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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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The translation of this document is outdated.
Translation validity: 21.08.2015.–10.11.2016.
Amendments not included: 08.11.2016., 07.08.2018., 03.09.2019.

Text consolidated by Valsts valodas centrs (State Language Centre) with amending regulations of:

13 November 2012 [shall come into force from 20 July 2013];
19 August 2014 [shall come into force from 23 August 2014];
18 August 2015 [shall come into force from 21 August 2015].

If a whole or part of a paragraph has been amended, the date of the amending regulation appears in square brackets at the end of the paragraph. If a whole paragraph or sub-paragraph has been deleted, the date of the deletion appears in square brackets beside the deleted paragraph or sub-paragraph.

 

Republic of Latvia

Cabinet
Regulation No. 132
Adopted 15 February 2011

Regulations Regarding the Safety of Toys

Issued pursuant to
Section 7 of the Law On Conformity Assessment and
Section 8.1 of the Law On the Safety of Goods and Services

[19 August 2014]

I. General Provisions

1. Terms used in this Regulation:

1.1. making available on the market - any supply of a toy for distribution, consumption or use on the market in the course of a commercial activity, whether in return for payment or free of charge;

1.2. placing on the market of a toy - the first making available of a toy on the European Union market;

1.3. manufacturer - a natural or legal person who manufactures a toy or upon whose assignment a toy is designed or manufactured, and markets that toy under his name or trademark;

1.4. authorised representative - any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

1.5. importer - any natural or legal person established within the European Union who places a toy from a third country on the European Union market;

1.6. distributor - any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;

1.7. toy - any article designed or intended for use in play by children under 14 years of age, except the articles listed in Annex 1 to this Regulation. The relevant article shall be deemed a toy even if it is not exclusively intended for use in play;

1.8. functional product - a product which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation;

1.9. functional toy - a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation;

1.10. aquatic toy - a toy intended for use in shallow water which is capable of carrying or supporting a child on the water;

1.11. design speed - representative potential operating speed that is determined by the design of the toy;

1.12. activity toy - a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for the performance by a child of any of the following activities: climbing, jumping, swinging, sliding, rocking, spinning, crawling and creeping, or any combination thereof;

1.13. chemical toy - a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult;

1.14. olfactory board game - a toy the purpose of which is to assist a child to learn to recognise different odours or flavours;

1.15. cosmetic kit - a toy the purpose of which is to assist a child to learn to make the following products: fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners;

1.16. gustative game - a toy the purpose of which is to allow children to make sweets or dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas;

1.17. harm - physical injury or any other damage to health, including long-term health effects;

1.18. hazard - a potential source of harm;

1.19. risk - the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm;

1.20. intended for use by means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group;

1.21. notified body - a toy conformity assessment body accredited by the Latvian national accreditation authority which has the status of a legal person and which has been notified to the European Commission in accordance with the laws and regulations regarding the procedures for establishing notification commission, and also the procedures for taking a decision by the commission and notifying to the European Commission regarding conformity assessment bodies which carry out conformity assessment in the regulated sphere, or a toy conformity assessment body notified by other Member States of the European Union or the European Economic Area states;

1.22. EC-type examination of a toy - activities of a notified body for verifying the conformity of the technical design of a toy to the safety requirements set out in Paragraphs 7, 8 and 9 of this Regulation and Annex 2 to this Regulation;

1.23. EC-type examination certificate of a toy - document by which a notified body certifies that the examined type of the toy conforms to the safety requirements set out in Paragraphs 7, 8 and 9 of this Regulation and Annex 2 to this Regulation;

1.24. CE conformity marking - a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in legal acts of the European Union providing for its affixing to products;

1.25. withdrawal from the market - any measure aimed at preventing a toy in the supply chain from being made available on the market; and

1.26. recall - any measure aimed at achieving the return of a toy that has already been made available to the end user.

[19 August 2014; 18 August 2015]

2. This Regulation prescribes the essential safety requirements for toys, the procedures for toy conformity assessment, the obligations of a manufacturer, the authorised representative thereof, importer and distributor, as well as the requirements for the notified body and the market surveillance procedures.

3. This Regulation shall not apply to the following toys:

3.1. playground equipment intended for public use;

3.2. automatic playing machines, whether coin operated or not, intended for public use;

3.3. toy vehicles equipped with a combustion engine;

3.4. toy steam engines;

3.5. slings and catapults.

4. Toys may not be placed and made available on the market unless they comply with the essential safety requirements set out in Paragraphs 7, 8 and 9 of this Regulation, and with the particular safety requirements laid down in Annex 2 to this Regulation (hereinafter jointly referred to as - essential safety requirements).

5. A toy shall bear the CE conformity marking.

6. A toy being in compliance, in full or in part, with requirements of any applicable standards referred to in the Official Journal of the European Union (hereinafter - applicable standards), shall be deemed to be in conformity with the essential safety requirements referred to in this Regulation covered by those standards. The Standardisation Office of the limited liability company "Latvian Standardisation, Accreditation and Metrology Centre" [Standartizācijas, akreditācijas un metroloģijas centrs] shall publish on its website (www.lvs.lv) a list of applicable standards adapted as national standards.

II. Essential Safety Requirements for Toys

7. Toys, including the chemicals they contain, shall not jeopardise the safety or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. The ability of the users and, where appropriate, their supervisors shall be taken into account when assessing the safety of toys, in particular, in the case of toys which are intended for use by children under 36 months or by other specified age group.

8. Labels affixed in accordance with Chapter VII of this Regulation and instructions for use that accompany toys shall draw the attention of users or their supervisors to the inherent hazards and risks of harm involved in using the toys, as well as to the ways of avoiding such hazards and risks.

9. Manufacturers, their authorised representatives and importers shall ensure that the toys placed on the market comply, throughout the estimated and commonly anticipated period of use, with the essential safety requirements.

10. The particular safety requirements for toys are laid down in Annex 2 to this Regulation.

III. Obligations of Manufacturers, Authorised Representatives Thereof, Importers and Distributors

11. When placing their toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements laid down in this Regulation.

12. The manufacturer of a toy shall have the following obligations:

12.1. to carry out, before placing the toy on the market, an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, and the potential exposure to such hazards;

12.2. to draw up the required technical documentation in accordance with Paragraph 23 of this Regulation (hereinafter - technical documentation) and to carry out one of the toy conformity assessment procedures provided for in Paragraph 21 of this Regulation;

12.3. to draw up, where compliance of the toy with the essential safety requirements has been demonstrated by carrying out a conformity assessment procedure, an EC declaration of conformity, as referred to in Sub-paragraph 22.3 of this Regulation, and to affix the CE conformity marking, as set out in Paragraph 59 of this Regulation;

12.4. to keep the technical documentation and the EC declaration of conformity for a time period of 10 years after the toy has been placed on the market;

12.5. to draw up procedures for series production of toys to remain in conformity and to take into account changes in toy design or characteristics and changes in the applicable standards by reference to which conformity of the toy has been declared;

12.6. to carry out, if necessary, in order to protect the health and safety of consumers with regard to hazards and risks presented by the toy, sample testing of toys placed and made available on the market, to investigate, and register complaints, non-conforming toys and toy recalls, as well as to keep distributors constantly informed regarding monitoring;

12.7. to ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy;

12.8. to indicate their name (firm name) or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy;

12.9. to ensure that the toy is accompanied by instructions and safety information in the official language;

12.10. in case of a manufacturer who considers or has a reason to believe that the toy which it has placed on the market is not in conformity with the relevant harmonisation legislation of the European Union with regard to rules for trading in those products, to immediately take the corrective measures necessary to bring that toy into conformity or, where appropriate, to withdraw or recall it. Where the toy presents a hazard, to immediately notify the Consumer Rights Protection Centre (hereinafter - market surveillance authority) to that effect, providing detailed information regarding the non-compliance and any corrective measures taken in order to eliminate the non-compliance;

12.11. further to a reasoned request from the market surveillance authority, to provide that authority with all the necessary information and documentation in the official language to demonstrate the conformity of the toy;

12.12. to co-operate with the market surveillance authority, upon its request, on any actions taken to eliminate the risks posed by the toy which it has placed on the market.

[19 August 2014]

13. A manufacturer may, by a written mandate, appoint an authorised representative. The obligation of manufacturers referred to in Paragraph 11 of this Regulation and the drawing up of technical documentation shall not form part of the mandate.

14. An authorised representative shall perform at least the following tasks, as specified in the mandate received from a manufacturer:

14.1. to keep the EC declaration of conformity and the technical documentation at the disposal of the market surveillance authority for a time period of 10 years after the toy has been placed on the market;

14.2. further to a reasoned request from the market surveillance authority, to provide that authority with all the necessary information and documentation in the official language or another language acceptable to that authority to demonstrate the conformity of the toy;

14.3. to co-operate with the market surveillance authority, upon its request, on any actions taken to eliminate the risks posed by toys covered by the received mandate.

[19 August 2014]

15. An importer shall place on the market only toys that comply with the requirements of this Regulation.

16. An importer shall have the following obligations:

16.1. to ensure that, before placing a toy on the market, the appropriate conformity assessment procedure has been carried out by the manufacturer;

16.2. to ensure that, before placing a toy on the market, technical documentation has been drawn up by the manufacturer, that the toy bears the required conformity marking and is accompanied by the documents specified in this Regulation and that the manufacturer has complied with the requirements referred to in Sub-paragraphs 12.7 and 12.8 of this Regulation;

16.3. where an importer considers or has reason to believe that a toy is not in conformity with the essential safety requirements, it shall not place the toy on the market until the toy has been brought into conformity. If the toy presents a risk, the importer shall inform the manufacturer and the market surveillance authority to that effect;

16.4. to indicate its name (firm name) or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy;

16.5. to ensure that the toy is accompanied by instructions and safety information in the official language;

16.6. to ensure that, while a toy is under its responsibility, storage or transport conditions do not jeopardise compliance of the toy with the essential safety requirements;

16.7. to carry out, when deemed appropriate in order to protect the health and safety of consumers with regard to risks presented by a toy, sample testing of toys placed and made available on the market, to investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls, and to keep distributors informed of any such monitoring;

16.8. in case of an importer who considers or has a reason to believe that a toy which it has placed on the market is not in conformity with the relevant harmonisation legislation of the European Union with regard to rules for trading in those products, to immediately take the corrective measures necessary to bring that toy into conformity or, where appropriate, to withdraw or recall it. If the toy presents a risk, to immediately inform the market surveillance authority to that effect, providing detailed information regarding the non-compliance and any measures taken in order to eliminate it;

16.9. to keep, for a time period of 10 years after the toy has been placed on the market, a copy of the EC declaration of conformity at the disposal of the market surveillance authority and ensure that the technical documentation can be made available to that authority upon request;

16.10. upon a reasoned request from the market surveillance authority, to provide that authority with all the information and documentation necessary to demonstrate the conformity of the toy, in the official language or another language acceptable to that authority, as well as to cooperate with that authority on any actions taken to eliminate the risks posed by the toy.

[19 August 2014]

17. When making a toy available on the market, a distributor shall act with due care in relation to the essential safety requirements for toys.

18. A distributor shall have the following obligations:

18.1. to verify, before making a toy available on the market, that the toy bears the CE conformity marking, that it is accompanied by the documents specified in this Regulation and by instructions and safety information in the official language and that the manufacturer has complied with the requirements referred to in Sub-paragraphs 12.7 and 12.8 of this Regulation and the importer has complied with the requirements referred to in Sub-paragraph 16.4 of this Regulation;

18.2. where the distributor considers or has reason to believe that a toy is not in conformity with the essential safety requirements, it shall not make the toy available on the market until the toy has been brought into conformity. If the toy presents a risk, the distributor shall inform the manufacturer or the importer, as well as the market surveillance authority, to that effect;

18.3. to ensure that, while a toy is under its responsibility, storage or transport conditions do not jeopardise compliance of the toy with the essential safety requirements;

18.4. to make sure, where it considers or has a reason to believe that a toy which it has made available on the market is not in conformity with the relevant harmonisation legislation of the European Union with regard to trading in those products, that the corrective measures necessary to bring that toy into conformity or, as the case may be, to withdraw or recall it, are taken. If the toy presents a risk, to immediately inform the market surveillance authority to that effect, providing detailed information regarding the non-compliance and any measures taken in order to eliminate it;

18.5. to co-operate with the market surveillance authority, upon its request, on any actions taken to eliminate the risks posed by toys made available on the market by, inter alia, providing the market surveillance authority with all the information and documentation necessary to demonstrate the conformity of the toy.

[19 August 2014]

19. An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and be subject to the obligations of the manufacturer referred to in Paragraphs 11 and 12 of this Regulation, where it places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the essential safety requirements may be affected.

20. A manufacturer, an authorised representative thereof, an importer and a distributor shall, upon request of the market surveillance authority, identify to that authority any manufacturer, an authorised representative thereof, importer or, as the case may be, distributor, which has supplied it with a toy, as well as any manufacturer, an authorised representative thereof, importer or, as the case may be, distributor, to which it has supplied a toy. Manufacturers shall be able to present the referred to information for a time period of 10 years after the toy has been placed on the market, whereas the authorised representatives thereof, importers and distributors shall be able to present the referred to information for a time period of 10 years after they have been supplied with the toy for making it available on the market.

IV. Conformity Assessment Procedures

21. Before placing a toy on the market, manufacturers shall use one of the following conformity assessment procedures to demonstrate that the toy complies with the essential safety requirements:

21.1. the internal production control procedure, where the manufacturer is using the applicable standards referred to in Paragraph 6 of this Regulation covering all essential safety requirements for the relevant toy;

21.2. the EC-type examination and the conformity type procedure together with the conformity to type procedure set out in Paragraph 24 of this Regulation, where applicable standards, covering all essential safety requirements for the relevant toy, do not exist or where the applicable standards exist but the manufacturer has not applied them or has applied them only in part, or where one or more of the applicable standards has been published with a restriction, or when the manufacturer considers that the nature, design, construction or purpose of the toy necessitate third party verification.

22. The internal production control procedure referred to in Sub-paragraph 21.1 of this Regulation shall include the following actions:

22.1. drawing up the technical documentation in accordance with Paragraph 23 of this Regulation;

22.2. ensuring the conformity of all toys produced in the production process to the technical documentation referred to in Paragraph 23 of this Regulation and to the essential safety requirements;

22.3. drawing up an EC declaration of conformity in respect of a particular toy, whereby the manufacturer acknowledges that the fulfilment of the essential safety requirements has been demonstrated. An EC declaration of conformity shall, as a minimum, contain the elements specified in Annex 3 to this Regulation and shall be continuously updated by the manufacturer;

22.4. affixing to a toy the CE conformity marking.

23. Technical documentation, in conformity with the requirements laid down in Paragraph 37 of this Regulation, shall be prepared in one of the official languages of the European Union Member States, and it shall include all the data or instructions regarding the means used by the manufacturer in order to ensure the compliance of the toy with the essential safety requirements, including:

23.1. a detailed description of the design and manufacture, including a list of components and materials used in the toy, as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers;

23.2. safety assessment of the toy carried out in accordance with Sub-paragraph 12.1 of this Regulation;

23.3. a description of the conformity assessment procedure followed;

23.4. a copy of the EC declaration of conformity;

23.5. the addresses of the places of manufacture and storage of the toy;

23.6. copies of documents that the manufacturer has submitted to the notified body (where the latter has been involved);

23.7. test reports and description of the means whereby the manufacturer ensured conformity of the toy with the applicable standards, if the manufacturer applied the internal production control referred to in Sub-paragraph 21.1 of this Regulation;

23.8. a copy of the EC-type examination certificate, a description of the means whereby the manufacturer ensured conformity of the toy with the product type as described in the EC-type examination certificate, and copies of the documents that the manufacturer has submitted to the notified body (where the manufacturer has submitted the toy to the EC-type examination, which has been followed by the conformity-to-type procedure referred to in Sub-paragraph 21.2 of this Regulation).

[19 August 2014]

24. The EC-type examination is a part of the procedure whereby the notified body examines, ascertains and certifies that the submitted sample toy complies with the requirements of this Regulation. In order to carry out the EC-type examination, the manufacturer shall submit to the notified body:

24.1. an application indicating a description of the toy and the place of manufacture of the toy, the given name, surname and address of the manufacturer as well as, where the application is to be submitted by an authorised representative of the manufacturer, the given name, surname and address of such an authorised representative;

24.2. a written declaration that such application has not been submitted to another notified body;

24.3. technical documentation complying with the requirements referred to in Paragraph 23 of this Regulation;

24.4. representative samples of the toy. The notified body may request additional samples, if necessary, in order to carry out a test programme;

24.5. evidence demonstrating that the technical design ensures the conformity of the toy with the essential safety requirements (such as design drawings, manufacture drawings, schemes on parts, mounting nodes and electric circuits). The evidence shall refer to all consulted documents and test reports.

