Changes from plenary report to adopted text

AddedInternal 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 any harmful electric shock, even when the toy is broken. [Am. 218]

Added2. 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.

Added3. 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.

Added4. Under foreseeable fault conditions, toys shall provide protection against electrical hazards arising from an electrical power source.

Added5. Electric toys shall provide adequate protection against fire hazards.

Added6. 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 account of specific Union measures.

Added7. 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 an outside factor.

Added8. 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.

Added9. The electrical transformer of a toy shall not be an integral part of the toy.

AddedPart V – Hygiene

Added1. Toys shall be designed and manufactured in such a way with regards to their hygiene and cleanliness that they do not present any risk of infection, sickness or contamination.

Added2. 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. [Am. 219]

Added3. 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.

AddedPart VI – Radioactivity

AddedToys shall comply with all relevant measures adopted under Chapter III of the Treaty establishing the European Atomic Energy Community.

AddedAppendix

AddedSpecific conditions for the presence of certain chemical substances or mixtures in toys

AddedPart A. Substances subject to specific limit values

Added1. The following migration limits, from toys, components of toys or micro-structurally distinct parts of toys, shall not be exceeded:

Added[Am. 257]

AddedThese limit values shall not apply to toys or components of toys or micro-structurally distinct parts of toys which, due to their accessibility, function, volume or mass, clearly exclude any risk due to sucking, licking, swallowing or prolonged contact with skin when used as specified in Article 5(2), first subparagraph.

Added1a. Toys shall not contain chromium VI, cadmium, mercury and lead, unless their presence is technically unavoidable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material. [Am. 255]

Added2. Nitrosamines and nitrosable nitrosatable substances are prohibited in all toys intended for use by children under 36 months or in other toys intended to be placed in the mouth where The migration of those substances is equal to or higher than from toys, components of toys or micro-structurally distinct parts of toys, shall not exceed 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosable nitrosatable substances. [Am. 256]

Added3. The following limit values, in toys or components of toys or micro-structurally distinct parts of toys, shall not be exceeded:

Added4. Toys shall not contain the following fragrance allergens unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed 100 10 mg/kg: [Am. 221]

AddedPart B. Substances subject to specific labelling requirements

Added1. The names of the following fragrance allergens shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, as well as in the digital product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 100 10 mg/kg: [Am. 222]

Added2. The use of fragrances referred to in entries 41 to 55 in the table in Part A, point 4, and of fragrances referred to in points 1 to 10 in the table in point 1 of this Part shall be allowed in olfactory board games, cosmetic kits and gustative games, under the following conditions:

Added(a) the fragrances are clearly labelled on the packaging of the toy, and the packaging contains the warning referred to in point 11 of Annex III;

Added(b) where applicable, the resulting products made by the child in accordance with the manufacturer’s instructions comply with Regulation (EC) No 1223/2009; and

Added(c) where applicable, the fragrances comply with the relevant Union legislation on food.

AddedSuch olfactory board games, cosmetic kits and gustative games shall not be used by children under 36 months and shall comply with point 2 of Annex III.

AddedPart C. Permitted uses of substances subject to generic prohibitions under Part III, point 4, of Annex II

AddedAnnex III

AddedWARNINGS AND INDICATIONS OF PRECAUTIONS TO BE TAKEN WHEN USING CERTAIN CATEGORIES OF TOYS

Added1. General rules - presentation

AddedAll warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram such as the following pictogram, which shall be displayed in a prominent way: [Am. 223]

Added2. Toys not intended for use by children under 36 months

AddedToys which might be dangerous for children under 36 months shall bear a warning such as ‘Not suitable for children under 36 months’ or ‘Not suitable for children under three years’ or a warning in the form of the following pictogram:

AddedThe pictogram shall be at least 10 mm diameter in size and shall contain a red circle with a white background and with the text and face in black colour. These warnings shall be accompanied by a brief indication, which may appear in the instructions for use, of the specific hazard calling for this precaution. [Am. 224]

AddedThis point shall not apply to toys which, on account of their function, dimensions, characteristics or properties, or on other cogent grounds, are manifestly unsuitable for children under 36 months.

Added3. Activity toys

AddedActivity toys shall bear the following warning:

Added‘Only for domestic use’.

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

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

Added4. Functional toys

AddedFunctional toys shall bear the following warning:

Added‘To be used under the direct supervision of an adult’.

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

Added5. Chemical toys

AddedWithout prejudice to the application of the provisions laid down in applicable Union legislation on the classification, packaging and labelling of certain substances or mixtures, the instructions for use of toys containing inherently dangerous substances or mixtures shall bear a warning of the dangerous nature of those substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them. These precautions shall be specified concisely and shall relate to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of the relevant type of toy shall also be mentioned. It shall also be stated that the toy is to be kept out of reach of children under a certain age, which shall be specified by the manufacturer.

AddedIn addition to the instructions referred to in the first subparagraph, chemical toys shall bear the following warning on their packaging:

Added‘Not suitable for children under … years. For use under adult supervision’.

Added6. Skates, roller skates, inline skates, skateboards, scooters and toy bicycles

AddedWhere skates, roller skates, inline skates, skateboards, scooters and toy bicycles are offered for sale as toys, they shall bear the following warning:

Added‘Protective equipment should be worn. Not to be used in traffic’.

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

Added7. Aquatic toys

AddedAquatic toys shall bear the following warning: