Act No. 22/1997 Coll., on technical requirements for products and on changes and amendments to some act (working compiled English version)

ÚNMZ informs that Act No. 22/1997 Coll., on Technical Requirements for Products and on Amendments and Additions to Certain Acts has been amended several times. A number of amendments to this Act and the timed entry into force of some parts of these amendments make it difficult to navigate through the text in terms of the actual effectiveness of individual provisions of the Act. Therefore, the Office of the Ministry of Industry and Trade has prepared and maintains the working text of the complete (compiled) version of Act No. 22/1997 Coll., on technical requirements for products and on amendments and supplements to certain acts, as amended. The following text contains the provisions effective as of 1 January 2021, after the entry into force of all the amendments made most recently by Act No 526/2020 Coll.

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22/1997 Coll. - on technical requirements for products - the latest text will not come into force until 1 January 2021

22/1997 Coll.

LAW

of 24 January 1997

on technical requirements for products and amending and supplementing certain acts

Amendment: 71/2000 Coll.

Amendment: 102/2001 Coll.

Amendment: 205/2002 Coll.

Amendment: 226/2003 Coll. (part)

Amendment: 205/2002 Coll. (part), 226/2003 Coll., 277/2003 Coll.

Amendment: 229/2006 Coll.

Amendment: 186/2006 Coll.

Amendment: 481/2008 Coll.

Amendment: 490/2009 Coll.

Amendment: 155/2010 Coll.

Amendment: 281/2009 Coll.

Amendment: 34/2011 Coll.

Amendment: 100/2013 Coll.

Amendment: 100/2013 Coll. (part)

Amendment: 64/2014 Coll.

Amendment: 91/2016 Coll.

Amendment: 183/2017 Coll.

Amendment: 265/2017 Coll.

Amendment: 526/2020 Coll.

Parliament has agreed on this law of the Czech Republic:

PART ONE

TECHNICAL REQUIREMENTS FOR PRODUCTS AND ACCREDITATION OF CONFORMITY ASSESSMENT BODIES

TITLE I

INTRODUCTORY PROVISIONS

§ 1 [Commentary WK] [DZ]

Subject of modification

(1) This Act regulates

(a) the method of establishing technical requirements for products which could endanger to an increased extent the health or safety of persons, property or the environment, or other public interest (hereinafter referred to as "legitimate interest"),

(b) the rights and obligations of persons who place on the market or distribute, or put into service, products which could endanger legitimate interests to an increased extent; this shall be without prejudice to the provisions of special legislation for the operation of products,1)

(c) the rights and obligations of persons entrusted with activities pursuant to this Act related to the development and application of Czech technical standards or state testing,

(d) the manner of ensuring information obligations related to the development of technical regulations and technical standards arising from international treaties and requirements of European Community law.

(2) This Act further regulates, in relation to the directly applicable regulation of the European Communities1a), the accreditation of conformity assessment bodies (hereinafter referred to as "accreditation").

(3) This Act also regulates, in relation to the directly applicable regulation of the European Union10) (hereinafter referred to as the "directly applicable regulation for construction products"), the performance of state administration in connection with the placing and supplying of construction products defined by the directly applicable regulation for construction products (hereinafter referred to as "construction products with CE marking") on the market, including supervision over the fulfilment of the obligations laid down by the directly applicable regulation for construction products and the imposition of penalties for their violation.

§ 2 [Commentary WK] [DZ]

Basic concepts

For the purposes of this Act, the following shall mean

(a) a product is any item that has been manufactured, mined or otherwise obtained, regardless of its degree of processing, and is intended to be placed on the market as new or used,

(b) the placing on the market of a product shall mean the first supply of a product on the market in the course of a commercial activity, which shall mean the handing over or offering for handing over of a product or the transfer of ownership of a product for the purpose of distribution, use or consumption on the market of the European Union, unless a specific law provides otherwise. Products manufactured or imported for operational purposes in the course of the manufacturers' or importers' own business and products made available for re-use shall also be considered to have been placed on the market if they are subject to a conformity assessment prior to re-use, where this is provided for in a Government Regulation. Where necessary, the Government shall, by regulation, further define the concept of placing on the market for products covered by this technical regulation,

(c) the putting into service of a product at the time when the product is first used by a user in the Member States of the European Union for the purpose for which it was manufactured; where a government regulation so provides, the product is put into service at the time when it is prepared or provided for that use. Where the product is put into service in the workplace,1(b) the user shall be the employer,

(d) a manufacturer is a person who manufactures or even merely designs a product and, in cases provided for by a Government Regulation, also a person who assembles, packages, processes or labels a product for which he is responsible under this Act and which he intends to place on the market under his name or trademark, as the case may be; a person who modifies a product already placed on the market in such a way as to affect its compliance with the relevant technical requirements shall also be deemed to be a manufacturer if a Government Regulation so provides for a product or group of products,

(e) the importer is a person established in a Member State of the European Union who places a product on the market from a Member State other than the European Union,

(f) an authorised representative, a person established in a Member State of the European Union who is authorised in writing by the manufacturer to act on his behalf with regard to the requirements arising for the manufacturer from this Act,

(g) a distributor, whoever in the supply chain makes products available on the market,

(h) the technical requirements for the product

1. a technical specification contained in a legal regulation, technical document or technical standard, which sets out the required characteristics of a product, such as quality level, performance, safety and dimensions, including requirements for the name under which it is sold, the regulation of nomenclature, symbols, product testing and test methods, packaging requirements, product labelling or marking, procedures for assessing the conformity of the product with legislation or technical standards, manufacturing methods and processes affecting the characteristics of products,

2. other requirements necessary for reasons of legitimate interest or consumer protection relating to the life cycle of the product after it has been placed on the market or put into service, such as conditions of use, recycling, reuse or disposal of the product, where such conditions may significantly affect the composition or nature of the product or its placing on the market or putting into service,

(i) a notified body is a legal person which has been notified by a Member State of the European Union to the authorities of the European Community and to all Member States of the European Union as a person authorised by a Member State of the European Union to carry out activities for the assessment of the conformity of products with technical requirements,

(j) the economic operator shall be the manufacturer, importer, distributor and authorised representative.

TITLE II

TECHNICAL REGULATIONS AND TECHNICAL STANDARDS

§ 3 [Commentary WK] [DZ]

Technical regulations and technical documents

(1) For the purposes of this Act, a technical regulation is a legal regulation containing technical requirements for products or, where applicable, rules for services, or regulating obligations in the placing on the market or putting into service of a product or in its use or in the provision or establishment of a service, or prohibiting the manufacture, import, sale or use of a product or the use, provision or establishment of a service.

(2) For the purposes of fulfilling the information obligations under section 7, a technical document means a document which contains technical requirements for a product and is not a technical regulation within the meaning of subsection (1) or a technical standard and which could create a technical barrier to trade.

§ 4 [Commentary WK] [DZ]

Czech technical standards

(1) A Czech technical standard is a document approved by the Office for Technical Standardization, Metrology and State Testing (hereinafter referred to as "the Office") for repeated or permanent use, created pursuant to this Act and marked with the letter designation CSN, the publication of which has been announced in the Bulletin of the Office. A Czech technical standard is not generally binding.

(2) The system of Czech technical standards consists of

a) original Czech technical standards,

(b) European or international standards adopted by translation; and

(3) The name Czech Technical Standard and the letter designation CSN may not be used to designate other documents.

(4) The Czech technical standard provides for general and repeated use rules, guidelines or characteristics of activities or their results aimed at achieving an optimal degree of organization in defined contexts.

§ 4a [Commentary WK]

Harmonised technical standards and designated standards

(1) A Czech technical standard becomes a harmonised Czech technical standard if it fully adopts the requirements set out in a European standard or harmonisation document recognised by the European Community authorities as a harmonised European standard or a European standard which has been established as a harmonised European standard in accordance with European Community law by a joint agreement of notified bodies (hereinafter referred to as "harmonised European standards"). For the specification of technical requirements for products resulting from a government regulation or other relevant technical regulation, the Office may, in agreement with the ministries and other central administrative authorities whose competence covers the relevant area, determine Czech technical standards, other technical standards or technical documents of international or foreign organisations, or other technical documents containing more detailed technical requirements (hereinafter referred to as "designated standards").

(2) The Office notifies in the Bulletin of the Office harmonised Czech technical standards, designated standards and their amendments or cancellations. It shall also indicate in the notification the technical regulation to which these standards relate.

