Working Consolidated Text of Act No. 22/1997 Coll., on Technical Requirements for Products

The Office for Standards, Metrology and Testing informs that Act No 22/1997 Coll., on Technical Requirements for Products and on Amendments to some Acts has been amended several times, namely by Acts No 71/2000 Coll., No 102/2001 Coll., No 205/2002 Coll., No 226/2003 Coll., No 277/2003 Coll., No 186/2006 Coll., No 229/2006 Coll., No 481/2008 Coll., No 281/2009 Coll., No 490/2009 Coll., No 155/2010 Coll., No 34/2011 Coll.,  Act No 100/2013 Coll., and Act No. 64/2014 Coll. The mentioned amendments and various dates of entry into force of parts thereof could cause a difficult orientation in the text as regards the actual effect of particular provisions of the Act. Therefore the Office keeps up to date the working consolidated text of the Act No 22/1997 Coll., on Technical Requirements for Products and on Amendments to some Acts, as amended. Below mentioned text includes the provisions which are effective on the date of 1. 9. 2017.

Act No. 22/1997 Coll. as amended by
Act No. 71/2000 Coll.
Act No. 102/2001 Coll.
Act No. 226/2003 Coll.
Act No. 277/2003 Coll.
Act No. 186/2006 Coll.
Act No. 229/2006 Coll.
Act No. 481/2008 Coll.
Act No. 281/2009 Coll.
Act No. 490/2009 Coll.
Act No. 155/2010 Coll.
Act No. 34/2011 Coll.
Act No. 100/2013 Coll.
Act No. 64/2014 Coll.
Act No. 91/2016 Coll.
Act No. 183/2017 Coll.
Act No. 265/2017 Coll.

22/1997 Coll.
Act

of 24 January 1997

on technical requirements for products and on changes and amendments to some Acts

The Parliament has adopted this Act of the Czech Republic:

PART ONE

TECHNICAL REQUIREMENTS FOR PRODUCTS AND ACCREDITATION OF CONFORMITY ASSESSMENT BODIES

TITLE I

INTRODUCTORY PROVISIONS

Section 1

Scope

(1)           This Act lays down

      a)      the method of establishing technical requirements relating to products which are likely to pose a higher degree of danger to public health and/or safety, property or environment or another public interest (hereinafter referred to as ‛justified concern’);

      b)      the rights and obligations of persons who place on the market, distribute or put into operation products which are likely to pose a higher degree of danger to a justified concern; this is without prejudice to the provisions of special legal regulations relating to the operation of products¹⁾;

      c)      the rights and obligations of persons designated to carry out activities under this Act relating to the creation and application of Czech standards or to the State testing;

      d)      the method of ensuring information obligations relating to creation of technical regulations and standards resulting from international agreements and requirements of the Law of the European Communities.

(2)           This Act furthermore lays down following the directly applicable Regulation of the European Communities^1a) the accreditation of conformity assessment bodies (hereinafter referred to as ‛accreditation’).

(3)           This Act lays down following the directly applicable Regulation of the European Union on construction products¹⁰⁾ (hereinafter referred to as ‛directly applicable Regulation on construction products’) also the exercise of State administration in connection with placing the construction products on the market and with making the construction products available on the market as defined by the directly applicable Regulation on construction products (hereinafter referred to as ‛construction products bearing the CE marking’) including the surveillance on the fulfilment of obligations laid down by the directly applicable Regulation on construction products and imposing of sanctions for their breach.

Section 2

Definitions

For the purpose of this Act the following definitions shall apply

      a)      ‛product’ means any object or substance which has been manufactured, extracted or otherwise acquired, irrespective of the level of its processing, and which is intended to be placed on the market as new or used;

      b)      ‛placing a product on the market’ means the first making available of a product on the market in the course of a commercial activity which means any supply or any offer of a supply or a transfer of the ownership right for the purpose of the distribution, use or consumption on the market of the European Union, unless a special Act provides otherwise. As placed on the market shall be also considered products manufactured or imported for the operational purposes of the business activities of producers or importers and products offered to be reused, if an assessment of their conformity with legal regulations is performed before their reuse, where a Government Order stipulates this. Where necessary, the Government shall provide in its Order a more detailed specification of the term “placing on the market” for the products covered by this technical regulation;

      c)      ‛putting a product into operation’ means the moment when a product is used for the first time by a user within the Member States of the European Union for the purpose for which it was made; where stipulated so by the Government in its Order, a product is put into operation in the moment when it is ready for use or provided for such a use. When a product is put into operation in a workplace^1b), a user shall mean the employer;

      d)      ‛producer’ means the person who manufactures or just has designed a product, and where stipulated so by the Government in its Order, also a person who assembles, packs, processes or marks a product for which he is responsible under this Act and which he intends to place on the market under his name or trademark; where stipulated so by the Government for a product or for a group of products in its Order, as a producer shall be deemed also a person who modifies a product already placed on the market in such a way that its compliance with the applicable technical requirements may be affected;

      e)      ‛importer’ means the person established within a Member State of the European Union who has placed on the market a product from a non-Member State of the European Union;

      f)       ‛authorised representative’ means the person established within a Member State of the European Union, who has received a written mandate from a manufacturer to act on his behalf with regard to the requirements arising for the producer from this Act;

      g)      ‛distributor’ means the person who in the supply chain makes products available on the market;

      h)      ‛technical requirements for products’ mean

1. the technical specification set out in a legal regulation, technical document or standard laying down required characteristics of a product such as a level of quality, performance, safety or dimensions, including the requirements concerning the name under which the product is marketed, terminology used, symbols, product testing and testing methods, the requirements for packaging, marking or labelling of a product, the procedures for an assessment of the conformity of a product with the legal regulations or standards, production methods and processes affecting the characteristics of a product;

2. other requirements necessary for the protection of a justified concern or for the consumer protection, which relate to the life cycle of a product after it has been placed on the market or put into operation, such as the conditions for use, recycling, reuse or disposal of a product, where such conditions can significantly influence the composition or nature of a product or its placing on the market or its putting into operation;

      i)       ‛notified body’ means the legal entity notified by a Member State of the European Union to the institutions of the European Community and to all Member States of the European Union as an entity authorised by the Member State of the European Union to act in the conformity assessment of products with technical requirements;

      j)       ‛economic operator’ means the producer, importer, distributor and authorised representative. 

 

TITLE II

TECHNICAL REGULATIONS AND STANDARDS

Section 3

Technical regulations and technical documents

(1)           For the purposes of this Act the technical regulation shall mean any legal regulation which covers technical requirements for products or rules for services, or which lays down obligations when a product is placed on the market, put into operation, used or when a service is provided or set up, or which prohibits to manufacture, import, sell or to use a certain product or which prohibits to use, provide or to establish a service.  

(2)           For the purposes of fulfilling the information obligations pursuant to Section 7 the technical document shall mean any document which contains technical requirements on a product, which is not a technical regulation within the meaning of subsection 1 or a standard, and which could create a technical barrier to trade.

 

Section 4

Czech standards

(1)           A Czech standard is a document approved by the Office for Standards, Metrology and Testing (hereinafter the ‛Office’) for a repeated or permanent use which was created pursuant to this Act and marked with the written ‛CSN’ designation; and whose publication was announced in the Journal of the Office. The Czech standard is not generally binding.

(2)           The system of Czech standards is formed by

      a)      original Czech standards;

      b)      European or international standards transposed by their translation;

      c)      European or international standards transposed in their original language or transposed by an approval for their direct use.

(3)           The term ‛Czech standard’ and the written ‛CSN’ designation may not be used to designate other documents.

