P9_TA(2024)0144Safety of toys and repealing Directive 2009/48/ECEuropean Parliament legislative resolution of 13 March 2024 on the proposal for a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC (COM(2023)0462 – C9-0317/2023 – 2023/0290(COD))(Ordinary legislative procedure: first reading)The European Parliament,

–having regard to the Commission proposal to Parliament and the Council (COM(2023)0462),

–having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9‑0317/2023),

–having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–having regard to the opinion of the European Economic and Social Committee of 13 December 2023 OJ C, 2024/1577, 5.3.2024, ELI: http://data.europa.eu/eli/C/2024/1577/oj.,

–having regard to Rule 59 of its Rules of Procedure,

–having regard to the opinion of the Committee on the Environment, Public Health and Food Safety,

–having regard to the report of the Committee on the Internal Market and Consumer Protection (A9-0044/2024),

1.Adopts its position at first reading hereinafter set out;

2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.

P9_TC1-COD(2023)0290Position of the European Parliament adopted at first reading on 13 March 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the European Commission,

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

Having regard to the opinion of the European Economic and Social CommitteeOJ C , , p. .,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1)Directive 2009/48/EC of the European Parliament and of the CouncilDirective 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). was adopted to ensure a high level of safety of toys and their free movement on the internal market.

(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]

(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.

(4)The Chemicals Strategy for SustainabilityCOM(2020) 667 final 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.

(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.

(6)Toys are also subject to Regulation (EU) 2023/988 on general product safetyOJ L 11, 15.1.2002, p. 4., 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.

(7)Regulation (EC) No 765/2008 of the European Parliament and of the CouncilRegulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). 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.

(8)Decision No 768/2008/EC of the European Parliament and of the CouncilDecision 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, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). 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.

(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]

(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.

(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 CouncilRegulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1)..

(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 CouncilRegulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1)..

(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.

(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 CouncilDirective 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).. 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]PO: Please insert in the text the number of the Regulation and insert the number, date, title and OJ reference of that Regulation in the footnote.. 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]

(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]

(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]

(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 CouncilRegulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).. 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]

(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 CouncilRegulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).. 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 CouncilRegulation (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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).. 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 1272/2008Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).. 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]

(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]

(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.

(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.

(20)As batteries are regulated by Regulation (EU) …/…[P.O. insert serial number for Regulation on batteries and waste batteries]PO: Please insert in the text the number of the Regulation …. and insert the number, date, title and OJ reference of that Regulation in the footnote., 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]

(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]

(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) 2020/2184Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast), OJ L 435, 23.12.2020, p. 1 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]

(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.

(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]

(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.

(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]

(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]

(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]

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

(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.

(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.

(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.

(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.

(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.

(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]

(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.

(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.

(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.

(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.

(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]

(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]

(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]

(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 CouncilRegulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). and published in the Official Journal of the European Union. [Am. 17]

(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]

(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.

(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]

(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]

(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 CouncilPO: Please insert in the text the number of the Regulation establishing a framework for setting ecodesign requirements for sustainable products and repealing Directive 2009/125/EC…. and insert the number, date, title and OJ reference of that Regulation in the footnote. 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]

(45)As the digital product passport is to replace the EU declaration of conformity, it is crucial to make clear that by creating the digital product passport for a toy and by affixing the CE marking, the manufacturer declares that the toy is in compliance with the requirements of this Regulation and that the manufacturer takes full responsibility thereof. [Am. 22]

(46)Where other information than the elements required for the digital product passport is provided digitally, it is necessary to clarify that the different types of information need to be provided separately and clearly distinguished from each other but through a single data carrier. This will facilitate the work of market surveillance authorities but also provide clarity to consumers regarding the different types of information that are available to them in a digital format. [Am. 23]

(46a) The majority of toy manufacturers subject to the requirements of this Regulation are micro, small and medium sized enterprises (SMEs), for which drawing up a digital product passport is a significant challenge from an administrative and operational perspective. Therefore, the Commission should provide SMEs with additional support in order to assist them in complying with the new requirements set out in this Regulation. To this end, the Commission should publish practical guidelines and tailor-made guidance for SMEs. In particular a direct channel of communication with experts should be set up to help them perform safety assessments and to set up a digital product passport for the toys they produce. [Am. 24]

(47)Chapter VII of Regulation (EU) 2019/1020, setting up the rules for of controls on products entering the Union market applies to toys. The authorities in charge of controls, which in almost all Member States are the customs authorities, are to perform them on the basis of risk analysis as referred to in Articles 46 and 47 of Regulation (EU) No 952/2013 of the European Parliament and of the CouncilRegulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ L 269, 10.10.2013, p. 1)., its implementing legislation and the corresponding guidance. This Regulation therefore does not modify in any way Chapter VII of Regulation (EU) 2019/1020 and the way the authorities in charge of controls on products entering the Union market organise themselves and perform their activities.

(48)In addition to the framework of controls established by Chapter VII of Regulation (EU) 2019/1020, customs authorities should be able to automatically verify that a digital product passport exists for imported toys subject to this Regulation in order to strengthen the controls at the Union’s external borders and prevent non-compliant toys from entering the Union market. [Am. 25]

(49)When toys coming from third countries are placed under the customs procedure of release for free circulation, the reference to a digital product passport for those toys should be made available to the customs authorities by the economic operator. The reference to the digital product passport should correspond to a unique product identifier that is stored in the product passport registry established under Article 12 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products] (the ‘registry’). Customs authorities should carry out an automatic verification of the product passport presented for that toy, so as to ensure that only toys with a valid reference to a unique product identifier as included in the registry are released for free circulation. To carry out that automatic verification, the interconnection between the registry and the customs IT systems as provided for in [Article 13 of Regulation (EU) …/… on ecodesign requirements for sustainable products] should be used. [Am. 26]

(50)Where other information than the unique product identifier and the unique operator identifier is stored in the registry, the Commission should be empowered to adopt delegated acts allowing customs authorities to verify the consistency between that additional information and the information made available by the economic operator to customs, in order to ensure the compliance of toys placed under the customs procedure of release for free circulation with this Regulation.

(51)The information included in the digital product passport allows customs authorities to enrich and facilitate risk management and enables more targeted controls at the Union’s external borders. Therefore, customs authorities should have the possibility to retrieve and use the information included in the digital product passport and the registry for carrying out their tasks in accordance with Union legislation, including for risk management in accordance with Regulation (EU) No 952/2013. [Am. 27]

(52)It is appropriate to provide for the publication of a notice in the Official Journal of the European Union indicating the date when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products] becomes operational in order to facilitate public access to that information. Similar publication should be provided in case further EU customs IT systems become operational. [Am. 28]

(53)The automatic verification by customs of the reference to the digital product passport for toys entering the Union market should not replace or modify the responsibilities of the market surveillance authorities but only complement the overall framework for controls on products entering the Union market. Regulation (EU) 2019/1020 should continue to apply to toys so as to ensure that market surveillance authorities carry out checks of the information contained in products passports, checks on toys within the market in accordance with that Regulation and, in case of suspension of release for free circulation by the authorities designated for controls at the Union’s external borders, determine the compliance and risks of toys pursuant to Chapter VII of Regulation (EU) 2019/1020. [Am. 29]

(54)Children are daily exposed to a wide range of different chemicals originating from various sources that have negative effects as individual substances or mixtures, but also through combined exposure. Significant progress has been made to close some knowledge gaps on the impact of the combination effect of those chemicals. However, the safety of chemicals is currently usually assessed through the evaluation of single substances and in some cases of mixtures intentionally added for particular uses. Further efforts are needed to better understand the impact of the combination effect of chemicals. In order to provide the highest protection for children and the environment in general, the most harmful substances should be generally banned in toys to ensure that there is no exposure to them in toys. The specific limit values for chemicals in toys should account for combined exposure from different sources to the same chemical substance. In addition, manufacturers should be required to carry out an analysis of the various hazards that the toy may present and an assessment of the potential exposure to such hazards and, as part of the assessment of chemical hazards, to consider known cumulative or synergistic effects of the chemicals present in the toy, to ensure that risks from simultaneous exposure to multiple chemicals are taken into account. Furthermore, toys are to comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European Parliament and of the Council; this Regulation does not modify the obligations for the assessment of the safety of the chemical substances or mixtures themselves that may be applicable in accordance with that Regulation. [Am. 250]

(54a) In order to provide adequate expertise, support, and thorough scientific evaluations, an appropriate and stable funding for ECHA should be ensured. [Am. 30]

(55)Manufacturers should prepare the technical documentation describing all relevant aspects of toys including the safety assessment of all hazards that the toy may present and how they have been addressed, to allow market surveillance authorities to perform their tasks efficiently. The manufacturer should be required to make that technical documentation available to national authorities on request or to notified bodies in the context of the relevant conformity assessment procedure.

(56)To ensure that toys comply with the essential requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Internal production control based on the manufacturer’s own responsibility for the conformity assessment is adequate where it has followed the harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all the particular safety requirements for the toy. In cases where such harmonised standards or common specifications do not exist, the toy should be submitted to third party verification, in this case EU-type examination. The same should apply if one or more such standards has been published with a restriction in the Official Journal of the European Union, or if the manufacturer has not followed such standards or specifications completely, or only in part. The manufacturer should submit the toy to EU-type examination in cases where it considers that the nature, design, construction or purpose of the toy necessitates third party verification.

(57)Since it is necessary to ensure a uniformly high level of performance of bodies performing conformity assessment of toys throughout the Union, and since all such bodies should perform their functions to the same level and under conditions of fair competition, requirements should be set for conformity assessment bodies wishing to be notified in order to provide conformity assessment services under this Regulation.

(58)If a conformity assessment body demonstrates conformity of the toy with the criteria laid down in harmonised standards, itthe toy should be presumed to comply with the corresponding requirements set out in this Regulation. [Am. 31]

(59)The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should be used for the purposes of notification. In particular, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be the only means of demonstrating the technical competence of conformity assessment bodies.

(60)Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for toys to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries. In particular, excessive recourse to subsidiaries and subcontractors, in a manner that would call into question the competence of the notified body or its supervision by the notifying authority should be avoided.

(61)In order to ensure a consistent level of quality in the performance of conformity assessment of toys, it is necessary not only to consolidate the requirements that conformity assessment bodies wishing to be notified must fulfil, but also, in parallel, to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies must fulfil.

(62)Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies. The Commission should by way of implementing acts request the notifying Member State to take the necessary corrective measures in respect of a notified body that does not meet the requirements for its notification.

(63)In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies. Such coordination and cooperation should respect the Union competition rules.

(64)Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Union legislation. Regulation (EU) 2019/1020 sets out the framework for market surveillance of products subject to Union harmonisation legislation, including toys. Since this Regulation replaces Directive 2009/48/EC, the rules on market surveillance and controls on products entering the Union market set out in Regulation (EU) 2019/1020, including the specific requirement set out in Article 4 of that Regulation that toys are to be placed on the market only if there is an economic operator established in the Union responsible for the tasks specified in that Article, continue to apply to toys. Member States should therefore organise and carry out market surveillance of toys in accordance with that Regulation.

(65)Directive 2009/48/EC provides for a safeguard procedure allowing the Commission and other Member States to examine the justification for a measure taken by a Member States against toys that the Member State considers to be non-compliant. That procedure ensures that interested parties are informed of measures intended to be taken with regard to toys posing a risk to the health or safety of persons and that such toys are consistently addressed by all market surveillance authorities in the Union market The procedure should therefore be maintained.

(66)Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required. Where there are objections to such a measure, the Commission should, by means of implementing acts, determine whether a national measure in respect of a toy is justified.

(67)Experience with Directive 2009/48/EC has shown that new toys available on the market which were compliant with the applicable particular safety requirements when placed on the market have in specific cases posed a risk to children and therefore do not comply with the general safety requirement. Provisions should be made to ensure that market surveillance authorities can take action against any toy presenting a risk to children, even when it is compliant with the particular safety requirements. The Commission should, by means of implementing acts, determine whether a national measure in respect of compliant toys which a Member State finds to pose a risk to the health and safety of children or other persons is justified.

(67a) Under Article 20 of the Regulation (EU) 2023/988 manufacturers are required to notify, through the Safety Business Gateway, of any occurrence of an injury as a result of using a product. On the basis of that information, the Commission should evaluate the need and the feasibility of a Pan-European injury database that could bring additional information and knowledge to economic operators, relevant stakeholders and experts, with a view to assessing the effectiveness of the specific Union regulatory framework for toys. [Am. 32]

(68)In order to take into account technical and scientific progress or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Regulation by adapting the specific warnings to be affixed on toys, adopting specific requirements concerning chemical substances in toys and granting derogations to include specific uses allowed in toys of substances subject to generic prohibitions.

