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 the Republic of Bulgaria, of the other part, on Conformity Assessment and Acceptance of Industrial Products
Date: 2006-09-29
Institutions: European Commission
Subjects: Bulgaria, Community certification, association agreement (EU), industrial product, mutual recognition principle, protocol to an agreement, signature of an agreement, trade by product

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.9.2006 
COM(2006) 559 final 

2006/0177 (ACC) 
2006/0176 (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 the Republic of Bulgaria, 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 the Republic of Bulgaria, 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 21.9.92 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 Agreement1 with the Republic of Bulgaria (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  assessment2 
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 
10.4  and  11.4  of  the  Europe  Agreement  with  Bulgaria  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 

1 
2 

OJ L358, 31.12.1994, p.3 
COM(96) 564 - final. 13.11.1996. 

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under this mechanism may freely move between the Parties. Annexes making this mechanism 
operational remain 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  Bulgarian 
market without having to undergo any further approval procedures, and vice-versa. Initially, 
the  following  sectors  are  covered:  Electrical  Safety;  Electromagnetic  compatibility;  Gas 
Appliances; Lifts; Toys; Machinery.  

Bulgaria  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  Bulgarian  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  Bulgaria  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 

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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 
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. 

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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.  

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. 

Annexes  on  Electrical  Safety;  Electromagnetic  Compatibility;  Gas  Appliances;  Lifts; 
Safety of Toys; and Machinery. 

The  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  of  each  Annex  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  Bulgaria.  Section  III,  on 
notified  bodies,  makes  reference  to  the  notification  of  all  Conformity  Assessment  Bodies 
notified  by  the  Member  States  and  by  Bulgaria.  Section  IV,  on  specific  arrangements,  fixes 
the two procedures for the safeguard clause, relating to industrial products and to harmonised 
standards. 

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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. 

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  Bulgarian  representatives 
at  Committees.  Through  this  declaration,  Bulgaria  is  invited  to  send  observers  to  the 
meetings of 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”3. 

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 Bulgaria. 

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 Bulgaria 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  Bulgaria.  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  estimated4  that  this  Protocol  would  create  cost  saving 
opportunities  of  around  €70  millions  per  year  for  the  European  exporting  industry  and  to 
Bulgarian exporters to the EC. Some of these savings will be passed on to European importers 
and consumers. 

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Point 4.2.b. COM(99) 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 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.  

In terms of the benefits to Bulgaria, the PECA will facilitate access to the Community market 
and will give political credit for having aligned its legislation. Bulgaria 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, competitivity  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 Bulgaria, and by ensuring 
the effective operation of the Internal Market in Bulgaria in the sectors that it covers, before 
Bulgarian 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 Bulgaria 
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 

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includes  delegation  of  the  power  to  add  new  Annexes,  since,  as  indicated  in  the  Preamble, 
membership  of  the  European  Union,  for  which  Bulgaria  has  applied,  implies  the  effective 
implementation of all the Community acquis. 

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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2006/0177 (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 the Republic of Bulgaria, 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 Commission5, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

The  Europe  Agreement  establishing  an  association  between 
the  European 
Communities and their Member States, of the one part, and Bulgaria of the other part,6 
entered into force on 1st February 1993. 

Article  75  of  the  Europe  Agreement  provides  that  co-operation  in  the  fields  of 
standardisation and conformity assessment shall seek, where appropriate, to conclude 
agreements on mutual recognition in these fields. 

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 .... should be signed. 

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OJ C …, …, p. … 
OJ L 358, 31.12.1994, p. 3. 

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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 the Republic of Bulgaria on Conformity Assessment 
and Acceptance of Industrial Products. 

Done at Brussels,  

For the Council 
The President 

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2006/01776(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 the Republic of Bulgaria, 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 Commission7, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

the  European 
The  Europe  Agreement  establishing  an  association  between 
Communities and their Member States, of the one part, and the Republic of Bulgaria 
of the other part,8 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 shall seek, where appropriate, to 
conclude agreements on mutual recognition in these fields. 

Article  109(2)  of  the  Europe  Agreement  provides  that  the  Association  Council  may 
delegate to the Association Committee any of its powers. 

