ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of February 23, 2022 No. 108

About approval of the Technical regulation about individual protection equipment

Based on part (1) Article 18 and line item of the 7th appendix 3 to the Law No. 235/2011 on activities for accreditation and assessment of conformity (The official monitor of the Republic of Moldova, 2012, Art. No. 46-47, 136), with subsequent changes, DECIDES: the Government

1. Approve the Technical regulation about individual protection equipment it (is applied).

2. Items 52, of 59, of 76, of 77, of 78, of 80, of 82, 83 and 102-105 Technical regulations about individual protection equipment become effective along with entry into force of the law on ratification of the Agreement on assessment of conformity and the acceptability of manufactured goods between the Republic of Moldova and the European Union.

3. Before the date of entry into force of the law on ratification of the Agreement on assessment of conformity and the acceptability of manufactured goods between the Republic of Moldova and the European Union:

1) presence in the market of individual protection equipment with marking of compliance of SM put according to provisions of the Law No. 235/2011 on activities for accreditation and assessment of conformity is allowed;

2) the manufacturer puts marking of compliance of SM and issues the declaration of conformity in cases when assessment of conformity of the individual protection equipment intended for the national market is carried out by acknowledged conformity assessment bodies by use of the procedures provided in Chapter IV of the Technical regulation about individual protection equipment. Availability of marking of SE on means excludes need of drawing on the same means of marking of compliance of SM;

3) the provisions of this resolution concerning marking of SE and the declaration of conformity of the EU are applied equally to marking of compliance of SM and to the declaration of conformity;

4) the Ministry of Economic Development and digitalizations recognizes the bodies performing assessment of conformity of individual protection equipment according to the procedures provided in Chapter V of the Technical regulation about individual protection equipment. Requirements to notified conformity assessment bodies are applied also to the acknowledged conformity assessment bodies having similar legal regime according to provisions of the Law No. 235/2011 on activities for accreditation and assessment of conformity.

5) the list including acknowledged conformity assessment bodies with indication of specific objectives for which they were acknowledged and their identification numbers is kept by the National center for accreditation of the Republic of Moldova (MOLDAC) and published on its official web page.

4. Obligations and responsibility of the manufacturer, his authorized representative, importer or distributor - legal entities with the location in the Republic of Moldova concerning the means presented at the market with marking of compliance of SM and to which the declaration of conformity is attached correspond to those that are provided by this resolution for the means having marking of SE and to which the declaration of conformity of the EU is attached.

5. Certificates for individual protection equipment and decisions made according to the Order of the Government No. 1289/2016 on approval of the Technical regulation about individual protection equipment are valid till April 21, 2023, except for case if the term of their action did not expire before this date.

6. From the effective date this resolution to declare invalid the Order of the Government No. 1289/2016 about approval of the Technical regulation about individual protection equipment (The official monitor of the Republic of Moldova, 2016, Art. No. 423-429, 1388).

7. To impose control over the implementation of this resolution on the Ministry of Economic Development and digitalizations.

8. This resolution becomes effective after 12 months from the date of publication in the Official monitor of the Republic of Moldova.

Approved by the Order of the Government of the Republic of Moldova of February 23, 2022, No. 108

The technical regulation about individual protection equipment

This Technical regulation shifts Regulations (EU) 2016/425 European parliament and Council of March 9, 2016 about individual protection equipment and about cancellation of the Directive 89/686/EEC (the text is applicable in the EEA), published in the Official magazine of the European Union of L 81/51 of March 31, 2016.

Chapter I General provisions

Section 1 Subject and scope

1. The technical regulation about individual protection equipment (further - the Technical regulation) establishes requirements to designing and production of the individual protection equipment (further - SIZ) which is subject to placement in the market for the purpose of ensuring health protection and safety of consumers.

2. This technical regulation is not applied to the following SIZ:

1) designed especially for application by armed forces or for law enforcement;

2) SIZ designed for use for the purpose of self-defense, except for intended for sporting events;

3) designed for individual use for protection from:

a) weather conditions of not extreme nature;

b) moisture and water when washing ware;

4) held for use it is exclusive onboard sea or the aircrafts falling under action of the corresponding international treaties which party the Republic of Moldova is;

5) the protective helmets and their viewing peaks intended for protection of the head, person or eyes of drivers and passengers of motorcycles and mopeds.

Section 2 of Determination. Placement in the market. Main requirements for health protection and safety

3. For the purposes of this technical regulation, in addition to the concepts determined in the Law No. 235/2011 on activities for accreditation and assessment of conformity and the Law No. 20/2016 on national standartization the following determinations are used:

individual protection equipment (IPE):

1) the means designed and made for carrying or use by person for the purpose of protection against one or several risks menacing to safety and health;

2) interchangeable components of the means specified in the subitem 1), necessary for accomplishment by appropriate means of protective function;

3) connecting systems of the means specified in the subitem 1) which are not provided in order that held them or was carried by person, and are designed for connection of appropriate means to the external device or accession to reliable point of fixture which are not designed as constantly fixed and do not require attachment before use;

response - any measure directed to return of SIZ which already arrived to the end user;

withdrawal - any measure directed to non-admission of placement in the market of SIZ which are in supply chain.

4. SIZ can be placed in the market only if they correspond to this Technical regulation and do not pose health hazard and safety of persons, pets or property on condition of their proper storage and proper use.

5. Placement in the market of SIZ conforming to requirements of this Technical regulation cannot be forbidden.

6. At fairs, exhibitions, the presentations and other similar actions demonstration of SIZ which are not conforming to requirements of this Technical regulation is allowed provided that well visible sign clearly specifies that the relevant SIZ do not conform to requirements of this Technical regulation and cannot be delivered on the market before their reduction in full compliance. During the presentations it is necessary to take proper measures for ensuring protection of persons.

7. SIZ shall meet the main requirements for health protection and the safety provided in appendix No. 2.

Chapter II of the Obligation of business entities

Section 1 of the Obligation of manufacturers

8. In case of introduction of SIZ on the market manufacturers shall make sure that they are designed and made according to the main requirements for health protection and safety provided in appendix No. 2.

9. Manufacturers constitute the technical documentation specified in appendix No. 3, and carry out the corresponding assessment procedure of compliance specified in Items 50 and 51.

If compliance of SIZ to the main requirements for health protection and safety was shown by means of carrying out the corresponding assessment procedure of compliance, the manufacturer constitutes the declaration of conformity of the EU specified in Items 39-42, and puts the marking of SE specified in Items 43 and 44 .

10. Manufacturers shall store technical documentation and the declaration of conformity of the EU within 10 years from the moment of introduction of SIZ on the market.

11. Manufacturers develop and provide functioning of the procedures providing compliance of serial production to requirements of this Technical regulation. It is necessary to consider properly the changes concerning designing or characteristics of SIZ, and also change of the harmonized standards or other technical specifications taking into account which it is declared compliance of SIZ.

Every time when it is justified by threats which are posed by SIZ, for the purpose of protection of health and safety of consumers and other end users manufacturers hold selective testing of SIZ presented at the market, study circumstances and keep the register of claims of rather inappropriate SIZ and withdrawal of SIZ, and also notify distributors on any similar monitoring activities.

12. Manufacturers shall provide drawing on SIZ entered by them on the market of type, batch, serial number or other designations allowing them to identify, or if the size or nature of SIZ does not allow it, manufacturers shall be convinced that availability of necessary information is provided on packaging or in the document attached to SIZ.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info