(3) Compliance with a harmonised Czech technical standard, a designated standard or compliance with a foreign technical standard adopting a harmonised European standard in the Member States of the European Union, or compliance with parts thereof, shall be deemed, to the extent and under the conditions laid down in the technical regulation, to be compliance with the requirements laid down in the technical regulations to which these standards or parts thereof relate. If the European Community authorities in the case of harmonised European standards or the Office in the case of designated standards conclude that compliance with those standards or parts thereof can no longer be regarded as meeting the requirements of the technical regulations, the Office shall notify in the Bulletin of the Office those harmonised Czech technical standards or designated standards to which this fact applies.

(4) The Authority shall publish in the Bulletin of the Authority a reference to a European standard published under European Community law1b) by the Commission of the European Community in the Official Journal of the European Communities which meets the conditions of this Directive.

§ 5 [Commentary WK] [DZ]

Ensuring the creation of Czech technical standards

(1) The creation, issue and distribution of Czech technical standards, their changes and cancellation within the scope defined by this Act shall be guaranteed by the State. These tasks shall be carried out by the Office, which is the national standardisation body of the Czech Republic according to the directly applicable European Union regulation governing European standardisation9). In doing so, the Office shall fulfil the obligations arising from international treaties by which the Czech Republic is bound and from membership in international and European standardisation organisations.

(2) The Office may establish the Czech Agency for Standardization (hereinafter referred to as the "Agency") as a state contributory organization with its seat in Prague. The Agency shall be subordinate to the Office. The Agency shall be headed by a Director General, who shall be appointed and dismissed by the President of the Office. The Agency ensures the production, publication and distribution of Czech technical standards and maintains a database of Czech technical standards and other technical documents (hereinafter referred to as 'the database').

(3) The Agency shall be entitled to charge a fee for the professional activities it carries out. Such activities and the amount of the fee shall be set out in a price list to be issued by the Authority through the Gazette of the Authority. The Agency shall also administer the fee for the provision of Czech technical standards and other technical documents, the fee for access to the database and the fee for sponsored access to Czech technical standards and other technical documents. The budget of the Agency is a public budget for the purpose of administering these fees.

(4) The Agency shall come into existence on the date set out in its constitution. The establishment charter shall further contain the definition of the basic organisational structure, the definition of the property of the Czech Republic entrusted to the contributory organisation upon its establishment and other details concerning the subject matter of its activities. The establishment shall be announced by the Office in the Bulletin of the Office within 30 days from the date on which the said fact occurred.

(5) The Authority may decide to abolish the Agency. In the decision it shall set the date of its dissolution and at the same time determine the manner of settlement of the rights and obligations exercised by the contributory organisation; if this does not happen, the rights and obligations of the dissolved contributory organisation shall be transferred to the Office. The dissolution of the contributory organisation shall be announced by the Office in the Gazette of the Office within 30 days of the date on which that fact occurred.

(6) If the Agency is not established, the tasks set out in this Act shall be performed by the Office, with the exception of providing sponsored access to Czech technical standards and other technical documents.

(7) The costs for the development of Czech technical standards shall be borne by the person who requests their development. The costs of the development of Czech technical standards, especially Czech technical standards adopting European standards, developed on the basis of a request from ministries or other central administrative authorities, and the costs associated with membership in international and European standardisation organisations shall be borne by the State.

(8) Czech technical standards and other technical documents or parts thereof issued on any medium may be reproduced and distributed only with the consent of the Agency.

(9) For the purpose of issuing a decree to implement Sections 6a(4), 6b(4) and 6d(3), the Authority shall submit to the Ministry of Industry and Trade (hereinafter referred to as "the Ministry") a proposal for the rate of the fee under Section 6a and a proposal for the amount of the fee under Sections 6b and 6d.

§ 6 [Commentary WK] [DZ]

Conditions for the creation and publication of Czech technical standards

The following conditions must be ensured when creating and issuing Czech technical standards, their amendments and cancellations:

a) timely publication of notices of forthcoming drafts of Czech technical standards, their issue, amendments and cancellation in the Bulletin of the Office,

b) uniformity and mutual consistency of Czech technical standards and their compliance with legal regulations,

(d) the exercise of legitimate interest protection,

e) fulfilling obligations arising from international treaties to which the Czech Republic is bound, from membership in international and European standardisation organisations and from the use of the results of international cooperation,

(f) discussing the draft Czech technical standard, its amendment or repeal with anyone who, within the time limit set out in the published notice of the commencement of the drafting of the Czech technical standard or of the proposal to amend or repeal the Czech technical standard, applies to the person specified in that notice, or with anyone who sends his or her opinion on the published draft within the time limit set out in the notice of its publication,

(g) the withdrawal of a Czech technical standard which has been negotiated pursuant to point (f) if it does not comply with the conditions set out in points (b) to (d),

h) proper distribution of the issued Czech technical standards and their amendments within two weeks after the delivery of the order.

§ 6a

Fee for providing Czech technical standards and other technical documents

(1) The fee for the provision of Czech technical standards and other technical documents is payable by the applicant for the provision of a Czech technical standard or other technical document included in the database.

(2) The subject of the fee for the provision of Czech technical standards and other technical documents is the provision of a Czech technical standard or other technical document included in the database.

(3) The basis of the fee for the provision of Czech technical standards and other technical documents is the number of pages of the provided Czech technical standard or other technical document included in the database.

(4) The rate of the fee for the provision of Czech technical standards and other technical documents is not more than CZK 20 per page. The rate of the fee shall be determined by an implementing legal regulation.

(5) The fee for the provision of Czech technical standards and other technical documents is payable within 14 days from the date of submission of the request for the provision of the Czech technical standard or other technical document included in the database. If the fee payer fails to pay the fee on time and in the correct amount, the fee administrator shall not provide the Czech technical standard or other technical document and the fee obligation shall expire.

(6) The income from the fee for the provision of Czech technical standards and other technical documents is a revenue of the Agency's budget. If the fee is administered by the Office, the fee shall be a revenue of the State budget.

§ 6b

Fee for access to the database

(1) The fee payer for access to the database is the applicant for access rights to the database or the applicant for additional printing facilities.

(2) The subject of the fee for access to the database is

(a) granting non-printing access rights to the database for a maximum of 12 consecutive calendar months,

(b) the granting of access rights to the database with the possibility of printing for a maximum of 12 consecutive calendar months,

c) additional possibility of printing Czech technical standards and other technical documents from the database.

(3) The amount of the fee for access to the database shall not exceed

(a) CZK 10 000 in the case of the fee referred to in paragraph 2(a),

(b) the sum of CZK 10 000 and CZK 20 per page in the case of the fee referred to in paragraph 2(b),

(4) The amount of the fee for access to the database shall be determined by implementing legislation.

(5) The fee for access to the database is payable within 14 days of the date of the application. If the fee is not paid on time and in the correct amount, the fee administrator shall not grant access rights to the database or the additional printing option and the fee obligation shall cease.

(6) The income from the fee for access to the database shall be a revenue of the Agency's budget. If the fee is administered by the Office, the fee shall be revenue of the State budget.

§ 6c

Sponsored access to Czech technical standards and other technical documents

(1) Sponsored access to Czech technical standards and other technical documents means the free provision of access to a Czech technical standard or other technical document, which are binding for the purposes specified in a special legal regulation, to end users on the basis of registration in a manner allowing remote access.

(2) If a Czech technical standard or other technical document is binding for the purposes referred to in a special legal regulation, the Ministry or other central administrative authority within whose competence the special legal regulation falls shall provide the Agency with sponsored access to that Czech technical standard or other technical document.

(3) The Agency shall negotiate the provision of sponsored access to Czech technical standards and other technical documents with the ministry or other central administrative authority within whose competence the special legal regulation under subsection (1) falls in an agreement on sponsored access to Czech technical standards and other technical documents.

§ 6d

Fee for sponsored access to Czech technical standards and other technical documents

(1) The payer of the fee for sponsored access to Czech technical standards and other technical documents is the ministry or other central administrative authority providing sponsored access to Czech technical standards and other technical documents.

(2) The subject of the fee for sponsored access to Czech technical standards and other technical documents is the provision of sponsored access to Czech technical standards and other technical documents.

(3) The amount of the fee for sponsored access to Czech technical standards and other technical documents shall not exceed CZK 23,000,000 for 12 consecutive calendar months, based on the number of pages of the Czech technical standard or other technical document made available and the expected number of end users. The amount of the fee shall be set by the implementing legislation.

(4) The fee for sponsored access to Czech technical standards and other technical documents is payable within 30 days of the effective date of the agreement on sponsored access to Czech technical standards and other technical documents between the fee payer and the fee administrator. If the fee payer fails to pay the fee on time and in the correct amount, the fee administrator shall not allow sponsored access to Czech technical standards and other technical documents and the fee obligation shall expire.