25. When carrying out the EC-type examination of a toy, the notified body shall:

25.1. examine the submitted technical documentation for a toy and the evidence referred to in Sub-paragraph 24.5 of this Regulation demonstrating that the technical design ensures the conformity of the toy with the essential safety requirements;

25.2. in respect of toy samples:

25.2.1. shall make sure that the toy sample has been manufactured in accordance with the said technical documentation and shall find out which parts have been designed in conformity with the applicable standards or technical specification terms and the design of which parts deviates from the applicable standards;

25.2.2. shall perform testing of the sample toy or delegate that to the task performer referred to in Paragraph 40 of this Regulation or a branch, in order to make sure whether the solutions implemented are in conformity with the requirements set out in the applicable standards or the technical specifications;

25.2.3. shall perform testing of the sample toy or delegate that to the task performer referred to in Paragraph 40 of this Regulation or a branch, in order to make sure that, where the applicable standards or the technical specification terms have not been used, the solutions implemented by the manufacturer are in conformity with the essential safety requirements;

25.2.4. shall agree with the applicant regarding the place where the testing of the sample toy will be carried out.

26. Where the notified body carries out the EC-type examination, it shall evaluate, if necessary jointly with the manufacturer, the analysis of the hazards that the toy may present carried out in accordance with Sub-paragraph 12.1 of this Regulation.

27. Following the EC-type examination, the notified body shall draw up an evaluation report. The evaluation report shall specify any activities performed in accordance with Paragraph 25 of this Regulation and their outcome. The notified body may disclose the contents of the evaluation report, in full or in part, only with the consent of the manufacturer or the authorised representative thereof.

28. Where the examined type of the toy complies with the essential safety requirements applicable to the relevant toy, the notified body shall draw up and issue to the manufacturer an EC-type examination certificate.

29. The EC-type examination certificate shall include:

29.1. the name and address of the manufacturer;

29.2. any conclusions drawn from the examination;

29.3. validity conditions for the certificate (if any);

29.4. data required for the identification of the approved type;

29.5. a reference to Directive 2009/48;

29.6. a colour image and a clear description of the toy, including its dimensions;

29.7. a list of the tests performed, with a reference to the relevant test report.

30. Where the type of the toy does not comply with the essential safety requirements, the notified body shall not issue an EC-type examination certificate but shall instead notify the applicant about the reasons for such refusal, with a detailed description of the grounds of refusal.

31. A manufacturer that has received an EC-type examination certificate shall ensure the conformity of the toy with the approved type and with the essential safety requirements, as well as:

31.1. shall take any action necessary to ensure, during the production process and its monitoring, the conformity of the produced toys with the approved type;

31.2. shall affix the CE conformity marking to any individual toy; and

31.3. shall draw up the EC-type examination certificate for the sample toy in writing and in line with the model set out in Annex 3 to this Regulation.

32. The notified body shall follow any changes in the applicable standards and shall determine whether it is necessary to carry out, due to those changes, a detailed examination of the toy. Where such examination is necessary, the notified body shall notify, to that effect, the manufacturer holding the relevant EC-type examination certificate.

33. The manufacturer shall inform the notified body on any changes to the approved type that may affect the conformity of the toy with the essential safety requirements or the validity conditions of the EC-type examination certificate. The notified body shall issue an additional approval appended to the original EC-type examination certificate.

34. The notified body shall review the EC-type examination certificate every five years or whenever necessary. In particular it applies to any case of a change to the manufacturing process, the raw materials or the components of the toy.

35. The notified body shall withdraw the EC-type examination certificate if the toy fails to comply with the essential safety requirements.

36. The notified body may not grant an EC-type examination certificate for a toy in respect of which a certificate has been refused or withdrawn.

37. The technical documentation and correspondence relating to the EC-type examination procedures shall be drawn up in the official language or in another language acceptable to the notified body.

V. Requirements for the Notified Body

38. The notified conformity assessment body shall meet the following requirements:

38.1. it shall act as a third-party body independent of the economic operator (an association of such operators), the product conformity of which it assesses and whose activities have not been related to the toy for which it carries out the EC-type examination;

38.2. the body has demonstrated its independence and the absence of any conflict of interest in case where it belongs to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of toys to be assessed;

38.3. the body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the toys which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed toys that are necessary for the operations of the conformity assessment body or the use of such toys for personal purposes;

38.4. the body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design or manufacture, the marketing, installation, use or maintenance of those toys, or represent the parties engaged in those activities;

38.5. the body, its top level management and the personnel shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified;

38.6. the body shall ensure that the activities of their subsidiaries or subcontractors specified in Paragraph 40 of this Regulation do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities;

38.7. the body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field. The relevant personnel shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities;

38.8. the body shall be capable of carrying out the conformity assessment tasks assigned to it by the provisions of Chapter IV of this Regulation and in relation to which they have been notified, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility;

38.9. for each conformity assessment procedure and each kind or category of toy in relation to which it has been notified, the notified body shall have at its disposal the necessary:

38.9.1. personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

38.9.2. descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures. The notified body shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

38.9.3. procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process;

38.10. the notified body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities;

38.11. the personnel responsible for carrying out the conformity assessment activities shall have:

38.11.1. sound technical and vocational training covering all the conformity assessment activities in relation to which the body has been notified;

38.11.2. satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

38.11.3. appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant harmonisation legislation of the European Union and of this Regulation;

38.11.4. the ability to draw up certificates, records and reports demonstrating that assessments have been carried out;

38.12. the impartiality of the notified body, its top level management and assessment personnel shall be ensured, in particular the remuneration of the top level management and assessment personnel of the body shall not depend on the number of assessments carried out or on the results of those assessments;

38.13. the notified body shall take out third-party liability insurance in respect of its activities it is authorised to perform;

38.14. the personnel of the notified body shall observe professional secrecy with regard to all information obtained in carrying out their tasks, except in relation to the market surveillance authority;

38.15. the notified body shall ensure that their assessment personnel is informed of the activities, related to toys, of the notified bodies co-ordination group organised by the European Commission and of the novelties in the standardisation field. The notified body may participate or ensure the participation of a delegated representative in the work of the referred to co-ordination group. The notified body shall apply as general guidance for the assessment methodology the administrative decisions and documents produced as a result of the work of that group.

39. Where the notified body demonstrates its conformity with the criteria laid down in the applicable harmonised standards or parts thereof, it shall be presumed to comply with the requirements laid down in Paragraph 38 of this Regulation insofar as the applicable harmonised standards cover those requirements.

40. Where the notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements referred to in Paragraph 38 of this Regulation and shall inform the Latvian national accreditation authority (hereinafter - Latvian National Accreditation Office) accordingly.

41. The notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries referred to in Paragraph 40 of this Regulation, wherever these are established.

42. The notified body may subcontract or delegate the carrying out of individual conformity assessment activities by a subsidiary only with the agreement of the client.

43. The notified body shall keep at the disposal of the Latvian National Accreditation Office the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary referred to in Paragraph 40 of this Regulation and the work carried out by them in accordance with Paragraphs 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36 and 37 of this Regulation.

44. The notified body shall carry out conformity assessment in accordance with the conformity assessment procedure set out in Chapter IV of this Regulation.

45. The notified body shall carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for the manufacturer, the authorised representative thereof, the importer or the distributor, taking due account of the sector in which the undertaking operates, its organisational structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process.

46. Where the notified body finds that the requirements set out in this Regulation or in the applicable standards have not been met by a manufacturer, it shall require that the manufacturer take appropriate corrective measures and shall issue the EC-type examination certificate after the rectification of such non-compliance only.

47. Where, in the course of the monitoring of conformity following the issue of an EC-type examination certificate, the notified body finds that a toy is no longer in compliance, it shall require the manufacturer to take appropriate corrective measures, and shall suspend or withdraw the EC-type examination certificate if necessary.

48. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EC-type examination certificate, as appropriate.

49. The notified body shall inform the Ministry of Economics of the following:

49.1. any refusal, restriction, suspension or withdrawal of an EC-type examination certificate, where there has been non-compliance with the requirements referred to in this Regulation;

49.2. any circumstances affecting the scope of and conditions for notification;

49.3. requests for information which it has received from the market surveillance authority regarding conformity assessment activities;

49.4. upon request, any conformity assessment activities performed and any other activity performed, including cross-border activities and subcontracting.

50. The notified body shall provide the other bodies notified under Directive 2009/48 that carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.

VI. Procedures for Notification of the Bodies to the European Commission

[18 August 2015]

51. [18 August 2015]

52. [18 August 2015]

53. [18 August 2015]

54. [18 August 2015]

55. [18 August 2015]

56. [18 August 2015]

57. [18 August 2015]

58. [18 August 2015]

VII. Labelling

59. Toys placed on the market, their labelling, or packaging shall carry the following information in such a way as to be easily visible, clearly legible and indelible:

59.1. the CE conformity marking;

59.2. the name (firm name) or registered trademark of the manufacturer and the importer;

59.3. the contact address of the manufacturer and the importer.

60. Before placing the toy on the market the CE conformity marking shall be affixed thereto, attesting the conformity of the toy with the requirements set out in this Regulation and warnings as to the use of the relevant toy shall be included, as well as, where appropriate, a pictogram or any other mark indicating a special risk or use may be added.

61. The CE conformity marking is subject to the general principles laid down in Article 30 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (hereinafter - Regulation No 765/2008).

62. Toys not bearing a CE conformity marking or which do not otherwise comply with this Regulation may be shown and used at trade fairs and exhibitions, provided that they are accompanied by a sign which clearly indicates that they do not comply with this Regulation and that they will not be made available in the market of the European Union before being brought into conformity.

63. In the case of small toys and toys consisting of small parts, the CE conformity marking may alternatively be affixed to a label or an accompanying leaflet. Where, in the case of toys sold in counter displays, that is not technically possible, and on condition that the counter display was originally used as packaging for the toy, the relevant information shall be placed on the counter display.

64. Where the CE conformity marking is not visible from outside the packaging for a packaged toy, it shall as a minimum be affixed to the packaging.

65. In order to guarantee the safe use of the toy, the user limitations indicated by the manufacturer in line with Paragraph 8 of this Regulation shall include at least the minimum or maximum age of users and, where appropriate, the abilities and the maximum or minimum weight of users and the need to ensure that the toy is used only under adult supervision.

66. The categories of toys listed in Annex 4 to this Regulation shall bear the warnings set out in that Annex 4 to this Regulation. The warnings set out in Chapters II, III, IV, V, VI, VII, VIII, IX and X of Annex 4 to this Regulation shall be used as worded therein.

67. Toys shall not bear one or more of the specific warnings set out in Annex 4 to this Regulation, where that warning conflicts with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.

68. The manufacturer shall mark the warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys which are sold without packaging shall have appropriate warnings affixed to them.

69. The warnings shall be preceded by the words "Warning" or "Warnings", as the case may be.

70. Warnings which determine the decision to purchase the toy, such as those specifying the minimum and maximum ages for users and the other applicable warnings set out in Annex 4 to this Regulation, shall appear on the consumer packaging or be otherwise clearly visible to the consumer before the purchase, including in cases where the purchase is made on-line.

71. In accordance with Sub-paragraph 12.9 of this Regulation, a toy being placed or made available on the market in Latvia shall bear warnings and safety instructions in the official language or shall be accompanied by a translation into the official language.

VIII. Market Surveillance

72. Surveillance of toys placed on the market shall be carried out by the market surveillance authority.

73. When carrying out market surveillance, the officials of the market surveillance authority may:

73.1. control and monitor the conformity of toys to be made available on the market with the requirements set out in this Regulation by attending the places of trade, storage and manufacture of toys, as well as examine (pre-test) sample goods, in particular by opening their packaging and carrying out testing of the sample;

73.2. request and receive, free of charge, any information (including the technical documentation, the EC declaration of conformity, the EC-type examination certificate and test reports) needed for carrying out surveillance in accordance with the requirements referred to in this Regulation;

73.3. request that the manufacturer or importer ensures translation of the respective parts of the technical documentation in the official language, providing justification for the necessity of translation. The market surveillance authority, upon requesting to submit the technical documentation, as well as translation of its parts, shall determine a submission deadline of 30 days, unless a shorter time period is justifiable due to detecting a serious and immediate risk;

73.4. request that the notified body provide information on the EC-type examination certificate, which that body has issued, recalled or refused, in particular any test reports and technical documentation;

73.5. request and receive, free of charge, sample toys, and organise the expert-examination of such toys, in order to determine whether the toys conform to the requirements laid down in this Regulation;

73.6. request that the manufacturer performs a check at the notified body and to provide, from its own resources, the conformity with the essential safety requirements, if it does not fulfil the requirements referred to in Paragraph 23 and Sub-paragraph 73.3 of this Regulation.

[19 August 2014]

74. The costs of toy testing shall be covered in accordance with the laws and regulations regarding the safety of goods and services.

75. Where the market surveillance authority ascertains that the EC declaration of conformity has not been drawn up in respect of a toy or that the EC declaration of conformity has not been drawn up correctly, or that technical documentation is either not available or incomplete, or that the CE conformity marking has been affixed to the toy in violation of the requirements of this Regulation, or that the CE conformity marking has not been affixed, the market surveillance authority shall request that the relevant manufacturer, the authorised representative thereof, importer or distributor put an end, by a specified deadline, to the non-compliance concerned.

76. Where the non-compliance referred to in Paragraph 75 of this Regulation is not eliminated by the specified deadline, the market surveillance authority may, in accordance with the laws and regulations regarding the safety of goods and services, decide on prohibiting the toy from being placed and made available on the market, or requesting to recall or withdraw it from the market.

77. Where the market surveillance authority ascertains that a toy does not comply with the requirements referred to in this Regulation (except the non-compliance referred to in Paragraph 75 of this Regulation), it shall, giving due consideration to the hazards posed by the toy, ensure that corrective measures be taken in due course, in order to bring the toy into conformity with the set requirements or to withdraw or recall it from the market. Where the relevant corrective measures are not taken in a reasonable time by a manufacturer, an authorised representative thereof, importer or distributor voluntarily, the market surveillance authority may decide in accordance with the laws and regulations regarding the safety of goods and services.

78. The market surveillance authority may propose to the relevant manufacturer, the authorised representative thereof, importer or distributor that voluntary corrective measures be taken to bring the toy into conformity.

79. The relevant manufacturer, the authorised representative thereof, importer or distributor shall have the obligation to take the relevant corrective measures in respect of toys placed and made available by it on the market.

80. Where the market surveillance authority has a sufficient reason to believe that a toy covered by this Regulation presents a risk to the health or safety of persons, it shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. Where the evaluation requires that the toy be tested, such testing shall be organised by the market surveillance authority, and the costs of such testing shall be borne in accordance with Sub-paragraph 73.5 and Paragraph 74 of this Regulation.

81. The relevant manufacturer, the authorised representative thereof, importer or distributor shall co-operate, as necessary, with the market surveillance authority.

82. Where the market surveillance authority ascertains, in the course of carrying out the evaluation of a toy referred to in Paragraph 80 of this Regulation, that the toy is not in conformity with the requirements set out in this Regulation, it shall, giving due consideration to the hazards posed by the toy, ensure that corrective measures are taken in a reasonable time, in order to bring the toy into conformity or to withdraw or recall it from the market.

83. Where the relevant manufacturer, the authorised representative thereof, importer or distributor fails to take, in a reasonable time, appropriate corrective measures voluntarily, the market surveillance authority is entitled to take a decision in accordance with the laws and regulations regarding the safety of goods and services.

84. Where a toy has an EC-type examination certificate, the market surveillance authority shall take the following actions:

84.1. inform the notified body, where it ascertains that a toy is not in conformity with the essential safety requirements so that the notified body can, if necessary, take the action referred to in Paragraphs 47 and 48 of this Regulation;

84.2. inform the notified body, where necessary, in particular in cases specified in Paragraph 34 of this Regulation, on the need to review an EC-type examination certificate.

IX. Co-operation with the European Commission and the European Union Member States

85. Where the market surveillance authority has sufficient reason to believe that a toy, which has been subject to the evaluation referred to in Paragraph 80 of this Regulation and in respect of which it has been ascertained that it does not comply with the requirements set out in this Regulation, is also being made available in other European Union Member States, it shall inform the European Commission and other European Union Member States of the results of the evaluation made in Latvia and the actions taken in accordance with Paragraph 82 of this Regulation.