(69)In order to take into account technical and scientific progress as well as the level of digital readiness of market surveillance authorities and of children and their supervisors, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should also be delegated to the Commission in respect of amending this Regulation with regard to the information that is to be included in the digital product passport and the information that is to be included in the digital product passport registry. [Am. 33]

(70)In order to facilitate the work of customs authorities in relation to toys and their compliance with the requirements set out in this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of supplementing this Regulation by determining the additional information stored in the registry to be controlled by customs authorities, and in respect of amending the list of commodity codes and product descriptions to be used for customs controls in accordance with this Regulation on the basis of Annex I to Regulation (EEC) No 2658/87 of the European Parliament and of the CouncilCouncil Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff, OJ L 256, 7.9.1987, p. 1..

(71)When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert and stakeholder level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-MakingOJ L 123, 12.5.2016, p. 1.. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. [Am. 34]

(72)In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish the detailed technical requirements for the digital product passport for toys, and to determine whether a specific product or group of products is to be considered a toy for the purposes of this Regulation. In exceptional cases where it is necessary in order to address new emerging risks that are not appropriately addressed by the particular safety requirements, the Commission should be empowered to adopt implementing acts setting out specific measures against toys or categories of toys made available on the market which present a risk for children. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the CouncilRegulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).. [Am. 35]

(73)Member States should provide for penalties applicable to infringements of this Regulation. Those penalties should be effective, proportionate and dissuasive.

(74)In order to allow manufacturers and other economic operators sufficient time to adapt to the requirements laid down by this Regulation, it is necessary to provide for a transitional period during which toys which comply with Directive 2009/48/EC may be placed on the market. In addition, the period during which t toys already placed on the market in compliance with that Directive may continue to be made available on the market after this Regulation becomes applicable should be limited.

(75)Since the objective of this Regulation, namely to ensure a high level of safety of toys with a view to ensuring the health and safety of children whilst guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

