EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 28.7.2023  
COM(2023) 462 final  
2023/0290 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on the safety of toys and repealing Directive 2009/48/EC  
(Text with EEA relevance)  
{SEC(2023)  297 final}  - {SWD(2023)  268 final}  - {SWD(2023)  269 final}  -
 {SWD(2023)  270 final}   EN 1  EN EXPLANATORY MEMORANDUM  
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 appli cation 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 th e 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 prohibit ion 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 una nimously 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 
                                                 
1 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of 
toys, OJ L 170, 30.6.2009 . 
2 Commission Staff Working Document - Evaluation of Directive 2009/48/EC of the European 
Parliament and of the Council on the safety of toys, SWD(2020) 288 final  
3 Communication  from the C ommission  to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the R egions - Chemicals Strategy for 
Sustainability Towards a Toxic-Free Environment , 14 October 2020, COM /2020/667 final  
4 Report  on the implementation of Directive 2009/48/EC of the European Parliament and of the Council 
on the safety of toys (Toy Safety Directive) , 2021/2040(INI)  
5 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions  - Long -term competitiveness of the 
EU: looking beyond 2030 , 16 March 2023  COM(2023) 168 final . EN 2  EN 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 t he 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 rel ation 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 t he 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 t his 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 
                                                 
6 SWD(202 3) 269 final, Impact assessment on the revision of the Toy Safety Directive.  
7 Decision No 768/2008/ EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 
13.8.2008, p. 82).  
8 Directive  2014/53/EU of the European Parliament and of the Counc il of 16  April  2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of radio 
equipment and repealing Directive  1999/5/EC, OJ  L 153, 22.5.2014, pp.  62‐106, available at   
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:02014L0053 -20180911   
9 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market 
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 
765/2008 and (EU) No 305/2011  5OJ L 169, 25.6.2019, p. 1 ). 
10 SWD(2022) 365 final . 
11 Sustainable products initiative (europa.eu) . Proposal for a Regulation of the European Parliament and of 
the Council establishing a framework for setting ecodesign requirements for sus tainable products and 
repealing Directive 2009/125/EC  of 30 March 2022, COM(2022) 142 final.  EN 3  EN Recommendation (EU) 2022/251012 which establish es 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 a nd 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 vulnerab le 
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 
whic h 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 concl uded 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 th e 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 pa st has le d to regula tory 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 
                                                 
12 Commission Recommendation (EU) 2022/2510 of 8 December 2022 establishing a European 
assessment framework for ‘safe and sustainable by design’ chemicals and mater ials C/2022/8854 (OJ L 
325, 20.12.2022, p. 179)  
13 OJ L 353, 31.12.2008, p. 1.  And the Commission Proposal for Regulation of the European Parliament 
and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council on classification, labelling and packaging of substances and mixtures (COM (2022) 748 final ). 
14 Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general 
product safety, amending Regulation (EU) No 1025/2012 of the Europea n Parliament and of the 
Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing 
Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 
87/357/EEC (OJ L 135, 23.5.2023, p. 1).  EN 4  EN 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 passpo rt 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 r egulation 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 intro ducing 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 thro ugh 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 sy stems 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 ind ustry’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 i s 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 cont radict 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.  
                                                 
15 See th e section on the ‘one in, one out’ below for a full estimate of such costs.  EN 5  EN 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 availa ble conformity -assessment procedures. The 
existing mechanisms supporting the implementation of the legislation (standardisation 
process es, 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 benef it 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 a llow 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 durin g 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 lack s effectiveness, in particular in 
the conte xt 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  effective ness, 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 E valuation 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 consultati on 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 EN 6  EN 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 ad ded to the toy -
safety rules for all toys, but did not support the extension of generic bans to other harmful 
substances. In particular, i ndustry voiced strong opposition to removing derogations to 
generic bans. The ir main concern was that removing derogati ons 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 
informat ion 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 i n 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 th e 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 compa red three 
policy options to address each of the two main problems i dentified. 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 . 
                                                 
16 Commission Staff Working Document - Evaluation of Directive 2009/48/EC of the European 
Parliament and of the  Council on the safety of toys S WD(2020) 288 final . 
17 Technopolis, EY, VVA (December 2014) Evaluation of Directive 2009/48/EC on the Safety of Toys - 
Final Report  
https://ec.europa.eu/docsroom/documents/23843/attachments/1/translations/en/renditions/native . 
18 VVA with CSES and Asterisk (2022) Impact Assessmen t study on the revision of the Toy Safety 
Directive.  EN 7  EN 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 mea sures 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 havin g 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 -complian t and unsafe toys that can still be found on the 
market , the impac t 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 und er 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 
Custom s 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 t he 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 g ains 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 include d third party conformity assessment we re 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.  EN 8  EN The combination of options will help to better protect childre n 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 (SDG s)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 optio ns 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 pa per-
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 considera ble 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 whi ch 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 c ould 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 w ould 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 w ill 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 o f 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 availa ble 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 
                                                 
19 https://www.un.org/sustainabledevelopment/sustainable -development -goals/  EN 9  EN for the overall industry. With more substances being subject to generic bans, as well as limit 
values added for new substances in to ys, 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 tra nsition 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 req uest could range between EUR 50, 000 and EUR 150 ,000 per derogation 
request, and that there would be a maximum of tw o 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 som e reduction of the 
administrative burden on authorities  and companies. I t 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 pro ducts 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 
                                                 
20 Based on provisional EU industry turnover of EUR 6.56 billion for 2020 .  EN 10  EN there is currently no requireme nt 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 efficien cy 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. Stakehol ders from all groups in 
that consultation agreed that digitalisation offers a potential solution to simplif y 
administrative obligation related to product -information requirements and CE marking, which 
is also applicable to toys.  
Finally, one aspect for si mplification 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 mai n 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  
                                                 
21 See European Chemicals Agency – proposal for a basic regulation (europa.eu)  EN 11  EN 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 r egulation have been set out in Annex I, 
which is now a single list. The products exempte d from the scope of the proposed r egulation 
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 implement ing acts whether a specific product or category of products should 
be considered as a toy or not.  
Requirements for toys  
Article s 5 and 6 contain the obl igation : (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 
phys ical health and safety of users, to include the psyc hological 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 sensiti sers and (iv) substances toxic to a specific organ . 
The possibilities for a derogation to this ban have been limit ed, 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 guidan ce 
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 substa nce, 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.  
Obli gations 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 prop ortionate 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 representa tive as the economic operator responsible for the tasks set out in 
Article 4 of Regulation 2019/1020 is also specifically provided for .  EN 12  EN Presumption of conformity of toys  
The presumption of conformity of toys when manufacturers apply the relevant harmonis ed 
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 specif ications. 
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 ca rrier 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 thi s 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 com bined 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. Therefo re, 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 wit h the individual 
Member State. This proposal specifies that notified bodies must : (i) have the competen ce to  
verify the tasks subcontracted ; and (ii) be able to oversee the work carried out by 
subcontractors.  
Union market surveillance and union safeguard p rocedure  
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 esse ntial requirements but 
pose a risk to children. The provision s 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.  Exceptional ly, the Comm ission should also be granted implementing 
powers to take measures in respect of compliant toys which are found to pose a risk to health EN 13  EN and safety of persons. Those implementing acts will be adopted in accordance with the 
provisions on implementing acts l aid 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 ta ke 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 pr ovisions 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 sci entific 
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 Eur opean 
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 a nd 
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 ar e 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 repl aced by the proposed regulation.  EN 14  EN 2023/0290 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on the safety of toys  and repealing Directive 2009/48/EC  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof,  
Having regard to the proposal from the European Commission,  
After transmi ssion of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European Economic and Social Committee22,  
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) Directive 2009/48/EC of the European Pa rliament and of the Council23 was adopted to 
ensure a high level of safety of toys and their free movement on the internal market.  
(2) Children are a particularly vulnerable group. It is essential to ensure a high level of 
safety of children when playing wi th toys. Children should be adequately protected 
from possible risks stemming from toys, in particular from the chemical substances 
that toys may contain. At the same time, compliant toys should be able to move freely 
across the internal market without add itional requirements.  
(3) The Commission evaluation of Directive  2009/48/EC  concluded that the Directive is 
relevant and generally effective in protecting children. However, it also  identified a 
number of deficiencies that have emerged during the practical application of the 
Directive  since its adoption in 2009. In particular, the evaluation identified certain 
shortcomings with regard to possible risks arising from harmful chemicals  in toys . The 
evaluation also concluded that  many  non-compliant and unsafe toys remain on the 
Union market . 
(4) The Chemicals Strategy for Sustainability24 called for strengthening the protection of 
consumers from the most harmful chemicals and to extending the generic approach 
towards harmful chemicals (based on generic preventive bans) to ensure that 
consumers, vulnerable groups and the environment are more consistently protected. In 
particular, the strategy  commits to strengthen Directive 2009/48/EC  with r egard to the 
                                                 
22 OJ C , , p. .  
23 Directive 2009/48/EC of the European Parliament and of t he Council of 18 June 2009 on the safety of 
toys (OJ L 170, 30.6.2009 , p. 1 ). 
24 COM(2020) 667 final  EN 15  EN protection from the risks of the most harmful chemicals and possible combination 
effects of chemicals.  
(5) Since the rules setting out the requirements for toys, in particular the essential 
requirements and the conformity assessment procedures , need to be of uniform 
application across the Union, and not give room for divergent implementation by 
Member States, Directive 2009/48/EC should be replaced by a regulation.  
(6) Toys are also subject to Regulation (EU) 2023/988 on general product safety25, which 
applies in a complementary manner in matters not covered by specific sectoral 
legislation on consumer products. In particular, Section 2 of Chapter III and Chapter 
IV in relation to online sales, Chapter VI on the Safety Gate Rapid Alert System and  
Safety Business Gateway and Chapter VIII on the right of information and remedy 
also appl y to toys. Therefore , this Regulation does not include specific provisions on  
distance and  online sales , accident reporting by economic operators  and the right of 
information and remedy  but rather require s economic operators provid ing information 
on safety issues concerning toys  to inform authorities and consumers in accordance 
with the procedures set out in Regulation (EU) 2023/988 .  
(7) Regulation (EC) No 765/2008 of  the European Parliament and of the Council26 lays 
down rules on the accreditation of conformity assessment bodies , and lays down the 
general principles of the CE marking . That Regulation should be applicable to toys in 
order to ensure that toys benefiting from the free movement of goods within the Union 
fulfil requirements providing a high level of protection of health and safety of persons 
and in particular children.  
(8) Decision No 768/2008/EC of the European Parliament and of the Council27 lays down 
commo n principles and reference provisions intended to apply across sectoral product 
legislation in order to provide a coherent basis for such legislation. This Regulation 
should therefore be drafted, to the extent possible, in accordance with those common 
principles and reference provisions.  
(9) This Regulation should lay down essential requirements for toys to ensure a high level 
of protection of health and safety of children when playing with toys as well as the 
free movement of toys in the Union. This Regula tion should be applied taking due 
account of the precautionary principle.  
(10) To facilitate the application of this Regulation by manufacturers and national 
authorities, its scope should be clearly defin ed. It should apply to all products designed 
or inte nded for use in play by children under 14 years of age. A product may be 
considered as a toy even if it is not exclusively intended for playing purposes and has 
other additional functions.  Whether a product has play value  depend s on the use 
envisioned by  the manufacturer or on the use of the product  reasonably foreseeable by 
a parent or a supervisor . At the same time, it is necessary to exclude from its scope 
certain toys which are not intended for domestic use, such as public playground 
                                                 
25 OJ L 11, 15.1.2002, p. 4.  
26 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and market surveillance relating to the marketing of products  and 
repealing Regulation (EEC) No 339/93  (OJ L 218, 13.8.2008, p. 30 ). 
27 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 
13.8.2008, p. 82 ). EN 16  EN equipment or automa tic machines intended for public use, or other toys equipped with 
combustion or steam engines, as such toys may present risks to the health and safety of 
children  that are not addressed by this Regulation.  In addition, a list of products that 
could be confused with toy s but are not to be considered toys within the meaning of 
this Regulation should be provided.  
(11) This Regulation should apply to toys which are new to the Union market when placed 
on the market, i.e. either new toys made by a manufactur er established in th e Union or 
toys, whether new or second hand, imported from a third country. The safety of other 
second hand products falls within the scope of Regulation (EU) 2023/988 of the 
European Parliament and of the Council28.  
(12) To ensure adeq uate protection of children and other persons, this Regulation should 
apply to all forms of supply of toys, including distance sales as referred to in Article 6 
of Regulation (EU) 2019/1020  of the European Parliament and of the Council29.  
(13) Essential sa fety requirements for toys  should ensure protection from all relevant health 
and safety hazards posed by toys, for users or third parties. Particular  safety 
requirements should cover the physical and mechanical properties, flammability, 
chemical properties, electrical properties, hygiene and radioactivity  to ensure that the 
safety of children is adequately protected  against those specific hazards . Since it is 
possible that toys which present hazards that are not covered by a  particular  safety 
requirement might exist or be developed, it is necessary to maintain a general 
requirement of safety to ensure protection  of children  in respect of such toys. The 
safety of toys should be determined by reference to the intended use, while taking into 
account also the foreseeable use, and bearing in mind the behaviour of children, who 
do not generally show the same degree of care as the average adult user. Together, the 
general safety requirement and the particular safety requirements should form the 
essential s afety requirements for toys.  
(14) Relying on  digital technologies  has led to new hazards in toys . Radio toys are to 
comply with essential requirements for the protection of privacy and internet -
connected toys are to incorporate safeguards towards cybersecurity and protection 
from fraud in accordance with Directive 2014/ 53/EU of the European Parliament and 
of the Council30. Toys which include artificial intelligence are to comply with 
Regulation (EU) …/… [P.O. insert serial number for Regulation layin g down 
harmonised rules on artificial intelligence]31. Therefore , particular safety requirements 
regarding cybersecurity, protection of personal data and privacy or other hazards 
stemming from the incorporation of artificial intelligence in toys should not be set out . 
                                                 
