Royal Decree 880/1990 of 29 June 1990 laying down the safety standards for toys incorporated into the Spanish legal order Council Directive 88 /378/EEC of 3 May 1988 on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to of the laws of the Member States on the safety of toys.

The aforementioned directive has been the subject of successive modifications, which have had its consequent reflection in our legal order with the modification of the royal decree cited.

Thus, Council Directive 93 /68/EEC of 22 July 1993 amending certain provisions of the content of 12 Directives, including those relating to the safety of toys, was transposed into the by Royal Decree 204/1995 of 10 February.

In December 2008, Directive 2008 /112/EC of the European Parliament and of the Council of 16 December 2008 amending various Directives, including 88 /378/EEC, was adopted to bring them into line with Regulation (EC) No 1272/2008, classification, labelling and packaging of substances and mixtures, and which in turn was transposed by Royal Decree 1285/2010 of 15 October 2010 amending Royal Decree 880/1990 of 29 June 1990 laying down rules for the safety of toys in relation to the substances or mixtures used in their manufacture.

Finally, in 2009, Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, which is necessary to review and improve certain aspects of Directive 88 /378/EEC, was adopted. progressively replacing it with the rules contained therein.

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of products horizontal provisions concerning the accreditation of conformity assessment bodies, the CE marking and the Community market surveillance framework, as well as the checks on the products which are placed on the market Community, which are also applicable in the toy sector.

This directive is also harmonised with the provisions of Decision No 768 /2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products. Consequently, certain definitions, the general obligations of the economic operators, the presumption of conformity, the formal objection against harmonised standards, the rules for the CE marking, the requirements of the assessment bodies of the conformity and the notification procedures, as well as the provisions on procedures relating to products presenting a risk should be harmonised with that Decision.

The incorporation into the Spanish legal order of Directive 2009 /48/EC, of the European Parliament and of the Council, of 18 June 2009 is carried out with this royal decree, from which it is necessary to highlight the aspects that relatan.

To make it easier for manufacturers and competent authorities to apply, their scope is clarified, completing the list of products to which it does not apply, especially in the case of some new products, such as: video games and peripherals, and establishing new specific definitions for the toy sector.

A clear and proportionate distribution of the obligations corresponding to the role of each agent in the supply and distribution process is established. Economic operators involved in the supply chain and distribution of toys should ensure a high level of protection of the public interest, as well as the health, safety and protection of consumers and the environment, and ensure fair competition within the market by taking appropriate measures to ensure that, under normal and reasonably foreseeable conditions of use, the toys which they place on the market do not endanger the safety and health of the children.

In addition, toys that are placed on the market must comply with the rules contained in this royal decree, as well as the rest of the regulations applicable to the safety of products and, in particular, that provided for in the Royal Decree 1801/2003 of 26 December 2003 on general product safety, which is applied in a complementary manner, with the responsibility of the economic operators to ensure compliance with the toys, in accordance with the function to perform in the supply chain.

On the other hand, it should be noted that Royal Decree 330/2008 of 29 February adopting measures for the control of imports of certain products in respect of the applicable safety standards for the products, it establishes a reinforced control procedure for a number of products from third countries, considered to be sensitive, including toys.

In the handling of this royal decree, the affected sectors have been heard and the autonomous communities and cities of Ceuta and Melilla have been consulted, with the Council of Consumers and Users having issued a report.

In its virtue, on the proposal of the Minister of Health, Social Policy and Equality and the Minister of Industry, Tourism and Trade, with the prior approval of the Minister of Territorial Policy, according to the State Council and after deliberation by the Council of Ministers at its meeting on 26 August 2011,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. This royal decree lays down the safety rules for toys, applying to products designed or intended, exclusively or not, to be used for the purpose of play by children under the age of 14, as well as the free movement of toys. same.

2. The marketing in the Spanish territory of toys that comply with this royal decree may not be prohibited, limited or hindered.

3. The products listed in Annex I to this royal decree shall not be considered as toys for the purposes of this Regulation.

4. This royal decree will not apply to the following toys:

a) playground equipment intended for public use;

(b) automatic gaming machines, whether operating or not with currency, intended for public use;

(c) toy vehicles equipped with combustion engines;

d) toy steam engines; and

e) hondes and tirachins.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

1) "marketing" means any supply, paid or free, of a toy for distribution, consumption or use on the Community market in the course of a commercial activity;

2) "placing on the market": first placing a toy on the Community market;

3) "manufacturer" means any natural or legal person who manufactures a toy, or who has a toy design or manufacture, and markets it under his name or trademark;

4) "authorised representative" means any natural or legal person established in the European Union who has received a written mandate from a manufacturer to act on his behalf in relation to specific tasks;

5) "importer" means any natural or legal person established in the European Union who introduces a toy from a third country to the Community market;

6) "distributor" means any natural or legal person in the supply chain, other than the manufacturer or importer, who markets a toy;

7) "economic operators" means the manufacturer, the authorised representative, the importer and the distributor;

8) "harmonised standard" means a non-compulsory technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), in the framework of a mandate from the Commission granted in accordance with the procedures laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998, establishes a procedure for the provision of information in the field of technical standards and regulations and of the rules concerning the services of the information society, transposed into Spanish domestic law by Royal Decree 1337/1999, of 31 July.

9) "Community harmonisation legislation" means any Community legislation which harmonises the conditions for the marketing of products;

10) "accreditation" means a declaration by a national accreditation body that a conformity assessment body complies with the requirements set out in accordance with harmonised standards and, where applicable, other requirements additional, including those laid down in the relevant sectoral schemes, for the purpose of carrying out specific conformity assessment activities, as provided for in Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 of July 2008 establishing the requirements for accreditation and market surveillance concerning the placing on the market of the products and repealing Regulation (EEC) No 339/93;

11) "conformity assessment" means a process by which the specific requirements for a toy are met;

12) "conformity assessment body" means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

13) "recovery" means any measure intended to obtain the return of a toy already made available to the end user;

14) "withdrawal" means any measure intended to prevent the placing on the market of a toy found in the supply chain;

15) "market surveillance" means activities carried out and measures taken by public authorities to ensure that toys comply with the legal requirements laid down by Community harmonisation legislation and not entailing a risk to health and safety or to other matters relating to the protection of the public interest;

16) 'CE marking' means the marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements laid down in the Community harmonisation legislation providing for its affixing;

17) "functional product" means a product that works and is used in the same way as a product, appliance or installation intended for use by adults and which can be a scale model for adults;

18) "functional toy" means a toy that works and is used in the same way as a product, appliance or installation intended for use by adults and which can be a scale model for those;

19) "aquatic toy" means a toy intended to be used in shallow water and capable of transporting or supporting a child in the water;

20) "design speed": the potential operating speed determined by the design of the toy;

21) "activity toy" means a toy for domestic use whose support structure remains stationary during the activity and which is intended for a child to practise any of the following activities: climbing, jumping, columping, slide, balance, rotate, drag or climb, or any combination thereof;

22) "chemical toy" means a toy intended for the direct handling of chemical substances and mixtures and to be used in a manner consistent with age and under the supervision of an adult;

23) "olfactory board game": a game that aims to help the child learn to recognize different smells or flavors;

24) "cosmetics kit": a toy intended to help the child learn how to make products such as fragrances, soaps, creams, shampoos, bath foams, enamels, lip bars, makeup, toothpastes and softeners;

25) "game of taste": a game that aims to allow children to make treats or dishes that involve the use of food ingredients, such as sweeteners, liquids, powders and aromas;

26) "damage": physical injury or other type of health injury, including long-term health effects;

27) "danger": possible cause of damage;

28) "risk": likely rate of occurrence of a hazard causing damage and severity of damage;

29) "intended for": an expression used to indicate that a parent or supervisor can reasonably assume that a toy, for its functions, dimensions and characteristics, is intended for the use of children of the age group indicated.

Article 3. Market surveillance authorities.

1. For the purposes of this royal decree, it is understood by market surveillance authorities as provided for in Articles 13 and 14 of Royal Decree 1801/2003 of 26 December 2003 on general product safety in their respective fields of powers and in Article 2.1 of Royal Decree 330/2008 of 29 February 2008 laying down control measures for the import of certain products with regard to the rules applicable to the safety of products.

2. The market surveillance authorities, in their respective fields of competence, are responsible for carrying out activities and taking measures, including those for coordination, with the aim of ensuring that toys comply with the provisions of Directive they are applicable to them and, in any event, do not constitute a risk to public interests protected by such provisions.

3. It is up to the autonomous communities and the cities of Ceuta and Melilla, in the field of their competences, to determine their market surveillance authorities. They will also be able to establish mechanisms for collaboration, cooperation and coordination with municipalities in this area. These autonomous communities shall communicate all these data-and any subsequent amendments-to the National Consumer Institute, in order to enable, by means of the procedure laid down, their information to the European Commission and to the the other Member States.

Article 4. Market surveillance.

1. The market surveillance activities of toys introduced on the Community market shall be organised and carried out in accordance with Articles 15 to 29 of Regulation (EC) No 765/2008. In addition to those articles, Article 35 of this royal decree will apply.

2. Where the competent authorities adopt measures provided for in this royal decree, and in particular those referred to in this Article, they shall take due account of the precautionary principle.

CHAPTER II

Obligations of economic operators

Article 5. Obligations of manufacturers.

1. When placing their toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements laid down in Article 11 and Annex II to this Royal Decree.