HAVE ADOPTED THIS REGULATION:CHAPTER IGENERAL PROVISIONS
Article 1Objective and subject matter [Am. 36]The objective of this Regulation lays down rules on the safety of toys, ensuringis to improve the functioning of the internal market while providing for a high level of consumer protection and a high level of protection of health and safety of children and other persons, and on the free movement of toys in the Union. [Am. 37]This Regulation lays down rules on the safety of toys and on the free movement of toys in the Union, contributing to strengthening of the internal market. [Am. 38]
Article 2Scope1.This Regulation applies to products which are designed or intended, whether or not exclusively, for use in play by children under 14 years of age (‘toys’).For the purposes of this Regulation, a product shall be considered to be intended for use in play by children under 14 years of age, or by children of any other specific age group below 14 years, where a parent or supervisor can reasonably assume, by virtue of the functions, dimensions and characteristics of that product, that it is intended for use in play by children of the relevant age group. [Am. 39]2.This Regulation does not apply to the products listed in Annex I.3.The Commission shall, before the application of this Regulation pursuant to Article 56 and where necessary to address existing safety risks after the application of this Regulation, be empowered to adopt implementing acts determining whether or not specific products or categories of products fulfil the criteria set out in paragraph 1 of this Article and therefore can or cannot be considered toys within the meaning of this Regulation. Those implementing acts shall be adopted in accordance with the procedure set out in Article 50(2). [Am. 40]3a. This Regulation shall be implemented taking due account of the precautionary principle. [Am. 41]
Article 3DefinitionsFor the purposes of this Regulation the following definitions apply:(1)‘making available on the market’ means any supply of a toy for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;(2)‘placing on the market’ means the first making available of a toy on the Union market;(3)‘manufacturer’ means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under that person’s name or trademark;(4)‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that person’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation; [Am. 42](5)‘importer’ means any natural or legal person established within the Union who places a toy from a third country on the Union market;(6)‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;(7)‘fulfilment service provider’ means fulfilment service provider as defined in Article 23, point 11, of Regulation (EU) 2019/1020; [Am. 43](8)‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with this Regulation; [Am. 44](9)‘provider of an online marketplace’ means a provider of an intermediary service using an online marketplace as defined ininterface which allows consumers to conclude distance contracts with traders for the sale of products according to Article 3, point (14), of Regulation (EU) 2023/988; [Am. 45](10)‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1), of Regulation (EU) No 1025/2012;(11)‘Union harmonisation legislation’ means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies;(11a) ‘intended for the use by’ means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group; [Am. 46](12)‘CE marking’ means a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;(12a) ‘essential safety requirements’ means the ‘general safety requirement’ laid down in Article 5 (2) together with the particular safety requirements set out in Annex II; [Am. 47](13)‘toy model’ means a group of toys that meet the following conditions:(a)they are under the responsibility of the same manufacturer,(b)they have uniform design and technical characteristics,(c)they are manufactured using uniform materials and manufacturing processes,(d)they are defined by a type number or other element allowing them to be identified as a group;(13a) ‘digital product passport’ means a set of data specific to a product that includes the information specified in Annex VI and that is accessible via electronic means through a data carrier; [Am. 48](14)‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a devicedata carrier as defined in Article 2 paragraph 1, point 30 of Regulation (EU) .../...) [OJ insert serial number for Ecodesign Requirements for Sustainable Products; [Am. 49](15)‘unique product identifier’ means unique string of characters for the identification of toys that also enables a web link to the product passportidentifier as defined in Article 2 paragraph 1, point 31 of Regulation (EU) .../...) [OJ insert serial number for Ecodesign Requirements for Sustainable Products]; [Am. 50](16)‘unique operator identifier’ means a unique string of characters for the identification of actors involved in the value chain of toysoperator identifier as defined in Article 2 paragraph 1, point 32 of Regulation (EU) .../...) [OJ insert serial number for Ecodesign Requirements for Sustainable Products]; [Am. 51](17)‘release for free circulation’ means the customs procedure laid down in Article 201 of Regulation (EU) No 952/2013;(18)‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013;(19)‘EU Customs Single Window Certificates Exchange System’ means the system referred to in Article 4 of Regulation (EU) 2022/2399 of the European Parliament and of the CouncilRegulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022 establishing the European Union Single Window Environment for Customs and amending Regulation (EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1).;(20)‘conformity assessment’ means the process demonstrating whether the essential safety requirements relating to a toy have been fulfilled; [Am. 52](21)‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;(22)‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC) No 765/2008;(23)‘national accreditation body’ means a national accreditation body as defined in Article 2, point (11), of Regulation (EC) No 765/2008;(24)‘hazard’ means a potential source of harm;(25)‘risk’ means the combination of the probability of an occurrence of a hazard and the degree of severity of the harm caused by that hazard;(26)‘recall’ means any measure aimed at achieving the return of a toy that has already been made available to the end user;(27)‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from being made available on the market;(28)‘market surveillance authority’ means a market surveillancean authority as defined indesignated by a Member State under Article 3, point (4),10 of Regulation (EU) 2019/1020 as responsible for organising and carrying out market surveillance in the territory of that Member State; [Am. 53](28a) ‘notifying authority' means an authority designated by a Member State under this Regulation as responsible for the assessment and notification of conformity assessment bodies in the territory of that Member State; [Am. 54](29)‘functional toy’ means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, which brings the same level of risk as the product used by adults and which may be a scale model of such product, appliance or installation; [Am. 55](30)‘aquatic toy’ means a toy that is intended for use in shallow water and which is capable of carrying or supporting a child in the water;(31)‘activity toy’ means a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for climbing, jumping, swinging, sliding, rocking, spinning, crawling, creeping, or any combination thereof;(32)‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult; [Am. 56](33)‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise or combine different odours or flavours; [Am. 57](34)‘cosmetic kit’ means a toy the purpose of which is to assist a child to learn to make cosmetic products such as fragrances, soaps, creams, shampoos, conditioners, bath foams, tooth pastes as well as glosses, lipsticks and other make-up;(35)‘gustative game’ means a toy the purpose of which is to allow children to make sweets or dishes through the use of food ingredients, including liquids, powders and aromas without using any heat source; [Am. 58](36) ‘substance of concern’ means substance of concern as defined in Article 2, point (28), of Regulation (EU) …/… [on Ecodesign Requirements for Sustainable Products]. [Am. 59]
Article 4Free movement1.Member States shall not prohibit, restrict or impede, for reasons relating to health and safety or other aspects covered by this Regulation, the making available on the market of toys which comply with this Regulation. [Am. 60]2.At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent the display of a toy which does not comply with this Regulation, provided that a visible sign clearly indicates that the toy does not comply with this Regulation and will not be available on the market until it has been brought into conformity.During fairs, exhibitions and demonstrations, adequate measures shall be taken by economic operators to ensure the protection of persons.
Article 5ProductEssential safety requirements [Am. 61]1.Toys shall only be placed on the market if they comply with the essential safety requirements which include the safety requirement set out in paragraph 2 (the ‘general safety requirement’) and the safety requirements set out in Annex II (the ‘particular safety requirements’).2.Toys shall not present a risk to the safety or health of users or third parties, including the psychological and mental health, well-being and cognitive development of children, when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. [Am. 62]When assessing the risk referred to in the first subparagraph, a manufacturer of digitally connected toys shall, where appropriate, according to reasonable best efforts, also take into account any risk posed to mental health, as well as the cognitive development, of children, that may arise when such toys are used in accordance with their intended use. [Am. 63]A manufacturer shall apply the second subparagraph in a manner that is proportionate to its capability in relation to adequately assessing those risks. [Am. 64]When assessing the risk referred to in the first subparagraph, the ability of the users and, where appropriate, their supervisors shall be taken into account. Where a toy is intended for use by children under 36 months or by another specified age groups, the ability of users in that specific age group shall be taken into account.3.Toys placed on the market shall comply with the essential safety requirements during their foreseeable period of use.
Article 6Warnings1.Where necessary to ensure their safe use and the health of children, toys shall bear a general warning specifying appropriate user limitations. The user limitations shall include at least the minimum or maximum age of the user and, where appropriate, the required abilities of the user, the maximum weight or minimum weight of the user and the need to ensure that the toy is used only under adult supervision. [Am. 65]2.The following categories of toys shall bear warnings in accordance with the rules for each category set out in Annex III: shall bear warnings. [Am. 66](a) toys not intended for use by children under 36 months; [Am. 67](b) activity toys; [Am. 68](c) functional toys; [Am. 69](d) chemical toys; [Am. 70](e) skater, roller skates, inline skates, skateboards, scooters and toy bicycles; [Am. 71](f) aquatic toys; [Am. 72](g) toys in food; [Am. 73](h) imitations of protective masks and helmets; [Am. 74](i) toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps; [Am. 75](j) packaging for fragrances in olfactory board games, cosmetic kits and gustative games. [Am. 76]Toys shall not bear one or more of the warnings set out in Annex III where such warnings conflict with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.3.The manufacturer shall mark warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small Toys which are sold without packaging shall have appropriate warnings affixed to them if the surface of the toy allows. If this is not possible, the warnings shall be placed on the label. The manufacturer may add a QR-code which provides a link to the instructions in a digital format, but shall always mark warnings on the toy, on an affixed label or on the packaging. [Am. 77]Warnings which determine the decision to purchase the toy shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made through distance and online sales. Warnings shall be of sufficient size to ensure theirthat they are also immediately visible and legible online. The Commission shall adopt implementing acts determining criteria related to the visibility and legibility of warnings, including for online sales, 12 months after the date of entry into force of this Regulation. [Am. 78]4.Labels and instructions for use shall draw the attention of children or their supervisors to the inherent hazards and risks to the health and safety of children involved in usingconsidering the age group of children for which the toys are intended, and to the ways of avoiding such hazards and risks. [Am. 79]
CHAPTER IIOBLIGATIONS OF ECONOMIC OPERATORS
Article 7Obligations of manufacturers1.When placing toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements.2.Before placing toys on the market, manufacturers shall draw up the required technical documentation in accordance with Article 23 and carry out the applicable conformity assessment procedure in accordance with Article 22 or have it carried out.Where compliance of a toy with the applicable requirements laid down in this Regulation has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall, before the toy is placed on the market:(a)create a digital product passport for the toy in accordance with Article 17; [Am. 80](b)affix the data carrier to the toy or to a label attached to the toy, in accordance with Article 17(5); [Am. 81](c)affix the CE marking in accordance with Article 16(1);(d)upload the unique product identifier and the unique operator identifier of the toy in the digital product passport registry referred to in Article 19(1), as well as any other additional information determined by a delegated act adopted in accordance with Article 46(2). [Am. 82]3.Manufacturers shall keep the technical documentation up to date and the digital product passport for a period of 10 years after the last item of the toy modeltoy covered by that documentation and digital product passport has been placed on the market. [Am. 83]4.Manufacturers shall ensure that procedures are in place for toys that are part of a series production to remain in conformity with this Regulation. Changes in the design or characteristics of toys, and changes in the harmonised standards referred to in Article 13 or the common specifications referred to in Article 14 by reference to which conformity of a toy is declared or by application of which its conformity is verified, shall be adequately taken into account.When manufacturers,deemed appropriate with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers, manufacturers shall, carry out sample testing of marketed toys. [Am. 84]5.Manufacturers shall ensure that toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.6.Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal andor electronic address at which they can be contacted on the toy or, where that is not possiblefeasible, on its packaging or in a document accompanying the toy or in the digital product passport. Manufacturers shall indicate a single point at which they can be contacted. [Am. 85]7.Manufacturers shall ensure that the toy is accompanied by instructions for use and safety information in a language or languages easily understood by consumers and other end-users including persons with disabilities if feasible, as determined by the Member State concerned. Such instructions and information shall be clear, understandable and legible. [Am. 86]8.Where manufacturers consider, or have reason to believe, on the basis of the information in that manufacturer´s possession, that a toy which they have placed on the market is not in conformity with this Regulation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate. [Am. 87]Where manufacturers consider, or have reason to believe, on the basis of the information in that manufacturer´s possession, that a toy presents a risk, they shall immediately provide information thereof to: [Am. 88](a)the market surveillance authorities of the Member States in which they have made the toy available, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988, giving details, in particular, of any non-compliance and of any corrective measures taken and if available, of the quantity, by Member State, of the toys still circulating on the market; and [Am. 89](b)the consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.9.Manufacturers shall, further to a reasoned request from a competent national authority, provide it, with all the information and documentation necessary to demonstrate the conformity of the toy, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.10.Manufacturers shall ensure that other economic operators, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020, and providers of online marketplaces, in the supply chain concerned, are kept informed in a timely manner of any non-conformity that the manufacturers have identified. [Am. 90]11.Manufacturers shall make publicly available communication channels such as a telephone number, an electronic address, a dedicated section of their website or another communication channel, allowing consumers or other end-users to filesubmit complaints concerning the safety of toys and to inform the manufacturers of any accident or safety issue they have experienced with such toys. In doing so, the manufacturers shall take into account the accessibility needs for persons with disabilities. The communication channel shall include a link to the section of the Safety Gate Portal referred to in Article 34(3) of Regulation (EU) 2023/988 for the transmission of information about toys that may present a risk to the health and safety of consumers. [Am. 91]12.Manufacturers shall investigate complaints and information referred to in paragraph 11 and shall keep an internal register of those complaints and that information, as well as of recalls and any other corrective measures taken to bring the toys into conformity with this Regulation.13.The internal register referred to in paragraph 12 shall only contain personal data that are necessary for the manufacturer to investigate the complaint or the information referred to in paragraph 11. Such data shall only be kept as long as is necessary for the purpose of the investigation and, in any event, no longer than 5 years after the data have been entered in the register.
Article 8Authorised representatives1.A manufacturer may appoint an authorised representative by written mandate. When manufacturers terminate the mandate of their authorised representative, they shall inform the market surveillance authority. A manufacturer established in the Union may also appoint an authorised representative. [Am. 92]2.The obligations laid down in Article 7(1), and the obligation to draw up technical documentation referred to in Article 7(2), shall not form part of the authorised representative’s mandate.3.An authorised representative shall perform the tasks specified in the mandate received from the manufacturer and shall provide a copy of the mandate to the market surveillance authorities upon their request. The mandate shall allow the authorised representative to do at least the following:(a)keep the technical documentation at the disposal of national surveillance authorities and ensure that the digital product passport is available, in accordance with Article 17(2), for a period of 10 years after the last item of the toy modeltoy covered by those documents has been placed on the market; [Am. 93](b)further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy in an official language, which can be understood, by that authority; [Am. 94](c)cooperate with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by toys covered by the written mandate.; [Am. 95](ca) inform the competent national authorities about any action taken to eliminate the risks posed by toys covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer. [Am. 96]4.Where a manufacturer not established in the Union appoints an authorised representative as referred to in paragraph 1 of this Article, the written mandate shall include the tasks set out in Article 4(3) of Regulation (EU) 2019/1020.
Article 9Obligations of importers1.Importers shall only place on the market toys complying with this Regulation.2.Before placing toys on the market, importers shall ensure the following:(a)the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation referred to in Article 7(2);(b)the toy is accompanied by instructions offor use and safety information in accordance with in Article 7(7) in a language or languages which can be easily understood by consumers or other end-users, as determined by the Member State concerned; [Am. 97](c)the manufacturer has created a digital product passport for the toy in accordance with Article 7(2); [Am. 98](d)the toy bears a data carrier is affixed in accordance with Article 17(5); [Am. 99](e)the relevant information in the digital product passport has been included in the digital product passport registry in accordance with Article 19(1); [Am. 100](f)the toy bears the CE marking in accordance with Article 16;(g)the manufacturer has complied with the requirements set out in Article 7(5) and (6).Where importers consider, or have reason to believe, on the basis of the information in that importer´s possession, that a toy is not in conformity with the essential safety requirements, they shall not placeinform the manufacturer and refrain from placing the toy on the market until it has been brought into conformity by the manufacturer. [Am. 101]Where importers consider, or have reason to believe, on the basis of the information in that importer´s possession, that the toy presents a risk, they shall immediately provide information thereof to: [Am. 102](a)the manufacturer;(b)the market surveillance authorities, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988 ;(c) consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both. [Am. 103]3.Importers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy.4.Importers shall ensure that, while a toy is under their responsibility, their storage or transport conditions do not jeopardise the toy’s compliance with the essential safety requirements.5.When importers, with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers or other end-users, they shall carry out sample testing of marketed toys.6.Where importers consider, or have reason to believe, that a toy which they have placed on the market is not in conformity with the relevant Union harmonisation legislation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate.Where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk to health and safety of consumers and other end-users, they shall immediately inform the manufacturer and the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken and inform consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both. [Am. 104]7.Importers shall, for a period of 10 years after the last item of the toy modeltoy has been placed on the market, keep the unique product identifier of the toy at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Article 23 can be made available to those authorities, upon request. [Am. 105]8.Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the toy in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.9.Importers shall verify whether the manufacturer has made a communication channelchannels as referred to in Article 7(11) publicly available to consumers or other end-users, allowing them to present complaints concerning the safety of toys and provide information on any accident or safety issue they have experienced with the toy. If a communication channel ischannels are not available, importers shall provide for such a channelthem, taking into account accessibility needs for persons with disabilities. [Am. 106]10.Importers shall investigate complaints and information referred to in paragraph 9 of this Article that they have received via a communication channel made available by the manufacturer, or via a communication channel made available by the importers themselves, and that concern the toys which they have made available on the market. Importers shall file those complaints, as well as recalls and any other corrective measures taken to bring the toys into conformity with this Regulation, in the register referred to in Article 7(12), or in their own internal register.Importers shall keep the manufacturer, distributors and, where relevant, providers of online marketplaces informed in a timely manner of the investigation performed and of the results of the investigation. [Am. 107]11.Personal data contained in the internal register of the importers referred to in paragraph 10 shall only be those personal data that are necessary for the importer to investigate the complaint or the information referred to in paragraph 9. Such data shall only be kept as long as is necessary for the purpose of the investigation and, in any event, no longer than 5 years after the data have been entered in the register.
Article 10Obligations of distributors1.When making a toy available on the market, distributors shall act with due care in relation to the requirements of this Regulation.2.Before making a toy available on the market, distributors shall verify that the following conditions have been met:(a)the toy is accompanied by instructions for use and safety information in a language or languages which can be easily understood by consumers or other end-users as determined by the Member State in which the toy is to be made available on the market; [Am. 108](b)the toy bears a data carrier in accordance with Article 17(5) and the CE marking in accordance with Article 16 and(c)the manufacturer and the importer have complied with the requirements set out in Article 7(2), second subparagraph, Article 7(5), (6) and (11) and Article 9(3) respectively.Where distributors consider, or have reason to believe, on the basis of the information in that distributor´s possession, that a toy is not in conformity with the essential safety requirements, they shall not makeinform the manufacturer and refrain from making the toy available on the market until it has been brought into conformity by the manufacturer. [Am. 109]Where distributors consider, or have reason to believe, on the basis of the information in that distributor´s possession, that the toy presents a risk, they shall immediately provide information thereof to: [Am. 110](a)the manufacturer or the importer;(b)the market surveillance authorities through the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988;(c) consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both. [Am. 111]3.Distributors shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the essential safety requirement.4.Where distributors consider, or have reason to believe, on the basis of the information in that distributor´s possession, that a toy which they have made available on the market is not in conformity with this Regulation, they shall ensure that the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate, are immediately taken. [Am. 112]Where distributors consider, or have reason to believe, that a toy that they have made available on the market presents a risk, they shall immediately inform the manufacturer or the importer, as applicable and the market surveillance authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken and inform consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both. [Am. 113]5.Distributors shall, further to a reasoned request from a competent national authority, provide it, with all the information and documentation necessary to demonstrate the conformity of the toy, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have made available on the market.
Article 11Cases in which obligations of manufacturers apply to importers and distributors other persons [Am. 114]An importer or a distributorA natural or legal person shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 7, where such importer or distributora natural or legal person places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected. [Am. 115]
Article 12Identification of economic operators1.Economic operators shall, on request, identify the following to the market surveillance authorities:(a)any economic operator who has supplied them with a toy;(b)any economic operator to whom they have supplied a toy.2.Economic operators shall be able to present the information referred to in the paragraph 1 for a period of 10 years after the toy has been placed on the market, in the case of the manufacturer, and for a period of 10 years after they have been supplied with the toy, in the case of other economic operators.
CHAPTER IIAOBLIGATIONS OF ONLINE MARKETPLACES
Article 12aFor the purposes of this Regulation, providers of online marketplaces shall comply with the requirements set out in Article 22 of Regulation (EU) 2023/988. [Am. 116]
CHAPTER IIICONFORMITY OF TOYS
Article 13Presumption of conformity of toys [Am. 117]Toys which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential safety requirements to the extent that those requirements are covered by those standards or parts thereof.
Article 14Common specifications1.Toys which are in conformity with the common specifications referred to in paragraph 2 of this Article or parts thereof shall be presumed to be in conformity with the essential safety requirements to the extent that those requirements are covered by those common specifications or parts thereof.2.The Commission may, by means of implementing actsdelegated acts supplementing this Regulation, establish common specifications for the essential safety requirements only where the following conditions are fulfilled: [Am. 118](a)there is no harmonised standard covering the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or revise European standards for those requirements the reference of which is published in the Official Journal of the European Union or the standard does not satisfy the requirements it aims to cover;and:(i) the request has not been accepted; or (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or (iii) the harmonised standards do not comply with the request; and [Am. 119](b)the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or to revise Europeanno reference to harmonised standards for thosecovering the product requirements and eitherhas been published in the Official Journal of the following conditions is fulfilled:European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period. [Am. 120](1) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; [Am. 121](2) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the European standards requested:(a) have not been adopted within the deadline set in the request;(b) do not comply with the request; or(c) do not satisfy the requirements they aim to cover. [Am. 122]Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(3). [Am. 123]2a. When preparing the delegated act referred to in paragraph 2, the Commission shall take into account the views of the relevant bodies and expert groups. [Am. 124]3.When references of a harmonised standard are published in the Official Journal of the European Union, the Commission shall assess whether the implementingdelegated acts referred to in paragraph 2 of this Article which cover the same essential safety requirement need to be repealed or amended. [Am. 125]
Article 15General principles of the CE markingToys made available on the market shall bear the CE marking.The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 16Rules and conditions for affixing the CE marking1.The CE marking shall be affixed visibly, legibly and indelibly to the toy, to a label attached to the toy or to the packaging of the toy.By way of derogation from the first subparagraph, in the case of small toys and toys consisting of small parts, the CE marking may be affixed to a leaflet accompanying the toy.By way of derogation from the first subparagraph, in the case of toys sold in counter displays where it is not technically possible to affix the CE marking to each individual toy, the CE marking may be affixed to the counter display on the condition that the counter display was originally used as packaging for the toy.Where the CE marking affixed to the toy is not visible from outside the packaging, it shall also be affixed to the packaging.2.The CE marking shall be affixed before the toy is placed on the market.3.The CE marking shall, where applicable in accordance with Article 6, be followed by a pictogram or any other warning indicating a special risk or use.4.Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
CHAPTER IVDIGITAL PRODUCT PASSPORT [Am. 126]
Article 17Digital Product passport [Am. 127]1.Before placing a toy on the market, manufacturers shall create adraw up a digital product passport for that toy. The digital product passport shall meet the requirements laid down in this Article and Article 18 and other relevant Union harmonised legislation requiring an EU declaration of conformity and it shall replace all EU declarations of conformity required. [Am. 128]2.The digital product passport shall: [Am. 129](a)correspond to a specific toy model;(b)state that compliance of the toy with the requirements set out in this Regulation and in other Union harmonised legislation requiring an EU declaration of conformity, in particular, the essential safety requirements, has been demonstrated; [Am. 130](c)contain at least the information set out in Part I of Annex VI;(d)be up to date;(e)be available in the language or languages required by the Member State where the toy is made available on the market;(f)depending on access rights, be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators in accordance with paragraph 2a and taking into account the need to protect confidential business information and trade secrets in accordance with Directive (EU) 2016/943; [Am. 131](g)be available for a period of 10 years after the last item of the toy modeltoy is placed on the market, also in cases of insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the digital product passport; [Am. 132](h)be accessible through a data carrier;(i)fulfil the specific and technical requirements laid down pursuant to paragraph 10 in order to facilitate the verification of product compliance by competent national authorities. [Am. 133]2a. The access rights referred to in paragraph 2, point (f) of this Article shall comprise:(a) information accessible to consumers or other end-users listed in points (c), (d), (i), (j), (ja), (jb) and (jc) of Part I of Annex VI and, where applicable, points (a) and (b) of Part II of Annex VI;(b) information accessible only to market surveillance authorities, customs authorities, notified bodies, and the Commission listed in points (a) to (j) of Part I of Annex VI and, where applicable, points (a) and (b) of Part II of Annex VI. [Am. 134]3.In addition to the information referred to in paragraph 2, the digital product passport may contain the information set out in Part II of Annex VI. [Am. 135]4.By creating the digital product passport, the manufacturer shall assume responsibility for the compliance of the toy with this Regulation and with any other Union legislation applicable to toys. [Am. 136]5.The data carrier shall be physically present on the toy or on a label attached to the toy, in accordance with the implementing act adopted in accordance with paragraph 10. In the case of small toys and toys consisting of small parts, the data carrier may alternativelyshall be affixed to its packaging. It shall be clearly visible to the consumer before any purchase and to market surveillance authorities, including in cases where the toy is made available through distance sales. [Am. 137]6.Where other Union legislation requires information on the toy to be available via a data carrier, a single data carrier shall be used to provide the information required under this Regulation and such other Union legislation.7.Where other Union legislation applying to toys requires a digital product passport, a single digital product passport shall be created for toys containing the information required under this Regulation as well as any other information required for the digital product passport by that other Union legislation. [Am. 138]8. By way of derogation from paragraph 2, point (c), where information requirements relating to substances of concern in toys are established in a delegated act adopted in accordance with Article 4 of Regulation …/… [OP please insert: the Ecodesign for Sustainable Products Regulation], the information referred to in Part I, point (k), of Annex VI to this Regulation is no longer required. [Am. 139]9.Economic operators may, in addition to the information referred to in paragraphs 6 and 7, make other information accessible through the data carrier referred to in paragraph 5. Where this is the case, that information shall be clearly separated from the information required under this Regulation and, where relevant, under other Union legislation.10.The Commission shallis empowered to adopt implementing actsdelegated acts in accordance with Article 47 to supplement this Regulation by determining the specific andbasic technical requirements related to the digital product passport for toys by ... [12 months after the entry into force of this Regulation]. Those requirements shall cover in particular the following: [Am. 140](a)the types of data carrier to be used;(b)the layout in which the data carrier is to be presented and its positioning;(c)the technical elements of the passport for which defined European or international standards are to be used;(d)the actors that may introduce or update the information in the digital product passport, including where needed the creation of a new passport, including manufacturers, notified bodies, competent national authorities, and the Commission, or any organisation acting on their behalf, and the types of information they may introduce or update. [Am. 141]Those implementingdelegated acts shall be adopted in accordance with the procedure set out in Article 50(3)46 (2). [Am. 142]
Article 18Technical design and operation of the digital product passport [Am. 143]1.The digital product passport shall be fully interoperable with digital product passports required by other Union legislation in relation to the technical, semantic and organisational aspects of end-to-end communication and data exchange. [Am. 144]2.All information included in the digital product passport shall be based on open standards developed with an interoperable format, including for the purpose of transmitting information via the Safety Business Gateway and the Safety Gate Portal referred to in Articles 27 and 34 of Regulation (EU) 2023/988. It and shall be machine readable, structured and searchable in accordance with the essential requirements set out in Regulation .../... [Ecodesign Regulation for Sustainable Products]. The digital product passport shall be designed and operated in an accessible manner, and incorporate the principle of security and privacy by design. [Am. 145]3.Consumers or other end-users, economic operators and other relevant actors shall have access on the basis of their respective access rights in accordance with Union legislation to the digital product passport free of charge. [Am. 146]3a. Consumers shall not be requested to download and install any software, register, or to provide a password to access the digital product passport. [Am. 147]4.The data included in the digital product passport shall be stored by the economic operator responsible for its creation or by operators authorised to act on their behalf. [Am. 148]5.Where the data included in the digital product passport is stored or otherwise processed by an operator authorised to act on behalf of the economic operators placing the toy on the market, that other operator shall not be allowed to sell, re-use or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services. [Am. 149]6.Economic operators mayshall not track, analyse or use any usage information for purposes other than what is absolutely and strictly necessary for providing the information on the digital product passport online. [Am. 150]
