Chapter 1 GENERAL PROVISIONS
§ 1. Purpose of Act
(1) The purpose of this Act is to ensure product safety and conformity and the free movement of goods.
(2) To achieve the purpose, this Act sets out the following:
1) the requirements for ensuring product safety and product conformity attestation (hereinafter conformity assessment) and the grounds of accreditation and market supervision;
2) the principles of evasion of obstacles to the free movement of goods, which may arise from technical rules and standards, and the grounds of standardisation;
3) the establishment of Product Contact Points and the rules of procedure for application of technical rules with regard to products that fall outside the scope of application of the legislation of the European Union (hereinafter EU harmonisation legislation) in accordance with Regulation (EC) No 2019/515 of the European Parliament and of the Council laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1–18).
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§ 2. Application of Act
(1) The requirements established for conformity assessment and conformity-assessment bodies set out in this Act are applied where their application is prescribed by another statute, a regulation issued on the basis of a statute or EU legislation (hereinafter legislation).
(2) This Act applies to products and their market supervision insofar as the aspects regulated by this Act have not been regulated by another statute. Where requirements for a product have been established in another stature, this Act applies only to the extent of the requirements not regulated by another statute.
(3) The requirements provided in Subchapter 3 of Chapter 2 and in Chapter 3 of this Act apply only where the requirements established for a product arise from EU harmonisation legislation (harmonised area), which is based on the principles provided in Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82–128) (hereinafter Decision No 768/2008/EC). The requirements arising from Subchapter 3 of Chapter 2 and from Chapter 3 do not apply where no EU harmonisation legislation regulates a product (non-harmonised area).
(4) This Act does not apply to the technical rules or standards of national defence and national security.
(5) In the event of adoption of legislation containing sanitary and phytosanitary measures, the notification requirements provided in § 43 of this Act apply.
(6) The provisions of the Administrative Procedure Act apply to the administrative procedure provided in this Act with the specifications provided in this Act.
(7) The provisions of this Act applicable to the European Union and to the Member States of the European Unions also apply to the Member States of the European Economic Area and to Switzerland and Turkey.
(8) The General Part of the Economic Activities Code Act applies to the commencement, carrying out and termination of the economic activities of an undertaking regulated by this Act, taking account of the specifics arising from this Act.
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§ 3. Product
(1) For the purposes of this Act, 'product' means a product that falls within the scope of application of Regulation (EU) 2019/1020 of the European Parliament and of the Council on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1–44) and Regulation (EU) 2023/988 of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1–51).
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(2) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(3) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(4) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(5) For the purposes of subsection 8 of § 5, §§ 10, 102 and 103 and Chapter 5 of this Act, ‘product’ means any product.
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§ 4. Definitions
(1) The definitions used in this Act and legislation established on the basis thereof have the following meaning:
1) importer means a person located in the European Union who places a product originating from a third country on the market of the Union;
2) withdrawal means any measure aimed at preventing a product in the supply chain from being made available on the market;
3) distributor means a person participating in the supply chain who places a product on the market, except a manufacturer or importer;
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31) competent authority means an authority engaged in regulatory enforcement of requirements established for a product in a non-harmonised field as per its area of authority;
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4) standard means a document drawn up by consensus by a standardisation body for overall and repeated use, which contains technical specifications of the activity or the result thereof. Adherence to a standard is usually voluntary;
5) standardisation body means a person engaged in drawing up, organising and adopting standards recognised on the national, regional or international level;
6) recall means any measure aimed at achieving the return of a product that has already been made available to the end user;
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7) consumer means a person specified in clause 1 of subsection 1 of § 2 of the Consumer Protection Act;
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8) technical rule means a technical specification applicable to a product, process or service provided in legislation. A provision of law that contains the obligation to pay a tax for the purpose of influencing the consumption of a product is also considered a technical rule. A technical regulation within the meaning of Regulation (EU) No 2019/515 of the European Parliament and of the Council is also considered a technical rule. The provisions of legislation regulating national social security are not considered technical rules;
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9) manufacturer means a person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark. An importer or distributor who places a product on the market under their name or trademark or who, in a manner that may affect the conformity of the product with the applicable requirements, alters the product that has already been placed on the market, is also considered a manufacturer;
10) placing on the market means a product first being made available on the European Union market;
11) making available on the market means any supply of a product for distribution, consumption or use on the European Union market in the course of commercial activity, whether in return of payment or free of charge;
12) conformity assessment means the process of demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;
13) conformity assessment body means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;
14) authorised representative means a person established within the European Union who has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks.
(2) In addition to the definitions set out in subsection 1 of this section, the definitions used in Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30–47) and in Regulations (EU) 2019/1020 and (EU) 2023/988 of the European Parliament and of the Council are also used in this Act.
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Chapter 2 REQUIREMENTS FOR PRODUCTS AND OBLIGATIONS OF ECONOMIC OPERATORS
Subchapter 1 Requirements for Products
§ 5. Placing products on market and putting products into service
(1) A product that is not safe may not be placed on the market or put into service.
(2) Where a requirement is established in legislation regarding a product, a product not conforming with the requirement cannot be placed on the market or put into service.
(3) Where a product has been subjected to conformity assessment by legislation, the product cannot be placed on the market or put into service where the procedure for conformity assessment provided in the legislation has not been followed.
(4) The Government of the Republic, a minister authorised by it and the minister in charge of the policy sector may, by a regulation, establish requirements for a product and a procedure for attestation of the conformity with these requirements and designate a market supervision authority who exercises market supervision over the fulfilment of these requirements.
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(5) The requirements established on the basis of this Act may be based on the purpose of ensuring the health and safety of people. The requirements established on the basis of this Act may also be based on another aspect of protection of public interests, including the need to ensure consumer protection, occupational safety, compatibility, interoperability, energy economy or environmental sustainability. The rules arising from Subchapter 1 of Chapter 5 of this Act are taken into account upon establishing requirements for products.
(6) Requirements established for products may also arise from directly applicable legislation of the European Union.
(7) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(8) Where a requirement that does not arise from EU harmonisation legislation is established for a product by Estonian legislation, a product that does not conform to such requirement may be placed on the market and put into service in Estonia, provided that the product has been lawfully manufactured in a contracting state of the European Economic Area or Switzerland or where it has been lawfully manufactured or placed on the market in a Member State of the European Union or Turkey, provided that protection equal to the protection provided in Estonian legislation has been ensured with regard to the product.
§ 6. Presumption and assessment of safety
(1) The safety of a product is presumed where the product conforms to:
1) the requirements of the EU harmonisation legislation applicable to the product to the extent of the requirements arising from the legislation and another market supervision authority of the European Union has not declared the product non-conforming, or
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2) the health protection and safety requirements of the contracting state of the European Economic Area where the product has been placed on the market, provided that the sphere has not been regulated by EU harmonisation legislation covering the product or product type and these requirements are in accordance with the Treaty on the Functioning of the European Union.
(2) Where a product conforms to the requirements of the harmonised standard specified in subsection 1 of § 41 of this Act, the safety of the product is presumed with regard to the requirements covered by the harmonised standard.
(3) Where the safety of a product cannot be presumed in accordance with subsections 1 and 2 of this section, its safety is assessed on the basis of the aspects for assessing the safety of products, presumption of conformity with the general safety requirement, and additional elements to be taken into account for assessing the safety of products laid down in Articles 6–8 of Regulation (EU) 2023/988 of the European Parliament and of the Council.