(5) The income from the fee for sponsored access to Czech technical standards and other technical documents is a revenue of the Agency's budget.

§ 7 [Commentary WK] [DZ]

Information obligations

(1) Information on the draft and the draft technical regulation or technical document, their amendments or supplements, which are subject to information obligations towards the Member States of the European Union and the institutions of the European Community or information obligations arising from international treaties, shall be submitted to the Office by ministries, other central administrative authorities, the Czech National Bank, authorities of territorial self-government units, the Government if it comments on draft technical regulations of which it is not the proposer, and in the case of technical documents also by persons if they are authorised to issue them pursuant to a special legal regulation.

(2) The information obligations concerning Czech technical standards are ensured by the Office. The manner of their fulfilment shall be determined by the Government by regulation.

(3) A technical regulation or technical document may not be submitted for approval or approved before the expiry of the period for submission of comments set by the Government, provided that the period of suspension of work on the preparation of a technical regulation or technical document during which a decision on approval or on the preparation of a harmonised regulation of the European Communities is to be taken may be extended under conditions set by the Government.

(4) As an information point, the Office shall provide

(a) notification abroad of technical regulations or technical documents referred to in paragraph 1,

(b) informing about foreign draft technical regulations and technical documents and about foreign documents related to the provision of information procedures by publication in the Bulletin of the Office,

(c) informing the European Community authorities of the issue of technical regulations, in so far as they transpose European Community directives, and sending the texts of those technical regulations to the European Community authorities,

(d) methodological guidance on the uniform submission of information and its scope in accordance with the guidelines and procedures of the Commission of the European Community and international treaties.

(5) Only a technical standard that has been adopted in accordance with the procedures set out in the Government Regulation may be used as the basis for the content of a technical regulation.

(6) The Government may, by regulation, regulate the procedure, scope and details of the provision of information concerning technical regulations, technical documents and technical standards.

(7) The Authority shall notify the authorities of the European Community and, where appropriate, the competent authorities of the Member States of the European Union, in particular

a) opinions on the finding that a provision of a harmonised European standard does not comply with the essential requirements laid down in European Community regulations, or other facts concerning harmonised European standards or other documents and measures related to the application of European Community regulations,

(b) persons authorised pursuant to § 11 to carry out conformity assessment activities pursuant to government regulations transposing European Community law, amendments, suspension and revocation of such authorisation.

(8) The Ministry shall notify the authorities of the European Community or, where appropriate, the competent authorities of the Member States of the European Union of the decision of the supervisory authorities to impose a safeguard measure1c) on specified products (§ 12) with the justification defined in the Government Regulations. The Ministry shall forward the notification of the European Community authorities of safeguard measures applied in other Member States of the European Union to the supervisory authorities.

(9) The supervisory authorities shall notify the Ministry and the Office of the decision to impose a safeguard measure on specified products; this notification shall always include a statement of the grounds for the threat to the legitimate interest specified in the Government Regulations issued pursuant to Section 12(1)(e) for which the safeguard measure has been imposed.

§ 8 [DZ]

Cancelled

TITLE III

STATE TESTING

§ 9 [Commentary WK] [DZ]

Testing

State testing is a set of activities carried out by the Office and persons authorised under this Act, the aim of which is to ensure, for products specified under this Act, the assessment of their conformity with the technical requirements laid down by government regulations (hereinafter referred to as "conformity assessment") and, for construction products with CE marking, the assessment and verification of the stability of their properties in accordance with the directly applicable regulation for construction products.

§ 10 [Commentary WK] [DZ]

Certification

(1) Certification under this Act is an activity

(a) by an authorised person, carried out within the scope defined by the technical regulation, or

(b) by a person accredited to do so, carried out at the request of the manufacturer, importer or other person,

whereby the issuance of a certificate certifies that the product or the activities related to its manufacture or reuse, as the case may be, comply with the technical requirements set out in the certificate.

(2) Certificates issued by an authorised person shall be used in conformity assessment pursuant to Section 13(1), certificates issued by an accredited person may be used in conformity assessment pursuant to Section 13(1) only in cases where the manufacturer, importer or other person is authorised to assess conformity.

§ 11 [Commentary WK] [DZ]

Authorization

(1) For the purposes of this Act, authorisation shall mean the authorisation of a legal person to carry out conformity assessment activities for products, including the assessment of activities related to their manufacture or their reuse, as defined in the technical regulations (hereinafter referred to as "authorised person"). Authorisation for activities under this Act shall be granted by the Office by a decision within the defined scope on the basis of an application, which must be supported by evidence of compliance with the conditions of authorisation set out in this Act and Government Regulations. In the case of an application for authorisation for conformity assessment for products specified in a Government Regulation, the application shall include a description of the procedures and other conformity assessment activities. The Authority shall ensure that authorised persons follow a uniform procedure in their activities.

(2) The Office shall issue a decision on authorisation if the applicant for authorisation meets all the conditions for the proper provision of conformity assessment activities set out in the Government Regulation issued to implement the Act. If the Government Regulation does not provide for such conditions, the Office shall issue a decision on authorisation if the applicant for authorisation meets the necessary conditions, which are

(a) professional level in relation to the conformity assessment process,

(b) the absence of financial or other interests that could influence the results of the authorised person's activities,

(c) the provision of its own facilities for technical and administrative operations and accessibility to facilities for special assessments,

(d) the existence of the necessary number of staff with the necessary training, knowledge and skills,

(e) the existence of an obligation of confidentiality on the part of the employees concerning the facts of which they become aware in the course of the authorised person's activities.

The findings demonstrated during accreditation may be used in the decision on authorisation (§§ 14 to 16).

(3) The authorised person shall be obliged to conclude a contract of liability insurance immediately after delivery of the decision on authorisation.

(4) The Authority shall check whether authorised persons comply with the provisions of this Act and the Government Regulation. When requesting information and documentation to carry out an inspection, the Office or the persons invited by it may not request the provision of information and documents already received by the Office or the persons invited by it when carrying out previous inspections in connection with the authorisation, unless their content has been changed.

(5) If the authorised person fails to fulfil the obligations laid down in or on the basis of this Act, if the facts on the basis of which the decision on authorisation was issued change, if the need for the existence of the authorised person ceases to exist or if the authorised person so requests, the Office shall decide on

(a) suspension of the authorisation decision,

(b) an amendment to the authorisation decision; or

(6) In the decision to suspend the effectiveness of the authorisation decision pursuant to paragraph 5(a), the Office shall set a deadline for the remedy. If the authorised person remedies the situation, it shall notify the Office without undue delay. If the Office finds that the remedy is sufficient, it shall revoke the decision to suspend the authorisation decision. If the authorised person fails to remedy the situation within the time limit, the Office shall decide to amend or revoke the authorisation decision.

(7) Authorisations, their scope and changes shall be published by notice in the Bulletin of the Office.

(8) Authorised persons shall become notified persons by notification pursuant to Section 7(7)(b) or, in the cases provided for in the Government Regulation, by the expiry of a specified period after notification, unless the European Commission or other Member States of the European Union have objected to the notification within that period, and may carry out the activities of a notified person from the date of receipt of the notification by the Authority that they have been notified.

(9) If it results from an international treaty, foreign persons notified within the framework of this treaty may also perform the tasks of authorised persons, about which the Office shall publish information in the Bulletin of the Office specifying the scope of their activities in conformity assessment of products.

(10) Where the authorisation relates to activities pursuant to a directly applicable regulation of the European Union in the field of medical devices17), the provisions of paragraphs 1 to 9 shall apply unless otherwise provided for in that directly applicable regulation.

§ 11a [Commentary WK]

Authorised persons

(1) Authorised persons shall carry out activities within the scope defined in the authorisation decision.

(2) Authorised persons shall

(a) to conclude, on the basis of a proposal by the manufacturer or importer or any other person, a contract for the performance of acts in accordance with the established conformity assessment procedure, or to notify him within 20 days of the conditions for the performance of such acts,

(b) to be guided by the technical regulations when assessing conformity and to make technical determinations objectively and with due professional care at the level of knowledge of science and technology known at the time they are made,

1. to issue a certificate or other document if it has been demonstrated by the relevant conformity assessment procedure that the product complies with the technical requirements laid down in the relevant Government Regulation pursuant to Section 12(1)(b); the validity of this certificate or other document may be limited or suspended by the authorised persons,

2. to require the manufacturer to take appropriate corrective measures if the authorised person finds, during or after the conformity assessment, that the products do not comply with the technical requirements laid down in the relevant government regulation pursuant to Section 12(1)(b),

3. to provide copies of certificates or other documents, including related documents, and information on the issue, refusal, amendment or revocation of certificates or other documents to the Authority, the competent supervisory authority, notified bodies or other persons whose activities are covered by the said documents,

4. to inform the Authority of all requests from supervisory authorities concerning conformity assessment activities,

5. to inform the Authority on request of conformity assessment activities carried out by them and of any other activities carried out, including cross-border activities and subcontracting.

d) notify the Office without delay in cases where they cannot ensure compliance with the conditions set for the exercise of the authorisation,

(e) report immediately to the supervisory authority that the product may endanger or endanger a legitimate interest, if it becomes aware of this in the course of its activities.