Article 2 of Decision 94/908/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 Bulgaria, of the 
other  part,9  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 358, 31.12.1994, p.3. 
OJ L 358, 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  the  Republic  of  Bulgaria  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 Protocol10. 

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  concerning  electrical  safety,  electromagnetic  compatibility,  gas 
appliances, lifts, safety of toys, and machinery. 

(c) 

if necessary, reply to requests in accordance with Article 11, Sections III and 
IV of the Annexes to the Protocol concerning electrical safety, electromagnetic 
compatibility, gas appliances, lifts, safety of toys, and machinery. 

10 

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  concerning  electrical  safety,  electromagnetic 
compatibility, gas appliances, lifts, safety of toys, and machinery; 

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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- D R A F T - 

PROTOCOL 

to the Europe Agreement establishing an Association between the European Communities 
and their Member States, of the one part, and the Republic of Bulgaria, of the other part, 
on Conformity Assessment and Acceptance of Industrial Products (PECA) 

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THE EUROPEAN COMMUNITY AND THE REPUBLIC OF BULGARIA, 

hereinafter referred to as "the Parties", 

WHEREAS  the  Republic  of  Bulgaria  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  the 
Republic of Bulgaria 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,  Bulgarian  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 the Republic of Bulgaria 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, 

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 the Republic of Bulgaria of national law, which is equivalent to Community 
law. 

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This Protocol provides for: 

(a) 

(b) 

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; 

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

ARTICLE 2 

Definitions 

For the purpose of this Protocol,  

(a) 

(b) 

(c) 

"industrial products" means products, as specified in Article 9 of the Europe Agreement 
and in Protocol 3 thereto; 

"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 the Republic of 
Bulgaria takes over 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 Bulgarian 
national law. 

ARTICLE 3 

Alignment of legislation 

For the purpose of this Protocol, the Republic of Bulgaria 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. 

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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 the Republic of Bulgaria 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 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. 

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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  the  Republic  of  Bulgaria  and  the  European  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) 

(b) 

a Party shall forward its notification to the other Party in writing; 

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. 

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. 

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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:  

(a) 

(b) 

(c) 

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

take part, as appropriate, in the relevant mechanisms of information, coordination and 
other related activities of the Parties; 

encourage  their  bodies  to  cooperate  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  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. 

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 107 of the Europe Agreement. In particular, it shall have the 
power to take decisions regarding: 

(a) 

(b) 

(c) 

(d) 

amending the Annexes; 

adding new Annexes; 

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

exchanging  information  on  proposed  and  actual  amendments  to  the  Community  and 
national law referred to in the Annexes;  

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(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 Protocol. 

The Association Council may delegate the above responsibilities set out under this Protocol, in 
accordance with Article 109(2) of the Europe Agreement. 

ARTICLE 15 

Technical cooperation and assistance 

The European Community may provide technical cooperation and assistance to the Republic of 
Bulgaria 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. 

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,  Hungarian,  Italian,  Latvian,  Lithuanian,  Maltese,  Polish, 
Portuguese,  Slovak,  Slovenian,  Spanish,  Swedish  and  Bulgarian  languages,  each  text  being 
equally authentic. 

Done at 

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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) 

Electrical Safety 

(2) 

Electromagnetic compatibility 

(3) 

Gas Appliances 

(4) 

Lifts 

(5) 

Toys 

(6)  Machinery 

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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, 
26.3.1973,  p.  29),  as  amended  by  Council  Directive  93/68/EEC  of 
22 July 1993 (OJ L 220, 30.8.1993, p.1). 