86. The market surveillance authority shall inform, without delay, the European Commission and other European Union Member States of any decisions taken in respect of the toys in accordance with Paragraph 83 of this Regulation, specifying all available details, including:

86.1. the data necessary for the identification of the non-compliant toy;

86.2. information on the origin of the toy;

86.3. the nature of the alleged non-compliance and the risk involved;

86.4. information on the measures taken in Latvia, as well as the arguments put forward by the relevant manufacturer, the authorised representative thereof, importer or distributor;

86.5. a reference to the failure of the toy to meet requirements relating to the health or safety of persons and to the shortcomings in respect of the applicable standards referred to in Paragraph 6 of this Regulation.

87. Where the information specified in Paragraph 86 of this Regulation should be notified in accordance with Article 22 of Regulation No 765/2008 through the Community Rapid Information Exchange System (RAPEX), it shall not be necessary to make a separate notification under Paragraph 86 of this Regulation, provided that the following conditions are met:

87.1. the notification through the Community Rapid Information Exchange System (RAPEX) indicates that the notification of the measure is also required by Directive 2009/48;

87.2. the supporting evidence referred to in Paragraph 86 of this Regulation is enclosed with the Community Rapid Information Exchange (RAPEX) notification.

88. Where, within three months after receipt of the information referred to in Paragraph 86 of this Regulation, no objection has been raised by either a European Union Member State or the European Commission in respect of a measure taken by the market surveillance authority, that measure shall be deemed to be justified.

89. If the European Commission takes a decision stating that the measure referred to in Paragraph 83 of this Regulation is not justified, the decision by the market surveillance authority shall be repealed.

90. Where the market surveillance authority, upon receipt of a notification from another European Union Member State, ascertains that a non-compliant toy is also available on the market in Latvia, it shall inform, without delay, the European Commission and other European Union Member States on the measures taken and shall provide any additional information at its disposal in relation to the non-compliance of the relevant toy. If the market surveillance authority has objections to the measures taken by another European Union Member State, it shall inform the European Commission and other European Union Member States on such objections.

X. Closing Provisions

91. The Cabinet Regulation No. 128 of 4 April 2000, Regulations on the Safety of Toys (Latvijas Vēstnesis, 2000, No. 125/126; 2001, No. 161; 2004, No. 68, 69; 2006, No. 101; 2008, No. 139; 2009, No. 200) is repealed.

92. Any toys placed on the market until 20 July 2011 may be made available on the market, if they comply with the requirements set out in Cabinet Regulation No. 128 of 4 April 2000, Regulations on the Safety of Toys.

93. In addition to the condition specified in Paragraph 92 of this Regulation, any toys placed on the market until 20 July 2013 may be made available on the market, if they comply with the requirements set out in this Regulation, except the requirements set out in Chapter III of Annex 2, provided that such toys are in conformity to the requirements set out in Paragraphs 26, 27, 27.1 and 28 of Cabinet Regulation No. 128 of 4 April 2000, Regulations on the Safety of Toys.

94. Paragraphs 1 and 2 of Chapter I, Paragraph 1 of Chapter II, Paragraph 2 of Chapter III, Paragraph 2 of Chapter IV and Paragraph 2 of Chapter V in Annex 5 to this Regulation shall apply until 31 May 2015.

95. Paragraph 3 of Chapter I, Paragraph 2 of Chapter II, Paragraph 3 of Chapter III, Paragraph 3 of Chapter IV and Paragraph 3 of Chapter V in Annex 5 to this Regulation shall apply as of 1 June 2015.

95.1 Sub-paragraph 7.2 of Chapter III in Annex 2 to this Regulation shall apply as of 21 December 2015.

[18 August 2015]

96. This Regulation shall come into force on 20 July 2011.

Informative Reference to European Union Directives

[13 November 2012; 18 August 2015]

This Regulation contains legal norms arising from:

1) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys;

2) Commission Directive 2012/7/EU of 2 March 2012 amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy safety;

3) Commission Directive 2014/79/EU of 20 June 2014 amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards TCEP, TCPP and TDCP;

4) Commission Directive 2014/81/EU of 23 June 2014 amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards bisphenol A;

5) Commission Directive 2014/84/EU of 30 June 2014 amending Appendix A of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards nickel.

Prime Minister V. Dombrovskis

Minister for Economics A. Kampars

 

Annex 1
Cabinet Regulation No. 132
15 February 2011

Products Not Considered As Toys Within the Meaning of this Regulation

1. Decorative objects for festivities and celebrations.

2. Products for collectors, provided that the product or its packaging bears a visible and legible indication that it is intended for collectors of 14 years of age and above. Examples of this category are:

2.1. detailed and faithful scale models;

2.2. kits for the assembly of detailed scale models;

2.3. folk dolls and decorative dolls and other similar articles;

2.4. historical replicas of toys; and

2.5. reproductions of real fire arms.

3. Sports equipment, including roller skates, inline skates, and skateboards intended for children with a body mass of more than 20 kg.

4. Bicycles with a maximum saddle height of more than 435 mm, measured as the vertical distance from the ground to the top of the seat surface, with the seat in a horizontal position and with the seat pillar set to the minimum insertion mark.

5. Scooters and other means of transport designed for sport or which are intended to be used for travel on public roads or public pathways.

6. Electrically driven vehicles which are intended to be used for travel on public roads, public pathways, or the pavement thereof.

7. Aquatic equipment intended to be used in deep water, and swimming learning devices for children, such as swim seats and swimming aids.

8. Puzzles with more than 500 pieces.

9. Guns and pistols using compressed gas, with the exception of water guns and water pistols, and bows for archery over 120 cm long.

10. Fireworks, including percussion caps which are not specifically designed for toys.

11. Products and games using sharp-pointed missiles, such as sets of darts with metallic points.

12. Functional educational products, such as electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision.

13. Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance of an adult instructor, such as science equipment.

14. Electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals, unless the electronic equipment or the associated peripherals are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels.

15. Interactive software, intended for leisure and entertainment, such as computer games, and their storage media, such as CDs.

16. Babies' soothers.

17. Child-appealing luminaires.

18. Electrical transformers for toys.

19. Fashion accessories for children which are not for use in play.

Minister for Economics A. Kampars

 

Annex 2
Cabinet Regulation No. 132
15 February 2011

Particular Safety Requirements

[13 November 2012; 19 August 2014; 18 August 2015; Chapter III, Sub-paragraph 7.2 of Annex shall be applicable from 21 December 2015. See Paragraph 95.1 of Regulation]

I. Physical and Mechanical Properties

1. Toys and their parts and, in the case of fixed toys, their anchorages, must have the requisite mechanical strength and, where appropriate, stability to withstand the stresses to which they are subjected during use without breaking or becoming liable to distortion at the risk of causing physical injury.

2. Accessible edges, protrusions, cords, cables and fastenings on toys must be designed and manufactured in such a way that the risks of physical injury from contact with them are reduced as far as possible.

3. Toys must be designed and manufactured in such a way as not to present any risk or only the minimum risk inherent to their use which could be caused by the movement of their parts.

4. Toys and their parts must not present a risk of strangulation and asphyxiation:

4.1. toys and their parts must not present a risk of asphyxiation by closing off the flow of air as a result of airway obstruction external to the mouth and nose;

4.2. toys and their parts must be of such dimensions as to not present a risk of asphyxiation by closing off the flow of air as a result of internal airway obstruction by objects wedged in the mouth or pharynx or lodged over the entrance to the lower airways;

4.3. toys, which are clearly intended for use by children under 36 months, as well as their component parts and any of their detachable parts must be of such dimensions as to prevent their being swallowed or inhaled. This also applies to other toys which are intended to be put in the mouth, and to their component parts and any of their detachable parts;

4.4. the packaging in which toys are contained for retail sale must not present a risk of strangulation or asphyxiation caused by airway obstruction external to the mouth and nose;

4.5. toys contained within food or co-mingled with food must have their own packaging. This packaging, as it is supplied, must be of such dimensions as to prevent its being swallowed and/or inhaled;

4.6. toy packaging, as referred to in Sub-paragraphs 4.4 and 4.5 of this Annex, which is spherical, egg-shaped or ellipsoidal, as well as any detachable parts of this or of cylindrical toy packaging with rounded ends, must be of such dimensions as to prevent it from causing airway obstruction by being wedged in the mouth or pharynx or lodged over the entrance to the lower airways; and

4.7. toys firmly attached to a food product at the moment of consumption, in such a way that the food product needs to be consumed in order to get direct access to the toy, is prohibited. Parts of toys otherwise directly attached to a food product shall fulfil the requirements referred to in Sub-paragraphs 4.2 and 4.3 of this Annex.

