Contents 1.Introduction 1.1. Purpose of this evaluation 1.2. Scope of the evaluation 2.Background to the intervention 2.1. Description of the intervention and its objectives 2.1.1. Market evolution 2.1.2. The EU legislative context 2.1.3. The intervention logic 3.Implementation and State of Play 4.Method 4.1. Supporting studies and reports 4.2. Stakeholder consultations 4.3. Limitations of available data 4.3.1. Data on toy-related injuries 4.3.2. Data on marketing restrictions for toys 4.3.3. Data on toy trade

4.3.4. Data on costs related to toy production 4.3.5. Lack of representativeness of the respondents in the stakeholder consultations 5.Analysis and answers to the evaluation questions 5.1. Effectiveness of the Toy Safety Directive 5.1.1. Effectiveness in relation to the safety of toys 5.1.2. Effectiveness related to the free movement of toys in the EU 5.1.3. Is the Directive effective with regard to market surveillance? 5.1.4. Does the legal form – Directive or Regulation – impact the effectiveness? 5.1.5. Has the law-making process affected the effectiveness of the Toy Safety Directive? 5.2. Efficiency of the Toy Safety Directive 5.2.1. Costs related to the Toy Safety Directive 5.2.1.1. One-off costs for adapting to the Toy Safety Directive 5.2.1.2. Recurring costs for manufacturers 5.2.2. Costs for SMEs 5.2.3. Are there any costs of consumers 5.2.4. Benefits of the Toy Safety Directive 5.2.5. Balance of benefits and costs 5.2.6. Is there scope for simplification? 5.3. Relevance 5.3.1. Is the Toy Safety Directive’s requirement that toys have to be safe still relevant?

5.3.2. Is the Directive still relevant in view of new type of risks such as cybersecurity? 5.3.3. Is the requirement on the free movement of goods in the Toy Safety Directive still relevant? 5.3.4. Is the current monitoring and evaluation system fit for purpose? 5.4. Coherence 5.4.1. Is the Toy Safety Directive coherent with other EU or Member State legislation? 5.4.2. Is the Toy Safety Directive coherent with the risk assessment and risk management approaches under other pieces of EU legislation? 5.4.3. Are there different limit values for chemicals in other EU or national legislation? 5.5. EU added value 6.Conclusions 6.1. Effectiveness 6.2. Efficiency 6.3. Relevance 6.4. Coherence 6.5. EU added value 1.Lead DG, Decide Planning/CWP references 2.Organisation and timing 3.Exceptions to the better regulation guidelines 4.Consultation of the RSB (if applicable) 5.Evidence, sources and quality Annex 4: Amendments to the Toy Safety Directive

Annex 5: Main provisions of the Toy Safety Directive Annex 6: How a toy safety standard supports the Toy Safety Directive Annex 7: Toy safety standards, the references of which have been published in the Official Journal Annex 8: Problems identified in the 2008 IA and addressed in the 2009 Toy Safety Directive Annex 9: Occurrence of nitrosamines and nitrosatable substances in toys – Market surveillance data Annex 10: Possible benefits of the Toy Safety Directive Annex 11: EU added value Glossary Term or acronym Meaning or definition AdCo Administrative Cooperation CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standardization CLP Classification, Labelling and Packaging CLP Regulation Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. CMR Carcinogenic, Mutagenic or toxic for Reproduction DG Directorate General DG ENV DG Environment DG GROW DG Internal Market, Industry, Entrepreneurship and SMEs DG JUST DG Justice and Consumers DG SANCO Former Directorate General for Health and Consumers DG SANTE Directorate General for Health and Food Safety DG TAXUD DG Taxation and Customs Union DoC Declaration of Conformity EC European Commission EN European Standard ESO(s) European Standardisation Organisation(s) ETSI European Telecommunications Standards Institute EU European Union GPSD General Product Safety Directive IA Impact Assessment IoT Internet of Things JRC Joint Research Centre IDB European Injuries Database MS Member State(s) MSA Market Surveillance Authority(ies) NB Notified Body(ies) OJEU Official Journal of the EU PROSAFE Product Safety Forum of Europe R&TTE Radio and Telecommunications Terminal Equipment RAPEX EU Rapid Exchange System for dangerous non-food products REACH Registration, Evaluation, Authorisation and Restriction of Chemicals RoHS Restriction of Hazardous Substances RPS Regulatory Procedure with Scrutiny SCCS Scientific Committee on Consumer Safety SCHER Scientific Committee on Health and Environmental Risks SG Secretariat-General SME(s) Small- and Medium-sized Enterprise(s) TIE Toy Industries of Europe UK United Kingdom US(A) United States (of America) WTO TBT World Trade Organization – Technical Barriers to Trade 1.Introduction Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, commonly known as the Toy Safety Directive, lays down the safety and other requirements that toys must meet before they can be marketed in the EU. Directive 2009/48/EC replaced the former Directive 88/378/EEC in order to adapt the requirements for toys to technical and scientific developments and previously unknown safety issues. The application and enforcement are aligned with the so-called 'New Legislative Framework’, adopted in July 2008 and laying down a horizontal framework of common principles and reference provisions intended to apply across sectorial legislation (such as the Toy Safety Directive). It defined all the necessary elements for an effective conformity assessment, accreditation and market surveillance, including the control of products imported into the European Union. The new Directive had to be transposed by the EU Member States into their national legislation by 20 January 2011 and was to be applied as of 20 July 2011, except for the chemical safety requirements which were to be applied as of 20 July 2013. Member States have to report every five years on the application of the Toy Safety Directive in their national territories. The first reporting exercise covered 2009 – 2013, the second 2014 – 2018. 1.1.Purpose of this evaluation The overarching purpose of this evaluation is to assess the performance of the Toy Safety Directive since its entry into force in relation to its two objectives of (1) ensuring a high level of safety of toys with a view to ensuring the health and safety of children, and of (2) guaranteeing the functioning of the internal market for toys. Following the 2014 Member States’ reports on the application of the Directive during 2009 – 2013 and an external study by a consultant in 2014 and 2015 (2015 external study) analysing the performance of the Directive with regard to its effectiveness, efficiency, relevance, coherence with other legislation (whether EU or Member States' national legislation) and EU added value, the Commission considered it necessary, about five years after the full applicability of the Directive in the Member States, to conduct an own evaluation of the performance of the Directive, in order to consolidate the information collected so far and to complement it with its own observations.

This evaluation assesses the extent to which the Toy Safety Directive is fit for purpose, hence continues to deliver effectively and efficiently the intended benefits for consumers and business. It also assesses whether the Directive is relevant to stakeholder needs, coherent with other EU legislation (EU or Member States' national legislation) and whether it has an EU added value. The evaluation provides conclusions on current drawbacks of the Toy Safety Directive that prevent it from fully achieving its objectives and generating the desired results. 1.2.Scope of the evaluation The period evaluated starts from the entry into force of the Toy Safety Directive in 2009, bearing in mind that its provisions only started applying on 20 July 2011 (chemicals-related provisions: 20 July 2013), and covers all the Member States of the EU; and the world as a whole, since obligations for toy manufacturers apply to both EU and non-EU manufacturers whose toys are placed on the EU market. This evaluation covers the 27 EU Member States and the United Kingdom as during the period covered by the evaluation (2009 – 2018) the United Kingdom was still a Member of the European Union . It should therefore be noted that when the document refers to EU Member States in the presentation of results these include also the United Kingdom. It focuses on the period from 2009 to 2018, seeking to understand trends over this period wherever possible. 2.Background to the intervention 1. 2. 2.1.Description of the intervention and its objectives 2.2.1.Market evolution The EU has the largest single market for goods and services worldwide. Toys valued at about € 18 billion were sold in the EU in 2016. Imports into the EU represented half of the sales (€ 9.1 billion). Most toy production takes place in China. Online sales are increasing and reach over 1 in every 4 toys in some countries. Almost 60,000 people are working in the EU toy sector and over 130,000 workers have an indirect role to play. The EU toy industry is an international player: in 2016, toys worth € 1.91 billion were exported from the EU to third countries. Moreover, it is a dynamic and innovative industry: around one third of the toys on the market each year have been newly developed. The structure of the EU toy industry is complex and very heterogeneous, ranging from large world-wide operating companies to very small producers of certain specific kinds of toys. About 99% of the EU’s 5,900 toy companies are SMEs, most of which have less than 10 members of staff and account for 90% of the total number of manufacturers. Almost half of the EU toy manufacturers are located in four countries: Germany, France, Poland and the UK. It is a dynamic market with 900 new companies which joined the sector since 2013. The turnover of the industry in 2016 accounted for € 7.75 billion and steadily grew since 2009 by 16%. According to Toy Industries of Europe (TIE), the trade association for the European toy industry providing, amongst others, relevant information both for and on the EU toy industry, there were 18,680 specialised retailers in toys in 2016 compared to 19,083 in 2011. According to the Retail-Index data, the biggest retailer in Europe was Amazon with € 45 million of turnover. The export from EU countries of toys covered by the Toy Safety Directive amounted to € 10.4 billion in 2018. This corresponds to 0.2% of the total EU exports. 86% of the export goes to other EU countries (intra EU trade), and the remaining 14% is sold outside the EU. Intra-EU export of toys covered by the Toy Safety Directive almost doubled since 2007 (real growth rate of 89%), while export of other toys grew by 12%, and the overall intra EU export of all goods grew by 9%. The traditional toys and games market shows moderate growth rates in Europe and the US and strong growth rates in China and especially in the rest of the world. Growth levels for traditional toys and games sales are higher than for the economy as a whole, offering a positive outlook for the toy sector with opportunities for expansion, especially for European toy producers, who are the second most important toy exporters after China. Figures from the association of the European toy industry suggest that 500 new companies have entered the sector between 2013 and 2017. This gave a total of 5,600 toy companies in the EU, of which 99% are SMEs. It may appear therefore that the toy sector was attractive enough, in particular for SMEs, so that the number of toy companies increased by some 10% within five years This is also confirmed by the Eurostat data according to which in 2011 in EU there were around 5,000 companies “Manufacturers of games and toys”. This number increased to around 6,000 in 2017. There were only 33 large companies (0.6%) in the EU, the rest were SMEs (90.7% micro companies, 7.4% small and 1.3% medium-sized). The majority of companies were located in France, Poland, UK and Germany. The highest number of large companies was located in Germany. Consumers are fairly price sensitive. In combination with a low concentration in the market, this means that producers face cost and price competition to a significant extent. This competition on costs is reflected in the production strategy of producers, with many producers offshoring and outsourcing production to China to reduce production costs. In toy production, margins in the entire sector are under pressure with long-term profit margins around 6% for the top 100 firms in terms of size. The margins are lower for small and medium sized (SME) firms than for large firms. Also, the profit margin for retail is lower than for the manufacture of toys. The short product life cycle of toys drives the need for innovation and research and development (R&D). Innovation is widely acknowledged in the sector as essential to maintaining a competitive position. In addition, it allows manufacturers to experience (temporarily) reduced price competition for the innovative toys. Nonetheless, R&D expenditures in the sector may seem modest, with actual R&D expenditure amounting to 0.6% to 2.6% of total turnover. This range, however, is in line with the R&D intensity of the entire manufacturing industry in the EU. Also marketing strategies are very important to the toy sector. The key is market research and introduction of novelties. 2.2.2.The EU legislative context

