LAW OF THE REPUBLIC OF MOLDOVA

of July 10, 2025 No. 197

About modification of some regulations (about activities for accreditation, assessment of conformity and standardization)

The Parliament adopts this organic law.

This law partially shifts:

- Regulations of the European parliament and Council (EC) No. 765/2008 of July 9, 2008 about establishment of requirements to accreditation and about cancellation of Regulations (EEC) No. 339/93 (the text concerning EEP) published in the Official magazine of the European Union of L 218 of August 13, 2008, CELEX: 02008R0765, with the subsequent changes made by Regulations of the European parliament and Council (EU) 2019/1020 of June 20, 2019;

- The decision of the European parliament and Council No. 768/2008/EC of July 9, 2008 determining general terms of sales of products and canceling the Decision of Council 93/465/EEC (the text concerning EEP), published in the Official magazine of the European Union of L 218 of August 13, 2008, CELEX: 32008D0768;

- Regulations of the European parliament and Council (EU) No. 1025/2012 of October 25, 2012 about the European standardization, about modification of directives of Council 89/686/EES and 93/15/EES and in directives of the European parliament and Council 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 and about cancellation of the Decision of Council 87/95/EES and Decisions of the European parliament and Council No. 1673/2006/EC (the text concerning EEP) published in the Official magazine of the European Union by L 316 of November 14, 2012, CELEX: 32012R1025, with the subsequent changes made by Regulations of the European parliament and Council (EU) 2023/988 of May 10, 2023.

Art. I. - The law on activities for accreditation and assessment of conformity No. 235/2011 (2012, Art. No. 46-47, 136), with subsequent changes, to mark the official monitor of the Republic of Moldova with the sign "UE" and to make the following changes to it:

1. Add with formula of harmonization of the following content:

"This law shifts:

- Regulations of the European parliament and Council (EC) No. 765/2008 of July 9, 2008 about establishment of requirements to accreditation and about cancellation of Regulations (EEC) No. 339/93 (the text concerning EEP) published in the Official magazine of the European Union by L 218 of August 13, 2008, CELEX: 02008R0765, with the subsequent changes made by Regulations of the European parliament and Council (EU) 2019/1020 of June 20, 2019;

- The decision of the European parliament and Council No. 768/2008/EC of July 9, 2008 determining general terms of sales of products and canceling the Decision of Council 93/465/EEC (the text concerning EEP), published in the Official magazine of the European Union by L 218 of August 13, 2008, CELEX: 32008D0768.".

2. In all text of the law:

"business entity" in the corresponding number and case shall be replaced with words words "the economic operator" in the corresponding number and case;

the words "the harmonizing legislation of Community" in the corresponding case shall be replaced with words "the harmonizing European Union law" in the corresponding case;

shall be replaced with words the words "declaration of conformity" in the corresponding case "the declaration CE/UE on compliance" in the corresponding case.

3. State Article 1 in the following edition:

"Article 1. Subject and scope of application

This law establishes:

a) the regulations regulating the organization and functioning of activities for accreditation of the conformity assessment bodies performing activities for assessment of conformity irrespective of whether accreditation on obligatory or voluntary basis, and also irrespective of legal status of the body performing activities for accreditation is used;

b) the regulations regulating general rules of realization of industrial output in the market of the Republic of Moldova;

c) the general principles concerning marking of CE and marking of compliance of SM.".

4. State Article 2 in the following edition:

"Article 2. Concepts

(1) for the purposes of this law the following concepts are used:

1) Agreement of ASAA - The agreement on assessment of conformity and the acceptability of industrial output - the protocol to the Agreement on association between the Republic of Moldova, on the one hand, both the European Union and European Atomic Energy Community and their state members, on the other hand;

2) accreditation - confirmation by national authority on accreditation of the fact that the conformity assessment body fulfills the requirements established by the harmonized standards and on circumstances any other additional requirements including provided in the corresponding sectoral schemes of accreditation, relating to implementation of specific activities for assessment of conformity;

3) the economic operator - the producer, the authorized representative, the importer and the distributor;

4) the appeal - the statement of conformity assessment body for review of any adverse judgement accepted by national authority on accreditation in connection with the status of accreditation for which the conformity assessment body applies;

5) the distributor - any physical person or legal entity in supply chain, except the producer or the importer, providing products in the market;

6) assessment of conformity - process by means of which accomplishment of the set requirements to product, process, service, system, face or body is estimated;