5. Aquatic toys must be designed and manufactured so as to reduce as far as possible, taking into account the recommended use of the toy, any risk of loss of buoyancy of the toy and loss of support afforded to the child.

6. Toys which it is possible to get inside and which thereby constitute an enclosed space for occupants must have a means of exit which the intended user can open easily from inside.

7. Toys conferring mobility on their users must, as far as possible, incorporate a braking system which is suited to the type of toy and is commensurate with the kinetic energy generated by it. Such a system must be easy for the user to operate without risk of ejection or physical injury for the user or for third parties.

8. The maximum design speed of electrically driven ride-on toys must be limited so as to minimise the risk of injury.

9. The form and composition of projectiles and the kinetic energy they may generate when fired from a toy designed for that purpose must be such that, taking into account the nature of the toy, there is no risk of physical injury to the user or to third parties.

10. Toys must be manufactured so as to ensure that:

10.1. the maximum and minimum temperature of any accessible surfaces does not cause injury when touched;

10.2. liquids and gases contained within the toy do not reach temperatures or pressures which are such that their escape from the toy, other than for reasons essential to the proper functioning of the toy, might cause burns, scalds or other physical injury.

11. Toys which are designed to emit a sound shall be designed and manufactured in such a way in terms of the maximum values for impulse noise and continuous noise that the sound from them is not able to impair children's hearing.

12. Activity toys shall be manufactured so as to reduce the risk of crushing or trapping of body parts or trapping of clothing and of falls, impacts and drowning as far as possible. In particular, any surface of such a toy accessible for one or more children to play on shall be designed to bear their load.

II. Flammability

1. The materials of which a toy is made must meet at least one of the following requirements:

1.1. the material does not burn if directly exposed to a flame or spark or other potential source of fire;

1.2. the material is not readily flammable (the flame goes out as soon as the fire cause disappears);

1.3. if the material ignites, it burns slowly and presents a low rate of spread of the flame;

1.4. irrespective of the toy's chemical composition, it is designed so as to mechanically delay the combustion process.

2. The materials referred to in Paragraph 1 of Chapter II to this Annex must not constitute a risk of ignition for other materials used in the toy.

3. Toys which, for reasons essential to their functioning, contain substances or mixtures that meet the classification criteria laid down in Chapter I of Annex 5 to this Regulation, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, must not contain, as such, substances or mixtures which may become flammable due to the loss of non-flammable volatile components.

4. Toys other than toy percussion caps must not be explosive or contain elements or substances likely to explode.

5. Toys and, in particular, chemical games and toys, must not contain as such substances or mixtures:

5.1. which, when mixed together, may explode through chemical reaction or through heating;

5.2. which may explode when mixed with oxidizing substances; or

5.3. which contain volatile components which are flammable in air and liable to form a flammable or explosive vapour/air mixture.

III. Chemical Properties

1. Toys shall be designed and manufactured in such a way that there are no risks to human health due to exposure to the chemical substances or mixtures of which the toys are made or which they contain when the toys are used as provided for in Paragraph 8 of this Regulation.

2. Toys shall comply with the relevant European Union legislation relating to certain categories of products or to restrictions for certain substances and mixtures.

3. Toys that are themselves substances or mixtures must comply, as far as classification, packaging and labelling of certain substances and mixtures is concerned, with the laws and regulations providing for the procedures for classification, packaging and labelling of chemical substances and chemical products and with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures and repealing Directive 67/548/EEC and amending Regulation (EC) No 1907/2006 (hereinafter - Regulation No 1272/2008).

4. Without prejudice to the restrictions referred to in Paragraph 2 of Chapter III of this Annex, substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A, 1B or 2 under Regulation No 1272/2008 shall not be used in toys, in components of toys or in micro-structurally distinct parts of toys.

5. By way of derogation from Paragraph 4 of this Chapter, substances or mixtures classified as CMR of the categories laid down in Chapter III of Annex 5 to this Regulation may be used in toys, in components of toys or micro-structurally distinct parts of toys provided that one or more of the following conditions is met:

5.1. these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the European Union legal acts referred to under Chapter II of Annex 5 to this Regulation on the classification of mixtures containing these substances;

5.2. these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as specified in Paragraph 8 of this Regulation;

5.3. a decision has been taken by the European Commission to permit the use of the substance or mixture that complements the list of substances and mixtures set out in this Regulation.

6. By way of derogation from Paragraph 4 of this Chapter, substances or mixtures classified as CMR of the categories laid down in Chapter IV of Annex 5 to this Regulation may be used in toys, in components of toys or micro-structurally distinct parts of toys provided that one of the following conditions is met:

6.1. these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the European Union legal acts referred to under Chapter II of Annex 5 to this Regulation on the classification of mixtures containing these substances;

6.2. these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as specified in Paragraph 8 of this Regulation;

6.3. a decision has been taken by the European Commission to permit the use of the relevant substance or mixture that complements the permitted uses of the relevant substance or mixture specified in this Regulation.

7. Paragraphs 4, 5 and 6 of Chapter III of this Annex do not apply to:

7.1. nickel in toys and toy components made of stainless steel and nickel in toy components which are intended to conduct an electric current;

7.2. the following chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if their content in the relevant articles complies with the indicated specific limit values:

Substance CAS No. Limit value
Tris(2-carboxyethyl)phosphine (TCEP) 115-96-8 5 mg/kg (content limit)
Tris(2-chloro-1-methylethyl)phosphate (TCPP) 13674-84-5 5 mg/kg (content limit)
Tris[2-chloro-1- (chloromethyl)ethyl] phosphate (TDCP) 13674-87-8 5 mg/kg (content limit)
Bisphenol A 80-05-7 0.1 mg/l (migration limit) in accordance with the methods laid down in the standards EN 71-10:2005 and EN 71-11:2005

7.3. materials that, in accordance with a decision by the European Commission, comply with the specific limit values for chemical substances used in toys intended for children under 36 months of age, or - until taking of the relevant regulations, but not later than by 20 July 2017 - to materials covered by and complying with the requirements that have been laid down for materials which come into contact with food set out in Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food, repealing Directives 80/590/EEC and 89/109/EEC, and in related special measures in respect of particular materials.

8. Without prejudice to the application of Paragraphs 4 and 5 of Chapter III of this Annex, nitrosamines and nitrosable substances are prohibited for use in toys intended for use by children under 36 months of age or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0.05 mg/kg for nitrosamines and 1 mg/kg for nitrosable substances.

9. Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional and labelling requirements laid down in the laws and regulations regarding the essential requirements for cosmetic products and the procedures for supervision thereof.