The twofold objective of the Toy Safety Directive is (1) to maintain a high level of safety for children and protection against possible health threats from toys, while (2) allowing the free circulation of toys in the internal market. Definition of ‘toys’ The scope of the Toy Safety Directive covers all ‘products designed or intended, whether or not exclusively, for use in play by children under 14 years of age’. Thus, a product does not have to be exclusively intended for playing purposes in order for it to be considered as a toy, but can have other functions as well. For example, a key-ring with a small plush teddy bear attached to it is considered as a toy, or a toy plastic figurine with a pencil sharpener in its foot. The main difficulty of this definition is the concept of ‘use in play’ or ‘play value’. Children may play with virtually everything, but this does not make every object fall within the definition of ‘toy’. To be considered as a toy for the purposes of the Directive, the play value has to be introduced in an intended way by the manufacturer since the intention for a (certain) use is included in the definition of ‘toy’ itself. On the other hand, ‘whether exclusively or not’ requires to consider whether a product can have a play value in addition to its intended use, such as in the case of the above-mentioned key-ring with a small plush teddy bear attached to it. Since that product may as well be used by children in play, in addition to its primary function as key-ring, the product is considered to be a toy. The declaration by the manufacturer of the intended use is thus only one of the criteria to be considered, the reasonably foreseeable use in play is considered to prevail over the declaration of the intended use by the manufacturer. The Directive does however not apply to some products for public use fulfilling the definition of toys, such as playground equipment intended for public use, automatic playing machines, whether coin operated or not, when intended for public use. Moreover, Annex I to the Toy Safety Directive enumerates examples of products that are not considered as toys but could be confused with toys. Since it would be impossible to enumerate all the products that are not considered as toys, the list is not exhaustive. Essential safety requirements The Toy Safety Directive lays down the safety criteria (‘essential safety requirements’) that toys must meet before they can be marketed in the EU. Toys must also comply with other EU legislation applicable to them, such as the following: Regulation (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), Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast). The essential safety requirements are designed to ensure a high level of product safety. They may cover identified hazards related to the characteristics of the product or to the product performance. As a consequence there may be several safety requirements associated to the same product. The essential safety requirements in the Toy Safety Directive cover: -general risks: the health and safety of children, as well as other people such as parents or supervisors; -particular risks: physical and mechanical, flammability, chemical, electrical, hygiene and radioactivity risks. How the Directive is keeping up with progress In order to keep pace with latest technical and scientific developments, the Commission can amend certain parts of the Toy Safety Directive via the Regulatory Procedure with Scrutiny (RPS). Such procedure may be used to amend specific provisions. It may adapt Annex I that lists examples of products that are not toys (but may be confused with them), the list of prohibited allergenic fragrances and the list of allergenic fragrances to be labelled in Annex II, it may adapt the limit values for heavy metals and other hazardous metals I Annex II, and the warnings for toys in Annex V. In addition, the Commission may establish maximum limit values for any chemical in toys intended for children under 36 months of age and in all toys intended to be placed in the mouth, and it may also amend those limits (Appendix C to Annex II). Finally, the Commission may allow the use of chemicals that are carcinogenic, mutagenic or toxic to reproduction (CMRs), albeit only following a strict scientific-technical assessment including an independent Scientific Committee. In the period 2012 – 2019, the Directive was amended 14 times to address newly identified chemical risks and to revise limit values for chemicals such as chromium VI, lead, phenol, bisphenol A. The list of the amendments so far adopted is presented in annex 4. Toy safety standards As described above the Toy Safety Directive establishes the mandatory ‘essential’ health and safety requirements for toys. However it does not translate those requirements into detailed specifications for testing toys. These are provided by toy safety standards that are thus ‘supporting’ the Directive (see annex 6). European standards are developed by recognised European Standardisation Organisations (ESOs): CEN, CENELEC, and ETSI. If developed following a request from the European Commission, the resulting standards are called European ‘harmonised’ standards.

The use of European harmonised standards is voluntary, including for toys. Manufacturers can refer to harmonised standards to demonstrate that their products comply with the relevant EU legislation. Even more so, when toys are manufactured in conformity with European harmonised standards, the references of which have been published in the Official Journal of the EU (OJEU), they are presumed to comply with the essential safety requirements of the Toy Safety Directive that are covered by those standards. Due to those toys being presumed to comply, and thus presumed to be safe, hardly any market surveillance authority will restrict the marketing of such a toy. Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from, the Official Journal of the European Union by means of 'Commission implementing decisions'. The latest list of 11 European harmonised standards on toy safety referenced in the Official Journal is in Annex 7. Conformity assessment Conformity assessment is the verification whether a product complies with the applicable essential requirements. It is to be carried out by the manufacturer or by a third party – a ‘Notified Body’ test laboratory that has been previously recognised for its quality both at national and EU level. In any case, manufacturers remain responsible for the safety of the product also after it has been placed on the market. There are two possible conformity assessments allowing toys to be sold in the EU. The manufacturer has to demonstrate the compliance of a toy: -either via self-verification by exclusively using referenced harmonised European standards ; -or by third party verification through a Notified Body . This procedure applies when existing referenced harmonised standards do not cover all relevant safety requirements, or when the toy manufacturer has not applied or only partly applied referenced harmonised standards, or when a referenced harmonised standard has been published with a restriction, or when the toy manufacturer considers that the characteristics of the toy require a third party verification. It is the manufacturer, whether established in the EU or outside the EU, who decides which of these two procedures is appropriate for him to follow. Evidence from Notified Bodies suggests that around 97% of toys in the EU market are subject to the self-verification procedure. By way of comparison with a non-EU regulatory framework, the USA requires a third party conformity assessment for any toy placed on the market in the USA. The only study identified in the desk research for this evaluation compares the US third party conformity assessment with the EU self-verification assessment. The study concluded that third party conformity assessment leads to a much lower number of market restriction measures on toys than the EU self-verification assessment. However, this conclusion appears questionable since the study does not take account of the intensity of market surveillance in the EU which, according to the study, is higher in the EU than in the USA. In this connection, it is important to consider that US attorneys can demand enormous sums on grounds of liability. This can put companies out of business if they cannot satisfy such demand. In contrast to this, the EU legal system is much less liability-prone. Therefore, any comparison between the EU and the US has to be considered with utmost care. Restrictive measures against dangerous toys: EU Safety gate RAPEX A EU wide Rapid Information Exchange System for dangerous products (RAPEX) was established in 2001 under Directive 2001/95/EC on general product safety (GPSD). Today the system is called Safety gate RAPEX. It aims to ensure the exchange of information between Member States and the European Commission on measures that have been taken to prevent or restrict the marketing or use of products posing a (serious) risk to the health and safety of consumers or to other public interests. This not only applies to consumer products covered by the GPSD, but also to any product under sectorial legislation, such as toys. Data on those measures can therefore be used as a source of information on market surveillance activities on toys that present a (serious) risk and whose marketing has been restricted. 2.2.3.The intervention logic The twofold objective of Directive 2009/48/EC is (1) to maintain a high level of safety for children and protection against possible health threats from toys, (2) while allowing toys’ free movement in the internal market. In order to ensure EU citizens’ (and particularly children’s) safety, the Toy Safety Directive lays down safety requirements and regulates the conditions for the manufacture and the trade of toys within – and across – Member States. How does the Directive require manufacturers to ensure the safety of toys? The Toy Safety Directive imposes considerable obligations on manufacturers in order that they ensure the safety of their toys and document that safety unambiguously. When developing a toy, the manufacturer, whether in the EU or elsewhere, has first to assess whether it will be safe. To this end he analyses the harm that the toy may cause when a child is playing with the toy. He analyses which mechanical, physical, flammability, chemical, electrical, hygiene or radioactivity hazards the toy may present, and subsequently how a child may be exposed to the hazards of the toy under the conditions of play. He not only considers the intended way to play with the toy, but also the reasonably foreseeable ways of how children may be (mis-) using the toy. The manufacturer then has to document the toy’s hazards and the exposure to them in the ‘safety assessment’ of the toy. The safety assessment should show why the toy can be considered to be safe, despite the hazards that it presents. To substantiate his safety assessment, the manufacturer has to demonstrate that his toy conforms to the safety requirements that the Toy Safety Directive imposes on a toy with the identified hazards. He has the choice between two ‘conformity assessments’ (see above):