(4)           A Czech standard provides for a common and repeated use the rules, guidelines or characteristics of activities or of their results aimed at achieving the optimal degree of an arrangement in the defined contexts.

Section 4a

Harmonised Czech standards and specified standards

(1)           A Czech standard becomes a harmonised Czech standard when it has fully transposed requirements specified in a European standard or in a harmonisation document recognized by the institutions of the European Community as a harmonised European standard, or a European standard established as a harmonised European standard in accordance with the Law of the European Communities by a common agreement of the notified bodies (hereinafter referred to as ‛harmonised European standards’). For the specification of technical requirements for products resulting from a Governmental Order or an another relevant technical regulation, the Office may, in agreement with ministries and other central administration authorities scope of which competence is relevant to the area concerned, specify Czech standards, other standards or technical documents of international or foreign organisations, or other technical documents containing more detailed technical requirements (hereinafter referred to as ‛specified standards’).

(2)           The Office shall publish in the Journal of the Office harmonised Czech standards, specified standards and their amendments or withdrawals. Their publications shall indicate also the technical regulation to which these standards relate.  

(3)           The compliance with a harmonised Czech standard, a specified standard or compliance with a foreign standard transposing in the Member States of the European Union a harmonised European standard, or compliance with their parts, shall be recognized within the scope and under the conditions laid down in the technical regulation as a compliance with those requirements laid down in technical regulations to which these standards or their parts relate to. Where in the case of harmonised European standards the institutions of the European Community or in the case of specified standards the Office conclude that the compliance with the standards or their parts cannot be no longer recognized as a compliance with the requirements of technical regulations, the Office shall publish in the Journal of the Office which harmonised Czech standards or specified standards are affected by this fact.

(4)           The Office shall publish in the Journal of the Office a reference to the European standard published in accordance with the Law of the European Community^1c) by the Commission of the European Community in the Official Journal of the European Communities, which fulfills the conditions of this Directive.

Section 5

Security of the creation of Czech standards

(1)           The creation, publication and distribution of Czech standards, their amendments and withdrawals within the scope of this Act shall be guaranteed by the State. The fulfilment of these tasks is ensured by the Office, which is the national standardisation body of the Czech Republic according to the directly applicable Regulation of the European Union governing the European standardisation⁹⁾. While doing so, the Office fulfills the obligations resulting from the international agreements which are binding for the Czech Republic and from the membership in international and European standardisation organisations.

(2)           The Office may establish the Czech Standardisation Agency (hereinafter referred to as ‛Agency’) as an organisation co-financed by the State budget based in Prague. The Agency shall be subordinated to the Office. The Agency shall be headed by the Director-General, appointed and dismissed by the President of the Office. The Agency secures the creation, publication and distribution of Czech standards.

(3)           The Agency is entitled to provide the professional activities it performs against payment. These activities and the amount of payment shall be set out in a price list published by the Office in the Journal of the Office.

(4)           The Agency shall be established by the date specified in the charter of its foundation. The charter also contains the definition of the basic organisational structure, the definition of assets of the Czech Republic entrusted to the organisation upon its establishment and further details concerning the subject of its activity. The Office shall publish the establishment in the Journal of the Office within 30 days of the date when this fact occurred.

(5)           The Office may decide on a closure of the Agency. The decision shall specify the date of its closure and at the same time it shall determine the method of the settlement of rights and obligations performed by the organisation; otherwise the rights and obligations of the dismissing organisation shall be transferred to the Office. The Office shall publish the closure of the organisation in the Journal of the Office within 30 days of the date when this fact occurred.

(6)           If the Agency is not established, the tasks provided by this Act shall be fulfilled by the Office. In such a case, the Office is entitled to collect the payments for the professional activities, which together with the amounts of payment shall be determined by the Ministry in its Decree.

(7)           The costs for the creation of Czech standards shall be borne by those who request their development. The costs for the creation of Czech standards, and particularly of Czech standards transposing European standards which were developed at a request of ministries or other central administration authorities and costs related to a membership in an international and European standardisation organisations shall be borne by the State.

(8)           A Czech standards or parts thereof issued on any medium may be reproduced and disseminated only with the approval of the Office.

Section 6

Conditions for creation and publication of Czech standards

In the process of creation and publication of Czech standards, their amendments and withdrawals, the following conditions must be met

      a)      timely publication of information on Czech standards under preparation, on their publication, amendments and withdrawals in the Journal of the Office;

      b)      uniformity and mutual compliance of Czech standards and their compliance with the legal regulations;

      c)      exploitation of the attained level of development in science and technology;

      d)      application of the justified concern protection;

      e)      fulfilment of obligations resulting from international agreements which are binding for the Czech Republic, from membership in international and European standardisation organisations and utilization of the results of international cooperation;

      f)       consideration of opinions on a draft Czech standard, its amendment or withdrawal submitted by any person who will contact, within the period specified in the published announcement on the beginning of the creation of a draft Czech standard or in the announcement on the amendment or withdrawal of it, the person mentioned in the announcement; or by any person who will submit his opinion to a published draft within the period specified in the announcement on its publication;

      g)      withdrawal of a Czech standard which was considered pursuant to paragraph f) where it does not comply with the conditions stipulated in paragraphs b) to d);

      h)      proper distribution of published Czech standards and their amendments within two weeks from the delivery of an order.

Section 7

Notification obligations

(1)           The information on a draft and the draft of a technical regulation or a technical document, their amendments or supplements, which are subject to the notification obligations towards the Member States of the European Union and institutions of the European Community or notification obligations resulting from international agreements, shall be submitted by the ministries, other central administration authorities, the Czech National Bank, authorities of local government units, the Government, where it gives opinion to draft technical regulations which were not initiate by the Government, and in a case of technical documents also by the persons, who are entitled to issue them pursuant to a special legal regulation, to the Office.

(2)           The notification obligations relating to Czech standards shall be ensured by the Office. The manner in which they shall be fulfilled shall be stipulated by the Government in its Order.

(3)           A technical regulation or technical document may not be submitted for approval or approved before the expiration of a time limit prescribed by the Government for submitting that comments, providing that the standstill period relating to the preparation of a draft technical regulation or a draft technical document, during which the decision on adoption or on preparation of a harmonised Regulation of the European Communities shall be taken, may be extended pursuant to the conditions laid down by the Government.  

(4)           The Office as a notification point shall ensure

     

      a)      notifications of technical regulations or technical documents pursuant to subsection 1 to foreign counterparts;

      b)      information about foreign draft technical regulations and technical documents and about foreign documents related to ensuring the procedures for providing information by publishing them in the Journal of the Office;

      c)      notification to institutions of the European Community on the issuance of technical regulations where they are transposing Directives of the European Communities and forwarding the texts thereof to the institutions of the European Community;

      d)      methodical guidance for the uniform submission of notifications and their scope in accordance with the guidelines and procedures of the Commission of the European Community and with the international agreements.

(5)           As a basis for a content of a technical regulation only a standard may be used, which has been adopted in compliance with the procedures laid down in a Governmental Order.

(6)           The Government may determine by an Order the method, scope and particulars of the provision of information relating to technical regulations, technical documents and standards.

(7)           The Office shall notify to the institutions of the European Community or competent authorities of the Member States of the European Union in particular

     

      a)      standpoints to the findings that a provision of a harmonised European standard does not meet essential requirements set out in Regulations of the European Communities, or other facts relating to harmonised European standards or other documents and measures relating to the application of the Regulations of the European Communities;

      b)      bodies designated pursuant to Section 11 to perform activities concerning the conformity assessment according to the Governmental Orders transposing the Law of the European Communities, and changes, suspensions and withdrawals of the designations.

