Pursuant to the provisions of article 18 and annex 3 of the position. 3 the law nr. 235 of 1 December concerning the activities of accreditation and conformity assessment (Official Gazette of the Republic of Moldova, 2012, nr. 46-47, art. 136), the Government DECIDES: 1. Approving the technical regulation on the safety of toys, according to the annex 1.
2. this decision shall enter into force 24 months after the date of its publication in the Official Gazette of the Republic of Moldova, with the exception of: 1) 53 points, 85, 88, 118, 121-122, 140-141 of the technical regulation on safety of toys, which will enter into force on the date of signing the agreement on conformity assessment and acceptance of industrial products between the Republic of Moldova and the European Union;
point 2 of 2) section II and sections 2 to 5 of section III of the annex. 2 the safety technical regulation of toys, which will enter into force simultaneously with the entry into force of national legislation concerning the classification, labelling and packaging of substances and mixtures;
3 section 10) of point III of the annex. 2 the safety technical regulation of toys, which will enter into force simultaneously with the entry into force of national laws relating to cosmetic products.
3. Before the signing of the agreement on conformity assessment and acceptance of industrial products between the Republic of Moldova and the European Union: 1) is allowed in making available of the toy on the market under the trademark of conformity under SM, applied the law. 235 of 1 December 2011 on the activities of the accreditation and conformity assessment;
2) the manufacturer or his authorised representative, a legal person with headquarters in the Republic of Moldova, applied mark SM where conformity assessment of toys for the domestic market shall be carried out by the conformity assessment bodies recognized by the Ministry of the economy, through the use of the procedures laid down in chapter XIV of regulation of technical safety of toys. It is prohibited, under the conditions laid down in this decision, the application of the same toy mark SM and has the CE marking;
3) Ministry of economy recognizes the bodies carrying out conformity assessment of toys for the domestic market in accordance with the procedures laid down in chapter XIV of regulation of technical safety of toys;
4) requirements relating to conformity assessment bodies notified also applies to conformity assessment bodies recognized. To conduct conformity assessment procedures the conformity assessment bodies recognized performing conformity assessment of toys will make out the type-examination certificates;
5) notification procedure is similar to the recognition procedure;
6) containing the list of recognized bodies, the specific tasks for which they have been recognised and their identification numbers is approved and will be updated by order of the Minister of economy, to be published in the Official Gazette of the Republic of Moldova;
7) this judgment relating to the CE marking apply to mark SM. Obligations of the manufacturer, his authorised representative, the importer or the Distributor, legal entities established in the Republic of Moldova concerning toys available on the market under the trademark SM are similar to those laid down in this decision for the toys with CE marking.
5. From the date of entry into force of the technical regulation on the safety of toys is repealed some of the Government's decisions, according to the annex 2.
6. control of the execution of the given decision is put in charge of the Ministry of economy.
Prime Minister Countersigns Larson: Deputy Prime Minister, Minister of economy, Minister of health Bridе Stephane Christophe Onofre Gallegos No. 808. Chisinau, October 29, 2015.
Annex 1 to Decision No. 808 of 29 October 2015 REGULATION TEHNICĂprivind regulating the safety of toys, the toy safety data transposing Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, as published in the official journal of the European Union L 170 of 30 June 2009.
I. SCOPE Of APPLICATION 1. Toy safety technical regulation (hereinafter-technical regulation) lays down the conditions concerning the safety of toys.
2. Technical Regulation shall apply to products designed or intended, exclusively or non-exclusive, to be used for playing by children with an age less than 14 years of age (hereinafter-toys).
3. the products listed in the annex. 1-technical regulation are not regarded as toys for the purposes of the present technical regulations.
4. Technical Regulation shall not apply to the following toys: 1) playground equipment intended for public use;
2) automatic entertainment machines that work with or without coins, intended audience;
3) toy vehicles equipped with combustion engine;
4) toys with the steam engine;
praștiile 5) and catapults.