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§ 7. Determination of safety
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§ 8. Dangerous products that appear to be other than they are
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§ 9. Display of non-conforming products
A product that does not conform to the requirements or whose conformity has not been assessed may be displayed at trade fairs, exhibitions, demonstrations and other public displays, provided that the product has been equipped with clearly visible and understandable information indicating that the product does not conform to the requirements and it cannot be placed on the market or put into service before it has been brought into compliance with the requirements. The presenter of the product ensures safety during the display.
§ 10. Product Contact Point
(1) The Product Contact Point contributes to the free movement of products in the European Economic Area by sharing information. Via the Product Contact Point, economic operators receive information about the requirements and technical regulations applicable to products in accordance with Regulations (EU) 2019/515, (EU) 2019/1020 and (EU) 2023/998 of the European Parliament and of the Council and Regulation (EU) No 305/2011 of the European Parliament and of the Council laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5–43).
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(2) The Consumer Protection and Technical Regulatory Authority ensures the performance of the functions of the Product Contact Point specified in Regulations (EU) 305/2011, (EU) 2019/515 and (EU) 2023/988.
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(3) The Consumer Protection and Technical Regulatory Authority may share the performance of the functions of the Product Contact Point with another person under an administrative contract.
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§ 101. Technical assessment body
(1) The minister in charge of the policy sector grants the right to act as an Estonian technical assessment body to a person who complies with the requirements provided in Regulation (EU) No 305/2011 of the European Parliament and of the Council. The scope of the right to act as an Estonian technical assessment body is provided in a public law contract concluded between the person and the minister in charge of the policy sector.
(2) A person who wishes to act as an Estonian technical assessment body submits to the minister in charge of the policy sector an application where the person certifies that it is able to perform the duties provided in Regulation (EU) No 305/2011 of the European Parliament and of the Council.
(3) Upon receipt of an application specified in subsection 2 of this section, the minister in charge of the policy sector establishes, by a directive, a committee for assessment of the compliance of the person with the requirements.
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§ 102. Communication between competent authorities
The competent authority communicates information on a product to the competent authority of another Member State on the basis of the latter’s request in accordance with the procedure provided in Regulation (EU) No 2019/515 of the European Parliament and of the Council.
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§ 103. Procedures of competent authority under Regulation (EU) No 2019/515 of European Parliament and of Council
The competent authority may prohibit placing products described in subsection 8 of § 5 of this Act on the Estonian market or demand that these be withdrawn from the market or altered or that additional tests be carried out in accordance with the procedure laid down in Regulation (EC) No 2019/515.
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Subchapter 2 General Obligations of Economic Operators and Providers of Online Marketplaces
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§ 11. Obligations of economic operators and providers of online marketplaces
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(1) Economic operators are subject to the requirements laid down in Chapter III and providers of online marketplaces are subject to the requirements laid down in Chapter IV of Regulation (EU) 2023/988 of the European Parliament and of the Council.
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(2) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(3) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(4) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(5) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(6) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(7) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
§ 12. Obligations of distributors
[Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
§ 13. Informing market supervision authority
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Subchapter 3 Additional Obligations of Economic Operators in Harmonised Areas
§ 14. Obligations of manufacturers
(1) When placing their products on the market, manufacturers ensure that they have been designed and manufactured in accordance with the requirements set out in the relevant legislation.
(2) Before placing their products on the market, manufacturers draw up the required technical documentation regarding the products and carry out the conformity assessment procedure applicable or have it carried out. When compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers draw up an EU declaration of conformity provided in § 19 of this Act and affix the conformity marking.
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(3) Manufacturers keep the technical documentation and the EU declaration of conformity for at least ten years after the product has been placed on the market, unless otherwise provided in legislation.
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(4) Manufacturers ensure that procedures are in place for series manufacturing to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared are taken into account.
(5) Manufacturers ensure that their products bear a type, batch or serial number or other element allowing their identification. Where the size or nature of the product does not allow it, the required information is provided on the packaging or in a document accompanying the product.
(6) Manufacturers indicate their name or trademark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product.
(7) Manufacturers ensure that the product is accompanied by instructions and safety information in the official language of a contracting state of the European Economic Area, which can be understood by potential end users. A product to be made available to consumers on the market must be accompanied at least by instructions and safety information in Estonian.
(8) Manufacturers who consider or have reason to believe that a product they have placed on the market is not in conformity with the requirements laid down in EU harmonisation legislation take without delay the necessary corrective measures to bring that product into conformity, to recall it from end users or to withdraw the product from the market.
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§ 15. Authorised representatives
(1) A manufacturer may, by a written mandate, appoint an authorised representative.
(2) The mandate allows the authorised representative to do at least the following:
1) to keep the EU declaration of conformity and the technical documentation at the disposal of the regulatory authority during the term specified in subsection 3 of § 14 of this Act;
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2) further to a request from the market supervision authority, provide the authority with all the information and documentation necessary to demonstrate the conformity of a product;
3) cooperate with the market supervision authority, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
(3) The functions of authorised representatives do not include the obligations specified in subsection 1 of § 14 of this Act or drawing up technical documentation.
§ 16. Obligations of importers
(1) Importers may only place compliant products on the market.
(2) Before placing a product on the market importers ensure that:
1) the appropriate conformity assessment procedure has been carried out by the manufacturer;
2) the manufacturer has drawn up the technical documentation;
3) the product bears the required conformity marking or markings;
4) the product is accompanied by the required documents;
5) the manufacturer has complied with the requirements set out in subsections 5 and 6 of § 14 of this Act.
(3) Importers ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements.
(4) Where deemed appropriate with regard to the risks presented by a product, importers must, in order to protect the health and safety of end users, carry out sample testing of marketed products, investigate, and, where necessary, keep a register of complaints, of non-conforming products and product recalls, and keep distributors informed of such monitoring.
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(5) During the term provided in subsection 3 of § 14 of this Act, importers keep a copy of the EU declaration of conformity at the disposal of the market supervision authority and ensure that the technical documentation can be made available to the market supervision authority, upon request.
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(6) In addition to the provisions of this section, the requirements provided in subsections 6 to 8 of § 14 of this Act apply to importers.
§ 17. Obligations of distributors
(1) When making a product available on the market distributors act with due care in relation to the requirements applicable.
(2) Before making a product available on the market, distributors must verify that:
1) the product bears the required conformity marking or markings;
2) the product is accompanied by the required documents and by instructions and safety information prescribed by legislation;
3) the manufacturer has complied with the requirements set out in subsections 5 and 6 of § 14 of this Act;
4) the importer has complied with the requirements set out in subsection 6 of § 14 of this Act.
(3) Distributors who consider or have reason to believe that a product is not in conformity with the applicable requirements make the product available on the market only after the product has been brought into conformity with the requirements. Where the product presents a risk, distributors inform the manufacturer or importer and the market supervision authority that exercises supervision over the product group.
(4) Distributors ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements.
(5) Distributors who find or have reason to believe that a product they have made available on the market is not in conformity with the applicable requirements arising from EU harmonisation legislation ensure that the corrective measures necessary to bring that product into conformity, to withdraw it from the market or recall it from end users, where appropriate, are taken.
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§ 171. Duties related to making certain products available
Requirements arising from Article 4 of Regulation (EU) 2019/1020 of the European Parliament and of the Council apply to making products specified in Article 4(5) thereof available on the market.
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Chapter 3 CONFORMITY ASSESSMENT
Subchapter 1 General Provisions
§ 18. Conformity assessment
(1) The conformity of a product is attested by way of due conformity assessment provided in legislation applicable to the product.
(2) It may be established in legislation that product conformity assessment must be attested by a state authority, the manufacturer or a conformity assessment body. Where legislation imposes the obligation of attestation of the conformity of a product on a state authority, the latter may, for the purpose of identifying the technical requirements, use the services of a competent accredited body that complies with the requirements established for conformity assessment bodies in § 28 of this Act.
(3) It may be established in legislation that upon placing a product on the market or putting a product into service the product must be accompanied by a declaration of conformity or other documents specifying the conformity, installation, maintenance or use of the product.
§ 19. EU declaration of conformity
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(1) With an EU declaration of conformity a manufacturer certifies that the requirements established for a product by relevant legislation have been complied with.
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(2) Where a product is subject to multiple instruments that require a declaration of conformity to be drawn up, one declaration of conformity is drawn up for the product. The declaration of conformity must specify the related EU harmonisation legislation.
(3) The EU declaration of conformity complies with the requirements provided in the instrument, follows the structure of the sample set out in Annex III of Decision No 768/2008/EC, contains the elements specified in the relevant modules set out in Annex II of the Decision, and it is updated regularly.
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§ 20. Conformity marking
(1) Where an instrument provides for the obligation to affix a conformity marking, i.e. the CE marking, the manufacturer or their authorised representative affixes the CE marking to the product that complies with the requirements provided in the instrument and whose conformity with the requirements has been evaluated and certified in accordance with the established procedure.
(2) CE marking is subject to the general principles provided in Regulation (EC) No 765/2008 and the requirements of the instrument providing for the obligation to install the conformity marking.
(3) EU harmonisation legislation may also provide for the obligation to install a conformity marking that differs from the conformity marking referred to in the instrument specified in subsection 2 of this section.
§ 21. Certificate of conformity
(1) A certificate of conformity is a document issued by a conformity assessment body, which certifies that the product or quality system conforms to the requirements established in the certificate.
(2) Where a conformity assessment body identifies that a manufacturer has failed to comply with the requirements arising from legislation serving as the basis for the issue of a conformity certificate, the relevant harmonised standard or other technical specifications, the conformity assessment body demands that the manufacturer take corrective measures and does not issue a conformity certificate until the corrective measures have been applied.
(3) Where a conformity assessment body identifies after the issue of a certificate that a product no longer complies with the requirements serving as the basis for the issue of the certificate, the conformity assessment body demands that the manufacturer take corrective measures and, where necessary, the conformity assessment body suspends or revokes the certificate.
(4) Where no corrective measures are taken or where they do not have the desired effect, the conformity assessment body limits the validity of the certificate or suspends or revokes the certificate.
Subchapter 2 Operating as Conformity Assessment Body
§ 22. General requirements for activities of conformity assessment bodies
(1) Conformity assessment bodies perform their functions in a competent, transparent, impartial, independent, non-discriminating and proportionate manner and follow the requirements established for the conformity assessment of specific products.
(2) Conformity assessment bodies participate in cooperation between conformity assessment bodies operating in the European Union within the scope of their field of activity.
§ 23. Information obligation of conformity assessment bodies
(1) A conformity assessment body that has obtained the right to operate in Estonia informs the body specified in subsection 11 of § 30 of this Act:
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1) of refusal to issue a certificate of conformity or limitation, suspension or cancellation of the validity thereof;
2) without delay of any circumstance that affects the scope of the right to operate granted under the activity license of the conformity assessment body;
3) [Repealed – RT I, 17.05.2016, 1 - entry into force 13.06.2016]
4) at the request of the committee, of conformity assessment carried out within the scope of the right to operate granted under the activity license, including of cross-border conformity assessments and contracting.
(2) A conformity assessment body, at its own initiative, informs other conformity assessment bodies operating in the same sphere in the contracting states of the European Economic Area of the suspicion that a person may address another conformity assessment body with the request of the conformity assessment of a product or quality system that the conformity assessment body has found to be non-conforming.
(3) Conformity assessment bodies inform the market supervision authority of the suspicion that a product placed on the market or a product put into service is non-conforming.
(4) [Repealed – RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(5) Conformity assessment bodies document their conformity assessment activities and preserve the respective documents for no less than ten years, unless otherwise provided by legislation.
§ 24. Confidentiality
(1) Conformity assessment bodies ensure the confidentiality of the information obtained in the course of their activities. This obligation of the employees and mandataries of conformity assessment bodies remains in force after termination of a contract made with the conformity assessment body.
(2) The confidentiality requirement applies where the market supervision authority requests information about conformity assessment while performing its tasks.
§ 25. Subsidiaries and subcontractors of conformity assessment bodies
(1) In the course of conformity assessment, conformity assessment bodies may use the services of subsidiaries or subcontractors (hereinafter contractors) with the consent of the person applying for conformity assessment.
(2) Where a conformity assessment body uses the services of a contractor in conformity assessment, the body ensures the compliance of the contractor with the requirements of the body. The conformity assessment body is fully liable for the services provided by contractors.
(3) Conformity assessment bodies ensure that the activities of their subsidiaries or contractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
(4) Conformity assessment bodies keep at the disposal of the market supervision authority the relevant documents concerning the assessment of the qualifications of the contractor and the conformity assessments carried out by them.
§ 26. Accredited in-house conformity assessment bodies
(1) It may be provided by legislation that an accredited in-house body may be used to carry out conformity assessment activities.
(2) An accredited in-house body constitutes a separate and distinct part of the undertaking and does not participate in the design, manufacture, distribution, installation, use or maintenance of the products it assesses. An accredited in-house body must meet the following requirements:
1) it has been accredited to carry out a specific conformity assessment;
2) the body and its personnel are organisationally identifiable and have reporting methods within the undertaking of which they form a part that ensure their impartiality and demonstrate it to the relevant national accreditation body;
3) neither the body nor its personnel are responsible for the design, manufacture, distribution, installation or maintenance of the products they assess nor engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities;
4) the body supplies its services exclusively to the undertaking of which it forms a part.
(3) Notification of an accredited in-house body is not given to the Member States or the European Commission.
Subchapter 3 Granting Activity Licenses to Conformity Assessment Bodies, Suspension and Revocation of Activity Licenses
§ 27. Activity license of conformity assessment bodies
(1) In order to operate as a conformity assessment body, an individual or entity (hereinafter person) ought to have an activity license issued by a contracting state of the European Economic Area, and the European Commission and other contracting states of the European Economic Area must be informed of the person.
(2) A body specified in an agreement of mutual recognition made between the European Union and a third country may also operate as a conformity assessment body.
(3) [Repealed – RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(4) [Repealed – RT I, 17.05.2016, 1 - entry into force 13.06.2016]
§ 28. Requirements for conformity assessment bodies
(1) A conformity assessment body, including a person who applies for an activity licence of a conformity assessment body, must comply with the following requirements:
1) the person has been registered in the commercial register, non-profit associations and foundations register or state register of state and local government agencies;
2) the person, including its shareholders and members who hold more that 50 percent of the shares as well as its employees who, based on their position, have a substantial decision-making capacity, has or have an impeccable reputation;
3) the person’s activities as a conformity assessment body have been organisationally and in terms of accounting been separated from its other activities;
4) the person is able to act in an independent, professional, impartial and non-discriminating manner;
5) the person has indicated in the submitted application a sufficient number of employees with the required education, training and experience for conformity assessment, who, within the scope of the right to operate specified in the application for the activity license and granted under the activity license, are familiar with the requirements arising from the applicable EU harmonisation legislation and harmonised standards regarding the products that are to be subjected to conformity assessment;
6) the person has the tools that allow for carrying out conformity assessment procedures;
7) the person is technically sufficiently competent to carry out conformity assessment procedures within the scope of the right to operate specified in the application for the activity license and in the activity license;
8) the person and the personnel must not be the designer, planner, manufacturer, authorised representative of the manufacturer, importer, distributor, supplier, installer, maintainer, owner or user of the products that they assess, not the representative of any of those parties, and their other activities must not be related to the products to an extent that arouses suspicion in their independence and impartiality, thereby the person or the personnel carrying out conformity assessment must not provide respective consultation services. This does not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes;
9) the personnel of the conformity assessment body is remunerated regardless of the number of conformity assessment procedures and results;
10) at the time of operating as a conformity assessment body the person has valid liability insurance to the extent of a sum insured that ensures the indemnification of possible damage caused to third parties by its activities as a conformity assessment body and that amounts to no less than 64 000 euros;
[RT I 2010, 31, 158 - entry into force 01.01.2011]
11) the person complies with other requirements arising from EU harmonisation legislation applicable to the person’s field of activity.
(2) Where a person demonstrates their compliance with the criteria laid down in the applicable harmonised standards or parts thereof, the person is presumed to comply with the requirements set out in the legislation in so far as the standards cover those requirements.
(3) The conformity assessment body and a person who applies for an activity license of a conformity assessment body must be accredited by an accreditation body compliant with Regulation (EC) No 765/2008 to carry out the conformity assessment applied for under the activity license.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(4) Where a conformity assessment body was accredited by the national accreditation body of another contracting state of the European Economic Area, the conformity assessment body submits to the body that granted it the right to operate a report on the follow-up inspection carried out by the accreditation body.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
§ 29. Submission of documents to obtain activity license
(1) In addition to the information required in the General Part of the Economic Activities Code Act, an application for an activity license must contain the following data and documents:
1) the products or product types with regard to which the applicant wishes to obtain the right to operate for the purpose of conformity assessment and references to applicable legislation;
2) the conformity assessment procedures the applicant would like to carry out as a conformity assessment body and references to applicable legislation;
3) a certificate certifying accreditation or a copy thereof,
4) a copy of the liability insurance policy.
[RT I, 29.06.2014, 1 - entry into force 01.07.2014]
(2) Where a conformity assessment body uses the services of a contractor, the body also submits information about the contractor and its compliance with the requirements, enclosing a copy of the respective cooperation contract.
(3) Where a conformity assessment body wishes to change the scope of the right to operate specified in an existing activity license or to extend the term of validity of the right to operate, the body submits in an application the data and documents it has not submitted before or that have changed to the extent covered by the previously submitted document.
§ 30. Granting activity license
(1) [Repealed – RT I, 29.06.2014, 1 - entry into force 01.07.2014]
(11) An activity licence is granted by the Consumer Protection and Technical Regulatory Authority. In the field of medical devices, an activity licence is granted by the State Agency of Medicines.
[RT I, 20.11.2024, 1 - entry into force 01.01.2025]
(12) The authority exercising market supervision in the respective field can be involved in granting an activity license.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(2) Unless otherwise provided by legislation, an activity license is granted for the term of validity of the accreditation certificate or existence of other objective and substantial circumstances serving as the basis for the license.
§ 31. Refusal to grant activity license
(1) [Repealed – RT I, 29.06.2014, 1 - entry into force 01.07.2014]
(2) The granting of an activity license may be refused where the applicant’s right to operate as a conformity assessment body has previously been revoked on the following grounds:
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
1) the conformity assessment body has failed to comply with a precept;
2) the conformity assessment body does not allow for regulatory enforcement regarding its activities;
3) the conformity assessment body has committed a fundamental breach or repeatedly breached the requirements established for its activities;
4) the conformity assessment body continues operating as a conformity assessment body during the term when the validity of its activity license has been suspended.
§ 32. Suspension of validity of activity license
[Repealed – RT I, 29.06.2014, 1 - entry into force 01.07.2014]
§ 33. Revocation of activity license
(1) [Repealed – RT I, 29.06.2014, 1 - entry into force 01.07.2014]
(2) [Repealed – RT I, 29.06.2014, 1 - entry into force 01.07.2014]
(3) The revocation of the activity license of a conformity assessment body must not influence the validity of the documents issued by the body.
(4) In the event of revoking the activity license of a conformity assessment body, the body hands its conformity assessment documentation over to the body specified in subsection 11 of § 30 of this Act. The documentation does not need to be handed over where the activity license of the conformity assessment body is revoked in part.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
§ 34. Notification of activity license and commencement of right to operate
(1) The body that granted an activity license to a conformity assessment body notifies the European Commission and other Member States of granting, suspending or revoking the license. Notification ensures in the Member States of the European Union the recognition of the conformity assessment procedures carried out by the conformity assessment body within the scope of the right to operate granted under the activity license. In the course of notification, the conformity assessment body receives an identification number.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(2) A conformity assessment body may commence operation within the limits of the right to operate specified in the activity license when a two-week waiting period has ended and the European Commission or any Member State has not raised any objections to the notification of the conformity assessment body.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(3) Where the European Commission or another Member State raises any objections to the notification of granting an activity license to a conformity assessment body, the body that granted the activity license takes these into account and renews the procedure for granting the activity license to the conformity assessment body.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
§ 35. Publication of information on activity license in register of economic activities
(1) For the purpose of informing the public, the body that granted the activity license publishes data on granting the activity license to the conformity assessment body or suspending or revoking the license in the register of economic activities as a registry entry.
[RT I, 17.05.2016, 1 - entry into force 13.06.2016]
(2) [Repealed – RT I, 29.06.2014, 1 - entry into force 01.07.2014]
(3) A registry entry on the granting of an activity license is made without delay after the waiting period specified in subsection 2 of § 34 of this Act is over and the conformity assessment body’s right to operate has entered into force. A registry entry on the suspension or revocation of the activity license is made without delay.
Chapter 4 ACCREDITATION
§ 36. Organisation of accreditation
Accreditation is organised and carried out in accordance with Chapter II of Regulation (EC) No 765/2008.
§ 37. Estonian accreditation body
(1) Estonian national accreditation body is a state-founded entity that operates on a not-for-profit basis and the goal of whose statutory activities is the accreditation of conformity assessment bodies.
(2) The person performing the tasks of the Estonian national accreditation body is appointed by an order of the Government of the Republic.
(3) The state finances the participation of the Estonian national accreditation body in the activities of European and international accreditation cooperation bodies and, where it is agreed on separately, other activities of the accreditation body.
§ 38. Operation as Estonian accreditation body
(1) The Estonian accreditation body:
1) administers the accreditation system, and accredits, assesses and attests the professional competency of measurers;
2) [Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
3) approaches all applications for professional competency assessment and accreditation in an impartial manner and in accordance with the principle of equal treatment;
4) complies with the requirements established for accreditation bodies in Regulation (EC) No 765/2008;
5) represents Estonia in international accreditation cooperation;
6) publishes on its website the names of accredited conformity assessment bodies, the scope of accreditation and notices of suspension or revocation of accreditations;
7) advises government agencies in accreditation-related matters.
(2) Where, as a result of an assessment by a conformity assessment body that obtained an activity license on the basis of this Act, the body is required to take corrective measures, the accreditation body submits a summary of the results of assessment to the body specified in subsection 11 of § 30 of this Act after taking the measures. The accreditation body also immediately informs the body that granted the activity license of the suspension or revocation of the accreditation, of complaints filed against the activities of the conformity assessment body and of measures taken to resolve these.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 381. Fee for accreditation and assessment of professional competency of measurer
(1) The Estonian accreditation body charges a fee for accreditation and assessment of the professional competency of a measurer.