1. Self-verification. The manufacturer is allowed to verify the toy’s conformity himself if all the requirements of the Directive, which apply to the toy, are represented in the relevant harmonised European toy safety standards the references of which have been published in the Official Journal (see above). 2. Third party verification. The manufacturer asks a ‘Notified Body’ to examine his toy. The Directive requires such third party’s verification in particular when the toy presents one or more hazards that are not covered by harmonised toy safety standards referenced in the Official Journal. A notified body is a test laboratory of recognised quality, which has been accredited by a Member State (where the test laboratory is located) for carrying out a conformity assessment (the ‘EC-type examination’). The Notified Body examines the toy and, if the toy passes all the tests successfully, issues an ‘EC-type examination certificate’ for the toy that the manufacturer had submitted for examination. The toy submitted is thus the ‘type’ for future routine production. The manufacturer then draws up the ‘EC Declaration of Conformity’ for his toy. With this he declares that the toy conforms with all relevant requirements of the Toy Safety Directive. The Declaration has to be signed by the manufacturer, he thus takes over the responsibility for the conformity of the toy. The manufacturer also draws up the ‘Technical documentation’ for the toy. Among others, the Technical documentation describes the toy and its manufacturing process, it includes the safety assessment and a copy of the EC Declaration of conformity, and it describes the conformity assessment used. In the case of third-party conformity assessment, the EC-type examination certificate is equally to be included in the Technical documentation. During routine production, the manufacturer has to ensure that each toy item produced is identical to the toy type that he submitted to the conformity assessment. On any toy item produced, the manufacturer affixes the CE mark (either directly on the toy, on an affixed label or on the packaging) and his address as well as an element allowing to trace back the toy (such as a serial number). Finally, the manufacturer adds instructions and safety information to the toy, and the required warnings. How does the Directive require importers and distributors to ensure the safety of toys? Importers have fewer obligations than manufacturers. An importer has to ensure that the manufacturer has fulfilled his obligations, such as carried out a conformity assessment demonstrating that the toy is safe. The importer further has to affix his own name and address on the toy. Distributors have even fewer obligations. A distributor has to verify that a toy bears the CE mark and a traceability number, that both the manufacturer and the importer have indicated their names and addresses (in the case of imported toys), and that instructions and safety information, including the required warnings, accompany a toy. How does the Directive ensure that its obligations are complied with by the economic operators? The Directive provides for the obligation for Member States to perform market surveillance and test toys on the market as well as verifying the manufacturers’ documentation, in order to take unsafe toys from the market and to prosecute those responsible for placing them on the market. Traceability requirements and penalties support the enforcement. How is the Directive ensuring the free movement of toys? The Directive requires Member States ‘not [to] impede the making available on the market in their territory of toys which comply with this Directive.’ Thus, as long as a toy complies with the safety and other requirements of the Directive, no Member State is allowed to impose any other condition that would hinder the free circulation of the toy in the EU. The Toy Safety Directive is thus a ‘maximum harmonisation’ Directive. This eliminates all barriers for cross-border trade and guarantees the proper functioning of the internal market. Overview on the intervention logic Two strategic objectives were identified, namely the safety of toys and the smooth functioning of the internal market (see table below). They correspond to the areas of major concern that emerged from the 2008 Impact Assessment (2008 IA) prepared to identify the possible impact of the then future Toy Safety Directive. While the two strategic objectives embrace long-term processes, the four specific objectives derived from them break them down into workable pieces.

In order to achieve the objectives, a number of provisions (‘input’; for details see annex 5) were included in the Toy Safety Directive that address different issues that can emerge along the life cycle of a toy – from manufacture to marketing and use. The Directive’s provisions are expected to lead to (short-term) output, (medium-term) outcome and (long-term) impact, thus eventually reaching the two strategic objectives as outlined in the table below. Baseline and points of comparison In the context of the internal market, the 1988 Toy Safety Directive was adopted in order to harmonise the different safety levels across Member States. This was crucial as the lack of regulatory and enforcement consistency not only caused obstacles to the free movement of toys across Member States, but also hampered an effective protection of children against risks that may arise from toys. The 1988 Directive was revised in 2009 based on a 2008 Impact Assessment (2008 IA) that identified three main areas for improvement: -Firstly, safety requirements were outdated and not fully responding to newly identified hazards, in particular those of chemicals. The limits for 8 ‘elements’ (mainly heavy metals) were expressed in terms of bioavailability in the 1988 Directive. The 2009 Toy Safety Directive added 11 further chemicals (mainly metals) and expressed the limits in terms of migration. Warning requirements also needed to be refined. The provisions on warnings in the 1988 Directive presented gaps because they did not, in particular, provide that the warnings should always indicate appropriate user limitations such as those related to age, ability and weight of the user, as well as the need to ensure that the toy be used under adult supervision. These warnings, essential to the safe use of the toy, might have been lacking in some cases. -Secondly, Member States highlighted the need for improving both the enforcement consistency and effectiveness of market surveillance and of the institutional framework concerning the implementation of the Directive and of toy-related information and traceability. For example, a specific problem linked to efficient market surveillance concerned the analysis of the hazards and risks that a toy may present. The 1988 Directive did not contain any explicit obligation for the manufacturers to carry out such an analysis. There was no requirement for them to document the hazard/risk analysis and to keep it available for inspection by the market surveillance authorities (in the technical file). Responsible manufacturers did already carry out a hazard/risk analysis. However, since the analysis was not mandatory, it was difficult for market surveillance authorities to check whether an analysis had been undertaken. -Finally, the scope and concepts of the 1988 Directive turned out to lack clarity. The 1988 Directive contained ambiguities, long and complicated sentences and internal and external cross-references. In addition, it needed a clarification on its relation with the General Product Safety Directive (GPSD). Following the 2008 IA and the Commission proposal for a new Toy Safety Directive that it accompanied, the new Directive was adopted on 18 June 2009. Annex 8 provides an outline of the problems identified in the 2008 IA (on scope and concepts, on safety requirements and on enforcement) and where they have been addressed in the 2009 Toy Safety Directive. In particular, the 2009 Toy Safety Directive puts in place stricter requirements for chemicals: -Chemicals that are susceptible to cause cancer, change genetic information, harm fertility or harm an unborn child (‘CMR substances’ ) were no longer allowed in toys beyond the concentration limits set in the Regulation on Classification, Labelling and Packaging of substances and mixtures , or unless they are inaccessible or considered safe following a rigorous scientific evaluation and if they are not prohibited in consumer articles under REACH. In addition, for CMR substances of categories 1A and 1B which are of most concern, no suitable alternatives must exist. (For the ‘less concerning’ CMRs category 2, no analysis of alternatives is necessary.) -19 'elements' such as mercury or cadmium were not allowed in toy parts accessible to children beyond the limits laid down in Toy Safety Directive. -Concerning the 19 'elements' the Directive draws a distinction among three types of materials used in toys – dry, brittle, powder-like or pliable; liquid or sticky; scraped-off – each subject to a different migration limit. -55 allergenic fragrances were prohibited because the relevant Scientific Committee considered that they must not form part of cosmetic products due to their allergenicity in most cases (fragrances 1 to 31 and 36 to 40); or they were (photo-) allergenic (fragrances 32 to 35); or because they were most frequently reported as contact allergens (fragrances 41 to 53); or because they contain allergenic species (fragrances 54 to 55). The presence of traces of these 55 fragrances is however allowed if technically unavoidable under good manufacturing practice and if they do not exceed 100 mg/kg. -A further 11 allergenic fragrances may be used in toys on condition that they are labelled when their concentration exceeds 100 mg/kg in the toy or any of its components. They were less frequently reported as contact allergens. -For 15 of the prohibited allergenic fragrances (namely numbers 41 to 55) and for the 11 allergenic fragrances that are to be labelled, specific conditions apply if such fragrances are used in olfactory board games, cosmetic kits and gustative games. Among others, the toys have to carry the warning that they are not suitable for children under 36 months. The law-making process that resulted in the 2009 Toy Safety Directive reinforced several chemical safety requirements in the proposal for the new Directive, and added further requirements: -CMR substances are only allowed in toys beyond the concentration limits of the Regulation on Classification, Labelling and Packaging of substances and mixtures if they are entirely inaccessible to children, including by inhalation. The proposal had only referred to the inaccessibility of parts of toys containing CMR substances, which however does not take account of the inhalation of such chemicals; -The limit values for the ‘elements’ ‘arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic, … should be set at levels that are half of those considered safe according to the criteria of the relevant Scientific Committee, in order to ensure that only traces that are compatible with good manufacturing practice will be present.’ The proposal had not foreseen an extra role for the six afore-mentioned ‘elements’.