(3) Authorised persons shall be entitled to revoke or amend a certificate or other document issued by them if it is shown that the circumstances under which it was issued have changed, in particular if it is found that the products do not meet the requirements of the technical regulations applicable to them, or to extend the validity of the certificate to the extent provided for in the relevant technical regulation, provided that the circumstances under which it was issued have not changed.

(4) Where an authorised person receives a complaint pursuant to section 18(3), he shall review the certificate or other document issued pursuant to section 11a(2)(c)(1) and report the result of the review to the supervisory authority.

§ 11b [Commentary WK]

title omitted

(1) A legal person whose authorization decision has been revoked or suspended by a final decision of the Office shall be obliged to

(a) inform all affected economic operators of the Authority's decision without undue delay,

(b) at the request of the economic operator affected by the consequences of this Decision, to transfer the rights and obligations related to the conformity assessment, including subsequent verification of the fulfilment of the conditions under which the certificate or other document was issued, to an authorised person designated by the economic operator, to hand over the related documentation, and to inform the Office of the transfer of rights and obligations, including the handing over of the documentation,

(c) ensure that the relevant documentation relating to the activities of the authorised person is made available to the Authority or the supervisory authority on request for the period of time specified by the Authority in this Decision.

(2) Certificates or other documents relating to conformity assessment, erroneously issued by an authorised person before the revocation of the decision on authorisation or suspension of its effectiveness, and not revoked by it, shall be revoked by the authorised person who has assumed the rights and obligations under paragraph (1)(b), or by the supervisory authority, if their erroneous issue is discovered during market surveillance.

(3) An authorised person who has taken over the rights and obligations under paragraph (1)(b) shall be entitled to use the documents from the transferring authorised person to complete the pending conformity assessment cases or to verify subsequently the fulfilment of the conditions under which the certificate or other document was issued.

(4) Where an authorised person intends to terminate or restrict its activities, it shall, before the authorisation decision is revoked or suspended, transfer its rights and obligations to another authorised person; paragraph (1)(b) shall apply mutatis mutandis.

(5) If a legal entity which is an authorised person is to be dissolved, it shall be obliged to submit the relevant documentation concerning the activities of the authorised person to the Office before the dissolution.

§ 11c [Commentary WK]

Technical assessment bodies

(1) The Ministry may entrust a legal person, upon its application, with the performance of the activities of a technical assessment body15), if it meets the requirements set out in the directly applicable regulation for construction products.

(2) The Ministry shall check whether the technical assessment body complies with the obligations and requirements set out in the directly applicable regulation for construction products. If the technical assessment body fails to comply with these obligations and requirements, the Ministry shall revoke its authorisation to perform the activities of the technical assessment body.

(3) The Ministry shall notify the European Commission and the Member States of the European Union in accordance with the directly applicable regulation for construction products of the name and registered office of the technical assessment body and the product groups for which the technical assessment body has been authorised, any change to these data, as well as the withdrawal of the authorisation. The Ministry shall also inform the European Commission of the national procedure for the designation of technical assessment bodies, the control of their activities and competence and any changes to this information.

§ 11d [Comment WK]

Notification of entities authorised to carry out the activities of a notified body in assessing and verifying the constancy of the properties of construction products with CE marking, the rights and obligations of these entities, their control and penalties for breach of their obligations, and the procedure for suspension, restriction or withdrawal of notification, including information obligations related to notification, are regulated by the Act on conformity assessment of specified products when they are placed on the market.

Conformity assessment

§ 12 [Commentary WK] [DZ]

title omitted

(1) The Government shall by regulations prescribe

(a) products which present a heightened degree of threat to a legitimate interest and for which conformity assessment must therefore be carried out (hereinafter referred to as "specified products"); ministries and other central administrative authorities may decide, exceptionally and in the public interest, for example to deal with the consequences of accidents or natural disasters, that for the duration of that public interest a particular product shall not be considered a specified product,

(b) technical requirements for specified products which these products must meet in order to be placed on the market or put into service, and amendments to the related provisions of decrees (technical regulations) issued by ministries and other central administrative authorities if a conflict with government regulations would arise,

(c) which of the specified products, and under what conditions, must or may bear a marking specified by Government Order when placed on the market or put into service (hereinafter referred to as "specified marking"),

(d) the definition of the range of persons or the identification of persons carrying out or participating in the conformity assessment,

(e) the reasons for the threat to a legitimate interest which shall be notified in accordance with Article 7(8) when protective measures1a) are imposed on specified products,

(f) a transitional period during which specified products not complying with the technical requirements laid down under point (b) may be placed on the market or put into service, provided that they comply with the legislation of a Member State of the European Union,

(g) the content of information on safeguard measures communicated to the European Community authorities or, where appropriate, to other persons within the scope of European Community law on conformity assessment,

(h) such other details as may be necessary to transpose European Community legislation on conformity assessment.

(2) Products which are placed on the market as used or reconditioned shall always be considered as specified products under paragraph (1).

(3) The Government shall regulate by regulation, for individual groups of specified products, depending on their technical complexity and the degree of potential danger associated with their use, the conditions for placing products on the market, or putting them into service, or for their re-use, including the procedures and tasks to be fulfilled during conformity assessment (hereinafter referred to as "conformity assessment procedures"), by specifying or combining individual conformity assessment procedures. The individual conformity assessment procedures are in particular

(a) conformity assessment under specified conditions by the manufacturer or importer,

(b) conformity assessment of the sample (prototype) of the product by an authorised person,

(c) conformity assessment, whereby the authorised person tests the specific characteristics of products and randomly checks compliance with the specified requirements for products,

(d) assessment of the production quality system or quality system elements in the undertaking by an authorised person and surveillance of its proper functioning,

(e) assessment of the product quality system or elements of the quality system in the undertaking by an authorised person and surveillance of its proper functioning,

(f) verification of conformity of products with the certified product type or with the specified requirements, carried out by the manufacturer, importer, accredited or authorised person on each product or on a statistically selected sample,

(g) verification of the conformity of each product with the specified requirements by an authorised person,

(h) supervision of the proper functioning of the quality system in the undertaking by an authorised person and, where necessary, verification of the conformity of the product with the requirements of the technical regulations at the design stage,

(i) assessment of activities related to the manufacture of products,

(j) other conformity assessment procedures, if necessary, including, where appropriate, the activities of an accredited or other person.

(4) If the Government Regulations adopt the regulations of the European Communities and the conformity assessment procedures referred to in paragraph 3 provide for the participation of an authorised person, this activity shall be carried out by notified persons or persons whose authorisation for conformity assessment activities results from an international treaty to which the Czech Republic is bound.

(5) The costs associated with the activities of an authorised person in conformity assessment shall be borne by the person who has requested such activities. The price for these activities shall be negotiated in accordance with a special regulation.2)

(6) The Government shall determine by regulation the graphic form of the marking of the specified product, its design and placement on the product or in the accompanying documentation, unless the graphic form of the marking of the specified product is determined by a directly applicable regulation of the European Communities.

§ 13 [Commentary WK] [DZ]

title omitted

(1) A specified product may be placed on the market or, in the case of products specified by government regulation, put into service only if it meets the technical requirements laid down under section 12(1)(b), following an assessment of conformity in accordance with the procedure laid down under section 12(3), and if the conditions referred to in paragraph (2) are met. Where, before placing a specified product on the market, the importer considers or has reason to believe that the product does not comply with the technical requirements laid down pursuant to Article 12(1)(b) and, in addition, poses a risk to health, he shall, in the case of products specified in a Government Regulation, inform the competent supervisory authority and the manufacturer thereof.

(2) A specified product, if it is to be placed on the market or put into service, must or may, to the extent and under the conditions laid down by Government Regulation, bear the specified marking, other markings and, if so provided by Government Regulation, be issued with or accompanied by an EC declaration of conformity or other document.

