COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, 28.11.2000
COM(2000) 748 final
2000/0293 (ACC)
2000/0294 (ACC)
Proposalfora
COUNCIL DECISION
on thesignature on behalfofthe Community ofan additionalProtocolto the Europe
Agreement establishing an Association betweenthe European Communities andtheir
MemberStates, ofthe onepart, and the Czech Republic , oftheotherpart,
on Conformity Assessment and AcceptanceofIndustrialProducts
Proposalfora
COUNCIL DECISION
on theconclusion ofan additionalProtocolto the Europe Agreement
establishing an Association between the European Communities and theirMember
States, ofthe onepart, andtheCzech Republic , ofthe otherpart,
on Conformity Assessment and AcceptanceofIndustrialProducts
(presented bythe Commission)
2EXPLANATORY 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 Agreement with the Czech Republic ( 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 ofthe Protocol in the light ofthe negotiating directives approved by the Council,
and proposes that the Council authorises the signature ofthe additionalProtocolto the Europe
Agreement and decides to approve its conclusion on behalfofthe Community.
I.1 ASSESSMENTOFTHE AGREEMENT
Considering that this agreement is intended to work onlyduring 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 rather than an stand alone agreement as foreseen previously.
Thedraft PECAfollowsthegeneralprinciples laiddowninthe Commission's communication
on Community External Trade Policy in the field of standards and conformity assessment1
under its paragraph49.
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 mutualacceptance of industrialproducts which fulfilthe requirements
to be lawfullyplaced onthe market in one of the Parties, and b) the mutualrecognition 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 11.5 of the Europe Agreement with the Czech Republic 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. The annexes
makingthis mechanismoperationalhavestilltobenegotiated.
The second mechanism is a particular type of mutual recognition agreement (MRA) in which
the mutualrecognitionoperatesonthe basis of the acquis communautaire. It allows industrial
products certified byNotified bodies inthe EuropeanUnionto be placed on the Czech market
without having to undergo any further approval procedures, and vice-versa. The following
sectors are covered: machinery, personal protective equipment, lifts, electrical safety,
electromagnetic compatibility, equipment and protective systems intended for use in
1COM (96)564-final. 13.11.96
3potentially explosive atmosphere, gas appliances, hot water boilers, pressure equipment and
medicinalproducts Good Manufacturing Practice inspectionand batchcertification .
The Czech Republic has taken over the Community technical legislation in the sectors
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 a series of annexes. Both a unilateral
declaration and a joint declaration are attached to the Final Act. The unilateral declaration
invites the Czech representatives to committees established under the Community law
referred to in the annexes, making it clear that this will not entail any participation in the
Community decision-making process. The joint declaration is aiming at preparing a further
annex on exchange of information in the area covered by Directive 98/34/EC. An assessment
ofthe PECA is made in the next paragraphs.
I.1.1 FrameworkAgreement
Anarticle-by-article assessment follows:
Pre-amble . This sets out the basic objective of the PECA which is that, as the application for
membership ofthe EuropeanUnion implies the implementationofthe acquis communautaire
by the applicant country, it provides the opportunity to extend certain benefits of the Single
Market incertainsectors alreadyaligned before accession.
Article 1: Purpose. This article establishes the purposeofthe PECA, namelythe elimination
of technical barriers to trade in respect to industrial products. The PECA provides for two
mechanisms, a) for the mutualacceptance of industrialproducts which fulfilthe requirements
to be lawfullyplaced onthe market in one of the Parties, and b) the mutualrecognition 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 law have been included. All pieces of 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.
Article 3: Alignment of legislation . This contains a commitment for the partner country 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
the4thwhereas, it means that the alignment is anongoing process and the Parties agree to iron
outanyproblemsoftranspositionthat couldappear 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.
Article 5: Mutual recognition of the results of conformity assessment procedures .T h i s
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
Communityand national legislation.
4Article6: Safeguard clause . This sets up the right of each Partyto 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 forthe detailed proceduresto be used insuchcases.
Article 7: Extension of coverage . The Parties may modify the scope and coverage of this
Protocolthrough an amendment ofthe annexes or the addition of new annexes as soon as all
alignment conditions are met.
Article 8: Origin. This provides that the Protocolwill applyto industrialproducts originating
in the Parties according to non-preferential rules of origin. This origin can be certified by
presentation of a certificate of origin or by a proof of origin according to Protocol 4 of the
EuropeAgreement .Incase ofdivergent rules, the rules ofthe importing Partywillbe applied.
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
carryou tth etas ksf orwhi chth eyh av ebeenn oti fi ed.
Article 10: Notified bodies . This describes the procedure for the notification of bodies to
assess conformityin relationtothe legalrequirements specified inthe corresponding annexes.
The procedure is simplified and similar to the one applied within the Community. The second
paragraphsets outthe procedure for the removalof 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 bythe authorities which have designated the bodyor together bythe authorities of both
Parties. If the Parties do not agree on the 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 to the
AssociationCounciluntila finaldecisionistaken.
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 cooperate 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 is responsible for the
effective functioning of the Protocol and may delegate its duties in conformity the provisions
oftheEuropeAgreement.
Article 15: Technical cooperation and assistance .T h i sc o n f i r m st h eC o m m u n i t yp o l i c yo n
technicalcooperationand assistance witha view to properlyimplementing this Protocol.
5Article 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 betweenthe other Partyand anyother third country.
Article 17: Entry into force. This is a standard provision that provides the arrangement for
theentryinto force.
Article 18: Status ofthe Protocol. This establishes the fact that the PECA is an integral part
oftheEuropeAgreement.
I.1.2 The Annexesto the Protocol
I.1.2.1Annexeson MutualRecognition ofResultsofConformity 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
mindthefollowingelements:
a) the overall consistency with the Community policy objectives in the field of
standardisation, certification and conformity assessment for the sectors and industrial
products covered;
b) the overall consistency with Community policy objectives in the field of the removal of
technicalbarriers totrade;
The sectoral assessment is followed in item I.2 by an overall appreciation of the benefits of
theProtocol.
Annexes on Machinery, Lifts, Personal Protective Equipment, Electrical Safety,
Electromagnetic Compatibility, Equipment and Protective Systems intended for Use in
Potentially Explosive Atmosphere (ATEX), Hot Water Boilers, Gas Appliances and
Pressure Equipment.
These annexes on mutual recognition of results of conformity assessment cover a range of
industrial products subject to third party conformity assessment under the New Approach
directives intherelevant sectors.Alltheseannexespresentthesamestructure.
Coverage isdeterminedbytherelevant Communityand nationallaw, listedunder Section I of
each annex. Section II , on notifying authorities, lists the authorities responsible for the
designation of bodies in the Member Sates and the Czech Republic. Section III , on notified
bodies, makes reference to the notification of all Conformity Assessment Bodies notified by
theMemberStatesandbytheCzechRepublic. Section IV , onspecific arrangements, fixes the
two procedures for the safeguard clause, relating to industrial products and to harmonised
standards.
6Although the ATEX "Old Approach" directives2have not been transposed by the Czech
Republic, and thus are not listed in Section I of the ATEX annex, an additional provision in
Section IV of this annex provides for the Czech recognition of the EC valid certificates in
conformitywiththose directives.
Annexon medicinalproductsGMPinspection andbatchcertification
This annex establishes the mutual recognition of the conclusions of each Party's Good
Manufacturing Practice (GMP) inspections, of each Party's manufacturing authorisations, and
of manufacturers' batch certificates. All medicinal products for human and veterinary use are
covered.
Section I lists the relevant Community and national law. Section II lists the official GMP
inspectionservices ofeachMember State and the CzechRepublic.
Section III includes provisions concerning common definitions of terms in conformity with
their respective legislation, and the scope and coverage of this annex. A pre-operationalphase
of 6 months is foreseen. The Association Council will decide on its termination or
prolongation. The operation of this annex will start immediately after the successful
terminationofthe pre-operationalphase.
Additionalprovisions include mechanisms for cooperation (transmission of reports, exchange
of information, training of inspectors, joint inspections, alert system, contact points) between
the respective inspection authorities. A safeguard clause for inspections is included to reserve
each Party's right to conduct exceptionally its own inspections for reasons identified in
advance to the other Party. The Parties are supposed to use their best endeavours to resolve
any divergence of views which could occur. Unresolved divergences of views may be
referred tothe AssociationCouncil.
This annex will remove the need for duplicating batch release procedures and thus save
important costs for each imported batch. In addition, recognition of inspections will permit to
avoid duplication inspections byauthorities. This should lead to important savings in terms of
time to access the market andother fees and inspectioncosts.
I.1.2.2Annexes on MutualAcceptance ofIndustrialProducts
No such annexes have been negotiated for the moment. The PECA, in line with the Europe
Agreement, provides nevertheless the basis for suchacceptance ofproducts, similar tothe one
whi choperatesi nth eCom m uni ty .
I.1.2.3Unilateraland JointDeclarations
These are attached to the Final Act and are annexed to this Communication.
a) Unilateral Community Declaration relating to the attendance of Czech
representatives to Committees. Through this declaration, the Czech Republic is invited to
send observers to the meetings of the Committees established or referred to under the
2Directives 76/117/EEC, 79/196/EEC and 82/130/EEC. The "New Approach" directive referred to in
Section I of this annex (94/9/EC) contains a provision saying: "EC certificates of conformity toharmonised standards obtained in accordance with the procedureslaid down in the directives referred toin paragraph 1 shall continue be valid until 30 June 2003 unless theyexpire before that date".
7Community 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.
b) JointDeclaration on exchange ofinformation. Throughthis declaration requested bythe
Czech Republic, the Parties agree to negotiate a further annex to the PECA with a view to
determining the conditions of extension of the scope of Article 12 to the non-harmonised
sectors (i.e. participation ina simplified procedure based onDirective 98/34/EC).
I.1.3 Relations with EFTA /EEA MemberCountries
In accordance with the general information and consultation procedures set out in the
Agreement onthe EuropeanEconomic Area and namely its Protocol12, the Commission has
kept EFTA/EEA Member Countries regularly informed on the progress and finalresult of the
negotiations. The EFTA/EEA Member Countries are in the initial stage of negotiating a
parallelmutualrecognitionagreement withthe CzechRepublic.
I.2 OVERALLAPPRECIATION
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 the Czech Republic has substantially taken over the Community
legislation in the relevant sectors. Both political and commercial benefits are achieved with
thePECA.
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.
Industrial groups, while supporting the Protocol, have not been able to quantify the costs or
time takentoobtainconformityassessment oftheir industrial products in the Czech Republic.
Thepreciseextentofsavings intime, cost andmarketopportunityofthisProtocolis therefore
not feasible in every case to determine. However, on the basis of a rough calculation, it is
estimated4that this Protocolwould create cost saving opportunities for the exporting industry
of around €65 millions and about €45 millions in terms of cost savings to exporters to the
EC, some part ofwhichwillbe passed onto Europeanimporters and consumers.