28 Regulation (EU) 2023/988 of the European Par liament and of the Council of 10 May 2023 on general 
product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the 
Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing 
Directive 2001/9 5/EC of the European Parliament and of the Council and Council Directive 
87/357/EEC (OJ L 135, 23.5.2023, p. 1).  
29 Regulation (EU) 2019/1020 of the European  Parliament and of the Council of 20 June 2019 on market 
surveillance and compliance of products and  amending Directive 2004/42/EC and Regulations (EC) No 
765/2008 and (EU) No 305/2011  (OJ L 169, 25.6.2019, p. 1 ). 
30 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the 
harmonisation of the laws of the Member States re lating to the making available on the market of radio 
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).  
31 PO: Please insert in the text the number of the Regulation and insert the number, date, title and OJ 
reference of that Regulat ion in the footnote.   EN 17  EN However, protecting the health of children should not merely ensure the absence of 
disease or infirmity and relying on digital technologies may pose risks to children 
which go beyond their physical health . To ensure that children are protected from any 
risk coming from the use of digital technologies  in toys , the general safety requirement 
should ensure the  psychological and mental health , as well as the  well-being and 
cognitive development , of children.  
(15) Toys should comply with physical and mechanical requirements that prevent children 
from getting physically injured when playing with toys and should not pose a risk of 
choking or suffocation to children.  In order to protect children from the risk of 
impair ed hearing , maximum values should be set out for both impulse noise and 
continuous noise emitted by toys.  Toys or their parts and their packaging which can be 
reasonably expected to be brought into contact with food or to transfer their 
constituents to foo d under normal or foreseeable conditions of use  are subject to 
Regulation (EC) No 1935/2004 of the European Parliament and of the Council32. In 
addition, i t is appropriate to lay down specific safety requirements to cover the 
potential specific hazard presented by toys in food, since the association of a toy and 
food could cause a risk of choking which is distinct from the risks presented by the toy 
alone an d which is, therefore, not covered by any specific measure at Union level.  
Toys should also ensure sufficient protection as regards flammability or electric 
properties, in particular to prevent burns or electric shocks. Moreover, t oys should 
meet certain hygiene standards to avoid microbiological risks or other risks of 
infection or contamination.  
(16) Chemicals that are classified as carcinogenic, mutagenic or toxic for reproduction 
(CMR substances), chemicals that affect the endocrine system, the respirat ory system 
or that are toxic to a specific organ  are particularly harmful for children and should be 
specifically addressed in toys. Given the essential role of the endocrine system during 
human development, early exposure during critical periods, such as early childhood, to 
endocrine disruptors can lead to adverse effects even at very low doses and affect 
health at a later stage of life. Respiratory sensitis ers can lead to an increase of 
childhood asthma and neurotoxic substances are particularly harmful t o the developing 
brain of children, which is inherently more vulnerable to toxic injury than the adult 
brain. Children should also be adequately protected from allergenic substances and 
certain metals.  The requirements for chemical substances set out in Directive 
2009/48/EC need to be updated  and strengthened . Toys are to comply with general 
chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council.  In order to provide further protection of children, who 
are a vulnerable group of consumers, and other persons, that legal framework should 
be supplemented by generic prohibitions in toys  covering certain hazardous chemicals, 
as classified in accordance with Regulation (EC) No 1272/2008 of the Eur opean 
Parliament and of the Council33. Those generic prohibitions should apply to CMR 
substances , endocrine disruptors, respiratory sensitis ers and substances targeting a 
                                                 
32 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004 , p. 4).  
33 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 19 07/2006 ( OJ L 353, 31.12.2008, p. 
1). EN 18  EN specific organ,  as soon as th ose substances are classified as hazardous under 
Regulati on (EC) No 1272/200834. In order to ensure toy safety, prohibited substances 
should be acceptable at trace  levels  but only if their presence at such levels is 
technologically unavoidable with good  manufacturing practices  and if the toy is safe . 
(17) In order to provide for flexibility where the safety of children is not compromised and 
where it is necessary for making certain toys available  on the market , it should be 
possible to derogate from the generic prohibitions of chemical substances in toys . 
Derogations to generic prohibitions  permitting the use of prohibited substances  should 
be of general application and should only be possible where the use of the relevant 
substance is considered safe for children, where there are no commercially viable 
alternatives  for the substance and where the use of the substance is not prohibited in 
consumer articles under Regulation (EC) No 1907/2006 . The assessment of the  safety 
of the substance in toys should be carried out by the relevant scientific committee s in 
the European Chemicals Agency (ECHA) in order to ensure consistency and efficient 
use of resources in the assessment of chemical substances in the Union.  
(18) Economic operators, industry associations or other interested parties should have the 
possibil ity to submit a request for assessment for a permitted use concerning a certain 
substanc e subject to a generic prohibition  to EC HA. EC HA should draw up and make 
available the format and medium  for the submission of request s for assessment . In 
addition, for reasons of transparency and foreseeability, ECHA  should issue technical 
and scientific guidance on such requests for assessment . 
(19) The use of nickel in stainless steel and in components that transmit electric current has 
been considered safe in toys  by the Scientific Committee on Health, Environment and 
Emerging risks and should be allowed.  Other substances that are necessary to transmit 
electric current should be permitted in toys to allow for the making available of 
electric toys if such substances  are completely inaccessible  for a child playing with the 
toy and therefore do not present a risk.  
(20) As batteries are regulated by Regulation (EU) …/… [P.O. insert serial number for 
Regulation on batteries and waste batteries ]35, the requirements regarding chemical 
substances in toys should not apply to the batteries included in toys. However, toys 
that include batteries should be designed in such a way that the batteries are difficult 
for children to access.  
(21) Existing limit values for certain chemical substances and the ir corresponding test 
methods have proven to be appropriate for the protection of children as regards those 
substances  and should be maintained . In order to adapt to new scientific knowledge, 
the Commission should be empowered to  revise t hose limit values  where necessary . 
Limit values for arsenic, cadmium, chromium VI, lead, mercury and organic tin, 
which are particularly toxic and which should therefore not be intentionally used in 
toys, should  be set  out at half th e values that are considered safe  by the relevant 
                                                 
34 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), 
establi shing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC a nd 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).  
35 PO: Please insert in the text the number of the Regulation ….  and insert the number, date, title and OJ 
reference of that Regulation in the footnote.  EN 19  EN scientific body , in order to ensure that only traces that are compatible with good 
manufacturing practice are present  in the toy .  
(22) Directive 2009/48/EC includ es limit values for certain substances in toys intended for 
children under 36 months or intended to be put in the mouth. Th ose substances have 
shown to  also pose a risk to older children , as they could be equally exposed to such 
chemicals via skin contact or  inhalation. Th ese limit values should therefore apply to 
all toys.  Since the adoption of the limit values for bisphenol A in Directive 
2009/48/EC, new scientific data has emerged. The European Food Safety Authority 
(EFSA) re -evaluated the risks to public health from dietary exposure to bisphenol A in 
April 2023 concluding that exposure to bisphenol A is a health concern for consumers 
across all age groups. EFSA has established a new tolerable daily intake of bisphenol 
A which is significantly lower than th e previous one. In view of this scientific 
evidence, b isphenol A should fall under the generic prohibition for CMR substances in 
toys.  
(23) To ensure adequate protection  from specific chemical substances  in case of new 
scientific knowledge , the Commission should be empowered  to adopt delegated acts  
establishing specific limit values for  any chemical  substance  used in toys . If justified 
in cases of toys involving a higher degree of exposure, those delegated acts should set 
out specific limit values for toys  intended for use by children under 36 months and in 
other toys intended to be put in the mouth, taking into account the requirements set out 
in Regulation (EC) No 1935/2004  and the differences between toys and materials 
which come into contact with food  or articles from which risks may arise due to oral 
contact through their use as a food contact material . Fragrances in toys  entail special 
risks for human health.  Therefore, specific rules should be set out for the use of 
fragrances in toys and for the label ling of fragrances.  The Commission should be 
empowered to adopt delegated acts to amend those rules to allow for adaptations to 
technical and scientific progress . 
(24) Where the hazards that a toy may present cannot be completely addressed by design, 
the residual risk should be addressed by product -related information directed at the 
supervisors of the children in the form of warnings, taking into account the capacity of  
those supervisors to take the necessary precautions.  
(25) To prevent misuse of warnings to circumvent the applicable safety requirements, the 
warnings provided for certain categories of toy should not be allowed if they conflict 
with the intended use of the toy. To ensure that supervisors are aware of any risks 
associated with the toy, it is necessary to ensure that the warnings are legible and 
visible.  
(26) Economic operators should act responsibly and in full accordance with the legal 
requirements appli cable when placing or making toys available on the market.  
(27) In order to ensure a high level of protection of the health and safety of children and 
fair competition on the internal market, economic operators should be responsible for 
the compliance of t oys with this Regulation, in relation to their respective roles in the 
supply chain.  
(28) As certain tasks can be executed only by the manufacturer, it is necessary to 
distinguish clearly between the obligations of the manufacturer and the operators 
furthe r down the distribution chain. It is also necessary to distinguish clearly between 
the obligations of the importer and the distributor, as the importer introduces toys from EN 20  EN third countries to the Union market. The importer should make sure that those toys 
comply with the applicable Union requirements.  
(29) In order to facilitate communication between economic operators, market surveillance 
authorities and consumers or other end -users, manufacturers and importers should 
indicate a website, email address or other digital contact in addition to the postal 
address.  
(30) The manufacturer, having detailed knowledge of the design and production process, is 
responsible for the compliance of the toy with the requirements of this Regulation and 
is best placed to carr y out the complete conformity assessment procedure for toys. 
Conformity assessment should therefore remain the obligation of the manufacturer 
alone.  
(31) To facilitate compliance of the manufacturers with their obligations under this 
Regulation, manufactur ers should be allowed to appoint an authorised representative 
to carry out specific tasks on their behalf. Moreover, to ensure a clear and 
proportionate distribution of tasks  between the manufacturer and the authorised 
representative , it is necessary to se t out a list of tasks that manufacturers should be 
allowed to entrust the authorised representative with. Further, to ensure the 
enforceability and compliance with this Regulation , where a manufacturer established 
outside the Union appoints an authorised r epresentative , the mandate should include 
the tasks set out in Article 4 of Regulation  (EU) 2019/1020 . 
(32) Economic operators intervening in the supply and distribution chain should take 
appropriate measures to ensure that the toys they place on the market do not jeopardise 
the safety and health of children under normal and reasonably foreseeable conditions 
of use, and that they make available on the market only toys which comply with the 
relevant Union legislation.  
(33) It is necessary to ensure tha t toys from third countries entering the Union market 
comply with all applicable Union requirements, and in particular that appropriate 
conformity assessment procedures have been carried out by manufacturers with regard 
to those toys. Importers should ther efore ensure that the toys they place on the market 
comply with the applicable requirements, that conformity assessment procedures have 
been carried out and that product marking and documentation drawn up by 
manufacturers are available for inspection by th e competent market surveillance 
authorities.  
(34) When placing a toy on the market, importers should indicate on the toy their name and 
the address at which they can be contacted. Exceptions should be provided for in cases 
where the size or nature of the toy does not allow for such an indication, including 
where importers would have to open the packaging to put their name and address on 
the product. In such cases, the name and address should be indicated on the packaging 
or an accompanying document.  
(35) As the distributor makes a toy available on the market after the toy has been placed on 
the market by the manufacturer or the importer, the distributor should act with due 
care to ensure that the handling of the toy does not adversely affect the compliance  of 
that toy with this Regulation.  
(36) Distributors and importers are close to the market place and should therefore be 
involved in market surveillance tasks carried out by competent national authorities, 
and should be required to participate actively in  such tasks and to provide those 
authorities with all necessary information relating to the toy concerned.  EN 21  EN (37) Economic operators that either place a toy on the market under their own name or 
trademark or modify a toy in such a way that compliance with ap plicable requirements 
of this Regulation may be affected, should be considered to be manufacturers and 
should assume the obligations of manufacturers.  
(38) Ensuring traceability of a toy throughout the whole supply chain helps to make market 
surveillance s impler and more efficient. An efficient traceability system facilitates 
market surveillance authorities' task of tracing economic operators who made non -
compliant toys available on the market.  
(39) In order to  facilitate the assessment of conformity with t he requirements  of this 
Regulation it is necessary to provide for a presumption of conformity for toys which  
are in conformity with harmonised standards that are adopted in accordance with 
Regulation (EU) No 1025/2012 of the European Parliament and of the Council36 and 
published in the Official Journal of the European Union . 
(40) In the absence of relevant harmonised standards, the Commission should be 
empowered to adopt implementing acts setting out common specifications for the 
essential requirements of th is Regulation, provided that in doing so it duly respects the 
standardisation organisations’ role and functions, as an exceptional fall back solution 
to facilitate the manufacturer’s obligation to comply with the essential requirements, 
when the standardis ation process is blocked or when there are delays in the 
establishment of appropriate harmonised standards.  
(41) The CE marking, indicating the conformity of a toy, is the visible consequence of a 
whole process comprising conformity assessment in a broad s ense. General principles 
governing the CE marking are set out in Regulation (EC) No 765/2008. Specific r ules 
governing the affixing of the CE marking with regard to toys should be laid down in 
this Regulation.  Those rules should ensure sufficient visibilit y of the CE marking in 
order to facilitate market surveillance of toys.  
(42) Manufacturers should create a product passport to provide information on the 
compliance of toys with this Regulation  and with any other Union legislation 
applicable to toys. The product passport should replace the EU declaration of 
conformity under Directive 2009/48/EC  and include the elements necessary to assess 
the conformity of the toy with the applicable requirements and harmonised standards 
or other specifications. In order t o facilitate checks on toys  by market surveillance 
authorities and to allow the actors in the supply chain and consumers to access 
information on the toy , the information on the product passport should be provided 
digitally and in a directly accessible man ner, through a data carrier affixed to the toy, 
its packaging or the accompanying documentation. Market surveillance authorities, 
customs authorities, economic operators and consumers should  have immediate access 
to the information on the toy through the d ata carrier.  
(43) To avoid duplication of investment into digitalisation by all actors involved, including 
manufacturers, market surveillance authorities and customs authorities, when other 
                                                 