Article 19Digital product passport registry [Am. 151]1.Before placing a toy on the market, and following the adoption of delegated acts in accordance with Article 17(10) of this Regulation, economic operators shall upload, in the registry established under Article 12(1) of Regulation (EU) …/… [POOJ insert serial number for Ecodesign Requirements for Sustainable Products] (the ‘registry’), the unique product identifier and unique operator identifier for that toy. [Am. 152]2.The Commission, market surveillance authorities and customs authorities shall have efficient access to the information stored in the registry referred to in paragraph 1 for carrying out their duties pursuant to this Regulation. [Am. 153]
Article 20Customs controls relating to the digital product passport [Am. 154]1.Toys entering the Union market shall be subject to verifications and other measures laid down in this Article.2.Declarants as defined in Article 5, point (15), of Regulation (EU) No 952/2013 shall include the unique product identifier in the customs declaration for release for free circulation of any toy.3.Customs authorities shall verify whether the unique product identifier indicated by the declarant in accordance with paragraph 2 of this Article corresponds to a unique product identifier included in the registry in accordance with Article 19(1).4.In addition to the verification referred to in paragraph 3 of this Article, customs authorities shall verify the consistency of information made available to customs by declarants with other information stored in the registry and listed in the delegated act referred to in Article 46(3).5.The verifications referred to in paragraphs 3 and 4 of this Article shall take place electronically and automatically using the interconnection between the registry referred to in Article 19(1) and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products]].6.Paragraphs 3, 4 and 5 of this Article shall apply from the day when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products]] becomes operational.The Commission shall publish a notice in the Official Journal of the European Union to that effect indicating the date when the interconnection is operational.7.Customs authorities may retrieve and use the information on toys included in the digital product passport and in the registry for carrying out their duties pursuant to Union legislation, including for risk management in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013. [Am. 155]8.The verifications and other measures laid down in this Article shall be carried out on the basis of the list of commodity codes and product descriptions set out in Annex VII.9.The verifications and measures laid down in this Article shall not affect the application of other Union legal acts governing the release for free circulation of products, including Articles 46, 47 and 134 of Regulation (EU) No 952/2013, and the controls referred to in Chapter VII of Regulation (EU) 2019/1020.
Article 20aAssistance for SMEs1. The Commission shall provide comprehensive assistance, in cooperation with the relevant national authorities, to SMEs that are required to establish a digital product passport for toys, by providing them with tailor-made guidance on how to efficiently set up and operate a digital product passport for toys and an automatic translation tool for the languages referred to in Article 17(2) point (e). This support, referred to in the first subparagraph, shall be provided no later than ... [12 months after the entry into force of this Regulation]. 2. The Commission shall evaluate the possibility of setting up an online tool to provide SMEs with the basic information and functions necessary to establish a digital product passport for their products. [Am. 156]
CHAPTER VCONFORMITY ASSESSMENT
Article 21Safety assessment1.In order to demonstrate that a toy complies with the essential safety requirements, manufacturers shall, before placing a toy on the market, carry out a safety assessment including an analysis of the hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.which shall at least the following:(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards;(b) in relation to chemical hazards, take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, taking into account the obligations under Regulation (EC) No 1907/2006 and the conditions set out therein;(c) be updated whenever additional relevant information is available.The safety assessment shall be included in the technical documentation referred to in Article 23. [Am. 157]2. The safety assessment shall in particular :(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards;(b) in relation to chemical hazards, take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, taking into account the obligations under Regulation (EC) No 1907/2006 and the conditions set out therein; (c) be updated whenever additional relevant information is available. The safety assessment shall be included in the technical documentation referred to in Article 23. [Am. 158]
Article 22Conformity assessment procedures1.Manufacturers shall use the conformity assessment procedures referred to in paragraphs 2 and 3.2.If the manufacturer has applied harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all relevant safety requirements for the toy, the manufacturer shall use the internal production control procedure set out in Part I of Annex IV.3.In the following cases, the manufacturer shall use the EU-type examination procedure set out in Part II of Annex IV together with the conformity to type procedure set out in Part III of that Annex:(a)where harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all relevant safety requirements for the toy, do not exist;(b)where harmonised standards or common specifications referred to in point (a) exist but the manufacturer has not applied them or has applied them only in part;(c)where one or more of the harmonised standards referred to in point (a) has been published with a restriction, in the event that the restriction is relevant to the toy in question; [Am. 159](d)where the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third party verification.4.The EU-type examination certificate issued in accordance with Part II, point 6, of Annex IV shall be reviewed whenever necessary, in particular in case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.
Article 23Technical documentation1.The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the toy complies with the essential safety requirements. It shall, in particular, contain the documents listed in Annex V.2.The technical documentation shall be drawn up in one of the official languages of the Union.3.Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the language of that Member State.When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may fix a deadline for receipt of such file or translation, which shall be 30 days, unless a shorter deadline is justified in the case of serious and immediate risk to health and safety.4.If the manufacturer does not comply with the requirements set out in paragraphs 1, 2 and 3, the market surveillance authority may require the manufacturer to have a test performed by a notified body at its own expense within a specified period in order to verify compliance with the essential safety requirements.
CHAPTER VINOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 24NotificationMember States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.
Article 25Notifying authorities1.Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies for the purposes of this Regulation, and for the monitoring of notified bodies, including compliance with Article 30.2.Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.3.Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26. In addition, that body shall have arrangements to cover liabilities arising out of its activities.4.The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Article 26Requirements relating to notifying authorities1.A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.2.A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of their activities.3.A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.4.A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, nor shall they offer or provide consultancy services on a commercial or competitive basis, however the notifying authority shall provide information to the economic operators about the procedures for the assessment and the conformity assessment bodies if requested to do so. [Am. 160]5.A notifying authority shall safeguard the confidentiality of the information they obtain.6.A notifying authority shall have a sufficient number of competent personnel and adequate resources at their disposal for the properefficient performance of their tasks. [Am. 161]7.A notifying authority shall monitor the nature and amount of tasks performed by subsidiaries of or subcontractors to notified bodies in accordance with Article 30.
Article 27Information obligation of notifying authoritiesMember States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.The Commission shall make that information publicly available.
Article 28Requirements relating to notified bodies1.For the purposes of notification under this Regulation, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. It shall be accredited in accordance with Regulation (EC) No 765/2008.2.Conformity assessment bodies shall be established under the national law of a Member State and shall have legal personality.3.A conformity assessment body shall be a third-party body independent of the organisation or the toy it assesses.A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of toys which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered a third-party body for the purposes of the first subparagraph.4.A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the toys which they assess, nor the authorised representative of any of those parties. This shall not preclude use of the assessed toys that is necessary for the operations of the conformity assessment body or the use of those toys for personal purposes.A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of those toys, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.6.A conformity assessment body shall be capable of carrying out the conformity assessment tasks assigned to it by Annex IV and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.At all times and for each conformity assessment procedure and each kind or category of toy in relation to which it has been notified, a conformity assessment body shall have at its disposal, or in place, the following:(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and ability of reproduction of those procedures;(c)appropriate policies and procedures that distinguish between tasks it carries out as a notified body and other activities;(d)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process.A conformity assessment body shall have the meansresources necessary to efficiently perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. [Am. 162]7.The personnel responsible for carrying out the conformity assessment activities (the ‘assessment personnel’) shall have the following:(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;(b)satisfactoryin-depth knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; [Am. 163](c)appropriatein-depth knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 13 of this Regulation and the common specifications referred to in Article 14 of this Regulation; [Am. 164](d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.8.The impartiality of conformity assessment bodies, their top level management and assessment personnel shall be ensured.The remuneration of the top level management and assessment personnel of a 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 take out liability insurance unless liability is assumed by the Member State in accordance with its national law, or the Member State itself is directly responsible for the conformity assessment.10.The personnel of a conformity assessment body shall observerespect professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Intellectual property rights and trade secrets, in accordance with Directive (EU) 2016/943, shall be protected. [Am. 165]11.Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 40, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Article 29Presumption of conformity of notified bodiesWhere a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 28 insofar as the applicable harmonised standards cover those requirements.
Article 30Subsidiaries of and subcontracting by notified bodies1.Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 28, and shall inform the notifying authority accordingly.2.Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.3.Notified bodies shall be capable of reviewing the tasks performed by the subcontractors or subsidiaries in all their elements.4.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.5.Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IV.
Article 31Application for notification1.A conformity assessment body shall submit an application for notification under this Regulation to the notifying authority of the Member State in which it is established.2.The application referred to in paragraph 1 shall be accompanied by a description of the conformity assessment activities and the toys for which that body claims to be competent, as well as by an accreditation certificate issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 28.
Article 32Notification procedure1.Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 28.2.Notifying authorities shall notify conformity assessment bodies to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.3.The notification shall include full details of the conformity assessment activities and the relevant accreditation certificate. The notification shall also include information on any tasks to be performed by subsidiaries and subcontractors.4.The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two months of a notification.Only such a body shall be considered a notified body for the purposes of this Regulation.5.The notifying authority shall inform the Commission and the other Member States of any subsequent relevant changes to the notification.
Article 33Identification numbers and lists of notified bodies1.The Commission shall assign an identification number to each notified body.It shall assign a single identification number even where the same body is notified under several Union acts.2.The Commission shall make publicly available a list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.The Commission shall ensure that the list is kept up to date.
Article 34Changes to notifications1.Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 28, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.2.In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available to the responsible notifying authorities and market surveillance authorities, at their request.
Article 35Challenge to the competence of notified bodies1.The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.2.The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.3.The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.4.Where the Commission ascertains that a notified body does not meet the requirements for notification, it shall, by means of an implementing act, request the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary.
Article 36Operational obligations of notified bodies1.A notified body shall carry out conformity assessments in accordance with the conformity assessment procedure provided for in Annex IV.2.Notified bodies shall carry out the conformity assessment activities set out in this Regulation in a proportionate manner, avoiding unnecessary burdens for economic operators. They shall perform their activities under this Regulation taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process.When performing their activities, the notified bodies shall respect the degree of rigour and the level of protection required for the compliance of the toy with this Regulation.3.Where a notified body finds that the toy does not meet the essential safety requirements, the requirements in corresponding harmonised standards, where such standards are applied or the requirements in corresponding common specifications referred to in Article 14, where such specifications are applied, it shall require that manufacturer to take appropriate corrective measures and shall not issue an EU-type examination certificate as referred to in Part II, point 6, of Annex IV.4.Where, in the course of the monitoring of conformity following the issue of a EU-type examination certificate, a notified body finds that a toy is no longer in compliance, it shall require the manufacturer to take appropriate corrective measures, and shall suspend or withdraw the EU-type examination certificate if necessary.5.Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EU-type examination certificates, as appropriate.6.Where a notified body is informed by a market surveillance authority that a toy for which the notified body has issued a EU-type examination certificate is not in conformity with the essential safety requirements, it shall withdraw the EU-type examination certificate in respect of that toy.
Article 37Appeals against decisions of notified bodiesA notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Article 38Information obligation of notified bodies1.Notified bodies shall inform the notifying authority of the following:(a)any refusal, restriction, suspension or withdrawal of an EU-type examination certificate;(b)any circumstances affecting the scope of and conditions for their notification;(c)any request for information which they have received from market surveillance authorities regarding conformity assessment activities;(d)on request, conformity assessment activities performed within the scope of their notification, and any other activity performed, including cross-border activities and subcontracting.2.Notified bodies shall provide the other bodies notified under this Regulation which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.3.Notified bodies shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation that relates to any EU-type examination certificate which they have issued or withdrawn, or that relates to any refusal to issue such a certificate, including test reports, and the technical documentation referred to in Article 23.
Article 39Exchange of experienceThe Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Article 40Coordination of notified bodiesThe Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group or groups of notified bodies.Notified bodies shall participate in the work of that group or groups, directly or by means of designated representatives.
CHAPTER VIIMARKET SURVEILLANCE
Article 41Procedure for dealing with toys presenting a risk at National levelmeasures concerning toys which are not compliant with the particular safety requirements [Am. 166]1.Where the market surveillance authorities of one Member State have sufficient reason to believe that a toy covered by this Regulation presents a risk to the health or safety of personschildren, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. They shall immediately inform the relevant economic operator, in accordance with Article 4(1) and (2) of Regulation (EU) 2019/1020, of the procedure they have initiated and of the possible risk they have identified in the toy, and give the economic operator the opportunity to react. The relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose. [Am. 167]Where, in the course of that evaluation, a market surveillance authority finds that a toy does not comply with the requirements laid down in this Regulation, it shall without delay require the relevant economic operator to take appropriate corrective action in accordance with Article 16(3) of Regulation (EU) 2019/1020 within a reasonable period of time prescribed by the market surveillance authority and taking into account the nature of the risk.The market surveillance authorities shall inform the relevant notified body accordingly.2.Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the relevant economic operator to take.3.The economic operator shall ensure that appropriate corrective action is taken in respect of all the concerned toys that the economic operator has made available on the market throughout the Union.4.Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authorities shall take appropriate provisional measures to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it.The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.5.The information referred to in paragraph 4, second subparagraph, shall include all available details, in particular the data necessary for the identification of the non-compliant toy including the unique product identifier, the origin of that toy, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:(a)failure of the toy to meet the essential safety requirements;(b)shortcomings in the harmonised standards referred to in Article 13;(c)shortcomings in the common specifications referred to in Article 14.6.Market surveillance authorities of Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned, and, in the event of disagreement with the notified national measure, of their objections.7.Where, within 3 months of receipt of the information referred to in paragraph 4, second subparagraph, no objection has been raised by either a market surveillance authority of a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed to be justified.8.Market surveillance authorities of other Member States shall ensure that appropriate restrictive measures, such as withdrawal of the toy from their market, are taken without delay in respect of the toy concerned, and shall inform the Commission and the other Member States of those measures.9.The information referred to in paragraphs 2, 4, 6 and 8 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020 and strictly enforce Article 19 of that Regulation given the vulnerability of children to defective, unsafe or counterfeit products. [Am. 168]
Article 42Union safeguard procedure1.Where, on completion of the procedure set out in Article 41(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission has reasons to believe that a national measure could be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.The Commission shall address its decision to all Member States and shall without delay communicate it to them and the relevant economic operator or operators.2.If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant toy is withdrawn or recalled from their market, and shall inform the Commission accordingly.If the national measure is considered unjustified, the Member State concerned shall withdraw it.3.Where the national measure is considered to be justified and the non-compliance of the toy is attributed to shortcomings in the harmonised standards referred to in Article 13 of this Regulation or the common specifications referred to in Article 14 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 or amend the common specifications as appropriate.
Article 43Formal non-compliance1.Without prejudice to Article 41, where a market surveillance authority makes one of the following findings with regard to a toy, it shall require the relevant economic operator to put an end to the non-compliance concerned:(a)the CE marking has been affixed in violation of Article 15 or 16;(b)the CE marking has not been affixed;(c)the digital product passport has not been drawn up in accordance with Article 17; [Am. 169](d)the data carrier through which the digital product passport is accessible has not been affixed in accordance with Article 17(5); [Am. 170](e)the technical documentation referred to in Article 23 is either not available or not complete.2.Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority concerned shall take appropriate measures to restrict or prohibit the making available on the market of the toy, or ensure that the toy is recalled or withdrawn from the market.
Article 44National measures concerning toys which are compliant with the particular safety requirements but which present a risk1.Where, having carried out an evaluation under Article 41(1), a market surveillance authority finds that, although a toy made available on the market is in compliance with the particular safety requirements it poses a risk to the health and safety of persons, it shall require the relevant economic operator to take all appropriate measures, within a reasonable period of time prescribed by the market surveillance authority taking into account the nature of the risk to ensure that the toy, when made available on the market, no longer presents that risk, to withdraw the toy from the market or to recall it.2.The economic operator shall ensure that corrective action is taken in respect of all the toys concerned that the economic operator has made available on the market throughout the Union.3.The market surveillance authority of the Member State shall immediately inform the Commission and the other Member States of its findings and any subsequent actions taken by the economic operator. That information shall include all available details, in particular the data necessary for the identification of the toy concerned including the unique product identifier, the origin and the supply chain of the toy, the nature of the risk involved and the nature and duration of the national measures taken.4.The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not and, where necessary, propose appropriate measures.The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.5.The information referred to in paragraph 3 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020.
Article 45Commission action concerning toys that present a risk1.Where the Commission becomes aware of a toy or a specific category of toys made available on the market which presents a risk to the health and safety of persons but is nonetheless either in compliance with the particular safety requirements or raising doubts about such compliance, it is empowered to adopt implementing acts setting out measures to ensure that the toy or category of toys, when made available on the market, no longer presents that risk, to withdraw it from the market or to recall it where all of the following conditions are met:(a)it emerges from prior consultations with the market surveillance authorities that their approaches to dealing with the risk differ from one market surveillance authority to another;(b)the risk cannot, in view of its nature, be dealt with under other procedures laid down by this Regulation.2.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(3). On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission is empowered to adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 50(4).
CHAPTER VIIIDELEGATED POWERS AND COMMITTEE PROCEDURE
Article 46Delegated powers1.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VI as regards the information to be provided in the digital product passport, in order to adapt it to technical and scientific progress and to the level of digital readiness of market surveillance authorities and of users and their supervisors. [Am. 171]2.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Article 19(1) by setting out that additional information among the information listed in Annex VI or that information on the non-compliance of the toy when measures are taken in accordance with Articles 41(2) or (4) and Article 44(1) is to be stored in the registry.When adopting the delegated acts in accordance with the first subparagraph, the Commission shall take into account the following criteria:(a)coherence with other relevant Union acts, where relevant;(b)the need to allow for the verification of the authenticity of the digital product passport; [Am. 172](c)the relevance of the information for improving the efficiency and effectiveness of market surveillance checks and customs controls for toys;(d)the need to avoid disproportionate administrative burden for economic operators.3.The Commission is empowered to adopt delegated acts in accordance with Article 47 to supplement this Regulation by determining which of the information stored in the registry is to be controlled by customs authorities, in addition to the information set out in Article 20(3).4.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VII to this Regulation in order to adapt the list of commodity codes and product descriptions to be used for the purposes of Article 20(8). Those adaptations shall be based on the list set out in Annex I to Regulation (EEC) No 2658/87.5.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex III in order to adapt it to technical and scientific progress.6.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in order to permit for a specified period of time a certain use in toys of a specific substance or mixture that is prohibited under Part III, point 4, of Annex II, or to limit a certain use that has been permitted. While assessing the requests for exemption and its duration, the Commission shall take into account the availability of alternatives and any potential adverse impacts on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant. Six months after the entry into force of this Regulation, the Commission shall adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in regard to nickel, in order to set out the validity period for the exemption from the generic prohibition under Part III, point 4, of Annex II, for that substance. The Commission shall justify any exemption granted and make this publicly available in an easily accessible and user-friendly manner. [Am. 251]7.The use in toys of a substance or mixture prohibited under Part III, point 4, points (a), (b), (db), (dc), (dd) and (de) of Annex II may onlyshall not be permitted whenunless all of the following conditions are met: [Am. 174](a)it has been found to be safe by the European Chemicals Agency (ECHA), in particular in view due to the absence of the possibility of exposure, including the overall exposure from other sources, and under reasonably foreseeable conditions of use in accordance with Article 5(2), first subparagraph, taking particular account of the vulnerability of children; [Am. 175](aa) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible; [Am. 176](b)there are no suitable alternative substances or mixtures available, as established by ECHA based on an analysis of alternatives;(c)the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.7a. The use in toys of a substance or mixture prohibited under Part III, point 4, points (c), (d) and (da) of Annex II shall not be permitted unless all of the following conditions are met:(a) it has been found to be safe by the ECHA, in particular in view of exposure, including the overall exposure from all potential sources as well as any known additional hazards from combined exposure to the different substances and mixtures present in the toy, and taking into account, in particular, the vulnerability of children;(b) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible;(c) there are no suitable alternative substances or mixtures available, as established by the ECHA based on an analysis of alternatives;(d) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006. [Am. 177]7b. Exemptions from the general prohibition in accordance with paragraphs 7 and 7a shall be time-limited. The validity period for each exemption shall be subject to a review and may be renewed, on a case-by-case basis for each substance or mixture. [Am. 252]8.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Parts A and B of the Appendix to Annex II in order to adapt them to technical and scientific progress, by:(a)introducing conditions for the presence of substances or mixtures in toys and, in particular, limit values for specific substances or mixtures in toys, including limit values for traces of prohibited substances or mixtures as referred to in Part III, point 4, of Annex II;(b)modifying the conditions or limit values for the presence of substances and mixtures in toys.9.For the purposes of paragraphs 6 and 7- 8, the Commission shall systematically and regularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In those evaluations, the Commission shall take into account reports of market surveillance bodies and scientific evidence presented by Member States and stakeholders. [Am. 178]
Article 47Exercise of the delegation1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.2.The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for an indeterminatefive years from … [the date of entry into force of the Regulation]. The Commission shall draw up a report in respect of the delegation of power no later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period of time. [Am. 179]3.The delegation of powers referred to in Article 46 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.4.Before adopting a delegated act, the Commission shall consult relevant stakeholders and experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. [Am. 180]5.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.6.Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of twothree months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by twothree months at the initiative of the European Parliament or of the Council. [Am. 181]
Article 48Requests for assessment for the purposes of Article 46(6)1.Requests for an assessment of a substance or mixture prohibited under Part III, point 4, of Annex II for the purposes of Article 46(6) shall be submitted to ECHA using the format and submission tools referred to in paragraph 3 of this Article. The requests shall be made publicly available in an easily accessible and user-friendly manner. [Am. 182]2.Without prejudice to the second subparagraph of this paragraph, any person submitting a request for assessment under paragraph 1 may request that certain confidential business information is not to be made publicly available in accordance with the relevant Union law. The request for confidentiality shall be accompanied by a justification as to why the disclosure of the information could be harmful to the commercial interests of the person submitting the request for assessment or of any other party concerned.The following information held by the ECHA shall be made publicly available, free of charge, and in a user-friendly format:(a) the name of the legal person making the request;(b) the name of the substance or mixture for which there is a request for an exemption;(c) type of toy or toy component;(d) the substitution plan, where relevant; [Am. 183]3.Before … [the first day of the month following 1 month after the date of entry into force of this Regulation], the ECHA shall draw up and make publicly available a format and tools for the submission of requests for assessment referred to in paragraph 1 as well as technical and scientific guidance on how to submit such requests. [Am. 184]
Article 49Opinions from ECHA1.For the purposes of Article 46(6), ECHA shall provide opinions to the Commission on the use in toys of substances or mixtures that are prohibited under Part III, point 4 of Annex II, where a request for an assessment is submitted to it in accordance with Article 48(1). ECHA shall assess in its opinions whether the criteria set out in Article 46(6), second subparagraph, points (a) and (b)46(7) and Article 46(7a), are met for a specific use. [Am. 185]1a. The Commission shall issue guidelines as to how this assessment shall be conducted, in particular as regards the availability of alternative substances or mixtures and how to address the combined exposure effects under this Regulation. [Am. 186]2.The ECHA may request the person submitting the request for assessment or any third party to submit additional information within a specified period. The ECHA shall take into account any information submitted by third parties. When the ECHA considers it necessary for the determination of an adequate validity period for the exemption, it may also request the person submitting the request for assessment to submit a substitution plan. [Am. 187]3.The opinions referred to in paragraph 1 shall be sent to the Commission and made publicly available in an easily accessible and user-friendly manner within a period of 12 months from the receipt of the request for an assessment. [Am. 188]4.That period may be extended once by a period of up to 6 months if ECHA needs to request information from a third party or if a high number of requests for assessment are submitted to ECHA under Article 48(1).5.ECHA shall re-evaluate its opinions on the use in toys of substances or mixtures listed in Part C of the Appendix to Annex II at least every 5 years from the date of entry into force of a delegated act adopted in accordance with Article 46(6).6.The Commission shall request an opinion from ECHA on the use in toys of substances or mixtures listed in Part C of the Appendix to Annex II as soon as new scientific information or technical developments that may affect the permitted use of a specific substance or mixture in toys becomes known to the Commission. [Am. 189]7.For the purposes of Article 46(7), (7a) and (8), the Commission may request an opinion from ECHA on the safety of a specific substance or mixture in toys, which shall take into consideration the overall exposure to the substance or mixture from other sources and the vulnerability of children. [Am. 190]8.When preparing an opinion in accordance with the provisions set out in this Article, ECHA shall make publicly available the information on the start of the assessment, the adoption of the opinion as well as any intermediate steps in the assessment procedure. In particular, ECHA shall make the draft opinions publicly available and provide an opportunity for any interested party to comment on those opinions within a period of at least 4 weeks.8a. The ECHA shall be provided with the adequate resources to support its work. [Am. 191]
Article 50Committee procedure1.The Commission shall be assisted by a Committee on Toy Safety. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.2.Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.3.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.4.Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
CHAPTER IXCONFIDENTIALITY AND PENALTIES
Article 51Confidentiality1.Competent national authorities, notified bodies, the ECHA and the Commission shall respect the confidentiality of the following information and data obtained in carrying out their tasks in accordance with this Regulation: [Am. 192](a)personal data;(b)commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless disclosure is in the public interest.(ba) the effective implementation of this Regulation, in particular for the purpose of investigations, inspections or audits. [Am. 193]2.Without prejudice to paragraph 1, information exchanged on a confidential basis between the competent national authorities and between competent national authorities and the Commission shall not be disclosed without taking into account the opinion of the originating competent national authority.3.Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to the exchange of information and the dissemination of warnings, or the obligations of the persons concerned to provide information under criminal law.4.Member States and the Commission may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Article 52PenaltiesMember States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.. Member States by … [P.O. insert date: the first day of the month following 30 months after the date of entry into force of this Regulation] notify the Commission of those rules and shall notify it without delay of any subsequent amendment affecting them.
CHAPTER IXAAMENDMENTS
Article 52aAmendment to Directive 2014/53/EUIn Article 10(3) of the Directive 2014/53/EU the following text is added:

‘If the radio equipment is in a toy, the digital product passport established by Regulation (EU) 2024/... of the European Parliament and of the Council of ... on the safety of toys includes also the elements set out in Annex VI and Annex VII of this Directive.’ [Am. 194]

CHAPTER XFINAL PROVISIONS
Article 53RepealDirective 2009/48/EC is repealed with effect from … [OP: please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation].References to the repealed Directive 2009/48/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VIII.
Article 54Transitional provisions1.Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation] may continue to be made available on the market until … [OP please insert the date = the first day of the month following 4250 months after the date of entry into force of this Regulation]. [Am. 195]1a. Toys placed on the market in conformity with Directive 2009/48/EC and compliant with this Regulation shall not be considered non-compliant solely due to the absence of a digital product passport, provided that the same information contained in the passport is made available by the manufacturer upon the request of the parties entitled to have access to the digital product passport under this Regulation. [Am. 196]2.Chapter VII of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and 45 of Directive 2009/48/EC to toys which were placed on the market in conformity with that Directive before … [PO insert date: the first day of the month following 30 months after the date of entry into force of this Regulation], including toys for which a procedure has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [PO insert date: the first day of the month following 3050 months after the date of entry into force of this Regulation]. [Am. 197]3.EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [PO insert date: the first day of the month following 4224 months after the date of entry into forceapplication of this Regulation], unless they expire before that date. [Am. 245]
Article 55Evaluation and review1.By … [OP please insert the date = the first day of the month following 6068 months after the date of entry into force of this Regulation] and every 5 years thereafter, the Commission shall carry out an evaluation of this Regulation. The Commission shall submit a report to the European Parliament and to the Council on the main findings. The report shall assess:(1) whether this Regulation, and in particular the provisions in Chapter IV, achieved the objective of ensuring a high level of protection of health and safety of children and shall assess the possibility to include adaptive toys in the scope of this Regulation;(2) the Regulation’s effect on the safety of toys' users and the proper functioning of the internal market, as well as a detailed summary of the effects on businesses, including costs of operations and competitiveness, in particular for SMEs;(3) the presence of chromium, cadmium, mercury and lead in toys and their effect on the safety of toys’ users. [Am. 199]2.Where the Commission finds it appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.
Article 56Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation].However, Articles 2(3), 17(10), 24 to 40, and 46 to 52, shall apply from … [OP: please insert the date of entry into force of this Regulation]. [Am. 200]This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

