of January 15, 2015 No. 124-VIII
About technical regulations and assessment of conformity
This Law determines legal and organizational basis of development, acceptance and application of technical regulations and the assessment procedures of compliance provided by them, and also implementation of voluntary assessment of conformity.
1. In this Law the stated below terms are used in such value:
commissioning - use of products to destination the consumer (user) in Ukraine for the first time;
issuance - provision of products in the market of Ukraine for the first time;
the specified requirements - the declared requirements or expectations which are fixed in technical regulations, standards, technical specifications or otherwise;
test laboratory - conformity assessment body which carries out testing;
testing - determination of one or several characteristics of object of assessment of conformity according to the procedure;
the producer - any physical person or legal entity (the resident or the nonresident of Ukraine) which makes products or charges its development or production and sells these products under the name or trademark (sign for goods and services). Provisions of this Law to producers are also applied to assemblers of elevators;
the harmonized European standard - the European standard accepted on the basis of request of the European Commission for application of the European Union law on harmonization;
declaring of compliance - confirmation of conformity by the first party;
the document on compliance - the declaration (including the declaration of conformity), the report, the conclusion, the certificate, the certificate (including the certificate of conformity) or any other document confirming accomplishment of the determined requirements, the assessments of conformity concerning object;
the concerned party - any physical person or legal entity or public association without the status of the legal entity (the resident or the nonresident of Ukraine) that has direct or indirect interest concerning activities for development, acceptance and application of technical regulations and assessment procedures of compliance provided by them and/or use of results of assessment of conformity to requirements of technical regulations;
the European Union law on harmonization - any acts of the European Union law which harmonize product introduction conditions on the market;
mark of conformity to technical regulations - marking by means of which the producer specifies that products conform to the relevant requirements determined in technical regulations which provide drawing this marking;
the importer - any physical person or legal entity - resident of Ukraine which introduces into market circulation of Ukraine products origin from other country;
inspection - check of products, process, service or installation or their project and determination of their compliance to specific requirements or, on the basis of professional judgment, to general requirements;
comments - notes and offers to technical regulations and assessment procedures of compliance and their projects;
the module of assessment of conformity - the unified assessment procedure of compliance or its part;
provision in the market - any paid or free delivery of products for distribution, consumption or use in the market of Ukraine in the course of implementation of economic activity;
object of assessment of conformity - specific material, products, installation, process, service, system, person or body to which assessment of conformity is applied;
the paragraph the twentieth is excluded according to the Law of Ukraine of 06.06.2019 No. 2740-VIII;
conformity assessment body - the body (the company, organization, the organization or their structural division) performing activities for assessment of conformity including calibration, testing, certification and inspection;
the paragraph of the twenty second is excluded according to the Law of Ukraine of 06.06.2019 No. 2740-VIII;;
body which appoints, - the central executive body, authorized to appoint conformity assessment bodies (including acknowledged independent organizations), to limit the sphere of their appointment, to temporarily stop or resume action of decisions on appointment or to cancel these decisions;
assessment of conformity - process of the proof that the specified requirements concerning products, process, service, system, person or body were executed;
confirmation of conformity - issue of the document on compliance which is based on the decision made after the critical overview that accomplishment of the determined requirements was proved;
compliance presumption - the assumption which is recognized reliable will not be proved the return yet, that products, the related process or production method or other object conform to requirements of the corresponding technical regulation which are determined in it, and the conformity assessment body meets the special requirements to the appointed conformity assessment bodies (further - the appointed body) or acknowledged independent organizations;
appointment - provision by body which appoints, to conformity assessment body (including acknowledged independent organization) the rights to carry out as the third party certain tasks on assessment of conformity according to the corresponding technical regulation;
products - substance, the medicine or goods made during production process (except services);
assessment procedure of compliance - any procedure which is directly or indirectly used for determination of the fact that the specified requirements are fulfilled;
risk - possibility and possible scales of consequences of negative impact during the certain period of time;
distribution - provision of products in the market after its introduction in turnover;
the distributor - any other, than the producer or the importer, physical person or legal entity in products supply chain which provides products in the market;
certification - confirmation of conformity by the third party which concerns products, processes, services, systems or personnel;
conformity assessment system - rules, procedures and managements for evaluating compliance;
subjects of managing are producers, authorized representatives, importers and distributors, and according to some technical regulations - also other physical persons and legal entities. In connection with certain technical regulations only some of specified persons can be considered as subjects of managing;
the sphere of appointment - the list of assessment procedures of compliance and types of products concerning which according to the corresponding technical regulation the conformity assessment body is appointed;
the technical specification - the document establishing technical requirements to which products, process or service shall satisfy;
technical regulation - legal regulation of the relations in the sphere of determination and accomplishment of mandatory requirements to product characteristics or the related processes and production methods, and also check of their observance by assessment of conformity and/or the state market supervision and control of non-food products or other types of the state supervision (control);
the technical regulation - the regulatory legal act in which product characteristics or the related processes and production methods, including the relevant administrative provisions which observance is obligatory are determined. It can also include or only contain requirements to terminology, designations, packaging, marking or labeling in that degree in which they are applied to products, process or production method;
the authorized representative - any physical person or legal entity - resident of Ukraine which received the written order from the producer to act from his name concerning certain tasks.