National law: 

Law on Technical Requirements for Products (SG No. 86/1.10.1999, 
amendments  published  in  SG  No.  63/2002,  93/2002,  18/2003, 
107/2003, 45/2005, 77/2005, 88/2005, 95/2005, 105/2005, 30/2006) 

Ordinance  on  conformity  marking,  adopted  with  Council  of 
Ministers’ Decree No. 191/16.08.2005 (SG No. 69/23.08.2005) 

Ordinance  on  the  essential  requirements  and  conformity  assessment 
of electrical equipment designed for use within certain voltage limits, 
adopted  with  Council  of  Ministers’  Decree  No.  182/6.07.2001  (SG 
No.  62/13.07.2001,  amendments  published  in  SG  No.  74/2003, 
24/2006) 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

– Belgium: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

– Denmark: 

Sikkerhedsstyrelsen 

(The Danish Safety Technology Authority) 

– Germany: 

Bundesministerium für Arbeitsschutz und Arbeitsmedizin 

– Greece: 

Υπουργείο Ανάπτυξης. Γενική Γραμματεία Βιομηχανίας 

(Ministry of Development. General Secretariat of Industry). 

– Spain: 

Ministerio de Industria, Turismo y Comercio 

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– France: 

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. 

– Ireland: 

Department of Enterprise, Trade and Employment.  

– Italy: 

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: 

Ministerie van Volksgezondheid, Welzijn en Sport (Verbrauchsgüter). 

Ministerie van Sociale Zaken en Werkgelegenheid (Sonstige).  

– Austria: 

Bundesministerium für Wirtschaft und Arbeit. 

– Portugal: 

Under the authority of the Government of Portugal: 

Instituto Português da Qualidade. 

– Finland: 

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet. 

– Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

– United Kingdom:  Department of Trade and Industry. 

– Estonia: 

Majandus- ja Kommunikatsiooniministeerium. 

Ministry of Economic Affairs and Communications 

– Slovenia: 

Ministrstvo za gospodarstvo. 

Ministry of the Economy 

– Hungary: 

Gazdasági és Közlekedési Minisztérium.  

Ministry of Economy and Transport 

– Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Czech Office for Standards, Metrology and Testing 

– Slovak Republic:  Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 

republiky. 

Slovak Office of Standards, Metrology and Testing 

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– Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Ministry of Economic Affairs and Labour 

– Latvia: 

Ekonomikas ministrija. 

Ministry of Economics 

– Lithuania: 

Ūkio ministerija. 

Ministry of Economy 

– Cyprus: 

Ministry of Commerce, Industry and Tourism 

– Malta: 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority.  

Republic of Bulgaria  Държавна агенция за метрологичен и технически надзор 

(State Agency for Metrological and Technical Surveillance) 

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 the Republic of Bulgaria in 
accordance with Article 10 of this Protocol. 

Republic of Bulgaria 

Bodies  which  have  been  designated  by  the  Republic  of  Bulgaria  in  accordance  with  the 
Bulgarian  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 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. 

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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 expert appraisal 
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 the Republic of Bulgaria 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 therefor. 

The  Association  Council  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 this Annex. 

The  European  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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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,  23.5.1989,  p.  19),  as  last  amended  by 
Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, 
p.1). 

National law: 

Law on Technical Requirements for Products (SG No. 86/1.10.1999, 
amendments  published  in  SG  No.  63/2002,  93/2002,  18/2003, 
107/2003, 45/2005, 77/2005, 88/2005, 95/2005, 105/2005, 30/2006) 

Ordinance  on  conformity  marking,  adopted  with  Council  of 
Ministers’ Decree No. 191/16.08.2005 (SG No. 69/23.08.2005) 

Ordinance  on  the  essential  requirements  and  conformity  assessment 
relating  to  electromagnetic  compatibility,  adopted  with  Council  of 
Ministers’  Decree  No.  203/29.08.2001  (SG  No.  78/11.09.2001, 
amendments published in SG No. 13/2003, 65/2004, 24/2006) 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

– Belgium: 

– Denmark: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

Ministeriet 
Telestyrelsen. 

for  Videnskab,  Teknologi  og  Udvikling, 

IT-og 

National IT and Telecom Agency 

– Germany: 

Bundesministerium für Arbeitsschutz und Arbeitsmedizin 

– Greece: 

Υπουργείο Ανάπτυξης. Γενική Γραμματεία Βιομηχανίας  

(Ministry of Development. General Secretariat of Industry). 

– Spain: 

Ministerio de Industria, Turismo y Comercio 

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– France: 

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.  

