What changed between the plenary report and the adopted text

Removed:SHORT JUSTIFICATION

Added:(Text with EEA relevance)

Removed:The Council position at first reading reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second-reading stage.

Added:THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Added:Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Added:Having regard to the proposal from the European Commission,

Added:After transmission of the draft legislative act to the national parliaments,

Added:Having regard to the opinion of the European Economic and Social Committee,

Added:Acting in accordance with the ordinary legislative procedure,

Added:Whereas:

Added:(1) Directive 2009/48/EC of the European Parliament and of the Council was adopted to ensure a high level of safety of toys and their free movement on the internal market.

Added:(2) Children are a particularly vulnerable group. It is essential to ensure a high level of safety of children when playing with toys. Children, including children with disabilities, should be adequately protected from possible risks stemming from toys, in particularincluding from the chemical substances that toys may contain. At the same time, compliant toys should be able to move freely across the internal market without additional requirements. [Am. 1]

Added:(3) The Commission evaluation of Directive 2009/48/EC concluded that the Directive is relevant and generally effective in protecting children. However, it also identified a number of deficiencies that have emerged during the practical application of the Directive since its adoption in 2009. In particular, the evaluation identified certain shortcomings with regard to possible risks arising from harmful chemicals in toys. The evaluation also concluded that many non-compliant and unsafe toys remain on the Union market.

Added:(4) The Chemicals Strategy for Sustainability called for strengthening the protection of consumers from the most harmful chemicals and to extending the generic approach towards harmful chemicals (based on generic preventive bans) to ensure that consumers, vulnerable groups and the environment are more consistently protected. In particular, the strategy commits to strengthen Directive 2009/48/EC with regard to the protection from the risks of the most harmful chemicals and possible combination effects of chemicals.

Added:(5) Since the rules setting out the requirements for toys, in particular the essential requirements and the conformity assessment procedures, need to be of uniform application across the Union, and not give room for divergent implementation by Member States, Directive 2009/48/EC should be replaced by a regulation.

Added:(6) Toys are also subject to Regulation (EU) 2023/988 on general product safety, which applies in a complementary manner in matters not covered by specific sectoral legislation on consumer products. In particular, Section 2 of Chapter III and Chapter IV in relation to online sales, Chapter VI on the Safety Gate Rapid Alert System and Safety Business Gateway and Chapter VIII on the right of information and remedy also apply to toys. Therefore, this Regulation does not include specific provisions on distance and online sales, accident reporting by economic operators and the right of information and remedy but rather requires economic operators providing information on safety issues concerning toys to inform authorities and consumers in accordance with the procedures set out in Regulation (EU) 2023/988.

Added:(7) Regulation (EC) No 765/2008 of the European Parliament and of the Council lays down rules on the accreditation of conformity assessment bodies, and lays down the general principles of the CE marking. That Regulation should be applicable to toys in order to ensure that toys benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of health and safety of persons and in particular children.

Added:(8) Decision No 768/2008/EC of the European Parliament and of the Council lays down common principles and reference provisions intended to apply across sectoral product legislation in order to provide a coherent basis for such legislation. This Regulation should therefore be drafted, to the extent possible, in accordance with those common principles and reference provisions.

Added:(9) This Regulation should lay down essential requirements for toys to ensure a high level of protection of health and safety of children when playing with toys as well as the free movement of toys in the Union. This Regulation should be appliedimplemented taking due account of the precautionary principle. [Am. 2]

Added:(10) To facilitate the application of this Regulation by manufacturers and national authorities, its scope should be clearly defined. It should apply to all products designed or intended for use in play by children under 14 years of age. A product may be considered as a toy even if it is not exclusively intended for playing purposes and has other additional functions. Whether a product has play value depends on the use envisioned by the manufacturer or on the use of the product reasonably foreseeable by a parent or a supervisor. At the same time, it is necessary to exclude from its scope certain toys which are not intended for domestic use, such as public playground equipment or automatic machines intended for public use, or other toys equipped with combustion or steam engines, as such toys may present risks to the health and safety of children that are not addressed by this Regulation. In addition, a list of products that could be confused with toys but are not to be considered toys within the meaning of this Regulation should be provided.

Added:(11) This Regulation should apply to toys which are new to the Union market when placed on the market, i.e. either new toys made by a manufacturer established in the Union or toys, whether new or second hand, imported from a third country. The safety of other second hand products falls within the scope of Regulation (EU) 2023/988 of the European Parliament and of the Council.