II. Getting Started 5. For the purposes of this Regulation shall be used as defined in the law. 235 of 1 December concerning the activities of accreditation and conformity assessment, as well as the basics below, with the following meaning: trader-the manufacturer, his authorised representative, the importer and the Distributor;
intended by a parent or guardian may reasonably consider, by virtue of its functions, dimensions and characteristics of a particular toy, this is intended for children from the age category in question;
aquatic toy-toy intended for use in water depth small, able to lead or support the child in water;
activity toy-toy intended for the home, whose supporting structure remains fixed throughout the work, to perform the following tasks by a child: escalation, skip, seesaw, gliders, rocking, învîrtire, tîrîş or crawling, or any combination thereof;
functional toy-toy that has the same role and is used in the same way as a product, appliance or installation intended for/intended by adulthood, which may be a reduced scale model of such a product, appliance or installation;
olfactory board game-toy whose purpose is to help a child to identify different smells or flavors;
taste game-toy whose purpose is to allow children to prepare sweets or to carry out the dishes that involve the use of food ingredients such as minerals that sweetness, liquids, powders and scents;
chemical-toy toy intended for direct handling of chemical substances and mixtures, which is used in a manner appropriate to the age and under the supervision of an adult;
CE marking-marking by which the manufacturer indicates that the toy complies with the applicable requirements set out in the technical regulations providing for its application on the toy;
hazard-potential source of harm;
functional product-product that has the same role and is used in the same way as a product, appliance or installation intended for/intended by adulthood, which may be a reduced scale model of such a product, appliance or installation;
recall-any measure taken in order to return a toy that was already available to the end user;
withdrawal-any measure taken in order to impede the making available on the market of a toy in the distribution chain;
risk-the probability of occurrence of a hazard of personal injury and the severity of the injury;
the harmonised european standard-standard, elaborated on the basis of a mandate from the European Commission and adopted by a European standards organisation, which confers a presumption of conformity with the essential requirements from a technical regulation is applicable, covered by such a standard;
market surveillance-activities and measures taken by the authorities to monitor the market to ensure that toys comply with the applicable requirements or are that it does not endanger health, safety or other issues relating to the protection of public interests;
cosmetic Kit-toy whose purpose is to help the child to learn to realize products such as perfumes, soaps, creams, shampoos, bath foams, lip gloss (glossuri), lipsticks, make-up products, toothpaste and hair conditioners;
personal injury-physical injury or any other harmful effects on health, including long-term effects on health;
the designed speed-normal operating speed, determined by the design of the toy.
III. OBLIGATIONS Of MANUFACTURERS 6. The placing on the market of toys, manufacturers shall ensure that they have been designed and manufactured in conformity with the essential safety requirements laid down in Chapter VIII, and annex 2 to this Regulation.
7. manufacturers shall draw up technical documentation required under Chapter XVI of technical regulation and perform or have performed the procedures applicable to conformity assessment as referred to in chapter XIV of the technical regulation.
Where it has been demonstrated compliance with the applicable requirements of a toy through the procedure, manufacturers shall draw up a written declaration of conformity and affix the CE marking.
8. manufacturers shall keep the technical documentation and Declaration of conformity for a period of 10 years after the toy has been placed on the market.
9. manufacturers shall ensure that procedures are in place to ensure the continued conformity of series production. Changes in the design or characteristics and changes of the toy of harmonised standards to which reference is made in order to declare conformity of a toy is taken into account properly.
Whenever this is justified by the risks presented by a toy, manufacturers, in order to protect the health and safety of consumers, try toys placed on sampling, investigates and shall keep a register of complaints for non-conforming toys and for consumer recalls of toys as well as inform distributors of any such monitoring.
10. manufacturers shall ensure that their toys are indicated on the type, batch or serial number or model number or other identifier. Where the size or nature of the toy does not allow it, manufacturers shall ensure that the information requested is provided on the packaging or in a document accompanying the toy.
11. manufacturers shall indicate their name on the toy, their trade name or registered trade mark, and the address to which they can be contacted. If this is not possible, this information indicates producers on the packaging or in a document accompanying the toy. The address must indicate a single point of contact for the manufacturer.
12. manufacturers shall ensure that the toy is accompanied by instructions and safety information translated into the State language to be understood by consumers.
13. manufacturers who consider or have reason to believe that a toy which they have entered the market do not comply with the legislation in force shall take immediate corrective measures to ensure that the toy is brought in accordance with the legislation of the time that it be withdrawn or recalled as appropriate. Where the toy presents a risk, manufacturers shall immediately inform the Consumer Protection Agency, indicating details, especially with regard to non-compliance and of any corrective measure taken.
14. producers, where possible noncompliance are obvious, at the reasoned request of the Consumer Protection Agency, provide its all information and documentation required, translated into the State language to demonstrate the conformity of the toy.
Producers cooperate with Consumer Protection Agency, at its request, on any action taken to eliminate the risks posed by toys placed on the market.
IV. OBLIGATIONS Of AUTHORISED REPRESENTATIVES 15. A producer may appoint an authorized representative by means of an authorization in writing.
16. the manufacturer's Obligations set out in point 6 of the technical regulation and technical documentation are not included in the authorised representative's mandate.
17. The authorised representative fulfils the tasks set out in the mandate received from the manufacturer. The mandate allows the authorised representative to meet at least the following: 1) keep the Declaration of conformity and the technical documentation at the disposal of the Agency for consumer protection for a period of 10 years after the toy has been placed on the market;
2) where possible noncompliance are obvious, at the reasoned request of the Consumer Protection Agency, to supply to the Commission all information and documentation necessary to demonstrate the conformity of a toy;
3) to co-operate with the Consumer Protection Agency, at their request, on any action taken to eliminate the risks posed by toys which they hold a warrant.