(8)           The Ministry shall notify to the institutions of the European Community or to the competent bodies of the Member States of the European Union the decisions of surveillance bodies on the imposition of safeguard measures^1c) in the case of the specified products (Section 12) indicating the reasons laid down in the Governmental Orders. Notifications received from the institutions of the European Community on safeguard measures applied in other Member States of the European Union shall be transmitted by the Ministry to the surveillance bodies.

(9)           The surveillance bodies shall notify to the Ministry and to the Office the decisions on imposition of safeguard measures in the case of specified products; the notification must always contain the identification of reasons for jeopardising the justified concerns due to which the safeguard measure was imposed as laid down by the Government in its Orders issued pursuant to Section 12 subsection 1 paragraph e).

 

 

TITLE III

STATE TESTING

Section 9

State testing

The State testing is a complex of activities ensured by the Office and by the persons designated in accordance with this Act, the purpose of which is, with the respect to the products specified by this Act, to ensure their conformity assessment with the technical requirements set out in Governmental Orders (hereinafter referred to as ‛conformity assessment’) and in the case of the construction products bearing the CE marking the assessment and verification of the stability of their characteristics pursuant to the directly applicable Regulation on construction products.

Section 10

Certification

(1)           The certification pursuant to this Act shall mean the activity

      a)      of an authorised body performed in the scope stipulated by a technical regulation; or

      b)      of an accredited body performed at the request of a producer, importer or another person;

                where the issuance of a certificate shall verify that a product or activities relating to its manufacturing or its reuse comply with the technical requirements specified in the certificate.

(2)          The certificates issued by the authorised body shall be used for the purposes of conformity assessment pursuant to Section 13 subsection 1, certificates issued by the accredited body may be used for the purposes of conformity assessment under Section 13 subsection 1 only in the cases where the producer, importer or another person are entitled to carry out the conformity assessment.  

 

Section 11

Authorisation

(1)           The authorisation for the purposes of this Act shall mean the designation of a legal entity for activities concerning the conformity assessment of products including the assessment of activities related to their manufacturing or reuse, and specified in the technical regulations (hereinafter referred to as ‛authorised body’). The authorisation for an activity within a specified scope pursuant to this Act shall be granted by the Office based on an application which must be supported by the evidence proving the fulfilment of authorisation conditions laid down by this Act and by the Governmental Orders. In the case of an application for an authorisation of conformity assessment for products specified in a Governmental Order, the description of procedures and of other conformity assessment activities shall be part of the application. The Office shall ensure the observance of a uniform procedure within the activities of the authorised bodies. 

(2)           The Office shall issue a decision on authorisation only if the applicant for authorisation meets all conditions for a proper performance of the conformity assessment laid down in a Governmental Order issued to implement the law. Where such conditions have not been stipulated by the Government in its Order, the Office shall issue a decision on authorisation provided that the applicant for authorisation meets the necessary conditions; namely

      a)      the professional competence with respect to the conformity assessment procedure;

      b)      the absence of financial or other interests which are likely to influence the results of the activity of the authorised body;

      c)      the availability of its own equipment for technical and administrative operations and access to facilities for specialised assessments;

      d)      the availability of a necessary number of employees with professional qualification, knowledge and abilities;

      e)      the commitment of the employees of the authorised body to maintain the confidentiality of any information they may receive during the activity of the authorised body.

Where a decision on authorisation is to be made; the findings acquired during the accreditation procedure (Sections 14 to 16) can be used.

(3)           The authorised body is without delay, after a delivery of the decision on authorisation, obliged to take out a professional liability insurance.

(4)           The Office shall control whether the authorised bodies act in compliance with the provisions of this Act and with the provisions of the Governmental Orders. When requesting information and documents for control, the Office or the persons invited by it may not require disclosure of information or documents which the Office or the persons invited by it have already received when performing the previous controls related to the authorisation procedure, unless a change in their content has occurred.

(5)           In the case of failure to fulfill the obligations laid down in this Act or based on this Act, if the situation changes based on which the decision on authorisation was issued, where the need for an existence of the authorised body ceases or where it is requested by the authorised body; the Office shall take a decision on

      a)      a suspension of the decision on authorisation;

      b)      a change of the decision on authorisation; or

      c)      a withdrawal of the decision on authorisation.

(6)           The Office in the decision on suspension of the decision on authorisation according to paragraph 5 subparagraph a) shall set up a time limit for the redress. When the authorised body takes a corrective action it shall inform without delay the Office. If the Office finds the corrective action sufficient it shall withdraw the decision on suspension of the decision on authorisation. When the authorised body fails to take the corrective action within a time limit determined by the Office the Office shall take a decision on a change or on a withdrawal of the decision on authorisation.

(7)          Each authorisation, including its scope and changes, shall be published in the form of an announcement in the Journal of the Office.

(8)           The authorised bodies become notified bodies by a notification pursuant to Section 7 subsection 7 paragraph b) or in the cases stipulated in a Governmental Order when the prescribed time limit from the notification has expired and where no objections to this notification were raised by the European Commission or by the other Member States within this time limit; and they may perform the activity of a notified body from the date when they have received from the Office the communication on notification. 

(9)           Where it results from an international agreement, the tasks of authorised bodies may be carried out also by foreign bodies notified under this agreement, on which the Office has published an information specifying the scope of their activities in the conformity assessment of products in the Journal of the Office.

(10)         Where the authorization relates to activities pursuant to the directly applicable Regulation of the European Union in the area of medical devices¹⁷⁾, the provisions of paragraphs 1 to 9 shall apply unless this directly applicable Regulation prescribes otherwise.

Section 11a

Authorised bodies

(1)           The authorised bodies shall ensure activities within the scope defined in the decision on authorisation.

(2)           The authorised bodies shall be obliged

1. to conclude, based on a proposal made by a producer, importer or another person, a contract for the performance of the operation in accordance with the specified conformity assessment procedure; or to announce to him, not later than within twenty days, the conditions for performing these operations;

      b)      to follow, when performing the conformity assessment, the technical regulations and carry out the technical examination objectively with the use of professional care at the level of knowledge of science and technology known at the time of the operation;

      c)      in the cases and within the scope laid down in the Governmental Orders

1. to issue a certificate or other document, where it has been proved by performing the relevant conformity assessment procedure that the product meets the technical requirements laid down in the relevant Government Order pursuant to Section 12 subsection 1 paragraph b); the validity of a certificate or other document may be restricted or suspended by the authorised bodies;

2. to request the manufacture to take appropriate corrective measures when the authorised body, in the course of the conformity assessment or subsequently, finds that the products fail to comply with the technical requirements laid down in the relevant Governmental Order pursuant to Section 12 subsection 1 paragraph b);

3. to provide copies of certificates or other documents including related documents and information on issuing, refusal, change or withdrawal of certificates or other documents to the Office, to the competent surveillance body and to notified or other bodies, to the activities of which the relevant documents relate;

4. to inform the Office of any request made by the surveillance bodies regarding the conformity assessment activities;

5. to inform, at a request, the Office of any conformity assessment activity and of any other activity including the cross-border activities and the subcontracting performed by them;

      d)      to notify to the Office without delay any case when they are unable to ensure the fulfilment of conditions set out for the performance of the authorisation;

      e)      to inform the surveillance body without delay that a product is likely to constitute or constitutes a danger to the justified concern, when they make such a finding within the performance of their activities.

