Working consolidated text[x)]
ACT No. 22/1997 COLL.
ON TECHNICAL REQUIREMENTS FOR PRODUCTS AND ON AMENDMENTS TO SOME ACTS
as amended by Act No. 71/2000 Coll., Act No. 102/2001 Coll., Act No. 205/2002 Coll. and Act No…./… Coll.[xx)]
Parliament has adopted this Act of the CzechRepublic:
PART ONE
TECHNICAL REQUIREMENTS FOR PRODUCTS
TITLE I
INTRODUCTORY PROVISIONS
Article 1
Scope
The Act lays down
a)the method of establishing technical requirements relating to products which are likely to pose a higher degree of danger to public health and/or safety, property or life environment or another public interest (hereinafter referred to as “ justified concern“),
b)the rights and obligations of the persons who place on the market or distribute or put into service products which are likely to pose a higher degree of danger to the justified concern; this is without prejudice to the provisions of special legal regulations, relating to the operation of products,[1)]
c)the rights and obligations of persons designated to carry out activities under this Act relating to the drafting and application of Czech standards or to State testing.
d)[ the method of ensuring information obligations relating to development of technical regulations and standards resulting from international agreements and requirements of the law of the European Communities..]
Article 2
Definitions
For the purpose of this Act the following definitions shall apply:
a)product means any object or substance which has been manufactured, extracted or otherwise acquired, irrespective of the level of its processing, and is intended to be placed on the market whether new or used,
b)placing on the market means the moment when a product, on the territory of the Czech Republic, is supplied or offered to be supplied for distribution or use, either as a subject of charge or free of charge, for the first time or when ownership rights concerning a product are transferred for the first time, unless a special act provides otherwise. As placed on the market shall also be considered products manufactured or imported for the operational purposes of business activities of the producer or importer, unless excluded by a Government Order. Where necessary the Government shall provide , by an Order, a more detailed specification of the term “placing on the market” with respect to the products covered by this technical regulation,
Note: this paragraph b) shall be effective until CR accession to the EU
b) [ PLACING ON THE MARKET means the moment when a product, within the market of the European Community, is supplies or offered to be supplied for distribution or use, either as a subject of charge or free of charge, for the first time or when ownership rights concerning a product a transferred for first time, unless a special act provides otherwise. As placed on the market shall also be considered products manufactured or imported for the operational purposes of business activities of the producer or importer, and products supplied for repeated use, where before the repeated use their conformity with legal regulations has been assessed, if a Government Order so provides. Where necessary, the Government shall provide, by an Order, a more detailed specification of the term “placing on the market” with respect to the products covered by this technical regulation, ]
c) [ putting into service means the moment when a product is used for the first time by the user in the Member States of the European Union for the purpose for which it was manufactured; if so specified in a Government Order, a product is put into service in the moment when it is ready or provided for such a use. When a product is put into service on a workplace[1a]), the user means the employer, ]
(c) d) producer means a person who manufactures or has designed, a product and in cases specified in a Government Order also a person who assembles, packs, works up or marks a product for which he assumes responsibility under this Act and which he intends to place on the market under his name,
d) importer means a person who has placed on the market a product from another country or who has mediated placing on the market of such a product,
Note: this paragraph shall be effective until CR accession to the EU
e) [importer means a person who has placed or intends to place on the market a product from another country than a Member State of the European Union or who has mediated placing on the market of such a product, ]
f) [authorized representative means a person established in the territory of a Member State of the European Union who has a written authorization from the producer to act on his behalf with regard to the requirements arising for the producer from this Act. ]
(e)g)distributor means a person who in the supply chain, conducts the subsequement commercial activities after a product has been placed on the market, (hereinafter referred to as “he who distributes“),
(f) h)technical requirements for a product cover
- technical specification set out in a legal regulation, (other)technical document or standard laying down required characteristics of a product such as level of quality, performance, safety or dimensions, including requirements concerning the name under which the product is marketed, establishing also the terminology used, symbols, testing of the product and test methods, packaging, labelling of the product, conformity assessment procedures for the product according to legal regulations or standards, manufacturing methods and processes affecting characteristics of the products,
- other requirements necessary for the purposes of justified concern protection or consumer´s safety protection which relate 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, where such conditions can significantly influence the composition or nature of the product or its placing on the market or putting into service.
Note: text in blue shall apply/be deleted on day of CR accession to EU (new amendment No…./… Coll.)
i)[notified body means a legal entity notified by a Member State of the European Union to the bodies of the European Community and to all Member States of the European Union as an entity authorized by the Member State of the European Union to act in conformity assessment of products with technical requirements. ]
TITLE II
TECHNICAL REGULATIONS AND STANDARDS
Article 3
Technical regulations and technical documents
(1) For the purpose of this Act technical regulation shall mean legal regulation which lays down technical requirements for products or rules for services, or establishes obligations undertaken in placing on the market or putting into service of a product, use of a product or offering or establishment of a service, or prohibiting manufacture, import, marketing or use of a product or use, offering or establishment of a service.