V. OBLIGATIONS Of IMPORTERS. Importers placed on the market only toys which are in conformity with the requirements of the present technical regulations.
19. before placing a toy on the market importers shall ensure that the procedure to be followed for the conformity assessment has been carried out by the manufacturer.
20. Importers shall ensure that the manufacturer has drawn up the technical documentation, that the toy bears the required conformity marking and is accompanied by the prescribed documents and that the manufacturer has respected the requirements set out in paragraphs 10 and 11 of this regulation.
21. Where an importer considers or has reason to believe that a toy does not comply with the essential safety requirements laid down in Chapter VIII, and annex No. 2 the technical regulation, it did not enter the toy on the market until it is not brought into conformity with those requirements.
Where the toy presents a risk, the importer shall inform the manufacturer and the Consumer Protection Agency.
22. Importers shall indicate their name on the toy, their registered name or mark, and the address to which they can be contacted. If this is not practicable, such information shall be indicated on the packaging or in a document accompanying the toy.
23. Importers shall ensure that the toy is accompanied by instructions and safety information translated into the State language to be understood by consumers.
24. Importers shall ensure that, while a toy is located under their responsibility, storage or transport conditions do not jeopardize its compliance with the requirements laid down in Chapter VIII, and annex 2 to this Regulation.
25. Where this is appropriate to the risks presented by a toy, in order to protect the health and safety of consumers, importers trying toys placed on sampling, investigating and, if necessary, keep a register of complaints for non-conforming toys and for consumer recalls of toys as well as inform distributors of any such monitoring.
26. Importers who consider or have reason to believe that a toy placed on the market do not comply with the legislation in force shall take the necessary corrective measures immediately to remove the noncompliance, to withdraw or recall a toy from the market. Where the toy presents a risk, importers shall immediately inform the Consumer Protection Agency, indicating details, especially with regard to non-compliance and of any corrective measure taken.
27. Importers shall keep a copy of the Declaration of conformity at the disposal of the Agency for consumer protection for a period of 10 years after the introduction of the toy market and ensure that the technical documentation can be made available to it, at your request.
28. Importers shall, where possible noncompliance are obvious, at the reasoned request of the Consumer Protection Agency, supplying all the information and documentation required, translated into the State language, to demonstrate compliance of a toy.
Importers shall cooperate with the Consumer Protection Agency, at its request, on any action taken to eliminate the risks posed by toys made available on the market.
Vi. OBLIGATIONS Of DISTRIBUTORS. In case you have a toy on the market, distributors shall act with responsibility in relation to the applicable requirements.
30. Before a toy on the market, distributors shall verify that the toy has the CE marking of conformity, shall be accompanied by the necessary documents, instructions and safety information translated into the national language and whether the manufacturer and the importer have respected the requirements set out in paragraphs 10, 11 and 22 of the present Technical Regulations.
31. When a distributor considers or has reason to believe that a toy does not comply with the requirements laid down in Chapter VIII, and annex No. 2 the technical regulation, it shall not make available the toy on the market until it is not brought into conformity with those requirements. Where the toy presents a risk, the distributor shall inform the manufacturer or importer and Consumer Protection Agency.
32. Distributors shall ensure that, while a toy is located under their responsibility, storage or transport conditions do not threaten compliance with the requirements laid down in Chapter VIII, and annex No. 2 to this Regulation.
33. Distributors who consider or have reason to believe that a toy placed on the market do not comply with the legislation in force shall ensure that the necessary corrective measures are taken to remove the noncompliance, to withdraw or recall a toy from the market. Where the toy presents a risk, distributors shall immediately inform the Consumer Protection Agency, indicating details, especially with regard to non-compliance and of any corrective measures taken.
34. Distributors, where possible noncompliance are obvious, at the reasoned request of the Consumer Protection Agency, supplying all the information and documentation necessary to demonstrate the conformity of a toy.
Distributors are cooperating with Consumer Protection Agency, at its request, on any action taken to eliminate the risks posed by toys made available on the market.
Vii. IDENTIFICATION Of 35 ECONOMIC AGENTS. An importer or a Distributor is deemed for the purposes of this regulation producer and producer obligations incumbent under Chapter III of the present Technical Regulations when placed on the market a toy under the name or trademark of the time change a toy already placed on the market in a way that may affect compliance with the requirements.
36. Businesses, where are obvious possible noncompliance shall, upon request, the Consumer Protection Agency identification data: 1) any economic operator who has supplied them a toy;
2) any economic operator to whom they have supplied a toy.
37. Economic operators shall be able to submit the information specified in point 36 of this Regulation for a period of 10 years following the placing on the market of toys, in case of a manufacturer, and for a period of 10 years after the toy has been provided, in the case of other economic agents.