(3)           The authorised bodies are entitled to withdraw or change a certificate or another document issued by them, if there is an evidence of a change of a situation under which they had been issued; especially if it has been found that the products no longer meet the requirements of technical regulations which apply to them; or to extend, to the extent specified by the relevant technical regulation, the validity of the certificate, if the situation, under which it had been issued, has not changed.

(4)           When the authorised body receives a suggestion according to Section 18 subsection 3, it is obliged to review the certificate or other document issued pursuant to Section 11a subsection 2 paragraph c) point 1 and to report the result thereof to the surveillance body.

Section 11b

(1)           A legal person whose decision on authorisation was withdrawn or suspended by a final decision shall be obliged

1. to inform on such a decision of the Office without undue delay all affected economic operators;
2. to transfer, at a request of the economic operator which is affected by the consequences of this decision, the rights and obligations related to the conformity assessment, including the subsequent verification of fulfilment of the assumptions under which the certificate or another document had been issued, to an authorised body designated by the economic operator, to deliver to it the associated documentation and to report the Office on the transfer of the rights and obligations including on the delivery of the documentation;
3. to secure that the relevant documentation related to the activities of the authorised body is at a request at disposal for the Office or the surveillance body, for such a time period as it has been set out by the Office in its decision.

(2)           The certificates or other documents related to conformity assessment which had been erroneously issued by an authorised body before the withdrawal or suspension of the decision on authorisation, and not withdrawn by this body, may be withdrawn by the authorisation body to which the rights and obligations pursuant to the paragraph 1 subparagraph b) were transferred, or by a surveillance body where the erroneous issuance is found in the course of the market surveillance activities.

(3)           The authorised body to which the rights and obligations were transferred pursuant to paragraph 1 subparagraph b) is entitled to use the documents from the transferring authorised body to complete the unfinished cases of conformity assessment, or to the subsequent verification of fulfilment of the assumptions under which the certificate or another document had been issued.

(4)           In the case the authorised body intends to terminate or restrict its activity, it shall be obliged, before a withdrawal or suspension of the decision on authorisation, to transfer the rights and obligations to another authorised body; paragraph 1 subparagraph b) shall apply mutatis mutandis.

(5)           If the legal person, which is an authorised body, is to be dissolved, it shall be obliged to transfer the documentation related to the activity of an authorised body before its extinction to the Office.

Section 11c

Technical assessment bodies

(1)           The Ministry may designate a legal person to carry out activities of a technical assessment body¹⁵⁾ on the basis of its application provided that the person meets the requirements laid down in the directly applicable Regulation on construction products.

(2)           The Ministry shall monitor if the technical assessment body complies with the obligations and meets the requirements laid down in the directly applicable Regulation on construction products. In the case that the technical assessment body does not meet these obligations and requirements, the Ministry shall withdraw the designation to carry out activities of a technical assessment body.

(3)           The Ministry in compliance with the directly applicable Regulation on construction products shall notify the European Commission and the Member States of the European Union the name and the registered address of the designated technical assessment body, the groups of products for which the body has been designated, all changes of these data as well as the withdrawal of the designation. The Ministry shall further inform the European Commission on the national procedure for the designation of technical assessment bodies, on the monitoring of their activities and their competence and on all changes of these data.

Section 11d

(1)           The notification of bodies entitled to carry out the activities of the notified body for the assessment and verification of the stability of characteristics of the construction products bearing the CE marking, the rights and obligation of these bodies, their control and sanctions for the breach of their obligations, and the procedure for the suspension, restriction or withdrawal of their notification, including the notification obligations, lays down the Act on the conformity assessment of specified products when made available on the market.

Conformity assessment

Section 12

(1)        The Government, in its Orders, shall lay down

      a)      products which constitute a higher degree of danger to the justified concern and where their conformity must be therefore assessed (hereinafter referred to as ‛specified products’); ministries and other central administration authorities may decide, exceptionally and in a public interest, e. g. in order to mitigate the effects of accidents or natural disasters, that for the duration of that public interest a certain product shall not be considered as a specified product;

      b)      the technical requirements which the specified products must meet for placing on the market or putting into operation, and the changes of related Decrees provisions (technical regulations) issued by the ministries and other central administration authorities where an inconsistency with the Governmental Orders would arise;

      c)      which of the specified products and under what conditions must or may bear, when placed on the market or put into operation, the marking as specified in a Governmental Order (hereinafter referred to as ‛specified marking’);

      d)      the range or the determination of persons who carry out or participate in the conformity assessment;

      e)      the reasons of the danger to the justified concern which shall be, where the safeguard measures^1a) are in the case of specified products imposed, notified pursuant to Section 7 subsection 8;

      f)       the transitional period during which the specified products not complying with the technical requirements set in paragraph b) may be placed on the market or put into operation, provided that they comply with the laws and regulations of a Member State of the European Union;

      g)      the content of the information on safeguard measures transmitted to the institutions of the European Community or to other persons within the scope determined by the Law of the European Communities relating for the conformity assessment;

      h)      other particulars if they are necessary for the transposition of the laws and regulations of the European Communities relating to conformity assessment.

(2)           As specified products pursuant to subsection 1 shall be always considered also products which are placed on the market as used or renewed.

(3)           The Government in its Order shall determine for each group of specified products, according to their technical complexity and to the degree of danger they may pose when they are used, conditions for placing the products on the market or for putting them into operation or for their repeated use, including procedures and tasks which must be met during the conformity assessment (hereinafter referred to as ‛conformity assessment procedures’). The particular conformity assessment procedures are in particular

      a)      the conformity assessment under specified conditions carried out by the producer or importer;

      b)      the conformity assessment of a sample (prototype) of the product carried out by an authorised body;

      c)      the conformity assessment whereby an authorised body examines specific characteristics of the products and checks randomly the compliance of the products with the given requirements;

      d)      the assessment of a production quality system or its components in the economic enterprise and the performance of a surveillance on its proper operation carried out by an authorised body;

      e)      the assessment of a products quality system or its components in the economic enterprise and the performance of a surveillance on its proper operation carried out by an authorised body;

      f)       the verification of the conformity of products with a certified type of the product or with the specified requirements which is carried out by the producer, importer, an accredited or authorised body on every product or on a statistically chosen sample of the products;

      g)      the verification of the conformity of every product with all of the specified requirements carried out by an authorised body;

      h)      the surveillance on the proper functioning of a quality system in the economic enterprise and, if necessary, the assessment of the conformity of the product with the requirements of technical regulations at the design stage carried out by an authorised body;

      i)       the assessment of activities related to the manufacturing of products;

      j)       other conformity assessment procedures including, if necessary, the activities also of an accredited body or another person.

(4)           Where the Governmental Orders transpose the Regulations of the European Communities and the conformity assessment procedures set out in subsection 3 foresee a participation of an authorised body, these activities shall be carried out by the notified bodies or by the persons whose conformity assessment authorisation results from an international agreement, which is binding for the Czech Republic.

(5)           The costs for the conformity assessment activities of an authorised body shall be borne by those who ask for these activities. The price for this performance shall be concluded in accordance with the special Act²⁾.

(6)           The Government shall lay down in its Order the graphic form of a specified product marking, its design and how to affix the marking to a product or to the accompanying documentation, unless the graphic form of the specified product marking is not provided by the directly applicable Regulation of the European Communities.

