COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the document PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the safety of toys and repealing Directive 2009/48/EC
Date: 2023-07-28
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, child, free movement of goods, market approval, product safety, safety standard, technical standard, toy industry

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   EUROPEAN COMMISSION  Brussels, 28.7.2023  SWD(2023) 269 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT REPORT    Accompanying the document PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the safety of toys and repealing Directive 2009/48/EC  {COM(2023) 462 final} - {SEC(2023) 297 final} - {SWD(2023) 268 final} - {SWD(2023) 270 final}  
 
 
Table of contents 

1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 5 

1.1.  Regulatory context: the Toy Safety Directive ................................................... 5 
1.2.  Link with other initiatives ................................................................................. 7 
1.3.  Economic context: The market for toys in the EU .......................................... 10 

2. 

PROBLEM DEFINITION .................................................................................................................. 11 

2.1.  What are the problems? ................................................................................... 11 
Problem 1- Insufficient protection of children from harmful chemicals ................ 11 
2.1.1. 

2.1.2. 
Problem 2- A high number of toys on the Union market do not comply with the Toy 
Safety Directive and are unsafe ............................................................................................. 15 

2.1.3.  New risks in toys, in particular from digital technologies ...................................... 17 

2.2.  What are the problem drivers? ........................................................................ 18 
Problem 1- Insufficient protection of children from harmful chemicals ................ 18 
2.2.1. 

Problem 2- A high number of toys on the Union market do not comply with the Toy 
2.2.2. 
Safety Directive and are unsafe ............................................................................................. 20 

2.3.  How likely is the problem to persist? .............................................................. 23 

3.  WHY SHOULD THE EU ACT? ........................................................................................................ 24 

3.1.  Legal basis ....................................................................................................... 24 
3.2.  Subsidiarity: Necessity of EU action ............................................................... 24 
3.3.  Subsidiarity: Added value of EU action .......................................................... 24 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 25 

4.1.  General objectives ........................................................................................... 25 
4.2.  Specific objectives ........................................................................................... 25 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 26 

5.1.  What is the baseline from which options are assessed? .................................. 26 
5.2.  Description of the policy options .................................................................... 29 
Policy options to strengthen the protection of children when playing with toys .... 29 
5.2.1. 

5.2.2. 

Policy options to reduce the number of non-compliant and unsafe toys ................ 32 

5.3.  Options discarded at an early stage ................................................................. 34 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 35 

6.1.  Policy option 1a – minimum changes to the Directive .................................... 36 
6.2.  Policy  option  1b  –  Improved  protection:  generic  bans  of  the  most  harmful 

substances with derogations ............................................................................ 39 

6.3.  Policy  option  1c  –  Maximum  protection:  generic  bans  of  the  most  harmful 

substances without derogations ....................................................................... 43 
6.4.  Policy option 2a: extending third-party conformity assessment ..................... 47 
6.5.  Policy option 2b: facilitation of market surveillance through digitalisation ... 49 
6.6.  Policy option 2c: Extending third party conformity assessment and facilitation of 

market surveillance through digitalisation ...................................................... 52 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................ 53 

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7.1.  Effectiveness of the proposed policy options .................................................. 53 
Impacts of policy options ................................................................................ 55 
7.2. 
7.3.  Summary of policy options assessment ........................................................... 57 

8. 

PREFERRED OPTION ...................................................................................................................... 58 

8.1.  Legal instrument: converting the Directive into a Regulation ........................ 60 
8.2.  REFIT (simplification and improved efficiency) ............................................ 60 
8.3.  Application of the ‘one in, one out’ approach ................................................. 61 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 61 

ANNEXES.................................................................................................................................................... 63 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 63 

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................ 66 

ANNEX 3: WHO IS AFFECTED AND HOW? .......................................................................................... 77 

ANNEX 4: ANALYTICAL METHODS ..................................................................................................... 81 

ANNEX 5. SME TEST SUMMARY ........................................................................................................... 93 

ANNEX 6: LEGAL CONTEXT: MAIN PROVISIONS OF THE TOY SAFETY DIRECTIVE AND MARKET 

SURVEILLANCE .............................................................................................................................. 95 

ANNEX 7: TOYS MARKET ..................................................................................................................... 109 

ANNEX 8: CONCLUSIONS OF THE EVALUATION OF THE TSD..................................................... 120 

ANNEX 9: EU CHEMICALS LEGISLATION ......................................................................................... 125 

ANNEX 10: THE MOST HARMFUL CHEMICALS CURRENTLY NOT ADDRESSED BY THE TSD132 

ANNEX 11: NON-COMPLIANT TOYS ON THE UNION MARKET .................................................... 152 

ANNEX 12: DIGITAL ASPECTS AND INTERNET-CONNECTED TOYS .......................................... 159 

ANNEX  13:  DIGITAL  PRODUCT  PASSPORT  UNDER  THE  PROPOSAL  FOR  AN  ECODESIGN  FOR 

SUSTAINABLE PRODUCTS REGULATION ............................................................................... 164 

ANNEX 14: IMPACTS OF THE OPTIONS ............................................................................................. 165 

ANNEX 15: BIBLIOGRAPHY .................................................................................................................. 215 

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Glossary 

Term or acronym 

Meaning or definition 

AI 

AdCo 

CASP 

CE 

CEN 

Artificial Intelligence 

Administrative Cooperation 

Coordinated Actions on the Safety of Products 

European conformity marking 

European Committee for Standardization 

CENELEC 

European 
Standardization 

Committee 

for 

Electrotechnical 

CLP 

Classification, Labelling and Packaging 

CLP Regulation 

CMR 

CSS 

DoC 

DPP 

EC 

ED 

EN 

ESO(s) 

ESPR 

ETSI 

Regulation  (EC)  No  1272/2008  of 
the  European 
Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and 
mixtures, amending and repealing Directives 67/548/EEC 
and  1999/45/EC,  and  amending  Regulation  (EC)  No 
1907/2006. 

Carcinogenic, Mutagenic or toxic for Reproduction 

Chemicals Strategy for Sustainability 

Declaration of Conformity 

Digital Product Passport 

European Commission 

Endocrine Disruptors 

European Standard 

European Standardisation Organisation(s) 

Proposal  for  an  Ecodesign  for  Sustainable  Products 
Regulation 

European Telecommunications Standards Institute 

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EU 

GPSD 

IA 

IoT 

IDB 

MS 

MSA 

NB 

OJEU 

European Union 

General Product Safety Directive 

Impact Assessment 

Internet of Things 

European Injuries Database 

Member State(s) 

Market Surveillance Authority(ies) 

Notified Body(ies) 

Official Journal of the EU 

PBTs and vPvBs 

persistent,  bioaccumulative  and  toxic  substances,  and 
very persistent and very bioaccumulative substances 

PROSAFE 

RAPEX 

REACH 

RED 

RoHS 

RPS  

SCCS 

SCHEER 

SME(s) 

TIE 

TSD 

Product Safety Forum of Europe 

EU  Rapid  Exchange  System  for  dangerous  non-food 
products 

Registration, Evaluation, Authorisation and Restriction of 
Chemicals 

Radio Equipment Directive 

Restriction of Hazardous Substances 

Regulatory Procedure with Scrutiny 

Scientific Committee on Consumer Safety 

Scientific  Committee  on  Health,  Environmental  and 
Emerging Risks 

Small- and Medium-sized Enterprise(s) 

Toy Industries of Europe 

Toy Safety Directive 

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1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

Play is an essential part of growing up: children discover the world and develop their capabilities 
through play. However, toys have to be safe for children. They are regulated by Directive 2009/48/EC 
on  the  safety  of  toys  (the  Toy  Safety  Directive,  TSD)1.  This  Directive  lays  down  the  safety 
requirements that toys must meet in order to be placed on the market in the EU, whether they are 
manufactured in the EU or in third countries. At the same time, the Directive aims at ensuring the 
free movement of toys within the Single Market.  
The Commission Evaluation of the Toy Safety Directive2 (the Evaluation) identified a number of 
deficiencies that have emerged during the practical application of the TSD since its adoption 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 a high number of unsafe toys on the Union market3. 
The  Chemicals  Strategy  for  Sustainability4  (the  CSS)  called  for  extending  the  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 aimed at 
strengthening the TSD with regard to the protection from the risks of the most harmful chemicals and 
with regard to possible combination effects of chemicals. Although the Directive already prohibits 
generally substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs) in toys, it 
does  not  refer  to  other  substances  of  particular  concern  such  as  endocrine  disruptors,  substances 
affecting the immune, neurological or respiratory systems or substances toxic to a specific organ.  

Finally, on 16 February 2022 the European Parliament adopted almost unanimously an own initiative 
report on the implementation of the Toy Safety  Directive5.  In its report, the European Parliament 
calls on the Commission to revise the Directive to strengthen the protection of children from chemical 
risks, ensure that risks posed by connected toys are addressed by EU law and improve enforcement 
of the Directive in particular in relation to online sales.  

Given the objectives of this initiative of better protecting children from harmful chemicals, as well 
as  reducing  the  number  of  unsafe  toys  on  the  Union  market,  it  is  expected  to  contribute  most 
significantly to  the United Nations  Sustainable  Development  Goal  (SDG) #3 for  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. 

1.1.  Regulatory context: the Toy Safety Directive 

The TSD is an EU product harmonisation measure which has the twofold objective (1) to maintain a 
high level of safety for children and protection against possible health threats from toys, while (2) 
allowing the free movement of toys in the internal market. 

The scope of the Toy Safety Directive covers all ‘products designed or intended, whether or not 
exclusively, for use in play by children under 14 years of age’.6  The Directive explicitly excludes 

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  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1852-Evaluation-of-the-Toy-Safety-Directive 
3 See annex 8 for an overview of the conclusions of the Evaluation. 
4 
towards-toxic-free_en 
5 https://www.europarl.europa.eu/doceo/document/A-9-2021-0349_EN.html 
6 Article 2.1 of the Toy Safety Directive. 

https://ec.europa.eu/knowledge4policy/publication/communication-com2020667-chemicals-strategy-sustainability-

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certain products from its scope7. Moreover, Annex I to the TSD enumerates examples of products 
that  are  not  considered  to  be  toys  but  could  be  confused  with  toys8.  In  this  Annex,  the  Directive 
excludes from its scope “electronic equipment, such as personal computers and game consoles, used 
to access interactive software and their associated peripherals…” and “interactive software, intended 
for  leisure  and  entertainment,  such  as  computer  games,  and  their  storage  media,  such  as  CDs”. 
Therefore,  whilst  a  physical  toy  which  has  play  value  and  incorporates  software  would  be 
considered a toy within the scope of the  Directive (for  example, a talking doll or animal), a 
videogame or other similar software would not. 

The TSD lays down the safety criteria (‘essential safety requirements’) that toys must meet to be 
marketed in the EU. The essential safety requirements are designed to ensure a high level of safety; 
they cover identified hazards related to the characteristics of the toy or to its performance.9 Essential 
requirements are supported by harmonised standards, which set out the technical specifications to 
comply with the essential requirements and once referenced in the Official Journal of the EU, provide 
presumption of conformity with the essential requirements they aim to cover. 

The essential safety requirements in the Toy Safety Directive cover: 

  general  risks:  the  health  and  safety  of  children,  as  well  as  other  people  such  as  parents  or 

supervisors; 

  particular  risks:  physical  and  mechanical,  flammability,  chemical,  electrical,  hygiene  and 
radioactivity risks. In particular, as regards chemical risks, there is  (i) a general prohibition of 
CMR substances subject to derogations, (ii) specific limit values for specific CMR substances 
(nitrosamines and nitrosatable substances), as well as for 19 ‘elements’ in different toy materials, 
(iii) prohibitions of certain allergenic fragrances and labelling requirements for others, and (iv) 
specific limit values in toys for children under 36 months or to be put in the mouth. 

In order to keep pace with latest technical and scientific developments, the Commission can amend 
certain parts of the TSD via the Regulatory Procedure with Scrutiny (RPS).10 The Commission may 
adapt Annex I that lists examples of products that are not toys (but may be confused with them), the 
list of prohibited allergenic fragrances and the list of allergenic fragrances to be labelled in Annex II. 
It  may  adapt  the  limit  values  for  heavy  metals  and  other  hazardous  metals  in  Annex  II,  and  the 
warnings for toys in Annex V. In addition, the Commission may establish maximum limit values for 
any  chemical  in  toys  intended for children under 36 months  of age and in all toys intended to  be 
placed in the mouth, and it may also amend those limits (Appendix C to Annex II). Since its adoption 
the  TSD  has  thus  been  amended  17  times11.  Finally,  the  Commission  may  allow  the  use  of 
chemicals that are carcinogenic, mutagenic or toxic to reproduction (CMRs), albeit only following a 
strict scientific-technical assessment including an independent Scientific Committee.  

The TSD requires that conformity assessment is carried out to verify whether a toy complies with 
the  applicable  essential  requirements.  It  is  to  be  carried  out  by  the  manufacturer  or  with  the 
intervention of a third party – a ‘Notified Body’ test laboratory that has been previously designated 
at EU level for the purposes of such assessments under the TSD. The TSD requires the intervention 
of a Notified Body only in certain cases, in particular when harmonised standards do not cover all 
relevant  safety  requirements  or  when  the  toy  manufacturer  has  not  applied  such  harmonised 

7  For example, slings and catapults or playground equipment intended for public use (see article 2.2 of the TSD). 
8  For example, decorative objects for festivities or celebrations, fashion accessories for children, or puzzles with more 
than 500 pieces. 
9 The ‘Blue Guide’ on the implementation of EU product rules, p. 32.   
https://ec.europa.eu/growth/content/%E2%80%98blue-guide%E2%80%99-implementation-eu-product-rules-0_en  
10 Article 46 of the Toy Safety Directive. 
11 See annex 6 for the list of amendments to the TSD. 

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standards12.  It  is  the  manufacturer,  whether  established  in  the  EU  or  outside  the  EU,  who  is 
responsible  for  the  compliance  of  the  toy  with  the  applicable  requirements.  When  a  toy  is  in 
conformity with the applicable requirements, the manufacturer must affix the CE marking to it.  

Market surveillance to  ensure compliance with the Toy Safety Directive is currently regulated by 
Regulation 2019/102013. This Regulation replaced Regulation (EC) No 765/200814 and became fully 
applicable on 16 July 2021. This Regulation requires that in order to place toys on the Union market, 
there must be an economic operator established in the EU and responsible for a number of tasks set 
out in that Regulation to facilitate market surveillance. 

More details on the current legal provisions of the TSD can be found in Annex 6. 

1.2.  Link with other initiatives 

Revision  of  the  CLP  Regulation15  -  Regulation  (EC)  No  1272/2008  on  hazard  classification, 
labelling and packaging of chemicals (the CLP Regulation) is the core piece of Union legislation for 
the hazard assessment of chemicals (human health, environment and physical hazards). It sets out the 
hazard classification of chemicals and how to communicate those hazards to consumers and workers. 
The  CLP  Regulation  follows  the  United  Nations’  Globally  Harmonized  System  (GHS)  of 
classification and labelling of chemicals setting up criteria for classification and communication of 
physicochemical, health, and environmental hazards.  The CLP Regulation is currently under revision 
and  the  introduction  of  new  hazard  classes  (such  as  endocrine  disruptors)  is  considered.  Hazard 
assessment is the starting point for risk-assessment and -management measures, which are in turn 
provided for in downstream legislation, such as the Toy Safety Directive. This means the hazards 
that chemicals present are established under the CLP Regulation: they may be carcinogenic, lead to 
skin allergies or to irritation in the eyes for example, in certain of their forms. The decision of how 
to address those hazardous substances in certain products are taken then in other legislation that apply 
to the product. For example, the Toy Safety Directive already prohibits the use of substances which 
are  classified  under  the  CLP  Regulation  as  CMRs.  Therefore,  the  future  hazard  classes  to  be 
introduced  in  the  CLP  Regulation  would  be  relevant  for  defining  the  regulatory  consequences  in 
certain  products,  such  as  in  the  context  of  the  current  revision  of  the  Toy  Safety  Directive.  The 
measures proposed under options 1b and 1c in this Impact Assessment are based on banning chemical 
substances classified under certain  hazard classes of the CLP Regulation. To fully implement  the 
generic bans of endocrine disrupting substances in a revision of the Toy Safety Directive (proposed 
in options 1b and 1c), it is necessary that the CLP Regulation be amended to include the hazard class 
for  endocrine  disrupting  chemicals.  This  has  been  done  in  the  recent  Commission  Delegated 
Regulation  (EU)  2023/70716.  Any  of  the  other  hazard  classes  considered  for  generic  bans  under 
options 1b and 1c already exist under the CLP Regulation and therefore do not require any change to 
this Regulation. 

12 This procedure is also required when the harmonised standards have been published with a restriction that may change 
or invalidate certain specification(s) in the standard referenced. The  manufacturer may voluntarily have recourse to a 
Notified Body for the conformity assessment. 
13 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. 
14 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 
15 Revision of EU legislation on hazard classification, labelling and packaging of chemicals (europa.eu) 
16  
Commission  Delegated  Regulation  (EU)  2023/707  of  19  December  2022  amending  Regulation  (EC)  No 
1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures,  
OJ L 93, 31.3.2023 

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Figure 1: Mapping of the pieces of legislation according to the different steps of hazard and risk assessments17 

Revision  of  the  REACH  Regulation18  -  The  REACH  Regulation  on  Registration,  Evaluation, 
Authorisation and Restriction of Chemicals, together with the CLP Regulation, are the key Union 
legislation for the assessment and management of chemicals. In accordance with the CSS, a targeted 
revision of REACH will explore extending the generic risk approach to restrictions to most harmful 
chemicals while allowing their use only when essential. In particular, criteria for essential uses will 
be defined to ensure that the most harmful chemicals are only allowed if their use is necessary for 
health,  safety  or  is  critical  for  the  functioning  of  society  and  if  there  are  no  alternatives  that  are 
acceptable from the standpoint of environment and health. Toys are within the scope of REACH 
as  consumer  articles  where  REACH  addresses  environmental  or  human  health  concerns. 
However, the Toy Safety Directive provides for a more comprehensive and targeted approach to toys 
as  regards  aspects  relating  to  human  health,  in  view  of  the  vulnerable  population  group  toys  are 
addressed to.  

Figure 2: Hazard identification and risk management in EU legislation 

The proposed measures under this Impact Assessment do not rely on any changes to be introduced 
in the REACH Regulation. The REACH revision could introduce generic bans for the most harmful 
chemicals  themselves  and  for  certain  uses,  in  particular  in  consumer  products.  This  may  have  an 
indirect impact on the functioning of the toys industry and the options  presented. This is because 
alternative  chemicals  will  be  more  likely  to  be  available  on  the  market,  including  for  toy 

17 See the Impact Assessment for the Review of the CLP Regulation, SWD(2022) 435 final, part 1. 
18 Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu) 

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manufacturers,  which  would  limit  the  negative  impacts  of  options  1b  and  1c  proposed  in  the  toy 
industry. However, these changes are not necessary for the revision of the Toy Safety Directive. Thus, 
the quantitative analysis of impacts of the different policy options in this impact assessment does not 
factor in the possible effects from the REACH revision.  

Digital  Services  Act  (DSA)19:  The  DSA  includes  a  new  set  of  horizontal  rules  to  regulate  the 
responsibility  of  online  intermediaries,  including  online  marketplaces.  It  will  establish  new 
obligations for online intermediaries inter alia in relation with how they handle all types of illegal 
content hosted on their websites including unsafe products. The DSA will reinforce actions to be 
taken on non-compliant toys sold online, such as mechanisms to counter illegal content online, new 
rules to trace sellers on online marketplaces and an obligation by online marketplaces to randomly 
check against existing databases whether products or services on their sites are compliant.  

General Product Safety Regulation20: The recently adopted Regulation (EU) 2023/933 on General 
Product Safety replaces the General Product Safety Directive21. One of the objectives of the proposal 
is to offer better protection of consumers when shopping online, including on online marketplaces, 
and  from  dangerous  products  coming  from  the  EU  and  outside.  The  General  Product  Safety 
Regulation,  as  the  current  Directive,  will  continue  to  address  only  products,  risks  and  aspects 
which  may  not  be  specifically  covered  by  the  Toy  Safety  Directive.  It  is  expected  to  include 
specific provisions on recalls, accident reporting and online marketplaces which would apply to all 
consumer products, including toys. 

Artificial  Intelligence  (AI)  horizontal  framework22:  The  new  legislative  proposal  for  the  AI 
horizontal framework (AI Act) will lay down harmonised rules for the placing on the market, the 
putting into service and the use of artificial intelligence systems (‘AI systems’) in the Union. It lays 
down specific requirements for high-risk AI systems, and it is expected to cover, as high-risk, AI 
systems intended to be used as safety components of toys covered by the TSD. Therefore, any risks 
posed  specifically  by  the  incorporation  of  AI  in  toys  would  be  addressed  by  that  Regulation. 
Nevertheless, the AI Act refers to the EU product legislation applicable to the product (in this case 
the  Toy  Safety  Directive)  to  determine  the  conformity  assessment  procedure  which  needs  to  be 
followed,  also  with  regards  to  the  verification  of  compliance  with  the  essential  requirements 
concerning AI systems that are to be imposed by the AI act. 
Delegated acts under the Radio Equipment Directive (RED)23: the RED establishes the possibility 
for  the  Commission  to  adopt  delegated  acts  in  relation  to  several  aspects,  including  requiring 
protection of networks, personal data and privacy and protection from fraud for specific categories 
of  radio  devices.  As  all  internet-connected  wireless  devices  fall  under  the  RED,  the  Commission 
adopted  on  29  October  2021  a  delegated  act  under  that  Directive  strengthening  the  level  of 
cybersecurity, personal data protection and privacy of certain  categories of radio  equipment. This 
delegated  act  applies  to  radio  toys  (protection  of  privacy)  and  to  internet-connected  radio  toys 

19 Digital Services Act – deepening the internal market and clarifying responsibilities for digital services (europa.eu) 
20 General Product Safety Directive – review (europa.eu) 
21  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, 
OJ L 11, 15.1.2002, p. 4. 
22  Artificial  intelligence  –  ethical  and  legal  requirements  (europa.eu).  Proposal  for  a  Regulation  of  the  European 
Parliament and of the Council laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) and 
amending  certain  Union  legislative  acts,  of  21  April  2021  and  available  at  https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206 
23 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  relating  to  the  making  available  on  the  market  of  radio  equipment  and  repealing 
Directive 1999/5/EC, OJ L 153, 22.5.2014, p. 62‐106, available at 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0053-20180911  

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(protection of networks and from fraud) and will become applicable as of 1 August 202424. It will 
require that radio toys incorporate safeguards to ensure that the aforementioned assets are protected. 

Circular Economy: The proposal for a Regulation on Ecodesign for Sustainable Products25 will 
set a framework and a process through which the Commission will be empowered to progressively 
set out sustainability requirements for each product or group of products. Safety concerns will not be 
a criterion to include products under the ESPR; this inclusion will be based on sustainability concerns. 
The ESPR will not regulate the safety of products. Toys may be covered in the long-term by one of 
the delegated acts setting sustainability requirements, however they are not  included in the list of 
high  priority  sectors  identified  in  the  Circular  Economy  Action  Plan  (CEAP)  adopted  by  the 
Commission  in  March  2020. The  ESPR  will  set  out  the  principle  of  the  Digital  Product  Passport 
(DPP) and will develop its technical design and operation. The technical design and operation of the 
DPP are already being developed, following the general principles of the proposed DPP. The ESPR 
also  foresees  that  the  reference  of  the  DPP  is  included  in  a  central  registry  managed  by  the 
Commission26,  that  this  reference  is  declared  at  customs,  and  that  this  central  registry  is 
interconnected with the customs IT environment27. This will allow an automatic verification of the 
existence of the DPP for products presented at customs prior to their release for free circulation. It is 
expected  that  the  DPP  will  become  the  vehicle  to  provide  digital  information  on  products  in  the 
future. 
Customs Union Reform28: The Commission has recently proposed a revision of the Union Customs 
Code in order to strengthen the legal framework for customs and address recent challenges such as 
e-commerce  and  to  protect  the  single  market  from  non-compliant  goods  imported  from  non-EU 
countries, among others. This initiative is expected to complement the current revision of the TSD 
by strengthening risk-based controls at the border and improving the supervision of the supply chain. 
The exact requirements for toys entering the Union market and being released for free circulation 
need to be set out in the toy safety rules.  

1.3.  Economic context: The market for toys in the EU 

The European toy market size was estimated to be worth around EUR 20 billion in 202029 in terms 
of overall value, making it the third-biggest  global market after North America and Asia. Online 
sales are increasing and reach over 1 in every 4 toys in some countries30. Market research estimates 
place the size of the global toy industry in the range of EUR 86-109 billion in sales in 2019, growing 
from  around  EUR  81.7  billion  in  2016.31,32  The  European  toys  manufacturing  market  achieved 

See the proposed article 12. 
See the proposed article 13 on customs controls relating to the product passport.  

24  Commission  Delegated  Regulation  (EU)  2022/30  of  29  October  2021  supplementing  Directive 2014/53/EU  of  the 
European  Parliament  and  of  the  Council  with  regard  to  the  application  of  the  essential  requirements  referred  to  in 
Article 3(3), points (d), (e) and (f), of that directive, OJ L 7/6 of 12.01.2022. 
25 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  sustainable  products  and  repealing  Directive 
2009/125/EC of 30 March 2022, COM(2022) 142 final. 
26  
27  
28 Revision of the Union Customs Code (europa.eu). Proposal for a Council Regulation amending Regulation (EEC) No 
2658/87 as regards the introduction of a simplified tariff  treatment for the distance sales of goods and Regulation (EC) 
No 1186/2009 as regards the elimination of the customs duty relief threshold (COM(2023) 259 final 
29 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
30  ECSIP  Consortium  (2013).  Study  on  the  competitiveness  of  the  toy  industry  –  Final  Report,  p.  17. 
https://ec.europa.eu/DocsRoom/documents/6653/attachments/1/translations/en/renditions/native  
31  Khajeheian,  D.  (2018).  Market  analysis,  strategy  diagnosis  and  opportunity  recognition  in  toy  industry  [in:] 
“International Journal of Entrepreneurship and Small Business”, 33(2), DOI:10.1504/ijesb.2018.090138, p. 221. 
32 https://www.toyassociation.org/ta/research/data/population/toys/research-and-data/data/global-sales-data.aspx 

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turnover of at least EUR 8.3 billion in 2019, increasing from EUR 7 billion in 2016.33 However, as 
for much of the global economy, 2020 also saw a downturn in turnover within the EU toys industry, 
to around EUR 6.6 billion (based on provisional Eurostat SBS data). In 2017, the EU was reportedly 
the biggest global importer of toys with EUR 7.2 billion worth of toys imported. The value of EU toy 
imports had grown by an estimated 70% during the preceding decade. Most toys imported to the EU 
come from Asia, with China the biggest supplier and the ASEAN countries, such as Thailand and 
Vietnam, increasing the volume of exported toy products.34 

Almost  50,000  people  are  working  in  the  EU  toy  sector.  The  structure  of  the  EU  toy  industry  is 
complex and very heterogeneous, ranging from large world-wide operating companies to very small 
producers  of  certain  specific  kinds  of  toys.  The  number  of  enterprises  has  been  progressively 
increasing from circa 5,332 in 2016, to an estimated 6,313 in 2020. Around 99% of European toy 
companies are SMEs, employing around two thirds of employees in the sector. Toy production is 
highly  concentrated,  with  96.2%  of  production  value  generated  across  ten  countries  and  88%  of 
turnover concentrated in seven EU Member States35.  
Online  sales  have  grown  significantly,  accelerated  by  the  global  pandemic36.  Consumers  are 
increasingly buying toys online instead of in brick and mortar stores. For instance, according to a 
study by a market research firm, all national markets in the EU recorded growth in online toy sales 
in 2020-2021. At the global level, online sales of toys were estimated to have increased markedly, by 
an estimated 20%, in 2020-2021.37 See annex 7 for a more detailed overview of the toys market. 

2.  PROBLEM DEFINITION 

2.1.  What are the problems? 

In the context of toy safety, two main separate problems can be currently identified. As the Evaluation 
concluded,  the  first  problem  is  that  the  Directive  does  not  ensure  adequate  protection  of  children 
when playing with toys from risks posed by hazardous chemicals: the Directive does not sufficiently 
address  the  risks  of  certain  harmful  chemicals  such  as  endocrine  disruptors  (EDs)  and  CMR 
substances.  The  possibilities  to  amend  the  TSD  in  relation  to  limit  values  for  toys  intended  for 
children over 36 months, or for certain problematic substances such as nitrosamines, are limited. In 
addition, there are a high number of non-compliant and unsafe toys on the Union market, which also 
put children at risk and create an uneven playing field for compliant companies. See Annex 8 for the 
main findings of the Evaluation. 

2.1.1.  Problem 1- Insufficient protection of children from harmful chemicals  

The  objective  of  the  TSD  is  to  ensure  that  toys,  including  the  chemicals  they  contain,  do  not 
jeopardise the safety of children. However, as the Evaluation concluded, the protection from most 
harmful chemicals in toys in the current Directive is not complete. Almost 60% of respondents (116 
out  of  196)  to  the  public  consultation  believed  that  the  TSD  should  set  stricter  requirements  for 
chemicals:  however,  47%  representatives  of  business  associations  and  companies  (strongly) 
disagreed  (42  out  of  89),  while  all  the  environmental  and  consumer  organisations  agree  to  some 
degree with the statement (57 out of 61 - over 90%). Similarly, 90 % of public authorities (28 out of 

33 As described further in Annex 4, the Eurostat Structural Business Statistics (SBS) data for 2016-2020 has a range of 
data gaps and the data for 2020 is provisional. 
34 Ismail, R., et al. (2020). Toy Safety in the ASEAN and European Union: A Comparative Approach [in:] International 
Journal of Innovation, Creativity and Change, vol. 10/11, online, p. 118-119. 
35 See Annex 4 for the details on the methodology and annex 7 for a more detailed overview of the data sources. Study 
for the revision of the Toy Safety Directive, 2022, by VVA, CSES and Asterisk, to be published.  
36 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
37 https://www.npd.com/news/thought-leadership/2021/whats-driving-online-toy-sales/  

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31) agreed or strongly agreed. Concerning other risks from toys (for example, preventing suffocation 
of  small  children  by  requiring  that  toys  for  younger  children  do  not  contain  small  parts),  the 
Evaluation concluded that the protection in the TSD  is adequate and no evidence has appeared since 
its publication which would affect that conclusion38. 

Chemicals  with  hazardous  properties  can  cause  harm  to  human  health  and  the  environment. 
Chemical substances may be classified under the hazard classes of the CLP Regulation on the basis 
of the hazardous properties they present to human health, the environment or their physical hazards. 
The  classification  under  the  CLP  Regulation  informs  on  the  hazardous  properties  of  a  chemical 
substance, but does not provide for the management of the risk. Other legislation, such as the TSD, 
is to define whether and how the risks posed by certain chemical substances must be addressed in 
specific products. While not all hazardous chemicals raise the same concerns, certain chemicals are 
particularly  harmful  as  they  can  cause  cancers,  affect  the  immune,  respiratory,  endocrine, 
reproductive  and  cardiovascular  systems,  weaken  human  resilience  and  capacity  to  respond  to 
vaccines, or increase vulnerability to diseases. Exposure to these harmful chemicals is therefore a 
threat  to  human  health.39  Children,  pregnant  women,  workers  and  the  elderly  are  particularly 
vulnerable to risks arising from chemical exposure, and have higher probabilities of adverse health 
symptoms or diseases throughout their lives40. 

The Toy Safety Directive does not sufficiently protect children from risks posed by the most harmful 
chemicals. Children are exposed to harmful chemicals from different sources (indoor air, food, water, 
consumer products in general, for example, as well as toys) and it is difficult to establish a clear link 
between their exposure to these substances through one of these sources, such as toys, and immediate 
health  consequences.  The  particular  vulnerability  of  children  to  the  harmful  effects  of  hazardous 
chemicals is  well documented41. There are physiological  differences between children (especially 
those  under  36  months  of  age)  and  adults,  affecting  the  accuracy  of  certain  exposure  assessment 
methodologies  (i.e.  immature  metabolic  and  immune  system,  proliferative  tissues)  42434445. 
Furthermore,  the  manner  in  which  children  interact  with  toys,  in  particular  in  their  earlier  years, 
makes  them  particularly  exposed  to  any  harmful  chemicals  that  may  be  present  in  toys.  Children 
exhibit specific habits and practices that may result in exposure scenarios not considered for other 
population groups. Under the age of 3, mouthing behaviour plays an important role regarding contact 
of children with toy materials46. As an example, the current migration limits for 19 substances or 
heavy metals in the Directive are based on the assumption that a child would ingest per day 100 mg 
of dry, brittle, powder-like or pliable toy material, 400 mg of liquid or sticky toy material, and 8 mg 
of scraped-off toy material. Studies show that children are currently exposed to known and unknown 

38 The essential requirements of the Directive addressing other risks, supported by harmonised standards, have allowed 
to address or adapt the detailed technical specifications whenever new issues have emerged. 
39 See the CSS. 
40 European Commission, Study for the Strategy for the Non-Toxic Environment, p. 74 
41 European Commission, Study for the Strategy for the Non-Toxic Environment, 
42 
https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2019)29&docLanguage=e
n 
43 Environmental Chemicals and Children | Washington State Department of Health 
44 SWD(2019) 199. 
45 Carroquino, Maria J. et al. “Environmental Toxicology: Children at Risk.” Environmental Toxicology: Selected Entries 
from the Encyclopedia of Sustainability Science and Technology 239–291. 4 Dec. 2012, doi:10.1007/978-1-4614-5764-
0_11  
46 See the SCHEER opinion on the estimates of amount of toy materials ingested by children Estimates of the amount of 
toy materials ingested by children (europa.eu): Toys not intended to be mouthed were mouthed almost as frequently as 
toys intended to be mouthed. 

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endocrine disrupting chemicals in toys47, or to other chemicals that pose risks to children48. See annex 
10. D. for an estimate of the potential harmful chemicals that could be currently present in toys. In 
particular, it has been mentioned by industry that toys like balloons, paints, modelling clays, glue or 
slime could be affected by the policy options proposed in this impact assessment.  

CMR (carcinogenic, mutagenic or toxic for reproduction) substances are particularly harmful, 
and  their  effects  can  only  be  seen  in  the  long  term  and  are  often  irreversible.  The  Evaluation 
concluded that the current requirements in the Directive for CMR substances are not effective 
and they do not sufficiently protect children from these substances in toys. As will be explained 
below  when  describing  the  drivers  of  this  problem  (see  section  2.2.1  below),  the  TSD  contains 
generic bans for CMR substances subject to derogations, but these derogations still allow for too high 
a presence of CMRs in toys. Furthermore, the limit values currently set in the TSD for nitrosamines 
and nitrosatable substances, which are strong carcinogens, are deemed to be too high, and these limits 
cannot be amended by the Commission with its empowerments. 

In addition, there are ongoing and emerging health concerns for other most harmful chemicals that 
are  not  addressed  by  the  Directive.  This  is  particularly  the  case  for  chemicals  that  affect  the 
endocrine system, the immune, neurological or respiratory systems or chemicals that are toxic 
to  a  specific  organ.  In  respect  of  these  chemicals,  the  Fitness  Check  on  Chemicals  legislation 
excluding  REACH49  pointed  to  shortcomings  in  current  legislation  in  meeting  the  objectives  of 
protecting  human  health  in  particular  as  regards  exposures  to:  neurotoxic  substances;  chemicals 
linked  to  cardiovascular  and  respiratory  (CVR)  disease;  and  endocrine  disrupting  chemicals.  The 
possible  risks  associated  with  the  combination  of  chemicals  are  also  not  addressed  in  the 
Directive.  There are no specific legal requirements to ensure that risks from simultaneous exposure 
to multiple chemicals are effectively and systematically taken into account in toys. While it may not 
be currently realistic or economically feasible to specifically assess and regulate an almost infinite 
number of possible combinations of chemicals, scientific consensus is emerging that the effect of 
chemical mixtures needs to be taken into account and integrated more generally into chemical risk 
assessments50.  

Endocrine-disrupting (ED) chemicals require specific attention; these chemical substances can 
alter the functioning of the endocrine (hormonal) system and negatively affect the health of humans 
or animals. Endocrine disrupting properties have been the focus of increasing scientific research, and 

of 

harmful 

chemicals 

“Chemicals 

47  See  for  example  “Potential  endocrine  disrupting  properties  of  toys  for  babies  and  infants”  available  at: 
https://doi.org/10.1371/journal.pone.0231171; where nine of the 18 products showed significant oestrogenic activity. For 
seven of those, the source of the activity could not be  accounted  for by reference to a list of 41 known or suspected 
endocrine disrupting chemicals that had been compiled primarily from literature reviews of substances authorised for use 
in food packaging materials. See also the UN Environment Programme (UNEP) report that finds 25% of children’s toys 
contain 
at: 
https://doi.org/10.1016/j.envint.2020.106194.  Results  indicate  that  a  relevant  amount  of  chemicals  used  in  plastic  toy 
materials may pose a non-negligible health risk to children, calling for more refined investigations and more human- and 
eco-friendly alternatives. Out of 419 chemicals found in hard, soft and foam plastic materials used in children toys, 126 
substances that can potentially harm children’s health either via cancer or non-cancer effects were identified, including 
31 plasticizers, 18 flame retardants, and 8 fragrances. See also “CMR Substances in Toys – Market Surveillance and 
Risk  Assessment”, 
at: 
https://www2.mst.dk/Udgiv/publications/2015/10/978-87-93352-79-7.pdf 
48 A Danish survey showed that 12 out of 12 tested squishies emitted chemical substances that posed a risk for children: 
Analysis 
toys, 
and 
https://www2.msl.dk/Ud£iv/Dub1ications/2oi8/o8/Q78-87-QT7io-64-i.ndf. 
49 https://ec.europa.eu/info/publications/fitness-check-most-relevant-chemical-legislation-excluding-reach_en 
50 See section 2.2.2. of the CSS. 

Protection  Agency, 

Environmental 

the  Danish 

assessment 

substances 

fragrances 

available 

available 

concern 

squishy 

organic 

plastic 

toys” 

other 

2015 

risk 

and 

by 

of 

in 

in 

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the accumulated knowledge identifies endocrine disruptors as a concern to public health5152. Given 
the  essential  role  of  the  endocrine  system  during  development,  exposure  to  endocrine  disruptors 
during vulnerable periods can induce long-lasting changes, with adverse effects in the short and long 
terms; some of these effects are expected at very low-doses53. Early exposure during critical periods 
of development can affect health at a later stage of life54. Many chronic health disorders have been 
clearly  linked  to  endocrine  disruptors55.  These  disorders  include  obesity  and  metabolic  disorders, 
male and female reproductive disorders, reproductive cancers, thyroid disorders, neurodevelopmental 
disease and IQ loss 56. It is not possible to quantify fully the impact on human health of chemicals 
with  the  most  critical  hazards.  However,  for  illustrative  purposes,  a  causal  link  of  70%  to  100% 
between  exposure  to  EDs  and  IQ  loss  and  intellectual  deficiencies  was  identified57.  EDs  are  also 
suspected  to  cause  male  fertility  troubles  with  a  probability  of  causation  between  40-69%. 
Researchers estimated that exposure to EDs leads to substantial health-related societal costs in the 
EU between 46 and 288 billion Euro per year58. The TSD does not currently have provisions that 
allow to address EDs in toys in general and limit children exposure wherever this is necessary.  

Chemicals that affect the immune, neurological or respiratory systems or chemicals that are 
toxic  to  a  specific  organ  are  also  amongst  the  most  harmful  chemicals.  It  is  equally  well 
documented that neurotoxic chemicals are particularly harmful to the developing brain of children, 
which is inherently more vulnerable to toxic injury than the adult brain59. Adverse effects of exposure 
to certain chemicals on IQ scores are well established and other disorders where the role of chemical 
exposure  is  suspected,  include  ADHD  and  autism.  Recent  research  has  focussed  on  links  to 
depression, bipolar disorder, OCD, psychoses, dementia, Parkinson and Alzheimer’s.60 For example, 
it can be estimated that, in the EU, some 30,000 disability adjusted life years (DALYs) related to 
neurotoxic disease may be a result of chemicals  exposure, with some 250,000 DALYs a result of 
chemicals exposure combined with underlying genetic predisposition. Developmental disabilities due 
to chemicals alone could cost the EU between €1.7 up to €4 billion per year directly and up to €14 – 
€33  billion  per  year  taking  into  account  chemical  exposure  and  combined  with  genetic  factors, 
depending on the valuation  used61. Environmentally  attributable childhood  asthma (i.e. where the 
onset of asthma has been triggered by exposure to pollution and hazardous chemicals) was estimated 
in  2013 to cost  the EU approximately €1.6 billion per  year (inclusive of direct  medical  costs and 
indirect economic losses due to productive time lost by care for children with asthma).62 The TSD 

51 United Nations Environment Programme, State of the Science of Endocrine Disputing Chemicals - IPCP-2012. 
52 L.N. Vandenberg & J.L. Turgeon, Endocrine disrupting chemicals: Understanding what matters. In L. N. Vandenberg, 
& J. L. Turgeon (Eds.), Endocrine-Disrupting Chemicals, 2021. Combined effects on two year old children (mst.dk) 
53 See also Prederi, Barbara, Alves, Crésio A.D. et Lughetti Lorenzo. “New insights on the effects of endocrine disrupting 
chemicals  on  children”  Jornal  de  Pediatria  Volume  98,  supplement  1,  March-April  2022,  p.  S73. 
https://doi.org/10.1016/j.jped.2021.11.003 
54  Fitness  Check  on  endocrine  disruptors  and  its  Executive  Summary,  accompanying  the  Chemicals  Strategy  for 
Sustainability SWD(2020) 251 final. 
55 Endocrine-related disorders impact in particular the functioning of the thyroid, the immune system, the reproduction 
system and the overall human metabolism. SWD(2020) 249. 
56 Endocrine Disruptors: from Scientific Evidence to Human Health Protection (aesan.gob.es) 
57  Technical  and  Scientific  Support  to  the  Commission’s  Impact  Assessment  for  the  Revision  of  the  Regulation  on 
Classification, Labelling and Packaging of Substances and Mixtures (CLP), to be published. 
58 I. Rijk, M. van Duursen, and M. van den Berg, Health cost that may be associated with Endocrine Disrupting Chemicals 
— An inventory, evaluation and way forward to assess the potential health impact of EDC-associated health effects in 
the EU, Institute for Risk Assessment Sciences, University of Utrecht, 2016. 
59 The toxic truth | UNICEF 
60 Fitness Check of Chemicals legislation (excluding REACH). 
61 Study on the cumulative health and environmental benefits of chemical legislation  - Publications Office of the EU 
(europa.eu) 
62 Study on the cumulative health and environmental benefits of chemical legislation  - Publications Office of the EU 
(europa.eu) 

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has specific limit values for some of the chemicals in these categories, but it does not address 
them in a general manner and new limit values for other substances in this category cannot be 
generally introduced either.  

Sufficient  protection  needs  to  be  provided  to  children  from  potential  exposure  to  those  risks  for 
human health when playing with toys. Risks coming from harmful substances are often only visible 
long term and parents are generally unaware of these risks in toys or of their potential severity; as 
opposed to mechanical risks, they cannot be avoided by parents being more or less vigilant of their 
children  playing  with  toys.  Increasing  the  requirements  in  the  TSD  for  harmful  chemicals  is  not 
expected  to  lead  to  less  surveillance  of  children  by  their  parents  when  playing  with  toys  (i.e.  the 
Peltzman effect is not expected to materialise).  

REACH already regulates the environmental aspects of toys and the chemical substances in toys that 
pose a risk to the environment. Furthermore, the ESPR will also apply to toys. Therefore, the extent 
to  which  harmful  substances  to  the  environment  may  be  limited  in  consumer  products  (such  as 
substances which are persistent, bioaccumulative and toxic – PBTs and vPvBs), including in toys, 
will continue to be addressed under horizontal legislation such as REACH and the ESPR and not in 
the revision of the TSD.    

2.1.2.  Problem 2- A high number of toys on the Union market do not comply with the 

Toy Safety Directive and are unsafe 

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 and, therefore, the exact share of non-compliant toys in the Union 
market  cannot  be  quantified  with  precision.  However,  there  are  sufficient  separate  indicators  that 
confirm that the number of non-compliant toys on the Union market is very high. Whenever market 
surveillance actions or inspections take place, the percentage of non-compliant and unsafe toys found 
is consistently high. 

2500

2000

1500

1000

500

0

1919

2048

2117

2202

2221

2130

482

595

667

635

588

1028

417

195

2016

2017

2018

2019

2020

2021

2022 (till 31
May)

All notifications

Toys notifications

Figure 3: RAPEX notifications per year and toys notifications  

First  of  all,  as  regards  notifications  in  the  Safety  Gate  for  alerts  of  dangerous  products  (RAPEX 
notifications), during the past years, toys were consistently one of the top categories of products 
with the highest number of notifications for dangerous products per year. 

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19%

40%

41%

Overall, during the period 2016- May 2022, a total of 
3579 dangerous toys were subject to an alert through 
the  RAPEX  system  for  exchange  of  information  on 
dangerous  products63.64  Around  40%  of 
these 
notifications concerned chemical risks, which means 
that  exposure  to  dangerous  chemical  substances 
through  unsafe  toys  is  a  matter  of  concern,  while 
another  40%  concerned  choking  risks  for  younger 
children that can lead to fatal injuries.   

Other

Chemical

Small parts

Figure 4: Types of risks in dangerous toys 
notified in RAPEX 

Market  surveillance  authorities  are  also  required  to 
enter into the information and communication system 
for  market  surveillance  (ICSMS)  information  in 
relation  to  products  made  available  on  the  Union 
market for which an in-depth check of compliance 
has been carried out, in addition to their obligation to 
alert  of  dangerous  products  under  RAPEX.  This 
obligation has become more explicit with the new Regulation 2019/1020 on market surveillance65, 
which is fully applicable since July 2021. Data on the period 2016- May 2022 reveals that 43% of 
the toys subject to in depth inspections were found to be non-compliant and more than half of 
these relate to substantive safety risks. Market surveillance authorities rely on risk management 
procedures to try and target their activities on toys with higher probabilities to be non-compliant. In-
depth checks are carried out on toys which present such higher risks of non-compliance. While these 
data  may  show  the  effectiveness  of  such  procedures,  it  still  evidences  the  high  number  of  non-
compliant and unsafe toys that are present on the Union market.  

3287

1172

762

472

699

488

3500

3000

2500

2000

1500

1000

500

0

1416

619

985

385

1364

503

2016

2017

2018

2019

2020

2021

Not compliant

Total investigations

Figure 5: non-compliant toys and total number of in-depth toy investigations per year in ICSMS 

686

343

2022 (until
31/05/2022)

63 Each of these notifications affects a significant number of toys; for example, in 2020 there were 592 notifications of 
toys in RAPEX which affected as a minimum almost 1.100.000 individual items, with almost 50.000 items more in follow 
up market surveillance measures in other Member States. Similarly, in 2021 there were 438 notifications of dangerous 
toys in RAPEX which affected again almost 1.100.000 individual items, as a minimum, with an additional 120.000 in 
follow up measures. Not all RAPEX notifications include the number of individual items affected and this is why this 
information is the minimum. 
64  To  note  that  RAPEX  notifications  only  concern  dangerous  products  (more  or  less  serious  risks)  but  not  non-
compliances that pose no risk for consumers (such as the wrong affixing of the CE marking, or lacking documentation…). 
65 See article 34 of 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. 

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Other recent but more targeted market surveillance joint actions focused on toys also confirm the 
high rates of non-compliance, see annex 11 for detailed results on coordinated activities on the safety 
of  products  (CASP)66.  Data  from  the  Evaluation  based  on  the  reports  on  market  surveillance 
submitted by Member States67 also shows a significant rate of non-compliant toys found on the Union 
market; almost every third toy inspected in the reported period was non-compliant. 

The high number of non-compliant toys means that children in the EU can be exposed to risks when 
playing with these toys. Unsafe toys can cause injuries and even fatal accidents, for example risks of 
choking or from very serious injuries such as from magnets, or button cells batteries that children can 
swallow. Children may also be exposed to dangerous chemicals, for example from phthalates in soft 
plastics or too high quantities of boron in slime. Unsafe toys may undermine consumer trust in the 
safety of toys available in the EU. They are also a risk to the environment as the harmful substances 
they contain are ultimately released into waste. 

Non-compliant toys also lead to an uneven playing field for compliant companies. Complying with 
the  stringent  requirements  is  costly  for  companies,  reputable  manufacturers  face  the  unfair 
competition of non-compliant toys from rogue traders who are able to sell their toys at lower prices. 
The value of the non-compliant toys market has been estimated for 2019 to span from EUR 248 
million to EUR 1.65 billion68.  

At the stakeholder workshop organised on 26 April 2020, all the intervening stakeholders (consumer 
organisations, industry and market surveillance authorities) expressed strong concerns about the high 
number of non-compliant and unsafe toys, in particular made available through online sales, and the 
urgent need to take action at EU level to address this. 

2.1.3.  New risks in toys, in particular from digital technologies 

The Evaluation also concluded on the TSD not being able to address new risks in toys linked to the 
use of digital technologies. The scope of the Directive is focused on health and safety and does not 
cover other issues such as privacy or information security. As a result, there were cases in the past 
where  risks  posed  by  cybersecurity  or  privacy  concerns  on  toys  could  not  be  addressed.  The 
application  of  the  RED  delegated  act  mid-2024  will  address  the  cybersecurity  and  personal  data 
privacy  issues  identified  in  the  Evaluation.  This  delegated  act  requires  radio  toys  to  guarantee 
protection of privacy and data of the users, through cybersecurity features. Cybersecurity should be 
strengthened by the Cyber Resilience Act as well, once adopted69. Additionally, the incorporation of 
AI  in  toys  may  also  lead  to  new  risks.  The  Commission  proposal  on  a  regulatory  framework  for 
artificial intelligence, once adopted, will ensure that any AI systems incorporated into toys comply 
with the rules that safeguard the functioning of markets and the public sector, and people’s safety and 
fundamental rights. Therefore, these risks have been addressed in legislation already adopted or under 
inter-institutional  discussions  and  it  does  not  appear  that  any  significant  legal  gap  remains  that 

66 For example, the 2021 CASP joint action on toys from non-EU workshops focused on plastic toys and toys with plastic 
parts for children under and above 36 months collected online and originated from third countries and found that 84% of 
toys tested did not meet the applicable safety requirements. 
67 Article 48 of the Toy Safety Directive. 
68 Using the non-compliance rates identified through various market reports, the CLP Impact Assessment established 
three  scenarios  for  the  level  of  non-compliance  with  chemical-related  requirements  in  the  product  ‘Children  toys  or 
childcare items’: a lower scenario of 3-4% non-compliance, a central scenario of 5-8% non-compliance, and an upper 
scenario of 10-20% non-compliance. These scenarios are primarily placed lower than the non-compliance rate identified 
above as the exercises used to generate the above rate target product types that are known for non-compliance. Using 
these scenarios, the value of the non-compliant toys market has been estimated as follows: considering turnover in the 
European toys market for 2019 was around EUR 8.3 billion, the non-compliant portion of this market could span from 
EUR 248 million (3%) to EUR 1.65 billion (20%). See the study supporting the revision of the Toy Safety Directive. 
69 Cyber resilience act – new cybersecurity rules for digital products and ancillary services (europa.eu) 

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requires intervention through the revision of the TSD for the purposes of addressing cybersecurity, 
personal data privacy or AI. 

2.2.  What are the problem drivers? 

2.2.1.  Problem 1- Insufficient protection of children from harmful chemicals  

a) The Directive allows for too high presence of CMR substances in toys 

The  Directive  includes  a  generic  ban  on  the  presence  of  CMRs  in  toys  subject  to  a  number  of 
derogations. The Evalution concluded that these derogations do not ensure sufficient protection of 
children from these harmful subtances. In particular, the Toy Safety Directive currently allows three 
possibilities to derogate from the generic ban to CMRs in toys: i) the TSD tolerates the presence of 
CMRs in toys or their components up to the ‘relevant concentrations’ of the CLP Regulation for 
the  classification  of  mixtures  containing  these  subtances.  ‘Relevant’  are  either  the  specific 
concentration limits assigned to specific substances in Annex VI, table 3.1 of the CLP Regulation or, 
if no specific concentration limits are indicated in that table, the generic concentration limits in Annex 
I  of  the  CLP  Regulation70.  In  addition,  the  TSD  allows  for  the  presence  of  CMRs  ii)  if  they  are 
inaccesible to children, including via inhalation and iii) if the Commission takes a decision to allow 
their presence if it is considered safe following a rigorous scientific evaluation and if they are not 
prohibited in consumer articles under REACH. For CMR substances of categories 1A and 1B which 
are of most concern, no suitable alternatives must exist for a Commission to take a decision granting 
the derogation. (For CMRs category 2, no analysis of alternatives is necessary.) 
The Evaluation found the first derogation inadequate71. These ‘relevant concentrations’ have been 
set for the purpose of classification and labelling of mixtures containing hazardous substances, with 
the primary aim to ensure that the hazards of such mixtures are properly identified and communicated. 
They do not take account of possible exposures and do not entail an assessment of risk related 
to the uses of a substance in an article such as a toy. Whenever risk-based limit values for certain 
CMRs were introduced in the TSD through the empowerments to the Commission, these have been 
15  to  1,000  times  lower  than  the  ‘relevant  concentrations’  in  the  CLP  Regulation.  However,  in 
accordance  with  the  empowerements  to  the  Commission  for  amending  the  Directive,  these  limit 
values could only be introduced for toys intended for children under 36 months, or to be put in the 
mouth  (Apendix  C).  The  Scientific  Committee  for  Health,  Environmental  and  Emerging  Risks72 
(SCHEER) also identified a number of problems with this approach, due to the fact that classification 
limits set for mixtures are applied to articles (as the toys should be considered) 73. This inadequacy 
of the CMR derogation based on the concentration limits for classification of mixtures from the CLP 
Regulation was referred to by public authorities (70% of public authorities responding – 22 out of 31 
-disagreed or strongly disagreed with having this derogation) and by consumer organisations (75%- 
46 out of 61) in the public consultation74.  

In  addition,  the  Evaluation  found  that  the  limit  values  in  the  Directive  for  nitrosamines  and 
nitrosatable substances were too high75. Certain nitrosamines may be genotoxic and very strong 
carcinogens (CMRs). Nitrosatable substances can be converted into nitrosamines in the human body. 

70 These limits are 0.1% and 1% for carcinogens (table 3.6.2 of the CLP Regulation) and mutagens (table 3.5.2 of the 
CLP Regulation) of categories 1 and 2, respectively, and 0.3% and 3% for reproductive toxins (table 3.7.2 of the CLP 
Regulation) of categories 1 and 2, respectively 
71 See section 5.1.1.2 of the Evaluation 
72 The SCHEER, on request of Commission services, provides Opinions on questions concerning health, environmental 
and emerging risks, including in toys. 
73 SCHER Opinion on risk from organic CMR substances in toys, 18 May 2010. 
74 See annex 2.4 for further details on the replies to the public consultation. 
75 See section 5.1.1.2 of the Evaluation 

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The TSD sets migration limits for nitrosamines and nitrosatable substances in toys intended for use 
by  children under 36 months  or in  other toys intended to  be placed in  the mouth:  0.05 mg/kg for 
nitrosamines, 1 mg/kg for nitrosatable substances.76 Germany however insisted on its lower national 
limits of 0.01 mg/kg for nitrosamines and of 0.1 mg/kg for nitrosatable substances in toys made of 
natural or synthetic rubber designed for children under 36 months and intended or likely to be placed 
in the mouth, which the Commission allowed77. Therefore, currently Germany has lower limits for 
these substances that do not correspond to the ones in the TSD. In their letter of April 2019 to the 
Commission,78 11 Member States considered that there was an urgent need to lower the limits for 
nitrosamines and nitrosatable substances. The Commission is not empowered to amend these limit 
values in the TSD via its possibilities for adaptation (see article 46 of the TSD and the section below); 
these limit values can only be amended via a revision of the TSD by the co-legislators. In the open 
public consultation, 31% (28 out of 89) of industry representatives believed that these limits should 
be lowered and a further 25 % were neutral about it; while 77% (24 out of 31) of public authorities 
and 73% (45 out of 61) of citizens and consumer associations were in favour of lowering them. In 
practice, most manufacturers have indicated to comply already with the lower limit values applicable 
in Germany, but a problem with enforcing this limit remains79. 

b) The possibilities to adapt the Directive to new scientific knowledge on chemical substances 
are too limited 

Having an effective and flexible system for adapting the protection from possible chemical risks in 
toys is  crucial because scientific knowledge about  chemical toxicity is  constantly  changing. Even 
chemicals with a long-known toxicity may turn out to be ‘more toxic’ when new knowledge arises80. 
In order to keep pace with latest technical and scientific developments, the Commission can amend 
certain parts of the Toy Safety Directive.81 82 In particular, the Commission may establish maximum 
limit values for any chemical in toys intended for children under 36 months of age and in all toys 
intended to be placed in the mouth, and it may also amend those limits (Appendix C to Annex II). 
However, the Commission is not empowered to introduce new limit values for any chemical in 

88 

Recital 

Decision 

2012/160/EU. 

https://eur-lex.europa.eu/legal-

76 Annex II, Part III, point 8 of the Toy Safety Directive. 
77 
Commission 
of 
content/EN/TXT/PDF/?uri=CELEX:32012D0160&qid=1571656440439&from=EN  
78  See  letter  of  25.4.2019  from  the  relevant  Ministers  of  Denmark,  Belgium,  Sweden,  Norway,  Lithuania,  The 
Netherlands, Hungary, Finland, Czech Republic, Luxembourg and France. 
79 Source: targeted survey and interviews. See annex 14 on the economic impacts and impacts on competitiveness from 
lowering the limit values on nitrosamines to the levels currently applicable in Germany. 
80 As an example, ‘[t]he toxicity of lead has been studied extensively in both animals and humans. On numerous occasions 
these data have been evaluated by expert committees.’ (National Institute for Public Health and the Environment (RIVM), 
Chemicals in Toys). The limit values for lead in toys were proposed (and eventually adopted in the 2009 Toy Safety 
Directive) on the basis of scientific reviews from 1995 – 2005. However, in 2013, the European Food Safety Authority 
(EFSA)  issued  a  scientific  opinion  on  lead  providing  that  lead  is  more  toxic  than  known  before.    (EFSA  Panel  on 
Contaminants in the Food Chain (CONTAM), Scientific Opinion on Lead in Food. EFSA Journal 2010; 8(4):1570) Even 
the smallest intake of lead by children can harm their intelligence. It was therefore necessary to lower the limit values in 
the Toy Safety Directive almost 7-fold. In 2012 and 2013, the limit values for cadmium and barium had to be lowered, 
respectively, due to updated knowledge on their toxicity. For the same reason the limit values for bisphenol A and for 
aluminium had to be lowered, respectively, in 2017 and 2019; new information from EFSA suggests that the limit value 
for bisphenol A is still too high. 
81 Article 46 of the Toy Safety Directive. 
82 In the period 2012 – 2021, the Directive was amended 17 times to address newly identified chemical risks and to revise 
limit values for chemicals such as chromium VI, lead, phenol, bisphenol A. More particularly, eight amendments to the 
Toy  Safety  Directive  have  inserted  specific  limit  values  for  a  number  of  CMR  substances  and  highly  sensitising 
substances in Appendix C.  

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other types of toys. This does not ensure sufficient protection of children or that the Directive can 
be appropriately adapted to address emerging scientific knowledge83. 

sensitising 

preservatives 

The distinction between (1) toys for children under 36 months and toys intended to be taken in the 
mouth, and (2) other toys, takes account of the oral exposure to chemicals. Indeed, children under 
36 months take ‘everything’ in their mouth, and toys such as a toy flute or a toy harmonica are by 
definition  played  in  contact  with  the  mouth.  However,  older  children  may  also  be  exposed  to 
chemicals via the skin or via inhalation. Experts in the Expert Group on Toys Safety repeatedly raised 
the need that older children be equally well protected for certain of these substances84. Examples are 
and 
benzisothiazolinone, 
the 
methylisothiazolinone  for  which  specific  limit  values  have  been  inserted  in  Appendix  C  to  the 
Directive while SCHEER recommends  that they are not  used in  toys85.  In addition,  the risk from 
chemicals may not be much different when comparing children under 36 months and older children 
based on bodyweight86. Finally, outside of Appendix C, all other chemical limit values in the Toy 
Safety  Directive apply to all toys for children of all ages.  In their letter  of 25 April 2019, the 11 
Ministers  also  stressed  their  concerns  about  the  lack  of  possibilities  in  the  Directive  to  add  limit 
values for toys for older children. Over 93% of public authorities (29 out of 31) and 65% of  industry 
(61 out of 89) responding to the public consutlation believed that the toy safety rules should allow 
for setting limit values for any toy when new scientific knowledge emerges.  

chloromethylisothiazolinone 

A further limitation to the effectiveness of the adaptations of the Directive resides in the legal form 
of the toy safety rules, a Directive, which requires transposition in the national legal systems of all 
Member States to become applicable. Only then can all provisions be concurrently enforced in all 
Member States. This makes the overall process for adaptation of newly set limit values through the 
empowerments to the Commission lengthy. In addition, delays in the transposition in one or several 
Member States would be detrimental to the protection of children in those States. The Evaluation of 
the Directive concluded that national transpositions of amendments to the Directive often turn out to 
be excessively burdensome and time-consuming87.  

2.2.2.  Problem 2- A high number of toys on the Union market do not comply with the 

Toy Safety Directive and are unsafe 

a) Global supply chains: non-compliant toys from third countries and online commerce 

Evidence shows that a significant proportion of non-compliant toys come from third countries and 
that they are particularly present online8889. Only 4% of dangerous toys notified in RAPEX come 

83 See section 5.1.1.2 of the Evaluation. 
84 See also section 5.1.1.2 of the Evaluation. 
85 Scientific Committee on Health and Environmental Risks (SCHER), Opinion on "CEN's response to the opinion of the 
CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys", adopted on 29 May 2007, 
p. 8 and table 1 on p. 9. 
86 The bodyweight of children under 36 months was estimated to be 7.5 kg86 when calculating the migration limits for 
toxic ‘elements’ such as arsenic, cadmium or lead; for children of 36 months and over the bodyweight was assumed to 
be 15 kg. 
87 See section 5.1.4 of the Evaluation 
88 See above the results of the CASP joint action on toys from non-EU marketplaces, as well as TIE report on EU Toy 
Safety:  the  problem  of  unreputable  sellers  on  online  marketplaces  TIE's  EU  Toy  Safety  report:  The  problem  of 
unreputable sellers on online marketplaces - Toy Industries of Europe or the BTHA report “Still Toying with Children’s 
Safety”  which  concerned  products  found  in  the  EU  market  at  that  time  BTHA-Online-Marketplace-Report.pdf 
(toysafety.co.uk).  Also,  BEUC  March  2022  “Products  from  online  marketplaces  continue  to  fail  safety  tests  – 
Compilation of research on unsafe products from online marketplaces from 2021 and 2022”. Similarly, as an illustration 
Life-threatening children's toys easy to sell via Bol.com - Radar - AVROTROS' consumer program 
89  Recent  joint  actions  and  targeted  campaigns  illustrate  that  the  rates  of  non-compliant  toys  available  online  are  of 
particular concern, as investigations regularly reveal that these products remain available online even after being subject 

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from EU countries. Online shopping is continuing to grow in the EU90 and toys are among the most 
popular categories of products ordered online. For example, the 2021 Eurostat survey showed that 
20% of people who bought online ordered toys or childcare articles.91  

The value of online sales in total (not limited to toys) increased by 20% between 2010 and 202092. 
The purchase of goods and services online has also increased the availability of products from outside 
the EU,  with  almost one  third  (31%) of online shoppers having purchased goods or services 
from outside the EU.93 94  

4%

11%

85%

EU

China

Other

Figure  6:  Country  of  origin  of  dangerous  toys 
notified in RAPEX (2016- May 2022) 

At  the  global  level,  online  sales  of  toys  were 
estimated  to  have  increased  markedly,  by  an 
estimated 20%, in 2020-2021.95 In 2020, 44 % of 
large enterprises conducted e-sales, corresponding 
to an e-sales value of 27 % of total turnover in this 
size  class96.  E-commerce  enables  traders  to 
introduce  products  that  comply  with  the  legal 
requirements  of  a  non-EU  country  where  they 
were  manufactured,  to  be  sold  to  other  markets, 
where  product  safety  and  chemical  legislation 
requirements  may  substantially  differ97.  New 
business models, including variety of intermediary 
services (e.g., social media, online marketplaces) 
that connect online sellers and buyers, increase the 

engagement in e-commerce of even more diverse players worldwide98.99 

to bans or recalls. OECD 2015 sweep, 62% of non-compliance rate for toys, and the most commonly reported category 
of banned/recalled products that can  still be  found online.  5jlnb5q64ktd-en.pdf (oecd-ilibrary.org). The BTHA report 
signals that 69% of recalled toys could still be found online, albeit from other sellers. 
90 https://ec.europa.eu/eurostat/statistics-explained/index.php?title=E-commerce_statistics_for_individuals 
91 90% of people aged 16 to 74 in the EU had used the internet in the 12 months prior to the 2021 Eurostat Survey, 74% 
of whom had bought or ordered goods or services for private use.  20% of people who bought online ordered toys or 
childcare articles. 
92 Eurostat 2021. 
93 Eurostat 2021 
94 Many products ordered online are shipped across borders in individual consignments, in what is known as parcel trade. 
This trade has helped consumers access the goods they need in times of confinement and also allowed firms, especially 
smaller ones, to maintain economic activity. The types of parcels traded during confinement vary significantly; however, 
information available for EU countries shows that growth has been dominated by purchases of computers and related 
accessories;  medical  goods  (pharmaceuticals);  and  leisure  items  such  as  books  or  games.  Compared  to  ‘traditional’ 
container trade, parcel trade involves an even more complex network of interlinked actors and policies, and so ensuring 
that parcels get to where they are needed during confinement, as well as during gradual reopening, requires policy action 
across  a  diverse  set  of  issues.  See  https://www.oecd.org/coronavirus/policy-responses/connecting-businesses-and-
consumers-during-covid-19-trade-in-parcels-d18de131/ 
95 https://www.npd.com/news/thought-leadership/2021/whats-driving-online-toy-sales/  
96 Eurostat 2021 
97 KEMI, Increased e-commerce – increased chemicals risks? A mapping of the challenges of e-commerce and proposed 
measures. Report of a government assignment, 2021. 
98 See KEMI (2021). 
99 The Study supporting the revision of the CLP Regulation (Technical Support to the Commissions Impact Assessment 
for the Revision of the Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP), page 
113)  assessed  the  compliance  with  chemical  requirements  detailed  in  the  CLP  and  REACH  Regulations  for  various 
product groups by analysing a wide range of market surveillance activities conducted by consumer associations, market 
surveillance authorities and other stakeholders. It concluded that 20% of the toys assessed across these reports and sold 
online were found to be non-compliant with regard to chemicals-related requirements. Furthermore, on the basis of reports 

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EU  consumers  are  able  to  buy  from  non-EU  websites  toys  which  were  never  intended  by  the 
manufacturer to be placed on the Union market, but that had been directed to it by other third parties 
through  global  distribution  chains  and  no  economic  operator  clearly  makes  sure  that  the  toy  is 
compliant with the Directive. Non-EU economic operators may not know the requirements applicable 
in  the  EU  or  they  may  choose  to  ignore  them.  Non-EU  sellers  may  only  rely  on  the  information 
provided by the manufacturer that the necessary steps have been taken to ensure that the toys are 
compliant with the applicable requirements. Rogue traders can benefit from these channels to sell 
their products at low prices avoiding the costs of complying with the legislation100. It has been found 
that many toys which have been recalled from the Union market because they are unsafe can still be 
found  for  sale  online,  sometimes  from  different  online  sellers.  70%  (43  out  of  61)  of 
consumers/environmental groups, 80% (25 out of 31) of public authorities and 67% of industry and 
industry associations responding (61 out of 89) to the public consultation believed that the lack of 
specific rules on online sales hamper the effectiveness of the TSD. 

b) Limits to market surveillance checks and customs controls 

The  data  on  non-compliant  products  set  out  above  illustrates  the  ability  of  market  surveillance 
authorities to target with their inspections non-compliant toys; the fact that toys are constantly one of 
the top categories of products subject to RAPEX notifications shows that significant efforts are put 
in  market  surveillance  activities  for  toys.  However,  certain  issues  remain.  The  high  rates  of  non-
compliance show the limits to the effectiveness of market surveillance in ensuring that only compliant 
and safe toys are placed on the Union market. 

In  particular,  the  Evaluation  concluded  that  the  compliance  information  (EC  Declaration  of 
conformity) is difficult to obtain and equally often incorrect or of questionable quality and/or only 
drafted  when  requested  by  authorities101.  Similarly,  the  safety  assessment  and  the  technical 
documentation also appear to be often incomplete, incorrect, difficult to obtain and only prepared on 
purpose  when  the  authorities  have  asked  for  them.  Parts  of  the  technical  documentation  can  be 
missing or even be faked. Re-launching a request for the obligatory documentation and the follow-
up can cause considerable delays. In many cases, it is not possible to link the documentation to the 
toy, resulting in the documentation being of limited (or of no) value102. 

An effective way to ensure that unsafe or non-compliant toys are not placed on the Union market 
would be to detect such products before they are released for free circulation. Controls on products 
entering the Union market  take place on a risk assessment basis and on a limited number of toys 
entering  the  Union  market.  The  recent  report  on  the  current  challenges  for  the  Customs  Union 
“Putting more Union in the European Customs”103 notes that the explosion of e-commerce presents 
customs with an inflow of small consignments with new financial, counterfeit, compliance, safety 
and security risks. In 2019, the volume of international trade that was handled by EU customs offices, 

from representatives of the same stakeholder groups assessing non-compliance with non-chemicals related requirements 
a  wide  range  of  compliance  levels  across  toys  sold  online  spanning  from  3%  to  90%  was  found,  depending  on  the 
requirements and types of toys examined. 
100  See the Europol 2021 campaign on identifying counterfeit toys online, and their operation LUDUS with OLAF and 
EUIPO between October 2020 and January 2021 which concluded in over 5 million counterfeit toys for a total value 
exceeding  €16  million.  How  to  recognise  fake  and  hazardous  toys  |  Europol  (europa.eu)  and  Cute,  but  deadly:  law 
enforcement seize over €16 million worth of fake toys | Europol (europa.eu). In 2019, revenue generated from counterfeit 
toys reached $32.3 billion in the US and $44.6 billion in Europe. Counterfeit toys are also very often non-compliant or 
unsafe, see Alarming consumer behavior with counterfeit toys (redpoints.com)  
101 See section 5.2.6 of the Evaluation. 
102 See section 5.2.6 of the Evaluation. 
103 Putting more Union in the European Customs - Ten proposals to make the EU Customs Union fit for a Geopolitical 
Europe  –  Wise  Persons  Group  Report  https://ec.europa.eu/taxation_customs/system/files/2022-03/TAX-20-002-
Future%20customs-REPORT_BIS_v5%20%28WEB%29.pdf. 

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in terms of import, export or transit was of over 868 million items104. From July to December 2021, 
e-commerce  represented  more  than  twice  the  number  of  traditional  customs  transactions  for  only 
0.4 % of the value.105 For customs, e-commerce means an exponential and unmanageable flow of 
millions  of  small  individual  consignments  to  be  controlled  and  checked  for  fiscal  and  non-fiscal 
requirements,  such  as  checking  toys  for  compliance  with  the  Toy  Safety  Directive.  Data  from 
European countries show the relevant importance of toys in cross border trade in individual parcels 
(10 % of small value parcels concerns toys), as well as the very high increase over the last period106. 
Evidence also suggests that the probability that small consignments will contain non-compliant or 
dangerous goods is very high107.  

2.3.  How likely is the problem to persist? 

Figure 7: Problems and drivers 

In the absence of  EU action, the protection of children  from  chemical  risks  by the Directive  will 
continue to be insufficient, and they will continue to face risks from non-compliant toys.  

The most harmful chemical substances will continue to be harmful in the future. Their toxicity or 
hazard is not expected to decrease; on the contrary, as scientific knowledge of chemical substances 
progresses, new scientific evidence is expected to appear refining previous conclusions on the risks 
of  harmful  substances  and  identifying  new  substances  presenting  hazardous  properties.  As 

104 That report notes that imports from third countries into the EU reached over EUR 2 trillion in 2019, rising from about 
EUR 1 trillion in 2004 and EUR 1.5 trillion in 2008. In recent years, a large proportion of these imports comes from e-
commerce. 
105 From July to December 2021, the first six months of compulsory customs declaration for all goods imported into the 
EU irrespective of their value – traditional trade in goods represented over 220 million import declarations for a value of 
EUR 1,250 billion. In contrast, it is estimated that e-commerce represented 490 million customs declarations for a total 
value of EUR 4.8 billion. One of the aspects identified in urgent need of reform is the declaratory nature of most of the 
information presented at customs, often unrelated to commercial information or even reality and that can only be verified 
after specific checks at Customs.  Source: DG TAXUD see the Wise Persons Report quoted above. 
106 An increase of over 500% took place from January to April 2020 compared with the same value the previous year. 
https://read.oecd-ilibrary.org/view/?ref=135_135520-5u04ajecfy&title=Connecting-Businesses-and-Consumers-
During-COVID-19-Trade-in-Parcels 
107 See  the  Wise Persons Report. The  WTO has also concluded that the increased number  of small packages ordered 
directly to consumers has raised challenges with regard to compliance with health and safety regulations in importing 
countries https://www.wto.org/english/tratop_e/covid19_e/ecommerce_report_e.pdf 

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highlighted  in  the  CSS,  the  sheer  number  of  chemicals  on  the  market  represents  an  immense 
knowledge challenge, and the expected future rise in chemical production and use risks  to further 
widen the ‘unknown territory of chemical risks’. Children will remain a vulnerable population with 
specific exposure to chemicals in toys, and the need for them to benefit from swift protection from 
the most harmful substances will remain. The TSD in its current form will continue to be unable to 
ensure sufficient protection of children from these risks. It would only be possible to ban new harmful 
substances in toys for children under 3 years or to be put in the mouth. 

The high rates of non-compliant and unsafe products on the Union market are expected to remain. 
Market surveillance authorities will continue to perform checks on toys to remove non-compliant and 
unsafe  toys  from  the  Union  market.  However,  e-commerce  will  continue  to  be  used,  probably 
increasingly, by EU customers108, in particular cross-border trade will continue its upward trend and 
the current pressure on customs and market surveillance authorities will continue to grow. From 2020 
to  2021 alone the proportion of online sales  coming from outside the EU increased from 20% to 
23%109. 

3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

The TSD is a ‘total harmonisation’ directive based on Article 114 TFEU (ex-Article 95 TEC) and 
follows the new legislative framework. As explained in Chapter 1, the TSD, like other EU product 
legislation, sets the ‘essential safety requirements’ which toys must satisfy to benefit from the free 
movement of products across the internal market. 

3.2. 

Subsidiarity: Necessity of EU action 

This initiative addresses the issues identified in the Evaluation of the TSD. The Evaluation concluded 
that the TSD is generally relevant, effective, efficient and coherent, and has EU added value, but that 
there was a need for specific improvements.  

The TSD is key in ensuring protection of children in the EU. The main objective of the Directive is 
to ensure a high level of safety of children, and to allow the free circulation of toys in the EU. In 
particular, the TSD helps to reduce social costs by preventing accidents or harm to children that may 
be caused by the use of unsafe toys. A key rationale for an EU-level toy safety legislation is to provide 
harmonisation across Member States based on Article 114 TFEU. The TSD is a total harmonisation 
measure  for  the  safety  of  toys,  so  Member  States  are  not  allowed  to  introduce  additional  safety 
requirements for toys; any changes to the scope or requirements of such a directive must be made at 
EU level.  

3.3. 

Subsidiarity: Added value of EU action 

In terms of toy safety and the creation of a large internal market for safe toys, the  Evaluation has 
confirmed  the  EU  added  value  of  the  Toy  Safety  Directive.  In  particular,  without  the  Directive, 
Member States could set diverging limit values for chemicals, which would be to the detriment of 
the internal market. The Evaluation also concluded that all categories of stakeholders welcomed the 
existence of harmonised safety requirements across the EU, and companies valued the creation of a 

108 The COVID-19 crisis accelerated an expansion of e-commerce towards new firms, customers and types of products. 
Some of these changes in the e-commerce landscape will likely be of a long-term nature, in light of the possibility of new 
waves  of  the  epidemic,  the  convenience  of  the  new  purchasing  habits,  learning  costs  and  the  incentive  for  firms  to 
capitalise on investments in new sales channels. https://www.oecd.org/coronavirus/policy-responses/e-commerce-in-the-
time-of-covid-19-3a2b78e8/#biblio-d1e705  
109 Impact Assessment study on a possible revision of the Toy Safety Directive 2009/48/EC, (2022) VVA, CSES and 
Asterisk, to be published. 

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large  market  for  toys  and  the  simplification  of  trade  as  major  achievements.  Possibly  diverging 
national rules were not considered as being more beneficial. Notified bodies in particular agreed that 
the Directive contributes to streamlining testing and standards, and public authorities welcomed the 
harmonisation of testing and standards and the opportunity to work together with authorities from 
other Member States. 

A  regulatory  action  at  EU  level  would  ensure  coherent  implementation  of  any  new  safety 
requirements for toys and thus a greater level of safety, and provide legal certainty and a level playing 
field for industry. Regulatory action at EU level should lay down EU-wide requirements for ensuring 
the health and safety of children when playing with toys, and allowing market enforcement at the 
national level.  