VIII. ESSENTIAL SAFETY REQUIREMENTS 38. The toys are placed on the market only if they comply with the basic safety requirements laid down respectively the General safety requirements laid down in points 39 to 41 and the particular safety requirements laid down in the annex. 2.39. Toys, including the chemicals they contain, must not endanger the safety or health of users or third parties when they are used in accordance with their intended purpose or when am in a foreseeable way, with regard to the normal behaviour of children.
40. The ability of users and, where applicable, to their supervisors shall be taken into account, in particular, in the case of toys which are intended for use by children under 36 months of age or any other age groups.
41. The labels applied in accordance with points 45 and 46 of the technical regulation and the instructions for use which accompany the toys attract attention of users or their supervisors to the inherent hazards and risks of injury arising from the use of toys and how to avoid them.
42. Toys placed on the market shall comply with the essential safety requirements along predictable period or normal use.
43. the making available of the toy on the national market which complies with the provisions of the present technical regulations may not be hindered.
IX. 44. In order to guarantee the safe use, warnings made under 39-41 of the technical regulation specifies limits to appropriate use, in accordance with part A of the annex. 5 the technical regulation.
45. For the categories of toys listed in part B of the annex. 5, taking into account the warnings set out therein. The warnings referred to in paragraphs 2 to 10 of part B of the annex. 5 the technical regulation must be used as are formulated.
46. Toys shall not be accompanied by one or more of the specific warnings set out in part B of the annex. 5 the technical regulation where the warnings do not correspond to the intended use for the toys in question, with regard to the position, size and characteristics.
47. the manufacturer shall affix the warnings in a clearly visible and easily legible, comprehensible and accurate on the toy, on an affixed label or on the packaging and, where appropriate, on the instructions for use which accompany the toy. Small toys sold without packaging have appropriate warnings affixed to them.
48. The warnings are preceded by the word "warning" or "Warnings", as appropriate.
49. Warnings that determine the decision to purchase the toy, such as those specifying the minimum and maximum age of the user and the other applicable warnings set out in the annex. 5 the technical regulation shall be indicated on the packaging or marketing are clearly visible to the consumer before the purchase, including when the purchase is made through electronic means.
50. The warnings and safety instructions must be written in language understandable to consumers.
X 51. PRESUMPTION Of CONFORMITY. Toys which comply, in whole or in part, the harmonized standards relating to toys whose references have been published in the official journal of the European Union, adopted by the Moldovan standards, are deemed to comply with the essential requirements laid down in Chapter VIII, and annex No. 2 to this Regulation.
52. the list of Moldovan standards which harmonised standards adopted toys is approved through order of the Ministry of economy shall be published in the Official Gazette of the Republic of Moldova and is updated as often as necessary to, but not less frequently than once a year. 53. Where it considers that a harmonised standard does not entirely satisfy the requirements of the subject and the requirements that are set out in Chapter VIII, and annex. 2 in this regulation, the Ministry of economy shall inform the European Commission for the purposes of the procedure for the provision of information in the field of technical standards and regulations, by giving the arguments of its intervention.
XI. STATEMENT Of COMPLIANCE 54. Declaration of conformity certifying that the requirements laid down in Chapter VIII, and annex No. 2 the technical regulation has been demonstrated.
55. Declaration of conformity shall contain at least the elements set out in the annex. 3 and in the relevant modules set out in annex 4. 6 the technical regulation and updated at all times. The Declaration of conformity shall be drawn up in the language or translated, in accordance with the model set out in annex 4. 3 to this Regulation.
56. by drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the toy.
XII. GENERAL PRINCIPLES Of The CE MARKING 57. Toys made available on the market bearing the CE marking.
58. The CE marking shall be applied only by the manufacturer or his authorized representative on Toys falling within the scope of the present technical regulations.
59. In that it applied or asked of the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the toy with the applicable requirements set out in this Regulation.
60. The CE marking is the only marking which attests conformity of the toy with the applicable requirements set out in this Regulation.
61. the affixing on products of some markings, signs or inscriptions which are likely to mislead third parties with regard to the meaning and/or form of the CE marking. The toys can be applied to any other mark, provided that the latter are not affected the visibility, legibility and meaning of the CE marking.
62. Toys which have CE marking comply with the technical regulation.
63. Toys which do not have CE marking, or in another manner the provisions of the present technical regulations can be presented without being displayed for sale in connection with fairs or exhibitions, provided that they are accompanied by a notice that clearly indicates that the toys do not comply with this regulation and that they will not be made available on the market before fulfilling the requirements of compliance.
Xiii. RULES And CONDITIONS For The AFFIXING Of The CE 64. The CE marking shall be affixed visibly, legibly and indelibly marked without could be either toy, a label affixed on the packaging, either.