 

Article 13

(1)           The specified product may be placed on the market or, with respect to products specified in a Governmental Order, put into operation provided that it meets the technical requirements pursuant to Section 12 subsection 1 paragraph b) after the conformity assessment procedure performed pursuant to Section 12 subsection 3 and if the conditions set out in subsection 2 are met. If the importer before placing the specified product on the market considers or has a reason to believe that the product does not meet the technical requirements pursuant to Section 12 subsection 1 paragraph b) and that it furthermore constitutes a risk for health, he shall inform, in the case of products specified by a Governmental Order, the competent surveillance body and the manufacturer.

 (2)          A specified product which is intended to be placed on the market or put into operation must or may, to the extent and under the conditions specified in a Governmental Order, bear the specified marking, other markings, and where a Governmental Order stipulates so, the EC declaration of conformity or another document must be issued or attached to it.

(3)           The CE marking affixed to a specified product means that the product meets the technical requirements laid down in all Governmental Orders which relate to it and which prescribe or enable this marking, and that the prescribed conformity assessment procedure had been observed.

(4)           The Czech conformity marking formed by the letters CCZ may be used only in the case of products to which the Regulations of the European Communities do not apply. This marking means that the product meets technical regulations laid down in all Governmental Orders which relate to it and which prescribe or enable this marking, and that the prescribed conformity assessment procedure had been observed.

(5)           Where a specified product bears the CE marking, it may not be marked concurrently by the Czech conformity marking or by a marking which might, by its meaning or appearance, cause confusion with the CE marking or another specified marking.

(6)           Where a Governmental Order stipulates so, the producer or importer or other person specified in the Governmental Order shall be obliged to submit, at a request, copies of certificates or other documents including the accompanying documentation to the Office or to the authorised bodies or to the designated foreign persons.

(7)           The producer or importer shall be obliged, to the extent specified in the Governmental Orders, to submit the documentation on conformity assessment up to 10 years from the termination of manufacturing, import or placing on the market at a request to the surveillance body. This period may be laid down by the Government in its Order differently.

(8)           The obligations of the producer or importer specified in Section 13, the details of which are specified by the Government in its Order, may be, to the extent specified in a Governmental Order, fulfilled also by the authorised representative.

(9)           The distributor must act in a way to prevent the distribution of specified products which do not apparently meet the requirements of the law, in particular of products which do not bear the prescribed marking and another marking. With respect to the products specified in a Governmental Order, the distributor may not place on the market a specified product when he considers or has a reason to believe that the product does not meet the technical requirements pursuant to Section 12 subsection 1 paragraph b). Furthermore, where the specified product constitutes a risk for health, the distributor shall inform the competent surveillance body, manufacturer and importer.

(10)         The manufacturer or importer shall take, with respect to the products specified in a Governmental Order and with respect to their nature and to the risks they constitute, measures to protect health and safety of persons.

 (11)        The manufacturer, importer or distributor who considers or has a reason to believe that the specified product which he has placed or made available on the market does not meet the requirements laid down by this Act or by the  Governmental Orders implementing it, must take, with respect to the products specified in the Governmental Orders, the necessary corrective measures to bring the product which has been already made available to the user into conformity with these requirements, to withdraw or to recall it; furthermore, where the specified product constitutes a risk for health, the manufacturer, importer or distributor shall immediately report this to the competent surveillance body.

(12)         The manufacturer, importer, distributor or the authorised representative shall keep in the case of products specified in a Government Order the data required for the identification of all economic operators who handed over a specified product to him and whom he handed over the specified product to.

(13)         The importer or distributor shall ensure storage and transport conditions for products specified in Governmental Orders that do not jeopardise the compliance of the product which he intends to place or make available on the market with the requirements of this Act.

(14)         Where a product complies with the conditions specified in Sections 12 and 13, its placing on the market or putting into operation may not be hindered, unless a special legal regulation based on important reasons of protection of the justified concern provides otherwise. This is without prejudice to the provisions of special legal regulations^2a).

(15)         The subsections 1 to 14 shall not be applied for construction products bearing the CE marking, the placing and making available on the market of which is laid down by the directly applicable Regulation on construction products.

Section 13b

(1)           Where the Governmental Orders pursuant to Sections 12 and 13 lay down requirements that do not transpose the requirements of the relevant laws and regulations of the European Communities, those requirements shall not apply to the products manufactured or placed on the market in a Member State of the European Union or in Turkey or originating in a State of the European Free Trade Association which is at the same time a contracting party of the European Economic Area, provided that such a product complies with

      a)      the technical regulations which are in some of these States for manufacturing and placing on the market or for use of this product mandatory;

      b)      the standards or rules of the good practise which are issued by a national standardisation body or a by a body at the same level in conformity with the laws and requirements of the State which is a contracting party of the European Economic Area;

      c)      the international standards which are lawfully used in some of the mentioned States; or

      d)      the traditional or innovative manufacturing processes used in some of the mentioned States in conformity with its laws for which a sufficiently detailed technical documentation exists ensuring that the product in question can be assessed for a given purpose of use, if necessary also on the basis of complementary (but not identical) examinations of the product,

provided that the said technical regulations, standards, rules of the good practise or procedures guarantee a degree of protection of the justified concern corresponding with the degree of this protection in the Czech Republic.  

Section 13c

If the construction product bearing the CE marking is placed or made available on the market in the Czech Republic, the declaration of performance provided together with this product and the instructions and safety information accompanying this product shall be in the Czech language.

Section 14

Accreditation

The exercise of the competence arising for the Czech Republic from the Regulations of the European Communities^1a) in the area of accreditation shall be ensured and performed by the Ministry.

Section 15

Accreditation body

(1)           The Ministry may designate by its decision only one legal person to exercise the competence of an accreditation body (hereinafter referred to as ‛accreditation body’).

(2)           The Ministry shall make the decision on the designation of a legal person to perform the accreditation on the basis of its application. The Ministry shall define in its decision the extent to which the accreditation shall be performed. It shall take into account particularly whether the legal person will be able to fulfill the requirements for the accreditation body specified in the directly applicable Regulation of the European Communities^1a).

(3)           If the accreditation body fails to comply with the obligations or does not meet any more the conditions set in the directly applicable Regulation of the European Communities^1a) or in the decision on the designation, or if the legal person requests it, the Ministry shall amend or withdraw the decision on the designation.

(4)           The Ministry shall publish the decision on the designation of an accreditation body and on the amendment or withdrawal of this decision in the Collection of Laws of the Czech Republic in form of a Notice.

Section 16

Granting of accreditation

(1)           The accreditation body shall decide on granting the accreditation upon the application of a conformity assessment body. The accreditation grant and the existence of the authorisation to act as an accredited conformity assessment body within the extent of the granted accreditation shall be certified by a certificate of accreditation (hereinafter referred to as ‛certificate’).

(2)           The application shall apart from the general requirements on a submission contain the scope of conformity assessment activities, for which the accreditation should be granted (hereinafter referred to as ‛the scope of accreditation’). The accreditation body can ask for other information or documents if they are necessary for the assessment of the required scope of accreditation.

(3)           The accreditation body shall grant the accreditation to a conformity assessment body which proves that it meets the requirements for performing the specific activities of conformity assessment set by harmonised standards or other documents valid in the field of conformity assessment (hereinafter referred to as ‛accreditation requirements’). When assessing the application the accreditation body shall take into account the accreditations which have been already granted for the same conformity assessment body. If the conformity assessment body does not meet the accreditation requirements, the accreditation body shall reject the application on granting the accreditation. Where it is not possible to decide immediately, the accreditation body shall be obliged to decide on the application at the latest within 120 days after the application has been received. In extra difficult cases, this time limit may be extended for additional 90 days.