(3) The CE marking on a specified product shall indicate that the product complies with the technical requirements set out in any Government Regulations which apply to it and which provide for or allow such marking, and that the prescribed procedure has been followed in assessing its conformity.

(4) The Czech mark of conformity, which consists of the letters CCZ, may be used only for products not covered by the regulations of the European Communities. This mark expresses that the product meets the technical requirements laid down in all the government regulations which apply to it and which provide for or allow this marking, and that the established procedure has been followed in assessing its conformity.

(5) If a specified product bears the CE marking, it may not be simultaneously marked with the Czech conformity marking or with a mark which, by its meaning or appearance, could lead to confusion with the CE marking or with another specified marking.

(6) Where the Government so provides by regulation, the manufacturer or importer or other person specified by Government regulation shall, on request, provide copies of certificates or other documents including related documents to the Authority or to authorised persons or specified foreign persons, as the case may be.

(7) Evidence of conformity assessment to the extent specified by government regulations shall be provided by the manufacturer or importer to the supervisory authority upon request within 10 years of the end of production, import or placing on the market. This period may be determined by a government regulation by way of derogation.

(8) The obligations of the manufacturer or importer referred to in § 13, the details of which are set out in the Government Regulation, may also be performed by an authorised representative to the extent set out in the Government Regulation.

(9) A distributor shall act to prevent the distribution of specified products that do not clearly meet the requirements of the Act, in particular products that do not bear the specified markings and other markings. In the case of products specified by Government Regulation, a distributor shall not supply to the market a specified product which he believes or has reason to believe does not meet the technical requirements laid down under section 12(1)(b). In addition, if the specified product poses a risk to health, the distributor shall inform the competent supervisory authority, the manufacturer and the importer.

(10) The manufacturer or importer shall, in respect of products specified by Government regulation and having regard to their nature and the risks posed by those products, take measures to protect the health and safety of persons.

(11) A manufacturer, importer or distributor who believes or has reason to believe that a specified product which he has placed or supplied on the market does not comply with the requirements of this Act or a Government Regulation issued in implementation thereof shall, in the case of products specified in the Government Regulation, take the necessary measures to bring the product into compliance with those requirements, to withdraw the product from the market or to return the specified product which has already been supplied to the user; if, in addition, the specified product poses a health hazard, the manufacturer, importer or distributor shall immediately inform the competent supervisory authority thereof.

(12) The manufacturer, importer, distributor or authorised representative shall keep, in respect of products specified in a Government Regulation, the data necessary to identify all economic operators who have handed over a specified product to him and to whom he has handed over a specified product.

(13) An importer or distributor shall ensure, in respect of products specified by Government Order, storage and transport conditions which do not jeopardise the compliance of the specified product which he intends to place or supply on the market with the requirements of this Act.

(14) If a product meets the conditions set out in Sections 12 and 13, it may not be prevented from being placed on the market or put into service, unless a special legal regulation provides otherwise for important reasons of protection of a legitimate interest. This is without prejudice to the provisions of special legislation.2a)

(15) Paragraphs (1) to (14) shall not apply to construction products bearing the CE marking, the placing and making available on the market of which is regulated by a directly applicable regulation for construction products.

§ 13a

Cancelled

§ 13b [Commentary WK]

Where a Government Regulation lays down requirements pursuant to Sections 12 and 13 which do not take over the requirements laid down in the relevant provisions of the European Communities, those requirements shall not apply to products which have been manufactured and/or placed on the market in a Member State of the European Union or in Turkey or which originate in a State of the European Free Trade Association which is also a contracting party to the European Economic Area, provided that such product complies with

(a) the technical regulations which are binding for the manufacture or placing on the market or use of the product in any of those States,

(b) technical standards or rules of good practice issued by a national standardisation body or its equivalent, in accordance with the legislation and requirements of a State which is a Contracting Party to the European Economic Area,

(d) traditional or innovative manufacturing processes used in one of these States in accordance with its legislation for which there is sufficiently detailed technical documentation to ensure that the product can be assessed for the intended use, if necessary on the basis of additional (not identical) product tests,

if these technical regulations, technical standards, rules of good practice or procedures guarantee a level of protection of the legitimate interest corresponding to the level of such protection in the Czech Republic.

§ 13c [Commentary WK]

If a CE-marked construction product is placed or supplied on the market in the Czech Republic, the declaration of performance provided with the product and the instructions and safety information accompanying the product must be in the Czech language.

TITLE IV

ACCREDITATION OF CONFORMITY ASSESSMENT BODIES

§ 14 [Commentary WK] [DZ]

Accreditation

The exercise of the competence, which results for the Czech Republic from the regulations of the European Communities1a) in the field of accreditation, is ensured and carried out by the Ministry.

§ 15 [Commentary WK] [DZ]

Accreditation body

(1) The Ministry may, by a decision, entrust only one legal entity (hereinafter referred to as the "accreditation body") to perform the activities of an accreditation body1a).

(2) The Ministry shall decide on the authorisation to carry out accreditation on the basis of an application from a legal entity. In the decision, the Ministry shall define the scope of the accreditation. In doing so, it shall assess whether the legal entity will be able to fulfil the requirements for an accreditation body laid down in a directly applicable regulation of the European Communities1a).

(3) If the accreditation body fails to fulfil its obligations or ceases to meet the requirements laid down in a directly applicable regulation of the European Community1a) or in the decision on authorisation, or if the Ministry itself so requests, it shall amend or revoke the decision on authorisation.

(4) The Ministry shall publish the decision on the authorisation to carry out accreditation and the decision on the amendment or revocation of this decision in the form of a notice in the Collection of Laws.

(5) The Ministry is the superior administrative body of the accreditation body.

§ 16 [Commentary WK] [DZ]

Grant of accreditation

(1) The accreditation body shall decide on the granting of accreditation at the request of the conformity assessment body. The granting of accreditation and the existence of the right to act as an accredited conformity assessment body within the scope of the granted accreditation shall be evidenced by an accreditation certificate (hereinafter referred to as "certificate").

(2) The application shall, in addition to the general particulars of the submission, include the scope of the conformity assessment activities for which accreditation is to be granted (hereinafter referred to as the "scope of accreditation"). The accreditation body may request additional information or documents if necessary to assess the requested scope of accreditation.

(3) The accreditation body shall grant accreditation to a conformity assessment body which demonstrates that it meets the requirements for carrying out a specific conformity assessment activity set out in harmonised standards or other documents applicable to the field of conformity assessment (hereinafter referred to as "accreditation requirements"). When assessing an application, the accreditation body shall also take into account previous accreditations granted to the same conformity assessment body. If the conformity assessment body does not meet the accreditation requirements, the accreditation body shall reject the application for accreditation by decision. If this cannot be done without delay, the accreditation body shall decide on the application within 120 days of the initiation of the procedure. In particularly complex cases, this time limit may be extended by a further 90 days.

(4) The conformity assessment body shall be obliged to reimburse the accreditation body for the costs actually incurred in connection with the accreditation, even in advance. If the conformity assessment body fails to pay the advance payment within the time limit set by the accreditation body, the accreditation body shall terminate the procedure.

(5) The certificate shall contain the designation of the accreditation body and the conformity assessment body, a definition of the scope of the accreditation granted, a list of harmonised standards or other documents used in the assessment of the application for accreditation, and the period of validity of the accreditation. The certificate shall also contain the certificate number, the date of issue, the official stamp, the name, surname, function and signature of the authorised official. The certificate may also be issued in a foreign language on request. The notification of the granting of accreditation shall be published in the Bulletin of the Office. The accreditation body shall also publish information on the granting of accreditation in a manner allowing remote access.

(6) The accreditation body shall subsequently verify with the conformity assessment body, at its expense, the fulfilment of the accreditation requirements. If the accreditation body finds that the conformity assessment body does not comply with the accreditation requirements on the basis of which it was granted accreditation, it shall decide to suspend the accreditation and set a time limit for remedial action. If the conformity assessment body fails to remedy the situation within the time limit, the accreditation body shall decide to limit the scope of the accreditation or to withdraw it. Where the accreditation body decides to limit the scope of accreditation, it shall issue a corresponding certificate to the conformity assessment body replacing the certificate previously issued. The fourth and fifth sentences of paragraph 5 shall apply mutatis mutandis to decisions to suspend or revoke accreditation.

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

a) extension of the scope of accreditation,

(b) limitation of the scope of accreditation,

c) extension of the validity of the accreditation granted,

(d) the merger of valid certificates issued for the same conformity assessment body,

(e) suspension of accreditation,

(f) revocation of accreditation, or

(g) revocation of the decision to suspend accreditation.