Added:(12) To ensure adequate protection of children and other persons, this Regulation should apply to all forms of supply of toys, including distance sales as referred to in Article 6 of Regulation (EU) 2019/1020 of the European Parliament and of the Council.

Added:(13) Essential safety requirements for toys should ensure protection from all relevant health and safety hazards posed by toys, for users or third parties. Particular safety requirements should cover the physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity to ensure that the safety of children is adequately protected against those specific hazards. Since it is possible that toys which present hazards that are not covered by a particular safety requirement might exist or be developed, it is necessary to maintain a general requirement of safety to ensure protection of children in respect of such toys. The safety of toys should be determined by reference to the intended use, while taking into account also the foreseeable use, and bearing in mind the behaviour of children, who do not generally show the same degree of care as the average adult user. Together, the general safety requirement and the particular safety requirements should form the essential safety requirements for toys.

Added:(14) Relying on digital technologies has led to new hazards in toys. Radio toys are to comply with essential requirements for the protection of privacy and internet-connected toys are to incorporate safeguards towards cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council. Toys which include artificial intelligence are to comply with Regulation (EU) …/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial intelligence]. Therefore, such toys should comply with standards of safety, security and privacy by design. Particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should not be set out. However, protecting the health of children should not merely ensure the absence of disease or infirmity and relying on digital technologies may pose risks to children which go beyond their physical healthbe dealt with within the specific legislation. To ensure that children are protected from any risk coming from the use of digital technologies in toys, the general safety requirement should ensure the psychological and mental health, as well as the well-being and cognitive development, of children. [Am. 3]

Added:(14a) Under Regulation (EU) …/…[OJ insert serial number for Regulation laying down harmonised rules on artificial intelligence] toys containing AI systems as safety components are considered as high-risk AI. Furthermore, under the Cyber Resilience Act internet connected toys that have social interactive features (e.g. speaking or filming) or that have location tracking features are considered important products with digital elements (Class I). On the basis of those Regulations, such toys require a third party conformity assessment, unless the manufacturer has applied relevant harmonised standards. [Am. 4]

Added:(14b) The safety assessment should take into account the health risk posed by digitally connected toys, where appropriate, including any risk posed to mental health. Therefore, when assessing the safety of digitally connected toys likely to have an impact on children, manufacturers should ensure that the products they make available on the market meet the highest standards of safety, security and privacy by design, in the best interests of children. [Am. 5]

Added:(15) Toys should comply with physical and mechanical requirements that prevent children from getting physically injured when playing with toys and should not pose a risk of choking or suffocation to children. In order to protect children from the risk of impaired hearing, maximum values should be set out taking into account studies and the recommendations of medical experts for both impulse noise and continuous noise emitted by toys which are designed to emit a sound. Toys or their parts and their packaging which can be reasonably expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council. In addition, it is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys in food, since the association of a toy and food could cause a risk of choking which is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measure at Union level. Toys should also ensure sufficient protection as regards flammability or electric properties, in particular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene standards to avoid microbiological risks or other risks of infection or contamination. [Am. 6]

Added:(16) Chemicals that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances), chemicals that affect the endocrine system, the respiratory system or that are toxic to a specific organ or are mobile, persistent, bioaccumalative and toxic are particularly harmful for children and the environment and should be specifically addressed in toys. Given the essential role of the endocrine system during human development, early exposure during critical periods, such as early childhood, to endocrine disruptors can lead to adverse effects even at very low doses and affect health at a later stage of life. Respiratory sensitisers can lead to an increase of childhood asthma and neurotoxic substances are particularly harmful to the developing brain of children, which is inherently more vulnerable to toxic injury than the adult brain. Persistence and bioaccumulation lead to continuous exposure and therefore enhance the risk of adverse effects. Some toxic chemicals are also mobile in the environment. Children should also be adequately protected from allergenic substances and certain metals. The requirements for chemical substances set out in Directive 2009/48/EC need to be updated and strengthened. Toys are to comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European Parliament and of the Council. In order to provide further protection of children, who are a vulnerable group of consumers, and other persons, that legal framework should be supplemented by generic prohibitions in toys covering certain hazardous chemicals, as classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council. Those generic prohibitions should apply to CMR substances, endocrine disruptors for human health and the environment, respiratory sensitisers and substances targeting a specific organ or that are mobile, persistent, bioaccumalative and toxic that meet the criteria for classification or that, as soon as those substances are classified as hazardous under Regulation (EC) No 1272/2008. In order to ensure toy safety, prohibited substances should be acceptable at trace levels but only if their presence at such levels is technologically unavoidable with good manufacturing practices and if the toy is safe. [Am. 7]