(2) The fee is charged for the following:
1) review of an application;
2) accreditation, including supervision over an accredited body;
[RT I, 21.06.2017, 1 - entry into force 04.07.2017]
3) keeping accreditation and the certificate certifying the professional competence of a measurer valid.
(3) The fee is paid in the manner and by the due date indicated in an invoice issued by the Estonian accreditation body.
(4) Where the accredited body has not paid an invoice by the due date, the Estonian accreditation body suspends the validity of its accreditation until the invoice has been paid. Where an invoice has not been paid within six months after the due date specified in the invoice, the Estonian accreditation body revokes the accreditation. Where an invoice is overdue, the Estonian accreditation body has the right to refuse accreditation. This subsection also applies to a measurer who has been declared professionally competent.
[RT I, 01.07.2016, 12 - entry into force 11.07.2016]
§ 382. Fee for review of application
(1) The applicant pays the following fee for having their application reviewed:
1) 300 euros for the review of an application for accreditation;
[RT I, 11.03.2025, 1 - entry into force 01.07.2025]
2) 200 euros for the review of an application for extending the scope of accreditation;
21) 100 euros for the review of an application for changing the scope of accreditation, except in the case specified in clause 2 of this subsection;
[RT I, 11.03.2025, 1 - entry into force 01.07.2025]
3) 175 euros for reviewing an application for assessment of the professional competency of a measurer.
(2) [Repealed – RT I, 11.03.2025, 1 - entry into force 01.07.2025]
(3) The fee is not refunded to the applicant where the applicant withdraws the application or where the application is not granted for a reason independent of the Estonian accreditation body.
[RT I, 01.07.2016, 12 - entry into force 11.07.2016]
§ 383. Accreditation and competency assessment fee
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(1) The applicant pays a fee for accreditation. The size of the fee depends on the time spent on assessment, the complexity of assessment, the hourly fee of the member of the accrediting staff appointed by the accreditation body (hereinafter member of the accrediting staff), the amount of the fee of the sectoral assessor (hereinafter professional assessor) and the direct costs incurred in carrying out the assessment.
[RT I, 11.03.2025, 1 - entry into force 01.07.2025]
(2) The amount of the fee of the professional assessor is agreed with the professional assessor. The Estonian accreditation body presents the estimated cost of accreditation to a body applying for accreditation or to an accredited body in advance and allows an opinion to be expressed on the fee of the professional assessor to be involved.
[RT I, 11.03.2025, 1 - entry into force 01.07.2025]
(3) The rate of the hourly fee of a member of the accrediting staff is up to 20 times the minimum hourly rate established pursuant to subsection 5 of § 29 of the Employment Contracts Act. The applicable hourly fee rates of members of the accrediting staff are established annually by the Estonian accreditation body.
[RT I, 11.03.2025, 1 - entry into force 01.07.2025]
(4) The direct costs of accreditation include business trip costs, translation costs where assessment is not made in Estonian, and other costs incurred in carrying out accreditation. An advance payment may be required to cover direct costs.
[RT I, 11.03.2025, 1 - entry into force 01.07.2025]
(5) This section also applies to the assessment of the professional competency of measurers.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 384. Annual fee for keeping accreditation and certificate valid
(1) An accredited body and a professionally competent measurer pay an annual fee for keeping accreditation and the certificate of the measurer valid.
(2) The amount of the annual fee depends on the expenses required for the sustainable functioning of the Estonian accreditation body, which are divided between accredited bodies and professionally competent measurers proportionally, taking account of the extent and complexity of the accreditation.
(3) Where the accreditation or the declaring of a measurer as professionally competent is suspended or declared invalid, the accredited authority or the measurer has the right to request that the Estonian accreditation body refund the paid annual fee for the full months in which the right covered by the annual fee remained unexercised. The portion of the annual fee to be refunded is returned to the applicant within one month as of the receipt of the application.
(4) The principles of setting the annual fee and the rates of the fee are established by a regulation of the minister in charge of the policy sector.
[RT I, 01.07.2016, 12 - entry into force 11.07.2016]
Chapter 5 TECHNICAL RULES AND STANDARDS
Subchapter 1 General Provisions
§ 39. Technical rules
(1) Legislation containing technical rules is drafted in accordance with international law binding upon Estonia, standards adopted by international or European standardisation bodies or the technical specifications set out in their final drafts. Deviation from the technical specifications set out in standards of their final drafts is permitted where taking these into account without any exceptions would be inefficient due to climatic or geographic conditions or technical problems or unfitting for achievement of the desired objectives.
(2) Legislation containing technical rules establishes uniform requirements for products manufactured in and imported to Estonia and for services provided.
(3) A reasonable interval is allowed between the publication and entry into force of legislation containing technical rules so manufacturers can bring their products or the method of manufacturing into compliance with the regulations. The requirement of a reasonable interval does not apply in cases where the rapid entry into force of a technical rule is necessary for the purpose of protecting human health or safety, protecting the environment or guaranteeing national security.
§ 40. Estonian standards
(1) Estonian standards are standards adopted by Estonian standardisation bodies. The abbreviation for Estonian standards is ‘EVS’.
(2) An Estonian standard is deemed adopted when a notice concerning its adoption is published in the official publication of the Estonian standardisation body.
(3) The Estonian national standardisation body ensures the availability of standards to the public as of the publication date of the notice provided in subsection 2 of this section.
(4) An Estonian standard may be:
1) a transposed standard of an international or European standardisation body;
2) a transposed original standard of another state;
3) an original Estonian standard.
(5) An original Estonian standard is adopted and made accessible at least in Estonian.
(6) In the event of transposition of a standard of an international or European standardisation body or an original standard of another state, the transposed standard does not have to be in Estonian. The Estonian standardisation body makes the transposed standard available in at least one of the official languages of the standardisation body that drew up the standard. Different language versions of the transposed standard are equal.
§ 41. Usage of harmonised standards
(1) Where a notice (reference) on a harmonised standard has been published in the Official Journal of the European Union and the standard has been adopted as the standard of at least one Member State of the European Union and unless legislation provides otherwise, it is presumed that products or services conforming with the standard also conform to technical rules to the extent of the requirements covered by the standard.
(2) Where a notice (reference) published on a harmonised standard in the Official Journal of the European Union has been repealed, products or services are not deemed to comply with the relevant technical rules in the event the standard is adhered to.
(3) Where an additional notice (reference) has been published on a harmonised standard in the Official Journal of the European Union, the conformity of products or services with the relevant technical rules is, in the event of adherence to the standard, presumed on the terms and conditions set out in the notice.
§ 42. Reference to standard in technical rule
(1) When taking the requirements of a standard into account in a technical rule, only the significant requirements or objectives are laid down and, where necessary, a reference to the standard is made. A standard may be referred to directly or in general in a technical rule. In terms of its legal meaning, a reference to a standard is recommended or mandatory.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(2) A reference to a standard is direct where it contains the designation of the standard, which is a combination of the abbreviation of the standardisation body that adopted or drew up the standard and the number of the standard. A direct reference is given with or without a date. In the event of a reference with a date, the standard is adhered to as of the date and, in the event of a standard without a date, the standard is adhered to as amended.
(3) A reference to a standard is general where reference is made to standards adopted by a standardisation body or to standards identified otherwise and the reference does not contain the designation of the standard.
(4) A reference to a standard is deemed recommended where other solutions besides following the referred standard can be applied for the purpose of complying with the requirements of law. In the present case another solution does not mean the obligation to follow another standard.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(5) A reference to a standard is mandatory where only the referred standard may be followed for the purpose of complying with the requirements of law. A mandatory reference to a standard may be a direct or general reference.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(6) A mandatory reference to a standard must not be made in a technical rule. By way of exception, a mandatory reference may be made upon performance of obligations of Estonia, which arise from international law or legislation of the European Union, provided that it is the only way of complying with the requirements arising from law.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(7) Where a recommended reference to a standard is set out in a technical rule, compliance with the relevant requirements of law is presumed upon adherence to the referred standard with regard to the requirements covered by the standard.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
§ 43. Notification
(1) The European Commission and contracting states of the European Economic Area are notified of legislation that is being drafted and that has been adopted, which contains a technical rule concerning the product or affecting the marketing of the product, including a sanitary or phytosanitary measure.
(2) There is no need to notify of draft legislation that follows the obligations arising from EU harmonised legislation and international agreements, as a result of which a common technical rule is adopted in the European Union.
(3) The drafter of legislation subject to notification submits the draft legislation to the authority coordinating notification. The draft legislation is submitted for notification at such stage of the proceedings where it is still possible to amend the draft legislation.
(4) The procedure for notification is established and the authority coordinating notification is appointed by a regulation of the Government of the Republic.
Subchapter 2 Organisation of Standardisation
§ 44. Estonian standardisation body and performance of obligations arising from European standardisation regulation
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(1) The Estonian standardisation body is a state-founded non-profit association that represents its members and the purpose of the activities of which, as specified in the articles of association, is to draw up and publish standards and represent Estonia in international standardisation. The interests of the state in the Estonian standardisation body are represented by a government agency as a member.
(2) The person performing the tasks of the Estonian standardisation body is appointed by an order of the Government of the Republic.
(21) The obligations of the standardisation body of the state, which arise from 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 (OJ L 316, 14.11.2012, p. 12–33 (hereinafter European standardisation regulation), are performed by the Estonian standardisation body.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(22) In the field of telecommunications, the obligations of the standardisation body of the state set out in the regulation specified in subsection 21 of this section are performed by the Consumer Protection and Technical Regulatory Authority.
[RT I, 12.12.2018, 3 - entry into force 01.01.2019]
(3) [Repealed – RT I, 10.05.2014, 1 - entry into force 20.05.2014]
§ 45. Obligations of Estonian standardisation body
(1) The Estonian standardisation body:
1) maintains the Estonian standardisation system and organises standardisation activities in Estonia;
2) performs the obligations of the standardisation body of the state arising from the European standardisation regulation;
3) performs the obligations arising from membership in international and European standardisation organisations and participates in the work of the organisations whose member it is;
4) performs standardisation obligations assumed under international agreements and standardisation obligations delegated by the state;
5) in the official publication made available on its website, publishes information on drafted Estonian standards as of making them available for an opinion poll or commenting and information on adopted, repealed or harmonised standard-transposing Estonian standards as of their adoption or repeal or the receipt or loss of the status of a harmonised standard;
6) uses the EVS trademark and ensures that it is not misused.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
(2) The Estonian standardisation body ensures the availability of Estonian standards in Estonia and the possibility to access them free of charge at least at the address of its seat. Upon making standards available, the Estonian standardisation organisation ensures the protection of copyright on standards and publish the terms and conditions of protection of copyright.
(3) The Estonian standardisation body may charge a fee for dissemination of standards. The fee is cost-based and ensure the availability of the standardisation service at the required level in Estonia and the availability of funds required for the development of the standardisation body.
(4) The Estonian standardisation body performs the tasks of an information centre of the World Trade Organization (hereinafter WTO). The tasks of the information centre arise from Article 10 of the WTO Agreement on Technical Barriers to Trade, Annex B of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, and other legislation and international agreements that lay down the coordination of the exchange of information pertaining to standards.
§ 46. Standardisation committee
[Repealed – RT I, 10.05.2014, 1 - entry into force 20.05.2014]
§ 47. Standardisation scheme
[Repealed – RT I, 10.05.2014, 1 - entry into force 20.05.2014]
§ 48. Drawing up Estonian standards and financing Estonian standardisation body
(1) The costs of drawing up and translating an Estonian standard are covered by interested persons. The drawing up and translating an Estonian standard commissioned by a state authority are financed by the state via the budget of the interested ministry.
(2) Interested persons can make proposals on drawing up or translating an Estonian standard to the Estonian standardisation body.
(3) The state finances the performance of the obligations of the Estonian standardisation body set out in clause 2 of subsection 1 of § 45 and subsections 2 and 4 of § 45 of this Act, compensates the membership fees of international and European standardisation bodies and the costs of participating in their work and, where agreed separately, the state also finances other activities of the standardisation body. Funds are allocated in the budget of the area of government of the Ministry of Economic Affairs and Communications.
[RT I, 10.05.2014, 1 - entry into force 20.05.2014]
Chapter 6 MARKET SUPERVISION AND SUPERVISION OVER CONFORMITY ASSESSMENT BODIES
Subchapter 1 Organisation of Market Supervision
§ 49. Organisation of market supervision
(1) In harmonised areas, market surveillance of products is organised and conducted in accordance with Chapters IV–VIII of Regulation (EU) 2019/1020 of the European Parliament and of the Council and, in non-harmonised areas, in accordance with Chapters V and VII of Regulation (EU) 2023/988 of the European Parliament and of the Council and this Act.
[RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(2) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(3) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
§ 50. Competence of authorities participating in market supervision
(1) The regulatory enforcement of compliance with the requirements established for products by legislation is carried out by market supervision authorities. For the purposes of this Act, market supervision authorities include the Consumer Protection and Technical Regulatory Authority, the Health Board, the State Agency of Medicines, the Transport Administration, the Agriculture and Food Board and the Environmental Board.
[RT I, 20.11.2024, 1 - entry into force 01.01.2025]
(2) [Repealed – RT I, 12.12.2018, 3 - entry into force 01.01.2019]
(3) The Health Board engages in the regulatory enforcement of compliance with the health requirements of products.
(31) The State Agency of Medicines engages in the regulatory enforcement of compliance with the safety requirements for medical devices on the basis of the Medical Devices Act, Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1–175) and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176–332).
[RT I, 20.11.2024, 1 - entry into force 01.01.2025]
(4) The Transport Administration engages in the regulatory enforcement of requirements established for the following products:
1) water craft for the purposes of the Maritime Safety Act;
2) cars for the purposes of the Road Traffic Act;
3) motorcycles for the purposes of the Road Traffic Act;
4) mopeds for the purposes of the Road Traffic Act;
5) tractors for the purposes of the Road Traffic Act;
6) light mopeds for the purposes of the Road Traffic Act;
7) interchangeable towed equipment for the purposes of the Road Traffic Act;
8) trailers of the vehicles specified in clauses 2 and 5 of this subsection;
9) parts, systems, separate technical units, accessories, add-ons and equipment of the vehicles specified in clauses 2–8 of this subsection.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(5) The Consumer Protection and Technical Regulatory Authority engages in regulatory enforcement of compliance with the requirements established for the following products:
[RT I, 12.12.2018, 3 - entry into force 01.01.2019]
1) building materials and products;
2) electrical equipment;
3) radio equipment;
[RT I, 11.03.2025, 1 - entry into force 21.03.2025]
4) gaseous fuels, appliances burning gaseous fuels, fittings of appliances burning gaseous fuels;
5) lifts, safety components of lifts, cableways, subsystems and safety components of cableways;
6) explosives and pyrotechnical products;
7) machinery, replaceable appliances of machinery, protection devices, auxiliary lifting equipment, chains, ropes and belts, removable transmission mechanisms, partially assembled machinery;
8) equipment used outdoors, based on the noise requirements established for it;
9) equipment, protection systems, components and fittings used in an explosive atmosphere;
10) measuring instruments and pre-packages subject to compulsory metrological control;
11) energy-related products with regard to their energy efficiency, energy labelling and ecodesign requirements;
[RT I, 11.03.2025, 1 - entry into force 21.03.2025]
12) pressure equipment, including pressure vessels, piping systems, safety and auxiliary devices, vessels for dangerous liquids, and aerosol dispensers;
121) products meant for consumers, including open-category unmanned aircraft systems for the purposes of Commission Delegated Regulation (EU) 2019/945 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems (OJ L 152, 11.6.2019, p. 1–40);
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
122) personal protective equipment;
[RT I, 12.12.2018, 3 - entry into force 01.01.2019]
123) products concerning which supervision over compliance with the imposed accessibility requirements has been placed within its competence by this Act or legislation adopted on the basis thereof;
[RT I, 15.06.2022, 1 - entry into force 28.06.2022]
124) toys;
[RT I, 03.02.2023, 2 - entry into force 01.06.2023]
13) other products whose supervision has been placed within its competence by this Act or legislation adopted on the basis of this Act.
(6) The Agriculture and Food Board engages in the regulatory enforcement of requirements established for the EU fertilising products.
[RT I, 15.07.2022, 4 - entry into force 16.07.2022]
(7) The Environmental Board engages in the regulatory enforcement of requirements established for products of concern and other products that potentially endanger the environment.
[RT I, 10.07.2020, 2 - entry into force 01.01.2021]
(8) [Repealed – RT I, 12.12.2018, 3 - entry into force 01.01.2019]
(81) [Repealed – RT I, 10.12.2020, 1 - entry into force 01.01.2021]
(9) The Tax and Customs Board inspects the safety of imported products and their compliance with the requirements, thereby cooperating with the appropriate market supervision authority.
§ 51. Cooperation and exchange of information between authorities participating in market supervision
(1) For the purpose of facilitating cooperation and exchange of information between the authorities participating in market supervision, the minister in charge of the policy sector forms a market supervision council in the Ministry of Economic Affairs and Communications.
(2) The market supervision council consists of representatives of all the authorities participating in market supervision under this Act and representatives of the ministries of their areas of government.
(3) The task of the market supervision council is to make proposals:
1) for establishment of the strategic goals of market supervision and product safety;
2) for shaping the structure and activity priorities of the market supervision authorities and for coordinated application for state budget funds;
3) for furthering cooperation between the market supervision authorities and the Tax and Customs Board;
4) for furthering the training and international cooperation of supervision officers;
5) in other matters concerning market supervision.
(4) The composition and rules of procedure of the market supervision council are approved by a directive of the minister in charge of the policy sector.
(5) [Repealed – RT I, 23.05.2020, 1 - entry into force 24.05.2020]
§ 52. Market supervision programmes
[Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 53. Review and assessment of supervision operations
[Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 531. Cross-border cooperation in supervision and national supervision strategy
(1) Cross-border cooperation between the market supervision authorities of the Member States of the European Union is pursued in accordance with Chapter VI of Regulation (EU) 2019/1020 of the European Parliament and of the Council.
(2) The single liaison office which performs the functions provided for in Article 10(4) of Regulation (EU) 2019/1020 of the European Parliament and of the Council and Article 23(1) of Regulation (EU) 2023/988 of the European Parliament and of the Council is designated by a regulation of the minister in charge of the policy sector.
[RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(3) The single liaison office appointed on the basis of subsection 2 of this section prepares in cooperation with the market supervision authorities the overall national supervision strategy in accordance with the requirements set out in Article 13 of Regulation (EU) 2019/1020 of the European Parliament and of the Council, sends it to the European Commission and other Member States of the European Union and makes its summary available on its website.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
Subchapter 2 Market Supervision Measures
§ 54. Regulatory enforcement
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]
(1) The market supervision authority has the right to check to the required extent the safety and conformity of each product placed on the market before the product has reached the end user as well as in cases where the product has been placed on the market as a conforming and safe product.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(2) The market supervision authority may, for the purpose of regulatory enforcement provided in this Act, take special measures of regulatory enforcement provided in §§ 30, 31, 32, 49, 50, 51 and 52 of the Law Enforcement Act on the grounds and in accordance with the rules provided in the Law Enforcement Act.
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]
(3) [Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(4) [Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(5) [Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(6) [Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(7) [Repealed – RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 55. Publication of information
(1) The market supervision authority makes public the information concerning the risks arising from products and information regarding identification of products, the characteristics of the risk arising from products, and the measures taken.
(2) The market supervision authority may obligate economic operators to disclose information about the risks arising from a product. Where an economic operator fails to perform the obligation to disclose information within the prescribed term, the market supervision authority may perform the obligation with the means and in accordance with the procedure provided in the Substitutional Performance and Non-Compliance Levies Act.
(3) The market supervision authority does not have the right to disclose the business secrets of economic operators obtained upon implementation of this Act, except for the information concerning the characteristics of a product, whose disclosure is justified by the need to ensure safety.
(4) The Public Information Act, taking into account the exceptions laid down in this Act, applies to publication of information.
§ 56. Specifics of regulatory enforcement
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]
(1) On the conditions set out in § 50 of the Law Enforcement Act, the market supervision authority may enter the premises where a product is made, stored or offered for sale.
(2) The market supervision authority has the right to:
1) where a product may pose a risk on certain conditions, demand that it be labelled with clear warnings in Estonian about the risks that the product may cause or establish prior conditions to placing the product on the market, which ensure safety;
2) where a product that may pose a risk to certain persons, demand that these persons are warned of the risk in a suitable manner and at a suitable time, including by publishing separate warnings;
3) where a product may be dangerous, demand the temporary withdrawal of the product from the market or prohibit the presentation of the product for a period that is necessary for assessment and checking of its safety;
4) prohibit the placing of a product on the market and take measures that ensure compliance with the prohibition;
5) demand and organise the immediate withdrawal of a dangerous product from the market;
6) demand, coordinate and organise jointly with economic operators the recall of dangerous products from end users and, where necessary, the destruction of the products. The product must be recalled from end users where other measures are insufficient.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(3) The market supervision authority has the right to take the measures specified in subsection 2 of this section also where a product complies with § 6 of this Act, but the market supervision authority has evidence that the product is dangerous.
(4) [Repealed – RT I, 23.05.2020, 1 - entry into force 24.05.2020]
(5) In the event of a serious risk the Tax and Customs Board, with the approval of the appropriate market supervision authority, has the right to prohibit making the product available on the market or exporting the product.
(6) Upon taking market supervision measures, the market supervision authority follows the appropriate rules of procedure arising from EU harmonisation legislation.
(7) The market supervision authority has the right to obtain samples of products placed on the market from economic operators free of charge for the purpose of checking their safety or conformity and, where necessary, commission an expert assessment in order to identify the safety or conformity of products. The market supervision authority bears the expenses of the expert assessment. Where it is established that the product is not safe or does not conform to the requirements, the economic operator pays the documented costs of the expert assessment.