(4)           The conformity assessment body shall be obliged to cover the actually incurred costs of the accreditation body related to the accreditation; even in advance. If the conformity assessment body does not advance the cost within the deadlines set out by the accreditation body, the accreditation body shall cancel the proceedings.

(5)           The certificate shall contain the identification of the accreditation body and of the conformity assessment body, the determined scope of accreditation, a list of harmonised standards or other documents used during the assessment of the application on accreditation and a period of the accreditation validity. The certificate shall further contain a number of the certificate, a date of its issuing, an imprint of the official stamp, the first name, the last name, a position and a signature of the authorised official person. Certificate may be, at a request, issued also in a foreign language. The announcement of a granted accreditation shall be published in the Journal of the Office. The accreditation body shall publish the information on the grant of accreditation also in the way permitting a remote access.

(6)           The accreditation body shall subsequently check the conformity assessment body if it meets the accreditation requirements at its expense. Where the accreditation body finds out that the conformity assessment body fails to meet the accreditation requirements based on which the accreditation has been granted, it shall take a decision on the suspension of the accreditation and set up a time limit for taking a corrective action. If the conformity assessment body fails take a corrective action within the set time limit, the accreditation body shall take a decision on a restriction of the scope of accreditation or on its withdrawal. If the accreditation body decides on a restriction of the scope of accreditation, it shall issue a corresponding certificate replacing the certificate issued previously for the conformity assessment body. For the decision on a suspension or on a withdrawal of accreditation the provisions of subsection 5 the fourth and fifth sentence shall apply mutatis mutandis.

(7)           The accreditation body shall decide at the request of a conformity assessment body on

      a)      the extension of the scope of accreditation;

      b)      the restriction of the scope of accreditation;

      c)      the extension of the validity of the granted accreditation;

      d)      the consolidation of the valid certificates issued for the same conformity assessment body;

      e)      the suspension of accreditation;

      f)       the withdrawal of accreditation; or

      g)      the withdrawal of the decision on the suspension of accreditation.

In the proceedings on an application pursuant to paragraphs a) to d) and g) it shall be proceeded pursuant to subsections 1 to 5 mutatis mutandis; the new certificates shall replace the certificates issued previously. The application pursuant to paragraph c) shall be submitted not later than 120 days before the expiry of the granted accreditation. In the proceedings pursuant to paragraph d) the accreditation body shall use the documentation from the proceedings on applications on the granting of the accreditation. Unless the accreditation body decided that the effects of a new decision, by which the application pursuant to paragraphs a) to f) has been accepted, occur at another time, the legal power of this decision shall prevent the previous decisions to take an effect. At a request of the conformity assessment body the accreditation body shall record other changes of the data in the documentation and issue a new certificate. 

(8)           The Ministry shall decide on appeals against decision of the accreditation body on the rejection of an application on the granting of accreditation, on the suspension of accreditation, on the withdrawal of accreditation, on the rejection of an application on the extension of the scope of accreditation, on the rejection of an application on the extension of validity of the granted accreditation and the rejection of an application on the withdrawal of the decision on the suspension of accreditation. On the appeals against the other decisions and resolutions of the accreditation body shall decide the statutory body of the accreditation body. An appeal shall not have a suspensive effect.

(9)           If the accreditation body has received a complaint on the activity of a conformity assessment body, to which it has issued a certificate, it shall be obliged to start the investigation and to inform the complainant on the result of the investigation within the time limit of 60 days following the reception of the complaint. If the complaint has been found out as reasonable, the accreditation body shall be obliged to take necessary corrective actions pursuant to subsection 6 without delay. In such a case the conformity assessment body shall bear the actually incurred costs of the accreditation body for the investigation of the complaint.

Section 17

Public law contract on accreditation
            

The accreditation body may conclude with a conformity assessment body a public law contract on the granting of accreditation, on the extension of the scope of accreditation, on the restriction of the scope of accreditation, on the extension of validity of the granted accreditation or on the consolidation of the valid certificates issued for the same conformity assessment body. The public law contract shall replace the process of proceedings on an application pursuant to Section 16 subsection 1 or Section 16 subsection 7 paragraphs a), b), c) or d). For the public law contracts Section 16  subsection 1, the second sentence,  Section 16 subsection 3, the second sentence,  Section 16 subsection 4, the first sentence, and Section 16 subsections 5, 6 and 9 shall apply mutatis mutandis. A proposal for concluding a public law contract on extension of validity of the granted accreditation shall be submitted by the conformity assessment body not later than 120 days before the expiry of the granted accreditation.

TITLE IV

COMMON AND TRANSITIONAL PROVISIONS

Section 18

Surveillance

(1)           The surveillance to ascertain, whether the specified products are placed and made available on the market or put into operation in compliance with the requirements laid down by this Act, whether the construction products bearing the CE marking are placed and made available on the market in accordance with the directly applicable Regulation on construction products, whether the economic operators comply with their obligations laid down by this Act and by the directly applicable Regulation on construction products, and whether the products are not unduly affixed with the CE marking pursuant to the directly applicable Regulation of the European Communities^1a) or with other specified marking pursuant to this Act shall be carried out by the Czech Trade Inspection⁴⁾ or to the extent specified by a special legal regulation by

      a)      the Czech Mining Office^4a);

      b)      the Rail Authority^4b);

      c)      or another authority; if a special Act provides so

(hereinafter referred to as ‛surveillance bodies’).

(2)           The surveillance bodies may

      a)      carry out the analysis or ensure that such analysis are carried out in order to verify whether the products meet the requirements laid down by this Act or by the directly applicable Regulation on construction products; the analysis shall be performed by the competent authorities or bodies; if the analysis shows that a product fails to meet the requirements laid down by this Act or by the directly applicable Regulation on construction products any costs of the analysis shall be borne by the controlled person;

      b)      impose on controlled persons to eliminate within a set time limit the detected shortcomings, their causes and the harmful consequences or to take immediately the necessary corrective action;

      c)      impose an obligation on controlled persons to inform on the risk without delay the persons who could be a subject to a risk related to the product.

(3)           Where the market surveillance body has a sufficient reason to believe that a product fails to meet the technical requirements specified in a Governmental Order pursuant to Section 12 subsection 1 paragraph b), it shall be entitled to require from the authorised body information and documents relating to the conformity assessment of this product, including the issued certificate pursuant to Section 11a subsection 2 paragraph c) point 1, technical documentation and test reports. In addition, the surveillance body may initiate the review of a certificate issued pursuant to Section 11a subsection 2 paragraph c) point 1 by the authorised body. If it is proven that a specified product does not meet the requirements referred to in the first sentence, the surveillance body shall notify this fact to the authorised body concerned. It may also impose on it to withdraw the certificate issued pursuant to Section 11a subsection 2 paragraph c) point 1.

(4)           Where the market surveillance body has a sufficient reason to believe that a product bearing the CE marking fails to meet the requirements specified by the directly applicable Regulation on construction products, it shall be entitled to require from the notified body concerned information and documents relating to the assessment and verification of the stability of characteristics of this product, including the issued certificate, technical documentation and test reports. Where the market surveillance body finds out that the construction product bearing the CE marking does not meet the requirements referred to in subsection 1, it shall notify this fact to the notified body which has took part in the assessment and verification of the stability of characteristics of this product.

 (5)          Where it is referred in the directly applicable Regulation on construction products to a competent national surveillance authority¹⁶⁾, this authority shall be in the Czech Republic the surveillance body.

Section 18a

Safeguard measures

(1)           Where the market surveillance body has a sufficient suspect that the product fails to meet the requirements laid down by this Act or by the directly applicable Regulation on construction products it shall prohibit its placing on the market, putting it into operation or distribution of it or its series for the time needed to carry out the control.