– Ireland: 

Department of Enterprise, Trade and Employment.  

– Italy: 

Ministero delle Attività Produttive. 

– Luxembourg: 

Ministère de l'Economie-Service de l'Energie de l'Etat.  

– Netherlands: 

EZ/Agentschap Telecom 

– Austria: 

Bundesministerium für Wirtschaft und Arbeit. 

– Portugal: 

Autoridade Nacional de Comunicaçoes (ANACOM) 

– Finland: 

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet. 

For EMC aspects of telecommunications and radio equipment: 

Liikenne-ja viestintäministeriö/Kommunikationsministeriet. 

– Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

– United Kingdom:  Department of Trade and Industry. 

– Estonia: 

Majandus- ja Kommunikatsiooniministeerium. 

Ministry of Economic Affairs and Communications 

– Slovenia: 

Ministrstvo za gospodarstvo. 

Ministry of the Economy 

– Hungary: 

Gazdasági és Közlekedési Minisztérium.  

Ministry of Economy and Transport 

– Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Czech Office for Standards, Metrology and Testing 

– Slovak Republic:  Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 

republiky. 

Slovak Office of Standards, Metrology and Testing 

– Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Ministry of Economic Affairs and Labour 

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– Latvia: 

Ekonomikas ministrija. 

Ministry of Economics 

– Lithuania: 

Ūkio ministerija. 

Ministry of Economy 

– Cyprus: 

Ministry of Commerce, Industry and Tourism 

– Malta: 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority.  

Republic of Bulgaria  Държавна агенция за метрологичен и технически надзор 

(State Agency for Metrological and Technical Surveillance) 

SECTION III 

NOTIFIED AND COMPETENT 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 the Republic of Bulgaria in 
accordance with Article 10 of this Protocol. 

Republic of Bulgaria 

Bodies  which  have  been  designated  by  the  Republic  of  Bulgaria  in  accordance  with  the 
Bulgarian  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. 

2. 

Safeguard clause relating to industrial products 

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. 

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3. 

4. 

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 expert appraisal 
carried out. 

5. 

Where the Association Council finds that the measure is: 

unjustified,  the  national  authority  of  the  Party  which  has  taken  the  measure  shall 

(a) 
withdraw it; 

justified, the Parties shall take appropriate measures to ensure that such products are 

(b) 
not placed on the market. 

B. 

Safeguard clause relating to harmonised standards. 

1. 
Where the Republic of Bulgaria 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 therefor. 

2. 
The  Association  Council  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 this Annex. 

The  European  Community  shall  keep  the  Association  Council  and  the  other  Party 

3. 
informed of the proceedings. 

4. 

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

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ANNEX ON MUTUAL RECOGNITION 
OF RESULTS OF CONFORMITY ASSESSMENT 

GAS APPLIANCES 

SECTION I 

COMMUNITY AND NATIONAL LAW 

Community law: 

Council Directive 90/396/EEC of 29 June 1990 on the approximation 
of  the  laws  of  the  Member  States  relating  to  appliances  burning 
gaseous  fuels  (OJ  L  196,  26.7.1990,  p.  15),  as  amended  by  Council 
Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). 

National law: 

Law on Technical Requirements for Products (SG No. 86/1.10.1999, 
amendments  published  in  SG  No.  63/2002,  93/2002,  18/2003, 
107/2003, 45/2005, 77/2005, 88/2005, 95/2005, 105/2005, 30/2006) 

Ordinance  on  conformity  marking,  adopted  with  Council  of 
Ministers’ Decree No. 191/16.08.2005 (SG No. 69/23.08.2005) 

Ordinance  on  the  essential  requirements  and  conformity  assessment 
of  gas  appliances,  adopted  with  Council  of  Ministers’  Decree  No. 
250/05.11.2003  (SG  No.  100/14.11.2003,  amendments  published  in 
SG No. 24/2006) 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

– Belgium: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

– Denmark: 

Arbejdstilsynet / Danish Working Environment Authority 

– Germany: 

Bundesministerium für Arbeitsschutz und Arbeitsmedizin 

– Greece: 

Υπουργείο Ανάπτυξης. Γενική Γραμματεία Βιομηχανίας  

– Spain: 

– France: 

– Ireland: 

– Italy: 

(Ministry of Development. General Secretariat of Industry). 