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

The revision of the Toy Safety Directive would pursue two general objectives, corresponding to the 
general objectives of the current Directive: 

  General Objective 1: Ensure a higher level of safety of toys so as to guarantee a higher level 

of protection of children 

Children are amongst the most vulnerable population in the EU; they must continue to benefit from 
a  high  level  of  protection  when  playing  with  or  enjoying  toys.  This  general  objective  will  also 
contribute to achieve another objective of the CSS: achieving safe products and non-toxic material 
cycles and directly to SDG#3: good health and well-being. 

  General Objective 2: Continue to guarantee the functioning of the internal market for toys, 
limiting the number of non-compliant toys and preserving the competitiveness of EU industry 

The objective of the functioning of the EU internal market is natural to a “total harmonisation” EU 
product legislation like the TSD. Toys complying with the Directive can circulate freely within the 
single market without further requirements. At the same time, it is essential to limit non-compliant 
products  in  the  Union  market,  which  put  children  at  risk  and  create  an  uneven  playing  field  for 
reputable  companies.  Manufacturers  producing  compliant  toys  must  be  protected  from  unfair 
competition, especially in online marketplaces.  

4.2. 

Specific objectives 

The initiative pursues the following specific objectives: 

  SO 1: Adapt the rules to ensure protection of children against the most harmful chemicals  

  SO 2.: ensure the necessary flexibility to be able to adequately address emerging scientific 

knowledge and risks 

The toy industry is very innovative as this is essential to maintain a competitive position. At the same 
time, scientific knowledge on chemical substances is constantly evolving. It is essential that the rules 
can easily adapt to emerging knowledge and risks. 

  SO 3: reduce the number of non-compliant and unsafe toys on the Union market 

There is a significant number of non-compliant and unsafe toys on the EU market. To ensure the 
safety of children and facilitate the development of the internal market there is a need to reduce the 
number of these unsafe or non-compliant toys on the market. Given the growing prominence of online 
sales of products coming from outside the EU, there is a risk of seeing toy manufacturers following 

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the requirements of the TSD having to compete with manufacturers producing toys which are not in 
conformity with the Directive. 

  SO 4: streamline enforcement of the TSD 

The work of market surveillance and enforcement authorities is crucial in ensuring the reduction of 
the number of non-compliant toys on the market and the internal market functions properly. Rogue 
traders can have an advantage against reputable manufacturers by exploiting the difficulties market 
surveillance authorities have in enforcing the rules. As such, one of the objectives of the revision of 
the Directive should be to facilitate the work on enforcement by market surveillance authorities. 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

5.1.  What is the baseline from which options are assessed? 

The baseline assumes no change in the current TSD. Other legislative developments taking place in 
parallel are nonetheless considered in the baseline. On chemical protection, the revision of the CLP 
Regulation  is  expected  to  define  new  hazard  classes  for  harmful  chemicals,  such  as  endocrine 
disruptors. However, the introduction of new hazard classes under the CLP Regulation will not have 
any  effects  in  terms  of  the  protection  of  children  under  the  TSD:  these  hazard  classes  are  not 
addressed in the TSD and the Commission is not empowered to introduce new limit values in all toys. 
The revision of the REACH Regulation has not been presented yet. It is expected to introduce generic 
bans on substances for the most harmful chemicals. It is also expected to address the risk management 
of  consumer  products  containing  chemicals  classified  under  the  most  harmful  hazard  classes 
identified  by  the  CLP  Regulation.  The  REACH  revision  is  not  expected  to  introduce  an  upfront 
generic ban of the most harmful substances in the legislation but rather to provide for the legal means 
for  the  Commission  to  introduce  such  generic  bans  of  the  most  harmful  substances  in  consumer 
articles. However, the extent to which it will apply to consumer articles including toys, the hazard 
classes it may cover as well as the timing is yet unclear. A work plan to define how the most harmful 
chemicals will be addressed in REACH as well as the priorities is being prepared. So far, REACH 
has not been able to fully address the protection of children when playing with toys described in the 
problem definition. The protection from harmful substances that it will offer is not expected to be as 
comprehensive as the targeted approach in the TSD for toys. Nevertheless, toys will remain within 
the scope of REACH also concerning the risks on human health and if a substance is restricted under 
REACH in consumer articles, this can continue applying to toys.  

Under the baseline, the Commission will continue to be able to amend the TSD with its empowerment 
under article 46. These regular amendments are expected to continue at the same pace as since the 
adoption  of  the  Directive,  and  will  continue  to  require  economic  operators  to  adjust  to  those. 
Economic operators will continue to face business-as-usual costs from complying with the current 
obligations of the TSD and its regular amendments.  

In terms of administrative burden, the total costs of the current TSD have been estimated at EUR 
4000 per toy model both in case of large firms and SMEs in case of self-certification, and EUR 4500 
in case of third-party certification. This includes drafting the technical documentation necessary to 
demonstrate compliance, the certification itself and labelling110.  

In terms of adjustment costs, the key costs considered are i) costs related to chemical substitution or 
withdrawal  and  ii)  testing.  The  analysis  on  adjustment  costs  makes  a  number  of  assumptions  but 
acknowledges that there are a number of uncertainties which do not make it possible to provide a 
precise  estimate  for  the  baseline  or  each  policy  option.  These  underlying  assumptions  and 

110 See more details for these calculations in Annex 14. 

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uncertainties concerning the cost estimates are explained in detail below111. In respect of the dynamic 
baseline, the uncertainties concern particularly i) the specific substances for which a new limit value 
may be introduced in accordance with the existing possibilities to adapt the Directive, ii) the number 
of toy models which would be affected by the new restrictions; iii) the precise costs of replacing the 
particular chemical substance which would be restricted; iv) the capacity of the EU industry to shift 
production to alternative toys; and v) in cases of product withdrawals, the extent to which demand 
will shift to other toys which remain on the market, or will rather shift to other non-toy products. This 
is why a range of economic impacts is provided for the baseline and each policy option. Adaptation 
and withdrawal costs are one-off costs but would occur over time with the regular amendments of 
the Directive; for the purpose of the analyisis a 10 year timeframe can be considered.  

As indicated above, in a dynamic baseline scenario the Commission will still be able to adapt the 
TSD’s  chemical  restrictions,  and  new  limit  values  for  chemical  substances  will  continue  to  be 
introduced in the Directive in accordance with the provisions of Article 46. Such changes would lead 
to product adjustment costs stemming from chemical substitutions and potential market withdrawals 
that would mostly affect toys intended for children under 36 months or to be put in the mouth. These 
costs, presented below, are considered business as usual compared to which costs of the different 
policy options should be presented. Assuming that the market for toys intended for use by children 
under 36 months and toys intended to be placed in the mouth accounts for around 20% of the total 
toys market, any new restriction could only apply to these toys, but any new limit value would not 
apply to all toys in that category, only to toys in which the restricted substance is used. It is estimated 
that the baseline scenario would require one-off product adaptation or withdrawal costs in 0.6-
1.2% of toy models112 to comply with newly adopted limit values. Approximately 0.4-0.8% toy 
models would be subject to adaptation, while a smaller segment of around 0.2-0.4% could no longer 
be  made  available  on  the  market.  While  there  are  a  number  of  uncertainties  around  these  cost 
estimates depending on the specific substances that will be limited113, adaptation costs to new limit 
values could range from EUR 6,700 per toy model produced by large firms and EUR 7,700 per toy 
model produced by SMEs to over EUR 15,000 per toy model114. Accordingly, the total one-off costs 
associated  with  product  adaptation  (including  chemical  substitution)  across  the  EU  toys 
industry in the baseline scenario could range from around EUR 2 million to EUR 44 million 
over the period considered 115. It is expected that the costs are closer to the lower range as these 
mirror the costs for complying with the updates of limit values calculated in the Evaluation.  

In terms of market withdrawals, although the ultimate impact would depend on the value of the toy 
models affected, it is possible to indicate an estimate based on the turnover achieved by the European 
toys industry. The baseline scenario could affect EUR 13.2 to 26.2 million worth of toys (based on 
the percentage of toy models of 0.2-0.4 % which could no longer be made available on the market 
because of new limit values and based on provisional EU industry turnover of EUR 6.56 billion for 
2020) over the period considered. In addition, given the time provided to accommodate such changes, 
the impact of such product withdrawals would likely be mitigated by: i) the ability for producers to 
shift resources to the production and sale of alternative toy products; and ii) the purchasing decisions 

111 See section 6 for the explanation on the underlying assumptions of these costs. 
112 Estimations by respondents to the SME survey.  
113 See Annex 14 for the precise description of the cost estimates. Data for the current administrative burden is calculated 
from  the  Evaluation,  as  well  as  interviews  with  industry  and  targeted  SME  survey  in  the  framework  of  consultation 
activities.  
114 See the details for these calculations in Annex 14. The cost of adapting to new limit values introduced in the Directive 
have been calculated based on the information from the Evaluation on the basis of past adaptations (lower range), as well 
as interviews with industry and the targeted SME survey (higher range). 
115 This is based on 78,702 new toys models across all business sizes per year, and applying to that number the percentages 
of  toy  models  that  would  be  impacted  by  substitution  costs  and  subsequently  applying  the  costs  for  redesign  or 
redevelopment that may be incurred. 

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of consumers, who, instead of choosing not to purchase a product, will in many instances purchase 
an alternative product and still contribute to the toys market. 

The Toy Safety Directive puts the responsibility for the compliance of the toy on the manufacturer, 
in line with all EU product legislation. Beyond one-off adaptation costs to find alternative chemicals 
to those which are subject to restrictions or generic bans, any new toy model will need to be tested 
by  the  manufacturer  for  compliance  with  the  applicable  requirements.  The  manufacturer  being 
responsible for the compliance of the toy, cannot simply rely on information provided by suppliers 
of raw materials for the toy, as he would not be complying with its obligations under EU product 
legislation. Testing costs for new toy models in the future will increase, as toys will have to be tested 
for more chemical substances. Testing of toys as part of assessing their compliance is estimated to 
cost currently EUR 2,200 per new toy model, but this is not considered to be administrative burden 
(testing per year for the overall EU industry under the baseline would be estimated at EUR 189.25 
million116). 

The  regular  amendments  of  the  Directive  should  continue  to  introduce  limit  values  for  specific 
substances that will ensure better and targeted protection of children health but will be mostly limited 
to younger children or mouthing exposure in toys intended to be put in the mouth. This will lead to 
certain health benefits, targeted to those substances which have been limited, where there are specific 
and demonstrated risks. However, developing appropriate risk assessments for single chemicals has 
proven to be laborious, if not cumbersome in the past117. It will only be possible to introduce a reduced 
number of new limit values per year, as is the case now. The precise benefits on human health will 
only be realized after the introduction of such  specific limit values and only for exposure to such 
substances.  Furthermore,  under  the  baseline,  the  increased  protection  of  human  health  will  only 
benefit younger children or children exposed to these substances through toys intended to be put in 
the mouth. This is because the current mechanisms to introduce new limit values in the Directive are 
limited to toys intended to be put in the mouth or intended for children under 3 years.  

Under the baseline, the Commission together with members of the Expert Group on Toy Safety will 
continue  to  produce  guidance  on  the  application  of  the  Toy  Safety  Directive  which  is  helpful  to 
economic operators in understanding how to comply with the Directive. Regulation 2019/1020 on 
market surveillance started applying fully on 16 July 2021. It is expected to improve the efficiency 
of  market  surveillance,  including  for  toys,  through  more  coordination  and  powers  for  market 
surveillance authorities; and to facilitate checks of toys coming from third parties and in particular 
online by being able to contact an economic operator established in the Union and responsible for the 
toy. The Digital Services Act will increase the involvement of online platforms in ensuring product 
safety  by  establishing  the  “know  your  business  customer”  principle.  This  legislative  measure, 
together  with  the  Regulation  on  General  Product  Safety  should  facilitate  that  non-compliant  and 
unsafe  products  are  withdrawn  from  online  marketplaces  when  they  have  been  subject  to  market 
surveillance measures (e.g. recalls). These initiatives should have positive effects on the rates of non-
compliance,  in  particular  concerning  products  sold  online,  but  a  high  number  of  non-compliant 
products is expected to persist, damaging competitiveness of reputable manufacturers and the single 
market.  E-commerce  will  continue  to  be  used  increasingly  by  EU  customers118,  and  the  current 
pressure on customs and market surveillance authorities will continue to grow.  

116 Based on a total number of tests per year of 86,024 across all business sizes, from information by companies at the 
targeted survey. 
117 See section 5.1.1.2 of the Evaluation. 
118 The COVID-19 crisis accelerated an expansion of e-commerce towards new firms, customers and types of products. 
Some of these changes in the e-commerce landscape will likely be of a long-term nature, in light of the possibility of new 
waves  of  the  epidemic,  the  convenience  of  the  new  purchasing  habits,  learning  costs  and  the  incentive  for  firms  to 

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The number of inspections in toys undertaken annually is estimated at a total of 25,259119, and 
the average cost per inspection has been estimated at EUR 739 on the basis of the annual budget 
available. Customs authorities carry out controls on toys entering the Union market on a risk based 
manner. Amendments to the TSD will continue to take place on a regular basis, which will require 
the transposition of the new rules into national legislation leading to one-off costs per amendment of 
the Directive (EUR 6,174 to EUR 18,522 per Member State)120.  

In  line  with  the  strategic  foresight  approach,  the  baseline  also  takes  into  account  relevant 
megatrends121 identified. Growing consumption is relevant for this initiative, and in particular new 
trends such as sustainable consumption and digital, as well as previous covered trends such as eco-
friendly products and e-commerce. Consumers are increasingly buying online, which will strengthen 
the role this channel plays in toys distribution, with the challenges that it poses for toy safety. The 
overall  trend  of  digitalisation  should  support  the  companies’  move  towards  digitalising  product 
documentation. Other megatrends have also been factored in in the analysis, such as shifting health 
challenges  and  that  new  health  burdens  may  appear  and  in  particular  the  current  trend  towards  a 
healthy environment. These megatrends strengthen the need to act as they show that the problem and 
the knowledge of hazardous substances will increase. 

5.2.  Description of the policy options 

Three policy options were identified to address each of the problems 1 and 2. In order to address all 
problems  that  the  initiative  aims  to  tackle,  option  1a,  1b  or  1c  (addressing  problem  1  relating  to 
strengthening the protection of children when playing with toys) would have to be combined with 
option 2a, 2b or 2c (addressing problem 2 related to the high number of non-compliant and unsafe 
toys). Addressing both different problems at the same time is essential, given that strengthening the 
requirements for toys will make compliance more costly, which will increase the incentives for rogue 
traders  not  to  comply  if  the  possibilities  for  detection  are  low.  This  risks  damaging  significantly 
competitiveness  of  industry  if  not  accompanied  with  effective  policy  options  to  tackle  non-
compliance. 

5.2.1.  Policy options to strengthen the protection of children when playing with toys 

Three  policy  options  are  presented,  which  are  incremental,  from  minimum  to  highest  level  of 
intervention  and  with  different  approaches  as  regards  risk  management  measures  for  harmful 
chemical  substances.  See  annex  9  for  the  different  risk  management  approaches  in  chemicals 
legislation and annex 9.4 for the description of the interaction between REACH and the TSD. 

Option 1a – Minimum changes to the Directive 

This  option  would  keep  the  overall  framework  of  the  Directive  unchanged,  but  would  allow  the 
Directive  to  adapt  to  emerging  knowledge  of  chemical  substances  by  imposing  new  limits  for 
substances in any toy (and not only in toys intended for children under 36 months or to be put in the 
mouth, as in the current Directive). Therefore, more specifically, this option would: 

capitalise on investments in new sales channels. https://www.oecd.org/coronavirus/policy-responses/e-commerce-in-the-
time-of-covid-19-3a2b78e8/#biblio-d1e705 
119 This information is based on summary of market surveillance reports provided by Member States in accordance with 
Regulation (EC) No 765/2008. See annex 14 for the detailed calculations and estimates.  
120  Data  about  the  amount  of  person  days  needed  for  transposition  considers  the  number  of  person  days  needed  for 
transposition of a Directive to be between 20 and 60. Using the Member State daily labour cost (i.e. EUR 309- Data about 
labour costs comes from Eurostat’s Labour Cost Survey, (2016), category ‘public administration and defence, compulsory 
social security’ per employee FTE and adjusted for inflation.), the overall cost of transposition is estimated to be in the 
range of EUR 6,174 to EUR 18,522 per Member State. Assuming the same number of amendments to the rules as in the 
last 10 years, this could amount to total costs of EUR 104,958 to EUR 314, 874 per Member State. 
121 Megatrends Hub; https://knowledge4policy.ec.europa.eu/foresight/tool/megatrends-hub_en 

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  Empower the Commission to set, and amend, limit values for any chemicals and for toys 
for children of any age by introducing an additional Annex for other toys that are not for 
young children or to be put in the mouth. Substances would be scientifically assessed and 
banned from toys when they are deemed unsafe in a particular use (specific risk assessment). 
Therefore, the Directive would have the possibility of introducing limit values for any toy and 
to differentiate between toys intended for children under 3 years or to be put in the mouth (in 
the current Appendix C) and for toys for older children (in a new Appendix) if this would be 
warranted. This approach would not distinguish between chemical substances depending on 
the hazards they present, but would allow that any substance is limited in toys if an assessment 
of the substance’s hazards and the exposure to those hazards in toys concludes that they pose 
a risk to children. 

  Reduce limit values for nitrosamines and nitrosatable substances to align them with those 

in force in Germany  

  Require manufacturers to assess the known risks from the combination of chemicals in the 

toy, by providing guidance; 

  Finally,  a  fast-track  mechanism  will  allow  the  Commission  in  consultation  with  national 
authorities  to  take  exceptional  measures  against  unsafe  toys  presenting  sudden  risks  not 
specifically foreseen in the TSD122. 

This option would not revise the general prohibition of CMRs substances in toys nor the derogations 
to that prohibition; these would remain unchanged. However, specific limit values for such CMRs 
substances could be added for any toy. A differentiation in limit values for toys intended for children 
under 36 months/to be put in the mouth and toys for older children will be possible where this is 
warranted. Limit values for other chemical substances would also remain unchanged but could be 
amended. In this manner, this option would address all the problem drivers with minimum changes 
to the Directive. 

Option  1b  –  Improved  prevention:  generic  bans  for  the  most  harmful  chemicals  subject  to 
derogations 

This option would include the following elements: 

  Extend the generic approach to risk management to other most harmful substances. This 
means  that  the  existing  general  prohibition  of  CMR  substances  would  be  extended  to 
endocrine disruptors (a new hazard class recently introduced in the CLP Regulation), 
substances  affecting  the  respiratory  system123,  substances  affecting  the  immune  or 
neurological systems and chemicals toxic to a specific organ (currently under specific 
target organ toxicity – STOT - classes in the CLP Regulation). These substances would 
be automatically banned from toys as soon as they are classified under the CLP Regulation 
in these most harmful hazard classes. As these generic bans will concern the most harmful 
chemicals, they would apply to all toys without distinction, i.e. toys for children under 36 
months or for older children as well as toys intended to be put in the mouth. 

  Derogations to these generic bans would be possible. Derogations would be based on 
one of the current provisions for derogations to the CMR ban, and would apply when all 
the following conditions are met: i) when the use of the specific substances in toys has 
been assessed as safe for children, ii) when there are no suitable alternatives for that 
substance and iii) when that specific substance is  not prohibited in consumer articles 
under REACH. In the current TSD, these derogations are adopted by the Commission 

122 Similar to the mechanism in Article 13 of the General Product Safety Directive 2001/95/EC. 
123 Classified as respiratory sensitizers in the CLP Regulation, see Annex 10. 

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following  a  scientific  assessment  and  discussed  with  experts  from  Member  States  and 
industry. Under this option, the scientific assessment should be carried out by ECHA the 
European Chemicals Agency in Helsinki. ECHA would evaluate whether the substance, 
despite its hazard classification, would not expose the children to any health or safety risk 
in the manner in which it is used in toys. This chemical risk assessment would require the 
consideration of the inherent hazardous properties of the substance or a mixture and the 
extent  of  exposure  to  that  substance  or  mixture  in  toys124.  Derogations  could  only  be 
granted where the scientific assessment concludes that the use of the substance in toys is 
safe and there are no alternatives. This is why derogations granted in this manner would 
ensure  that  the  safety  of  children  is  not  put  at  risk.  The  intention  is  to  streamline  this 
assessment as much as possible with other health and safety assessments done by ECHA 
for  other  EU  safety  legislation.  The  ECHA  opinion  would  then  serve  as  a  basis  for  a 
Commission decision on the derogation request. 

This option only retains one of the current derogations to the generic prohibition of 
substances  classified  as carcinogenic, mutagenic or toxic for reproduction (CMRs) 
and is therefore more stringent than the current system. Accordingly, derogations will only 
be possible if the scientific assessment concludes that the use of the substance is safe. This 
means that where there are uncertainties about its safety in toys, a derogation should not 
be granted.  

  Other derogations to generic bans in the current TSD, such as the possibilities of harmful 
substances to be present in toys up to the relevant concentration limits for classification 
established under the CLP Regulation will be deleted. The Evaluation concluded that this 
derogation still allowed for too much presence of CMRs in toys, posing a risk to children. 
The derogations proposed in this option 1b would not allow for this exposure. In addition, 
the derogation allowing for harmful substances in toys if they are inaccessible to children 
will be removed too. There were uncertainties in the past on the correct interpretation of 
this  derogation.  If  they  are  inaccessible  and  they  are  safe,  this  should  be  scientifically 
assessed in the context of the remaining derogation. Lower limits or limits of quantification 
and/or detection would be set for the purposes of verifying compliance.  

  In addition, this option would include all the elements of option 1a and would allow the 
introduction of specific limit values for specific chemicals if these are not covered by the 
generic bans. 

With  the  introduction  of  generic  bans  for  the  most  harmful  substances  and  the  removal  of  the 
derogation allowing the presence of such substances up to the ‘relevant concentrations’ of the CLP 
Regulation, this option is expected to address the problem drivers in a more preventive manner. 
As in option 1a, whenever scientific knowledge would point to the Directive still allowing for too 
high presence of other chemical that is posing a risk to children, specific limit values for such 
substance in any toy could be introduced125. A differentiation in limit values for toys intended for 
children under 36 months/to be put in the mouth and toys for older children would be possible 

124 Previous scientific opinions on hazardous substances in toys have assessed the possible ways in which children may 
be exposed to the substances (either via inhalation, ingestion or dermal contact) and whether there was any risk from that 
exposure. It may be that a substance is classified as hazardous via inhalation but it is only included in toys in metals 
containing that substance, so that the risk that children would be exposed to inhaling the substance is negligible. See the 
SCHEER  opinion  on  nickel 
toys:  https://health.ec.europa.eu/document/download/af3a05ea-2f9f-4939-89c6-
1637796d285b_en?filename=scher_o_163.pdf 
125 These limit values would be based, as is the case today for the limits in Appendix C of the TSD, on the experts views 
of the members of the Subgroup of Chemicals of the Expert Group on Toy Safety, as well as a relevant scientific opinion. 
Under this option, the scientific opinion is expected to be delivered by ECHA. 

in 

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where this is warranted. However, in view of all the substances that would be covered by generic 
bans, these specific limit values should be less frequent than with the current TSD or option 1a. 

Option  1c  –  Maximum  protection  from  harmful  chemicals:  generic  bans  for  the  most 
harmful chemicals without derogations 

This option would include all the elements in option 1a, it would also include the general bans of 
the  most  harmful  substances  in  toys,  as  soon  as  these  substances  are  classified  under  the  CLP 
Regulation as presenting hazardous properties for human health in the most hazardous classes, as 
in option 1b. However, this option would not allow for derogations to the generic bans for the 
most harmful substances. As toys are intended for a vulnerable population group, this option 
would offer zero tolerance for the most harmful chemicals in toys. This would ensure the most 
preventive approach for children, and if new scientific knowledge emerged indicating that these 
harmful substances are even more harmful than considered before, exposure of children to those 
would have been prevented. As in option 1a and 1b, whenever scientific knowledge would point 
to a certain chemical that is posing a risk to children in toys and is not included among the hazard 
classes  covered  by  generic  bans,  specific  limit  values  for  such  substance  in  any  toy  could  be 
introduced. A differentiation in limit values for toys intended for children under 36 months/to be 
put in the mouth and toys for older children would be possible where this is warranted. However, 
in view of the number of substances covered by generic bans, these specific limit values should 
be less frequent than under the current TSD or in option 1a. 

5.2.2.  Policy options to reduce the number of non-compliant and unsafe toys 

Three policy options are presented, with a different focus in its intervention: 

Option 2a – Extending third-party conformity assessment  

To reduce the number of non-compliant toys on the European market, pre-marketing conformity 
assessment  (third-party  conformity  assessment)  would  be  extended  for  certain  toys.  The 
Directive  currently  requires  third-party  conformity  assessment  only  under  very  specific 
circumstances.  With  the  extension  of  third-party  conformity  assessment,  the  intervention  of  a 
notified body could be required for a) those types of toys which present higher risks, as well as b) 
for toys for which higher rates of non-compliance are found. As shown in section 2 above, the 
notifications  of  toys  intended  for  children  under  36  months  which  do  not  comply  with  the 
requirement not to have small parts which may cause a child to choke constitute around 40% of 
unsafe products notified under RAPEX. Notifications of toys non-compliant with chemical risks 
constitute around 40 % of notifications, too. While these may concern chemical risks on any toy, 
toys which are chemical substances or mixtures can lead to higher exposure of children to any 
harmful chemicals in them. Therefore, with this option, third-party conformity assessment would 
be extended to: 

  Toys marketed at children under the age of 36 months old or designed to be put in the mouth. 
These toys are subject to the specific requirement not to include small parts which may cause 
the child to choke.  

  Toys which are chemical mixtures or substances (i.e. such as slime, modelling clay or finger 

paint).  

Option  2b  –  Facilitation  of  market  surveillance  checks  and  customs  controls  through 
digitalisation 

To reduce the number of non-compliant and unsafe toys on the European market option 2b would 
include  post-marketing  facilitation  of  market  surveillance  checks.  It  would  require  the 
introduction of a digital product passport (DPP) containing the EU declaration of conformity that 

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could be immediately consulted by market surveillance authorities. In addition, the reference of 
this DPP would be presented at customs so that its presence can be automatically verified when 
the toy enters the Union market. Release for free circulation of such toys would not be granted if 
it is absent. This would be based on the Digital Product Passport under the proposal for Ecodesign 
for Sustainable Products Regulation126, in order to avoid multiplication of digitalisation systems 
but this option is independent from the regulation of sustainability of toys under the ESPR. While 
toys are not currently included in the list of high priority sectors identified in the Circular Economy 
Action Plan, sustainability requirements under the ESPR may be imposed in the medium or longer 
term.  Furthermore,  it  is  expected  that  the  DPP  will  become  the  vehicle  to  provide  digital 
information  on  products  in  the  future.  The  ESPR  already  foresees  that  the  DPPs  would  be 
registered in a central registry which will be interconnected with the EU Customs Single Window 
Certificate Exchange System (EU CSW-CERTEX), which is the central module of the EU Single 
Window Environment for Customs127. Relying on the DPP under the ESPR and its registry for the 
revised  toy  safety  rules  will  guarantee  that  these  efforts  are  not  duplicated.  By  means  of  this 
interconnection,  when  toys  coming  from  third  countries  are  presented  at  the  borders,  customs 
authorities will check that the DPP is referenced in the central registry. This will apply to any toy, 
either sold online or distributed through more traditional supply chains, and therefore cover also 
small or individual parcels containing toys and coming into the Union market from third countries. 
In order to be registered, the DPP for toys will have to include the EU declaration of conformity.  

All  commercial  goods  imported  into  the  EU  require  a  customs  declaration  for  release  for  free 
circulation. The main benefit of the DPP as proposed in option 2b will be that a reference to it 
should be included in the customs declaration for every toy, and this includes online purchases by 
individual EU customers from third countries. The reference of the DPP, which for toys would 
include the product  compliance information,  will also  have to  be included in  a central  registry 
managed by the Commission, which will be interconnected with the IT customs environment to 
allow for its automatic verification. This will allow that any toy which does not indicate a valid 
DPP reference in the customs declaration is automatically stopped at EU customs and is not 
released for free circulation. Customs authorities will be able to carry out this automated control 
on all products entering the Union market, rather than controls on a risk-based manner on a limited 
amount of products as is the case today. Automated controls on every toy cannot take place today; 
a legislative change is necessary in the Toy Safety Directive to improve controls on toys in this 
manner.  

With this option, the revised Toy Safety rules would require that the compliance information on 
the toy is presented at customs when it enters the Union market. The proposed measures under 
option 2b can take place independently from the revision of the UCC but they would support the 
general objectives of the revision of the UCC, including improved access to data to improve risk 
management at customs, to increase the capacity of customs to detect non-compliant toys. When 
both are adopted, there will be better controls at the border for toys. 

126  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  establishing  a  framework  for  setting 
ecodesign requirements for sustainable products and repealing Directive 2009/125/EC, COM(2022) 142 final 
127 Proposal for a  Regulation  of the European Parliament  and of the Council establishing the European Union Single 
Window Environment for Customs and amending Regulation (EU) No 952/2013, COM(2020) 673 final 

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Option  2c  –  Extension  of  third-party  conformity  assessment  and  facilitation  of  market 
surveillance checks and customs controls through digitalisation 

This option would combine options 2a and 2b.  

5.3.  Options discarded at an early stage 

Several potential options were discarded at an earlier stage: 

Figure 8: Intervention logic 

Introducing essential requirements for Internet-connected or other digital aspects of toys – The 
Evaluation  had concluded that the  issue of the security of internet-connected toys and the  related 
protection of privacy (cybersecurity) emerged as a concern: the security threats that new technologies 
(including toys) pose cannot  be addressed by the Directive in  force, because of its limited scope, 
which focuses on health and safety, but not on privacy and security issues. Nevertheless, since the 
publication of the Evaluation, the RED delegated act128 establishing essential requirements for the 
personal data protection and privacy as well as cybersecurity was adopted, covering radio toys within 
its scope. Similarly, a proposal for a Regulation on Artificial Intelligence129 has been put forward and 
should address the specific risks that the integration of AI may pose on toys. Cybersecurity should 
be strengthened by the Cyber Resilience Act as well, once adopted130. With these initiatives, the risks 
for privacy, those concerning cybersecurity as well as artificial intelligence should be addressed and 
no remaining gap has been observed in the field of toys.  

Derogations for “essential uses” to the generic bans of the most harmful chemicals 

The Chemicals Strategy for Sustainability committed generally to extend the generic approach to risk 
management  (preventive  bans)  to  the  most  harmful  chemicals  in  consumer  products,  while  still 
allowing their use where proven essential for society. While the concept of essential use is still under 
development, including for its application under REACH and possibly other downstream legislation, 
it is not presented as an option or criterion for derogating from the generic bans under the Toy Safety 

128 Commission Delegated Regulation (EU) 2022/30 of 29 October 2021 supplementing Directive 2014/53/EU of the 
European Parliament and of the Council with regard to the application of the essential requirements referred to in Article 
3(3), points (d), (e) and (f), of that Directive. 
129 Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on Artificial 
Intelligence (Artificial Intelligence Act) and amending certain Union legislative acts, of 21 April 2021  
130 Cyber resilience act – new cybersecurity rules for digital products and ancillary services (europa.eu) 

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Directive. First of all, toys will remain under the scope of REACH in the future, both for human 
health and environmental considerations. If a harmful substance would be banned under REACH in 
consumer  articles  (be  it  due  to  generic  risk  to  human  health  or  to  the  environment),  for  instance 
because it has no essential use, it can be prohibited for toys. If this is not (yet) the case, substances 
under the most harmful hazard classes will be covered by the generic bans under the TSD and subject 
to its derogations. As the main objective of the TSD is ensuring children safety, the assessment of 
the derogations under the TSD will remain based on the safety of the use of the substance in toys. 
Consequently,  in  PO1b  presented  in  this  Impact  Assessment,  derogations  to  the  generic  bans  are 
considered possible if (i) the use of the chemical is safe, (ii) there are no alternatives to the presence 
of the chemical in the toy, and (iii) the specific substance is not prohibited for use in consumer articles 
under REACH131. The latter condition would continue to ensure consistency with REACH.  

Creating an injury database 

The Evaluation indicated that data on injuries or accidents caused by toys was not readily available. 
Nonetheless, addressing this issue identified in the Evaluation through the maintenance of a European 
injury database has not been considered as part of the options. First of all, since the publication of the 
Evaluation,  Regulation  2019/1020  on  market  surveillance  has  become  fully  applicable.  This 
Regulation requires market surveillance authorities to share information on all the in-depth checks of 
compliance that they perform, and the results of those investigations, in addition to any notification 
of dangerous products they may need to perform through RAPEX – Safety Gate. This information 
should provide a comprehensive picture of non-compliance of toys in the EU including on the specific 
type  of  non-compliance  and  the  percentage  of  toys  inspected  which  are  not  compliant.  This 
information can also provide information on new risks emerging in toys. As such, these data provide 
more thorough information on the extent to which in the Union there are unsafe toys which do not 
comply with the applicable requirements of the legislation, and which may be putting children at risk.  
In  addition,  the  General  Product  Safety  Regulation  includes  a  provision  on  mandatory  accident 
reporting,  which  would  be  applicable  to  harmonised  products  such  as  toys.  This  obligation  is 
primarily for manufacturers to notify accidents caused by products, within two working days from 
the moment they know about the accident, to the competent authorities of the Member State where 
the  accident  has  occurred.  This  should  already  ensure  greater  availability  of  data  regarding  the 
accidents related to toys. Setting up and maintaining an injury database would be costly, and it would 
not provide sufficiently reliable information on toy safety in the EU. Information should be filled in 
by doctors when accidents happen, this may not be done consistently or in a comparable manner, or 
in a way that identifies the product at stake precisely enough and even when accidents concern toys, 
they may not relate to a safety issue of the toy or to a malfunction, as many accidents can be caused 
by safe toys (for example, injuries caused by falling from toy scooters). Furthermore, such an injury 
database should be addressed generally for all products in a manner that could provide additional 
sources of evidence for policy monitoring, but creating it only for specific toys injuries would not be 
efficient. 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

The following sections provide estimations of the costs based on certain assumptions (see annex 14 
for the detailed estimates) and address in particular economic impacts for economic operators, for 
public authorities, competitiveness and innovation, human health and the environment. Regarding 
fundamental rights, none of the policy options is expected to have significant impacts, but the first 
three  policy  options  should  generally  assist  in  the  rights  of  children  and  their  possibility  to  play. 
While  the  objectives  of  the  revision  of  the  TSD  are  focused  on  strengthening  the  protection  of 

131 See Annex II, part III point 4(c)(iii) of the TSD. 

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children health, the different policy options should have a limited positive impact on the environment. 
As  such,  the  policy  options  devised  respect  the  ‘do  not  significant  harm’  to  the  environment 
principle but  do not  address  it specifically.  In  addition,  the policy  options  do not  have  a relevant 
impact on the climate-neutrality objective of the Union. PO2b could, by means of digitalisation, lead 
to increased energy needs in terms of IT servers or cloud services by toy manufacturers, but these 
should be covered by the overall digitalisation of industry and balanced by energy efficiency efforts 
by the underlying IT infrastructure. On the other hand, it should reduce the use of paper.  

Approach for the analysis of economic impacts and adjustment costs 

This impact assessment considers the costs of product adaptation for economic operators, mainly 
toy manufacturers, stemming from possible new restrictions of chemicals in toys and based on the 
percentage  of  toy  models  to  which  those  costs  would  apply  in  the  different  policy  options  under 
consideration. It also considers the sales value of the percentage of toys that could no longer be 
made available on the market, if alternatives to the chemical substances are not found and, in case 
of option 1c, if derogations are not available. These costs are relevant for a dynamic baseline scenario 
and the first set of policy options. 

Adjustment costs have thus been estimated under a dynamic baseline scenario and for all the first set 
of policy options 1a, 1b and 1c of this impact assessment. The key costs considered as adjustment 
costs  are  i)  costs  related  to  chemical  substitution  or  withdrawal  and  ii)  testing.  The  analysis  on 
adjustment costs of the baseline and compared to that, of the different policy options 1a, 1b and 1c 
makes a number of assumptions but acknowledges that there are a number of uncertainties which do 
not  make  it  possible  to  provide  a  precise  estimate  for  the  baseline  and  each  policy  option.  These 
uncertainties concern: i) the specific substances that may be banned in toys under option 1a; ii) the 
specific substances covered by generic bans in options 1b and 1c, and in particular the substances 
that will be classified as endocrine disruptors under the new hazard class proposed to be introduced 
in the CLP Regulation; iii) the number of toy models which would be affected by the new restrictions; 
iv) the precise costs of replacing the particular chemical substance which would be restricted; v) the 
extent to which derogations would be granted under option 1b; vi) the capacity of the EU industry to 
shift  production  to  alternative  toys;  and  vii)  in  cases  of  product  withdrawals,  the  extent  to  which 
demand  will  shift  to  other  toys  which  remain  on  the  market,  or  will  rather  shift  to  other  non-toy 
products. This is why a range of adjustment costs is provided as regards costs related to chemical 
substitution or withdrawal of products and testing costs. The different policy options 1a, 1b and 1c 
are presented with ranges of adjusment costs incremental to the baseline.  

Adaptation  and  withdrawal  costs  are  one-off  costs  but  would  occur  over  time  with  the  regular 
amendments of the Directive in the dynamic baseline and in policy option 1a, and with the substances 
being classified under the relevant hazard classes covered by generic bans under policy options 1b 
and 1c. For the purpose  of this impact  assessment and comparison  of the  options and against the 
baseline, an overall figure corresponding to the total one-off adaptation or withdrawal costs over a 
10 year timeframe has been considered.  

6.1. 

Policy option 1a – minimum changes to the Directive  

Economic impacts - Impacts on economic operators 

In terms of administrative burden, this option would not entail a direct increase of the administrative 
burden reported in the baseline since it does not involve any specific change in terms of information 
obligations or certification. In terms of adjustment costs, the lowering of limit values for nitrosamines 
and nitrosatable substances to the levels already applicable in German law would have a minimal 
impact,  as  manufacturers  are  already  complying  with  these  lower  values.  Similarly,  most 

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manufacturers  are  already  assessing  and  addressing  the  risks  stemming  from  combination  of 
chemicals132 and therefore the need to consider known risks of combination of particular chemicals 
was not considered to lead to increased costs. The primary adjustment costs anticipated form this 
option are costs of chemical substitution and redevelopment resulting from new limit values which 
would  apply  to  all  toys  (in  contrast  to  the  baseline  in  which  new  limit  values  only  apply  to  toys 
intended  for  children  under  36  months  or  to  be  put  in  the  mouth).  Should  suitable  chemical 
alternatives not exist, or product redesign not be possible, it may no longer be possible to make certain 
toys available on the market. The precise costs of product adaptation and product withdrawal will 
depend on the specific limit values that could be progressively introduced in the TSD and as such are 
difficult to quantify at this stage. Also, the scale of impact could differ based on the make-up of a 
manufacturer’s portfolio and to what extent they manufacture toys using the restricted substance.  

Potential  impacts  could  be  estimated  to  require  adaptation  or  withdrawal  of  2.4-4.8%  of  toy 
models on the market in addition to the baseline133. In particular, it could be estimated that 1.6-
3.2%  of  toy  models  would  require  redevelopment  to  identify  and  use  safe,  alternative  chemicals, 
while the remaining 0.8-1.6% could no longer be made available on the market if no alternatives to 
the  restricted  chemicals  are  available134.  Based  on  these  estimates  and  the  cost  estimates  for 
adjustments per toy model detailed in the baseline above which indicate that adaptation costs to new 
limit values could range from EUR 6,700 per toy model produced by large firms and EUR 7,700 per 
toy model produced by SMEs to over EUR 15,000 per toy model135, the total incremental one-off 
adjustment  costs  associated  with  product  redesign  and  redevelopment  to  adapt  to  greater 
restrictions over the period considered could range from EUR 8.18 million to EUR 176.3 million 
compared to the baseline136. As this option would be similar to the current system of the TSD but 
allow that limit values are introduce for all toys, costs are expected to be closer to the lower range as 
these mirror the costs calculated in the Evaluation.  

With limit values being added for new substances in toys, new toy models will need to be tested in 
order  to  ensure  compliance.  The  increased  complexity  of  testing  for  lower  limit  values  would 
reportedly lead to increases in testing costs from EUR 2,200 to around EUR 3,300 per toy model 
when toys need to be tested for the substances subject to new limit values137. In view of the fact that 
products subject to adaptation efforts will be subject to these increased testing costs, yearly testing 
costs are estimated to incrementally increase compared to the baseline by around EUR 1.89-
3.79 million138.  

These are overall estimates for the EU market, given that the specific number of substances that will 
be  addressed  with  future  limit  values  for  chemicals  is  not  currently  known.  Depending  on  which 
substances are addressed by new limit values, companies will have to determine which products in 

132 See Annex 14 for further details. Source: Study on the possible revision of the Toy Safety Directive, 2022, VVA, 
CSES and Asterisk, to be published. 
133 Estimates from manufacturers in the targeted survey are that this option would affect 3-6 % of toy models (compared 
to the baseline of 0.6-1.2%). 
134 This is based on a number of assumptions considering information provided by industry, and that this option will lead 
to the introduction of limit values that may affect all toys rather than only toys intended for children under 36 months or 
toys to be put in the mouth, as is the case today. See Annex 14 for further details on these calculations. 
135 See the details for these calculations in Annex 14. The cost of adapting to new limit values introduced in the Directive 
have been calculated based on the information from the Evaluation on the basis of past adaptations, as well as interviews 
with industry and the targeted SME survey. 
136 This is based on an estimation of 78,702 new toys models put at the market yearly across all business sizes, out of 
which the percentage of those impacted by substitution costs is calculated, and on the range of costs that redesigning each 
of those affected toy models could represent. 
137 Estimates by businesses interviewed in the framework of the supporting study. 
138 Based on the percentage of tests per year (from the total 86,024 test per year) that would be more complex (1.6-3.2%) 
and for which the costs will be higher. See annex 14 for more detailed estimates.  

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their portfolios are affected and need to be redesigned. This is why precise cost estimates per type of 
company could not be calculated. Nevertheless, SMEs account for a fourth of turnover in the sector 
so they will bear a proportionate amount of these costs; they are also expected to have higher costs 
per  new  toy  model  than  larger  firms,  as  they  face  higher  unit  costs.  As  it  was  reported  in  the 
Evaluation, while large companies have had adaptation costs of EUR 6,700 per toy model, these cost 
are  of  EUR  7,700  per  SME.  SMEs  were  concerned  about  facing  higher  unit  costs  than  large 
manufacturers in particular for testing139. Specific differences per size of SMEs were not available 
either. 

In terms of product withdrawals, although the ultimate impact would depend on the value of the toy 
models impacted, it is possible to indicate an estimate based on the turnover achieved by the European 
toys industry. Accordingly, this option could affect EUR 52.47 to 104.9 million worth of toys in 
addition to the baseline (based on provisional EU industry turnover of EUR 6.56 billion for 2020). 
As detailed under the baseline, these impacts would be mitigated by the time provided to adjust to 
the  updated  rules,  which  would  allow  producers  to  shift  resources  to  the  production  and  sale  of 
alternative products, and the fact that, in many instances, consumers would choose to purchase an 
alternative toy product, rather than not purchasing anything, thereby ensuring the revenue to the toys 
market remains. 

Impacts on public authorities 

It is likely that there would not be any additional costs for national authorities. The budget available 
is expected to remain the same, as well as the number of inspections. Even if the number of substances 
subject to limit values would increase, market surveillance authorities are expected to conduct testing 
only for certain types of products inspected, as is currently the case.  

Impacts on innovation, competitiveness and the internal market 

It has been estimated that for a number of restricted chemicals, alternatives may not be found and 
certain  toys  could  no  longer  be  made  available  on  the  market  (around  0.8-1.6%).  This  would  be 
mitigated  in  terms  of  the  impact  on  the  toy  industry  overall  as  consumers  may  instead  purchase 
alternative products that remain on the market and that meet more stringent limit value thresholds, as 
well as the possibility for producers to adapt production through a sufficiently long transition period. 
The  impacts  on  competitiveness  will  depend  strongly  on  the  specific  substances  concerned  by  a 
change in the limit values. Regarding the impacts on innovation, no evidence was identified that there 
are alternative substitutes to many chemicals used in toy production and therefore, if major changes 
to limit values are introduced, this could incentivise producers to search for alternatives, which could 
spur innovation.  

This option is not expected to have net impacts on employment, as it is expected that companies will 
require more man hours dedicated to research of alternative chemicals and product redesign. Overall, 
complementing  this  option  with  another  option  to  effectively  address  the  high  number  of  non-
compliant  toys  on  the  Union  market  was  considered  essential  by  industry  to  preserve  its 
competitiveness140. There would be positive impacts on the single market for having uniform limit 
values for all substances in toys, and responding to consumer expectations regarding the safety of 
chemicals in toys. 

Social impacts - Impacts on human health 

The available evidence on potential human health impacts of PO1a was limited mainly due to the 
lack of detail on which limit values would be updated or introduced (apart from nitrosamines). Most 

139 Source: interviews. See Annex 14 for further details. 
140 Source: interviews and targeted survey. See annex 14 for further details. 

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manufacturers already comply with the lower limits for nitrosamines141, but this option would ensure 
enforceability of those lower limits if this may not be the case and thus lead to better protection from 
these strong carcinogens. For other specific limit values, this option will lead to better and targeted 
protection of children health by ensuring that only those cases based on scientific evidence of hazards 
and  risks  would  be  addressed,  with  due  account  of  mouthing  exposure  by  younger  children,  as 
appropriate. This will guarantee a targeted approach for the protection of specific and demonstrated 
risks.  However,  developing  appropriate  risk  assessments  for  single  chemicals  has  proven  to  be 
laborious,  if  not  cumbersome  in  the  past142.  The  time  between  the  identification  of  a  hazard  for 
children or from the classification of a chemical as hazardous under the CLP Regulation until it is 
banned in toys is likely to be too long (around 2 years in past instances), leaving children unprotected 
for a certain period of time and requiring prioritisation of substances to be tackled in toys. For these 
reasons,  it may only be possible to  introduce a limited number of new limit  values per  year. The 
precise benefits on human health will only be realized after the introduction of such precise limit 
values.  

In terms  of consumer welfare, as this option is only  expected to  have limited impacts  on product 
redesign and adaptations, it should not lead to lower choice of products or increased prices. A certain 
improvement of toy safety and trust could be expected but, like the benefits for human health, these 
are expected to be limited. 

Environmental impacts 

PO  1a  will  not  address  chemical  substances  that  are  harmful  to  the  environment  as  such.  It  will 
address specific chemical substances that would pose a risk to children’s health. Nevertheless, this 
PO  could  still  have  a  minor  positive  effect  on  the  environment,  as  it  would  lead  to  less  harmful 
substances from toy materials once they are banned in toys. This means that less harmful chemicals 
would reach the environment by means of end-of-life toys in waste or recycling.  

Stakeholders’ views 

92% of consumers/environmental groups (56 out of 61), 94% (29 out of 31) of public authorities and 
68% of industry (61 out of 89) agreed or strongly agreed that the Commission should be empowered 
to amend the Directive to set new requirements for chemicals in any toy.  

6.2. 

Policy  option  1b  –  Improved  protection:  generic  bans  of  the  most  harmful 
substances with derogations 

Economic impacts - Impacts on economic operators 

Similar to PO1a, this option would not entail a direct increase of the administrative burden since it 
does  not  introduce  any  specific  change  in  terms  of  information  obligations  or  certification. 
Nevertheless, if industry intends to request a derogation from generic bans, it will need to submit a 
dossier with this request, justifying that the specific substance is safe and that there is no alternative. 
This cost is considered as administrative burden even if it will only be incurred if manufacturers want 
to continue using substances subject to generic bans in toys. This administrative burden will depend 
on the specific derogations that will be requested. In the past, requests for derogations have been 
made by industry associations, which means that the administrative cost for requesting a derogation 
could  be  expected  to  be  shared  among  industry  rather  than  born  by  a  specific  company.  Past 
derogation requests have been estimated by the toy industry at roughly EUR 50.000 per derogation 
request (per industry association, not per company), including the work that manufacturers incur in 
verifying  whether  a  derogation  appears  necessary,  formally  requesting  the  derogation  through 

141 Source: interviews and targeted survey. See annex 14 on the economic impacts and impacts on competitiveness. 
142 See section 5.1.1.2 of the Evaluation. 

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industry associations and commissioning a study on the scientific aspects. Other industries which 
need  to  request  derogations  for  continued  use  of  chemicals  under  generic  bans,  through  similar 
procedures, have indicated a rough estimate of EUR 150.000 to EUR 200.000 per derogation request 
in  the  most  complex  cases.  Based  on  this  information,  it  could  be  estimated  that  the  cost  per 
derogation request could range from EUR 50.000 to EUR 150.000 per derogation request, and that 
there  could  be  a  maximum  of  two  derogation  requests  per  year,  which  would  represent  a  total 
administrative burden for the overall industry of EUR 100.000 to EUR 300.000 per year. Derogations 
would be requested by companies as a means to mitigate the adjustment costs.   

As  for  PO1a,  the  primary  adjustment  costs  anticipated  under  PO1b  are  the  costs  of  chemical 
substitution or product redesign and redevelopment resulting from greater restrictions on the use of 
chemical substances in toys. Should suitable chemical alternatives not exist, or product redesign not 
be possible, or derogations are not possible, certain products could no longer be made available on 
the market. The challenge in providing specific cost estimates is the uncertainty about the precise 
number  of  substances  that  might  be  included  in  extension  of  the  generic  bans143.  The  specific 
substances that may be covered in future hazard classes of the CLP Regulation is not  yet known. 
Furthermore,  manufacturers  will  need  to  assess  the  extent  to  which  their  portfolio  is  affected.  In 
addition, if similar generic bans are applied to substances themselves under REACH, it will be much 
less costly for the toy industry to comply with this option as chemical substitution will already be 
carried out by chemical producers. It could be estimated that the number of substances covered by 
generic bans under PO1b might increase by about 10-30%. This could affect a significant number of 
toy models, but  derogations  would limit  the toy  models that  would  need  to  be subject  to  product 
adaptations  or  which  could  no  longer  be  made  available.  A  total  of  8.4-12.8%  of  toy  models 
additional  to  the  baseline  may  be  impacted  under  PO1b  and  for  which  a  derogation  may  not  be 
possible144,  with  4.6-7.2%  subject  to  product  adaptation  efforts  (including  chemical  substitution 
efforts)  and  3.8-5.6%  could  no  longer  be  made  available  on  the  market  if  no  alternatives  to  the 
restricted chemicals are available. Using the same data on cost estimates for product adaptation and 
redevelopment detailed above for the baseline (from EUR 6,700 for large firms and EUR 7.700 for 
SMEs per toy model to over EUR 15,000 per toy model), the estimated impact on 4.6-7.2% of all EU 
new toy models could result in total incremental one-off adjustment costs associated with product 
redesign and redevelopment of EUR 23.5 to 396.66 million compared to the baseline145. With 
more substances being subject to general bans, as well as limit values added for new substances in 
toys, new toy models will need to be tested in order to ensure compliance with such limit values. Due 
to the need to have more complex and sensitive testing for the toy models that may be impacted by 
the new requirements for chemical substances, the costs of testing may increase from EUR 2,200 to 
EUR 3,900 per toy model.  In view of the products subject to adaptation efforts will be subject to 
these  increased  testing  costs,  yearly  testing  costs  are  estimated  to  incrementally  increase 
compared to the baseline by around EUR 7.31-11.70 million146. 

As in PO1a, these are overall estimates but the specific costs of this option and the precise impacts 
depending on the size of the company could not be quantified. Nevertheless, as mentioned for PO1a 
above, SMEs are expected to have higher costs per new toy model than larger firms, as they face 
higher unit costs. Also, as SMEs account for one fourth of the turnover in the sector, they are expected 
to bear costs in proportion to that.   

143 See annex 10 for a more detailed estimate of substances that could be covered by generic bans. 
144 Based on information by manufacturers in the targeted survey. 
145 Applying the relevant percentages of toy models affected to the estimate of 78,702 new toys, and based on the range 
of costs that such redesign may require. 
146 Based on the percentage of tests per year (from the total 86,024 test per year) that would be more complex (4.6-7.2%) 
and for which the costs will be higher. 

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In terms of product withdrawals, although the ultimate impact would depend on the value of the toy 
models impacted, it is possible to indicate an estimate based on the turnover achieved by the European 
toys industry. This option could thus affect EUR 249 to 367 million worth of toys in addition to 
the baseline147. As mentioned throughout, this would not lead to a direct market contraction of that 
size, given manufacturers will be provided with an appropriate transition period in which they will 
be able to assess the viability of existing products and, if needed, shift resources to the production 
and sale of alternative toy products. Moreover, consumers will in many cases simply purchase an 
alternative toy product rather than not purchase anything.  

There would be additional costs for companies to request a derogation insofar as they will need to 
prepare a dossier justifying the request. These costs could not be quantified with precision at  this 
stage, as it will depend on the specific derogations that will be requested and on whether a number 
of derogations are requested at the same time, in particular in the initial application of GRA. In the 
past, derogations have been requested jointly by industry, and sometimes for a number of substances 
at the same time, which helped generate savings. 

Impacts on public authorities 

As in PO1a, it is likely that there would not be any additional costs. The budget available is expected 
to remain the same, as well as the number of inspections. Even if the number of substances subject 
to limit values would increase, market surveillance authorities are expected to conduct testing only 
for certain types of products inspected, as is currently the case. 

Impacts on innovation, competitiveness and the internal market 

The  extension  of  the  GRA  to  other  harmful  chemicals  could  have  certain  negative  impacts  on 
competitiveness. It has been estimated that if alternatives to restricted chemicals cannot be found, 
3.8-5.6% of toy models could no longer be made available on the market. The impacts of market 
withdrawals may be limited to a certain extent by transition periods, shift of production to alternative 
toys and consumers purchasing an alternative safer product. While some industry stakeholders noted 
that most toy manufacturers already adopt a risk management approach centred on exposure risk and 
do not use the substances that would be subject to restrictions under the extension of the GRA, others 
highlighted the potential scale of the substances that could be banned and stated that there would be 
a potentially significant impact on their product portfolio148. There are a number of concerns among 
industry  (especially  SMEs)  regarding  adverse  impacts  on  competitiveness,  as  SMEs  have  less 
resources to allocate for research and innovation149. These negative impacts may be limited by the 
discussed  implementation  of  the  GRA  in  REACH.  If  the  same  hazard  classes  and  substances  are 
banned  under  REACH,  it  will  be  much  easier  for  the  toy  industry  to  be  compliant  as  chemical 
manufactures  themselves  will  need  to  adapt  their  practices.  Innovation  could  be  stimulated  e.g. 
through  investment  in  R&D&I  for  alternative  chemical  substitutes.  In  order  to  preserve 
competitiveness of EU industry, measures under the second set of policy options to address the high 
number  of  non-compliant  products  are  essential  and  which  would  harm  even  more  compliant 
manufacturers  which  face  these  adaptation  costs.  PO1b  is  not  expected  to  have  net  impacts  on 
employment, as it is expected that companies will require more man hours dedicated to research of 
alternative chemicals and product redesign and that the toys that may no longer be made available on 
the market should not lead to loss of turnover for the overall sector. In terms of working conditions, 

147 Based on provisional EU industry turnover of EUR 6.56 billion for 2020. 
148  Source:  interviews.  See  Annex  2  for  the  results  of  the  consultations  and  in  particular  annex  14  for  the  detailed 
explanations on impacts on competitiveness. 
149  Source:  interviews.  See  Annex  2  for  the  results  of  the  consultations  and  in  particular  annex  14  for  the  detailed 
explanations on impacts on competitiveness. 

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it could lead to certain benefits in terms of reduced exposure to harmful substances of workers for 
toy manufacturers.  

Social impacts - Impacts on human health 

The human health impacts of an extension of the GRA and the removal of the derogation up to the 
concentration limits of the CLP regulation would bring high benefits for the protection of children 
health. The health benefits would be immediate for children, as the generic bans will apply as soon 
as substances are classified in one of the relevant most harmful hazard classes in the CLP Regulation. 
The study analysing the extension of the GRA in REACH150 is looking into the overall damages that 
endocrine disruptors in particular are causing. It is not possible to establish the precise contribution 
of  toys  to  exposure  to  such  harmful  substances.  However,  certain  indicative  health  benefits  are 
presented from the introduction of generic bans based on the value of the avoided health damage 
from exposure to harmful chemicals in toys, in particular to endocrine disrupting chemicals, taking 
into account currently identified health outcomes from exposure to these chemical substances. The 
estimate considers a number of assumptions and relies on the study analysing the extension of the 
GRA in  REACH. As indicated, the precise  chemical  substances that would  be covered under the 
generic  bans  in  the  TSD,  as  well  as  their  current  presence  in  toys  are  not  known  at  this  stage. 
Therefore, the precise exposure that children have today to these harmful chemicals in toys is not 
known either. Due to these uncertainties, the value of the health damage is estimated for endocrine 
disrupting  chemicals  only,  as  it  is  known  that  children  are  particularly  vulnerable  to  the  harmful 
effects of those. Exposure during childhood and puberty, even at low doses, has been found to lead 
to significant health damage that can only be observed at later stages. Even if the contribution of toys 
to the exposure to harmful chemicals is not known with precision, specific limit values in the current 
TSD are based on the fact that toys should only contribute to 10% of tolerable daily intakes of harmful 
chemicals, and 5% for particularly toxic metals151. Furthermore, the limit values are also based on 
the assumption that a child would ingest per day 100 mg of dry, brittle, powder-like or pliable toy 
material,  400  mg  of  liquid  or  sticky  toy  material,  and  8  mg  of  scraped-off  toy  material.  These 
assumptions  are  based  on  a  number  of  studies  on  children  exposure  scenarios  and  mouthing 
behaviour and have been validated by the relevant scientific committee152. 

On this basis, it is considered that from 1 up to 5% of health damage can be avoided due to reduced 
exposure  to  endocrine  disruptors  in  toys.  For  other  classes  of  harmful  substances,  the  precise 
contribution that toys could have to the health damages and the benefits that could be expected from 
the  proposed  policy  options  were  considered  more  uncertain  and  could  not  allow  for  reasonable 
estimates. Even if only 1-5% of the exposure could be attributed to toys, banning those substances 
from toys would have considerable health benefits (EUR 240 million to EUR 1.2 billion per year) 
153  in terms of avoided health damage. This is compared to limited benefits under the baseline in 
terms of reduced exposure to specific substances in toys intended for children under 3 years or to be 
put in the mouth and which will only happen after a certain time after the substance has been found 
to pose a risk to the endocrine system and a limit value for it has been added to the Directive. It is 
worth  noting  though  that  comparing  them  with  the  cost  estimates  is  very  difficult  as  the  benefits 

150 See annex 14 for detailed explanations on the health benefits. The REACH study is not yet published. 
151  
Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on “Assessment 
of  the  bioavailability  of  certain  elements  in  toys”,  June  2004,  Opinion  on  bioavailability  of  certain  elements  in  toys, 
CSTEE plenary, written procedure (europa.eu) 
152  
SCHER (Scientific Committee on Health and Environmental Risks), Final Opinion on estimates of the amount 
of  toy  materials  ingested  by  children,  8  April  2016  Estimates  of  the  amount  of  toy  materials  ingested  by  children 
(europa.eu) 
153 See Annex 14 for the calculations of human health benefits, based on the avoided health damage currently caused by 
endocrine disruptors. Source: Study for the revision of the Toy Safety Directive. Calculations in the REACH study would 
reflect overall health benefits from reducing exposure to endocrine disruptors in all products jointly considered. 

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would accrue over the life time of a child exposed (or not exposed) to endocrine disruptors now which 
means that the time span can be over several generations far exceeding standard appraisal periods of 
20-30 years, while industry will face adaptation costs after the entry into force and start of application 
of the TSD and thus in an earlier timeframe154. As derogations will be allowed only when it has been 
considered  that  the  use  of  that  chemical  in  toys  is  safe,  derogations  to  general  bans  should  not 
compromise the health benefits of this option. In addition, by removing the derogation that allows 
substances  subject  to  generic  bans  to  be  present  in  quantities  below  the  concentration  limits  for 
classification under the CLP Regulation, this minimum exposure will also be eliminated. Requiring 
regular reviews of the derogations granted, it will ensure that any new scientific knowledge that may 
have emerged is  duly  considered.  In  addition,  as is  required by the current  derogation procedure, 
derogations  granted  should  be  reassessed  every  five  years  to  ensure  that  their  use  remains  safe. 
Product  withdrawals  estimated  would  result  in  corresponding  reduction  of  exposure  to  the  most 
harmful substances. This should lead to direct health benefits, in particular as these substances may 
cause harm at very low doses, and to a vulnerable population which is particularly sensitive to such 
harmful effects.  

In terms  of consumer welfare, this option may have certain  impacts  on the choice of products  or 
increased prices, though these should be moderate, as the possibility to have derogations should limit 
the impacts on categories of products. Improvements in toy safety and trust could be expected, in line 
with the significant benefits for human health that can be expected from this option. 

Impacts on the environment 

PO1b would address substances that are hazardous for human health. It would introduce generic bans 
on  substances  classified  as  hazardous  for  human  health  under  certain  hazard  classes  in  the  CLP 
Regulation, as well as additional limit values for other substances that may pose a risk to children 
health.  However,  this  option  would  have  certain  benefits  for  the  environment  too.  The  CLP 
Regulation  includes  different  hazard  classes  for  hazards  to  human  health  or  the  environment. 
However, harmful substances can be classified under several such hazard classes at the same time. 
Substances which can be harmful both for human health and for the environment, such as EDs and 
CMR would not be present in toys, as they would be subject to generic bans due to their hazardous 
classification for human  health. This  would lead  to  certain benefits  for the environment.  If fewer 
harmful chemicals are included in toys, there would be less harmful substances that would reach the 
waste stream or recycling. Derogations to generic bans will still be possible under this option, limiting 
these benefits on environmental protection.  

Stakeholders’ views 

Over 85% (between 50 and 55 out of 61, depending on the specific harmful substance) of consumer 
groups  and  environmental  associations  would  like  to  see  the  most  harmful  substances  banned 
preventively.  Also  while  58%  of  public  authorities  (18  out  of  31)  would  like  to  see  certain  of 
endocrine disruptors preventively banned by the TSD, 40% (13 out of 31) considered that generic 
bans  should  also  cover  other  harmful  substances  such  as  substances  affecting  the  immune  or 
neurologic systems. Only 10% (8 or 10 out of 89, depending on the substance) of industry supported 
this option. 

6.3. 

Policy  option  1c  –  Maximum  protection:  generic  bans  of  the  most  harmful 
substances without derogations 

Economic impacts - Impacts on economic operators 

154 See annex 14 for the detailed estimates. Source: Study for the revision of the Toy Safety Directive. 

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Concerning administrative burden, as for PO1a and PO1b, this option would not entail direct costs 
because it does not affect information obligations, labelling or certification.  In terms of adjustment 
costs,  the  removal  of  all  derogations  under  PO1c  would  implement  further  adjustment  costs  on 
industry stakeholders. In particular, this option could lead to a significant number of toys that could 
no longer be made available on the market.  Indicative estimates  of the potential adjustment costs 
related to PO1c could lead to a total of 19.4-28.8% of toy models in addition to the baseline155 that 
will be impacted under  PO1c, with  9.6-14.2% subject to product adaptation efforts (including 
chemical  substitution)  and  9.8-14.6%  that  could  no  longer  be  made  available  on  the  market. 
Using the same data on cost estimates for product adaptation and redevelopment detailed above in 
the baseline (from EUR 6,700 for large firms and EUR 7.700 for SMEs per toy model to over EUR 
15,000 per toy model), the estimated impact on 9.6-14.2% of all EU toy products could result in total 
incremental one-off adjustment costs associated with product redesign and redevelopment of EUR 
49.1 – 782.3 million compared to the baseline156. As in PO1b, due to the need to carry out more 
complex and sensitive testing, testing costs would increase from EUR 2,200 to around EUR 3,900 
per new toy model. In view of products subject to adaptation efforts will be subject to these increased 
testing  costs,  yearly  testing  costs  are  estimated  to  incrementally  increase  compared  to  the 
baseline by around EUR 14.62-21.94 million157. 

In terms of product withdrawals, although the ultimate impact would depend on the value of the toy 
models impacted, an estimate based on turnover would imply that this option could affect EUR 642 
to 957 million worth of products (based on provisional EU industry turnover of EUR 6.56 billion 
for 2020). As mentioned throughout, this would not lead to a direct market contraction of that size, 
given manufacturers will be provided with an appropriate transition period in which they will be able 
to assess the viability of existing products and, if needed, shift resources to the production and sale 
of alternative toy products. Moreover, consumers will in many cases simply purchase an alternative 
toy product rather than not purchase anything. However, the lack of derogations will render it very 
difficult to find alternatives for certain categories of products. Derogations under option 1b would set 
out permitted uses in toys which have been considered safe for prohibited substances. As such, they 
would be included in the legislation itself, benefitting the whole industry and not only the applicant. 
Since the adoption of the Toy Safety Directive including a generic ban for CMR substances, only 3 
derogations have been requested. Even if the number of derogations requested under  PO1b is not 
expected to  be high, the absence of specific  derogations  for certain  substances may mean that an 
entire  category  of  toys  could  no  longer  be  available  in  the  Union  market.  For  example,  nickel  is 
classified  as  a  carcinogenic  substance  and  as  such  is  not  allowed  in  toys  in  accordance  with  the 
provisions for generic bans of CMRs of the current Toy Safety Directive. Nevertheless, it is allowed 
in toys and toy components made of stainless steel or in those toy components which are intended to 
conduct an electric current, and it actually prevents corrosion of metals.  Nickel is allowed in toys 
because it has been scientifically assessed in the past that nickel present in toys as set out above does 
not pose a risk for children158. According to the scientific opinion of the predecesor of SCHEER, 
nickel  only  causes tumours in  the respiratory tract  after inhalation exposures to  nickel-containing 
dusts and fumes, but not after oral intake. Since inhalation of nickel from toy materials intended to 
transmit the electric current is extremely unlikely, SCHER concluded that a tumor risk due to nickel 

155 Based on the information provided by manufacturers in the interviews and SME survey. 
156 Based on applying those percentages to 78,702 new toy models and also based on the range of costs that redesign 
could represent. 
157 Based on the percentage of tests per year (from the total 86,024 test per year) that would be more complex (9.6-14.2%) 
and for which the cost will be higher. 
158 
1637796d285b_en?filename=scher_o_163.pdf  

https://health.ec.europa.eu/document/download/af3a05ea-2f9f-4939-89c6-

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exposure when handling toys is not present159. Nickel in these uses has thus been considered to be 
safe and that it does not expose children to the hazardous properties of the substance. Nevertheless, 
without a derogation to allow for the presence of nickel in the materials described above, electric toys 
would not be allowed on the Union market. This is why the adjustment costs and product withdrawals 
in PO1c are significantly higher than in PO1b.   

As in PO1a and PO1b, the number of specific substances that will be covered by the generic bans, as 
well as the precise number of products impacted and the availability of alternatives are not possible 
to quantify with precision. Thus, data on the detailed impacts on the different sizes of company is not 
available. However, as in PO1a and PO1b, SMEs are expected to have higher costs per new toy model 
than larger firms, as they face higher unit costs and, as they account for a fourth of the turnover in 
the EU market, they are expected to bear costs in that proportion.  

Impacts on public authorities 

It is likely that there would not be any additional costs for national authorities. The budget available 
is expected to remain the same, as well as the number of inspections. Even if the number of substances 
subject to limit values would increase, market surveillance authorities are expected to conduct testing 
only for certain types of toys inspected, as is currently the case.  

Impacts on innovation, competitiveness and the internal market 

This option would have a negative impact on competitiveness due to the inability of manufacturers 
to  rely  on  derogations  to  generic  bans.  If  there  are  no  viable  alternative  substitutes,  it  has  been 
estimated that a number of products could no longer be made available on the market (9.8-14.6%).  
This would be unlikely to be fully mitigated as consumers would not be able to purchase alternative 
products not containing these chemicals if they are necessary for production in the specific product 
concerned across the whole product category. There could therefore be loss of revenue for the overall 
toy sector. The removal of the derogations related to the use of nickel (which is a CMR substance) in 
certain  forms  for example would lead to  a significant  withdrawal  of toys  across different  product 
lines, as its use is necessary in toys and toy components made of stainless steel and toy components 
which  are  intended  to  conduct  an  electric  current160.  Therefore,  the  non-availability  of  a  specific 
derogation for this substance would have impacts on an entire category of toys. 

The vast majority of SMEs responding to the public consultation disagreed with the option not to 
have derogations to general bans (67.4 % - 31 out of 46). SMEs view this option as having significant 
adverse impacts on firm and sectoral level competitiveness, as the impacts of the option on product 
categories will be significant and SMEs would have less resources available to invest on research and 
development  of products which would not  contain these chemicals.  This  option could  have some 
positive impacts on innovation. As with the other options, PO1c should be accompanied by measures 
under PO2 to  address  the high number of non-compliant toys, and which would harm even more 
competitiveness of compliant manufacturers which face these adaptation costs. 

This option could lead to certain negative impacts on employment. Even if, as in the previous PO1a 
and 1b, it is expected that companies will require more man hours dedicated to research of alternative 
chemicals and product redesign, the extent of the restrictions could lead to loss of turnover for the 
overall  sector.  In  terms  of  working  conditions,  it  would  limit  exposure  of  workers  for  toy 

159 Scientific Committee on Health and Environmental Risks SCHER Assessment of the Health Risks from the Use of 
Metallic  Nickel  (CAS  No  7440-02-0)  in  Toys,  25  September  2012,  https://health.ec.europa.eu/system/files/2016-
11/scher_o_163_0.pdf 
160  See  annex  14  for  the  detailed  explanation  on  these  concerns  on  competitiveness.  Source:  targeted  survey  and 
interviews. 

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manufacturers to harmful chemicals, and this limitation would be higher than in PO1b in view of the 
lack of derogations. 

Social impacts - Impacts on human health 

The extension of the GRA and the removal of derogations on CRM substances would have strong 
benefits to human health. Exposure of children to such harmful substances would be significantly 
reduced, similar to PO1b. The health benefits would be immediate for children, as substances would 
be banned from toys as soon as they are classified in one of the relevant most harmful hazard classes 
in the CLP Regulation. The product withdrawals estimated would be due to the presence of these 
harmful chemicals in such toys. Their withdrawal will result in a corresponding reduction of exposure 
of children to the most harmful substances (only toys containing these harmful substances will be 
withdrawn from the market). The measures envisaged in this option to address chemical substances 
will lead to direct health benefits, in particular as these are the most harmful substances that generally 
cause harm at very low doses, and exposure will be reduced for a vulnerable population which is 
particularly sensitive to such harmful effects. If the criteria for the derogations under PO1b are sound 
and the risks can be clearly limited with the conditions to grant such derogations, PO1c would not 
provide significant additional health impacts but similar health impacts as PO1b (EUR 240 million 
to 1.2 billion EUR per year)161, based on the assumptions and estimates as explained under that 
policy option. Derogations should only allow uses of substances subject to generic bans for which 
safety  can  be  scientifically  concluded.  Generic  bans  will  cover  hundreds  of  substances  while 
derogations are expected to cover only a limited number of them and for limited uses. Derogations 
under PO1b would be of general  application to  allow certain  uses of substances in  toys, but  only 
where this  has been considered to be safe for children in  terms of exposure to  the substances.  In 
addition, derogations should be reassessed every 5 years.  

The  estimated  health  benefits  stem  from  the  introduction  of  generic  bans  for  the  most  harmful 
chemicals. Generic bans are proposed in both options 1b and 1c and will apply to a significant number 
of  substances  and  will  protect  children  from  exposure  to  these  harmful  chemicals.  Based  on  the 
explanations  above,  derogations  should  not  allow  for  exposure  to  the  harmful  effects  of  these 
chemicals  and  this  is  why  the  estimates  for  health  benefits  in  both  option  1b  and  1c  should  be 
quantitatively similar. If derogations are only granted for a use that has been evaluated as safe and 
there  are  no  alternatives,  it  should  not  diminish  the  overall  estimated  health  benefits  achieved  by 
reducing exposure of children to these substances. The overall health benefits in option 1c should not 
be significantly higher than in PO1b. However, derogations could affect entire categories of products; 
see the example of nickel explained above which could affect all electric toys on the Union market. 
This is why, while the health benefits of PO1c are expected to be substantially the same as in PO1b, 
the economic impacts in terms of adjustment costs in PO1c are expected to be much higher than in 
PO1b. 

In terms of consumer welfare, this lack of possibility for derogations is expected to limit significantly 
the choice of products and possibly lead to higher prices. Improvements in toy safety and trust could 
be expected, but comparable to those under PO1b. 

Impacts on the environment 

Similar to PO1b, PO1c would introduce generic bans on harmful substances classified as hazardous 
for  human  health  under  certain  hazard  classes  in  the  CLP  Regulation,  as  well  as  additional  limit 
values for other substances that may pose a risk to children health, this option would have certain 
benefits for the environment. The CLP Regulation includes classification of harmful substances as 
hazardous for human health or the environment. Chemical substances can be classified under several 

161 See annex 14 for detailed calculations on health benefits. Source: Study on the revision of the Toy Safety Directive.  

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such hazard classes at the same time. Where substances are considered as hazardous not only for 
human health but also to the environment and are subject to generic bans in toys, this  option will 
have positive impacts on the environment. This option will bring more benefits to the environment 
than the previous options, given that substances which can be harmful both for human health and for 
the  environment,  such  as  EDs  and  CMRs,  would  not  be  present  in  toys  at  all.  If  there  are  no 
derogations to the generic bans, this should mean that less harmful substances will be present in the 
waste stream, which would thus have a positive impact on the environment. Less harmful substances 
would be present in recycled materials from toys, which could then be used more safely. In addition, 
this option may have other indirect positive impact on the environment; by leading to higher prices 
of toys, there may be less consumption and waste.   

Stakeholders’ views 

A number of respondents to the public consultation believed that there should be no derogations to 
the general bans: most support came from consumer and environmental groups (50% - 31 out of 61- 
of respondents) while only 35% (11 out of 31) of public authorities supported that there would be no 
derogations. 73% (66 out of 89) of industry respondents disagreed with removing derogations from 
general  bans.  Consumer  and  environmental  groups  believed  that  maximum  protection  should  be 
offered  to  children,  while  public  authorities  and  industry  were  concerned  about  the  impacts  on 
competitiveness and choice of toys that the lack of derogations would have. 

6.4. 

Policy option 2a: extending third-party conformity assessment 

Economic impacts: Impacts on economic operators 

This  option would lead to  additional costs in terms  of  administrative burden for companies. The 
proportion of new toys undergoing third party conformity assessments would increase from currently 
3% to about 20%162. The current administrative burden has been estimated at an average of EUR 
4,000 per new toy model in case of self-certification and EUR 4,500 in case of third party conformity 
assessment.  Applying  this  extra  cost  to  the  percentage  of  additional  toy  models  which  would  be 
required to go through third party conformity assessment, it has been estimated the yearly increase 
of the administrative burden for the EU market would amount approximately to EUR 7.8 million163. 
No differences in the administrative burden were identified depending on the type of company, as 
these  costs  are  associated  with  the  amounts  that  Notified  Bodies  charge  for  their  services.  There 
would be no adjustment costs stemming from this option.  

For notified bodies, the number of EU-type examinations would be expected to increase, leading to 
benefits. Notified bodies may incur costs relating to the increase in the testing capacity required to 
undertake these additional tests, since only around 3% of the toys in the EU market  are currently 
subject to third-party testing.164 These costs are not expected to be borne by notified bodies but rather 
to be passed on to manufacturers who will pay for the additional EU-type examinations. 

Impacts on public authorities  

It can be estimated that this option will reduce the time necessary to collect information for market 
surveillance authorities, as the time needed to collect information from a notified body is significantly 
lower than economic operators. It can be estimated that PO2a would result in a 5% time saving for 
the average inspection by market surveillance authorities which would translate into a 5% increase 
in  the  number  of  inspections165,  as  it  could  be  assumed  that  the  budget  allocated  to  market 

162 Estimates by businesses interviewed in the framework of the supporting study and on 78,702 new toy models per year. 
163  Based  on  an  estimation  of  78,702  new  toy  models  placed  on  the  market  every  year.  See  annex  14  for  detailed 
calculations on the economic impacts. 
164 Information from the Notified Bodies-Toys group. 
165 Based on assumptions of experts consulted in the framework of the supporting study. 

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surveillance activities in toys will remain the same and that the efficiency gains will be redirected to 
additional toy inspections. The number of inspections in the EU is expected to rise to a maximum 
of  an  additional  1000  per  year  (from  25,259  to  26,522)  leading  to  a  reduction  of  the  cost  per 
inspection from EUR 738.52 to EUR 703.35166. There would also need to be more efforts, and costs, 
to control conformity assessment bodies’ quality by public authorities.  

Impacts on innovation, competitiveness and single market 

The main negative impacts on competitiveness were considered by industry to include: the higher 
costs of mandatory third-party conformity assessment for toys, and increased lead times to market. 
In particular, while the costs of lead times to market are difficult to quantify, mandatory third-party 
conformity assessment could add an additional 4-6 months to the process of placing a product on the 
European market, with an adverse impact on competitiveness. The reduction of non-compliant toys 
on the single market would lead to positive effects on competitiveness for EU and other compliant 
industry, as they will face less competition from rogue traders selling non-compliant products, often 
at cheaper prices. However these positive effects on competitiveness will not be very significant, as 
the improvements on the number of non-compliant toys are expected to be limited. This is because 
this  option  will  facilitate  enforcement  by  market  surveillance  authorities  to  a  limited  extent,  and 
therefore  it  will  not  significantly  increase  the  incentives  to  comply  for  rogue  traders.  It  may  be 
expected that those manufacturers that already comply with the requirements of the TSD will also 
comply with the obligation to perform third party examination, but those rogue traders which already 
ignore the rules will continue to do so. Nonetheless, these limited positive effects will likely not offset 
the costs for EU industry (in particular SMEs)  who will continue to face unfair competition from 
rogue traders to a significant extent. SMEs were particularly concerned by this option, as they were 
of the opinion that this would adversely affect their competitiveness.  