(2) For the purpose (of this Act) of fulfilment of information obligations under Article 7 a technical document shall mean a document which contains technical (specifications of a product) requirements for products and is neither a technical regulation in the sense of paragraph 1 nor a standard, and which could create a technical barrier to trade.
Note: text in blue shall apply/be deleted on day of CR accession to EU (new amendment No…./… Coll.)
Article 4
Czech standards
(1) A Czech standard is a document approved by a designated legal entity (Article 5) for repeated or permanent use, developed under this Act and marked with the initials „CSN“, the issuance of which has been published in the Official Journal of the Czech Office for Standards, Metrology and Testing (hereinafter referred to as „Journal of the Office“). The Czech standard is not of general cogency.
(2) The term „standard“ and its symbol „CSN“ shall not be used for marking other documents.
(3) A Czech standard (hereinafter referred to as “standard”) provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at achieving the optimal degree of order in a given context.
Article 4a
Standards and conformity assessment documents
(1) A standard becomes a harmonized standard when it has fully transposed requirements specified in a harmonized European standard. Where it appears necessary in order to meet technical requirements for products specified in a Government Order issued under this Act, the Office for Standards, Metrology and Testing (hereinafter referred to as “the Office” may specify, for the purposes of conformity assessment, other standards or technical documents from international organizations, containing technical requirements, the issuance of which has been published in the Journal of the Office (hereinafter referred to as “specified standards”).
(2) The Office will announce in the Journal of the Office harmonized standards and harmonized European standards, their amendments or withdrawals, and specified standards, their amendments or withdrawals, indicating at the same time the technical regulation these standards relate to.
(3) Compliance with harmonized standard or a specified standard, and in cases resulting from an international agreement also compliance with a foreign standard transposing a harmonized European standard, shall be regognized, within the scope of its contents, as compliance with the requirements laid down by the Government Order these standards relate to.
Note: this text of Article 4a shall be effective until CR accession to the EU
[ Article 4a
Harmonized Czech standards and specified standards
(1) A Czech standard becomes a harmonized Czech standard when it has fully transposed requirements specified in a European standard or in a harmonization document recognized by the bodies of the European Community as a harmonized European standard, or in a European standard established as a harmonized European standard in accordance with regulations of the European Communities by common agreement of the notified bodies (hereinafter referred to as “harmonized European standards”). For specification of technical requirements for products specified in a Government Order or another technical regulation , the Office for Standards, Metrology and Testing (hereinafter referred to as „the Office“) may specify, by agreement with ministries and other central administration authorities to the sphere of which the relevant Government Order relates, may specify Czech standards, other standards or technical documents from international or foreign organizations, or other technical documents, containing more detailed technical requirements (hereinafter referred to as “specified standards”).
(2) The Office will announce in the Journal of the Office harmonized Czech standards and specified standards, their amendments or withdrawals, indicating time the technical regulation these standards relate to.
(3) Compliance with a harmonized Czech standard, a specified standard or compliance with a foreign standard transposing in the Member States of the European Union a harmonized European standard or compliance with parts thereof , shall be recognized, within the scope of its contents and under the conditions laid down in the technical regulation as compliance with those requirements laid down in technical regulations these standards or their parts relate to. Where the bodies of the European Community, in the case of harmonized European standards, or the Office, in the case of specified standards, conclude that compliance with the standards or their parts cannot be further recognized as compliance with requirements of technical regulations, the Office shall announce in the Journal of the Office which harmonized Czech standards or specified standards are concerned by this fact. ]
Article 5
Ensuring of development of Czech standards
(1) Within the scope of this Act, the development and publication of Czech standards, their amendments and withdrawals shall be guaranteed by the State.
(2) The Ministry of Industry and Trade (hereinafter referred to as „the Ministry“) may designate a legal entity to carry out the development and publication of Czech standards, their amendmends and withdrawals (hereinafter referred to as „designated legal entity“). The designation is not transferable. During the period of the validity of the designation no other legal entity can be designated to perform this activity. There is no legal claim to obtain the designation.
(3) The Ministry shall decide on the designation of a legal entity on the basis of its application. It shall be taken into account, in particular, whether the applicant is able to satisfy all the conditions imposed by this Act.
(4) If the designated legal entity fails to satisfy the conditions laid down in this Act and in the decision on its designation, or upon its own request, the Ministry shall withdraw the designation.