36 Regulation (EU) No 1025/2012 of the European Parliament an d of the Council of 25 October 2012 on 
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliam ent and of the Council and repealing Council Decision 
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council  (OJ L 316, 
14.11.2012, p. 12 ). EN 22  EN Union legislation requires a product passport for toys,  a single product passport should 
be available containing the information required under this Regulation and the other 
Union legislation. In addition, the product passport should be fully interoperable with 
any product passport required under other Union l egislation.  
(44) In particular, Regulation (EU) …/… [P.O. insert serial number for the Regulation on 
ecodesign requirements for sustainable products] of the European Parliament and of 
the Council37 also lays down requirements and technical specifications f or a product 
passport, the establishment of a Commission central registry where passport 
information is stored and the interconnection of that registry with the customs IT 
systems.  That Regulation may include toys within its scope in the medium term, thus 
requiring that a product passport is available for toys. Therefore, it should be possible 
in the future to inclu de more precise information in the product passport, in particular 
information related to environmental sustainability, such as the environmenta l 
footprint of a product, information useful for recycling purposes, the recycled content 
of a certain material, information about the supply chain, and other  similar 
information . The product passport for toys created under this Regulation should 
therefore comply with the same requirements and technical elements as those set out 
in Regulation  (EU) …/…  [P.O. insert serial number for the Regulation on ecodesign 
requirements for sustainable products] , including the technical, semantic and 
organisation al aspects of end -to-end communication and data exchange .  
(45) As the product passport is to replace the EU declaration of conformity, it is crucial to 
make clear that by creating the product passport for a toy and by affixing the CE 
marking, the manufact urer declares that the toy is in compliance with the requirements 
of this Regulation and that the manufacturer takes full responsibility thereof.   
(46) Where other information than the elements required for the product passport  is 
provided digitally, it is  necessary to clarify that the different types of information need 
to be provided separately and clearly distinguished from each other but through a 
single data carrier. This will facilitate the work of market surveillance authorities but 
also provide clar ity to consumers regarding the different types of information that are 
available to them in a digital format.  
(47) Chapter VII of Regulation (EU) 2019/1020, setting up the rules for of controls on 
products entering the Union market applies to toys . The authorities in charge of 
controls, which in almost all Member States are the customs authorities, are to perform 
them on the basis of risk analysis as referred to in Articles 46 and 47 of Regulation 
(EU) No 952/2013 of the European Parliament and of the Co uncil38, its implementing 
legislation and the corresponding guidance. This Regulation therefore does not modify 
in any way Chapter VII of Regulation (EU) 2019/1020 and the way the authorities in 
charge of controls on products entering the Union market organ ise themselves and 
perform their activities.  
(48) In addition to the framework of controls established by Chapter VII of Regulation 
(EU) 2019/1020, customs authorities should be able to automatically verify that a 
                                                 
37 PO: Please insert in the text the number of the Regulation establishing a framework for setting 
ecodesign requirements for sustainable products and repealing Directive 2009/125/EC …. and insert the 
number, date, title and OJ reference of that Regulation in the footnote.   
38 Regulation (EU) No 952/2013 of the European Parliament and of the C ouncil of 9 October 2013 laying 
down the Union Customs Code (recast) (OJ L 269, 10.10.2013, p. 1).  EN 23  EN product passport exists for imported toys  subject to this Regulation  in order to 
strengthen the controls at the Union’s external borders and prevent non -compliant toys 
from entering the Union market .  
(49) When toys coming from third countries are placed under the customs procedure of  
release for  free circulation, the reference to a product passport for those toys should be  
made available to the customs authorities  by the economic operator . The  reference to 
the product passport should correspond to a unique product identifier that is stored in 
the product passport registry established under Article 12 of [P.O. insert serial number 
for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products]  (the 
‘registry’) . Customs authorities should carry out an automatic verification of the 
product passport presented for that toy, so as to ensure that only toys with a valid 
reference to a unique product identifier as included in the registry are released for free 
circulati on. To carry out th at automatic verification, the interconnection between the 
registry and the customs IT systems as provided for in [Article 13 of Regulation (EU) 
…/… on ecodesign requirements for sustainable products] should be used.  
(50) Where other inf ormation than the unique product identifier and the unique operator 
identifier is stored in the registry, the Commission should be empowered to adopt 
delegated acts allowing customs authorities to verify the consistency between th at 
additional information and the information made available by the economic operator 
to customs, in order to ensure the compliance of toys placed under the customs 
procedure of release for free circulation with this Regulation .  
(51) The information included in the product passpor t allow s customs authorities to enrich 
and facilitate risk management and enable s more targeted  controls at the Union’s 
external borders. Therefore, customs authorities should have the possibility to retrieve 
and use the information included in the product  passport and the registry for carrying 
out their tasks in accordance with Union legislation , including for risk management in 
accordance with Regulation (EU) No 952/2013 . 
(52) It is appropriate to provide for the publication of a notice in the  Official Jo urnal of the 
European Union  indicating the date when the interconnection between the registry and 
the EU Customs Single Window Certificates Exchange System referred to in Article 
13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign 
Require ments for Sustainable Products] becomes operational in order to facilitate 
public access to that information.  
(53) The automatic verification by customs of the reference to the product passport for toys 
entering the Union market should not replace or modif y the responsibilities of the 
market surveillance authorities but only complement the overall framework for 
controls on products entering the Union market. Regulation (EU) 2019/1020  should 
continue to apply to toys so as to ensure that market surveillance authorities  carry out 
checks of the information contained in products passports, checks on toys within the 
market in accordance with that Regulation and, in case of suspension of release for 
free circulation by the authorities designated for controls at the Union’s external 
borders, determine the compliance and risks of toys pursuant to Chapter VII of 
Regulation (EU) 2019/1020 . 
(54) Children are daily exposed to a  wide range of different chemicals originating from 
various sources.  Significant progress has  been made to close some knowledge gaps on 
the impact of the combination effect of those chemicals.  However, the safety of 
chemicals is usually assessed through the evaluation of single substances and in some 
cases of mixtures intentionally added for parti cular uses.  In order to provide the EN 24  EN highest protection for children, the most harmful substances should be generally 
banned in toys to ensure that there is no exposure to them in toys.  The specific  limit 
values for chemicals in toys should account for comb ined exposure from different 
sources to the same chemical substance. In addition, manufacturers should be required 
to carry out an analysis of the various hazards that the toy may present and an 
assessment of the potential exposure to such hazards and , as part of the assessment of 
chemical hazards,  to consider known cumulative or synergistic effects of the 
chemicals present in the toy, to ensure that risks from simultaneous exposure to 
multiple chemicals are taken into account.  Furthermore, toys are to comp ly with 
general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council; this Regulation does not modify the 
obligations for the assessment of the safety of the chemical substances or mixtures 
themsel ves that may be applicable in accordance with that Regulation.  
(55) Manufacturers should prepare the technical documentation describing all relevant 
aspects of toys including the  safety assessment of all hazards that the toy may present 
and how they have b een addressed,  to allow market surveillance authorities to perform 
their tasks efficiently.  The manufacturer should be required to make that technical 
documentation available to national authorities on request or to notified bodies in the 
context of the re levant conformity assessment procedure.  
(56) To ensure that toys comply with the essential requirements, it is necessary to lay down 
appropriate conformity assessment procedures to be followed by the manufacturer. 
Internal production control based on the manufacturer’s own responsibility for the 
conformity assessment is adequate where it has f ollowed the harmonised standards , 
the reference of which has been published in the Official Journal of the European 
Union , or common specifications covering all the  particular  safety requirements for 
the toy. In cases where such harmonised standards  or common specifications  do not 
exist, the toy should be submitted to third party verification, in this case E U-type 
examination. The same should apply if one or more such  standards has been published 
with a restriction in the Official Journal of the European Union , or if the manufacturer 
has not followed such standards or specifications completely, or only in part. The 
manufacturer should submit the toy to E U-type examinat ion in cases where it 
considers that the nature, design, construction or purpose of the toy necessitates third 
party verification.  
(57) Since it is necessary to ensure a uniformly high level of performance of bodies 
performing conformity assessment of toys  throughout the Union, and since all such 
bodies should perform their functions to the same level and under conditions of fair 
competition, requirements should be set for conformity assessment bodies wishing to 
be notified in order to provide conformity as sessment services under this Regulation.  
(58) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be presumed to comply with the corresponding 
requirements set out in this Regulation.  
(59) The system set out in this Regulation should be complemented by the accreditation 
system provided for in Regulation (EC) No 765/2008. Since accreditation is an 
essential means of verifying the competence of conformity assessment bodies, it 
should be used f or the purposes of notification. In particular, t ransparent accreditation 
as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of 
confidence in certificates of conformity, should be the only means of demonstrating 
the technical comp etence of conformity assessment bodies.  EN 25  EN (60) Confo rmity assessment bodies frequently subcontract parts of their activities linked to 
the assessment of conformity or have recourse to a subsidiary. In order to safeguard 
the level of protection required for t oys to be placed on the market, it is essential that 
conformity assessment subcontractors and subsidiaries fulfil the same requirements as 
notified bodies in relation to the performance of conformity assessment tasks. 
Therefore, it is important that the as sessment of the competence and the performance 
of bodies to be notified, and the monitoring of bodies already notified, cover also 
activities carried out by subcontractors and subsidiaries. In particular, excessive 
recourse to subsidiaries and subcontracto rs, in a manner that would call into question 
the competence of the notified body or its supervision by the notifying authority 
should be avoided.  
(61) In order to ensure a consistent level of quality in the performance of conformity 
assessment of toys, i t is necessary not only to consolidate the requirements that 
conformity assessment bodies wishing to be notified must fulfil, but also, in parallel, 
to set requirements that notifying authorities and other bodies involved in the 
assessment, notification an d monitoring of notified bodies must fulfil.  
(62) Since notified bodies may offer their services throughout the Union, it is appropriate to 
give the other Member States and the Commission the opportunity to raise objections 
concerning a notified body. It is therefore important to provide for a period during 
which any doubts or concerns as to the competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. The Commission should 
by way of implementing acts reque st the notifying Member State to take the necessary 
corrective measures in respect of a notified body that does not meet the requirements 
for its notification.  
(63) In the interests of competitiveness, it is crucial that notified bodies apply the 
conformity assessment procedures without creating unnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achieved through appropriate coordination and 
cooperation between notified bodies. Such coordination and cooperation should 
respect the Union competition rules.  
(64) Market surveillance is an essential instrument inasmuch as it ensures the proper and 
uniform application of Union legislation. Regulation (EU) 2019/1020 sets out the 
framework for market surveillance of products subject to Union harmonisation 
legislation, including toys. Since this Regulation replaces Directive 20 09/48/EC, the 
rules on market surveillance and controls on products entering the Union market set 
out in Regulation (EU) 2019/1020, including the specific requirement set out in 
Article 4 of that Regulation that toys are to be placed on the market only if there is an 
economic operator established in the Union responsible for the tasks specified in that 
Article, continue to apply to toys. Member States should therefore organise and carry 
out market surveillance of toys in accordance with that Regulation.  
(65) Directive 2009/48/EC provides for a safeguard procedure allowing the Commission 
and other Member States to examine the justification for a measure taken by a 
Member States against toys that the Member State considers to be non -compliant. That 
procedure ensures that interested parties are informed of measures intended to be taken 
with regard to toys posing a risk to the health or safety of persons and that such toys 
are consistently addressed by all market surveillance authorities in the Union market 
The procedure should therefore be maintained.  EN 26  EN (66) Where the Member States and the Commission agree as to the justification of a 
measure taken by a Member State, no further involvement of the Commission should 
be required. Where there are objections to such a measure, the Commission should, by 
means of implementing acts, determine whether a national measure in respect of a toy 
is justified.  
(67) Experience with Directive 2009/48/EC has shown that new toys available on the 
market which were compliant with the ap plicable particular safety requirements when 
placed on the market have in specific cases posed a risk to children and therefore do 
not comply with the general safety requirement. Provisions should be made to ensure 
that market surveillance authorities can take action against any toy presenting a risk to 
children, even when it is compliant with the particular safety requirements. The 
Commission should, by means of implementing acts, determine whether a national 
measure in respect of compliant toys which a Me mber State finds to pose a risk to the 
health and safety of children or other persons is justified.   
(68) In order to take into account technical and scientific progress or new scientific 
evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the 
Functioning of the European Union should be delegated to the Commission in respect 
of amending this Regulation by adapting the specific warnings to be affixed on toys, 
adopting specific requirements concerning chemical substances in toys and granting 
derogations to include specific uses allowed in toys of substances subject to generic 
prohibitions . 
(69) In order to take into account technical and scientific progress as well as the level of 
digital readiness of market surveillance authoriti es and of children and their 
supervisors, the power to adopt acts in accordance with Article 290 of the Treaty on 
the Functioning of the European Union should also be delegated to the Commission in 
respect of amending this Regulation with regard to the inf ormation that is to be 
included in the product passport and the information that is to be included in the 
product passport registry.  
(70) In order to  facilitate the work of customs authorities in relation to toys and their 
compliance with the requirements  set out in this Regulation, the power to adopt acts in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should be delegated to the Commission in respect of supplementing this Regulation by 
determining the additional infor mation stored in the registry to be controlled by 
customs authorities , and in respect of amending the list of commodity codes and 
product descriptions to be used for customs controls in accordance with this 
Regulation on the basis of Annex I to Regulation (EEC) No 2658/87 of the European 
Parliament and of the Council39. 
(71) When adopting delegated acts under this Regulation, it is of particular importance that 
the Commission carry out appropriate consultations during its preparatory work, 
including at exper t level, and that those consultations be conducted in accordance with 
the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better 
Law-Making40. In particular, to ensure equal participation in the preparation of 
delegated acts, the European Parliament and the Council receive all documents at the 
                                                 