Ministerio de Industria, Turismo y Comercio 

Ministère de l'économie, des finances et de l'industrie, DGE/DARQSI 

Department of Enterprise, Trade and Employment.  

Ministero delle Attività Produttive. 

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31 

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– Luxembourg: 

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

– Netherlands: 

SZW/ Arbo/P&G 

– Austria: 

Bundesministerium für Wirtschaft und Arbeit. 

– Portugal: 

Under the authority of the Government of Portugal: 

Instituto Português da Qualidade. 

– Finland: 

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet. 

– Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

– United Kingdom:  Department  of  Trade  and  Industry,  Standards  and  Technical 

Regulations Directorate; Department for Transport (DfT) 

Dangerous Goods Unit 

– Estonia: 

Majandus- ja Kommunikatsiooniministeerium. 

Ministry of Economic Affairs and Communications 

– Slovenia: 

Ministrstvo za gospodarstvo. 

Ministry of the Economy 

– Hungary: 

Gazdasági és Közlekedési Minisztérium.  

Ministry of Economy and Transport 

– Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Czech Office for Standards, Metrology and Testing 

– Slovak Republic:  Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 

republiky. 

Slovak Office of Standards, Metrology and Testing 

– Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Ministry of Economic Affairs and Labour 

– Latvia: 

Ekonomikas ministrija. 

Ministry of Economics 

– Lithuania: 

Ūkio ministerija. 

Ministry of Economy 

EN 

32 

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– Cyprus: 

– Malta:  

Ministry of Commerce, Industry and Tourism 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority.  

Republic of Bulgaria  Държавна агенция за метрологичен и технически надзор 

(State Agency for Metrological and Technical Surveillance) 

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 the Republic of Bulgaria in 
accordance with Article 10 of this Protocol. 

Republic of Bulgaria 

Bodies  which  have  been  designated  by  the  Republic  of  Bulgaria  in  accordance  with  the 
Bulgarian  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. 

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. 

The Parties shall consider the matter and the evidence brought to their knowledge, and 

2. 
shall report to each other the results of their investigations. 

In  the  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that 

3. 
such products are not placed on the market. 

In the case of disagreement on the outcome of such investigations the matter shall be 
4. 
forwarded to the  Association Council  which may decide to have an  expert  appraisal carried 
out. 

5. 

Where the Association Council finds that the measure is: 

EN 

33 

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unjustified,  the  national  authority  of  the  Party  which  has  taken  the  measure  shall 

(a) 
withdraw it; 

justified, the Parties shall take appropriate measures to ensure that such products are 

(b) 
not placed on the market. 

B. 

Safeguard clause relating to harmonised standards: 

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

The  Association  Council  shall  consider  the  matter  and  may  request  the  European 
2. 
Community  to  proceed  in  accordance  with  the  procedure  provided  for  in  the  Community 
legislation identified in this Annex. 

The  European  Community  shall  keep  the  Association  Council  and  the  other  Party 

3. 
informed of the proceedings. 

4. 

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

EN 

34 

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ANNEX ON MUTUAL RECOGNITION 
OF RESULTS 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, 7.9.1995, p. 1) 

National law: 

Law on Technical Requirements for Products (SG No. 86/1.10.1999, 
amendments  published  in  SG  No.  63/2002,  93/2002,  18/2003, 
107/2003, 45/2005, 77/2005, 88/2005, 95/2005, 105/2005, 30/2006) 

Ordinance  on  conformity  marking,  adopted  with  Council  of 
Ministers’ Decree No. 191/16.08.2005 (SG No. 69/23.08.2005) 

Ordinance  on  the  essential  requirements  and  conformity  assessment 
of  lifts  and  their  safety  components,  adopted  with  Council  of 
Ministers’  Decree  No.  242/24.10.2001  (SG  No.  94/2.11.2001, 
amendments  published  in  SG  No.  87/2002,  115/2002,  100/2003, 
24/2006) 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

– Belgium: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

– Denmark: 

Sikkerhedsstyrelsen / The Danish Safety Technology Authority 

– Germany: 

Bundesministerium für Arbeitsschutz und Arbeitsmedizin 

– Greece: 

Υπουργείο Ανάπτυξης. Γενική Γραμματεία Βιομηχανίας  

– Spain: 

– France: 

(Ministry of Development. General Secretariat of Industry). 

