Explanatory Memorandum to COM(2023)462 - Safety of toys - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)462 - Safety of toys. |
|---|---|
| source | COM(2023)462 |
| date | 28-07-2023 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Toys are regulated by Directive 2009/48/EC on the safety of toys (the Toy Safety Directive or the Directive)1. This Directive lays down the safety requirements that toys must meet in order to be placed on the EU market, whether they are manufactured in the EU or in non-EU countries. At the same time, the Directive aims at ensuring the free movement of toys within the internal market.
The Commission evaluation of the Directive2 (the Evaluation) identified a number of deficiencies that have emerged during the practical application of the Directive since it was adopted in 2009. In particular, the Evaluation identified certain shortcomings in ensuring a high level of protection of children from possible risks in toys, in particular from risks posed by harmful chemicals. The Evaluation also concluded that the enforcement of the Directive lacked effectiveness, in particular in the context of online sales, and there remain many unsafe toys on the Union market.
The chemicals strategy for sustainability3 (CSS) called for extending the so-called generic approach towards harmful chemicals (based on generic preventive bans) to ensure that consumers, vulnerable groups and the natural environment are more consistently protected. In particular, the CSS called for strengthening the Directive with regard to protection from the risks posed by the most harmful chemicals and with regard to possible combination effects of chemicals. The Directive already contains a general prohibition on substances in toys that are carcinogenic, mutagenic or toxic for reproduction (CMRs). However, it does not refer to other substances of particular concern, such as endocrine disruptors or substances affecting the immune, nervous or respiratory systems.
On 16 February 2022 the European Parliament adopted almost unanimously an own initiative report on the implementation of the Directive4. In its report, the European Parliament calls on the Commission to revise the Directive to: (i) strengthen the protection of children against chemical risks; (ii) ensure that risks posed by internet-connected toys are addressed by EU law; and (iii) improve enforcement of the Directive in particular in relation to online sales.
Finally, the Commission Communication of 16 March 2023 on the long-term competitiveness of the EU5 outlines how the EU can build on its strengths and go beyond merely bridging the growth and innovation gap. To foster competitiveness, the Commission proposes in this Communication to work on nine mutually reinforcing drivers of competitiveness, including a functioning internal market and digitalisation through broad-based take-up of digital tools across the economy. This focus on the internal market and digitalisation is taken up in the current proposal.
To deal with the issues highlighted in the Evaluation and developed in the accompanying impact assessment report6, and to respond to the Commission’s CSS, this proposal expects to tackle the following two problems found in the Directive.
The first problem is that the Directive does not sufficiently protect children from the risks posed by hazardous chemicals in toys. The power given to the Commission to amend the Directive and adapt it to scientific knowledge is too limited. In particular, it is not possible to adapt the Directive in relation to limit values for toys intended for children over 36 months.
In addition, there are many toys on the EU market which do not comply with the Directive. Unsafe toys put children at risk and may lead to accidents that can even be fatal. Not all toys on the market can be subject to checks. This means that the exact share of non-compliant toys in the Union market cannot be quantified with precision. However, there are sufficient separate indicators that confirm that the number of non-compliant toys on the Union market is very high. Whenever market surveillance actions or inspections take place, the percentage of non-compliant and unsafe toys that are found is consistently high.
• Consistency with existing policy provisions in the policy area
This proposal is based on Decision No 768/2008/EC7 on a common framework for the marketing of products, which ensures consistency with other pieces of EU harmonisation legislation that may apply to other aspects of toys, such as the Radio Equipment Directive (RED)8. This proposal is also consistent with Regulation (EU) No 2019/1020 on market surveillance9 which sets out the regulatory framework for market surveillance checks and customs controls on toys. In addition this proposal is consistent with priorities and current trends on ‘digitalisation by default’ including the conclusions on digitalising product information in the evaluation of the new legislative framework10. By relying on the ‘product passport’ proposed by the Commission in its proposal for a regulation on ecodesign Requirements for sustainable products (‘ESPR’)11 consistency of the product passport under both Regulations will be guaranteed and synergies can be achieved once toys are covered by delegated acts under ESPR. The safety of toys will be regulated within the scope of this proposal, while in the medium term sustainability aspects of toys may be covered within the framework of the ESPR. Moreover, the proposal acknowledges the Commission Recommendation (EU) 2022/251012 which establishes the ‘safe and sustainable by design’ framework for chemicals and materials.