2. Manufacturers shall draw up the product dossier required in accordance with Article 20 and apply or have applied the conformity assessment procedure in accordance with Article 18. Where the conformity of a toy with the requirements applicable by this procedure has been demonstrated, manufacturers shall draw up an EC declaration of conformity, as referred to in Article 14, and affix the CE marking to such a as set out in Article 16.1.

3. Manufacturers shall keep the product file and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market.

4. Manufacturers shall ensure that there are procedures for serial production to maintain their conformity. Changes in the design or characteristics of the toy and changes in the harmonised standards according to which the conformity of a toy is declared shall be taken into due consideration. Whenever deemed appropriate with regard to the risks presented by a toy, manufacturers shall, in order to protect the health and safety of consumers, test samples of the toys placed on the market, investigate and, where appropriate, maintain a register of complaints, non-compliant toys and those withdrawn, and keep distributors informed of any monitoring. In any event, the establishment of a complaint register should be motivated in a timely manner, justifying its need and proportionality to protect the health and safety of consumers.

5. Manufacturers shall ensure that their toys bear a type, batch, series or model number or other element allowing their identification, or, if the size or nature of the toy does not permit, that the required information is contained in the packaging or in a document accompanying the toy.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark and their contact address on the toy or, where that is not possible, on their packaging or in a document accompanying the toy. The address shall indicate a single point of contact with the manufacturer.

7. Manufacturers shall ensure that the toy is accompanied by instructions and safety information at least in Spanish.

8. Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in accordance with this royal decree shall immediately take the corrective measures necessary to do so in accordance with, withdraw it or, if appropriate, ask for its return. In addition, where the toy presents a risk, manufacturers shall immediately inform the market surveillance authority thereof, in accordance with the procedure described in Article 6 of Royal Decree 1801/2003 of 26 December 2003 on safety general of the products, giving details, in particular, of the non-compliance and the corrective measures taken.

9. On the basis of a reasoned request from a market surveillance authority, manufacturers shall provide it with all the information and documentation necessary to demonstrate the conformity of a toy, in a language which is easily understood by the manufacturer. authority. They shall cooperate with that authority, at the request of the latter, in any action to eliminate the risks posed by the toys which they have placed on the market.

Article 6. Authorised representatives.

1. A manufacturer may designate, by written mandate, an authorised representative.

2. The obligations laid down in Article 5.1 of this royal decree and the preparation of the product file shall not form part of the authorised representative's mandate.

3. The authorised representatives shall carry out the tasks specified in the mandate received from the manufacturer. The command must allow the authorized representative to perform at least the following tasks:

(a) maintain the EC declaration of conformity and the technical documentation at the disposal of the surveillance authorities for a period of 10 years after the toy has been placed on the market;

(b) on the basis of a reasoned request from a market surveillance authority, to provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy;

(c) cooperate with the competent authorities, at their request, in any action aimed at eliminating the risks involved in the toys which are the subject of their mandate.

Article 7. Obligations of importers.

1. Importers shall only place compliant toys on the market.

2. Before placing a toy on the market the importers shall ensure that the manufacturer has carried out the appropriate conformity assessment procedure. They shall ensure that the manufacturer has produced the product dossier, that the toy bears the required conformity mark and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 5, paragraphs 5 and 6.

If an importer considers or has reason to believe that a toy does not comply with the requirements set out in Article 11 and Annex II, it shall not place it on the market until it is compliant. In addition, where the toy presents a risk, the importer shall inform the manufacturer and the relevant market surveillance authority thereof.

3. Importers shall indicate their name, registered trade name or registered trade mark and their address of contact on the toy or, where that is not possible, on its packaging or in a document accompanying it.

4. Importers shall ensure that the toy is accompanied by instructions and safety information at least in Spanish.

5. As long as they are responsible for a toy, importers shall ensure that storage or transport conditions do not jeopardise compliance with the requirements set out in Article 11 and Annex II to this royal decree.

6. Where it is considered relevant to the risks presented by a toy, importers shall, in order to protect the health and safety of consumers, carry out sampling tests on toys placed on the market, investigate and, in their they shall keep records of complaints, non-compliant toys and recalls, and shall keep distributors informed of such monitoring.

7. Importers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with this royal decree shall immediately take the corrective measures necessary to bring it into conformity, to withdraw it or, if appropriate, ask for their return. In addition, where the toy presents a risk, importers shall immediately inform the relevant market surveillance authority thereof, in accordance with the procedure described in Article 6 of Royal Decree 1801/2003 of 26 June 2003. December, and give details, in particular, of the non-compliance and the corrective measures taken.

8. Importers shall keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities for a period of 10 years from the marketing of the toy and shall ensure that, upon request, the authorities receive a copy of the technical documentation.

9. On the basis of a reasoned request from a market surveillance authority, importers shall provide it with all the information and documentation necessary to demonstrate the conformity of the toy in a language which is easily understandable for that purpose. authority. They shall cooperate with that authority, at the request of the latter, in any action to eliminate the risks posed by the toys which they have placed on the market.

Article 8. Obligations of distributors.

1. When placing a toy on the market, distributors shall act with due care in relation to the applicable requirements.

2. Before placing a toy on the market, distributors shall ensure that it bears the required mark of conformity, that it is accompanied by the necessary documents and the instructions and information relating to security at least in the (a) the manufacturer and the importer have complied with the requirements set out in Article 5 (5) and (6) and Article 7 (3). If a distributor considers or has reason to believe that a toy does not comply with the requirements laid down in Article 11 and Annex II, it shall only be placed on the market after it has done so. In addition, where the toy presents a risk, the distributor shall inform the manufacturer and the relevant market surveillance authority.

3. Distributors shall ensure that, while they are responsible for a toy, storage or transport conditions do not jeopardise compliance with the requirements laid down in Article 11 and Annex II.

4. Distributors who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the relevant Community harmonisation legislation shall ensure that the necessary corrective measures are taken to do so. to be withdrawn from the market or, if appropriate, to ask for their refund. In addition, where the toy presents a risk, distributors shall immediately inform the market surveillance authorities thereof in accordance with the procedure described in Article 6 of Royal Decree 1801/2003 of 26 December 2003. details, in particular, on the non-compliance and the corrective measures taken.

5. On the basis of a reasoned request from a market surveillance authority, distributors shall provide it with all the information and documentation necessary to demonstrate the conformity of the toy in a language which is easily understandable to that authority. They shall cooperate with that authority, at the request of the latter, in any action to eliminate the risks posed by the toys which they have placed on the market.

Article 9. Cases where the obligations of the manufacturers apply to importers and distributors.

For the purposes of this royal decree, it shall be considered a manufacturer and shall therefore be subject to the obligations of the manufacturer in accordance with Article 5, to an importer or distributor who places a toy on the market with his trade name or mark or modify a toy already placed on the market in such a way as to affect compliance with the applicable requirements.

Article 10. Identification of economic operators.

The economic operators shall, upon request, identify with the market surveillance authorities:

(a) any economic operator who has supplied them with a toy;

(b) to any economic operator to whom they have supplied a toy.

Economic operators shall be able to present the information referred to in the first subparagraph for a period of 10 years after the toy has been placed on the market, in the case of the manufacturer, and during a period of ten-year period after they have supplied the toy, in the case of other economic operators.

CHAPTER III

Toy compliance

Article 11. Essential security requirements.

1. The competent authorities shall take all necessary measures to ensure that toys cannot be placed on the market if they do not meet the essential safety requirements laid down in paragraph 2 of this Article. general safety requirement, and in Annex II, as regards the particular safety requirements.

2. Toys, including chemicals containing them, shall not compromise the safety or health of users or other persons when used for their normal use or are used in accordance with their foreseeable use, taking into account the behaviour of the children. Account shall be taken of the capacity of the users and, where appropriate, their supervisors, in particular in the case of toys intended for the use of children under the age of thirty-six months or other specific age groups.

The labels affixed in accordance with Article 12.2, and the instructions accompanying the toys shall alert the users or their supervisors of the hazards inherent in the toys and the risks of damage which enter your usage and indicate how to avoid them.

3. Toys placed on the market shall comply with the essential safety requirements during their foreseeable and normal period of use.

Article 12. Warnings.

1. Where appropriate, for safe use, warnings made for the purposes of Article 11.2 shall specify appropriate restrictions on the user in accordance with Annex V, Part A. As regards the categories of toys listed in Annex V, Part B, the warnings set out in that Part shall be used. The warnings set out in points 2 to 5 of Annex V, Part B, shall be used as they are in the same way. Toys shall not bear any of the specific warnings referred to in paragraph 1 if they are in contradiction with their intended use, determined by virtue of their function, size and characteristics.

2. The manufacturer shall indicate the warnings in a clearly visible and legible manner, easily understandable and accurate in the toy, on a sticker or on the packaging and, if appropriate, on the instructions for use accompanying the toy. Small toys sold without packaging shall bear the appropriate warnings placed directly on them. The warnings will be preceded by the word "Warning" or "Warnings", as the case may be. Warnings determining the purchase decision of the toy, such as those specifying the minimum and maximum age of the users, as well as the other applicable warnings set out in Annex V, shall be included in the packaging for which the toy is intended. consumer or, if not, they will be clearly visible to the consumer before the purchase, even when the purchase is made "on line".

3. In accordance with Article 5.7, security warnings and instructions shall be drawn up at least in Spanish.

Article 13. Presumption of conformity and harmonised standards.

Toys bearing the CE marking and accompanied by the EC declaration of conformity, the contents of which are set out in Annex III, shall be deemed to comply with the provisions of this royal decree.

A toy manufactured in accordance with a harmonised standard, the reference of which has been published in the Official Journal of the European Union, shall be considered in accordance with the essential health and safety requirements covered by that harmonised standard.