65. In the case of small toys and toys consisting of small parts the CE marking may alternatively be affixed on a label or an accompanying leaflet. If this is not possible for technical reasons, in the case of toys sold through vending machines, and provided that the machine may have been originally used as packaging for toys, CE marking is applied to on automatically.
66. If the CE marking is not visible from outside the packaging, if any, should be applied at least on the packaging.
67. The CE marking shall be applied before the toy to be placed on the market. It may be accompanied by a pictogram or any other mark indicating a special risk or use special and the identification number of the notified body.
Xiv. The Conformity Assessment PROCEDURES 68. Before placing on the market of a toy, manufacturers shall carry out an analysis of the dangers of chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity that the toy may present and an assessment of the potential exposure to them.
69. Before inserting toys on the market, manufacturers shall use the conformity assessment procedures referred to in paragraphs 70 to 72 of this technical regulation, to demonstrate that the toys comply with the requirements laid down in Chapter VIII, and annex No. 2 to this Regulation.
70. If the manufacturer has applied the harmonised standards relating to toys whose references have been published in the official journal of the European Union, adopted by the Moldovan standards, under which are all relevant safety requirements for the toy, it applies the internal production control procedure set out in module A of annex 4. 6 to this regulation.
71. The toy is subject to the EC type-examination referred to in Chapter XV of the technical regulation, combined with the conformity to type procedure set out in module C of annex 4. 6 to this Regulation, in the following cases: 1) when harmonised standards whose references have been published in the official journal of the European Union, adopted by the Moldovan standards, under which are all relevant safety requirements for the toy does not exist;
2) when harmonised standards referred to in subparagraph (1)) of this section exists, but the manufacturer has not applied, or has applied them only in part;
3) where the harmonised standards referred to in subparagraph (1)) of this paragraph or any of these have been published with a restriction.;
4) when the manufacturer considers that the nature, design, construction or purpose of the toy necessitate verification by a third party.
Xv. EC TYPE-EXAMINATION 72. Submission of an application for EC type-examination, the conduct of the examination and the issuance of the certificate of EC type-examination shall be conducted in accordance with the procedure set out in module B of the annex. 6 to this regulation.
73. In addition to the provisions set out in module B, shall apply the requirements set out in sections 74-79 of this regulation.
74. the application for EC type-examination shall include a description of the toy and an indication of the place of manufacture, including the address.
75. Where a conformity assessment body notified shall carry out the EC type-examination, it shall evaluate, if necessary in conjunction with the manufacturer, the analysis of the hazards that the toy may present, carried out by the manufacturer in accordance with section 68 of the present Technical Regulations.
76. a certificate of EC type-examination shall include a reference to technical regulation, a colorful image and a clear description of the toy, including its dimensions, and a list of the tests performed, making reference to the relevant test report.
77. a certificate of EC type-examination shall be reviewed whenever necessary, in particular in the event of a change in the manufacturing process, the raw material or components of the toy and, in any case, every 5 years.
78. a certificate of EC type-examination is withdrawn if the toy fails to comply with the requirements laid down in Chapter VIII, and annex No. 2 to this Regulation.
79. It is prohibited to notified bodies to issue an examination certificate for toys which have been refused or revoked a certificate of EC type-examination by a notified body.
Xvi. TECHNICAL DOCUMENTATION. The technical documentation referred to in point 7 of the technical regulation shall contain all relevant data and details of the means used by the manufacturer to ensure that toys comply with the requirements laid down in Chapter VIII, and annex No. 2 the technical regulation and, in particular, contain the documents listed in the annex. 4 the technical regulation.
81. The technical documentation and correspondence relating to the procedures for the EC type-examination are drawn up in the official language or in an international language.
82. At the duly motivated request of the Agency for the protection of consumers, the manufacturer provides the translation of the relevant parts of the technical documentation.
83. When the Consumer Protection Agency is requesting a technical documentation or a translation of parts of it, it may fix a time limit of 30 days to comply with the request, if the existence of a serious and immediate risk does not justify the establishment of a shorter period.
84. Where the manufacturer does not comply with the obligations laid down in paragraphs 80 to 83 of this technical regulation, Consumer protection agency requesting him to make an attempt at a notified body at his own expense, in order to verify conformity with the harmonised standards and essential safety requirements.
Xvii. NOTIFICATION AUTHORITIES 85. The Ministry of economy shall notify the European Commission of the conformity assessment bodies designated to carry out conformity assessment tasks as third parties, under the present technical regulations.
86. The Ministry of Economic Affairs is the authority responsible for notification of establishment and completion of the procedures necessary for the assessment and notification of conformity assessment bodies for the purposes of this regulation and for the monitoring of notified bodies.
87. The assessment and monitoring referred to in paragraph 86 of this technical regulation is carried out by the national accreditation body.