• Consistency with other EU policies
This initiative is consistent with wider EU policy and regulatory developments, in terms of future and ongoing regulatory actions following the CSS. This proposal relies on existing and future hazard classes to be included under 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 (the CLP Regulation)13 and is consistent with the overall objectives of the CSS to strengthen the protection of consumers, and in particular vulnerable groups, from the most harmful chemicals. This proposal is also consistent with and complemented by Regulation (EU) 2023/98814 of the European Parliament and of the Council on general product safety, which contains in particular provisions on online sales, or on the right to information and remedy, which are applicable to toys.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
This proposal is based on Article 114 of the Treaty on the Functioning of the European Union. This is because its purpose is to harmonise the health and safety requirements for toys in all Member States, and to ensure that there are no obstacles to the free movement of toys between the Member States. This Regulation should replace the current Directive 2009/48/EC which has the former Article 95 of the Treaty establishing the European Community (current Article 114 TFEU) as its legal basis.
• Subsidiarity
This initiative addresses the issues identified in the Evaluation of the Toy Safety Directive. The Evaluation concluded that the Directive is generally relevant, effective, efficient and coherent, and has EU added value, but that there was a need for specific improvements.
The main objectives of this regulation are to ensure the highest level of safety for children, and to enable the free circulation of toys in the EU. A key rationale for a piece of EU-level toy safety legislation is to provide harmonisation across Member States based on Article 114 TFEU. The Toy Safety Directive is a total harmonisation measure for the safety aspects of toys, so Member States are not allowed to introduce additional or different safety requirements for toys. Nevertheless, Member States are required to transpose the regular amendments of the Directive, which in the past has led to regulatory amendments applying inconsistently across the EU. The regular adaptations of the Directive have also proven to be resource intense for Member States. A regulatory action at EU level would ensure consistent implementation of any new safety requirements for toys and any subsequent amendment to them, and thus a greater level of safety. It would also provide legal certainty and a level playing field for industry. Furthermore, the introduction of a product passport and the relevant controls at the Union external borders require that the underlying legal instrument be a Regulation.
• Proportionality
The approach proposed in this regulation will address all the problems identified in the most effective and efficient manner. This regulation will strengthen the protection of children from the most harmful chemicals when playing with toys by introducing generic bans on the most harmful substances. It will also allow for derogations to those generic bans under limited circumstances where the use of these substances in toys do not pose a risk to children and where there are no alternatives. Introducing generic bans for the most harmful substances as soon as their hazards have been established under the CLP Regulation will guarantee that children are more swiftly protected from the possible risks of these substances when present in toys. In addition, by allowing for derogations to these generic bans under limited circumstances, it will limit the costs for industry from introducing such bans in those cases where the safety of children is not compromised.
The introduction of a product passport that contains compliance information will be effective in reducing the number of non-compliant toys in the Union market, including through online sales. The regulation will ensure that any toy which is presented at customs is released for free circulation and placed on the Union market only if it has a corresponding product passport. This will lead to significant efficiency gains for both market surveillance authorities and customs authorities. This will achieve the objectives in an effective manner without disproportionate costs on industry15; while the introduction of the product passport will lead to costs for businesses to set up the systems and create the digital passports, it will also lead to savings in producing the necessary documentation digitally rather than on paper and when dealing with inspections from authorities. In addition, it is expected to lead to a significant reduction of non-compliant toys on the Union market, thus benefitting the competitiveness of compliant industry. The product passport will meet the same technical requirements as the product passport proposed under the ESPR in order to: (i) avoid duplications of industry’s digitalisation efforts; and (ii) ensure interoperability with product passports created under other EU legislation.
• Choice of the instrument
The proposal takes the form of a regulation. The proposed change from a directive to a Regulation takes into account both the Commission’s general objective to simplify the regulatory environment and the need to ensure uniform implementation throughout the EU of the proposed legislation.
In addition, the Toy Safety Directive is a total harmonisation directive. In this respect, a regulation would by its legal nature, better ensure that Member States do not impose national technical requirements that go beyond the safety requirements laid down in the current Directive and/or contradict those safety requirements. Furthermore, the introduction of a product passport including compliance information as well as the related customs controls on toys entering the Union market require that the underlying legal instrument be a Regulation.