39 Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on 
the Common Customs Tariff, OJ L 256, 7.9.1987, p. 1.  
40 OJ L 123, 12.5.2016, p. 1.   EN 27  EN same time as Member States’ experts, and their experts systematically have access to 
meetings of Commi ssion expert groups dealing with the preparation of delegated acts.  
(72) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be conferred on the Commission to establish the detailed 
technical require ments for the product passport for toys, and to determine whether a 
specific product or group of products is to be considered a toy for the purposes of this 
Regulation. In exceptional cases where it is necessary in order to address new 
emerging risks that are not appropriately addressed by the particular safety 
requirements, the Commission should be empowered to adopt implementing acts 
setting out specific measures against toys or categories of toys made available on the 
market which present a risk for chil dren. Those powers should be exercised in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council41. 
(73) Member States should provide for penalties applicable to infringements of this 
Regulation. Those penalties should be effective, proportionate and dissuasive.  
(74) In order to allow manufacturers and other economic operators sufficient time to adapt 
to the requirements laid down by this Regulation, it is necessary to provide for a 
transitional period during which toys whi ch comply with Directive 2009/48/EC may 
be placed on the market. In addition, the period during which t toys already placed on 
the market in compliance with that Directive may continue to be made available on the 
market after this Regulation becomes applic able should be limited.  
(75) Since the objective of this Regulation, namely to ensure a high level of safety of toys 
with a view to ensuring the health and safety of children whilst guaranteeing the 
functioning of the internal market, cannot be sufficientl y achieved by the Member 
States and can therefore, by reason of its scale and effects, be better achieved at Union 
level, the Union may adopt measures, in accordance with the principle of subsidiarity 
set out in Article 5 of the Treaty. In accordance with the principle of proportionality, 
as set out in that Article, this Regulation does not go beyond what is necessary in order 
to achieve that objective.  
HAVE ADOPTED THIS REGULATION:  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject  matter  
This Regulation lays down rules on the safety of toys , ensuring a high level of protection of 
health and safety of children and other persons , and on the free movement of toys in the 
Union . 
                                                 
41 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerning mechanisms for control by Member States of 
the Commission’s exercise of i mplementing powers (OJ L 55, 28.2.2011, p. 13).  EN 28  EN Article 2 
Scope  
1. This Regulation applies to products which are  designed  or intended , whether or not 
exclusively,  for use in play by children under 14 years of age (‘toys’) . 
For the purposes of this Regulation, a product shall be considered to be intended for use in 
play by children under 14 years of age, or by children of any other specific age group  below 
14 years , where a parent or supervisor can reasonably assume , by virtue of the functions, 
dimensions and characteristics of that product , that it is intended for use in play  by children of 
the relevant age group . 
2. This Regulation  does not apply  to the products listed in Annex I.  
3. The Commission shall be empowered to  adopt implementing acts  determin ing whether or 
not specific product s or categories of products fulfil the criteria set out in paragraph 1 of this 
Article and therefore can or cannot be considered toys within the meaning  of this Regulation . 
Those implementing acts shall be adopted in accordance with the procedure set out in Article 
50(2). 
Article  3 
Definitio ns 
For the purposes of this Regulation the following definitions apply:  
(1) ‘making available on the market’ means any supply of a toy for distribution, 
consumption or use on the Union market in the course of a commercial activity, 
whether in retu rn for payment or free of charge;  
(2) ‘placing on the market’ means the first making available of a toy on the Union 
market;  
(3) ‘manufacturer’ means any natural or legal person who manufactures a toy or has a 
toy designed or manufactured, and markets that  toy under that person’s name or 
trademark;  
(4) ‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate from a manufacturer to act on that 
person’s behalf in relation to specified tasks;  
(5) ‘importer’ means any natural or legal person established within the Union who 
places a toy from a third country on the Union market;  
(6) ‘distributor’ means any natural or legal person in the supply chain, other than the 
manufacturer or the importer, who makes a toy available on the market;  
(7) ‘fulfilment service provider’ means fulfilment service provider as defined in Article 
2, point 11 , of Regulation (EU) 2019/1020;   
(8) ‘economic operator’ means the manufacturer, the authorised representative, the 
importer , the distributor  and the fulfilment service provider ;  
(9) ‘online marketplace’ means online marketplace as defined in Article 3, point (14), of 
Regulation (EU) 2023/988 ;  EN 29  EN (10) ‘harmonised standard’ means a harmonised standard as defined in Ar ticle 2, point 
(1), of Regulation  (EU) No  1025/2012;  
(11) ‘Union harmonisation legislation’ means Union legislation listed in Annex I to 
Regulation (EU) 2019/1020 and any other Union legislation harmonising the 
conditions for the marketing of products to w hich that Regulation applies;  
(12) ‘CE marking’ means a marking by which the manufacturer indicates that the toy is in 
conformity with the applicable requirements set out in Union harmonisation 
legislation providing for its affixing;  
(13) ‘toy model’ mean s a group of toys that meet the following conditions:  
(a) they are under the responsibility of the same manufacturer,  
(b) they have uniform design and technical characteristics,  
(c) they are manufactured using uniform materials and manufacturing processes , 
(d) they are defined by a type number or other element allowing them to be 
identified as a group ;  
(14) ‘data carrier’ means a linear bar code symbol, a two -dimensional symbol or other 
automatic identification data capture medium that can be read by a device ; 
(15) ‘unique product identifier’ means unique string of characters for the identification of 
toys that also enables a web link to the product passport ; 
(16) ‘unique operator identifier’ means a unique string of characters for the identification 
of actors involved in the value chain of toys ; 
(17) ‘release for free circulation’ means the customs procedure laid down in Article 201 
of Regulation (EU) No 952/2013;  
(18) ‘customs authorit ies’ means customs authorit ies as defined in Article 5, point (1), of  
Regulation (EU) No 952/2013;  
(19) ‘EU Customs Single Window Certificates Exchange System’ means the system 
referred to in Article 4 of Regulation (EU) 2022/2399 of the European Parliament 
and of the Council42; 
(20) ‘conformity assessment’ means the process  demonstrating whether the essential 
requirements relating to a toy have been fulfilled;  
(21) ‘conformity assessment body’ means a body that performs conformity assessment 
activities, including calibration, testing, certification and inspection;  
(22) ‘accr editation’ means accreditation as defined in Article 2, point (10), of Regulation 
(EC) No 765/2008;  
(23) ‘national accreditation body’ means a national accreditation body as defined in 
Article 2, point (11), of Regulation (EC) No 765/2008;  
(24)   ‘hazard’ means a potential source of harm;  
                                                 