Trade figures between the EC and the Czech Republic are attached for information. The
general trade balance in sectors covered by this Protocol shows a trade surplus for the
Community (factor of 1,4:1, varying from 10:1 in the pharmaceutical sector to 1,1:1 in the
pressure equipment sector). It is expected that trade will increase further when the PECA is in
force.
3Point4.2.b). COM (99)710- final. 20.12.1999.
4Working hypothesis that certification and other related costs amount toan average of 1% of trade.
8In 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
conformityassessment.
These advantages outweigh greatly the resources that the Commission will have to engage in
maintenance activities of the Protocol, evaluated at 2.0 person per year and some travel and
other expenses relating to meetings and other activities suchas editing guides.
In terms of the benefits to the Czech Republic, the PECA will facilitate access to the
Community market and will give political credit for having aligned its legislation. The Czech
Republic regards the PECAas a means to develop closer industrial relations with the EU and
fullyto integrate certainsectorswiththe Single Market before accession.
II. THEDRAFTCOUNCILDECISIONS
Aproposalfortwo Councildecisions isattached.
The first one is concerned with the signature of the Protocol. Signature is required by the
Czech Republic for adoption of any international agreement. It is accordingly proposed that
the President of the Council be authorised to designate the person empowered to sign the
Protocolonbehalfofthe Community, subject to conclusion later, onthe basis ofArticles 133
and 300 ofthe 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
mutual recognition agreements establish the appropriate Community procedure for the
implementationand management oftheProtocol.
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
certaincases the Communitypositionwithregardtothis Protocolin the Association Council,
or where applicable the AssociationCommittee.
Inallother cases, the Communitypositionwith respect to the Protocolshall be determined by
theCouncil, acting byqualified majority, onaproposalfromtheCommission.
The Commission therefore proposes that the Council adopts the attached decisions on the
signature and conclusionofthe PECA.
92000/0293 (ACC)
Proposalfora
COUNCIL DECISION
on thesignature on behalfofthe Community ofan additionalProtocolto the Europe
Agreement establishing an Association betweenthe European Communities andtheir
MemberStates, ofthe onepart, and the Czech Republic , oftheotherpart,
on Conformity Assessment and AcceptanceofIndustrialProducts
THE COUNCIL OFTHE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article
133, inconjunctionthe first sentence ofthe first subparagraphofArticle 300 (2)thereof,
Having regard tothe proposalfromthe Commission5,
Whereas:
(1) The Europe Agreement establishing an association between the European
Communities and their Member States, of the one part, and the Czech Republic of the
other part,6entered into forceon1 February1995;
(2) 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
agreementsonmutualrecognition;
(3) The Protocolto the Europe Agreement on Conformity Assessment and Acceptance of
Industrial Products has been negotiated by the Commission on behalf of the
Community;
(4) Subject to its possible conclusionat alater date, the Protocolto the Europe Agreement
on Conformity Assessment and Acceptance of Industrial Products initialled in
Brussels on10 July2000 should be signed,
HAS DECIDED AS FOLLOWS:
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 Czech Republic on Conformity Assessment and
Acceptance ofIndustrialProducts.
Done at Brussels, […]
For the Council
The President
5OJ NoC […],[…], p.[…]
6OJ NoL360, 31.12.1994, p.2
102000/0294(ACC)
Proposalfora
COUNCIL DECISION
on theconclusion ofan additionalProtocolto the Europe Agreement
establishing an Association between the European Communities and theirMember
States, ofthe onepart, andtheCzech Republic , ofthe otherpart,
on Conformity Assessment and AcceptanceofIndustrialProducts
THE COUNCIL OFTHE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article
133 in conjunction Article 300 paragraph 2, first subparagraph, first sentence, paragraph 3,
first subparagraph, first sentence, and paragraph4 thereof,
Having regard tothe proposalfromthe Commission7,
Whereas:
(1) The Europe Agreement establishing an association between the European
Communities and their Member States, of the one part, and the Czech Republic of the
other part8, entered into forceon1 February1995;
(2) 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
agreementsonmutualrecognition;
(3) Article 108 of the Europe Agreement provides that the Association Council may
delegatetotheAssociationCommitteeanyofitspowers;
(4) Article 2 ofDecision94/910/EECofthe Council and the Commission of19 December
of 1994 on the conclusion of the Europe Agreement between the European
Communities and their Member States, of the one part, and the Czech Republic, of the
other part9, provides for the Community decision-making procedures and for the
presentation of the Community position in the Association Council and in the
AssociationCommittee;
(5) Article 14 of Decision No 1/95 of the Association Council between the European
Communities and their Member States, of the one part, and the Czech Republic, of the
other part of 4 April 1995 on its rules of procedure provides that the Association
Committee may set up further subcommittees or groups to assist in carrying out its
duties;
7OJ NoC ,, p. .
8OJ NoL360, 31.12.1994, p.2
9OJ NoL360, 31.12.1994, p.1.
11(6) The draft Protocol to the Europe Agreement on Conformity Assessment and
Acceptance of Industrial Products has been signed in Brussels on […2000] on behalf
oftheCommunity;andshouldbeapproved;
(7) Certain tasks for implementation have been attributed to the Association Council and
inparticular the powerto amend certainaspects ofthe annexes;
(8) The appropriate internal procedures should be established to ensure the proper
functioningoftheProtocol;and
(9) It is necessary to empower the Commission to make certain technical amendments to
this Protocoland to takecertaindecisions for its implementation.
HAS DECIDED AS FOLLOWS:
Article 1
The additional Protocol to the Europe Agreement between the European Community and the
Czech Republic on Conformity Assessment and Acceptance of Industrial Products
(hereinafter"theProtocol"), is herebyapprovedonbehalfoftheEuropeanCommunity.
The text ofthe Protocolis attached to this Decision.
Article 2
The President ofthe Council shall, on behalf ofthe Community, transmit the diplomatic note
provided for in Article 17 of the Protocol10.
Article 3
1. The Commission, after consultation with the special committee appointed by the
Council, shall:
(a) proceed to 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, and Section III of the
Good Manufacturing Practice (GMP) annextothe Protocol;
(b) make 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 machinery, lifts, personal protective equipment, electrical safety,
electromagnetic compatibility, equipment and protective systems intended for
use in potentially explosive atmospheres (ATEX), hot water boilers, gas
appliances, pressure equipment and good manufacturing practice (GMP);
10The date of entry into force of the Protocol will be published in the Official Journal of the European
Communities bythe General Secretariat of the Council.
12(c) if necessary, reply to requests in accordance with Article 11, Sections III and
IV of the annexes to the Protocol concerning machinery, lifts, personal
protective equipment, electrical safety, electromagnetic compatibility,
equipment and protective systems intended for use in potentially explosive
atmospheres (ATEX), hot water boilers, gas appliances, pressure equipment
and goodmanufacturing practice (GMP).
2 . T h ep o s i t i o nt ob et a k e nb yt h eC o m m u n i t yi nt h eA s s o c i a t i o nC o u n c i l ,a n dw h e r e
applicable in the Association Committee shall be determined by the Commission,
following consultation of the special committee referred to in paragraph 1 of this
Article, withregardto:
(a) Amendments of the annexes in accordance with Article 14, indent a) of the
Protocol;
(c) Any decisions regarding disagreements on the results of the verifications and
the suspensions, in part or totally, of any notified body in accordance with
Article 11, paragraphs 2 and 3 ofthe Protocol;
(d) Any measures taken inthe applicationofthe safeguard clauses in Section IV of
the annexes of the Protocol concerning machinery, lifts, personal protective
equipment, electrical safety, electromagnetic compatibility, equipment and
protective systems intended for use in potentially explosive
atmospheres(ATEX), hot water boilers, gas appliances, and pressure
equipment;
(e) The pre-operational phase and the measures to be taken in accordance with
paragraphs 3.3, 3.4 and 5.1 of Section III of the Good Manufacturing Practice
(GMP) annexofthe Protocol;
(e) 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
proposalfromtheCommission.
Done at Brussels, […2000]
For the Council
The President
13ANNEX
PROTOCOL
TOTHEEUROPEAGREEMENTESTABLISHINGAN ASSOCIATIONBETWEEN
THEEUROPEAN COMMUNITIES AND THEIR MEMBERSTATES,OF THE ONE
PART,
AND THECZECHREPUBLIC,OF THE OTHER PART
ONCONFORMITY ASSESSMENT AND ACCEPTANCE OF INDUSTRIAL
PRODUCTS
-P E CA-
TABLE OF CONTENTS
1. Framework
2. Annexon MutualRecognition ofResultsofConformity Assessment
1. Machinery
2. Lifts
3. PersonalProtective Equipment
4. ElectricalSafety
5. Electromagnetic Compatibility
6. Equipment and Protective Systems intended for Use in
Potentially Explosive Atmosphere
7. Hot WaterBoilers
8. GasAppliances
9. Pressure Equipment
10. Good Manufacturing Practice (GMP) for Medicinal Products:
inspection and batch certification
14Protocolto the Europe Agreement establishing an Association betweenthe
European Communitiesand theirMemberStates, oftheone part, andthe Czech
Republic, ofthe otherpart on Conformity Assessment and Acceptance of
IndustrialProducts
-P E C A-
The European Community and the Czech Republic, hereinafter referred to as "the
Parties",
Whereas the Czech Republic has applied for membership of the European Union and
such membership implies the effective implementation of the acquisof the European
Community,
Recognising that the progressive adoption and implementation of Community law by
the Czech Republic provides the opportunity to extend certain benefits of the Internal
Market andto ensure its effective operation incertainsectors before accession,
Considering that, in the sectors covered by this Protocol, the Czech national law
substantiallytakes over the Community law,
Considering their shared commitment to the principles of free movement ofgoods and
to promoting product quality, so asto ensure the healthand safetyoftheir citizens and
the protection of the environment, including through technical assistance and other
forms ofco-operationbetweenthem,
Desiring to conclude a Protocol to the Europe Agreement on Conformity Assessment
and Acceptance of Industrial Products (hereafter the Protocol) providing for the
application of the mutual acceptance of industrial products which fulfil the
requirements to be lawfully placed on the market in one of the Parties and of the
mutual recognition of the results of conformity assessment of industrial products
whichare subject to Communityor national law, noting that Article 75 ofthe Europe
Agreement provides, where appropriate, forthe conclusionofan 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 Czech Republic and these countries
equivalent tothisProtocol,
Bearing in mind their status as Contracting Parties to the Agreement establishing the
World Trade Organisation, and conscious in particular of their obligations under the
World Trade OrganisationAgreement onTechnical Barriers to Trade,
Have agreed as follows:
15Article 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 Czech Republic of national law,
which is equivalent to Community law.