Added:(17) In order to provide for flexibility Where the safety of children is not compromised and where it is necessary for making certain toysthere are no suitable alternative substances or mixtures available on the market, it shouldit may be possible to derogateexempt from the generic prohibitions of chemical substances and mixtures in toys. Derogations toExemptions from generic prohibitions permitting the use of prohibited substances and mixtures should be time-limited, of general application and should only be possible where the use of the relevant substance or mixtures is considered safe for children, where elimination or substitution of such prohibited substances via design changes or other materials or components is not technically possible, where there are no commerciallytechnically viable alternatives for the substance or mixture, where a substitution plan upon ECHA request has been submitted and where the use of the substance or mixture is not prohibited in consumer articles under Regulation (EC) No 1907/2006. The assessment of the safety of thethis substance in toys should be carried out by the relevant scientific committees in the European Chemicals Agency (ECHA) in order to ensure consistency and efficient use of resources in the assessment of chemical substances and mixtures in the Union. [Am. 247]

Added:(18) Economic operators, industry associations or other interested parties should have the possibility to submit a request for assessment for a permitted use concerning a certain substance subject to a generic prohibition to ECHA. ECHA should draw up and make available the format and medium for the submission of requests for assessment. In addition, for reasons of transparency and foreseeability, ECHA should issue technical and scientific guidance on such requests for assessment.

Added:(19) The use of nickel in stainless steel and in components that transmit electric current has been considered safe in toys by the Scientific Committee on Health, Environment and Emerging risks and should be allowed. Other substances that are necessary to transmit electric current should be permitted in toys to allow for the making available of electric toys if such substances are completely inaccessible for a child playing with the toy and therefore do not present a risk.

Added:(20) As batteries are regulated by Regulation (EU) …/…[P.O. insert serial number for Regulation on batteries and waste batteries], the requirements regarding chemical substances in toys should not apply to the batteries included in toys. However, toys that include batteries should be designed in such a way that the batteries are difficult for children to access. In situations where, due to the nature, size or form factor of the toy, or of the small electronics contained within, it would not be possible to design the toy in a way that the internal battery would be removable and replaceable by the end-user while also ensuring the safety of the child and the safe continued use of the toy, the toy could be designed in such a way as to make the battery removable and replaceable by independent operators. [Am. 8]

Added:(21) Existing limit values for certain chemical substances and their corresponding test methods have proven to be appropriate for the protection of children as regards those substances and should be maintained. In order to adapt to new scientific knowledge, the Commission should be empowered to revise those limit values where necessary in line with the precautionary principle and the One Health approach. Limit values for arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic and which should therefore not be intentionally used in toys, should be set out at half the values that are considered safe by the relevant scientific body, in order to ensure that only traces that are compatible with good manufacturing practice are present in the toy. Use of chromium VI, cadmium, mercury and lead, highly toxic elements, should not be allowed in toys, unless their presence is technically unavoidable under good manufacturing practice and their residues do not exceed the limit of detection in the homogenous material. [Am. 248]

Added:(21a) Lead is a naturally occurring toxic metal that may cause lung, brain, stomach, and kidney cancer in humans. It can enter drinking water when plumbing materials that contain lead corrode, especially where the water has high acidity or low mineral content that corrodes pipes and fixtures. The Directive (EU) 2020/2184 sets out provisions as regards lead content in water intended for human consumption. It can therefore not be excluded that toys produced with the use of water might contain minimal residues of lead due to the water used in the manufacturing process. Such residues should be considered as technically unavoidable under good manufacturing practice where it is not possible to eliminate them via available filtering or absorption methods. [Am. 249]

Added:(22) Directive 2009/48/EC includes limit values for certain substances in toys intended for children under 36 months or intended to be put in the mouth. Those substances have shown to also pose a risk to older children, as they could be equally exposed to such chemicals via skin contact or inhalation. These limit values should therefore apply to all toys. Since the adoption of the limit values for bisphenol A in Directive 2009/48/EC, new scientific data has emerged. The European Food Safety Authority (EFSA) re-evaluated the risks to public health from dietary exposure to bisphenol A in April 2023 concluding that exposure to bisphenol A is a health concern for consumers across all age groups. EFSA has established a new tolerable daily intake of bisphenol A which is significantly lower than the previous one. In view of this scientific evidence, bisphenol A should fall under the generic prohibition for CMR substances in toys.