42 Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022 
establishing the European Union Single Window Environment for Customs and amending Regulation 
(EU) No 952/2013 (OJ  L 317, 9.12.2022, p. 1).  EN 30  EN (25) ‘risk’ means the combination of the probability of an occurrence of a hazard and the 
degree of severity of th e harm  caused by that hazard ; 
(26) ‘recall’ means any measure aimed at achieving the return of a toy that has already 
been made available to the end user;  
(27) ‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from 
being made available on the market;  
(28) ‘market surveillance authority’  means a market surveillance authority as define d in 
Article 3, point (4), of Regulation (EU) 2019/1020;  
(29) ‘functional toy’ means a toy which performs and is used in the same way as a 
product, appliance or installation intended for use by adults, and which may be a 
scale model of such product, applia nce or installation;  
(30) ‘aquatic toy’ means a toy that is intended for use in shallow water and which is 
capable of carrying or supporting a child in the water;  
(31) ‘activity toy’ means a toy for domestic use in which the support structure remains 
stationary while the activity is taking place and which is intended for climbing, 
jumping, swinging, sliding, rocking, spinning, crawling , creeping, or any 
combination thereof;  
(32) ‘chemical toy’ means a toy intended for the direct handling of chemical su bstances 
and mixtures;  
(33) ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn 
to recognise different odours or flavours;  
(34) ‘cosmetic kit’ means a toy the purpose of which is to assist a child to learn to make 
cosmetic  products such as fragrances, soaps, creams, shampoos, conditioners, bath 
foams, tooth pastes as well as glosses, lipsticks  and other make -up; 
(35) ‘gustative game’ means a toy the purpose of which is to allow children to make 
sweets or dishes through  the use of food ingredients , including liquids, powders and 
aromas;  
(36) ‘substance of concern’ means substance of concern as defined in Article 2 , point 
(28),  of Regulation (EU) …/… [ on Ecodesign Requirements for Sustainable 
Products ]. 
Article 4  
Free mov ement  
1. Member States shall not impede, for reasons relating to health and safety  or other 
aspects covered by this Regulation, the making available on the market of toys which 
comply with this Regulation.  
2. At trade fairs, exhibitions and demonstrations or similar events, Member States shall 
not prevent the display of a toy which does not comply with this Regulation, 
provided that a visible sign clearly indicates that the toy does not comply with this 
Regulat ion and will not be available on the market until it has been brought into 
conformity.  
During fairs, exhibitions and demonstrations, adequate measures shall be taken by 
economic operators  to ensure the protection of persons.  EN 31  EN Article 5  
Product  requirement s  
1. Toys shall only be placed on the market if they comply with the essential  safety 
requirement s which include  the safety requirement set out in paragraph 2 (the 
‘general safety requirement’)  and the safety  requirements set out in Annex II  (the 
‘particular safety requirements’) . 
2. Toys shall not present a risk to the safety or health of users or third parties , including 
the psychological and mental health, well-being  and cognitive development  of 
children , when they are used as intended or in a foreseeable way, bearing in mind the 
behaviour of children.   
When assessing the risk referred to in the first subparagraph, t he ability of the users 
and, where appropriate, their supervisors shall be taken into account . Where a toy is 
intended for use by children under 36 months or by another specified age groups , the 
ability of users in that specific age group shall be taken into account . 
3. Toys placed on the market shall comply with the essential safety requirements during 
their fo reseeable period of use.  
Article 6  
Warnings  
1. Where necessary to ensure their safe use , toys shall bear a general warning 
specifying appropriate user limitations. The user limitations shall include at least the 
minimum or maximum age of the user and, wher e appropriate, the required abilities 
of the user, the maximum or minimum weight of the user and the need to ensure that 
the toy is used only under adult supervision.   
2. The following categories of toy s shall bear warnings in accordance with the rules for  
each category set out in Annex III: 
(a) toys not intended for use by children under 36 months;  
(b) activity toys;  
(c) functional toys;  
(d) chemical toys;  
(e) skater, roller skates, inline skates, skateboards, scooters and toy bicycles;  
(f) aquatic toys;  
(g) toys in food;  
(h) imitations of protective masks and helmets;  
(i) toys intended to be strung across a cradle, cot or perambulator by means of 
strings, cords, elastics or straps;  
(j) packaging for fragrances in olfactory board games, cosmetic kits and g ustative  
games.  
Toys shall not bear one or more of the warnings set out in Annex III where such 
warning s conflict with the intended use of the toy, as determined by virtue of its 
function, dimension and characteristics.  EN 32  EN 3. The manufacturer  shall mark warnings in a clearly visible, easily legible and 
understandable and accurate manner on the toy, on an affixed label or on the 
packaging and, if appropriate, on the instructions for use which accompany the toy. 
Small toys which are sold without  packaging shall have appropriate warnings affixed 
to them.  
Warnings shall be clearly visible to the consumer before the purchase, including in 
cases where the purchase is made through distance sales . Warnings shall be of 
sufficient size to ensure their vi sibility.  
4. Labels  and instructions for use shall draw the attention of children or their 
supervisors to the inherent hazards and  risks to the health and safety of children  
involved in using the toys, and to the ways of avoiding such hazards and risks.  
CHAPTER II  
OBLIGATIONS OF ECONOMIC OPERATORS   
Article 7 
Obligations of manufacturers  
1. When placing toys on the market, manufacturers shall ensure that they have been 
designed and manufactured in accordance with the essential safety requirements . 
2. Befor e placing toys on the market, m anufacturers shall draw up the required 
technical documentation in accordance with Article 23 and carry out the applicable 
conformity assessment procedure in accordance with Article  22 or have it carried 
out. 
Where compliance of a toy with the applicable requirements laid down in this 
Regulation has been demonstrated by the procedure referred to in the first 
subparagraph , manufacturers shall , before the toy is placed on the market : 
(a) create a product passport  for the toy in accordance with Article 1 7; 
(b) affix the data carrier to the toy or to a label attached to  the toy, in accordance 
with Article 1 7(5); 
(c) affix the CE marking  in accordance with Article 1 6(1);  
(d) upload  the unique product identifier  and the unique operator identifier  of the 
toy in the product passport registry referred to in Article 1 9(1), as well as any 
other additional information determined by a delegated act adopted in 
accordance with Article 4 6(2). 
3. Manufacturers shall keep th e technical documentation and the product passport for a 
period of 10 years after the toy covered by that documentation and product passport 
has been placed on the market.  
4. Manufacturers shall ensure that procedures are in place for toys that are part of  a 
series production to remain in conformity  with this Regulation . Changes in the 
design or characteristics of toys , and changes in the harmonised standards referred to 
in Article 13 or the common  specifications referred to in Article 14 by reference to 
which conformity of a toy is declared or by application of which its conformity is 
verified , shall be adequately taken into account.  EN 33  EN When manufacturers, with regard to the risks presented by a toy,  consider it 
necessary for the protection o f health and safety of consumers,  manufacturers shall , 
carry out sample testing of marketed toys.  
5. Manufacturers shall ensure that toys bear a type, batch, serial or model number or 
other element allowing their identification, or, where the size or natur e of the toy 
does not allow it, that the required information is provided on the packaging or in a 
document accompanying the toy.  
6. Manufacturers shall indicate their name, registered trade name or registered trade 
mark and the postal and electronic  address at which they can be contacted on the toy 
or, where that is not possible, on its packaging or in a document accompanying the 
toy. Manufacturers  shall indicate a single point at which they can be contacted.   
7. Manufacturers shall ensure that the t oy is accompanied by instructions and safety 
information in a language or languages easily understood by consumers  and other 
end-users , as determined by the Member State concerned.  Such instructions and 
information shall be clear, understandable  and legible.  
8. Where m anufacturers consider , or have reason to believe , that a toy which they have 
placed on the market is not in conformity with this Regulation , they  shall 
immediately take the corrective measures necessary to bring that toy into conformity,  
withdraw it or recall it, as appropriate.  
Where manufacturers consider , or have reason to believe , that a toy presents a risk,  
they shall immediately provide inform ation thereof to:  
(a) the market  surveillance  authorities of the Member States in which th ey have 
made the toy available, via the Safety Business Gateway referred to in Article 
26 of Regulation (EU) 2023/ 988, giving details, in particular, of any non-
compliance and of any corrective measures taken ; and   
(b) the consumers  or other end -users , in accordance with Article 35 or 36 of 
Regulation (EU) 2023/988 , or both . 
9. Manufacturers shall, further to a reasoned request from a competent national 
authority, provide it, with all the information and documentation necessary to 
demonstrate the confo rmity of the toy, in a language which can be easily understood 
by that authority. They shall cooperate with that authority, at its request, as regards 
any action taken to eliminate the risks posed by toys which they have placed on the 
market.  
10. Manufactu rers shall ensure that other economic operators, the economic operator 
referred to in Article 4(1) of Regulation (EU) 2019/1020 , and online marketplaces , in 
the supply chain concerned , are kept informed in a timely manner of any non -
conformity that the manufacturers have identified.  
11. Manufacturers shall make publicly available a telephone number, an electronic 
address , a dedicated section of their website  or another communication channel , 
allowing consumers or other end -users to file complaints concer ning the safety of 
toys and to inform the manufacturers of any accident or safety issue they have 
experienced with such toys. In doing so, the manufacturers shall take into account the 
accessibility needs for persons with disabilities.  
12. Manufacturers s hall investigate complaints and information referred to in paragraph 
11 and shall keep an internal register of those complaints and that information, as EN 34  EN well as of recalls and any other corrective measures taken to bring the toys into 
conformity  with this Regulation . 
13. The internal register referred to in paragraph 1 2 shall only contain personal data that 
are necessary for the manufacturer to investigate the complaint or the information 
referred to in paragraph 1 1. Such data shall only be kept as long as is necessary for 
the purpose of the investigation and , in any event , no longer than 5 years after the 
data have been entered in the register .  
Article 8 
Authorised representatives  
1. A manufacturer may appoint an a uthorised representative  by written mandate . 
2. The o bligations laid down in Article 7(1), and the obligation to draw up technical 
documentation referred to in Article 7(2) , shall not form part of the authorised 
representative’s mandate.  
3. An authorised representative shall perform the tasks specified in the mandate 
received from the manufacturer  and shall provide a copy of the mandate to the 
market surveillance authorities upon their request. The mandate shall allow the 
authorised representative to do at  least the following:  
(a) keep the technical documentation at the disposal of national surveillance 
authorities and ensure that the product passport is available , in accordance with 
Article 1 7(2), for a period of 10 years after the toy covered by those doc uments 
has been placed on the market;  
(b) further to a reasoned request from a competent national authority, provide that 
authority with all the information and documentation necessary to demonstrate 
the conformity of a toy;  
(c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risks posed by toys covered by the mandate . 
4. Where a manufacturer not established in the Union appoints an authorised 
representative as referred to in paragraph 1  of this Article , the written mandate shall 
include the tasks set out in Article 4 (3) of Regulation (EU) 2019/1020.   
Article 9 
Obligations of importers  
1. Importers shall only place on the market toys complying with this Regulation . 
2. Before placing toy s on the market, importers shall ensure the following : 
(a) the manufacturer has carried out the appropriate conformity assessment 
procedure and drawn up the technical documentation  referred to in Article 
7(2); 
(b) the toy is accompanied by instructions of u se and safety information in 
accordance with in Article 7(7 ) in a language or languages which can be easily 
understood by consumers or other end -users, as determined by the Member 
State concerned ; EN 35  EN (c) the manufacturer has created a product passport for the  toy in accordance with 
Article 7(2) ;  
(d) the toy bears a data carrier in accordance with Article 1 7(5); 
(e) the relevant information in the product passport has been included in the  
product passport  registry in accordance with  Article 1 9(1); 
(f) the toy bears the CE marking  in accordance with Article 16 ; 
(g) the manufacturer has complied with the requirements set out in Article 7(5) and 
(6).  
Where importer s consider , or ha ve reason to believe , that a toy is not in conformity 
with the essential  safety requirement s, they shall not place the toy on the market until 
it has been brought into conformity.  
Where importers consider , or have reason to believe , that the toy presents a risk, they 
shall immediately  provide inform ation thereof to:  
(a) the manufacturer ; 
(b) the market surveillance authorities, via the Safety Business Gateway referred to 
in Article 26 of Regulation (EU) 2023/988  ;  
(c) consumers  or other end -users , in accordance with Article 35 or 36 of 
Regulation (EU) 2023/988 , or both .  
3. Importers shall indicate their name, registered trade name or registered trade mark 
and the postal and electronic address at which they can be contacted on the toy or, 
where that is not possible, on its packaging or in a document accompanying the toy.   
4. Importers shall ensure that, while a toy is under their responsibility, their storage or 
transport conditions do not jeopardise the toy’s compliance with the essential safety 
requirement s. 
5. When importers, with regard to the risks presented by a toy, consider it necessary for 
the protection of health and safety of consumers or other end -users, they shall  carry 
out sample testing of marketed toys .  
6. Where i mporters consider , or have reason to believe , that a toy which they have 
placed on the market is not in conformity with the relevant Union  harmonisation 
legislation , they  shall immediately take the corrective measures necessary to bring 
that toy into conformity, withdraw it or recall it, as appropria te.  
Where importers consider , or have reason to believe , that a toy that they have placed 
on the market presents a risk  to health and safety of consumers and other end -users , 
they shall immediately inform the competent national authorities of the Member 
States in which they made the toy available to that effect, giving details, in particular, 
of the non -compliance and of any corrective measures taken.  
7. Importers shall, for a period of 10 years after the toy has been placed on the market, 
keep the unique product identifier of the toy  at the disposal of the market 
surveillance authorities and ensure that the technical documentation referred to in 
Article 23 can be made available to those authorities, upon request.   
8. Importers shall, further to a reasoned request from a competent national authority, 
provide it with all the information and documentation necessary to demonstrate the 
conformity of the toy in a language which can be easily understood by that authority. EN 36  EN They shall cooperate with that authority, at its request, as regards any action taken to 
eliminate the risks posed by toys which they have placed on the market.  
9. Importers shall verify whether the  manufacturer has made a  communication channel 
as referred to  in Article 7( 11) publicly available to consumers  or other end -users , 
allowing them to present complaints concerning  the safety of toys and provide 
information on any accident or safety issue they have experienced with the toy. If a 
communication channel is not available, importers shall provide for such a channel , 
taking into account accessibility needs for persons with disabilities.  
10. Importers shall investigate complaints and information referred to in paragraph 9 of 
this Article that they have received via a communication channel made available by 
the manufacturer , or via a communication channel made available by the importers 
themselves , and that concern the toys which they have made available on the market . 
Importers shall  file those complaint s, as well as recalls and any other corrective 
measures taken to bring the toys into conformity  with this Regulation , in the register 
referred to in Article 7( 12), or in their own internal register.  
Importers shall keep the manufacturer, distributors and,  where relevant , online 
marketplaces informed in a timely manner of the investigation performed and of the 
results of the investigation.  
11. Personal data contained in the internal register of the importers referred to in 
paragraph 1 0 shall only be those p ersonal data that are necessary for the importer to 
investigate the complaint  or the information referred to in paragraph 9. Such data 
shall only be kept as long as is necessary for the purpose of the investigation and , in 
any event , no longer than 5 years  after the data have been entered in the register . 
Article 10 
Obligations of distributors  
1. When making a toy available on the market, distributors shall act with due care in 
relation to the requirements  of this Regulation .  
2. Before making a toy available on the market, distributors shall verify that  the 
following conditions have been met:  
(a) the toy  is accompanied by instructions and safety information in a language or 
languages which can be easily understood by consumers  or other end -users  as 
determined by the Member State in which the toy is to be made available on 
the market ;  
(b) the toy bears a data carrier in accordance with Article 1 7(5) and the CE 
marking in accordance with Article 1 6 and 
(c) the manufacturer and the importer have complied with the requirements set out 
in Article 7(2), second subparagraph, Article 7(5), (6) and (11) and Article 9(3)  
respectively . 
Where distributor s consider , or ha ve reason to believe , that a toy is not in confo rmity 
with the essential  safety requirement s, they shall not make the toy available on the 
market until it has been brought into conformity.  
Where distributors consider , or have reason to believe , that the toy presents a risk, 
they shall immediately provide inform ation thereof to:  
(a) the manufacturer or the importer ; EN 37  EN (b) the market surveillance authorities  through the Safety Business Gateway 
referred to in Article 26 of Regulation (EU) 2023/988 ; 
(c) consumers or other end -users, in accordance with Ar ticle 35  or 36  of 
Regulation (EU) 2023/988 , or both.   
3. Distributors shall ensure that, while a toy is under their responsibility, storage or 
transport conditions do not jeopardise its compliance with the essential  safety 
requirement.  
4. Where d istributors consider , or have reason to believe , that a toy which they have 
made available on the market is not in conformity with this Regulation , they  shall 
ensure that the corrective measures necessary to bring that toy into conformity, to 
withdraw it o r recall it, if appropriate, are taken.  
Where distributors consider , or have reason to believe , that a toy that they have made 
available on the market presents a risk, they shall immediately inform the market 
surveillance authorities of the Member States in which they made the toy available to 
that effect, giving details, in particular, of the non -compliance and of any corrective 
measures taken.  
5. Distributors shall, further to a reasoned request from a competent national authority, 
provide it, with all t he information and documentation necessary to demonstrate the 
conformity of the toy , in a language which can be easily understood by that 
authority . They shall cooperate with that authority, at its request, as regards any 
action taken to eliminate the risk s posed by toys which they have made available on 
the market.  
Article 11 
Cases in which obligations of manufacturers apply to importers and distributors   
An importer  or a distributor  shall be considered a manufacturer for the purposes of this 
Regulation , and shall be subject to the obligations of the manufacturer under Article 7, where 
such importer or distributor  places a toy on the market under its name or trademark or 
modifies a toy already placed on the market in such a way that compliance with the applicable 
requirements of this Regulation may be affected.   
Article 12 
Identification of economic operators  
1. Economic operators shall, on request, identify the following to the ma rket 
surveillance authorities:  
(a) any economic operator who has supplied them with a toy;  
(b) any economic operator to whom they have supplied a toy.  
2. Economic operators shall be able to present the information referred to in the 
paragraph 1 for a period of 10 years after the toy has been placed on the market, in 
the case of the manufacturer, and for a period of 10 years after they have been 
supplied with the toy, in the case of  other economic operators . EN 38  EN CHAPTER III  
CONFORMITY OF TOYS   
Article 13  
Presumption of conformity  
Toys  which are in conformity with harmonised standards or parts thereof, the references of 
which have been published in the Official Journal of the European Union , shall be presumed 
to be in conformity with the essential  safety requirement s to the extent that those requirements 
are covered by those standards or parts thereof . 
Article 14 
Common specifications  
1. Toys  which are in conformity with the common specifications referred to in 
paragraph 2 of this Article  or parts thereof shall be presumed to be in conformity 
with the essential  safety requirement s to the extent that those requirements are 
covered by those common specifications or parts thereof.  
2. The Commission may, by means of implementing acts, establi sh common 
specifications for the essential  safety requirement s where the following conditions 
are fulfilled:  
(a) there is no harmonised standard covering those requirements the reference of which 
is published in the Official Journal of the European Union or the standard does not 
satisfy the requirements it aims to cover;  
(b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, 
one or more European standardisation organisations to draft or to revise European 
standard s for those requirements and either of the following conditions is fulfilled:  
(1) the request has not been accepted by any of the European standardisation 
organisations to w hich the request was addressed;  
(2) the request has been accepted by at least one of the European standardisation 
organisations to which the request was addressed, but the European standards 
requested:  
(a) have not been adopted within the deadline set in  the request;  
(b) do not comply with the request;  or  
(c) do not satisfy the requirements they aim to cover.  
Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article  50(3).  
3. When references of a harmo nised standard are published in the Official Journal  of the 
European Union , the Commission shall assess whether the implementing acts 
referred to in paragraph 2  of this Article which cover the same essential safety 
requirement  need to be repealed or amended .  EN 39  EN Article 15 
General principles of the CE marking  
Toys made available on the market shall bear the CE marking.   
The CE marking shall be subject to the general principles set out in Article 30 of Regulation 
(EC) No 765/2008.  
Article 16 
Rules and con ditions for affixing the CE marking   
1. The CE marking shall be affixed visibly, legibly and indelibly to the toy, to a label 
attached to the toy  or to the packaging  of the toy .  
By way of derogation from the first subparagraph, i n the case of small toys and toys 
consisting of small parts, the CE marking may be affixed to a leaflet  accompanying 
the toy .  
By way of derogation from the first subparagraph, i n the case of toys sold in counter 
displays  where it is not technically possible  to affix the CE marking to each 
individual toy , the CE marking may be affixed to the counter display  on the 
condition that the counter display was originally used as packaging for the toy . 
Where the CE marking affixed to the toy is not visible fro m outside the packaging, it 
shall also be affixed to the packaging.  
2. The CE marking shall be affixed before the toy is placed on the market.  
3. The CE marking shall, where applicable  in accordance with Article 6 , be followed by 
a pictogram or any other warning indicating a special risk or use.  
4. Member States shall build upon existing mechanisms to ensure correct application of 
the regime governing the CE marking and shall take appropriate action in the event 
of improper use of that marking.  
 