ThisProtocolprovides for:
1) the mutual acceptance of industrial products, listed in the annexes on "mutual
acceptance of industrialproducts", which fulfil the requirements to be lawfullyplaced
onthe market inoneoftheParties;
2) the mutual recognition of the results of conformity assessment of industrial
products subject to Community law and to the equivalent Czech national law, both
listed inthe annexes on"mutualrecognitionofresults ofconformityassessment".
Article 2
Definitions
ForthepurposeofthisProtocol,"Industrialproducts" means products, as specified in Article 9 and in Protocol3 ofthe
EuropeAgreement.
“Community law” means any legal act and implementing practice of the European
Communityapplicable to aparticular situation, risk or categoryof industrialproducts,
as interpreted bythe Court ofJustice ofthe EuropeanCommunities.
"National law" means any legal act and implementing practice by which the Czech
Republic takes over the Community law applicable to a particular situation, risk or
categoryof industrialproducts.
The terms used in this Protocol shall have the meaning given in Community law and
the Czech national law.
Article 3
Alignmentoflegislation
For the purpose of this Protocol, the Czech Republic agrees to take appropriate
measures, inconsultationwiththe EuropeanCommission, to maintain or complete the
take-over of Community law, in particular in the fields of standardisation, metrology,
accreditation, conformity assessment, market surveillance, general safety of products,
and producer's liability.
16Article 4
Mutual acceptance of industrial products
The Parties agree that, for the purpose of mutualacceptance, industrial products listed
in the annexes on "mutual acceptance of industrial products", which fulfil the
requirements to be lawfully placed on the market of a Party, may be placed on the
market of the other Party, without further restriction. This shall be without prejudice
toArticle36oftheEuropeAgreement.
Article 5
Mutual recognition oftheresultsof conformity assessment procedures
The Parties agree to recognize the results ofconformityassessment 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 ofaccepting that conformity.
Article 6
Safeguard clause
Where a Party finds that an industrial product placed on its territory by virtue of the
present Protocol, and used in accordance with its intended use, may compromise the
safetyor healthofusers orother persons, or anyother 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
procedureto be applied insuchcases.
Article 7
Extension of coverage
As the Czech Republic adopts and implements further national law taking over
Community law, the Parties may amend the annexes or conclude new ones, in
accordance withthe procedure laid down in Article 14.
17Article 8
Origin
The provisions of this Protocol shall apply to industrial products which originate in
the Parties according to non-preferential rules of origin. In the case of divergent rules,
the rules of the Party in whose territory the product is marketed are determining.
Proof of origin may be demonstrated by a certificate of origin. Such certificate is not
required in the case of importation ofproducts covered by a proof of origin according
toProtocol4oftheEuropeAgreement.
Article 9
Obligations ofParties 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 withdrawalfromthe market .
The Parties shall ensure that bodies, notified under their respective jurisdiction to
assess conformity in relation to requirements ofCommunityor national law specified
inthe annexes, continuouslycomplywith the requirements ofCommunityor national
law. Further, they shall take all necessary steps to ensure that these bodies maintain
the necessarycompetence to carryout thetasks for whichtheyare notified.
Article 10
Notified bodies
Initially, the bodies notified for the purpose of this Protocol will be those included in
the lists which the Czech Republic and the European Community have exchanged
before the completionofthe procedures for entryinto 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 Partyshall forward its notificationto theother Partyinwriting;
b) on the acknowledgement of the other Party, given in writing, the body will be
considered as notified and as competent to assess conformity in relation to the
requirements specified in the annexes fromthat date.
IfaPartydecidestowithdrawanotifiedbodyunder its jurisdiction, it shall informthe
other Party in writing. The body will cease to assess conformity in relation to the
requirements specified in the annexes from the date of its withdrawal at the latest.
Nevertheless, conformity assessment carried out before that date shall remain valid,
unless otherwise decided bythe AssociationCouncil.
18Article 11
Verification of notified bodies
Each Party may request the other Party to verify the technical competence and
compliance of a notified body under its jurisdiction. Such request will be justified in
order to allow the Party responsible for the notification to carry out the requested
verification and report speedily to the other Party. The Parties may also jointly
examine the body, with the participation of the relevant authorities. To this end, the
Partiesshallensurethe fullco-operationofbodies under their jurisdiction. The Parties
shall take all appropriate steps, and use whatever available means may be necessary,
witha view to resolving anyproblems whichare detected.
If the problems cannot be resolved to the satisfaction of both Parties, they may notify
the chairman of the Association Council of their dissent, giving their reasons. The
AssociationCouncilmaydecide onappropriate 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 inpart or totally fromthe dateonwhichthe disagreement of the Parties has
been notified to the chairman ofthe Association Council.
Article 12
Exchange of information andcooperation
In order to ensure a correct and uniform application and interpretation of this
Protocol, the Parties, their authorities and their notified bodies shall:
a) exchange all relevant information concerning implementation of law and practice
including, inparticular, onprocedureto ensure compliance ofnotified bodies;
b) take part, as appropriate, in the relevant mechanisms of information, co-ordination
and other related activities of the Parties;
c) encourage their bodies to co-operate with a view to establishing mutualrecognition
arrangements inthe voluntarysphere.
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 maynot be used for purposesother thanthose envisaged bythis Protocol.
19Article 14
Management of theProtocol
Responsibility for the effective functioning of this Protocol shall be held by the
Association Council in conformity with Article 106 of the Europe Agreement. In
particular, it shall have the power totake decisions regarding:
a) amendingtheannexes;
b) adding new annexes;
c) appointing a joint team or teams of experts to verify the technical competence of a
notified bodyand its compliance withthe requirements;
d) exchanging information on proposed and actual modifications of the Community
and nationallaw referredto inthe annexes;
e) considering new or additional conformity assessment procedures affecting a sector
covered byanannex;
f) resolving anyquestions relating to the applicationofthis Protocol.
The Association Council may delegate the above responsibilities set out under this
Protocol, inconformitywith Articles 108(2)ofthe Europe Agreement.
Article 15
Technical co-operation and assistance
The European Community may provide technical co-operation and assistance to the
Czech Republic where necessary in order to support the effective implementation and
applicationofthis Protocol.
Article 16
Agreements with other Countries
Agreements on conformity assessment concluded by either Party with a country
which is not a Partyto this Protocolshall 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 Protocolshallenter into force onthe first day of the second month following the
date on which the Parties have exchanged diplomatic notes confirming the completion
oftheir respective procedures for entryinto force ofthe Protocol.
20Article 18
StatusoftheProtocol
This Protocolconstitutes an integralpart ofthe EuropeAgreement.
This Protocol is drawn up in two originals in Czech, Danish, Dutch, English, Finnish,
French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each
text being equally authentic.
Done at………….
…….
21Annexes
onMutualRecognitionofresults ofConformity Assessment
Table ofcontents
1. Machinery2. Lifts
3. PersonalProtectiveEquipment
4. ElectricalSafety
5. Electromagnetic Compatibility
6. Equipment and Protective Systems intended for Use in PotentiallyExplosive
Atmospheres
7. Hot Water Boilers
8. Gas Appliances
9. Pressure Equipment
10. Good Manufacturing Practice (GMP) for Medicinal Products : inspection and
batchcertification
22Annexon MutualRecognition ofresultsofConformity Assessment:
MACHINERY
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: European Parliament and Council Directive 98/37/EC of
22 June 1998 on the approximation of the laws of the
Member States relating to machinery (OJ L 207,
23.07.1998, p.1), as amended by European Parliament and
Council Directive 98/79/EC of 27 October 1998 (OJ L
331, 07.12.1998, p.1).
Nationallaw: Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act No. 71/2000 Coll. (part
24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986) of the Czech
National Council, on the Czech Trade Inspection, as
amended by Act No. 240/1992 Coll. (part 49/29.05.1992),
Act No. 22/1997 Coll. (part 6/27.02.1997), Act
No.110/1997 Coll. (part 38/19.05.1997), and Act No.
71/2000 Coll. (part 24/03.04.2000).
Government Order No.170/1997 Coll. (part
60/31.07.1997), that lays down the technical requirements
for machinery, as amended by Government Order No.
15/1999 Coll. (part 6/25.01.1999)and …
SECTION II
NOTIFYING AUTHORITIES
European Community:
•Austria: Bundesministeriumfür wirtschaftliche Angelegenheiten.
•Belgium: Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark: Direktoratet for Arbejdstilsynet.
•Finland: Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet.
•France: Mi n i s tè r ed el ' em pl oie td el as ol i d a ri té .
23Directiondes relations dutravail, Bureau CT 5.
Ministère de l'économie, des finances et de l' industrie. Secrétariat
d'Etat à l'industrie.
Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) - SQUALPI.
•Germany: Bundesministerium für Arbeit und Sozialordnung.
•Greece: MinistryofDevelopment. GeneralSecretariat ofIndustry.
•Ireland: Department ofEnterpriseand Employment.
•Italy: Ministero dell'Industria, delCommercio e dell'Artiginiato.
•Luxembourg: Ministère du Travail(Inspectiondu travailet des Mines).
•Netherlands: Minister vanSociale Zakenen Werkgelegenheid.
•Portugal: Under the authority of the Government of Portugal: Instituto
Português da Qualidad.
•Spain: Ministerio de Industria yEnergía.
•Sweden: Under the authority of the Government of Sweden: Styrelsen för
ackreditering ochteknisk kontroll(SWEDAC).
•United Kingdom: Department ofTrade and Industry.
Czech Republic: Ú řad pro technickou normalizaci, metrologii a státní zkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 Czech
Republic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
24SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shall take appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause related relating to harmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
25ANNEX ON MUTUALRECOGNITIONOFRESULTSOF CONFORMITY ASSESSMENT :
LIFTS
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: European Parliament and Council Directive 95/16/EC of
29 June 1995 on the approximation of the laws of the
Member States relating to lifts (OJ L 213 , 07.09.1995,
p.1).
Nationallaw: Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act No. 71/2000 Coll. (part
24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the Czech
National Council, on the Czech Trade Inspection, as
amended by Act No. 240/1992 Coll. (part 49/29.05.1992),
Act No.22/1997 Coll. (part 6/27.02.1997), Act
No.110/1997 Coll. (part 38/19.05.1997), and Act No.
71/2000 Coll. (part 24/03.04.2000).
Government Order No.14/1999 Coll. (part 6/25.01.1999),
that lays down the technical requirements for lifts, as
amended by Government Order No. 227/1999 Coll. (part
77/14.10.1999), and …
SECTION II
NOTIFYING AUTHORITIES
European Community
•Austria Bundesministeriumfür wirtschaftliche Angelegenheiten.
•Belgium Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark Direktoratet for Arbejdstilsynet.
•Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet.
26•France Mi n i s tè r ed el ' em pl oie td el as ol i d a ri té .