2. The terms "user", "products supply chain", "delivery of products", "public concerns" are used in the value given in the Law of Ukraine "About general safety of non-food products".
3. In technical regulations and assessment procedures of compliance which application is provided by technical regulations the terms and their determinations specified in part one of this Article can be supplemented and/or specified.
1. This Law governs the relations arising in connection with development and adoption of technical regulations and the assessment procedures of compliance provided by them, their application concerning products which are introduced into circulation, are provided in the market or are put into operation in Ukraine, and also implementation of voluntary assessment of conformity.
Features of regulation of the relations to which operation of this Law extends can be established by technical regulations and assessment procedures of compliance which application is provided by technical regulations.
2. Operation of this Law extends to all types of products, except for:
works of art and unique products of national art trade;
pieces of antiques.
4. Action of the provisions of this Law concerning appointment of conformity assessment bodies and the appointed bodies, and also Sections VI, VII and VIII (except Article part one 45) of this Law, does not extend on:
certification of seeds and landing material;
certification of organic production and/or turnover of organic products;
certification (approval) of subjects and objects of aviation activities;
approval of design of wheel vehicles, pieces of the equipment and parts (except Article 24, Article parts two 31, parts two, third and fourth article 45 of this Law);
approval like agricultural and forestry and landscape tractors, their trail cars and the replaceable trailing equipment, systems, components and separate technical nodes (except Article 24, Article parts two 31, parts two, third and fourth article 45 of this Law);
actions for state examination in the sphere of cryptographic protection of the office information and information which is the state secret and also technical information security which requirement concerning protection is established by the law;
assessment of conformity of services (except Article 24, Article parts two 31, parts four of article 45 of this Law).
5. Operation of this Law does not extend to the legislative procedure connected with consideration by the Verkhovna Rada of Ukraine of drafts of technical regulations and assessment procedures of compliance which affirm the laws, their acceptance, modification of them and recognition their invalid.
The points of order connected with development and adoption of technical regulations and assessment procedures of compliance which application is provided by technical regulations, modification of them, recognition their invalid and their cancellation not determined by this Law, are determined by the corresponding regulatory legal acts.
6. No. 2740-VIII is excluded according to the Law of Ukraine of 06.06.2019.
1. The legislation on technical regulations and assessment of conformity consists of this Law, international treaties of Ukraine which consent to be bound is provided by the Verkhovna Rada of Ukraine, and other regulatory legal acts governing the relations in this sphere.
2. If the international treaty of Ukraine which consent to be bound is provided by the Verkhovna Rada of Ukraine establishes other rules, than those which are stipulated by the legislation about technical regulations and assessment of conformity are applied rules of the international treaty of Ukraine.
Article 4 is excluded according to the Law of Ukraine of 06.06.2019 No. 2740-VIII.
provides implementation of state policy in the sphere of technical regulation;
directs and coordinates work of the central executive bodies, interacts with the Security Service of Ukraine to whom functions of technical regulation in certain fields of activity are assigned (further - the relevant state bodies);
determines fields of activity in which the relevant state bodies perform functions of technical regulation;
within the competence approves technical regulations if they are not approved by the laws or acts of the relevant state bodies or ministries determined by part three of article 8 of this Law;
approves assessment procedures of compliance which application is provided by technical regulations;
signs the international contracts of Ukraine on mutual recognition of results of assessment of conformity;
performs other powers in the sphere of technical regulation determined by the laws of Ukraine.
1. The central executive body providing forming of state policy in the sphere of technical regulation:
determines the priority directions of development of technical regulation in Ukraine;
provides normative legal regulation in the sphere of technical regulation;
coordinates activities for development and review of technical regulations and assessment procedures of compliance;
approves the plan of development of technical regulations for one or several calendar years;
approves the drafts of technical regulations and assessment procedures of compliance developed by the relevant state bodies;
performs methodical ensuring activities for development and review of technical regulations and assessment procedures of compliance;
determines procedure for forming and maintaining the database about technical regulations and the register of the intended bodies and acknowledged independent organizations;
prepares offers on the conclusion of international treaties of Ukraine on mutual recognition of results of assessment of conformity and on other questions of technical regulation;
performs international cooperation in the field of technical regulation with relevant organs of other states;
performs other powers determined by the laws of Ukraine.
1. The central executive body realizing state policy in the sphere of technical regulation:
appoints conformity assessment bodies;
will organize carrying out by the relevant state bodies assessment of the conformity assessment bodies applying for appointment (further - the applicant for appointment), concerning their compliance to requirements of the intended bodies or acknowledged independent organizations (further - assessment of applicants for appointment);
carries out with involvement of the relevant state bodies monitoring of the appointed bodies and acknowledged independent organizations regarding their compliance to requirements of the intended bodies or acknowledged independent organizations and accomplishment of the obligations established by this Law and the corresponding technical regulations by them (further - monitoring of the appointed bodies and acknowledged independent organizations);
creates and keeps the database about technical regulations and the register of the appointed bodies and acknowledged independent organizations;
performs other powers determined by the laws of Ukraine.
2. The central executive body realizing state policy in the sphere of technical regulation is body which appoints.
1. The relevant state bodies within the competence and of certain fields of activity:
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