CHAPTER IV  
PRODUCT PASSPORT  
Article 17 
Product passport  
1. Before placing a toy on the market, manufacturers shall create a product passport for 
that toy . The product passport shall meet the requirements laid down in this Article 
and Article 18. 
2. The product passport shall:  
(a) correspond to a specific toy model;  
(b) state that compliance of the toy with the requirements set out in this Regulation 
and, in particular, the essential  safety requirement s, has been demonstrated;  
(c) contain at least the information  set out in Part I of Annex VI ; 
(d) be up  to date;  EN 40  EN (e) be available in  the language or languages required by the Member State where 
the toy is made available on the market;  
(f) be accessible to consumers  or other end -users , market surveillance authorities,  
customs authorities, notified bodies, the Commission and other economic 
operators;  
(g) be available for a period of 10 years after the toy is placed on the market, also 
in cases of insolvency, a liquidation or a cessation of activity in the Union of 
the economic operator that created the product passport;  
(h) be accessible through a data carrier;  
(i) fulfil the specific and technical requirements laid down pursuant to paragraph 
10. 
3. In addition to the information referred to in paragraph 2, the product passport may 
contain the information set out in Part II of Annex VI.  
4. By creating the product passport, the manufacturer shall assume responsibility for the 
compliance of the toy wit h this Regulation.  
5. The data carrier shall be physically present on the toy or on a label  attached to the 
toy, in accordance with the implementing act adopted in accordance with paragraph 
10. In the case of small toys and toys consisting of small parts, the data carrier may 
alternatively be affixed to its packaging. It shall be clearly visible to the consumer 
before any purchase and to market surveillance authorities, including in cases where 
the toy is made available through distance sales.  
6. Where oth er Union legislation requires information on the toy to be available via a 
data carrier, a single data carrier shall be used to provide the information required 
under this Regulation and such other Union legislation.  
7. Where other Union legislation applying to toys requires a product passport, a single 
product passport shall be created for toys containing the information required under 
this Regulation as well as any other information required for the product passport by 
that other Union legislation.   
8. By way of derogation from paragraph 2, point (c), w here information requirements 
relating to substances of concern in  toys are established in a delegated act adopted in 
accordance with Article 4 of Regulation …/… [OP please insert: the Ecodesign for 
Sustainable Products Regulation], the information referred to in Part I, point (k),  of 
Annex VI to this Regulation is no longer required.   
9. Economic operators may, in addition to the information referred to in paragr aphs 6 
and 7, make other information accessible through the data carrier referred to in 
paragraph 5. Where this is the case, that information shall be clearly separated from 
the information required under this Regulation and, where relevant, under other 
Union legislation . 
10. The Commission shall adopt implementing act s determining the specific and 
technical requirements related to the product passport for toys. Those requirements 
shall cover  in particular  the following:  
(a) the types of data carrier to be used;  
(b) the layout in which the data carrier is to be presented and its positioning;  EN 41  EN (c) the technical elements of the passport for which defined European or 
international standards are to be used;  
(d) the actors that may introduce or update the informa tion in the product passport, 
including where needed the creation of a new passport, including 
manufacturers, notified bodies, competent national authorities, and the 
Commission, or any organisation acting on their behalf, and the types of 
information they  may introduce or update.  
Those implementing acts shall be adopted in accordance with the procedure set out in 
Article 50(3). 
Article 18 
Technical design and operation of the product passport   
1. The product passport shall  be fully interoperable with prod uct passports required by 
other Union legislation in relation to the technical, semantic and organisational 
aspects of end -to-end communication and data exchange . 
2. All information included in the product passport shall be based on open  standards 
developed with an interoperable format and shall be machine readable, structured 
and searchable .  
3. Consumers  or other end -users , economic operators and other relevant actors shall 
have access to the product passport free of charge . 
4. The data included i n the product passport shall be stored by the economic operator 
responsible for its creation or by operators authorised to act on their behalf . 
5. Where the data included in the product passport is stored or otherwise processed by 
an operator authorised to  act on behalf of the economic operators placing the toy on 
the market, th at other operator shall not be allowed to sell, re -use or process such 
data, in whole or in part, beyond what is necessary for the provision of the relevant 
storing or processing ser vices . 
6. Economic operators  may not track, analyse or use any usage information for 
purposes other than what is absolutely necessary for providing the information on the 
product passport online.  
Article 19 
Product passport registry  
1. Before placing a toy on the market, economic operators shall upload, in the registry 
established under Article 12(1) of Regulation (EU) …/… [PO insert serial number 
for Ecodesign  Requirements  for Sustainable Products ] (the ‘registry’) , the unique 
product i dentifier and unique operator identifier for that toy. 
2. The Commission, market surveillance authorities and customs authorities shall have 
access to the information stored in the registry referred to in paragraph 1 for carrying 
out their duties pursuant to this Regulation.  
Article 20 
Customs controls relating to the product passport  
1. Toys entering the Union market shall be subject to verifications and other measures 
laid down in this Article.  EN 42  EN 2. Declarants as defined in Article 5, point (15), of Regulation (EU) No 952/2013 shall 
include the unique product identifier in the customs declaration for release for free 
circulation of any toy.   
3. Customs authorities shall verify whether the unique produ ct identifier indicated by 
the declarant in accordance with paragraph 2 of this Article corresponds to a unique 
product identifier included in the registry in accordance with Article 19(1).  
4. In addition to the verification referred to in paragraph 3  of this Article , customs 
authorities shall verify the consistency of information made available to customs by 
declarants with other information stored in the registry and listed in the delegated act 
referred to in Article 46(3).  
5. The verification s referred to in paragraphs 3 and 4 of this Article shall take place 
electronically and automatically using the interconnection between the registry 
referred to in Article 19(1) and the EU Customs Single Window Certificates 
Exchange System referred to in [Articl e 13 of [P.O. insert serial number for 
Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products] ]. 
6. Paragraphs 3, 4 and 5 of this Article  shall apply from the day when the 
interconnection between the registry and the EU Customs Single Window 
Certificates Exchange System referred to in [Article 13 of [P.O. insert serial number 
for Regulation (EU) …/… on Ecodesign  Requirements  for Sustainable Products] ] 
becomes operational.  
The Commission shall publish a notice in the Official Journal of the European Union  
to that effect indicating the date when the interconnection is operational.  
7. Customs authorities may retrieve and use the information on toys included in the 
product passport and in the registry for carrying out their duties pursuant to Union 
legislation, including for risk management in accordance with Articles 46 and 47 of 
Regulation (EU) No 952/2013.  
8. The verifications and other measur es laid down in this Article shall be carried out on 
the basis of the list of commodity  codes  and product descriptions set out in Annex 
VII. 
9. The verifications and measures laid down in this Article shall not affect the 
application of other Union legal acts governing the release for free circulation of 
products, including Articles 46, 47 and 134 of Regulation (EU) No 952/2013, and the 
controls r eferred to in Chapter VII of Regulation (EU) 2019/1020.  
CHAPTER V 
CONFORMITY ASSESSMENT   
Article 21 
Safety assessment  
1. In order to demonstrate that a toy complies with the essential  safety requirements , 
manufacturers shall, before placing a toy on the market, carry out a safety assessment 
including  an analysis of the hazards that the toy may present, as well as  an 
assessment of the  potential exposure to such hazards.  EN 43  EN 2. The safety assessment  shall  in particular  :  
(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene 
and radioactivity hazards and the potential exposure to such hazards;   
(b) in relation to chemical hazards, take account of the possible exposure to 
individual chemicals, and any known additional hazards from combined 
exposure to the different chemicals present in the toy , taking into account the 
obligations under  Regulation (EC) No 1907/2006 and the conditions set out 
therein ; 
(c) be updated whenever additional relevant information is available.  
The safety assessment shall be included in t he technical documentation referred to in 
Article 23.  
Article 22 
Conformity assessment procedures  
1. Manufacturers shall use the conformity assessment procedures referred to in 
paragraphs 2 and 3.  
2. If the  manu facturer has applied harmonised standards, the reference of which has 
been published in the Official Journal of the European Union, or common  
specifications covering all relevant safety requirements for the toy, the manufacturer 
shall use the internal production control procedure set out in Part I of Annex IV. 
3. In the following cases, the manufacturer shall use the EU-type examinati on 
procedure set out in Part II of Annex IV  together with the conformity to type 
procedure set out  in Part III of that Annex : 
(a) where harmonised standards, the reference of which has been published in the 
Official Journal of the European Union , or common  specifications covering all 
relevant safety requirements for the toy, do not exist;  
(b) where harmonised standards  or common  specifications  referred to in point (a) 
exist but the manufacturer has not applied them or has applied them only in 
part; 
(c) where one or more of the harmonised standards  referred to in point (a) has been 
published with a restriction;  
(d) where the manufacturer considers that the nature, design, construction or 
purpose of the toy necessitate s third party verification.  
4. The EU -type examination certificate issued in accordance with Part II, point 6, of 
Annex IV shall be rev iewed whenever necessary, in particular in case of a change to 
the manufacturing process, the raw materials or the components of the toy, and, in 
any case, every five years.  
Article 2 3 
Technical documentation  
1. The technical documentation shall contain al l relevant data or details of the means 
used by the manufacturer to ensure that the toy compl ies with the essential  safety 
requirement s. It shall, in particular, contain  the documents listed in Annex V. EN 44  EN 2. The technical documentation shall be drawn up in one of the official languages of the 
Union . 
3. Following a reasoned request from the market surveillance authority of a Member 
State, the manufacturer shall provide a translation of the relevant parts of the  
technical documentation into the language of that Member State.  
When a market surveillance authority requests the technical documentation or a 
translation of parts thereof from a manufacturer, it may fix a deadline for receipt of 
such file or translation,  which shall be 30 days, unless a shorter deadline is justified 
in the case of serious and immediate risk  to health and safety . 
4. If the manufacturer does not comply with the requirements set out in paragraphs 1, 2 
and 3, the market surveillance authority  may require the manufacturer to have a test 
performed by a notified body at its own expense within a specified period in order to 
verify compliance with the essential safety  requirements.  
CHAPTER V I 
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES   
Article 2 4 
Notification  
Member States shall notify the Commission and the other Member States of bodies authorised 
to carry out third -party conformity assessment tasks under this Regulation . 
Article 2 5 
Notifying authorities  
1. Member States shall designate a notifyi ng authority that shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and 
notification of conformity assessment bodies for the purposes of this Regulation , and 
for the monitoring of notified bodies, including co mpliance with Article 30. 
2. Member States may decide that the assessment and monitoring referred to in 
paragraph 1 shall be carried out by a national accreditation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008.   
3. Where th e notifying authority delegates or otherwise entrusts the assessment, 
notification or monitoring referred to in paragraph 1 of this Article to a body which is 
not a governmental entity, that body shall be a legal entity and shall comply mutatis 
mutandis  with the requirements laid down in Article 2 6. In addition, that body shall 
have arrangements to cover liabilities arising out of its activities.  
4. The notifying authority shall take full responsibility for the tasks performed by the 
body referred to in paragraph 3.  EN 45  EN Article 2 6 
Requirements relating to notifying authorities  
1. A notifying authority shall be established in such a way that no conflict of interest 
with conformity assessment bod ies occurs.  
2. A notifying authorit y shall be organised and operat ed so as to safeguard the 
objectivity and impartiality of their activities.  
3. A notifying authorit y shall be organised in such a way that each decision relating to 
notification of a conformity assessment body is taken by competent persons different 
from those who carried out the assessment.  
4. A notifying authorit y shall not offer or provide any activit ies that conformity 
assessment bodies perform, nor shall they offer or provide consultancy services on a 
commercial or competitive basis.  
5. A notifying authorit y shall safeguard the confidentiality of the information they 
obtain.  
6. A notifying authorit y shall have a sufficient number of competent personnel at their 
disposal for the proper performance of their tasks.  
7. A notifying authorit y shall monitor the nature and amount of tasks performed by 
subsidiaries of or subcontractors to notified  bodies in accordance with Article 30.  
Article 2 7 
Information obligation of notifying authorities  
Member States shall inform the Commission of their procedures for the assessment and 
notification of conformity assessment bodies and the monitoring of notif ied bodies, and of 
any changes thereto.  
The Commission shall make that information publicly available.  
Article 2 8 
Requirements relating to notified bodies  
1. For the purposes of notification under this Regulation , a conformity assessment body 
shall meet th e requirements laid down in paragraphs 2 to 11.  It shall be accredited in 
accordance with Regulation (EC) No 765/2008.  
2. Conformity assessment bodies  shall be established under the national law of a 
Member State and shall have legal personality.  
3. A con formity assessment body shall be a third -party body independent of the 
organisation or the toy it assesses.  
A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufacturing, provision, as sembly, use or 
maintenance of toys which it assesses, may, on condition that its independence and 
the absence of any conflict of interest are demonstrated, be considered a third -party 
body  for the purposes of the first subparagraph . EN 46  EN 4. A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conformity assessment tasks shall not be the 
designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of 
the toys which they assess, nor the authorised representative of any of those parties. 
This shall not preclude use of the assessed toys that is necessary for the operations of 
the conformity assessment body or the use of those toys for personal purposes.  
A conformity assessme nt body, its top level management and the personnel 
responsible for carrying out the conformity assessment tasks shall not be directly 
involved in the design , manufacture, marketing, installation, use or maintenance of 
those toys, or represent the parties engaged in those activities. They shall not engage 
in any activity that may conflict with their independence of judgement or integrity in 
relation to conformity assessment activities for which they are notified. This shall in 
particular apply to consultanc y services.  
Conformity assessment bodies shall ensure that the activities of their subsidiaries or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their 
conformity assessment activities.  
5. Conformity assessment bodies and their personnel shall carry out the conformity 
assessment activities with the highest degree of professional integrity and the 
requisite technical competence in the specific field and shall be free from all 
pressures and inducements, particularly financial , which might influence their 
judgement or the results of their conformity assessment activities, especially as 
regards persons or groups of persons with an interest in the results of those activities.  
6. A conformity assessment bod y shall be capable of ca rrying out the conformity 
assessment tasks assigned to it by Annex IV  and in relation to which it has been 
notified, whether those tasks are carried out by the conformity assessment body itself 
or on its behalf and under its responsibility.   
At all times a nd for each conformity assessment procedure and each kind or category 
of toy in relation to which it has been notified, a conformity assessment body shall 