This  option  is  not  expected  to  have  impacts  on  employment  by  toy  manufacturers,  but  a  slight 
increase in employment by Notified Bodies would be likely, as they would need to ensure additional 
capacity to provide conformity assessment services. 

Social impacts - Impacts on human health 

The available evidence suggests that only a limited improvement in the number of illicit toys is to be 
expected from this option, as explained in the previous sections on impacts on public authorities and 
on competitiveness,  innovation  and the single market. Accordingly, the risks  of illicit toys would 
only  decrease  slightly  and  this  option  would  only  have  limited  benefits  on  children’s  health. 
Similarly, as the reduction of non-compliant toys is expected to be limited, this option is not expected 
to have significant impacts on consumer welfare and trust. 

Impacts on the environment 

This option is not expected to have positive impacts on the environment. Illicit toys could be more 
harmful to the environment as they could contain more dangerous substances, therefore, a reduction 
of the number of such toys would mean less pollution. Less harmful substances would be present in 
recycled materials from toys, which could then be used more safely. However, it is expected that this 
option  will  only  lead  to  minor  reductions  on  the  number  of  non-compliant  toys,  thereby  yielding 
limited benefits to the environment. 

Stakeholders’ views 

166 The extent to which the efficiency gains will translate into a precise increase in the number of inspections may vary 
in practice depending on the specific time and resources saved as well as the precise toys subject to inspection. As such, 
this  analysis  presents  certain  estimates  to  illustrate  the  impact  of  the  policy  options  in  the  increase  of  number  of 
inspections, but the precise increase in practice would probably be lower. 

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In the public consultation, 83% (51 out of 61) of consumer/environment groups and 75% (23 out of 
31) of authorities supported the extension of third-party conformity assessment while 75% of industry 
was against it (67 out of 89). Industry believes that it will impose additional costs without bringing a 
significant improvement to the problem of a high number of non-compliant toys. 

6.5. 

Policy option 2b: facilitation of market surveillance through digitalisation 

Economic impacts - Impacts on economic operators 

This option requires the introduction of a digital passport that would include the EU declaration of 
conformity so that it is digitally accessible (via a machine-readable code) and the registration of the 
reference in a central registry. This will be based on the Digital Product Passport proposed under the 
ESPR. Toys may be covered in the longer term by one of the delegated acts setting sustainability 
requirements, however they are currently not included in the list of high priority sectors identified in 
the Circular Economy Action Plan (CEAP) adopted by the Commission in March 2020. This is why 
the impacts for economic operators are considered under PO2b and not part of the baseline. In terms 
of administrative burden, this option can lead to one-off costs (such as development of required IT 
tools, new procedures for the preparation of the product documentation, and potentially additional IT 
services) and recurrent costs (e.g. the FTE required to collect and provide electronically the required 
documentation). For the calculation of the overall market costs, SMEs have been assumed to incur 
in yearly costs of EUR 3,000 per company, while for larger companies, up to EUR 140,000167, 
but the specific breakdown of these costs into one-off and recurring costs for the toy sector was not 
available. Previous research in other markets has found a split of 80% one-off vs 20% annual costs 
for large firms, and 62% one-off vs 38% annual costs for SMEs168. Applying this breakdown to the 
estimates for toys169 would suggest a total one off cost of EUR 18 million in addition to an annual 
recurring cost of EUR 10.5 million. It is therefore expected that companies will incur in significant 
initial costs, but that these would be lower in subsequent years thanks to economies of scale and the 
fact  that  after  the  systems  are  set  up  and  most  initial  data  entered,  there  are  only  expected  to  be 
additional costs related to updating and maintenance costs. 

The Digital  Product  Passport will contain the compliance documentation that economic operators 
must possess and be able to present upon request in any case. This option is also expected to lead to 
savings  as  compliance  information  that  economic  operators  currently  need  to  create  will  only  be 
provided digitally. The digital passport under option 2b will replace the EU declaration of conformity 
that  manufacturers  have  to  produce  currently  for  every  toy.  Previous  studies  have  suggested  a 
benchmark of about 10-15% savings in administrative costs from the full digitalisation of product 
information (not only compliance but also user-related information)170. These studies also estimate 
the cost of the provision of compliance information at 0.4% of turnover of the sector.171 Accordingly, 

167 Estimations of respondents from different SME sizes participating in the SME survey. 
168  Study  to  support  the  Impact  Assessment  on  the  use  of  digital  labelling  for  EU  fertilising  products,  European 
Commission’s DG GROW, 2022  
169  The  range  3000  –  140,000  per  company  reflects  the  range  of  prices  per  administrative  action  of  producing  non-
labelling information between EUR 300 and 1100 per toy model. Further calculations are based on a cautious estimation 
of EUR 325 per action per toy. 
170 European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, Supporting 
study for the evaluation of certain aspects of the New Legislative Framework (Decision No 768/2008/EC and Regulation 
(EC) No 765/2008), Publications Office of the European Union, 2022, https://data.europa.eu/doi/10.2873/625443 
171 0.4% of turnover of EU toy industry in 2020 was EUR 26.2 million. The share of 0.4% is the result of a multiplication 
of  the  total  cost  of  compliance  (2%  of  annual  turnover,  based  on  previous  literature)  by  the  share  of  the  total  cost 
compliance  related  only  to  the  cost  of  indicating  compliance  with  EU  harmonisation  legislation  (20%,  based  on 
stakeholder consultation in the study supporting the Evaluation of the New Legislative Framework). 

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savings could be estimated at around EUR 2.62 to EUR 3.93 (EUR 3.275 on average) million per 
year  only from moving to the digital provision of compliance information.  

In addition, there would be savings from the immediate availability of information when dealing with 
market surveillance authorities for specific inspections. These are independent from the savings on 
the digitalisation of compliance information that are detailed above; these savings will happen when 
toys are subject to inspections. The Evaluation provides an indication of the average cost – per new 
toy for an average importer or distributor – to “ensure that the toy is accompanied by the required 
documents”.172 The average cost of such activities per new toy model are estimated to be between 
EUR 548 and EUR 651. This can serve as a basis to estimate the amount of time and relative cost a 
company would incur in retrieving all the necessary information for a toy model and supplying it to 
market surveillance authorities when inspections are conducted173. With the implementation of the 
DPP,  this  cost  would  likely  disappear  for  companies,  since  relevant  documentation  would  be 
available online for market surveillance authorities, as well as the supply chain information. Since 
the annual number of inspections in Europe is calculated to be around 25,000 (and may rise to 30,000 
in case of implementation of the DPP), and each inspection would concern a specified toy model, it 
can be estimated that the average  annual  saving for EU companies could be between EUR 13 
million and EUR 16 million in case inspections remain at the same levels or increase slightly, 
or even up to EUR 20 million in case of increased number of inspections. 

It is reasonable to assume that in the long term the internal costs for companies to implement the DPP 
will diminish, and the benefit of less burdensome inspections for compliant companies will lead to a 
visible economic benefit in terms of reduction of administrative burden.  Efficiencies are expected 
from having all the information about a given toy available via a single QR code or a similar machine 
readable item, which is how the DPP will be implemented in practice. 

Impacts on public authorities  

While it is difficult to assess the exact scale of the reduction by this option in the time needed to 
undertake inspections, it is estimated that it could range between 10% to 20%, which could translate 
into an equivalent percentage increase in the number of inspections which could be undertaken with 
the resources available174. The number of inspections in the EU is expected to rise to a maximum 
of an additional 2500 to 5000 per year (from 25,259 to between 27,785 and 30,311) assuming that 
the overall budget for market surveillance authorities for toys will remain the same and that efficiency 
gains will be reinvested in additional toy inspections, thus lowering the cost per inspection from 
EUR 738.52 to between EUR 671.37 and EUR 615.42175. There would be one-off costs relating to 
market surveillance authorities adapting their information systems and procedures to the digitalised 
information but this would already be covered by the ESPR176; additional costs are not expected to 
be attributed to the revision of the TSD. The ESPR also foresees that the reference to the DPP will 
be included in a central registry, managed by the Commission, as well as the interconnection with 
the underlying IT infrastructure for customs purposes, in order to allow for the automatic verification 
of the existence of a DPP at the time of import. In terms of customs controls, this option would entail 
the submission of the required documentation by the importer at a stage before the actual shipping of 

172 Evaluation of Toys safety Directive, p. 64 
173 The Evaluation also estimated costs for “getting supply chain information” of EUR 700 per toy model. 
174 Based on assumptions of experts consulted in the framework of the supporting study. See annex 14 for the detailed 
explanations on these estimates. 
175 The extent to which the efficiency gains will translate into a precise increase in the number of inspections may vary 
in practice depending on the specific time and resources saved as well as the precise toys subject to inspection. As such, 
this  analysis  presents  certain  estimates  to  illustrate  the  impact  of  the  policy  options  in  the  increase  of  number  of 
inspections, but the precise increase in practice would probably be lower.  
176 Commission staff document SWD(2022) 82 final, p.61. 

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the toy, which will apply to any toy entering the EU. This would lead to potential savings for customs 
with less shipments on hold at the border177. Customs authorities would check through automated 
systems the provision with the imported shipment of the DPP, thereby ensuring a minimum automatic 
check of the existence of the DPP on any toy entering the EU, either in small consignments or in 
higher volumes. The actual content of the DPP and the toy itself could still be subject to checks by 
the relevant national market surveillance authorities. Carrying out automatic controls would allow 
customs to reduce their costs and likely allow more effective and targeted controls. 

Impacts on innovation, competitiveness and single market 

This option is expected to lead to significant benefits for the competitiveness of companies. Firstly, 
the  digitalisation  of  product  information  (including  regulatory  compliance  aspects)  could  lead  to 
greater efficiencies and cost savings. Once toys are subject to the ESPR, relying on the DPP already 
for  compliance  under  the  toy  safety  rules  will  lead  to  important  savings  for  the  toy  industry.  In 
addition, the information that could be mandatorily required under the ESPR in the DPP could bring 
synergies  if  it  helps  contribute  both  towards  meeting  toy  safety  compliance  requirements,  for 
example,  and  information  on  specific  chemicals.  Furthermore,  this  option  is  expected  to  lead  to 
important reductions in the number of non-compliant toys in the EU. This is because, first of all, it 
will allow market surveillance authorities to be more efficient in their inspections and target products 
without the DPP which may be more likely non-compliant. In addition, currently toys entering the 
Union market from third countries are subject to controls at the border on a risk- based approach. 
Under PO2b the presence of the DPP in toys will be automatically verified at customs when toys are 
presented  for  release  for  free  circulation.  These  will  apply  to  any  toy  entering  the  Union  market, 
either bought online or through other distribution channels. Toys without the DPP will be prevented 
from being released for free circulation in the Union market. These automatic controls at customs are 
expected  to  have  significant  impacts  in  reducing  the  number  of  non-compliant  toys  entering  the 
Union market. This will prevent that toys not intended for the Union market reach EU customers. It 
will only be possible to create the DPP if a valid EU declaration of conformity exists for the toy. All 
toys imported into the Union market will have the EU declaration of conformity, and this will be 
easier to verify when market surveillance authorities inspect them. 

The  overall  reduction  of  the  number  of  non-compliant  toys  will  have  a  positive  impact  on  the 
competitiveness of compliant manufacturers by improving the level playing field and curtailing illicit 
competition. A shift in demand to compliant products in the EU can also occur. SMEs were concerned 
about the impacts of this option on their competitiveness as they are less able to invest in digitalisation 
compared with large firms. Despite this, this option was still seen very positively by industry, both 
by  large  firms  and  SMEs178.  Digitalisation  of  product  information  was  therefore  welcomed  by 
industry  as  a  means  of  modernising  the  provision  of  regulatory  compliance  and  supply  chain 
information, despite certain concerns on costs by SMEs. This in turn could improve the functioning 
of the single market as digitalisation of certain information is being actively considered and is close 
to being introduced in other EU legislation (e.g. fertilisers, chemicals and detergents) and other global 
jurisdictions that have also embraced digital labelling.  

This option could have certain positive impacts on employment, as toy manufacturers will need to 
dedicate  resources  to  ensure  the  digitalisation  of  information.  There  might  be  a  shift  in  demand 
towards IT skills and qualifications. 

177 See annex 14 for the detailed explanations on the impacts for authorities. Source: study for the revision of the Toy 
Safety Directive. 
178 Source: targeted survey and interviews, see annex 2 on the consultation activities and annex 14 on detailed impacts 
on competitiveness. 

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Social impacts - Impacts on human health 

The  introduction  of  a  DPP  could  have  significant  impacts  on  the  number  of  illicit  toys  and  in 
protection from the health risks of those. Controls at customs of the presence of the DPP would be 
rendered automatic in the first place, facilitating that a significant percentage of non-compliant toys 
are prevented from being released for free circulation in the Union market.  In terms of consumer 
welfare, it will lead to positive impacts on product safety and consumer trust, and should not affect 
the choice or price of toys. 

Impacts on the environment 

As  explained  in  PO2a,  non-compliant  and  dangerous  toys  are  more  harmful  to  the  environment, 
therefore, a reduction of the number of such toys would mean less pollution. As this option is likely 
to significantly reduce the number of non-compliant toys, the benefits on the environment may also 
be relevant. Less harmful substances would be present in recycled materials from toys, which could 
then be used more safely. Additionally, the digital passport for toys could help reduce the number of 
papers  used  by  economic  operators  and  national  authorities;  however  this  impact  could  not  be 
quantified.  

Stakeholders’ views 

59% of consumer/environmental groups (36 out of 61), 96% of public authorities (30 out of 31) and 
52 % of industry (47 out of 89) supported that toys should have a DPP with compliance information 
to improve enforcement. 

6.6. 

Policy option 2c: Extending third party conformity assessment and facilitation of 
market surveillance through digitalisation 

Economic impacts - Impacts on economic operators 

The costs and savings  of this PO2c will be the sum  of costs and savings  estimated for  PO2a and 
PO2c. No additional adjustment costs are expected. 

Impacts on public authorities  

While  it  is  difficult  to  assess  the  exact  scale  of  the  reduction  in  the  times  needed  to  undertake 
inspections under PO 2c, the effects of option 2a and 2b are expected to be aggregated. As such, the 
time  savings  for  inspections  would  be  in  the  range  of  15%  25%179.  The  average  number  of 
inspections in the EU is expected to rise to a maximum by an additional 3500 to 6000 per year 
(from 25,259 to between 29,048 and 31,573) assuming the budget allocated for market surveillance 
in  toys  will  remain  the  same  and  that  the  efficiency  gains  will  be  reinvested  in  additional  toy 
inspections thus lowering the cost per inspection from EUR 738.52 to between EUR 642.18 and 
EUR 590.83180. Other impacts for market surveillance and customs were already highlighted in the 
analysis of PO2b. 

179 See annex 14 for detailed explanations on these estimates. These calculations are based on interviews with market 
surveillance authorities and the efficiency in conducting inspections they have declared if the DPP would be available. 
180 The extent to which the efficiency gains will translate into a precise increase in the number of inspections may vary 
in practice depending on the specific time and resources saved, the reallocation of those resources to toy inspections, as 
well as the precise toys subject to inspection. As such, this analysis presents certain estimates to illustrate the impact of 
the policy options in the increase of number of inspections, but the precise increase in practice would probably be lower. 

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Impacts on innovation, competitiveness and single market 

The  impacts  on  innovation,  competitiveness,  the  single  market  and  employment  were  already 
highlighted in the analysis of PO2a and PO2b. However this option will lead to a stronger reduction 
of the number of non-compliant toys thereby strengthening the competitive position of compliant 
manufacturers.  

Social impacts: Impacts on human health 

This  option  will  have  strong  impacts  on  improving  human  health,  as  it  will  lead  to  significant 
reductions  of  the  number  of  non-compliant  toys.  The  two  PO2a  and  2b  combined  in  PO  2c  will 
reinforce  each  other.  A  real  improvement  in  market  surveillance  could  be  achieved  with  more 
certainty on the assessments coming from third party conformity assessments and the information 
more easily available with the DPP. The impacts on consumer welfare in terms of increased product 
safety and trust will also be high. 

Impacts on the environment 

Both measures combined would lead to less non-compliant toys in the EU market, and thus more 
benefits for the environment. Less harmful substances would be present in recycled materials from 
toys, which could then be used more safely. Digitalisation should lead to less paper consumption.  

7.  HOW DO THE OPTIONS COMPARE? 

7.1.  Effectiveness of the proposed policy options 

The following table presents the effectiveness of the proposed options against the relevant specific 
objectives. 

SO1: 
protection 
children 
harmful chemicals 

Higher 
of 
from 

SO2:  Flexibility 
to 
adapt to new scientific 
knowledge 

SO3:  Reduce  the  number 
of  non-compliant 
and 
unsafe products 

SO4: 
enforcement 

facilitate 

Option 1a 

Option 1b 

Option 1c 

Option 2a 

Option 2b 

Option 2c 

++ 

+++ 

+++ 

+ 

++ 

++ 

++ 

+++ 

++ 

+- 

+- 

+- 

+- 

+- 

+- 

+ 

+++ 

+++ 

+- 

+- 

+- 

++ 

++ 

+++ 

Legend: +- no relevance; + limited effectiveness; ++ effective; +++ very effective 

Introducing generic bans for chemicals classified under the most harmful hazard classes181 as 
proposed  in  options  1b  and  1c  is  the  most  preventive  approach  for  regulating  chemical 
substances. This is because substances are preventively banned in toys as soon as they are classified 
without having to assess whether their use in toys poses a risk to children (as required in option 1a). 
These specific risk assessments in toys have proven to be laborious and time consuming in the past, 
although ensuring tailor-made protection. The time between the identification of a hazard for children 
or from the classification of a chemical as hazardous under the CLP Regulation until it is banned in 
toys is likely to be too long (around 2  years in past instances), leaving children unprotected for a 

181  

The so-called generic risk approach for chemicals (GRA). 

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certain period of time and requiring prioritisation of substances to be tackled in toys. This is why 
PO1a is not considered as effective in ensuring protection of children from harmful chemicals. 

PO1a  will  ensure  that  the  TSD  can  adapt  to  emerging  scientific  knowledge  though  in  a  less 
streamlined  manner  than  PO1b  and  PO1c.  This  is  because  under  PO1b  and  PO1c,  as  soon  as 
substances are classified in one of the most harmful hazard classes under the CLP Regulation, they 
will be banned in toys. PO1a will require the identification of specific substances that are found to 
pose a specific risk in toys, substance per substance, and carry out a detailed risk assessment of their 
use in toys, before they are actually regulated.  

PO 1b and PO1c will be similarly effective in ensuring SO1 and the protection of children from the 
most  harmful  chemicals,  as  substances  will  be  preventively  banned  in  toys  as  soon  as  they  are 
classified under the most harmful hazard classes in the CLP Regulation, and derogations will only be 
possible in PO1b if substances are safe for use in toys. The possibility for derogations proposed 
under option 1b would constitute the main possibility for costs mitigation. If there would be an 
absolute  ban  of  the  most  harmful  substances  without  the  possibility  to  have  any  derogation,  the 
consequences  for  the  toys  industry  and  for  entire  categories  of  toys  would  be  extremely  severe, 
without corresponding benefits in the protection of children. For example, as explained above, nickel 
is classified as a carcinogenic substance. Nevertheless, it is allowed in toy and toy components made 
of stainless steel or in those toy components which are intended to conduct an electric current, and it 
actually prevents corrosion of metals. It has been scientifically assessed in the past that nickel present 
in toys as set out above does not pose a risk for children182. Without a derogation to allow for the 
presence of nickel, electric toys would not be allowed on the Union market.  

As  regards  the  objectives  to  reduce  the  number  of  unsafe  toys  and  facilitate  compliance  and 
enforcement, PO2a will be less effective in reaching the objectives than PO2b, as PO2a is expected 
to allow a moderate increase in the number of inspections, while option PO2b is expected to lead to 
more significant efficiency gains and be more effective in increasing inspections. All commercial 
goods imported into the EU require a customs declaration for release for free circulation. The main 
benefit of the DPP as proposed in option 2b will be that a reference to it should be included in the 
customs declaration for every toy, and this includes online purchases by individual EU customers 
from third countries. The reference of the DPP, which for toys would include the product compliance 
information, will also have to be included in a central registry managed by the Commission, which 
will be interconnected with the IT customs environment to allow for its automatic verification. This 
will allow that any toy which does not indicate a valid DPP reference in the customs declaration 
is  automatically  stopped  at  EU  customs  and  is  not  released  for  free  circulation.  Customs 
authorities will be able to carry out this automated control on all toys entering the Union market, 
rather  than  controls  on  a  risk-based  manner  on  a  limited  amount  of  toys  as  is  the  case  today. 
Automated controls should have a significant impact on the number of non-compliant toys reaching 
the Union market. It will prevent that toys not intended for the Union market reach EU customers. 
All toys imported into the Union market will have the compliance information, and this will be easier 
to verify when market surveillance authorities inspect them. 

Furthermore, PO2a will not be as effective in addressing rogue traders who deliberately ignore the 
rules to gain a competitive advantage, as it will not increase the probability of getting caught and 
these traders will probably not carry out the third-party conformity assessment. PO2c is however the 
most  effective  as  it  will  cumulate  the  impacts  of  PO2a  and  PO2b  in  achieving  the  objectives. 
Nonetheless, most of the effectiveness in PO2c is attributable to PO2b.  

182 https://health.ec.europa.eu/document/download/af3a05ea-2f9f-4939-89c6-1637796d285b_en?filename=scher_o_163.pdf  

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7.2. 

Impacts of policy options 

The  following  table  summarises  the  costs  and  benefits,  for  each  policy  option,  quantified  and 
presented in section 6.  

Costs & Benefits summary table183 

Incremental benefits 
compared to baseline 

Incremental costs compared to baseline 

Incremental 
adjustment costs –
one-off  

Incremental 
product 
withdrawals one-
off  

Incremental testing 
costs 
(recurrent) 

Incremental 
administrative 
burden  

Low end 

High end 

Low 
end 

PO1a 

N/A 

N/A 

€8.18m 

High 
end 

€176.3
m 

Low 
end 

€52.47
m 

High 
end 

€104.9
m 

PO1b 

€240m 
per year 

€ 1.2b per 
year 

€23.5m 

€396.66
m 

€249.21
m 

€367.25
m 

Low end 

High end 

€1.89m 
per year 

€7.31m 
per year 

€3.79m 
per year 

€11.7m 
per year 

One-
off 

N/A 

Recurren
t 

N/A 

€ 
100.000 
to 
€300.000 
per year  

PO1c 

€ 240m 
per year 

€1.2b per 
year 

€49.11
m 

€782.3
m 

€642.69
m 

€957.47
m 

€14.62m 
per year 

€21.94m 
per year 

N/A 

N/A 

PO2a 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

PO2b 

€ 15.62 m 
per year 

€ 23.93 m 
per year 

PO2c 

€ 15.62 m 
per year 

€ 23.93 m 
per year 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

€18m  

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

€18m 

€7.8m 
per year 

€10.5m 
per year 

€18.3m 
per year 

Summary of incremental costs per policy options. See annex 14 for details. 

The aim of the assessment is to provide ranges of the magnitude of potential impacts generated by 
each policy option. While costs are borne by industry and the benefits of PO2b and 2c are also savings 
for industry, PO1b and 1c present overall health benefits for citizens and society. The following table 
summarises  the  quantitative  and  qualitative  assessments,  presented  in  section  6,  on  the  potential 
effects of policy options to industry, consumers, internal market, and competitiveness as well as on 
the environment.  

Summary of Economic, social and environmental impacts 

Policy option 

Economic impact184 

Social impact 

Environmental impact 

Option 1a 

Option 1b 

Option 1c 

Option 2a 

Option 2b 

- 

-- 

--- 

- 

+++ 

+ 

+++ 

+++ 

+ 

+++ 

+ 

+ 

+++ 

+ 

++ 

183 While the benefits of policy options 1a, 1b and 1c refer to benefits for human health, the benefits of policy options 2a, 
2b and 2c refer to savings in administrative burden. Similarly, the costs in policy options 1a, 1b and 1c refer to adjustment 
costs while the costs of options 2a, 2b and 2c refer to increase of administrative burden. 
184 The scoring of the economic impacts takes account not only of the costs and savings of the different policy options 
but also the impacts in terms of competitiveness of companies and the single market.  

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Policy option 

Economic impact184 

Social impact 

Environmental impact 

Option 2c 

++ 

+++ 

++ 

Legend: +- no / neutral impact; + minor positive impact; ++ positive impact; +++ significant positive impact; - minor 
negative impact; -- negative impact; --- significant negative impact  

The scale of the negative economic impacts will increase with the level of intervention. In contrast, 
however,  the  policy  options  with  high  levels  of  intervention  are  anticipated  to  have  potentially 
significant positive social impacts on the protection of health of children.  

PO1a  would  have  certain  negative  impacts  for  industry  and  competitiveness  but  slight  positive 
impacts on innovation the functioning of the internal market and the environment. It would also have 
limited impacts on the protection of children. PO1b and 1c would have strong positive impacts on 
the protection of children due to the more preventive approach towards the most harmful substances 
in toys. These options would entail important costs for industry, higher in PO1c than in PO1b. While 
PO1b would mitigate to a certain extent the negative consequences in costs and competitiveness for 
companies by allowing derogations to the generic bans, PO1c would lead to very important number 
of  product  withdrawals  which  will  lead  to  high  costs  for  industry  and  hinder  innovation.  If 
derogations are granted only where safety and protection of children is not compromised, there will 
not be substantial differences in terms of benefits for human health between PO1b and PO1c. 

PO 2a would have some benefits for the internal market and minor impacts on competitiveness and 
innovation. However, it would have important costs for the industry while not clearly yielding very 
high impacts on reducing the number of non-compliant products in the EU. Under policy option 2b, 
a certain economic impact is to be expected to adjust to digitalisation, with a potential for savings 
over the longer run in producing compliance information as well as in simplifications of contacts 
with the market surveillance authorities. The incremental benefits of option 2c in comparison with 
2b alone are not evident, while this option represents higher costs for the reputable manufacturers 
who are complying with the TSD. PO2a and 2c would be particularly burdensome for SMEs. 

Policy options face greater opposition from the industry as the level of intervention increases, while 
receiving greater support from consumers. 

Option 1a 

Option 1b 

Option 1c 

Option 2a 

Option 2b 

Option 2c 

MS 

+++ 

+++ 

+- 

+ 

++ 

++ 

Stakeholder support 

Stakeholder support 

Industry 

Consumers 

++ 

+ 

+- 

+- 

++ 

+- 

+ 

++ 

+++ 

++ 

++ 

+++ 

Legend: +- no support; + limited support; ++ support; +++ strong support 

In particular, industry stakeholders supported that new limit values could be added in the TSD for all 
toys, but voiced strong opposition in particular to removing derogations to generic bans. The main 
concern was that removing derogations completely would have strong consequences by requiring the 
removal from the market of a significant number of toys (for example electric toys). Industry was 
also opposed to extending third party conformity assessment in PO2a, but supported the digitalisation 
of  compliance  information.  Member  States  expressed  clear  support  for  revising  the  TSD  and 
strengthening the chemical requirements, both with specific limit values and with additional generic 

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prohibitions for certain substances. There was also support to digitalising product information as well 
as for extending third party conformity assessment but to a lesser extent. Consumers favoured the 
options  with  stricter  chemical  requirements  for  products  for  children  and  the  more  limited 
derogations. 

7.3. 

Summary of policy options assessment 

The  table  below  summarises  the  assessment  presented  so  far,  providing  an  overview  of  the 
effectiveness, efficiency and coherence with the EU law for each of the policy option analysed.  

Summary table 

Effectiveness 

Efficiency 

Coherence with EU law 

Option 1a 

Option 1b 

Option 1c 

Option 2a 

Option 2b 

Option 2c 

+ 

+++ 

+++ 

++ 

+++ 

+++ 

+ 

+++ 

++ 

+ 

+++ 

++ 

+++ 

+++ 

++ 

++ 

+++ 

+++ 

Legend: +- no / neutral impact; + minor positive impact; ++ positive impact; +++ significant positive impact;  

For the first set of policy options, PO1b and PO1c will more effective in strengthening the protection 
of children (SO1), as they will introduce generic bans to the most harmful chemicals. While all three 
PO1 will allow for adaptations to new scientific knowledge (SO2), PO1b and PO1c will be more 
effective as substances will be banned in toys immediately after they are classified under the most 
harmful hazard classes in the CLP Regulation, while in PO1a a specific assessment for each substance 
will be required. In achieving both objectives, PO1b will be the most efficient. PO1a will require 
resources to analyse each substance that may pose a risk in toys, and this has proven in the past to be 
a laborious process. By not allowing for derogations, PO1c will be less efficient as it will achieve the 
same results as PO1b with higher costs for industry.  

For the second set of policy options, PO 2a will be the least effective and efficient in achieving the 
related  SO:  it  will  lead  to  limited  improvements  in  the  number  of  non-compliant  toys  (SO3)  and 
limited facilitation of enforcement (SO4), but with significant costs for compliant industry. PO2b and 
2c  will  be  more  effective  in  achieving  the  reduction  of  non-compliant  toys  in  the  Union  market, 
including for online sales, as they will prevent that any toy which is presented at customs and does 
not have a DPP is placed on the Union market and lead to significant efficiency gains for market 
surveillance authorities. PO2c will be more effective in facilitating enforcement and lead to higher 
efficiency  gains  for  market  surveillance  authorities,  as  it  will  cumulate  the  benefits  of  PO2a  and 
PO2b. However, it is not clear that PO2c would lead to significantly lower levels of non-compliance 
than option 2b, while having higher costs for industry. PO2b is considered to be the most efficient, 
as it will achieve the objectives in an effective manner without disproportionate costs on industry.  

PO1a  and  1b  are  considered  to  generally  be  coherent  with  wider  EU  policy  and  regulatory 
developments, in terms of future and ongoing regulatory actions following the Chemicals Strategy 
for Sustainability. PO1b will introduce generic bans for the most harmful hazard classes, coherent 
with other measures EU chemicals legislation and in particular those considered under the REACH 
Revision. Option 1c would be the least coherent, though, as it would not allow for derogations to 
generic bans which are currently possible in all chemicals legislation where generic bans are present. 
Derogations to generic bans are expected to continue to be possible under EU chemicals legislation 
in the future.  

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PO2a  is  coherent  with  the  New  Legislative  Framework  and  other  EU  product  legislation  which 
requires the intervention of a notified body for assessing the compliance of certain products. PO2b is 
also be coherent with priorities and current trends towards digitalisation by default, the conclusions 
regarding digitalisation of product information in the Evaluation of the New Legislative Framework, 
which also covers the TSD as well as the recent proposed ESPR. Considering that the digital passport 
will contain the documentation that economic operators must possess and be able to present upon 
request in any case, it will be coherent with the existing relevant obligations under EU product and 
market surveillance legislation. As PO2b follows the current and future trends towards digitalization, 
it is scored as more coherent than PO2a. For the same reasons, the coherence of PO2c is considered 
to be high as it contains the measures included in both PO2a and PO2b. 

8.  PREFERRED OPTION 

Based on the comparative assessment of policy options above, the preferred combination of policy 
options consists of PO1b and PO2b. They scored well across a range of criteria (positive social and 
environmental impacts, with less important economic costs, effective, efficient and coherent). PO2b 
also  responds  to  the  “digital-by-default”  principle,  by  providing  for  a  move  towards  the  digital 
provision of compliance information.  

Impacts of the combination of PO1b and PO2b 

Economic impacts – Impacts on economic operators: The economic impacts will correspond to 
the sum of PO1b in terms of product adaptations and withdrawals and relevant administrative costs 
(in respect of applications for derogations), as described above, and PO2b in terms of administrative 
burden and savings for the implementation of the DPP.  

The number of substances covered by generic bans under PO1b might increase by about 10-30%. A 
total of 8.4-12.8% of products additional to the baseline may be impacted under PO1b and for which 
a derogation may not be possible, with 4.6-7.2% subject to product adaptation efforts and 3.8-5.6% 
could no longer be made available on the market if no alternatives to the restricted chemicals are 
available. The estimated impact on 4.6-7.2% of all EU toy products could result in total incremental 
one-off adjustment costs associated with product redesign and redevelopment of additional EUR 
23.5 to 396.66 million. Yearly testing costs are estimated to incrementally increase compared to the 
baseline by around EUR 7.31-11.70 million. In terms of product withdrawals, this option could 
affect EUR 249 to 367 million worth of products185, which should be mitigated by an appropriate 
transition period in which manufacturers 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. 
Administrative burden incurred if derogations are requested could amount to EUR 100.000 to EUR 
300.000 per year. Derogations would be requested as a means to limit the adjustment costs that the 
restrictions on chemical substances could lead to.  

For the introduction of the DPP under PO2b it is estimated that the cost for the EU manufacturers 
could  be  around  EUR  18  million  of  one  –off  costs  and  EUR  10.5  million  per  year  due  to  the 
incidence of initial costs, and decrease after the systems are set up and most initial data entered, there 
are only expected to be additional costs related to updating and maintenance costs. PO2b could lead 
to  savings  of around EUR 2.62 to EUR 3.93  million per year  only from  moving to  the digital 
provision of compliance information. In addition, savings from no need to prepare for dealing with 
inspections  by  market  surveillance  authorities  could  range  from  EUR  13  million  up  to  EUR  20 
million per year.  

185 Based on provisional EU industry turnover of EUR 6.56 billion for 2020. 

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Impacts on public authorities: PO2b will lead to significant efficiency gains for market surveillance 
authorities (if reinvested in toy inspections, the number of inspections is expected to increase by a 
maximum of 2,500 to 5,000), that are not expected to be lowered by the increased number of chemical 
substances  banned  in  toys  under  PO1b.  This  is  because  market  surveillance  authorities  do  not 
necessarily  test  all  toys  inspected,  nor  for  all  substances  concerned.  In  many  cases  they  conduct 
documentary checks only, in other cases they identify the toys that would need to be subject to testing, 
as well as the chemical substances are most relevant for the specific toy at stake. 

Impacts on innovation, competitiveness and single market: The impacts on innovation and the 
single market for both 1b and 2b will cumulate. However, PO1b and 2b will have synergistic impacts 
in improving competitiveness. While PO1b will impose costs on industry for the compliance with 
new requirements on chemical substances, it will be accompanied by effective measures under 2b to 
significantly  reduce  unfair  competition  from  non-compliant  toys.  This  will  help  preserving  the 
competitiveness  of  compliant  industry.  Without  PO2b,  PO1b  may  lead  to  more  rogue  traders 
benefitting from selling non-compliant (and often cheaper) toys. 

Social  impacts  –  impacts  on  human  health:  Although  PO1b  and  PO2b  each  address  a  distinct 
problem, they will complement each other in terms of protection of human health. The human health 
benefits estimated in PO1b (EUR 240 million to EUR 1.2 billion per year) will be reinforced by 
ensuring under PO2b that non-compliance will be significantly reduced. 

Environmental impacts : While the protection of the environment is not part of the SO pursued, the 
preferred combination of options will lead to certain benefits for the environment, due to the reduction 
of harmful substances in toys as well as the significant reduction of non-compliant toys. It is also 
consistent with the objectives of the Climate Law186. This is detailed in the analysis of each of these 
options. 

Stakeholders’ views: Industry stakeholders supported that new limit values could be added in the 
TSD  for  all  toys  in  all  policy  options,  but  did  not  support  the  extension  of  generic  bans  to  other 
harmful substances (PO1b). Industry supported the digitalisation of compliance information in PO2b. 
Member  States  expressed  clear  support  for  revising  the  TSD  and  strengthening  the  chemical 
requirements,  both  with  specific  limit  values  and  with  additional  generic  prohibitions  for  certain 
substances (PO1a and PO1b). There was also support to digitalising product information (PO2b) as 
well as for extending third party conformity assessment (PO2a) but to a lesser extent. Consumers 
favoured the options with stricter chemical requirements for products for children (PO1b) and the 
more limited derogations (PO1c). Consumers also favoured the introduction of the DPP (PO2b) as 
well as the extension of third party conformity assessment (PO2a and PO2c). 

Conclusion on the preferred option: In terms of protection of children from harmful substances, 
PO1b strikes a more appropriate balance between the negative impacts for industry which should be 
limited  by  providing  for  appropriate  derogations  to  generic  bans,  and  significant  reduction  on 
children exposure to these harmful substances. It will also ensure that the toy safety rules can continue 
to adapt to new scientific knowledge. PO 2b will ensure that toys presented at customs without the 
declaration of conformity included in the DPP would be automatically prevented from being released 
for  free  circulation  in  the  Union  market.  This,  together  with  the  efficiency  gains  for  market 
surveillance  authorities  will  have  a  potential  to  reduce  the  number  of  non-compliant  toys.  In  this 
manner, PO2b better addresses the drivers of the problem.  

186 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework 
for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate 
Law’) 

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The preferred option will contribute achieving Sustainable Development Goals: to SDG 3 due to its 
positive impacts on children health and well-being, to SDG 6 by reducing harmful substances in toys 
that may become waste, to SDG 9 by providing incentives for businesses to innovate in substitution 
of harmful chemicals and digitalisation and to SDG 12 by enhancing that toys and children health are 
protected in a more sustainable manner.  

8.1.  Legal instrument: converting the Directive into a Regulation 

A directive leaves Member States to choose which means they will use to comply with the legislative 
objectives. As the TSD is a ‘total harmonisation’ directive it does not allow the Member States to 
impose more restrictive obligations. The existing legal instrument being a Directive means that every 
amendment to the text (of which there has been 17 to date) must be transposed by all Member States. 
Therefore, to increase efficiency, the legal text would fit better with a regulation approach rather than 
with  a  directive  approach187.  There  was  a  broad  consensus  across  all  stakeholder  groups  on  the 
benefits  of  this  conversion.  A  large  majority  of  public-consultation  respondents  (85%  of  all 
respondents including 80 % of public authorities, 82% of businesses and business associations and 
88% of consumers, consumer organisations and NGOs) expressed support for this change. Finally, 
PO2b  requires  that  the  underlying  legal  instrument  be  a  Regulation  to  ensure  a  harmonised 
enforcement of the Regulation in the Union and, in particular, at the EU external borders.  

With a Regulation the costs of transposing any amendment to the Directive would disappear. The 
transposition of each amendment to the Directive is estimated to be in the range of EUR 6,174 to 
EUR 18,522 per Member State. The annual savings of the policy measure for public authorities in 
the EU would therefore be EUR 435,979188. A Regulation will also lead to savings for the industry 
and benefit the single market, as it will enter into force simultaneously across the EU, as well as any 
subsequent amendment to it.  

8.2.  REFIT (simplification and improved efficiency) 

The Evaluation assessed the potential for simplification of the TSD and concluded that there was no 
potential for simplification on the substantial obligations and administrative burden of the TSD, as 
simplification  entailing  fewer  obligations  for  economic  operators  would  risk  losing  protection  of 
children.  Similarly,  currently  under  the  TSD  there  is  no  requirement  to  go  through  third-party 
conformity if there are harmonised standards covering all aspects of toys; this could not be simplified 
further.  

The option to move to digital in the compliance information will lead to simplification and improved 
efficiency in the contacts between economic operators and market surveillance authorities. This is 
supported  by  outcomes  from  the  public  consultation  for  the  Evaluation  of  the  New  Legislative 
Framework, 79.2% of the respondents (54.2% to a great extent and 25% to some extent) considered 
that digitalisation of the declaration of conformity / technical product information / technical 
file  would  improve  the  efficiency  of  the  conformity  assessment  procedure,  without  hindering 
market  surveillance  activities.  Stakeholders  from  all  groups  in  that  consultation  agreed  that 
digitalisation  offers  a  potential  solution  for  simplification  of  administrative  obligation  related  to 
product information requirements and CE marking, which is also applicable to toys.  

Finally, one aspect for simplification that was raised very frequently by stakeholders was the need 
for the warnings required by the TSD to be preceded by the word “warning” which  needed to be 

187 See also section 5.1.4 of the Evaluation 
188 See annex 14 for the detailed calculations of these estimates, based on an estimate of the amount of person days needed 
for transposition to be between 20 and 60. Using the Member State daily labour cost (i.e. EUR 309 - Data about labour 
costs comes from Eurostat’s Labour Cost Survey, (2016), category ‘public administration and defence, compulsory social 
security’ per employee FTE and adjusted for inflation.), the overall cost of transposition is estimated to be in the range 
of EUR 6,174 to EUR 18,522 per Member State.  

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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 will also lead to savings to the industry 
when producing the labels but these cannot be quantified with precision.  

8.3.  Application of the ‘one in, one out’ approach  

As indicated in the previous sections, the first set of policy options is  only expected to lead to an 
increase in the administrative burden as compared with the business as usual costs of the baseline if 
derogations are requested to continue using in toys substances which have been banned. It could be 
estimated that the cost per derogation request could range between EUR 50.000 to a maximum of 
EUR 150.000 per derogation request, and that there would be a maximum of two derogation requests 
per year, which would lead to a recurrent cost of EUR 100.000 to a maximum of EUR 300.000 per 
year (with an average of EUR 200.000 per year).  Option 2b would entail administrative costs for 
businesses  and  benefits.  Based  on  current  market  structure  and  expected  average  production  per 
enterprise, the overall additional administrative burden has been estimated at approximately EUR 
18 million one-off and EUR 10.5 million recurrent, per year.  

In  terms  of  benefits,  option  2b  is  likely  to  bring  some  reduction  of  the  administrative  burden  on 
companies  and  authorities:  the  introduction  of  the  DPP,  while  it  would  lead  to  initial  costs  for 
companies, it has the potential to reduce the administrative burden on public authorities, in particular 
customs, when importing toys from third countries since the DPP would allow for more automatic 
documentation  checks  and  prevent  the  import  of  non-conform  toys  that  would  be  held  on  border 
premises and subject to physical controls. PO2b could lead to savings for companies from moving 
to digitalised information of around EUR 2.62 to EUR 3.93 (EUR 3.275 on average) million per 
year. In addition, a cost reduction would also incur for manufacturers during inspections by market 
surveillance authorities but these are not savings that are accounted for offseetting under the ‘one in, 
one out’ apporach.  

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

The  Commission  will  monitor  the  application  of  the  future  Toy  Safety  Regulation  and  its 
implementation in the Member States, possibly 5 years after the start of application. It will monitor 
that when new substances are classified under the most harmful hazard classes under the CLP and 
covered by generic bans, all the relevant stakeholders are sufficiently informed and testing methods 
are available in advance. The Commission will also monitor the requests for derogations to these 
generic bans and their regular evaluation, and any derogation granted should be reassessed every 5 
years, as is the case in the current TSD.  

The Commission will continue to follow with experts emerging scientific knowledge in the field of 
chemical substances to determine whether additional or stricter limit values should be introduced in 
the future Toy Safety Regulation. The Commission will continue to produce guidance documents in 
cooperation with Experts in the Expert Group on Toy Safety, to ensure that stakeholders have the 
best possible understanding of the obligations under the Toy Safety Regulation so that compliance is 
facilitated. 

The coordination of notified bodies in the relevant NB group for toys will inform of the types of toys 
for which an EU type certificate is requested, and risks that may appear in novel toys. 

As regards the evolution of the rates of non-compliance and possibly the number of toys stopped at 
the border, the Commission will monitor the implementation by Member States of their obligation 
under article 34 of Regulation 2019/1020 on market surveillance to notify under ICSMS information 
on  the  inspections  they  conduct  on  toys,  and  on  the  results  of  those  inspections.  First  of  all,  the 
Commission will monitor the number of inspections carried out by market surveillance authorities, 

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which is expected to grow. The information on the results of investigations should report as far as 
possible  if  the  toy  is  available  online  or  not.  This  information,  together  with  the  notifications 
performed  under  the  RAPEX-Safety  Gate  on  dangerous  toys,  should  allow  for  a  more  complete 
picture on the evolution of non-compliance for toys in the EU, and the percentage of toys inspected 
which are compliant or not, and the extent of the non-compliance including online sales. It is expected 
that the number and share of non-compliant toys will be reduced. Furthermore, information on the 
number  of  toys  which  are  not  released  for  free  circulation  because  the  digital  product  passport 
including the declaration of conformity was absent, will also allow for evaluating the success of that 
measure in preventing that non-compliant toys are placed on the Union market. 

Objective 

Indicator 

Strengthen  the  protection  of  children  from  harmful 
chemicals 

Flexibility to adapt to emerging scientific knowledge 

Reduce the number of non-compliant toys  

Number of derogations to generic bans requested 

Notifications of measures taken againts toys containing 
harmful substances 

Number  of  specific  limit  values  introduced  for  other 
harmful substances 

Time  taken  for  the  adoption  of  such  additional  limit 
values 

Number of non-compliant toys found, if possible with 
a breaking down as to the sales channels used and origin 
of products 

Number  of  non-compliant  toys  stopped  at  the  border 
without a DPP 

Facilitate enforcement 

Total number of inspections on toys 

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ANNEXES 

ANNEX 1: PROCEDURAL INFORMATION 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

Lead DG: DG Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) 

Directorate: Directorate F – Ecosystems I: Chemicals, Food, Retail 

This impact assessment corresponds to the initiative with the Decide reference PLAN 2021/11623, 
for the revision of the Toy Safety Directive. 

2.  ORGANISATION AND TIMING 

The inception impact assessment feedback period ran from 5 October to 2 November 2021. 

The public consultation period ran from 2 March 2022 to 25 May 2022. 

An  inter-service  steering  group  was  convened  and  chaired  by  DG  GROW.  The  following 
Directorates-General participated: SG, JUST, GROW, CNECT, SANTE, ENV, TAXUD. The ISSG 
met 8 times. The last meeting on the final draft impact assessment report was held on 23 September 
2022.  

3.  CONSULTATION OF THE RSB 

The  RSB  was  consulted  in  an  informal  upstream  meeting  on  22  February  2022.  This  impact 
assessment was submitted to the RSB on 28 September 2022. The meeting with the RSB took place 
on 26 October 2022. 

Following the opinion of the RSB from 28 October 2022, changes were made to the IA in order to 
reflect  the  recommendations  of  the  Board.  The  table  below  presents  an  overview  of  the  RSB's 
recommendations and how these have been addressed. 

Opinion of the RSB 

How the comments have been addressed 

Summary of findings 

the  process 

(1)  The  report  does  not  provide  sufficient 
information  about 
to  grant 
derogations  for  the  most  harmful  chemicals 
under the preferred option.  It does not  explain 
how  this  process  will  ensure  that  children’s 
safety is not compromised. 

A  better  description  of  the  process  to  grant 
derogations has been included in section 5.2.1. 
The  report  also  includes  explanations  on  how 
once a chemical has been classified in one of the 
most  harmful  hazard  classes  the  derogation 
process  should  look  into  whether  there  is 
children exposure to it and only uses which are 
considered to be safe for children and pose no 
risk should be allowed. 

(2) The report is not sufficiently clear about the 
robustness of the cost and benefit estimates.  It 
does  not  explain  sufficiently  why  granting 

now 

report 

The 
explanations 
concerning how the costs and benefits have been 
calculated and the limitations of this assessment, 

includes 

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derogations  does  not  have  any  impact  on  the 
expected health benefits. 

What to improve 

(1)  The  report  should  provide  additional 
information  about  the  scientific  assessment  to 
be  carried  out  by  the  European  Chemicals 
Agency 
to  grant  derogations  for  harmful 
substances. It should discuss to what extent this 
the 
approach 
experience with certain substances, which new 
scientific  knowledge  found  more  toxic  than 
known before. The report should also consider 
the  expected  costs  of  requesting  and  assessing 
derogations under the preferred policy option. 

is  future-proof 

in  view  of 

for the dynamic baseline as well as for all policy 
options.  A  better  description  of  the  derogation 
process  has  been  included  in  5.2.1.  indicating 
that  derogations  can  only  be  granted  where 
children exposure to the harmful chemical and 
the risk can be excluded. If derogations are only 
granted for a use that has been evaluated as safe 
and  there  are  no  alternatives,  it  should  not 
diminish 
the  health  benefits  achieved  by 
these 
reducing  exposure  of  children 
substances. Further explanations are provided in 
section 6 as well. 

to 

A  better  description  of  the  process  to  grant 
derogations has been included in section 5.2.1., 
making reference to the scientific assessment to 
be  carried  out  by  the  European  Chemicals 
Agency.  Section  6.2.  considers  in  the  analysis 
that  there  are  likely  to  be  administrative  costs 
from 
requesting  a  derogation,  with  an 
approximate order of magnitude based on past 
experience from this and other sectors. Section 
6.2.  also  includes  explanations  on  how  the 
approach  in  this  option  is  expected  to  ensure 
health benefits. 

(2) The report should better explain the evidence 
base, reliability and robustness of the estimates 
of  costs  to  businesses.  In  particular,  it  should 
explain why the industry would bear high costs 
in case derogations are not allowed, considering 
the low number of derogations on Carcinogenic, 
Mutagenic or toxic for Reproduction substances 
having  been  requested  and  granted  under  the 
current Directive. It should also clarify how the 
business- as-usual  costs are taken into account 
in the estimates. 

(3) The report should clarify the analysis of the 
expected health benefits. It should better explain 
the methodology used (in particular, whether the 
estimates  are  only  based  on  the  value  of  the 
avoided  health  damage  from  exposure 
to 
endocrine  disruptors)  and  what  the  limitations 
of  these  estimates  are.  It  should  also  explain 
why the overall health benefits  for the options 
with derogations and without are quantitatively 
that  a  derogation  could 
the  same  given 

Section  5.1.  has  been  modified  to  include  a 
better explanation of the business-as-usual costs 
which  are  taken  as  the  baseline  against  which 
the  other  policy  options  are  compared.  In 
addition,  the  introduction  to  section  6  now 
includes  more  detailed  explanations  as  to  the 
methodology of the cost estimates, the evidence 
base and the limitations and uncertainties of the 
assessment.  Section 
further 
information  on  the  impact  that  not  having 
specific derogations could have on the market. 

gives 

6.3. 

Sections  6.2.  and  6.3.  have  been  amended  to 
include better explanations of the estimates for 
the health benefit, the fact that they are based on 
avoided  health  damage  and  why  they  are  only 
based on exposure to endocrine disruptors. The 
limitations of this assessment are also explained 
in  those  sections.  These  sections,  as  well  as 
section 7.1. explain the role of the derogations 

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potentially  allow  for  minimum  exposure  to  a 
specific substance. 

and why they would not compromise the health 
benefits of that policy option. 

Section 1.2. and section 5 on the description of 
the policy options has been amended to include 
better explanations of the articulation with these 
initiatives. 

(4)  The  report  should  further  elaborate  on  the 
articulation  between  this  initiative  and  other 
related  proposals.  It  should  clarify  that  this 
initiative builds on the forthcoming inclusion of 
new  hazard  classes 
the  Classification, 
in 
Labelling  and  Packaging  Regulation  but  is 
independent  from  the  revision  of  the  REACH 
Regulation, the revision of the Union Customs 
Code  and  the  proposal  for  a  Regulation  on 
Ecodesign  for  Sustainable  Products.  It  should 
also clarify the role of the existing CE label in 
this initiative. 

(5)  The  report  should  explain  how  a  Digital 
Product  Passport  under  the  preferred  option 
would  address  the  problems  related  to  an 
exponential increase in small individual parcels 
incorrect  and 
containing 
questionable  quality  of  the  EC  declaration  of 
conformity. 

toys  and 

the 

Section  5.2.  and  6.5.  have  been  amended  to 
provide a better explanation of this policy option 
and how it would address the problem identified 
including in relation to small individual parcels. 

4.  EVIDENCE, SOURCES AND QUALITY 

The  Evaluation  of  the  Toy  Safety  Directive189  identified  the  key  areas  for  the  revision.  It  was 
supported by a study by an external contractor190 .  

This impact assessment is also supported by a study undertaken by another external contractor191, 
who  carried  out  dozens  of  interviews,  analysed  data  from  public  and  targeted  consultations  and 
complemented this through desk research. 

189 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 
190 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 
191 VVA with CSES and Asterisk (2022) Impact Assessment study on the revision of the Toy Safety Directive 

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ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) 

1.  CONSULTATION STRATEGY  

The  objectives  of  the  consultation  were  to  collect  evidence  and  views  from  a  broad  range  of 
stakeholders,  on  the  identified  problems  and  the  potential  solutions  concerning  the  TSD.  The 
activities  included  a  12-week  dedicated  public  consultation  (PC)  concluded  in  May  2022,  a 
Stakeholder Workshop held on 26 April 2022, discussions with Member States at the Administrative 
Cooperation formation of the Expert Group on Toy Safety and feedback collected in response of the 
Commission’s inception impact assessment. Also, as part of the impact assessment study, an external 
contractor organised interviews with 41 relevant stakeholders and an online targeted consultation for 
SMEs ran between 7 April 2022 and 15 May 2022. Consulted stakeholders included EU and national 
consumer associations; industry associations; economic operators; citizens; and national authorities.  

Summary table on the numbers and type of activities  

Stakeholder group 

Companies and business associations 
Authorities and notified bodies 
Consumer associations 
Other (NGOs, individuals etc.) 
Total 

Consultation methods 
Interviews  SME Survey  OPC 
89 
31 
12 
64 
196 

201 
- 
- 
- 
201 

15 
23 
3 
- 
41 

2. 

INCEPTION IMPACT ASSESSMENT (IIA) 

The Inception Impact Assessment for this initiative was launched in 2021, with a feedback period 
running from 5 October to 2 November 2021. There were a total of 34 responses, of which 12 from 
business  associations,  6  from  companies/business  organisations,  5  from  non-governmental 
organisations, 6 from public authorities, 3 from consumer organisations, 1 from an environmental 
organisation and 1 from an EU citizen. Responses from industry argued that the TSD is currently 
sufficiently protective and that there was no need to strengthen its requirements. Conversely, public 
authorities, consumer and environmental organisations strongly advocated for a revision of the TSD 
which would ensure that children are protected from the most harmful chemical substances.  

3.  STAKEHOLDER WORKSHOP 

The Stakeholder Workshop on 26 April 2022 brought together approximately 120 representatives of 
EU-level consumer, business and industry organisations, manufacturers, standardisation and notified 
bodies, as well as Member State authorities. The objective of the workshop was to present the state 
of  play  on  the  impact  assessment  work  and  to  discuss  ways  to  adapt  the  TSD  to  ensure  a  higher 
protection of children from the most harmful chemicals, and to reduce the number of unsafe products 
in the Union. Consumer groups and public authorities considered that the requirements for chemical 
substances should be strengthened,  while industry  and business associations were more sceptical. 
There was consensus among all participants that it should be possible to add new limit values for toys 
for any children in the TSD, and not only for children under 36 months or to be put in the mouth, as 
is the case today. On the other hand, all participants agreed that it was necessary to tackle the high 
number of non-compliant toys on the Union market, in particular those sold online. While consumer 
associations and notified bodies were in favour of extending the third party conformity assessment 

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under the TSD, the option to require the EU Declaration of conformity in digital form as part of a 
Digital Product Passport, to be presented at customs too, gathered the most support.  

4.  PUBLIC CONSULTATION 

The consultation was open during 12 weeks between 2 March and 25 May 2022, via the EU Survey 
online system in 24 EU languages. A total of 17 position papers were attached by stakeholders to the 
consultation.  

4.1.  Respondents by Stakeholder category 

All in all, 196 responses were submitted, the biggest represented group (34%) was of companies and 
business organisations, but EU citizens (22%), public authorities (16%) and business associations 
(12%) were also represented. Albeit in smaller proportion, NGOs, environmental organisations and 
academic, research institutions also shared their insights on the topic. Out of the 31 responding public 
authorities 48% is national, 32% is regional, 13% is international and 7% is local.     

Figure 1: Respondents by category of their organisation  

Academic/research 
institution; 2

Business association; 
23

Public authority; 31

Other; 5

Non-governmental 
organisation (NGO); 10

Company/business 
organisation; 66

EU citizen; 44

Environmental 
organisation; 3

Consumer 
organisation; 12

4.2.  Respondents by country of origin 

The 196 respondents are coming from 24 different countries, most from EU Member States, but there 
are  respondents  from  Mexico,  Singapore  and  the  United  Kingdom  too.  From  Germany,  an 
outstanding number of answers were received (59), but Spain (21), France (19) and Belgium (19) can 
also be considered as well represented.  

4.3. 

Setting stricter requirements for chemical substances 

The participants of the consultation were asked whether they agree or disagree that the EU rules on 
toy safety should set  stricter requirements for chemicals  in  toys. The sample shows a support for 
stricter rules with 43% strongly agreeing and an additional 16% agreeing with setting stricter rules. 
The other end of the scale appears to be much less committed, as those who strongly disagree only 
amount to 9%.  

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Figure 2: Ratio of respondents supporting the stricter EU rules on toy safety  

90

80

70

60

50

40

30

20

10

0

Strongly disagree

Disagree

Neutral

Agree

Strongly agree

No opinion

If the type of organisation is also taken into consideration when analysing this question, it becomes 
evident that those who (strongly) disagree are representatives of business associations and companies 
(47%),  while  all  the  environmental  and  consumer  organisations  agree  to  some  degree  with  the 
statement  (over  90%).  Similarly,  90  %  of  public  authorities  agreed  or  strongly  agreed  with  the 
statement. 

  Specific chemical substances and regulatory approach 

The respondents were asked how the TSD should handle the different substances that pose health 
risks. The answers show that the option of the TSD not regulating the harmful chemicals presented 
was preferred to a much lesser degree. From the sample, it seems that the respondents were most 
worried about  the substances that are endocrine  disruptors or immune system disruptors and they 
would  like  to  see  these  substances  banned.  Over  85%  of  consumer  groups  and  environmental 
associations would like to see them banned preventively. Also over 85% of public authorities would 
like to see these substances addressed by the TSD, but the specific approach to address them (specific 
risk assessment or generic risk assessment) is balanced. Over 70 % of industry believed that they 
should only be banned after they have been scientifically assessed as unsafe in toys. 

The respondents also had the possibility to give further comments on the subject. Several of them 
underlined the importance for the revised Toy Safety Directive to ban certain categories of chemicals 
(rather than individual substances), in line with the "Chemicals Strategy for Sustainability - Towards 
a Toxic-Free Environment" of the Commission published in October 2020, which foresees to use 
generic bans ("generic approach to risk management") not just for endocrine disruptors but also for 
CMRs, substances of very high concern (SVHCs) or sensitizing substances as default approach. 

Industry argued that harmful substances could be regulated through REACH restrictions and that the 
form or specific route in which the substance has been classified (for example, causing cancer by 
inhalation) should be taken into account. 

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Figure 3: Ratio of the preferred action for the substances posing different health risks 

Skin sensitizer

Toxin to a specific organ

Respiratory system distruptor

Neurological system distruptor

Immune system distruptor

Suspected endocrine disruptor

Known or presumed endocrine disruptors

0%

10%
Banned only after specific risk assessment
Banned after generic risk assessment
Not regulated in the TSD

20%

30%

40%

50%

60%

70%

80%

90% 100%

  Use of derogations 

The participants were asked whether they agree or disagree that the Toy Safety Directive should, by 
way of exception, allow the presence of chemicals which are subject to current and new general bans. 
While a number of respondent think that there should be no derogations to the general bans (35% 
public authorities and 50% of consumer and environmental groups), 73% of industry respondents 
disagreed with this statement.  

The use of derogations is perceived differently by the participants of the PC depending on the reason 
behind the given derogation. The biggest support is visible in those cases when the used chemicals 
are found to be safe for human health for that particular use in toys and there are no alternatives or 
when  the  used  chemicals  are  found  to  be  safe  for  human  health  (as  evaluated  by  a  scientific 
committee)  for  that  particular  use  in  toys  (91%  of  industry,  68%  public  authorities  and  39%  of 
consumer and environmental groups).   

The participants of the PC were asked about their opinion on the likely overall impact of introducing 
general bans for the most harmful chemicals with some limited derogations if necessary. The answers 
were  collected  in  5  different  categories  (in  addition  to  “no  opinion”  or  “I  don’t  know”  answers), 
where the higher numbers represent an expected very positive impact  and a lower number means 
very negative impact.  

From the diagram below, it is visible that the respondents expect that the general bans will have a 
different  impact  on  different  aspects.  While  industry  respondents  indicate  that  it  will  affect  very 
negatively (42%) or negatively (26% answers) the costs of companies which have to adapt to the new 
requirements and it will also have a predominantly negative impact (in the same percentages) on the 
administrative burden for businesses, it is expected to have a very good impact on the protection of 
children (84% of public authorities, 80% consumer and environmental groups, and 30% of industry).  

Out of the different aspects, most respondents thought that the most positive impact will be on the 
protection of children and on the appearance of innovative products on the market. Positive impact 
is expected mainly on free movement of toys within the EU single market and on consumer demand. 

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At  the  same  time,  industry  and  in  particular  SMEs  were  concerned  about  costs,  administrative 
burdens and loss of competitiveness for SMEs. 

Figure 4: The ratio of the respondents expecting different impacts for the different aspects  

When prompted to explain their opinions, industry feared that the result will be more non-compliant 
toys in the market and less compliant toys offering for consumers.  

  Requirements for toys intended for children under 36 months or to be put in the 

mouth 

Firstly,  stakeholders  were  asked  whether  the  toy  safety  rules  should  continue  to  allow  different 
requirements to be set for chemicals in toys for younger children (under 3 years) compared to older 
children.  Almost  half  of  the  respondents  (90%  industry,  50%  public  authorities  and  48%  of 
consumer/environmental  groups)  (strongly)  agree  with  the  statement.  The  same  trends  in  the 
responses per different group appear when asked if the TSD should continue to allow for different 
requirements to be set for chemicals in toys intended to be put in the mouth.  

When asked whether the toy safety rules should allow new requirements to be set for chemicals in 
any toy should new scientific knowledge emerge, 92% of consumers/environmental groups, 94% of 
public authorities and 68% of industry agreed or strongly agreed.  

  Requirements on nitrosamines 

32%  of  industry,  77%  of  public  authorities  and  73%  of  consumer/environmental  groups  agree  to 
some degree that limit values in the Directive for nitrosamines and nitrosatable substances should be 
lowered.  

  Labelling of chemicals in toys 

When asked whether the toys should be labelled with their chemical composition or not, the answers 
are painting a quite divided picture where 53% thought it would be a good idea and 39% does not 
support  it.  Companies  (50  answers)  and  business  associations  (18  answers)  are  those  who 
predominantly  oppose  labelling  the  products.  The  vast  majority  of  answering  EU  citizens  (86%) 
however would like to see the chemical composition on the label.  

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4.4. 

Protecting children from other risks in toys 

Consumer and environmental organisation were supporting that the TSD addresses privacy breaches 
(88%), cyber security (90%) and protection from psychological harm (83%). Public authorities were 
slightly less supportive of the TSD handling these aspects (54% privacy breaches, 58% cybersecurity 
and 54% for protection from psychological harm). Least of support came from industry respondents 
(28% for privacy, 27% for cybersecurity and 29% for protection from psychological harm). 

Among the additional comments, it was mentioned by industry that as children usually have access 
to  "other"  (non-toy)  digital  equipment  like  mobile  phones,  tablet  computers,  video  consoles  etc. 
which potentially pose comparable risks for children. Therefore, cybersecurity and data protection 
need to be regulated horizontally and not be treated differently than other products used by children 
and already covered by GDPR, GPSR, RED, Cyber Resilience Act, AI etc (52% indicated this as 
their preferred option). In contrast, 51% of public authorities and 52% of consumer/environmental 
groups chose as their preferred option to ensure that the TSD would protect not only the physical but 
also the psychological wellbeing of children. 

4.5. 

Single Market 

  Factors hampering the application of the TSD 

The participants of the public consultation were also asked to what extent five different issues hamper 
the  application  of  the  directive.  The  most  problematic  issue  identified  by  all  different  respondent 
groups was the lack of specific requirements for online sales (70% consumers/environmental groups, 
80% of public authorities and 67% of industry). Industry considered to a much smaller extent that 
the need to transpose the adaptations of the Directive into national law could hamper the effectiveness 
of the Directive (37% to a (very) large extent and 27% to a moderate extent, or chemical values being 
set in different pieces of legislation (31% to a (very) large extent and 24% to a moderate extent). 
Public authorities and consumer/environmental groups  rather referred to other factors such as the 
fact that conformity assessment is carried out without the intervention of a NB (58% of authorities 
and 70% of consumer/environmental groups considered this affected the effectiveness of the TSD to 
a (very) large or to a moderate (20% for authorities)  extent). Similarly, the fact that documentation 
is provided only upon request affected to a (very) large extent for 58% of public authorities and 65% 
of consumer/environment groups and to a moderate extent for an additional 19% of authorities and 
13 % of consumer/environmental groups. 

  Third-party conformity assessment 

When asked whether the participants think the toy safety rules should extend the obligation of third-
party  conformity  assessment  to  more  toys  (EU-type  examination)  the  results  are  quite  balanced 
depending  on  the  interest  group.  83%  of  consumer/environment  groups  and  75%  of  authorities 
support  it  while  75%  of  industry  is  against.  Out  of  those  who  were  in  favour  of  extending  this 
obligation,  44%  of  consumer/environment  associations  and  32%  of  authorities  thought  it  should 
apply to all toys, while close to 40% of authorities and consumer/environment groups supported that 
it  covers  chemical  mixtures  and  an  additional  25%  of  public  authorities  and  37%  of 
consumer/environment groups believed it should cover toys intended for children under 36 months.  

In  terms  of  impacts  of  the  measures,  consumer  groups  rather  believed  that  it  would  have  a  very 
positive impact in the protection of children (63%) and in compliance of toys (50%). Similarly, public 
authorities considered it could improve the protection of children (54%) and the compliance of toys 
to a high or moderate extent (80%). Conversely, industry was concerned about the negative impacts 
on their costs and administrative burden (over 60%) and on price of toys (52%). Negative impacts on 

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the competitiveness of SMEs was also raised as a strong concern (55%). In general, industry did not 
believe  this  option  would  have  a  strong  positive  impact  on  the  protection  of  children  or  on 
compliance.  

  Digital tools 

The participants to the open consultation seem to agree that it would be a mistake to have certain 
information available only digitally in the case of name and address of the manufacturer, instruction 
for  use,  safety  information  and  information  on  chemical  substances;  there  are  no  significant 
differences  in  the  different  responding  groups.  Industry  supports  that  the  EU  declaration  of 
conformity (56%) and EU-type examination certificates (54%) are enough if published digitally. For 
the EU declaration of conformity, public authorities agree that it can be provided digitally (35%) or 
which basic information on paper (61%). Consumer groups rather support that this documents are 
either made available on paper (EU declaration of conformity 44% and EU type certificates 31%) or 
with  basic  information  on  paper  and  more  details  provided  digitally  (EU  DoC  47%  and  EU  type 
certificates 49%).  

Public authorities and consumer/environmental groups considered that this measure would have the 
most  important  impacts  in  terms  of  protection  of  children,  compliance  of  toys  with  the  TSD  and 
efficiency of market surveillance. Similarly, industry respondents also considered that the measure 
could have benefits for the protection of children (40%) for the compliance of toys (47%) and for the 
efficiency of market surveillance (59%). However, they were also concerned to a certain extent about 
possible costs (43%) and administrative burden (45%). SMEs were concerned to a certain extent of 
the possible negative impacts on their competitiveness (43%).   

  Compliance and enforcement 

The respondents were asked whether they would like to see the Toy Safety Directive converted into 
a  Regulation.  85%  agrees  with  the  conversion  without  significant  differences  across  respondent 
groups (82% industry, 80% of public authorities and 87% of consumer/environment groups.  
From the additional comments, it turns out that some of the respondents from industry think that the 
conversion of the Directive into a Regulation should only be carried out with a view to clarifying a 
number  of  provisions  in  the  current  framework,  and  not  to  increase  in  any  way  the  burden  on 
manufacturers.  It  was  also  pointed  out  that  the  same  rules  must  apply  everywhere.  Either  way,  a 
Regulation  would  allow  for  stronger  enforcement  of  the  provision  and  guarantee  a  harmonized 
implementation of the provisions across the EU, guaranteeing the same level of protection for all 
children. 

When asked about their preferred measures to be included in the Directive to improve compliance 
and  enforcement,  the  respondents  could  select  multiple  replies  simultaneously.  Public  authorities 
were  strongly  in  favour  of  a  digital  passport  (96%)  of  converting  the  Directive  into  a  Regulation 
(74%) and of extending third party conformity assessment (67%). Consumer/environmental groups 
were  strongly  in  favour  of  converting  the  Directive  into  a  Regulation  and  extending  third-party 
conformity assessment (78% for each response) and also to have a digital passport (59%). Industry 
was  also  quite  in  favour  of  converting  the  Directive  into  a  Regulation  (67%)  and  of  the  digital 
passport  (52%)  but  in  a much  smaller  percentage  of  extending  third  party  conformity  assessment 
(19%). 

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5.  TARGETED SURVEY FOR SMES 

5.1.  Number and basic characteristics of the respondents 

A targeted online survey was carried out to collect as many views from the representatives of SMEs 
as possible. In total, 201 completed responses were received.  

Most of the answers were received from the United States (65), the United Kingdom (21), Germany 
(15), Spain (14) and Italy (13). Out of the 32 represented countries, 19 were based in one the European 
Union Member State with 40% of the companies in the sample.  

Figure 5: Ratio of the respondents’ States where they are based192 

France
3%

China
3%

Belgium
2%

Greece
2%

Latvia
2%

Lithuania
1%

Poland
4%

Italy
6%

Spain
7%

Germany
7%

United States
38%

United Kingdom
10%

Other
15%

In terms of the size of the organisations, most of the respondents (73.6%) were categorised as micro-
organisations  employing  1  to  9  employees.  Small  enterprises  employing  10  to  49  employees  and 
medium  ones  employing  50  to  249  employees  were  represented  in  a  more  balanced  way,  having 
11.9% and 14.4% respectively.  

5.2.  Costs related to the revision of the TSD 

  Administrative burden  

In connection with bureaucracy and extent of requirements, the respondents stated that the biggest 
burdens are rooted in the testing obligations. Also, it is quite burdensome that companies have to 
continuously  update  the  documents,  especially  the  Declaration  of  Compliance.  Others  referred  to 
costs in relation to keeping the technical documentation up to date as all data from purchased parts 
and raw materials (for each batch), all test reports (from both raw-materials as finished products), all 
the updating of DOC's and every additional document are required to have a complete and complying 

192 Under the category “other” those countries are aggregated from where less than 3 responses were collected (such as 
Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, Hungary, India, Romania, Sweden, The Netherlands) and 
those responses who selected originally the option “other” wishing not to specify the country they are based in. 

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dossier. Furthermore, there are specific challenges such as the length of the custom process in certain 
countries; the strict fire safety testing requirements; or storing the documentation for 10 years.  

Another administrative burden stems from the need for specific knowledge, skills and extensive 
human resources for following the changing requirements.  

In terms of staff costs expressed in number of working days per new SKU, for the costs of making 
available the declaration of conformity on the website 59 companies assigned a greater number of 
working  days  than  zero,  the  majority  estimating  it  to  be  between  1  and  10.  To  adapt  the  labels 
indicating the chemical content of a product 56 estimations greater than 0 were received. The least 
resource intensive intervention would be to  register the link to  the DoC on the website, this only 
receiving 39 votes. The vast majority of respondents estimated that all of the interventions could be 
carried out in 1-10 working days per new SKU.  

Table 1: The number  of companies that estimated that each intervention would  require the given 
number of working days 

Number of working days per new SKU / 
Interventions  
Costs of an EU type examination before 
introducing a new product  
Costs of testing the products in general 
Costs of replacing / redesigning a new product 
if the product is found to be not compliant  
Costs of adapting the labels indicating the 
chemical content of a product 
Costs of making available the declaration of 
conformity on the website  
Costs of registering the link to the website in a 
database 

0 

 1-10 

 11-20 

 21-45 

 46-200  >200 

7 

8 
9 

9 

5 

38 

35 
22 

39 

42 

11 

29 

7 

6 
11 

4 

5 

2 

7 

5 
6 

4 

6 

1 

1 

5 
8 

5 

3 

4 

0 

0 
6 

4 

3 

3 

The outsourcing costs and equipment costs were also assessed by the respondents193. According 
to the answers, from the point of view of outsourcing, the costs of an EU type examination before 
introducing a new product would be the highest (most of the companies estimating that it would cost 
between 201 and 1 000 EUR per new toy model, while the lowest would be the costs of registering 
the link to the website in a database (around 30 000 EUR in total). From the point of view of the 
equipment costs, the picture is quite different as the costs of registering the link to the website in a 
database would require the largest sum (around 420 000 EUR) in total, together with the costs of 
replacing / redesigning a new product if the product is found to be not compliant (around  145 000 
EUR  in  total)  and  the  cheapest  would  be  to  make  available  the  declaration  of  conformity  on  the 
website (around 13 000 EUR) in total.  

193 Even though a data cleaning process was completed, the data analysed here primarily relies on the responses of the SMEs who 
filled out the survey, consequently any distortion is a result of their indications, which in turn can result from not having the proper 
sources of information.    

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Figure 6: The outsourcing and equipment costs according to the respondents 

1200 000 EUR

1000 000 EUR

800 000 EUR

600 000 EUR

400 000 EUR

200 000 EUR

 0 EUR

Costs of an EU
type examination
before
introducing a new
product

Costs of testing
the products in
general

Costs of replacing
/ redesigning a
new product if
the product is
found to be not
compliant

Costs of adapting
the labels
indicating the
chemical content
of a product

Costs of making
available the
declaration of
conformity on the
website

Costs of
registering the
link to the
website in a
database

Outsourcing

Equipment

The respondents were also asked to assess the total costs of process in relation to the total expected 
revenues. In connection with the EU type examination, 16 companies claimed that they would lose 
anywhere between 11-50% of their expected revenues, with an additional 8 saying they would lose 
between 51-100% and another 8 claiming that it would seriously question the sustainability of their 
respective companies. The interventions connected to the websites are considered to cause the least 
loss from the expected revenues.  

  Impacts of potential policy measures  

The first policy measure envisions to introduce new limit values for toys or lowering the limit values 
following  the  newest  scientific  evidence.  The  responding  SMEs  were  asked  to  assess  this  policy 
measure’s impact on their competitiveness. The responses show that almost half (41,8%) claimed 
that the competitiveness will decrease as a result and only a mere 8% expected that as a result of this 
measure the competitiveness of their company will increase to some degree.  

The second policy measure is the ban on specific substances. Based on the newest scientific evidence 
on  chemical  risks,  some  substances  might  be  banned  from  toys  altogether  or  only  allowed  using 
derogations. The ban on specific substances would have an adverse effect on their competitiveness. 
44,8% considers that their competitiveness would deteriorate. The number of those who are unsure 
or do not want to share their opinion was relatively high, however, the ratio of those who consider 
that  this  measure  will  help  their  competitiveness  is  quite  low  (7,5  and  4%  respectively).  Each 
tightening  of  chemical  requirements  causes  a  significant  increase  in  costs  (tests,  searching  for 
materials,  documentation etc.) and this is why they feel  that they are losing competitiveness  with 
companies that do not comply with these requirements, if enforcement of the TSD is not improved.  

Another proposed policy option is to extend third-party conformity assessment for certain toys. Only 
7,5% of respondents considers that their competitiveness compared to imports outside of the EU will 
increase  and  5,5%  thinks  similarly  optimistically  in  connection  with  large  manufacturers,  in 
particular if nothing is improved in relation to the enforcement of the Directive.   

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The last proposed policy option is the introduction of a digital product passport containing the EU 
declaration  of  conformity  which  can  be  presented  at  customs  and  used  by  market  surveillance 
authorities could be based on the Digital Product Passport under the ESPR. This option is the most 
supported, as 10% and 5% of the respondents think that their competitiveness would increase thanks 
to  this.  Nonetheless,  SME  companies  fear  they  will  be  less  competitive  compared  to  larger 
companies, since the administrative and economic burdens will be bigger for them.  

6. 

INTERVIEWS 

All in all 41 interviews were carried out with authorities, notified bodies, companies and business 
associations as well as consumer associations. 

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ANNEX 3: WHO IS AFFECTED AND HOW? 

1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

The preferred policy package would lead to policy objectives related to strengthening the protection 
of children from harmful substances and ensuring that the toy safety rules are flexible to adapt to 
updated scientific knowledge. Furthermore, it would achieve a significant reduction of non-compliant 
toys  in  the  EU  and  facilitate  enforcement  of  the  rules.  The  TSD’s  legislative  revision  would 
contribute towards the achievement of EU policy objectives in strategic areas for the future of the EU 
economy such as green and digital economy. 

Impacts on businesses 

The  preferred  PO  will  lead  to  adaptation  costs  of  product  redesign  and  product  adaptations  to 
substitute  the  harmful  chemicals  which  will  be  subject  to  generic  bans.  There  will  be  product 
withdrawals of products in which the chemical substances cannot be substituted but this should be 
mitigated to a certain extent by a shift in demand to other products that will remain on the market. 
With the preferred PO,  businesses will be  required to  include a Digital  Product  Passport on their 
products containing the EU declaration of conformity. The reference of this Digital Product Passport 
will be included in a central registry and indicated at the time of import into the Union. While this 
will  lead  to  costs  for  businesses,  it  will  also  lead  to  benefits  in  streamlining  the  provision  of 
compliance  information,  updating  such  information  and  replying  to  requests  from  authorities. 
Furthermore, it will  yield significant  benefits  in  terms  of competitiveness of reputable  companies 
which now face unfair competition by rogue traders.  

Impacts on consumers 

The preferred PO will lead to significant health benefits in terms of strengthen protection of children 
from  the  most  harmful  substances.  These  are  substances  such  as  CMRs,  endocrine  disruptors  or 
substances which are toxic for the immune, neurological and respiratory systems. These substances 
are particularly harmful for children who are a vulnerable population group, and can produce adverse 
effects sometimes at very low doses. In addition, a significant reduction of non-compliant toys on the 
Union market can be expected from relying on the Digital Product Passport, thus reducing also the 
possible risks that children face from non-compliant toys. 