(2)           The market surveillance body shall notify the imposition of measures pursuant to subsection 1 orally to the economic operator and shall make, without undue delay, a written record. If the economic operator does not agree with the measure imposed, he may raise objections, which shall be stated in the record, or he may raise his objections in writing no later than 10 days after the date of receiving the record. The surveillance body shall decide on the raised objections without delay. The written consideration of the objections shall be delivered to the controlled person. No appeal lies against this decision.

(3)           Where the market surveillance body finds out that the product fails to meet the requirements laid down by this Act or by the directly applicable Regulation on construction products or that the product is bearing the CE marking or other specified marking according to this Act or according to the directly applicable Regulation on construction products unduly, it shall prohibit its placing on the market, putting it into operation or distribution of it. If the reasons for the imposed prohibition are no longer applicable, the surveillance body shall take a decision on its change or withdrawal. An appeal against a decision pursuant to the first sentence shall not have a suspensive effect.

(4)           If the surveillance body finds out that the product or the series of the product constitute a danger to justified concern it shall decide on the withdrawal of the product or of the series of the product from the market or from circulation. The surveillance body may accordingly order, if it is necessary, the destruction of the product or of the series of the product or another way of its depreciation. An appeal against a decision pursuant to the first sentence shall not have a suspensive effect.

(5)           In the case of a measure imposed according to subsections 3 or 4, the surveillance body shall always state in the grounds of its decision the specific reasons for the imposing of the measure, which are defined for the specified product in the Governmental Order.

Section 18b

Notification

(1)           The surveillance bodies are obliged to notify to the Ministry the adoption of a measure relating to a product or series of a product in case that the product constitutes a significant risk^4e). This shall apply also for a measure which has been taken by the controlled person on its own initiative and where the surveillance body has obtained an information on this measure.

(2)           The information notified to the Ministry shall contain all available details, especially data necessary for the identification of the product, of its origin, supply chain, danger constituted by the product, nature and duration of the measure taken by the surveillance body and eventually information about the voluntary measure taken by the controlled person.

(3)           If the risk referred to in subsection 1 exceeds the territory of the Czech Republic, the Ministry shall be obliged to notify to the European Commission without delay the presence of such a product.

(4)           When the Ministry receives from the European Commission information on a measure taken in case of a product or of series of a product that constitute a significant risk, it shall forward such information without delay to the surveillance bodies for the purposes of a next proceeding.

(5)           To ensure that the system for the exchange of information according to subsections 1 to 3 would work, the special legal regulation laying down procedures, content and format of information on the occurrence of dangerous non-food products shall be applied accordingly^4f).

(6)           The employees of the relevant ministries and of the surveillance bodies are obliged to maintain the confidentiality regarding any information related to the products and received during the performance of their competence, excluding information that shall be published in the interest of the health protection and consumer safety and in the interest of ensuring the effective performance of the market surveillance and of the surveillance body activities.

(7)           The subsections 1 to 6 shall not apply to construction products bearing the CE marking.

Section 18c

Provision of information on construction products bearing the CE marking

(1)           Where the surveillance body finds out that a construction product bearing the CE marking fails to meet the requirements laid down by the directly applicable Regulation on construction products, or that this product constitutes a threat to the justified concern, and the non-compliance can threaten also the justified concerns of operators and other entities in the Member States of the European Union, it shall inform the European Commission and the bodies of other Member States concerned.

(2)           Where the surveillance body imposes on a construction product bearing the CE marking a measure pursuant to Section 18 subsection 3 or 4, it shall, without delay, inform the European Commission and the bodies of other Member States concerned.

(3)           The scope of information provided pursuant to subsections 1 and 2 lays down the directly applicable Regulation on construction products.

(4)           When the surveillance body receives from the European Commission or from the relevant body of other Member States a notification on imposing a measure on a construction product bearing the CE marking, it shall, without delay, submit this notification to the Ministry. Together with this notification, the surveillance body shall provide the Ministry with all information on the non-compliance of this product with the requirements laid down by the directly applicable Regulation on construction products which it has available, and it shall inform the Ministry on any measure that it has already taken with respect to this product. The Ministry shall, without delay, provide this information together with eventual objections to measures which have been taken by the competent authorities of other Member States of the European Union to the European Commission and to the competent authorities of the Member States of the European Union.

Offences

Section 19

Offences of natural persons

(1)           A natural person will commit an offence when

      a)      misuses the CE marking or other specified marking, certificate or another document pursuant to this Act or pursuant to the directly applicable Regulation on construction products, or counterfeits or alters a certificate or another document pursuant to this Act or pursuant to the directly applicable Regulation on construction products;

      b)      uses the CSN marking for marking of a document contrary to Section 4 subsection 3; or

      c)      duplicates or proliferates a Czech standard or a part thereof contrary to Section 5 subsection 8.

(2)           The penalty up to 20 million CZK may be imposed in case of an offence pursuant to subsection 1 paragraph a) and in case of an offence pursuant to subsection 1 paragraphs b) or c) the penalty may be imposed up to 10 million CZK.

Section 19a

Offences of legal persons and natural persons doing business

(1)           A legal person or natural person doing business will commit an offence when

      a)      misuses the CE marking or other specified marking, certificate or another document pursuant to this Act or counterfeits or alters a certificate or another document pursuant to this Act;

      b)      uses the CSN marking for marking of a document contrary to Section 4 subsection 3;

      c)      duplicates or proliferates a Czech standard or a part thereof contrary to Section 5 subsection 8;

      d)      performs the conformity assessment activity, which is reserved, for the purposes of this Act, to the authorised person, without a granted authorisation pursuant to Section 11 subsection 1;

      e)      acts contrary to the Section 16 subsection 1 as an accredited conformity assessment body without the a granted accreditation or outside of the scope of the granted accreditation;

      f)       fails to comply with some of the safeguard measures imposed pursuant to Section 18 subsection 1, 3 or 4; or

      g)      fails to comply with some of the obligations imposed by the surveillance body pursuant to Section 18 subsection 2 paragraph b) or c).

(2)           An authorised body will commit an offence when fails to meet some of the obligations pursuant to Section 11a subsection 2 or Section 11b subsection 1 or 4.

(3)           A manufacturer, importer, authorised representative or distributor will commit an offence when places on the market or puts into operation or distributes the specified products

      a)      without the CE marking or another specified marking or document prescribed by the Governmental Order;

      b)      with a marking or document contrary to Section 13.

(4)           A legal person or natural person doing business will commit an offence when as

      a)      an importer fails to meet the obligation pursuant to the second sentence of Section 13 subsection 1;

      b)      a distributor fails to meet some of the obligations pursuant to Section 13 subsection 9;

      c)      a manufacturer or importer fails to meet some of the obligations pursuant to Section 13 subsection 10;

      d)      a manufacturer, importer or distributor fails to meet some of the obligations pursuant to Section 13 subsection 11;

      e)      a manufacturer, importer, distributor or an authorised representative fails to meet the obligation pursuant to Section 13 subsection 12; or

      f)       an importer or distributor fails to meet the obligation pursuant to Section 13 subsection 13.

(5)           A legal person or natural person doing business will commit an offence when as

      a)      a producer, importer or authorised representative according to the directly applicable Regulation on construction products fails to meet some of the obligations pursuant to the directly applicable Regulation; or

      b)      a distributor according to the directly applicable Regulation on construction products fails to meet some of the obligations pursuant to the directly applicable Regulation on construction products.