It shall be presumed that toys conforming to national standards or parts thereof, corresponding to the harmonised ones for which references have been published in the Official Journal of the European Union, fulfil the requirements laid down in this Directive. they provide for such rules or parts thereof, as laid down in Article 11 and Annex II.

Article 14. EC declaration of conformity.

1. The EC declaration of conformity shall state that compliance with the requirements specified in Article 11 and Annex II has been demonstrated.

2. The EC declaration of conformity shall contain at least the elements specified in Annex III to this royal decree and the relevant modules set out in Annex II to Decision No 768 /2008/EC and shall be continuously updated if requests a market surveillance authority. This declaration shall conform to the model set out in Annex III to this royal decree and shall be drawn up at least in Spanish.

3. When drawing up an EC declaration of conformity, the manufacturer shall assume responsibility for the conformity of the toy.

Article 15. General principles of the CE marking.

1. Toys placed on the market shall bear the CE marking.

2. The CE marking shall be subject to the general principles referred to in Article 30 of Regulation (EC) No 765/2008.

3. Toys bearing the CE marking shall be presumed to comply with this royal decree.

4. Toys which do not bear the CE marking or which otherwise do not comply with this royal decree may appear at trade fairs and exhibitions, provided that they are accompanied by a sign indicating clearly that they do not comply with it and that they do not shall be placed on the market before they have been made compliant.

Article 16. Rules and conditions for affixing the CE marking.

1. The CE marking shall be affixed visibly, legibly and indelibly to the toy, either on a sticker or on the packaging. In the case of small-sized toys and toys consisting of small parts, the CE marking may be affixed to a label or to an accompanying leaflet. If it is not possible from a technical point of view in the case of toys sold at counter exhibitors, and provided that the display is originally used as a package of toys, the CE marking shall be affixed to the display of the toys. counter. If the CE marking is not visible from the outside of the packaging, if any, it shall be placed at least on the packaging.

2. The CE marking shall be affixed before the toy is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.

CHAPTER IV

Assessment of compliance

Article 17. Security assessments.

Before placing a toy on the market, manufacturers will carry out an analysis of the chemical, physical, mechanical, electrical, inflammation, hygiene and radioactive hazards that the toy may present, as well as a assessment of the possible exposure to these hazards. They'll leave record of it.

Article 18. Applicable conformity assessment procedures.

1. Before placing a toy on the market, the manufacturer shall apply the conformity assessment procedures specified in paragraphs 2 and 3 to demonstrate that the toy complies with the requirements laid down in Article 11 and Annex II of this royal decree.

2. If the manufacturer has applied the national standards corresponding to the harmonised standards the reference number of which has been published in the Official Journal of the European Union, covering all the relevant safety requirements for the toy, shall use the internal production control procedure set out in Module A of Annex II to Decision No 768 /2008/EC.

3. The toy shall be subject to the EC type-examination referred to in Article 19 combined with the procedure in accordance with the type set out in Module C of Annex II to Decision No 768 /2008/EC in the following cases:

(a) where there are no harmonised standards that provide for all the relevant safety requirements for the toy;

(b) where the harmonised standards referred to in point (a) exist but the manufacturer has not applied them or has only partially applied them;

(c) where the harmonised standards referred to in (a), or some of them, have been published with a restriction;

(d) where the manufacturer considers that the nature, design, manufacture or purpose of the toy must be subject to the verification of a third party.

Article 19. EC type examination.

1. The application for the EC type examination, the completion of the examination and the issue of the corresponding certificate shall be carried out in accordance with the procedures laid down in Module B of Annex II to Decision No 768 /2008/EC. The EC type-examination shall be carried out in accordance with the conditions laid down in the second indent of paragraph 2 of that module (combination of type of production and type of design). In addition to those provisions, the requirements set out in paragraphs 2 to 5 of this Article shall apply.

2. The application for an EC type examination shall include a description of the toy and the indication of the place of manufacture and its address.

3. Where a conformity assessment body notified under Article 21 of this royal decree (hereinafter referred to as the 'notified body') carries out an EC type examination, it shall assess, if necessary, the manufacturer-the analysis of the the hazards which may be presented by the toy made by the manufacturer in accordance with Article 17.

4. The EC type-examination certificate shall include a reference to this royal decree and Directive 2009 /48/EC, a colour image, a clear description of the toy, with its dimensions, and a list of the tests carried out with the reference of the corresponding test report. The EC type-examination certificate shall be reviewed whenever necessary, in particular if the manufacturing process, the raw materials or the components of the toy and, in any case, every five years are modified.

The EC type examination certificate shall be withdrawn if the toy does not meet the safety requirements set out in Article 11 and Annex II to this royal decree.

The National Consumer Institute shall ensure that the bodies it has notified do not grant an EC examination certificate to toys to which a certificate has been refused or withdrawn.

5. The technical documentation and correspondence on the EC type-examination procedures shall be drawn up in the official Spanish language of the State or another acceptable to the notified body.

Article 20. Product dossier.

1. The product dossier referred to in Article 5.2 shall include all relevant data or details concerning the means used by the manufacturer to ensure that the toys comply with the essential and particular requirements of applicable security laid down in Article 11 and Annex II, and in particular the documents referred to in Annex IV.

2. The product dossier shall be drawn up in one of the official languages of the EU, taking into account the requirement laid down in Article 19.5.

3. Upon reasoned request from the market surveillance authority, the manufacturer shall provide the translation of the parts of the product dossier in the language requested by that authority within 30 days, unless a serious risk is immediately justify a shorter time frame.

4. If the manufacturer does not comply with the obligations laid down in paragraphs 1, 2 and 3, the market surveillance authority may require him to request a notified body to carry out a test, at his own expense, within a period of no more than 30 calendar days to verify compliance with harmonised standards and essential safety requirements.

CHAPTER V

Notification of compliance assessment bodies

Article 21. Notification.

The National Consumer Institute shall notify the Commission and the other Member States of the European Union of the bodies authorised to carry out conformity assessment tasks for third parties in accordance with the provisions of the Article 19.

Article 22. Notifying authorities.

1. The National Consumer Institute, as the notifying authority, shall be responsible for the establishment and implementation of the procedures necessary for the assessment and notification of conformity assessment bodies for the purposes of this royal decree and to monitor the notified bodies, including compliance with Article 28.

2. This authority may entrust the assessment and supervision referred to in paragraph 1 to the national accreditation body, taking full responsibility for the tasks carried out by the national accreditation body.

Article 23. Requirements relating to notifying authorities.

1. The authority referred to in Article 22 of this royal decree shall comply with the following requirements:

a) It should be established in such a way that there is no conflict of interest with conformity assessment bodies.

b) It shall be organised and managed in such a way as to preserve the objectivity and impartiality of its activities.

(c) It shall be organised in such a way that any decision on the notification of the conformity assessment body is taken by competent persons other than those who carried out the assessment.

(d) shall not offer or exercise any activity, including commercial or competitive consultation services, carried out by conformity assessment bodies.

e) Preserve the confidentiality of the information obtained.

f) Dispose of sufficient competent personnel to perform their tasks properly.

Article 24. Reporting obligation.

The authority referred to in Article 22 of this royal decree shall inform the Commission of its procedures for the assessment and notification of conformity assessment bodies and the supervision of notified bodies, as well as any changes in the transmitted information.

Article 25. Requirements of notified bodies.

1. For the purposes of the notification, the conformity assessment body shall comply with the requirements set out in paragraphs 2 to 11 of this Article.

2. The conformity assessment body shall be constituted in accordance with the legal order and shall have its own legal personality.

3. The conformity assessment body shall be independent of the organisation or toy it assesses. A body belonging to a trade association or a professional federation that represents the companies involved in the design, manufacture, supply, assembly, use or the use of the equipment may be considered as an assessment body. maintenance of the toys it evaluates, provided that its independence and the absence of conflicts of interest are guaranteed.

4. The conformity assessment body, its top management and the staff responsible for carrying out the conformity assessment tasks shall not be the designer, the manufacturer, the supplier, the installer, the buyer, the owner, the the user or the keeper of the toys to be assessed, or the authorised representative of any of them. This does not prevent the use of the assessed toys necessary for the activities of the conformity assessment body or for the use of such toys for personal purposes. The conformity assessment bodies, their top management and the staff responsible for carrying out the conformity assessment tasks shall not be directly involved in the design or manufacture, the placing on the market, the installation, use or maintenance of these toys, or represent the parties involved in these activities. They shall not engage in any activity that may conflict with their independence of criteria or their integrity in relation to the conformity assessment activities for which they have been notified. This will apply in particular to advisory services. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their conformity assessment activities.

5. The conformity assessment bodies and their staff shall carry out the conformity assessment activities with the highest level of professional integrity and with the required technical competence for the specific field, and shall be free of any pressure or incentive, in particular of a financial nature, which may influence its assessment or the outcome of its conformity assessment activities, in particular that which may be exercised by persons or groups of persons who have some interest in the results of these activities.

6. The conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it in accordance with Article 19 and for which it has been notified, irrespective of whether it carries out the tasks. the body itself or be carried out on its behalf and under its responsibility. At all times, for each conformity assessment procedure and for each type or category of toys for which it has been notified, the conformity assessment body shall have:

(a) of the required personnel with sufficient and appropriate expertise and experience to perform the conformity assessment tasks;

b) of the descriptions of procedures under which conformity assessment is carried out, ensuring the transparency and the possibility of reproduction of these procedures; of policies and procedures appropriate to distinguish between the tasks it performs as a notified body and any other activity;

(c) procedures for carrying out their activities, taking due account of the size of the undertakings, the sector in which they operate, their structure, the degree of complexity of the toy technology concerned and whether the production process is in series. The conformity assessment body shall have the necessary means to carry out appropriate technical and administrative tasks relating to conformity assessment activities and shall have access to all or the equipment of the conformity assessment body. facilities that you need.