The change from a directive to a regulation will not lead to specific changes in the regulatory approach. The characteristics of the new legislative framework to which the Directive is already aligned will be fully preserved, in particular the flexibility given to manufacturers: (i) in the choice of the means employed to comply with the essential requirements (harmonised standards or other technical specifications); and (ii) in the choice of the procedure used to demonstrate compliance from among the available conformity-assessment procedures. The existing mechanisms supporting the implementation of the legislation (standardisation processes, expert groups, market surveillance, Member States’ administrative cooperation (AdCo), the development of guidance documents, etc.) will not be affected by the nature of the legal instrument and will continue to operate in the same manner under the Regulation as they currently do under the Directive.
Finally, the use of regulations in the area of internal market legislation (in accordance also with the preference expressed by stakeholders) avoids the risk of ‘gold plating’, in which the requirements in an EU directive are extended when transposed into the national laws of a Member State. It also allows manufacturers to work directly with the regulation text instead of needing to identify and examine 27 national laws transposing the Directive. A Regulation will also lead to savings for the industry and benefit the internal market, as it will enter into force simultaneously across the EU, as will any subsequent amendment to it. On this basis, it is considered that the choice of a regulation is the most appropriate solution for all involved parties as it will allow a more rapid and coherent application of the legislation adopted at EU level and will establish a clearer regulatory environment for economic operators.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
The Evaluation of the Directive concluded that the Directive was generally effective in protecting children when playing with toys. However, it also identified a number of deficiencies that have emerged during the practical application of the Directive since its adoption in 2009. In particular, the Evaluation identified two main problems. The first main problem were certain shortcomings in ensuring a high level of protection of children from possible risks in toys, in particular from risks posed by harmful chemicals. The second main problem identified is that the enforcement of the Directive lacks effectiveness, in particular in the context of online sales, and that there remain many unsafe toys on the Union market. The Evaluation also concluded that the legal instrument being a Directive lacked effectiveness, in particular in view of the fact that the repeated amendments of the Directive had to be transposed into national legislation.
The results of the Evaluation have been taken on board in this proposal, which addresses the two main problems identified in it.
• Stakeholder consultations
The Commission carried out a number of consultation activities to collect: evidence and views from a broad range of stakeholders on the identified problems with the Toy Safety Directive. The activities included (i) a twelve-week dedicated public consultation concluded in May 2022; (ii) a stakeholder workshop held on 26 April 2022; (iii) discussions with Member States and other stakeholders in the Expert Group on Toy Safety; and (iv) feedback collected in response to the Commission’s inception impact assessment. As part of the impact assessment study, an external contractor also organised interviews with 41 relevant stakeholders, and an online targeted consultation for SMEs ran between 7 April 2022 and 15 May 2022. Consulted stakeholders included EU and national consumer associations; industry associations; economic operators; citizens; and national authorities.
Industry stakeholders supported the idea that new limit values could be added to the toy-safety rules for all toys, but did not support the extension of generic bans to other harmful substances. In particular, industry voiced strong opposition to removing derogations to generic bans. Their main concern was that removing derogations completely would have strong consequences preventing the making available on the market of a significant number of toys (for example electric toys). Industry supported the digitalisation of compliance information in the product passport.
Member States expressed clear support for revising the Toy Safety Directive and strengthening the chemical requirements, both with specific limit values and additional generic prohibitions for certain substances. There was also support for digitalising product information as well as for extending third party conformity assessment, albeit to a lesser extent. Consumers favoured the options with: (i) stricter chemical requirements for products for children; and (ii) more limited derogations, or in some cases no derogations. Consumers also favoured the introduction of a product passport as well as the extension of third-party conformity assessment.
• Collection and use of expertise
The Evaluation of the Toy Safety Directive16 was supported by a study by an external contractor17.
The impact assessment accompanying this proposal is also supported by a study undertaken by another external contractor18, which carried out interviews, analysed data from public and targeted consultations and complemented this with desk research.
The Commission has consulted widely and has received input from various sources during the preparation of this proposal. In addition to the studies mentioned above, the Commission has relied on publicly available information and scientific opinions available in the field of chemical substances and input received from relevant stakeholders.
• Impact assessment
The Commission carried out an impact assessment on the revision of the Toy Safety Directive. The Regulatory Scrutiny Board issued a positive opinion on the draft impact assessment on 28 October 2022. The opinion of the Board as well as the final impact assessment and its executive summary are published together with this proposal.
Based on the available information, the impact assessment examined and compared three policy options to address each of the two main problems identified. These policy options were in addition to the baseline option of no change, which would still allow for the possibility to introduce specific restrictions on harmful chemicals for toys intended for children under the age of 3.