Ministerio de Industria, Turismo y Comercio 

Ministère  de  l’équipement,  des  transports  et  du  logement,  Direction 
générale de l’urbanisme, de l’habitat et de la construction. 

– Ireland: 

Department of Enterprise and Employment.  

– Italy: 

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

EN 

35 

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– Luxembourg: 

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

– Netherlands: 

SZW/ Arbo/P&G 

– Austria: 

Bundesministerium für Wirtschaft und Arbeit. 

– Portugal: 

Direcçao-Geral de Geologia e Energia 

– Finland: 

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet. 

– Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

– United Kingdom:  Department of Trade and Industry. 

– Estonia: 

Majandus- ja Kommunikatsiooniministeerium. 

Ministry of Economic Affairs and Communications 

– Slovenia: 

Ministrstvo za gospodarstvo. 

Ministry of the Economy 

– Hungary: 

Gazdasági és Közlekedési Minisztérium.  

Ministry of Economy and Transport 

– Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Czech Office for Standards, Metrology and Testing 

– Slovak Republic:  Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 

republiky. 

Slovak Office of Standards, Metrology and Testing 

– Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Ministry of Economic Affairs and Labour 

– Latvia: 

Ekonomikas ministrija. 

Ministry of Economics 

– Lithuania: 

Ūkio ministerija. 

Ministry of Economy 

– Cyprus: 

Ministry of Commerce, Industry and Tourism 

EN 

36 

   EN 

 
– Malta: 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority.  

Republic of Bulgaria  Държавна агенция за метрологичен и технически надзор 

(State Agency for Metrological and Technical Surveillance) 

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 the Republic of Bulgaria in 
accordance with Article 10 of this Protocol. 

Republic of Bulgaria 

Bodies  which  have  been  designated  by  the  Republic  of  Bulgaria  in  accordance  with  the 
Bulgarian  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. 

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. 

The Parties shall consider the matter and the evidence brought to their knowledge, and 

2. 
shall report to each other the results of their investigations. 

In  the  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that 

3. 
such products are not placed on the market. 

4. 
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  expert  appraisal carried 
out. 

5. 

Where the Association Council finds that the measure is: 

unjustified,  the  national  authority  of  the  Party  which  has  taken  the  measure  shall 

(a) 
withdraw it; 

EN 

37 

   EN 

 
justified, the Parties shall take appropriate measures to ensure that such products are 

(b) 
not placed on the market. 

B. 

Safeguard clause relating to harmonised standards: 

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

2. 
The  Association  Council  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 this Annex. 

The  European  Community  shall  keep  the  Association  Council  and  the  other  Party 

3. 
informed of the proceedings. 

4. 

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

EN 

38 

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ANNEX ON MUTUAL RECOGNITION 
OF RESULTS OF CONFORMITY ASSESSMENT 

TOYS 

SECTION I 

COMMUNITY AND NATIONAL LAW 

Community law: 

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

National law: 

Law on Technical Requirements for Products (SG No. 86/1.10.1999, 
amendments  published  in  SG  No.  63/2002,  93/2002,  18/2003, 
107/2003, 45/2005, 77/2005, 88/2005, 95/2005, 105/2005, 30/2006) 

Ordinance  on  conformity  marking,  adopted  with  Council  of 
Ministers’ Decree No. 191/16.08.2005 (SG No. 69/23.08.2005) 

Ordinance  on  the  essential  requirements  and  conformity  assessment 
toys,  adopted  with  Council  of  Ministers’  Decree  No. 
of 
177/4.07.2001 (SG No. 62/13.07.2001, amendments published in SG 
No. 13/2003, 104/2003, 24/2006) 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

– Belgium: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

– Denmark: 

Sikkerhedsstyrelsen / The Danish Safety Technology Authority 

– Germany: 

Bundesministerium für Arbeitsschutz und Arbeitsmedizin 

– Greece: 

Υπουργείο Ανάπτυξης. Γενική Γραμματεία Βιομηχανίας  

(Ministry of Development. General Secretariat of Industry). 