For the European Parliament For the Council

The President The President

Annex I

PRODUCTS TO WHICH THIS REGULATION DOES NOT APPLY

Part I – Toys excluded from the scope of this Regulation

1.Playground equipment intended for public use;

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

3.toy vehicles equipped with combustion engines;

4.toy steam engines

Part II – Products that are not considered as toys within the meaning of this Regulation

1.Decorative objects for festivities and celebrations;

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

(a)detailed scale models;

(b)kits for the assembly of detailed scale models;

(c)folk dolls and decorative dolls and other similar articles;

(d)historical replicas of toys; and

(e)reproductions of real fire arms;

3.sports equipment, including roller skates, inline skates, and other means of transport, such as skateboards and scooters intended for children with a body mass of more than 20 kg; [Am. 201]

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

5.scooters and other means of transport designed for sport or which are intended to be used for travel on public roads or public pathways; [Am. 202]

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

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

8.puzzles with more than 500 pieces;

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

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

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

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

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

14.electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals or components, unless the electronic equipment or the associated peripherals or components are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels; [Am. 203]

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

16.babies’ soothers;

17.child-appealing luminaires;

18.electrical transformers for toys;

19.fashion accessories for children which are not for use in play;

19a.Books intended for children older than 36 months, that are made entirely of paper or cardboard, without additional materials or components. [Am. 204]

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 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, must 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).

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 third parties.

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 third parties.

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 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 limit values shall be set through a delegated act, while the maximum values shall not exceed those set in Directive 2003/10/EC. [Am. 205]

11.Activity 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, any surface of such a toy that is accessible for one or more children to play on shall be designed to bear their load.

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 meeting both conditions below shall not, as such, contain substances or mixtures which may become flammable due to the loss of non-flammable volatile components:

(a)toys which, for reasons essential to their functioning, contain substances or mixtures that meet the classification criteria of any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(1)hazard classes 2.1 to 2.4, 2.6 and 2.7, hazard class 2.8 types A and B;

(2)hazard classes 2.9, 2.10 and 2.12, hazard class 2.13 categories 1 and 2;

(3)hazard class 2.14, categories 1 and 2, hazard class 2.15 types A to F; hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development;

(4)hazard class 3.8 effects other than narcotic effects;

(5)hazard classes 3.9, and 3.10 and 3.11; [Ams 206 and 253]

(6)hazard class 4.1, 4.2, 4.3 and 4.4; [Am. 254]

(7)hazard class 5.1;

(b)and toys containing materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities.

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 as such substances or mixtures:

(a)which, when mixed together, may explode through chemical reaction or through heating;

(b)which may explode when mixed with oxidizing substances; or

(c)which 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 are no risks 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 relevant Union legislation 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 as well as with the labelling requirements laid down in Regulation (EC) No 1223/2009. [Am. 207]

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 use in toys, components of toys or micro-structurally distinct parts of toys, of substances or mixtures meeting the criteria laid down in Article 57 of this Regulation and being identified in accordance with Article 59(1) of Regulation (EC) No 1907/2006, classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or meeting the criteria for classification in any of the following categories is prohibited: [Am. 208]

(a)carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR) category 1A, 1B or 2;

(b)endocrine disruption category 1 or 2, for human health and the environment; [Am. 209]

(c)specific target organ toxicity category 1, either in single exposure or in repeated exposure;

(d)respiratory sensitisation category 1;

(da) skin sensitisation category 1; [Am. 210]

(db) persistent, bioaccumulative and toxic; [Am. 211]

(dc) very persistent, very bioaccumulative; [Am. 212]

(dd) persistent, mobile and toxic; [Am. 213]

(de) very persistent, very mobile; [Am. 214].

(4a) The use in toys, components of toys or micro-structurally distinct parts of toys, of per- and polyfluoroalkyl substances (PFAS) and of bisphenols is prohibited. Toys intended for use by children under 36 months or other toys intended to be placed in the mouth shall not contain any fragrances. [Am. 215]

5.The non-intended presence of a substance or mixture referred to in point 4 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.

6.By way of derogation from point 4, substances or mixtures prohibited under that point may be used in toys if they are listed in Part C of the Appendix, under the conditions specified therein.

7.Points 4 to 6 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; or

(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 the first subparagraph of Article 5(2). [Am. 216]

8.Cosmetic toys, such as play cosmetics for dolls or children, slime, finger-paint or modelling clay shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilRegulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).. [Am. 217]

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

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 account of specific Union measures.

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 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.

Part V – Hygiene

1.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.

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. [Am. 219]

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 under Chapter III of the Treaty establishing the European Atomic Energy Community.

Appendix

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

Part A. Substances subject to specific limit values

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

Element

mg/kg in dry, brittle, powder-like or pliable toy material

mg/kg in liquid or sticky toy material

mg/kg in scraped-off toy material

Aluminium

2250

560

28130

Antimony

45

11,3

560

Arsenic

3,8

0,9

47

Barium

1 500

375

18750

Boron

1 200

300

15 000

Cadmium

1,3

0,3

17

Chromium (III)

37,5

9,4

460

Chromium (VI)

0,02

0,005

0,053

Cobalt

10,5

2,6

130

Copper

622,5

156

7 700

Lead

2,0

0,5

23

Manganese

1 200

300

15 000

Mercury

7,5

1,9

94

Nickel

75

18,8

930

Selenium

37,5

9,4

460

Strontium

4 500

1 125

56 000

Tin

15 000

3 750

180 000

Organic tin

0,9

0,2

12

Zinc

3 750

938

46 000

[Am. 257]

These 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.