Contents
To strengthen the requirements to protect children from harmful chemicals, there were three options:
- Policy option 1a proposes to empower the Commission to add and amend limit values for chemicals in any toy (not only for children under the age of 3), as well as to lower the limit values for nitrosamines and nitrosatable substances.
- Policy option 1b includes the same measures as option 1a but also extends the current generic ban on CMRs to other most harmful chemicals in toys (e.g. endocrine disruptors). This means that substances under these most harmful hazard classes would be automatically banned in toys, without having to assess the specific risk they pose for children in toys. This option would still allow for derogations to the generic bans under certain conditions, when the use of the substance in toys is considered to be safe by the relevant scientific committee in the European Chemicals Agency and there are no alternatives.
- Policy option 1c is the same as policy option 1b (generic bans for most harmful chemicals) but without derogations being possible to the generic bans.
To reduce the high number of non-compliant and unsafe toys that can still be found on the market, the impact assessment identified three options:
- Policy option 2a would extend third-party conformity assessment to (i) toys intended for children under the age of 3; and (ii) toys which are chemical mixtures. These categories of toys where identified as having higher rates of non-compliance or presenting higher risks.
- Policy option 2b would require the compliance documentation to accompany the toy digitally, relying on the digital product passport under the ESPR. It would also require this information to be presented at customs. Based on the model already set out in the ESPR, the reference to the product passport containing compliance information should be included in a Commission central registry. The reference of the passport and of its inclusion in the Commission registry would be presented at customs when a toy is placed under the customs procedure of release for free circulation. Through interconnection of the Commission central registry and Customs systems, the reference of the passport in the registry could be automatically checked, and toys which do not have a valid reference to the product passport in the Commission registry would not be released for free circulation.
- Policy option 2c would be the combination of policy option 2a and policy option 2b.
The preferred option is policy option 1b together with policy option 2b. In terms of protection of children from harmful substances, policy option 1b will lead to a significant reduction in children’s exposure to these harmful substances but limit negative impacts for industry by providing for appropriate derogations to generic bans. It will also ensure that the toy safety rules can continue to adapt to new scientific knowledge. Policy option 2b will ensure that toys presented at customs without the declaration of conformity included in the product passport would be automatically prevented from being released for free circulation in the Union market. In addition, there will be significant efficiency gains for market-surveillance authorities when inspecting toys. Accordingly, policy option 2b has the potential to significantly reduce the number of non-compliant toys in the internal market. Other options that included third party conformity assessment were not considered to be as effective or efficient; it was assessed that they would increase costs for compliant manufacturers while not leading to a significant reduction of non-compliant toys.
The combination of options will help to better protect children from harmful chemicals, as well as reducing the number of unsafe toys on the Union market. This combination is also expected to contribute to the United Nations Sustainable Development Goals (SDGs)19, in particular SDG#3 on good health and well-being. In addition, it will contribute to SDG#9 (industry, innovation and infrastructure); SDG#12 (responsible production and consumption); and SDG#6 (clean water and sanitation).
Regarding fundamental rights, none of the policy options is expected to have significant impacts. Policy option 1b should generally have a positive contribution to the overall rights of the child and to the possibility of children to play. Equality, including gender equality, is not significantly impacted by this initiative. While the objectives of the revision of the Directive are focused on strengthening the protection of children health, the preferred option is expected to have a limited positive impact on the environment, given the expected reduction in paper-based documentation. Therefore, the current initiative is consistent with the fulfilment of the climate-neutrality objective as requested by the European Climate Law. The proposal respects ‘do not significant harm’ to the environment principle but do not address it specifically. The proposal is consistent with the ‘digital by default’ principle.
The impact assessment considers that banning the most harmful substances from toys (policy option 1b) would have considerable health benefits (between EUR 240 million and EUR 1.2 billion per year) in terms of avoided health damage from endocrine disruptors alone. These benefits would accrue over the life time of a child exposed (or not exposed) to endocrine disruptors now which means that the time span could be over several generations and exceeding standard appraisal periods of 20-30 years. In addition, policy option 2b would lead to significant efficiency gains for market surveillance authorities (the number of inspections could increase from around 25 000 per year by a maximum of between 2 500 and 5 000, assuming that the dedicated budget remains equal and that the efficiency gains are dedicated to more toy inspections). In addition, the provision of digital information by manufacturers could lead to savings of between EUR 2.62 million and EUR 3.93 million per year. Policy option 2b would also lead to savings for industry in dealing with market surveillance inspections that could range from EUR 13 million to EUR 20 million per year.
Both options combined will significantly improve the protection of children when playing with toys, because: (i) the most harmful substances will be better addressed by the toy-safety-rules; and (ii) the number of non-compliant and unsafe toys will be significantly reduced. It will also improve the functioning of the internal market and the competitiveness of industry when facing illicit competition.
The impact assessment makes the assumption that the number of substances covered by generic bans under Policy option 1b might increase by about 10-30%. This could affect a significant number of toy models, but derogations will limit the toy models that will need to be subject to product adaptations or which could no longer be made available. A total of 8.4-12.8% of toy models may be impacted under policy option 1b and for which a derogation may not be possible, with 4.6-7.2% subject to product adaptation efforts (including chemical substitution efforts) and 3.8-5.6% which could no longer be made available on the market if no alternatives to the restricted chemicals are found. The estimated impact on 4.6-7.2% of EU toy models could result in total incremental one-off adjustment costs associated with product redesign and redevelopment of between EUR 23.5 million and EUR 396.66 million. The costs of requesting derogations could range between EUR 100 000 to EUR 300 000 per year for the overall industry. With more substances being subject to generic bans, as well as limit values added for new substances in toys, new toy models will need to be tested to ensure compliance with such limit values. Due to the need for more complex and sensitive testing, the costs of testing may increase from EUR 2 200 at present to EUR 3 900 per toy model. It is estimated that yearly testing costs will increase compared to the baseline by between EUR 7.31 million and EUR 11.70 million. In terms of toy models that could no longer be made available, the actual impacts will depend on the value of the toy models impacted, but based on the EU industry turnover, this option could affect between EUR 249 million and EUR 367 million worth of products20. This is not expected to lead to a direct market contraction of that size, given that manufacturers will be provided with an appropriate transition period in which they will be able to assess the viability of existing products and, if needed, shift resources to the production and sale of alternative toy products. Moreover, consumers will in many cases simply purchase an alternative toy product rather than not purchase anything. SMEs are expected to have higher costs per new toy model than larger firms, as they face higher unit costs.
For the introduction of the digital product passport under policy option 2b it is estimated that the cost for EU manufacturers could be around EUR 18 million in one-off costs and a subsequent EUR 10.5 million per year. After the systems are set up and most initial data are entered, there are only expected to be additional costs related to updating and maintenance costs.
• Application of the ‘one in, one out’ approach
The reinforcement of the chemical requirements for toys included in this proposal is only expected to lead to an increase in the administrative burden if derogations are requested to continue using in toys substances which have been banned. It could be estimated that the cost per derogation request could range between EUR 50,000 and EUR 150,000 per derogation request, and that there would be a maximum of two derogation requests per year (with an average of EUR 200,000 per year). Option 2b would entail administrative costs for businesses and benefits. The overall additional administrative burden of the introduction of the digital product passport has been estimated, based on current market structure and expected average production per enterprise, at approximately EUR 18 million one-off and EUR 10.5 million recurrent, per year.
The introduction of the digital product passport is likely to bring some reduction of the administrative burden on authorities and companies. It has the potential to reduce the administrative burden on public authorities, in particular customs, since the product passport would allow for more automatic controls on imported products from third countries and prevent the import of non-compliant toys that would be held on border premises and subject to physical controls. The product passport could lead to savings for companies from moving to digitalised information of around EUR 2.62 to EUR 3.93 million (EUR 3.275 million on average) per year.
• Regulatory fitness and simplification
The Evaluation assessed the potential for simplification of the Directive and concluded that there was no potential for simplification on the substantial obligations and administrative burden of the Directive This is because simplification entailing fewer obligations for economic operators would risk reducing protection for children. Similarly, under the Directive there is currently no requirement to go through third-party conformity assessment if there are harmonised standards covering all aspects of toys; this could not be simplified further.
The option to move to digital compliance information will lead to simplification and improved efficiency in the contacts between economic operators and market surveillance authorities. There will be costs in adapting to the digital provision of information, but also cost savings and overall simplification for industry in providing compliance information digitally rather than on paper. In addition, market surveillance authorities will be more efficient and able to conduct more inspections of toys (see the section on the impacts above). This is supported by the outcome of the Evaluation of the new legislative framework that considered that digitalisation of the declaration of conformity / technical product information / technical file would improve the efficiency of the conformity-assessment procedure, without hindering market surveillance activities. Stakeholders from all groups in that consultation agreed that digitalisation offers a potential solution to simplify administrative obligation related to product-information requirements and CE marking, which is also applicable to toys.
Finally, one aspect for simplification that was raised very frequently by stakeholders was the need for the warnings required by the Directive to be preceded by the word ‘Warning’ which needed to be translated into all languages required by the Member States in which the toy was going to be made available. Replacing the word ‘Warning’ by a generic pictogram would lead to simplification for the industry without compromising the protection of children. It would also lead to savings to the industry when producing the labels but these savings cannot be quantified with precision.
4. BUDGETARY IMPLICATIONS
This proposal does not have any implications for the EU budget. One of the retained measures will require additional scientific assessments to be performed by the European Chemicals Agency. It is expected that these scientific assessments will require the work of 2 FTEs in ECHA. As announced21, the Commission is currently carrying out a review of the European Chemicals Agency, which will include a wider reassessment on the tasks of the European Chemicals Agency. Any potential resource implications of the scientific assessments linked to the regulation will be incorporated in that reassessment.
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
The Commission will evaluate the Regulation five years after its entry into force and every five years thereafter, with a view to assessing its effectiveness, efficiency, relevance, added-value and coherence. The Commission will submit a report on the main findings to the European Parliament and to the Council. In an effort to rationalise the reporting obligations, Member States will no longer be obliged to submit reports on the application of the regulation every 5 years.
• Detailed explanation of the specific provisions of the proposal
Chapter I
Scope and definitions
The scope of the proposed regulation remains the same; the definition of ‘toy’ is not changed from Directive 2009/48/EC.
The general definitions of Decision 768/2008/EC have been kept. However, additional definitions in relation to the introduction of the product passport have been added.
Exclusions
The products that are not covered by the proposed regulation have been set out in Annex I, which is now a single list. The products exempted from the scope of the proposed regulation remain the same as in the current Directive, with the exception of slings and catapults, which are no longer excluded from the scope of the Regulation. Article 2 empowers the Commission to determine via implementing acts whether a specific product or category of products should be considered as a toy or not.
Requirements for toys
Articles 5 and 6 contain the obligation: (i) for toys to conform with the general and particular safety requirements; and (ii) to affix specific warnings when these are necessary for the safe use of the toys. While the categories of particular safety requirements in Annex II remain the same as for Directive 2009/48/EC, the general safety requirement goes beyond protecting the physical health and safety of users, to include the psychological well-being and cognitive development of children.
Particular safety requirements for toys
The main categories of essential requirements for toys are set out in Annex II and they concern: (i) physical and mechanical properties; (ii) flammability; (iii) chemical properties; (iv) electrical properties; (v) hygiene; and (vi) radioactivity. The chemical properties are amended and simplified. The generic restrictions of particularly harmful substances now include: (i) substances which are carcinogenic, mutagenic or toxic for reproduction; (ii) endocrine disruptors, (iii) respiratory sensitisers and (iv) substances toxic to a specific organ. The possibilities for a derogation to this ban have been limited, and an assessment is now required by the relevant scientific committees in the European Chemicals Agency (ECHA) to conclude on: (i) the safety of certain substances; (ii) the lack of alternatives to the presence of these substances. In addition, derogations will only be possible if these substances are not prohibited for use in consumer articles under Regulation (EC) No 1907/2006. Businesses will be able to ask ECHA to examine possible derogations. ECHA is expected to develop guidance for businesses, and especially SMEs, to help them with: (i) the practical aspects of these requests; and (ii) the application of the chemical requirements for toys more generally. Based on the ECHA’s opinion on a derogation request for a specific substance, the Commission will insert permitted uses in the proposed regulation, as these derogations will be of general application. A single appendix contains all the specific restrictions for chemicals in toys, which the Commission is empowered to amend.
Obligations of economic operators
The proposal incorporates obligations for manufacturers, importers and distributors aligned with Decision 768/2008/EC, as is already the case in the current Directive. This clarifies the respective obligations, which are proportionate to the economic operators’ role. The manufacturer is required to create a product passport for the toy including the relevant compliance information which will replace the EU declaration of conformity. The designation of the authorised representative as the economic operator responsible for the tasks set out in Article 4 of Regulation 2019/1020 is also specifically provided for.
Presumption of conformity of toys
The presumption of conformity of toys when manufacturers apply the relevant harmonised standards or parts thereof published in the Official Journal of the European Union remains. However, in order to ensure the presumption of conformity when there are no relevant harmonised standards the Commission will be empowered to adopt common specifications. This will be a fall-back option to be used only when the standardisation bodies are not able to provide standards or provide standards that do not respond to the Commission standardisation request and the essential requirements of Annex II.
Product passport
The EU declaration of conformity is replaced by the obligation to have a product passport available for toys to declare compliance with the requirements of this proposed regulation. The product passport will be connected through a data carrier to a unique product identifier, and meet the same technical requirements for a product passport contained in the ESPR. The reference of the product passport must be included in a Commission central registry that will be set up under the ESPR, and this information needs to be indicated at customs when toys coming from outside the EU are placed under the customs procedure of release for free circulation.
Conformity assessment
The proposal keeps the manufacturer internal control option when the manufacturer applies the relevant harmonised standards or common specifications. Third-party certification by a notified body will continue to be necessary where harmonised standards or common specifications: (i) do not exist; (ii) are not followed; or (iii) do not cover all the risks of the toy. The proposal includes the corresponding modules in line with the Decision 768/2008/EC. The proposal specifies that, as part of the safety assessment, the manufacturer needs to consider the possible risks of the combined or cumulative presence of chemicals in the toy.
Notified bodies
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and for the confidence of all interested parties in the new approach. Therefore, in line with Decision 768/2008/EC, the proposal maintains the requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State. This proposal specifies that notified bodies must: (i) have the competence to verify the tasks subcontracted; and (ii) be able to oversee the work carried out by subcontractors.
Union market surveillance and union safeguard procedure
The proposal keeps the provisions based on Decision 768/2008/EC in respect of the safeguard-clause procedure. In addition, a specific provision based on Decision 768/2008/EC gives specific grounds for acting against toys that comply with the essential requirements but pose a risk to children. The provisions also give the Commission the power to adopt measures against specific toys under very specific circumstances.
Implementing acts
The proposal empowers the Commission to adopt, where appropriate, implementing acts to ensure the uniform application of this Regulation. In particular, implementing powers should be conferred on the Commission to establish the detailed technical requirements for the product passport. Exceptionally, the Commission should also be granted implementing powers to take measures in respect of compliant toys which are found to pose a risk to health and safety of persons. Those implementing acts will be adopted in accordance with the provisions on implementing acts laid down in Regulation (EU) No 182/2011.
The Commission should be granted implementing powers to establish whether a national measure in respect of a toy presenting a risk to health and safety of persons is justified and on requesting a Member State to take measures against a notified body which is found to be no longer competent to carry out the conformity assessment tasks under this Regulation. Given their special and technical nature, those implementing acts will not be adopted in accordance with the provisions on implementing acts set out in Regulation (EU) No 182/2011.
Delegated acts
The proposal empowers the Commission to adopt delegated acts in order to adapt: (i) the provisions on warnings in Annex III to adapt these provisions to technical and scientific progress; and (ii) provisions to permit specific substances and mixtures indicating their permitted use in toys and new limit values for specific substances in toys. In relation to the product passport, the proposal empowers the Commission to amend the specific information that should be included the passport, as well as the information to be included in the Commission registry. The Commission should also be empowered to determine the additional information stored in the registry to be controlled by customs authorities, as well as amend Annex VII to this Regulation containing a list of commodity codes, as set out in Annex I to Regulation (EEC) No 2658/87, and product descriptions of toys and update such Annex.
Evaluation and review
The Commission shall evaluate the Regulation five years after its entry into force and every five years thereafter, with a view to assess effectiveness, efficiency, coherence, relevance and EU added value. The Commission shall submit a report on the main findings to the European Parliament and to the Council.
Final provisions
The proposed regulation will become applicable 30 months after its entry into force, on the one hand, to allow the Commission to prepare the implementation of the product passport’s technical requirements and, on the other hand, to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the provisions on notified bodies, and on the Commission implementing and delegated powers need to be applied shortly after the entry into force of this Regulation. Transitional provisions are laid down for both products manufactured and the certificates issued by notified bodies under Directive 2009/48/EC so as to allow stocks to be absorbed and ensure a smooth transition to the new requirements. Directive 2009/48/EC will be repealed and replaced by the proposed regulation.