constitute an integral part of the Europe Agreement. 

This Protocol is drawn up in two originals in the Czech, Danish, Dutch, English, Estonian, Finnish, 
French,  German,  Greek,  Italian,  Hungarian,  Latvian,  Lithuanian,  Maltese,  Polish,  Portuguese, 
Slovak, Slovene, Spanish, Swedish and Romanian languages, each text being equally authentic. 

Done at Brussels, 

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ANNEXES ON MUTUAL ACCEPTANCE 
OF INDUSTRIAL PRODUCTS 

(for the record) 

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ANNEXES ON MUTUAL RECOGNITION 
OF RESULTS OF CONFORMITY ASSESSMENT 

Table of contents 

(1) 

Pressure equipment 

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DRAFT 
ANNEX ON MUTUAL RECOGNITION 
OF RESULTS OF CONFORMITY ASSESSMENT 
PRESSURE EQUIPMENT 

SECTION I 

COMMUNITY AND NATIONAL LAW 

Community law: 

National law: 

Directive 97/23/EC of the European Parliament and of the Council of 
29 May 1997 on the approximation of the laws of the Member States 
concerning pressure equipment 

Government Decision no. 584/2004 establishing the conditions for 
placing  on  the  market  of  pressure  equipment,  as  subsequently 
amended. 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

Belgium: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Germany: 

Bundesministerium für Arbeit und Sozialordnung. 

Greece: 

Estonia: 

France: 

Ireland: 

Italy: 

Latvia: 

Malta: 

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

Majandus- ja Kommunikatsiooniministeerium. 

Ministère  de  l’emploi  et  de  la  solidarité,  Direction  des  relations  du 
travail, Bureau CT 5. 

Department of Enterprise and Employment. 

Ministero dell’Industria, del Commercio e dell’Artigianato. 

Ekonomikas ministrija. 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority. 

Hungary: 

Austria: 

Gazdasági és Közlekedési Minisztérium. 

Bundesministerium für Wirtschaft und Arbeit. 

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Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Slovak Republic: 

Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 
republiky. 

Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

United Kingdom: 

Department of Trade and Industry. 

Romania 

Ministerul  Economiei  si  Comertului  –  Ministry  of  Economy  and 
Commerce. 

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 Romania in accordance with 
Article 10 of this Protocol. 

Romania 

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

SECTION IV 

SPECIFIC ARRANGEMENTS 

Safeguard Clauses 

A. 

1. 

Safeguard clause relating to industrial products: 

Where a Party has taken a measure to deny free access to its market: 

for industrial products subject to this Annex bearing the CE marking; 

or,  

for industrial products subject to this Annex which are referred to in Article 3 (3) or 
article  14  of  Directive  97/23/EC  corresponding  to  Articles  10  and  Article  17 
respectively of Government Decision No. 584/2004, but for which CE marking is 
not required;  

it shall immediately inform the other Party, indicating the reasons for its decision and 
how non-compliance has been assessed. 

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2. 

3. 

4. 

5. 

(a) 

(b) 

B. 

1. 

2. 

3. 

4. 

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

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

Where the Association Council finds that the measure is: 

unjustified,  the  national  authority  of  the  Party  which  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. 

Safeguard clause relating to harmonised standards: 

Where  Romania  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 Association Council giving the reasons therefore. 

The Association Council 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 Association Council and the other Party informed of 
the proceedings. 

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

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DECLARATION BY THE COMMUNITY 
ON THE ATTENDANCE OF ROMANIAN 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 Romania is invited, under the following 
conditions, to the meetings of the committees established or referred to under the Community 
law on electrical safety, electromagnetic compatibility, machinery 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. 

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