Impacts on public authorities 

The  preferred  PO  will  lead  to  significant  efficiency  gains  for  public  authorities  in  tackling  non-
compliant toys in the Union. Non-compliant toys come particularly from non-EU countries. Customs 
controls of the existence of the Digital Product Passport can be rendered automatic on all toys coming 
into the Union market, rather than risk-based, which will stop a significant number of non-compliant 
toys  which  do  not  have  this  Digital  Product  Passport  from  being  placed  on  the  Union  market.  In 
addition,  checks  by  market  surveillance  authorities  will  be  rendered  more  efficient  by  allowing 
immediate access to the compliance information of the toy via a machine readable code on the toy. 
This will allow for an increase in the number of inspections between 10 to 20%. 

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2.  SUMMARY OF COSTS AND BENEFITS 

I. Overview of Benefits (total for all provisions) – Preferred Option 

Description 

Improved  well-being  and 
health 

Efficiency  gains  in  market 
surveillance  and  customs 
controls 

Efficiency 
providing 
information 

in 
gains 
compliance 

Amount 

Direct benefits 

Comments 

Consumers and in particular children 

Market surveillance authorities 
Customs authorities 

Businesses 

Total amount not quantifiable with precision but 
generated  from  the  improved  protection  from 
harmful  chemicals  and  the  reduction  of  non-
compliant toys on the market.  
Estimates  €240  million  to  €1.2  billion  per  year 
materialising within 30 years at least 

Facilitation  of  checks  for  market  surveillance 
authorities leading to lower costs per inspection, 
generated by the DPP, as the information will be 
readily  available.  Automated  customs  controls 
will ensure more efficient checks at the border of 
toys. 
Estimated increase of inspections by a maximum 
of 2500- 5000 per year. 

Savings  generated  from  digitalisation  of  the 
compliance  information  and  the  possibility  to 
quickly update it, which could range from € 2.62 
million to € 3.93 (€3.275 on average) million per 
year.   
There  will  also  be  savings  from  dealing  with 
inspections  on  products  by  market  surveillance 
authorities; estimates range from € 13 million to 
€ 20 million 

Indirect benefits 

Competitiveness 
Single Market 

in 

the 

Total  amount  not  quantifiable  but  generated  by 
the  introduction  of  the  DPP  with  compliance 
information and its verification at customs. 

Businesses 

direct 

Administrative cost savings related to the ‘one in, one out’ approach 

Savings in producing  information digitally only, 
which could range from € 2.62 million to € 3.93 
million  (€3.275 million on average) per year. 

Businesses 

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II. Overview of costs – Preferred option 

Citizens/Consumers 

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Direct adjustment 
costs 

N/a 

N/a 

€23.5m 
€396.66m 
product 
adaptations 

to 
per 
in 

to 
in 

€7.31m 
€11.70m 
year 
increased 
testing 

N/a 

N/a 

Direct 
administrative 
costs 

N/a 

N/a 

€18m on setting 
up the DPP 

to 

€100.000 
€300.000 
yearly 
if 
derogations  are 
requested 
€10.5m  yearly 
costs for DPP 

N/a 

N/a 

Action (a)   

Direct regulatory 
fees and charges 

N/a 

Direct 
enforcement costs 

N/a 

Indirect costs 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

N/a 

to 

€249.21m 
€367.25m 
worth  of  toys 
that  could  no 
longer  be  made 
available on the 
market  

N/a 

N/a 

N/a 

Costs related to the ‘one in, one out’ approach 

Direct adjustment 
costs  

N/a 

N/a 

Indirect 
adjustment costs 

N/a 

N/a 

23.5m 
€ 
€396.66m  

to 

€7.31m 
€11.70m 
year 

to 
per 

to 

n/a 

€249.21m 
€367.25m 
worth of toys 

Total   

Administrative 
costs (for 
offsetting) 

N/a 

N/a 

€18m 

per 

€10.5m 
year 
to 
€100  000 
€300  000  per 
year 
if 
derogations  are 
requested 

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3.  RELEVANT SUSTAINABLE DEVELOPMENT GOALS 

III. Overview of relevant Sustainable Development Goals – Preferred Option(s) 
Relevant SDG 

Expected progress towards the Goal 

Comments 

SDG  #3  Good  health 
and well-being 

Reduction of exposure of children in toys 
to the most harmful substances as meeting 
one  of  the  relevant  hazard  classes  under 
the  CLP  Regulation  should    lead  to  a 
reduction  of  the  mortality  rate  attributed 
to cardiovascular disease, cancer, diabetes 
or chronic respiratory disease. 

SDG  #6  Clean  water 
and sanitation 

The reduction in toys of the most harmful 
substances  will  lead  to  less  amounts  of 
these substances ending up as waste.  

Specific Target 3.4 ‘By 2030, reduce 
by  one  third  premature  mortality 
from  non-  communicable  diseases 
through prevention and treatment and 
promote  mental  health  and  well-
being’ and 
Specific  Target  3.9 
‘By  2030, 
substantially  reduce  the  number  of 
deaths  and  illnesses  from  hazardous 
chemicals  and  air,  water  and  soil 
pollution and contamination’ 

Specific  Target  6.3 
‘By  2030, 
improve  water  quality  by  reducing 
pollution,  eliminating  dumping  and 
minimising  release  of  hazardous 
chemicals and materials, halving the 
proportion  of  untreated  wastewater 
and 
increasing 
recycling and safe reuse globally’ 

substantially 

#9 
SDG 
innovation 
infrastructure 

Industry, 
and 

of 

The introduction of a digital passport for 
the  compliance  information  will  foster 
digitalisation 
and 
innovation. A more stringent regulation of 
enhance 
substances  will 
chemical 
innovation  and  substitution  of  the  most 
harmful chemical substances. 

companies 

increased 

‘By  2030, 
Specific  Target  9.4 
upgrade  infrastructure  and  retrofit 
industries to make them sustainable, 
with 
resource-use 
efficiency  and  greater  adoption  of 
clean  and  environmentally  sound 
technologies 
industrial 
processes,  with  all  countries  taking 
their 
in  accordance  with 
action 
respective capabilities’ 

and 

#12 

SDG 
sustainable 
consumption 
production patterns 

Ensure 

and 

A  higher  protection  of  children  in  toys 
through  more  stringent  requirements  for 
the  most  harmful  chemicals  will  reduce 
significantly exposure of children in toys 
and  will  also  ensure  that  less  harmful 
substances end up as waste.  

Specific  Target  12.4  ‘By  2020, 
achieve  the  environmentally  sound 
management  of  chemicals  and  all 
wastes throughout their life cycle, in 
accordance with agreed international 
frameworks, and significantly reduce 
their release to air, water and soil in 
order 
their  adverse 
impacts  on  human  health  and  the 
environment’ 

to  minimise 

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ANNEX 4: ANALYTICAL METHODS 

In  order  to  support  the  Impact  Assessment,  a  study  was  carried  out  using  a  set  of  dedicated  data 
collection and analytical tools to maximise relevance of the results and minimise the limitations of 
the study.  

See annex 11 for further details on the methodology for calculation of number of non-compliant toys 
in the Union, and annex 14 for details on the methodology for the assessment of the different impacts 
of the policy measures. 

1.  OVERVIEW OF THE METHOD 

The study was carried out between January 2022 and October 2022. The work was structured around 
three phases, each of them with various sub-tasks. This section summarizes the work under the key 
evidence-gathering and analysis activities.  

Intervention logic and identification of the key problems  

To  prepare  the  work  for  the  development  of  the  policy  options,  the  study  first  established  the 
intervention logic and mapped and assessed the 1) key drivers, 2) problems and sub-problems, and 
3) consequences of these problems to consumers, national regulatory authorities, the internal market 
and businesses. The intervention logic was regularly updated based on evidence gathered from the 
various data collection tasks. 

1)  Literature review 

The study included a review of relevant documentation and literature. The review covered a broad 
catalogue from a variety of EU and Member State sources, including legal and policy documents, 
statistical data, studies and academic papers, position papers and other publications from relevant 
stakeholders. 

2)  Development and appraisal of the policy options 

Based  on  the  analysis  carried  out  in  the  legal  gap  analysis,  literature  review  and  analysis  of  the 
consumer journey and on the feedback collected from stakeholders, 6 different policy options for the 
future of the TSD were identified: 

Policy option 0: no change (baseline) 

Policy option 1a: minimum changes 

Policy option 1b: improved protection 

Policy option 1c: maximum changes 

Policy option 2a: extending the conformity assessment 

Policy option 2b: facilitation of control through digitalisation 

Policy option 2c: extending the conformity assessment and facilitation of control (combination of 
options 2a and 2b) 

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3)  Consultation with EU and national-level stakeholders 

The stakeholder consultation aimed to collect information and feedback for the assessment of impacts 
and on the different policy options. The stakeholder activities included: 

  Scoping interviews with notified bodies, business associations and consumer associations to 

gather preliminary information on the topic and assess key issues and challenges; 

  SME survey: the survey was shared with SMEs, SME associations and business associations 

to ensure that specific input from SMEs was gathered, especially on impacts; 

  Semi-structured  interviews  with  EU-level  and  national  stakeholders,  particularly  from  the 
following  stakeholder  groups:  businesses  and  business  associations,  national  regulatory 
authorities  and  notified  bodies,  and  consumer  associations.  The  key  aim  of  the  semi-
structured  interviews  was  to  receive  feedback  from  the  stakeholders  on  potential 
improvements of the Toy Safety Directive, and insight to feed into the assessment of impacts 
and comparison of policy options; 

  Open public consultation questionnaire: the PC ran for 12 weeks from the end of March 2022 
to May 2022 and gathered information and views on how the Toy Safety Directive can better 
protect children, and to collect information on how to improve the Directive. 

Table 2: Summary table on the number and type of consultation activities 

Stakeholder group  Consultation methods 

Scoping 

SME survey 

Interviews 

OPC 

and 

Businesses 
business 
associations 
National  Regulatory 
and 
Authorities 
notified bodies 
Consumer 
associations 
Academic 
institutions 
Environmental 
organisations 
Other 
individuals etc. 
Total 

(NGOs, 

201 

2 

2 

2 

15 

23 

3 

6 

201 

41 

89 

31 

12 

2 

3 

59 

196 

2.  LIMITATIONS ENCOUNTERED AND MITIGATION MEASURES 

The key limitation of the study was the shortened timeline of the data collection which made the 
setup of the data collection tools extremely challenging and left no time for further probing into the 
evidence and reconnecting with stakeholders after the data collection had been done. Some limitation 
in the assembled evidence was therefore unavoidable and will be addressed as soon as possible:  

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  The overall number of third-party conformity assessments both in the baseline option and in 
option  2a  was  not  available  to  stakeholders.  Further  discussions  with  stakeholders  on  this 
specific topic will continue to revise the estimate as appropriate.  

  Cost  estimates  for  all  of  the  options  under  1  but  especially  1a  were  very  uncertain  as  the 
details of the chemical substances may only be determined later on. It is not clear which limit 
values would be introduced or how many toy relevant substances would be affected by an 
extension of the GRA.  

 

Information on toy specific health risks were also scarce. On the one hand, information on 
illnesses  or  accidents  with  toys  is  patchy  at  best  while,  on  the  other  hand,  there  is  ample 
evidence of dangerous substances still present in toys on the EU market. The study could not 
fully resolve that gap in the data.  

To  mitigate  these  deficiencies,  the  study  triangulated  the  information  from  the  SME  survey,  the 
interviews and the literature to  develop  robust estimates for  each of the options. For some topics 
knowledgeable stakeholders were asked for further input to fill the gaps.   

3.  STRUCTURE OF THE ANALYSIS 

The analysis followed a step-by-step approach, where each step built on the outcome of the previous 
step. The steps mirrored the different elements mapped in the intervention logic, from the drivers to 
the  problems  and  consequences  and  then  to  policy  objectives  and  policy  options.  In  terms  of  the 
impact assessment of the options, first a baseline assessment of the toys market was carried out. The 
policy  options  were  then  assessed  with  regard  to  their  impacts  and  compared,  based  on  feedback 
collected from stakeholders through the online survey. The following impacts were assessed: 

  Administrative burden  

  Cost for companies 

 

Impacts on competitiveness and the single market 

  Costs for authorities and notified bodies  

  Human health impacts 

  Environmental impacts  

4.  LEGAL ANALYSIS - METHODOLOGY 

A legal comparative analysis was conducted to see possible overlaps, duplications and gaps between 
the TSD and other relevant EU legislation (both legislation in force and proposed). The legal analysis 
did not intend to repeat the comprehensive legal analysis performed for the 2020 evaluation of the 
TSD,  therefore  it  was  focused  on  the  legislation  adopted  or  proposed  since  then.  Nonetheless,  to 
understand the overall approach to product safety, including toy safety, many of the older legal acts 
were reviewed as well. All legal acts were reviewed in the latest consolidated version. 

The following legislation (in chronological order) was reviewed: 

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Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on 

• 
general product safety, OJ L 11 of 15.01.2002 

• 
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 

Regulation  1907/2006,  concerning 

• 
the  Registration,  Evaluation,  Authorisation  and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) 
No  1488/94  as  well  as  Council  Directive  76/769/EEC  and  Commission  Directives  91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC 

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 

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 

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and 
• 
mixtures  (CLP),  amending  and  repealing  Directives  67/548/EEC  and  1999/45/EC,  and  amending 
Regulation  (EC)  No  1907/2006Directive  2011/65/EU,  on  the  restriction  of  the  use  of  certain 
hazardous substances in electrical and electronic equipment (RoHS) 

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the 

• 
safety of toys 

• 

Regulation No 1223/2009 on cosmetic products 

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the 

• 
restriction of the use of certain hazardous substances in electrical and electronic equipment 

• 
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 relating to the making available on the market of 
radio equipment and repealing Directive 1999/5/EC 

• 
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 
on the protection of natural persons with regard to the processing of personal data and on the free 
movement of such data, and repealing Directive 95/46/EC 

• 
Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 
on ENISA (the European Union Agency for Cybersecurity) and on information and communications 
technology cybersecurity certification and repealing Regulation (EU) No 526/2013 

• 
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 

The following proposals for legal acts (in chronological order) were reviewed:  

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Proposal for a Regulation of the European Parliament and of the Council on a Single Market 

• 
for Digital Services (Digital Services Act) and amending Directive 2000/31/EC, COM(2020) 825 

• 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down 
harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain union 
legislative acts, COM(2021) 206 

• 
Proposal for a Regulation of the European Parliament and of the Council on general product 
safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and 
repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and 
of the Council, COM(2021) 346  

• 
Commission  Delegated  Regulation  (EU)  …/…  of  29.10.2021  supplementing  Directive 
2014/53/EU  of  the  European  Parliament  and  of  the  Council  with  regard  to  the  application  of  the 
essential requirements referred to in Article 3(3), points (d), (e) and (f), of that directive, C(2021) 
7672 

• 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  establishing  a 
framework  for  setting  ecodesign  requirements  for  sustainable  products  and  repealing  Directive 
2009/125/EC, COM(2022) 142 

To put legal developments in context, several policy documents were analysed: 

• 

• 

• 

Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment, COM(2020) 667  

New Consumer Agenda, COM(2020) 696 

Cyber Resilience Act, Call for evidence for an impact assessment (2021) 

• 
European  Parliament  resolution  of  16  February  2022  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) 

The analysis of the legal documents was supported by the literature review of the relevant scholarship 
and other studies. All publications are referenced in the text of the report. 

5.  GLOBAL AND EUROPEAN TOYS MARKET 

Descriptive  statistics  on  the  European  toys  industry  draw  mainly  on  Eurostat  Structural  Business 
Statistics (SBS), C32.4 – Manufacture of games and toys (NACE Rev 2). The analysis focuses on 
data covering the EU-27 and EFTA countries, while highlighting the respective shares of leading 
countries  in  the  European  toys  industry.  Detailed  data  tables  presenting  disaggregation  for  all 
Member States and EEA / EFTA countries where Eurostat SBS data is available are provided below. 

It is important to highlight data gaps and shortcomings in the quality of data. The statistical analysis 
was partly hampered by data gaps in Eurostat SBS data in some Member States and EEA / EFTA 
countries, especially for some variables, such as turnover and the number of people employed. In 
some cases, there were insufficient data for Eurostat to estimate the total for the EU-27, while those 
estimates that are available are marked as low reliability by Eurostat. The most recent year for which 
data  was  available  was  2020  for  some  variables,  but  there  were  provisional  estimates  only  and 
remained gaps.  

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Regarding mitigation measures, the methodology focuses on reporting the sum of the available data 
across the EU-27 and EEA/EFTA countries, rather than the overarching Eurostat EU-27 estimates. 
This allows increased traceability and analysis between the overarching figures and the country data. 
To ensure this is transparent, it is clearly stated in each case the number of countries whose data is 
included in the estimate. Furthermore, where appropriate, data imputations have been calculated for 
certain missing data points based on average market changes year on year. More detail on the data 
gaps  and  the  approach  to  mitigating  these  challenges  is  provided  throughout  the  analysis  of  the 
different elements. 

Supporting data tables with full disaggregation 

This section contains supporting data with full disaggregation by country and year. It should be noted 
that  in  Eurostat  SBS,  the  majority  of  2020  data  is  provisional  only  –  marked  by  a  (p)  below. 
Furthermore, the data does not cover all countries across all years and all variables; for instance, no 
data on the number of toy industry enterprises is provided in Ireland, Malta and Liechtenstein for the 
entire period 2016-2020, while no data on this indicator exists for Cyprus in 2016-2017. To mitigate 
this challenge, data imputations have been developed for certain countries and years, but only where 
they can be based on robust assumptions. The methodology for developing the imputations is detailed 
in the box below. 

Method for developing data imputations 

In the absence of relevant supporting data, the methodology for developing data imputations was 
based  on  the  assumption  that  the  changes  in  a  particular  country  for  a  particular  variable  will 
follow average market changes year-on-year; i.e. that missing 2020 data for a particular variable 
can  be  estimated  based  on  overall  market  changes  in  that  variable  from  2019-2020.  This  is 
particularly relevant given the unique and challenging nature of the market in 2020, which resulted 
from the COVID-19 pandemic. Furthermore, most of the data imputations developed were  for 
2020. 

On this basis, the following three steps were conducted to estimate each missing data point: 

i. 

ii. 

iii. 

For  each  country  that  has  data,  we  calculated  the  absolute  change  and  percentage 
change in the relevant variable from year n to year n+1 (e.g. from 2019 to 2020). 

Calculate the average percentage change across all countries for year n to year n+1. 

Apply the average percentage change to the data from year n in the country without 
data to develop a value for year n+1. 

Data for countries which had no data across the examined time period was not estimated due to 
the inherent lack of baseline data on which any data imputations could be developed. 

Each table first presents, where available, the Eurostat composite figures for the EU-27 and former 
EU-28. However, in most cases, these figures are marked by Eurostat as low reliability due primarily 
to the use of different definitions in some countries. As such, each table also provides the sum of the 
available data for the EU-27 and the EU-27 + EEA/EFTA countries. However, as data is missing for 
certain countries and years, these overarching figures are accompanied by notes detailing the number 
of countries for which data is available.  

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In  the  main  body  of  the  analysis,  the  combined  EU-27  +  EEA/EFTA  figures  for  each  year  are 
presented;  this  is  due  to  the  limited  reliability  of  the  composite  EU-27  figures  and  the  increased 
traceability and comparability provided by the EU-27 + EEA/EFTA figures in combination with the 
country-specific data. 

Table 3: No. of enterprises in the European toys industry (disaggregated among EU-27 and EEA/ EFTA countries)  

European Union – 27 countries (from 2020) 

5,300 

5,400 

5,800 

6,000 

European Union – 28 countries (2013-2020) 

5,900 

6,000 

2016 

2017 

2018 

2019 

Belgium 

Bulgaria 

Czechia 

Denmark 

Germany (until 1990 former territory of the FRG) 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

42 

45 

554 

95 

579 

29 

74 

379 

787 

47 

359 

71 

60 

2 

162 

43 

520 

96 

568 

30 

77 

386 

641 

50 

374 

75 

92 

3 

198 

207 

417 

92 

732 

67 

119 

40 

211 

31 

432 

94 

771 

67 

143 

43 

218 

35 

71 

42 

529 

97 

605 

19 

83 

401 

729 

44 

382 

3 

88 

108 

4 

222 

478 

93 

872 

72 

183 

42 

315 

35 

88 

47 

513 

103 

697 

22 

81 

404 

771 

71 

327 

4 

103 

119 

4 

232 

495 

101 

870 

69 

194 

40 

362 

33 

2020 
(p) 

103 

52 

506 

105 

683 

25 

79 

409 

848 

73 

338* 

4 

112 

139 

4 

235 

536 

92 

904 

78 

207 

42 

398 

32 

EN 

87 

  EN 

 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
Sweden 

Total EU-27 

2016 

2017 

2018 

2019 

224 

241 

239 

243 

2020 
(p) 

242 

5,254 

5,368 

5,756 

5,993 

6,246 

Total EU-27 (# of countries with data available) 

24 

24 

25 

25 

25 

Iceland 

Liechtenstein 

Norway 

Switzerland 

14 

13 

10 

10  

10*  

32 

32 

37 

30 

32 

28 

34 

30* 

25 

31* 

Total EU27 + EEA/ EFTA 

5,332 

5,448 

5,826 

6,067 

6,313 

Total  EU-27  +  EEA/EFTA  (#  of  countries  with  data 
available) 

27 

27 

28 

28 

28 

Source: Eurostat SBS. 

* Data imputations developed for the following data points and years: IT (2020), IS (2020), and CH 
(2019-2020). 

Table 4: Turnover generated in the European toys industry in million EUR (disaggregated among EU-27 and EEA/ EFTA 
countries) 

2016 

2017 

2018 

2019 

2020 
(p) 

European Union - 27 countries (from 2020) 

European Union - 28 countries (2013-2020) 

Belgium 

Bulgaria 

Czechia 

Denmark 

128.7 

119.0 

144.0 

137.0 

134.5 

210.7 

236.7 

228.6 

287.9 

175.0 

850.9 

790.8 

850.5 

861.6 

898.2 

Germany (until 1990 former territory of the FRG) 

2,939.5 

3,067.1 

4,191.8 

3,915.2 

2,608.2 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

1.3 

1.1 

0.8 

14.6 

13.9 

13.9 

15.0 

13.6 

552.1 

548.2 

574.7 

592.4 

546.4 

448.7 

357.0 

457.3 

447.1 

421.5 

11.0 

7.4 

7.3 

5.4 

674.9 

581.1 

516.6 

589.1 

560.1 

5.5 

6.2 

4.7 

5.9 

4.5 

6.0 

2.6 

7.7 

EN 

88 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

Sweden 

2016 

2017 

2018 

2019 

3.0 

3.5 

4.1 

6.1 

2020 
(p) 

6.3 

170.8 

184.5 

175.7 

180.8 

198.1 

523.3 

567.8 

775.8 

601.6 

453.0 

208.9 

237.1 

247.0 

268.4 

296.3 

5.2 

39.0 

3.0 

42.3 

4.5 

88.5 

5.8 

97.1 

118.7 

134.5 

118.3 

136.5 

62.9 

33.1 

33.2 

34.3 

30.0 

32.6 

33.3 

29.0 

28.3 

33.1 

29.1 

31.3 

8.8 

42.8 

75.6 

29.0 

31.1 

41.3 

Total EU-27 

7,025 

7,002 

8,500 

8,253 

6,556 

Total EU-27 (# of countries with data available) 

20 

21 

21 

21 

22 

Iceland 

Liechtenstein 

Norway 

Switzerland 

0.4 

3.1 

2.7 

2.5 

2.2 

63.2 

2.1 

1.7 

Total EU-27 + EEA/EFTA 

7,028 

7,070 

8,503 

8,255 

6,558 

Total  EU-27  +  EEA/EFTA  (#  of  countries  with  data 
available) 

22 

24 

22 

22 

23 

Source: Eurostat SBS. 

Table 5: Production value in billion EUR 

European Union – 27 countries (from 2020) 

European Union – 28 countries (2013-2020) 

Belgium 

Bulgaria 

Czechia 

Denmark 

2016 

2017 

2018 

2019 

2020 
(p) 

127.5 

112.6 

133.4 

130.8 

130.5 

219.2 

242.0 

229.6 

290.9 

175.6 

873.6 

811.7 

886.1 

890.1 

919.6 

EN 

89 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
Germany (until 1990 former territory of the FRG) 

2,724.6 

2,884.0 

3,573.6 

3,555.8 

2,462.7 

2016 

2017 

2018 

2019 

2020 
(p) 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

Sweden 

1.4 

1.1 

0.9 

10.6 

8.9 

9.3 

10.1 

9.2 

522.6 

525.6 

536.8 

550.6 

491.3 

388.5 

316.7 

374.4 

377.2 

368.6 

9.3 

7.5 

7.9 

6.0 

641.1 

566.0 

499.6 

608.5 

597.2 

5.6 

3.0 

6.3 

3.5 

5.1 

5.7 

4.0 

4.6 

5.9 

6.0 

2.6 

7.5 

6.3 

164.1 

178.7 

169.2 

174.4 

191.2 

518.7 

541.3 

692.7 

485.7 

388.9 

198.1 

233.8 

221.1 

244.1 

269.4 

4.3 

40.1 

3.2 

41.9 

4.2 

58.4 

5.3 

73.5 

118.3 

142.6 

123.3 

138.1 

42.2 

30.1 

30.8 

23.1 

25.1 

31.1 

25.7 

30.9 

25.5 

30.8 

23.6 

29.3 

7.8 

43.5 

58.1 

24.7 

26.9 

38.5 

Total EU-27 

6,664 

6,709 

7,616 

7,643 

6,227 

Total EU-27 (# of countries with data available) 

20 

21 

21 

21 

22 

Iceland 

Liechtenstein 

Norway 

Switzerland 

0.4 

2.8 

2.9 

2.5 

2.2 

62.9 

2.1 

1.7 

Total EU-27 + EEA/EFTA 

6,667 

6,776  

7,619 

7,645 

6,229  

Total  EU-27  +  EEA/EFTA  (#  of  countries  with  data 
available) 

22 

24 

22 

22 

23 

Source: Eurostat SBS.  

EN 

90 

  EN 

 
 
  
  
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
  
 
 
 
 
 
Table 6: Number of persons employed among toy producers 

European Union – 27 countries (from 2020) 

55,786 

58,910 

61,153 

European Union – 28 countries (2013-2020) 

60,612 

60,330 

2016 

2017 

2018 

2019 

2020 
(p) 

Belgium 

Bulgaria 

Czechia 

Denmark 

602 

743 

679 

732 

574 

2,663 

2,867 

2,843 

2,855 

2,886 

7,278 

7,327 

7,180 

7,206 

7,308 

Germany (until 1990 former territory of the FRG) 

14,383 

14,287 

16,161 

18,024 

13,353 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Italy 

Cyprus 

Latvia 

Lithuania 

Luxembourg 

Hungary 

Malta 

Netherlands 

Austria 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Finland 

Sweden 

36 

38 

33 

211 

238 

304 

287 

284 

3,363 

3,337 

3,389 

3,490 

3,397 

2,366 

2,057 

2,394 

2,857 

122 

170 

135 

163 

165 

2,662 

2,643 

2,599 

2,378 

2,358 

286 

169 

293 

191 

64 

256 

213 

58 

229 

243 

41 

243 

262 

4,093 

4,074 

3,961 

3,955 

4,088 

703 

713 

864 

735 

722 

1,848 

1,891 

2,337 

2,242 

2,218 

4,182 

4,360 

4,797 

4,794 

4,785 

229 

185 

214 

216 

278 

1,836 

2,018 

2,550 

2,364 

1,642 

465 

634 

192 

182 

525 

611 

203 

216 

568 

684 

220 

233 

596 

749 

212 

218 

558 

750 

191 

229 

Total EU-27 

48,505 

48,987 

52,645 

54,603 

49,123 

Total EU-27 (# of countries with data available) 

22 

22 

22 

22 

23 

Iceland 

7 

27 

25 

EN 

91 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Liechtenstein 

Norway 

Switzerland 

2016 

2017 

2018 

2019 

2020 
(p) 

31 

403 

29 

297 

32 

504 

21 

21 

Total EU-27 + EEA/EFTA 

48,946 

49,340 

53,206 

55,150 

49,652 

Total  EU-27  +  EEA/EFTA  (#  of  countries  with  data 
available) 

25 

25 

25 

25 

26 

Source: Eurostat SBS. 

EN 

92 

  EN 

 
 
 
 
 
 
 
 
 
 
 
ANNEX 5. SME TEST SUMMARY 

Step 1/4: Identification of affected businesses 

According  to  the  most  recent  Eurostat  SBS  data,  SMEs  account  for  99%  of  the  approximately  6,313  (2020) 
manufacturers of toys in Europe. In terms of turnover, SMEs account for a fourth of the overall EU market (EURbn 
2,19) and they employ about half (approximately 29 thousand) of the workforce in the industry as shown in the charts 
below.  
SMEs are in scope of the revision of the Toys Safety Directive, however the initiative does not specifically target 
SMEs. According to the estimates, it is likely that the SMEs will be highly impacted by the preferred policy options 
since these would affect the manufacturing process of certain toys. Due to the nature of the measures – increase of 
the safety of toys by reducing the limit values of chemical substances and additional restrictions on a wider range of 
substances  –  all  companies  will  be  affected  in  their  production  processes,  however,  larger  companies,  due  to 
economies of scale, are likely to be able to better sustain the additional costs (i.e. substitution costs, adjustment costs). 
On the other hand, these measures increase  the  safety standards of toys on the European market and are likely to 
reduce the amount of non-compliant toys (which current estimates are around 20% of the overall EU toys market) 
and  thus  reduce  the  unfair  competition  of  rogue  manufacturers.  Such  measure  would  impact  positively  the  EU 
competition and benefit especially the competitiveness of SMEs.  

Key question: To what extent is the initiative relevant for SMEs? (not relevant, relevant, 
highly relevant) 

This initiative is considered highly relevant for SMEs, as it would impact horizontally all EU businesses operating in 
the  sector  due  to  the  nature  of  the  initiatives  under  Option  1b  (increase  of  the  safety  of  toys)  and  Option  2b 
(introduction of the Digital Product Passport).  

Step 2/4: Consultation of SME Stakeholders 

The  public  consultation  captured  the  specific  input  of  SMEs  by  asking  respondents  to  indicate  the  size  of  their 
organisation. The public consultation was signalled to SMEs organisations in general to ensure sufficient feedback 
in the public consultation. In addition, sectoral organisations (in particular TIE) which include a number of SMEs 
were also represented in the public consultation, not only at organisation level but also by their individual members. 
An SME targeted consultation was also carried out to assess the impacts of the different policy options. In terms of 
the  interviews,  the  questionnaire  was  also  distributed  in  writing  allowing  respondents  to  send  their  written 
contributions  to  this  process,  too,  with  a  number  of  SMEs  providing  their  contributions.  This  ensured  that  SME 
feedback was captured from different sources. 
The compliance efforts are expected to be significant, in particular regarding the substitution costs and the adjustment 
costs.  The  impact  assessment  conducted  a  specific  survey  targeting  SMEs  which  sought  the  participation  of  201 
businesses.  
The input received in the survey by SMEs has informed significantly the analysis and provided precious information 
for the calculation of the administrative burden and other costs and potential benefits for SMEs. 
In particular, respondents consider that the biggest sources of compliance costs linked to the application of the TSD 
are:  (1)  bureaucracy  and  extent  of  requirements,  (2)  need  for  specific  knowledge  or  skills  and  extensive  human 
resources for following the changing requirements and (3) testing requirements (especially done separately for similar 
products). 
The input provided by SMEs has been carefully considered in the choice of the preferred option, and in particular the 
options to address the problem of the high number of non-compliant products. As such, options 2a and 2c increasing 
the number of products that should be subject to third-party conformity assessment were ultimately not chosen. In 
particular, while option 2c was considered to yield the most benefits in terms of reducing non-compliant products 
and streamlining market surveillance for toys, it was deemed to be particularly burdensome for SMEs.  

EN 

93 

EN 

 
 
 
 
 
 
 
Step 3/4: Assessment of the impact on SMEs 

In the SME  survey, companies  were  also asked to provide several quantitative information  which allowed for the 
calculation of the compliance costs of the TSD for SMEs (baseline) and the estimates of the proposed policy options. 
More specifically, SMEs were asked: 

1.  Main causes of compliance costs, linked to the application of the Toy Safety Directive; 
2.  Measures that would help reducing costs for SMEs; 
3.  Type of costs of an EU type examination before introducing a new product (toy); 
4.  Cost of an EU type examination before introducing a new product (toy) (staff, outsourcing, equipment); 
5.  Cost of testing of a new toy-model (staff, outsourcing, equipment); 
6.  Costs of replacing / redesigning a new product if the product is found to be not compliant (or not compliant 

any more due to new regulations)? (staff, outsourcing, equipment)  

7.  Costs of adapting the labels indicating the chemical content of a product  (staff, outsourcing, equipment); 
8.  Costs  of  making  available  the  declaration  of  conformity  online  (per  toy  model)  (staff,  outsourcing, 

equipment) 

9.  Number of new Stock Keeping Unit (SKU), per year, to which the administrative costs would apply. 

These estimates supported the quantification of the impacts on businesses of the proposed policy options individually 
and by business size. Nevertheless, the uncertainty of some aspects of the proposed measures (i.e. the actual means of 
implementation of the DPP, the expected increase of the share of toys subject to additional testing costs, etc.) allowed 
only for some approximation of the impacts. 

 Step 4/4: Minimising negative impacts on SMEs 

SMEs are particularly concerned about the costs of banning additional chemicals in toys, as well as the possible 
impacts on their competitive position. In the SME survey, respondents were directly asked about potential measures 
able  to  minimize  the  negative  impacts  and  maximise  benefits.  The  respondents  identified  a  number  of  different 
potential  intervention  points  through  which  the  most  difficult  compliance  costs  could  be  to  a  certain  degree 
alleviated. In particular, SMEs requested that the procedures should be simplified and that an advisory support should 
be offered as many producers and sellers (especially among the SMEs) are struggling to understand the requirements 
as they pertain to their businesses. If hands-on and preferably free consultancy would be available on the different 
rules regarding production, labelling and packaging that would certainly alleviate some of the administrative burdens 
currently felt. Finally, testing of products should be alleviated as much as possible. 

The final policy options were selected also taking into account the need to achieve the policy objectives in a manner 
which creates less burden to  SMEs. First of all,  while the  introduction of the  generic bans  for chemicals certain 
hazard  classes  in  toys  will  have  costs  for  companies,  and  it  may  be  more  costly  for  SMEs,  the  possibility  for 
derogations under this PO will mitigate the negative impacts to a certain extent. A sufficient transition period will 
be granted to allow for the costs to be accrued gradually rather than upfront. The actual implementation of this policy 
option in the future legal text will strive to make the provisions as straightforward for SMEs as possible, and in a 
manner that limits the need to carry out additional testing as much as possible. While PO2c was considered to be 
most effective in achieving the pursued policy objectives of reducing non-compliant products, it was ultimately not 
chosen as it could prove to be too burdensome for reputable industry, including SMEs. Indeed, it was considered 
only  compliant  manufacturers  would  face  the  additional  costs  of  third-party  certification,  and  that  the  policy 
objectives could be achieved with other policy options less burdensome. Finally, in order to help SMEs in complying 
with the toy safety rules, the Commission will continue relying on harmonised standards as well as producing and 
regularly updating a significant body of Guidance documents on all aspects related to toy safety.  

EN 

94 

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ANNEX 6: LEGAL CONTEXT: MAIN PROVISIONS OF THE TOY 
SAFETY DIRECTIVE AND MARKET SURVEILLANCE 

1.  DEFINITION OF ‘TOYS’ 

The scope of the Toy Safety Directive covers all ‘products designed or intended, whether 
or not exclusively, for use in play by children under 14 years of age’.194  Thus, a product 
does  not  have  to  be  exclusively  intended  for  playing  purposes  in  order  for  it  to  be 
considered as a toy, but can have other functions as well. For example, a key-ring with a 
small plush teddy bear attached to it is considered as a toy, or a toy plastic figurine with a 
pencil sharpener in its foot.195 

The main difficulty of this definition is the concept of ‘use in play’ or ‘play value’. Children 
may  play  with  virtually  everything,  but  this  does  not  make  every  object  fall  within  the 
definition of ‘toy’. To be considered as a toy for the purposes of the Directive, the play 
value has to be introduced in an intended way by the manufacturer since the intention for 
a (certain) use is included in the definition of ‘toy’ itself. 

On the other hand, ‘whether exclusively or not’ requires to consider whether a product can 
have a play value in addition to its intended use, such as in the case of the above-mentioned 
key-ring with a small plush teddy bear attached to it. Since that product may as well be 
used  by  children  in  play,  in  addition  to  its  primary  function  as  key-ring,  the  product  is 
considered to be a toy.  The declaration by the manufacturer of the intended use is thus 
only  one  of  the  criteria  to  be  considered,  the  reasonably  foreseeable  use  in  play  is 
considered to prevail over the declaration of the intended use by the manufacturer.196 

The  Directive  does  however  not  apply  to  some  products  for  public  use  fulfilling  the 
definition  of  toys,  such  as  playground  equipment  intended  for  public  use,  automatic 
playing  machines,  whether  coin  operated  or  not,  when  intended  for  public  use.197 
Moreover, Annex I to the Toy Safety Directive enumerates examples of products that are 
not considered as toys but could be confused with toys. Since it would be impossible to 
enumerate all the products that are not considered as toys, the list is not exhaustive. 

2.  ESSENTIAL SAFETY REQUIREMENTS 

The Toy Safety Directive lays down the safety criteria (‘essential  safety  requirements’) 
that toys must meet before they can be marketed in the EU. Toys must also comply with 
other  EU  legislation  applicable  to  them,  such  as  the  following:  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 December  2006 
concerning  the  registration,  evaluation,  authorisation  and  restriction  of  chemicals 
(REACH),198  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the 

194 Article 2.1 of the Toy Safety Directive. 
195 Paragraph 4 of section 2 of Guidance document No 4 ‘Grey zone problem: Is a specific product covered 
by the Toy Safety Directive 2009/48/EC or not?’ 
https://ec.europa.eu/growth/sectors/toys/safety/guidance/  
196 Paragraph 5 of section 2 of Guidance document No 4. 
197 Article 2.2 of the Toy Safety Directive. 
198 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), establishing 

EN 

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Council of 16 December 2008 on classification, labelling and packaging of substances and 
mixtures,199  and  Regulation  (EC)  No 1223/2009  of  the  European  Parliament  and  of  the 
Council of 30 November 2009 on cosmetic products (recast).200 

The essential safety requirements are designed to ensure a high level of product safety. 
They may cover identified hazards related to the characteristics of the product or to the 
product  performance.201  As  a  consequence  there  may  be  several  safety  requirements 
associated to the same product. 

The essential safety requirements in the Toy Safety Directive cover: 

  general risks: the health and safety of children, as well as other people such as parents 

or supervisors; 

  particular risks: physical and mechanical, flammability, chemical, electrical, hygiene 

and radioactivity risks. 

3.  THE REQUIREMENTS FOR CHEMICAL SUBSTANCES IN DETAIL 

  Chemicals  that  are  susceptible  to  cause  cancer,  change  genetic  information,  harm 
fertility  or  harm  an  unborn  child  (‘CMR  substances’  202)  are  not  allowed  in  toys 
beyond  the  concentration  limits  set  in  the  CLP,  or  unless  they  are  inaccessible  to 
children, including by inhalation, or considered safe following a rigorous scientific 
evaluation  and  if  they  are  not  prohibited  in  consumer  articles  under  REACH.  In 
addition, for CMR substances of categories 1A and 1B which are of most concern, no 
suitable alternatives must exist. (For CMRs category 2, no analysis of alternatives is 
necessary.)  

  Limit values are set out for nitrosamines (0,05 mg/kg) and for nitrosatable substances 

(1 mg/kg). 

  19 'elements' such as mercury or cadmium are not allowed in toy parts accessible to 
children beyond the limits laid down in Toy Safety Directive.203 The Directive draws 
a distinction among three types of materials used in toys – dry, brittle, powder-like or 
pliable; liquid or sticky; scraped-off – each subject to a different migration limit. 
  58  allergenic  fragrances  are  prohibited  because  the  relevant  Scientific  Committee 
considered that they must not form part of cosmetic products due to their allergenicity 
in most cases (fragrances 1 to 31 and 36 to 40);204 or they were (photo-) allergenic 

a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 
No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council  Directive  76/769/EEC  and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396 30.12.2006, p. 1.  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1907-20180301  
199 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and  repealing  Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance). OJ 
L 353, 31.12.2008, p. 1. 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008R1272-20180301  
200 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on 
cosmetic products. OJ L 342, 22.12.2009, p. 59. 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20171225  
201 The ‘Blue Guide’ on the implementation of EU product rules  
202 Substances that are carcinogenic, mutagenic or toxic for reproduction. 
203 Annex II, part III, point 13 of the Toy Safety Directive. 
204 Scientific Committee on Non-Food Products (SCCNFP) An initial list of perfumery materials which must 
not form part of cosmetic products. Opinion SCCNFP/0320/00 final, 3.5.2000.   
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out116_en.pdf 

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(fragrances  32  to  35);205  or  because  they  were  most  frequently  reported  as  contact 
allergens  (fragrances  41  to  53);206 or  because  they  contain  allergenic  species 
(fragrances  54  to  55).207  The  presence  of  traces  of  these  55 fragrances  is  however 
allowed if technically unavoidable under good manufacturing practice and if they do 
not exceed 100 mg/kg. 

  A  further  72 allergenic  fragrances  may  be  used  in  toys  on  condition  that  they  are 
labelled  when  their  concentration  exceeds  100 mg/kg  in  the  toy  or  any  of  its 
components. They were less frequently reported as contact allergens.208 

  For 15 of the prohibited allergenic fragrances (namely numbers 41 to 55) and for the 
11  allergenic  fragrances  that  are  to  be  labelled,  specific  conditions  apply  if  such 
fragrances  are  used  in  olfactory  board  games,  cosmetic  kits  and  gustative  games. 
Among others, the toys have to carry the warning that they are not suitable for children 
under 36 months. 

  Specific limit values can be set for any chemical in toys but these limit values can only 
apply to toys for children under 36 months (who take ‘everything’ into their mouth) 
and to toys intended to be placed in the mouth, since those toys lead to a high exposure 
of children to chemicals. As a result, a new appendix C includes limit values in toys 
intended  for  children  under  36  months  or  to  be put  in  the  mouth  for  the  following 
chemical  substances:  TCEP,  TCPP  and  TDCP,  Bisphenol  A,  Formamide, 
Benzisothiazolinone,  chloromethylisothiazolinone  and  methylisothiazolinone,  both 
individually and in a ratio of 3:1, Phenol, formaldehyde and aniline. 

4.  HOW THE DIRECTIVE IS KEEPING UP WITH PROGRESS 

In order to keep pace with latest technical and scientific developments, the Commission 
can amend certain  parts of the Toy Safety Directive via the Regulatory Procedure with 
Scrutiny (RPS).209 Such procedure may be used to amend specific provisions. It may adapt 
Annex I that lists examples of products that are not toys (but may be confused with them), 
the list of prohibited allergenic fragrances and the list of allergenic fragrances to be labelled 
in Annex II, it may adapt the limit values for heavy metals and other hazardous metals I 
Annex II, and the warnings for toys in Annex V. 

205  Scientific  Committee  on  Non-Food  Products  (SCCNFP)  An  update  of  the  initial  list  of  perfumery 
materials  which  must  not  form  part  of  cosmetic  products.  Opinion  SCCNFP/0771/03  final,  9.12.2003. 
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out251_en.pdf 
206  Scientific  Committee  on  Non-Food  Products  (SCCNFP)  Fragrance  allergy  in  consumers.  Opinion 
SCCNFP/0017/98 final, 8.12.1999. Table 6a, p. 22.   
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out98_en.pdf 
207 Scientific Committee on Non-Food Products (SCCNFP) An initial list of perfumery materials which must 
not  form  part  of  cosmetic  products  except  subject  to  the  restrictions  and  conditions  laid  down. 
SCCNFP/392/00 final, 25.9.2001 
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf 
and Scientific Committee on Consumer Products (SCCP) Opinion on Oak moss / Tree moss (sensitisation 
only). SCCP/1131/07, 15.4.2008. 
https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_131.pdf  
208 Scientific Committee on Non-Food Products (SCCNFP). SCCNFP/0017/98 final, 8.12.1999, Table 6b, p. 
23. See footnote above. 
209 Article 46 of the Toy Safety Directive. 

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In addition, the Commission may establish maximum limit values for any chemical in toys 
intended for children under 36 months of age and in all toys intended to be placed in the 
mouth, and it may also amend those limits (Appendix C to Annex II). 

Finally, the Commission may allow the use of chemicals that are carcinogenic, mutagenic 
or  toxic  to  reproduction  (CMRs),  albeit  only  following  a  strict  scientific-technical 
assessment including an independent Scientific Committee. 

In the period 2012 – 2020, the Directive was amended 17 times to address newly identified 
chemical risks and to revise limit values for chemicals such as chromium VI, lead, phenol, 
bisphenol A. The list of the amendments so far adopted is presented in section 8 below. 

5.  TOY SAFETY STANDARDS 

As described above the Toy Safety Directive establishes the mandatory ‘essential’ health 
and safety requirements  for toys. However it does  not  translate those requirements into 
detailed specifications for testing toys. These are provided by toy safety standards that are 
thus ‘supporting’ the Directive. 

For example, ‘[t]oys, which are clearly intended for use by children under 36 months, and 
their component parts and any of their detachable parts must be of such dimensions as to 
prevent their being swallowed or inhaled. This also applies to other toys which are intended 
to be put in the mouth, and to their component parts and any of their detachable parts.’210 
In short, toys for children under 36 months (who take ‘everything’ in their mouth) and toys 
intended to be put in the mouth (such as a toy flute) must not be or release small parts on 
which a child can choke. 

Standard EN 71-1 supports this requirement of the Directive by setting specifications how 
to test such toys: Any small part must not fit in the ‘small parts cylinder’,211 which has the 
dimensions of a small child’s throat. Even more, the standard also specifies that a toy for 
children  under  36 months  must  not  break  off  into  small  parts  when  it  is  dropped  or 
compressed, or when someone is trying to pull off or twist off a part of the toy. 212 The 
standard  thus  sets  the  detailed  specifications  for  testing  a  toy  against  the  Directive’s 
requirements. 

European standards are developed by recognised European Standardisation Organisations 
(ESOs): CEN,213 CENELEC,214 and ETSI.215 If developed following a request from the 
European  Commission,  the  resulting  standards  are  called  European  ‘harmonised’ 
standards. 

If a standard’s specifications are considered sufficiently strict so that they indeed support 
the Directive, the Commission publishes a reference to the standard in the Official Journal. 
With  such  publication,  a  toy  that  complies  with  the  specifications  of  the  standard  is 
presumed to be in conformity with the Directive, and thus to be safe. It will therefore be 

210 Annex II, Part I, point 4 (d) of the Toy Safety Directive 2009/48/EC. 
211 Standard EN 71-1:2014+A1:2018, clause 5.1 a). 
212 Standard EN 71-1:2014+A1:2018, clause 5.1 b). 
213 European Committee for Standardization. https://www.cen.eu/Pages/default.aspx  
214 European Committee for Electro-technical Standardization. https://www.cenelec.eu/  
215 European Telecommunications Standards Institute. https://www.etsi.org/  

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hardly possible for any market surveillance authority to restrict or ban the marketing of 
such a toy. 

The use of European harmonised standards is voluntary, including for toys. Manufacturers 
can  refer  to  harmonised  standards  to  demonstrate  that  their  products  comply  with  the 
relevant  EU legislation. Even more so,  when toys are manufactured in  conformity  with 
European  harmonised  standards,  the  references  of  which  have  been  published  in  the 
Official Journal of the EU (OJEU), they are presumed to comply with the essential safety 
requirements of the Toy Safety Directive that are covered by those standards. Due to those 
toys  being  presumed  to  comply,  and  thus  presumed  to  be  safe,  hardly  any  market 
surveillance authority will restrict the marketing of such a toy. 

Since  1 December  2018  the  references  of  harmonised  standards  are  published  in,  and 
withdrawn from, the Official  Journal  of the European Union by means of 'Commission 
implementing decisions'. The latest list of 11 European harmonised standards on toy safety 
referenced in the Official Journal216 is below: 

Toy  safety  standards,  the  references  of  which  have  been  published  in  the  Official 
Journal 

No 

Reference of standards published in the Official Journal 

1.    EN  71-1:2014+A1:2018  Safety  of  toys  –  Part  1:  Mechanical  and  physical 

properties 

2.    EN 71-2:2020 Safety of toys – Part 2: Flammability 
3.    EN 71-3:2019+ A1:2021 Safety of toys – Part 3: Migration of certain elements 
4.    EN 71-4:2020 Safety of toys – Part 4: Experimental sets for chemistry and related 

activities 

5.    EN  71-5:2015  Safety  of  toys  –  Part  5:  Chemical  toys  (sets)  other  than 

experimental sets 

6.    EN 71-7:2014+A3:2020 Safety of toys – Part 7: Finger paints – Requirements 

and test methods 

7.    EN 71-8:2018 Safety of toys – Part 8: Activity toys for domestic use 
8.    EN 71-12:2016 

Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances 
Informative note: The limit values in point (a) of Table 2 of clause 4.2 of standard 
‘EN 71-12:2016 Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable 
substances’ are lower than the limit values to be complied with set in point 8 of 
part III of Annex II to  Directive 2009/48/EC.  In particular those values are as 
follows: 
Substance 

Standard EN 71-12:2016  Directive 2009/48/EC 

N-nitrosamines 

0,01 mg/kg 

0,05 mg/kg 

216  Commission Implementing Decision (EU) 2021/1992 of 15 November 2021 on harmonised standards for 
toys drafted in support of Directive 2009/48/EC of the European Parliament and of the Council, OJ L 
405, 16.11.2021, p. 14  http://data.europa.eu/eli/dec_impl/2021/1992/oj 

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N-nitrosatable 

0,1 mg/kg 

1 mg/kg. 

9.    EN 71-13:2021 Safety of toys — Part 13: Olfactory board games, cosmetic kits 

and gustative games 

10.   EN 71-14:2018 - Safety of toys — Part 14: Trampolines for domestic use 
11.   EN IEC 62115:2020 

Electric toys — Safety 
EN IEC 62115:2020/A11:2020 

6.  CONFORMITY ASSESSMENT 

Before  placing  their  toys  on  the  Union  market,  manufacturers  must  carry  out  a  safety 
assessment of the toy, to determine the risks that the toy may present as well as the essential 
requirements of the Toy Safety Directive that are applicable to it. This safety assessment 
also includes an assessment of the chemical substances in the toy and the risks they may 
present. This assessment must be documented in the technical documentation drawn up by 
the manufacturer; this document being of a commercially sensitive nature, is not provided 
to any economic operator in the distribution chain (for example, it is not to be provided to 
the importer or distributor) but  only to market  surveillance authorities upon a  reasoned 
request, and only the parts of the documentation related to that request217. The conformity 
assessment of the toy is then mostly done by internal checks of the manufacturer. 

Conformity assessment in the Toy Safety Directive is based on Decision No 768/2008/CE. 
The  essential  objective  of  a  conformity  assessment  procedure  is  to  demonstrate  that 
products placed on the market conform to the requirements expressed in the provisions of 
the  relevant  legislation.  This  Decision  contains  a  number  of  conformity  assessment 
modules to be used EU product legislation, enabling the legislator to choose a procedure 
from the least to the most stringent, in proportion to the level of risk involved and the level 
of safety required. The least onerous modules should be selected taking into account the 
type of products and hazards involved, the impact on the protection of public interests, the 
economic infrastructure of the given sector, the methods of production, etc. Conformity 
assessment must not be confused with market surveillance, which consists of checks by 
the national market surveillance authorities after the product has been placed on the market. 
However  both  techniques  are  complementary  and  equally  necessary  to  ensure  the 
protection of the public interests at stake and the smooth functioning of the internal market. 

Conformity  assessment  under  the  Toy  Safety  Directive  is  to  be  carried  out  by  the 
manufacturer  or  by  a  third  party  –  a  ‘Notified  Body’  test  laboratory  that  has  been 
previously  recognised  for  its  quality  both  at  national  and  EU  level.  In  any  case, 
manufacturers remain responsible for the safety of the product also after it has been placed 
on the market. 

There are two possible conformity assessments allowing toys to be sold in the EU. The 
manufacturer has to demonstrate the compliance of a toy: 

  either  via  self-verification  by  exclusively  using  referenced  harmonised  European 

standards; 

217  See  the  Blue  Guide  on  the  implementation  of  EU  product  rules  https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=OJ:C:2022:247:TOC 

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  or by third party verification through a Notified Body. This procedure applies when 
existing  referenced  harmonised  standards  do  not  cover  all  relevant  safety 
requirements,  or  when  the  toy  manufacturer  has  not  applied  or  only  partly  applied 
referenced harmonised standards, or when a referenced harmonised standard has been 
published  with  a  restriction,218  or  when  the  toy  manufacturer  considers  that  the 
characteristics of the toy require a third party verification. 

It is the manufacturer, whether established in the EU or outside the EU, who decides which 
of these two procedures is appropriate for him to follow. Evidence from Notified Bodies 
suggests  that  around  97%  of  toys  in  the  EU  market  are  subject  to  the  self-verification 
procedure. 

By  way  of  comparison  with  a  non-EU  regulatory  framework,  the  USA  requires  a  third 
party conformity assessment for any toy placed on the market in the USA. The only study 
identified in the desk research for this evaluation compares the US third party conformity 
assessment  with  the  EU  self-verification  assessment.219  The  study  concluded  that  third 
party conformity assessment leads to a much lower number of market restriction measures 
on toys than the EU self-verification assessment. However, this conclusion does not take 
account of the intensity of market surveillance in the EU which, according to the study, is 
higher in the EU than in the USA. 

7. 

IMPLEMENTATION AND STATE OF PLAY 

The 2009 Toy Safety Directive has been transposed by all Member States, although such 
transposition was not notified within the deadline by some of them. Following the failure 
by several Member States to timely notify the Commission about national transposition 
measures  before  the  January  2011  deadline,  the  Commission  opened  15  non-
communication  cases,  but  all  of  them  were  closed  before  the  end  of  2011,  once 
transposition had been completed and notified.220 The data in the European Commission 
database on infringements show that, except for a few delays in the transposition of the 
Directive in the member States’ legislations, there have not been major problems in the 
transposition of the Directive and of its amendments into national legislation leading to the 
opening of infringement proceedings. 

However, there have been cases of Member States going beyond the requirements of the 
Toy Safety Directive. For example, in 2011 Germany submitted an application to obtain 
the  authorisation  to  maintain  its  (stricter)  national  provisions  on,  among  others, 
nitrosamines  and  nitrosatable  substances.  Germany  based  its  request  on  the  need  of 
protection  of  human  health.  In  support  of  the  request,  the  German  authorities  provided 
detailed justifications including scientific studies on the health assessment of the concerned 
substances. The Commission acknowledged in a 2012 Decision221 that the limit values for 

218 A restriction may change or invalidate certain specification(s) in the standard referenced. 
219 Larson DB, Jordan SR (2018) Playing it safe: toy safety and conformity assessment in Europe and the 
United States. Sage journals.  https://journals.sagepub.com/doi/full/10.1177/0020852317747370  
220 Commission Staff Working Document – Situation per Member State Accompanying the document Report 
from the Commission 29th Annual report on monitoring the application of Community law [COM(2012)714 
final] [SWD(2012)399 final], p.50.  
https://ec.europa.eu/info/publications/2011-commission-report-monitoring-application-eu-law_en 
221 Commission Decision 2012/160/EU. OJ L 80, 20.3.2012, p. 19. 
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1495625630954&uri=CELEX:32012D0160  

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nitrosamines222 requested by Germany were justified for a part of the toys covered by the 
Toy  Safety  Directive  limits,  due  to  a  ‘major  need  of  protection  of  human  health.’  The 
Decision thus allowed Germany to keep its lower, stricter national limits. 

Member  States  are  required  to  appoint  competent  authorities  responsible  for  the 
implementation  of  the  Directive  at  national  level  and  for  ensuring  that  the  Directive  is 
effectively enforced within their territories. As such, they are also responsible for market 
surveillance,  including  penalties.  In  addition  to  that,  they  appoint  and  monitor  Notified 
Bodies who assess and certify compliance with the Toy Safety Directive when requested 
to do so. 

At  EU  level,  the  European  Commission  is  organising  meetings  of  Member  States 
representatives and other stakeholders in order to support the effective implementation and 
application  of  the  Directive  through,  amongst  others,  sharing  of  information  and  best 
practices, or addressing potential issues and barriers that could arise: 

  The  Toy  Safety  Committee  is  responsible  for  assisting  the  Commission  in  the 
implementation  of  the  Directive,  notably  in  the  adoption  of  implementing 
measures.  The  possibility  to  adopt  such  measures  is  provided  in  the  Toy  Safety 
Directive  for  the  update  of  certain  provisions  of  the  Directive  to  technical  and 
scientific developments via the regulatory procedure with scrutiny.223 

  The Expert Group on Toys Safety224 is the setting for EU Member States, EEA-
EFTA  countries,  Switzerland,  Candidate  Countries,  stakeholders  and  the 
Commission. It assists in the consistent implementation of legislation on toy safety 
across the EU and provides advice on the preparation of new legislative proposals 
and policy initiatives. The Expert Group also develops guidance material. Its sub-
group on Chemicals has been a forum for discussion between representatives of 
Member  States  on  chemicals  of  concern  and  assists  the  Expert  Group  in  the 
preparation of amending directives setting (stricter) limit values for chemicals. 

  The  Administrative  Cooperation  (AdCo)225  group  brings  together  the  national 
market surveillance authorities responsible for enforcing the Toy Safety Directive. 
It  enables  the  cooperation  and  exchange  of  information  on  market  surveillance 
issues, including the discussion of 'grey zone' classification problems (toy or not, 
toy for children under 36 months of age or for older children, etc.). 

  The co-ordination group of Notified Bodies under the Toy Safety Directive, known 
as NB-Toys, is a forum for the exchange of experience between Notified Bodies. 
It meets twice a year in order to harmonise their practices through the adoption of 
guidance documents, also known as Recommendations and Protocols, to help them 
fulfil their tasks.226 They are applied by the Notified Bodies on a voluntary basis. 

222 ‘Nitrosamines’ is here understood to mean ‘nitrosamines and nitrosatable substances’. 
223 See Articles 46 and 47 of the Toy Safety Directive. 
224 Register of Commission Expert Groups and other similar entities. 
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360 
225 The Toys-AdCo is the closed session of the Expert Group on Toys Safety (E01360) and comprises only 
market surveillance authorities. 
226 Recommendations and Protocols under the Toy Safety Directive are available at 
https://ec.europa.eu/growth/sectors/toys/safety/guidance_en  

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Industry 

Another important mechanism supporting the implementation of the Toy Safety Directive 
the  European 
is  European  standardisation. 
standardisation  organisations  (CEN,  CENELEC)  together  with  Member  States  and 
consumer organisations have developed so far 11 harmonised European standards (hENs) 
which  have  been  referenced  in  the  Official  Journal  and  thus  give  presumption  of 
conformity  and  therefore  facilitate  the  implementation  of  the  Toy  Safety  Directive.227 
Harmonised  standards  translate  the  essential  safety  requirements  of  the  Toy  Safety 
Directive into detailed technical specifications for a large range of toys.  

representatives  active 

in 

8.  AMENDMENTS TO THE TOY SAFETY DIRECTIVE 

To adapt the safety requirements on chemicals in toys to the latest technical and scientific 
developments, the Commission can amend certain parts of the Directive. The following 
amendments have so far been made: 

1)  June 2021: Adoption of specific limit values for aniline in toys intended for children 
under 36 months and in other toys intended to be placed in the mouth (Commission 
Directive (EU) 2021/903) 

2)  December 2020: Addition of 50 allergenic fragrances which are subject to labelling 

requirements in toys (Commission Directive (EU) 2020/2088) 

3)  December 2020: Prohibition of 3 additional allergenic fragrances in toys (Commission 

Directive (EU) 2020/2089) 

4)  November 2019: Adoption of specific limit values for the monomer and preservative 
formaldehyde in toys intended for children under 36 months and in other toys intended 
to be placed in the mouth (Commission Directive (EU) 2019/1929)  

5)  November  2019:  Revision  of  the  migration  limits  for  aluminium  (Commission 

Directive (EU) 2019/1922) 

6)  May  2018:  Revision  of  the  specific  limit  value  for  chromium  VI   (Commission 

Directive (EU) 2018/725) 

7)  May 2017: Revision of the specific limit value for the monomer bisphenol A in toys 
intended for children under 36 months and in other toys intended to be placed in the 
mouth (Commission Directive (EU) 2017/898)  

8)  May 2017: Adoption of specific limit values for the monomer and preservative phenol 
in toys intended for children under 36 months and in other toys intended to be placed 
in the mouth (Commission Directive (EU) 2017/774)  

9)  March  2017: Revision  of  the  migration  limits  for  lead  (Council  Directive  (EU) 

2017/738)  

10) November  2015: Adoption  of  specific 

the  preservatives 
chloromethylisothiazolinone  (CMI),  methylisothiazolinone  (MI)  and  CMI  and  MI 
mixed together in a ratio of 3 to 1 (CMI/MI 3:1) in toys intended for children under 
36 months and in other toys intended to be placed in the mouth (Commission Directive 
(EU) 2015/2117)  

limit  values 

for 

11) November  2015:  Adoption  of  a  specific 

the  preservative 
benzisothiazolinone (BIT) in toys intended for children under 36 months and in other 
toys intended to be placed in the mouth (Commission Directive (EU) 2015/2116)  
12) November 2015: Adoption of a specific limit value for formamide in toys intended for 
children  under  36  months  and  in  other  toys  intended  to  be  placed  in  the  mouth 
(Commission Directive (EU) 2015/2115)  

limit  value  for 

227 https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/toys_en  

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13) June  2014:  Additional  permitted  use  of  the  CMR  substance  nickel  (Commission 

Directive 2014/84/EU)  

14) June 2014: Adoption of a specific limit value for the monomer bisphenol A in toys 
intended for children under 36 months and in other toys intended to be placed in the 
mouth (Commission Directive 2014/81/EU)  

15) June  2014:  Adoption  of  specific  limit  values  for  the  three  flame  retardants  TCEP, 
TCPP  and  TDCP  in  toys  intended  for  children  under  36  months  and  in  other  toys 
intended to be placed in the mouth (Commission Directive 2014/79/EU)  

16) July 2013: Revision of the migration limits for barium (Commission Regulation (EU) 

No 681/2013)  

17) March 2012:  Revision of the migration limits  for cadmium  (Commission Directive 

2012/7/EU) 

9.  ENFORCEMENT OF THE TSD: MARKET SURVEILLANCE 

The  TSD  imposes  responsibilities  on  various  economic  operators  along  the  toy  supply 
chain and on competent national authorities. By way of overview, the relevant obligations 
of economic operators are as follows: 

  Toy  manufacturers  are  exclusively  responsible  for  conducting  a  complete 
conformity assessment of their toys before placing them on the market (Articles 4 
and  18  TSD).  This  is  done  either  through  a  self-verification  procedure  if 
harmonised European standards are used, (Article 19 TSD) or through a third-party 
assessment by a notified body (Article 20 TSD). 

  Toys’ importers have the responsibility to  ensure that the imported toys  comply 
with the relevant EU rules and that the necessary conformity assessment has been 
conducted (Article 6 TSD). 

  Toys’ distributors have the responsibility to ensure that the toys have the necessary 

conformity marking and accompanying documentation (Article 7 TSD). 

Market surveillance is carried out for the TSD in line with Regulation 2019/2020 on market 
surveillance.  The  competent  national  authority  (market  surveillance  authority)  must 
organise  and  perform  the  surveillance  of  the  market  within  its  jurisdiction  (Chapter  VI 
TSD). This includes testing toys, verifying toys’ documentation, ordering withdrawals and 
recalls of toys from the market if they present a safety risk and other tasks. 

Market surveillance authorities have to perform appropriate checks on an adequate scale 
of products made available online and offline (Article 11(1)(a) and 11(3) of Regulation 
(EU) 2019/1020). For market surveillance to be efficient, a risk-based approach has to be 
followed (Article 11(3) of Regulation (EU) 2019/1020). Resources should be concentrated 
where  risks  are  likely  to  be  higher  or  non-compliance  more  frequent.  The  risk-based 
approach  should  take  into  account  aspects  of  products  (level  of  potential  hazards,  non-
compliance and associated risks; occurrence on the market), economic operators (activities 
and operations, past record of non-compliance) and information about both received from 
other actors (such as border control authorities, consumer complaints, media) as well as 
other sources that might indicate non-compliance such as incidents and accidents.  

Market surveillance authorities do not necessarily check all the possible requirements on, 
or all properties of, a product. Usually, only some of these requirements and properties are 
selected for inspection.  

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Checks  by  market  surveillance  authorities  may  include  inter  alia:  —  conducting  online 
inspections;  —  visiting  commercial,  industrial  and  storage  premises;  —  visiting,  if 
appropriate, work places and other premises where products are put into service; requesting 
necessary  information;  and  —  taking  samples  of  products,  and  to  subject  them  to 
examination and testing.  

The first level of control comprises documentary and visual checks, for example regarding 
the CE marking and its affixing, the availability of the EU declaration of conformity, the 
information accompanying the product and the correct choice of conformity assessment 
procedures.  In  the  case  of  online  checks,  the  first  level  of  control  is  checking  the 
information  available  on  the  website  where  the  product  is  offered  for  sale,  potentially 
followed  by  requesting  compliance  documentation  or  acquiring  the  product  for  further 
inspection. More in-depth checks may, however, be necessary to verify the conformity of 
the product, for example regarding the correct application of the conformity assessment 
procedure, the compliance with the applicable essential requirements, and the contents of 
the EU declaration of conformity. Especially when there are sufficient reasons to believe 
that a product presents a risk, market surveillance authorities carry out an evaluation in 
relation  to  the  product  concerned  covering  the  requirements  of  the  relevant  Union 
harmonisation legislation. 

Where,  having  performed  an  evaluation,  a  market  surveillance  authority  finds  that  a 
product is non-compliant or that a product is compliant but presents a risk to the health or 
safety of persons or to other aspects of public interest protection, it has to follow a sequence 
of procedures aimed at ensuring that appropriate and proportionate action is undertaken 
across the EU. These procedures are laid down in Articles 16, 18, 19 and 20 of Regulation 
(EU) 2019/1020 and, for a large part, in more detail in the TSD, in line with the safeguard 
procedures laid down in Articles 42 and 43 of the TSD. 

9.1.  Enforcement in online sales  

The adoption of the Regulation 2019/1020 on market surveillance228 is expected to lead 
to  stronger  and  more  consistent  checks  on  products  by  national  market  surveillance 
authorities across the EU. In particular, toys as products with a high risk of non-compliance 
can only be placed on the EU market if there is an economic operator (i.e. manufacturer, 
importer,  authorised  representative  of  these  toys  or  the  fulfilment  service  provider) 
established in the EU and responsible for a number of tasks in relation to the compliance 
of the toy (Article 4 of the Market Surveillance Regulation).  

The inclusion of fulfilment service providers in the scope of Regulation 2019/1020 closes 
a  significant  gap  that  had  emerged  in  market  surveillance  due  to  the  development  of 
business models supporting e-commerce, in particular the growing importance of online 
platforms. However, currently, the gaps in the coverage of the supply chain of toys persist 
as various online intermediaries enabling sales of toys in the EU are not yet included in the 
surveillance mechanism. This would change once two legal acts recently adopted become 
applicable: the General Product Safety Regulation and the Digital Services Act. 

228 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 of 25.06.2019. 

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The General Product Safety Regulation (GPSR) 2023/988 will replace the GPSD.229 The 
GPSR is designed to be a safety net, just like the GPSD, and it will apply to the toys as 
long as there are relevant aspects not covered by the TSD (Article 2 GPSR). The GSPR 
will  considerably  enhance  the  safety  of  products,  especially  by  introducing  new  rules 
applicable to the products (including toys) sold online; these provisions will apply to all 
consumer products, including toys. 

Article 19 GPSR lists minimum information requirements for the products sold online or 
other means of distance sales, which includes any warning or safety information that must 
accompany those products in accordance with the applicable legislation. This will include 
all  safety  information  on  the  toys  sold.  To  enable  such  information  provision,  online 
marketplaces must design and organise their interface so that this mandatory information 
can be provided by the trader. To effectively and efficiently inform consumers about any 
safety  issues  with  the  products  they  purchased,  the  GPSR  introduces  an  obligation  for 
economic operators to notify all affected consumers that they can identify of the safety 
issues. To this end, economic operators can make use of the personal data they collect on 
consumers. 

Chapter VI GPSR contains a new set of rules on the Safety Gate rapid alert system and 
how notifications should be exchanged via it. Importantly, Article 25 GPSR also states that 
the European Commission shall maintain a Safety Business Gateway – a web-based portal, 
through  which  economic  operators  can  inform  consumers  (and  competent  authorities) 
about product safety issues. In this way, economic operators shall inform consumers about 
safety accidents. 

Under Article 22 (4) GPSR, market surveillance authorities shall have the power to order 
online marketplaces to “remove specific illegal content referring to a dangerous product 
from its online interface, to disable access to it or to display an explicit warning to end-
users  when  they  access  it”.  Furthermore,  online  marketplaces  shall  take  into  account 
regular information on dangerous products received via the Safety Gate and apply their 
voluntary content management measures to them.  

The  GPSR  complements  both  the  TSD  and  other  relevant  legislation  by  strengthening 
product safety rules in relation to online sales, which is the way of product acquisition that 
has  grown  considerably,  especially  due  to  the  pandemic.  Whilst  online  sales  via 
marketplaces have grown exponentially in recent years (see analysis of market size and 
structure which includes estimates), a further major trend relates to the Direct to Consumer 
(D2C) element whereby producers in the EU and third countries sell products directly to 
consumers without the need for an importer, distributor or other intermediary, such as an 
online platform.  

The new rules seem to be well designed to improve consumer information both before the 
purchases and after if a product safety issue comes to the fore. The new rules add more 
channels for communication between consumers and economic operators and economic 
operators and competent authorities.  

229 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 European Parliament and of the Council and 
Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC 
of the European Parliament and of the Council and Council Directive 87/357/EEC. 

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These provisions of the GPSR are complementary to the provisions of the proposed Digital 
Services Act (DSA)230 that will apply to online platforms of various kinds and to different 
types  of  online  content.  In  particular,  according  to  Recital  12  DSA,  the  term  “illegal 
content” shall be understood as information – disregarding its form – relating inter alia to 
illegal  products  (for  instance,  textual  descriptions  and  images  of  toys  do  not  have  the 
required CE marking). Concerning illegal products – namely such that do not comply with 
the  relevant  EU  or  national  legislation  –  several  additional  obligations  are  imposed  on 
online platforms.  

9.2.  Customs controls 

The  TSD  requires  enforcement  as  a  prohibition  and  restriction  at  entry  from  the  EU 
customs territory. Such enforcement of the current TSD is carried out within the framework 
of Regulation 2019/1010 on market surveillance.  

All  products  made available on the Union market  must comply with  the applicable EU 
legislation,  irrespective  of  their  origin.  The  most  effective  approach  to  prevent  non-
compliant  products  or  products  presenting  a  risk  from  entering  the  EU  is  to  carry  out 
controls during the import process, before the products are released for free circulation and 
can subsequently circulate within the European Union. Thus, the authorities in charge of 
the control on products entering the Union market (mostly, though not always, customs 
and therefore hereafter referred to as ‘border authorities’) play a crucial role in carrying 
out first-line controls on the compliance and the absence of risks on products originating 
from third countries (hereafter referred to as ‘border controls’). 

9.2.1.  Role of border authorities  

Border authorities may be the customs authorities of a Member State, market surveillance 
authorities  or  other  entities  depending  on  the  national  organisational  structure  (Article 
25(1) of Regulation (EU) 2019/1020). In most countries, border controls are carried out by 
customs authorities. However, customs officials usually do not have the technical expertise 
to decide on compliance with the applicable EU product legislation: for this, they have to 
refer  suspicious  cases  identified  in  their  controls  to  the  competent  market  surveillance 
authorities.  Border  controls  therefore  require  close  cooperation  between  customs  and 
market  surveillance  authorities  in  order  to  be  effective.  When  the  border  authority  is  a 
market  surveillance  authority,  it  can  carry  out  its  tasks  autonomously  in  its  fields  of 
competence  and  does  not  have  to  interact  with  another  authority  in  order  to  reach 
conclusions.  

9.2.2.  Principles of border controls  

Border  authorities  perform  controls  on  imported  products  regardless  of  their  means  of 
transport (sea, air, road, rail, inland waters) or shipment (containers, small packages and 
any other form). They perform such controls on the basis of risk analysis in accordance 
with the Union Customs Code. Where relevant, they should also consider the risk-based 
approach  required  from  market  surveillance  authorities  by  Article  11(3)  of  Regulation 
(EU)  2019/1020  (Article  25(3)  of  Regulation  (EU)  2019/1020).  Border  authorities  and 
market  surveillance  authorities  should  regularly  exchange  risk  information  in  order  to 
increase the effectiveness of their risk analysis and the risk-based approach. In particular, 
market surveillance authorities are required to provide border authorities with information 

230  Regulation  (EU)  2022/2065 of  the  European  Parliament  and  of  the  Council  of  19  October  2022 on  a 
Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act)  

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on the categories of products and economic operators that are more often found to be non-
compliant  (Article  25(5)  of  Regulation  (EU)  2019/1020).  This  information  should  be 
regularly updated.  

Border authorities may perform documentary or physical checks, and may also carry out 
laboratory checks. They may always contact the declarant or another relevant economic 
operator  to  request  documents  or  additional  information.  The  conditions  for  detailed 
controls, such as laboratory checks, can be agreed between customs authorities and market 
surveillance  authorities,  taking  into  account  the  working  method  they  consider  most 
efficient. Customs and market surveillance authorities should in any case work in close 
cooperation with each other.  

The release for free circulation shall not be deemed to be proof of conformity with Union 
law (Article 27 of Regulation (EU) 2019/1020), since such a release does not necessarily 
include  a  complete  check  of  compliance.  Thus,  even  if  released  for  free  circulation, 
products may later be checked by market surveillance authorities and can be found non-
compliant. 

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ANNEX 7: TOYS MARKET 

Market research estimates place the size of the global toys industry in the range of EUR 
86-109 billion in sales in 2019, growing from around EUR 81.7 billion in 2016.231,232 As 
detailed further below, the European toys market achieved turnover of at least EUR 8.3 
billion in 2019, increasing from EUR 7 billion in 2016. For 2019, this placed the European 
share of the global toys market at 7.6 - 9.7%, representing a significant decrease from the 
28%  market  share  calculated  for  2011  in  the  context  of  the  2013  study  on  the 
competitiveness  of  the  European  toy  industry.  However,  given  missing  data  within 
Eurostat and  a lack of clarity  on the definitions and parameters used for the  global toy 
industry market research, this key competitiveness figure should be viewed with caution. 

This reduction in market share is supported by data on imports. In 2017, the EU was found 
to be the biggest global importer of toys with EUR 7.2 billion value of toy imports. The 
value of EU toy imports had grown by an estimated 70% during the preceding decade. The 
majority of toys imported to the EU come from Asia, with China the biggest supplier and 
the ASEAN countries, such as Thailand and Vietnam, increasing the volume of exported 
toy products.233 The ASEAN countries are the third biggest toy exporters globally after 
China and Europe.234 

Overview of the European toys industry  

Overall, the data show that, since the Study on the Competitiveness of the European Toys 
Industry  was  published  in  2013,  key  industry  indicators  have  experienced  some 
turbulence, but have overall shown modest growth to 2019:235 

  There has been a favourable evolution in market size over the past decade. In the 
Study on the Competitiveness of the European Toys Industry (2013), based on 2010 
data, there were around 5,300 enterprises. Although this figure was very similar in 
2016 (5,332 enterprises), the European toys industry has experienced an increase 
in the years since to an estimated 6,067 in 2019 and 6,313 in 2020. This 18.4% 
increase  has  arisen  despite  Brexit  (the  UK  also  has  a  large  toy  manufacturing 
sector) and the COVID-19 pandemic. 

  Regarding  turnover,  the  picture  is  more  static  over  the  last  decade.  Whereas 
sectoral  turnover  for  the  European  toys  market  was  EUR  7.9  billion  in  2008,  it 
dropped to just under EUR 6 billion in 2012 and 2013. By 2016, it had risen to 

and 

Small 

Journal 

Business”, 

“International 

https://www.toyassociation.org/ta/research/data/population/toys/research-and-data/data/global-sales-

231 Khajeheian, D. (2018). Market analysis, strategy diagnosis and opportunity recognition in toy industry 
[in:] 
33(2), 
Entrepreneurship 
of 
DOI:10.1504/ijesb.2018.090138, p. 221. 
232 
data.aspx 
233 Ismail, R., et al. (2020). Toy Safety in the ASEAN and European Union: A Comparative Approach [in:] 
International Journal of Innovation, Creativity and Change, vol. 10/11, online, p. 118-119. 
234 Ismail, R., et al. (2021). Towards a Framework for Establishing Children’s Toys Safety Policy in ASEAN 
[in:]  “International  Journal  of  Academic  Research  in  Business  and  Social  Sciences”,  vol.  11(3), 
DOI:10.6007/IJARBSS/v11-i3/8812, p. 894. 
235 As described further throughout, the 2020 Eurostat Structural Business Statistics (SBS) data is provisional 
and incomplete. For all indicators, this analysis presents overall figures based on available country-level data 
for the EU27 + EEA/EFTA, as well as data imputations where appropriate. As such, no figures consider data 
from the UK. 

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around EUR 7 billion before increasing further to EUR 8.5 billion in 2018 and EUR 
8.3 billion in 2019. However, as for much of the global economy, 2020 also saw a 
downturn in turnover within the EU toys industry, to around EUR 6.6 billion (based 
on provisional Eurostat SBS data). 