10. Toys shall not contain the following allergenic fragrances:

No. Name of the allergenic fragrance CAS number
1. Alanroot oil (Inula helenium) 97676-35-2
2. Allylisothiocyanate 57-06-7
3. Benzyl cyanide 140-29-4
4. 4 tert-Butylphenol 98-54-4
5. Chenopodium oil 8006-99-3
6. Cyclamen alcohol 4756-19-8
7. Diethyl maleate 141-05-9
8. Dihydrocoumarin 119-84-6
9. 2,4-Dihydroxy-3-methylbenzaldehyde 6248-20-0
10. 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) 40607-48-5
11. 4,6-Dimethyl-8-tert-butylcoumarin 17874-34-9
12. Dimethyl citraconate 617-54-9
13. 7,11-Dimethyl-4.6,10-dodecatrien-3-one 26651-96-7
14. 6,10-Dimethyl-3.5,9-undecatrien-2-one 141-10-6
15. Diphenylamine 122-39-4
16. Ethyl acrylate 140-88-5
17. Fig leaf, fresh and preparations 68916-52-9
18. trans-2-Heptenal 18829-55-5
19. trans-2-Hexenal diethyl acetal 67746-30-9
20. trans-2-Hexenal dimethyl acetal 18318-83-7
21. Hydroabietyl alcohol 13393-93-6
22. 4-Ethoxy-phenol 622-62-8
23. 6-lsopropyl-2-decahydronaphthalenol 34131-99-2
24. 7-Methoxycoumarin 531-59-9
25. 4-Methoxyphenol 150-76-5
26. 4-(p-Methoxyphenyl)-3-butene-2-one 943-88-4
27. 1-(p-Methoxyphenyl)-1-penten-3-one 104-27-8
28. Methyl trans-2-butenoate 623-43-8
29. 6-Methylcoumarin 92-48-8
30. 7-Methylcoumarin 2445-83-2
31. 5-Methyl-2,3-hexanedione 13706-86-0
32. Costus root oil (Saussurea lappa Clarke) 8023-88-9
33. 7-Ethoxy-4-methylcoumarin 87-05-8
34. Hexahydrocoumarin 700-82-3
35. Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch) 8007-00-9
36. 2-Pentylidene-cyclohexanone 25677-40-1
37. 3.6,10-Trimethyl-3.5,9-undecatrien-2-one 1117-41-5
38. Verbena oil (Lippia citriodora Kunth) 8024-12-2
39. Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene) 83-66-9
40. 4-Phenyl-3-buten-2-one 122-57-6
41. Amyl cinnamal 122-40-7
42. Amylcinnamyl alcohol 101-85-9
43. Benzyl alcohol 100-51-6
44. Benzyl salicylate 118-58-1
45. Cinnamyl alcohol 104-54-1
46. Cinnamal 104-55-2
47. Citral 5392-40-5
48. Coumarin 91-64-5
49. Eugenol 97-53-0
50. Geraniol 106-24-1
51. Hydroxy-citronellal 107-75-5
52. Hydroxy-methylpentylcyclohexenecarboxaldehyde 31906-04-4
53. Isoeugenol 97-54-1
54. Oakmoss extracts 90028-68-5
55. Treemoss extracts 90028-67-4

11. The presence of traces of the fragrances specified in Paragraph 10 of Chapter III of this Annex shall be allowed provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg.

12. The names of the following allergenic fragrances shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, as such, at concentrations exceeding 100 mg/kg in the toy or components thereof:

No. Name of the allergenic fragrance CAS number
1. Anisyl alcohol 105-13-5
2. Benzyl benzoate 120-51-4
3. Benzyl cinnamate 103-41-3
4. Citronellol 106-22-9
5. Farnesol 4602-84-0
6. Hexyl cinnamaldehyde 101-86-0
7. Lilial 80-54-6
8. d-Limonene 5989-27-5
9. Linalool 78-70-6
10. Methyl heptine carbonate 111-12-6
11. 3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one 127-51-5

13. The use of the fragrances set out in points 41 to 55 of the list set out in Paragraph 10 of Chapter III of this Annex and of the fragrances set out in points 1 to 11 of the list set out in Paragraph 12 shall be allowed in olfactory board games, cosmetic kits and gustative games, provided that:

13.1. those fragrances are clearly labelled on the packaging, and the packaging contains the warning set out under Chapter X of Annex 4 to this Regulation;

13.2. if applicable, the resulting products made by the child in accordance with the instructions comply with the laws and regulations regarding the essential requirements for cosmetic products and the procedures for supervision thereof;

13.3. if applicable, those fragrances comply with the relevant legal acts on food.

14. Such olfactory board games, cosmetic kits and gustative games shall not be used by children under 36 months of age and shall comply with Chapter I of Annex 4 to this Regulation.

15. Without prejudice to Paragraphs 4, 5 and 6 of Chapter III of this Annex, the following migration limits, from toys or components of toys, shall not be exceeded:

No. Element mg/kg in dry, brittle, powder-like or pliable toy material mg/kg in liquid or sticky toy material mg/kg in scraped-off toy material
1. Aluminium 5625 1406 70000
2. Antimony 45 11.3 560
3. Arsenic 3.8 0.9 47
4. Barium in accordance with Commission Regulation (EU) No 681/2013 of 17 July 2013 amending part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys 1500 375 18750
5. Boron 1200 300 15000
6. Cadmium 1.3 0.3 17
7. Chromium (III) 37.5 9.4 460
8. Chromium (VI) 0.02 0.005 0.2
9. Cobalt 10.5 2.6 130
10. Copper 622.5 156 7700
11. Lead 13.5 3.4 160
12. Manganese 1200 300 15000
13. Mercury 7.5 1.9 94
14. Nickel 75 18.8 930
15. Selenium 37.5 9.4 460
16. Strontium 4500 1125 56000
17. Tin 15000 3750 180000
18. Organic tin 0.9 0.2 12
19. Zinc 3750 938 46000

16. The limit values specified in Paragraph 15 of Chapter III of this Annex shall not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used, as specified in Paragraph 8 of this Regulation.

IV. Electrical Properties

1. Toys shall not be powered by electricity of a nominal voltage exceeding 24 volts direct current (DC) or the equivalent alternating current (AC) voltage. Their parts shall not exceed 24 volts DC or the equivalent AC voltage, unless it is ensured that the voltage and the current combination generated do not lead to any risk or harmful electric shock, even when the toy is broken.

2. Parts of toys which are connected to, or liable to come into contact with, a source of electricity capable of causing electric shock, together with the cables or other conductors through which electricity is conveyed to such parts, must be properly insulated and mechanically protected so as to prevent the risk of such shock.

3. Electric toys must be designed and manufactured in such a way as to ensure that the maximum temperatures reached by all directly accessible surfaces are not such as to cause burns when touched.

4. Under foreseeable fault conditions, toys must provide protection against electrical hazards arising from an electrical power source.

5. Electric toys must provide adequate protection against fire hazards.

6. Electric toys must be designed and manufactured in such a way that electric, magnetic and electromagnetic fields and other radiations generated by the equipment are limited to the extent necessary for the operation of the toy, and must operate at a safe level in compliance with the generally acknowledged state of the art, taking account of specific European Union measures.

7. Toys which have an electronic control system must be designed and manufactured in such a way that the toy operates safely even when the electronic system starts malfunctioning or fails due to failure of the system itself or an outside factor.

8. Toys must be designed and manufactured in such a way that they do not present any health hazards or risk of injury to eyes or skin from lasers, light-emitting diodes (LEDs) or any other type of radiation.

9. The electrical transformer of a toy shall not be an integral part of the toy.

V. Hygiene

1. Toys must be designed and manufactured in such a way as to meet hygiene and cleanliness requirements in order to avoid any risk of infection, sickness or contamination.

2. A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer's instructions.

VI. Radioactivity

Toys shall comply with the requirements of the laws and regulations regarding the protection against ionising radiation.

Minister for Economics A. Kampars

 

Annex 3
Cabinet Regulation No. 382
15 February 2011

EC Declaration of Conformity

1. Identification No of the toy(s).

2. Name and address of the manufacturer or his authorised representative.

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of toy allowing traceability, including a colour image of sufficient clarity to enable the identification of the toy).

5. The specified toy is in conformity with the relevant European Union legal acts.

6. References to the relevant applicable standards used, or references to the specifications in relation to which conformity is declared.

7. Where applicable: the notified body (name, number) performed specific activities (description of intervention) and issued the certificate.

8. Additional information.

EC Declaration of Conformity prepared      
  (place)   (date)
           
Declaration prepared by          
  (position)   (given name, surname)   (signature)

Minister for Economics A. Kampars

 

Annex 4
Cabinet Regulation No. 382
15 February 2011

Warnings and Indications of Precaution to Be Taken When Using Certain Categories of Toys

I. Toys not Intended for Use by Children under 36 Months

1. Toys which might be dangerous for children under 36 months of age shall bear a warning such as: "Not suitable for children under 36 months" or "Not suitable for children under three years" or a warning in the form of the following graphic:

The sign and crossing line included in the picture shall be red, the background - white, the digits (restriction of age) and the drawing (human face) - black. The diameter of the sign shall be 20 mm. The size of the picture may be reduced proportionately due to lack of space, however, it shall not have a diameter of less than 10 mm. The symbol in the picture may not be used in respect of age groups other than the one indicated in the picture.

2. The warnings shall be accompanied by a brief indication of the specific hazard calling for such precaution. Such indication may also appear in the instructions for use.

3. Paragraphs 1 and 2 of this Chapter do not apply to toys which, on account of their function, dimensions, characteristics, properties or other cogent grounds, are manifestly unsuitable for children under 36 months of age.

