Annex II — PARTICULAR SAFETY REQUIREMENTS

Part I Physical and mechanical properties 1. Toys and their parts and, in the case of fixed toys, their anchorages shall have the requisite mechanical strength and, where appropriate, stability to withstand the stresses to which they are subjected during use without breaking or becoming liable to distortion at the risk of causing physical injury. 2. Accessible edges, protrusions, cords, cables and fastenings on toys shall be designed and manufactured in such a way that the risks of physical injury from contact with them are reduced as much as possible. 3. Toys shall be designed and manufactured in such a way as not to present any risk to health and safety or only the minimum risk inherent to their use which could be caused by the movement of their parts. 4. (a) Toys and their parts shall not present a risk of strangulation. (b) Toys and their parts shall not present a risk of asphyxiation by closing off the flow of air as a result of airway obstruction external to the mouth and nose. (c) Toys and their parts shall be of such dimensions as to not present a risk of asphyxiation by closing off the flow of air as a result of internal airway obstruction by objects wedged in the mouth or pharynx or lodged over the entrance to the lower airways. (d) Toys which are clearly intended for use by children under 36 months and toys which, although not foodstuff, resemble foodstuff such that it is likely that they are confused with foodstuff by children, and their component parts and any of their detachable parts, shall be of such dimensions as to prevent them being swallowed or inhaled. This also applies to other toys which are intended to be put in the mouth, and to their component parts and any of their detachable parts. (e) The packaging in which toys are contained for retail sale shall not present a risk of strangulation or asphyxiation caused by airway obstruction external to the mouth and nose. (f) Toys contained within food or co-mingled with food shall have their own packaging. This packaging, as it is supplied, shall be of such dimensions as to prevent it from being swallowed and/or inhaled. (g) Toy packaging, as referred to in points (e) and (f), which is spherical, egg-shaped or ellipsoidal, and any detachable parts of this or of cylindrical toy packaging with rounded ends, shall be of such dimensions as to prevent it from causing airway obstruction by being wedged in the mouth or pharynx or lodged over the entrance to the lower airways. (h) Toys firmly attached to a food product at the moment of consumption, in such a way that the food product needs to be consumed in order to get direct access to the toy, shall be prohibited. Parts of toys otherwise directly attached to a food product shall fulfil the requirements set out in points (c) and (d). (i) Toys shall not cause a risk to the obstruction of the intestines due to the expansion of the toy if swallowed. 5. Aquatic toys shall be designed and manufactured so as to reduce as much as possible, taking into account the recommended use of the toy, any risk of loss of buoyancy of the toy and loss of support afforded to the child. 6. Toys which it is possible to get inside and which thereby constitute an enclosed space for occupants shall have a means of exit which the intended user can open easily from the inside. 7. Toys conferring mobility on their users shall, as far as possible, incorporate a braking system which is suited to the type of toy and is commensurate with the kinetic energy generated by it. Such a system shall be easy for the user to operate without risk of ejection or physical injury for the user or for other persons. For electrically driven ride-on toys, the maximum representative potential operating speed determined by the design of the toy shall be limited so as to minimise the risk of injury. 8. The form and composition of projectiles and the kinetic energy they may generate when fired from a toy designed for that purpose shall be such that, taking into account the nature of the toy, there is no risk of physical injury to the user or to other persons. 9. Toys shall be manufactured so as to ensure that: (a) the maximum and minimum temperature of any accessible surfaces does not cause injury when touched; (b) liquids and gases contained within the toy do not reach temperatures or pressures which are such that their escape from the toy, other than for reasons essential to the proper functioning of the toy, might cause burns, scalds or other physical injury. 10. Toys that are designed to emit a sound and toy mechanisms that are activated by a child and emit reproducible sound shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The maximum values shall not lead to an exposure of children to continuous and peak sound pressure exceeding the lower exposure action values set in Directive 2003/10/EC. The maximum values for impulse noise and continuous noise in toys shall take into account their intended and reasonably foreseeable use in accordance with Article 5(2) of this Regulation. 