  Considering employment, around 53,000 persons were employed in the EU toys 
sector in 2010. This had decreased to just under 49,000 in 2016 before increasing 
to  55,150  by  2019  (a  4.1%  increase).  As  for  turnover,  and  due  to  COVID-19, 
provisional data for 2020 indicates a decrease in the number of employed persons 
in the EU toys market to an estimated 49,652 employees. 

  Turnover per enterprise, turnover per employee and employees per enterprise 
generally follow similar trends, with a decrease from 2008/2010 to 2016, before 
growth to 2018-2019 and poor performance in 2020. 

Table 7: Key indicators – European toy industry 2016-2020 (in million EUR) 

Key indicators 
Turnover 
Enterprises 
Employees 

2016 

2017 

2018 

2019 

€ 7,028 
5,332 
48,946 

€ 7,070 
5,448 
49,340 

€ 8,503 
5,826 
53,206 

€ 8,255 
6,067 
55,150 

2020 (p) 
€ 6,558 
6,313 
49,652 

Turnover per enterprise 
Turnover per employee 
Employees per enterprise 

€ 1.32 
€ 0.14 
9.18 

€ 1.30 
€ 0.14 
9.06 

€ 1.46 
€ 0.16 
9.13 

€ 1.36 
€ 0.15 
9.09 

€ 1.04 
€ 0.13 
7.87 

Over this period, a few notable market developments have emerged within the global 
toy  industry.  Most  prominently,  in  contrast  to  the  decreasing  EU  share  of  the  global 
market, the role of Chinese manufacturers has continued to grow. The influence of online 
sales and online marketplaces has significantly increased, with global online sales of toys 
estimated to have increased by an estimated 20% just in 2020-2021.236 Considering the 
types  of  toys  placed  on  the  EU  market,  market  research  reports  indicate  increasing 
popularity  of  eco-friendly  toys,  as  well  as  toys  with  digital  components  (e.g.  internet-
connected  or  AI-driven  toys).237  While  the  demand  for  innovative  digital  toys  may  be 
increasing,  European  manufacturers  interviewed  for  this  study  have  so  far  limited  their 
development of internet-connected and AI-driven smart toys. This reticence is primarily 
due  to  instances  of  toy  products  being  placed  on  the  EU  market  without  sufficient 
cybersecurity protections, thus leaving children vulnerable and impacting the reputation of 
manufacturers (e.g. My Friend Cayla doll238). 

Beyond  these  market  changes,  some  structural  characteristics  of  the  European  toy 
industry have remained similar to those identified in the 2013 competitiveness study. 
For instance:  

236 https://www.npd.com/news/thought-leadership/2021/whats-driving-online-toy-sales/  
237 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
238 Holloway, D. & Green, L. (2016).  The Internet of Toys. [in:] “Communication Research and Practice, 
Special Issue: ANZCA 2016 Creating Space in the Fifth Estate”, Vol. 2, Issue 4, (eds. Fulton, J. & McIntyre, 
P.), DOI:  10.1080/22041451.2016.1266124, p. 513. 

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  There  remains  a  strong  geographical  concentration  of  the  European  toy 
manufacturing industry both in terms of the number of enterprises, production and 
turnover.  

  However, there are some differences based on which indicator is in question. For 
instance, whereas 8 countries (PL, FR, DE, NL, CZ, ES, SK and IT) cumulatively 
account for 73.2% of all enterprises, the share of turnover is much higher in some 
countries (e.g. DE, AT) relative to their share of the number of enterprises. 

  A large proportion of European toy companies are reportedly SMEs. In 2020, the 
proportion  was  reportedly  99%  of  companies,  employing  around  two  thirds  of 
employees in the sector.239 

  Many toy manufacturing companies in Europe outsource a significant amount of 

their total production to East Asia, mainly China. 

Shortcomings in official statistics and mitigation measures 

It  is  important  to  highlight  data  gaps  and  shortcomings  in  the  quality  of  data.  The 
statistical  analysis  was  partly  hampered  by  data  gaps  in  Eurostat  SBS  data  in  some 
Member  States  and  EEA  /  EFTA  countries,  especially  for  some  variables,  such  as 
turnover and the number of people employed. In some cases, there were insufficient 
data  for  Eurostat  to  estimate  the  total  for  the  EU-27,  while  those  estimates  that  are 
available are marked as low reliability by Eurostat. The most recent year for which data 
was available was 2020 for some variables, but there were provisional estimates only 
and remained gaps.  

Regarding mitigation measures, we have focused on reporting the sum of the available 
data across the EU-27 and EEA/EFTA countries, rather than the overarching Eurostat 
EU-27  estimates.  This  allows  increased  traceability  and  analysis  between  the 
overarching figures and the country data. To ensure this is transparent, we have clearly 
stated  in  each  case  the  number  of  countries  whose  data  is  included  in  the  estimate. 
Furthermore,  where  appropriate,  data  imputations  have  been  calculated  for  certain 
missing data points based on average market changes year on year.  

1. Detailed analysis – EU statistics on the European toys industry 

Descriptive statistics on the European toys industry are now provided, drawing mainly on 
Eurostat  Structural  Business  Statistics  (SBS),  C32.4  –  Manufacture  of  games  and  toys 
(NACE Rev 2). The analysis focuses on data covering the EU-27 and EFTA countries, 
while highlighting the respective shares of leading countries in the European toys industry. 
In section 9.2.7, detailed data tables presenting disaggregation for all Member States and 
EEA / EFTA countries where Eurostat SBS data is available are provided. 

An  overview  of  the  number  of  enterprises  in  the  European  toys  industry  is  provided 
below: 

239 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 

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Table 8: No. of enterprises in the European toys industry (aggregate-level):  

TIME 

EU-27  +  EEA 
EFTA 

2016 

/ 

5,332 

2017 

5,448 

2018 

5,826 

2019 

6,067 

2020 (p) 

6,313 

Source:  Eurostat  SBS.  p  –  provisional  data,  with  some  data  imputations  developed  by 
CSES for 2019/2020 data gaps.240 

In the table above, the evolution in the number of enterprises in the European toy industry 
is shown. The number of enterprises has been progressively increasing from circa 5,332 in 
2016, to an estimated 6,313 in 2020. This data excludes the UK, meaning that the number 
of firms in the toys industry has grown irrespective of Brexit, which is interesting as the 
UK market  comprised accounted for around 600 firms in 2016, rising to around 675 in 
2017 and 2018. 

The data has also been analysed at a disaggregated data by Member State and EEA / EFTA 
country. Among the Member States that are the most significant producers of toys are:  

Table 9: Number of enterprises among leading European countries in toy production  

Member State 
Poland 
France 
Germany 
Netherlands 
Czechia 
Spain 
Slovakia 
Italy 
Others 
EU27 + EEA / EFTA 

Number 
904 
848 
683 
536 
506 
409 
398 
338 
1,691 
6,313 

% 
14.3% 
13.4% 
10.8% 
8.5% 
8.0% 
6.5% 
6.3% 
5.4% 
26.8% 
100% 

Reference year (p) 
2020 
2020 
2020 
2020 
2020 
2020 
2020 
2020 (e) 
2020 
2020 (e) 

Source: Eurostat SBS. e – data estimate; p – provisional data. 

As shown in the previous table, a significant percentage (e.g. 73.2% or 4,622 enterprises) 
of  toy  manufacturers  are  located  in  eight  Member  States.  It  can  be  observed  that  toy 
production is concentrated in Member States either with a bigger population size (e.g. FR, 
DE, ES, IT), a significant tradition in the toys industry (e.g. NL) or major manufacturing 
countries of all types of products (e.g. PL, SK and CZ).  

An overview of the turnover of the European toys industry at an aggregate level is now 
provided.  

Table 10: Turnover in the European toys industry – 2016-2020 (million EUR) 

Year 

2016 

2017 

2018 

2019 

2020 (p) 

EU-27  +  EEA  / 
EFTA 

7,028 

7,070 

8,503 

8,255 

6,558 

240 Approach to incomplete data - Data is missing in Eurostat for the following years and countries: IT (2020), 
CY (2016-2017), IE and MT (2016-2020), IS (2020), LI (2016-2020) and CH (2019-2020). Data imputations 
have been developed for IT (2020), IS (2020) and CH (2019-2020). Furthermore, all available 2020 data is 
marked as provisional by Eurostat. 

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Source: Eurostat SBS. p – provisional data.241 

Annual  turnover  was  approximately  EUR  7.03  billion  in  2016,  increasing  to  EUR  8.5 
billion  in  2018  and  EUR  8.3  billion  in  2019.  However,  2020  data  is  provisional.  A 
weakness in the data is that there are data gaps for 2016-2020 in eight Member States (DK, 
EE, IE, HR, CY, LU, MT, NL), and all four EEA/EFTA countries. Moreover, given that 
there is no data in the Netherlands, which has a significant number of enterprises in the toy 
production  sector,  turnover  could  be  considerably  under-estimated  (e.g.  by  10-15%). 
However, as illustrated by the above table, turnover for the European toys market is likely 
to be lower than in 2019 due to the pandemic, even if sales of toys shifted partially online 
(see later in this section for an analysis of online toy sales). 

Table 11: Leading European countries by turnover in the production of toys 

Million EUR 
2,608.2 
898.2 
560.1 
546.4 
453.0 
421.5 
296.3 
774.3 

Member State 
Germany 
Czechia 
Italy 
Spain 
Austria 
France 
Poland 
Others 
EU-27  +  EEA 
EFTA 
Source:  Eurostat  SBS  covering  23  countries.  p  –  all  available  data  from  2020  is 
provisional. 

Reference year (p) 
2020 
2020 
2020 
2020 
2020 
2020 
2020 
2020 

% 
39.8% 
13.7% 
8.5% 
8.3% 
6.9% 
6.4% 
4.5% 
11.8% 

100% 

6,558 

2020 

/ 

The highest turnover in 2020 has been reported by Germany, which contributed 39.8% of 
the European toy market’s overall turnover. The second biggest turnover has been reported 
by  Czechia,  which  contributed  13.7%  of  the  total,  despite  being  only  the  10th  most 
populous EU country (as of 1st January 2020). The next biggest turnovers were reported 
by Italy, Spain and Austria, followed by France and Poland. 

Interestingly,  the  comparative  analysis  of  the  number  of  enterprises  in  the  toys 
manufacturing industry operating in given countries and total turnover rates achieved by 
the local toys’ manufacturing sectors indicates the significant diversification in the patterns 
observed across European industry. For example, in Germany, the Member State where 
around 11% of toy manufacturing enterprises operate, generates proportionally almost 12 
times higher turnover per enterprise than Poland, more than twice as high as Czechia and 
Italy, and approximately three times more than Spain. Another country with high turnover 
per enterprise is Austria, hosting merely 92 toy manufacturing firms and achieving total 
turnover results similar to France, where over 9 times more toys’ producing firms operate. 
This suggests that a disproportionate number of medium to large toy manufacturers operate 
in Germany and Austria.  

In the following table, an overview of production value in billion EUR is provided. The 
data shows that production increased from circa EUR 6.7 billion to EUR 7.6 billion EUR 

241 Data is missing in Eurostat for the following countries and years: DK, IE, LU, MT, NL, LI (2016-2020); 
EE (2018-2019); HR (2016); CY (2016-2017); IS (2019-2020); NO (2018); and CH (2016, 2018-2020). As 
such, the number of countries covered by the data per year are as follows: 2016 (22); 2017 (24); 2018-2019 
(22); 2020 (23). Furthermore, all available 2020 data is marked as provisional by Eurostat. 

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by 2019, an increase of 13.4%. However, production value declined to approximately EUR 
6,229 billion in 2020. While the fact that the Eurostat data  for 2020 is provisional may 
have  an  impact,  it  is  anticipated  that  this  decline  is  primarily  due  to  the  impact  of  the 
national and EU responses to the COVID-19 pandemic on production capacities across the 
internal market.  

Table 12:  Production value of the European toys industry – 2016-2020 (in million EUR) 

Year 

2016 

2017 

EU-27 + EEA / EFTA  6,667 
Source: Eurostat SBS. p – provisional data.242 

6,776 

2018 

7,619 

2019 

7,645 

2020 (p) 

6,229 

According  to  Eurostat  data,  the  Member  States  in  the  EU-27  that  had  the  highest 
production value were as follows: 

Table 13: Production value in billion EUR in leading European countries 

Number 
2,462.7 
919.6 
597.2 
491.3 
388.9 
368.6 
269.4 
191.2 
175.6 
130.5 
234 

Member State 
Germany 
Czechia 
Italy 
Spain 
Austria 
France 
Poland 
Hungary 
Bulgaria 
Belgium 
Others 
EU-27  +  EEA 
EFTA 
Source:  Eurostat  SBS  covering  23  countries.  p  –  all  available  data  from  2020  is 
provisional. 

Reference year(p) 
2020 
2020 
2020 
2020 
2020 
2020 
2020 
2020 
2020 
2020 
2020 

% 
39.5% 
14.8% 
9.6% 
7.9% 
6.2% 
5.9% 
4.3% 
3.1% 
2.8% 
2.1% 
3.8% 

100% 

6,229 

2020 

/ 

The biggest toys' producer in Europe is Germany, which generates approximately 40% of 
total EU production value. The value generated by Germany is close to three times as large 
as that reached by the second largest manufacturing Member State in the EU – Czechia – 
and four times as big as the production value generated by Italy in third place. The next 
best performers in terms of production value are Spain, Austria, and France. 

The data for the 2016-2020 period for the ten highest performing countries indicates that 
only four countries have experienced overall increases in the production value of the toy 
manufacturing industry over that period. The biggest increase was witnessed in Poland, 
where the production value of the industry rose by 36% from 2016 to 2020, followed by 
Hungary (17% increase), Czechia (5%) and Belgium (2%). These four Member States are 
also the only countries from this group that did not experience a reduction of production 
value in 2020. 

242 Data is missing in Eurostat for the following countries and years: DK, IE, LU, MT, NL, LI (2016-2020); 
EE (2018-2019); HR (2016); CY (2016-2017); IS (2019-2020); NO (2018); and CH (2016, 2018-2020). As 
such, the number of countries covered by the data per year are as follows: 2016 (22); 2017 (24); 2018-2019 
(22); 2020 (23). Furthermore, all available 2020 data is marked as provisional by Eurostat. 

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In the remaining six countries, an overall decrease in production value was experienced 
from  2016-2020.  The  biggest  proportional  decrease  was  witnessed  in  Austria,  where 
production  value  dropped  by  around  25%  (EUR  129.8  million).  In  absolute  terms, 
Germany experienced the largest decrease, by EUR 261.9 million (around 10% of 2016 
production value).  

However,  there  is  more  nuance  within  these  overarching  figures,  primarily  driven  by 
national  responses  to  the  COVID-19  pandemic.  This  is  illustrated  by  the  following 
findings: 

 

In each year from 2016-2019, at least six of the ten highest performing countries 
reported increased production value compared to the previous year. 

  Seven of the ten highest performing countries reported higher production value in 

2019 than 2016, with increases of 33% (BG), 31% (DE) and 23% (PL). 

Contrastingly, from 2019 to 2020, six of these countries reported decreases in production 
value. These decreases vary significantly from limited reductions of around 2% in France 
and Italy to more extensive contractions of around 40% in Bulgaria, 31% in Germany, and 
20%  in  Austria.  In  total,  across  all  23  countries  where  data  is  available,  only  eight 
experienced  an  increase  in  production  value  from  2019  to  2020,  while  total  production 
value across these countries declined by around 19%. 

Regarding the number of workers employed in toy manufacturing, the sector employed 
approximately 55,150 persons in 2019, rising from around 48,946 in 2016; however, this 
figure is anticipated to have dropped under 50,000 for 2020. As for the data on number of 
enterprises, the data shows positive progression in the number of employees in the sector 
from 2016-2019, with a decrease in 2020. This is illustrated in the following table: 

Table 14: Number of persons employed in the European toys industry 

Year 

2016 

2017 

2018 

2019  

2020 (p) 

EU-27 + EEA / EFTA 
(e) 

48,946 

49,340 

53,206 

55,150 

49,652 

Source: Eurostat SBS. e – data estimate; p – provisional data243 

As was the case for data on other variables presented earlier, the data on workers employed 
is  not  complete  across  the  EU-27  and  EEA  /  EFTA  countries.244  The  available  data 
indicates approximately 13% increase in the number of employees working in the EU toys' 
manufacturing sector between 2016 and 2019. This  was followed by an  estimated 10% 
decrease from 2019 to 2020. 

The EU countries where the biggest shares of those persons employed in toy manufacturing 
have been presented in the table below: 

243 Data is missing in Eurostat for the following countries and years: DK, IE, LU, MT, LI (2016-2020); EE 
(2018-2019); FR (2020); CY (2016-2017); IS (2019-2020); and CH (2019-2020). However, data imputations 
have been developed for FR in 2020, and IS / CH in 2019 and 2020. As such, the number of countries covered 
by the data per year are as follows: 2016-2019 (25); and 2020 (26). All available 2020 data is marked as 
provisional  by  Eurostat.  Furthermore,  Eurostat  provides  overall  figures  for  the  EU-27  in  the  years  2017-
2019; however, to provide comparability with data for 2016 and 2020, we have presented our estimated  
244 There are no national datasets on no. of workers employed for DK, IE, LU, MT, LI.  Data is missing for 
2  years  /  5  years  for  CY  and  CH.  However,  unlike  for  the  turnover  data,  data  exists  for  major  producer 
countries, such as NL. 

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Table 15: Leading European countries by number of employees 

Member State 
Germany 
Czechia 
Poland 
Hungary 
Spain 
Bulgaria 
France 
Italy 
Austria 
Romania 
Others 
EU-27 + EEA / EFTA 
Source: Eurostat SBS. e – data estimate; p – provisional data 

Number 
13,353 
7,308 
4,785 
4,088 
3,397 
2,886 
2,758 
2,358 
2,218 
1,642 
4,859 
49,652 

% 
26.9% 
14.7% 
9.6% 
8.2% 
6.8% 
5.8% 
5.6% 
4.7% 
4.5% 
3.3% 
9.8% 
100% 

Reference  year 
(p) 
2020 
2020 
2020 
2020 
2020 
2020 
2020 (e) 
2020 
2020 
2020 
2020 
2020 (e) 

The largest number of employees in the European toy manufacturing industry is found in 
Germany, covering just over one quarter of all workers. The next biggest EU employment 
markets  in  the  context  of  toys  manufacturing  are  Czechia  (around  15%  of  employees), 
Poland  (~10%),  Hungary  (~8%),  Spain  (~7%),  Bulgaria,  and  France  (~6%).  Together, 
these  10  Member  States  account  for  90.2%  of  total  persons  employed  in  the  toy 
manufacturing industry in the EU-27 plus EEA / EFTA countries. 

A comparison of the number of toy manufacturing enterprises with the number of people 
employed in the industry indicates that the average number of employees per enterprise 
varies significantly across the EU. In Bulgaria, where this rate is the highest, there are, on 
average,  around  56  people  employed  per  enterprise.  Austria  averages  24  people,  while 
Germany (~20), Hungary (~17) and Switzerland (~16) all employ more than 15 people per 
enterprise. Czechia (~14), Slovenia (~13) and Cyprus (~10) all report an average of 10 or 
more employees per enterprise, while the remaining 18 countries for which comparable 
data is available employ between 0.8 and 8.3 people per enterprise. 

Interestingly, Poland and France, two of the highest performing countries in terms of the 
number  of  toy  manufacturing  firms,  turnover  and  production  value,  as  well  as  the 
Netherlands, which has the fourth highest number of toy manufacturing enterprises, have 
low enterprise to employee ratios. Poland has around 5 employees per firm, while France 
and the Netherlands have an average of 3.3 and 1.3 employees per enterprise, respectively. 
This  suggests  that,  in  these  countries,  small  and  micro-enterprises  may  play  a  more 
important role in the toy sector. 

In common with the comparison of the number of enterprises operating in a given Member 
State and the overall turnover, this analysis points to the fact that the characteristics of the 
local toy manufacturing sector vary significantly across the European market, with some 
hosting significant numbers of micro and small enterprises, compared with others where 
there are more medium and large-sized businesses (e.g. CZ, BG). 

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2. Key trends in the European toys industry 

Whilst  Eurostat  data  is  more  reliable  regarding  the  overall  size  of  the  European  toys 
industry, it is worth complementing the analysis by reviewing available market research 
reports and other literature on the industry. These provide additional estimates as to the 
industry’s size, including the speed of growth of particular national markets, and share of 
the  market  accounted  for  by  online  sales.  The  remainder  of  this  section  presents  the 
findings on these issues. 

The  European  toy  market  size  was  estimated  to  be  worth  around  EUR  20  billion  in 
2020245,  making  it  the  third-biggest  global  market  after  North  America  and  Asia.  This 
figure suggests the European market is significantly larger than the Eurostat data indicates. 
However, the definitions used by the market research reports identified for both the toys 
and the countries covered by the analysis are either unclear or differ significantly from the 
Eurostat SBS data. 

Within  the  market  research  report  identified,  the  four  most  significant  EU-27  national 
markets with highest revenue from toys in 2020 were as follows: 

  Germany: ~EUR 3.6 billion worth of revenue. 

  France: ~EUR 3.3 billion worth of revenue. 

  Italy: ~EUR 1.2 billion worth of revenue. 

  Spain: ~EUR 0.9 billion worth of revenue.  

As  for  the  overall  sales  figure,  these  estimates  are  significantly  higher  than  the  data 
provided within Eurostat SBS, suggesting differences in the types of toys covered by the 
datasets. 

Key trends in the toys market include:  

  Toy production is highly concentrated, with 96.2% of production value generated 
across ten countries and 88% of turnover concentrated in seven EU Member States 
(see earlier table).  

  Around 99% of European toy companies are SMEs, employing around two thirds 

of employees in the sector.246 

  Online sales have grown significantly, accelerated by the global pandemic, with 
one  market  research  commentator  noting  that  “the  European  toy  market 
aggressively moved online in all countries”247 (see sub-section below for further 
information). 

  Eco-friendly  toys,  as  well  as  toys  with  digital  components,  are  becoming 

increasingly popular. 

  Volume  of  sales  reportedly  decreased  slightly  in  2020;  however,  this  was 

accompanied by an increase in average prices. 

245 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
246 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
247 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 

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3. Estimates of online sales of toys in Europe 

Consumers  are  increasingly  buying  toys  online  instead  of  in  retail  stores.  For  instance, 
according to a study by a market research firm, all national markets in the EU recorded 
growth in  online toy sales in  2020-2021. At the global level,  online sales of toys were 
estimated to have increased markedly, by an estimated 20%, in 2020-2021.248  

The main drivers of increased sales of online toys are now considered:  

  Digitalisation trends, including the increase in e-commerce and role of online 
marketplaces.  In common with other types of products, there is a general trend 
towards e-commerce and click and collect away from physical stores. In the EU’s 
Market Monitoring Reports, there is an increased tendency towards e-commerce 
across a range of industry sectors, even in Member States where online transactions 
were historically less prevalent (e.g. in some Southern European and Central and 
Eastern European Member States). 

  COVID-19  pandemic.  As  a  response  to  the  pandemic,  consumers  sought 
alternative retail channels through which to purchase toys and the trend towards 
buying  toys  online  accelerated.  For  instance,  in  the  US  between  January  and 
September 2020, online sales reportedly gained 10% share points, growing from a 
23%  share  in  2019.  This  ultimately  brought  a  75%  increase  in  online  toy  sales 
overall, year-on-year. Over a similar time-period, the average 2020 traffic growth 
in online shops for the EU-27 rose by 13% in the area of ‘sporting goods, toys & 
hobbies’ in comparison to the pre-pandemic year of 2019. Based on Eurostat data, 
the authors of the European E-Commerce Report for 2021 estimated that, for the 
analysed  period  of  3  months,  online  purchases  comprised  17%  of  EU-27 
purchasing of children toys and childcare items.249 

There  is  an  apparent  correlation  between  different  geographies  within  the  EU-27  and 
online sales, with  a bigger e-commerce market  for toys  in  northern  European countries 
(e.g. Germany,  Netherlands,  and  the  Nordic  countries).  During  the  pandemic,  the  same 
countries also experienced the strongest increase in online revenues of around 50%.250 In 
southern  Europe  (France,  Spain,  Italy,  and  Portugal),  the  online  toys  market  is  still 
growing (by a reported 30-35% in 2020251), but it is smaller overall. 

This mirrors the findings in EU-funded market monitoring reports on a range of product 
markets,  as  well  as  consumer  attitudes,  where  online  sales  are  catching  up  in  southern 
Europe, but from a much lower baseline than in northern European countries. 

At a general level, there has been a major shift in purchasing trends in recent years, with 
consumers  moving  towards  e-commerce  in  search  of  time-savings  and  lower  prices. 
Overall, in the several years prior to 2020, the number of European online shoppers had 
risen by 85%, and it is now expected to reach around 36% of overall world trade in less 
than a decade.252 According to the 2021 European E-commerce Report, between 2017 and 

https://ecommerce-europe.eu/wp-content/uploads/2021/09/2021-European-E-commerce-Report-

248 https://www.npd.com/news/thought-leadership/2021/whats-driving-online-toy-sales/  
249 
LIGHT-VERSION.pdf 
250 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
251 https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-2021/ 
252 Bjerkan, K. Y., Bjørgen, A., Hjelkrem, O. A. (2020).  E-commerce and prevalence of last mile practices, 
[in:] “Transportation Research Procedia”, vol. 46, DOI: 10.1016/j.trpro.2020.03.193, p. 293. 

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2021, the share of EU-27 internet users involved in e-commerce as customers rose from 
65% to 75%.253 This growth pattern has been additionally reinforced by the impact of the 
COVID-19 pandemic, which is expected to shift EUR 650 billion of non-food spending 
towards  online  sales  by  2025,  with  20%  of  consumers  (and  42.2%  of  home-working 
consumers) permanently increasing the volume of online purchases in their daily habits.254  

The negative impact of the increasing trend in online sales in the context of the European 
toy market is that online shopping enables customers not only to purchase products directly 
from  the  websites  of  economic  operators,  but  also  from  secondary  sources,  such  as 
Amazon, AliExpress or Alibaba. This makes it much more difficult to ensure the correct 
application of the product safety requirements stipulated through EU legislation. That is, 
because many of those online purchases are made internationally from markets where the 
relevant,  precautionary  regulations  are  not  (yet)  introduced.255  However,  even  though 
online customers are able to purchase considerably cheaper products via online shopping 
platforms, it needs to be acknowledged, based on the recent study on Amazon’s practices 
connected  to  toy  sales,  that  online  shopping  platforms  might  increase  the  prices  of  the 
products they sell once they gain enough market power to do so, hence reducing the price 
difference between toys sold online and in the physical world.256 

In  addition,  through the  current  IA study, toy manufacturers, including both  SMEs and 
leading global firms were asked to estimate the percentage of their sales that were online. 
Although one large toy manufacturer noted that almost all products are available for sale 
online,  manufacturers  in  general  were  unable  to  provide  further  information  on  the 
percentage of their sales that were conducted online. 

253  Lone,  S.,  Harboul,  N.,  &  Weltevreden,  J.  W.  J.  (2021).  2021  European  E-commerce  Report,  online: 
https://www.cmihva.nl/wp-content/uploads/2021/09/EuropeanEcommerce-Report-2021.pdf, p. 13. 
254  Metapack  (2022).  Ecommerce  Delivery  Benchmark  Report  2022.  Welcome  to  the  age  of  ecommerce, 
online:https://info.metapack.com/rs/700-ZMT-
762/images/Ecommerce%20Delivery%20Benchmark%20Report%202022%20%282%29.pdf, p. 6. 
255 Negev, M. et al. (2018). Regulation of Chemicals in Children's Products: How U.S. and EU Regulation 
Impacts  Small  Markets 
the  Total  Environment”,  vol.  616-617,  DOI: 
https://doi.org/10.1016/j.scitotenv.2017.10.198, p. 469. 
256 He, L., Reimers, I., & Shiller, B. (2021) Does Amazon Exercise its Market Power? Evidence from Toys 
R Us. Online: http://dx.doi.org/10.2139/ssrn.3910636, p. 16. 

[in:]  “Science  of 

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ANNEX 8: CONCLUSIONS OF THE EVALUATION OF THE TSD257 

Toys have to be safe when children play with them. The Toy Safety Directive (Directive 
2009/48/EC) therefore lays down rules to make toys safe, including when they are exposed 
to children’s sometimes ‘unforeseeable’ behaviour. 

At the same time, the Directive ensures the successful functioning of the internal market 
for toys, worth almost EUR 20 billion a year. The toy industry is dynamic and innovative: 
around  one  third  of  the  toys  on  the  market  each  year  have  new  features  or  are  newly 
developed. 

The Toy Safety Directive had been adapted 12 times since its adoption at the time of the 
Evaluation,  resulting  most  often  in  strict(er)  limit  values  for  hazardous  chemicals  that 
might be present in toys, such as for chromium VI, lead, phenol and bisphenol A. There is 
a  focus  on  chemicals  because  knowledge  about  their  toxicity  evolves  more  often  than 
knowledge about other hazards in toys; chemicals are more often recognised to be more 
hazardous than previously known. 

The evaluation of the Toy Safety Directive assessed the functioning of the Directive since 
its entry into force. It is based on the following sources: 

  a 2015 external study evaluating the Directive; 
  online  questionnaires  addressed  to  Member  States  and  stakeholders  (a  public 
consultation and a specific consultation of economic operators on the costs caused 
by the Directive);  
the  Member  States’  reports  on  the  application  of  the  Directive  in  their  national 
territory; these are due every 5 years, covering 2009–2013 and 2014–2018; 

 

  a study on the Directive’s costs and benefits, supplied by the Commission’s Joint 

Research Centre (JRC); and  

  several  Commission  fitness  checks  and  related  studies  on  chemicals  legislation, 

insofar as they refer to toys;  

  a 2013 external report on the toy industry prepared on behalf of the Commission;  
  knowledge  and  experience  acquired  in  the  Directive’s  day-to-day  management, 

including from discussions with Member States and stakeholders. 

1.  Effectiveness 

The scope of the Toy Safety Directive is effectively defined: a toy is defined as a product 
that has a play value for children under 14 years of age, even if it may have other uses. 
Products that fall into a ‘grey zone’ of ‘toy or not a toy?’ are classified through guidance 
documents, which are continuously being updated, and email exchanges between Member 
State  authorities.  These  documents  and  exchanges  also  make  it  possible  to  distinguish 
between toys for children under 3 years of age, who are particularly vulnerable to harm 
since they regularly put objects in their mouth, and toys for older children. 

The  Directive  is  more  effective  than  its  predecessor  regarding  protecting  children  from 
chemicals in toys. This is due to a higher number of restrictions on specific (groups of) 

257  Commission  Staff  Working  Document  (2020)  287  final  –  Evaluation  of  Directive  2009/48/EC  of  the 
European Parliament and of the Council on the safety of toys 

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dangerous chemicals. However, the Directive’s effectiveness as regards the protection of 
children is limited in the following aspects that require urgent attention: 

  Under the Directive, specific limit values for chemicals can only be set for toys for 
children under 36 months of age and toys that are intended to be placed in the mouth, 
instead of for all toys. 

  The Directive makes it possible to derogate from the prohibition on using chemicals 
that are carcinogenic, mutagenic or toxic for reproduction (CMR). In particular, CMR 
chemicals may be present in toys if they do not exceed certain concentrations, which 
are  set  in  a  separate  piece  of  legislation  and  which  are  useful  to  classify  chemical 
mixtures as dangerous. The concentrations allowed however appear to be too high and 
can still pose a risk to children. 

  The  Directive  sets  limit  values  for  carcinogenic  nitrosamines  and  nitrosatable 
substances (that may convert into nitrosamines). However, a Commission Decision of 
2012 has recognised that these limit values are too high and can still pose a risk to 
children. 

  The  Directive  provides  labelling  requirements  for  specific  allergenic  substances  in 
certain ‘experimental’ toy sets. However, these requirements cannot be easily updated 
when the related lists of allergenic substances are being updated. 

For  risks  other  than  those  related  to  chemicals,  the  Directive  appears  to  be  sufficiently 
effective. There is no reason to doubt any of the non-chemical safety requirements, there 
have  been  no  discussions  about  their  application.  The  ‘small  parts  requirement’  is  an 
exception and is discussed almost permanently. It requires that toys must not be or release 
small parts that children under 36 months of age could easily swallow and choke on. Since 
the requirement is demanding in the eyes of manufacturers, some rogue manufacturers try 
to circumvent it by claiming that their toys are intended for children of 36 months and over. 
However,  guidance  documents  and  exchanges  of  views  between  market  surveillance 
authorities have so far ensured a consistent (and protective) approach in such cases. 

Standards  appear  to  effectively  support  the  requirements  of  the  Directive  through  their 
detailed  technical  specifications.  There  have  been  no  major  incidents  with  toys,  formal 
objections highlighting insufficiencies of standards have been rare, and standards newly 
adopted by the standardisation organisations can  be promptly  referenced in the Official 
Journal in virtually all cases. 

The Directive’s effectiveness as regards the enforcement of its rules appears to be only 
partially  satisfactory.  The  Directive  only  provides  for  a  general  obligation  for  Member 
States to carry out market surveillance, however detailed (and binding) EU-wide market 
surveillance  rules  have  recently  been  set  in  the  Regulation  on  market  surveillance  and 
compliance  of  products.  It  can  be  expected  that  these  detailed  rules  will  make  the 
enforcement of the Directive’s provisions more effective. 258 

The Directive's effectiveness as regards the free movement of toys was analysed by looking 
at  the  intra-EU  trade  of  toys  and  its  evolution  over  the  years,  as  well  as  stakeholder 

258 See 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, Article 2.1 (“Scope”): “This Regulation shall apply to products that are 
subject to the Union harmonisation legislation listed in Annex I (‘Union harmonisation legislation’), in so 
far as there are no specific provisions with the same objective in the Union harmonisation legislation, which 
regulate in a more specific manner particular aspects of market surveillance and enforcement. 

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feedback. The figures on intra-EU export of toys covered by the Toy Safety Directive, and 
in  particular  on  the  remarkable  increase  since  2012/2013,  suggest  that  applying  the 
Directive and all its requirements since mid-2013 did not hamper growth in this area. 

The  Directive  is  a  maximum  harmonisation  directive:  toys  that  comply  with  all  of  its 
applicable requirements can move freely and be made available throughout the EU. There 
is therefore no need for other provisions on free movement: the current provisions have 
proven to be effective in ensuring the smooth functioning of the internal market for toys. 

The Directive could possibly be more effective if it were converted into a Regulation, as 
this would free up staff in Member States working on transposing the repeated amendments 
of the Directive into national legislation,  and free up staff in  the Commission  from  the 
required transposition and conformity checks necessary to detect possible infringements. 
Moreover, since the Directive provides for maximum harmonisation of the provisions on 
toys, it leaves no room for Member States to deviate and could thus appear to be a ‘de facto 
regulation’.  

2.  Efficiency 

Complying with  the Toy Safety  Directive when it  became applicable in  mid-2009 (and 
when new chemical requirements were introduced in mid-2013) has reportedly caused one-
off  costs  to  economic  operators,  in  particular  manufacturers,  due  to  the  many  new 
requirements. These one-off costs were reported to be between 1% and 3% of turnover. 
The ongoing costs for producing toys are considered to be higher than under the previous 
Directive, since there are now more requirements to be met. 

On  the  other  hand,  costs  did  not  prevent  several  hundred  companies  from  entering  the 
market, increasing the total number of companies by some 10% between 2013 and 2017. 
– To note that 99% of the companies in the toy sector are SMEs. 

Furthermore,  the  Toy  Safety  Directive  does  not  appear  to  have  hindered  the  cost 
competitiveness of the toy industry. Profits dropped in 2009, probably due to the financial 
crisis of 2008 and perhaps also due to companies internalising some of the one-off costs. 
However the EU toy industry recovered during the following years, its turnover growing 
steadily since 2009 by a total of 16% and its profits being almost 15% higher in 2017 than 
in 2008. 

Furthermore, manufacturers are only exceptionally required to request the intervention of 
a third party (a 'notified body'), namely when producing novel toys that have hazardous 
features not covered by the existing toy safety standards, the references of which have been 
published in the Official Journal. 

Whereas the costs related to the Toy Safety Directive have been quantified to a certain 
extent, it does not appear possible to quantify the benefits due to missing data. The 2008 
impact assessment on the then-proposal for the current Toy Safety Directive already noted 
that  ‘[t]hese  benefits  cannot  be  quantified  based  on  the  available  data.’  Nevertheless, 
stakeholders  see  benefits  in  the  Directive’s  detailed  provisions,  whether  regarding  the 
definition of ‘toy’ or the roles of economic operators, because they ensure legal certainty 
and a level playing field. 

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In addition, although it is not possible to provide a quantitative balance of benefits and 
costs, some 50% of the companies and business  associations that took  part in  the 2018 
public consultation  considered the benefits  of the Toy Safety Directive to  outweigh the 
costs,  sometimes  even  by  far;  a  further  20%  of  participating  companies  considered  the 
costs proportionate to the benefits. Public authorities, consumer organisations and notified 
bodies responded that the benefits outweigh the costs even by 60% to 80% (or outweigh 
them by far). 

The efficiency of the Toy Safety Directive is limited because chemical limit values for toys 
are currently also provided in other pieces of legislation, such as REACH. This means that 
economic  operators,  Member  States’  market  surveillance  authorities  and  other 
stakeholders cannot find all applicable limit values in the Directive. 

3.  Relevance 

The requirement that all toys be safe in order to protect children – which is one of the two 
key objectives of the Toy Safety Directive – is undoubtedly still relevant, in particular in 
light  of  the  weekly  notifications  on  dangerous  toys  in  the  EU's  safety  gate  RAPEX. 
Member  States  and  stakeholders  also  confirmed  this  requirement  as  relevant.  The  Toy 
Safety Directive is, therefore, still a relevant policy measure for ensuring the safety of toys, 
in that it requires that all toys placed on the EU market comply with its safety provisions.  

However, there have been doubts about the speed with which the Toy Safety Directive is 
being  adapted  to  technical  and  scientific  developments;  this  is  in  contrast  to  the  2015 
external study, where authorities had generally confirmed the relevance of the adaptation 
mechanisms. In the 2018 public consultation, public authorities complained mostly about 
the slow adaptation process in general, compared to the rapidly evolving market. However, 
the  allegedly  slow  adaptation  progress  was  due  to  the  need  to  collect  sufficient  data  to 
ensure  the  quality  of  the  adaptation  directives,  so  that  they  could  be  resistant  to  any 
potential legal challenge, including before the WTO. 

The recent issue of the security of internet-connected toys and the related protection of 
privacy (cybersecurity) emerged as a concern: the security threats that new technologies 
(including toys) pose cannot be addressed by the Directive in force, because of its limited 
scope, which focuses on health and safety, but not on privacy and security issues. In order 
to increase the security of internet-connected toys whilst ensuring a level-playing field for 
businesses, these issues could be (and are being) addressed under the Radio Equipment 
Directive, as they are not only relevant for toys but also for other Internet of Things (IoT) 
devices for many daily-use products. Covering toy-related aspects of security and privacy 
risks separately could lead to a fragmentation of privacy and cyber security rules and thus 
undermine the internal market.  

The requirement that toys move freely in the EU market – the second key objective of the 
Toy  Safety  Directive  –  is  equally  relevant,  as  confirmed  by  a  very  large  majority  of 
Member States and stakeholders. Harmonising national requirements is crucial in order to 
eliminate any possible barriers that would stem from different regulatory systems in the 
Member States, and to ensure a level playing field for all toys placed in the EU market. 

The current data monitoring system does not seem to make it possible to clearly relate the 
Toy Safety Directive to effects on health protection or the internal market. The available 
data are often incomplete or not representative, or there are too many confounding factors. 

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As a consequence the data available did not make it possible to draw firm conclusions on 
the effects of the Toy Safety Directive, whether with regard to safety or the free movement 
of toys. Only information on implementation costs for the toy industry could be considered 
as data on the effects of the Directive, but this was collected as part of a non-representative 
consultation. 

The  Toy  Safety  Directive  provides  for  only  a  general  reporting  obligation  for  Member 
States. It does not identify the indicators and related data needs for future monitoring and 
evaluation  that  could  help  draw  a  detailed  picture  of  the  Directive's  effects  or  identify 
impediments to its functioning. The data reported are not always comparable, for example 
those on the number of non-compliant toys vis-à-vis the total number of inspections carried 
out or the total number of toys traded in each Member State. Furthermore, Member States 
are not obliged to report on their measures relating to specific (categories of) toys, novel 
toys ‘flooding’ the market, blockages of toys at the EU border, or similar matters. 

4.  Coherence 

In their daily management of the Directive, the Commission has not identified any areas 
in which the Toy Safety Directive is incoherent with other EU or national legislation, with 
the exception of the limit values for nitrosamines and nitrosatable substances (see section 
on ‘effectiveness’). Where Member States and stakeholders claimed that ‘different limit 
values for chemicals’ exist, they may have been referring to the existence of migration and 
content limit values for the same chemical, which can be  confusing but does not signal 
incoherence, and other similar situations. 

5.  EU added value 

In terms of toy safety and the creation of a large internal market for safe toys, the current 
evaluation has confirmed the EU added value of the Toy Safety Directive. In particular, 
without the Directive, Member States could set diverging limit values for chemicals, which 
would be to the detriment of the internal market. 

All  categories  of  stakeholders  highly  appreciated  the  existence  of  the  same  safety 
requirements across the EU, and companies valued the creation of a large market for toys 
and the simplification of trade as major achievements. Possibly diverging national rules 
were not considered as being more beneficial. Notified bodies in particular agreed that the 
Directive  contributes  to  streamlining  testing  and  standards,  and  public  authorities 
welcomed the harmonisation of testing and standards and the opportunity to work together 
with authorities from other Member States. 

Therefore, the Directive clearly provides EU added value by harmonising the rules on toy 
safety and facilitating the free movement of safe toys in the internal market. 

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ANNEX 9: EU CHEMICALS LEGISLATION 

1.  THE CLP REGULATION 

CLP  requires  manufacturers,  importers  and  downstream  users  to  classify  hazardous 
substances and mixtures. CLP contains rules on how to classify chemicals. A classification 
can be harmonised and applied across the EU to all duty holders. Such classification is 
adopted  at  EU  level  according  to  a  regulatory  procedure.  Where  such  harmonised 
classification does not exist, duty holders have to assess and classify according to available 
data (‘self-classification’). 

The  hazard  classification  determines,  amongst  others,  the  appropriate  labelling  and 
packaging of the chemicals in the supply chain, in particular to protect workers, consumers 
and  the  environment.  Hazard  communication  also  relies  on  notifications  of  substances 
which are self-classified by industry and included in the CLP classification and labelling 
inventory, a public database managed by ECHA. CLP also covers the notifications self-
classifications of mixtures of chemicals to poison centres, to provide adequate emergency 
health response.  

CLP focuses on the identification and classification of the intrinsic hazards of chemicals, 
i.e.  the  hazardous  effects  of  chemicals  on  human  health  or  the  environment,  and  on 
communicating them to users of chemicals and decision makers (consumers, industry and 
authorities). Identifying the intrinsic hazardous properties of substances to derive a hazard 
classification  is  the  first  step  in  assessing  chemical  risks.  The  second  step  aims  at 
quantifying at which dose the adverse effects happen, whose outcome is a reference value, 
and is currently performed outside CLP. Risk management measures are adopted under 
REACH and relevant sectorial pieces of legislation (e.g. cosmetics, toys, waste, detergents 
etc.), see Figure 7 and Figure 8 below. 

Figure 7: Steps in risk assessment and related EU regulations. Steps in dark green are based on the intrinsic 
properties of a chemical (hence covered by CLP), whereas the blue ones relate to the context of use (relevant for 
REACH and other sectorial regulations). Deliverables are displayed in bubbles.259 

259  Source:  Commission  Staff  Working  Document  -  Impact  Assessment  Report  -  Accompanying  the 
document Proposal for a 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} - {SEC(2022) 452 final} - {SWD(2022) 434 final} - 
{SWD(2022) 436 final}  

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CLP follows the  United  Nations’ Globally Harmonized System  (GHS) of classification 
and  labelling  of  chemicals  setting  up  criteria  for  classification  and  communication  of 
physicochemical,  health,  and  environmental  hazards.  GHS  is  partly  established  on  a 
“building blocks” approach, whereby each jurisdiction has the option to implement a GHS 
block into its own legislation260. So far, 83 countries worldwide implement the GHS261. 
CLP implements the GHS criteria into EU legislation, but complements them with certain 
elements from former EU legislation (Dangerous Substances Directive262 and Dangerous 
Preparations Directive263). 

Figure 8: Mapping of the pieces of legislation according to the different steps of hazard and risk assessments264 

2.  MAIN  STEPS  IN  LEGISLATING  CHEMICALS:  FROM  HAZARD  IDENTIFICATION  TO 

RISK MANAGEMENT MEASURE  

Chemical risk assessment involves the analysis of the inherent hazardous properties of a 
substance or a mixture and the extent of exposure to that substance or mixture. The human 
health and environmental risks related to exposure to hazardous chemicals are addressed 
via the hazard and risk assessment procedures and requirements set out in the different key 
pieces of the EU chemicals legislation such as the CLP, the Plant Protection Products and 
Biocidal Products Regulations, etc.  

The main steps of these procedures involve (see figure 7 above):  

 hazard identification (based on toxicity tests and other relevant information);  
 dose (concentration) – response (effect) assessment;  
 exposure assessment – exposure scenarios (based on models and measurements of the 
occurrence of the chemical);  
 risk characterisation; and  
 risk estimation.  

260 Global implementation map of GHS, September 2021.  
261 GHS Implementation, last updated 19 October 2021.  
262 Directive 67/548/EEC. 
263 Directive 1999/45/EC. 
264 Commission SWD- Impact assessment report on the revision of the CLP Regulation, see footnote 259 
above.  

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Risk management measures – which can be policy-based and/or technical in nature - are 
then decided in light of the identified hazards and/or risks. Risk management measures can 
range from (and involve a mix of) a total ban to any condition to the manufacture, use or 
placing  on  the  market  of  chemicals  (such  as  setting  emission/concentration/migration 
limits, obligations to communicate hazards and risks, labelling requirements, obligations 
to use personal protection equipment, etc.).  

3.  RISK MANAGEMENT APPROACHES  

There are two basic approaches to risk management often used in combination, in the EU 
chemicals acquis: one based on specific risk assessment (SRA) and the other one based on 
generic  risk  management  approach  (GRA).  The  main  difference  between  these  two 
approaches  is  the  point  in  time  when  the  exposure  assessment  is  considered  and  the 
specificity of the exposure assessment. For risk management based on GRA, the potential 
exposures and risks are considered generically, prior to the adoption of legislation. The 
GRA is built into the legislation in the form of an automatic trigger of pre-determined risk 
management  measures  (e.g.  packaging  requirement,  communication  requirement, 
restrictions, bans, etc.) based on the hazardous properties of the chemical, without the need 
or possibility to assess and take into account specific exposure levels for a specific situation 
or use. One could also note that even when the GRC approach is applied, a specific risk 
assessment in some cases will still be carried out including when considering a possible 
derogation from an automatically triggered measure. For example, this is the approach the 
TSD currently follows as regards any substance classified as CMR 11 categories 1A/B and 
2 which is banned from use in toys (subject to strict derogations). Similar approaches have 
been taken for active ingredients in plant protection products and biocides, in cosmetics, 
etc.  

The decision to  link particular hazard properties  (e.g. CMR, persistent  bioaccumulative 
and toxic substances (PBTs), endocrine disruptors (EDs)) to automatic risk management 
measures without the intervening step of a specific risk assessment is done on the basis of 
generic risk consideration without prejudice to performing also a full risk assessment for 
the other properties of the substances which are not linked to the related hazard properties.  

In  the  legislation  evaluated  in  the  Fitness  Check  on  chemicals  legislation  excluding 
REACH265, the generic risk consideration approach was found to be typically applied for 
the following use applications and the following substances:  

Use applications:  

 when there is a need to obtain and pass on information to enable [further/specific] risk 
assessment  or  risk  management  (e.g.  labelling  obligations  under  the  CLP,  labelling 
requirements  and  use  instructions  under  the  Plant  Protection  Products  and  the  Biocidal 
Products Regulations).  
 for use in widely dispersive or open applications which result in a significant exposure 
of humans or the environment (e.g. plant protection products).  

265 SWD(2019) 199. See section 2.1.5 

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 for use in applications where the exposure is considered to be more difficult to control 
and monitor (e.g. plant protection products).  
 for use in applications resulting in exposure of vulnerable groups (e.g. children).  
 for use to prioritise the risk assessment of certain chemicals and under certain conditions 
(e.g. food contact materials)  

Substances:  

 for substances with hazard properties that result in severe adverse effects on human health 
or the environment should exposures occur (e.g. CMRs, PBTs, EDs, chemicals with Single 
Target Organ Toxicity (STOT) properties); and  
 for substances where it is difficult/impossible to identify a safe threshold and, therefore, 
where most specific risk assessments are likely to identify risks that lead to a need for risk 
management measures (e.g. PBTs, vPvBs, respiratory sensitizers).  

On  the  other  hand,  in  the  case  of  the  specific  risk  assessment  approach,  the  exposure 
assessment  is  performed  on  a  case-by-case  basis  when  each  substance  is  risk  assessed 
under a specific legal framework. The risk management measures are triggered based on 
the outcomes of the specific risk assessment which considers the use of the substances and 
in which both the hazards and the potential specific exposure scenarios for humans and the 
environment to the hazardous substance or mixture in question are assessed at the same 
time. The specific risk assessment approach is used more widely for uses which are not 
necessarily  or  obviously  going  to  lead  to  widespread  and  difficult  to  control  exposures 
and/or where the hazard properties of a substance are of less concern. In many instances, 
individual pieces of chemicals legislation use a combination of both of these approaches. 
For example, the current TSD applies the specific risk management approach to establish 
limit values for certain substances in toys intended for children under 36 months or to be 
put in the mouth. In addition, for substances identified and classified as a CMRs categories 
1A/B and 2, the generic risk management approach is applied (such substances shall be 
banned and cannot, therefore, be used in toys subject to strict derogations). 

Overall, findings of the Fitness Check in section 5.2.7 show that both the GRC and SRA 
have  their  role  to  play  in  the  EU  chemicals  legislative  framework  and  that  the  current 
balance between the use of generic and specific risk management approaches works well, 
each under particular circumstances:  

Generic 
Approach (GRA) 

Risk 

Advantages 
Provide a clear signal to all the 
actors  involved  (enforcement 
authorities, 
and 
downstream users) on the types 
of hazardous substances which 
should be avoided 

industry 

the 

The  outcome  of 
risk 
management  decision  making 
process  is  more  predictable 
(compared to SRA) 

Drawbacks 
triggered  risk 
Automatically 
management  measures  may 
disproportionate 
lead 
to 
unintended 
and 
outcomes 
(legal  and/or  socio-economic) 
consequences  if  a  mechanism 
for derogation is absent or not 
appropriate 
of 
Potential 
triggered 
automatically 
measures 
downstream 
legislation might influence the 

consequences 

in 

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Specific 
Risk 
Assessments (SRA) 

where 

Might be more appropriate for 
substances  of  higher  concern 
and 
vulnerable 
populations  are  at  risk  and/or 
cannot  be  protected  through 
e.g. 
training  or  protection 
equipment (e.g. children under 
the Toy Safety Directive) 
Allow  more 
targeted  and 
differentiated  consideration  of 
exposures  and  thus  risks  and 
therefore  more  appropriate 
identification  of  actual  risks 
and  of 
risk  management 
measures 
Allow 
targeted 
more 
consideration  of  costs  and 
risk 
benefits 
management options 

various 

of 

debate 

scientific 

upstream 
leading to the classification 
Less 
where 
appropriate 
exposures  are  minimal  or 
would  not  occur  through  the 
route  of  exposure  of  concern 
and therefore can lead to over-
regulation 
for  non-relevant 
routes of exposure 

The  process  might  be  slower 
compared  to  GRA  and  often 
more costly 

Predictability 
risk 
management  decisions  can  be 
more difficult 

of 

Table  16:  Main  comments  received  from  stakeholders  regarding  the  GRA  and  SRA 
application in the context of the Fitness check  

Where a derogation mechanism is connected to the GRA approach (i.e. a derogation from 
e.g. an automatic restriction or ban if certain conditions are fulfilled, such as demonstration 
of negligible exposure), industry stakeholders stated that it helps to  ensure that the risk 
management  measure  stipulated  will  not  lead  to  disproportionate  costs  or  unintended 
effects e.g. regrettable substitution. 

CLP, together with other pieces of EU legislation, was evaluated in 2019266. An additional 
and  more  targeted  Fitness  Check  was  also  published  on  endocrine  disruptors267.  Those 
evaluations, identified important issues and weaknesses holding CLP back from delivering 
its full potential. These evaluations pinpointed nine potential areas of intervention: 

Introducing criteria for five outstanding new hazard classes  

Improving harmonised classification  
Improving and streamlining industry’s self-classifications  

 
  Providing harmonised reference values in addition to harmonised classification  
 
 
  Clarifying rules for hazard (physical) labelling  
 
  Reviewing the exemption of a number of chemical products from CLP  
  Addressing low compliance rate for online sales of chemicals  
  Closing notification gaps for poison centres  

Introducing digital labelling  

266 SWD(2019) 199.  
267 SWD(2020) 251.  

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Accordingly,  the  CLP  Regulation  is  currently  under  revision.  In  particular,  new  hazard 
classes will be added in the CLP Regulation for endocrine disruptors.   

4.  LINK BETWEEN THE TSD AND REACH 

REACH aims at improving the protection of human health and the environment from the 
risks  that  can  be  posed  by  chemicals,  while  enhancing  the  competitiveness  of  the  EU 
chemicals  industry.  It  also  promotes  alternative  methods  for  the  hazard  assessment  of 
substances in order to reduce the number of tests on animals.  

In principle, REACH applies to all chemical substances; not only those used in industrial 
processes but also in our day-to-day lives, for example in cleaning products, paints as well 
as in articles such as clothes, furniture and electrical appliances. Therefore, REACH has 
an impact on most companies across the EU. 

REACH  places  the  burden  of  proof  on  companies.  To  comply  with  the  regulation, 
companies must identify and manage the risks linked to the substances they manufacture 
and  market  in  the  EU.  They  have  to  demonstrate  to  the  European  Chemicals  Agency 
(ECHA)  how  the  substance  can  be  safely  used,  and  they  must  communicate  the  risk 
management measures to the users. 

If the risks cannot be managed, authorities can restrict the use of substances in different 
ways.  In  the  long  run,  the  most  hazardous  substances  should  be  substituted  with  less 
dangerous ones. 

REACH applies to a great variety of products supplied and used in the form of chemical 
substances, mixtures and articles. REACH and CLP define a substance, mixture and article 
as follows: Substance means a chemical element and its compounds in the natural state or 
obtained by any manufacturing process, including any additive necessary to preserve its 
stability and any impurity deriving from the process used, but excluding any solvent which 
may  be  separated  without  affecting  the  stability  of  the  substance  or  changing  its 
composition:  examples:  metals  (aluminium,  zinc,  iron,  chromium,  etc.),  acetone, 
phthalates, ethanol. Substances are very exceptionally classified as toys; only if they are 
supplied for example as part of a chemistry set. 

Mixture  means  a  mixture  or  solution  composed  of  two  or  more  substances:  examples: 
paint,  glue,  ink,  metal  alloys,  household  cleaners.  Certain  toys  are  considered  to  be 
mixtures, for example finger paints, modelling clay or bubble solutions.  

Article  means  an  object  given  a  special  shape,  surface  or  design  that  determines  its 
function  to  a  greater  degree  than  its  chemical  composition  does:  examples:  clothing, 
furniture, electronics and practically all objects of modern life. Most toys are considered 
to be articles under REACH. 

Some substances or mixtures which pose unacceptable risks can be totally banned on the 
EU market (e.g. asbestos), have restrictions on specific uses (e.g. phthalates in toys and 
childcare articles), or have limits on the concentration of the substance (e.g. in consumer 
products  such  as  tyres,  clothing  or  jewellery).  When  certain  uses  are  restricted  or  the 
substance is banned on the EU market, substitution is a must. Restrictions are not linked 
to the procedure of registration.  

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Restrictions are designed to manage unacceptable risks that are not addressed by the other 
REACH processes or by other EU legislation. These restrictions therefore co-exist with 
those  set  out  in  the  product  safety  and  sector  specific  legislation,  for  example,  on 
detergents,  cosmetics,  toys,  electronics.  In  order  to  ensure  a  high  level  of  protection  of 
children against risks caused by chemical substances in toys, the TSD specifies that toys 
should  comply  with  general  chemicals  legislation,  in  particular  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). By means of the TSD, these provisions are adapted to the particular needs of 
children, who are a vulnerable group of consumers.  

Accordingly,  toys  are  covered  by  REACH  and  restrictions  can  be  applied  to  them  as 
articles, for the purposes of protection of human health or the environment. In addition, the 
TSD provides for a more complete and targeted approach for toys to protect the safety and 
health of children. Coherence between the two has been assured in the past for example by 
exempting toys from a REACH restriction if the limits in the TSD were more protective. 
Around 40% of businesses or business associations and 45% of SMEs considered that the 
limit values in other pieces of legislation beyond the TSD were not problematic at all or to 
a small extent. 

Figure 9: Hazard identification and risk management in EU legislation 

A central aspect of the revision of REACH is reforming the processes of risk management 
for  both  REACH  authorisations  and  restrictions.  One  option  envisaged  especially  for 
REACH restrictions is the extension of the generic approach to risk management for which 
REACH will rely on the hazard classes in the CLP Regulation. Currently, the faster, more 
preventive  REACH  restriction  procedure  is  available  for  consumer  uses  to  substances 
classified  as  carcinogenic,  mutagenic  or  reprotoxic  under  CLP.  The  REACH  revision 
envisages  extending  this  procedure  to  some  of  the  newly  introduced  or  existing  hazard 
classes such as endocrine disruptors or PBT/vPvB substances.  

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ANNEX 10: THE MOST HARMFUL CHEMICALS CURRENTLY NOT 
ADDRESSED BY THE TSD 

1.  THE MOST HARMFUL CHEMICALS AND THEIR CONSEQUENCES ON HUMAN HEALTH 

Endocrine disruption268 

The  World  Health  Organisation  defines  an  endocrine  disruptor  (ED)  as  ‘an  exogenous 
substance  or  mixture  that  alters  function(s)  of  the  endocrine  system  and  consequently 
causes adverse health effects in an intact organism, or its progeny, or (sub)populations’.269 

Over the last 30 years, the endocrine disrupting properties of chemicals have been the focus 
of  increasing  scientific  research,  and  the  accumulated  knowledge  identifies  EDs  as  a 
concern  to  public  and  wildlife  health270.  The  high  and  increasing  incidence  of  many 
endocrine-related disorders in humans – such as asthma, birth defects, neurodevelopmental 
disorders,  cancer,  diabetes  and  obesity  in  children  and  cardiovascular  diseases,  cancer, 
diabetes and obesity, allergic and autoimmune diseases in adults – have important parallels 
in  some  wildlife  populations.  Evidence  on  the  roles  played  in  the  disease  outcomes  by 
environmental  and  other  non-genetic  factors,  including  chemical  exposure,  is  growing. 
Some links have become apparent (e.g. polychlorinated biphenyls’ exposure as a risk factor 
in breast and prostate cancers; relationships between perfluoroalkyl substances and child 
and adult obesity, impaired glucose tolerance, gestational diabetes, reduced birthweight, 
reduced  semen  quality,  polycystic  ovarian  syndrome,  endometriosis,  and  breast  cancer) 
while more research is necessary on the associations between EDs and other endocrine-
related diseases271.  

Importantly, only a small proportion of the chemicals on the market have been tested for 
endocrine  effects  and  the  disease  risk  due  to  EDs’  exposure  may  be  significantly 
underestimated272. 

268 See the Commission Staff Working Document – Impact Assessment report accompanying the Proposal 
for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 
of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on  classification,  labelling  and 
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006. 
269 International Programme on Chemical Safety. (2002). Global assessment on the state of the science of 
endocrine disruptors. World Health Organization. https://apps.who.int/iris/handle/10665/67357 
270  UNEP  State  of  the  Science  of  Endocrine  Disputing  Chemicals  -  IPCP-2012,  available  at: 
https://www.unep.org/resources/publication/state-science-endocrine-disputing-chemicals-ipcp-
2012?_ga=2.148289463.183897156.1643356524-1526509983.1643356524 
271  UNEP  State  of  the  Science  of  Endocrine  Disputing  Chemicals  -  IPCP-2012,  available  at: 
https://www.unep.org/resources/publication/state-science-endocrine-disputing-chemicals-ipcp-
2012?_ga=2.148289463.183897156.1643356524-1526509983.1643356524 
272  UNEP  State  of  the  Science  of  Endocrine  Disputing  Chemicals  -  IPCP-2012,  available  at: 
https://www.unep.org/resources/publication/state-science-endocrine-disputing-chemicals-ipcp-
2012?_ga=2.148289463.183897156.1643356524-1526509983.1643356524 

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Since 1999, the European Commission has been working on prioritising suspected EDs for 
evaluation, monitoring exposures and effects, develop and validate new testing methods 
and increase public awareness on EDs273.  

 

Identification of known or presumed EDs is required for actives substances by the 
Plant  Protection  Products  Regulation  (PPPR)274  and  for  actives  substances  and 
products  by  the  Biocidal  Products  Regulation  (BPR)275  according  to  criteria 
established, respectively, in 2017 and 2018. REACH does not contain identification 
criteria  for  EDs,  but  these  are  identified  as  substances  of  very  high  concern 
(SVHCs)  on  a  case-by-case  basis  following  the  IPCS/WHO  definition  and  the 
assessment of the “equivalent level of concern” carried out by the REACH Member 
State  Committee.  It  should  be  noted  that  the  same  definition  and  guidelines  are 
used by REACH, BPR and PPPR. 

  Sector-specific  legislation  on  toys  but  also  cosmetic  products,  medical  devices, 
food  contact  materials  or  detergents  does  not  require  the  identification  of  EDs. 
However, the use of potential endocrine disrupting substances may be subject to 
the scientific opinion of expert advisory bodies. For example, while the TSD does 
not  have  specific  provision  for  endocrine  disruptors,  it  does  ban  the  use  of 
substances that are toxic to reproduction (which may for some substances also be 
toxic via an endocrine disrupting mode of action). 

is 

there 

incomplete 

information  on 

  Because the lack of CLP on EDs is not filled by systematic identification in other 
the  human  health  and 
regulations, 
environmental hazards of these substances. It should also be noted that EDs are not 
included  at  UN  GHS.  As  substances  and  mixtures  with  ED  properties  are  not 
systematically identified and classified, this has been identified as resulting in the 
failure  to  define  risk  management  provisions  in  downstream  sector-specific 
regulations  and  directives  referring  to  CLP  hazard  classification.  Moreover, 
substances  suspected  of  having  ED  properties  may  be  assessed  multiple  times 
according  to  different  regulations,  contributing  to  the  inefficient  use  of  limited 
resources. 

The  inclusion  of  horizontal  criteria  for  the  identification  and  classification  of  EDs  was 
identified as an area for action in the EU's 7th EAP and their absence has been criticized 
by many stakeholders276277. 

Table 17 The number of substances expected to be identified as ED in the CLP Regulation 
differentiated by ED category and impact area among all substances is set out below. The 
last column shows the total number of substances identified as ED already reported above. 
As noted earlier, the impact areas used here are not mutually exclusive: in other words, 
any given substance may be counted in HH and ENV.  

273 COM(2018) 734 final.  
274  Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009. 
275 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning 
the making available on the market and use of biocidal products. OJ L 167 27.6.2012. 
276 SWD(2020) 251.  
277 SWD(2019) 199. 

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Table  17:  Estimated  number  of  substances  expected  to  be  identified  as  ED  with  categorisation  and 
differentiation by impact area 
Type of estimate 

ED Cat. 1 
HH 
Lower end (AA-1) 
334 
1,772 
Central estimate (ECHA approach)*  405 
2,145 
2,705 
510 
Upper end (AA-2) 
Notes: * Note again that ECHA only derives the ED Cat. 1 estimate and does not differentiate by impact area. 
The sum of 1012 ED Cat. 1 substance is included in ECHA (2021a), but the assignment to HH (N=405) and 
ENV (N=607) is performed in this study. 

ED Cat. 2 
HH 
374 
453 
572 

ED Total 
HH 
708 
858 
1,082 

ENV  All 
1,064 
1,287 
1,623 

ENV 
562 
680 
857 

ENV 
502 
607 
766 

Based on the total number of 23,751 unique substances in ECHA’s combined inventory, 
the central estimate of 1,012 substances identified as ED Cat. 1 represents 4.3%. Using the 
derived factor of 1.12, an additional 1,133 substances are estimated to be identified as ED 
Cat. 2 (4.8% of the combined inventory). In total, 2,145 substances (9.0%) are identified 
as ED in the central estimate. 

Overall, the high uncertainty of the estimated figures reflects the fact that the data required 
for the classification as ED (including categorisation and differentiation by impact area) 
are not yet available. It must also be stressed that – even if the estimated numbers prove to 
be close to the real numbers – they would only materialise if all necessary studies have 
been conducted for all substances. 

Human and environmental exposure to EDs — through multiple routes — is the result of 
their presence in a wide variety of products, including food packaging, pharmaceuticals, 
cosmetics  and  personal  care  products,  pesticides,  fabrics  and  upholstery,  electronics, 
plastic bottles, metal food cans, detergents and toys. EDs can mimic or interfere with the 
body’s  endocrine  system,  and  associated  effects  include  impacts  on  male  and  female 
reproduction,  breast  development  and  cancer,  prostate  cancer,  neuroendocrinology, 
thyroid, metabolism and obesity, and cardiovascular endocrinology.278 Vulnerable groups, 
such as young children, are particularly affected by exposure to EDs, which can have life-
long  impacts  and  exhibit  in  adulthood.  The  table  below  reproduces  health  outcomes 
attributable  to  exposure  to  specific  EDs  —  with  strength  of  human  evidence  and 
probability of causation — as reported by Kahn et al. (2020). 

Probability of causation 

Strength of human evidence 

Not assessed 
Not assessed 
Not assessed 

Table 18: Strength of evidence and probability of causation for outcome-exposure associations 
Outcome 
Perinatal outcomes 
Low birthweight 
Preterm birth 
Reduced anogenital distance 
Neurodevelopmental 
IQ loss and intellectual disability  Moderate to high 
Low to moderate 
Attention-deficit disorder 
Autism spectrum disorder 
Low 
Metabolic 
Childhood obesity 
Adult obesity 
Adult diabetes 

Not assessed 
Not assessed 
Not assessed 

Moderate 
Low 
Low 

70-100% 
20-69% 
20-39% 

40-69% 
40-69% 
40-69% 

278  National 
https://www.niehs.nih.gov/health/topics/agents/endocrine/index.cfm 

of  Environmental  Health  Sciences. 

Institute 

(n.d.)  Endocrine  Disruptors. 

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in 

use 

Low 

40-69% 

resulting 

Low 
Low 

in 
assisted 

40-69% 
40-69% 

resulting 
of 

20-39% 
20-39% 
0-19% 
Not assessed 
Not assessed 
Not assessed 

Low 
Low 
Very low to low 
Not assessed 
Not assessed 
Not assessed 

Reproductive outcomes 
Cryptorchidism 
testosterone, 
Low 
increased early mortality 
Male 
infertility, 
increased 
reproductive technology 
Endometriosis 
Fibroids 
Testicular cancer 
Semen quality 
Polycystic ovarian syndrome 
Breast cancer 
Notes: Kahn et al. (2020) report strength of evidence and probability of causation per specific EDs and time of exposure 
(prenatal, pregnancy, adult, lifetime). This table reproduces only the highest strength of human evidence and probability 
of causation among specific EDs and time of exposure. 
Kahn  et  al.  (2020)  is  part  of  a  series  of  papers  published  by  Trasande  and  colleagues 
starting in 2015279 estimating the socioeconomic impacts of health outcomes attributable 
to EDs’ exposure. These papers use the population attributable fraction methodology and 
calculate  the  attributable  costs  as  the  product  of  disease  rate,  attributable  fraction, 
population  size  and  cost  per  case.  The  cost  per  case  includes  health  care  direct  costs, 
rehabilitation  costs  and  lost  productivity.  To  establish  the  probability  of  causation,  the 
authors  adapted  the  Intergovernmental  Panel  on  Climate  Change  (IPCC)  approach, 
combining  the  assessment  of  the  strength  of  the  epidemiological  and  toxicological 
evidence. Bond and Dietrich (2017) have criticised the methodology used in this series of 
papers,  pointing  to  a  number  of  criticalities:  skewed  and  non-transparent  selection  of 
experts  for  the  panels  establishing  probability  causation  for  each  outcome-exposure 
association;  limited  evidence  for  certain  outcome-exposure  association;  non-transparent 
selection of the literature evaluated; monetisation of health outcomes with low to moderate 
probability of causation; insufficient number of experts in the panels. 

For  the  purpose  of  this  assessment,  one  outcome  for  each  outcome  category  has  been 
selected: 

IQ loss and intellectual disability (neurodevelopmental); 

  Low birth weight (perinatal outcomes); 
 
  Childhood obesity (metabolic); 
  Male infertility (reproductive outcomes). 

A very low weight at birth can have consequences on development, including an increased 
prevalence of neurosensory problems, behavioural and social competence problems, and 
intellectual  and  learning  disabilities.  As  noted  in  ECHA  (2016c),  the  actual  outcomes 
associated  to  very  low  birth  weight  cannot  be  known  in  advance.  Alberini  and  Ščasný 
(2014) value that the prevention of one case of very low birth weight at €2012405,000 (equal 
to €2021450,000)280 from a public perspective. 

279 Trasande et al. (2015); Bellanger et al. (2015); Hauser et al. (2015); Legler et al. (2015); Hunt et al. (2016); 
Trasande et al. (2016) 
280 Rounded to the nearest ten thousand. 

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Neurodevelopmental  disabilities  have  been  associated  with  IQ  productivity  losses  and 
other associated health and societal costs. A number of authors281 282 283 have estimated the 
cost of an IQ point lost as USD201019,269 (equal to EUR202130,500) in discounted lifetime 
costs. Honeycutt et al. (2004) report average lifetime costs per case of intellectual disability 
of USD20031,014,000 (equal to €20211,690,000).284 

Obesity presents significant healthcare costs to society and can result in  various related 
conditions and subsequent reductions in life expectancy. Direct costs considered include 
drugs, hospitalisations, monitoring and obesity-associated pathologies. Indirect costs are 
productivity losses, in terms of both presenteeism and absenteeism.285 Hamilton and Dee 
(2017) value the total lifetime excess cost per obese child as €2021160,000.286 

There are significant individual and societal costs associated with male reproductive health 
problems, with costs including medical and fertility treatment. Alberini and Ščasný (2014) 
estimated the value of a statistical pregnancy among the general population in €201237,900 
(equal to €202142,000). 

Single Target Organ Toxicity (STOT) 

A substance will be classified as a Specific Target Organ Toxicant (STOT) under the CLP 
Regulation  if  it  produces  target  organ  toxicity/systemic  effects  that  are  not  specifically 
addressed in any of the other hazard classes of the CLP Regulation. STOT substances cause 
specific but non-lethal effects, reversible or irreversible, on organs or organ systems in the 
body  following  exposure  to  a  substance.  All  significant  health  effects  that  can  impair 
function, both reversible and irreversible, following single exposure or repeated exposure, 
are  included.  Other  specific  toxic  effects,  such  as  acute  lethality/toxicity,  eye  and  skin 
corrosivity/irritation, skin and respiratory sensitisation, carcinogenicity, mutagenicity and 
reproductive toxicity are not considered since they are assessed by other hazard classes 
under the CLP Regulation.  

There  are  two  main  classifications  as  STOT:  Single  Exposure  and  Repeated  Exposure. 
STOT Single Exposure is differentiated into: 

—Specific target organ toxicity — single exposure, Category 1 and 2; 

—Specific target organ toxicity — single exposure, Category 3. 

Categories 
Category 1 Substances that have produced significant toxicity in humans or that, on the 
basis of evidence from studies in experimental animals, can be presumed to 

Criteria 

281 Attina TM, Trasande L (2013): Economic costs of childhood lead exposure in low and middle-income 
countries. Environ Health Perspect 121:1097-1102 
282  Trasande  L,  Liu  Y  (2011):  Reducing  the  Staggering  Costs  of  Environmental  Disease  in  Children, 
Estimated at $76.6 Billion In 2008. Health Affairs 30:863-870 
283 Bellanger et al. (2013): Economic benefits of methylmercury exposure control in Europe: monetary value 
of neurotoxicity prevention Environmental Health 12 
284  Converted  using  the  purchasing  power  parities  and  inflation  rates  reported  by  the  OECD 
and 
(https://data.oecd.org/conversion/purchasing-power-parities-ppp.htm) 
(https://stats.oecd.org/index.aspx?queryid=82174) 
285 Presenteeism refers to the lost productivity that occurs when employees are not fully functioning in the 
workplace because of an illness, injury, or other condition. Absenteeism occurs when people are sick, injured, 
unwell or are unable to come to work due to circumstances. 
286 Rounded to the nearest ten thousand. 

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have the potential to produce significant toxicity in humans following single 
exposure 

Substances  are  classified 
toxicity (single exposure) on the basis of: 

in  Category  1 

for specific 

target  organ 

(a)  reliable and good quality evidence from human cases or epidemiological 
studies; or 
(b)  observations from appropriate studies in  experimental animals in which 
significant  and/or  severe  toxic  effects  of  relevance  to  human  health  were 
produced at generally low exposure concentrations.  

Category 2 Substances that, on the basis of evidence from studies in experimental animals 
can  be  presumed  to  have  the  potential  to  be  harmful  to  human  health 
following single exposure 

Substances  are  classified 
target  organ 
in  Category  2 
toxicity (single exposure) on the basis of observations from appropriate studies 
in  experimental  animals  in  which  significant  toxic  effects,  of  relevance  to 
human health, were produced at generally moderate exposure concentrations.  

for specific 

Category 3 Transient target organ effects 

This  category  only  includes  narcotic  effects  and  respiratory  tract irritation. 
These are target organ effects for which a substance does not meet the criteria 
to be classified in Categories 1 or 2 indicated above. These are effects which 
adversely alter human function for a short duration after exposure and from 
which humans may recover in a reasonable period without leaving significant 
alteration of structure or function.  

From the unofficial  information made available  by ECHA, there appear  to  be currently 
around 291 substances classified as STOT SE, in all three categories combined.  

Chemicals under STOT repeated exposure are differentiated into: 

—Specific target organ toxicity — repeated exposure, Category 1; 

—Specific target organ toxicity — repeated exposure, Category 2. 

Categories 
Category 1 Substances that have produced significant toxicity in humans or that, on the 
basis of evidence from studies in experimental animals, can be presumed to 
have the potential to produce significant toxicity in humans 
following repeated exposure. 

Criteria 

Substances are classified in Category 1 for target organ toxicity 
(repeat exposure) on the basis of: 

— reliable and good quality evidence from human cases or epidemiological 

studies; or 

EN 

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— observations from appropriate studies in experimental animals in which 

significant and/or severe toxic effects, of relevance to human health, were 
produced at generally low exposure concentrations.  

Category 2 Substances that, on the basis of evidence from studies in experimental 

animals can be presumed to have the potential to be harmful to human health 
following repeated exposure. 

Substances are classified in category 2 for target organ toxicity 
(repeat exposure) on the basis of observations from appropriate studies in 
experimental animals in which significant toxic effects, of relevance to 
human health, were produced at generally moderate exposure concentrations.  

From the unofficial  information made available  by ECHA, there appear  to  be currently 
around 542 substances classified as STOT repeated exposure, in both categories combined. 

Under the Biocidal Products Regulation, substances classified as STOTs under the CLP 
Regulation are subject to risk management measures based on generic risk considerations 
(i.e.  automatically  prohibited  from  use  by  the  general  public).  There  are  no  equivalent 
provisions under other product specific legislation within the scope of the Fitness Check 
for Chemicals Legislation (excluding REACH).  

In the Fitness Check, NGOs and some Member State authorities pointed out a potential 
gap for some "new emerging endpoints" e.g. neurotoxicity, immunotoxicity. These hazard 
aspects  present  health  and  environmental  risks  of  a  similar  level  of  concern  to  those 
associated with CMRs, PBTs/vPvBs and EDs but are not always explicitly addressed by 
the EU framework of chemicals legislation e.g. these do not constitute a hazard class under 
the  CLP  Regulation.  In  principle,  neurotoxicity  can  be  addressed  via  the  STOT  hazard 
class  under  CLP.  However,  in  practice,  expert  stakeholders  indicated  that  testing  for 
neurotoxicity is rarely undertaken despite the availability of internationally recognised test 
methods. With respect to immunotoxicity, there are currently no internationally recognised 
test  methods  to  identify  substances  with  this  hazard  characteristic.  It  requires  further 
research and development for legislation to be able to address the potential adverse effects 
on human health. 

Respiratory sensitizers 

Respiratory sensitizer means a substance that will lead to hypersensitivity of the airways 
following inhalation of the substance. 

Sensitisation includes two phases: the first phase is induction of specialised immunological 
memory in an individual by exposure to an allergen. The second phase is elicitation, i.e. 
production  of  a  cell-mediated  or  antibody-mediated  allergic  response  by  exposure  of  a 
sensitised individual to an allergen. 

For  respiratory  sensitisation,  the  pattern  of  induction  followed  by  elicitation  phases  is 
shared  in  common  with  skin  sensitisation.  For  skin  sensitisation,  an  induction  phase  is 
required  in  which  the  immune  system  learns  to  react;  clinical  symptoms  can  then  arise 

EN 

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when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). 
As a consequence, predictive tests usually follow this pattern in which there is an induction 
phase,  the  response  to  which  is  measured  by  a  standardised  elicitation  phase,  typically 
involving a patch test. The local lymph node assay is the exception, directly measuring the 
induction  response. Evidence of skin  sensitisation  in  humans normally is assessed by  a 
diagnostic patch test. 