-15 allergenic fragrances proposed for labelling were moved to prohibition to give the total of 55. 13 of the 15 had been ‘most frequently reported as contact allergens’ by the Scientific Committee, 2 of the 15 were very strong allergens. -Specific limit values for any chemical in toys can be set. These limit values apply to toys for children under 36 months (who take ‘everything’ into their mouth) and to toys intended to be placed in the mouth, since those toys lead to a high exposure of children to chemicals. The proposal had not foreseen the establishment of such specific limit values; -Limit values for nitrosamines (0,05 mg/kg) and for nitrosatable substances (1 mg/kg) were added to the proposal. There are no specific or quantified estimates published of the potential impact (i.e., the expected costs and benefits) of the 1988 Directive. The 2008 IA which accompanied the revision of the Toy Safety Directive provided quantification of costs and benefits related to planned chemical provisions and three illustrative case studies with large ranges of costs and a number of assumptions for multinational, SME and medium size manufacturers. The 2008 IA however did not foresee any monitoring and evaluation arrangements and did not provide a clear description of the baseline. Therefore, the baseline for this evaluation is the 2009 Directive and a comparison of data before and after the adoption of the 2009 directive was not possible. Therefore, it is difficult to identify clear points of comparison for the purpose of this evaluation, especially as concerns the main changes (outdated safety requirements or scope and concept clarification). In the present evaluation the estimates of costs and benefits have been contrasted with the estimates from the 2008 IA where possible (see section 5.2). The reproduction of assessment of costs and benefits of chemical provisions for the purpose of this evaluation was considered disproportionate. In the data gathering, it was decided not to artificially separate costs of chemical requirements and other provisions and instead to concentrate on one-off adaptation costs and recurring costs related to the Toy Safety Directive. The additional difficulty in relation to points of comparison relies in different dates of entry into force of different provisions (mid-2013 for chemical provisions and mid-2011 for the remaining provisions) and a number of amendments to the Toy Safety Directive adapting the chemical requirements between 2012 and 2019. In the meantime, other EU initiatives have been adopted that may affect the functioning of the Toy Safety Directive, such as the EU Regulation on Market Surveillance and Compliance of Products, which aims to improve market surveillance by strengthening controls by national authorities to ensure that products (including toys) are safe and comply with the rules. This new Regulation takes into account the increasingly complex supply chains, as well as the increase of products that are offered online to end users within the EU. Practical experience of market surveillance has shown that such supply chains sometimes involve economic operators whose novel functions and activities do not allow to fit them easily into the traditional supply chain operators in the existing legal framework. Such is the case, in particular, with online sales platforms that qualify as ‘fulfilment service providers’, which perform many of the same functions as importers but which might not always correspond to the traditional definition of importer in EU law (and in the Toy Safety Directive). In order to ensure that market surveillance authorities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, these fulfilment service providers have been included in the recent Regulation on Market Surveillance and Compliance of Products. They are part of the list of economic operators against whom it is possible for market surveillance authorities to take enforcement measures. Market surveillance authorities will be better able to deal with new forms of economic activity in order to ensure the safety of consumers and the smooth functioning of the internal market, including those cases where the economic operator acts both as an importer as regards certain products and as a fulfilment service provider as regards other products. 3.Implementation and State of Play The 2009 Toy Safety Directive has been transposed by all Member States, although such transposition was not notified within the deadline by some of them. Following the failure by several Member States to timely notify the Commission about national transposition measures before the January 2011 deadline, the Commission opened 15 non-communication cases, but all of them were closed before the end of 2011, once transposition had been completed and notified. The data in the European Commission database on infringements show that, except for a few delays in the transposition of the Directive in the member States’ legislations, there have not been major problems in the transposition of the Directive and of its amendments into national legislation leading to the opening of infringement proceedings. However, there have been cases of Member States going beyond the requirements of the Toy Safety Directive. For example, in 2011 Germany submitted an application to obtain the authorisation to maintain its (stricter) national provisions on, among others, nitrosamines and nitrosatable substances. Germany based its request on the need of protection of human health. In support of the request, the German authorities provided detailed justifications including scientific studies on the health assessment of the concerned substances. The Commission acknowledged in a 2012 Decision that the limit values for nitrosamines requested by Germany were justified for a part of the toys covered by the Toy Safety Directive limits, due to a ‘major need of protection of human health.’ The Decision thus allowed Germany to keep its lower, stricter national limits. Member States are required to appoint competent authorities responsible for the implementation of the Directive at national level and for ensuring that the Directive is effectively enforced within their territories. As such, they are also responsible for market surveillance, including penalties. In addition to that, they appoint and monitor Notified Bodies who assess and certify compliance with the Toy Safety Directive when requested to do so. At EU level, the European Commission is organising meetings of Member States representatives and other stakeholders in order to support the effective implementation and application of the Directive through, amongst others, sharing of information and best practices, or addressing potential issues and barriers that could arise: -The Toy Safety Committee is responsible for assisting the Commission in the implementation of the Directive, notably in the adoption of implementing measures. The possibility to adopt such measures is provided in the Toy Safety Directive for the update of certain provisions of the Directive to technical and scientific developments via the regulatory procedure with scrutiny. -The Expert Group on Toys Safety is the setting for EU Member States, EEA-EFTA countries, Switzerland, Candidate Countries, stakeholders and the Commission. It assists in the consistent implementation of legislation on toy safety across the EU and provides advice on the preparation of new legislative proposals and policy initiatives. The Expert Group also develops guidance material. Its sub-group on Chemicals is a forum for discussion between representatives of Member States on chemicals of concern and assists the Expert Group in the preparation of amending directives setting (stricter) limit values for chemicals. -The Administrative Cooperation (AdCo) group brings together the national market surveillance authorities responsible for enforcing the Toy Safety Directive. It enables the cooperation and exchange of information on market surveillance issues, including the discussion of 'grey zone' classification problems (toy or not, toy for children under 36 months of age or for older children, etc.). -The co-ordination group of Notified Bodies under the Toy Safety Directive, known as NB-Toys, is a forum for the exchange of experience between Notified Bodies. It meets twice a year in order to harmonise their practices through the adoption of guidance documents, also known as Recommendations and Protocols, to help them fulfil their tasks. They are applied by the Notified Bodies on a voluntary basis. Another important mechanism supporting the implementation of the Toy Safety Directive is European standardisation. Industry representatives active in the European standardisation organisations (CEN, CENELEC) together with Member States and consumer organisations have developed so far 11 harmonised European standards (hENs) which have been referenced in the Official Journal and thus give presumption of conformity and therefore facilitate the implementation of the Toy Safety Directive. Harmonised standards translate the essential safety requirements of the Toy Safety Directive into detailed technical specifications for a large range of toys. 3. 4.Method

This evaluation of the Toy Safety Directive 2009/48/EC began in 2014 with the work of an external consultant and continued until March 2020 with an internal evaluation by the Commission services. It used two main sources of input: 1. studies, reports and databases, 2. stakeholder consultations. Output was aimed to be qualitative and, where possible, quantitative. The evaluation was monitored by a steering group composed of representatives of several European Commission services, namely of the Secretariat-General and of Directorates-General Internal Market, Industry, Entrepreneurship and SMEs (GROW), Justice and Consumers (JUST), Health and Food Safety (SANTE), Environment (ENV), Taxation and Customs Union (TAXUD). Details on the procedure are given in annex 1. 4. 4.1.Supporting studies and reports The 2015 external study, prepared by an external consultant in 2014 and 2015, analysed existing evidence relating to the functioning of the Toy Safety Directive, including literature data as well as views and suggestions of Member States in their five yearly reports 2009 – 2013 on the application of the Toy Safety Directive. Input from industry, a European consumer association, standardisation organisations and Notified Bodies were collected through interviews. For this evaluation, data from the 2015 external study have been updated and complemented as appropriate by the Commission services. The Commission’s Joint Research Centre (JRC) conducted a study on costs and benefits of the Toy Safety Directive (JRC study) for the purpose of this evaluation. The study provided a review of quantitative literature data on the costs and benefits of regulation in the toys sector. The study deployed counterfactual impact analysis by looking at imports and at product restrictions under the Safety gate RAPEX data, and company level data from Bureau van Dijk were used to analyse the possible cost impact of the Toy Safety Directive on manufacturers and distributors. In addition, several Fitness Checks (FC) and related studies on chemicals legislation have been taken into account for the purpose of the present evaluation to the extent that they referred to toys or to the Toy Safety Directive. The present evaluation further takes account of the first five yearly reports 2009 – 2013 from the Member States on the application of the Toy Safety Directive, as well as of the second five yearly reports 2014 – 2018 as far as available. 4.2.Stakeholder consultations Both a public and a targeted consultation of stakeholders have been carried out in the context of this evaluation. The table below gives an overview of the two consultations. Table 4.1. Public and targeted online consultations carried out for this evaluation Public consultation Targeted consultation Data collection source Public online survey Targeted online survey Expected outcome Views of all interested parties Industry feedback Target All stakeholders: -general public including consumers; authorities in 28 Member States and EEA-EFTA countries; -industry including SMEs: manufacturers, importers, distributors; -consumer associations: ANEC (The European consumer voice in standardisation), BEUC (The European Consumer Organisation); -Notified Bodies: NB-Toys Group; -European Standardisation Organisations: CEN, CENELEC. Industry: manufacturers, importers, distributors Number of responses 116 responses from: -32 companies; -12 business associations; -7 Notified Bodies; -31 public authorities; -6 EU and national consumer organisations; -26 citizens; -2 others. 32 responses Moreover, within the framework of the 2015 external study, direct interviews with economic operators, consumer representatives, test laboratories' representatives and the relevant European Standardisation Organisations (ESOs) were conducted. A synopsis summarising the different consultation activities is given in annex 2. 4.3.Limitations of available data This evaluation covers the application of the Toy Safety Directive since mid-2011, when the Directive's provisions were to be applied in the Member States. The evidence is more recent for the chemicals provisions that were to be applied as of mid-2013, thus two years later.