Paragraphs 1 to 5 shall apply mutatis mutandis to applications under points (a) to (d) and (g); new certificates shall replace certificates previously issued. An application under point (c) shall be submitted at least 120 days before the expiry of the accreditation granted. In the procedures referred to in point (d), the accreditation body shall use the basis of the decision on the application for accreditation. Unless the accreditation body determines that the effects of the new decision granting the request under points (a) to (f) shall take effect at another time, the legal force of the decision shall preclude the effects of the previous decisions. At the request of the conformity assessment body, the accreditation body shall record any other changes to the information on file and issue a new certificate.

(8) The appeal against the decision of the accreditation body shall be decided by its statutory body. The appeal shall not have suspensive effect. A proposal for a decision on the appeal shall be submitted to the statutory body by a committee set up for that purpose. This committee shall have at least 5 members. The chairman and the other members of the committee shall be appointed by the statutory body. The members of the committee shall be experts who are not otherwise involved in the exercise of the accreditation body's competence.

(9) If an accreditation body receives a complaint about the activities of a conformity assessment body to which it has issued a certificate, it shall investigate the complaint and report to the complainant on the outcome of the investigation within 60 days from the date of receipt of the complaint. Where the complaint has been found to be justified, the accreditation body shall immediately take the necessary remedial measures in accordance with paragraph 6. In this case, the conformity assessment body shall reimburse the accreditation body for the actual costs incurred in investigating the complaint.

§ 17 [Commentary WK] [DZ]

Public Accreditation Agreement

The accreditation body may conclude a public contract with the conformity assessment body on granting accreditation, on extending the scope of accreditation, on limiting the scope of accreditation, on extending the validity of the granted accreditation or on merging valid certificates issued for the same conformity assessment body. The public law contract shall replace the application procedure under Article 16(1) or 16(7)(a), (b), (c) or (d). The second sentence of Article 16(1), the second sentence of Article 16(3), the first sentence of Article 16(4) and Article 16(5), (6) and (9) shall apply mutatis mutandis to public contracts. A proposal for the conclusion of a public contract for the extension of the validity of the accreditation granted shall be submitted by the body at the latest 120 days before the expiry of the validity of the accreditation granted.

TITLE V

COMMON AND TRANSITIONAL PROVISIONS

§ 18 [Commentary WK] [DZ]

Surveillance

(1) Supervision of whether specified products are placed and supplied on the market or put into service in accordance with the requirements laid down in this Act, whether construction products bearing the CE marking are placed and supplied on the market in accordance with the directly applicable regulation for construction products, whether economic operators fulfil their obligations laid down in this Act and the directly applicable regulation for construction products, and that products are not unlawfully affixed with the CE marking in accordance with the directly applicable regulation of the European Communities1a), or with other markings established pursuant to this Act, is carried out by the Czech Trade Inspection Authority4), or to the extent provided for by special legislation

a) The Czech Mining Authority4a),

(b) The Railway Authority4b),

(hereinafter referred to as "supervisory authorities").

(2) The supervisory authorities may

(a) carry out analyses or arrange for analyses to be carried out to verify whether the products meet the requirements of this Act or a directly applicable regulation for construction products; the carrying out of such analyses shall be arranged with the competent authorities or persons; where the analysis has established that the product does not meet the requirements of this Act or a directly applicable regulation for construction products, the costs of carrying out the analysis shall be borne by the person inspected,

(b) require the persons inspected to remedy the deficiencies, their causes and harmful consequences within a specified period of time or to take the necessary remedial measures to remedy them without delay,

(c) impose an obligation on persons under inspection to inform without delay persons who may be exposed to the danger arising from the product.

(3) The supervisory authority may, where it has reasonable doubt that a specified product does not meet the technical requirements laid down in the relevant Government Regulation pursuant to Section 12(1)(b), require from the authorised person information and documents relating to the conformity assessment of that product, including the certificate issued pursuant to Section 11a(2)(c)(1), technical documentation and test reports. In addition, the supervisory authority may instruct the notified body to review the certificate issued pursuant to point (c)(1) of Article 11a(2). At the same time, it may order the withdrawal of the certificate issued pursuant to point (1) of Section 11a(2)(c).

(4) Where the supervisory authority has reasonable doubt that a construction product bearing the CE marking does not meet the requirements laid down in a directly applicable regulation for construction products, it may request from the relevant notified body information and documents relating to the assessment and verification of the stability of the characteristics of that product, including the certificate issued, technical documentation and test reports. Where a surveillance authority finds that a construction product bearing the CE marking does not comply with the requirements referred to in paragraph 1, it shall inform the notified body which has been involved in the assessment and verification of the stability of the characteristics of that product.

(5) Where the directly applicable regulation for construction products refers to a competent national authority16), this authority in the Czech Republic is the supervisory authority.

§ 18a [Commentary WK]

Protective measures

(1) Where the supervisory authority has reasonable suspicion that a product does not comply with the requirements of this Act or a directly applicable regulation for construction products, it shall prohibit the placing on the market, putting into service or distribution of the product or a series of the product for the period necessary to carry out the inspection.

(2) The supervisory authority shall verbally notify the inspected person of the imposition of the measure referred to in paragraph (1) and shall immediately make a written record thereof. If the supervised person disagrees with the measure imposed, he or she may lodge objections to it, which shall be stated in the record, or may lodge them in writing within 10 days of the date on which the supervised person was informed of the record. The supervisory authority shall decide on the objections lodged without delay. A written copy of the decision on the objections shall be delivered to the inspected person. No appeal shall be admissible against the decision on objections.

(3) If the supervisory authority finds that a product does not comply with the requirements of this Act or a directly applicable regulation for construction products, or that it is a product which has been unlawfully affixed with the CE marking or other marking provided for under this Act or a directly applicable regulation for construction products, it shall decide to prohibit the placing on the market, putting into service or distribution of such a product. If the grounds for imposing the prohibition cease to exist, the supervisory authority shall decide on its amendment or revocation. An appeal against a decision under the first sentence shall not have suspensive effect.

(4) Where the supervisory authority finds that a product or a batch of products poses a threat to a legitimate interest, the supervisory authority shall decide to withdraw the product or batch of products from the market or from circulation. The supervisory authority may at the same time, if necessary, order the destruction of the product or batch of product or order another form of destruction. An appeal against a decision under the first sentence shall not have suspensive effect.

(5) In the case of imposing a measure pursuant to paragraph 3 or 4, the supervisory authority shall always state in the grounds for the decision also the specific reasons for imposing the measure, which are defined for the specified product by a government regulation.

§ 18b [Commentary WK]

Notification obligation

(1) The supervisory authorities shall be obliged to notify the Ministry of measures taken in respect of a product or a series of products in cases where the product presents a serious risk4e). This shall also apply in the case of a measure taken by the supervised person on his own initiative and the supervisory authority receives information about this measure.

(2) The information provided to the Ministry shall include all available details, in particular the data necessary to identify the product, its origin, the supply chain, the threat posed by the product, the nature and duration of the measure taken by the supervisory authority and, where appropriate, information on voluntary action taken by the supervised person.

(3) If the threat referred to in paragraph (1) exceeds the territory of the Czech Republic, the Ministry shall immediately inform the Commission of the European Communities of the presence of such a product.

(4) If the Ministry receives information from the Commission of the European Communities about the adoption of measures in respect of a product or a series of products posing a serious risk, it shall forward this information without undue delay to the supervisory authorities for further action.

(5) In order to ensure the functioning of the information exchange system referred to in paragraphs 1 to 3, the special legislation regulating the procedures, content and form of information on the occurrence of dangerous non-food products4f) shall apply mutatis mutandis.

(6) Employees of the relevant ministries and supervisory authorities shall be obliged to maintain the confidentiality of information relating to products and obtained within the scope of their competence, except for information that must be disclosed in the interest of protecting the health and safety of consumers and in order to ensure effective market control and the activities of supervisory authorities.

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

§ 18c [Commentary WK]

Provision of information on CE-marked construction products

(1) Where the supervisory authority finds that a construction product bearing the CE marking does not comply with the requirements laid down in a directly applicable regulation for construction products, or that this product poses a threat to a legitimate interest, and the non-compliance may also threaten the legitimate interests of entities in the Member States of the European Union, it shall inform the European Commission and the competent authorities of the Member States of the European Union.

(2) Where the supervisory authority takes measures in respect of a construction product bearing the CE marking pursuant to Section 18(3) or (4), it shall immediately inform the European Commission and the competent authorities of the Member States of the European Union thereof.

(3) The scope of the information to be provided pursuant to paragraphs 1 and 2 shall be determined by the directly applicable regulation for construction products.