Usually,  for  both  skin  and  respiratory  sensitisation,  lower  levels  are  necessary  for 
elicitation than are required for induction. 

Hazard categories 

Respiratory sensitisers are classified in Category 1 where data are not sufficient for sub-
categorisation. 

Where  data  are  sufficient  a  refined evaluation   shall  allow  the  allocation  of  respiratory 
sensitisers  into  sub-category  1A,  strong  sensitisers,  or  sub-category  1B  for  other 
respiratory sensitisers. 

Effects seen in either humans or animals will normally justify classification in a weight of 
evidence approach for respiratory sensitisers. Substances may be allocated to one of the 
two sub-categories 1A or 1B using a weight of evidence approach in accordance with the 
criteria given in Table 3.4.1 and on the basis of reliable and good quality evidence from 
human cases or epidemiological studies and/or observations from appropriate studies in 
experimental animals. 

Substances shall be classified as respiratory sensitisers in accordance with the criteria in 
Table 3.4.1 in the CLP Regulation: 

Category  Criteria 
Category 1  Substances  shall  be  classified  as  respiratory  sensitisers  (Category  1)  where 
data are not sufficient for sub-categorisation in accordance with the following 
criteria: 

(a)  if  there  is  evidence  in  humans  that  the substance can  lead  to  specific 
respiratory hypersensitivity; and/or 

(b)  if there are positive results from an appropriate animal test. 

Sub-
category 
1A: 

Substances  showing  a  high  frequency  of  occurrence  in  humans;  or  a 
probability  of  occurrence  of  a  high sensitisation rate  in  humans  based  on 
animal or other tests. Severity of reaction may also be considered. 

Sub-
category 
1B: 

Substances showing a low to moderate frequency of occurrence in humans; or 
a probability of occurrence of a low to moderate sensitisation rate in humans 
based on animal or other tests. Severity of reaction may also be considered. 

EN 

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Human evidence 

Evidence that a substance can lead to specific respiratory hypersensitivity will normally be 
based on human experience. In this context, hypersensitivity is normally seen as asthma, 
but other hypersensitivity reactions such as  rhinitis/conjunctivitis and alveolitis are also 
considered. The condition will have the clinical character of an allergic reaction. However, 
immunological mechanisms do not have to be demonstrated. 

When considering the human evidence, it is necessary for a decision on classification to 
take into account, in addition to the evidence from the cases: 

(a) the size of the population exposed; 

(b) the extent of exposure. 

The evidence referred to above could be: 

(a) clinical  history  and  data  from  appropriate  lung  function  tests  related  to exposure to 
the substance, confirmed by other supportive evidence which may include: 

(i) in vivo immunological test (e.g. skin prick test); 

(ii) in vitro immunological test (e.g. serological analysis); 

(iii) studies  that  indicate  other  specific  hypersensitivity  reactions  where  immunological 
mechanisms  of  action  have  not  been  proven,  e.g.  repeated  low-level irritation, 
pharmacologically mediated effects; 

(iv) a chemical structure related to substances known to cause respiratory hypersensitivity; 

(b) data from one or more positive bronchial challenge tests with the substance conducted 
according  to  accepted  guidelines  for  the  determination  of  a  specific  hypersensitivity 
reaction. 

Clinical  history  shall  include  both  medical  and  occupational  history  to  determine  a 
relationship  between exposure to  a  specific substance and  development  of  respiratory 
hypersensitivity. Relevant information includes aggravating factors both in the home and 
workplace, the onset and progress of the disease, family history and medical history of the 
patient in question. The medical history shall also include a note of other allergic or airway 
disorders from childhood, and smoking history. 

The  results  of  positive  bronchial  challenge  tests  are  considered  to  provide  sufficient 
evidence for classification on their own. It is however recognised that in practice many of 
the examinations listed above will already have been carried out. 

From the unofficial  information made available  by ECHA, there appear  to  be currently 
around 116 substances classified as respiratory sensitisers, in both categories combined.. 

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Asthma287  

Despite  considerable  research  over  the  last  few  decades,  there  is  still  an  incomplete 
understanding of why and how asthma develops. This in part reflects the various causal 
factors and the complexity of their interaction. Figure 10 illustrates the impact of different 
environmental  factors  on  individuals  who  in  turn  have  different  genetic  susceptibility. 
Exposure to specific environmental factors (green boxes) will give rise to specific asthma 
phenotypes (red boxes) in individuals with specific genotypic susceptibility profiles (blue 
boxes).  One  environmental  factor  (i.e.  chemicals  exposure)  may  have  very  different 
impacts on individuals with different genotypic susceptibilities.  

Occupational asthma may develop in persons with no previous history of chest disease and 
can sometimes persist  after exposure to the  causal  agent is  removed. The EAAC noted 
additional  research  was  required  on  the  causes  of  asthma  as  well  as  on  the  effects  of 
workplace practices – such as personal protective equipment and of regulation288.  

Figure 10: complex interactions in asthma incidence 

287 Study on the cumulative health and environmental benefits of chemical legislation, Amec Foster Wheler 
Environment & Infrastructure UK Limited June – 2017 
288  EAACI  Global  Atlas  of  asthma  2014  http://www.eaaci.org/GlobalAtlas/Global_Atlas_of_Asthma.pdf 
Page 41. 

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Figure 11 Average annual costs of childhood asthma per country (2005) 

Source: EAACI, Global Atals of Asthma (2014) Yellow denotes annual costs of less than €100 million; orange between €100 and €300 
million and red more than €300 million.  
[1] Average annual costs in the figure are based on published EU-level estimates and include direct medical costs, direct non-medical 
costs  and 
found  at:  http://onlinelibrary.wiley.com/doi/10.1111/j.1398-
9995.2005.00692.x/full 

indirect  costs.  Detailed  methodology  can  be 

What is clear from the available evidence is that childhood, adult and occupational asthma 
is a major issue across Europe.  

o  The ERS White book, published in 2003 estimated the total costs of asthma in 
Europe  at  approximately  €17.7  billion  per  annum.  The  UK  has  the  highest 
number  of  asthma  related  consultations  followed  by  Greece  and  Germany, 
whilst Poland had amongst the least. Costs per patient in Europe were identified 
in 2012 study at €1,583289. 

o  An estimate of the costs of asthma in children in 25 EU countries was published 
in 2005, which estimated the costs at €3 billion (note this is all cause, not just 
environmentally attributable asthma). The estimate is based on average annual 
costs shown in Figure 11. If “wheeze” is included within the definition, this 
leads  to  higher  costs  of  €5.2  billion.  In  terms  of  childhood  asthma,  data 
presented in the EAACI Global atlas of asthma 2014 contains estimated annual 
costs per country (Figure 11). Yellow denotes a cost of less than €100 million; 
orange between €100 and €300 million and red more than €300 million290. A 
paper from Bartlett and Trasande study estimates the environmental attributable 

289 Source: EAACI, Global Atals of Asthma (2014) 
290 (Based on data from van den Akker-van Marle ME, Bruil J, Detmar SB. Evaluation of cost of disease: 
assessing the burden to society of asthma in children in the European Union. Allergy 2005; 60:140-149.) 
presented in EAACI, Global Atals of Asthma (2014). 

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costs  of  childhood  asthma  to  the  EU  in  2013  amounted  to  €1.6  billion  per 
year291. 

2.  REGULATING CHEMICALS IN THE TOY SAFETY DIRECTIVE 

The  Toy  Safety  Directive  emphasizes  the  protection  from  chemical  risks  in  its  general 
safety requirement: ‘Toys, including the chemicals they contain, shall not jeopardise the 
safety and health of users …’. 292  

The Directive further lists a range of ‘particular’ safety requirements on chemicals in its 
Annex II, Part III. In addition, cosmetic toys have to comply with the compositional and 
labelling requirements of the Cosmetics Regulation.293 Finally, toys that are themselves 
substances or mixtures have to comply with the CLP Regulation.294 

In addition, the Toy Safety Directive was given the possibility to include ‘Specific limit 
values for chemicals used in toys intended for use by children under 36 months or in other 
toys  intended  to  be  placed  in  the  mouth  …’.  The  specific  limit  values  in  the  related 
Appendix C should ‘ensure adequate protection [of children] in the case of toys involving 
a high degree of exposure … intended for use by children under 36 months and in other 
toys intended to be put in the mouth …’.295 

Indeed, eight amendments to the Toy Safety Directive have inserted specific limit values 
for a number of CMR substances and highly sensitising substances in Appendix C (see 
annex 5). However, experts in the subgroup Chemicals, but also in the Expert Group on 
Toys Safety,296 repeatedly raised the need that children of 36 months and over be equally 
well  protected  as  those  under  36 months.  Over  80%  of  respondents  to  the  public 
consutlation believed that the toy safety rules sohuld allow for setting limit values for any 
toy when new scientific knowledge emerges.  

In  the  2018  public  consultation  in  the  context  of  the  Evaluation,  two  Member  States 
submitted position papers calling to expand Appendix C in order that the limit values also 
be applicable to toys for children of 36 months and over. In their 2009  – 2013 national 
reports on the application of the Toy Safety Directive,297 four Member States proposed that 
Appendix C limit values also apply to toys for children of 36 months and over. These views 
have  been  confirmed  in  the  2014  –  2018  national  reports,  submitted  in  2019,  where 
Member States indicated that the limitation to toys for children under 36 months and to 
toys intended to be taken in the mouth is clearly inadequate, in particular for sensitising 
substances and preservatives, and that such limits should apply to all toys.  

291  Bartlett,  E,  Trasande,  L  (2013)  Economic  impacts  of  environmentally  attributable  childhood  health 
outcomes in the European Union. 
292 Article 10(2) of the Toy Safety Directive. 
293 See footnote on Regulation (EC) No 1223/2009 further above. 
294 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and  repealing  Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. 
295 Recital 24 of the Toy Safety Directive. 
296 See footnote on the Register of Commission Expert Groups further above. 
297 See footnote on the Commission Summary of Member States’ Reports further above. 

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In the ‘Fitness check on chemicals legislation (excluding REACH)’,298 the supporting case 
study on toys299 reports that, in light of specific limit values for allergenic isothiazolinones 
in Appendix C, a Member State expressed the view that ‘Limiting these restrictions to toys 
used by children under  36 months or toys intended to  be placed in  the  mouth does not 
reduce the health risk in the case of relevant  dermal exposure of hazardous substances, 
which might  increase the health  risk for  children over 36 months  of age.’ The  Notified 
Bodies  under  the  Toy  Safety  Directive  (NB-Toys  group)  noted  at  their  meeting  on 
17 September 2019 that allergies in children are independent of the age, a 36 months divide 
for  sensitising  substances  is  therefore  not  justifiable.  Finally,  11 Member  States 
underlined, in  a letter of April 2019 to  the Commission,300 their strong belief that  limit 
values in Appendix C should also apply to children of 36 months and older, in light of the 
chemicals emitted from squishy toys and preservatives in toy slimes and in toy modelling 
clays. An adaptation of the Toy Safety Directive in this regard was urgently requested. 

The above shows that the Toy Safety Directive is not considered effective enough in the 
eyes  of  Member  States  and  Notified  Bodies.  They  suggest  the  specific  limit  values  for 
chemicals apply to the toys for children of all ages. 

Older children may also be exposed to chemicals via the skin or via inhalation. Examples 
are the sensitising preservatives benzisothiazolinone,301  chloromethylisothiazolinone and 
methylisothiazolinone302 for which specific limit values have been inserted in Appendix C 
to the Directive. Taking account of all exposure paths for chemicals thus would require the 
specific limit values in Appendix C to apply to all toys for children of all ages. 

In addition, the risk from chemicals is not much different when comparing children under 
36 months and older children. The bodyweight of children under 36 months was estimated 
to be 7.5 kg303 when calculating the migration limits for toxic ‘elements’ such as arsenic, 
cadmium or lead; for children of 36 months and over the bodyweight was assumed to be 
15 kg. This 2-fold difference is only minor from the toxicological point of view, a notable 
difference would be 10-fold. 

Finally,  only  the  limit  values  in  Appendix  C  have  an  age  limit  and  the  limitation  to 
mouthing toys, all other chemical limit values in the Toy Safety Directive apply to all toys 
for children of all ages. This puts a general question mark on the Appendix C limit values. 

a.  CMR SUBSTANCES IN GENERAL – GENERAL BAN AND DEROGATIONS 

The Toy Safety Directive prohibits the use of substances that are classified, under the CLP 
Regulation, as carcinogenic, mutagenic or toxic for reproduction (CMR). CMR substances 
may be identified  as substances of very high  concern under REACH.304 The hazardous 
effects of such substances are of particular severity, they can only be seen in the long term 
and can almost never be traced back to the chemical of origin, and are often irreversible. 

http://ec.europa.eu/growth/sectors/chemicals/ec-support_en.  Click 

298 
consultations’, click ‘Annex VI’. 
299 http://ec.europa.eu/DocsRoom/documents/22063/attachments/3/translations/  
300 Letter of 25.4.2019. 
301 See the related amendment in annex 6. 
302 See the related amendment in annex 6. 
303 National Institute for Public Health and the Environment (RIVM) 
304 See footnote on Regulation (EC) No 1907/2006 further above, Articles 55 and 57. 

‘Supporting 

studies 

and 

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However,  the  Toy  Safety  Directive  tolerates  the  presence  of  CMRs  in  toys  or  its 
components  up  to  the  ‘relevant  concentrations’  of  the  CLP  Regulation.  ‘Relevant’  are 
either  the  specific  concentration  limits  assigned  to  specific  substances  in  Annex  VI, 
table 3.1 of the CLP Regulation; if no specific concentration limits are indicated in that 
table, the generic concentration limits in Annex I of the CLP Regulation apply: 0.1% and 
1% for carcinogens305 and mutagens306 of categories 1 and 2, respectively, and 0.3% and 
3% for reproductive toxins307 of categories 1 and 2, respectively. 

These ‘relevant concentrations’ of the CLP Regulation are hazard-based and have been set 
for the purpose of classification and labelling of mixtures containing hazardous substances, 
with the primary aim to ensure that the hazards of such mixtures are properly identified 
and  communicated.  They  do  not  take  account  of  possible  exposures,  do  not  entail  an 
assessment of risk related to the uses of a substance, and thus are inadequate to manage the 
risk when a substance is present in an article such as a toy. 

To take account of the exposure of children to chemicals in toys the subgroup Chemicals 
was established to recommend limit values for chemicals in toys when those chemicals 
could pose a risk. On the basis of the work of the subgroup the Toy Safety Directive was 
amended six times to include (in its Appendix C) risk-based limit values for several CMRs: 
TCPP and two similar flame retardants, bisphenol A, formamide, phenol, bisphenol A and 
formaldehyde.308 

Those risk-based limit values are often migration limits. They cannot be compared with 
the  ‘relevant  concentrations’  taken  from  the  CLP  Regulation,  which  are  content  limits.  
There is no relationship between the concentration of a substance inside a material, i. e., 
its  content,  and  the  migration  of  the  substance  out  of  that  material  though  the  highest 
possible  migration  of  the  substance  would  be  its  content.  Both  therefore  cannot  be 
converted into one another. Nevertheless, for a few substances the Directive sets risk-based 
content limits and comparisons are therefore possible: 

Chemical 
substance 
TCEP 
Phenol 
Formamide 
Formaldehyde 

‘Relevant  concentration’  in 
the CLP Regulation, mg/kg 

3,000 
10,000 
3,000 
1,000 

limit 

Content 
in 
Appendix C, mg/kg 
5 
10 
200 
30 and 10 

Difference factor 

600 
1,000 
15 
33 and 100 

The  limit  values  in  Appendix  C  are  thus  15  to  1,000  times  lower  than  the  ‘relevant 
concentrations’ in the CLP Regulation. The Toy Safety Directive’s derogation from the 
CMR  prohibition  therefore  does  not  appear  to  be  well  justifiable  with  regard  to  the 
protection of children’s health. 

This  likely  inadequacy  of  the  CMR  derogation  based  on  the  concentration  limits  for 
classification of mixtures from the CLP Regulation was referred to by public authorities 

305 
306 
307 
308 

Table 3.6.2 of the CLP Regulation. 
Table 3.5.2 of the CLP Regulation. 
Table 3.7.2 of the CLP Regulation. 
See the related amendments in annex 6. 

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(70%  of  public  authorities  responding  disagreed  or  strongly  disagreed  with  it)  and  by 
consumer organisations (75%) in the open public consultation.  

The fitness check on chemicals legislation (excluding REACH)309 reported in its case study 
on toys310 about a consumer association indicating that the thresholds outlined in the CLP 
Regulation  for  CMR  substances  were  not  originally  intended  to  be  used  as  a  limit  for 
consumer  products  and  were  therefore  not  appropriate  for  application  to  consumer 
products (and in particular toys, as children are vulnerable). Also, a Member State authority 
noted  that  the  CLP  Regulation  follows  a  hazard-based  approach  and  the  generic 
classification limits of 0.1% for human carcinogens were too high meaning that health risks 
to  children  could  not  be  excluded.  Also  the  2015  external  study  reported  consumer 
organisations deeming the limits for CMR substances to be too high. 

The SCHEER also identified a number of problems that can arise from the approach to 
address CMRs in relation to content limits, due to the fact that classification limits set for 
substances or mixtures are applied to articles (as the toys should be considered). First of 
all, the percentage composition refers to the toy as a whole, to components of the toy and 
to  distinct,  microstructural  parts  of  the  toy.  However,  a  CMR  substance  present  in  a 
specific  part  of  the  toy  may  not  be  homogeneously  distributed,  so  that  the  local  % 
concentration could be higher in that specific part and possibly above the limit. Secondly, 
limits  are  cut-  off  values,  defined  for  a  practical  approach  to  be  used  for  regulatory 
purposes. Finally, the classification of mixtures as CMRs is based on the presence of at 
least one of the CMR substances above the classification limits, without taking into account 
possible interactive effects of the CMR substances in the mixture, hence in the toys. These 
considerations  make  the  suitability  of  the  classification  approach  applied  to  toys  quite 
limited, according to SCHEER311. 

In addition to the above the Toy Safety Directive provides for two further derogations for 
the use of CMRs in general: 

  The second derogation in the Toy Safety Directive allows CMRs in toys that exceed 
the ‘relevant  concentration’ in  the CLP Regulation. Such higher concentrations are 
allowed if the CMRs are inaccessible in any form, including through inhalation, when 
children are playing with the toys.  

  The third derogation that allows CMRs in toys is conditioned by an evaluation by the 
relevant Scientific Committee that a CMR is safe in toys, and that REACH does not 
prohibit the CMR in consumer articles. For the ‘stronger’ CMRs (categories 1A and 
1B  under  the  CLP  Regulation),  the  third  condition  is  the  non-availability  of 
alternatives,  which  is  not  needed  for  CMRs  category  2.  –  So  far  only  a  single 
derogation of this kind was allowed, namely for nickel in toys and toy components 
made of stainless steel and in toy components which are intended to conduct an electric 
current.312  

From the above it appears that a generic approach to the risks of a whole class of chemicals 
could be missing effectiveness if derogations are set that ignore one of the two constituents 
of risk, namely in this case the exposure of a vulnerable group of consumers.  

309 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52019DC0264&from=EN  
310 http://ec.europa.eu/DocsRoom/documents/22063/attachments/3/translations/ , p. 33. 
311 SCHER Opinion on risk from organic CMR substances in toys, 18 May 2010. 
312 Annex II, Appendix A of the Toy Safety Directive. 

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b.  SPECIFIC CMRS: NITROSAMINES AND NITROSATABLE SUBSTANCES 

The Toy Safety Directive sets migration limits for nitrosamines and nitrosatable substances 
in toys intended for use by children under 36 months or in other toys intended to be placed 
in  the  mouth:  0.05 mg/kg  for  nitrosamines,  1 mg/kg  for  nitrosatable  substances.313 
Relevant  nitrosamines  may  be  genotoxic  and  very  strong  carcinogens.  Nitrosatable 
substances can be converted into nitrosamines in the human body. 

Germany however insisted on its lower national limits of 0.01 mg/kg for nitrosamines and 
of  0.1 mg/kg  for  nitrosatable  substances  in  toys  made  of  natural  or  synthetic  rubber 
designed for children under 36 months and intended or likely to be placed in the mouth. 
The Commission allowed Germany in a Decision of March 2012 to keep its lower limits, 
acknowledging  that  ‘the  German  request  is  based  on  a  real  concern  with  regard  to 
children’s health …’.314 The German limits were consistent with the limits for (parts of) 
teats  and  soothers  made  of  elastomer  or  rubber,  of  0.01 mg/kg  for  nitrosamines  and  of 
0.1 mg/kg  for  nitrosatable  substances.315  –  And  the  Commission  declared  in  its  2012 
Decision  to  ‘…  require  CEN  to  consider  …  to  lower  the  limit  values  within  the 
standardisation process.’ 

As a consequence, the Commission mandated CEN in March 2012 to revise the limits for 
nitrosamines and nitrosatable substances in Standard EN 71-12 on N-nitrosamines and N-
nitrosatable  substances.316  Standardisation  should  take  account  of  the  latest  data  on  the 
mouthing behaviour of children (which is related to all toys), not only of the mouthing of 
balloons. With this, CEN’s work resulted in the adoption of standard EN 71-12:2017, made 
available  in  January  2017,  and  including  lower  limits  for  nitrosamines  and  nitrosatable 
substances in accordance with the Commission’s mandate. 

Thus,  the  Evaluation  concluded  that  the  Directive  was  not  effective  with  regard  to  the 
protection  from  nitrosamines  and  nitrosatable  substances.  Also,  referencing  EN  71-
12:2017  with  its  strengthened limits  for nitrosamines and nitrosatable substances in  the 
Official Journal is not possible since that would lead to a conflict with the limits in the 
Directive. EN 71-12:2017 therefore cannot provide the presumption of conformity until 
the Directive has been revised. 

In their letter of April 2019 to the Commission,317 11 Member States considered that there 
was an urgent need to lower the limits for nitrosamines and nitrosatable substances. In the 
2018 public consultation, public authorities commented that the limits for nitrosamines and 
nitrosatable  substances  should  be  aligned,  according  to  position  papers  submitted  by 
Denmark, Germany and Sweden, with the limits that the Commission had requested from 
CEN and available in standard EN 71-12:2017. Industry and Notified Bodies considered 
the existence of lower limits in national legislation as an incoherence with the Toy Safety 

88 

of  Commission  Decision 

313 Annex II, Part III, point 8 of the Toy Safety Directive. 
314  Recital 
content/EN/TXT/PDF/?uri=CELEX:32012D0160&qid=1571656440439&from=EN  
315 Directive 93/11/EEC concerning the release of the N-nitrosamines and N-nitrosatable substances from 
elastomer  of  rubber  teats  and  soothers.  OJ  L  93,  17.4.1993,  p.  37.  https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:31993L0011&qid=1571656528598&from=EN  
316 Letter of 29.3.2012. 
317 See letter of 25.4.2019. 

https://eur-lex.europa.eu/legal-

2012/160/EU. 

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Directive. Consumer organisations considered the limits for nitrosamines and nitrosatable 
substances to be inadequate already in the 2015 external study on the Directive.  

c.  AN ILLUSTRATION OF THE PROBLEM - BISPHENOL A 

The substance Bisphenol A is a high volume chemical that is widely used in the production 
of  a  large  variety  of  consumer  products.  Bisphenol  A  is  used  in  the  manufacture  of 
polycarbonate plastics. Since 2002 Bisphenol A was classified under the CLP Regulation 
as toxic for reproduction category 2. In the absence of any specific requirements, the Toy 
Safety Directive allowed the presence of Bisphenol A in toys in concentrations equal to or 
smaller  than  the  relevant  concentration  established  for  the  classification  of  mixtures 
containing it as CMRs, namely 5 % as from 20 July 2013 and 3 % as from 1 June 2015 
respectively.  

European standards318 provided a migration limit of 0,1 mg/l for Bisphenol A in toys, as 
well as the relevant test methods. These were used by the toy industry but did not constitute 
harmonised standards as they did not correspond to requirements in the Directive. 

The risk assessment  report,  entitled ‘Updated European Union Risk Assessment  Report 
4,4'-isopropylidenediphenol (Bisphenol-A)’319, found, among other things, that Bisphenol 
A has endocrine modulating activity and concluded that further research was needed to 
resolve  the  uncertainties  surrounding  the  potential  for  Bisphenol  A  to  produce  adverse 
effects on development at low doses. Nevertheless, a high level of protection of children 
against risks caused by chemical substances in toys, in the light of the particular needs of 
children,  who  are  a  vulnerable  group  of  consumers,  warranted  incorporating  the 
migration limit of 0,1 mg/l for Bisphenol A into Directive 2009/48/EC. This was done by 
Commission Directive 2014/81/EU amending appendix C of the Directive320.  

This limit value was subsequently revised by Commission Directive 2017/897 amending 
appendix C in view of new data on Bisphenol A and refined methodologies by the European 
Food Safety Authority (EFSA)321. According to the EFSA322, high doses of Bisphenol A are 
likely to harm kidney and liver.  

Since  then,  in  January  and  June  2017,  the  ECHA  Member  States  Committee  identified 
Bisphenol  A  as  a  substance  of  very  high  concern  (SVHC)  because  of  its  repro-toxic 
properties, and endocrine disrupting properties on human health, respectively. Bisphenol 
A  may  damage  fertility  and  has  been  identified  as  a  substance  affecting  the  hormonal 
systems of humans and animals. In addition, it damages eyes and may cause allergic skin 

S.(editor), 

Aschberger, 

318 EN 71-9:2005+A1:2007 and EN 71-10:2005 and EN 71-11:2005 
319  Joint  Research  Centre,  Institute  for  Health  and  Consumer  Protection, Updated  European  Union  risk 
assessment report 4,4’-isopropylidenediphenol (bisphenol-A) : human health addendum of February 2008, 
Office, 
K.(editor),  Munn, 
Pakalin, 
2010, https://data.europa.eu/doi/10.2788/40301 
320  COMMISSION  DIRECTIVE  2014/81/EU  of  23  June  2014  amending  Appendix  C  of  Annex  II  to 
Directive  2009/48/EC  of  the  European  Parliament  and  of  the  Council  on  the  safety  of  toys,  as  regards 
bisphenol A, OJ L 183, 24.6.2014, p. 49. 
321 COMMISSION DIRECTIVE (EU) 2017/898 of 24 May  2017 amending,  for the purpose of adopting 
specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the 
European Parliament and of the Council on the safety of toys, as regards bisphenol A, OJ L 138, 25.5.2017, 
p. 128. 
322 http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/factsheetbpa150121.pdf 

Publications 

S.(editor), 

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reactions  and  respiratory  irritation.  This  is  why  as  of  1  March  2018,  Bisphenol  A  is 
classified in the EU under the CLP regulation as a substance that: causes toxic effects on 
our ability to reproduce (Repr. 1B); may cause respiratory irritation (STOT SE 3); causes 
serious eye damage (eye dam. 1); and may cause skin allergies (skin sens. 1)323.  

EFSA has re-evaluated the risks of Bisphenol A and in its April 2023 opinion considers 
that scientific literature since 2013 until 2018 indicate adverse effects of Bisphenol A on 
the immune system and suggests a significantly lower tolerable daily intake324. The TDI is 
around 20,000 times lower than before. 

In light of the scientific evidence, the derogation in the Toy Safety Directive allowing for 
the presence of CMRs up to the relevant concentrations of the CLP Regulation allows for 
too much presence of Bisphenol A in toys. While the Toy Safety Directive has allowed for 
the introduction of specific limit values for Bisphenol A, this can only be done in appendix 
C of the Directive, which applies to toys intended for children under 36 months or to be 
put  in  the  mouth.  Older  children  than  36  months  are  not  protected  under  the  current 
Directive from exposure to Bisphenol A in toys.   

d.   

USES OF CHEMICALS IN TOYS 

In the framework of the Study being conducted to support the revision of REACH and the 
extension of the Generic Risk Management approach (GRA)325, a use mapping has been 
conducted on the basis of the ECHA registration dossiers. For the most relevant product 
categories an assessment on the number of substances that would fall under specific hazard 
classes was developed. Below, as an illustration, are the results for 3 product categories 
particularly relevant for toys: PC 32: Polymers, PC9a: Finger paints and PC9c: Plasters 
and modeling clay. It is quite clear that many substances counted under this will not be 
used in toys but seeing the variety of toys and the polymer compounds used in them it is 
nonetheless a good approximation to understand the scale of the challenge. 

The  list  consisted  of  3  baskets  with  the  following  characteristics,  according  to  an 
accompanying ECHA document: 

o  Basket 1- Substances with confirmed hazard(s): For endpoints included in 
CLP  these  are  based  on  either  their  harmonised  classification  (inclusion  in 
Annex VI to CLP) or the reported self-classification in the registration dossier. 
For other endpoints, these are based on identification as SVHC (inclusion in 
the  Candidate  List),  identification  under  the  Biocidal  Products  Regulation 
(BPR)  or  agreed  in  the  ED/PBT  Expert  Groups.  Hazard(s)  are  based  on 
available information; lists as well as numbers of substances provided. 

o  Basket 2 – Substances where the hazard(s) are under consideration : These 
are substances with on-going data generation or assessments; lists as well as 

323  COMMISSION  REGULATION  (EU)  2016/1179  of  19  July  2016  amending,  for  the  purposes  of  its 
adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament 
and  of  the  Council  on  classification,  labelling  and  packaging  of  substances  and  mixtures,  OJ  L  195, 
20.7.2016, p. 11. 
324 Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs - - 
2023 - EFSA Journal - Wiley Online Library https://doi.org/10.2903/j.efsa.2023.6857 
325 Study to support the impact assessment for potential amendments of the REACH Regulation to extend 
the use of the generic risk management approach to further hazard classes and uses, and to reform REACH 
authorisation and restriction, Annex 1: report on task 2 – use. To be published. 

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numbers of substances are provided; it also includes an estimate on the number 
of substances for which the hazards are likely to be confirmed (based on past 
experience). 

o  A third basket is represented by estimates of the number of substances in the 
chemical universe that may be classified according to the new hazard classes 
based  on  the  assumption  that  the  same  proportion  of  hazardous  substances 
exists  regardless  of  their  manufactured  and/or  imported  quantities  (and 
therefore registered providing different information requirements according to 
REACH Annex VII, VIII, IX and X). It is important to note that Basket 3 is not 
a list of identified substances and therefore cannot be used for the purpose of 
use mapping.  

The initial list in Basket 1 contains both cat. 1 and cat. 2 substances in the area of STOT 
SE and RE substances. Cat. 2 substances, analogous to CMR substances, would possibly 
not  be  the  subject  of  a  future  GRA.  It  was  therefore  not  considered  further  in  the  use 
mapping. STOT RE and SE is only represented by cat 1. This distinction was not made in 
Basket  2,  as  there  was  no  information  on  this.  it  is  possible  that  the  same  substance  is 
assigned several times to the individual PCs due to several hazardous properties. It should 
be noted that substances can not only appear in an additional hazard class but can also be 
named in three or four categories (especially in the comparison of Baskets 1 and 2 due to 
the  high  number  of  suspected  substances  in  PBT/vPvB,  ED  and  PMT).  In  addition, 
environmental hazards (ED ENV, PBT/vPvB and PMT) are not within the scope of the 
revision of the TSD. 

Table 19: Number of substances Basket 1 according to PC with consumer Life cycle stage326 

PC 

ED 
ENV 

ED 
HH 

PBT/ 
vPvB 

Resp
. 
Sens. 

STOT 
RE 
(Cat. 
1) 

STOT 
SE 
(Cat. 
1) 

PMT  CMR 

PC  32:  Polymer  preparations  and 
compounds  
PC 9c: Finger paint  
PC  9b:  Fillers,  putties,  plasters, 
modelling clay  

6 

0 

1 

5 

1 

2 

11 

16 

2 

4 

1 

7 

15 

20 

25 

3 

0 

1 

0 

30 

50 

62 

≤10 green, >10 - ≤ 50 light green, >50 - ≤ 100 yellow, > 100 red 

Table 20: Number of substances Basket 2 according to PC with consumer Life cycle stage 

PC 

PC 32: Polymer preparations and compounds  
PC 9c: Finger paint  
PC 9b: Fillers, putties, plasters, modelling clay  

ED 

83 
48 
82 

PBT/ 
vPvB 
55 
31 
41 

Resp 
Sens 
8 
8 
8 

STOT 
RE 
7 
6 
9 

STOT 
SE 
7 
7 
9 

PMT 

54 
31 
43 

≤10 green, >10 - ≤ 50 light green, >50 - ≤ 100 yellow, > 100 red 

In  that  Study,  a  number  of  caveats  were  highlighted  in  respect  of  this  information.  In 
particular, it was argued that the use of CMR substances in PC 32 polymers seems to rather 

326  When  data  are  shown  for  a  hazard  class,  duplicates  are  always  included  to  make  a  description  of  the 
respective hazard class.  

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reflect  the  further  application  of  polymers  and  plastics.  Substances  are  found  that  are 
incorporated  as  monomers  into  more  complex  compounds  and  subsequently  no  longer 
exist. Therefore, a CMR property would no longer exist in the service life.  

Nevertheless, the above could give a broad illustration of the implications of the generic 
risk management approach (options 1b and 1c) in toys.  

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ANNEX 11: NON-COMPLIANT TOYS ON THE UNION MARKET 

1.  NON-COMPLIANT PRODUCTS: RAPEX DATA 

The Safety Gate system, formerly known as the Rapid Exchange of Information System (RAPEX), 
is the EU’s rapid alert system for sharing information between national authorities on measures taken 
against dangerous non-food products, including toys. The system operates as follows: 

  When a national authority in an EU Member State or EEA / EFTA country identifies and 
adopts measures against dangerous products placed on the market, it submits an alert to Safety 
Gate. Each alert follows a template and provides a wide range of information, including the 
type of product, a description of the risk, the country of origin and the measures ordered by 
the authority or taken by the economic operator. 

  All other authorities are required to follow up on each alert and share any information on the 

presence of the dangerous product on their own market. 

Data  on  SafetyGate  (/RAPEX)  alerts  are  available  for  the  period  2005-2021.  This  section  first 
presents an overview of the key methodological considerations related to the SafetyGate alert data, 
before presenting an analysis of the toy-related alerts across the period 2016-2021, in line with the 
time period examined through the market analysis. 

Within this context, the SafetyGate alert data for the period 2016-2021 is now analysed, focusing 
first  on  headline  data  points,  before  examining  a  range  of  relevant  variables,  including  the  risk 
categories  for  alerted  toy  products,  the  types  of  alerts,  the  countries  of  origin  and  the  countries 
submitting alerts. 

Over the period 2016-2021, the ‘Toy’ category comprised 27.4% of total SafetyGate alerts (3,449 of 
12,610 alerts); the highest proportion of any specific product category. This proportion has varied 
significantly over the years, with a peak of 31.8% of total alerts in 2018 and a low of 19.9% in 2021. 
The below figure 12 illustrates this percentage per year since 2005, alongside the total number of toy 
and non-toy alerts.  

As  can  be  seen,  the  number  of  alerts  increased  year  on  year  between  2005-2010,  as  market 
surveillance authorities became more familiar with SafetyGate following its introduction. However, 
a clear drop in both toy and non-toy alerts was experienced in 2011 followed by an increase to 2014 
– the highest year to date in terms of total alerts and the third highest for toy-related alerts. Given the 
entry into force of Regulation (EC) No 765/2008 – part of the New Legislative Framework (NLF) – 
in 2010 and the subsequent application of national transpositions of the updated Toy Safety Directive 
2009/48/EC  by  July  2011  (as  well  as  the  alignment  of  many  other  pieces  of  industrial  product 
legislation to the NLF), one prominent explanation for this trend is the need for market surveillance 
authorities to familiarise and integrate these new rules into their processes and procedures. 

In the  years since 2014,  the level  of both  non-toy  and toy related SafetyGate alerts has remained 
relatively stable. In line with the abovementioned challenges, this result could indicate a plateau in 
terms  of  market  surveillance  authorities  capacity  (in  terms  of  resources)  to  identify  and  report 
dangerous products. 

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Figure 12: SafetyGate alerts 2005-2021: Toy and non-toy product categories 

From the above, it is also clear that the toys comprise a sizeable proportion of total SafetyGate alerts. 
In fact, the ‘Toys’ category has been the product category subject to the highest number of alerts in 
five of the last six years. The next highest categories across this period were ‘Motor vehicles’ (22.5%, 
2,840 alerts), ‘Clothing, textiles and fashion items’ (9.4%, 1,182 alerts) and ‘Electrical appliances 
and equipment’ (8.6%, 1,088 alerts). The remaining 57 categories comprised around 32.1% of alerts. 

Within the ‘Toys’ category, the two most common risk categories over the period 2016-2021 by 
more than 1,000 alerts are choking risks (1,507, 37.7%) and chemical risks (1,404, 35.1%). In fact, 
with  general  injury  risks  added  (398,  10%),  these  three  risk  types  comprise  82.8%  of  toy  related 
SafetyGate alerts in this period. No other risk type makes up more than 4% of toy-related alerts. 

Figures 13 and 14: SafetyGate alerts 2005-2021: Types of risks in dangerous toys 

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1600

1400

1200

1000

800

600

400

200

0

1464

1418

77

5

89

12

23

3

22

101

2

40

65

31

227

19%

40%

41%

Chemical

Small parts

Other

Concerning the types of alerts possible within SafetyGate, the vast majority (91.4%) concern serious 
risks. The other options (‘Other risk levels’ and ‘Other types of alerts’) are used in a relatively limited 
manner. 

Another  important  variable  to  analyse  is  the  country  of  origin  of  alerted  products;  particularly 
given the challenges raised by all stakeholder types of non-compliant products being placed on the 
market  by  third  country  economic  operators,  often  via  online  marketplaces.  In  this  respect,  the 
analysis of the SafetyGate data supports the views of stakeholders, with a significant proportion of 
85.6% of toy-related alerts (2,951) in the period 2016-2021 concerning products originating in China. 
This proportion has remained relatively stable over the entire history of RAPEX / SafetyGate, starting 
at 75.1% in 2005, rising to 90.7% in 2016 and 2017, before decreasing in 2020 (78.5%) and 2021 
(81.1%). 

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A further 5.5% of the products subject to alerts are of ‘Unknown’ national origin; however, experts 
in the field believe many of these are likely to also originate in China. The next most common country 
of origin is Germany (1.3% of toy-related alerts), while each of the remaining countries comprises 
less than 1% of alerts. 

Figure 15: Country of origin of dangerous toys in RAPEX (2016-2021) 

11%

4%

85%

EU

China

Other

Beyond the product’s country of origin, it is also interesting to examine which European countries 
are submitting the most toy-related alerts. Poland has submitted the most toy-related alerts in the 
period 2016-2021, with 435 (12.6% of toy-related alerts). In addition, Hungary (327, 9.5%), Spain 
(323, 9.4%), France (283, 8.2%) and Cyprus (277, 8.0%) are particularly active.  

Building on these data, the proportion of total alerts per country that are focused on toy products 
could be used as a proxy for the level of priority different market surveillance authorities place on 
toys. In this respect, the data suggest that while some countries place significant focus on toy-related 
product safety issues, others do not. More specifically, the proportion of total alerts that relate to toy 
products is higher than the overall EU-wide average (27.4%) in 17 countries. In fact, this figure is 
above 50% in  Czechia (60.2%), Poland (59.2%), Slovakia (56.3%) and Spain  (53.9%) and above 
40% in a further seven countries (LV, LT, IS, AT, CY, NL, LU). 

This  finding  suggests  not  only  that  these  countries  place  a  particular  focus  on  identifying  and 
submitting alerts related to toy products, but that the EU-wide average is strongly influenced by the 
data from Germany. Only 3.8% (93) of the 2,465 SafetyGate alerts submitted by Germany in the 
period 2016-2021 related to toys. Indeed, when removing the German data, the proportion of total 
alerts that are related to toys increases from 27.4 to 33.1%. 

According to this assumption, other European countries that appear to place less of a focus on toy-
related  products  included  Ireland  (1.5%  of  total  alerts),  Bulgaria  (2.4%),  Portugal  (6.8%)  and 
Romania (6.8%). 

2.  NON-COMPLIANT PRODUCTS: ICSMS DATA 

Market surveillance authorities are also required to enter into the information and communication 
system for market surveillance (ICSMS) information in relation to products made available on the 

EN 

155 

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Union market for which an in-depth check of compliance has been carried out, in addition to their 
obligation to alert of dangerous products under RAPEX. This obligation has become more explicit 
with the new Regulation 2019/1020 on market surveillance327, which is fully applicable since July 
2021.  Data  from  the  period  2016-May  2022  shows  that  out  of  the  9199  toys  subject  to  in-depth 
investigations, 3982 were found to be non-compliant, which corresponds to 43.2% of inspected toys. 

Figure  16  :  non-compliant  toys  and  total  number  of  in-depth  toy  investigations  per  year  in 
ICSMS 

3500

3000

2500

2000

1500

1000

500

0

3287

762

472

699

488

1172

1416

619

1364

985

385

503

2016

2017

2018

2019

2020

2021

Not compliant

Total investigations

686

343

2022 (until
31/05/2022)

The data on the country of origin of products subject to in-depth investigations also corroborates the 
fact that most risks in toys of non-compliance come from third countries. 

Figure 17: country of origin of inspected toys in ICSMS (2016-2022) 

327 See article 34 of this Regulation. 

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3.  DATA FROM THE EVALUATION BASED ON THE NATIONAL REPORTS 

Under their obligation to report on the application of the Directive,328 Member States have to present 
their market surveillance activities. For 2014 – 2018, 21 Member States (mostly small Member States 
corresponding to a little more than 50% of the EU-28 population329) provided for the first time data 
on marketing restrictions of toys that could be consistently evaluated.  

The  evaluation  showed  that  market  surveillance  authorities  in  all  21 Member  States  together 
(visually) inspected a little more than 14,000 toys on average each year during 2014 – 2018. As an 
average during each of these year five years, tests were carried out on 2,100 toys; 2,800 toys were 
assessed as non-compliant (due to the fact that some defects were so obvious that they did not need 
laboratory tests) and restrictive measures were taken on 690 toys found to be dangerous. 

Looking at each individual Member State (of the 21), almost 30% of the inspected toys were tested, 
more than 30% of the inspected toys were assessed as non-compliant, and on a little more than 15% 
of the inspected toys national measures to restrict the marketing were taken. 

Thus,  almost  every  third  toy  inspected  was  non-compliant.  This  reflects  the  capacities  of  market 
surveillance authorities to find non-compliant toys through targeting economic operators likely to 
break  the  rules  (such  as  those  that  have  a  history  of  non-compliance)  and  toys  marketed  in  large 
numbers or having severe health impacts when non-compliant. 330 

By  comparison,  four  joint  market  surveillance  actions  on  toys,331  supported  by  the  Consumer 
Programme  of  the  European  Commission,332  showed  non-compliance  rates  for  the  tested  toys 
between 10% and 96%, with an average of 43%.  

It thus appears that market surveillance is able to detect non-compliant toys at an average rate of 30% 
– 40%, although with a sometimes considerable variability around this average. Rates around 10% 
or less in some small Member States may however be caused by too little testing compared to those 
Member States that were nearer to the average. This became evident from the Member States’ 5-
yearly reports 2014 – 2018. Any reasons for the low rates were not reported but can be assumed, 
based on informal contacts with market surveillance authorities, to be linked to too little  financial 

or 

of 

Chairpersons 

various  Administrative 

328 Article 48 of the Toy Safety Directive. 
329 Population data taken from Council Decision (EU, Euratom) 2018/2076 amending the Council’s Rules of Procedure. 
OJ L 331, 28.12.208, p. 218.  
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018D2076&qid=1571646130303&from=EN  
330  Good  practice  for  market  surveillance.  Guidance  document  developed  by  market  surveillance  experts  who  are 
members 
7. 
https://ec.europa.eu/docsroom/documents/23041/attachments/1/translations/en/renditions/pdf  
331 Chemical risks in plasticised toys 
http://prosafe.org/images/Documents/JA2015/Reports/PROSAFE_Final_Technical_Report%20_TOYS-
JA2015_09.04.2018.pdf 
Acoustic toys 
http://prosafe.org/images/Documents/JA2014/2017_Deliverable%20D7.6-final_technical_report%20-
%2012.04.2017%20rev%20CHAFEAnt.pdf  
Toys intended for childrens under 3 years 
http://prosafe.org/images/Documents/JA2013/JA2013_Toys_Final_Technical_Report_24-02-2016.pdf 
Children’s kick scooters 
http://prosafe.org/images/Documents/JA2013/JA2013-Kick_scooters-Deliverable_D11.2-
Final_Technical_Report.v6_24.03.2016.pdf  
332 

Consumer Programme 2014-2020.  http://ec.europa.eu/chafea/consumers/programme/index_en.htm  

Cooperation 

(AdCo) 

groups. 

P. 

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means or the non-existence of a national test laboratory. A ‘best practice’ conclusion may thus be 
that market  surveillance  has to  be sufficiently well equipped, whether with financial  resources or 
other, in order to perform well. 

Due to the fact that the only available data for measuring the effectiveness of market surveillance is 
data on non-compliant toys, a more detailed differentiation according to Member States, type of toys, 
company size, EU toys vs. Third Country toys could not be made in the context of the evaluation.  

4.  RESULTS  FROM  2020  AND  2021  COORDINATED  ACTIONS  ON  THE  SAFETY  OF  PRODUCTS 

(CASP)  

The  2020  CASP  joint  action  on  nitrosamines  in  toys  focused  on  the  level  of  nitrosamines  and 
nitrosatable substances in balloons, squeeze toys and finger paints. 16% of the 220 products tested 
exceeded  the  limit  values  set  in  standard  EN  71-12:2013  for  nitrosamines  and/or  nitrosatable 
substances. Eight samples of balloons exceeded the limit values for both substances. Only 24% of 
the samples met the labelling and warnings requirements. The percentage of balloons that did not 
meet the chemical requirements (33%) was significantly higher than that of finger paints (9%) and 
squeeze toys (3%). The majority of samples (179) were purchased in physical stores. The percentage 
of samples that exceeded the limit  values for chemical  testing did  not  vary  considerably between 
samples  purchased  online  and  those  from  physical  stores.  However,  a  higher  percentage  of  the 
samples purchased online (88%) did not meet the labelling and warnings requirements compared to 
the samples purchased in physical stores (73%). 

The 2021 CASP joint action on toys from non-EU workshops focused on plastic toys and toys with 
plastic  parts  for  children  under  and  above  36  months  collected  online  and  originated  from  third 
countries: 84% of toys tested did not meet the applicable safety requirements. The detailed results of 
the project were as follows: Number of toys tested: 92 (50 toys intended for children above 36 months 
and  42  toys  intended  for  children  under  36  months).  A  total  of  15  toys  (16%)  met  the  testing 
requirements while 77 toys (84%) did not meet the testing requirements. Toys intended for children 
under 36 months presented a slightly larger number of samples that did not meet the requirements 
(88%) than toys for children above 36 months (80%). The market surveillance authorities’ checks on 
warnings,  labelling  and  instructions  showed  that  all  the  samples  (except  one)  did  not  meet  the 
requirements. Full report expected to be published in June 2022. 

The 2021 CASP joint action on electrical toys focused on electric toys with button cells/other cells; 
electric ride-on toys; electric toys with lasers/ other lights; and remote-control toys. Compliance with 
the  Toy  Safety  Directive  but  also  other  legislation  like  Directive  2011/65  on  the  Restriction  of 
Hazardous  Substances  in  Electrical  and  Electronic  Equipment  (RoHS)  was  assessed:  25%  of  the 
samples  did  not  meet  all  the  applicable  requirements.  The  detailed  results  of  the  project  were  as 
follows: The number of toys tested was 130 (58 electric toys with button cells/other cells; 34 electric 
ride-on toys; 24 electric toys with lasers/ other lights; and 14 remote-control toys). A total of 75%of 
the samples (97) met the requirements while 25% of the samples (33) did not meet all the applicable 
requirements. The product categories where the most samples did not meet all requirements were 
remote-control  toys  (36%)  and  electric  toys  with  button  cells/other  cells  (33%).  The  majority  of 
samples  (72%)  came  from  physical  shops.  A  considerably  higher  percentage  of  electric  toys 
purchased  online  did  not  meet  at  least  one  of  the  relevant  requirements  (47%)  compared  to  the 
percentage of those purchased in physical shops (17%). Full report expected to be published in June 
2022. 

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ANNEX 12: DIGITAL ASPECTS AND INTERNET-CONNECTED TOYS 

The Evaluation concluded on the Directive not being able to quickly adapt to technical and scientific 
progress, compared to the rapidly evolving market. The scope of the Directive is focused on health 
and safety (see the particular safety requirements in Annex II: physical and mechanical properties, 
flammability, chemical properties, electrical properties, hygiene, radioactivity333) and does not cover 
other issues such as privacy or information security. As a result, there were cases in the past where 
risks posed by cybersecurity or privacy concerns on toys could not be addressed.  

Currently, advanced children’s toys on the market include varieties of dolls and toy creatures that can 
change  their  behaviour  in  order  to  entertain  (such  as  by  remembering  answers  given  by  a  child, 
knowing what time it is or giving a weather forecast, and otherwise adapting to the child’s responses); 
construction  games  permitting  children  to  build  programmable  gadgets;  and  specially-designed 
tablets that have various features permitting children to interact with their environment in different 
ways (including by uploading photos and documents to personalise) 334.  

Regarding internet-connected toys, the new connecting functionalities can create new vulnerabilities 
for children and require that internet-connected toys are protected against cyberattacks. Children are 
particularly  at  risk  because  they  may  not  become  aware  that  a  toy  speaking  to  them,  such  as  an 
internet-connected doll or robot, can actually be  a misleading intruder who has hacked the toy in 
order to get access to the home of a child. This is also the case with regards to toys which rely on 
artificial  intelligence335.  In  2017, My  Friend  Cayla336,  a  smart  doll  that  used  facial  and  voice 
recognition, was declared an illegal surveillance tool in a number of countries, including Germany. 
With  the  abundance  of  personal  information  collected,  processed  and  shared  through  advanced 
technologies such as artificial intelligence and predictive analytics, children’s data may also be used 
for the purpose of profiling, potentially affecting their fundamental legal rights and freedoms. The 
age and maturity of the child may affect their ability to understand the motivation behind this type of 
data collection and uses or the longer term privacy consequences337. 

The  TSD  does  not  contain  any  rules  on  cybersecurity,  and  in  common  with  other  Union 
harmonisation  legislation  does  not  explicitly  mention  the  word  “security”,  although  this  could  be 
argued to be implicitly covered, as in other sectoral legislation as it is part of the broader concept of 
product safety.  

However, cybersecurity risks relating to personal data protection and privacy and protection from 
fraud for toys are now addressed through the adoption of a delegated act pertaining to Articles 3(3)(e) 
and 3(3)(f) of the Radio Equipment Directive (RED) in October 2021338 (as of 01/08/2024, radio 
toys  have  to  comply  with  minimum  baseline  security  requirements  pertaining  to  personal  data 
protection and privacy and as of 01/08/2024, internet-connected toys have to comply with minimum 
baseline  security  requirements  pertaining  to  protection  from  fraud).  This  delegated  act  has 

333 See section 2.1.2 above. 
334 See also Consumer Product Safety in the Internet of Things (oecd-ilibrary.org) 
335 See for example https://www.datanami.com/2022/03/29/are-we-ready-for-the-dangers-of-smart-toys/ 
336  Generation  AI:  What  happens  when  your  child's  friend  is  an  AI  toy  that  talks  back?  |  World  Economic  Forum 
(weforum.org) 
337 
en.pdf?expires=1649682232&id=id&accname=guest&checksum=75B41EC6A1648ACD89848BB4F8FB1FF5  
338 Commission Delegated Regulation (EU)  2022/30 of 29 October 2021 supplementing Directive 2014/53/EU of the 
European  Parliament  and  of  the  Council  with  regard  to  the  application  of  the  essential  requirements  referred  to  in 
Article 3(3), points (d), (e) and (f), of that directive, OJ L 7/6 of 12.01.2022. 

https://www.oecd-ilibrary.org/docserver/9b8f222e-

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strengthened cybersecurity by requiring manufacturers of radio equipment, including of radio toys, 
as defined in the delegated act, to ensure that minimum security requirements are complied with from 
the outset. This has further embedded the specific provisions in the GDPR pertaining to ensuring 
privacy by design and default but emphasising broader security by default principles.  

This ought to ensure that connected toys area designed in a way that ensures they remain cybersecure, 
with software updates to ensure product security post-market placement. Although there are concerns 
expressed by stakeholders regarding the need to strengthen cybersecurity in connected toys through 
the TSD, this has already been addressed through parallel legislation, which all radio toys would have 
to adhere to. This has closed the regulatory gap. 

The Delegated Regulation, applicable from 1 August 2024, will apply to the radio equipment covered 
by the TSD processing personal data, traffic and location data and require the manufacturers to take 
data protection and privacy measures before putting toys on the internal market. The manufacturers 
will have to perform a conformity assessment to meet such requirements as regulated by Article 17 
RED. This would mean that they need to demonstrate full compliance of their toys with the GDPR 
requirements,339 thus, operationalising the GDPR’s focus on data protection by design and default in 
relation to toys.  

Safety issues specific to AI-based toys will be subject to the EU Artificial Intelligence Act (AIA)340 
when  it  is  adopted.  According  to  Article  6  in  conjunction  with  Annex  II  AIA,  toys  with  AI 
components  may  be  classified  as  high-risk  systems  “if  the  product  in  question  undergoes  the 
conformity  assessment  procedure  with  a  third-party  conformity  assessment  body  pursuant  to  that 
relevant Union harmonisation legislation”. Toys are expected to be included as high risk AI in the 
final  Regulation  once  adopted,  they  will  be  subject  to  ex-ante  and  ex-post  compliance  and 
enforcement mechanisms both under the TSD and under the AIA. The risk management for such 
high-risk  AI  systems  will  be  an  iterative  process  that  runs  throughout  the  entire  life  cycle  of  the 
system,  with  regular  updates,  following  the  steps  described  in  Article  9  (2)  AIA.  Article  10  AIA 
prescribes special data governance requirements for training, validation and testing data for high-risk 
systems. In this context, the AIA is well placed to complement the TSD by closing one of the gaps 
in the scope of product safety, namely the safety of AI-based toys. In addition, the AIA also prohibits 
a  number  of  AI  practices,  and  in  particular  deploying  subliminal  techniques  beyond  a  person’s 
consciousness  in  order  to  distort  a  person’s  behaviour  in  a  manner  that  can  cause  physical  or 
psychological harm (Article 5.1 (a)) and exploiting the vulnerabilities of a specific group of persons 
due to their age that could distort the behaviour of that person in a manner that can cause harm (Article 
5.1(b)).  

Smart connected toys often involve the collection and processing of data, including the data generated 
by  children  playing  with  such  toys,  in  order  to  ensure  the  toy  functionality  and  optimal  playing 
experience. Such sensitive personal data is subject to strict rules of the General Data Protection 
Regulation (GDPR).341 The TSD does not contain any relevant rules; the GDPR is a horizontal legal 
act complementing sectoral legislation such as the TSD. 

339 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) 287 final of 19.11.2020, p 80. 
340 European Commission (2021). Proposal for a Regulation of the European Parliament and of the Council laying down 
harmonised  rules  on  artificial  intelligence  (Artificial  Intelligence  Act)  and  amending  certain  union  legislative  acts, 
COM(2021) 206 final of 21.04.2021. 
341 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural 
persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 
95/46/EC, OJ L 119 of 4.5.2016. 

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Recital 38 GDPR recognises that children merit special protection because they may be less aware 
of risks, consequences and safeguards concerned and their rights  in  relation to  their data. Special 
protection should apply when children are using services offered to them directly (e.g., when playing 
with smart connected toys). Recital 71 GDPR recommends that such practices as profiling should not 
concern children (though there is no explicit prohibition of this practice in their regard).342 

The GDPR introduces data protection by design and by default (Article 25), lawfulness, transparency 
and  fairness  of  data  collection  and  processing,  data  minimisation,  purpose  limitation  of  data 
collection  and  processing,  accuracy,  integrity  and  confidentiality  of  data  storage  and  processing 
(Article  5).  The  GDPR  imposes  certain  obligations  on  data  controllers  and  processors.  Data 
controllers are any natural or legal person that determines the purposes and means of the processing 
of personal data (Article 4(7) GDPR), which means that a producer would fall under this category 
and have to  comply with special obligations. Recital 78 GDPR encourages producers of products 
who are not themselves controllers to take due account of data protection requirements and to design 
their products in such a way that controllers and processors can fulfil data protection requirements. 
Article  32  GDPR  mandates  the  controllers  and  processors  to  ensure  a  level  of  data  security 
appropriate to the risk of the processing and lists security mechanisms that need to be implemented. 
This  is  of  particular  importance  for  smart  connected  toys,  as  children  are  characterised  as 
“vulnerable” data subjects in Recital 75 GDPR that explains risks to rights and freedoms of natural 
persons. 

Sales of connected toys in the EU 

The study underpinning the IA has also sought estimates of sales of connected toys. In this section, 
we first provide an overview of available market research data on connected toys, before presenting 
the results of our consultations with manufacturers and industry representatives. 

The connected toys’ market, worth approximately EUR 2.66 billion in 2015, was expected to reach 
a high of EUR 10.75 billion by 2020.343 Other more conservative market research estimates suggest 
an increase to a 2020 market value of EUR 7.23 billion344, or EUR 5.32 billion345. For the period 
2021-2026, the estimated CAGR amounts to 24.3%, or, in line with some alternative estimations, 
19% for a period of 2020-2027, with the global industry reaching the value of EUR 17.94 billion by 
2027.346  One  of  the  explanations  for  this  extensive  development  of  the  market  for  connected  toy 
products  might  be  the  possibility  of  selling  them  at  prices  significantly  higher  than  those  of  the 

Reports, 

342 Article 29 Data Protection Working Party (2018). Guidelines on Automated individual decision-making and Profiling 
for the purposes of Regulation 2016/679, WP251rev.01: https://ec.europa.eu/newsroom/article29/items/612053 . 
343 Chaudron, S., et al. (2017) Kaleidoscope on the Internet of Toys Safety, security, privacy and societal insights, JRC 
Technical 
online: 
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC105061/jrc105061_final_online.pdf, DOI:10.2788/05383. 
344  Mordor  Intelligence  (2021).  Connected  Toys  Market  –  Growth,  Trends,  COVID-19  Impact,  and  Forecasts  (2022-
2027), online: https://www.mordorintelligence.com/industry-reports/connected-toys-market 
345 BusinessWire (2021). Global Connected Toys Market Report 2021: Market to Reach $18.9 Billion by 2027 - Console-
online: 
Connected  Toys 
https://www.businesswire.com/news/home/20210318005627/en/Global-Connected-Toys-Market-Report-2021-Market-
to-Reach-18.9-Billion-by-2027---Console-Connected-Toys-is-Projected-to-Account-for-7.7-Billion---
ResearchAndMarkets.com 
346 BusinessWire (2021). Global Connected Toys Market Report 2021: Market to Reach $18.9 Billion by 2027 - Console-
Connected Toys is Projected to Account for $7.7 Billion - ResearchAndMarkets.com. 

-  ResearchAndMarkets.com, 

is  Projected 

$7.7  Billion 

to  Account 

for 

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‘traditional’  toys.  For  example,  a  study  carried  out  in  Korea  proved  that  installation  of  ‘smart’ 
elements in toys might increase their market prices to levels not seen in non-smart toy products.347 

Although these market research data report rapid market expansion in this area, interviews with toy 
industry  representatives  have  noted  that this  is  being  significantly limited  by  concerns  relating  to 
cybersecurity and the protection of personal data and privacy in connected toys. There have been 
extensive  discussions  in  the  public  discourse  about  the  cybersecurity  challenges  and  resulting 
children’s safety implications of internet-connected toys.348 This has been sparked by instances of 
toy  products  without  sufficient  protective  minimum  baseline  security  requirements  or  privacy  by 
design measures built into their IT-systems, such as the My Friend Cayla doll349, VTech Tablets, or 
Fisher Price Smart Toy Bear350. 
More specifically, a 2016 report by the Norwegian Consumer Council351 investigated issues relating 
to  toy  safety  in  the  Toy  Fail  report.352  This  found  that  Internet  of  things  (IoT)  technologies  raise 
serious issues regarding their suitability for use in toys without due consideration of cybersecurity 
and child safety risks and without adequate cybersecurity measures. 

As  regards  the  manufacturing  industry,  it  needs  to  be  acknowledged  that  the  overall  toys’  EU 
manufacturing  sector  consists  mostly  of  the  SMEs,  as  99%  of  the  EU  firms  in  this  sector  can  be 
categorised as such. The small and medium-sized companies provide also 61% of employment within 
the overall industry353. In comparison, according to a 2018 study, 80% of the 1,800 toy manufacturing 
firms in China were considered to be small, medium or micro-sized enterprises.354 In light of these 
statistics,  it  should  be  emphasised  that  the  challenges  faced  by  the  small  stakeholders  in  industry 
might be proportionally bigger, in comparison with the situation of the biggest industry players. This 
pertains particularly to the lack of IT capabilities and regulatory compliance355 – both substantially 
significant as regards manufacturing of connected toys. 

During  the interview programme, it was confirmed that the size of the connected toys’ market  is 
smaller than the adverse publicity surrounding children’s safety when using connected toys would 
suggest. All respondents addressed with the question concerning the market for connected toys (i.e. 

347 Jung, S. (2017). Research on synchronization between smart toys and smart phones for classifying smart toys, [in:] 
“International  Journal  of 
Internet,  Broadcasting  and  Communication”,  Vol.9,  No.4,  pp.  25-30,  DOI: 
10.7236/IJIBC.2017.9.4.25, p. 29. 
348 Holloway, D. & Green, L. (2016). The Internet of Toys. [in:] “Communication Research and Practice, Special Issue: 
ANZCA  2016  Creating  Space  in  the  Fifth  Estate”,  Vol.  2,  Issue  4,  (eds.  Fulton,  J.  &  McIntyre,  P.),  DOI:  
10.1080/22041451.2016.1266124, p. 516. 
349 Holloway, D. & Green, L. (2016). The Internet of Toys. [in:] “Communication Research and Practice, Special Issue: 
ANZCA  2016  Creating  Space  in  the  Fifth  Estate”,  Vol.  2,  Issue  4,  (eds.  Fulton,  J.  &  McIntyre,  P.),  DOI:  
10.1080/22041451.2016.1266124, p. 513. 
350  Nelson,  B.  (2016).  Children’s  Connected  Toys:  Data  Security  and  Privacy  Concerns.  Office  of  Oversight  and 
Investigations,  Minority  Staff  Report,  Committee  On  Commerce,  Science,  and  Transportation,  United  States  Senate, 
online: https://www.hsdl.org/?view&did=797394, pp. 10-12. 
351 https://www.forbrukerradet.no/siste-nytt/connected-toys-violate-consumer-laws/  
352 Toyfail report by Norwegian Consumer Association - https://fil.forbrukerradet.no/wp-content/uploads/2016/12/toyfail-
report-desember2016.pdf  
353 Michalitsi-Psarrou, et al. (2019).  Empowering Product Co-creation Approaches Through Business Interoperability 
Concepts: The Toy Industry Case, [in:] (K. Popplewell et al., eds.) “Enterprise Interoperability VIII, Proceedings of the 
I-ESA Conferences 9”, DOI: 10.1007/978-3-030-13693-2_33, pp. 397-398. 
354 Kwong, C. W., Mak, S. L. & Li, C. H. (2020). The Exploration of a Technical Model for Toy Factories in China to 
Deal  with  European  and  US  Toy  Safety  Requirements,  [in:]  “International  Journal  of  Business,  Humanities  and 
Technology”, Vol. 10, No. 2, DOI:10.30845/ijbht.v10n2p4, p. 26. 
355 Michalitsi-Psarrou, et al. (2019).  Empowering Product Co-creation Approaches Through Business Interoperability 
Concepts: The Toy Industry Case, [in:] (K. Popplewell et al., eds.) “Enterprise Interoperability VIII, Proceedings of the 
I-ESA Conferences 9”, DOI: 10.1007/978-3-030-13693-2_33, pp. 397-398. 

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manufacturers  and  industry  representative  organisations)  assessed  the  share  of  the  toys’  market 
constituted by the connected products as very low, or insignificant. For instance:  

  Overall, from this small sample of manufacturers and industry representative organisations, 
most  of  those  consulted  either  do  not  work  with  internet-connected  toys  or  reported 
percentages  of  below  1%.  One  organisation  stated  an  internet-connect  toy  portfolio  that 
comprised around 5% of their total toy product portfolio. 

  A major top 3 toys manufacturer interviewed stated that they had steered away from designing 
or producing connected toys since the My Friend Cayla Doll scandal for reputational reasons. 
As a result, they currently have no active internet-connected toy products on the market. 

  One of the business organisations pointed out that its member-firms are mostly SMEs, and 
that only a tiny part of their products portfolios are the connected toy products, as SMEs tend 
not  to  have  technological  capabilities  to  manufacture  this  type  of  products.  Another 
interviewee assessed that the discussion on connected toys’ safety as being disproportionate 
in its scope compared to the actual share of this type of products in the market. 

However, as noted above, this is a small sample that primarily comprises EU-based manufacturers 
and industry associations. As such, the extent to which internet-connected toys are being produced 
in other regions and imported into the EU is largely unknown.  

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ANNEX 13: DIGITAL PRODUCT PASSPORT UNDER THE PROPOSAL FOR 
AN ECODESIGN FOR SUSTAINABLE PRODUCTS REGULATION 

The proposal for the ESPR foresees the possibility for the Commission to require that for products 
covered under the delegated acts, a Digital Product Passport (DPP) containing specific information 
is available (see chapter III). The precise information to be included in the DPP is expected to be 
determined  when  preparing  product-specific  rules.  It  may  include  information  such  as  the 
environmental footprint of a product, information useful for recycling purposes, the recycled content 
of  a  certain  material,  information  about  the  supply  chain,  and  others.  The  proposal  for  the  EPSR 
contains  detailed  provisions  as  to  the  technical  design  and  operation  of  the  DPP,  as  well  as  the 
requirements. It already foresees that other Union legislation requires information to be added to the 
DPP.  Work  will  now  be  carried  out  with  standardisation  organisations  to  prepare  the  necessary 
technical  features for the implementation of the DPP with the adoption of the ESPR and the first 
delegated acts on specific products.  Furthermore, Annex III specifies the type of information that 
may  be  required  as  part  of  the  DPP.  The  DPP  may  contain  compliance  documentation  and 
information required under this Regulation or other Union law applicable to the product, such as the 
declaration of conformity, technical documentation or conformity certificates. 

As to the interaction with customs, the proposal for the ESPR foresees that the DPP are registered in 
a Product Passport Registry to be set up and maintained by the Commission (see article 12). In order 
to  ensure  the  customs  controls,  the  registry  will  be  interconnected  with  the  EU  Customs  Single 
Window  Certificates  Exchange  (EU  CSW-CERTEX).  If  discrepancies  between  the  information 
contained in the registry and the customs declaration occur, the release for free circulation of that 
product will be refused.  

For more information:  

o  Proposal  for  a  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE 
COUNCIL establishing a framework for setting ecodesign requirements for sustainable 
products and repealing Directive 2009/125/EC,  COM (2022) 142 in particular Chapter 
III. 

o  Annex III of the Proposal, on the requirements for the DPP. 
o  Staff Working Document – Impact Assessment accompanying the proposal and annex 18 

to the Impact Assessment. 

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ANNEX 14: IMPACTS OF THE OPTIONS356 

1.  ECONOMIC IMPACTS 

1.1. 

Public authorities 

Reliable data on the costs for market surveillance authorities (MSAs) of implementing the Directive 
and  the  impact  of  the  policy  options  on  these  costs  is  difficult  to  obtain  in  a  detailed  way.  No 
information was available on the ‘cost of an inspection’ by a market surveillance authorities. As such, 
a number of proxies have been used in developing these cost calculations.  

A) Baseline 

The Summary of EU Member States and EEA EFTA States' assessment and review of the functioning 
of market surveillance activities according to article 18(6) of Regulation (EC) No 765/2008 for the 
period 2014-2016 is the latest period for which information on the costs of market surveillance is 
available disaggregated by sector. Out of the 18 reporting Member States and Norway (BE, BG, HR, 
CY, DK, EE, FI, FR, ES, HU,  IE,  IT,  LU, NL,  NO, PL, RO, SI, SE), a  total  budget  of EUR 8.5 
million  was  available  to  market  surveillance  for  toys,  almost  equally  divided  between  laboratory 
testing and in-house testing on average per annum between  2014 and 2016. Furthermore, internal 
staff resources represented a total of 373.4 FTE for these 19 countries. 

Over the same period, an average of 11,533.6 inspections on toy products were undertaken per annum 
by the reporting countries. On the basis of this information, the average price per inspection can be 
calculated  as  being  the  total  cost  of  inspection  (EUR  8,517,890.09)  divided  by  the  number  of 
inspections (11,533.6) = EUR 738.52. In terms on staff resources, it is estimated that that one staff 
member  can  undertake  30.89  inspections  per  annum.  This  is  of  course  a  gross  oversimplification 
given the different roles of staff in market surveillance authorities, but it provides a rough estimate 
to help assess the impact of the different policy options on market surveillance authorities. 

The REFIT evaluation accompanying the proposal for a Regulation laying down rules and procedures 
for  compliance  with  and  enforcement  of  Union  harmonisation  on  products  provides  more 
comprehensive  data  on  toy  inspections.  The  table  below  provides  the  number  of  inspections 
undertaken in 22 Member States. By using proxies for the number of inspections for those Member 
States for which no data is available (DE, ES, LT, NL, SK), we have extrapolated the number of 
inspections undertaken annually at a total of 25,259357. 

Table 21: Annual number of inspections  

Country 

Inspections 

Inspections 
million inhabitants 

per 

Proxy used  Total inspections for all 

Member States  

AT 
BE 
BG 

584 
1,270 
1,739 

65.38  
109.90  
251.43  

584.00  
1,270.00  
1,739.00  

356 See the accompanying Impact Assessment Study on the revision of the Toy Safety Directive 2009/48/EC, 2022, VVA, 
CSES and Asterisk 
357 By using these proxies and the average price per inspection calculated above, the overall budget for toy inspections 
across the EU would be EUR 18,654,257. 

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Country 

Inspections 

Inspections 
million inhabitants 

per 

Proxy used  Total inspections for all 

Member States  

CY 
CZ 
DE 
DK 
EE 
EL 
ES 
FI 
FR 
HR 
HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PO 
PT 
RO 
SE 
SI 
SK 

960 
1,631 

113 
402 
28 

1,351 
2,834 
384 
1,180 
4 
1,115 

51 
116 
149 

754 
420 
1,496 
84 
1,757 

1,123.07  
152.40  

-    

42.02358 

19.35  
302.24  
2.62  

-    

40.78359 

244.14  
42.02  
95.14  
121.26  
0.80  
18.82  

-    

61.27360 

80.35  
61.27  
288.70  

-    

109.9361 

19.93  
40.78  
77.97  
8.09  
833.11  

18,422 

179.94  

-    

152.4362 

960.00  
1,631.00  
3,490.20  
113.00  
402.00  
28.00  
423.31  
1,351.00  
2,834.00  
384.00  
1,180.00  
4.00  
1,115.00  
171.29  
51.00  
116.00  
149.00  
1,920.53  
754.00  
420.00  
1,496.00  
84.00  
1,757.00  
832.10  
25,259.43  

If  no  change  to  the  TSD  would  occur,  the  costs  for  public  authorities  in  conducting  market 
surveillance are expected to remain equal. The share of online sales is expected to grow, following 
the path of the previous years (increasing by 20% between 2010 and 2020). Member States authorities 
would have to increase their market surveillance activity in order to identify the same share of non-
compliant toys. However, given their budget is unlikely to be increased, it is likely that the impact 
would not be on Market Surveillance authorities (MSAs), but would merely result in a greater number 
of non-compliant toys on the market. 

In the baseline scenario, changes to the TSD could still be made as is the case today, by introducing 
limit values in Appendix C of the TSD for toys intended for children under 36 months. In order to 
estimate  the  cost  of  the  human  resources,  data  about  the  amount  of  person  days  needed  for 
transposition is taken from previous Impact Assessments, which assesses the number of person days 
needed for transposition of a Directive to be between 20 and 60. Using the Member State daily labour 

358 inspections per million inhabitants in France. 
359 inspections per million inhabitants in Portugal. 
360 inspections per million inhabitants in Latvia. 
361 inspections per million inhabitants in Belgium. 
362 inspections per million inhabitants in Czechia. 

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cost (i.e. EUR 309363), the overall cost of transposition is estimated to be in the range of EUR 6,174 
to EUR 18,522 per Member State. 364. 

Impacts on customs 

In case of physical controls of toys, customs authorities will notably check:  

1)  CE marking and any labelling requirements, and the declaration of conformity (DoC). 

2)  User instructions  

3)  Technical  file  (upon  request  if  evidence  is  requested  by  market  surveillance  authorities 

liaising with customs authority) 

The customs will also control compliance with other EU environmental legislation applicable to toys, 
such as the Packaging Directive. 

Under  the  baseline  situation  in  the  TSD,  the  controls  by  customs  occur  at  the  import  stage,  in 
cooperation with the relevant market surveillance authorities, as appropriate on a risk based approach. 
The enforcement applies on the entire EU customs territory. 

As concerns Information Technology (IT) aspects and customs, currently, a number of IT systems 
are coexisting at EU level to allow for improved coordination of customs controls amongst Member 
States with the support of the European Commission, such as the Single Window Environment for 
Customs and the TARIC Information System. Specific resources are allocated for these tools.  

If toys are found to be non-compliant at EU borders, a restriction on their release for free circulation 
may be imposed until such time as the compliance issues have been addressed. 

If not detected by customs, the introduction in the EU customs territory of a toy infringing the TSD 
could present a serious risk for health, safety and the environment. For example, products with higher 
limit  values  than  permitted  under  the  TSD  (and/  or  in  EN  standards  supporting  the  essential 
requirement) may indeed pose health risks to children. The nature and magnitude will depend on 1) 
the type of substance and its harmful effects) and 2) the level of potential exposure. If no change to 
the Directive was to take place, and with the increasing use of the internet to sell toys, the number of 
non-conforming toys on the EU market would only increase.  

B) Policy options to strengthen the protection of children from harmful chemicals - PO1a, PO1b 
and PO1c  

These options are not expected to lead to significant costs for public authorities, as compared to the 
baseline scenario. 

One-off costs relating to the transposition of the new limit values into national legislation will be 
similar to the baseline. These costs would disappear if the legal instrument chosen was a Regulation; 

For market surveillance authorities, the number of inspections would not be expected to rise. In any 
case, it is likely that their budgets would not be increased.  

Impacts on customs  

Under policy options 1a, 1b and 1c, the role of customs would be the same as under the baseline. In 
case  of  identification  of  a  product  with  high  risk,  competent  market  surveillance  authorities  are 

363  Data  about  labour  costs  comes  from  Eurostat’s  Labour  Cost  Survey,  (2016),  category  ‘public  administration  and 
defence, compulsory social security’ per employee FTE and adjusted for inflation. 
364 IA study on the revision of the Toy Safety Directive by VVA, CSES and Asterisk. 

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notified following the already existing cooperation procedures in place between national customs and 
market surveillance authorities.  

However, it is  likely that,  in  case of changes  in  limit  values of substances in  toys, manufacturers 
located in third-countries might adapt to new rules only after a transition period. This might lead to 
a higher number of imported toys to be identified by competent market surveillance authorities as 
being non-compliant and subsequently increase the number of alerts to customs to block imports of 
those specific products. This would thus indirectly lead to an initial increase of the burden on customs 
(for  example  an  increase  in  number  of  alerts  received  from  market  surveillance  authorities,  or 
increase of physical checks of imported products or of shipments that are placed on hold at the border 
subject  to  a  refusal  for  free  circulation).  These  cases  are  expected  to  progressively  decrease  in 
proportion to the adaptation of third-country manufacturers to EU standards, but it is likely that in an 
initial period customs might incur in additional burden. 

C) Policy options to reduce the number of non-compliant toys 

PO2a 

Under  Option  2a,  no  significant  costs  are  expected  for  market  surveillance  authorities.  Market 
surveillance authorities consulted explained that the time necessary to inspect EU-type examined toys 
was  the  same  as  for  those  that  were  self-tested  by  manufacturers.  While  some  suggested  that 
extending  third-party  conformity  assessment  would  not  significantly  change  the  amount  of  time 
necessary for inspections (under 3% of efficiency gain), other disagreed. They argued that the time 
necessary to collect information from a notified body is significantly lower than economic operators. 
They assumed that the time saving would be over 5%. This only relates to time saving on requesting 
documents and not on any tests market surveillance authorities may undertake. As an average, the 
introduction  of  option  2a  would  result  in  a  5%  time  saving  for  the  average  inspection  by  market 
surveillance authorities, which would translate into a 5% increase in the number of inspections. 
Given  the  average  number  of  inspections  was  25,259365,  the  number  of  inspections  in  the  EU  is 
expected to rise to 26,522 per year. Dividing the total budget available by the increased number of 
inspections, the cost per inspection could be reduced to EUR 738.52 to EUR 703.35. This is based 
on the assumption that the budget will remain equal at national level and that the resources freed up 
by the efficiency will continue to be dedicated to inspections on toys. In addition, the precise number 
of inspections also depends on other practical factors including the specific toys subject to inspection 
and or tests. Therefore, the precise impact of this option on the number of inspections could be lower. 

With the extension of third-party conformity assessment to i) toys intended for children under 36 
months and ii) toys which are chemical mixtures,  Notified bodies may incur costs relating to the 
increase  in  the  testing  capacity  required  to  undertake  these  tests.  In  certain  MS  (in  particular 
Germany) NBs argue that the necessary capacity exists already. 