(5) The decision on the designation of a legal entity as well as withdrawal of the decision shall be published in the form of a communication in the Collection of Laws.
(6) Where the development and publication of Czech standards, their amendmends and withdrawals is not ensured by a designated legal entity, the Office shall ensure the performance of designated legal entity‘s tasks.
(7) Expenses incurred in the course of the development of a Czech standard shall be borne by the person who has requested its development. The expenses incurred in the course of the development of a standard, particularly a Czech standard transposing a European standard which has been developed at the request of a ministry or a central administration authority, and costs connected with membership in international and European standardization organizations, shall be met by the State.
(8) Czech standards or parts thereof published on whatever carrier, may be proliferated and distributed only with prior consent of the designated legal entity (designated for development and publication of these standards) or under the conditions set out in paragraph 6, with prior consent of the Office.
Note: text in blue shall apply/be deleted on day of CR accession to EU (new amendment No…./… Coll.)
Article 6
Conditions for development and publication of Czech standards
In the process of development and publication of Czech standards, their amendments and withdrawals, the conditions given in the decision on the designation must be satisfied, particularly the following:
a)timely publication of information on Czech standards under preparation, their publication, their amendments and withdrawals in the Journal of the Office,
b)uniformity and mutual harmony of Czech standards, and their accordance with legal regulations,
c)application of the attained state of art in science and technology,
d)protection of the justified concern,
e)fulfilment of obligations resulting from international agreements which are binding for the Czech Republic and from membership in international and European standardization organizations, and utilization of the results of international cooperation,
f)discussion of a draft Czech standard, its amendment and withdrawal with every person who will report at a place and within the period determined in the public announcement on the beginning of elaboration of the draft Czech standard or of the proposal to amend or withdraw a Czech standard, or who will submit his opinion on the published motion within the time limit determined in the announcement,
g)withdrawal of a Czech standard discussed under letter f) if it does not comply with conditions set out under letters b) to d),
h)proper distribution of the published Czech standards and their amendments within two weeks from the delivery of the order.
Article 7
Information obligations
(1) Information on a draft technical regulation, or an amendment to the existing one, sent for comments to the ministries, other central administration authorities and the Czech National Bank, that is subject to notification obligation resulting from international agreements, shall be conferred by the ministries, other central administration authorities and the Czech National Bank upon the Office. In a similar way the Government shall proceed when submitting comments on the laws or amendments to the laws, if they concern technical regulations.
(2) If so provided in an international agreement, a draft technical regulation ahall not be submitted for approval before the end of a standstill period for comments.
(3) The Office as an information centre shall provide, within the scope defined by international agreements,
a)notification of draft technical regulations, standards and conformity assessment procedures to foreign countries, and
b)information about similar foreign drafts in the Journal of the |Office.
(4) By an Order, the Government shall lay down the procedure for providing information in the field of technical regulations and standards.
(5) The Office shall notify to the bodies of the European Communities and relevant bodies of the States with which international agreements hereon have been concluded, and within the scope resulting from these agreements, particularly:
a)standpoints concerning the fact that a provision of a harmonized European standard has been found not to satisfy essential requirements set out in technical regulations issued by the bodies of the European Communities, or other facts relating to standards,
b)authorized bodies (Article 11) designated to perform tasks of notified bodies acting within the European Union.
(6) The Ministry shall notify to the bodies of the European Communities and relevant bodies of the States with which international agreements hereon have been concluded, and within the scope resulting from these agreements, decisions on imposition of safeguard measures[1a)] in case of specified products (Article 12) including those originating in States with which the respective agreement has been concluded.
Note: this text of Article 7 shall be effective until CR accession to the EU
[ Article 7
Information obligations
(1) Information on a draft and the draft of a technical regulation or (another)technical document or its amendment,which are subject to information obligations towards Member States and bodies of the European Community orinformation obligations resulting from international agreements shall be submitted to the officeby the ministries, other central administration authorities,the czech national bank, territorial self-government bodies, the government if it gives opinion on draft technical regulations which pursuant to a special legal regulation[1b)] it is not to submit, and in case of technical documents also the persons entitled to issue such documents according to a special legal regulation.
(2) Information obligations relating to Czech standards shall be ensured by the designated legal entity (Article 5 (2)). The manner in which they will be fulfilled is specified in a Government Order.
(3) A technical regulation or (another) technical document must not be submitted for approval or approved before expiration of the time for submitting comments prescribed in the Government Order providing that the standstill period relating to preparation of a draft technical document, during which the decision on adoption or on preparation of a harmonized regulation of the European Communities is to be taken, may be extended under the conditions laid down by the Government.