7) parity assessment - the process of assessment of national authority on accreditation performed by national authorities on accreditation of the states of the European Union according to requirements of this law and for circumstances according to other additional sectoral specifications;

8) the importer - any physical person or legal entity which enters on the market products from other country;

9) introduction on the market - the first provision of product in the market;

10) the harmonizing European Union law - the legislation harmonizing products sales terms;

11) marking of SE - marking by means of which the producer specifies that the product conforms to the applicable requirements established by the technical regulations providing its drawing on product;

12) conformity assessment body - the body performing activities for assessment of conformity including calibration, testing, certification and inspection;

13) national authority on accreditation - the body, single at the national level, having powers on carrying out accreditation according to this law;

14) the producer - any physical person or legal entity which makes product or for which such product is developed or made, realizing product under own name or under own brand;

15) provision in the market - delivery of product to the market for its placement, consumption or use within business activity on paid or free basis;

16) the authorized representative - any physical person or legal entity which is in writing authorized by the producer to carry out from his name the certain tasks connected with obligations of the producer according to this law and the corresponding technical regulations;

17) specifications - the document establishing technical requirements to which shall correspond product, process or service;

18) the harmonized standard - the standard accepted by one of the European bodies for standardization based on the requirement of the European commission about application of the harmonizing European Union law.

(2) for the purposes of this law technical regulations are the regulations shifting the harmonizing European Union law, and products are understood as nonfood and nonagricultural products in the regulated areas specified in appendix 3, intended for consumption or professional use.".

5. Recognize Article 3 invalid.

6. State Article 4 in the following edition:

"Article 4. The central industry body of public management, the politician, responsible for development, in the field of accreditation and assessment of conformity of products

(1) State policy in the field of accreditation and assessment of conformity is developed by the Ministry of Economic Development and digitalizations as the central industry body of the public management responsible for quality infrastructure.

(2) Ministry of Economic Development and digitalizations:

a) provides appointment of national authority on accreditation on the basis of the competences confirmed to them;

b) informs the European commission and the "European Cooperation on Accreditation" organization on appointment of the national authority for accreditation and on all types of activity on assessment of conformity for which this body performs activities for accreditation in support of technical regulations, and also about any changes concerning national authority on accreditation;

c) performs regular monitoring of national authority on accreditation for the purpose of ensuring its permanent compliance to the requirements provided by this law and fully considers results of the parity assessment which is carried out by the "European Cooperation on Accreditation" organization;

d) guarantees regular passing of parity assessment by national authority on accreditation and considers results of this assessment;

e) provides application of the adequate adjusting measures in case of non-compliance by national authority on accreditation of requirements of this law or failure to carry out of the obligations assigned to it by it according to this law and informs on it the European commission.

(3) For the purpose of assistance to enforcement of provisions of this law the Ministry of Economic Development and digitalizations places for acquaintance of the public and concerned parties on official web to the page of management, published by the European commission, concerning activities for accreditation of conformity assessment bodies.".

7. Add the law with Article 4-1 of the following content:

"Article 4-1. General principles

(1) Activities for accreditation of conformity assessment bodies in the Republic of Moldova are performed by the National center for accreditation as the single national authority on accreditation. The abbreviated name of the National center for accreditation - MOLDAC.

(2) the National center for accreditation develops sectoral schemes of accreditation in cooperation with the regulating bodies. In case of recognition of certain schemes of accreditation economically unjustified or unstable conformity assessment bodies in the Republic of Moldova can use services of accreditation body in the state of the European Union having competence of the relation of the corresponding schemes.

(3) Activities for accreditation are performed by the public organization "National Center for Accreditation" operating in the mode of the public power.

(4) for the purposes of notification of task and obligation of the National center for accreditation differ from tasks and obligations of the regulating bodies connected with recognition of conformity assessment bodies.

(The National center for accreditation does not offer 5) / does not provide any types of activity or the services provided by conformity assessment bodies and also does not provide consulting services, does not hold shares or has no other financial or administrative interests in any conformity assessment body.

(6) the National center for accreditation is member of the organizations for accreditation "The European cooperation on accreditation", "International cooperation on accreditation of laboratories", "The international forum on accreditation".

(7) the National center for accreditation does not compete with conformity assessment bodies.".

8. In Article 5:

to state the name of Article in the following edition:

"Article 5. Principles of activities National

center for accreditation";

in part (1):

in water part of the word "The national authority on accreditations and conformity assessment bodies is carried out" shall be replaced with words "The national center for accreditation carries out";

in Item and) to exclude the words "and regional";

in part (2):

in water part of the word "The national authority on accreditations and conformity assessment bodies is performed" shall be replaced with words "The national center for accreditation performs";

Items a) - c) to state in the following edition:

"a) application of single procedures for accreditation of the conformity assessment bodies developed on the basis of the special documents published by the European and international organizations for accreditation specified in part (6) Article 41;

b) competence, objectivity and impartiality;

c) transparency;";

Item f) to declare invalid;

Item h) to state in the following edition:

"h) objective and impartial consideration of appeals and claims.".

9. State Article 6 in the following edition:

"Article 6. The harmonized standards

(1) the Harmonized standards or their parts, references to which are published in the Official magazine of the European Union and which, in addition, establish criteria of competence of national authority on accreditation and conformity assessment bodies are accepted as the Moldavian standards.

(2) the National center for accreditation and conformity assessment bodies shall observe constantly the Moldavian standards accepting the applicable harmonized standards.

(3) If application of the harmonized European Union law provides use of the harmonized standards, the list of the Moldavian standards accepting these standards affirms the order of the Minister of Economic Development and digitalization and is published in the Official monitor of the Republic of Moldova. The list of standards is updated as required.".

10. In Article 7:

to state the name of Article in the following edition:

"Article 7. Organization and functioning of the National center for accreditation";

parts (1) and (to recognize 2) invalid;

part (to state 3) in the following edition:

"(3) the National center for accreditation is the public organization created according to the Law on the central branch public management No. 98/2012, of which founder the Ministry of Economic Development and digitalizations acts.";

add Article with part (3-1) following of content:

"(3-1) National center for accreditation as national authority on accreditation do not submit to any public or private subject.";

in part (the words "under preliminary approval of the Commission of Parliament on economy, the budget and finance" to exclude 4);

in parts (5) and (6) words of "the head of the central industry body of the public management responsible for quality infrastructure" shall be replaced with words "the Minister of Economic Development and digitalizations";

in part (7) change concerns only the text in Romanian;

in Item b) parts (8) words "accreditations and assessments of conformity in cases when the Center is not capable to plow back." to replace with the word "accreditations".

11. State Article 8 in the following edition:

"Article 8. Powers of the National center for accreditation

(1) National center for accreditation:

a) develops accreditation and certifies in technical competence and integrity of conformity assessment bodies;

b) establishes the procedures necessary for ensuring effective management and proper internal control;

c) creates and supports the relevant structures for ensuring the effective and balanced participation of all concerned parties both within own organization, and within the "European Cooperation on Accreditation" organization;

d) determines types of activity by assessment of conformity concerning which he is competent to perform accreditation, with sending, in case of need, on provisions of the harmonizing European Union law or corresponding national legal system, and also on the Moldavian standards or the conforming European standards;

e) based on request carries out assessment of conformity assessment body regarding his competence to perform the certain type of activity relating to assessment of conformity and in case of confirmation of such competence issues the certificate of accreditation for the corresponding type of activity;

f) performs competence maintenance monitoring by conformity assessment bodies which issued certificates of accreditation;

g) provides competent and operational accomplishment of the functions without establishment of exacting terms for applicants of accreditation;

h) participates in the European system created for supervision of activities for carrying out parity assessment, but does not participate in separate procedures of parity assessment;

i) cooperates with the national regulating authorities determined by the Law on technical regulation No. 420/2006, and the politician in the field of accreditation and assessment of conformity interacts with non-profit organizations in development national;

j) establishes and applies selection criteria, monitoring, training and appointment of appraisers, the technical experts involved in accreditation process;

k) constitutes documentation determining tasks, obligations and powers of personnel which can exert impact on quality of evaluating and certification of competence;

l) participates at national, European and international level in the course of development of standards in the field of activity;

m) books audit of the annual financial reporting and publishes this reporting, and also the corresponding audit opinion according to provisions of the Law on financial accounting and the financial reporting No. 287/2017.

(2) the National center for accreditation can wage on demand the information and training campaigns for conformity assessment bodies and other interested economic operators concerning importance and role of accreditation.

(3) For the purpose of accomplishment of the powers the National center for accreditation shall:

a) keep accounting records about activities for accreditation, including about activities of the technical committees, appraisers and experts involved in activities for accreditation;

b) make available to the public information on the activities, including managements, instructions and other;

c) inform the regulating bodies on activities in the field of accreditation and provide on demand examination;

d) develop politicians, rules and procedures of system of management providing transparency and reliability of process of accreditation;

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