(4) Where the supervisory authority receives a notification from the European Commission or a competent authority of a Member State of the European Union concerning the adoption of measures in respect of a construction product bearing the CE marking, it shall immediately forward the notification to the Ministry. Together with the notification, the supervisory authority shall provide the Ministry with all information in its possession concerning the non-compliance of the product with the requirements laid down in the directly applicable regulation for construction products and shall inform the Ministry of any measures it has already taken in respect of the product. The Ministry shall provide this information, together with any objections to measures taken by the competent authorities of other Member States of the European Union, without delay to the European Commission and to the competent authorities of the Member States of the European Union.

Offences

§ 19 [Commentary WK] [DZ]

Offences by natural persons

(1) A natural person commits an offence by

(a) misuses the CE marking or any other prescribed marking, certificate or other document pursuant to this Act or directly applicable regulation for construction products, or falsifies or alters the certificate or other document pursuant to this Act or directly applicable regulation for construction products,

(b) marks a document with a CSN mark in contravention of Section 4(3), or

(2) A fine of up to CZK 20,000,000 may be imposed for an offence under subsection (1)(a) and a fine of up to CZK 1,000,000 for an offence under subsection (1)(b) or (c).

§ 19a [Commentary WK]

Offences by legal entities and natural persons engaged in business

(1) A legal or natural person commits an offence by

(b) in contravention of section 4(3), marks a document with a CSN mark,

(d) carries out a conformity assessment activity reserved for the purposes of this Act to an authorised person without authorisation under section 11(1),

(e) acts as an accredited conformity assessment body without accreditation or outside the scope of accreditation, in breach of Section 16(1),

(f) fails to comply with any of the protective measures issued pursuant to Article 18a(1), (3) or (4); or

(g) fails to comply with any of the obligations imposed by the supervisory authority under Article 18(2)(b) or (c).

(2) An authorised person commits an offence by failing to comply with any of the obligations under section 11a(2) or 11b(1) or (4).

(3) A manufacturer, importer, authorised representative or distributor commits an offence by placing on the market or putting into service or distributing specified products

(a) without the CE marking or any other prescribed marking or document laid down by government regulation; or

(b) with a marking or document which contravenes Section 13.

(4) A legal person or a natural person engaged in business commits an offence by

(a) the importer fails to comply with the obligation referred to in the second sentence of Section 13(1),

(b) the distributor fails to fulfil any of the obligations referred to in Article 13(9),

(d) the manufacturer, importer or distributor fails to comply with any of the obligations referred to in Article 13(11),

(e) the manufacturer, importer, distributor or authorised representative fails to comply with the obligation referred to in Article 13(12); or

(f) the importer or distributor fails to comply with the obligation referred to in Article 13(13).

(5) A legal person or a natural person engaged in business commits an offence by

(a) the manufacturer, importer or authorised representative under the directly applicable Construction Products Regulation fails to fulfil any of the obligations under the directly applicable Construction Products Regulation; or

(b) the distributor fails to fulfil any of the obligations under the directly applicable Construction Products Regulation.

(6) The offence is punishable by a fine not exceeding

(a) CZK 50 000 000 if the offence is an offence under paragraph 1(f) or (g) or paragraph 1(f) or (g) or paragraph 3,

(b) CZK 20 000 000 if the offence is an offence under paragraph 1(a), (d) or (e),

(d) CZK 500 000 if the offence is an offence under paragraph 4 or 5.

§ 19b [Commentary WK]

Common provisions on offences

(1) Offences under section 19(1)(b) and (c), section 19a(1)(b) to (e) and section 19a(2) shall be dealt with by the Office. Offences under Section 19(1)(a), Section 19a(1)(a), (f) and (g) and Section 19a(3) to (5) shall be dealt with by the supervisory authority.

(2) Fines shall be collected by the authority which imposed them.

(3) The imposition of an administrative penalty may not be waived for offences under section 19a(1)(f) and (g) and section 19a(3).

§ 19c

Bulletin of the Office

The Office publishes the Bulletin of the Office, which is a collection of publications in the field of technical standardization, metrology and state testing. The Bulletin of the Office publishes, in particular, important notices concerning the development and issue of Czech technical standards and other technical documents, notices concerning notified bodies in the field of state testing, notices concerning authorised bodies in the field of metrology and the Agency's price list. The Office publishes the Bulletin of the Office in a manner allowing remote access.

§ 20 [Commentary WK] [DZ]

Management

The administrative authority shall decide on the authorisation procedure within 120 days of the initiation of the procedure. In exceptional cases, the authorisation procedure may be extended by the Ministry for a further 60 days.

§ 20a [Commentary WK]

Persons who are involved in activities under Title III or Title IV of this Act shall be obliged to maintain confidentiality within the meaning of special legal regulations8) of the facts of which they have become aware in the course of such activities and the disclosure of which could endanger the interests of other persons.

§ 20b [Commentary WK]

The provisions of the Act that relate to relations with the Member States of the European Union also apply to relations with the countries of the European Free Trade Association that are also contracting parties to the European Economic Area.

§ 21 [Commentary WK] [DZ]

Transitional provisions

(1) Specified products placed on the market before the entry into force of a Government Regulation issued pursuant to section 12(1) shall be subject to the provisions in force at the time of their placing on the market, unless the legislation expressly provides otherwise.

(2) Existing technical standards designated as CSNs and in force on the date of entry into force of this Act shall be deemed to be standards under this Act.

(3) Until 31 December 1999, legal or natural persons authorised to engage in business activities and administrative authorities shall be obliged to comply with those provisions of the standards which are designated as binding pursuant to Section 3 of Act No 142/1991 Coll., as amended by Act No 632/1992 Coll.

(4) Proceedings initiated pursuant to Section 29 of Act No. 30/1968 Coll., on State Testing, as amended, shall be completed in accordance with the existing regulations.
(5) Authorizations granted under the previous regulations on state testing shall be considered as authorizations under this Act for a maximum period of two years from the effective date of this Act.

(6) Proceedings for the approval and certification of products initiated before the entry into force of this Act shall be discontinued on the date of entry into force of this Act, unless the manufacturer or importer and the State Testing Service agree otherwise by that date. Where a Government Regulation issued pursuant to this Act provides for conformity assessment with the participation of an authorized person, the authorized person shall assess the conformity of the relevant product according to the conformity assessment procedure established by the relevant Government Regulation without an application, using the findings to date. In other cases, the State Examination Body shall forward the results of the findings to the applicant.

(7) Decisions on approval of products or on certification of products issued under the previous regulations on state testing shall be considered as certificates of conformity within the meaning of this Act for the period of their validity and may be used as a basis for a declaration of conformity under section 13(2) of this Act. The validity of these decisions shall expire on expiry of the period specified therein. If no period of validity is indicated in these decisions, they shall expire five years after the entry into force of this Act.

(8) Certificates of accreditation issued prior to the entry into force of this Act by the Czech Institute for Accreditation shall remain valid for the period of time specified therein, unless revoked pursuant to this Act.

§ 22 [Commentary WK] [DZ]

Empowerment

(1) The Government shall make regulations to implement sections 2(b), (c), (d), 3(2), 7, 11(1), (2) and (9), 11a(2), 12, 13 and 18(3).

(2) The Ministry shall issue a decree to implement sections 6a(4), 6b(4) and 6d(3).

PART TWO

AMENDMENT AND SUPPLEMENTATION OF CERTAIN LAWS

TITLE I

AMENDMENT AND SUPPLEMENT TO ACT OF THE CZECH NATIONAL COUNCIL NO. 64/1986 COLL., ON THE CZECH TRADE INSPECTION, AS AMENDED BY ACT OF THE CZECH NATIONAL COUNCIL NO. 240/1992 COLL.

§ 23 [DZ]

Act of the Czech National Council No. 64/1986 Coll., on the Czech Trade Inspection, as amended by Act of the Czech National Council No. 240/1992 Coll., is amended as follows:

1. in Section 2(2)(f), the full stop shall be replaced by a comma at the end and the following point (g) shall be added, including Note 1a):

'(g) whether a declaration of conformity has been issued for the specified products placed on the market, and whether the characteristics of the specified products placed on the market and the particulars of the conformity assessment comply with the specified conditions of the declaration of conformity issued.1a)

1a) Act No. 22/1997 Coll., on technical requirements for products and on amendment and supplementation of certain acts.".

2. In footnote (1), the words:

"Act No. 142/1991 Coll., on Czechoslovak Technical Standards".