Directiondes relations dutravail, Bureau CT 5.Ministère de l'économie, des finances et del' industrie.Secrétariat d'Etat à l'industrie.Direction générale de l'industrie, des technologies de l'information et
des postes (DiGITIP) –SQUALPI
•Germany Bundesministerium für Arbeit und Sozialordnung.
•Greece MinistryofDevelopment. GeneralSecretariat ofIndustry.
•Ireland Department ofEnterpriseand Employment.
•Italy Ministero dell'Industria, delCommercio e dell'Artiginiato.
•Luxembourg Ministère du Travail(Inspectiondu Travailet desMines).
•Netherlands Minister vanSociale Zakenen Werkgelegenheid.
•Portugal Ministério da Economia. Direcção Geralda Energia.
•Spain Ministerio de Industria yEnergía.
•Sweden Under the authorityofthe Government ofSweden :
Styrelsen för ackreditering ochteknisk kontrol(SWEDAC)
•United Kingdom Department ofTrade and Industry.
Czech Republic: Ú
řad pro technickou normalizaci, metrologiia státnízkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 Czech
Republic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
27SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
28ANNEX ON MUTUALRECOGNITIONOFRESULTSOF CONFORMITY ASSESSMENT :
PERSONAL PROTECTIVE EQUIPMENT
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: Council Directive 89/686/EEC of 21 December 1989
onthe approximation ofthe laws ofthe Member States
relating to personal protective equipment (OJ L 399,30.12.1989, p. 18), as last amended by Parliament andCouncil Directive 96/58/EC of 3 September 1996 (OJL 236, 18.09.1996, p.44).
Nationallaw: Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act No. 71/2000 Coll. (part
24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the
Czech National Council, on the Czech Trade
Inspection, as amended by Act No. 240/1992 Coll.
(part 49/29.05.1992), Act No.22/1997 Coll. (part
6/27.02.1997), Act No.110/1997 Coll. (part
38/19.05.1997), and Act No. 71/2000 Coll. (part
24/03.04.2000).
Government Order No.172/1997 Coll. (part
61/04.08.1997), that lays down the technicalrequirements for personal protective equipment, asamended by….
SECTION II
NOTIFYING AUTHORITIES
European Community:
•Austria Bunderministerium für wirtschaftliche Angelegenheiten.
•Belgium Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark Direktoratet for Arbejdstilsynet.
•Finland Sosiaali-ja terveyministeriö/Social-och hälsovårdsministeriet.
29•France Mi n i s tè r ed el ' em pl oie td el as ol i d a ri té .
Directiondes relations dutravail, Bureau CT 5.Ministère de l'économie, des finances et del'industrie.Secrétariat d'Etat à l'industrie.Direction générale de l'industrie, des technologies de l'information et
des postes (DiGITIP) –SQUALPI
•Germany Bundesministerium für Arbeit und Sozialordnung.
•Greece MinistryofDevelopment. GeneralSecretariat ofIndustry.
•Ireland Department ofEnterpriseand Employment.
•Italy Ministero dell'Industria, delCommercio e dell'Artiginiato.
•Luxembourg Ministère du Travail(Inspectiondu Travailet desMines).
•Netherlands Minister vanVolksgezondheid, WelzijnenSport.
•Portugal Ministério da Economia. Instituto Português daQualidade.
•Spain Ministerio de Industria yEnergía.
•Sweden Under the authorityofthe Government ofSweden:
Styrelsen för ackreditering ochteknisk kontroll(SWEDAC).
•United Kingdom Department ofTrade and Industry.
Czech Republic: Ú
řad pro technickou normalizaci, metrologii a státní zkušebnictví
(CzechOffice for Standards, Metrologyand Testing)
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 Czech
Republic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
30SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses.
A. Safeguard clause relating to industrialproducts
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
31ANNEX ON MUTUALRECOGNITIONOFRESULTSOF CONFORMITY ASSESSMENT :
ELECTRICAL SAFETY
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: Council Directive 73/23/EEC of 19 February 1973 on the
approximation of the laws of the Member States relating to
electrical equipment designed for use within certain voltage
limits (OJ L 77, 26.03.1973, p. 29), as last amended by
Directive 93/68/EECof22 July1993 (OJ L 220, 30.08.1993,
p.1).
Nationallaw: Act No.22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts,
as amended by Act No. 71/2000 Coll. (part 24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the Czech
National Council, on the Czech Trade Inspection, as
amended by Act No. 240/1992 Coll. (part 49/29.05.1992),
Act No.22/1997 Coll. (part 6/27.02.1997), Act No.110/1997
Coll. (part 38/19.05.1997), and Act N° 71/2000 Coll. (part
24/03.04.2000).
Government Order No.168/1997 Coll. part 60/31.07.1997),
that lays down the technical requirements for low voltage
electricalequipment, as amended by…
SECTION II
NOTIFYING AUTHORITIES
•Austria: Bundesministeriumfür wirtschaftliche Angelegenheiten.
•Belgium: Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark: Boligministeriet.
•Finland: Kauppa ja teo llisuusministeriö.
Handels och industriministeriet.
•France: Ministère de l'économie, des finances et del'industrie.
Secrétariat d'Etat à l'industrie.
32Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) –SQUALPI.
•Germany: Bundesministeriumfür Arbeit und Sozialordung.
•Greece: MinistryofDevelopment. GeneralSecretariat ofIndustry.
•Ireland: Department ofEnterpriseand Employment.
•Italy: Ministero dell'Industria, delCommercio e dell' Artigianato.
•Luxembourg: Ministère de l'Economie- Service de l'Energie de l'Etat.
Ministère du Travail(Inspectiondu Travailet desMines).
•Netherlands: Minister van Volksgezondheid, Welzijn en Sport (consumer
goods).
Minister vanSociale Zakenen Werkgelegenheid (others).
•Portugal: Under the authority of the Government of Portugal:
Instituto Português da Qualidade.
•Spain: Ministerio de Industria yEnergía.
•Sweden: Under the authority of the Government of Sweden :
Styrelsen för ackreditering ochteknisk kontrol(SWEDAC).
•United Kingdom Department ofTrade and Industry.
Czech Republic: Ú řad pro technickou normalizaci, metrologiia státnízkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 Czech Republic in
accordance with Article 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the Czech
national law ofSectionI and notified tothe European Community in accordance with Article
10ofthisProtocol.
33SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for industrial
products bearing the CE marking, subject to the present annex, it shall immediately
inform to the other Party, indicating the reasons for its decision and how non
compliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their knowledge,
and shallreportto eachother the results oftheir investigations.
3. In case ofagreement, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter shall be
forwarded to the Association Council who may decide to have an expertise carried
out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the measure
shall withdraw it;
b) justified, the Parties shall take appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to in the
legislation defined in the present annex, does not meet the essential requirements of
suchlegislation, it shallinformthe AssociationCouncilgivingthereasonsthereof.
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 the present annex.
3. The European Community shall keep the Association Council and the other Party
informed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
34ANNEX ON MUTUALRECOGNITIONOFRESULTSOF CONFORMITY ASSESSMENT :
ELECTROMAGNETIC COMPATIBILITY
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: Council Directive 89/336/EEC of 3 May 1989 on the
approximation of the laws of the Member States relating to
electromagnetic compatibility (OJ L 139, 23.05.1989, p. 19),
as last amended by Directive 93/68/EEC of 22 July 1993 (OJ
L 220, 30.08.1993, p.1).
Nationallaw: Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts,
as amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the Czech
National Council, on the Czech Trade Inspection, as amended
by Act No. 240/1992 Coll. (part 49/29.05.1992), Act No.
22/1997 Coll. (part 6/27.02.1997), Act No. 110/1997 Coll.
(part 38/19.05.1997), and Act N°. 71/2000 Coll. (part
24/03.04.2000).
Government Order No. 169/1997 Coll. (part 60/31.07.1997),
that lays down the technical requirements for products relating
totheir electromagnetic compatibility, as amended by…
SECTION II
NOTIFYING AUTHORITIES
European Community:
•Austria: Bundesministeriumfür wirtschaftliche Angelegenheiten.
•Belgium: Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark: Telestyrelsen.
•Finland: Kauppa-ja teo llisuusministeriö/Handels-och industriministeriet.
For EMC aspects of telecommunications and radio
equipment:Liikenneministeriö/Trafikministeriet.
•France: Ministère de l'économie, des finances et del'industrie.
Secrétariat d'Etat à l'industrie.
35Direction générale de l'industrie, des technologies de
l'informationet despostes(DiGITIP) -SQUALPI.
•Germany: Bundesministeriumfür Wirtschaft und Technologie.
•Greece: MinistryofDevelopment. GeneralSecretariat ofIndustry.
•Ireland: Department ofEnterpriseand Employment.
•Italy: Ministero dell'Industria, delCommercio e dell' Artigianato.
•Luxembourg: Ministère de l'Economie- Service de l'Energie de l'Etat.
•Netherlands: Minister vanVerkeer en Waterstaat.
•Portugal: Under the authority of the Government of Portugal: Instituto
Português da Qualidade.
•Spain: Ministerio de Industria yEnergía.
For EMC aspects of telecommunications and radio equipment:
Ministerio de Fomento.
•Sweden: Under the authorityofthe Government ofSweden : Styrelsen för
ackreditering ochteknisk kontrol(SWEDAC).
•United Kingdom: Department ofTrade and Industry.
Czech Republic: Ú řad pro technickou normalizaci, metrologii a státní
zkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 CzechRepublic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
36SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
37ANNEX ON MUTUALRECOGNITIONOFRESULTSOF CONFORMITY ASSESSMENT :
EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE
IN POTENTIALLY EXPLOSIVE ATMOSPHERES
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: European Parliament and of the Council Directive
94/9/EC of23 March 1994 on the approximation of the
laws of the Member States concerning equipment and
protective systems intended for use in potentially
explosive atmospheres (OJ L 100, 19.04.1994, p.1 ).
Nationallaw: Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some
Acts, as amended by Act N°. 71/2000 Coll; (part
24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the
Czech National Council, on the Czech Trade
Inspection, as amended by Act No. 240/1992 Coll.
(part 49/29.05.1992), Act No. 22/1997. Coll. (part
6/27.02.1997), Act No. 110/1997 Coll. (part
38/19.05.1997), and Act N°. 71/2000 Coll. (part
24/03.04.2000).
Government Order No. 176/1997 Coll. (part
63/08.08.1997), that lays down the technical
requirements for equipment and protective systems
intended for use in potentially explosive atmospheres,
asamendedby…
SECTION II
NOTIFYING AUTHORITIES
European Community
•Austria Bundesministeriumfür wirtschaftliche Angelegenheiten.
•Belgium Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark Elektricitetsrådet.
38•Finland Kauppa-ja teo llisuusministeriö/Handels-och industriministeriet.
•France Ministère de l'économie, des finances et del'industrie.