– Spain: 

– France: 

Calidad del Consumo 

Ministère de l’économie et des finances ; DGE/DARQSI 

SQUALPI/BARMI 

– Ireland: 

Department of Enterprise and Employment.  

EN 

39 

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– Italy: 

Ministero delle Attività Produttive. 

– Luxembourg: 

Ministère du travail et de l’emploi.  

– Netherlands: 

VWS/ directie GMT 

– Austria: 

Bundesministerium für soziale Sicherheit und Generationen. 

– Portugal: 

Divisao de Estudos de Produtos do Instituto do Consumidor. 

– Finland: 

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet. 

– Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

– United Kingdom:  Department of Trade and Industry; Consumer and Competition Policy 

Directorate 

– Estonia: 

Majandus- ja Kommunikatsiooniministeerium. 

Ministry of Economic Affairs and Communications 

– Slovenia: 

Ministrstvo za gospodarstvo. 

Ministry of the Economy 

– Hungary: 

Gazdasági és Közlekedési Minisztérium.  

Ministry of Economy and Transport 

– Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Czech Office for Standards, Metrology and Testing 

– Slovak Republic:  Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 

republiky. 

Slovak Office of Standards, Metrology and Testing 

– Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Ministry of Economic Affairs and Labour 

– Latvia: 

Ekonomikas ministrija. 

Ministry of Economics 

– Lithuania: 

Ūkio ministerija. 

Ministry of Economy 

– Cyprus: 

Ministry of Commerce, Industry and Tourism 

EN 

40 

   EN 

 
– Malta: 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority.  

Republic of Bulgaria  Държавна агенция за метрологичен и технически надзор 

(State Agency for Metrological and Technical Surveillance) 

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 the Republic of Bulgaria in 
accordance with Article 10 of this Protocol. 

Republic of Bulgaria 

Bodies  which  have  been  designated  by  the  Republic  of  Bulgaria  in  accordance  with  the 
Bulgarian  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. 

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. 

The Parties shall consider the matter and the evidence brought to their knowledge, and 

2. 
shall report to each other the results of their investigations. 

In  the  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that 

3. 
such products are not placed on the market. 

4. 
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  expert  appraisal carried 
out. 

5. 

Where the Association Council finds that the measure is: 

unjustified,  the  national  authority  of  the  Party  which  has  taken  the  measure  shall 

(a) 
withdraw it; 

EN 

41 

   EN 

 
justified, the Parties shall take appropriate measures to ensure that such products are 

(b) 
not placed on the market. 

B. 

Safeguard clause relating to harmonised standards: 

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

2. 
The  Association  Council  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 this Annex. 

The  European  Community  shall  keep  the  Association  Council  and  the  other  Party 

3. 
informed of the proceedings. 

4. 

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

EN 

42 

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ANNEX ON MUTUAL RECOGNITION 
OF RESULTS OF CONFORMITY ASSESSMENT 

MACHINERY 

SECTION I 

Community law: 

COMMUNITY AND NATIONAL 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,  23.7.1998,  p.  1),  as  amended  by  European 
Parliament and Council Directive 98/79/EC of 27 October1998 (OJ L 
331, 7.12.1998, p. 1). 

National law: 

Law on Technical Requirements for Products (SG No. 86/1.10.1999, 
amendments  published  in  SG  No.  63/2002,  93/2002,  18/2003, 
107/2003, 45/2005, 77/2005, 88/2005, 95/2005, 105/2005, 30/2006) 

Ordinance  on  conformity  marking,  adopted  with  Council  of 
Ministers’ Decree No. 191/16.08.2005 (SG No. 69/23.08.2005) 

Ordinance  on  the  essential  requirements  and  conformity  assessment 
of  machinery,  adopted  with  Council  of  Ministers’  Decree  No. 
232/11.10.2001  (SG  No.  91/23.10.2001,  amendments  published  in 
SG No. 115/2002, 13/2003, 52/2004, 24/2006) 

SECTION II 

NOTIFYING AUTHORITIES 

European Community 

– Belgium: 

Ministère  des  Affaires  Economiques/Ministerie  van  Economische 
Zaken. 