88. The Ministry of economy shall inform the European Commission in relation to their recognition procedures and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereof.
XVIII. REQUIREMENTS TOWARDS the REGULATORY AUTHORITY RESPONSIBLE for NOTIFICATION of conformity ASSESSMENT BODIES 89. The Ministry of economy shall notify only conformity assessment bodies which have satisfied all the requirements applicable to them set out in this Regulation.
90. The Ministry of economy: 1) ensures objectivity and impartiality in decision-making with regard to notification of the conformity assessment bodies;
2) shall ensure that the decision regarding the notification of conformity assessment bodies by a different person than the one who participated in the evaluation of the conformity assessment bodies;
3) does not provide and does not provide any one of the activities which they provide conformity assessment bodies, no consulting services in commercial or competitive conditions;
4) guarantees the confidentiality of the information obtained;
5) available to competent personnel in order to accomplish their tasks properly.
Xix. REQUIREMENTS CONCERNING NOTIFIED BODIES 91. To be notified, a conformity assessment body meets the requirements set out in paragraphs 92-107 of the technical regulation.
92. the conformity assessment Bodies are established on the basis of national law and have legal personality.
93. the conformity assessment Bodies are impartial and independent bodies are not directly involved in the organization or the toy which it assesses, avoiding conflicts of interest during the evaluation.
94. An organism that belongs to an Association of undertakings or a professional Federation representing undertakings involved in the design, manufacturing, provision, Assembly, use or maintenance of toys which it assesses may be considered to be such a body, provided that it is shown that is independent and that there are no conflicts of interest.
95. the conformity assessment Body, the General management of the staff and the staff responsible for carrying out the conformity assessment tasks may not be the designer, manufacturer, supplier, Installer, purchaser, owner, user or operator maintenance of toys which they assess, nor the authorised representative of any of those parties. This does not prevent the use of toys which are necessary for the evaluated operations of the conformity assessment body or the use of these toys for personal purposes.
96. the conformity assessment Body, the General management of the staff and the staff responsible for carrying out the conformity assessment tasks may not be directly involved in the design or construction, the marketing, installation, use or maintenance of the toy concerned and do not represent the parties engaged in those activities. They shall not engage in any activities that might affect their impartiality or integrity in relation to conformity assessment activities for which they are notified. These provisions shall apply, in particular consultancy services.
97. the conformity assessment Bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their activities for conformity assessment.
98. the conformity assessment Bodies and their staff meet conformity assessment activities at the highest degree of professional integrity and technical competence necessary in this area and are free from all pressures and inducements, particularly financial, which might influence their assessment of their activities or the results of the conformity assessment, in particular with regard to persons or groups of persons with an interest in the results of the activities concerned.
99. the conformity assessment Bodies are able to carry out all the conformity assessment tasks assigned to them and in relation to which it has been notified, whether their respective tasks are fulfilled by the conformity assessment body or on behalf and under its responsibility.
100. Each time and for each conformity assessment procedure and each kind or category of toy for which it is notified, a conformity assessment body shall have at its disposal the necessary staff: 1) having technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
2 descriptions of procedures) required in accordance with which conformity assessment is carried out, assuring transparency and be able to reproduce the procedures concerned. It has appropriate policies and procedures that make a distinction between tasks carried out as a notified body and other activities;
3) procedures to carry out their activities with regard to the size of an undertaking, the areas of activity and its structure, the degree of complexity of the technology used to produce the toy and character table or of the production process.
101. the conformity assessment Body shall have at its disposal the means required to perform adequately the technical and administrative tasks connected with conformity assessment activities and access to all necessary equipment or facilities.
102. The staff responsible for carrying out conformity assessment activities must meet the following conditions: 1) technical and vocational training covering all the conformity assessment activities for which the conformity assessment body has been notified;
2) to hold the knowledge requirements for the satisfactory assessments they carry out and adequate authority for carrying out such assessments;
3) to know and understand properly the essential requirements, harmonized standards applicable and relevant provisions of the national legislation in force;
4) have the necessary capacity to draw up the certificates, records and reports demonstrating that assessments have been carried out.
103. It must be ensured the impartiality of the conformity assessment bodies, personnel with managerial and personnel evaluation.
104. The remuneration of personnel with managerial and staff assessment of a conformity assessment body shall not depend on the number of assessments carried out or on the results of the assessment in question.
105. the conformity assessment bodies shall take out liability insurance where the responsibility lies with the State, not in accordance with national legislation.
106. The personnel of a conformity assessment body shall keep professional secrecy with regard to all information gained in carrying out its functions, or any provision of national law implementing it, less regulatory authorities. Copyrights are protected.
107. the conformity assessment Bodies shall participate in standardization activities.