7. The personnel carrying out the conformity assessment activities shall have:

(a) good technical and professional training to carry out all conformity assessment activities corresponding to the area for which the conformity assessment body has been notified;

(b) a satisfactory knowledge of the requirements of the assessments it makes and the authority necessary to carry out such operations;

(c) adequate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of the applicable Community harmonisation legislation, as well as of the rules of corresponding application;

(d) the capacity required for the preparation of certificates, documents and reports showing that evaluations have been carried out.

8. The impartiality of the conformity assessment bodies, their top management and their assessment staff shall be ensured. The remuneration of the maximum managers and the assessment staff of the conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9. Conformity assessment bodies shall subscribe to a liability insurance or other financial guarantee covering the civil liability in which they may incur the development of the functions provided for in this royal decree, during the time that you maintain the status of accredited.

10. The staff of the conformity assessment body shall observe the professional secrecy concerning all the information collected in the course of their duties, except in respect of the competent authorities. Industrial property rights shall be protected.

11. The conformity assessment bodies shall participate in the relevant standardisation activities and the activities of the notified body coordination group established in accordance with Article 37, or shall ensure that their staff members are responsible for the assessment is informed in this respect, and shall apply in the form of general guidelines the decisions and administrative documents resulting from the work of the group.

Article 26. Presumption of conformity.

If a conformity assessment body demonstrates that it meets the criteria laid down in the Spanish standards or parts thereof corresponding to the relevant harmonised standards, the references of which have been published in the 'Official Journal of the European Union' shall be presumed to comply with the requirements laid down in Article 25 to the extent that those applicable rules cover those requirements.

Article 27. Contestation of harmonised standards.

Where a competent authority contests the harmonised standards referred to in Article 26, the provisions of Article 38 shall apply.

Article 28. Subsidiaries and subcontracting of notified bodies.

1. Where the notified body subcontracts specific tasks relating to conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary complies with the requirements laid down in Article 25 and shall inform the notifying authority accordingly.

2. The notified body shall assume full responsibility for the tasks performed by the subcontractors or the subsidiaries, irrespective of where they are based.

3. Activities may only be subcontracted or delegated to a subsidiary prior to the consent of the client.

4. The notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary, as well as the work carried out by them in accordance with Article 19.

Article 29. Request for notification.

1. The conformity assessment bodies shall submit a request for notification to the National Consumer Institute in accordance with this royal decree.

2. The application referred to in paragraph 1 shall be accompanied by a description of the conformity assessment activities, the conformity assessment module (s) and the toy (s) for which the conformity assessment body (s) is to be considered. competent as well as a certificate of accreditation, if any, issued by a national accreditation body which has passed the peer review, stating that the conformity assessment body meets the requirements set out in Article 25.

3. If the conformity assessment body in question is unable to provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary to verify, recognise and monitor regularly that it complies the requirements set out in Article 25.

Article 30. Notification procedure.

1. The notifying authority may only notify conformity assessment bodies which satisfy the requirements laid down in Article 25.

2. In its notifications to the Commission and to the other Member States, the notifying authority shall use the electronic notification system developed and managed by the Commission.

3. The notification shall include details of the conformity assessment activities, the conformity assessment module (s), the toy (s) or the toys which are the subject of the relevant competence assessment and certification.

4. If the notification is not based on the accreditation certificate referred to in Article 29.2, the notifying authority shall transmit to the Commission and to the other Member States of the European Union documentary evidence showing the competence of the conformity assessment body and the existing provisions to ensure that the body is regularly monitored and that the body will continue to meet the requirements set out in Article 25.

5. The body concerned may carry out the activities of a notified body only if no objection has been raised by the Commission or the other Member States within two weeks of the notification in the event of the use of a certificate of accreditation or two months from the date of notification in the event of no accreditation being used. Only that body shall be considered a notified body for the purposes of this royal decree and Directive 2009 /48/EC.

6. The National Consumer Institute shall inform the Commission and the other Member States of the European Union of any relevant changes after the notification.

Article 31. Identification numbers and lists of notified bodies.

Each notified body shall have a single identification number to be assigned to it by the Commission, even if the body is notified under several Community acts.

Article 32. Changes to the notification.

1. If the notifying authority finds or is informed that a notified body no longer complies with the requirements laid down in Article 25 or is not fulfilling its obligations, the notifying authority shall restrict, suspend or withdraw the notified body. notification, as the case may be, depending on the seriousness of the non-compliance with those requirements or obligations. It shall immediately inform the Commission and the other Member States thereof.

2. In the event of a restriction, suspension or withdrawal of the notification or if the notified body has ceased its activity, the notifying Member State shall take appropriate measures to ensure that the files of that body are processed by another Member State. notified body or made available to the responsible notifying and surveillance authorities when they request them.

Article 33. Operational obligations of notified bodies.

1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures laid down in Article 19.

2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens on economic operators. The conformity assessment bodies shall carry out their activities taking due account of the size of the undertaking, the sector in which it operates, its structure, the degree of complexity of the toy technology in question and the mass or serial character of the production process. To do so, they will in any case respect the degree of rigour and the level of protection required for the toy to comply with this royal decree.

3. If a notified body finds that the manufacturer does not comply with the requirements laid down in Article 11 and Annex II or the relevant harmonised standards or technical specifications, it shall ask it to take appropriate corrective action and shall not issue the EC type-examination certificate referred to in Article 19.4.

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

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

Article 34. Reporting obligation for notified bodies.

1. Notified bodies shall inform the notifying authority:

(a) of any refusal, restriction, suspension or withdrawal of EC-type examination certificates;

b) of any circumstance that affects the scope and conditions of notification;

(c) of any request for information that they have received from market surveillance authorities in relation to conformity assessment activities;

(d) upon request, of the conformity assessment activities carried out within the scope of its notification and of any other activities carried out, including cross-border activities and subcontracting.

2. The notified bodies shall provide the other notified bodies in accordance with Directive 2009 /48/EC with similar conformity assessment activities, which assess the same toys with relevant information on issues related to negative results and, upon request, with positive results of the conformity assessment.

Article 35. Instructions for the notified body.

1. The market surveillance authorities may request a notified body to provide information relating to any EC type-examination certificate which it has issued or withdrawn, or concerning any refusal of such a certificate, includes test reports and technical documentation.

2. If the market surveillance authorities consider that a particular toy does not meet the essential safety requirements set out in Article 11 and Annex II, they shall, where appropriate, give instructions to the notified body to withdraw the toy. EC type-examination certificate for such toys.

3. Where necessary, in particular in the cases specified in the second paragraph of Article 19.4, the market surveillance authorities shall instruct the notified body to review the EC type-examination certificate.

Article 36. Exchange of experience.

The notifying authority shall participate in the exchange of experience with other notifying authorities of the Member States of the European Union, as the Commission has available.

Article 37. Coordination of notified bodies.

The Spanish notified bodies will be obliged to participate, directly or by delegation in others, in the exchanges of experience which the European Commission will organise between the authorities responsible for the appointment, notification and monitoring of notified bodies in each Member State, and the notified bodies themselves, in order to coordinate the uniform application of Directive 2009 /48/EC, as well as in the forums of notified bodies organised to Community level.

CHAPTER VI

Particular measures

Article 38. Contestation of harmonised standards.

1. Where the competent authority for market surveillance, on its own initiative or at the request of a person concerned, considers that a harmonised standard does not fully satisfy the essential health and safety requirements of the Member State concerned, and that they are included in Article 11 and in Annex II of this royal decree, it shall communicate it to the National Institute of Consumption.

2. The National Consumer Institute shall bring the matter before the Committee set up pursuant to Article 5 of Directive 98 /34/EC, by means of the established channel, stating its reasons, in order to enable the European Commission, in accordance with the opinion of the Committee, take the decision-as appropriate-to publish, not publish, publish with restrictions, maintain, maintain with restrictions or withdraw the reference of the harmonised standard in question in the "Official Journal of the European Union".

Article 39. Safeguard clause.

1. Where a market surveillance authority, on its own initiative or at the request of an interested party, finds that a toy bearing the CE marking, together with the EC declaration of conformity and used in accordance with its intended use or under conditions, reasonably foreseeable, it may endanger the health and safety of persons, it shall take all necessary measures to remove such a toy from the market, prohibit its marketing and/or limit its free movement, Instituto Nacional del Consumo.

2. The National Consumer Institute shall, by means of the established procedure, immediately inform the European Commission and the other Member States of such measures and indicate the reasons for its decision, in particular if the non-conformity is:

(a) That the essential requirements referred to in Article 11 are not met.

(b) A defect in the harmonised standards referred to in Article 26.

(Previous Deleted b.)

3. Where the measures provided for in paragraph 1 of this Article are based on a defect in the harmonised standards, the procedure for the impeachment of Article 38 of this royal decree shall be initiated.

4. As a result of the decision taken by the European Commission in this respect, the competent market surveillance authority shall take appropriate measures to comply with it. In the case of safeguard clauses brought by other Member States, which the Commission would have considered justified, the corresponding measures may also be applied to identical toys which are on the market

5. Where a toy does not comply with the CE marking, the competent market surveillance authority shall take appropriate action against the person responsible for the product and shall communicate it to the National Consumer Institute, in order to ensure that the this to the European Commission.