3. Section 4(1)(d) reads as follows:

'(d) take, for compensation, from the persons inspected the necessary samples of products or goods to assess the quality and safety of those products or goods. For the samples of products or goods taken, the inspected person shall be compensated at the price at which the product or goods are offered at the time the sample is taken. The refund shall not be granted if the person inspected waives it. No entitlement to reimbursement shall arise in respect of a product or goods which does not meet the requirements laid down in the special provisions,'.

4. In Section 4(1)(e), the full stop is replaced by a comma at the end and the following point (f) is added, including Note 1(b):

'(f) enter the premises of the manufacturer, importer or distributor and require the production of relevant documentation and the provision of truthful information. The manufacturer, importer or distributor may be requested by the inspector to provide and submit expert opinions on the subject matter of the surveillance by an authorised person, or the inspector may invite an authorised person to participate in the surveillance for a fee. The price for the performance of the authorised person shall be negotiated in accordance with a special regulation.1b)

1b) Act No. 526/1990 Coll., on prices, as amended by Act No. 135/1994 Coll.

5. After § 7, the following § 7a is inserted:

"§ 7a

(1) The Director of the Inspectorate is authorised to impose by decision on the manufacturer, importer or distributor a protective measure, which is

(a) suspending the placing on the market of a product or parts thereof for a specified period of time where there is a suspected risk of serious danger to the health or safety of persons, property or the natural environment (hereinafter referred to as "legitimate interest"),

(b) a prohibition on the placing on the market of the product or production batches thereof or a decision to withdraw such products from the market or, where appropriate, from use, where the products are demonstrably liable to endanger a legitimate interest,

(c) establishing an obligation to inform persons who may be exposed to the danger arising from the product of the danger in an effective manner without delay, in cases where a safeguard measure has been imposed pursuant to point (a) or point (b).

(2) An appeal against a decision on a protective measure shall not have suspensive effect.

(3) The costs associated with the implementation of protective measures shall be borne by the person who placed the products threatening the legitimate interest on the market.

(4) Where inspectors find that the manufacturer, importer or distributor has failed to fulfil its obligations, the manufacturer, importer or distributor shall bear the costs associated with the supervision and the activities of the authorised persons.".

6. In Section 17(1), the words "fine or orderly penalty" shall be replaced by "fine, orderly penalty or protective measure".

TITLE II

AMENDMENT TO LAW No. 20/1993 SB., OF THE CZECH NATIONAL COUNCIL, ON SECURING THE PERFORMANCE OF STATE ADMINISTRATION IN THE FIELD OF TECHNICAL NORMALIZATION, METROLOGY AND STATE EXPERIENCE

§ 24 [DZ]

Act No. 20/1993 Coll., of the Czech National Council, on ensuring the performance of state administration in the field of technical standardisation, metrology and state testing, is amended as follows:

1. in Section 2, point (d) is deleted, in point (c) the comma is replaced by a full stop.

2. Part Two reads:

"PART TWO

Competence of state administration bodies in the field of technical standardisation, metrology and state testing

§ 3

Ministry of Technical Standardisation, Metrology and State Testing

(a) draw up a proposal for the development of the sector,

b) shall be managed by the Office and the Czech Metrology Institute,

§ 4

Office for Technical Standardisation, Metrology and State Testing

a) manage and ensure metrology to the extent provided by law3) to the Federal Office for Standardization and Measurement,

(b) ensure the uniformity and accuracy of established measuring instruments and measurements and the performance of state metrology to the extent provided for by law,3)

d) ensure the organisation of the preparation of the adoption of the European Community technical regulations adopted by the Government Regulations,

e) contractually secures tasks arising from international treaties by which the Czech Republic is bound and tasks arising from the requirements of ministries and other central administrative authorities.

§ 5

The Czech Metrology Institute ensures the professional and executive activities of state metrology within the scope provided by law to the Czechoslovak Metrology Institute and the State Metrology Inspectorate.9)

2) Act No. 71/1967 Coll., on Administrative Proceedings (Administrative Procedure Code).

3) Act No. 505/1990 Coll., on Metrology.

7) Section 4(1) of Act No. 505/1990 Coll.

9) Sections 14 and 15 of Act No 505/1990 Coll.

3. Notes 4), 5), 6), 8) and 10) are deleted.

4. Note 11) reads as follows: '11) Section 13(2)(c), Section 16, 20 and 21 of Act No 505/1990 Coll.'.

PART THREE

FINAL PROVISIONS

§ 25 [DZ]

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. Act No. 142/1991 Coll., on Czechoslovak Technical Standards, as amended by Act No. 632/1992 Coll. 3. Decree No. 104/1984 Coll. of the Office for Standardisation and Measurement on the verification of weapons and control of ammunition for civil use. 4. Decree of the Office for Standardisation and Measurement No 101/1988 Coll., on product certification, as amended by Decree No 233/1993 Coll.

§ 26 [DZ]

Efficiency

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

Zeman v. r.

Havel v. r.

Klaus v. r.

Selected provisions of the amendments

Article II of Act 490/2009 Coll.

Transitional provisions

1. The accrediting body authorised to carry out accreditation of conformity assessment bodies under the existing legal regulations shall be deemed to be an accreditation body under Act No. 22/1997 Coll., as in force from the date of entry into force of this Act, until a new decision on the authorisation of the accreditation body is issued, but for no longer than 2 years from the date of entry into force of this Act.

2. The accrediting person shall issue a certificate of accreditation pursuant to Act No 22/1997 Coll., as in force until the date of entry into force of this Act, to a legal person or a natural person who is an entrepreneur and who has applied for accreditation by the date of entry into force of this Act and complies with the accreditation rules under the existing legislation.

3. An accreditation certificate issued under the existing legislation shall be deemed to be an accreditation certificate under Act No 22/1997 Coll., as amended from the date of entry into force of this Act, only for the period for which it was issued, but no longer than until 31 December 2014.

4. Proceedings on fines commenced before the date of entry into force of this Act shall be completed in accordance with the existing legislation.

Article II of Act No 100/2013 Coll.

Transitional provisions

1. Proceedings for authorization for activities in conformity assessment of construction products pursuant to Government Regulation No. 190/2002 Coll., laying down technical requirements for CE marked construction products, as in force until the date of entry into force of this Act, which have not been finally terminated before the date of entry into force of this Act, shall be discontinued as of 1 July 2013.

2. Decisions on authorization for activities in conformity assessment of construction products according to Government Regulation No. 190/2002 Coll., laying down technical requirements for CE marked construction products, as in force until the date of entry into force of this Act, issued according to the existing legal regulations, shall expire on 1 July 2013.

3. Proceedings for the issuance of a certificate of accreditation initiated pursuant to Act No. 22/1997 Coll., as in force before the date of entry into force of this Act, shall be completed in accordance with the existing legislation.

4. Certificates of accreditation issued pursuant to Act No. 22/1997 Coll., as in force before the date of entry into force of this Act, shall be deemed to be certificates of accreditation pursuant to Act No. 22/1997 Coll., as in force from the date of entry into force of this Act.

Article II of Act No. 91/2016 Coll.

Transitional provisions

Proceedings commenced before the date of entry into force of this Act and not completed by that date shall be completed and the rights and obligations relating thereto shall be assessed in accordance with Act No. 22/1997 Coll., as in force before the date of entry into force of this Act.

Article II of Act No. 526/2020 Coll.

Proceedings which have not been finally concluded before the date of entry into force of this Act shall be completed in accordance with Act No. 22/1997 Coll., as in force before the date of entry into force of this Act.

____________________

1) For example, Act No. 114/1995 Coll., on Inland Navigation, as amended, Act No. 61/2000 Coll., on Maritime 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) Article 4 of Directive 2001/95/EC of the European Parliament and of the Council on general product safety.

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

1c) For example, Section 7a(1)(a) and (b) of Act No. 64/1986 Coll., on the Czech Trade Inspection, as amended.

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

2a) For example, Act No. 102/2001 Coll., on General Product Safety and on Amendments to Certain Acts (Act on General Product Safety), Act No. 258/2000 Coll., on Protection of Public Health, as amended by Act No. 254/2001 Coll. and Act No. 274/2001 Coll.

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

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

4b) Act No. 266/1994 Coll., on Railways, as amended.

4e) Article 20 of Regulation (EC) No 765/2008 of the European Parliament and of the Council.

4f) Government Regulation No. 396/2004 Coll., on the procedures, content and form of information on the presence of dangerous non-food products.

8) For example, § 17 et seq. of the Commercial Code.

9) Article 27 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council 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 Regulation (EU) No 305/2011 of the European Parliament and of the Council.

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

17) Commission Regulation 920/2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.