Secrétariat d'Etat à l'industrie.
Direction de l'action régionale et de la petite et moyenne industrie
(DARPMI). Sous-directionde la sécurité industrielle.
Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) –SQUALPI
•Germany Bundesministerium für Arbeit und Sozialordnung.
•Greece MinistryofDevelopment. GeneralSecretaryofIndustry.
•Ireland Department ofEnterpriseand Employment.
•Italy Ministero dell'Industria, delCommercio e dell'Artiginiato.
•Luxembourg Ministère de l'Economie- Service de l'Energie de l'Etat.
•Netherlands Minister vanSociale Zakenen Werkgelegenheid.
•Portugal Ministério da Economia. Direcção Geralda Energia.
•Spain Ministerio de Industria yEnergía.
•Sweden Under the authorityofthe Government ofSweden :
Styrelsen för ackreditering ochteknisk kontrol(SWEDAC)
•United Kingdom Department ofTrade and Industry.
Czech Republic: Ú řad pro technickou normalizaci, metrologii a státní zkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 Czech
Republic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
39SECTION IV
SPECIFIC ARRANGEMENTS
1. TransitionalarrangementsThe certificates issued in the EC Member States in conformity with Directives
76/117/EEC, 79/196/EEC and 82/130/EEC will be recognised as a proof of the
conformity assessment under the Article 17 of Act No. 22/197 Coll., on technical
requirements for products and on amendments to some acts, as amended by Act No.
71/2000 Coll. Based on these certificates, the importer of these products in the Czech
Republic will issue a declaration of conformity of the relevant product to the
applicable requirementsreferred to inthisparagraph.
2. Safeguard ClausesA. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
403. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
41ANNEXONMUTUAL RECOGNITIONOF RESULTSOF CONFORMITYASSESSMENT :
HOT WATER BOILERS
SECTION I
COMMUNITY AND NATIONAL LAW
Community law: Council Directive 92/42/EEC of 21 May 1992 on efficiency
requirements for new hot-water boilers fired with liquid or
gaseous fuels (OJ No L 167, 22.06.1992 p.17), as amended by
Council Directive 93/68/EEC of 22 July 1993 (OJ L 220,
30.08.1993, p.1).
Nationallaw: Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts, as
amended byAct N°. 71/2000 Coll. (part 24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the Czech
National Council, on the Czech Trade Inspection, as amended
by Act No. 240/1992 Coll. (part 49/29.05.1992), Act No.
22/1997 Coll. (part 6/27.02.1997), Act No. 110/1997 Coll. (part
38/19.05.1997), and Act N°. 71/2000 Coll. (part
24/03.04.2000).
Government Order No. 180/1999 Coll. (part 61/17.08.1999),
that lays down the technical requirements for new hot-water
b oi l e r sf i r e dwi thl i q ui dorg a s e ou sf u el s ,a sam en d edb y … .
SECTION II
NOTIFYING AUTHORITIES
European Community:
•Austria Bunderministerium für wirtschaftliche Angelegenheiten.
•Belgium Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark Boligministeriet.
•Finland Ympäristöministeriö/Miljöministeriet.
•France Ministère de l'économie, des finances et del'industrie.
Secrétariat d'Etat à l'industrie.
42Direction de l'action régionale et de la petite et moyenne
industrie (DARPMI). Sous-directionde la sécurité industrielle.
Direction générale de l'industrie, des technologies de
l'informationet despostes(DiGITIP) -SQUALPI.
•Germany Bundesministeriumfür Wirtschaft und Technologie.
•Greece MinistryofDevelopment. GeneralSecretaryofIndustry.
•Ireland Department ofEnterpriseand Employment.
•Italy Ministero dell'Industria, delCommercio e dell'Artiginiato.
•Luxembourg Ministère de l'Environnement.
•Netherlands Ministerie van Economische Zaken.
•Portugal Ministério da Economia. Instituto Português daQualidade.
•Spain Ministerio de Industria yEnergia.
•Sweden Under the authority of the Government of Sweden: Styrelsen för
ackreditering ochteknisk kontroll(SWEDAC).
•United Kingdom Department ofthe Environment, Transport and the Regions.
Czech Republic: Ú řad pro technickou normalizaci, metrologiia státnízkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 Hungary in
accordance with Article 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
43SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
44ANNEX ON MUTUALRECOGNITIONOFRESULTSOF CONFORMITY ASSESSMENT :
GASAPPLIANCES
SECTION I
COMMUNITY AND NATIONALLAW
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, 26.07.1990, p. 15)
, as last amended by Council Directive 93/68/EEC of 22 July
1993 (OJ No L 220, 30.08.1993, p. 1).
Nationallaw: Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts,
as amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the Czech
National Council, on the Czech Trade Inspection, as amended
by Act No. 240/1992 Coll. (part 49/29.05.1992), Act No.
22/1997 Coll. (part 6/27.02.1997), Act No.110/1997 Coll.
(part 38/19.05.1997), and Act N°. 71/2000 Coll. (part
24/03.04.2000).
Government Order No. 177/1997 Coll. (part 64/12.08.1997),
that lays down the technical requirements for appliances
burning gaseous fuels, as amended by….
SECTION II
NOTIFYINGAUTHORITIES
European Community
•Austria Bundesministeriumfür wirtschaftliche Angelegenheiten.
•Belgium Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
•Denmark Danmarks GasmaterialPrøvning.
•Finland Kauppa-ja teo llisuusministeriö/Handels-och industriministeriet.
•France Ministère de l'économie, des finances et del'industrie.
Secrétariat d'Etat à l'industrie.Direction de l'action régionale et de la petite et moyenne
industrie (DARPMI). Sous-directionde la sécurité industrielle.
Direction générale de l'industrie, des technologies de
45l'informationet des postes (DiGITIP) - SQUALPI
•Germany Bundesministerium für Arbeit und Sozialordnung.
•Greece MinistryofDevelopment. GeneralSecretaryofIndustry.
•Ireland Department ofEnterpriseand Employment.
•Italy Ministero dell'Industria, delCommercio e dell'Artiginiato.
•Luxembourg Ministère du Travail(Inspectiondu Travailet desMines).
•Netherlands Ministerie van Economische Zaken.
•Portugal Ministério da Economia. Instituto Português daQualidade.
•Spain Ministerio de Industria yEnergía.
•Sweden Under the authority of the Government of Sweden: Styrelsen för
ackreditering ochteknisk kontroll(SWEDAC)
•United Kingdom Department ofTrade and Industry.
Czech Republic: Ú řad pro technickou normalizaci, metrologiia státnízkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
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 Czech
Republic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
46shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
47ANNEXONMUTUAL RECOGNITIONOF RESULTSOF CONFORMITYASSESSMENT
PRESSURE E QUIPMENT
SECTION I
COMMUNITY AND NATIONALLAW
Community law: Council Directive 87/404/EEC of 25 June 1987 on the
approximation of the laws of the Member States relating to
simple pressure vessels (OJ L 220, 08.08.1987, p. 48), as last
amended by Council Directive 93/68/EEC of 22 July 1993
(OJ L 220, 30.08.1993, p.1).
European Parliament and Council Directive 97/23/EC of 29
May 1997 on the approximation of the laws of the Member
States concerning pressure equipment (OJ L 181, 09.07.1997,
p. 1).
Nationallaw: Act No. 22/1997 Coll. (part 6/27.02.1997) on technical
requirements for products and on amendments to some Acts,
as amended by Act N°. 71/2000 Coll. (part 24/03.04.2000).
Act No. 64/1986 Coll. (part 22/03.11.1986), of the Czech
National Council, on the Czech Trade Inspection, as
amended by Act No. 240/1992 Coll. (part 49/29.05.1992),
Act No. 22/1997Coll. (part 6/27.02.1997), Act No. 110/1997
Coll. (part 38/19.05.1997), and Act N°. 71/2000 Coll. (part
24/03.04.2000).
Government Order No. 175/1997 Coll. (part 63/08.08.1997),
that lays down the technical requirements for simple pressure
vessels, as amended byGovernment Order No. 80/1999 Coll.
(part 30/04.05.1999) and …
Government Order No. 182/1999 Coll. (part 62/24.08.1999),
that lays down the technical requirements for pressure
equipment, as amended by….
SECTION II
NOTIFYING AUTHORITIES
European Community:
•Austria Bundesministeriumfür Wirtschaftliche Angelegenheiten.
•Belgium Ministère des Affaires Economiques.
Ministerie van Economische Zaken.
48•Denmark Direktoratet for Arbejdstilsynet.
•Finland Kauppa-ja teo llisuusministeriö/Handels- och industriministeriet.
•France Ministère de l'économie, des finances et del'industrie.
Secrétariat d'Etat à l'industrie.
Direction de l'action régionale de la petite et moyenne industrie
(DARPMI).Sous-directionde la sécurité industrielle.
Direction générale de l'industrie, des technologies de l'information
et des postes (DiGITIP) –SQUALPI.
•Germany Bundesministerium für Arbeit und Sozialordnung.
•Greece MinistryofDevelopment. GeneralSecretariat ofIndustry.
•Ireland Department ofEnterpriseand Employment.
•Italy Ministero dell'Industria, delCommercio e dell'Artigianato.
•Luxembourg Ministère du Travailet de l'Emploi.
•Netherlands Minister vanSociale Zakenen Werkgelegenheid.
•Portugal Under the authorityofthe Government ofPortugal:
Instituto Português da Qualidade.
•Spain Ministerio de Industria yEnergía.
•Sweden Under the authorityofthe Government ofSweden:
Styrelsen för ackreditering ochteknisk kontroll(SWEDAC).
•United
KingdomDepartment ofTrade and Industry.
Czech Republic: Ú řad pro technickou normalizaci, metrologii a státní zkušebnictví
(CzechOffice for Standards, Metrologyand Testing).
49SECTION 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 Czech
Republic in accordance withArticle 10 ofthis Protocol.
Czech Republic:
Bodies which have been authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the European Community in
accordance with Article 10 ofthis Protocol.
SECTION IV
SPECIFIC ARRANGEMENTS
Safeguard Clauses
A. Safeguard clause relating to industrialproducts.
1. Where a Party has taken a measure to deny free access to its market for
industrial products bearing the CE marking, subject to the present annex, it
shall immediately inform to the other Party, indicating the reasons for its
decisionand hownoncompliance has beenassessed.
2. The Parties shall consider the matter and the evidence brought to their
knowledge, and shallreport to eachother the results oftheir investigations.
3. In case of agreement, the Parties shall take appropriate measures to ensure
that suchproducts are not placed onthe market.
4. In case of disagreement on the outcome of such investigations the matter
shall be forwarded to the Association Council who may decide to have an
expertise carried out.
5. Where the Association Council finds that the measure is:
a) unjustified, the national authority of the Party who has taken the
measure shallwithdraw it;
b) justified, the Parties shalltake appropriate measures to ensure that such
products arenot placed onthe market.