As for the role of customs under this policy option, for toys for children under 36 months, and toys 
designed to be put in the mouth, market surveillance authorities would need to indicate to customs 
(e.g.  an  alert  on  TARIC)  a  specific  notice  on  identified  product  categories  that  would  require  an 
additional EC type approval certificate (i.e., mandatory 3rd party conformity assessment check by 
notified body). Customs systems would then be required to ensure that such certificate is present for 
the identified product categories. 

365 See Table 21: Annual number of inspections   

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PO2b 

The introduction of a digital passport would simplify the work of market surveillance authorities and 
would therefore significantly reduce the time spent chasing information from manufacturers. As such, 
the number of inspections undertaken by market surveillance authorities for the same resources would 
be expected to increase. While it is difficult to assess the exact scale of the reduction in the times 
needed to undertake inspections, interviews undertaken during the study, suggest that this could be 
in the range of 10% to 20%, which would translate into an equivalent percentage increase in the 
number of inspections which could be undertaken with the resources available. Given the average 
number of inspections was 25,259366, the number of inspections in the EU is expected to rise to 
between  27,785  and  30,311.  Dividing  the  total  budget  available  by  the  increased  number  of 
inspections, the cost per inspection is expected to lower from EUR 738.52 to between EUR 671.37 
and EUR 615.42. This is based on the assumption that the budget will remain equal at national level 
and that the resources freed up by the efficiency will continue to be dedicated to inspections on toys. 
In addition, the precise number of inspections also depends on other practical factors including the 
specific toys subject to inspection and or tests. Therefore, the precise impact of this option on the 
number of inspections would probably be lower. 

There would be one-off costs relating to market surveillance authorities adapting their information 
systems and procedures to allow them to verify these. However, these would be required by the ESPR 
regardless of whether toys are included in a delegated act by the ESPR. 

Under Option 2b, there would be no significant impact for notified bodies. 

Customs authorities 

This option would require that the existence of a DPP with the Declaration of Conformity is verified 
at customs. The reference to the DPP will be included in a central registry; when the release for free 
circulation is requested, customs authorities will verify that this DPP is included in the registry. DPPs 
will have to include the DoC for toys to be generated and included in the registry.  

Currently,  customs  controls  are  done  on  a  risk-based  manner.  This  option  will  rely  on  the 
interconnection of the DPP central registry with  the customs IT infrastructure (as proposed in the 
ESPR) leading to automatic controls at customs of the presence of the DPP. The costs associated with 
the interconnection of the relevant  IT infrastructures are required under the ESPR, this option for 
revision of the TSD would not impose additional costs in this respect. The automation of controls 
would allow customs to decrease their costs and it would allow them also to do more checks, and to 
be able to prevent more non-compliant toys being released for free circulation and thus placed on the 
Union market. 

The technical aspects of the DPP under this option are not set but it is expected that there would be 
some  costs  associated  with  defining  the  data  needs  and  information  exchange  protocols  and 
permissions between any DPP system and the EU SWE-C to allow customs authorities to check for 
the existence of the DPP on imported toys. Interconnection between the central registry of DPP and 
the EU SWE-C is already foreseen under the ESPR. 

On the other hand, the introduction of the DPP would likely entail the submission of the required 
documentation by the importer at a stage before the actual shipping of the product. This would lead 
to  potential  savings  for  customs  with  less  shipments  on  hold  at  the  border.  In  case  of  actual 
harmonisation and standardisation of the DoC within the DPP, this would also lead to a reduction of 
the physical controls. Customs, however, would exclusively check through automated systems of the 

366 See Table 21: Annual number of inspections   

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provision with the imported shipment of the DPP, not its actual content which would be still subject 
to checks of the relevant national market surveillance authority. 

PO2c 

Under Option 2c the effect of option 2a and option 2b would be cumulated. For market surveillance 
authorities, the time savings for inspections would be in the range of (5% for option 2a + 10% for 
option 2b =) 15% and (5% for option 2a + 20% for option 2b =) 25%. The cumulative effect is due 
to the fact that under 2a saving are linked to the reduced time in collecting documents, while under 
2b they relate to the reduced testing, as well as the time needed to chase and find the manufacturer. 
Given  the  average  number  of  inspections  was  25,259367,  the  number  of  inspections  in  the  EU  is 
expected to rise to between 29,048 and 31,573. Dividing the total budget available by the increased 
number of inspections, the cost per inspection could lower from EUR 738.52 to between EUR 642.18 
and EUR 590.83. This is based on the assumption that the budget will remain equal at national level 
and that the resources freed up by the efficiency will continue to be dedicated to inspections on toys. 
In addition, the precise number of inspections also depends on other practical factors including the 
specific toys subject to inspection and or tests. Therefore, the precise impact of this option on the 
number of inspections would probably be lower. 

Notified bodies would incur costs relating to the increase in the testing capacity required to undertake 
these tests, although these costs will be passed on to businesses. 

The impacts for customs authorities would be the same as in PO2b. 

1.2.  Economic operators – Administrative burden 

A) Baseline 

In the case of the Toy Safety Directive, the information obligations to be taken into account for the 
estimation of the administrative burden are the activities related to the safety assessment, such as the 
identification of the applicable safety requirements, generating the safety assessment, identification 
of the necessary tests and collecting all the necessary information  – in particular from the supply 
chain – needed for the completion of the required documentation. 

The safety assessment is performed by manufacturers for each toy. This requires considering all the 
hazards that a toy presents and that could lead to a risk when a child is exposed to a hazard during 
play. In the public consultation for the evaluation of the Toys Safety Directive (2020), manufacturers 
highlighted that taking into account all safety requirements causes significant costs and the safety 
assessment itself causes significant costs. 

It is thus possible to identify three main classes of costs: 

  Certification: which include all the activities related to the production of the safety assessment 
and the EC-type examination certificate. The actual testing of toys is  not considered  per se  an 
administrative burden but is accounted in this study as an adjustment cost.368 These certification 
costs can range between EUR 500 in case of self-assessment, and EUR 1000 in case of third-party 
assessment. 

367 See Table 21: Annual number of inspections   
368 “Testing costs. When business have to submit their products & processes to a test in order to get an authorisation or 
a certificate, these testing costs are not considered as administrative costs.”, Better Regulation Toolbox, p.525 

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  Technical Documentation: including costs incurred in coordination with the supply chain and 
gathering of the information needed for the technical documentation of the toy. According to the 
TSD  evaluation  estimates,  the  production  of  the  technical  documentation  would  amount  to 
approximately EUR 2,800 per new toy model. 

  Labelling: labelling is also part of the administrative burden and would entail the activities related 
to the identification of the applicable rules on CE marking, on warnings and other toy markings. 
According to the estimates, the average cost for a company would amount to EUR 700 per new 
toy model. 

The purpose of the following analysis is to estimate the potential changes in the administrative burden 
due to the application of the envisaged policy options. The information and data have been collected 
through multiple sources, including desk research, interviews and a survey with toy manufacturers 
and market surveillance authorities. The estimates provided in the different policy options are based 
on the information provided by consulted stakeholders and their expectations of the impacts based 
on the current descriptions of the policy options. The lack of definition of some details, prevented the 
possibility of having more specific estimates.  

The purpose of the analysis of the policy options is to estimate the potential increment with respect 
to  the  current  level  of  administrative  burden  (baseline)  and  the  impact  on  the  costs  -  increase  or 
reduction – due to the specific provisions. In this section, we define the baseline against which the 
policy options are compared to. 

According to the conducted interviews, the analysis of the responses to the SME survey and the data 
collected for the evaluation of the Toy Safety Directive (2020) it is possible to approximately estimate 
the current average administrative burden for a new toy model placed on the market: 

  Approximately EUR 4,000 in case of self-assessment; 

  Approximately EUR 4,500 in case of third-party conformity assessment.  

Table 22: Detail of administrative burden and related monetary estimates 

Type 

Certification: 

Self-assessment 

3rd-party 

Technical documentation: 

Self-assessment 

3rd-party 

Labelling: 

Self-assessment 

3rd-party 

Activities in scope 

Source 

  Generating the self-assessment 

 

Review of the technical 
documentation by NB 

  Obtaining an EC-type examination 

certificate 

 

 

Familiarising with the information 
obligation 
Retrieving relevant information 
from existing data 
  Generating technical 
documentation 

  Application of the CE marking 
 
Identification of applicable 
warnings and traceability elements 

TSD 
evaluation / 
Interviews 
TSD 
evaluation / 
Interviews 

TSD 
evaluation / 
Interviews 
TSD 
evaluation / 
Interviews 

TSD 
evaluation 
TSD 
evaluation 

500 

1000 

2800 

2800 

700 

700 

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B) Policy options to strengthen the protection of children from harmful chemicals -  

These policy options would not entail a direct increase of the administrative burden on companies 
since it does not entail any specific change in terms of information obligations for companies but 
focus on how the chemical composition of toys is. The indirect effect of these measures would most 
likely  include  an  increase  of  the  complexity  of  the  technical  documentation  and  the  effort  to 
familiarise with applicable safety measures, but these are considered to be marginal. In addition, there 
may be certain administrative costs from applying for derogations under option 1b, which will depend 
on whether the derogations are requested and for which specific substances.  It has been estimated 
that these could range from EUR 100.000 to EUR 300.000 per year, for the whole industry.  

C) Policy options to reduce the number of non-compliant toys 

PO2a 

Policy option 2a would entail the extension of pre-marketing conformity assessments to toys that are 
chemicals mixtures or substances for which there are higher risks of exposure; and that are marketed 
to under 36 months old or designed to be put in the mouth. Based on the responses obtained through 
the interviews and the SME survey by toy manufacturers, the administrative burden for conformity 
assessments would likely increase in comparison to the baseline. Currently only around 3% of toys 
have to undergo third party conformity assessments.369 Under option 2a, considering the extension 
of the mandatory third-party conformity assessment to additional categories of toys, this proportion 
would likely rise to about 20% of new toys according to consulted stakeholders. Since third-party 
assessments are more expensive in comparison to self-assessments (at least EUR 500 more per new 
toy model) and companies consulted for this study reported a range of new toy models placed on the 
market every year ranging between 10 and 125 units (and in total 78,702), the expectations are an 
overall additional administrative burden of approximately EURm 7.8 per year. 

PO2b 

Policy option 2b involves the post-marketing facilitation of controls through the introduction of a 
digital passport that would require that the EU declaration of conformity is digitally accessible (via 
a  machine-readable  code)  and  the  registration  of  the  reference  in  a  central  registry  (based  on  the 
Digital Product Passport of the ESPR). 

Data on the administrative burden for Digital Product Passport, is still not available, and thus it is not 
possible to make a baseline estimate on this aspect. However, through the Impact Assessment on the 
Sustainable  Productive  Initiative  (ESPR)370,  specific  burdens  have  been  identified  in  which 
businesses are most likely to encounter, these include:  

  Administrative burden for businesses:  

-  Setting-up  of  ICT  systems  that  are  compatible  with  the  European  Digital  Product 

Passport; 

369 European Commission (2020). Evaluation of Directive 2009/48/EC of the European Parliament and of the Council on 
the safety of toys. 
370 https://op.europa.eu/en/publication-detail/-/publication/8c3a27e6-b3fa-11ec-9d96-01aa75ed71a1/language-en  

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-  The provision of information that is required in a digital format; 

-  Consolidation of information based on inputs of suppliers. 

The implementation  of the DPP, including the one-off costs (such  as development  of required  IT 
tools, new procedures for the preparation of the product documentation, and potentially additional IT 
services) and recurrent costs (e.g. the FTE required to collect and provide electronically the required 
documentation) may generate additional administrative burden for toy manufacturers. According to 
consulted stakeholders, to adapt to the introduction of the DPP would generate internal, outsourcing 
and equipment costs. For the calculation of the overall market costs, SMEs have been assumed to 
incur in costs of EUR 3,000 per new toy model, while for larger companies, up to EUR 140,000. This 
calculation provides an estimate of around EURm 28.5. While there is no specific breakdown of these 
costs into one-off and recurring costs for the toy sector, previous research in other markets has found 
a split of 80% one-off vs 20% annual costs for large firms, and 62% one-off vs 38% annual costs for 
SMEs371. Applying this breakdown to the estimates for toys would suggest a total one-off cost of 
EURm 18, in addition to an annual recurring cost of EURm 10,5.  

On the other hand, the provision of a digitalised and harmonised declaration of conformity and the 
availability  of  the  compliance  information  online,  is  also  expected  to  lead  to  savings  y.  Previous 
studies have suggested a benchmark of about 10-15% savings in administrative costs from the full 
digitalisation  of  product  information  (not  only  compliance  but  also  user-related  information)372. 
These  studies  also  estimate  the  provision  of  compliance  information  at  0.4%  of  turnover  of  the 
sector.373 Accordingly, savings could be estimated at around EUR 2.62 to EUR 3.93 million per year 
only from moving to the digital provision of compliance information.  

The implementation of the DPP would also facilitate the control by market surveillance authorities 
of the existence of the required documentation for each toy model thanks to the immediate availability 
of these documents online. This  would likely reduce the information  obligations of companies to 
market surveillance authorities in case of inspections. According to the evaluation study of the toys 
directive, the average cost – per new toy model for an average importer or distributor – to “ensure 
that the toy is accompanied by the required documents”374 amounts between EUR 548 and EUR 651. 
The  Evaluation  also  estimated  costs  for  “getting  supply  chain  information”  of  EUR  700  per  toy 
model. 

In absence of a specific cost indication of this activities in case of inspections, but being a similar 
activity  requested  by  market  surveillance  authorities  to  manufacturers,  we  assume  the  burden  on 
companies  to  be  on  the  same  range.  With  the  implementation  of  the  DPP,  this  cost  would  likely 
disappear  for  companies,  since  relevant  documentation  would  be  available  online  for  market 
surveillance authorities.  

371  Study  to  support  the  Impact  Assessment  on  the  use  of  digital  labelling  for  EU  fertilising  products,  European 
Commission’s DG GROW, 2022  

372 European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, Supporting 
study for the evaluation of certain aspects of the New Legislative Framework (Decision No 768/2008/EC and Regulation 
(EC) No 765/2008), Publications Office of the European Union, 2022, https://data.europa.eu/doi/10.2873/625443 
373 0.4% of turnover of EU toy industry in 2020 was EUR 26.2 million. The share of 0.4% is the result of a multiplication 
of  the  total  cost  of  compliance  (2%  of  annual  turnover,  based  on  previous  literature)  by  the  share  of  the  total  cost 
compliance  related  only  to  the  cost  of  indicating  compliance  with  EU  harmonisation  legislation  (20%,  based  on 
stakeholder consultation in the study supporting the Evaluation of the New Legislative Framework referred to above). 
374 Evaluation of Toys safety Directive, p. 64 

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Considering  the  annual  number  of  inspections  by  market  surveillance  authorities  in  Europe  is 
calculated to be around 25,000 (and may rise to 30,000 in case of implementation of the DPP), we 
can  estimate  that  the  average  annual  saving  for  EU  companies  could  be  between  EURm  13  and 
EURm 16 in case of inspections remain at the same levels or increase slightly, or even up to EURm 
20 in case of a significant increase in the number of inspections. 

In  addition,  it  is  reasonable  to  assume  that  in  the  long  term  the  internal  costs  for  companies  to 
implement the DPP will diminish thanks to economies of scale, while the benefit of less burdensome 
inspections for compliant companies will remain the same and lead to a visible economic benefit in 
terms of reduction of administrative burden for companies. 

Some  aspects  of  the  DPP  are  very  cost-effective.  For  instance,  impact  assessment  studies  on  the 
digital labelling of fertilisers and chemicals have shown that the costs of generating unique QR labels 
containing extensive information are very small (i.e. 0.0016 EUR / unique QR code generated), with 
cost-efficiencies the more SKUs a producer has in its portfolio. This low cost was confirmed in an 
earlier McKinsey study, which estimated 0.001451 cost per unique identifier375.  

PO2c 

Including both the extension of the conformity assessment procedures and the facilitation of control, 
entails that the administrative burden that will have to be incurred through this policy option would 
be the combination of both policy option 2a and 2b.  

1.3.  Economic operators – Adjustment costs 

Beyond  the  administrative  costs  for  economic  operators  detailed  in  the  previous  section,  it  is 
important to assess the adjustment costs for companies that could stem from the different policy 
options, as well as the possible indirect impacts on innovation, competitiveness, and the EU Single 
Market. The  key  adjustment  costs  to  be  considered  are:  i)  the  potential  costs  related  to  chemical 
substitutions  or  product  withdrawal  resulting  from  extended  restrictions  to  the  use  of  chemical 
substances and mixtures; and ii) increases in the costs associated with product testing. 

The  first  set  of  policy  options  –  i.e.  those  relating  to  improving  toy  safety  –  include  a  range  of 
measures that will result in changes to the rules on the use of chemicals in toys: 

  Policy  option  1a  would  give  the  Commission  greater  regulatory  powers  to  change  Limit 
Values for any chemicals for any toys depending on scientific evidence presented regarding 
the safety of chemicals used in toys. It would also reduce the limit values for nitrosamines 
and nitrosatable substances, and require manufacturers to address combinations of chemicals 
in toys following guidance. 

  Policy option 1b would, in addition to the measures under PO1a, extend the generic approach 
to risk management to introduce generic bans on additional substances classified among the 
most harmful hazard classes. PO1b would also remove the derogation based on the relevant 
concentrations of the CLP Regulation, but it would allow for a quantification/testing limit and 
retain the other derogations. 

375 McKinsey & C. “Want to improve consumer experience? Collaborate to build a product data standard”, April 2020. 

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  Policy option 1c would include all the measures under PO1a and 1b, whilst also removing 

the possibility of derogations to the generic bans detailed under PO1b. 

Within this context, manufacturers of toys that use chemical substances that are subject to restrictions 
or bans under the above policy options would be required to either reduce the levels of chemical use, 
identify and use alternative substances or no longer make available the affected toys on the market. 

No notable adjustment costs for companies have been assessed under policy options 2a, 2b or 2c. 

Therefore,  this  section  first  considers  background  literature  on  the  issue  of  safe  chemicals  and 
substitution, in  particular,  how  far  this has  served  as  a  driver  or  inhibitor  of  innovation  and 
competitiveness. The review considers literature on the impacts of chemical substitution by industry 
generally,  as  more  desk  research  is  available  on  the  generalised  impacts  on  industry  than  on  the 
impacts on the toy sector specifically. The impact this will likely have on costs for companies is then 
analysed, before the extent to which this may affect the competitiveness of the European toys sector 
(and  international  toy  manufacturers  exporting  to  Europe)  and  innovation  in  the  toy  sector  is 
considered. 

1.3.1.  Chemical substitution: Context and mechanisms 

Chemical substitution has become of increasing significance in the context of the development (and 
possible revision) of European chemicals legislation. In recent years, EU chemicals legislation has 
evolved, notably through the EU’s REACH Regulation (EC/1907/2006) and the CLP Regulation 
(1272/2008)376.  Additionally,  the  European  Commission  published  the  Chemicals  Strategy  for 
Sustainability in 14 October 2020377.  

Current EU chemicals legislation puts an emphasis on encouraging the substitution of chemicals by 
incentivising  producers  to  use  safer  chemicals  through  the  system  of  the  registration, 
evaluation, authorisation and restriction of chemicals. If chemicals are banned, manufacturers are 
forced  to  either  identify  an  alternative  or  to  withdraw  the  product. Alternatively,  if  a  particular 
chemical  substance  is  restricted  or  requires  authorisation  from  the  European  Chemicals Agency 
(ECHA), manufacturers are instead incentivised to explore safe alternatives, where available. They 
may also choose to continue using the same chemicals and to monitor the risks of that chemical no 
longer  being  available  in  future.  EU  chemicals  legislation  may  therefore  promote  innovation  but 
conversely,  if  no  suitable  substitutes  are  available,  it  may  damage  competitiveness  as  if  toy 
manufacturers cannot get hold of or use a particular substance needed for the production of certain 
types of toys, this may lead to a product withdrawal.  

One of the key differences between the positions of stakeholders towards the chemical substitution 
principle is whether it should be carried out based on a risk-based or a hazard-based assessment, 
with the hazard defined as a: ‘potential risk’. The difference between the two approaches pertains to 
the fact  that  hazard ‘refers to  the inherent  properties of the substance  as such’, whereas  risk also 

376 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, 
labelling and packaging of substances 
377 
Commission, 
https://ec.europa.eu/environment/strategy/chemicals-strategy_en  

Sustainability 

Chemicals 

European 

Strategy 

(2020) 

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considers issues of effective usage and exposure378 379. The safety assessment of chemicals allowed 
to be used in toy products is relevant as this is an area where there have been disagreements between 
certain stakeholder groups, as it is not always clear whether a given substance should be allowed 
for industrial use or not.  

An important consideration for the implementation of chemicals substitution as a policy change is 
that,  according  to  Girling,  they  should  be  introduced  slowly,  and  the  policy  development  process 
should be based on scientific grounds, to ensure its transparency. This would also guarantee that it is 
not  driven  by  a  political  rationale,  hence,  allowing  for  ‘adequate  time  for  the  substitution  of 
substances with genuinely safer alternatives.’  

Chemical  substitution  principles  have  some  advantages,  but  also  disadvantages  as  per  the  table 
below:  

Table 23: Chemical substitution - advantages and disadvantages 

Advantages 

Disadvantages 

 

Improving the sustainability of chemicals in line with 
the EU chemicals sustainability strategy.  

  Strengthening  the  safety  of  chemicals  used  in  toys, 
thereby promoting improved health and safety. 

 

Improving competitiveness by promoting investment 
into  R&D&I  by  industry  into  alternative  chemicals 
and innovation (although this may take years for the 
substitutes  to  become  available  and  produced  in 
sufficient quantity.  

  There may not be any suitable alternative chemicals 
leading  to  product  withdrawal  (or prospect of  such 
substances being developed medium-term)380.  

  Alternative  chemical  substances  can  be  costlier,  at 

least in the short term. 

  Potentially, indirect costs for industry incurred due to 
the  unpredictability  of  future  development  of  EU 
regulations and the position on specific substances. 

  Controversial  exclusions  of  some  substances  from 
usage  from  an  industry  perspective,  particularly  in 
cases where they are hard to replace with alternatives  

 

insufficient  attention  on 

If chemicals legislation is not well-implemented, or 
the  scientific 
places 
evidence  as  a  rationale  for  changes,  there  may  be 
disadvantages. 

According  to  the  ECHA:  ‘replacing  unwanted  substances  might  give  a  company  competitive 
advantage’  […],  especially  if  a  given  company  adopts  ‘the  strategy  based  on  anticipating  legal 
requirements’. This is because ‘better and safer alternatives may already be available, and they can 
open new opportunities for companies’. The ChemSec Business Group argued that enforcement of 
the  regulatory  framework  on  chemicals  replacement  might  boost  industry  innovation,  forcing 
companies to adjust to the ‘global move towards sustainability’, and towards estimating the costs of 
chemicals replacement ‘looking further than a simple kilo-by-kilo price comparison’ and anticipate 

378 Hansson, S.O., Molander, L., Rudén, C., 2011. The substitution principle. Regulatory Toxicology and Pharmacology 
59, pp. 454–460. https://doi.org/10.1016/j.yrtph.2011.01.011, p. 456. 
379 Operationally, the first notion is a ‘non-quantitative concept’, and the latter is usually ‘described by risk ratios, i.e. the 
estimated  or  measured  exposure  compared  to  the  estimated  or  observed  effect  concentration/dose  of  a  substance 
combined with assessment factors’ which in some cases takes the form of ‘probability assessment or similar descriptors’ 
380 A frequently cited example during the interviews in this regard was titanium dioxide used in a wide variety of toys, 
covered in a case study later in this section. 

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the regulations which is seen as ‘an extremely effective driver for innovation, which in turn is the 
foundation of economic development.’381,382  

However, policy theories regarding how chemical substitutes may drive firm-level innovation and 
competitiveness  does  not  always  match  the  practice.  On  the  contrary,  the  relationship  between 
substitution and innovation was found to be complex and nuanced in previous studies that have 
considered  how  far  EU  chemicals  legislation  has  promoted  competitiveness  and  innovation, 
including through chemical substitution. 383  

Specifically in the area of toys, there is a lack of available literature on the extent to which substitutes 
are available. However, this issue was probed through the interview programme in relation to the 
various policy options. The main stakeholder feedback from both large firms and SMEs is that, as 
the toy sector is a relatively modest intermediate user of chemicals compared with other sectors, it 
frequently purchases chemicals in smaller quantities than other sectors and is dependent on specialist 
substances. This creates particular risks for the toy industry’s competitiveness as if these substances 
are subject to a ban or require authorisation due to a restriction, then many products would have to 
be withdrawn from the market. Related issues are explored in more detail under the analysis of POs 
below.  

1.3.2.  Costs of product adaptation and withdrawal for economic operators 

This  sub-section  considers  the  costs  of  product  adaptation  for  economic  operators,  mainly  toy 
manufacturers, resulting from the different policy options under consideration. It also considers the 
percentage  of  toys  which  could  no  longer  be  made  available  on  the  market,  if  alternatives  to  the 
chemical substances are not found. It should be noted there is a close link with the previous sub-
section, in that stakeholder views about the drivers of costs were already outlined, therefore the two 
should be read in parallel.  

There are three main considerations in relation to chemicals substitution that will impact on the toys 
industry as a result of the policy options under consideration in 1a, 1b and 1c:  

  The impacts on regulatory uncertainty – some costs could arise from the fact that changes 
to limit values will be difficult to anticipate for industry, and the extent to which it is realistic 
for toy manufacturers, especially SMEs, to comply with these.  

  The  availability  of  substitute  chemicals  –  the  main  difficulty  highlighted  by  industry 
stakeholders is that there are often no suitable alternatives for chemical substances or mixtures 
where alternative substances may need to be identified.  

  The  cost  of  substitution  –  where  alternatives  are  available,  the  costs  are  typically  higher 
during the early stages of substitution but may reduce over time. Nonetheless, there are costs 
of switching to more expensive substituted substances in the short to medium term. 

One of the challenges is that, whilst a general analysis can be performed with selected examples, it 
is  difficult  to  provide  a  comprehensive  assessment  as  there  are  considerable  uncertainties 
regarding the number of chemical substances and mixtures that would be impacted and the 

381  ChemSec  (2016).  The  bigger  picture.  Assessing  economic  aspects  of  chemicals  substitution,  online: 
https://chemycal.com/dap/files/The_bigger_picture_160217_print.pdf, accessed: 30.05.2022, p. 31. 
382  ChemSec  (2016).  The  bigger  picture.  Assessing  economic  aspects  of  chemicals  substitution,  online: 
https://chemycal.com/dap/files/The_bigger_picture_160217_print.pdf, accessed: 30.05.2022, p. 5. 
383 Study on Monitoring the Impacts of REACH on Innovation, Competitiveness and SMEs, European Commission’s 
DG GROW, 2015. Study by CSES, RPA and Okopol.  

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resulting impacts on market behaviours / toys (i.e. how will toy manufacturers respond to changes 
in limit values and / or to generic bans). This may vary between large firms and SMEs, and it would 
also  vary by  chemical  as  a very  wide variety of chemicals  are used in  toy production. There is  a 
complex interplay of factors determining whether chemicals producers decide to pursue substitution 
/ reformulation or market withdrawal. This in turn will influence the behaviours of toy manufacturers 
who as intermediate users but purchasing in small quantities may not have much choice regarding 
whether chemical producers continue to supply them with the speciality chemicals needed.  

In  the  IA  of  the  CLP  study384,  further  estimates  regarding  costs  are  provided.  Under  PO1a  in  the 
possible  revision  of  the  CLP  (adding  new  hazard  classes),  it  has  been  estimated  that  the  CLP  — 
without  considering  the  linked  effect  of  the  generic  approach  to  risk  management  —  would  put 
indirect market pressure to substitute and reformulate or withdraw from the market between 9-25% 
of  the  total  chemical  product  portfolio  in  terms  of  turnover.  The  IA  study  also  recommends 
“monitoring of the ECHA’s registered substances database could provide information on the number 
of  substances  substituted  or  withdrawn  from  the  market  because  of  classification  —  or  potential 
classification — for the new hazard classes”. This would need to be carefully monitored in the toys 
sector to ascertain the impacts on competitiveness.  

The CLP study also provides some quantitative estimates about the impacts of putting in new hazard 
warnings. Companies consulted in the context of a Ricardo (2021) study estimated that around 43% 
of product portfolios may be affected by the inclusion of new hazard classes to CLP and the extension 
of the generic approach to risk management (GRA). It moreover states that substances and mixtures 
reclassified for the new hazard classes would be affected by the application of the GRA, where a 
CLH triggers the restriction or ban of a classified substance for some specific or all uses. The study 
adds that whilst some products will not be directly affected by changes to the application of the GRA, 
“CLP  classification  and  labelling  for  the  new  hazard  classes  may  still  put  pressure  for  market 
withdrawal or substitution and reformulation”. 385 

In the CLP IA study, it is assumed that a range between 9% and 25% of the total number of mixtures 
have to be reformulated due to hazard classification changes, which although a horizontal piece of 
legislation  will  impact  different  industries  including  toys  as  intermediate  users  of  chemicals. The 
costs of these changes are already in the several billions of EUR for industry as a whole.  

Under the policy options being considered by this impact assessment study, potential changes to the 
Toy Safety Directive include granting the European Commission (or a delegated technical body) the 
possibility of tightening limit values for any chemicals, specifically reducing the limit values for N-
nitrosamines  and  N-nitrosatable  substances  to  the  level  of  the  EN  standard  (PO1a),  introducing 
generic bans on additional hazardous substances and removing the derogations based on the ‘relevant 
concentrations’ of the CLP Regulation (PO1b) or introducing generic bans and removing derogations 
(PO1c). If these POs were to be adopted, then the impact would be that toy manufacturers would 
need to consider the identification of safe chemical substitutes or would need to withdraw particular 
product lines from the market.  

The main finding is that the costs of substitution are difficult to ascertain for various reasons, such 
as the lack of available substitutes presently, the fact that there is considerable uncertainty (i.e. unclear 
when and which types of safe chemical alternatives will be developed in future and how relevant to 

384  Technical  and  Scientific  Support  to  the  Commission’s  Impact  Assessment  for  the  Revision  of  the  Regulation  on 
Classification, Labelling and Packaging of Substances and Mixtures (CLP), to be published.  
385 Idem. Pg 73 annexes to the CLP IA study.  

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the toys sector). As such, where no data is available, general observations regarding the nature and 
magnitude of costs is provided. 

General discussion on the costs of substitution 

A general discussion on the costs of substitution, relevant across the baseline scenario and all sub-
options  within  PO1,  is  now  provided.  However,  as  explained  further  below,  it  is  not  possible  to 
specify precise costs for most of the measures proposed under PO1, rather this section focuses on 
providing  anecdotal  data  on  the  impacts  and  rough  estimates  of  the  costs  based  on  consultation 
feedback. 

The  desk  research  and  discussions  with  key  toy  manufacturers  have  shown  that  key  factors 
determining the  costs associated with  increased restrictions to  the use of  chemicals  are firstly the 
availability of chemical substitutes (as otherwise at least medium-to-longer term, there may be a 
need to cease making available certain products on the market, which has a different set of costs).  

Secondly,  where  alternative  chemicals  are  available,  substitution  costs  compared  with  the 
chemical(s) currently being used need to be considered. A key consideration in relation to costs is 
that “new alternatives are often expensive initially, while prices tend to decline as supply increases. 
Comparing prices of a hazardous substance and an alternative that has just reached the market, or 
doing so before the hazardous substance has been banned, can therefore be very misleading”.386 

Chemical  substitutes  are  generally  costlier  than  the  original  substance,  according  to  literature. 
However,  the  prices  of  alternative  substances  can  be  expected  to  fall  over  time  as  the  substance 
becomes more widely known, used and available. Among the concerns about chemicals legislation 
requiring substitutes is the potential increase in costs due to the necessity of relying on alternative 
substances. Oosterhuis, referring to the experiences of Scandinavian countries, argued that, whilst it 
might be the case that there are higher costs now, the price of chemical substitutes might be expected 
to  decrease  with  time,  as  the  “growth  in  production  of  the  alternative  implies  cost  and  price 
reductions, making it more attractive for an increasing number of actors”.  

The same argument has  been put forward by the ChemSec Business Group, who emphasised  that 
prices are ‘not stable, but market dependent’. However, this concern should not be entirely dismissed. 
A 2015 report from the European Commission emphasised that:  

“the availability of private funding is crucial, [as] in the absence of supportive private investors, 
innovation, and therefore substitution of hazardous chemicals with safer alternatives, is not possible. 
An  important  role  for  public  authorities  would  be  to  bridge  the  gap  between  SMEs  and  private 
investors: regulatory pressure without adequate financial incentives and subsidies is often negatively 
perceived by companies and does not trigger virtuous behaviour”. 

R&D&I processes may lead to the development of new alternative substitute chemicals at least in 
some  industries  (e.g.  in  Scandinavian  countries,  such  as  Sweden  and  Denmark).  According  to 
Oosterhuis: ‘The introduction of new regulations can cause an initial ‘innovation-shock’ to industry 
which decreases the rate of innovation, but competitive and innovative firms survive through creative 
substitution and by moving into higher value markets’. 

386  Chemsec 
https://chemycal.com/dap/files/The_bigger_picture_160217_print.pdf   

(2016).  The  bigger  picture:  Assessing 

the  economic  aspects  of  chemicals  substitution, 

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Furthermore,  if  appropriate  chemical  substitutes  and  appropriate  incentives  to  identify  chemical 
substances do not exist, toy manufacturers may be required to withdraw products from the market 
as a result of further restrictions on the use of chemicals. 

Within this context, accurately calculating the product adaptation and withdrawal costs associated 
with  each policy option would require data on:  i) the precise number of  chemical  substances and 
mixtures impacted by each PO; ii) the type of restriction (e.g. reduced limit values, generic ban etc.); 
iii) the total number of new toy products placed on the market in a given year, as well as the number, 
types  and  values  of  products  impacted  by  each  PO;  iv) the  proportion  of  toy  products  currently 
making use of the existing derogations; v) the proportion of impacted products where adjustment, 
including  the  identification  of  chemical  substitutes,  would  be  attempted;  vi)  the  proportion  of 
impacted  products  that  would  be  withdrawn  from  the  market;  vii)  the  costs  associated  with 
identifying  product  adjustments,  including  chemical  substitutes  (where  possible),  as  well  as  the 
success rate of identifying appropriate alternatives; and viii) the costs associated with withdrawing 
products  from  the  market,  including  industry  behavioural  responses  to  replacing  withdrawn  toy 
products and consumer behavioural responses to purchasing alternative toys. 

Although data is available and has been collected on some of these elements (e.g. total number of 
new toy products per year), the quantitative estimates presented in the following analysis rely heavily 
on a range of assumptions, detailed throughout. This limits the certainty associated with the accuracy 
and precision of the estimates. As such, these estimates should, at all times, be read in conjunction 
with information on the nature of the assumptions and the related caveats on data availability. 

A) Baseline 

The evaluation of the TSD highlighted a range of challenges related to the protection of children that 
would persist under the baseline situation. These include: 

  Additional limit values for chemicals can only be set for toys for children under 36 months of 

age and toys that are intended to be placed in the mouth.  

  The TSD provides derogations that permit the use of CMR chemicals when they do not exceed 
certain  concentrations  detailed  in  the  CLP  Regulation.  Although  the  necessity  of  such 
derogations is argued by industry, the evaluation concluded that the concentrations permitted 
currently were too high and still pose a risk to children. 

  Limit values for nitrosamines and nitrosatable substances set by the TSD can reportedly still 
pose a threat to children and are not in line with the EN71-12:2017 standard or German law. 

In this context, under the baseline the Commission will still be able to adapt the TSD’s chemical 
restrictions and derogations in accordance with the provisions of Article 46: 

  Through Article 46(1), the Commission will, amongst other possibilities, be able to amend the 

limit values for chemical substances listed in Annex II, Part III, point 13. 

  Through Article 46(2), the Commission may adopt specific limit values for toys intended for 
use  by  children  under  36  months  or  toys  intended  to  be  placed  in  the  mouth  and  amend 
Appendix C of Annex II. 

  Through Article 46(3), the Commission may adopt new derogations for CMR substances or 

mixtures and amend Appendix A of Annex II. 

The following table summarises the amendments made to the TSD using the above provisions since 
its adoption. 

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Table 24: Summary of key amendments to the TSD chemical requirements 

TSD Section 

Overview of amendments 

Appendix A 

One amendment in July 2014 permitting the use of Nickel in toy components that are intended to 
conduct an electric current (i.e. derogation). 

Appendix C 

Nine amendments relating to the addition of specific limit values for 12 substances (e.g. Aniline, 
Phenol,  Formaldehyde  etc.)  and  the  further  amendment  of  the  limit  values  for  one  of  those 
substances (Bisphenol A). 

Point 13 

Five  amendments  reducing  limit  values  for  Cadmium,  Barium,  Lead,  Chromium  VI  and 
Aluminium. 

Amendments  to  limit  values  under  the  baseline  scenario  would  result  in  new,  ad  hoc  product 
adaptation costs for industry, while new derogations would limit such costs. However, although some 
information is available on the types of toys impacted by past amendments, limited data is available 
and limited input has been received from stakeholders on the scale of the adjustment costs that would 
result  from  future  changes.  This  is  primarily  because  the  substances  and  mixtures  that  could  be 
impacted by future amendments are unknown. 

If we assume that the market for toys intended for use by children under 36 months and toys intended 
to be placed in the mouth accounts for 20% of the total toys market, the baseline scenario would 
require product adaptation or withdrawal  costs in 0.6-1.2% of toy models387. Approximately 
0.4-0.8% of toy models  would be subject to adaptation, while 0.2-0.4% could no longer be made 
available on the market. 

With these assumptions established, we now present the available data on costs of substitution, before 
extrapolating indicative industry-wide figures. 

On the scale of the product adaptation costs, data has been collected from a range of relevant sources: 

  The  evaluation  of  the  TSD  reported  data  on  the  costs  of  the  12  amendments  to  the  TSD 
implemented  in  the  period  2012-2018.  As  highlighted  above,  these  primarily  aimed  to 
strengthen  the  limit  values  for  CMR  substances.  In  its  analysis,  the  evaluation  found  that 
stakeholders  across  all  groups  considered  the  amendments  of  the  TSD  to  be  costly.  In 
addition, the evaluation calculated the average cost of the amendments to be EUR 6,500 per 
toy model produced for large firms and EUR 7,700 per toy model produced by SMEs. 
In  response  to  the  stakeholder  consultations  conducted  for  this  impact  assessment  support 
study,  one  manufacturer  noted  that,  in  a  previous  situation,  the  process  of  identifying  a 
replacement dye took the company five months and nine tests. Considering the costs of testing 
alone,  without  a  detailed  understanding  of  the  other  resources  utilised,  this  product 
adaptation challenge would have cost more than EUR 19,800 (based on estimated testing 
costs under the baseline scenario of EUR 2,200 per toy model). 

 

  Furthermore, a small number of manufacturers provided estimates for the full costs associated 
with product redesign and redevelopment, specifically in response to the POs presented and 
analysed in this study. Considering staff, outsourcing and equipment costs, these estimates 

387 To derive these figures, the proportion of the total toys market accounted for by toys for children under 36 months and 
mouthing toys (20%) has been applied to the assumed proportion of toys impacted by PO1a (3-6% of toys), which was 
derived from stakeholder feedback and consultations with the Commission. 

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indicate a total cost of product redesign and redevelopment at EUR 17,000-70,000 per 
product. Given its position within the above range, the impacts on the costs of testing alone 
will be considered as a middle product redesign and redevelopment estimate. 

Based  on  these  figures,  the  total  one-off  costs  associated  with  product  adaptation  (including 
chemical substitution) across the toys industry under the baseline scenario could range from 
around EUR 2 million to EUR 44 million (see Table 25 below). This is based on 78,702 new toy 
models across all business sizes on which those percentages of toy models that may be impacted by 
substitution  are  applied.  As  highlighted  above,  the  accuracy  and  precision  of  these  estimates  are 
limited by a lack of comprehensive data on the costs associated with product adaptation, as well as a 
wide range of other variables. As such, it is necessary to include product ranges that illustrate the 
possible variance in these costs. However, under the baseline scenario, it is anticipated that the costs 
of any new restrictions would strongly mirror the costs of the amendments made under the TSD in 
the period 2012-2018. As such, the costs to industry per toy type under the baseline are likely to be 
closer to the figures detailed in the evaluation. 

Table 25: Cost estimates associated with chemical restrictions implemented under the baseline scenario 

Estimated  %  of 
products impacted 

Evaluation 
(large firms) 

Evaluation 
(SMEs) 

/ 

 Total 
redesign 
redevelopm
ent 
estimate) 

(low 

Total  redesign  / 
redevelopment 
(middle 
estimate) 

Total  redesign  / 
redevelopment 
(high estimate) 

Costs  per  toy  type 
(EUR) 

€6,500 

€7,700 

€17,000 

€19,800 

€70,000 

of 

% 
impacted 
estimate - 0.4%) 

products 
(low 

of 

% 
impacted 
estimate - 0.8%) 

products 
(high 

€2.05 m 

€2.42 m 

€ 5.35 m 

€6.23 m 

€22.04 m 

€4.09 m 

€4.85 m 

 €10.70 m 

€12.47 m 

€44.07 m 

Beyond the one-off product adjustment costs highlighted above, the below options will also impact 
ongoing testing costs. As such, it is necessary to establish the ongoing costs of testing within the 
baseline. Testing per toy has been estimated to cost around €2,200 (as determined in the Evaluation 
of the TSD). Considering the total number of tests to be conducted per year (approximately 86,024 
across all sizes of business), the total ongoing costs of product testing per year are and will continue 
to be around EUR189.25 million.  

In addition, in terms of product withdrawals, although the ultimate impact would depend on the value 
of the toy models impacted, it is possible to indicate an estimate based on the turnover achieved by 
the European toys industry. Considering the size of the toys industry in 2019, an estimated EUR 
16.5-33.0 million worth of toys could no longer be made available on the market. Based on 2020 
provisional data, this could affect EUR 13.1 to 26.2 million worth of toys. Given the time provided 
to accommodate such changes, the impact of such product withdrawals would likely be mitigated by: 
i) the ability for producers to shift resources to the production and sale of alternative toy products; 
and ii) the purchasing decisions of consumers, who, instead of choosing not to purchase a product, 
will in many instances purchase an alternative product and still contribute to the toys market. 

B) Policy options to strengthen the protection of children from harmful chemicals - PO1a 

Under PO1a, all four of the following measures could result in adjustment costs for companies: 

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Limit values: Granting legal powers to the European Commission to make changes to limit values 
does not necessarily mean that a toy manufacturer will have to replace chemicals with a substitute 
and incur an adjustment cost. In some cases, they could instead continue using the same chemicals, 
but with the added risk that lower limit values will be more challenging to test for and comply with. 
Moreover, such restrictions and the related risks of generic bans could incentivise producers to search 
for alternative safe chemical substitutes. 

However,  in  other  cases,  toy  manufacturers  highlighted  that  it  may  be  impossible  to  continue  to 
produce certain products in their current forms if they are subject to further chemical use restrictions. 
This  could  lead  to  the  need  for  product  adaptation  or  withdrawals  from  the  market.  An  example 
provided was that a major reduction in limit values for nitrosamines beyond the reductions proposed 
below would result in the removal of balloon products from the market. 

Considering the scale of the impact and related costs under PO1a, 17 amendments to limit values 
have  been  made  under  the  TSD  to  date  (see  baseline  scenario  above),  which  could  indicate  the 
frequency  of  possible  amendments  to  limit  values  under  PO1a.  However,  most  of  these  past 
amendments relate only to toys intended for children under 36 months and mouthing toys. This means 
that any limit value changes under PO1a, which will apply to all toys, will impact a much wider range 
of products and thus result in greater adaptation and withdrawal costs for manufacturers compared to 
the baseline. 

Nitrosamines  and  nitrosatable  substances:  Most  industry  stakeholders  interviewed  noted  that 
reducing the limit values for nitrosamines and nitrosatable substances to the levels already detailed 
in the EN standard and German law would have a minimal impact. In this respect, producers either 
make limited use of these substances or already use them at the lower limit values. However, certain 
manufacturers  and  SMEs  in  particular  were  concerned  about  the  reduction  of  these  limit  values 
beyond the levels prescribed by Germany and the EN standard. 

Combination  effects:  Although  limited  input  was  received  on  the  impact  of  this  measure,  those 
manufacturers that did respond noted that it would have limited impact on their product portfolio as 
most reputable manufacturers already assess and address the risks stemming from the combination 
of chemicals.  

Although the mechanisms of impact are clear across these measures, the precise costs of product 
adaptation (incl. chemical substitution) and product withdrawal are difficult to quantify. Many 
toy  manufacturers  and  industry  associations  highlighted  this  point,  noting  that  the  scale  of  the 
potential impacts is difficult to assess given: i) the lack of information on the types of substances that 
could  be  subject  to  restrictions  through  limit  values  changes;  and  ii)  the  possible  level  of  the 
restrictions and the specific requirements on assessing combinations of chemicals. 

Furthermore, the scale of the impact would reportedly differ significantly based on the make-up of 
a manufacturer’s product portfolio. For instance, industry estimates on the possible proportion of 
their product portfolio that would be impacted ranged from 0% to 20% to 100%.  

While most manufacturers were unable to provide any insight, in line with the above reasoning, a 
small number of manufacturers provided rough figures on the potential impact of PO1a, allowing the 
calculation of indicative impact estimates. Based on stakeholder consultations, the below estimates 
assume  that  PO1a  will  either  require  adaptation  or  withdrawal  of  3-6%  of  toy  models  on  the 
market compared to the baseline. This is based on 78,702 new toy models across all business sizes 
on which those percentages of toy models that may be impacted by substitution or withdrawal are 
applied. Furthermore, we assume that 2-4% of toy models would require redevelopment to identify 
and use safe, alternative chemicals, while the remaining 1-2% could no longer be made available on 
the market. Some of the effects relating to product withdrawal would be partially mitigated in terms 

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of the impact on the toy industry overall as consumers may instead purchase alternative products that 
meet  more stringent  limit  value thresholds. However, these impacts  are complex to  assess as this 
depends on the toy product type in question and the extent to which there is easy substitutability for 
products using less harmful chemicals. 

Based on these estimates and the cost estimates detailed above, the total one-off costs associated 
with  product  redesign  and  redevelopment  to  adapt  to  greater  restrictions  could  range  from 
EUR  10.23  million  to  EUR  220.4  million  compared  to  the  baseline  (see  Table  26).388  It  is 
anticipated that the costs of any new restrictions under PO1a would strongly mirror the costs of the 
amendments made under the TSD in the period 2012-2018. As such, the costs to industry per toy 
type under the baseline are likely to be closer to the figures detailed in the evaluation. 

Table 26: Cost estimates associated with chemical restrictions implemented under PO1a 

Estimated  %  of 
products 
impacted 

Evaluation 
(large firms) 

Evaluation 
(SMEs) 

/ 

 Total 
redesign 
redevelopme
nt 
estimate) 

(low 

Total  redesign  / 
redevelopment 
(middle 
estimate) 

Total  redesign  / 
redevelopment 
(high estimate) 

Costs per toy type 
(EUR) 

%  of  products 
impacted 
(low 
estimate - 2%) 

%  of  products 
impacted 
(high 
estimate - 4%) 

€6,500 

€7,700 

€17,000 

€29,700 

€70,000 

€10.23 m 

€12.12 m 

€26.76 m 

€46.75 m 

€110.18 m 

€20.46 m 

€24.24 m 

€53.52 m 

€93.50 m 

€220.37 m 

Industry stakeholders indicated that the unit costs of testing would likely increase within PO1a, as 
compared to the baseline. In particular, the increased complexity of testing for lower limit values 
would reportedly lead to increases in testing costs from EUR 2,200 to around EUR 3,300. Assuming 
that the 2-4% of toy models subject to adaptation efforts will be subject to these increased testing 
costs, applying the same percentages to the yearly number of tests (86,024),  yearly testing costs are 
estimated to incrementally increase compared to the baseline by around EUR 1.89-3.79 million. 

In  addition,  1-2%  of  toy  models  could  no  longer  be  made  available  on  the  market. Although  the 
ultimate impact would also depend on the value of the toy models impacted, it is possible to indicate 
the impact based on the turnover achieved by the European toys industry. Using provisional Eurostat 
data  from  2020,  this  impact  could  result  in  a  EUR  65.6-131.2  million  worth  of  toys  no  longer 
available on the market, compared to the baseline. Given the impact of COVID-19 on the 2020 
figure, it is worth also noting the impact when applied to the 2019 industry turnover data. In this case, 
EUR 82.6 – 165.1 million worth of toys could no longer be made available under PO1a. However, 
as detailed under the baseline, these impacts would be mitigated by the time provided to adjust to the 
updated rules, which would allow producers to shift resources to the production and sale of alternative 
products, and the fact that, in many instances, consumers would choose to purchase an alternative 

388 These figures have been calculated using the following equation: total number of new toys in a given year (78,702) x 
the  proportion  of  products  impacted  by  product  adaptation  x  the  costs  of  testing/redevelopment.  These  figures  are 
compared to the baseline while the main impact assessment report considers costs which are additional to the baseline. 

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toy product, rather than not purchasing anything, thereby ensuring the revenue to the toys market 
remains. 

Although these figures should be read alongside the abovementioned caveats and the uncertain nature 
of the number of products impacted by PO1a, they illustrate the potential scale of the impact and how 
it might differ based on the proportion of products impacted. 

PO1b 

In  comparison  to  PO1a,  the  adjustment  costs  stemming  from  PO1b  would  be  higher,  as,  in 
addition  to  all  the  above  measures,  PO1b  would  involve  a  generic  ban  on  additional  chemical 
substances  and  the  removal  of  the  derogation  based  on  the  ‘relevant  concentrations’  for  CMR 
substances detailed in the CLP Regulation. This finding on adjustment costs was confirmed by many 
industry stakeholders. Below, we present the nature of the impacts per measure before discussing the 
overall adjustment costs for the option. 

Extension of the GRA: PO1b would extend the existing general prohibition of CMR substances to 
a  potentially  significant  number  of  other  chemical  substances,  including  endocrine  disruptors, 
neurotoxic and immunotoxic substances (currently classified as STOT RE or STOT SE), as well as 
substances affecting the respiratory system. In total, this could mean an increase in the current list of 
substances restricted in toys by 10-30%389. 

Removal of CLP derogation: Although other derogations would be maintained, manufacturers noted 
that the removal of the derogation based on the relevant concentrations in the CLP Regulation could 
also have an impact on the use of chemicals in and the viability of certain toy products. A limit of 
detection or testing would still be allowed. 

While  the  CLP-related  derogation  will  be  removed,  manufacturers  will  still  be  able  to  apply  for 
derogations under Article 46(3) where the following conditions are met: i) the use of the substance 
or  mixture  has  been  evaluated  by  the  relevant  Scientific  Committee  and  found  to  be  safe;  ii)  the 
substance is not prohibited for use in consumer articles under REACH; and, iii) there are no suitable 
alternative substances or mixtures available. Although it is anticipated such applications would occur 
where the costs for manufacturers would be particularly high (and could result in products no longer 
made available on the market), only two derogations have been applied using this mechanism since 
the adoption of the TSD, for the use of nickel in stainless steel and in components that are used to 
conduct an electric current. 

Beyond  this  limited  use  of Article  46(3),  no  feedback  has  been  provided  on  the  extent  to  which 
manufacturers are currently relying on the other two existing derogation possibilities (one based on 
CLP concentrations and one based on inaccessibility) . In addition to the other limitations highlighted 
previously, this makes it is difficult to assess the exact impact of this policy option. 

Furthermore,  the  toy  industry  is  an  intermediate  user  of  chemicals  that  often  only  makes  small 
purchases of specialty chemicals. As such, toy manufacturers noted that they have limited market 
weight  to  influence  the  decisions  of  chemicals  producers  with  regard  to  identifying  chemical 
substitutes that are relevant and appropriate for use in toy products. This would have an impact on 
the number of products withdrawn rather than redesigned and redeveloped. 

389 See annex 10.d for an estimation of the number of substances that could potentially be affected by the GRA in toys. 

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However, as for the baseline and the other sub-options, many manufacturers noted that the lack of 
clarity on which substances would be covered by the extension of the GRA and which products would 
be impacted by the removal of the derogation makes estimating the number of products impacted, as 
well as the other required data points, very difficult. The narrative on costs from industry was similar 
to PO1a; namely, PO1b has the potential to impact a large proportion of products, but the potential 
scale of the firm-level impact depends on the substances and mixtures banned, as well as the types 
of toys produced by a particular manufacturer. 

In the same manner as for PO1a, we now present rough indicative estimates of the adjustment costs 
related to PO1b on the basis of available data. Given the increase in the impact of PO1b as compared 
to PO1a, we assume the following for the purposes of these estimates: a total of 9-14% of toy models 
will  be  impacted  under  PO1b  compared  to  the  baseline,  with  5-8%  subject  to  product  adaptation 
efforts (including chemical substitution efforts) and 4-6% that could no longer be made available on 
the  market.  This  is  based  on  78,702  new  toy  models  across  all  business  sizes  on  which  those 
percentages of toy models that may be impacted by substitution or withdrawal are applied. The effect 
of product withdrawals on market contraction should be nonetheless mitigated, to a certain extent, in 
a demand shift to other toys remaining on the market.  

Using  the  same  data  on  cost  estimates  for  product  adaptation  and  redevelopment  detailed  above, 
PO1b could result in the costs for industry in the range detailed in the below table. More specifically, 
the estimated impact on 5-8% of all toy models could result in total one-off costs associated with 
product redesign and redevelopment of EUR 25.6 – 440.7 million compared to the baseline.390 

While the costs of adaptation under the baseline scenario and PO1a were considered to mirror the 
adaptation costs identified through the evaluation, it is anticipated that the costs per toy type under 
PO1b  will  be  more  costly.  This  is  because  the  types  of  adaptations  necessary  as  a  result  of  the 
measures  implemented  through  PO1b  are  more  likely  to  require  the  identification  of  substitute 
chemicals rather than only lowering the levels of the chemicals already in use. 

Table 27: Cost estimates associated with chemical restrictions implemented under PO1b 

Estimated  %  of 
products 
impacted 

Evaluation 
(large firms) 

Evaluation 
(SMEs) 

/ 

 Total 
redesign 
redevelopme
nt 
estimate) 

(low 

Total  redesign  / 
redevelopment 
(middle 
estimate) 

Total  redesign  / 
redevelopment 
(high estimate) 

Costs per toy type 
(EUR) 

%  of  products 
(low 
impacted 
estimate - 5%) 

%  of  products 
impacted 
(high 
estimate - 8%) 

€6,500 

€7,700 

€15,000 

€35,100 

€70,000 

€25.58 m 

€30.30 m 

€66.90 m 

€138.12 m 

€275.46 m 

€40.92 m 

€48.48 m 

€107.03 m 

€221.00 m 

€440.73 m 

390 These figures have been calculated using the following equation: total number of new toys in a given year (78,702) x 
the proportion of products impacted by product adaptation x the costs of testing/redevelopment. As indicated above, the 
main impact assessment reports costs additional to the baseline. 

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In addition, as for PO1a, the costs of testing products would reportedly increase under PO1b and 
PO1c due to an anticipate increase in the complexity of the testing required. Based on industry input, 
the costs of testing per product under PO1b and PO1c would increase to approximately EUR 3,900 
per toy type. Assuming that the 5-8% of products subject to adaptation efforts will be subject to these 
increased  testing  costs,  and  applying  the  same  percentage  to  the  yearly  number  of  tests  (86,024), 
yearly testing costs are estimated to incrementally increase compared to the baseline by around EUR 
7.31-11.70 million. 

Product withdrawals: In terms of product withdrawals, although the ultimate impact would depend 
on the value of the toy models impacted, it is possible to indicate an estimate based on the turnover 
achieved by the European toys industry. This option could impact 4-6% of toy models that could no 
longer be made available on the market. On the basis of 2020 data, PO1b could result in EUR 
262.3-393.5 million worth of toys no longer being made available on the market. Considering 
2019 data, this value could be of EUR 330.2 – 495.3 million. 

As detailed under PO1a, these figures should not be read in isolation, as they are subject to a range 
of  important  caveats.  However,  they  illustrate  the  potential  scale  of  the  impact  arising  from  the 
measures planned under PO1b. 

Beyond these issues, it is important to note that, if PO1b is not implemented together with better 
enforcement, there is  a risk  that non-compliant toys  and their manufacturers would become more 
competitive, as reputable manufacturers would have to comply with the extension of the GRA and 
the  removal  of  CLP  derogations,  and  thus  incur  the  related  costs,  whereas  non-compliant 
manufacturers do not presently comply with the essential requirements and would continue not to do 
so. 

PO1c 

While PO1b will lead to greater adjustment costs than PO1a, the removal of all derogations under 
policy  option  1c  would  implement  further  incremental  adjustment  costs  on  industry 
stakeholders. 

Many  manufacturers  and  industry  associations  interviewed  noted  that  the  removal  of  derogations 
related  to  substances  that  are  inaccessible  or  listed  in  Appendix  A  could  lead  to  extensive 
withdrawals of products. While many stakeholders again highlighted the difficulty of assessing the 
scale  of  the  impacts  of  this  policy  option  due  to  a  lack  of  detail,  the  following  indications  were 
provided: 

  A large top 5 global manufacturer estimated that, under PO1c, 10-20% of toys would have to 
be removed from the European market, equating to up to 2000 Stock Keeping Unit (SKUs). 

  Another  manufacturer  noted  that  approximately  20-30%  of  all  their  products  would  be 

impacted. 

  Without offering precise figures, other manufacturers stated that the majority, if not all their 

products would be impacted under PO1c. 

Notable impacts are anticipated under PO1c in relation to the use of nickel in toys and toy components 
made of stainless steel and in toy components which are intended to conduct an electric current, for 
example. . These changes will therefore not only bring a significant cost for manufacturers, but they 
could severely impact the competitiveness of the European toys industry. 

Based on these figures and further discussions with industry stakeholders, we now present rough, 
indicative estimates of the potential adjustment costs related to PO1c. Given the incremental increase 

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in the impact of PO1c as compared to PO1b, as well as the input on the balance between the relative 
impact on product withdrawals versus substitution efforts, we assume the following for the purposes 
of these estimates: a total of 20-30% of toy models will be impacted under PO1c, with 10-15% that 
could no longer be made available on the market and 10-15% subject to product adaptation efforts 
(including chemical substitution). In this case, as certain categories of products may be impacted by 
the restrictions, shift in demand to other products may be more limited. 

Using  the  same  data  on  cost  estimates  for  product  adaptation  and  redevelopment  detailed  above, 
PO1c could result in the costs for industry in the range detailed in the below table. More specifically, 
the estimated impact on 10-15% of all toy models could result in total one-off costs associated with 
product redesign and redevelopment of EUR 51.2 – 826.4 million compared to the baseline.391 
It is anticipated that the costs per toy type under PO1c will be more costly than under PO1a and the 
baseline scenario. As for PO1b, this is because the types of adaptations required as a result of the 
measures  implemented  through  PO1b  are  more  likely  to  require  the  identification  of  substitute 
chemicals rather than lowering the levels of the chemicals already in use. 

Table 28: Cost estimates associated with chemical restrictions implemented under PO1c392 

Estimated  %  of 
products impacted 

Evaluation 
(large firms) 

Evaluation 
(SMEs) 

/ 

 Total 
redesign 
redevelopme
nt 
estimate) 

(low 

Total  redesign  / 
redevelopment 
(middle 
estimate) 

Total  redesign  / 
redevelopment 
(high estimate) 

Costs per toy type 
(EUR) 

%  of  products 
impacted 
(low 
estimate - 10%) 

%  of  products 
impacted 
(high 
estimate - 15%) 

€6,500 

€7,700 

€15,000 

€35,100 

€70,000 

€51.16 m 

€60.60 m 

€133.79 m 

€276.24 m 

€550.91 m 

€76.73 m 

€90.90 m 

€200.69 m 

€414.37 m 

€826.37 m 

In addition, as under PO1b, the costs of testing products would reportedly increase under PO1c due 
to an anticipate increase in the complexity of the testing required. Based on industry input, the costs 
of testing per product under PO1c would increase to approximately EUR 3,900 per new toy model. 
Assuming  that  the  10-15%  of  toy  models  subject  to  adaptation  efforts  will  be  subject  to  these 
increased testing costs, and applying the same percentages to  the  yearly number of tests  (86,024) 
yearly testing costs are estimated to incrementally increase compared to the baseline by around EUR 
14.62-21.94 million. 

Product withdrawals: In terms of product withdrawals, although the ultimate impact would depend 
on the value of the toy models impacted, it is possible to indicate an estimate based on the turnover 
achieved by the European toys industry. This option could impact between 10% and 15% of all toy 
models that could no longer be made available. On the basis of 2020 data, PO1c could impact EUR 
656 – 984 million worth of toys. Considering 2019 data EUR 826 million and 1.24 billion worth of 

391 These figures have been calculated using the following equation: total number of new toys in a given year (78,702) x 
the proportion of products impacted by product adaptation x the costs of testing/redevelopment. 
392 These figures have been calculated using the following equation: total number of new toys in a given year (78,702) x 
the proportion of products impacted by product adaptation x the costs of testing/redevelopment. 

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toys could no longer be made available. However, as mentioned throughout, this would not lead to a 
direct  market  contraction  of  that  size,  given  manufacturers  will  be  provided  with  an  appropriate 
transition period in which they will be able to assess the viability of existing products and, if needed, 
shift resources to the production and sale of alternative toy products. Moreover, consumers will in 
many  cases  simply  purchase  an  alternative  toy  product  rather  than  not  purchase  anything. 
Nonetheless,  the  severity  of  the  measures  under  PO1c  will  render  certain  categories  of  toys 
unavailable. 

As detailed under the other policy options, these figures should not be read in isolation, as they are 
subject  to  a range of important  caveats.  However, they illustrate the potential  scale of the impact 
arising from all measures proposed under policy option 1. 

C) Policy options to reduce the number of non-compliant toys – Overarching analysis 

There  are  no notable adjustment  costs stemming  from  PO2a. All  additional costs for industry are 
discussed within the above section on administrative burden.  

For  PO2b,  there  are  no  adjustment  costs  either  as  costs  associated  to  the  DPP  are  factored  in  as 
administrative  burden  above.  There  could  be  some  cost  synergies  and  savings  in  that  product 
information digitalized through the DPP could be useful in demonstrating compliance with the toy 
safety rules, as well as for meeting the requirements set out in horizontal legislation (such as REACH 
and the CLP in relation to substances used in toys). The precise level of savings is not possible to 
estimate. 

2. 

IMPACTS ON INNOVATION AND  COMPETITIVENESS  

As per the Better Regulation guidelines, it is important to assess the impacts of changes to the TSD 
and its possible transition to a Regulation on innovation, competitiveness and the single market.  

In this section, we discuss how the proposed changes to the TSD outlined under the different policy 
options (POs) could potentially contribute towards the achievement of EU policy objectives relating 
to strengthening innovation and industrial competitiveness. A summary is provided here, before a 
more detailed analysis is presented below, by policy option: 

  Under PO1a, the ability  for the Commission  to  more easily change  chemical  Limit Values 
could  impact  the  ongoing  feasibility  of  continuing  to  use  the  same  substances  in  toy 
production. There could be ongoing competitiveness risks related to the uncertainty of relying 
on substances if they can only be used safely in very small quantities with a risk of them being 
banned in future. This could incentivise producers to explore the use of chemical substitutes, 
which could in theory drive innovation. However, in practice, industry stakeholders note that, 
although  the  specific  substances  this  option  will  impact  are  unknown,  there  are  generally 
limited  suitable  alternatives  available  and  the  toy  industry  lacks  influence  in  the  market  to 
drive targeted activities by the chemicals industry to identify appropriate alternatives. 

  Under PO1a, a reduction in the limit values stipulated in the TSD relating to N-Nitrosamines 
and N-nitrosatable substances to the levels already set out in the EN standard and in German 
national legislation, which are lower, was generally supported by large toy manufacturers on 
the basis that they largely already follow lower limit values compared with the TSD as per the 
EN standard. As such, toy producers would not need to use chemical substitutes even if limit 
values were reduced, as they are already below those reduced limit values anyway. However, 
an  exception  in  this  regard  was  producers  of  certain  toy  products,  such  as  balloons,  where 

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SMEs were highly concerned that changes beyond the limit values detailed in the EN standard 
could result in them having to withdraw their products from the market.  

  Under  PO2a,  if  conformity  assessment  was  to  be  extended,  with  additional  pre-conformity 
assessment required through an EC-type examination, industry feedback was that this would 
result in considerable additional compliance costs during the conformity assessment process 
for the product types covered by the extended requirements. In case the measures would lead 
to an improvement in enforcement this would have a very positive effect on competitiveness 
of complying producers as they would win market share and the cheaper illicit competition 
will be curtailed. 

  Under PO2b, the facilitation of controls, a Digital Product Passport would be introduced. This 
could facilitate the work of market surveillance authorities and customs authorities and lead 
to  efficiency  savings,  but  this  would  not  necessarily  impact  directly  on  innovation  and 
competitiveness  per  se.  Again,  in  case  the  measures  would  lead  to  an  improvement  in 
enforcement this would have a very positive effect on competitiveness of complying producers 
as they would win market share and the cheaper illicit competition will be curtailed. 

The impacts by policy option are now considered in detail:  

A) Baseline 

The current baseline situation in relation to competitiveness and innovation is as follows:  

  Currently, a very selected number of derogations from restrictions on chemical substances are 
possible under the TSD under Appendix A. This allows the toys sector to avoid the costs of 
generic bans, given the absence of suitable substitute chemicals in many cases, which prevents 
product withdrawal.  

  Limit  values  change  rarely,  and  it  can  take  considerable  time  to  get  limit  values  changed, 
therefore  there  is  a  challenge  that  no  fast-track  mechanism  exists  to  respond  quickly  if 
scientific  evidence  suggests  that  limit  values  are  unsafe.  Whilst  this  avoids  damaging 
competitiveness by avoiding a situation in which limit values change regularly, it is not ideal 
as  the  system  for  setting  limit  values  is  slow  and  inflexible,  which  may  damage  industry 
competitiveness in the medium-long term.  

  The great majority of toys (around 97%) are not presently subject to an EC type examination. 
This is viewed as being cost-effective by industry, who have a strong preference for following 
Module A (internal production control).  

  The  very  high  number  of  non-compliant  toys  in  the  Union  market  create  a  competitive 
disadvantage  for  reputable  manufacturers  that  spend  a  significant  amount  of  resources  in 
complying with the TSD. 

B) Policy options to strengthen the protection of children from harmful chemicals - PO1a 

Strengthening  the  limit  values  for  chemical  substances  could  have  mixed  impacts,  given  that 
tightening chemicals rules for toys is likely to serve as both a driver and inhibitor of innovation 
and competitiveness. 

Under PO1a, there would be an impact on innovation and competitiveness. In particular, the proposed 
changes would  incentivise, but  not mandate chemicals substitution. Reductions  in  limit values 
could require producers to reconsider which chemicals they use in toy production, for instance if they 
can only use these in small quantities to avoid exceeding new limit values. Whilst in some cases, they 

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could continue to use the same chemicals, there could be an increased risk in terms of the supply of 
those  chemicals  in  future  if  scientific  evidence  evolves  and  requires  further  changes  to  the  limit 
values, or even the substance being banned. The nature and magnitude of impacts would depend on 
which limit values are put in place, which is not yet known at this stage, as PO1a is about giving 
regulatory powers to change limit values to be more flexible and quicker to reflect evolving scientific 
evidence. 

Where no suitable alternative chemicals are available, this could lead to the withdrawal of particular 
products from the market. However, whilst there could arguably be some withdrawals of products 
from the market, estimated in the cost-benefit assessment at between 1% in a low case and 2% in a 
high case, regarding the impacts on industry overall, this would be partially mitigated through the 
effects of consumers switching to purchasing compliant products instead of a product they would 
have otherwise purchased had it not been withdrawn from the market, as well as the possibility for 
producers to adapt production through a sufficiently long transition period. 

The  SME  survey  examined  views  on  what  difference  this  package  of  options  would  make  to 
competitiveness  of  products.  It  should  be  noted  that  the  views  expressed  cover  all  sub-measures 
included in PO1a, which go beyond making changes to chemicals limit values alone. 

Figure 18: PO1a minimum changes. Impacts on SMEs – on a scale of 1-5 (1 strong decrease, and 5 strong 
increase in competitiveness), how would these measures presented above make your products more or less 
competitive in comparison to imports and to larger manufacturers? 

Source: SME survey 

Regarding the SME survey results, interestingly, SMEs are more concerned about the impact on 
their relative competitiveness in comparison to large manufacturers compared with any concerns 
they might have regarding the impact on imports from outside the EU. However, this is not surprising, 
as  any  importers  or  toy  manufacturers  outside  the  EU  would  be  subject  to  the  same  rules  as 
manufacturers within the EU-27, whereas SMEs would arguably be more impacted by changes to 

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limit values in chemicals as they lack the economic clout of large producers and are more at risk of 
speciality chemical producers discontinuing the production and supply of particular chemicals. 

More positively, if limit values could be changed more easily by the Commission, this would promote 
adaptability in case particular concerns come to light regarding chemicals used in toys and allow for 
a rapid and flexible regulatory response to adjust limit values in light of any new or changed scientific 
evidence. It is difficult to anticipate the impact on competitiveness and innovation that this would 
have at a more granular level, as the precise chemicals whose limit values would be amended are not 
known at this point in time. 

The timing of changes to limit values could also impact on toy manufacturers’ competitiveness. 
If these occur at short notice, this would cause regulatory uncertainty and make it more difficult to 
adjust  to  the  new  limit  values.  This  may  hamper  competitiveness  and  innovation  in  some  cases. 
Conversely, if sufficient time is  given to  manufacturers (especially SMEs) to  adapt  to  changes to 
limit values, then there would be fewer costs and adverse consequences on their competitiveness. 

Balanced against this, if stricter limit values are introduced for certain chemicals used in toys, it could 
incentivise toy manufacturers to search for safer chemical substitutes, which in turn could drive 
innovation by spearheading investment in R&D&I. Some SME manufacturers interviewed (as well 
as those taking part in workshops on the possible revision of the TSD) mentioned that, whilst changes 
to limit values could be managed, the impact would strongly depend on what changes are made to 
existing limit values, which is not yet known by the Commission as changes to limit values would be 
made  in  future  depending  on  which  scientific  evidence  emerges  regarding  the  use  of  particular 
substances.  

Moreover, large firms interviewed commented that, generally, where particular substances are under 
review  or  require  authorisation  under  REACH,  there  could  be  a  negative  impact  on  their 
competitiveness  for  two  reasons  1)  the  lack  of  suitable  alternative  substances  (i.e.  chemical 
substitutes)  and  2)  the  impact  of  regulatory  uncertainty,  as  this  may  lead  to  delayed  investment, 
uncertainty about whether they can continue to produce certain product lines in future etc. Regulatory 
uncertainty will thus have a cost for toy manufacturers, although the precise level of cost is difficult 
to ascertain.  

If  limit  values  are  made  more  stringent,  in  the  short  term,  there  could  be  negative  impacts  on 
innovation and competitiveness, as firms may have to consider not using particular chemicals in the 
manufacturing of particular toy product lines, and this could in turn lead to product withdrawals in 
instances where there are no safe substitutes available. In addition, any decision to focus resources 
on identifying chemical substitutes could also represent an opportunity cost for innovation, research 
and development in relation to other types of toys. However, the scale of this opportunity cost is also 
difficult to assess. 

A 2021 Economic Analysis of the Impacts of the Chemicals Strategy for Sustainability undertaken by 
consultants for CEFIC, for instance, attests to the difficulty in predicting how far products will either 
be discontinued or substituted/reformulated. “The extent to which products will be discontinued or 
substituted/reformulated as a result of CLP changes only has not been investigated directly, although 
an assumption based on expert input has been considered”. 

Regarding the innovation and competitiveness-related impacts of reducing the limit values for 
nitrosamines and nitrosatable substances, these were seen as being neutral by many but not all 
industry associations and manufacturers. The measure to adjust the limit values for N-nitrosatable 

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substances393 and N-nitrosamines from the current level set out in the TSD to the levels already set 
out in both the EN standard and in German national legislation, which are considerably lower, would 
largely  reflect  current  industry  standards  and  not  require  much  adjustment  (apart  from  those 
producers not presently following the EN standard).  Among large toy manufacturers interviewed 
and also during the stakeholder workshop on the possible revision of the TSD held in April 2022, 
there was a broad stakeholder consensus that the current limit values for nitrosamines and nitrosatable 
substances (0.5 mg of N-nitrosamines per kg of material) used in Directive 2009/48/EC are currently 
too high and should be reduced. 

The rationale for reducing limit values under PO1a is for health reasons, as some N-nitrosamines are 
carcinogenic (Category 1B). However, as the limit values are widely acknowledged as being set too 
high,  reducing  the  limit  values  to  more  realistic  safety  levels  was  not  viewed  by  stakeholders 
(including industry) as causing problems from a competitiveness perspective. 

In terms of the impact on innovation, arguably this could encourage manufacturers to reduce levels 
of nitrosamines and nitrosatable substances in existing products and / or to search for alternatives 
chemicals not containing such substances. However, there are limitations as to what is realistic. For 
instance, several SMEs responding to the survey mentioned that there are no alternatives to these 
substances for balloons. 

An area where there could be a positive impact on innovation is not in manufacturing itself, but rather 
improving  the  quality  of  test  methods  and  the  development  of  new  equipment  to  test  lower 
levels  of  N-nitrosamines  and  N-nitrosatable  substances  for  certain  types  of  toys.  EN  71-12 
mentioned above provides test methods in support of the EU requirements for N-nitrosamines and 
N-nitrosatable  substances  in  certain  types  of  toys.  However,  there  needs  to  be  new  and  more 
sensitive testing equipment and validation techniques developed so as to ensure that limit values 
of these substances can be tested to lower levels. According to stakeholder feedback, current testing 
equipment is insufficient to test such substances to much lower limit values, which is a barrier to 
regulatory  change  but  would  also  result  in  costs  for  toy  manufacturers.  Whilst  larger  firms  may 
purchase the equipment themselves, SMEs would likely have to use a third-party testing house and 
pay  for  the  costs  of  testing  as  they  would  be  unlikely  to  purchase  new  highly  sensitive  testing 
equipment themselves as the costs could be prohibitive. 

An  SME  responding  to  the  SME  survey  agreed  with  other  stakeholders  interviewed  (especially 
market  surveillance  authorities  and  notified  bodies)  that  testing  of  nitrosamines  and  nitrosatable 
substances is presently unreliable, such that this causes uncertainty for business which can damage 
competitiveness. Regarding nitrosamine and nitrosatable substance testing, they stated that  “there 
are discrepancies at the testing level between different laboratories, and within the same laboratories 
themselves  on  chemically  identical  samples.  We  believe  further  work  is  required  on  why  these 
discrepancies occur to ensure that tests are robust, reliable and fit for purpose”. 

PO1b 

Many toy industry representatives and individual manufacturers interviewed (both large firms and 
SMEs) expressed major concerns about the impacts on competitiveness of the extension of the 
GRA  and  the  removal  of  derogations  related  to  the  relevant  concentrations  in  the  CLP 
Regulation so that certain chemical substances cannot continue to be used by the toy industry.  

393 “N-nitrosatable substances” refers to any substances capable of being converted into N-nitrosamines; 

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Concerning the extension of the GRA to other substances, an industry association noted that, in their 
understanding, many reputable toy manufacturers do not use the materials that would be subject to 
generic bans under PO1b. However, this extension of the GRA could result in a 10-30% increase in 
the number of substances and mixtures banned under a future Toy Safety Regulation. In this context, 
other manufacturers noted that there would be an impact on their product portfolio, but the level of 
the impact is difficult to estimate due to the lack of clarity on the substances that would be covered. 
The  removal  of  derogations  related  to  the  CLP  will  put  an  onus  on  individual  firms  to  request 
derogations. Whilst some may do so, others may decide to withdraw their product from the market 
instead. 

Manufacturers also anticipated some impact from the removal of the CLP derogations, given that 
residual  presence  of  certain  chemical  substances  is  common  in  some  toy  products.  Even  though 
manufacturers consider such use safe, it would not be permitted under PO1b. However, the scale of 
such impacts was again difficult for industry to anticipate. 

In this context, toy industry manufacturers detailed a further challenge related to the identification of 
appropriate  chemical  substitutes.  More  specifically,  they  noted  that  the  toy  industry  is  highly 
dependent on the chemicals sector as intermediate users for the availability of chemicals despite these 
being crucial to their competitiveness.  

Feedback was that, in comparison with other sectors that are bigger intermediate users of chemicals, 
the  toys  sector  (especially  SMEs)  habitually  purchase  speciality  chemicals  in  low  quantity. 
Therefore,  their  market  power  is  not  that  strong  and  any  changes  in  the  availability  of  particular 
chemicals due to the implementation of horizontal legislation through REACH would have a major 
impact if chemical producers decided to no longer produce particular substances, as there are often 
no  substitutes  available,  and  most  toy  manufacturers  (except  the  leading  global  players)  lack  the 
market weight to work with chemical producers to carry out R&D&I into safe alternatives.  

Some product withdrawals would occur as a result of this policy option, estimated as being equivalent 
to  approximately  4%  in  the  low  case  and  6%  in  the  high  case.  The  ultimate  impact  of  product 
withdrawals  on  the  size  of  the  market  would  be  mitigated  to  some  extent  by  the  purchasing  of 
alternative  toy  products  by  consumers  and  the  ability  for  manufacturers  to  shift  resources  to  the 
production  and  sale  of  alternative  toy  products  should  sufficiently  long  transition  periods  be 
implemented.  However,  it  is  not  clear  that  chemical  substitutes  will  be  available  for  all  products 
affected. 

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Figure 19: PO1a On a scale of 1-5 (1 strong decrease, and 5 strong increase in competitiveness), how would those 
measures presented above make your products more or less competitive in comparison to imports and to larger 
manufacturers? 