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]
(8) The market supervision authority has the right to, by a written or electronic enquiry, demand that an electronic communications undertaking provide data specified in clause 3 of subsection 3 of § 1111 of the Electronic Communications Act in order to identify the owner of a website where it is necessary to combat a threat or eliminate a disorder.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(9) The market supervision authority has the right to make test transactions in accordance with the rules set out in § 561 of this Act and demand that access to a web interface be restricted, information be removed or warnings be added in accordance with the rules set out in § 562 of this Act.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 561. Test transaction
(1) The market supervision authority has the right to make a test transaction where exercising supervision over compliance with the requirements arising from this Act or other legislation in another way is not possible or is significantly impaired in the case of other market supervision measures set out in this Act. The making of a test transaction is decided by the Director General of the market supervision authority or an official authorised by the Director General of the market supervision authority.
(2) A test transaction is an operation with elements of a transaction made under the law of obligations whereby it is permitted to hide the purpose of making the transaction.
(3) The official making a test transaction does not have to introduce themselves upon making the transaction, wear a uniform or present their identification before attaining the purpose of the test transaction.
(4) When making a test transaction, it is not allowed to carry out surveillance acts, to abet a person to commit an offence, commit an act that has the characteristics of an offence, pretend being a legal person for ensuring the making of a test transaction or use covert measures for the purpose of §§ 751 and 754–756 of the Police and Border Guard Act.
(5) In making a test transaction, the official acts as an average end user. Where due to the nature of the test transaction it is not possible to attain the purpose of the test transaction, the official may, where necessary, use a made-up name or involve in the making of the transaction a person not responsible for the public order upon consent of such person.
(6) Without delay after the attainment of the purpose of the test transaction, the person making a test transaction informs the person with respect to whom the test transaction was made about the fact that a test transaction was made, stating the reasons for making the test transaction. The informing of the person may be postponed where it is necessary for continuing supervision related to the activities of the same person or for inspecting compliance with requirements established by other persons to the making of such transactions. Notification may not be postponed by more than three months from the date of making the transaction.
(7) A test transaction is recorded in a report in accordance with the procedure established in § 12 of the Law Enforcement Act.
(8) The report sets out the following:
1) a reference to the decision serving as the basis for the test transaction;
2) the officials who participated in the transaction and the person with respect to whom the test transaction was made and other parties to the proceedings and persons involved;
3) the statements of the officials regarding the circumstances and results;
4) a description of the things and documents handed over or accepted;
5) the statements, testimonies and opinions of the other parties to the proceedings and persons involved in the proceedings.
(9) Where notification of the test transaction is postponed, the test transaction report refers to the postponement decision. The report is served on the person with respect to whom the test transaction was made.
(10) Where necessary, the market supervision authority has the right, in accordance with the rules set out in subsection 51 of § 49 of the Law Enforcement Act, to inspect, disassemble and test the movable acquired by way of the test transaction. The compensation of costs related to the test transaction is subject to the provisions of § 83 of the Law Enforcement Act.
(11) The transaction made in the course of a test transaction is void.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 562. Removal of information given via web interface, adding warning to web interface and restricting access to web interface
(1) Where there is a serious risk and there are no other effective means of averting or eliminating the risk, the market supervision authority has the right to issue a compliance notice to the administrator of a web interface and demand the removal of the information given via the web interface or, in the event of access to the web interface, that a warning be displayed to the end users.
(2) Where the demand made on the basis of subsection 1 of this section is not met, the internet connection-providing provider of an electronic communications service of general use is required to, in the event and on the basis of a compliance notice issued by the market supervision authority, restrict the domain name specified in the compliance notice in the name servers owned by it.
(3) Where the demand made on the basis of subsection 1 of this section is not met, the administrator or keeper of the domain registry is required to, in the event and on the basis of a compliance notice issued by the market supervision authority, restrict access to a domain or delete the registration of the domain name specified in the compliance notice and allow the market supervision authority to register the domain name.
(4) The provider of a service specified in subsections 1–3 of this section, the domain registry administrator or keeper is not liable for damage caused by the failure to make a transaction in the course of performance of the duties arising from this section, by the making of a transaction in a non-timely manner and by the restriction of the provision of the service.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 57. Notification of restrictions on placing products on market and information collected in course of market supervision
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(1) Dangerous products are notified to the Safety Gate Rapid Alert System of the European Union in accordance with Article 26 of Regulation (EU) 2023/988 of the European Parliament and of the Council.
[RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(2) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(3) [Repealed – RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(4) The procedure for notifying the European Commission of restrictions on placing a product on the market and information collected in the course of market supervision is established by a regulation of the Government of the Republic.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(5) Market supervision authorities submit information collected in the course of the market supervision of a harmonised area to the European Commission to the extent and in accordance with the procedure set out in Article 34 of Regulation (EU) 2019/1020 of the European Parliament and of the Council.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 58. Specifics of issuing precepts and maximum non-compliance levy
(1) Before a compliance notice is issued for the withdrawal from the market of products or recall of products from end users, or before the performance of a corresponding operation, the economic operator must be given the opportunity to submit objections. No opportunity to submit objections has to be given to the economic operator where the market surveillance authority is obligated to take measures without delay.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(2) Where an economic operator is not given the opportunity to submit objections before a compliance notice is issued for the withdrawal from the market of products or recall of products from end users or before a corresponding operation is performed due to the fact that the market supervision authority had to take measures without delay, the opinion of the economic operator must be obtained after the compliance notice is issued or the operation is performed.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
(3) In a compliance notice issued for the withdrawal of products from the market or recall of products from end users, and upon the performance of corresponding operations, the distributors and end users must be encouraged to participate in the implementation of the measures.
[RT I, 11.03.2025, 1 - entry into force 21.03.2025]
(4) The filing of an intra-authority appeal against a precept or step does not release the economic operator of the obligation to comply with the precept.
(5) In the event of failure to comply with a precept the maximum non-compliance levy imposed in accordance with the rules provided in the Substitutional Performance and Non-Compliance Levies Act is 10 000 euros.
[RT I 2010, 31, 158 - entry into force 01.01.2011]
§ 581. Joint measures for improving conformity
Market supervision authorities may conclude an administrative contract with organisations representing economic operators or consumers, which sets out the taking of joint measures in accordance with the rules and for the purpose provided in Article 9 of Regulation (EU) 2019/1020 of the European Parliament and of the Council and in the Administrative Co-operation Act.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
Chapter 7 LIABILITY
§ 59. Violation of conditions of placing products and making products available on market
(1) The penalty for violation of the conditions of placing a product on the market or making a product available on the market
is a fine of up to 300 fine units.
(2) The penalty for the same act committed by a legal person
is a fine of up to 32,000 euros.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 60. Failure to give notice of risks arising from products
(1) The penalty for failure to give notice of risks arising from products already placed on the market
is a fine of up to 200 fine units.
(2) The penalty for the same act committed by a legal person
is a fine of up to 32,000 euros.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 61. Misuse of conformity markings
(1) The penalty for the misuse of a conformity marking
is a fine of up to 200 fine units.
(2) The penalty for the same act committed by a legal person
is a fine of up to 32,000 euros.
[RT I, 22.10.2021, 3 - entry into force 01.11.2021]
§ 62. Proceedings
The out-of-court proceedings authorities regarding the misdemeanours provided in this Chapter are, within the limits of their competence, the Consumer Protection and Technical Regulatory Authority, the Health Board, the State Agency of Medicines, the Transport Administration, the Agriculture and Food Board and the Environmental Board.
[RT I, 20.11.2024, 1 - entry into force 01.01.2025]
Chapter 8 IMPLEMENTING PROVISION
§ 63. Entry into force of Act
This Act enters into force at the time and in accordance with the procedure provided in the Product Conformity Act Implementation Act.
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