1a. 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]

2.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]

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

Substance

CAS No

Limit value and conditions for application

TCEP

115-96-8

5 mg/kg (content limit)

TCPP

13674-84-5

5 mg/kg (content limit)

TDCP

13674-87-8

5 mg/kg (content limit)

Formamide

75-12-7

20 μg/m3 (emission limit) after a maximum of 28 days from the start of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content)

1,2-benzisothiazol-3(2H)-one

2634-33-5

5 mg/kg (content limit) in aqueous toy materials, in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005

Reaction mass of: 5-chloro-2- methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1)

55965-84-9

1 mg/kg (content limit) in aqueous toy materials

5-Chloro-2-methyl-isothiazolin-3(2H)-one

26172-55-4

0,75 mg/kg (content limit) in aqueous toy materials

2-methylisothiazolin-3(2H)-one

2682-20-4

0,25 mg/kg (content limit) in aqueous toy materials

Phenol

108-95-2

5 mg/l (migration limit) in polymeric materials in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.

10 mg/kg (content limit) as a preservative in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.

Formaldehyde

50-00-0

1,5 mg/l (migration limit) in polymeric toy material

0,062 mg/m3 (emission limit) in wood toy material

30 mg/kg (content limit) in textile toy material

30 mg/kg (content limit) in leather toy material

30 mg/kg (content limit) in paper toy material

10 mg/kg (content limit) in water-based toy material

Aniline

62-53-3

30 mg/kg (content limit) after reductive cleavage in textile toy material and leather toy material

10 mg/kg (content limit) as free aniline in finger paints

30 mg/kg (content limit) after reductive cleavage in finger paints

4.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]

No

Name of the allergenic fragrance

CAS number

(1)

Alanroot oil (Inula helenium)

97676-35-2

(2)

Allylisothiocyanate

57-06-7

(3)

Benzyl cyanide

140-29-4

(4)

4 tert-Butylphenol

98-54-4

(5)

Chenopodium oil

8006-99-3

(6)

Cyclamen alcohol

4756-19-8

(7)

Diethyl maleate

141-05-9

(8)

Dihydrocoumarin

119-84-6

(9)

2,4-Dihydroxy-3-methylbenzaldehyde

6248-20-0

(10)

3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)

40607-48-5

(11)

4,6-Dimethyl-8-tert-butylcoumarin

17874-34-9

(12)

Dimethyl citraconate

617-54-9

(13)

7,11-Dimethyl-4.6,10-dodecatrien-3-one

26651-96-7

(14)

6,10-Dimethyl-3.5,9-undecatrien-2-one

141-10-6

(15)

Diphenylamine

122-39-4

(16)

Ethyl acrylate

140-88-5

(17)

Fig leaf, fresh and preparations

68916-52-9

(18)

trans-2-Heptenal

18829-55-5

(19)

trans-2-Hexenal diethyl acetal

67746-30-9

(20)

trans-2-Hexenal dimethyl acetal

18318-83-7

(21)

Hydroabietyl alcohol

13393-93-6

(22)

4-Ethoxy-phenol

622-62-8

(23)

6-lsopropyl-2-decahydronaphthalenol

34131-99-2

(24)

7-Methoxycoumarin

531-59-9

(25)

4-Methoxyphenol

150-76-5

(26)

4-(p-Methoxyphenyl)-3-butene-2-one

943-88-4

(27)

1-(p-Methoxyphenyl)-1-penten-3-one

104-27-8

(28)

Methyl trans-2-butenoate

623-43-8

(29)

6-Methylcoumarin

92-48-8

(30)

7-Methylcoumarin

2445-83-2

(31)

5-Methyl-2,3-hexanedione

13706-86-0

(32)

Costus root oil (Saussurea lappa Clarke)

8023-88-9

(33)

7-Ethoxy-4-methylcoumarin

87-05-8

(34)

Hexahydrocoumarin

700-82-3

(35)

Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch)

8007-00-9

(36)

2-Pentylidene-cyclohexanone

25677-40-1

(37)

3.6,10-Trimethyl-3.5,9-undecatrien-2-one

1117-41-5

(38)

Verbena oil (Lippia citriodora Kunth)

8024-12-2

(39)

Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene)

83-66-9

(40)

4-Phenyl-3-buten-2-one

122-57-6

(41)

Amyl cinnamal

122-40-7

(42)

Amylcinnamyl alcohol

101-85-9

(43)

Benzyl alcohol

100-51-6

(44)

Benzyl salicylate

118-58-1

(45)

Cinnamyl alcohol

104-54-1

(46)

Cinnamal

104-55-2

(47)

Citral

5392-40-5

(48)

Coumarin

91-64-5

(49)

Eugenol

97-53-0

(50)

Geraniol

106-24-1

(51)

Hydroxy-citronellal

107-75-5

(52)

Hydroxy-methylpentylcyclohexenecarboxaldehyde

31906-04-4

(53)

Isoeugenol

97-54-1

(54)

Oakmoss extracts

90028-68-5

(55)

Treemoss extracts

90028-67-4

(56)

Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde)

526-37-4

(57)

Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde)

57074-21-2

(58)

Methyl heptine carbonate

111-12-6

Part B. Substances subject to specific labelling requirements

1.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]

No

Name of the allergenic fragrance

CAS number

(1)

Anisyl alcohol

105-13-5

(2)

Benzyl benzoate

120-51-4

(3)

Benzyl cinnamate

103-41-3

(4)

Citronellol

106-22-9; 1117-61-9; 7540-51-4

(5)

Farnesol

4602-84-0

(6)

Hexyl cinnamaldehyde

101-86-0

(7)

Lilial

80-54-6

(8)

d-Limonene

5989-27-5

(9)

Linalool

78-70-6

(10)

3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

127-51-5

(11)

Acetylcedrene

32388-55-9

(12)

Amyl salicylate

2050-08-0

(13)

trans-Anethole

4180-23-8

(14)

Benzaldehyde

100-52-7

(15)

Camphor

76-22-2; 464-49-3

(16)

Carvone

99-49-0; 6485-40-1;

2244-16-8

(17)

beta-Caryophyllene (ox.)

87-44-5

(18)

Rose ketone-4 (Damascenone )

23696-85-7

(19)

alpha-Damascone (TMCHB)

43052-87-5; 23726-94-5

(20)

cis-beta-Damascone

23726-92-3

(21)

delta-Damascone

57378-68-4

(22)

Dimethylbenzyl carbinyl acetate (DMBCA)

151-05-3

(23)

Hexadecanolactone

109-29-5

(24)

Hexamethylindanopyran

1222-05-5

(25)

(DL)-Limonene

138-86-3

(26)

Linayl acetate

115-95-7

(27)

Menthol

1490-04-6; 89-78-1;

2216-51-5

(28)

Methyl salicylate

119-36-8

(29)

3-Methyl-5-(2,2,3-trimethyl-3-cyclopentelnyl)pent-4-en-2-ol

67801-20-1

(30)

alpha-Pinene

80-56-8

(31)

beta-Pinene

127-91-3

(32)

Propylidene phthalide

17369-59-4

(33)

Salicylaldehyde

90-02-8

(34)

alpha-Santalol

115-71-9

(35)

beta-Santalol

77-42-9

(36)

Sclareol

515-03-7

(37)

alpha-Terpineol

10482-56-1; 98-55-5

(38)

Terpineol (mixture of isomers)

8000-41-7

(39)

Terpinolene

586-62-9

(40)

Tetramethyl acetyloctahydro naphthalenes

54464-57-2; 54464-59-4; 68155-66-8; 68155-67-9

(41)

Trimethyl benzenepropanol (Majantol)

103694-68-4

(42)

Vanillin

121-33-5

(43)

Cananga odorata and Ylang-ylang oil

83863-30-3; 8006-81-3

(44)

Cedrus atlantica bark oil

92201-55-3; 8000-27-9

(45)

Cinnamomum cassia leaf oil

8007-80-5

(46)

Cinnamomum zeylanicum bark oil

84649-98-9

(47)

Citrus aurantium amara flower oil

8016-38-4

(48)

Citrus aurantium amara peel oil

72968-50-4

(49)

Citrus bergamia peel oil expressed

89957-91-5

(50)

Citrus limonum peel oil expressed

84929-31-7

(51)

Citrus sinensis (syn.: Aurantium dulcis) peel oil expressed

97766-30-8; 8028-48-6

(52)

Cymbopogon citratus / schoenanthus oils

89998-14-1; 8007-02-01; 89998-16-3

(53)

Eucalyptus spp. leaf oil

92502-70-0; 8000-48-4

(54)

Eugenia caryophyllus leaf / flower oil

8000-34-8

(55)

Jasminum grandiflorum / officinale

84776-64-7; 90045-94-6; 8022-96-6

(56)

Juniperus virginiana

8000-27-9; 85085-41-2

(57)

Laurus nobilis fruit oil

8007-48-5

(58)

Laurus nobilis leaf oil

8002-41-3

(59)

Laurus nobilis seed oil

84603-73-6

(60)

Lavandula hybrida

91722-69-9

(61)

Lavandula officinalis

84776-65-8

(62)

Mentha piperita

8006-90-4; 84082-70-2

(63)

Mentha spicata

84696-51-5

(64)

Narcissus spp.

diverse

(65)

Pelargonium graveolens

90082-51-2; 8000-46-2

(66)

Pinus mugo

90082-72-7

(67)

Pinus pumila

97676-05-6

(68)

Pogostemon cablin

8014-09-03; 84238-39-1

(69)

Rose flower oil (Rosa spp.)

Diverse

(70)

Santalum album

84787-70-2; 8006-87-9

(71)

Turpentine (oil)

8006-64-2; 9005-90-7;

8052-14-0

2.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:

(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;

(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

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

Such 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.

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

Substance

Classification

Permitted use

Dates of applicability [Am. 258]

Nickel

Carc 2

In toys and toy components made of stainless steel.

In toy components which are intended to conduct an electric current.

 

Annex III

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

1.General rules - presentation

All 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]

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

Toys 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:

The 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]

This 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.

3.Activity toys

Activity toys shall bear the following warning:

‘Only for domestic use’.

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

Instructions 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.

4.Functional toys

Functional toys shall bear the following warning:

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

In 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.

5.Chemical toys

Without 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.

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

‘Not suitable for children under …Age to be specified by the manufacturer. years. For use under adult supervision’.

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

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

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

The 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.).

7.Aquatic toys

Aquatic toys shall bear the following warning:

‘Only to be used in water in which the child is within his or her depth and under adult supervision’.

8.Toys in food

Toys contained in Packaging of food containing toys or packaging of food or co-mingled with food toys shall bear the following warning: [Am. 225]

‘Toy inside. Adult supervision recommended’.

9.Imitations of protective masks and helmets

Where imitations of protective masks and helmets are offered for sale as toys, they shall bear the following warning:

‘This toy does not provide protection’.

10.Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps

For toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps, the following warning shall be given on the packaging of the toy and shall be permanently marked on the toy:

‘To prevent possible injury by entanglement, remove this toy when the child starts trying to get up on its hands and knees in a crawling position’.

11.Packaging for fragrances in olfactory board games, cosmetic kits and gustative games

Packaging for fragrances in olfactory board games, cosmetic kits and gustative games that contain fragrances referred to in entries 41 to 55 in the table in Part A, point 4, of the Appendix to Annex II and of fragrances referred to in entries 1 to 10 in the table in Part B, point 1, of that Appendix shall contain the following warning:

‘Contains fragrances that may cause allergies’.

Annex IV

CONFORMITY ASSESSMENT PROCEDURES

Part I - Module A: Internal production control

1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares, on the manufacturer’s sole responsibility, that the toy satisfies the requirements of this Regulation.

2.Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, to the extent relevant for the assessment, the design, manufacture and operation of the toy. The technical documentation shall contain at least the elements set out in Annex V.

3.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Regulation.

4.CE marking and digital product passport [Am. 226]

4.1.The manufacturer shall affix the CE marking to each individual toy that satisfies the applicable requirements of this Regulation.

4.2.The manufacturer shall draw up the digital product passport for a toy model and ensure that together with the technical documentation, it remains available for 10 years after the product last item of the toy model has been placed on the market. The digital product passport shall identify the toy for which it has been drawn up. [Am. 227]

5.Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by the manufacturer’s authorised representative, on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate.

Part II - Module B : EU-type examination

1.EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a toy and verifies and attests that the technical design of the toy meets the requirements of this Regulation.

2.EU-type examination may be carried out in any of the following manners:

(a)examination of a specimen, representative of the production envisaged, of the complete toy (production type),

(b)assessment of the adequacy of the technical design of the toy through an examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the toy (combination of production type and design type),

(c)assessment of the adequacy of the technical design of the toy through an examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).