Source: SME survey 

As for PO1a, the results show that a greater proportion of SMEs are concerned about the impact of 
the  policy  option  on  their  competitiveness  vis-à-vis  large  firms  compared  with  their  performance 
against imports from outside the EU. However, as can be seen, an overall negative impact on SME 
competitiveness is anticipated under PO1b. 

PO1c 

A large top 5 global manufacturer estimated that, under PO1c, an estimated 10-20% of toys would 
have to be removed from the market, especially electric toys. The precise percentage of toys that 
would have to be removed would depend on how rules on CMRs evolve in a future TSR. For example, 
some monomers are CMRs, but the toy industry uses them only as polymers. Previous studies have 
found that the migration of monomers from polymers has not led to children being exposed to 
hazardous substances. This raises an issue as to the imperative of scientific evidence being robust 
otherwise it could damage the competitiveness of the European toys industry (including international 
toy manufacturers selling toys in Europe). This could be counter-productive from a safety perspective 
too, given that such firms invest significantly in regulatory compliance with the TSD in comparison 
with  non-compliant  firms  in  countries  like  China  that  may  not  be  compliant  with  toy  safety 
requirements.  

A particular concern from a competitiveness perspective was that some monomers could also be 
banned, even though no safety issues have been shown when used in polymers (ABS). Such polymers 
have a significant mechanical impact on reliability and safety, and on the safety of users. 

An example of a substance for which there is  presently a derogation under the TSD is  nickel, 
which is mentioned in Annex A of the TSD. Nickel is essential as a conductor of electricity and is 
extensively  used  in  electric  toys.  Feedback  from  interviewees  was  that  if  such  derogations  were 

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removed,  it  would  also  be  very  costly  for  industry.  However,  there  was  no  data  on  the  costs  of 
substitutes, largely as there were not seen as being any viable alternative safe chemicals presently. 
Instead, the costs would relate more to the costs of product withdrawal. 

As for PO1b, there will likely be some mitigation in terms of the ultimate impact of such product 
withdrawals on the overall toy market. However, certain product types would likely cease to be sold 
if appropriate substitutes cannot be identified. 

Large  industry  players  in  chemicals  can  carry  out  periodic  monitoring  of  the  development  of 
legislation concerning their area of business operations, which is more difficult for SMEs. Secondly, 
it has been pointed out that tightening the rules on chemicals under the TSD may not lead to a level 
playing field as non-compliant firms might be favoured, as they would not be expected to invest in 
compliance, whereas the ‘fair’ players would be forced to do so, which, again, would harm relative 
competitive position of the compliant SMEs. 

In the following figure, feedback from SMEs regarding the impacts of PO1c is provided.  

Figure 20: PO1c Maximum changes. On a scale of 1-5 (1 strong decrease, and 5 strong increase in competitiveness), 
how would those measures presented above make your products more or less competitive in comparison to imports and 
to larger manufacturers? 

1: Our competitiveness would strongly decrease

33,8% (68)

28,4% (57)

2: Our competitiveness would decrease

14,4% (29)

13,4% (27)

3: No change

22,9% (46)

24,9% (50)

4: Our competitiveness would increase

5: Our competitiveness would strongly increase

3,5% (9)

5,0% (10)

2,0% (4)

3,0% (6)

I do not know – No opinion 

23,4% (47)

25,4% (51)

Large manufacturers

Imports from outside the EU

0,0% 5,0% 10,0% 15,0% 20,0% 25,0% 30,0% 35,0% 40,0%

Source: 

SME survey 

The concerns of SMEs regarding PO1c were captured in the responses to the SME survey. Nearly 
half  of  SME  respondents  (48.2%,  97)  were  concerned  that  their  competitiveness  would  decrease 
(14.4%) or strongly decrease (33.8%) compared  with  large firms,  with  a  clear indication towards 
stronger  negative  impacts. Although  a  negative  impact  on  competitiveness  is  still  anticipated,  the 
responses in respect of the impact of PO1c on the competitiveness of SMEs compared with importers 
were lower, with 28.4% of SMEs responding that it would strongly decrease and 13.4% stating there 
would be a decrease. 

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However, it can be noted that there were a high percentage of ‘I do not knows’ for POs 1a, 1b and 1c, 
which  suggests  that  the  impacts  on  competitiveness  are  difficult  to  confirm  without  further 
information, for instance, on which chemical substances and mixtures would be restricted and to what 
extent. 

In summary, the main industry concerns regarding the removal of all derogations under PO1c are:  

  The  general  lack  of  suitable  substitute  substances  for  those  presently  the  subject  of  a 
derogation in the TSD’s Appendix A, which are permitted for specific use (example, the use 
of nickel in stainless steel used in electric toys).  

  Whether if none of the existing derogations are permitted, substances will be available in a 

sufficiently cost-effective and timely manner; and 

  Whether alternative chemicals can be supplied on a large enough scale for the purposes of 
their usage in toy manufacturing. Chemical substitutes are only any good to industry if they 
can be produced at sufficient scale.  

C) Policy options to reduce the number of non-compliant toys 

PO2a 

It was estimated that this option would increase the costs of conformity assessment for manufacturers. 
Increasing the use of EU type examinations for products deemed higher-risk was viewed as costly in 
comparison  to  the  self-declaration  of  conformity  (SDoC).  Secondly,  it  was  perceived  by  large 
manufacturers interviewed that more extensive mandatory use of a notified body to perform an EC-
type examination could lengthen lead times to market, which may undermine the competitiveness of 
the  European  toys  market  compared  with  third  countries  not  having  any  such  requirements.  The 
percentage  of  toy  products  that  would  be  affected  by  PO2a  is  difficult  to  estimate  but  evidence 
gathered through the interview programme and desk research suggests about 20% of toys would be 
affected in total (e.g. mainly those designed for the under 3s and to be put in the mouth plus toys such 
as slimes, clays and paints for children). 

The  impacts  on  competitiveness  would  vary,  however,  between  each  of  the  proposed  areas  to  be 
covered  as  some  situations  in  which  conformity  assessment  would  be  extended  are  much  more 
common than others. Feedback on the specific types of products that would be subject to additional 
conformity assessment procedures is summarised in the following table:  

Table 29: PO2a – specific types of products subject to additional CA procedures 

PO2a 
– 
conformity assessment  

extending 

Toys  which  are  chemical 
mixtures  or  substances 
(i.e.  e.g.  slime,  modelling 
clay  or  finger  paint)  for 
which  there  are  higher 
to 
risks  of 
chemicals.  

exposure 

Baseline situation/ background 

Feedback on impacts 

Industry’s  main  concern  is  that 
they  would  face  higher  costs  of 
undertaking 
third-party 
conformity assessment.  

toy  products  are  chemical 
Many 
mixtures  or  substances,  as  slime, 
modelling  clay  and  finger  paints  are 
very popular among children. There are 
greater health risks associated with such 
products.  

Although  the  toys  industry  has  argued 
(e.g. during workshops, interviews) that 
they  proactively  manage  the  risks  of 

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PO2a 
– 
conformity assessment  

extending 

Baseline situation/ background 

Feedback on impacts 

children  ingesting  chemicals  used  in 
toys by managing exposure risks.  

Toys marketed at children 
under 
the  age  of  36 
months old or designed to 
be put in the mouth.  

Toys marketed at children under the age 
of 36 months old or designed to be put 
in  the  mouth  are  very  common  and 
industry stakeholders interviewed were 
concerned  that  this  would  lead  to 
and 
greatly 
compliance  costs  as  currently,  only  an 
estimated 3% of toys require an EC type 
examination. 

increased 

testing 

The main feedback from industry 
was  that  they  already  implement 
risk  management  approaches  for 
toys for the under 36 months and 
for those designed to be put in the 
mouth. 

third 

They  were  concerned  about  the 
cost  increase  of  having  to  carry 
-party 
out  mandatory 
conformity  assessment  for  such 
toys.  The  concern  was  that  this 
cost would be borne by reputable 
compliant 
and 
manufacturers rather than by non-
compliant  manufacturers  who do 
not  carefully  test  the  chemicals 
used in such products.  

already 

increase 

Any 
adversely 
competitiveness.  

in  costs  may 
on 
impact 

Stakeholders were concerned about the impacts on competitiveness by the delays in marketing a toy. 
The costs of lead times to market are difficult to quantify, a leading top 5 global producer estimated 
that mandatory could third-party conformity assessment could add an additional 4-6 months in the 
process to place a product on the European market, with an adverse impact on competitiveness. 

On a more positive note, stakeholders across a range of groups noted that any increase in costs for 
rogue  traders  and  producers  would  have  a  positive  effect  on  the  competitiveness  of  compliant 
manufacturers, thereby improving the level playing field in the EU market and curtailing cheap, illicit 
competition.  Although  the  European  toys  industry  may  experience  some  negative  impacts  on 
competitiveness  through  the  above,  PO2a  should  also  help  to  strengthen  the  single  market  by 
promoting a more level playing field between reputable and rogue manufacturers placing products 
on the European market. However, PO2a would only have a positive effect on removing more non-
compliant products from the European market if market surveillance authorities adopt a proactive 
approach in checking whether such products have been subject to a mandatory third-party conformity 
assessment or not. There would remain a risk that reputable manufacturers invest in complying with 
additional requirements which would impose additional costs, but rogue producers would still find 
ways to manage to get their products on to the market illegally.  

However, some market surveillance authorities pointed out that it is more straight forward to check 
technical compliance and make a decision whether they need to investigate if a third-party conformity 
assessment body has already checked the product and the test results. This could save time for market 
surveillance authorities and therefore allow them to perform more checks, which in turn could help 
to  reduce  non-compliant  products  on  the  market.  The  positive  impacts  would  be  limited  in  this 
instance to the types of products covered by this measure.  

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Beyond  the  above  general  points,  some  targeted  feedback  through  the  SME  survey  was  obtained 
regarding the impacts on SMEs of making mandatory third-party conformity assessment for certain 
higher-risk  product  categories. As  shown  below,  nearly  a  quarter  of  respondents  were  unable  to 
provide or did not have an opinion on the issue. This suggests that many SMEs found it difficult to 
conceptualise the impact of PO2a on their overall competitiveness. 

However, of those SMEs that were able to respond, the figure illustrates a clear inclination towards 
a  decrease  in  SME  competitiveness  as  compared  to  both  larger  manufacturers  and  imports  from 
outside the EU. 

Figure 21: PO2a: Extending conformity assessment.  Impacts on SMEs. On a scale of 1-5 (1 strong decrease, and 5 
strong increase in competitiveness), how would these measures presented above make your products more or less 
competitive in comparison to imports and to larger manufacturers? 

Source: SME survey 

Overall, this PO would have some benefits but relatively minor impacts  in terms of their scale in 
reducing non-compliant products on the European market. Balanced against this would be a relatively 
significant increase in testing costs as many reputable producers would face both internal and external 
mandatory third party testing costs.  

PO2b 

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There  would  be  benefits  from  this  PO  that  contribute  towards  enhancing  toy  producers’ 
competitiveness. Firstly, the digitalisation of product information (including regulatory compliance 
aspects) could lead to greater efficiencies and cost savings. A potential impact is that the information 
mandatorily required under the DPP could bring synergies if it also helps contribute towards meeting 
TSD  compliance  requirements.  This  PO  is  difficult  to  assess  in  detail  as  the  precise  information 
requirements of the DPP at the product level are not yet known. 

However,  it  is  highly  likely  that  for  instance,  the  chemical  content  of  products  will  need  to  be 
disclosed in a toy producers’ DPP. This could lead to cost savings for producers if having some of 
this information  already  available in  digital  form could  also  be useful to  demonstrate compliance 
with the toy safety requirements. 

Furthermore, stakeholders across a range of groups noted that any improvements in the functioning 
of market surveillance and enforcement within the EU, but also at the EU border, would improve the 
identification and control of non-compliant toys, thereby placing additional challenges and costs on 
rogue traders and producers. This option should have significant impacts in the reduction of non-
compliant toys in the Union market. In turn, this would have a positive impact on the competitiveness 
of reputable and compliant manufacturers by improving the level playing field and curtailing cheap, 
illicit competition. 

The views of SMEs, as expressed through the SME survey on this issue are now provided:  

Figure 22:  PO2b: Facilitation of control. Impacts on SMEs. On a scale of 1-5 (1 strong decrease, and 5 strong increase 
in  competitiveness),  how  would  these  measures  presented  above  make  your  products  more  or  less  competitive  in 
comparison to imports and to larger manufacturers? 

1: Our competitiveness would strongly decrease

29,4% (59)

24,4% (49)

2: Our competitiveness would decrease

9,5% (19)

10,4% (21)

3: No change

28,4% (57)

27,4% (55)

4: Our competitiveness would increase

5: Our competitiveness would strongly increase

3,0% (6)

6,0% (12)

2,0% (4)

4,0% (8)

I do not know – No opinion 

27,9% (56)
27,9% (56)

0,0% 5,0% 10,0% 15,0% 20,0% 25,0% 30,0% 35,0%

Large manufacturers

Imports from outside the EU

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Whereas  the EU’s mandatory  DPP initiative will require some investment  by toy producers, they 
could potentially recoup some of this investment through cost savings as they would have the same 
product information already available under digital form under the DPP for compliance. Generally, 
the direction of travel is of increased digitalisation of product information, including to demonstrate 
regulatory  compliance  to  customs  and  market  surveillance  authorities,  and  enhancing  traceability 
within  value  chains.  There  could  be  potential  cost  savings  for  industry  from  digitalising  product 
compliance information. Previous studies have suggested a benchmark of about 10-15% savings from 
full  digitalisation,  as  the  DPP  will  provide  an  alternative  means  to  provide  product  compliance 
information digitally and as physical documents (e.g DoCs) will no longer be required, then there 
would be greater savings.394. These studies also estimate the provision of compliance information at 
0.4% of turnover of the sector.395 Accordingly, savings could be estimated at around EUR 2.62 to 
EUR 3.93 million per year only from moving to the digital provision of compliance information.  

Whilst 28.4% (57) of SMEs did not think this would lead to any changes in their competitiveness 
vis-à-vis large firms and 27.4% (55) compared with imported products, 29.4% (59) were concerned 
that this would strongly decrease their competitiveness compared with large firms. The rationale was 
that  large  firms  are  more  easily  able  to  invest  in  digitalisation  and  the  digitisation  of  product 
information compared with SMEs.  

In general, this PO of introducing a DPP for all toy products was seen very positively by industry, 
both  by  large  firms  and  SMEs  interviewed.  This  could  provide  a  practical  solution  for  toy 
manufacturers  as  over  time,  there  is  an  increasing  volume  of  information  to  be  provided  about 
products  to  different  users  and  readers  of  product  labels.  market  surveillance  authorities  require 
detailed product information to check regulatory compliance. Toy product information also needs to 
be  communicated  to  other  economic  operators  in  the  supply  chain  to  ensure  traceability.  Lastly, 
consumers also  need  relevant  product  information about  products,  such as whether the product  is 
intended for the under 3 years, and more generally, consumers increasingly demand more information 
about chemicals used in products, including toys.  

PO2c  

The impacts on competitiveness and innovation would therefore be similar to those described under 
PO2a and PO2b previously. However, there would also be the cumulative impacts on industry of 
both requiring more mandatory third-party conformity assessments under PO2a and the digitalisation 
of information under PO2b.  

Moreover, as for PO2a and PO2b separately, the implementation of PO2c would likely improve the 
functioning  of  market  surveillance  and  enforcement,  thereby  placing  additional  burdens  on  rogue 
traders and limiting their ability to place non-compliant toys on the European market. In this respect, 
reputable manufacturers would receive the benefits of a more level playing field and reduced illicit 
competition. 

394 European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, Supporting 
study for the evaluation of certain aspects of the New Legislative Framework (Decision No 768/2008/EC and Regulation 
(EC) No 765/2008), Publications Office of the European Union, 2022, https://data.europa.eu/doi/10.2873/625443 
395 0.4% of turnover of EU toy industry in 2020 was EUR 26.2 million. The share of 0.4% is the result of a multiplication 
of  the  total  cost  of  compliance  (2%  of  annual  turnover,  based  on  previous  literature)  by  the  share  of  the  total  cost 
compliance  related  only  to  the  cost  of  indicating  compliance  with  EU  harmonisation  legislation  (20%,  based  on 
stakeholder consultation in the study supporting the Evaluation of the New Legislative Framework referred to above). 

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Stakeholders  did  not  have  particular  views  about  2c  as  a  combined  package.  Instead,  industry 
stakeholders  reiterated  their  concerns  about  the  increased  cost  of  compliance  under  2a  and 
highlighted that this could lead to a significant increase in their conformity assessment costs. 

3. 

IMPACTS ON THE SINGLE MARKET 

Article 1 of the TSD establishes the focus of the Directive on ensuring the free movement of toys 
within the EU, supported by Recital 1 and Article 12. Although the evaluation of the TSD reported a 
generally  positive  assessment  of  the  impact  of  the  Directive  on  the  European  toys  market,  it  did 
highlight a range of application and market development challenges that limited this effectiveness to 
some extent. Most prominently, the evaluation highlighted the presence of too many non-compliant 
toys on the market and the associated impact on market fairness and product safety, as well as the 
existence of implementation differences across the Member States in terms of both legal transposition 
and practical implementation (e.g. regarding surveillance and enforcement). 

As the free movement of toys will remain as an important objective under the future proposal for a 
TSR, this section considers the impact of each policy option on the EU single market for toys and the 
related application challenges identified through the evaluation. 

A) Baseline 

The 2020 evaluation concluded positively on the achievement of the TSD in relation to ensuring the 
free  movement  of  toys  within  the  EU.  In  particular,  manufacturers  and  other  economic  operators 
highlighted the harmonisation of procedures and requirements as highly effective in supporting the 
functioning of the single market. 

However, the evaluation, as well as the research conducted for this impact assessment, identified a 
range of challenges in the application and particularly the enforcement of the Directive that act as 
barriers to the full realisation of the EU single market for toys: 

Differences across the EU: In some cases, Member States have gone beyond the requirements of 
the TSD. The most prominent example is the 2011 application by Germany to maintain certain stricter 
national provisions on chemicals, including nitrosamines and nitrosatable substances. In 2012, this 
application was approved by the Commission.396 In addition, under the current TSD, changes can be 
made  to  limit  values,  with  some  17  changes  having  been  made  to  the  TSD  since  its  adoption. 
However, there have been delays in the transposition of the different amendments to the Directive. 
The fact that the legal instrument covering toy safety is a Directive means that every amendment to 
the  text  must  be  transposed  by  all  Member  States.  Significant  resources  are  spent  to  ensure  the 
transposition of amendments in a timely manner. The study underpinning the evaluation identified 
that the transposition of amendments of the TSD was excessively burdensome and time consuming.  

Surveillance and enforcement challenges: Given market surveillance is the responsibility of the 
Member States, the resources allocated, and the approaches taken to surveillance and enforcement 
were found to differ across the EU based on the specific circumstances of each country. This included 
differences in the number and type of control procedures implemented, differing, and in some cases 
insufficient,  financial  means  allocated,  and  differences  in  testing  capabilities,  including  lack  of 

396 Commission Decision 2012/160/EU. OJ L 80, 20.3.2012, p. 19. 

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1495625630954&uri=CELEX:32012D0160 

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appropriate  testing  laboratories  in  some  countries.  As  a  result,  the  evaluation  found  that  the 
effectiveness of market surveillance can be considered as limited. 

Beyond these challenges, the study supporting the evaluation highlighted key emerging market trends 
that impact the functioning and effectiveness of the single market, as well as the safety of toys and 
are thus important to consider within the baseline. These most prominently include an increase in 
online sales of toys, which has caused both enforcement and traceability issues, as well as a reported 
increase in counterfeit toys being placed on the EU market, bringing both product safety and IP risks. 

Within this context, the evaluation noted the concerns of stakeholders that too many non-compliant 
products were being placed on the EU single market, stating that this can impact market fairness. 
Tackling this overarching challenge is a key policy objective for the possible revisions to the TSD. 

One recent development that is important to note within the context of the baseline scenario is the 
adoption of the Market Surveillance Regulation (EU) 2019/1020, which has applied since 16 July 
2021. More specifically, the Regulation aims to address key surveillance and enforcement challenges, 
including the challenges related to online sales and the role played by foreign manufacturers in the 
market.  Given  its  recent  application,  the  effectiveness  of  these  measures  is  yet  to  be  evaluated; 
however, the impacts on surveillance, and thus the functioning of the single market (including for 
toys), are anticipated to be positive. 

B)  Policy  options  to  strengthen  the  protection  of  children  from  harmful  chemicals  – 
Overarching analysis 

The  proposed  sub-options  under  PO1  aim  to  address  problems  of  toy  safety,  rather  than  the 
functioning and effectiveness of the single market. However, as detailed in the above discussion on 
innovation and competitiveness, the introduction of further chemical restrictions through these policy 
options could lead to the need for toy manufacturers to identify chemical substitutes for use in certain 
toys.  

Any changes to the limit values would continue to be applicable across the whole EU to all economic 
operators who would all be affected by the same set of changes to the limit values. However, there 
could be some disbenefits for the single market if the limit values are set in a very stringent manner, 
such that products would have to be withdrawn from the market, thus reducing consumer choice. 

There would be some positive single market benefits by having a uniform approach across the EU to 
meeting the limit values for nitrosamines and nitrosatable substances in line with the German and EN 
standards.  

C) Policy options to reduce the number of non-compliant toys 

The  proposed  sub-options  under  PO2  aim  to  address  challenges  related  to  the  functioning  and 
effectiveness  of  the  single  market;  namely,  the  existence  of  too  many  non-compliant  toys  on  the 
market.  According  to  stakeholders  across  all  relevant  groups  (e.g.  industry,  national  authorities, 
notified  bodies  etc.),  this  non-compliance  is  driven  by  products  sold  into  Europe  from  economic 
operators based outside the EU and facilitated by increased access to the EU market through online 
platforms / marketplaces. 

Although the SafetyGate alert data is not representative in this regard, due to the influence of differing 
approaches and priorities of Member State market surveillance authorities, the data do suggest that 
foreign-manufactured toys pose extensive safety and non-compliance problems. For instance, 85.6% 

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of  the  toy-related  alerts  in  the  period  2016-2021  concern  products  originating  in  China  (see  full 
analysis in Annex 11). 

Moreover, the SafetyGate data suggests that non-compliance in relation to specific types of product 
safety risk requires further attention within the TSD. In fact, over the period 2016-2021, the two most 
common toy-related risks – by a large margin – were choking risks (1,507 alerts, 37.7%) and chemical 
risks (1,404, 35.1%). 

PO2a  

Policy  option  2a  seeks  to  extend  the  list  of  toys  for  which  mandatory  pre-marketing  third  party 
conformity assessment is necessary. The logical mechanism for tackling the identified problem (i.e. 
too many non-compliant toys on the market) is that, for certain products that pose a particularly high 
safety and/or non-compliance risk, obliging manufacturers to independently test those products prior 
to placement on the market will improve compliance rates for those product types. The product types 
to would be subjected to mandatory 3rd party examination by a notified body under the policy option 
and commentary on their relevance is now provided: 

  Toys  using  chemicals  mixtures  or  substances  for  which  there  are  higher  risks  of 
exposure – as highlighted by the abovementioned SafetyGate data, chemical-related risks are 
among the most common reasons for safety and non-compliance issues in toys. As such, their 
coverage through option 2a appears relevant. 

  Toys  marketed  to  under  36  months  old  or  designed  to  be  put  in  the  mouth  –  as  for 
chemical risks, such toys have been found to be particularly challenging from a compliance 
and  safety  standpoint.  As  highlighted  in  the  SafetyGate  data,  choking  (primarily  on  small 
parts) is the most common safety risk identified and alerted by market surveillance authorities, 
whilst the evaluation of the TSD noted that there is insufficient clarity regarding whether a 
toy is marketed to children under 3 years or not. As such, their coverage within this policy 
option appears relevant. 

In terms  of the functioning and effectiveness  of the EU single market  for toys, this policy option 
could  improve  compliance  levels  and  product  safety  within  the  above  categories  by  ensuring 
independent  testing  of  these  product  types.  Such  an  impact  could  benefit  the  single  market  by 
improving  consumer  trust,  stimulating  market  growth  and  improving  market  fairness  for  these 
product types. 

However,  many  stakeholders  noted  a  dichotomy  between  compliant  manufacturers,  who  already 
undertake appropriate compliance checks and report limited instances of identified non-compliance, 
and  rogue  economic  operators,  who  place  potentially  non-compliant  and  unsafe  products  on  the 
market will little chance of being identified and punished.  

According to these stakeholders, this policy option would not improve the functioning of the single 
market  but  would  in  fact  negatively  impact  market  fairness.  The  rationale  being  that  compliant 
manufacturers of these types of toys will bear the further costs (i.e. related to engaging a notified 
body), while rogue traders, who it is assumed are responsible for the vast majority of non-compliant 
and  unsafe  products  placed  on  the  market,  will  continue  to  operate  in  the  market  without  fear  of 
punishment (e.g. by using fraudulent test certificates). 

In this respect, these stakeholders note that the primary factor limiting the effective functioning of 
the  single  market  for  toys  is  the  lack  of  effective  market  surveillance,  rather  than  any  provisions 

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within the TSD itself. Regulation 2019/1020 on market surveillance introduces measures aimed at 
tackling online sales and foreign manufacturers; however, it is not yet known whether these measures 
will have the desired impact on product compliance. 

PO2b  

Policy option 2b aims to facilitate controls by market surveillance authorities through the introduction 
of a digital product passport containing the EU declaration of conformity (DoC). This would provide 
market  surveillance  authorities  –  with  the  support  of  customs  authorities,  who  will  verify  the 
existence  of  the  DPP  –  with  more  efficient  access  to  the  key  information  on  which  to  assess  the 
compliance of a toy product. 

In  practice,  this  improved  access  to  information  could  enable  market  surveillance  authorities  to 
conduct more checks over a given time-period and improve cross-border circulation of toys, both into 
and within the EU. However, although the efficiency benefits for these stakeholders are clear, their 
potential effectiveness in tackling the key problem of product non-compliance was questioned by 
industry and market surveillance stakeholders. 

PO2b  would  also  have  a  beneficial  impact  on  the  level  playing  field  as  non-compliance  with  the 
mandatory  requirement  to  ensure  that  a  toy  is  accompanied  by  a  DPP  could  lead  to  customs 
authorities  preventing  the  free  circulation  of  any  product  missing  a  DPP.  Strengthening  the 
transparency of product compliance information through its inclusion in a DPP would make it easier 
for market surveillance authorities to determine which products are non-compliant thereby improving 
efficiency and allowing for higher volumes of checks. 

Conversion to a Regulation 

In addition to the above measures, the proposed conversion of the TSD to a Regulation would bring 
single  market  benefits.  As  highlighted  above,  the  evaluation  of  the  TSD  identified  instances  of 
inconsistency in the transposition and application of the Directive by the Member States. Through its 
direct application, the Regulation would remove the possibility for such inconsistencies, while also 
freeing up the resources currently used by Member State authorities and the Commission to ensure 
transposition  and  alignment.  This  could,  for  instance,  allow  for  greater  investment  in  market 
surveillance and enforcement  

4.  SOCIAL IMPACTS: IMPACTS ON HUMAN HEALTH 

Seeing that the main objective of the TSD is safeguarding the health of children in their use of toys 
it is  not  surprising that the two main problems  identified in  the TSD evaluation  of 2020  and this 
impact assessment are also very much linked to potential risks for human health.  

  Scientific evidence on human health risks is constantly evolving and the TSD needs to keep 

pace with the available knowledge on human health risks of substances used for toys. 

  Too many toys in the market are not complying with the TSD provisions and some of them 

pose an additional risk to children’s health due to this non-compliance.   

The impact assessment considers the following human health impacts to be the most relevant for the 
proposed policy options.  

A) Baseline 

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The current problems identified in the protection of health of children will remain. The evaluation, 
stakeholders and the literature have identified several safety concerns from dangerous substances for 
children when using toys. Without a quick and regular update of substances and limit values these 
concerns will increase over time.  
There is also significant evidence of remaining human health challenges caused by chemical hazards 
despite the existing regulatory frameworks and a significant number of them relate to illnesses and 
risk for children too. A study397 from 2017 listed the following relevant human health impacts:  

  The costs of childhood asthma were estimated to be approximately EUR 1.6 billion per year. 

This is linked to the respiratory hazard class.   

  30,000 DALYs per year are estimated to be potentially caused by chemical exposure.  

  Exposure  to  endocrine  Disruptors  are  linked  with  several  illnesses  linked  to  children  like 
childhood  obesity  and  diabetes,  autism  and  ADS.  The  costs  of  that  are  conservatively 
estimated to be between EUR 8-29 billion a year.  

Establishing with precision the quantitatively exposure to harmful chemicals via toys is not possible 
as children are exposed to chemicals in many other ways. However, seeing the time that children 
spend with their toys every day it is likely that an important part of the exposure happens through 
them.  For  example  in  terms  of  metals,  the  main  source  of  exposure  of  children  is  via  the  diet. 
Ingestion of metals through chewing toys will be an additional source. Under these circumstances 
the  Scientific  Committee  (CSTEE,  predecessor  of  SCHEER)  recommended  that  the  current 
maximum tolerable intakes or limit values for food should be used and 10% allowed as a maximum 
contribution from toys398. In practice, the limit values for other chemicals in the TSD are set at 10% 
of  the  tolerable  daily  intake  set  by  the  European  Food  Safety  Agency  (see  for  example  the 
amendments to the TSD setting limit values for BPA) and for particularly toxic substances, at half of 
that level (5%) (see recital 22 of the TSD).  

B) Policy options to strengthen the protection of children from harmful chemicals - PO1a 

Lower limit values for nitrosamines and nitrosatable substances will align the limit values with other 
products relevant for children using similar substances (e.g. dummies). This could improve the safety 
especially of balloons and similar toys. 

Many respondents also agreed with the need to amend the TSD to enable the Commission to introduce 
and  change  these  limit  values  for  all  toys  as  scientific  evidence  evolves.  Several  examples  were 
mentioned, where limit values for chemicals in toys for children above three years are necessary, e.g. 
preservatives and emission of volatile organic chemicals (VOCs). Most authorities therefore assessed 
that a modest increase in safety is likely if those limit values were introduced. At the same time, some 
authorities thought this solution would not their perceived challenge of regulatory processes being 
too slow and that it would take too long to reach the protection goals. There have been severe delays 
in  updating  annexes,  as  well  as  an  inability  in  addressing  emerging  risks  under  the  Toy  Safety 
Directive as mentioned in a joint letter of several ministers to the Commissioner in 2019399. Some 
commentators  therefore  suggested  to  limit  the  annex  to  a  reduced  number  of  the  most  hazardous 

397 Study on the cumulative health and environmental benefits of chemical legislation, 2017. 
398 Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on “Assessment of the 
bioavailability of certain elements in toys”, June 2004, Opinion on bioavailability of certain elements in toys, CSTEE 
plenary, written procedure (europa.eu) 
399 Evaluation of the toy safety Directive 2019 

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substances. In their view, the Commission would never have the time and resources to go through 
the full list of substances, which is why they support an umbrella solution limited to 40 or less specific 
items as opposed to thousands of substances. 

Combination  Effects:  Not  many  interviewees  had  an  opinion  on  the  human  health  impacts  of 
combination  effects.  One  interviewee  though  argued  that  an  inclusion  would  increase  safety,  as 
children  are  exposed  to  other  chemicals  with  the  same  mode  of  action  from  other  toys  and  other 
products and this exposure is not taken into account today. 
There is by now a significant body of evidence400 on the human health impacts of mixtures. For many 
mixtures the assessment by the risks of the single substances is appropriate as their combined risk 
levels are lower or equal to the additions of the risk of the single substances. But in some cases, the 
combined risk level can be higher and currently the TSD has no legal provisions to take account of 
those cases where the assessment of single substances leaves a significant risk factor out.  

PO1b 

The human health impacts of an extension of the GRA and the end of existing derogations on CRM 
substances would bring overall a positive impact on human health but the scale of this benefit was 
controversially discussed by stakeholders.  

Currently  the  extension  of  the  GRA  approach  is  also  discussed  in  the  review  of  the  REACH 
regulation.  A  use  mapping  was  conducted  in  that  Impact  Assessment  on  the  basis  of  the  ECHA 
registration  dossiers.  For  the  most  relevant  product  categories  an  assessment  on  the  number  of 
substances that would fall under specific hazard classes was developed. The results for 3 product 
categories particularly relevant for toys: PC 32: Polymers, PC9a: Finger paints and PC9c: Plasters 
and modelling clay have been considered. It is quite clear that many substances counted under this 
will not be used in toys but seeing the variety of toys and the polymer compounds used in them it is 
nonetheless a good approximation to understand the scale of the challenge. Another caveat is that the 
analysis eliminated as far as possible the overlap to substances already covered. But as the TSD and 
REACH do not have the same scope this might mean that some substances relevant for the TSD were 
eliminated while others should have been eliminated (as already banned in the TSD) but were not. 
An extension to all the hazard classes for the most harmful chemicals (EDs, respiratory sensitizers, 
immunotoxic  and  neurotoxic  substances  (currently  under  STOT)  would  mean  that  the  number  of 
substances covered might increase by about 10-30%401. That has of course implications for the costs 
of substitution, the cost of regulation and the human health and environmental impacts.  

The evidence on existing chemical risks (although not directly linked to toys) on especially children’s 
illnesses  shows  that  especially  the  ban  of  endocrine  disruptors  and  substances  affecting  the 
respiratory  systems  could  be  very  relevant  for  toys.  A  significant  amount  of  research  has  been 
conducted on the risks for human health of endocrine disruptors, immunotoxic, neurotoxic, STOTs 
and substances affecting the respiratory systems. Recent studies402 have revealed alarming levels of 
cadmium and lead in products intended for children and compounds in plastics, such as phthalates 
and bisphenol A, that are suspected of harmful effects. Especially the risks of endocrine disruptors 
for children are set out in recent literature403. Given their capacity to mimic, obstruct and block natural 
hormones, exposure to  even tiny amounts of EDs may result in severe and irreversible effects on 
human  health,  such  as  infertility,  cancers,  genital  malformations,  IQ  loss  or  obesity.  Other 

400 https://ec.europa.eu/environment/pdf/chemicals/2020/10/SWD_mixtures.pdf  
401 See annex 10.D for the precise estimates. 
402 https://pubs.acs.org/doi/10.1021/es1009407  
403 https://www.beuc.eu/publications/beuc-x-2020-004_endocrine_disruptors.pdf 

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literature404 showed that the exposure of children especially by mouthing to endocrine disruptors does 
surpass safe levels in a very significant number of cases. A special focus of the research405 has been 
the impact of phthalates and Bisphenol A in plastic applications. 

The findings of the baseline show that especially two hazard classes might be most important for the 
Toy sector. Due to the closer link of endocrine disruptors and substances affecting the respiratory 
systems tor childhood diseases these hazard classes can be seen as the most urgent to be included in 
the GRA.  

The  not  yet  published  impact  assessment  for  the  REACH  revision  on  an  extension  of  the  GRA 
approach provides some interesting estimates on the impact of a generic ban on endocrine disruptors. 
The assessment of different health outcomes linked to endocrine disruptors in that IA brought the 
following results. Overall 11 health outcomes were identified, where a statistical relationship with 
the  exposure  to  endocrine  disruptors  can  be  established  (Very  low  birth  weight,  Intellectual 
disabilities,  Childhood  obesity,  Male  infertility,  Cryptorchidism,  Hypospadias,  Testicular  cancer, 
Autism  Spectrum Disorder, ADHD in  children and adolescents,  ADHD in adults, Diabetes) . For 
those 11 health outcomes information  on the prevalence , the costs  per case  and the PAF (Prevalence 
attributable  Fraction) were available.  For the attributable fraction the evidence was much less robust 
and therefore estimates of 1%, 2.5% and 10% were used.  

The estimates show that exposure to endocrine disruptors causes very significant health effects that 
can be estimated on the basis of these 11 identified health outcomes to be at around 24 billion EUR 
per year). It is important to note that this annual benefit will be only reached after a very long time 
span as many of the avoided negative health outcomes will only not materialise in 50 years or more. 
This is especially true for endocrine disruptors and children where the costs of infertility or diabetes 
will show only many years after the exposure to EDs. So even a 20 year or even 30 year assessment 
period will not capture many of those benefits. On the other hand the costs for toy companies will 
happen in the very near future.  

As  explained  above  only  a  part  of  this  exposure  is  linked  to  toys.  The  evidence  on  the  share  of 
exposure that is linked to toys is missing. On the one hand the type of adverse health outcomes are 
especially relevant to be avoided in children as they are linked to chronic illnesses like Diabetes or 
infertility.  On  the  other  hand  children  are  only  a  smaller  part  of  the  population  so  many  of  the 
damages described above are happening to the adult population not much affected by toy legislation, 
but exposure to such substances at a young age can lead to such health problems. But certainly seeing 
the  amount  of  time  children  spend  with  their  toys  and  especially  in  young  age  how  closely  they 
interact with them may suggest that the fraction is not trivial. First of all, the specific limit values in 
the current TSD are based on the fact that toys should only contribute to 10% of tolerable daily intakes 
of harmful chemicals, and 5% for particularly toxic metals406. Furthermore, the limit values were also 
based on the assumption that a child would ingest  per day 100 mg of dry, brittle, powder-like or 
pliable toy material, 400 mg of liquid or sticky toy material, and 8 mg of scraped-off toy material. 

404 
and 
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0231171 
https://link.springer.com/article/10.1007/s11356-016-7616-y and https://sdg.iisd.org/news/harmful-chemicals-found-in-
25-of-childrens-toys-unep-study-finds/ 
405 
Bagdassarian/publication/282972605_Phthalate_Plasticizers_and_Safety_of_Toys_-
_Problems_and_Perspectives/links/56247c5c08ae93a5c92cbb0a/Phthalate-Plasticizers-and-Safety-of-Toys-Problems-
and-Perspectives.pdf and https://drive.google.com/file/d/1FubTn67W1Y-mjpydS6OeFpaS68hjxQBv/view 
406 Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on “Assessment of the 
bioavailability of certain elements in toys”, June 2004, Opinion onbioavailability of certain elements in toys, CSTEE 
plenary, written procedure (europa.eu) 

https://www.researchgate.net/profile/Valentina-Christova-

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These assumptions are based on a number of studies on children mouthing behaviour and have been 
validated by SCHEER407. 

Based on the overall figures above, if only 1-5% of the overall exposure to endocrine disruptors will 
be caused by toys that would mean that the damage caused by exposure to endocrine disruptors could 
be valuated at between EUR 240 million and EUR 1.23 billion per year, in terms of avoided health 
damage. This is certainly an estimate on the low side due to the lack of evidence on the attributable 
portion  of  toy  exposure.  It  is  also  worth  noting  that  this  is  only  the  estimate  for  the  impacts  of 
endocrine disruptors and the GRA will include other hazard classes too.  

Table 30: Estimated values of current human health damages caused by endocrine disruptors  

Hazard  classes/ 
properties 

Health 
outcome 

Type 
metric 

of 

2022 Value* 

Prevalence 
incidence 

/ 

Population 

Casses  per 
year  

Attributable 
cases of EDs 
year 
per 
(PAF: 1%) 

Endocrine 
disruptors  and 
reprotoxicants 

Very  low  birth 
weight 

Endocrine 
disruptors  and 
neurotoxicants 

Intellectual 
disabilities 

Endocrine 
disruptors 

Childhood 
obesity 

€140,000 
€450,000 

- 

€ 1,700,000 

€ 160,000 

€25,000 
€45,000 

- 

Willingness 
to  pay 
avoid a case 

to 

Average 
lifetime costs 
per  case  of 
intellectual 
disability 

Total  lifetime 
cost 
excess 
per 
obese 
child 

Value  of  a 
statistical 
pregnancy 
among 
general 
population 

the 

1% (incidence) 

4,000,000  (EU  27  - 
live  births  in  each 
and every year) 

40,000  

400  

1% (incidence) 

12% (incidence) 

4,000,000  (EU  27  - 
live  births  in  each 
and every year) 

4,000,000  (EU27  – 
number  of  8  years 
old 
in  each  and 
every year) 

40,000  

400  

480,000  

4,800  

150,000 
Men  born 
with 
reduced 
semen 
quality 
resulting 
infertility 

in 

Fertility 
ratio: 
1.50461 

Number  of 
children 
that will not 
be 
born 
naturally 
due 
reduced 
semen 
quality: 
230,000 

to 

2,300  

Endocrine 
disruptors  and 
reprotoxicants 

Male infertility 

(50%  of 
of 

7.50% 
prevalence 
couple infertility) 

2,000,000  (EU  27  - 
live  male  births  in 
each 
every 
and 
year) 

Endocrine 
disruptors  and 
reprotoxicants 

Cryptorchidism 

€ 40,000 

Direct, 
indirect  and 
intangible 
costs 
case 

per 

1% 

2,000,000  (EU  27  - 
live  male  births  in 
each 
every 
and 
year) 

20,000  

200 

407 SCHER (Scientific Committee on Health and Environmental Risks), Final Opinion on estimates of the amount of toy 
materials ingested by children, 8 April 2016 Estimates of the amount of toy materials ingested by children (europa.eu) 

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Hazard  classes/ 
properties 

Health 
outcome 

Type 
metric 

of 

2022 Value* 

Prevalence 
incidence 

/ 

Population 

Casses  per 
year  

Attributable 
cases of EDs 
year 
per 
(PAF: 1%) 

Endocrine 
disruptors  and 
reprotoxicants 

Hypospadias 

Endocrine 
disruptors  and 
reprotoxicants 

Testicular 
cancer 

Endocrine 
disruptors  and 
neurotoxicants 

Autism 
Spectrum 
Disorder 

Endocrine 
disruptors  and 
neurotoxicants 

ADHD 
children 
adolescents 

in 
and 

Endocrine 
disruptors  and 
neurotoxicants 

ADHD in adults 

Endocrine 
disruptors 

Diabetes 

€ 45,000 

€90,000 

€490,000 

€ 120,000 

€ 270,000 

€ 55,000 

Direct, 
indirect  and 
intangible 
costs 
case 

per 

Direct, 
indirect  and 
intangible 
costs 
case 

per 

Lifetime 
excess costs - 
Direct  health 
care costs and 
indirect 
societal costs 

Average total 
ADHD-
related  costs 
per  child  / 
adolescent 

Lifetime 
excess  costs 
per case  

and 

Lifetime 
direct 
indirect 
healthcare 
costs per case 

*Rounded to the nearest five thousand 

0.2%  (19.9  over 
10,000 
births 
regardless of sex) 

4,000,000  (EU27  - 
live  births  in  each 
and every year) 

10,000 

100 

130,000,000  (EU27 
adult 
male 
– 
population 
(20-
69y)) 

0.01% (incidence) 

10,000 

100 

1% (incidence) 

4.8% (prevalence) 

0.15% 
(prevalence) 

4,000,000  (EU  27  - 
live  births  in  each 
and every year) 

66,000,000  children 
and  adolescents  (3-
18 years old) in 2050 
in EU27 

240,000,000  work-
age  adults 
(19-65 
years old) in 2050 in 
EU27 

40,000 

400 

3,170,000 

32,000 

360,000 

3,600 

10.4% 

310,000,000  (EU27 
adult 
population 
(20-79y) in 2050) 

32,000,000 

320,000 

The increased speed of the regulation is the key benefit of this option too. By reaching the protection 
targets quicker than under the baseline or PO1a human health impacts could be achieved quicker too.  

It is worth noting though that this increase in safety could only be realised for the compliant toys on 
the market. Without proper enforcement the higher risks of illicit toys would stay the same or even 
increase due to higher compliance costs of the compliant producers.  

The human health impacts of the removal of the CLP-based derogation are hard to predict but would 
be potentially significant.   

Another  important  condition  is  the link  to  the  currently  discussed  implementation  of  the  GRA  in 
REACH. If the same hazard classes and substances are banned under REACH it will be much easier 
for the Toy industry to be compliant as chemical manufactures will need to adapt their practices.   

PO1c 

Most of the benefits for human health described above under PO1b are also relevant also for PO1c. 
The key difference is the number of derogations that can be expected. Under this option both the 

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existing  derogations  for  CRM  substances  and  also  potential  future  derogations  on  other  hazard 
categories would be not implemented or abandoned.  

Regarding the existing derogations, the evaluation of the TSD concluded that they do not pose an 
additional human health risk, beyond the CLP-based derogation.  

Companies  were  very  sceptical  about  the  positive  health  impacts  of  removing  derogations.  Their 
argument was that if derogations follow the procedure and the risk can be clearly avoided following 
the conditions of the derogations, no extra human health risks are avoided by scraping the derogation. 
In their opinion, the existing derogations are not abused and do not result in additional risks.  

Apart from the CLP-based derogation authorities did not point out either to another derogation that 
would cause additional risk to the health of children.  

Consumer organisations considered that option 1c will give better tools to responsible authorities to 
protect children. It should ensure the higher possibility of safe toys present in the single market of 
the EU and if it will also implement new provisions which strengthen the requirements to ensure that 
only safe toys enter the market, this should significantly increase the protection of the children health. 

Many commentators from all sides argued that the derogation criteria are an important factor in the 
choice between option 1b and 1c. If the derogation criteria can avoid all residual risks, no derogations 
would be a regulation overreach but if not the human health impacts of 1c compared to 1b might be 
significant. Yet, derogations for the most harmful substances under PO1b could be based on minimal 
effects as a means to determine the safe use and in that respect PO1c could be more protective of 
human health, as in that there could be no exposure to those substances. 

Many commentators also formulated the concern that criteria that are too strict could inadvertently 
foster the illicit toys market and increase human health risks in this way.  

 C) Policy options to reduce the number of non-compliant toys 

PO2a 

Non-compliant toys  are on average less safe for children.  The available evidence and stakeholder 
comments showed that this PO is expected to lead only to a very limited improvement in the number 
of  illicit  toys  is  to  be  expected  from  the  market  and  with  that  the  risks  of  illicit  toys  would  only 
decrease  slightly.  Both  authorities  and  companies  agree  overall  that  even  third  party  conformity 
assessments would be too easy to forge. Rogue traders could place their products on the EU market 
without  complying  with  the  third-party  conformity  assessment,  as  they  do  today  for  other 
requirements. 

On the other hand the available evidence showed that the health risks of illicit toys are very substantial 
and any positive impacts on the market share of those toys could would have an important impact on 
human health. 

PO2b 

As this PO is expected to reduce significantly the number of non-compliant toys on the Union market, 
it would have significant impacts on the health risks of those. The introduction of a DPP would make 
it easier and less resource intensive for customs authorities and other market surveillance authorities 
to identify non-compliant products. Digital product passports would help in reducing the number of 

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illicit  toys  in  the  EU  as  currently  authorities  needs  to  reach  out  to  the  seller,  importer  and 
manufacturer to collect all the necessary information, which can be a lengthy process. Withdrawing 
non-compliant toys from the market will be quicker with the digital product passport.  

Finally, as the DPP will be required for toys coming from third countries to be placed on the Union 
market, it will prevent a significant number of non-compliant toys from reaching the Union market.  

PO2c 

Overall it is  very likely  that option 2c will  be more effective than 2b and 2a in  safeguarding and 
improving human health. The two options combined in option 2c could reinforce each other with 
more  certainty  on  the  assessments  coming  from  third  party  conformity  assessments  and  the 
information more easily available with the DPP a real improvement in surveillance and controls at 
customs could be achieved. However, seeing that the main impact will be expected from option 2b 
though it can be discussed whether the added impact of option 2c is  (compared to 2b) more than 
marginal. 

5.  ENVIRONMENTAL IMPACTS 

While the TSD concerns the safety of children and not  environmental protection or sustainability 
aspects, certain indirect environmental impacts could be expected from the different policy options. 
Several  environmental  concerns  linked  to  TSD  can  clearly  be  identified,  such  as  the  presence  of 
hazardous substances (e.g., ED, CMR) in the toys that may be harmful not only for human health but 
also  for  the  environment,  the  recycling  process  of  these  toys  and  the  submission  in  paper  of 
information on toys by the manufacturers.  

A) Baseline 

Under the baseline scenario, specific environmental concerns regarding chemical substances will be 
addressed  by  REACH.  Sustainability  requirements  for  toys  may  be  set,  as  appropriate,  under  the 
ESPR even though this is not foreseen in the medium term.  

Most  information  on  the  toy  will  continue  to  be  provided  on  paper,  such  as  the  technical 
documentation or the Declaration of Conformity, upon request of the market surveillance authorities. 

B) Policy options to strengthen the protection of children from harmful chemicals - PO1a 

Policy option 1a could have a positive effect on the environment, notably because it could lead to 
less dangerous substances from toy materials and from  recycled materials. This means that fewer 
harmful chemicals would reach the environment through end-of-life toys.  

If depending on transition period requirements, already ordered and produced toys may need to be 
sent for destruction, and this could thus have a negative impact on waste. 

As concerns the combination of chemicals under this option, it should be consistently approached 
across EU legislation on chemicals. 

PO1b 

The majority of stakeholders who expressed their opinion on the impacts of policy option 1b on the 
environment  highlighted  that  the  main  environmental  concern  linked  to  toys  is  the  presence  of 
endocrine  disruptors  (EDs),  PBT,  vPvBs  and  CMR  substances  in  the  toys.  These  substances  are 
indeed present in toys, but not mentioned in the TSD (apart from CMR substance) and they are not 

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all regulated yet at the level of horizontal chemical legislation. Many of the chemical substances that 
would be covered by a generic ban in PO1b may not only be harmful for human health but also for 
the environment. This PO will thus have greater benefits for the environment by addressing those. 

If less chemicals are included in the toys produced, it could have a positive impact on the environment 
as  less  dangerous  substances  from  toy  materials  and  from  recycled  materials  would  reach  the 
environment. As this option is expected to have more substances banned from the outset, it would 
have higher benefits on the environment than PO1b.  

PO1c 

Many of the impacts described above are relevant also for option 1c. The key difference is the number 
of  derogations  that  can  be  expected.  Under  this  option  both  the  existing  derogations  for  CMR 
substances and also potential future derogations on other hazard categories would be not implemented 
or  abandoned.  Less  derogations  could  mean  that  less  harmful  substances  would  be  present  in  the 
waste stream, which would thus have a positive impact on the environment, greater than for PO1b. 

C) Policy options to reduce the number of non-compliant toys 

PO2a 

An increased number of third-party conformity assessment would allow to reduce the number of non-
compliant toys. Non-compliant toys are likely to be more harmful to the environment, therefore, a 
reduction of the number of such toys would mean less pollution. Such a reduction would also favour 
recycling as safer materials could be used to produce recycled toys. 

Additionally, toys found to be non-compliant would not be shipped to the EU (and in some cases not 
even produced) and this would have a positive impact on the environment as these non-compliant 
toys  would  not  have  to  be  destroyed.  This  would  mean  that  less  waste  is  created,  and  the 
environmental costs are also decreased due to the products not being transported.  

PO2b 

Illicit toys are more harmful to the environment, therefore, a reduction of the number of such toys 
would mean less pollution. It would also favour recycling for the production of toys as less harmful 
substances would be present in recycled materials. 

A  post-marketing  facilitation  of  controls  on  toys  through  the  introduction  of  the  digital  product 
passport could help reduce the number of non-compliant toys, and thus have a positive impact on the 
environment.  It could also help reducing the packaging of toys,  which is an important part of the 
waste creation linked to toys. Also, toys without proper documentation would not be shipped to the 
EU, so it would not have to be destroyed in the EU either.  

Additionally, the digital passport for toys could help reduce the number of papers used by economic 
operators and national authorities. It could even incentivise toy manufacturers to use higher quality 
materials that do not have a negative impact on the environment. 

In particular, policy option 2b would have overall a positive impact on the environment.  

Less non-compliant toys: The introduction of a digital product passport for toys would facilitate the 
control of illicit toys as the EU declaration of conformity and information related to the toys could 
be consulted by the market surveillance authorities quicker and at the entry into the EU market. This 
would  help  to  reduce  the  number  of  illicit  toys  on  the  EU  market.  As  non-compliant  toys  have 
negative impacts  on the environment  due to  the harmful  substances contained in  them, a reduced 
number of such toys would be beneficial for the environment. 

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Less waste: The introduction of a digital passport for toys would benefit the environment because 
digitalisation would reduce the packaging of toys, which is an important part of the waste creation 
linked to toys. Also, as toys without proper documentation would not be shipped to the EU, it would 
not have to be destroyed in the EU either. Thus, this would decrease overall the amount of waste 
produced in the EU and the amount of energy needed for the destruction of the products.  

Paper savings: the digital passport for toys could help reduce the number of papers used by economic 
operators and national authorities. Indeed, if part of the information that accompanies the toys in a 
physical  form  now  can  be  added  to  the  digital  product  passport,  it  could  reduce  the  amount  of 
packaging and of paper accompanying the products.  

Higher quality materials: A national authority added that the introduction of a digital passport for 
toys would incentivise toy manufacturers to use higher quality materials that do not have a negative 
impact on the environment.  

PO2c 

On the one hand, the digital product passport would facilitate the control of toys by allowing a quicker 
verification of market surveillance authorities and check before entering the EU market. On the other 
hand, more conformity assessments would make it more likely that toys are overall compliant and do 
not include harmful substances. 

Both measures combined would thus allow to have fewer non-compliant toys in the EU market, and 
thus less negative impact on the environment. This would also incentivise recycling as the toys could 
use safer recycled materials. 

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ANNEX 15: BIBLIOGRAPHY 

1.  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on 

general product safety, OJ L 11 of 15.01.2002 

2.  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 

3.  Regulation 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction 
of  Chemicals  (REACH),  establishing  a  European  Chemicals  Agency,  amending  Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation 
(EC)  No  1488/94  as  well  as  Council  Directive  76/769/EEC  and  Commission  Directives 
91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC 

4.  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 

5.  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 

6.  Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and 
mixtures  (CLP),  amending  and  repealing  Directives  67/548/EEC  and  1999/45/EC,  and 
amending Regulation (EC) No 1907/2006Directive 2011/65/EU, on the restriction of the use 
of certain hazardous substances in electrical and electronic equipment (RoHS) 

7.  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the 

safety of toys 

8.  Regulation  (EC)  No  1223/2009  of  the  European  Parliament  and  of  the  Council  of  30 

November 2009 on cosmetic products (recast)  

9.  Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the 
restriction of the use of certain hazardous substances in electrical and electronic equipment 

10. 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 relating to the making available on the market 
of radio equipment and repealing Directive 1999/5/EC 

11. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on 
the protection of natural persons with regard to the processing of personal data and on the free 
movement of such data, and repealing Directive 95/46/EC 

12. Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on 
ENISA  (the  European  Union  Agency  for  Cybersecurity)  and  on  information  and 
communications  technology  cybersecurity  certification  and  repealing  Regulation  (EU)  No 
526/2013 

EN 

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  EN 

 
13. 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 

14. Commission  Delegated  Regulation 

supplementing 
Directive 2014/53/EU  of  the  European  Parliament  and  of  the  Council  with  regard  to  the 
application of the essential requirements referred to in Article 3(3), points (d), (e) and (f), of 
that directive, C(2021) 7672 

(EU)  2022/30  of  29.10.2021 

15. Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 
on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services 
Act) OJ L 277, 27.10.2022, p. 1 

16. Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down 
harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain 
union legislative acts, COM(2021) 206 

17. 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 European Parliament 
and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, 
and  repealing  Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  and 
Council Directive 87/357/EEC, OJ L 135, 23.5.2023, p. 1  

18. Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  establishing  a 
framework for setting ecodesign requirements for sustainable products and repealing Directive 
2009/125/EC, COM(2022) 142 

19. Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment, COM(2020) 667  

20. New Consumer Agenda, COM(2020) 696 

21. Cyber Resilience Act, Call for evidence for an impact assessment (2021) 

22. European  Parliament  resolution  of  16  February  2022  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) 

23. 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), 19 November 
2020. 

24. Commission  notice  The  ‘Blue  Guide’  on  the  implementation  of  EU  product  rules  2022  - 

2022/C 247/01 

25. Commission  Decision  2012/160/EU  of  1  March  2012  concerning  the  national  provisions 
notified by the German  Federal  Government  maintaining the limit  values for lead, barium, 
arsenic, antimony, mercury and nitrosamines and nitrosatable substances in toys beyond the 
entry into application of Directive 2009/48/EC of the European Parliament and of the Council 
on 
https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1495625630954&uri=CELEX:32012D0160 

safety 

toys, 

the 

of 

EN 

216 

  EN 

 
26. Study for the revision of the Toy Safety Directive, 2022, by VVA, CSES and Asterisk, to be 

published. 

27. Commission staff working document - Impact Assessment report accompanying the Review 

of the CLP Regulation, not yet published. 

28. The  European  Toy  Market  2020  and  Digital  Trends  2021,  February  2021. 
https://globaltoynews.com/2021/02/05/the-european-toy-market-2020-and-digital-trends-
2021/ 

29. ECSIP Consortium (2013). Study on the competitiveness of the toy industry – Final Report, 
p. 
17. 
https://ec.europa.eu/DocsRoom/documents/6653/attachments/1/translations/en/renditions/nat
ive 

30. Khajeheian, D. (2018). Market analysis, strategy diagnosis and opportunity recognition in toy 
industry  [in:]  “International  Journal  of  Entrepreneurship  and  Small  Business”,  33(2), 
DOI:10.1504/ijesb.2018.090138. 

31. Ismail,  R.,  et  al.  (2020).  Toy  Safety  in  the  ASEAN  and  European  Union:  A  Comparative 
Approach [in:] International Journal of Innovation, Creativity and Change, vol. 10/11, online. 
32. What is driving online toy sales? July 2021, available at:  https://www.npd.com/news/thought-

leadership/2021/whats-driving-online-toy-sales/ 

33. Commission staff working document - Fitness check of the most relevant chemicals legislation 
(excluding REACH), as well as related aspects of legislation applied to downstream industries, 
COM(2019)264 final, 18 July 2019. 

34. Commission staff working document - Progress report on the assessment and management of 
combined  exposures  to  multiple  chemicals  (chemical  mixtures)  and  associated  risks 
SWD(2020) 250, 14 October 2020. 

35. United  Nations  Environment  Programme,  State  of  the  Science  of  Endocrine  Disputing 

Chemicals - IPCP-2012. 

36. L.N.  Vandenberg  &  J.L.  Turgeon,  Endocrine  disrupting  chemicals:  Understanding  what 
matters.  In  L.  N.  Vandenberg,  &  J.  L.  Turgeon  (Eds.), Endocrine-Disrupting  Chemicals, 
2021. Combined effects on two year old children (mst.dk) 

37. Prederi,  Barbara,  Alves,  Crésio  A.D.  et  Lughetti  Lorenzo.  “New  insights  on  the  effects  of 
endocrine disrupting chemicals on children”  Jornal de Pediatria Volume 98, supplement 1, 
March-April 2022, p. S73. https://doi.org/10.1016/j.jped.2021.11.003 

38. Commission  staff  working  document  -  Fitness  Check  on  endocrine  disruptors  and  its 
Executive  Summary,  accompanying  the  Chemicals  Strategy  for  Sustainability  SWD(2020) 
251 final, 14 October 2020. 

39. Endocrine Disruptors: from Scientific Evidence to Human Health Protection, 2019 available 

at: 
https://www.aesan.gob.es/AECOSAN/docs/documentos/noticias/2019/Disruptores_endocrin
os.pdf 

EN 

217 

  EN 

 
40. Commission Implementing Decision (EU) 2021/1992 of 15 November 2021 on harmonised 
standards for toys drafted in support of Directive 2009/48/EC of the European Parliament and 
of the Council, OJ L 405, 16.11.2021, p. 14  http://data.europa.eu/eli/dec_impl/2021/1992/oj 

41. Study for the technical and Scientific Support to the Commission’s Impact Assessment for the 
Revision  of  the  Regulation  on  Classification,  Labelling  and  Packaging  of  Substances  and 
Mixtures (CLP), to be published. 

42. I.  Rijk,  M.  van  Duursen,  and  M.  van  den  Berg,  Health  cost  that  may  be  associated  with 
Endocrine Disrupting Chemicals — An inventory, evaluation and way forward to assess the 
potential  health  impact  of  EDC-associated  health  effects  in  the  EU,  Institute  for  Risk 
Assessment Sciences, University of Utrecht, 2016. 

43. The  toxic  truth  Children’s  exposure  to  lead  pollution  undermines  a  generation  of  future 
potential,  UNICEF  2020,  https://www.unicef.org/reports/toxic-truth-childrens-exposure-to-
lead-pollution-2020. 

44. European Commission, Directorate-General for Environment, Study on the cumulative health 
and  environmental  benefits  of  chemical  legislation  :  final  report,  Publications  Office, 
2017, https://data.europa.eu/doi/10.2779/070159 

45. European Commission, Directorate-General for Environment, Bakker, J., Reihlen, A., Meura, 
L., et al., Study for the strategy for a non-toxic environment of the 7th Environment Action 
Programme : final report, Publications Office, 2017, https://data.europa.eu/doi/10.2779/025 

46. OECD  -  Considerations  when  assessing  children’s  exposure  to  chemicals  from  products  - 
Series 
2019 
Assessment 
https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(
2019)29&docLanguage=en. 

September 

Testing 

310, 

No. 

and 

on 

47. Carroquino,  Maria  J.  et  al.  “Environmental  Toxicology:  Children  at  Risk.” Environmental 
Toxicology:  Selected  Entries  from  the  Encyclopedia  of  Sustainability  Science  and 
Technology 239–291. 4 Dec. 2012, doi:10.1007/978-1-4614-5764-0_11 

48. Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), Opinion of the 
toys”,  June  2004, 
the  bioavailability  of  certain  elements 

on  “Assessment  of 
https://ec.europa.eu/health/ph_risk/committees/sct/documents/out235_en.pdf 

in 

49. Scientific  Committee  on  Health  and  Environmental  Risks  (SCHER)  Final  Opinion  on 
ingested  by  children,  8  April  2016, 
Estimates  of 
https://health.ec.europa.eu/publications/estimates-amount-toy-materials-ingested-children_en 

the  amount  of 

toy  materials 

50. Kirchnawy  C,  Hager  F,  Osorio  Piniella  V,  Jeschko  M,  Washüttl  M,  Mertl  J,  et  al. 
(2020)  “Potential endocrine disrupting properties of toys for babies and infants” PLoS ONE 
15(4): e0231171: https://doi.org/10.1371/journal.pone.0231171 

51. UN  Environment  Programme  (UNEP)  “Chemicals  of  concern  in  plastic  toys”  available  at: 

https://doi.org/10.1016/j.envint.2020.106194 

EN 

218 

  EN 

 
52. Danish Environmental Protection Agency “CMR Substances in Toys – Market Surveillance 
at: 

Assessment” 
and 
https://www2.mst.dk/Udgiv/publications/2015/10/978-87-93352-79-7.pdf 

available 

2015, 

Risk 

53. Scientific Committee on Health and Environmental Risks (SCHER) “Risk from organic CMR 
2010 
substances 
https://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_121.pdf 

toys”, 

May 

18 

in 

54. Scientific  Committee  on  Health  and  Environmental  Risks  (SCHER),  Opinion  on  "CEN's 
response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment 
of 
2007 
toys", 
https://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_056.pdf 

29  May 

chemicals 

adopted 

organic 

on 

in 

55. TIE  report  on  EU  Toy  Safety:  the  problem  of  unreputable  sellers  on  online  marketplaces 

https://www.toyindustries.eu/ties-eu-toy-safety-the-problem-of-unreputable-sellers-on-
online-marketplaces/ 

56. BTHA 

report  “Still  Toying  with  Children’s  Safety”  https://toysafety.co.uk/wp-

content/uploads/2021/10/BTHA-Online-Marketplace-Report.pdf 

57. BEUC  March  2022  “Products  from  online  marketplaces  continue  to  fail  safety  tests  – 
Compilation of research on unsafe products from online marketplaces from 2021 and 2022” 
https://www.beuc.eu/sites/default/files/publications/beuc-x-2022-
029_products_from_online_marketplaces_continue_to_fail_safety_tests.pdf 

58. OECD (2016), "Online Product Safety Sweep Results: Australian Competition and Consumer 
Commission",  OECD  Digital  Economy  Papers,  No.  262,  OECD  Publishing,  Paris, 
https://doi.org/10.1787/5jlnb5q64ktd-en. 

59. Eurostat E-commerce statistics based on the results of the 2021 Survey on ICT usage and e-
commerce in enterprises, https://ec.europa.eu/eurostat/statistics-explained/index.php?title=E-
commerce_statistics 

60. Eurostat E-commerce statistics for individuals based on the results of the 2021 survey on ICT 
individuals,  https://ec.europa.eu/eurostat/statistics-

usage 
and  by 
explained/index.php?title=E-commerce_statistics_for_individuals 

in  households 

61. OECD  Policy  Responses  to  Coronavirus  (COVID-19)  -  Connecting  Businesses  and 
2020, 

Consumers 
https://www.oecd.org/coronavirus/policy-responses/connecting-businesses-and-consumers-
during-covid-19-trade-in-parcels-d18de131/ 

COVID-19: 

Parcels 

During 

Trade 

July 

in 

9 

62. Swedish Chemicals Agency (KEMI) Increased e-commerce – increased chemicals risks? A 
mapping of the challenges of e-commerce and proposed measures. Report of a government 
assignment, 
2021 
https://www.kemi.se/download/18.10a06a7017c771cb35422e/1634280087819/Report-6-21-
Increased-e-commerce-increased-chemicals-risks.pdf 

63. Europol  Guide  How 

to 

recognise 

fake 

and 

hazardous 

toys, 

2022 

https://www.europol.europa.eu/operations-services-and-innovation/public-awareness-and-
prevention-guides/how-to-recognise-fake-and-hazardous-toys 

EN 

219 

  EN 

 
64. Europol 2021, Cute, but deadly: law enforcement seize over €16 million worth of fake toys 
https://www.europol.europa.eu/media-press/newsroom/news/cute-deadly-law-enforcement-
seize-over-%E2%82%AC16-million-worth-of-fake-toys 

65. Putting more Union in the European Customs - Ten proposals to make the EU Customs Union 
fit  for  a  Geopolitical  Europe  Report  by  the  Wise  Persons  Group  on  the Reform  of  the  EU 
Customs 
https://taxation-
customs.ec.europa.eu/system/files/2022-03/TAX-20-002-Future%20customs-
REPORT_BIS_v5%20(WEB).pdf 

Brussels 

March 

Union 

2022 

– 

66. World  Trade  Organization  E-commerce,  trade  and  the  Covid-19  pandemic,  4  May  2020 

https://www.wto.org/english/tratop_e/covid19_e/ecommerce_report_e.pdf 

67. European Commission, Directorate-General for Internal Market,  Industry, Entrepreneurship 
and  SMEs,  Supporting  study  for  the  evaluation  of  certain  aspects  of  the  New  Legislative 
Framework  (Decision  No  768/2008/EC  and  Regulation  (EC)  No  765/2008),  Publications 
Office of the European Union, 2022, https://data.europa.eu/doi/10.2873/625443 

68. Scientific Committee on Non-Food Products (SCCNFP) An initial list of perfumery materials 
which must not form part of cosmetic products.  Opinion SCCNFP/0320/00 final, 3.5.2000.

https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out116_en.pdf 

69. Scientific  Committee  on  Non-Food  Products  (SCCNFP)  An  update  of  the  initial  list  of 
perfumery  materials  which  must  not  form  part  of  cosmetic  products.  Opinion 
SCCNFP/0771/03 
9.12.2003. 
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out251_en.pdf 

final, 

70. Scientific  Committee  on  Non-Food  Products  (SCCNFP)  Fragrance  allergy  in  consumers. 

Opinion SCCNFP/0017/98 final, 8.12.1999. Table 6a, p. 22. 
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out98_en.pdf 

71. Scientific Committee on Non-Food Products (SCCNFP) An initial list of perfumery materials 
which must not form part of cosmetic products except subject to the restrictions and conditions 
laid 
25.9.2001. 
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf 

SCCNFP/392/00 

down. 

final, 

72. Scientific  Committee  on  Consumer  Products  (SCCP)  Opinion  on  Oak  moss  /  Tree  moss 

(sensitisation only). SCCP/1131/07, 15.4.2008. 
https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_131.pdf 

73. Larson DB, Jordan SR (2018) Playing it safe: toy safety and conformity assessment in Europe 
journals.  

and 
United 
https://journals.sagepub.com/doi/full/10.1177/0020852317747370 

States. 

Sage 

the 

74. Ismail, R., et al. (2021). Towards a Framework for Establishing Children’s Toys Safety Policy 
in  ASEAN  [in:]  “International  Journal  of  Academic  Research  in  Business  and  Social 
Sciences”, vol. 11(3), DOI:10.6007/IJARBSS/v11-i3/8812 

EN 

220 

  EN 

 
  
 
 
75. Holloway, D. & Green, L. (2016). The Internet of Toys. [in:] “Communication Research and 
Practice, Special Issue: ANZCA 2016 Creating Space in the Fifth Estate”, Vol. 2, Issue 4, (eds. 
Fulton, J. & McIntyre, P.), DOI:  10.1080/22041451.2016.1266124. 

76. 2021 

European 

e-commerce 

report, 

https://ecommerce-europe.eu/wp-

content/uploads/2021/09/2021-European-E-commerce-Report-LIGHT-VERSION.pdf 

77. Bjerkan, K. Y., Bjørgen, A., Hjelkrem, O. A. (2020).  E-commerce and prevalence of last mile 
DOI: 

“Transportation 

Procedia”, 

Research 

vol. 

46, 

practices, 
10.1016/j.trpro.2020.03.193 

[in:] 

78. Lone, S., Harboul, N., & Weltevreden, J. W. J. (2021). 2021 European E-commerce Report, 
https://www.cmihva.nl/wp-content/uploads/2021/09/EuropeanEcommerce-Report-

online: 
2021.pdf 

79. Metapack  (2022).  Ecommerce  Delivery  Benchmark  Report  2022.  Welcome  to  the  age  of 
https://info.metapack.com/rs/700-ZMT-
ecommerce, 
762/images/Ecommerce%20Delivery%20Benchmark%20Report%202022%20%282%29.pd
f 

online: 

80. Negev, M. et al. (2018). Regulation of Chemicals in Children's Products: How U.S. and EU 
Regulation Impacts Small Markets [in:] “Science of the Total  Environment”, vol. 616-617, 
DOI: https://doi.org/10.1016/j.scitotenv.2017.10.198 

81. He, L., Reimers, I., & Shiller, B. (2021) Does Amazon Exercise its Market Power? Evidence 

from Toys R Us. Online: http://dx.doi.org/10.2139/ssrn.3910636 

82. International Programme on Chemical Safety. (2002). Global assessment on the state of the 
Organization. 

disruptors. 

Health 

World 

science 
https://apps.who.int/iris/handle/10665/67357 

endocrine 

of 

83. UNEP  State  of  the  Science  of  Endocrine  Disputing  Chemicals  -  IPCP-2012,  available  at: 
https://www.unep.org/resources/publication/state-science-endocrine-disputing-chemicals-
ipcp-2012?_ga=2.148289463.183897156.1643356524-1526509983.1643356524 

84. National  Institute  of  Environmental  Health  Sciences.  (n.d.)  Endocrine  Disruptors. 

https://www.niehs.nih.gov/health/topics/agents/endocrine/index.cfm 

85. Attina  TM,  Trasande  L.  Economic  costs  of  childhood  lead  exposure  in  low-  and  middle-
countries.  Environ  Health  Perspect.  2013  Sep;121(9):1097-102.  doi: 

income 
10.1289/ehp.1206424 

86. Trasande  L,  Liu  Y.  Reducing  the  staggering  costs  of  environmental  disease  in  children, 
estimated  at  $76.6  billion  in  2008.  Health  Aff  (Millwood).  2011  May;30(5):863-70.  doi: 
10.1377/hlthaff.2010.1239.  

87. Bellanger,  M.,  Pichery,  C.,  Aerts,  D.  et  al.  Economic  benefits  of  methylmercury  exposure 
control in Europe: Monetary value of neurotoxicity prevention. Environ Health 12, 3 (2013). 
https://doi.org/10.1186/1476-069X-12-3 

EN 

221 

  EN 

 
88. National Institute for Public Health and the Environment (RIVM) Chemicals in Toys A general 
methodology for assessment of chemical safety of toys with a focus on elements RIVM report 
320003001/2008 at https://www.rivm.nl/bibliotheek/rapporten/320003001.pdf 

89. Joint Research Centre, Institute for Health and Consumer Protection, Updated European Union 
risk assessment report 4,4’-isopropylidenediphenol (bisphenol-A) : human health addendum 
of February 2008, Pakalin, S.(editor), Aschberger, K.(editor), Munn, S.(editor), Publications 
Office, 2010, https://data.europa.eu/doi/10.2788/40301 

90. Good practice for market surveillance. Guidance document developed by market surveillance 
experts  who  are  members  or  Chairpersons  of  various  Administrative  Cooperation  (AdCo) 
groups.  
https://ec.europa.eu/docsroom/documents/23041/attachments/1/translations/en/renditions/pdf 

91. OECD (2018), "Consumer product safety in the Internet of Things", OECD Digital Economy 

Papers, No. 267, OECD Publishing, Paris, https://doi.org/10.1787/7c45fa66-en 

92. World Economic Forum Generation AI: What happens when your child's friend is an AI toy 
talks  back?,  2018  https://www.weforum.org/agenda/2018/05/generation-ai-what-

that 
happens-when-your-childs-invisible-friend-is-an-ai-toy-that-talks-back/ 

93. OECD (2021), "Children in the digital environment: Revised typology of risks", OECD Digital 
Economy Papers, No. 302, OECD Publishing, Paris, https://doi.org/10.1787/9b8f222e-en 

94. Article  29  Data  Protection  Working  Party  (2018).  Guidelines  on  Automated  individual 
decision-making  and  Profiling  for  the  purposes  of  Regulation  2016/679,  WP251rev.01: 
https://ec.europa.eu/newsroom/article29/items/612053  

95. Chaudron, S., et al. (2017) Kaleidoscope on the Internet of Toys Safety, security, privacy and 
online: 

societal 
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC105061/jrc105061_final_online.
pdf, DOI:10.2788/05383. 

Technical 

Reports, 

insights, 

JRC 

96. Mordor Intelligence (2021). Connected Toys Market – Growth, Trends, COVID-19 Impact, 
https://www.mordorintelligence.com/industry-

(2022-2027), 

online: 

and  Forecasts 
reports/connected-toys-market 

97. BusinessWire (2021). Global Connected Toys Market Report 2021: Market to Reach $18.9 
Billion  by  2027  -  Console-Connected  Toys  is  Projected  to  Account  for  $7.7  Billion  - 
online: 
ResearchAndMarkets.com, 
https://www.businesswire.com/news/home/20210318005627/en/Global-Connected-Toys-
Market-Report-2021-Market-to-Reach-18.9-Billion-by-2027---Console-Connected-Toys-is-
Projected-to-Account-for-7.7-Billion---ResearchAndMarkets.com 

98. Jung,  S.  (2017).  Research  on  synchronization  between  smart  toys  and  smart  phones  for 
toys,  [in:]  “International  Journal  of  Internet,  Broadcasting  and 

classifying  smart 
Communication”, Vol.9, No.4, pp. 25-30, DOI: 10.7236/IJIBC.2017.9.4.25, p. 29. 

99. Nelson, B. (2016). Children’s Connected Toys: Data Security and Privacy Concerns. Office 
of Oversight and Investigations, Minority Staff Report, Committee On Commerce, Science, 
and Transportation, United States Senate, online: https://www.hsdl.org/?view&did=797394 

EN 

222 

  EN 

 
100. Toyfail  report  by  Norwegian  Consumer  Association  -  https://fil.forbrukerradet.no/wp-

content/uploads/2016/12/toyfail-report-desember2016.pdf 

101. Michalitsi-Psarrou,  et  al.  (2019).  Empowering  Product  Co-creation  Approaches  Through 
Business Interoperability Concepts: The Toy Industry Case, [in:] (K. Popplewell et al., eds.) 
“Enterprise  Interoperability  VIII,  Proceedings  of  the  I-ESA  Conferences  9”,  DOI: 
10.1007/978-3-030-13693-2_33 

102. Kwong, C. W., Mak, S. L. & Li, C. H. (2020). The Exploration of a Technical Model for Toy 
Factories  in  China  to  Deal  with  European  and  US  Toy  Safety  Requirements,  [in:] 
“International  Journal  of  Business,  Humanities  and  Technology”,  Vol.  10,  No.  2, 
DOI:10.30845/ijbht.v10n2p4 

103. Hansson,  S.O.,  Molander,  L.,  Rudén,  C.,  2011.  The  substitution  principle.  Regulatory 
Toxicology and Pharmacology 59, pp. 454–460. https://doi.org/10.1016/j.yrtph.2011.01.011 

104. Lofstedt, R., 2014. The substitution principle in chemical regulation: a constructive critique. 
Journal of Risk Research 17, pp. 543–564. https://doi.org/10.1080/13669877.2013.841733 

105. Öberg, T., 2014. Substitution of chemicals based on assessment of hazard, risk and impact. 
Journal of Risk Research 17, pp. 565–568. https://doi.org/10.1080/13669877.2013.841737 

106. ChemSec (2016). The bigger picture. Assessing economic aspects of chemicals substitution, 
accessed: 
https://chemycal.com/dap/files/The_bigger_picture_160217_print.pdf, 

online: 
30.05.2022 

107. BEUC 

Factsheet 

on 

Endocrine 

disruptors, 

2020 

https://www.beuc.eu/sites/default/files/publications/beuc-x-2020-
004_endocrine_disruptors.pdf 

108. Szczepańska, N., Namieśnik, J. & Kudłak, B. Assessment of toxic and endocrine potential of 
substances migrating from selected toys and baby products. Environ Sci Pollut Res 23, 24890–
24900 (2016). https://doi.org/10.1007/s11356-016-7616-y 

109. Gangadhar Andaluri, Muruganandham Manickavachagam & Rominder Suri Plastic toys as a 
facilities, 

to  bisphenol-A  and  phthalates  at 

childcare 

source  of 
https://doi.org/10.1007/s10661-017-6438-9 

exposure 

EN 

223 

  EN