Many of the elements assessed under the current evaluation, such as the principle of free movement of toys in the internal market, were already present in the 1988 Toy Safety Directive. Therefore, many observable outputs and outcomes cannot be attributed exclusively to the 2009 Toy Safety Directive. It is important to highlight the limited availability of data and the limitations of the available data for the use in this evaluation. 4.3.1.Data on toy-related injuries The number of toy-related injuries of children and their possible reduction could provide a quantitative analysis of the benefits of the Toy Safety Directive in terms of protection. However, already the 2008 IA pointed to the very limited availability of data related to such injuries. It was therefore impossible to quantify the benefits of the protective effect of the Directive: -There were no consistent EU-wide statistics on toy-related accidents; -Only three Member States – Denmark, the Netherlands and the United Kingdom – had injury reporting systems with the potential to provide useful data. In these national systems, the exact cause of accidents was however not available, and the link with a toy or its manufacturer could not be established; -Not all products included in these reporting systems were toys within the meaning of the Toy Safety Directive; -Accidents and incidents not involving hospital visits or consultation of a medical doctor were not reported. Another source that registers injuries with products is the European Injury Database (IDB); it is the only ‘EU wide’ data base of this kind. It was set up by former Directorate SANCO (today: SANTE) under the Injury Prevention Programme since a better availability of injury and accident data was considered important for public authorities and other stakeholders to identify possible risks and to spot what types of products may pose a threat. The IDB however only collected data from around 100 hospital emergency departments across 20 EU Member States since the years 1990. Patients were asked about the cause of the injuries and accidents (activity when the injury occurred, area, unintentional, intentional injuries, etc.) and their socio-demographic characteristics (age, gender, country, etc.). For this evaluation of the Toy Safety Directive the information in the IDB was analysed by the JRC to potentially quantify the impact of the Directive on the number of toy-related injuries. The JRC however concluded that the IDB contains too little usable information. The Susy Safe registry aiming to establish an international surveillance system for suffocation injuries could not be used either, since, according to the JRC, these injuries are reported on a voluntary basis by physicians, otorhinolaryngologists, pneumologists and general practitioners and will therefore not be representative of all injuries that occurred. Moreover, as the Susy Safe project is concerned with only a single, particular type of injury, an analysis would be too narrow. The lack of available data on injuries has also been highlighted in various reports, , and by several organisations. In 2010, twenty-two Member States signed up for a Joint Action for Injury Monitoring in Europe, with the aim of having a common hospital-based injury data collection system in place by 2015. However, several consumer and business associations pointed out that most Member States and the European Institutions have failed to give political commitment to the continued exchange of injury data after 2014. In addition, the same associations found that whilst injury data are available from several sources in Member States, they are usually limited in size and scope. Moreover, data are not comparable among Member States and are not exhaustive enough to identify the circumstances leading to accidents and injuries. Finally, a lack of coordination and funding at EU level has been pointed out as the root cause for the absence of consistent accident data. The use of US statistics in the 2015 external study on the Toy Safety Directive is limited to the identification of main toy-related issues. Toy-related injuries that occurred in the US may indeed contribute to provide a picture of major risk categories related to toys. However, taking account of the different contexts and legal frameworks in place in the US and in the EU, the relevance of these risk categories may be questioned. Finally, market developments may affect the number of injuries. The market of toys changes continuously, certain (dangerous) toys may flood the market in a specific year, such as fidget spinners in 2017 (with easy-to-open compartments for dangerous electrical button cells). The advent of such toy ‘hypes’ may contribute to an increasing number of injuries that interferes with the effects of toy safety regulation and its enforcement by market surveillance. Thus, in light of the above, the possible impact of the Toy Safety Directive on injuries have been analysed only qualitatively. 4.3.2.Data on marketing restrictions for toys Also the number of toys banned or otherwise restricted from (further) marketing could provide a quantitative analysis of the benefits of the Toy Safety Directive in terms of protection. A higher number of dangerous toys that are no longer allowed on the market could mean a better protection of children. Looking at the number of toys restricted from marketing and notified via the Safety gate RAPEX from 2009 to 2018 (see figure below) however shows no unambiguous link to the application of the Toy Safety Directive. When its provisions (without the provisions on chemicals) became applicable in mid-2011, an expected rise in the number of notifications did not materialise in that year, and neither in 2012.

On the other hand, the number of toy notifications increased steeply in 2013. This might have been the result of the application of the many new chemical requirements in the 2009 Toy Safety Directive. However, the number toy notifications with a chemical risk went already up in 2012 and decreased in 2013, followed by a further downward trend in the following years before going up again in 2018 (see figure below). Thus, it appears that the Safety Gate RAPEX data are not useful to reflect an impact of the Toy Safety Directive. It seems more likely that the yearly changing numbers of notifications may be heavily influenced by national market surveillance campaigns that target different types of toys in the course of the years, by changes in the number of market surveillance staff and of inspectors who actually take the samples, by more or less imports into the EU, by ‘hypes’ for certain toys which are easier (or less easy) to test for (non-) compliance, by new economic operators entering or leaving the toy market, and others. It may also be that a new legal requirement for toys takes time to be applied in practice by market surveillance authorities, simply because no laboratories are yet known that are able to competently test toys against the new requirement. The impact of a new, stricter requirement may thus only be phasing in over time and therefore not be clearly discernible from the volatility effects of the ‘remaining’ market surveillance activities. 4.3.3.Data on toy trade A further approach to measuring possible benefits of the Toy Safety Directive could be a comparison of the trade in toys before and after the application of the Directive. Manufacturing toys compliant with the more numerous and more demanding requirements of the Directive requires adaptation time and causes costs. This might cause a drop in toys trade until the adaptation is complete and trade returns to its usual pace. An analysis of the evolution of toy imports into the EU was contrasted with the imports of similar products. As a result, the introduction of the Toy Safety Directive in 2009 and the application of its chemical requirements since 2013 seem to have reduced the imports of toys. The effect was less pronounced between 2010 and 2013. Overall, the analysis suggested that the Toy Safety Directive may have reduced the imports of toys. Yet, the results should be interpreted with caution due to many confounding factors in the marketing of toys as described further above. 4.3.4.Data on costs related to toy production Costs related to the Toy Safety Directive, in particular to the manufacture of toys, may be an indicator of the strictness of the Directive’s requirements. Additional or more ambitious safety requirements may lead to higher costs. The 2015 external study on the Toy Safety Directive mainly relied on data retrieved from stakeholders’ qualitative perceptions gathered through interviews to assess costs (and benefits) of the Toy Safety Directive. The lack of data on costs could perhaps have been compensated by a large survey, but this was not in the scope of the 2015 external study. As a result, the available data made it difficult to obtain exhaustive and comprehensive information on costs encountered by companies to comply with the Directive’s requirements. Furthermore, there are a number of factors that can influence manufacturing costs. Toy manufacturers will permanently seek to reduce costs by looking for cheaper sources for raw materials and by becoming more efficient in the manufacturing process such as when scaling up or automating more extensively the production processes, or by shifting manufacture to lower-wage countries. Also, a company may decide to develop innovative toys that are more expensive to manufacture but, if successful, allow higher profit margins. Taking manufacturing costs as an indicator for the impact of legislation may therefore have intrinsic limitations. As a consequence, economic operators in the 2015 external study were not always able to distinguish cost increases directly caused by the Directive from those induced by exogenous factors. Also on the costs borne by Member States no quantification was possible in the 2015 external study since no related data were provided in the 2009 – 2013 national reports on the application of the Directive. For the present evaluation of the Toy Safety Directive, in order to collect at least some quantitative information on the costs of the toy industry, a consultation was targeted to economic operators. It provided 32 responses (26 from toy manufacturers, 5 from toy importers and 1 from a toy distributor). Due to this limited number of responses, the analysis of costs presented in this evaluation should of course be considered with caution. An effort was made in this evaluation to compare the present analysis, where possible, with the estimates in the 2008 IA. The 2008 IA estimates were however based on only a few case studies and a number of assumptions. Different cost categories and timeframes were used in the 2008 IA compared to the data collected for this evaluation. Therefore the comparison had to remain limited. A counterfactual analysis of cost impacts on distributors and manufacturers confirmed a possible cost impact of the Toy Safety Directive on economic operators. However the methodology applied did not allow to identify which elements of the Directive might have been particularly burdensome. 4.3.5.Lack of representativeness of the respondents in the stakeholder consultations The more than 150 responses received through the different consultations provided a good overall number of inputs for the analysis, taking into account that some of the respondents, such as TIE and consumer organisations (ANEC and BEUC) represented the views of all their individual corporate members and national associations. It can therefore be trustfully assumed that the input received represents the meaningful views of the stakeholders having toy safety as their core business. It should be underlined that the consultations reached all types of relevant stakeholders, ranging from industry, consumer organisations, public authorities and citizens.