Article 40. Procedure in the case of toys involving a risk at national level.

1. Where the market surveillance authorities take measures in accordance with Article 20 of Regulation (EC) No 765/2008 or have sufficient reason to believe that a toy subject to this royal decree poses a risk to health or safety of the persons, shall carry out an evaluation related to the toy in question regarding all the requirements established in this royal decree. The relevant economic operators shall cooperate on the basis of needs with market surveillance authorities.

If in the course of the assessment, the market surveillance authorities check that the toy does not meet the requirements set out in this royal decree, they shall without delay request the relevant economic operator to adopt the appropriate corrective measures to bring it into conformity with those requirements, to withdraw it from the market or to recall it within a reasonable time, proportionate to the nature of the risk, which they prescribe.

Market surveillance authorities will therefore inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2. Where the market surveillance authorities consider that the non-compliance is not limited to the national territory, it shall inform the National Consumer Institute, which shall inform the Commission and the other Member States of the results. the assessment and the measures they have requested to be taken by the relevant economic operator.

3. The relevant economic operator shall ensure that all relevant corrective measures are taken in relation to the toys concerned which it has placed on the market throughout the European Union.

4. If the relevant economic operator does not take appropriate corrective action within the time limit referred to in paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the the placing on the market of the toy, removing it from the market or recovering it, shall inform the National Consumer Institute, which shall inform the Commission and the other Member States of these measures.

If, within three months of receipt of the information referred to in the preceding paragraph, no objection has been raised by any Member State or the Commission to the provisional measures taken by the supervisory authorities in the market, the measures shall be deemed justified.

5. The information referred to in paragraph 4 of this Article shall include all available details, in particular the data necessary to identify the non-compliant toy and to specify its origin, the nature of the alleged non-compliance and the risk the nature and duration of the measures taken, together with the arguments put forward by the relevant economic operator. In particular, market surveillance authorities shall indicate whether the non-compliance is due to one of the following reasons:

(a) the toy does not meet the requirements related to the health or safety of persons; or

(b) the harmonised standards referred to in Article 26 conferring the presumption of conformity present defects.

6. If the procedure is initiated in another Member State of the European Union, the National Consumer Institute shall, on its own initiative or on the proposal of a market surveillance authority, inform the Commission and the other Member States without delay. of any measure which has been adopted in Spain and of any additional information concerning the non-conformity of the toy in question which it has at its disposal and, in the event of disagreement with the measure notified by the Member State which initiated the procedure, present their objections to it.

7. Market surveillance authorities shall ensure that appropriate restrictive measures are taken without delay in respect of the toy in question, such as the removal of the toy from the market.

Article 41. Exchange of information: Community system for the rapid exchange of information.

If a measure referred to in Article 40.4 is a type of measure which, in accordance with Article 22 of Regulation (EC) No 765/2008, is to be notified through the Community Rapid Information Exchange System, the the procedure described in Article 19 of Royal Decree 1801/2003 of 26 December 2003 on general product safety.

In that case, it is not necessary to make a separate notification in accordance with that Article 40.4, provided that the following conditions are met:

(a) the notification of the Community Rapid Information Exchange System indicates that this royal decree also requires the notification of the measure;

(b) the notification of the Community Rapid Information Exchange System is accompanied by the information referred to in Article 40.5.

Article 42. Formal non-compliance.

1. Without prejudice to Article 40, if the market surveillance authorities find one of the following situations, they shall ask the relevant economic operator to remedy the non-compliance in question:

(a) the CE marking has been affixed in violation of Article 15 or Article 16;

b) the CE marking of compliance has not been affixed;

c) the EC declaration of conformity has not been established;

d) the CE declaration of compliance was not set correctly;

e) the technical documentation is not available or incomplete.

2. If the lack of conformity referred to in paragraph 1 persists, the authorities concerned shall take all appropriate measures to restrict or prohibit the placing on the market of the toy, or ensure that the toy is recovered or withdrawn from the market.

Article 43. Measures taken.

The measures referred to in this Chapter are not sanctioning and their adoption does not prejudge the criminal or administrative responsibility of the subjects to which they are affected.

CHAPTER VII

Specific administrative provisions

Article 44. Reporting.

At least three months before 20 July 2014 and every five years thereafter, the market surveillance authorities shall send to the National Consumer Institute a report on the implementation of this royal decree, which shall include: an assessment of their effectiveness and the situation of the safety of toys, as well as a presentation of market surveillance activities.

The National Consumer Institute will forward to the Commission what is reflected in these reports by 20 July 2014 at the latest, and then every five years.

Article 45. Transparency and confidentiality.

When the market surveillance authorities adopt measures in accordance with the provisions of this royal decree, the requirements of transparency and confidentiality provided for in Article 17 of the Royal Decree shall apply. 1801/2003, dated December 26.

Article 46. Motivation of the measures.

Any measure taken pursuant to this royal decree prohibiting or limiting the placing on the market of a toy, or ordering its withdrawal from the market or recovery, shall indicate the exact grounds on which it is based.

Such measures shall be notified immediately to the interested party, indicating the remedies available in accordance with the provisions of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations. and the Common Administrative Procedure.

CHAPTER VIII

Sanctioning Regime

Article 47. Sanctioning regime.

1. The regime of violations and penalties for non-compliance with what is established in this royal decree will be the one foreseen in the Royal Legislative Decree 1/2007, of 16 November, approving the recast text of the General Law for the Defense of the Consumers and Users and other complementary laws, as well as the autonomous rules of application in the field.

2. The infringements will be classified as minor, serious and very serious. As far as this royal decree is concerned, they will be:

a) minor violations:

Formal labeling defects that do not have an impact on the conditions of the safe use of the toy.

The formal defects of CE marking.

b) serious violations:

Toy Labeling Defects with Safety Incidence, such as those for warnings, instructions for use, or recommendations about the child's proper age.

The lack of identification data of the person responsible for placing the toy on the market.

Use of CE marking incorrectly.

The non-disposition or presentation, at the request of the authorities, of the documentation referred to in Annexes III and IV of the royal decree.

c) very serious violations:

Failure to comply with the security requirements referred to in Article 11 and Annex II of the royal decree.

3. The offences identified shall be sanctioned in respect of type and amount in accordance with Articles 51 and 52 of the said Royal Legislative Decree 1/2007 of 16 November.

4. The competent authorities to agree and impose the corresponding penalties shall be those established in accordance with the provisions of Article 3 of this Royal Decree.

In cases where the sanctioning competence corresponds to the State, the competent authority would be the Ministry of Health, Social Policy and Equality through the National Consumer Institute.

Single additional disposition. Applicable rules.

1. This royal decree shall be without prejudice to the application of Articles 129 to 148 (Book III) of the recast of the General Law for the Defence of Consumers and Users and other supplementary laws, approved by the Royal Decree Legislative 1/2007 of 16 November.

2. Similarly, Royal Decree 1801/2003 of 26 December 2003 on general product safety shall apply to toys in accordance with the provisions of Article 1 (2) and (4

.

Single transient arrangement. Transitional arrangements for placing on the market.

1. The placing on the market of toys which are in conformity with Royal Decree 880/1990 of 29 June 1990 and which have been placed on the market before 20 July 2011 shall not be prevented.

2. In addition to paragraph 1, the competent authorities shall not prevent the placing on the market of toys which satisfy all the requirements of this royal decree, except those laid down in Part III of Annex II, provided that such toys comply with the requirements set out in point 3 of Part II of Annex II to Royal Decree 880/1990 of 29 June and which have been placed on the market before 20 July 2013.

Single repeal provision. Regulatory repeal.

Royal Decree 880/1990 of 29 June is hereby repealed from the entry into force of this Royal Decree, with the exception of Article 2.1, and point 3 of Part II of Annex II, which shall be repealed as from 20 July 2013.

The references made in the legal order to the actual repealed decree will be construed as references to this royal decree.

Final disposition first. Competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.16 of the Constitution, which attributes to the State the competence to lay the foundations and general coordination in the field of health, except for Articles 7 and 9. Article 149.1.16 of the first paragraph of Article 149.1.16 gives the State exclusive competence in the field of external health.

Final disposition second. Incorporation of European Union law.

This royal decree incorporates into Spanish law Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys.

Final disposition third. Enabling regulatory development.

The Minister for Health, Social Policy and Equality and the Minister for Industry, Tourism and Trade are empowered to lay down, in the field of their powers, the provisions necessary for the implementation and development of the willing in this royal decree.

The Minister of Health, Social Policy and Equality and the Minister of Industry, Tourism and Trade are authorised to modify jointly or separately, in accordance with their respective competences, the annexes of this royal decree, to the purpose of keeping them adapted to technical progress and, in particular, to the provisions of Community legislation.

The Minister for Health, Social Policy and Equality and the Minister for Industry, Tourism and Trade are empowered to fix the amount of liability insurance that is to be subscribed to in accordance with Article 25 (9). the conformity assessment bodies.

Final disposition fourth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on August 26, 2011.

JOHN CARLOS R.

The Minister of the Presidency,

RAMON JAUREGUI STUNNED

ANNEX I

List of products that are not, in particular, considered to be toys for the purposes of this royal decree (referred to in Article 1.3)

1. Decorative objects for festive events and celebrations.

2. Products for adult collectors, provided that the products or their packaging bear a visible and legible indication that they are intended for collectors not less than fourteen years old. Examples of this category:

a) detailed and faithful scale models,

b) detailed scale model assembly kits,

c) Popular and decorative dolls and other similar items,

d) historical reproductions of toys, and

e) reproductions of real firearms.