have at its disposal , or in place,  the following : 
(a) personnel with technical knowledge and sufficie nt and appropriate experience 
to perform the conformity assessment tasks;  
(b) descriptions of procedures in accordance with which conformity assessment is 
carried out , ensuring the transparency and ability of reproduction of those 
procedures ; 
(c) appropriate policies and procedures that distinguish between tasks it carries out 
as a notified body and other activities;  
(d) procedures for the performance of activities which take due account of the size 
of an undertaking, the sector in which it operate s, its structure, the degree of 
complexity of the technology of the toy in question and the mass or serial 
nature of the production process.  
A conformity assessment body shall have the means necessary to perform the 
technical and administrative tasks connected with the conformity assessment 
activities in an appropriate manner and shall have access to all necessary equipment 
or facilities.  
7. The personnel responsible for carrying out the conformity assessment activities (the 
‘assessment personnel’) shall have  the following : EN 47  EN (a) sound technical and vocational training covering all the conformity assessment 
activities in relation to which the conformity assessment body has been 
notified;  
(b) satisfactory knowledge of the requirements of the assessments th ey carry out 
and adequate authority to carry out those assessments;  
(c) appropriate knowledge and understanding of the requirements  set out in this 
Regulation , of the applicable harmonised standards referred to in Article 13  of 
this Regulation  and the  comm on specifications referred to in Article 14  of this 
Regulation ; 
(d) the ability to draw up certificates, records and reports demonstrating that 
assessments have been carried out.  
8. The impartiality of conformity assessment bodies, their top level management and 
assessment personnel shall be ensured.  
The remuneration of the top level management and assessment personnel of a 
conformity assessment body shall not depend on the number of assessments carried 
out or on the results of those assessments.  
9. Conformity assessment bodies shall take out liability insurance unless liability is 
assumed by the Member State in accordance with its national law, or the Member 
State itself is directly responsible for the conformity assessment.  
10. The personnel of a c onformity assessment body shall observe professional secrecy 
with regard to all information obtained in carrying out their tasks under Annex IV , 
except in relation to the competent authorities of the Member State in which its 
activities are carried out. Intellectual property  rights shall be protected.  
11. Conformity assessment bodies shall participate in, or ensure that their assessment 
personnel are informed of, the relevant standardisation activities and the activities of 
the notified body coordination gr oup established under Article 40, and shall apply as 
general guidance the administrative decisions and documents produced as a result of 
the work of that group.  
Article 2 9 
Presumption of conformity  of notified bodies  
Where a conformity assessment body demo nstrates its conformity with the criteria laid down 
in the relevant harmonised standards or parts thereof, the references of which have been 
published in the Official Journal of the European Union , it shall be presumed to comply with 
the requirements set o ut in Article 2 8 insofar as the applicable harmonised standards cover 
those requirements.  
Article 30 
Subsidiaries of and subcontracting by notified bodies  
1. Where a notified body subcontracts specific tasks connected with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or 
the subsidiary meets the requirements set out in Article 2 8, and shall inform the 
notifying authority accordingly.  EN 48  EN 2. Notified bodies shall take full responsibility for the tasks performed  by 
subcontractors or subsidiaries, wherever these are established.  
3. Notified bodies shall be capable of reviewing the tasks performed by the 
subcontractors or subsidiar ies in all their elements.  
4. Activities may be subcontracted or carried out by a su bsidiary only with the 
agreement of the client.  
5. Notified bodies shall keep at the disposal of the notifying authority the relevant 
documents concerning the assessment of the qualifications of the subcontractor or the 
subsidiary and the work carried out by them under Annex IV . 
Article 31 
Application for notification  
1. A conformity assessment body shall submit an application for notification under this 
Regulation  to the notifying authority of the Member State in which it is established.  
2. The application  referred to in paragraph 1 shall be accompanied by a description of 
the conformity assessment activities  and the toys  for which that body claims to be 
competent, as well as by an accreditation certificate  issued by a national accreditation 
body attesting that the conformity assessment body fulfils the requirements laid 
down in Article 2 8. 
Article 32 
Notification procedure  
1. Notifying authorities may only notify conformity assessment bodies which have 
satisfied the requirements laid down in Article 2 8. 
2. Notifying authorities shall notify conformity assessment bodies to the Commission 
and the other Member States using the electronic notification tool developed and 
managed by the Commission.  
3. The notification shall include full details of the conformity a ssessment activities and 
the relevant accreditation certificate . The notification shall also include information 
on any tasks to be performed by subsidiaries and subcontractors.  
4. The body concerned may perform the activities of a notified body only where  no 
objections are raised by the Commission or the other Member States within two 
months  of a notification.  
Only such a body shall be considered a notified body for the purposes of this 
Regulation . 
5. The notifying authority shall inform t he Commission and  the other Member States of 
any subsequent relevant changes to the notification.  
Article 33 
Identification numbers and lists of notified bodies  
1. The Commission shall assign an identification number to each notified body.  
It shall assign a single identifi cation number even where the same body is notified 
under several Union  acts. EN 49  EN 2. The Commission shall make publicly available a list of bodies notified under this 
Regulation , including the identification numbers that have been assigned to them and 
the activities for which they have been notified.  
The Commission shall ensure that the list is kept up to date.  
Article 3 4 
Changes to notifications  
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the req uirements laid down in Article 2 8, or that it is failing to fulfil 
its obligations, the notifying authority shall restrict, suspend or withdraw the 
notification as appropriate, depending on the seriousness of the failure to meet those 
requirements or fulfi l those obligations. It shall immediately inform the Commission 
and the other Member States accordingly.  
2. In the event of restriction, suspension or withdrawal of notification, or where the 
notified body has ceased its activity, the notifying Member Stat e shall take 
appropriate steps to ensure that the files of that body are either processed by another 
notified body or kept available to the responsible notifying authorities and market 
surveillance authorities, at their request.  
Article 3 5 
Challenge to the  competence of notified bodies  
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its 
attention regarding, the competence of a notified body or the continued fulfilment by 
a notified body of the requirements and responsib ilities to which it is subject.  
2. The notifying authority  shall provide the Commission, on request, with all 
information relating to the basis for the notification or the maintenance of the 
competence of the body concerned.  
3. The Commission shall ensure that all sensitive information obtained in the course of 
its investigations is treated confidentially.  
4. Where the Commission ascertains that a notified body does not meet the 
requirements for notification, it shall , by means  of an implementing act, request  the 
notifying authority to take the necessary corrective measures, including the 
withdrawal of the notification if necessary.  
Article 3 6 
Operational obligations of notified bodies  
1. A notified bod y shall carry out conformity assessments in accordance with the 
conformity assessment procedure provided for in Annex IV . 
2. Notified bod ies shall carry out the conformity assessment  activities set out in this 
Regulation  in a proportionate manner, avoiding unnecessary burdens for economic 
operators. They shall perform their activities under this Regulation taking due 
account of the size of an undertaking, the sector in which it operates, its structure, the 
degree of complexity of the technology of the toy in  question and the mass or serial 
nature of the production process.  EN 50  EN When performing their activities, the notified bod ies shall respect the degree of 
rigour and the level of protection required for the compliance of the toy with this 
Regulation . 
3. Where a notified body finds that the toy does not meet the essential safety 
requirement s, the requirements in corresponding harmonised standards , where such 
standards are applied  or the requirements in corresponding common specifications 
referred to in Article 14 , where  such specifications are applied,  it shall require that 
manufacturer to take appropriate corrective measures and shall not issue an EU-type 
examination certificate as referred to in Part II, point 6,  of Annex IV . 
4. Where, in the course of the monitoring of conformity following the issue of a E U-
type examination certificate, a notified body finds that a toy is no longer in 
compliance, it shall require the manufacturer to take appropriate corrective measures, 
and shall suspend or withdraw the  EU-type examination certificate if necessary.  
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any E U-type examination 
certificates, as appropriate.  
6. Where a notified bo dy is informed by a market surveillance authority that a toy for 
which the notified body  has issued a EU -type examination certificate is not in 
conformity with the essential  safety requirement s, it shall withdraw the E U-type 
examination certificate in resp ect of that toy.  
Article 3 7 
Appeals against decisions of notified bodies  
A notified body shall ensure that a transparent and accessible appeals procedure against its 
decisions is available.  
Article 3 8 
Information obligation of notified bodies  
1. Notified  bodies shall inform the notifying authority of the following:  
(a) any refusal, restriction, suspension or withdrawal of an E U-type examination 
certificate;  
(b) any circumstances affecting the scope of and conditions for their notification;  
(c) any request  for information which they have received from market surveillance 
authorities regarding conformity assessment activities;  
(d) on request, conformity assessment activities performed within the scope of 
their notification, and any other activity performed, including cross -border 
activities and subcontracting.  
2. Notified bodies shall provide the other bodies notified under this Regulation  which 
carry out similar conformity assessment activities covering the same toys with 
relevant information on issues relat ing to negative and, on request, positive 
conformity assessment results.   
3. Notified bodies shall, further to a reasoned request from a market surveillance 
authority, provide it with all the information and documentation that relates to any 
EU-type examination certificate which they have issued or withdrawn, or that relates EN 51  EN to any refusal to issue such a certificate, including test reports , and the technical 
documentation referred to in Article 23.  
Article 3 9 
Exchange of experience  
The Commission sha ll provide for the organisation of exchange of experience between the 
Member States' national authorities responsible for notification policy.  
Article 40 
Coordination of notified bodies  
The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified under this Regulation  are put in place and properly operated in the form of a sectoral 
group or groups of notified bodies.  
Notified bodies shall participate i n the work of that group or groups, directly or by means of 
designated representatives.  
CHAPTER VI I 
MARKET SURVEILLANCE  
Article 41 
Procedure for dealing with toys presenting a risk  at national level  
1. Where the market surveillance authorities of one Member State have sufficient 
reason to believe that a toy covered by this Regulation  presents a risk to the health or 
safety of persons, they shall carry out an evaluation in relation to the toy concerned 
covering all the requirements laid down in this Regulation . The relevant economic 
operators shall cooperate , as necessary , with the market surveillance authorities  for 
that purpose . 
Where, in the course of that evaluation, a market surveillance authorit y finds that a 
toy does not comply with the requirements laid down in this Regulation , it shall 
without delay require the relevant economic operator to take appropriate corrective 
action  in accordance with Article 16 (3) of Regulation  (EU)  2019/1020  within a 
reasonable period  of time prescribed by the market surveillance authorit y and taking 
into account  the nature of the risk . 
The market surveillance authorities shall inform the relevant notified body 
accordingly.  
2. Where the market surveillance authorities consider that non -compliance is not 
restricted to their national territory, they shall inform the Commission and the other 
Member States of the results of the evaluation and of the actions which they have 
required the relevant economic operator to take.  
3. The economic operator shall ensure that appropriate corrective action is taken in 
respect of all the concerned toys that the economic  operator has made available on 
the market  throughout the Union . EN 52  EN 4. Where the relevant economic operator does not take ade quate corrective action 
within the period referred to in paragraph  1, second subparagraph , the market 
surveillance authorities shall take appropriate provisional measures to prohibit or 
restrict the toy being made available on their national market, to wit hdraw the toy 
from that market or to recall it.  
The market surveillance authorities shall inform the Commission and the other 
Member States, without delay, of those measures.  
5. The information referred to in paragraph 4 , second subparagraph,  shall include  all 
available details, in particular the data necessary for the identification of the non -
compliant toy  including the unique product identifier , the origin of th at toy, the 
nature of the alleged non -compliance and the risk involved, the nature and duratio n 
of the national measures taken and the arguments put forward by the relevant 
economic operator. In particular, the market surveillance authorities shall indicate 
whether the non -compliance is due to any of the following : 
(a) failure of the toy to meet the essential  safety requirements;  
(b) shortcomings in the harmonised standards referred to in Article  13; 
(c) shortcomings in the common  specifications referred to in Article 14. 
6. Market surveillance authorities of Member States other than the Member S tate 
initiating the procedure under this Article shall without delay inform the Commission 
and the other Member States of any measures adopted and of any additional 
information at their disposal relating to the non -compliance of the toy concerned, 
and, in the event of disagreement with the notified national measure, of their 
objections.  
7. Where, within 3 months of receipt of the information referred to in paragraph 4, 
second subparagraph,  no objection has been raised by either a market surveillance 
authori ty of a Member State or the Commission in respect of a provisional measure 
taken by a Member State, that measure shall be deemed to be justified.  
8. Market surveillance authorities of other Member States shall ensure that appropriate 
restrictive measures, such as withdrawal of the toy from their market, are taken 
without delay in respect of the toy concerned , and shall inform the Commission and 
the other Member States of those measures . 
9. The information referred to in  paragraphs 2, 4, 6 and 8 of this Article shall be 
communicated through the information and communication system referred to in 
Article 34 of Regulation  (EU)  2019/1020 . That communication shall not affect the 
obligation  on market surveillance authorities t o notify measures taken against 
products presenting a serious risk in accordance with Article 20 of Regulation (EU) 
2019/1020 . 
Article 42 
Union  safeguard procedure  
1. Where, on completion of the procedure set out in Article 41(3) and (4), objections 
are raised against a measure taken by a Member State, or where the Commission has 
reason s to believe that a national measure could be contrary to Union  legislation, the 
Commission shall without delay enter into consultation with the  Member States and 
the relevant economic operator or operators and shall evaluate the national measure.  EN 53  EN On the basis of the results of that evaluation, the Commission shall adopt an 
implementing act determining  whether the national measure is justified or not.  
The Commission shall address its decision to all Member States and shall without 
delay  communicate it to them and the relevant economic operator or operators.   
2. If the national measure is considered justified, all Member States shall take the 
measures necessary to ensure that the non -compliant toy is withdrawn or recalled 
from their market, and shall inform the Commission accordingly.  
If the national measure is co nsidered unjustified, the Member State concerned shall 
withdraw it.  
3. Where the national measure is considered to be justified and the non -compliance of 
the toy is attributed to shortcomings in the harmonised standards  referred to in 
Article 13 of this Re gulation or the common specifications referred to in Article 14 
of this Regulation , the Commission shall apply the procedure provided for in Article 
