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.
Prime Minister
Natalya Gavrilitsa
|
Countersigns: Minister of Economic Affairs |
Serdzhiu Gaybu |
Approved by the Order of the Government of the Republic of Moldova of February 23, 2022, No. 108
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.
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) the 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 visors intended for protection of the head, person or eyes of drivers and passengers of motorcycles and mopeds.
3. For the purposes of this Technical regulation the following determinations are used:
1) individual protection equipment (IPE):
a) 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;
b) interchangeable components of the means specified in letter and), necessary for accomplishment by appropriate means of protective function;
c) connecting systems of the means specified in letter and) which are not provided in order that held them or carried 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;
2) placement in the market - delivery of SIZ for their distribution, consumption or use in the market of the Republic of Moldova within business activity on paid or free basis;
3) introduction on the market - the first ensuring presence of SIZ in the market of the Republic of Moldova;
4) the producer - any physical person or legal entity which makes SIZ or for which SIZ realizing SIZ under own name or trademark is developed or made;
5) the authorized representative - any physical person or legal entity with the location in the Republic of Moldova which was in writing authorized by the producer to carry out certain tasks from his name;
6) the importer - any physical person or legal entity with the location in the Republic of Moldova which enters on the market of the Republic of Moldova SIZ from the third country;
7) the distributor - any physical person or legal entity in supply chain, except the producer or the importer, the providing placement of SIZ in the market;
8) economic operators - the producer, the authorized representative, the importer and the distributor;
9) the technical specification - the document ordering technical requirements to SIZ;
10) the harmonized standard - the harmonized standard as it is determined in article 2 of the Law No. 20/2016 on national standartization;
11) accreditation - accreditation as it is determined in article 2 of the Law No. 235/2011 on activities for accreditation and assessment of conformity;
12) national authority on accreditation - national authority on accreditation as it is determined in article 2 of the Law No. 235/2011 on activities for accreditation and assessment of conformity;
13) assessment of conformity - process by means of which SIZ compliance degree to the main requirements for health protection and the safety specified in this Technical regulation is shown;
14) conformity assessment body - the body performing activities for assessment of conformity including calibration, testing, certification and inspection;
15) response - any measure taken for the purpose of return of SIZ which were already made available to the end user;
16) withdrawal - any measure taken for the purpose of prevention of placement in the market of SIZ in supply chain;
17) the harmonizing legislation of the Union - any European Union law harmonizing products sales terms;
18) marking of SE - marking by means of which the producer specifies that SIZ conform to all applicable requirements established in the harmonizing European Union law providing its drawing on products
.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 corresponding 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.
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.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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