B.Safeguard clause relating toharmonised standards.
1. Where the Czech Republic considers that a harmonised standard referred to
in the legislation defined in the present annex, does not meet the essential
50requirements of such legislation, it shall inform the Association Council
givingthereasonsthereof.
2. The Association Council shall consider the matter and may request the
European Community to proceed in accordance with the procedure provided
for inthe Communitylegislation identified inthe present annex.
3. The European Community shall keep the Association Council and the other
Partyinformed ofthe proceedings.
4. The outcome ofthe procedure shall be notified to the other Party.
51Annexon MutualRecognition ofresultsofConformity Assessment:
GOODMANUFACTURING PRACTICE (GMP) FORMEDICINALPRODUCTS :INSPECTION AND
BATCHCERTIFICATION
SECTION I
COMMUNITY AND NATIONALLAW
Community law: Council Directive 65/65/EEC of 26 January 1965 on the
approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products (OJ L 22,
09.02.1965), as last amended by Council Directive 93/39/EEC
of14 June 1993 (OJ L 214, 24.08.1993, p.22).
Council Directive 75/318/EEC of 20 May 1975 on the
approximation of the laws of the Member States relating to
analytical, pharmacotoxicological and clinical standards and
protocols in respect of the testing of medicinal products (OJ L
147, 09.06.1975, p.1), as last amended by Commission
Directives 1999/82/EC and 1999/83/EC of 8 September 1999
(OJ L 243, 15.09.1999, p. 7and 9).
Council Directive 75/319/EEC of 20 May 1975 on the
approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products (OJ L 147,
09.06.1975, p. 13), as last amended by Council Directive
93/39/EECof14 June 1993 (OJ L 214, 24.08.1993, p. 22)
Council Directive 81/851/EEC of 28 September 1981 on the
approximation of the laws of the Member States relating to
veterinary medicinal products (OJ L 317, 06.11.1981, p.1), as
last amended byCouncilDirective 90/676/EEC of13 December
1990 (OJ L 373, 31.12.1990, p.15).
Council Directive 81/852/EEC of 28 September 1981 on the
approximation of the laws of the Member States relating to
analytical, pharmacotoxicological and clinical standards and
protocols in respect of the testing of veterinary medicinal
products (OJ L 317, 06.11.1981, p.16), as last amended by
Commission Directive 1999/104/EC of 22 December 1999 (OJ
L 3, 06.01.2000, p.18).
Commission Directive 91/356/EEC of 13 June 1991 laying
down the principles and guidelines of good manufacturing
practice for medicinal products for human use (OJ L 193,
17.07.1991, p.30).
Commission Directive 91/412/EEC of 23 July 1991 laying
down the principles and guidelines of good manufacturing
practice for veterinary medicinal products (OJ L 228,
17.08.1991, p.70).
52Council Regulation (EEC) N° 2309/93 of 22 July 1993 laying
down Community procedures for the authorisation and
supervision of medicinal products for human and veterinary use
and establishing a European Agency for the Evaluation of
Medicinal Products (OJ L, 214, 24.08.1993, p.1) as last
amended by Commission Regulation (EC) N° 649/98 of 23
March1998 (OJ L 88, 24.03.1998, p. 7).
Council Directive 92/25/EEC of 31 March 1992 on the
wholesale distribution of medicinal products for human use (OJ
L 113, 30.04.1992. p.1) &Guide to Good DistributionPractice.
Guide to Good Manufacturing Practice, Volume IV of the Rules
Governing MedicinalProducts in the European Community.
Compilation of Community Procedures on Administrative
Collaboration and Harmonisation of Inspections (III/5698/94-
EN).
Nationallaw: Act No. 79/1997 Coll. (part 26/15.04.1997) on pharmaceuticals
a n do na m e n d m e n t st os o m eA c t sa sa m e n d e db yA c tN o .
149/2000 Coll. (part 47/13.06.2000).
Decree of the Ministry of Health and Ministry of Agriculture
No. 355/1997 Coll. (part 115/31.12.1997) on Good
Manufacturing Practice, Good Distribution Practice and More
Detailed Conditions for Licensing of Manufacture and
Distribution of Pharmaceuticals as amended by Decree No. …
(part …).
Recommended Procedures for Implementation of Good
Manufacturing Practice and Good Distribution Practice, Official
JournalofSUKL, SpecialIssue, February1998.
General Requirements of the State Institute for Drug Control,
Praha (SUKL) on Validation of Manufacturing Process, Official
JournalofSUKL No. 12/1995(VYR-3).
General Requirements of SUKL on Cleaning Procedures and
Their Validation, Official Journal of SUKL No. 7/1996 (VYR-
5).
CleanRooms, OfficialJournalofSUKL No. 6/1997 (VYR-7).
Principles of Control Activities of SUKL in the Field of Good
Manufacturing Practice (GMP) for Manufacturers and
Distributors of Pharmaceuticals, Official Journal of SUKL No.
3/1998, (VYR-8).
Issuing of GMP Certificates, Official Journal of SUKL No.
10/1998 (VYR-9).
General Requirements of SUKL on Validation of Aseptic
53Procedures, OfficialJournalofSUKL No. 12/1998 (VYR-10).
Requirements of SUKL on Distributors of Medicinal Gases,
OfficialJournalofSUKL No. 12/1998(DIS-5).
Guidelines of the Institute for State Control of Veterinary
Immunologicals and Medicaments, Brno (USKVBL)
- Recommended Procedures for Implementation of Good
DistributionPractice, OfficialJournalofUSKVBL No. 1/1998.
SECTION II
OFFICIALGMPINSPECTIONSERVICESOFEACH PARTY
European Community
•Austria Bundesministeriumfür Arbeit, Gesundheit und Soziales.
•Belgium Ministère de la Santé Publique, de l'Environment et de l'Intégratio n
Sociale. InspectionPharmaceutique.
Ministerie van Volksgenzondheid, Leefmilieu en Sociale Integratie.
Farmaceutische Inspectie.
•Denmark Lægemiddelstyrelsen (Danish Medicines Agency).
•Finland Sosiaali-ja terveyministeriö/Social-och hälsovardsministeriet.
•France Ministère de l'emploi et de la solidarité. Direction générale de l a
santé.
Agence française de sécurité sanitaire des produits de santé (huma n
medicinalproducts).
Agence française de sécurité sanitaire des aliments (veterinar y
medicinalproducts).
•Germany Bundesministerium für Gesundheit.
•Greece Ministry of Health and Welfare, National Drug Organizatio n
(E.O.F.).
•Ireland IrishMedicinesBoard.
•Italy Ministero della Sanità. Dipartimento Farmaci e Farmacovigilanz a
(human medicinalproducts).
Ministero della Sanità. Dipartimento alimenti e nutrizione e sanit à
pubblica veterinaria – DivIX (veterinarymedicinalproducts).
•Luxembourg Direction de la Santé, Division de la Pharmacie et de s
Médicaments.
•Netherlands Ministerie van Volksgezondheid, Welzijn en Sport; inspecti e
Volksgezondheid.
54•Portugal Instituto da Farmácia e do Medicamento (INFARMED).
•Spain AgenciaEspañoladelMedicamento.
•Sweden Läkemedelsverket (MedicalProducts Agency).
•United
KingdomMedicinesControlAgency.
VeterinaryMedicinesDirectorate.
Czech Republic: Státní ústav pro kontrolu lé čiv - SUKL (State Institute for Dru g
Control) Praha.
Ústav pro státní kontrolu veterinárních biopreparát ůal é čiv–
USKVBL. (Institute for State Control of Veterinar y
Immunologicals and Medicaments) Brno.
SECTION III
SPECIFIC ARRANGEMENTS
1. DEFINITION
"Medicinal products": means all products regulated by the pharmaceutical legislation in the
EuropeanCommunityand the CzechRepublic as listed inSectionI above.
"Good Manufacturing Practice (GMP)": as defined in Council Directive 91/356/EEC and
Council Directive 91/412/EEC and the relevant legislation of the Czech Republic as listed in
SectionI above.
"Inspection": means an on-site evaluation of a manufacturing facility carried out by an
inspection service listed in Section II above to determine whether such manufacturing facility
is operating in compliance with Good Manufacturing Practice or commitments made as part
ofthe marketingauthorisation.
"Inspection Report": means the written observations and Good Manufacturing Practice
compliance assessment completed byanauthoritylisted inSectionII above.
2. SCOPE AND COVERAGE
2.1 The provisions of this Sectoral Annex cover all medicinal products for human and
veterinary use which are industrially manufactured in the Czech Republic and the
EuropeanCommunity, and to whichthe GMP requirements apply.
2.2 For the medicinal products covered by this Sectoral Annex, each Party shall
recognise the conclusions of inspections carried out by the relevant inspection
services of the other Party and the relevant manufacturing authorisations granted by
theCompetent AuthoritiesoftheotherParty.
2.3 In addition, the manufacturer's certification of the conformity of each batch to its
specifications shallbe recognised bythe other Partywithout re-controlat import.
553. PRE-OPERATIONAL PHASE
3.1 Inthe pre-operationalphase the following activities will be carried out:
The effective implementation of legislative, regulatory and administrative
requirements of the European Community on GMP by the Czech Republic will be
determined according to a procedureestablished bythe EuropeanCommunity.
The practical implementation of the requirements of the European Community on
GMP will be determined through joint inspections, examination of inspection reports
and other documents linked to aninspection.
3.2 The length ofthe pre-operationalphase will be 6 month.
3.3 The results of the activities in the pre-operational phase will be discussed in the
competent expert group (European Community inspector's Working Party) with the
participation of the Competent Authorities of the Czech Republic. The Parties will
decide on the prolongation or termination of the pre-operational phase in the
Association Council. The operational phase will start immediately after the
successfulterminationofthe pre-operationalphase.
3.4 The Parties may decide, in the Association Council, to renounce the pre-operational
phase at any time in the light of the demonstration of implementation and
maintenance ofGood Manufacturing Practice inthe CzechRepublic.
4. OPERATIONAL PHASE
Certification ofmanufacturers
4.1 At the request ofanexporter, importer orthe Competent Authorityof the other party,
the authorities responsible for granting manufacturing authorisations and for
supervision of the manufacture and control of medicinal products shall certify that
themanufacturerofthemedicinalproduct:
a) is appropriately authorised to manufacture and/or control the relevant
medicinalproduct orto carryout the relevant specified operations;
b) complies with the European Community and Czech Republic GMP
requirements;and,
c) is regularly inspected bythe competent inspectionservice.
4.2 The certificates shall also identify the site(s) of manufacture. Guidance on a common
format for suchcertificate willbe given.
4.3 Certificates shall be issued expeditiously, and the time taken should not exceed 30
calendar days. In exceptional cases, e.g. when a new inspection has to be carried out,
thisperiod maybeextendedto 60days.