The replies to the 2018 public consultation were mainly provided by companies/business organisations and public authorities, followed by EU citizens. Fewer replies came from business associations, Notified Bodies and consumer organisations. It is evident that all these responses cannot be seen as representative from a statistical viewpoint. They represent opinions of those who decided to participate. Also, the robustness of the consultations that targeted industry and other economic operators may be influenced by these stakeholders’ inherent interest to generally favour the status quo, because changes in the legislation can lead to additional costs which can hinder business. Notwithstanding the above-mentioned limitations, partially compensated by the fact that replies came from those stakeholders that are really concerned with toys and whose input is most significant, the overall availability and reliability of data and the approach followed are generally considered as satisfactory. Care was taken to accurately report different opinions and findings while also ensuring that the evidence and sources can be traced back. Wherever possible the data gathered were cross-checked and validated against several sources in order to ensure reliability and robustness. 5. Analysis and answers to the evaluation questions 5. 5.1.Effectiveness of the Toy Safety Directive 5.1.1.Effectiveness in relation to the safety of toys The safety of toys is one of the two key objectives of the Toy Safety Directive. Safety is the focus of the Directive, almost all provisions aim to ensure the safety of toys. The free movement of toys in the internal market is covered by a single provision: the Directive obliges Member States to not impede the making available on the market in their territory of toys which comply with this Directive. Thus, as long as toys are safe in accordance with the Directive, they can move freely in the internal market. This means that if the internal market provision is correctly implemented and enforced, the required high level of safety is ensured across the EU and no Member States is allowed to go beyond what is required. This evaluation therefore focusses on the safety of toys, and less on the internal market. 5. 5.1. 5.1.1. 5.1.1.1.Why focus on chemical safety? According to the 2008 IA the safety requirements of the 1988 Toy Safety Directive had to be improved in particular on chemicals. Indeed, a range of chemical requirements were added to the proposal for the 2009 Toy Safety Directive, and they were further reinforced during the law-making process. Furthermore, the ‘subgroup Chemicals’ was set up under the Directive to inform the Commission in particular about new limit values that were to be set for specific chemicals. All the 14 amendments of the Toy Safety Directive so far were based on the work of the subgroup. Finally, chemicals deserve particular attention because knowledge about their toxicity may change. Even chemicals with a long-known toxicity may become ‘more toxic’ when new knowledge arises. As an example, ‘[t]he toxicity of lead has been studied extensively in both animals and humans. On numerous occasions these data have been evaluated by expert committees.’ The limit values for lead in toys were proposed (and eventually adopted in the 2009 Toy Safety Directive) on the basis of scientific reviews from 1995 – 2005.However, in 2013, the European Food Safety Authority (EFSA) issued a scientific opinion on lead providing that lead is more toxic than known before. Even the smallest intake of lead by children can harm their intelligence. It was therefore necessary to lower the limit values in the Toy Safety Directive almost 7-fold. In 2012 and 2013, the limit values for cadmium and barium had to be lowered, respectively, due to updated knowledge on their toxicity. For the same reason the limit values for bisphenol A and for aluminium had to be lowered, respectively, in 2017 and 2019. These examples show that chemical risks deserve permanent attention. For risks other than chemical, such as physical and mechanical risks, knowledge does not increase in the same way, if at all. When children under the age of three years choke on small parts, that risk will not change over time. Provisions addressing these risks therefore need less updating once they have been put in place. Mechanical and physical risks are thus covered by European toy safety standard EN 71-1. Certainly, the standard is improved when new toys can cause new risks. This was the case in 2013 when more extensive specifications to limit the noise from toys were included in the standard. 5.1.1.2.Is the Directive effective in protecting children from the risk of chemicals?

Chemicals in general The Toy Safety Directive emphasizes the protection from chemical risks in its general safety requirement: ‘Toys, including the chemicals they contain, shall not jeopardise the safety and health of users …’. The reference to chemicals in toys was added during the law-making process, and thus considered as important by the EU co-legislators. The Directive further lists a range of ‘particular’ safety requirements on chemicals in its Annex II, Part III, as described in section ‘Baseline and points of comparison’ further above. In addition, cosmetic toys have to comply with the compositional and labelling requirements of the Cosmetics Regulation. Finally, toys that are themselves substances or mixtures have to comply with the CLP Regulation. The many detailed safety requirements on chemicals in the 2009 Toy Safety Directive are based on the recognition in the 2008 IA that its predecessor, the 1988 Toy Safety Directive, needed additional safety requirements especially in the field of chemicals. In addition, during the law-making process the 2009 Toy Safety Directive was given the possibility to include ‘Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth …’. The specific limit values in the related Appendix C should ‘ensure adequate protection [of children] in the case of toys involving a high degree of exposure … intended for use by children under 36 months and in other toys intended to be put in the mouth …’. Indeed, eight amendments to the Toy Safety Directive have inserted specific limit values for a number of CMR substances and highly sensitising substances in Appendix C (see annex 4). However, experts in the subgroup Chemicals, but also in the Expert Group on Toys Safety, repeatedly raised the need that children of 36 months and over be equally well protected as those under 36 months. Furthermore, in the 2018 public consultation, two Member States submitted position papers calling to expand Appendix C in order that the limit values also be applicable to toys for children of 36 months and over. In their 2009 – 2013 national reports on the application of the Toy Safety Directive, four Member States proposed that Appendix C limit values also apply to toys for children of 36 months and over. These views have been confirmed in the 2014 – 2018 national reports, submitted in 2019, where Member States indicated that the limitation to toys for children under 36 months and to toys intended to be taken in the mouth is clearly inadequate, in particular for sensitising substances and preservatives, and that such limits should apply to all toys. In the ‘Fitness check on chemicals legislation (excluding REACH)’, the supporting case study on toys reports that, in light of specific limit values for allergenic isothiazolinones in Appendix C, a Member State expressed the view that ‘Limiting these restrictions to toys used by children under 36 months or toys intended to be placed in the mouth does not reduce the health risk in the case of relevant dermal exposure of hazardous substances, which might increase the health risk for children over 36 months of age.’ The Notified Bodies under the Toy Safety Directive (NB-Toys group) noted at their meeting on 17 September 2019 that allergies in children are independent of the age, a 36 months divide for sensitising substances is therefore not justifiable. Finally, 11 Member States underlined, in a letter of April 2019 to the Commission, their strong belief that limit values in Appendix C should also apply to children of 36 months and older, in light of the chemicals emitted from squishy toys and preservatives in toy slimes and in toy modelling clays. An adaptation of the Toy Safety Directive in this regard was urgently requested. The above shows that the Toy Safety Directive is not considered effective enough in the eyes of Member States and Notified Bodies. They suggest the specific limit values for chemicals apply to the toys for children of all ages. In the Commission services’ view, the distinction between (1) toys for children under 36 months and toys intended to be taken in the mouth, and (2) other toys, takes good account of the oral exposure to chemicals. Indeed, children under 36 months take ‘everything’ in their mouth, and toys such as a toy flute or a toy harmonica are by definition played in contact with the mouth. However, children may also be exposed to chemicals via the skin or via inhalation. Examples are the sensitising preservatives benzisothiazolinone, chloromethylisothiazolinone and methylisothiazolinone for which specific limit values have been inserted in Appendix C to the Directive. Taking account of all exposure paths for chemicals thus would require the specific limit values in Appendix C to apply to all toys for children of all ages. In addition, the risk from chemicals is not much different when comparing children under 36 months and older children. The bodyweight of children under 36 months was estimated to be 7.5 kg when calculating the migration limits for toxic ‘elements’ such as arsenic, cadmium or lead; for children of 36 months and over the bodyweight was assumed to be 15 kg. This 2-fold difference is only minor from the toxicological point of view, a notable difference would be 10-fold. Finally, only the limit values in Appendix C have an age limit and the limitation to mouthing toys, all other chemical limit values in the Toy Safety Directive apply to all toys for children of all ages. This puts a general question mark on the Appendix C limit values. Thus, in light of the above, it appears that the limitation of the scope of the specific limit values in Appendix C, both in terms of children’s age and types of toys, hampers the effectiveness of the Toy Safety Directive. CMR substances in general The Toy Safety Directive prohibits the use of substances that are classified, under the CLP Regulation, as carcinogenic, mutagenic or toxic for reproduction (CMR). CMR substances may be identified as substances of very high concern under REACH. The hazardous effects of such substances can only be seen in the long term and can almost never be traced back to the chemical of origin, and are often irreversible. However, the Toy Safety Directive tolerates the presence of CMRs in toys or its components up to the ‘relevant concentrations’ of the CLP Regulation. ‘Relevant’ are either the specific concentration limits assigned to specific substances in Annex VI, table 3.1 of the CLP Regulation; if no specific concentration limits are indicated in that table, the generic concentration limits in Annex I of the CLP Regulation apply: 0.1% and 1% for carcinogens and mutagens of categories 1 and 2, respectively, and 0.3% and 3% for reproductive toxins of categories 1 and 2, respectively. These ‘relevant concentrations’ of the CLP Regulation are hazard-based and have been set for the purpose of classification and labelling of mixtures containing hazardous substances, with the primary aim to ensure that the hazards of such mixtures are properly identified and communicated. They do not take account of possible exposures, do not entail an assessment of risk related to the uses of a substance, and thus are inadequate for establishing a safe level when a substance is present in an article such as a toy. To take account of the exposure of children to chemicals in toys the subgroup Chemicals was established to recommend limit values for chemicals in toys when those chemicals could pose a risk. On the basis of the work of the subgroup the Toy Safety Directive was amended six times to include (in its Appendix C) risk-based limit values for several CMRs: TCPP and two similar flame retardants, bisphenol A, formamide, phenol, bisphenol A and formaldehyde. Those risk-based limit values are often migration limits. They cannot be compared with the ‘relevant concentrations’ taken from the CLP Regulation, which are content limits. There is no relationship between the concentration of a substance inside a material, i. e., its content, and the migration of the substance out of that material. Both therefore cannot be converted into one another. Nevertheless, for a few substances the Directive sets risk-based content limits and comparisons are therefore possible: Chemical substance ‘Relevant concentration’ in the CLP Regulation, mg/kg Content limit in Appendix C, mg/kg Difference factor TCEP 3,000 5 600 Phenol 10,000 10 1,000 Formamide 3,000 200 15 Formaldehyde 1,000 30 and 10 33 and 100 The limit values in Appendix C are thus 15 to 1,000 times lower than the ‘relevant concentrations’ in the CLP Regulation. The Toy Safety Directive’s derogation from the CMR prohibition therefore does not appear to be well justifiable with regard to the protection of children’s health.

This likely inadequacy of the CMR derogation based on the CLP Regulation was referred to by public authorities and by consumer organisations in the 2018 public consultation. The fitness check on chemicals legislation (excluding REACH) reported in its case study on toys about a consumer association indicating that the thresholds outlined in the CLP Regulation for CMR substances were not originally intended to be used as a safe limit for consumer products and were therefore not appropriate for application to consumer products (and in particular toys, as children are vulnerable). Also, a Member State authority noted that the CLP Regulation follows a hazard-based approach and the generic classification limits of 0.1% for human carcinogens were too high meaning that health risks to children could not be excluded. Also the 2015 external study reported consumer organisations deeming the limits for CMR substances to be too high. In light of the above, the CMR provisions in the Toy Safety Directive can be considered not to be sufficiently effective to protect children’s health. To note that, according to the 2008 IA, these provisions had been explicitly inserted in the Directive because the 1988 Toy Safety Directive had no specific provisions on CMRs. It is however not clear why the inadequacy of such a prohibition, which does not take account of exposure, remained unrecognised before the adoption of the Directive. In addition to the above the Toy Safety Directive provides for two further derogations for the use of CMRs in general: -The second derogation in the Toy Safety Directive allows CMRs in toys that exceed the ‘relevant concentration’ in the CLP Regulation. Such higher concentrations are allowed if the CMRs are inaccessible in any form, including inhalation, when children are playing with the toys. This derogation takes full account of exposure: When there is no exposure to CMRs, there is no risk. This derogation puts children’s safety at the highest rank. This second derogation was possibly less strict in the Commission’s proposal for the Toy Safety Directive, because the proposal allowed CMRs in toy parts ‘that are not accessible to any physical contact by children.’ The proposal thus clearly took account of oral and skin exposure, but it is unclear whether it also covered inhalation. -The third derogation that allows CMRs in toys is conditioned by an evaluation by the relevant Scientific Committee that a CMR is safe in toys, and that REACH does not prohibit the CMR in consumer articles. For the ‘stronger’ CMRs (categories 1A and 1B under the CLP Regulation), the third condition is the non-availability of alternatives, which is not needed for the ‘weaker’ CMRs (category 2). – So far only a single derogation of this kind was allowed, namely for nickel in toys and toy components made of stainless steel and in toy components which are intended to conduct an electric current. This third derogation in the Toy Safety Directive is the same as in the Commission proposal, however the Directive as adopted is more explicit, which makes its implementation easier. From the above it appears that a generic approach to the risks of a whole class of chemicals could be missing effectivity if derogations are set that ignore one of the two constituents of risk, namely in this case the exposure to a vulnerable group of consumers. This calls for utmost attention when applying a generic approach to risk for example to newly identified groups of chemicals causing concern, such as endocrine disruptors. On the other hand, developing appropriate risk assessments for single chemicals has proven to be laborious, if not cumbersome, although ensuring tailor-made protection. Specific CMRs: Nitrosamines and nitrosatable substances The Toy Safety Directive sets migration limits for nitrosamines and nitrosatable substances in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth: 0.05 mg/kg for nitrosamines, 1 mg/kg for nitrosatable substances. Relevant nitrosamines may be genotoxic and very strong carcinogens. Nitrosatable substances can be converted into nitrosamines in the human body. Limit values for nitrosamines and nitrosatable substances were added to the Commission’s proposal for the Directive during the co-decision process. The amendment of the European Parliament proposed to take over the limit values applicable to teats and soothers from the related directive, namely 0.01 mg/kg for nitrosamines, 0.1 mg/kg for nitrosatable substances. That directive referred to an opinion of the Scientific Committee for Food recommending ‘to keep the amounts of nitrosamines and nitrosatable substances migrating from such rubber articles below the detection limit of agreed appropriate sensitive methods.’ Indeed those migration limits were based on detection limits and not on toxicological evaluation, because for genotoxic carcinogenic substances no safe level of exposure exists; a toxicological evaluation by the Scientific Committee on Consumer Products (SCCP) concluded however that 0.05 mg/kg for nitrosamines in balloons was acceptable. The final position of the European Parliament adopted the limit values as they are in the Directive eventually adopted in 2009, namely 0.05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances. Germany however insisted on its lower national limits of 0.01 mg/kg for nitrosamines and of 0.1 mg/kg for nitrosatable substances in toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth. The Commission allowed Germany in a Decision of March 2012 to keep its lower limits, acknowledging that ‘the German request is based on a real concern with regard to children’s health …’. The German limits were consistent with the limits for (parts of) teats and soothers made of elastomer or rubber, of 0.01 mg/kg for nitrosamines and of 0.1 mg/kg for nitrosatable substances. – And the Commission declared in its 2012 Decision to ‘… require CEN to consider … to lower the limit values within the standardisation process.’ As a consequence the Commission mandated CEN in March 2012 to revise the limits for nitrosamines and nitrosatable substances in Standard EN 71-12 on N-Nitrosamines and N-nitrosatable substances. Standardisation should take account of the latest data on the mouthing behaviour of children (which is related to all toys), not only of the mouthing of balloons. With this, CEN’s work resulted in the adoption of standard EN 71-12:2017, made available in January 2017, that included lower limits for nitrosamines and nitrosatable substances in accordance with the Commission’s mandate. Thus, the Directive’s effectiveness with regard to the protection from nitrosamines and nitrosatable substances is compromised. Also, referencing EN 71-12:2017 with its strengthened limits for nitrosamines and nitrosatable substances in the Official Journal is not possible since that would lead to a conflict with the limits in the Directive. EN 71-12:2017 therefore cannot provide the presumption of conformity until the Directive has been revised. Finally, market surveillance authorities in the Member States continue to find both nitrosamines and nitrosatable substances in toys in excess of the current limits in the Directive, in particular in balloons, much less so in finger paints or other toys. Nitrosatable substances are more often found in toys than the nitrosamines themselves (annex 9). In their letter of April 2019 to the Commission, 11 Member States considered that there was an urgent need to lower the limits for nitrosamines and nitrosatable substances. In the 2018 public consultation, public authorities commented that the limits for nitrosamines and nitrosatable substances should be aligned, according to position papers submitted by Denmark, Germany and Sweden, with the limits that the Commission had requested from CEN and available in standard EN 71-12:2017. Industry and Notified Bodies considered the existence of lower limits in national legislation as an incoherence with the Toy Safety Directive. Consumer organisations considered the limits for nitrosamines and nitrosatable substances to be inadequate already in the 2015 external study on the Directive. The 2008 IA mentioned nitrosamines as an example of dangerous chemicals requiring regulation. In conclusion, the Toy Safety Directive is less effective than required to ensure a high level of protection from nitrosamines and nitrosatable substances in toys. At the same time these carcinogens continue to be found in toys in excess of the limit values in the Directive. Allergenic fragrances The Toy Safety Directive prohibits 55 allergenic fragrances, with certain derogations, and requires to label a further 11 when used in toys; in addition, specific labelling provisions apply to olfactory board games, cosmetic kits and gustative games.

Notwithstanding the prohibition of the 55 allergenic fragrances, the presence of traces of these fragrances is allowed if technically unavoidable under Good Manufacturing Practice and if they do not exceed 100 mg/kg. This tolerance of 100 mg/kg, corresponding to 0.01%, does not appear to compromise toy safety. The Scientific Committee on Consumer Safety (SCCS) noted, when assessing fragrance allergens in cosmetic products, that ‘The studies available, however, indicate that a general level of exposure of up to 0.8 μg/cm² (0.01% in cosmetic products) may be tolerated by most consumers, including those with contact allergy to fragrance allergens. The SCCS is of the opinion that this level of exposure (up to 0.01%) would suffice to prevent elicitation for the majority of allergic individuals, unless there is experimental or clinical substance-specific data allowing the derivation of individual thresholds.’ Since cosmetic products such as face creams or hand creams will stay 12 hours or more per day on the skin, exposure to allergenic fragrances from such products will normally be more pronounced than from toys. The 100 mg/kg tolerance in the Toy Safety Directive, legally acceptable only if unavoidable under Good Manufacturing Practice conditions, therefore appears to go hand in hand with a high level of protection. The only caveat to this could be the presence of allergenic fragrances in toys for children under 36 months of age, because those children take ‘everything’ into their mouth by bringing their lips and their mouth’s mucous membranes in contact with a toy material. On the other hand, allergies from the fragrances in question are caused by contact with the external skin, but not the (oral) mucosa, and exposure of the latter may therefore be tolerated. An example for this is the maximum limit of 1% for hydroxy-citronellal in cosmetics in general combined with a labelling requirement as of 0.001% in leave-on cosmetics and as of 0.01% in rinse-off cosmetics, however no limit applies to oral cosmetics. An analogous example is isoeugenol: maximum limit of 0.02% for cosmetics in general (plus the same labelling requirements), but unlimited use in oral cosmetics. The further 11 allergenic fragrances that may be used in toys if labelled above a concentration of 100 mg/kg in the toy or any of its components were less frequently reported as contact allergens. In cosmetics they have to be labelled as of 0.001% (= 10 mg/kg) in leave-on products, and as of 0.01% (= 100 mg/kg) in rinse-off products. In this light the Toy Safety Directive appears to be sufficiently protective, since most toys will lead to a lower exposure than leave-on cosmetics, with a possible exception for finger paints, which may stay for several hours on children’s skin, and thus rather resemble a leave-on cosmetic. This will require further expert consideration. An exception amongst the 11 allergenic fragrances is methyl heptine carbonate that has a maximum limit of 0.01% in cosmetics in general, but can be used without limit in oral cosmetics. The maximum limit being based on a Scientific Committee opinion and corresponding to a prohibition under the Toy Safety Directive, the transfer of methyl heptine carbonate to the group of 55 prohibited allergenic fragrances in the Toy Safety Directive is under preparation. Finally, for amending the specific labelling provisions for olfactory board games, cosmetic kits and gustative games in the Toy Safety Directive Council and Parliament have to decide in an ordinary legislative procedure. This is time consuming and seems disproportionate given that amending the list of allergenic fragrances follows the regulatory procedure with scrutiny which requires much less time. This appears to be an in-built design defect of the Toy Safety Directive which could reduce its effectiveness. Setting limit values for chemicals Under the Toy Safety Directive, limit values for the (mostly heavy metal) ‘elements’ have been set at 10% of the toxicological reference value, as recommended by Scientific Committee opinions., This takes satisfactory account of the intake of elements from other sources, in particular from food, reported to be generally between 20% and 70%. The 10% have to be reduced to half (i.e., 5%) when such an element is ‘particularly toxic’, as provided for in the Directive and applied to the adaptation of the limit values for lead. The 10% allocation has also been used in the case of bisphenol A. In other cases, such as on highly allergenic preservatives, the limit values were set so low that even sensitised individuals would not suffer if exposed to a toy complying with the limit values. At the same time these preservatives would have no preserving effect in a toy. The limit values thus effectively prohibit the use of those chemicals while allowing legal certainty when testing for compliance. On the other hand, in the case of chromium-VI the toxicological assessment would require limit values that are so low that they cannot be tested for compliance. The chromium-VI limit value for scraped-off toy material in the Toy Safety Directive has thus been adapted to a level that can reliably be tested with the most recent standard test method referenced in the Official Journal. In conclusion, limit values in the Toy Safety Directive are normally set at levels that leave a sufficient reserve against the background exposure from sources other than toys. Where this is not possible due to modern test methods not being sufficiently sensitive, they are set at a level that allows compliance testing and unambiguous enforcement. Identifying chemicals for limit setting Chemicals to be considered for setting specific limit values in the Directive have regularly been identified by the dedicated subgroup Chemicals. Its chemical experts from several Member States, the toy industry and a consumer organisation have identified (and have been working on) chemicals that are particularly hazardous, such as CMRs or very strong sensitisers, or on chemicals recognised to be more toxic than previously known, such as aluminium. Suggestions (and work) of the subgroup have also concerned chemicals newly identified in toys, such as volatile chemicals in squeezing toys made from foam materials. Furthermore, opinions of the Commission’s independent Scientific Committees, such as the Scientific Committee on Consumer Safety (SCCS), that is primarily working on cosmetics, or of the European Food Safety Authority (EFSA) have constituted a source of advice, normally via the subgroup. Finally, the subgroup has been discussing ‘Anything to signal on risks from chemicals in toys?’ at its meetings, this being an opportunity to bring up any relevant aspect on chemical risks in toys. – Chemical issues are also discussed in the Expert Group on Toys Safety, which has equally been suggesting chemicals for limitation, such as for certain allergenic fragrances. Thus the identification of chemicals for potential limit-setting in toys has so far been based on expert advice regarding existing or new concerns, and the opportunity for experts to raise any concern they may have. So far there has been no oversight of a risk from chemicals in toys, and the absence of an explicit, more systematic link to activities elsewhere in the EU or worldwide has shown to be sufficient. 5.1.1.3.Is the Directive effective in protecting children from risks other than chemical? The safety requirements in the Toy Safety Directive for hazards other than chemical have not led to any major discussion with Member States or stakeholders about their effectiveness, it seems that they can be applied in practice without further ado. The only safety requirement triggering almost permanent discussion is the ‘small parts requirement’: ‘Toys, which are clearly intended for use by children under 36 months, and their component parts and any of their detachable parts must be of such dimensions as to prevent their 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.’ This requirement is based on the fact that children under 36 months put ‘everything’ in their mouth to explore the world. They therefore run the highest risk of choking on a small part that they have swallowed. This mouthing behaviour fades out with the completion of their 36 months. Nevertheless, toys or their components that are intended to or may be put in the mouth continue to present the ‘small parts risk’: for those toys the safety requirement applies regardless of the age of children. An example for the latter are suction cups at the tip of a toy arrow that children may wet in their mouth (so that it sticks better when shot onto a surface).

Manufacturing toys that comply with the small parts requirement is a challenge, because the toys have to be particularly resistant to mechanical stress. The demanding specifications are circumvented by some manufacturers who disregard the rules and who, although their toys are apparently for children under 36 months, claim that they would be for children of 36 months and over. Such cases have led to discussions amongst Member States’ authorities in the AdCo about the sometimes fine line between toys for children under 36 months and toys for older children. A toy mouse with a wind-up mechanism to be activated by simply pushing the mouse over the ground was thus considered to be for children under 36 months, whereas a pony with a mechanism to be winded up with the fingers was seen by some as too complex for the dexterity of such children, and thus categorised for children of 36 months and over. A guidance document on the classification of toys intended for children under 36 months of age has been developed by Member State authorities and eventually adopted by the Expert Group (which also includes the stakeholders) in 2009. Nevertheless, discussions are taken up when necessary, and a once-for-all remedy for this less-than-optimal effectiveness of the Toy Safety Directive does not appear to exist: new toys with new features are continuously being placed on the market, which requires a case-by-case approach. 5.1.1.4.Are standards effectively supporting the safety of toys? The specifications in the harmonised toy safety standards referenced in the Official Journal cover a wide range of requirements of the Toy Safety Directive. Only hygiene specifications are limited to ‘Material cleanliness’ in clause 4.1 of EN 71-1, without further details. Details on the maximum presence of specific microorganisms can however be taken from Protocol no 2 on the microbial safety of toys, drafted and adopted by the Notified Bodies under the Directive. The radioactivity requirement in the Toy Safety Directive refers to the Treaty establishing the European Atomic Community. So far the harmonised standards referenced in the Official Journal appear to have effectively supported the Directive and thus the safety of toys. There have been no major incidents with toys complying with such standards. Also, on only very rare occasions did Member States object to a standard for being insufficient. For example, a formal objection in 2016 from a Member State regarding EN 71-1 (mechanical and physical properties) considered that specifications for balance bikes were missing, and another formal objection from a Member State regarding EN 71-2 (flammability) in 2012 considered not to cover the easily flammable plastic puffer balls. Furthermore, toy safety standards delivered by CEN are normally of a quality that allows the Commission to reference them without further ado in the Official Journal. Only the 2018 publication of the references to toy safety standards had to be completed by the Commission with a note on the maximum concentration of a preservative in finger paints. The note limited the preservative to the maximum concentration recommended by the Scientific Committee on Consumer Safety (SCCS) for leave-on cosmetics (such as hand creams). CEN was not able to amend the standard on time because the SCCS opinion was published only shortly before the standard publication by CEN. Harmonised referenced standards play a major role in the conformity assessment of toys (see ‘Conformity assessment’ in section 2.1.2). They appear to help manufacturers to bring their toys more swiftly to the market, by avoiding the extra effort in time and money that an EC-type examination requires in comparison to self-certification. 5.1.1.5.Is the Directive effective in defining its scope? The Toy Safety Directive defines toys as ‘… products designed or intended, whether or not exclusively, for use in play by children …’. Thus, products may be considered as toys subject to the Directive when they have a play value for children, although children’s play may not be the main intended use (‘not exclusively’). Due to this wide definition some 15 guidance documents on the related Commission web site are dealing with the distinction between toys and other products, such as dolls (dolls for play by children or for adult collectors; the latter are not toys), toys used in and on the water (such as inflatable plastic animals or inflatable life-saving rings; the latter are not toys), pools, books, musical instruments, and so on. These guidance documents have been primarily developed by the AdCo and eventually agreed by the majority of all stakeholders in the Expert Group on Toys Safety, they thus indicate the view that has been generally adopted in the EU. Nevertheless these guidance documents are not binding and do not relieve national authorities from their obligation to determine for any individual product, on a case-by-case basis, whether it falls within the scope of application of the Toy Safety Directive or within the scope of application of other sectorial legislation. The guidance documents are valued by all: Member States, the toy industry, notified bodies, and others. Updates of existing guidance documents is a recurrent task, such as on pools or on musical instruments, and new guidance documents are being drafted, such as on puffer balls and similar toys, or soother holders. Still, the classification of products as toys (or not) is a permanent, almost daily task for market surveillance authorities, which they are discussing via email exchanges amongst themselves, with the Commission taking the role of an observer to ensure that the provisions of the Directive are not infringed. Experience with the AdCo exchanges shows that products, which previously had never been classified as toys, are suddenly given a child-attractive design by manufacturers. This may give them a play value for children and thus may make them subject to the Toy Safety Directive. Those ‘grey zone products’ lead to hesitations, inquiries and exchanges between the authorities. These hesitations have been confirmed by the 2014 – 2018 national reports of Member States, where many countries referred to difficulties on how to interpret the provisions of the Toy Safety Directive, in particular as concerns the concept of play value and the foreseeable use of a toy. Als