3.The manufacturer shall lodge an application for EU-type examination with a single notified body of the manufacturer’s choice.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, as well as the name and address of that representative,

(b)a written declaration that the same application has not been lodged with any other notified body,

(c)the technical documentation, which is to make it possible to assess the product's conformity with the applicable requirements of this Regulation and is to include an adequate analysis and assessment of the risk(s), including the safety assessment referred to in Article 21; it is to specify the applicable requirements and cover, to the extent relevant for the assessment, the design, manufacture and operation of the toy; and it is to contain at least the elements set out in Annex V,

(d)the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme,

(e)the supporting evidence for the adequacy of the technical design solution; it is to mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full; and it is to include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer’s behalf and under the manufacturer’s responsibility.

4.The notified body shall:

For the toy:

4.1.examine the technical documentation and supporting evidence to assess the adequacy of its technical design;

For the specimen:

4.2.verify that the specimen has been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or common specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;

4.3.carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or common specifications, these have been applied correctly;

4.4.carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or common specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;

4.5.agree with the manufacturer on a location where the examinations and tests will be carried out.

5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 as well as their results. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.Where the type meets the requirements of this Regulation, the notified body shall issue an EU-type examination certificate to the manufacturer. The EU type examination certificate shall include a reference to this Regulation, a colour image, a clear description of the toy, including its dimensions, and a list of the tests performed, together with a reference of the relevant test report. The certificate shall contain the name and address of the manufacturer, an indication of the place of manufacture, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have annexes attached.

The certificate and the annexes thereto shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type might no longer comply with this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the toy with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

8.Each notified body shall inform its notifying authorities of the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

Member States, the Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, Member States and the Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

9.The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the last item of the toy model has been placed on the market. [Am. 228]

10.The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

Part III - Module C: Conformity to type based on internal production control [Am. 229]

1.Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of the legislative instrument that apply to them.

3.CE marking and digital product passport [Am. 230]

3.1.The manufacturer shall affix the CE marking to each individual product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of the legislative instrument.

3.2.The manufacturer shall create a digital product passport for a toy model and ensure that it remains available for 10 years after the last item of the toy model has been placed on the market. The digital product passport shall identify the toy for which it has been drawn up. [Am. 231]

4.Authorised representative

The manufacturer's obligations set out in point 3 may be fulfilled by the manufacturer’s authorised representative, on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that they are specified in the mandate.

Annex V

ELEMENTS TO BE INCLUDED IN THE TECHNICAL DOCUMENTATION

(as referred to in Article 23)

(1)A detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on substances and mixtures used, to be obtained from the chemical suppliers;

(2)The safety assessment(s) carried out in accordance with Article 21;

(3)A description of the conformity assessment procedure followed;

(4)The addresses of the places of manufacture and storage;

(5)Copies of documents that the manufacturer has submitted to any notified body, where relevant; [Am. 232]

(6)Test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonised standards, if the manufacturer followed the internal production control procedure referred to in Article 22(2); and

(7)a copy of the EU-type examination certificate, a description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the EU-type examination certificate, and copies of the documents that the manufacturer submitted to the notified body, if the manufacturer submitted the toy to EU-type examination and followed the conformity to type procedure referred to in Article 22(3).

Annex VIDIGITAL PRODUCT PASSPORT [Am. 233]

Part I – Information to be included in the digital product passport [Am. 234]

(a)unique product identifier of the toy;

(b)name and address of the manufacturer or of the manufacturer’s authorised representative, as well as the unique operator identifier;

(c)name and address of the economic operator responsible for carrying out the tasks set out in Article 4 of Regulation (EU) 2019/1020, as well as the unique operator identifier;

(d)object of the passport (identification of toy allowing traceability, including a colour image of sufficient clarity to enable the identification of the toy); [Am. 235]

(e)the commodity code under which the toy is classified at the moment the passport is created, as set out in Council Regulation (EEC) No 2658/871Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).;

(f)references to all Union legislation that the toy complies with;

(g)references to the relevant harmonised standards used, or references to common specifications in relation to which conformity is declared;

(h)where applicable: the notified body name and number which has intervened in the conformity assessment procedure and issued a certificate, as well as the reference to the certificate;

(i)the CE marking;

(j)a list of allergenic fragrances that are present in the toy and that are subject to specific labelling requirements as set out in Part B, point 1, of the Appendix to Annex II;

(ja) the communication channel as provided for in Article 7(11); [Am. 236]

(jb) if the toy includes radio equipment the information provided for in Annex VI of Directive 2014/53/EU of the European Parliament and of the Council; [Am. 237]

(jc) a link to the Safety Business Gateway and to the section of the Safety Gate Portal referred to in Articles 27 and 34(3) of Regulation (EU) 2023/988 for the transmission of information about toys that might present a risk to the health and safety of consumers. [Am. 238]

(k) any substance of concern that is present in the toy. [Am. 239]

Part II – Information that may be included in the digital product passport [Am. 240]

(a)safety information and warnings;

(b)instructions of use.

(ba) image or drawing of the toy. [Am. 241]

Annex VII

LIST OF COMMODITY CODES AND PRODUCT DESCRIPTIONS FOR THE PURPOSES OF ARTICLE 20(8)

1

ex 3604; pyrotechnic toys

2

ex 61, ex 62 Fancy dresses for children under 14 years of age, excluding goods classified under 6111, 6112, 6115, 6116, 6209, 6211, 6212, 6213, 6216

3

ex 8711, ex 8712, ex 8714 Children's cycles, whether or not motorised, and parts thereof.

4

ex 9503 Tricycles, scooters, pedal cars and similar wheeled toys; dolls' carriages; dolls; other toys; reduced-size ('scale') models and similar recreational models, working or not; puzzles of all kinds

5

ex 9505 Festive, carnival or other entertainment articles, including conjuring tricks and novelty jokes

Annex VIII

CORRELATION TABLE

Directive 2009/48/EC

This Regulation

Article 1

Article 1

Article 2(1)

Article 2(1)

Article 2(2)

Article 2(2)

Article 3(1)

Article 3(1)

Article 3(2)

Article 3(2)

Article 3(3)

Article 3(3)

Article 3(4)

Article 3(4)

Article 3(5)

Article 3(5)

Article 3(6)

Article 3(6)

Article 3(7)

Article 3(8)

Article 3(8)

Article 3(10)

Article 3(9)

—

Article 3(10)

Article 3(22)

Article 3(11)

Article 3(20)

Article 3(12)

Article 3(21)

Article 3(13)

Article 3(26)

Article 3(14)

Article 3(27)

Article 3(15)

-

Article 3(16)

Article 3(12)

Article 3(17)

-

Article 3(18)

Article 3(29)

Article 3(19)

Article 3(30)

Article 3(20)

-

Article 3(21)

Article 3(31)

Article 3(22)

Article 3(32)

Article 3(23)

Article 3(33)

Article 3(24)

Article 3(34)

Article 3(25)

Article 3(35)

Article 3(26)

-

Article 3(27)

Article 3(24)

Article 3(28)

Article 3(25)

Article 3(29)

-

Article 4(1)

Article 7(1)

Article 4(2)

Article 7(2)

Article 4(3)

Article 7(3)

Article 4(4)

Article 7(4)

Article 4(5)

Article 7(5)

Article 4(6)

Article 7(6)

Article 4(7)

Article 7(7)

Article 4(8)

Article 7(8)

Article 4(9)

Article 7(9)

Article 5(1)

Article 8(1)

Article 5(2)

Article 8(2)

Article 5(3)

Article 8(3)

Article 6(1)

Article 9(1)

Article 6(2)

Article 9(2)

Article 6(3)

Article 9(3)

Article 6(4)

Article 9(2)(b)

Article 6(5)

Article 9(4)

Article 6(6)

Article 9(5)

Article 6(7)

Article 9(6)

Article 6(8)

Article 9(7)

Article 6(9)

Article 9(8)

Article 7(1)

Article 10(1)

Article 7(2)

Article 10(2)

Article 7(3)

Article 10(3)

Article 7(4)

Article 10(4)

Article 7(5)

Article 10(5)

Article 8

Article 11

Article 9

Article 12

Article 10(1)

Article 5(1)

Article 10(2)

Article 5(2)

Article 10(3)

Article 5(3)

Article 11(1) first subparagraph

Article 6(1)

Article 11(1) second subparagraph

Article 6(2)

Article 11(2)

Article 6(3)

Article 11(3)

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Article 12

Article 4(1)

Article 13

Article 13

Article 14

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Article 15

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Article 16(1)

Article 15 first subparagraph

Article 16(2)

Article 15 second subparagraph

Article 16(3)

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Article 16(4)

Article 4(2)

Article 17(1)

Article 16(1)

Article 17(2)

Article 16(2)(3)

Article 18

Article 21

Article 19(1)

Article 22(1)

Article 19(2)

Article 22(2)

Article 19(3)

Article 22(3)

Article 20

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Article 21(1)

Article 23(1)

Article 21(2)

Article 23(2)

Article 21(3)

Article 23(3)

Article 21(4)

Article 23(4)

Article 22

Article 24

Article 23(1)

Article 25(1)

Article 23(2)

Article 25(2)

Article 23(3)

Article 25(3)

Article 23(4)

Article 25(4)

Article 24(1)

Article 26(1)

Article 24(2)

Article 26(2)

Article 24(3)

Article 26(3)

Article 24(4)

Article 26(4)

Article 24(5)

Article 26(5)

Article 24(6)

Article 26(6)

Article 25

Article 27

Article 26(1)

Article 28(1)

Article 26(2)

Article 28(2)

Article 26(3)

Article 28(3)

Article 26(4)

Article 28(4)

Article 26(5)

Article 28(5)

Article 26(6)

Article 28(6)

Article 26(7)

Article 28(7)

Article 26(8)

Article 28(8)

Article 26(9)

Article 28(9)

Article 26(10)

Article 28(10)

Article 26(11)

Article 28(11)

Article 27

Article 29

Article 28

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Article 29(1)

Article 30(1)

Article 29(2)

Article 30(2)

Article 29(3)

Article 30(4)

Article 29(4)

Article 30(5)

Article 30(1)

Article 31(1)

Article 30(2)

Article 31(2)

Article 30(3)

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Article 31(1)

Article 32(1)

Article 31(2)

Article 32(2)

Article 31(3)

Article 32(3)

Article 31(4)

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Article 31(5)

Article 32(4)

Article 31(6)

Article 32(5)

Article 32(1)

Article 33(1)

Article 32(2)

Article 33(2)

Article 33(1)

Article 34(1)

Article 33(2)

Article 34(2)

Article 34(1)

Article 35(1)

Article 34(2)

Article 35(2)

Article 34(3)

Article 35(3)

Article 34(4)

Article 35(4)

Article 35(1)

Article 36(1)

Article 35(2)

Article 36(2)

Article 35(3)

Article 36(3)

Article 35(4)

Article 36(4)

Article 35(5)

Article 36(5)

Article 36(1)

Article 38(1)

Article 36(2)

Article 38(2)

Article 37

Article 39

Article 38

Article 40

Article 39

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Article 40

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Article 41(1)

Article 38(1)

Article 41(2)(3)

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Article 42(1)

Article 41(1)

Article 42(2)

Article 41(2)

Article 42(3)

Article 41(3)

Article 42(4)

Article 41(4)

Article 42(5)

Article 41(5)

Article 42(6)

Article 41(6)

Article 42(7)

Article 41(7)

Article 42(8)

Article 41(8)

Article 43(1)

Article 42(1)

Article 43(2)

Article 42(2)

Article 43(3)

Article 42(3)

Article 44

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Article 45(1)

Article 43(1)

Article 45(2)

Article 43(2)

Article 46

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Article 47(1)

Article 47(1)

Article 47(2)

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Article 48

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Article 49

Article 51

Article 50

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Article 51

Article 52

Annex I

Annex I

Annex II Part I

Annex II Part I

Annex II Part II

Annex II Part II

Annex II Part III, 1-2

Annex II, Part III, 1-2

Annex II Part III, 3

Annex II, Part III4

Annex II, Part III, 6

Appendix to Annex II, part C

Annex II Part III, 7

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Annex II, Part III, 8

Appendix to Annex II, part A, point 2

Annex II, Part III, 9

Article 46(8)

Annex II, Part III, 10

Annex II, Part III, 8

Annex II, Part III, 11

Appendix to Annex II, Part A, point 4 and Part B, point 1

Annex II, Part III, 12

Appendix to Annex II, Part B, point 2

Annex II, Part III, 13

Appendix to Annex II, Part A, point 1

Annex II, Part IV

Annex II, Part IV

Annex II, Part V

Annex II, Part V

Annex II, Part VI

Annex II, Part VI

Appendix A

Appendix to Annex II, Part C

Appendix B

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Appendix C

Appendix to Annex II, Part A, point 3

Annex III

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Annex IV

Annex V

Annex V

Annex III