56Batchcertification
4.4 Each batch exported shall be accompanied by a batch certificate issued by the
manufacturer (self certification) after a full qualitative analysis, a quantitative
analysis of all the active constituents and all the other tests or checks necessary to
ensure the quality of the product in accordance with the requirements of the
marketing authorisation. This certificate shall attest that the batch meets its
specification and has been manufactured in accordance with the relevant marketing
authorisation. This certificate shall be retained by the importer of the batch and will
be made available uponrequest ofthe Competent Authority.
4.5 When issuing a certificate, the manufacturer shall take account of the provisions of
the current European Community certification. The batch certificate shall be signed
by the person responsible for releasing the batch for export, i.e. the "qualified
person" referred to in Article 17 ofDirective 75/319/EEC and Article 29 ofDirective
81/851/EEC, and inSections 4 and 19 ofAct 79/1997 Coll.
Officialbatch release
4.6 The official batch release procedure is an additional verification of safety and
efficacy of immunological medicinal products (e.g. vaccines) and blood derivatives,
carried out by the competent authorities before the distribution of each batch of
product. This Protocoldoes not encompass mutualrecognition of these official batch
releases.
Inspections
4.7 GMP inspections shall be carried out by the locally competent inspection service
against the GMP requirements as listed inSectionI.
4.8 The following types of inspections maybe carried out:
a) General or System Inspections: carried out to verify whether a manufacturer
complies generally with GMP requirements (e.g. routine inspection covering
especiallythe fundamentalrequirementsofGMP).
b) Process inspections: carried out to verify whether a manufacturer conducts a
certainprocess(es) according to GMPrequirements (e.g. productionofsterile water).c) Product inspection: carried out to verify whether a manufacturer produces
certain medicinalproductora series ofproduct(s) according to GMP requirements. It
focuses on the validation of compliance with specific process or control aspects as
described in the marketing authorisation (e.g. "pre-marketing" inspections) and
therefore the inspector shall have available and be conversant with the relevant
information(the qualitydossier and anapplication/authorisationdossier).
4.9 The regime of inspection/establishment fees is determined by the manufacturer's
location. Inspection/establishment fees will not be charged to manufacturers located
ontheterritoryoftheotherPartyforproductscoveredbythisProtocol.
57Transmission of inspection reports
4.10 Upon reasoned request, the relevant inspection services shall forward a copy of the
last inspection report of the manufacturing or control site, in case control operations
are contractedout. EachPartyshalldealwiththese inspectionreports with the degree
ofconfidentialityrequested bythe Partyoforigin.
4.11 If the manufacturing operations of the medicinal product in question have not been
inspected recently, i.e. when the last inspection dates back to more than two years or
a particular need to inspect has been identified, a specific and detailed inspection
may be requested. The Parties will ensure that inspection reports are forwarded in no
more than 30 calendar days, this period being extended to 60 days should a new
inspection be carried out.
Alert system
4.12 The Competent Authorities will inform the authorities of the other Party with the
appropriate speed in case of quality defect, batch recalls, counterfeiting and other
problems concerning quality, which could necessitate additional controls or
suspension of the distribution of the batch. A detailed alert procedure shall be agreed
between the Parties.
4.13 The Parties shall ensure that any suspension or withdrawal (total or partial) of a
manufacturing authorisation, based on non compliance with GMP and which could
affect the protection of public health, is communicated to each other with the
appropriate degreeofurgency.
Exchange of information between authorities and approximation of quality
requirements
4.14 In accordance with the general provisions of the Protocol, the Parties shall exchange
any informationnecessaryfor the mutualrecognitionof inspections.
4.15 In addition, the relevant Competent Authorities shall keep each other informed of
any new technical guidance or inspection procedure. Each Party shall consult the
other before their adoption and will endeavour to proceed towards their
approximation.
Inspectors training
4.16 In accordance with the general provisions of the Protocol, training sessions for
inspectors, organised by the Competent Authorities, shall be accessible to inspectors
ofthe other Party. The Parties willkeep eachother informed ofthese sessions.
Joint inspections
4.17 In accordance with the general provisions of the Protocol, and by mutual agreement
between the Parties, joint inspections may be authorised. These inspections are
intended to develop common understanding and interpretation of practice and
requirements. The setting up of these inspections and their form shall be agreed
throughprocedures approved bythe Parties.
58Contact points
4.18 For the purpose ofthis Protocol, the contact points for the alert system, any technical
question, such as exchange of inspection reports, inspectors training sessions,
technicalrequirementsare
for the EuropeanCommunity:
theDirectoroftheEuropeanAgencyfortheEvaluationofMedicinalProducts.
for the CzechRepublic:
in case of human medicinal product - the Director of the State Institute for Drug
Control,
in case of veterinary medicinal product - the Director of the Institute for State
ControlofVeterinaryImmunologicals and Medicaments.
Divergence ofviews
4.19 Both Parties shall use their best endeavours to resolve any divergence of views
concerning inter alia compliance of manufacturers and conclusions of inspection
reports. Unresolved divergences ofview will be referred to the Association Council.
5. S AFEGUARD MECHANISMS
5.1 Where a partyestablishes inwriting and inanobjective and reasoned manner that the
other Party is failing to comply with the conditions of this Annex, it may consult the
AssociationCouncil. The AssociationCouncilmay decide on measures to be taken.
5.2 Each Party reserves the right to conduct its own inspection for reasons identified to
the other Party. Such inspections are to be notified in advance to the other Party,
which has the option of joining the inspection. Recourse to this safeguard clause
should be an exception. Should such an inspection take place, inspection costs may
be recovered.
59DECLARATION ON EXCHANGE OF INFORMATION
The Parties see the merit of adopting a further annex to this PECA, concerned with exchange
of information referred to in Article 12. The objective is to prevent any potential new
technical barrier through an extension, to the Czech Republic, of some of the principles
contained in Directive 98/34/EC of 22 June 1998, laying down a procedure for the provision
of information in the field of technical standards and regulations, as amended by Directive
98/48/EC of 20 July 1998. To this effect, a simplified procedure will be prepared as a new
ann extothi sProtoc ol .
60DECLARATION BY THE EUROPEAN COMMUNITY ON THE ATTENDANCE OF
THE CZECH REPRESENTATIVES TO COMMITTEES
In order to ensure a better understanding of the practical aspects of the application of the
acquis communautaire, the European Community declares that the Czech Republic is invited,
under the following conditions, to the meetings of the committees established or referred to
under the Communitylaw on machinery, lifts, personalprotective equipment, electromagnetic
compatibility, equipment and protective systems intended for use in potentially explosive
atmosphere, gas appliances, simple pressure vessels and pressure equipment.
This participation shall be limited to meetings or partsthereofduring which the application of
the acquis is discussed; it shall not entail attendance to meetings intended to prepare and issue
opinions on implementing 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
theEuropeanCommission.
61FINANCIAL STATEMENT 2001-2005
External trade relations - Protocol to the Europe Agreement between the European
Community and the Czech Republic on Conformity Assessment and Acceptance of
IndustrialProducts(PECA)
1. TITLE
ExternalTradeRelations-
Protocol to the Europe Agreement between the European Communities and the Czech
Republic onConformityAssessment and Acceptance ofIndustrialProducts(PECA)
2. BUDGETARY HEADINGS: B7-8500
3. LEGAL BASISArticle 133 ofthe Treatyestablishing the EuropeanCommunity.Proposal for a Council decision N°.... on the conclusion by the European Community of an
additional Protocol to the Europe Agreement between the European Community and the
CzechRepublic onConformity Assessment and Acceptance ofIndustrialProducts (PECA).
4. DESCRIPTION OF OPERATION:
4.1 Generalobjective:
The main objective of the PECA is to facilitate trade by means of the elimination of technical
barriers in respect of industrial products in certain sectors in which the candidate country has
aligned its legislationonthe acquis communautaire.
The purpose of this PECA is to establish the mutual acceptance of industrial products which
fulfil the requirements to be lawfully placed on the market and the mutual recognition of the
results of conformity assessment of industrial products subject to the Community technical
regulations and to the equivalent Czechnationallegislation.
The major actions, which will be pursued by the Commission under this budget line, will be
the following:
•Confidence-building activities to facilitate the proper implementationofthe PECA.
•Management ofthe PECA and maintenance ofthe necessarydegree ofconfidence.
•Extension ofthe PECA to new sectors.
The Commissionwill be assisted byexperts, particularlyin regard to sectoralactivities. It will
however remainthe finalarbiter inthe managementofthisPECA.
4.2 Durationofthe action; means foreseen for its renewal:
The generalaction undertaken will be of a definite duration. The PECA has a lifetime limited
to the pre-accession period of the Czech Republic. The initial period of confidence building
will require a more intensive effort but the expenditure should be substantially less after 1
62year. However, during the life of the PECA a continued effort will be needed to ensure
management and maintenance ofconfidence.
5. CLASSIFICATION OF EXPENDITURE/REVENUE
5.1 Non-compulsory expenditure ("DNO")
5.2 Differentiated appropriation ("CD")
5.3 Type of revenue involved:
None6. TYPE OF EXPENDITURE/REVENUE
- 100% subsidy: No- subsidy for co-financing with other sources in the public or private sector?
Yes, this may be envisaged as a method of funding. Subsidies will be awarded according to
the Commission's "Vademecumongrant management". Grant can be provided to professional
associations and other responsible organisations for activities related to the implementation of
thePECA.
- Interest subsidy: No
-O t h e r s
Financing ofevents, acquisitionofstudies, publications and conferences.
- Should the action prove an economic success, is there provision for all, or part of, the
Community contribution to be reimbursed? Notrelevant
- Will the proposed operation cause any changes in the level of revenue? No
7. FINANCIAL IMPACT ON APPROPRIATIONS FOR OPERATIONS
7.1 Methodofcalculating the totalcost ofthe operation:
The estimation of costs is based on the anticipated requirements in terms of expenses related
to seminars, workshops, travel of experts, verification of conformity assessment bodies,
informationand studies. The totalestimated cost is based onthe sumofthe individualactions.
Arange ofdifferent actions is foreseento meet theobjectives ofthe budget-line and costs will
vary depending on the nature of action undertaken. Even for similar types of action (e.g.
seminars) costs will varydepending on the scope ofthe action and the degree of specialisation
needed.
The costsofspecific actions willbe determined either:
•bythe Commissionwhen it organises activities itself, e.g. seminars
•following invitations to tender issued bythe Commission
63•following requests for subsidies. In such cases, projects are selected according to how well
they meet the criteria that have been established for selection. Subsidies will be awarded
and managed according to the rules ofthe "Vademecumongrant management".
A. Attendance at the Association Council, the Association Committee or any special
subcommittee orgroupto whichhas beendelegatedthe management ofthe PECA .