II. Activity Toys

1. Activity toys shall bear the following warning: "Only for domestic use".

2. Activity toys attached to a crossbeam, as well as other activity toys, where appropriate, shall be accompanied by instructions drawing attention to the need to carry out checks and maintenance of the main parts (suspensions, fixings, anchorages, etc.) at intervals, and pointing out that, if these checks are not carried out, the toy may cause a fall or overturn.

3. Instructions must also be given as to the correct assembly of the toy, indicating those parts which can present a danger if incorrectly assembled. Specific information regarding a suitable surface on which to place the toy shall be given.

III. Functional Toys

1. Functional toys shall bear the following warning: "To be used under the direct supervision of an adult".

2. Functional toys shall be accompanied by directions giving working instructions, as well as the precautions to be taken by the user, with the warning that failure to take these precautions will expose the user to the hazards - to be specified - normally associated with the appliance or product of which the toy is a scale model or imitation. It shall also be indicated that the toy must be kept out of the reach of children under a certain age, which shall be specified by the manufacturer.

IV. Chemical Toys

1. Without prejudice to the application of the provisions laid down in Regulation No 1272/2008 the instructions for use of toys containing inherently dangerous substances or mixtures shall bear a warning of the dangerous nature of these substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, which shall be specified concisely according to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of this type of toy shall also be mentioned. It shall also be stated that the toy must be kept out of reach of children under a certain age, which shall be specified by the manufacturer.

2. In addition to the instructions provided for in the first subparagraph, chemical toys shall bear the following warning on their packaging: "Not suitable for children under (*) years. For use under adult supervision". Age shall be specified by the manufacturer.

3. In particular, the following are regarded as chemical toys: chemistry sets, plastic embedding sets, miniature workshops for ceramics, enamelling or photography and similar toys which lead to a chemical reaction or similar substance alteration during use.

V. Skates, Roller Skates, Online Skates, Skateboards, Scooters and Toy Bicycles for Children

1. Where skates, roller skates, online skates, skateboards, scooters and toy bicycles for children are offered for sale as toys, they shall bear the following warning: "Protective equipment should be worn. Not to be used in traffic".

2. Moreover, the instructions for use shall contain a reminder that the toy must be used with caution, since it requires great skill, so as to avoid falls or collisions causing injury to the user and third parties. Some indication shall also be given as to recommended protective equipment (helmets, gloves, knee-pads, elbow-pads).

VI. Aquatic Toys

Aquatic toys shall bear the following warning: "Only to be used in water in which the child is within its depth and under adult supervision."

VII. Toys in Food

Toys contained in food or co-mingled with food shall bear the following warning: "Toy inside. Adult supervision recommended."

VIII. Imitations of Protective Masks and Helmets

Imitations of protective masks and helmets shall bear the following warning: "This toy does not provide protection."

IX. Toys Intended to be Strung across a Cradle, Cot or Perambulator by Means of Strings, Cords, Elastics or Straps

Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps shall carry the following warning on the packaging, which shall also be permanently marked on the toy: "To prevent possible injury by entanglement, remove this toy when the child starts trying to get up on its hands and knees in a crawling position."

X. Packaging for Fragrances in Olfactory Board Games, Cosmetic Kits and Gustative Games

Packaging for fragrances in olfactory board games, cosmetic kits and gustative games that contain the fragrances referred to in points 41 to 55 of the list set out in Paragraph 10 and of the fragrances referred to in points 1 to 11 of the list set out in Paragraph 12 of Chapter III of Annex 2 shall contain the following warning: "Contains fragrances that may cause allergies."

Minister for Economics A. Kampars

 

Annex 5
Cabinet Regulation No. 382
15 February 2011

Classification of Substances and Mixtures

I. Criteria for Classifying Substances and Mixtures Specified in Paragraph 3 of Chapter II of Annex 2 to this Regulation

1. The substance fulfils the criteria for any of the following hazard classes or categories referred to in Annex I to Regulation No 1272/2008:

1.1. hazard classes 2.1, 2.2, 2.3, 2.4, 2.6, and 2.7, types A and B of hazard class 2.8, hazard classes 2.9, 2.10, 2.12, categories 1 and 2 of hazard class 2.13, categories 1 and 2 of hazard class 2.14, types A to F of hazard class 2.15;

1.2. hazard classes 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6, hazard class 3.7 with adverse effects on sexual function and fertility or on development, effects of hazard class 3.8 other than narcotic effects, hazard classes 3.9 and 3.10;

1.3. hazard class 4.1;

1.4. hazard class 5.1.

2. The mixture is dangerous within the meaning of the laws and regulations regarding the procedures for classification, labelling and packaging of chemical substances and chemical products.

3. The substance or mixture fulfils the criteria for any of the following hazard classes or categories referred to in Annex I to Regulation No 1272/2008:

3.1. hazard classes 2.1, 2.2, 2.3, 2.4, 2.6, and 2.7, types A and B of hazard class 2.8, hazard classes 2.9, 2.10, 2.12, categories 1 and 2 of hazard class 2.13, categories 1 and 2 of hazard class 2.14, types A to F of hazard class 2.15;

3.2. hazard classes 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6, hazard class 3.7 with adverse effects on sexual function and fertility or on development, effects of hazard class 3.8 other than narcotic effects, hazard classes 3.9 and 3.10;

3.3. hazard class 4.1;

3.4. hazard class 5.1.

II. European Union Legal Acts Governing the Use of Certain Substances for the Purposes of Sub-paragraphs 5.1 and 6.1 of Chapter III of Annex 2 to this Regulation

1. The relevant concentrations for the classification of mixtures containing the substances shall be those established in accordance with Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (hereinafter - Directive 1999/45/EC).

2. The relevant concentrations for the classification of mixtures containing the substances shall be those established in accordance with Regulation No 1272/2008.

III. Categories of Substances and Mixtures Classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) for the purposes of Paragraph 5 of Chapter III of Annex 2 to this Regulation

1. Paragraph 5 of Chapter III of Annex 2 to this Regulation concerns substances classified as CMR category 1A and 1B under Regulation No 1272/2008.

2. Paragraph 5 of Chapter III of Annex 2 to this Regulation concerns mixtures classified as CMR category 1 and 2 under Directive 1999/45/EC and in accordance with the laws and regulations regarding the procedures for classification, labelling and packaging of chemical substances and chemical products.

3. Paragraph 5 of Chapter III of Annex 2 to this Regulation concerns mixtures classified as CMR category 1A and 1B under Regulation No 1272/2008.

IV. Categories of Substances and Mixtures Classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) for the purposes of Paragraph 6 of Chapter III of Annex 2 to this Regulation

1. Paragraph 6 of Chapter III of Annex 2 to this Regulation concerns substances classified as CMR category 2 under Regulation No 1272/2008.

2. Paragraph 6 of Chapter III of Annex 2 to this Regulation concerns mixtures classified as CMR category 3, as appropriate, under Directive 1999/45/EC and in accordance with the laws and regulations regarding the procedures for classification, labelling and packaging of chemical substances and chemical products.

3. Paragraph 6 of Chapter III of Annex 2 to this Regulation concerns mixtures classified as CMR category 2 under Regulation No 1272/2008.

V. Categories of Substances and Mixtures Classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) for the Purposes of Sub-paragraphs 5.3 and 6.3 of Chapter III of Annex 2 to this Regulation

1. Sub-paragraphs 5.3 and 6.3 of Chapter III of Annex 2 to this Regulation concern substances classified as CMR categories 1A, 1B and 2 under Regulation No 1272/2008.

2. Sub-paragraphs 5.3 and 6.3 of Chapter III of Annex 2 to this Regulation concern mixtures classified as CMR categories 1, 2 and 3 under Directive 1999/45/EC and in accordance with the laws and regulations regarding the procedures for classification, labelling and packaging of chemical substances and chemical products.

3. Sub-paragraphs 5.3 and 6.3 of Chapter III of Annex 2 to this Regulation concern mixtures classified as CMR categories 1A, 1B and 2 under Regulation No 1272/2008.

Minister for Economics A. Kampars

 


Translation © 2016 Valsts valodas centrs (State Language Centre)

 
Document information
Status:
In force
in force
Issuer: Cabinet of Ministers Type: regulation Document number: 132Adoption: 15.02.2011.Entry into force: 20.07.2011.Publication: Latvijas Vēstnesis, 40, 11.03.2011.
Language:
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