– Denmark: 

Arbejdstilsynet / Danish Working Environment Authority 

– Germany: 

Bundesministerium für Arbeitsschutz und Arbeitsmedizin 

– Greece: 

Υπουργείο Ανάπτυξης. Γενική Γραμματεία Βιομηχανίας  

– Spain: 

– France: 

(Ministry of Development. General Secretariat of Industry). 

Ministerio de Industria, Turismo y Comercio 

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

– Ireland: 

Department of Enterprise and Employment.  

EN 

43 

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– Italy: 

Ministero delle Attivita’ Produttive 

– Luxembourg: 

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

– Netherlands: 

SZW/ Arbo/P&G 

– Austria: 

Bundesministerium für Wirtschaft und Arbeit. 

– Portugal: 

Direcçao-Geral de Empresa 

– Finland: 

Kauppa- ja teollisuusministeriö/Handels- och industriministeriet. 

– Sweden: 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontrol (SWEDAC). 

– United Kingdom:  Department of Trade and Industry. 

– Estonia: 

Majandus- ja Kommunikatsiooniministeerium. 

Ministry of Economic Affairs and Communications 

– Slovenia: 

Ministrstvo za gospodarstvo. 

Ministry of the Economy 

– Hungary: 

Gazdasági és Közlekedési Minisztérium.  

Ministry of Economy and Transport 

– Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví. 

Czech Office for Standards, Metrology and Testing 

– Slovak Republic:  Úrad  pre  normalizáciu,  metrológiu  a  skúšobníctvo  Slovenskej 

republiky. 

Slovak Office of Standards, Metrology and Testing 

– Poland: 

Ministerstwo Gospodarki, Pracy i Polityki Społecznej. 

Ministry of Economic Affairs and Labour 

– Latvia: 

Ekonomikas ministrija. 

Ministry of Economics 

– Lithuania: 

Ūkio ministerija. 

Ministry of Economy 

– Cyprus: 

Ministry of Commerce, Industry and Tourism 

EN 

44 

   EN 

 
– Malta: 

Under the authority of the Government of Malta: 

Consumer  and  Industrial  Goods  Directorate  of  the  Malta  Standards 
Authority.  

Republic of Bulgaria  Държавна агенция за метрологичен и технически надзор 

(State Agency for Metrological and Technical Surveillance) 

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 the Republic of Bulgaria in 
accordance with Article 10 of this Protocol. 

Republic of Bulgaria 

Bodies  which  have  been  designated  by  the  Republic  of  Bulgaria  in  accordance  with  the 
Bulgarian  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. 

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. 

The Parties shall consider the matter and the evidence brought to their knowledge, and 

2. 
shall report to each other the results of their investigations. 

In  the  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that 

3. 
such products are not placed on the market. 

4. 
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  expert  appraisal carried 
out. 

5. 

Where the Association Council finds that the measure is: 

unjustified,  the  national  authority  of  the  Party  which  has  taken  the  measure  shall 

(a) 
withdraw it; 

EN 

45 

   EN 

 
justified, the Parties shall take appropriate measures to ensure that such products are 

(b) 
not placed on the market. 

B. 

Safeguard clause relating to harmonised standards: 

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

2. 
The  Association  Council  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 this Annex. 

The  European  Community  shall  keep  the  Association  Council  and  the  other  Party 

3. 
informed of the proceedings. 

4. 

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

EN 

46 

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DECLARATION BY THE COMMUNITY ON THE ATTENDANCE 
OF BULGARIAN 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  the  Republic  of  Bulgaria  is  invited, 
under the following conditions, to the meetings of the committees established or referred to 
under Community law on Electrical Safety; Electromagnetic Compatibility; Gas Appliances; 
Lifts; Safety of Toys; and Machinery. 

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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47 

   EN