(6)           For an offence may be imposed a penalty up to

      a)      50 million CZK in case of an offence pursuant to subsection 3 or subsection 1 paragraph f) or g);

      b)      20 million CZK in case of an offence pursuant to subsection 1 paragraph a), d) or e);

      c)      1 million CZK in case of an offence pursuant to subsection 1 paragraph b) or c) or subsection 2;

      d)      500 000 CZK in case of an offence pursuant to subsection 4 or 5.

Section 19b

Common provisions for offences

(1)           The offences pursuant to Sections 19 subsection 1 paragraphs b) and c), to Section 19a subsection 1 paragraphs b) to e) and to Section 19a subsection 2 shall be under consideration of the Office. Offences pursuant to Sections 19 subsection 1 paragraph a), to Section 19a subsection 1 paragraphs a), f) and g) and to Section 19a subsection 3 to 5 shall be under consideration of the surveillance body.

(2)           The penalties shall be collected by the body which has imposed them.

(3)           In the case of offences pursuant to Section 19 subsection 1 paragraphs f) and g) and to Section 19a subsection 3, the administrative penalty cannot be waived.

Section 20

Proceedings

In a proceeding on the authorisation the administrative authority shall decide at the latest within 120 days from the beginning of the proceeding. In exceptional cases the proceedings on the authorisation may be extended by the Ministry by further 60 days.

Section 20a

The persons taking part in the activities pursuant to Title III or IV of this Act shall be obliged to maintain the confidentiality within the meaning of special legal regulations⁸⁾ of any information acquired during such activities and the disclosure of which could threaten the interests of other persons.

Section 20b

The provisions of the Act related to relations to the Member States of the European Union shall relate also to the States of the European Free Trade Association which are at the same time a contracting party of the European Economic Area.

Section 21

Transitional provisions

(1)           The specified products placed on the market prior to entry into force of a Governmental Order pursuant to Section 12 subsection 1 shall be laid down by the regulations valid in the time of their placing on the market, unless it is by a legal regulation expressly provided otherwise.

(2)           The existing standards marked with ‛CSN’ and being in force on the date when this Act entered into force, shall be considered as standards pursuant to this Act.

(3)           The legal persons or natural persons having authorisation for business activities and administrative authorities shall until 31 December 1999 observe those provisions of standards which had been specified as mandatory pursuant to Section 3 of the Act No 142/1991 Coll. as amended by the Act No 632/1992 Coll. If the binding nature of the relevant provisions of those standards was established on the basis of opinions of the ministries or other central administration authorities, only these ministries or other central administration authorities are entitled to permit exceptions to these provisions.

(4)           The proceedings initiated pursuant to Section 29 of the Act No 30/1968 Coll., on State testing, as later amended, shall be completed pursuant to existing regulations.

(5)           The authorisations granted in accordance with existing regulations on State testing shall be considered as authorisations pursuant to this Act for a maximum period of two years from the date on which this Act entered into force.

(6)           The proceedings concerning approval and certification of products initiated before this Act entered into force shall be suspended on the date of entry into force of this Act, unless the producer or importer and the State testing laboratory have by that time agreed otherwise. Where a Governmental Order issued pursuant to this Act establishes the conformity assessment with the participation of an authorised body, the authorised body shall, without request, carry out the conformity assessment of the product according to the procedure specified by the relevant Governmental Order and use the existing findings. In all other cases the State laboratory shall transfer the existing findings to the applicant.

(7)           The decisions on the approval of products or on certification of products issued pursuant to existing regulations on State testing shall be considered, within the period of their validity, as certificates proving the conformity within the meaning of this Act and may be used as supporting evidence for the declaration of conformity pursuant to Section 13 subsection 2 of this Act. Validity of these decisions shall expire on the date set therein. Where these decisions do not specify the period of their validity, the validity shall expire five years from the date on which this Act entered into force.

(8)           The certificates of accreditation issued by the Czech Institute for Accreditation before the date on which this Act entered into force shall remain valid for the period set therein, unless such certificates are withdrawn pursuant to this Act.

Section 22

Powers

The Government shall issue Orders for implementation of the provisions of Section 2 paragraphs b), c), d), Section 3 subsection 2, Section 7, Section 11 subsections 1, 2 and 9, Section 11a subsection 2, Section 12, Sections 13 and 18 subsection 3.

PART TWO

CHANGES AND AMENDMENTS TO SOME ACTS

/Note: Articles 23 and 24 concerning amendments to Act No 64/1986 Coll. on the Czech Trade Inspection and to Act No 20/1993 Coll. are not reproduced/.

PART THREE

FINAL PROVISIONS

Section 25

Hereby are repealed

(1)           Act No 30/1968 Coll., on State Testing, as amended by Act No 54/1987 Coll., Act No 194/1988 Coll., Act No 479/1992 Coll., and Act No 539/1992 Coll.

(2)           Act No 142/1991 Coll. on Czechoslovak Standards, as amended by Act No 632/1992 Coll.

(3)           Decree No 104/1984 Coll., of the Office for Standardisation and Measurement, on the Testing of Arms and Ammunition for Use by Civilians.

(4)           Decree No 101/1988 Coll., of the Office for Standardisation and Measurement, on the Certification of Products, as amended by Decree No 233/1993 Coll.

(5)           Decree No 585/1992 Coll., of the Federal Office for Standardisation and Measurement implementing Act No 30/1968 Coll., on State Testing, as amended by Decree No 232/1993 Coll.

Section 26

Entry into force

This Act shall enter into force on the first day of the seventh month following the day of its promulgation.

/Note: Act No 22/1997 Coll. entered into force on 1 September 1997/

Zeman (signed)

Havel (signed)

Klaus (signed)

_________________

¹⁾ e.g. Act No 114/1995 Coll. on the Inland Navigation, as amended by other Acts, and Act No 61/2000 Coll. on the Sea Navigation.

^1a) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

^1b) Section 134a of the Act. No 65/1965 Coll., Labour Code, as amended by the Act No 155/2000 Coll.

^1c)  Article 4 of the Directive 2001/95/EC of the European Parliament and of the Council on general product safety.

²⁾ Act No 526/1990 Coll., on Prices, as amended by the Act No 135/1994 Coll.

^2a) e.g. Act No 102/2001 Coll. on General Safety of Products and on Amendments to some Acts (Act on General Safety of Products), Act No 258/2000 Coll. on Protection of Public Health, as amended by the Act No 254/2001 Coll. and the Act No 274/2001 Coll.

⁴⁾  Act No 64/1986 Coll., on the Czech Trade Inspection, as amended by other Acts.

^4a) Act No 61/1988 Coll., on Mining Activities, Explosives and the State Mining Administration, as amended by other Acts.

^4b) Act No 266/1994 Coll., on Rails, as amended by other Acts.

^4e) Article 10 of the Regulation (EC) No 765/2008 of the European Parliament and of the Council.

^4f) Governmental Order No 396/2004 Coll., on Procedures, content and form of information on occurrence of dangerous non-food products.

⁵⁾ Sections 13 and 14 of the Act No 121/2000 Coll., on the Copyright, related Rights and Amendment of other Acts (Act on Copyright).

⁸⁾ e.g. Section 17 and seq. of the Commercial Code.

⁹⁾ Article 27 of the Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council.

¹⁰⁾ Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC.

¹⁵⁾ Article 30 of the Regulation (EU) No 305/2011 of the European Parliament and of the Council.

¹⁶⁾ Articles 11 to 14 and Article 43 of the Regulation (EU) No 305/2011 of the European Parliament and of the Council.

¹⁷⁾ Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.