3. Sports equipment, including roller skates, in-line skates and skateboards for children with a body mass exceeding 20 kg.

4. Bicycles with a maximum height of sillin greater than 435 mm, measured as the vertical distance between the ground and the highest point of the sillin surface, with the sillin placed in a horizontal position and the tija at the lower mark.

5. Skateboards and other means of transport designed for sport or intended for use on public roads or public roads.

6. Electric vehicles intended for use on public roads, public roads or their sidewalks.

7. Aquatic equipment intended for use in deep water and accessories to learn to swim for children, such as seat floaters and relief items for swimming.

8. Puzzles over 500 pieces.

9. Compressed gas guns and guns, except for guns and water guns, and shooting arches over 120 cm long.

10. Fireworks, including fulminant capsules that are not specifically designed for toys.

11. Products and games using pointed projectiles, such as dart assemblies with metal tips.

12. Functional educational products, such as electric ovens, irons or other functional products whose voltage exceeds 24 volts sold exclusively for educational purposes under adult supervision.

13. Products intended for use for pedagogical purposes, as scientific equipment, in schools and other educational contexts under the supervision of adult instructors.

14. Electronic equipment, such as personal computers and gaming consoles, used to access interactive software and its associated peripherals, if the electronic equipment or associated peripherals are not designed and intended specifically for children and have a playful value of their own, such as special design personal computers, keyboards, command levers or flyers.

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

16. Baby pacifiers.

17. The attractive lamps for children.

18. Electric transformers for toys.

19. Fashion accessories for children who are not destined for the game.

ANNEX II

Particular security requirements

I. Physical and mechanical properties.

1. Toys and parts thereof, as well as their fixations in the case of fixed toys, must have the mechanical strength and, where appropriate, stability sufficient to withstand the stresses resulting from their use without any breakage or deformation which may cause physical injury.

2. The accessible edges, projections, ropes, cables and fixings of the toys shall be designed and constructed in such a way as to reduce as much as possible the risk of physical injury which may cause contact with them.

3. Toys must be designed and constructed in such a way that they do not present risks or only the minimum risks inherent in the use of toys which may cause the movement of their parts.

4.

(a) Toys and their parts must not be at risk of strangulation.

(b) The toys and their parts must not present any risk of suffocation by interruption of the flow of air as a result of obstruction of the airways outside the mouth and nose.

(c) Toys and their parts must have such dimensions that they do not present a risk of suffocation by interruption of the air flow as a result of internal obstruction of the airways by objects blocked in the mouth or pharynx or lodged at the entrance of the lower respiratory tract.

(d) Toys clearly intended for use as children under thirty-six months, as well as their components and separable parts, must have such dimensions that they cannot be swallowed or inhaled. This rule also applies to other toys intended to be put in the mouth, as well as to their parts and parts.

e) The retail packaging of toys must not present any risk of strangulation or asphyxiation as a result of an obstruction of the airway outside the mouth and nose.

(f) Toys distributed in food or mixed with food must have a packaging of its own which, in the form provided, has dimensions that prevent it from being swallowed or inhaled.

g) The packaging of toys referred to in points (e) and (f) which are spherical, egg-shaped or ellipsoidal and the separable parts thereof, or of cylindrical packages with rounded edges, must have a dimensions such as to prevent an obstruction of the airways from being blocked in the mouth or the pharynx, or lodged at the entrance of the lower respiratory tract.

(h) The toys are strongly prohibited attached to a food at the time of consumption, so that the food must be consumed for direct access to them. Parts of toys which otherwise go directly to the food shall meet the requirements laid down in points (c) and (d)

5. Aquatic toys shall be designed and constructed in such a way as to reduce as much as possible, taking into account the recommended use of toys, the risk of loss of toy buoyancy and loss of child bearing capacity.

6. Toys in which it is possible to enter and which therefore constitute a closed space must have an exit system which the intended user can easily open from the inside.

7. Toys conferring mobility on their users shall, as far as possible, incorporate a brake system adapted to the type of toy and proportional to the kinetic energy generated by it. Such a system should be easy to use for the user and not be at risk of ejection or physical injury of the user or other persons. The maximum design speed of the electric toys in which the child is mounted shall be limited to minimise the risk of injury.

8. The shape and composition of the projectiles and the kinetic energy they may generate when they are released by a toy designed for that purpose shall not be at risk of physical injury to the user or other persons, having regard to the nature of the projectiles. of the toy.

9. The manufacture of toys must ensure that:

(a) the maximum and minimum temperature that reaches any accessible surface cannot cause injury by touching it; and

(b) liquids and gases within the toy do not reach temperatures or pressures which, in the event of escape other than that required for the proper functioning of the toy, may cause burns or other physical injuries.

10. Toys intended to emit a sound shall be designed and constructed in terms of maximum values of pulse noise and continuous noise in such a way that their sound cannot damage the hearing of children.

11. The activity toys shall be manufactured in such a way as to reduce as much as possible the risk of crushing or prating parts of the body and clothing and the risk of falls, shocks and drowning. In particular, all surfaces of activity toys that are accessible for one or more children to play on them will be designed to support the weight of those.

II. Flammability.

1. Toys must not constitute a dangerous flammable element in the child's environment. Consequently, they must be composed of materials that meet one or more of the following conditions:

a) do not burn if exposed directly to a flame, spark or other possible source of fire;

b) are not easily inflamed (the flame is turned off as soon as the cause of the fire ceases);

c) if they burn, they do so slowly and the speed of flame propagation is reduced; and

d) whatever the chemical composition of the toy, it has been designed to mechanically delay the combustion process.

Fuel materials do not pose any risk of ignition for the other materials used in the toy.

2. Toys which, for essential reasons related to their operation, contain substances or mixtures which meet the classification criteria set out in Section 1 of Appendix B to this Annex, in particular materials and equipment for chemical experiments, the assembly of models, plastic or ceramic moulding, enamelling, photography or other similar activities shall not contain substances or mixtures which, as such, may become flammable as a result of the loss of non-flammable volatile components.

3. Toys other than fulminant toys for toys shall not be explosive or contain any elements or substances which may be exploited if they are used as provided for in the first subparagraph of Article 11 (2).

4. Toys, and in particular the games and toys of chemistry, shall not contain substances or mixtures which:

(a) may explode, by chemical reaction or by heating, if they are mixed;

b) can be exploited if mixed with oxidizing substances; or

c) contain volatile components that are flammable in the air and can form flammable or explosive vapour/air mixtures.

III Chemical properties.

1. Toys shall be designed and manufactured in such a way that they do not present any risk of adverse effects on human health due to exposure to chemicals or mixtures containing or entering their composition, if the toys are used as as provided for in the first subparagraph of Article 11 (2).

Toys shall comply with relevant Community legislation concerning certain categories of products or restrictions for certain substances and mixtures.

2. Toys which are, in themselves, substances or mixtures must also be in accordance with the provisions of Royal Decree 363/1995 of 10 March 1995 on the regulation on the classification, packaging and labelling of dangerous substances, to Royal Decree 255/2003 of 28 February 2003 adopting the Regulation on the classification, packaging and labelling of dangerous preparations and 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, as appropriate, in relation to the classification, packaging and labelling of certain substances and mixtures.

3. Without prejudice to the application of the restrictions referred to in the second subparagraph of point 1, substances classified as carcinogens shall not be used in toys, in components or in parts of microstructurally different toys. mutagens or toxic for reproduction (CMR substances), category 1A, 1B or 2, in accordance with Regulation (EC) No 1272/2008.

4. Without prejudice to point 3, substances or mixtures classified as CMR of the categories set out in Section 3 of Appendix 8 may be used in toys, in components or in parts of toys microstructurally other than the condition that one or more of the following conditions are satisfied:

(a) those substances and mixtures are contained in individual concentrations equal to or less than the relevant concentrations laid down in the Community legal acts referred to in Section 2 of Appendix B to the classification of mixtures containing such substances;

(b) such substances or mixtures are inaccessible to children by the means, including inhalation, when the toy is used in accordance with the first subparagraph of Article 11 (2

;

(c) a decision has been taken in accordance with Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 to permit the substance or mixture and its use, and the substance or mixture in issue and its permitted uses are listed in Appendix A.

This decision may be adapted if the following conditions are met:

(i) the relevant scientific committee has evaluated the use of the substance or mixture and considered it safe, in particular as regards exposure;

(ii) no suitable alternative substances or mixtures are available, which is documented in an analysis of the alternatives; and

(iii) the use of the substance or mixture in consumer goods in accordance with Regulation (EC) No 1907/2006 is not prohibited.

The Commission will give a mandate to the relevant scientific committee to re-assess these substances or mixtures as soon as there is concern about their safety and, at the latest, every five years from the the date of adoption of a decision in accordance with Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009.

5. Without prejudice to point 3, substances or mixtures classified as CMR of the categories set out in Section 4 of Appendix B may be used in toys, in components or in parts of toys microstructurally different provided that one of the following conditions is satisfied:

(a) those substances and mixtures are contained in individual concentrations equal to or less than the relevant concentrations laid down in the Community legal acts referred to in Section 2 of Appendix B to the classification of mixtures containing such substances;

(b) such substances or mixtures are inaccessible to children by the means, including inhalation, when the toy is used in accordance with the first subparagraph of Article 11 (2);

(c) a decision has been taken in accordance with Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 to permit the substance or mixture and its use, and the substance or mixture in issue and its permitted uses are listed in Appendix A.

This decision may be adapted if the following conditions are met:

(i) the relevant scientific committee has evaluated the use of the substance or mixture and considered it safe, in particular as regards exposure;

(ii) the use of the substance or mixture in consumer goods pursuant to Regulation (EC) No 1907/2006 is not prohibited.

The Commission will give a mandate to the relevant scientific committee to re-assess these substances or mixtures as soon as there is concern about their safety and, at the latest, every five years from the the date of adoption of a decision in accordance with Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009.

6. Points 3, 4 and 5 do not apply to nickel in stainless steel.

7. Points 3, 4 and 5 do not apply to materials that comply with the specific limit values set out in Appendix C, or, until such provisions have been drawn up, but not later than 20 July 2017, to the materials covered by the the provisions concerning materials intended to come into contact with food and which comply with those provisions, in accordance with Regulation (EC) No 1935/2004 and the respective specific measures for particular materials.

8. Without prejudice to the application of points 3 and 4, nitrosamine and nitrosable substances shall be prohibited for use in toys intended for children under thirty-six months or in other toys intended to be placed in the mouth if the migration of the substance is equal to more than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances.

9. The Commission will systematically and regularly assess the occurrence of hazardous substances in toys.

The reports of market surveillance bodies and concerns expressed by Member States and stakeholders will be taken into account in these evaluations.

10. Toy cosmetics, such as doll cosmetics, will meet the composition and labelling requirements set out in Royal Decree 1599/1997 of 17 October on cosmetic products.

11. Toys may not contain the following allergenic fragrances:

(3)

(10)

97-54-1

°	Name of the fragrance that produces allergy	CAS number
(1)	Helenium (Inull helenium)	97676-35-2
(2)	Alilisothiocyanate	57-06-7
benzyl cyanide	140-29-4
(4)	4-terc-butylphenol	98-54-4
(5)	Quenpodium Oil	8006-99-3
(6)	Cyclamen alcohol	4756-19-8
(7)	diethyl Maleate	141-05-9
(8)	119-84-6
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)	Etil acrylate	140-88-5
(17)	fig leaf, fresh, and in preparations	68916-52-9
	(18)	trans-2-heptenal	18829-55-5
(19)	trans-2-hexenal diethylacetal	67746-30-9
trans-2-hexenal dimethylacetal		18318-83-7
(21)	Hydroabiethyl alcohol	13393-93-6
(22)	4-ethoxyphenol	622-62-8
(23)	6-lsopropyl-2-decahydronafthalenol	34131-99-2
(24)	7 -methoxycoumarin	531-59-9
(25)	4-methoxyphenol	150-76-5
(26)	4-(p-methoxyphenyl) -3-buten-2 -one	943-88-4
(27)	1-(p-methoxyphenyl) -1-penten-3-one	104-27-8
(28)	methyl trans-2-butenoate	623-43-8
6-methylcoumarin	6-methylcoumarin	Table_table_izq"> 92-48-8
(30)	7 -methylcoumarin	2445-83-2
(31)	5-methyl-2,3-hexanedione	13706-86-0
(32)	Cost root oil (Saussurea lappa Clarke)	8023-88-9
(33)	7 -ethoxy-4-methylcoumarin	87-05-8
(34)	Hexahydrocoumarin	700-82-3
(35)	Balsamo de Perú, en brute (Exudación de Myroxylonpereirae (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)	Oil verbena (Lippia citriodora Kunth)	8024-12-2
(39)	Abelmosco Musk (4-tert-butyl-3-methoxy-2,6-dinitrotoluene)	83-66-9
(40)	4-phenyl-3-buten-2-one	122-57-6
(41)	122-40-7
	(42)	Amilcinamyl alcohol	(42)	(42)	101-85-9
(43)	Benzyl alcohol	100-51-6
(44)	Salicilate benzyl	118-58-1
(45)	Cinamyl alcohol	1 04-54-1
	(46)	Cinamal	104-55-2
(47)	Citral	5392-40-5
(48)	Cumarina	91-64-5
(49)	Eugenol	97-53-0
(50)	106-24-1
106-24-1
	107-75-5
(52)	(52)	(52)	(52)	(52)	31906-04-4
	(53)	97-54-1
90028-68-5
(55)
(55)	(55)	Extracts of Evernia furfuracea	90028-67-4

However, the presence of remains of these fragrances will be authorized if such presence is technically unavoidable, even with good manufacturing practices, and if not greater than 100 ppm.

On the other hand, in the toy, on a sticker, on the packaging or in the accompanying leaflet, the following allergenic fragrance names shall be mentioned if, as such, a toy is added to a toy in excess of a 0,01% by weight of the toy or components thereof:

N.

(3)

Name of the fragrance that produces allergy	CAS number
(1)	Anisilic Alcohol	105-13-5
	Benzyl Benzoate	120-51-4
Benzyl Cinamate	103-41-3
4)	Citronelol	106-22-9
(5)	Farnesol	4602-84-0
(6)	Hexilcinamaldehyde	101-86-0
(7)	Lilial	80-54-6
(8)	d-Limonene	5989-27-5
(9)	Linalol	78-70-6
(10)	Heptincarbonate Methyl	111-12-6
11)	3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl) -3-buten-2-one	127-51-5

12. The use of the fragrances referred to in points 41 to 55 of the list set out in the first paragraph of point 11 and the fragrances referred to in points 1 to 11 of the list set out in the third subparagraph of that point shall be authorised. olfactory board games, cosmetic kits and taste games, provided that:

i) Those fragrances are clearly shown on a label on the packaging and the packaging bears the warning provided for in Annex V, Part B, point 10;

(ii) if applicable, the resulting products manufactured by the child in accordance with the instructions comply with the requirements set out in Royal Decree 1599/1997 of 17 October; and

iii) where appropriate, those fragrances respect the relevant food law.

These olfactory board games, cosmetic kits and taste kits may not be used by children under the age of thirty-six months and must comply with the provisions of Annex V, Part B, point 1.

13. Without prejudice to points 3, 4 and 5, the following migration limits for toys or their components may not be exceeded:

Cobalt

Lead

Strontium

Estano

	mg/kg of dry, brittle, powder, or malleable toys	mg/kg in liquid or sticky toy material	mg/kg in scraped toy
	5 625	1 406	70 000
Antimony	45	11.3	560
arsenic	3.8	0.9	47
Barium	4 500	1 125	56 000
1 200		300	15 000
1.9		0.5	1.9
37.5		9.4	9.4	460
0.02		0.005
10.5	2.6	130
	622.5	156	7 700
13.5	3,4	160
200		300	15 000
7.5		1.9	94
		18.8	930
Selenium	37.5	9.4	460
4 500	1 125	56000
15 000	3750	180 000
stout	0.9	0.2	12
Cinc	3750	938	46 000

These limits shall not apply to toys or their components when, due to their accessibility, function, volume or mass, any danger is clearly excluded by the fact of sucking, licking, swallowing or maintaining skin contact. prolonged with them if they are used in accordance with the provisions of the first subparagraph of Article 11 (2).

IV. Electrical properties

1. Toys shall not operate with an electric current whose nominal voltage is greater than 24 volts of continuous current or the equivalent alternating current voltage and the voltage of its accessible parts shall not exceed 24 volts of continuous current or the equivalent alternating current voltage.

The internal voltages shall not exceed 24 volts of continuous current or the equivalent alternating current voltage, unless it is ensured that the voltage and the generated current combination do not give rise to any risk of shock Harmful electrical, even if the toy is broken.

2. Parts of toys in contact or which may come into contact with a source of electricity capable of causing an electrical shock, as well as cables or other electricity conductors to such parts, shall be sufficiently insulated and mechanically protected to avoid the risk of shock.

3. Electric toys must be designed and constructed in such a way as to ensure that all directly accessible surfaces do not reach temperatures that can cause burns.

4. In foreseeable conditions of failure, toys shall provide protection against electrical hazards arising from an electrical current source.

5. Electric toys must provide adequate protection against the danger of fire.

6. Electric toys must be designed and constructed in such a way that the electrical, magnetic and electromagnetic fields or other radiation generated by the equipment are kept within the limits necessary for their operation to be carried out. correspond to a safe level in accordance with the current state of the generally recognised technique, taking into account the specific Community measures.

7. Toys having an electronic control system shall be designed and constructed in such a way that they function safely even when the electronic system ceases to function properly or fails due to a breakdown of the system itself or by a system. external factor.

8. Toys must be designed and constructed in such a way that they do not present any danger to the health or risk of eye or skin injury from the effect of laser beams, luminescent 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 satisfy the conditions of hygiene and cleanliness to avoid any risk of infection, disease and contamination.

2. Toys intended for children under thirty-six months must be designed and constructed in such a way that they can be cleaned. A textile toy shall be washable for this purpose, except if it contains a mechanism that can be damaged if it is wet when washing. Toys shall continue to comply with safety requirements after they have been cleaned in accordance with the provisions of this paragraph and the manufacturer's instructions.

VI. Radioactivity

Toys shall comply with all relevant provisions adopted in accordance with Chapter III of the Treaty establishing the European Atomic Energy Community.

Appendix A

List of CMR substances and their authorised uses in accordance with Annex II, Part III, points 4, 5 and 6

Substance

Classification	Authorized Use
CMR		CMR 2

Appendix B

Classification of substances and mixtures

Due to the timing of application of Regulation (EC) No 1272/2008, there are equivalent ways of referring to a particular classification to be used at various times.

1. Criteria for the classification of substances and mixtures for the purposes of Annex II, Part II, point 2, and Annex V, Part B, point 4.