11. Toys shall be manufactured so as to reduce the risk of crushing or trapping of body parts or trapping of clothing and the risk of falls, impacts and drowning as much as possible. In particular, for activity toys any surface of such a toy that is accessible for one or more children to play on shall be designed to bear their load. 12. Toys that contain magnets or magnetic parts shall be designed and manufactured in such a way that the size and strength of the magnets do not present a risk of intestinal perforation or blockage. Part II Flammability 1. Toys shall not constitute a dangerous flammable element in the child’s environment. They shall therefore be composed of materials which fulfil one or more of the following conditions: (a) they do not burn if directly exposed to a flame or spark or other potential source of fire; (b) they are not readily flammable (the flame goes out as soon as the fire cause disappears); (c) if they do ignite, they burn slowly and present a low rate of spread of the flame; (d) irrespective of the toy’s chemical composition, they are designed so as to mechanically delay the combustion process. Combustible materials in the toy shall not constitute a risk of ignition for other materials used in the toy. 2. Toys, in particular toys containing materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography, toy foam soap or similar activities, shall not, as such, contain substances or mixtures which may become flammable due to the loss of non-flammable volatile components. 3. Toys other than toy percussion caps shall not be explosive or contain elements or substances likely to explode when used as specified in Article 5(2), first subparagraph. 4. Toys, and in particular chemical games and toys, shall not contain substances or mixtures which: (a) when mixed together, may explode through chemical reaction or through heating; (b) may explode when mixed with oxidising substances; or (c) contain volatile components which are flammable in air and liable to form a flammable or explosive vapour/air mixture. Part III Chemical properties 1. Toys shall be designed and manufactured in such a way that there is no risk of adverse effects on human health due to exposure to the chemical substances or mixtures of which the toys are composed or which they contain, when the toys are used as specified in Article 5(2), first subparagraph. Toys shall comply with the applicable Union law relating to certain categories of products or to restrictions for certain substances and mixtures. Toys or their parts and their packaging that can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use shall also comply with Regulation (EC) No 1935/2004. 2. Toys that are themselves substances or mixtures shall comply also with Regulation (EC) No 1272/2008. 3. Toys shall comply with the specific requirements and conditions for chemical substances set out in Part A of the Appendix and with the labelling requirements set out in Part B of the Appendix. 4. The presence in toys, components of toys or micro-structurally distinct parts of toys of substances in the form classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in any of the following categories is prohibited: (a) carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR) category 1A, 1B or 2; (b) endocrine disruption for human health category 1 or 2; (c) specific target organ toxicity category 1, either in single exposure or in repeated exposure; (d) respiratory sensitisation category 1; (e) skin sensitisation category 1A. 5. The intentional use in toys, components of toys or micro-structurally distinct parts of toys, of per- and polyfluoroalkyl substances (PFAS) is prohibited. 6. The presence in toys, components of toys or micro-structurally distinct parts of toys, of the bisphenols included in Part D of the Appendix is prohibited. 7. The non-intended presence of a substance or mixture referred to in point 4, 5 or 6 that stems from impurities of natural or synthetic ingredients, or from the manufacturing process and that is technically unavoidable in good manufacturing practice, shall be permitted provided that, despite such presence, toys remain in conformity with the general safety requirement. 8. By way of derogation from points 4, 5 and 6 substances or mixtures prohibited in accordance with those points may be used in toys if they are listed in Part C of the Appendix, in accordance with the conditions specified therein. 9. Points 4 to 8 shall not apply to: (a) materials that comply with the conditions set out for specific substances in Part A of the Appendix, as regards those substances; (b) batteries in toys; (c) toy components necessary for electronic or electric functions of the toy where the substance or mixture is fully inaccessible to children, including by inhalation, when the toy is used as specified in Article 5(2), first subparagraph; or (d) materials that comply with a substance-specific restriction for toys in Annex XVII to Regulation (EC) No 1907/2006, in accordance with the conditions specified therein, as regards those substances, unless a more protective restriction is set out for that substance for toys in the Appendix. 10. By way of derogation from points 4, 5 and 6, the presence in toys of a prohibited substance or mixture may be permitted only where all of the following conditions are met: (a) it has been found to be safe by the European Chemicals Agency (ECHA), in particular in view of exposure, including the overall exposure from other sources, as well as any known additional hazards from combined exposure to the different substances and mixtures present in the toy, and taking particular account of the vulnerability of children; (b) there are no suitable alternatives available to the presence of the substances or mixtures in the toy, including via technical alternatives, as established by ECHA on the basis of an analysis of alternatives; (c) the substance or mixture is not prohibited for use in consumer articles pursuant to Regulation (EC) No 1907/2006. For the purposes of point (b) of this point, the assessment shall consider as a priority the safety of any alternative identified and also consider the technical feasibility and availability of such an alternative. 