Added:(22a) Per- and polyfluorinated alkyl substances (PFASs) are a large family of more 10 000 man-made chemicals. Since their emergence in the late 1940s, PFASs have been used in an increasingly wide range of consumer products. Exposure to the most studied PFASs has been associated with a range of adverse health effects, including thyroid disease, liver damage, obesity, diabetes and reduced response to routine vaccinations, as well as increased risk of breast, kidney and testicular cancer. Toys should not contain any per- and polyfluorinated alkyl substances (PFASs). [Am. 9]

Added:(23) To ensure adequate protection from specific chemical substances in case of new scientific knowledge, the Commission should be empowered to adopt delegated acts establishing specific limit values for any chemical substance used in toys. If justified in cases of toys involving a higher degree of exposure, those delegated acts should set out specific limit values for toys intended for use by children under 36 months and in other toys intended to be put in the mouth, taking into account the requirements set out in Regulation (EC) No 1935/2004 and the differences between toys and materials which come into contact with food or articles from which risks may arise due to oral contact through their use as a food contact material. Fragrances in toys entail special risks for human health. Therefore, specific rules should be set out for the use of fragrances in toys and for the labelling of fragrances. The Commission should be empowered to adopt delegated acts to amend those rules to allow for adaptations to technical and scientific progress.

Added:(24) Where the hazards that a toy may present cannot be completely addressed by design, the residual risk should be addressed by product-related information directed at the supervisors of the children in the form of warnings, taking into account the capacity of those supervisors to take the necessary precautions. In order to make sure the information is displayed efficiently, the manufacturer can add a QR-code that provides a link to the instruction in a digital format, but should always mark warnings on the toy, on an affixed label or on the packaging. [Am. 10]

Added:(25) To prevent misuse of warnings to circumvent the applicable safety requirements, the warnings provided for certain categories of toy should not be allowed if they conflict with the intended use of the toy. To ensure that supervisors are aware of any risks associated with the toy, it is necessary to ensure that the warnings are clearly intelligible, legible and visible. [Am. 11]

Added:(25a) To ensure awareness of any risks associated with the toy, especially in cases where the purchase is made through distance and online sales, it should be ensured that the warnings online are clearly legible and immediately visible. [Am. 12]

Added:(26) Economic operators should act responsibly and in full accordance with the legal requirements applicable when placing or making toys available on the market.

Added:(27) In order to ensure a high level of protection of the health and safety of children and fair competition on the internal market, economic operators should be responsible for the compliance of toys with this Regulation, in relation to their respective roles in the supply chain.

Added:(28) As certain tasks can be executed only by the manufacturer, it is necessary to distinguish clearly between the obligations of the manufacturer and the operators further down the distribution chain. It is also necessary to distinguish clearly between the obligations of the importer and the distributor, as the importer introduces toys from third countries to the Union market. The importer should make sure that those toys comply with the applicable Union requirements.

Added:(29) In order to facilitate communication between economic operators, market surveillance authorities and consumers or other end-users, manufacturers and importers should indicate a website, email address or other digital contact in addition to the postal address.

Added:(30) The manufacturer, having detailed knowledge of the design and production process, is responsible for the compliance of the toy with the requirements of this Regulation and is best placed to carry out the complete conformity assessment procedure for toys. Conformity assessment should therefore remain the obligation of the manufacturer alone.

Added:(31) To facilitate compliance of the manufacturers with their obligations under this Regulation, manufacturers should be allowed to appoint an authorised representative to carry out specific tasks on their behalf. Moreover, to ensure a clear and proportionate distribution of tasks between the manufacturer and the authorised representative, it is necessary to set out a list of tasks that manufacturers should be allowed to entrust the authorised representative with. Further, to ensure the enforceability and compliance with this Regulation, where a manufacturer established outside the Union appoints an authorised representative, the mandate should include the tasks set out in Article 4 of Regulation (EU) 2019/1020.

Added:(32) Economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that the toys they place on the market do not jeopardisepose risks to the safety and health of children under normal and reasonably foreseeable conditions of use, and that they make available on the market only toys which comply with the relevant Union legislation. [Am. 13]

Added:(33) It is necessary to ensure that toys from third countries entering the Union market comply with all applicable Union requirements, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those toys. Importers should therefore ensure that the toys they place on the market comply with the applicable requirements, that conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers are available for inspection by the competent market surveillance authorities.

Added:(34) When placing a toy on the market, importers should indicate on the toy their name and the address at which they can be contacted. Exceptions should be provided for in cases where the size or nature of the toy does not allow for such an indication, including where importers would have to open the packaging to put their name and address on the product. In such cases, the name and address should be indicated on the packaging or an accompanying document.