A. Criteria to be applied from 20 July 2011 until 31 May 2015:

Substances:

The substance meets the criteria of any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

a) Hazard classes 2.1 to 2.4, 2.6, 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2.2.14 categories 1 and 2, 2.15 types A to F;

b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 distinct effects of narcotics, 3.9 and 3.10;

c) hazard class 4.1;

d) hazard class 5.1.

Mixes:

The mix is dangerous according to the provisions of Royal Decree 363/1995 of March 10.

B. Criterion applicable from 1 June 2015:

The substance or mixture meets the criteria of any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

a) Hazard classes 2.1 to 2.4, 2.6, 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2.2.15 types A to F;

b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 distinct effects of narcotics, 3.9 and 3.10;

c) hazard class 4.1:

d) hazard class 5.1.

2. Legislative acts governing the use of certain substances for the purposes of Part III, points 4 (a) and 5 (a)

As from 20 July 2011 and until 31 May 2015, the corresponding concentrations for the classification of mixtures containing the substances shall be those laid down in accordance with Royal Decree 255/2003 of 28 June 2011. February.

As from 1 June 2015, the corresponding concentrations for the classification of mixtures containing the substances shall be those laid down in accordance with Regulation (EC) No 1272/2008.

3. Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) for the purposes of Part III, point 4.

Substances:

The provisions of Part III, point 4, relate to substances classified as CMR of category 1 A and 1 B in accordance with Regulation (EC) No 1272/2008.

Mixes:

As from 20 July 2011 and until 31 May 2015, the provisions of Part III, point 4, relate to mixtures classified as CMR of categories 1 and 2 according to Royal Decree 255/2003 of 28 February 2003 and to the Royal Decree 363/1995 of 10 March, as appropriate.

As of 1 June 2015, the provisions of Part III, point 4, relate to mixtures classified as CMR of categories 1A and 1B in accordance with Regulation (EC) No 1272/2008.

4. Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) for the purposes of Part III, point 5.

Substances:

The provisions of Part III, point 5, relate to substances classified as category 2 CMR in accordance with Regulation (EC) No 1272/2008.

Mixes:

As from 20 July 2011 and until 31 May 2015, the provisions of Part III, point 5, relate to mixtures classified as category 3 CMR under Royal Decree 255/2003 of 28 February 2003 and Royal Decree No 255/2003 of 28 February 2011. Decree 363/1995 of 10 March, as appropriate.

As of 1 June 2015, the provisions of Part III, point 5, relate to mixtures classified as category 2 CMR in accordance with Regulation (EC) No 1272/2008.

5. Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) for the purposes of Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009.

Substances:

The provisions of Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 concern substances classified as CMR of category 1A, 1B and 2 under the terms of the Regulation (EC) No 1272/2008.

Mixes:

As from 20 July 2011 and until 31 May 2015, the provisions of Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 on classified mixtures as CMR of categories 1, 2 and 3 according to Royal Decree 255/2003 of 28 February and Royal Decree 363/1995 of 10 March, as appropriate.

As of 1 June 2015, the provisions of Article 46 (3) of Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 relate to mixtures classified as CMR of categories 1A, 1B and 2 in accordance with Regulation (EC) No 1272/2008.

Appendix C

Specific limit values for chemicals used in toys intended for children under 36 months of age or in other toys intended to be placed in the mouth, adopted in accordance with Article 46 (2) of the Directive. Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009.

ANNEX III

EC Declaration of Compliance

1. No ... (unique identification of the toy or toys)

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. Purpose of the declaration (identification of the toy to enable its traceability). It will include a sufficient sharpness color image to allow the toy to be identified.

5. The purpose of the statement described above is in accordance with the relevant Community harmonisation legislation:

6. References to the harmonised standards applied or references to the specifications for which conformity is declared:

7. Where appropriate, the notified body ... (name, number) ... has made ... (description of the intervention) ... and issue the certificate:

8. Additional information:

Signed by and on behalf of:

(place and date of issue)

(name, charge) (signature)

ANNEX IV

Product case

The product dossier referred to in Article 20 shall include, in particular, whether it is relevant for the assessment:

(a) a detailed description of the design and manufacture, including the list of components and materials used in the toy and the safety data sheets on the chemicals used to be requested from the suppliers of the chemical substances;

(b) security assessments carried out in accordance with Article 17;

c) a description of the conformity assessment procedure applied;

d) a copy of the EC declaration of conformity;

e) the address of the manufacturing and storage places;

(f) copies of the documents that the manufacturer has submitted to a notified body if he has participated in the process;

(g) the test reports and the description of the means by which the manufacturer ensures conformity of production with the harmonised standards if he has applied the internal control procedure of the production referred to in Article 18.2; and

(h) a copy of the EC type-examination certificate, a description of the means by which the manufacturer ensures conformity of production with the type of product as described in the EC type-examination certificate and copies of the documents which the manufacturer submitted to the notified body, if he submitted the toy to the EC type-examination and complied with the procedure in accordance with the type in accordance with Article 18.3.

ANNEX V

Warnings

(As referred to in Article 12.)

Part A

General warnings

The restrictions on the user referred to in Article 12.1 shall include at least the minimum or maximum age of the users of the toys and, where appropriate, their capacity and their maximum or minimum weight, as well as the need for ensure that the toy is used only under adult supervision.

Part B

Specific warnings and precautions to be taken when using some categories of toys

1. Toys not intended for children under thirty-six months.

Toys that may be dangerous for children under the age of thirty-six months will bear a warning, for example, "Not suitable for children under 36 months", "Not suitable for children under three years" or one warning with the following pictogram:

These warnings shall be accompanied by a brief indication, which may appear in the instructions for use, of the specific hazard to which the precaution applies.

This point shall not apply to toys which, by virtue of their functions, dimensions, characteristics, properties or other obvious elements, are not capable of being intended for children under 30 and six. months.

2. Activity toys.

Activity toys will bear the warning: "For domestic use only."

Activity toys tied to a crossbar, as well as other toys of activity, where appropriate, shall be accompanied by instructions for use which highlight the need for regular checks and checks of its most important parts (suspensions, fasteners, fixings to the ground, etc.) and which require that, in the event of omission of such controls, the toy could present a risk of falling or overturning. Instructions must also be provided on the correct way to mount them, with the indication of the parts which may be dangerous in the case of incorrect assembly. The appropriate surface shall be specifically indicated.

3. Functional toys.

Functional toys will carry the warning: "Use under the direct surveillance of an adult."

In addition, they shall be accompanied by instructions for use indicating the precautions to be taken by the user, warning that in the event of omission of such precautions the user shall be exposed to the hazards. be specified-own of the apparatus or product of which the toy is a scale model or an imitation. It shall also be stated that the toy must be kept out of the reach of children under a given age, the age to be decided by the manufacturer.

4. Chemical toys.

Without prejudice to the application of the provisions laid down in the applicable Community legislation concerning the classification, packaging and labelling of certain substances or mixtures, the instructions for the use of toys containing dangerous substances or mixtures by nature shall warn of their danger and indicate the precautions to be taken by users in order to avoid the dangers involved, which must be specified in a concise manner of the type of toy. First aid to be administered in the event of serious accidents which may cause the use of such toys shall also be mentioned. It shall also be indicated that the toy must be kept out of the reach of children under a given age, the age to be decided by the manufacturer. In addition to the information referred to in the preceding paragraph, the chemical toys shall display the following warning in their packaging: ' It is not appropriate for children under (*) years of age. Use under the surveillance of an adult. "

They are considered, in particular, chemical toys: chemical games, plastic inclusion equipment, ceramic, enamelled or photographic minitallers and similar toys which carry a chemical reaction or a chemical reaction. similar alteration of the substance during use.

(*) Age to be decided by the manufacturer. In addition to the indications cited in the preceding paragraph, the chemical toys shall display the following warning in their packaging: " It is not appropriate for children under the age of years. Use under the surveillance of an adult. "

5. Skates, roller skates, inline skates, skateboards, skateboards and children's toy bikes.

When these products are sold as toys they will bear the following warning: " Protection equipment should be used. Do not use in places with traffic ".

In addition, the instructions for use will remember that the toy should be used with caution, as it requires a lot of skill, to avoid falls or shocks that cause injury to the user or other people. There will also be some indication of the recommended protective equipment (helmets, gloves, knee pads, coderas, etc.).

6. Toys intended for use in water.

Toys intended for use in water shall bear the following warning:

"Use only in water where the child can stand and under surveillance of an adult."

7. Toys in food.

Toys distributed in food or mixed with food shall bear the following warning:

" Contains a toy. Surveillance of an adult is recommended. "

8. Toys that mimic masks and protective helmets.

Toys that mimic masks and protective helmets will bear the following warning: "This toy offers no protection."

9. Toys intended to be suspended on top of a cot, a park or a baby stroller by means of cords, ropes, elastics or straps.

Toys intended to be suspended on top of a cot, a park or a stroller for babies by means of laces, ropes, elastics or straps shall be accompanied, on the packaging, by the following warning: permanently on the toy:

"To avoid possible strangulation damage, this toy should be removed when the child starts trying to get up by using hands and knees."

10. Packaging for olfactory board games, cosmetics kit and taste games.

Packaging for olfactory board games, cosmetics kit and taste kits containing the fragrances referred to in points 41 to 55 of the list set out in the first paragraph of Part III, point 11 of Annex II and fragrances referred to in points 1 to 11 of the list set out in the third subparagraph of that point shall bear the following warning:

"Contains fragrances that can cause allergies."