11. Restrictions or prohibitions on the use of PFAS laid down in accordance with Regulation (EC) No 1907/2006 or (EU) 2019/1021 of the European Parliament and of the Council shall take precedence over point 5. 12. Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the Council. 13. Toys shall not: (a) have a biocidal function insofar as the toy would thereby be considered to be a biocidal product according to the definition set out in Article 3(1), point (a), of Regulation (EU) No 528/2012 of the European Parliament and of the Council; or (b) be treated with, or intentionally incorporate, one or more biocidal products, as defined in Article 3(1), point (a), of Regulation (EU) No 528/2012. By way of derogation from point (b) of the first subparagraph, toys intended to be permanently placed outdoors may be treated with, or intentionally incorporate, one or more biocidal products provided that all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2) of Regulation (EU) No 528/2012 for the relevant product-type of preservatives falling in the main group 2 of Annex V or in Annex I to that Regulation, and any relevant conditions or restrictions specified therein are met, or are under assessment in the work programme for the systematic examination of all existing active substances set up in accordance with Article 89 of Regulation (EU) No 528/2012 for the relevant product-type falling in the main group 2 of Annex V to that Regulation. 14. By way of derogation from points 4 and 13, preservatives may be used in toys where the preservative is allowed for use in leave-on cosmetics as listed in Annex V to Regulation (EC) No 1223/2009 in accordance with the conditions set out in that Annex, except those that are not to be used for children under 3 or 10 years of age, or those that are not allowed to be used in products applied on mucous membranes or for which contact with the eyes should be avoided. Part IV Electrical properties 1. Toys shall not be powered by electricity of a nominal voltage exceeding 24 volts direct current (DC) or the equivalent alternating current (AC) voltage, and their accessible parts shall not exceed 24 volts DC or the equivalent AC voltage. Internal voltages shall not exceed 24 volts DC or the equivalent AC voltage unless it is ensured that the voltage and the current combination generated do not lead to any risk for health and safety or harmful electric shock, even when the toy is broken. 2. Parts of toys which are connected to, or liable to come into contact with, a source of electricity capable of causing electric shock, and any cables or other conductors through which electricity is conveyed to such parts shall be properly insulated and mechanically protected so as to prevent the risk of such a shock. 3. Electric toys shall be designed and manufactured in such a way as to ensure that the maximum temperatures reached by all directly accessible surfaces are not such as to cause burns when touched. 4. Under foreseeable fault conditions, toys shall provide protection against electrical hazards arising from an electrical power source. 5. Electric toys shall provide adequate protection against fire hazards. 6. Electric toys shall be designed and manufactured in such a way that electric, magnetic and electromagnetic fields and other radiations generated by the toy are limited to the extent necessary for the operation of the toy and shall operate at a safe level in compliance with the generally acknowledged state of the art, taking specific Union measures into account. 7. Toys which have an electronic control system shall be designed and manufactured in such a way that the toy operates safely even when the electronic system starts malfunctioning or fails due to failure of the system itself or of an outside factor. 8. Toys shall be designed and manufactured in such a way that they do not present any health hazards, or risk of injury to eyes or skin, from lasers, light-emitting diodes (LEDs) or any other type of radiation. 9. The electrical transformer of a toy shall not be an integral part of the toy. 10. Electric toys with batteries that constitute small parts shall be designed and manufactured in such a way as to ensure that the battery cannot be accessed without the use of a tool. Where the size or nature of the toy so requires, a rechargeable battery may instead be made inaccessible, and removable or replaceable only by independent professionals. Part V Hygiene 1. Toys shall be designed and manufactured in such a way as to meet hygiene and cleanliness requirements in order to avoid any risk of infection, sickness or contamination. 2. A toy intended for use by children under 36 months or intended to be put in the mouth shall be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer’s instructions. 3. Toys with accessible aqueous materials shall be designed and manufactured in such a way as to ensure that they do not present a microbiological risk. Part VI Radioactivity Toys shall comply with all relevant measures adopted pursuant to Chapter III of the Treaty establishing the European Atomic Energy Community.