108. Where a conformity assessment body demonstrates its conformity with the criteria laid down in the standards or in parts thereof, approved by the Ministry of Economic Affairs and published in the Official Gazette of the Republic of Moldova, it is assumed that it complies with the requirements set out in paragraphs 92-101 of this Regulation, to the extent that those requirements are governed by the applicable reference standards.
Xx. SUBSIDIARIES And SUBCONTRACTING Of NOTIFIED BODIES The NOTIFIED BODIES 109. Where a notified body subcontracts specific tasks pertaining to the assessment of conformity or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Chapter XIX of the present Technical Regulations and inform the Ministry of Economic Affairs in this respect.
110. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these set.
111. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the customer.
112. Notified bodies shall provide the Ministry of economy and the relevant documents concerning the assessment of the subcontractor's or subsidiary's qualifications and on the activities carried out by them under Chapter XV of the present Technical Regulations.
Xxi. 113. NOTIFICATION PROCEDURE For the purposes of notification for activity in the area covered, the conformity assessment body shall submit an application for notification to the National Accreditation Body.
114. The National Accreditation Body shall inform the Ministry of economy where the conformity assessment body shall require notification and after the granting of accreditation, it shall transmit the request accompanied by the documents of the Ministry of Economy, in order to be notified.
115. the application referred to in section 113 of the present Technical Regulations must be accompanied by a description of the conformity assessment module or modules of conformity assessment and of the toy or toys for which body shall be deemed to be competent, as well as the accreditation certificate issued by a national accreditation body attesting that the conformity assessment body meets the requirements laid down in Chapter XIX of the present Technical Regulations.
116. The Ministry of economy shall examine the documents submitted for the purpose of notification under the procedure provided for in national legislation.
117. Notification of conformity assessment bodies shall include full details of the conformity assessment activities, the module or modules of conformity assessment and the toy or toys concerned, together with an attestation of competence.
118. the conformity assessment Body may perform the activities of a notified body only where no objections from the European Commission, transmitted within two weeks of notification.
119. Where the Ministry of economy or is informed that finds a notified body no longer meets the requirements set out in Chapter XIX of technical regulation or that it does not fulfil his obligations, the Ministry of economy take the necessary measures in order for the suspension or withdrawal of the notification, the fall, if necessary, depending on the seriousness of the breach or non-compliance with the obligations in accordance with the procedure laid down by national law.
120. In case of suspension or withdrawal of restraining notification or where the notified body has ceased its activity, it must ensure the teaching documents and records in connection with assessments made or in the making of the period in which it has been notified by another notified body in the field and to inform the Ministry of the Economy or to make them available to the Ministry of the economy and the Consumer Protection Agency at their request.
121. The Ministry of economy shall notify the European Commission of any subsequent changes to the notification. At the request of the European Commission, the Ministry of economy, submit all of the information which formed the basis of the notification or the maintenance of the competence of the conformity assessment body.
122. If the Commission ascertains that a notified body does not meet or no longer meets the requirements for being notified, it shall inform the Ministry of the economy and is required to take the necessary corrective measures, including withdrawal of the notice, if necessary.
Xxii. The OBLIGATIONS Of The Conformity Assessment BODIES To BE NOTIFIED To 123. Notified bodies the conformity assessments carried out in accordance with the conformity assessment procedures laid down in chapter XIV of the technical regulation.
124. The conformity assessment shall be carried out accordingly, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall carry out its work with regard to the size of an enterprise, by activity and its structure, the degree of complexity of the technology used in the case of the toy in question, as well as the character of series or mass production process.
Procedînd thus, the organizations in question complies with the degree of accuracy, however, and the level of protection required for the compliance of the toy with the technical regulation.
125. Where a notified body finds that a producer does not meet the requirements laid down in Chapter VIII, and annex No. 2 the technical regulation or in the corresponding harmonized standards, it shall require the manufacturer to adopt appropriate corrective measures and shall not issue a certificate of EC type-examination.
126. Where, in the course of monitoring compliance, subsequent to the issuance of a certificate of EC type-examination by a notified body finds that a toy no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate of EC type examination according to need.
127. Where corrective measures are not taken or do not have the required effect, the notified body shall suspend or withdraw the certificate, the persistence of the EC type-examination, as appropriate.
128. Notified bodies shall inform the Ministry of economy in relation to: 1) any refusal, suspension, or withdrawal of restraining a certificate of EC type-examination;
2) all circumstances affecting the scope and conditions for notification;
3) any request for information regarding the conformity assessment activities acceptable to the Consumer Protection Agency;
4) on request, conformity assessment activities performed within the limits of the scope of the notification and any other activity performed, including cross-border activities and subcontracting.
129. Notified bodies shall provide the other bodies notified that fulfil similar tasks for conformity assessment that refers to the same toys relevant information concerning aspects of negative results and, on request, positive conformity assessment results.
Xxiii. 130 MARKET SUPERVISION. Surveillance of toys placed on the market shall be organised and carried out in accordance with the legislation in force regarding market surveillance.
131. Consumer Protection Agency may ask a notified body to provide information on any certificate of EC type examination which that body has issued or it it retreated times of any refusal to issue such a certificate, including the test reports and technical documentation.
132. If the Consumer Protection Agency finds that a toy does not meet the requirements laid down in Chapter VIII, and annex No. 2 the technical regulation, it shall provide the notified body, if applicable, instructions with a view to the withdrawal of the certificate of EC type-examination for the toy.
133. As necessary, and in particular in the cases referred to in paragraph 77 of this technical regulation, Consumer Protection Agency provides instructions to the notified body to review the certificate of EC type-examination.
XXIV. The PROCEDURE APPLICABLE To TOYS PRESENTING A RISK At NATIONAL LEVEL 134. If the Consumer Protection Agency has sufficient reason to believe that a toy covered by this technical regulation poses a serious risk to the health or safety of individuals, which requires rapid intervention, including a serious risk the effects are not immediate, it carries out an evaluation with regard to the toy concerned covering all the requirements laid down in this regulation. The relevant economic operators shall cooperate with the Agency in order to protect Consumers whenever necessary.
135. Where, during the evaluation mentioned in paragraph 134 of this technical regulation, Consumer Protection Agency finds that the toy does not comply with the requirements provided for in this Regulation, it shall, without delay, the relevant economic operator to take all appropriate corrective action to bring the toy into compliance with these requirements, to withdraw the toy from the market or to a recheme within a reasonable timeframe , proportional to the nature of the risk involved, or prohibit the making available on the market, in accordance with the provisions laid down by the Consumer Protection Agency.
136. Consumer Protection Agency shall notify conformity assessment body notified, respectively.
137. Where the Consumer Protection Agency considers that non-compliance is not limited to the national territory, it shall inform the Ministry of economy regarding the results of the evaluation and the actions required to be taken by the relevant economic operator.
138. The economic operator shall ensure that appropriate corrective actions are taken for the toys that he has made available on the market.
139. If the trader does not undertake appropriate corrective action within a reasonable period, the Consumer Protection Agency take appropriate provisional measures to prohibit or restrict the making available of the toy on the market, to withdraw the toy from the market or recall.
140. The Ministry of Economic Affairs, on the proposal of the Agency for the protection of consumers, it shall inform the European Commission about the measures.
141. The information referred to in paragraph 140 of the present Technical Regulations shall include all available details, in particular the data necessary for identification of the non-compliant toy, the origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of national measures taken and the arguments put forward by the relevant economic operator. Consumer Protection Agency indicate, in particular, whether non-conformity is due to: 1) failure to comply with the requirements of toy relating to the health or safety of persons; times 2) deficiencies in existing harmonized standards, which confers a presumption of conformity.
XXV. NON-CONFORMITY 142 FORMAL. Without prejudice to chapter XXIV of technical regulation, Consumer Protection Agency calls the trader concerned to eliminate non-conformities concerned when he finds any of the following issues: 1) the CE marking has been affixed in violation of the provisions of Chapters XII and XIII of the technical regulation;
2) CE marking has not been affixed;
3) Declaration of conformity has not been drawn up;
4) Declaration of conformity has not been drawn up correctly;
5) technical documentation is not available or is incomplete.
143. Where the non-compliance referred to in section 142 of the present Technical Regulations shall maintain, Consumer Protection Agency takes appropriate measures to restrict or prohibit the making available on the market of the toy or ensure that it is recalled or withdrawn from the market.
Annex 1 Annex 2 annex 3 Annex 4 Annex 5 Annex 6 Annex No. 2 to the Government decision No. 808 of 29 October 2015 LISTAhotărîrilor Government-1 are repealed. Government decision No. 83 of 31 January 2008 approving the technical regulation "toys. Security requirements "(Official Gazette of the Republic of Moldova, 2008, nr. 32-33, art. 175).
2. Paragraph 26 of annex 3 to the Government decision No. 384 of 12 May 2010 "regarding the service supervisors of public health State" (Official Gazette of the Republic of Moldova, 2010, no. 78-80, art. 455).
3. Government decision No. 411 of 8 June 2011 "on the amendment and completion of technical regulation" toys. Security requirements ", approved by Government decision No. 83 of January 31, 2008 (Official Gazette of the Republic of Moldova, 2011, no. 99-101, art. 465).
4. Point 10 of annex 3 to the Decision of the Government No. 936 of 9 December 2011 "on creation of the Agency for the protection of consumers and the approval of the regulation, structure and maximum personnel thereof" (Official Gazette of the Republic of Moldova, 2012, 222-226, section 1022).