This will be attended by Commission officials and some experts from the Member States.
Travel and per diem expenses should be foreseen within the normal range of such expenses.
The travel expenditure for officials will be covered by the "Mission budget" (A-7010). The
reimbursement oftraveland related expenses for experts will be made on line B7-8500.
B. Workshopsand Seminars
These will be held to familiarise economic and other operators with the requirements of the
PECA. The cost of these seminars will vary according to the subject matter and location, and
will include traveland organisational costs (when in the EC) and substantial travel costs when
in the Czech Republic. Organisational costs will cost c. 3000 Euro each. The number of
seminars willvarydepending onthe individual industrialsectorscovered bythe PECA.
C. Verificationactions
The competence of the notified bodies will in some cases have to be checked, more so in the
initial period of the PECA, but as a matter of course throughout the life of the PECA to
maintain confidence in the system.
This will involve on-site assessment by teams of experts of notified bodies in the partner
country in the initial stages, and subsequently investigation of complaints. This expenditure
willcover allsectorsofthe PECAand may involve severalnotified bodies ineachsector.
D. Productionanddisseminationofinformation
Certain costs may need to be incurred for the dissemination of information. Guides to
regulations and assessment procedures maybe needed typicallyat a cost of10000 Euro.
647.2 Breakdownbyelements oftheoperation
InEuro
(current prices)
Breakdown Year
2001Year
2002 2003 2004 2005Total
2001-2005
A. Committee
C.Seminars
D. VerificationsE. Information9.136
9.854
6.93620.0009.136
9.854
6.9365.0009.136
3.468
5.0009.136
3.4689.136
3.46845.680
19.708
24.27630.000
Total 45.926 30.926 17.604 12.604 12.604 119.664
From the year 2002 on the estimates are for information. The year number and the total
amount willdepend onthe accession year ofthe CzechRepublic.
7.3 Indicationofthe timetable for commitment and payment appropriations
1000 Euro
Year
2001 2002 2003 2004 20052005 and
following
years Total
Schedule of
Commitment46 31 18 13 13 13 132
Payment
appropriations
2001
20022003
2004
2005200646
31
18
13
13
1346
3118
13
1313
T o t a l 4 63 1 1 8 1 31 31 3 1 3 2
The year number and the total amount will depend on the accession year of the Czech
Republic.
658. WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL FOR
THE OPERATION?
Methods of control (submission of reports, etc.) will be included in all contracts or grant
agreementsbetweentheCommissionand beneficiaries.
A close co-operation with the delegations of the Commission and the participation of a
representative ofthe Commission at events in third countries will check onthe spot the work
to ensure that it corresponds with the terms of reference, contract provisions and required
professionalism.
The checks take place before the final payment. The same rule applies to the financial
incentives paid to participating companies. Where appropriate, agreements also require
organisations to submit financialaccounts certified bytheir auditors.
9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS
9.1. Specific objectives ofthe proposedoperation, populationtargeted- The specific objectives of Protocols on Conformity Assessment and Acceptance of
Industrial Products are:
•to avoid duplicationofcertificationbyeconomic operators.
•to promote exports, employment, competitivity and investment.
•to reduce costs, inparticular for smalland medium-sized enterprises and ultimately for the
consumer,
•to extend certain benefits ofthe InternalMarket to the CzechRepublic
•to ensure the effective operation of the Internal Market in certain sectors before accession
ofthe CzechRepublic.
- Target population
The target population are the exporting companies, business associations, chambers of
commerce and public institutions ofthe European Union and the general consumer which will
benefit, or have an interest in, the mutualacceptance of industrial products and recognition of
results ofconformityassessment certification.
9.2. Reasons fortheoperation
- Need for interventionfrom the Community budget
Under Article 133 of the Treaty the Community has exclusive competence for commercial
policy and this agreement have been negotiated in accordance with a mandate of the Council
of Ministers and in consultation with the 133 Committee. The Commission will be
responsible forimplementationand management ofthisProtocol.
- Choice of methods of intervention
•advantages over alternative measures (comparative advantages)
66•analysisofsimilaroperationsat Communityornationallevel
•results and expected multipliers
The choice of management method (Association Council) has been set out in the PECA and
constitute a minimum necessary for the proper functioning of the PECA. The use of seminars
inthe initialphaseswillallowensuring familiaritywithother systems.
These seminars and verifications are also designed to build mutual confidence; verifications
will also be required to ensure this confidence is maintained throughout the life of the PECA.
Confidenceand its maintenancearekeystothesuccessfuloperationofthePECA.
The importance of this budget is justified when put in perspective with the trade involved in
this PECA and the yearly savings for EU exporters which are expected (estimated on a yearly
basis at €63million for EU exportersto the CzechRepublic).
- Mainfactors of uncertainty which could affect the specific results of the operation.
*N on e
9.3 Monitoringandevaluationoftheoperation
- Performance indicators selected
* Output indicators
* indicators of impact,following the objectives chosen
In the case of this PECA, success can be quantified by trade facilitation through avoidance of
duplication of testing and certification and costs. Yearly estimated savings for the European
Communityare indicated above (9.2).
Success can also be measured by increased EU exports and this factor will be taken into
consideration although export performance is subject to such a wide range of variables (e.g.
changes in exchange rates) that this can never be the sole factor for evaluation.
- Evaluation of results
Progress intheattainmentofthePECAobjectiveswillbe monitored byCommissionofficials,
the AssociationCounciland bythe economic operators concerned.
Details andfrequency of the plannedevaluation
The evaluation of the effectiveness and usefulness of the PECA will be regularly monitored
by the Commission, by the Association Council at its annual meeting, by the Association
Committee at its annual meeting, or by any special subcommittee or group to which the
Association Council has delegated the management of the PECA. At least, the first major
evaluationwill be two years after the entryinto force.
6710. ADMINISTRATIVE EXPENSES
Human resources and administrative means are to be covered by the credits already allocated
tothe managing service. There is no request for additionalstaff.
10.1 Effect onthe number ofposts (considering that 10 industrialsectors are covered bythe
PECA).
Type ofpost Staff to be assigned to managing
theoperationSource Duration
Permanent posts
DG I
+
sectoral DGsTemporary
postsExisting resources in
the DGs (DG Trade,Enlarge, Enter and
Trend) or
departmentsconcernedAdditional
resources
Officials A
BC1.5
0.5None 1.5
0.5None Permanent
Other
resourcesNone
Total 2.0 2.0
10.2 Overall financial impact of additional human resources: 2.0 staff ( 108.000 Euro per
staffmember per year = 216.000 Euro). (Headings A1, A2, A4, A5 and A7)
10.3 Increase in other administrative expenditure as a result of the operation (A-7010:
missions)
Theexpensessetout belowrelatetotravelexpenses for officials ofthe Commissionattending
meetingsofthe AssociationCouncil, the AssociationCommitteeoranyspecialsubcommittee
or group to which has been delegated the management of the PECA; seminars and
verifications, when these are outside Brussels. These will be taken care of by the relevant
budget allocations of various Directorates Generals involved.
68For 2001 this involves the following calculation (the additional missions will be covered by
the allocationonA-7010):
Budget heading Amounts (Euro) Methodof calculation
No. of missions MissionUnit cost
Committee
A-70104.624 CzechRepublic:4
Seminars
A-70101.526 CzechRepublic:1
Verifications
A-70102.312 CzechRepublic:2Brussels: Travel: 800 Euro;
per diem:150 Euro
Czech Republic: Travel 786
Euro; per diem:185 Euro
A-7010:Total 8.462 7
InEuro
Year
2001Year
2002 2003 2004 2005Total
2001-2005
A. Committee 4.624 4.624 4.624 4.624 4.624 23.120
B. Seminars 1.526 1.526 3.052
C. Verifications 2.312 2.312 1.156 1.156 1.156 9.092
TOTAL 8.462 8.462 5.780 5.780 5.780 39.468
The above-mentioned figures are for information only. The impact on staff and missions will
be covered by the allocations on the A-7 budget starting in the year 2001, and will depend on
the accessiondateofthe CzechRepublic.
69IMPACT ASSESSMENT FORM
THE IMPACT OFTHE PROPOSAL ON BUSINESS
withspecialreferencetosmalland medium-sizedenterprises
Titleofproposal
Proposal for Council Decisions on the signature and on the conclusion of an additional
Protocoltothe Europe Agreement between the European Community and the Czech Republic
onConformityAssessment and Acceptance ofIndustrialProducts(PECA).
Reference number
Theproposals
These decisions are necessary to conclude the Protocol to the Europe Agreement between the
European Community and the Czech Republic on Conformity Assessment and Acceptance of
Industrial Products. The Commission negotiated the draft Protocol in accordance with the
negotiating guidelines for the negotiation of European Conformity Assessment Agreement
withthe CentralEasternEuropeanCountries, adoptedbythe Councilin June 1997.
The impact onbusiness
The business sectors affected are machinery, personal protective equipment, lifts, electrical
safety, electromagnetic compatibility, equipment and protective systems intended for use in
potentially explosive atmosphere, gas appliances, hot water boilers, pressure equipment and
medicinalproducts Good Manufacturing Practice inspectionand batchcertification.
The PECA provides to extend certain benefits of the Internal Market in industrial sectors
already aligned. The PECA permits certification of conformity with technical regulations on
product safety, etc, to be conducted in the European Union for exports destined the Czech
Republic. This avoids the need for further certification by Czech conformity assessment
bodies before putting themon the Czech market. The certification procedure and the technical
regulationsare the same asthe Communityone.
The PECA also envisages acceptance of industrial products that fulfil the requirements to be
legally placed on the EU market by the Czech Republic without subject further requirement.
Annexes under this mechanism have stillto be negotiated.
The PECA therefore presents important advantages from the point of view of transparency,
market access, avoidance of duplication especially of cost, effective operation in certain
sectors before accession and general facilitation of trade. This is of particular importance for
small and medium-sized enterprises. The PECA covers a wide range of sectors and therefore
affects an extensive range of firms both large and small. The advantages are not limited to
specific geographicalareas inthe Community.
Businesses will have to apply Czech regulations and procedures. However, these are aligned
on the EC ones in sectors covered by the PECA. Furthermore, certification, as stated above,
will be conducted by conformity assessment bodies located and already designated by the
Member States in the Community, and not in the Czech Republic. The PECA will
substantially reduce certification costs and improve prospects for exports, employment,
investment and competitiveness byCommunityfirms.
70The PECA does not contain measures to take account of the specific situation of small and
medium-sized firms, but by its nature and by reducing certification costs which are the same
for allfirms, the agreement willbenefit smalland mediumsized enterprises to a greater extent
proportionatelythan larger firms.
Consultation
The main industry organisations (e.g. EFPIA, Eurobit, and Orgalime) have been consulted
and have declared their support forthis Protocol.