Added:(35) As the distributor makes a toy available on the market after the toy has been placed on the market by the manufacturer or the importer, the distributor should act with due care to ensure that the handling of the toy does not adversely affect the compliance of that toy with this Regulation.

Added:(36) Distributors and importers are close to the market place and should therefore be involved in market surveillance tasks carried out by competent national authorities, and should be required to participate actively in such tasks and to provide those authorities with all necessary information relating to the toy concerned.

Added:(37) Economic operatorsAny natural or legal person that either placeplaces a toy on the market under their own name or trademark or modify a toy in such a way that compliance with applicable requirements of this Regulation may be affected, should be considered to be manufacturersmanufacturer for the purposes of this Regulation and should assume the obligations of manufacturersmanufacturer. [Am. 14]

Added:(37a) Online marketplaces play a crucial role in the supply chain, allowing economic operators to reach a large number of customers. Given their important role in intermediating the sale of toys between economic operators and customers, online marketplaces should take responsibility for addressing the sale of toys that do not comply with this Regulation and should cooperate with market surveillance authorities. Directive 2000/31/EC of the European Parliament and of the Council provides the general framework for e-commerce and lays down certain obligations for online platforms. Regulation (EU) 2022/2065 regulates the responsibility and accountability of providers of intermediary services online with regard to illegal content, including products that do not comply with this Regulation. [Am. 15]

Added:(38) Ensuring traceability of a toy throughout the whole supply chain, in accordance with Regulation (EU) 2023/988, helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non-compliant toys available on the market. [Am. 16]

Added:(39) In order to facilitate the assessment of conformity with the requirements of this Regulation it is necessary to provide for a presumption of conformity for toys which are in conformity with the applicable harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council and published in the Official Journal of the European Union. [Am. 17]

Added:(40) In the absence of relevant harmonised standards, the Commission should be empowered to adopt implementing actsdelegated acts supplementing this Regulation by setting out common specifications for the essential safety requirements of this Regulation, provided that in doing so it duly respects the standardisation organisations’ role and functions, as an exceptional fall back solution to facilitate the manufacturer’s obligation to comply with the essential requirements, when the standardisation process is blocked or when there are delays in the establishment of appropriate harmonised standards. [Am. 18]

Added:(41) The CE marking, indicating the conformity of a toy, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Specific rules governing the affixing of the CE marking with regard to toys should be laid down in this Regulation. Those rules should ensure sufficient visibility of the CE marking in order to facilitate market surveillance of toys.

Added:(42) Manufacturers should create a digital product passport to provide information on the compliance of toys with this Regulation and with any other Union legislation applicable to toys. They should keep the digital product passport up to date according to reasonable best efforts and make any necessary changes when required. The digitalThe product passport should replace the EU declaration of conformity under Directive 2009/48/EC, Directive 2014/53/EU and any other Union legislation applicable to toys. It should also and include the elements necessary to assess the conformity of the toy with the applicable requirements and harmonised standards or other specifications or elements. In order to facilitate checks on toys by market surveillance authorities and to allow the actors in the supply chain and consumers to access information on the toy and on communication channels, the information on the digital product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the toy, its packaging or the accompanying documentation. Depending on access rights, market surveillance authorities, customs authorities, economic operators and consumers should have immediate access to the respective information on the toy through the data carrier. [Am. 19]

Added:(43) To avoid duplication of investment into digitalisation by all actors involved, including manufacturers, market surveillance authorities and customs authorities, when other Union legislation requires a product passport for toys, a single product passport should be available containing the information required under this Regulation and the other Union legislation. In addition, the digital product passport should be fully interoperable with any product passport required under other Union legislation. [Am. 20]

Added:(44) In particular, Regulation (EU) …/… [P.O. insert serial number for the Regulation on ecodesign requirements for sustainable products] of the European Parliament and of the Council also lays down requirements and technical specifications for a digital product passport, the establishment of a Commission central registry where passport information is stored and the interconnection of that registry with the customs IT systems. That Regulation may include toys within its scope in the medium term, thus requiring that a digital product passport is available for toys. Therefore, it should be possible in the future to include more precise information in the digital product passport, in particular information related to environmental sustainability, such as the environmental footprint of a product, information useful for recycling purposes, the recycled content of a certain material, information about the supply chain, and other similar information. The. The digital product passport for toys created under this Regulation should therefore comply with the same requirements and technical elements as those set out in Regulation (EU) …/… [P.O. insert serial number for the Regulation on ecodesign requirements for sustainable products], including the technical, semantic and organisational aspects of end-to-end communication and data exchange. [Am. 21]