11 of Regulation (EU) No 1025/2012  or amend  the common specifications as 
appropriate .  
Article 4 3 
Formal non-compliance  
1. Without prejudice to Article 41, where a market surveillance authority  makes one of 
the following findings  with regard to a toy , it shall require the relevant economic 
operator to put an end to the non -compliance concerned:  
(a) the CE mar king has been affixed in violation of Article 15 or 16; 
(b) the CE marking has not been affixed;  
(c) the produc t passport has not been drawn up in accordance with Article 1 7; 
(d) the data carrier through which the product passport is accessible has not bee n 
affixed  in accordance with Article 1 7(5); 
(e) the technical documentation referred to in Article 23 is eithe r not available or 
not complete.  
2. Where the non -compliance referred to in paragraph 1 persists, the market 
surveillance authority  concerned shall take appropriate measures to restrict or 
prohibit the making available on the market  of the toy , or ensure that the toy is 
recalled or withdrawn from the market.  
Article 4 4 
National measures concerning toys which are compliant with the par ticular safety 
requirements but which present a risk  
1. Where, having carried out an evaluation under Article 41(1), a market surveillance 
authority  finds that , although a toy made available on the market is in compliance 
with the particular safety  requirements it poses a  risk to the health and safety of 
persons , it shall  require the relevant economic operator to take all appropriate 
measures , within a reasonable period of time prescribed by the market surveillance 
authority taking into account  the n ature of the risk  to ensure that the toy, when made 
available on the market, no longer presents that risk, to withdraw the toy from the 
market or to recall it.  EN 54  EN 2. The economic operator shall ensure that corrective action is taken in respect of all the 
toys concerned that the economic operator has made available on the market  
throughout the Union .  
3. The market surveillance authority of the Member State shall immediately inform the 
Commission and the other Member States  of its findings and any subsequent actions  
taken by the economic operator . That information shall include all available details, 
in particular the data necessary for the identification of the toy concerned  including 
the unique product identifier , the origin and the supply chain of the toy, the nature of 
the risk involved and the nature and duration of the national measures taken.  
4. The Commission shall without delay enter into consultation with the Member States 
and the relevant economic operator or operators and shall evaluate the national  
measures taken. On the basis of the results of that evaluation, the Commission shall 
adopt an implementing act determining whether the national measure is justified or 
not and, where necessary, propos e appropriate measures.  
The Commission shall address i ts decision to all Member States and shall 
immediately communicate it to them  and the relevant economic operator or 
operators.  
5. The information referred to in paragraph 3 of this Article shall be communicated 
through  the information and communication system referred to in Article 34 of 
Regulation (EU) 2019/1020.  That communication shall not affect the obligation on 
market surveillance authorities to notify measures taken against products presenting 
a serious risk in a ccordance with Article 20 of Regulation (EU) 2019/1020.  
Article  45  
Commission action concerning toys that present a risk  
1. Where  the Commission becomes aware of a toy  or a specific category of toys  made 
available on the market  which present s a risk to the health and safety of persons  but 
is nonetheless  either in compliance with the particular safety  requirements or raising 
doubts about such compliance , it is empowered to  adopt implementing acts setting 
out measures to ensure that the toy  or category of toys , when made available on the 
market, no longer presents that risk, to withdraw it from the market or to recall it  
where all of the following conditions are met : 
(a) it emerges from prior consultations with the market surveillance authorities  that 
their approaches to deal ing with the risk differ  from one market surveillance 
authority to another ; 
(b) the risk cannot , in view of its nature,  be dealt with  under other procedures laid 
down by this Regulatio n. 
2. Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article 50(3). On duly justified imperative grounds of 
urgency relating to the protection of the health and safety of persons, the 
Commission is empowered to adopt an immediately applicable implementing act in 
accordance with the procedure referred to in Article 50(4). EN 55  EN CHAPTER VII I  
DELEGATED POWERS AND COMMITTEE PROCEDURE  
Article 4 6  
Delegated powers  
1. The Commission is empowered to adopt delegated acts in accordance with Article 4 7 
to amend Annex VI as regards the information to be provided in the product 
passport, in order to adapt  it to technical and scientific progress and to the level of 
digital readiness of market surveillance authorities and of use rs and their supervisors.  
2. The Commission is empowered to adopt delegated acts in accordance with Article 4 7 
to amend Article 1 9(1) by setting out that additional information among the 
information listed in Annex VI  or that information on the non -compli ance of the toy  
when measures are taken in accordance with Articles 41(2) or (4) and Article 44(1)  is 
to be stored in the registry.  
When adopting the delegated acts in accordance with the first subparagraph, the 
Commission shall take into account the foll owing criteria:  
(a) coherence with other relevant Union acts , where relevant;  
(b) the need to allow for the verification of the authenticity of the product passport;  
(c) the relevance of the information for improving the efficiency and effectiveness 
of market surveillance checks and customs controls for toys;  
(d) the need to avoid disproportionate administrative burden for economic 
operators.  
3. The Commission is empowered to adopt delegated acts in accordance with Article 4 7 
to supplement this Regulatio n by determining which of the  information stored in the 
registry is to be controlled by customs authorities , in addition to the information set 
out in Article 20(3) .  
4. The Commission is empowered to  adopt delegated acts in accordance with Article 4 7 
to amend Annex VII to this Regulation in order to adapt  the list of commodity  codes  
and product descriptions  to be used for the purposes of Article 20( 8). Th ose 
adaptations  shall be based on the list set out in Annex I to Regulation (EEC) No 
2658/87.  
5. The Commission is empowered to adopt delegated acts in accordance with Article 4 7 
to amend Annex III in order to adapt it to technical and scientific progress.  
6. The Commission is empowered to adopt delegated act s in accordance with Article  47 
to amend Part C of the Appendix to Annex II  in order to permit a certain use in toys 
of a specific substance or mixture that is prohibited under Part III , point 4,  of Annex 
II, or to limit a certain use that has been permitted .  
7. The use in toys of a substance or mixture prohibited under Part III, point 4 , of Annex 
II may only be permitted when all of the following conditions are met:  
(a) it has been found to be safe by the European Chemicals Agency (ECHA), in 
particular in view of exposure , including the overall e xposure from other 
sources, and taking particular account of the vulnerability of children;  EN 56  EN (b) there are no suitable alternative substances or mixtures available, as established 
by ECHA based on an analysis of alternatives;  
(c) the substance or mixture i s not prohibited for use in consumer articles under 
Regulation (EC) No 1907/2006.  
8. The Commission is empowered to adopt delegated acts in accordance with Article 4 7 
to amend  Parts A  and B of the  Appendix  to Annex II  in order to adapt them to 
technical and scientific progress, by : 
(a) introduc ing conditions for the presence of substances or mixtures in toys and, 
in particular, limit values for specific  substances or mixtures in toys , including 
limit values for traces of prohibited substance s or mixtures  as referred to in 
Part III , point 4, of Annex II ;  
(b) modifying the conditions or limit values for the presence of substances and 
mixtures in toys.  
9. For the purposes of paragraphs 6 and 7, the Commission shall systematically and 
regularly evaluate the occurrence of hazardous chemical substances or mixtures in 
toys. In those evaluations , the Commission  shall take into account reports of market 
surveillance bodies and scientific evidence presented by Member States and 
stakeholders.  
Article 47 
Exercise of the delegation  
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article.  
2. The power to adopt delegated acts  referred to in Article 4 6 shall be conferred on the 
Commission for a n indeterminate period of time .  
3. The delegation of powers referred to in Article 4 6 may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke shall put an end to the 
delegation of the power specified in that decision.  It shall take effect the day 
following the publication of the decision in the Official Journal of the European 
Union or at a later date specified therein. It shall not affect the validity of any 
delegated acts already in force.  
4. Before adopting a deleg ated act, the Commission shall consult experts designated by 
each Member State in accordance with the principles laid down in the 
Interinstitutional Agreement of 13 April 2016 on Better Law -Making.  
5. As soon as it adopts a delegated act, the Commission sh all notify it simultaneously to 
the European Parliament and to the Council.  
6. Delegated act s adopted pursuant to Article 4 6 shall enter into force only if no 
objection has been expressed either by the European Parliament or by the Council 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the Council have both informed the Commission that they will not object. That 
period shall be e xtended by two months at the initiative of the European Parliament 
or of the Council.  EN 57  EN Article 48 
Requests for assessment for the purposes of Article 46(6)  
1. Requests for an assessment of a substance or mixture prohibited under Part III, point 
4, of Anne x II for the purposes of Article 46(6)  shall be submitted to ECHA using 
the format and submission tools referred to in paragraph 3 of this Article.  
2. Any person submitting a request for assessment under paragraph 1 may request that 
certain information is  not to be made publicly available. The request for 
confidentiality shall be accompanied by a justification as to why the disclosure of the 
information could be harmful to the commercial interests of the person submitting 
the request for assessment or of a ny other party concerned.  
3. ECHA shall draw up and make publicly available a format and tools for the 
submission of requests for assessment referred to in paragraph 1 as well as technical 
and scientific guidance on how to submit such requests.  
Article  49 
Opinions from ECHA  
1. For the purposes of Article 46(6), ECHA shall provide opinion s to the Commission 
on the use in toys of substances or mixtures that are prohibited under Part III, point 4 
of Annex II, where a request for an assessment is submitted to it in accordance with 
Article 48(1). ECHA shall assess in its opinions  whether the criteria set out in Article 
46(6), second  subparagraph , points  (a) and (b), are met  for a specific use . 
2. ECHA may request the person submitting the request for assessment or any third 
party to submit additional information within a specified period. ECHA shall take 
into account any information submitted by third parties.   
3. The opinions  referred to in paragraph 1 shall be sent to the Commission within a 
period of 12 months from the receipt of the request for an assessment.  
4. That period may be extended once by a period of up to 6 months if ECHA needs to 
request information from a third  party or if a high number of requests for assessment 
are submitted to ECHA under Article 48(1). 
5. ECHA shall re -evaluate its opinions on the use in toys of substances or mixtures 
listed in Part C of the Appendix to Annex II at least every 5 years from th e date of 
entry into force of a delegated act adopted in accordance with Article 46(6).  
6. The Commission shall request an opinion from ECHA on the use in toys of 
substances or mixtures listed in Part C of the Appendix to Annex II as soon as new 
scientifi c information that may affect the permitted use of a specific substance or 
mixture in toys becomes known to the Commission .  
7. For the purposes  of Article 46(7), the Commission may request an opinion from 
ECHA  on the safety of a specific substance or mixt ure in toys, which shall take into 
consideration the overall exposure to the substance or mixture from other sources 
and the vulnerability of children.  
8. When preparing an opinion in accordance with the provisions set out in this Article, 
ECHA shall make  publicly available the information on the start of the assessment, 
the adoption of the opinion as well as any intermediate steps in the assessment 
procedure. In particular, ECHA shall make the draft opinions publicly available and EN 58  EN provide an opportunity f or any interested party to comment on those opinions within 
a period of at least 4 weeks.  
Article 50 
Committee procedure  
1. The Commission shall be assisted by a Committee on Toy Safety. That committee 
shall be a committee within the meaning of Regulation (EU) No 182/2011.  
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 
182/2011 shall apply.  
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 
182/2011 shall apply.  
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 
182/2011, in conjunction with Article 5 thereof, shall apply.  
CHAPTER I X  
CONFIDENTIALITY AND PENALTIES  
Article 51 
Confidentiality  
1. Competent national authorities, notified bodie s and the Commission shall respect the 
confidentiality of the following information and data obtained in carrying out their 
tasks in accordance with this Regulation:  
(a) personal data;  
(b) commercially confidential information and trade secrets of a natur al or legal 
person, including intellectual property rights, unless disclosure is in the public 
interest.  
2. Without prejudice to paragraph  1, information exchanged on a confidential basis 
between the competent national authorities and between competent national 
authorities and the Commission shall not be disclosed without taking into account the 
opinion of  the o riginating competent national authority.  
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, 
Member  States and notified bodies with regard to the exchange of information and 
the dissemination of warnings, or the obligations  of the persons concerned to provide 
information under criminal law.  
4. Member States and t he Commission may exchange confidential information with 
regulatory authorities of third countries with which they have concluded bilateral or 
multilateral confident iality arrangements.  
Article 52  
Penalties  
Member States shall lay down the rules on penalties applicable to infringements of this 
Regulation and shall take all measures necessary to ensure that they are implemented . The 
penalties provided for shall be eff ective, propor tionate and dissuasive .. Member States by … EN 59  EN [P.O. inse rt date: the first day of the month following 30 months after the date of entry into 
force of this Regulation ] notify the Commission of those rules and shall notify it  without 
delay of any subsequent amendment affecting them.  
CHAPTER X  
FINAL PROVISIONS  
Article 53 
Repeal  
Directive 2009/48/EC is repealed with effect from … [ OP: please  insert the date = the first 
day of the month following 30 months after the date of e ntry into force of this Regulation ].  
References to the repealed Directive 2009/48/EC  shall be construed as references to this 
Regulation  and shall be read in accordance with the correlation table in Annex VIII. 
Article  54 
Transitional provisions  
1. Toys placed on the market in conformity  with Directive 2009/48/EC before … [OP 
please insert the date = the first day of the month following 30 months after the date 
of entry into force of this Regulation] may continue to be made available on the 
market unt il … [OP please insert the date = the first day of the month following 42 
months after the date of entry into force of this Regulation] . 
2. Chapter VI I of this Regulation shall apply mutatis mutandis instead of Article 42, 43 
and 45  of Directive  2009/48/EC  to toys which were placed on the market in 
conformity with that Directive before … [PO insert date: the first day of the month 
following 30 months after the date of entry into force of this Regulation] , including 
toys for which a procedure has already been initiated under Article 42 or 43  of 
Directive 2009/48 /EC before … [PO insert date: the first day of the month following 
30 months after the date of entry into force of this Regulation] . 
3. EC type -examination certifi cates issued in accordance with Article 20 of Directiv e 
2009/48 /EC shall remain valid until … [ PO insert date: the first day of the month 
following 42 months after the date of entry into force of this Regulation ], unless they 
expire before that date.  
Article 55 
Evaluation and review  
1. By … [OP please insert the date = the first day of the month following 60 months 
after the date of entry into force of this Regulation ] and every 5 years thereafter, the 
Commission shall carry out an  evaluation of this Regulation . The Commission shall 
submit a report  to the European Parliament and to the Council  on the main findings .  
2. Where the Commission finds it appropriate, the report shall be accompanied by a 
legislative proposal for amendment of the relevant provisions of this Regulation.  EN 60  EN Article 56 
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from … [ OP please insert the date = the first da y of the month following 30 
months after the date of entry into force of this Regulation ]. 
However,  Articles 17(10), 24 to 40 , and 46 to 52, shall apply from …  [OP: please insert the 
date of entry into force of this Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President