COMMISSION STAFF WORKING DOCUMENT EVALUATION of Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys
Date: 2020-11-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European standard, dangerous substance, free movement of goods, health risk, market supervision, product safety, safety standard, technical standard, toy industry

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.11.2020  SWD(2020) 287 final  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}  
 
 
Contents 

1. 

INTRODUCTION ............................................................................................................................... 6 

1.1. 

Purpose of this evaluation....................................................................................... 6 

1.2. 

Scope of the evaluation .......................................................................................... 7 

2. 

BACKGROUND TO THE INTERVENTION ................................................................................. 7 

2.1.  Description of the intervention and its objectives .................................................... 7 

2.1.1.  Market evolution .................................................................................................... 7 

2.1.2. 

The EU legislative context ...................................................................................... 9 

2.1.3. 

The intervention logic ........................................................................................... 14 

3. 

IMPLEMENTATION AND STATE OF PLAY ............................................................................. 22 

4.  METHOD .......................................................................................................................................... 24 

4.1. 

Supporting studies and reports ............................................................................. 24 

4.2. 

Stakeholder consultations ..................................................................................... 25 

4.3. 

Limitations of available data ................................................................................. 26 

4.3.1. 

Data on toy-related injuries ................................................................................. 26 

4.3.2. 

Data on marketing restrictions for toys ............................................................... 28 

4.3.3. 

Data on toy trade .................................................................................................. 29 

4.3.4. 

Data on costs related to toy production .............................................................. 30 

4.3.5. 

Lack of representativeness of the respondents in the stakeholder consultations
31 

5.  ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS ...................................... 31 

5.1. 

Effectiveness of the Toy Safety Directive ............................................................... 31 

5.1.1. 

Effectiveness in relation to the safety of toys ..................................................... 31 

5.1.2. 

Effectiveness related to the free movement of toys in the EU ........................... 46 

5.1.3. 

Is the Directive effective with regard to market surveillance? ........................... 49 

5.1.4. 

Does the legal form – Directive or Regulation – impact the effectiveness?....... 53 

Has the law-making process affected the effectiveness of the Toy Safety 
5.1.5. 
Directive? .............................................................................................................................. 54 

5.2. 

Efficiency of the Toy Safety Directive ..................................................................... 56 

5.2.1. 

Costs related to the Toy Safety Directive .......................................................... 56 

5.2.1.1. 

One-off costs for adapting to the Toy Safety Directive ................................... 56 

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5.2.1.2. 

Recurring costs for manufacturers ................................................................... 58 

5.2.2. 

Costs for SMEs .................................................................................................... 67 

5.2.3. 

Are there any costs of consumers ....................................................................... 69 

5.2.4. 

Benefits of the Toy Safety Directive ................................................................... 69 

5.2.5. 

Balance of benefits and costs .............................................................................. 70 

5.2.6. 

Is there scope for simplification? ....................................................................... 71 

5.3. 

Relevance ............................................................................................................. 74 

Is the Toy Safety Directive’s requirement that toys have to be safe still 

5.3.1. 
relevant? 74 

5.3.2. 

Is the Directive still relevant in view of new type of risks such as cybersecurity?
77 

Is the requirement on the free movement of goods in the Toy Safety Directive 

5.3.3. 
still relevant? ........................................................................................................................ 80 

5.3.4. 

Is the current monitoring and evaluation system fit for purpose? ..................... 81 

5.4. 

Coherence ............................................................................................................ 83 

Is the Toy Safety Directive coherent with other EU or Member State 
5.4.1. 
legislation? ............................................................................................................................ 83 

Is the Toy Safety Directive coherent with the risk assessment and risk 
5.4.2. 
management approaches under other pieces of EU legislation? ..................................... 84 

Are there different limit values for chemicals in other EU or national 
5.4.3. 
legislation? ............................................................................................................................ 85 

5.5. 

EU added value ..................................................................................................... 89 

6.  CONCLUSIONS ............................................................................................................................... 91 

6.1. 

Effectiveness ........................................................................................................ 91 

6.2. 

Efficiency .............................................................................................................. 93 

6.3. 

Relevance ............................................................................................................. 93 

6.4. 

Coherence ............................................................................................................ 95 

6.5. 

EU added value ..................................................................................................... 95 

1. 

LEAD DG, DECIDE PLANNING/CWP REFERENCES ............................................................. 96 

2.  ORGANISATION AND TIMING ................................................................................................... 96 

3. 

EXCEPTIONS TO THE BETTER REGULATION GUIDELINES ........................................... 96 

4.  CONSULTATION OF THE RSB (IF APPLICABLE) ................................................................. 96 

5. 

EVIDENCE, SOURCES AND QUALITY .................................................................................... 100 

Annex 4: Amendments to the Toy Safety Directive ......................................................... 127 

Annex 5: Main provisions of the Toy Safety Directive ...................................................... 128 

Annex 6: How a toy safety standard supports the Toy Safety Directive ............................ 131 

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Annex 7: Toy safety standards, the references of which have been published in the Official 
Journal .......................................................................................................................... 132 

Annex 8: Problems identified in the 2008 IA and addressed in the 2009 Toy Safety Directive

133 

Annex 9: Occurrence of nitrosamines and nitrosatable substances in toys – Market 
surveillance data............................................................................................................ 135 

Annex 10: Possible benefits of the Toy Safety Directive................................................... 136 

Annex 11: EU added value .............................................................................................. 137 

3 

 
 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

AdCo 

CEN 

Administrative Cooperation 

European Committee for Standardization 

CENELEC 

European Committee for Electrotechnical Standardization 

CLP 

Classification, Labelling and Packaging 

CLP Regulation 

CMR 

DG 

DG ENV 

DG GROW 

DG JUST 

DG SANCO 

DG SANTE 

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 

Directorate General 

DG Environment 

DG Internal Market, Industry, Entrepreneurship and SMEs 

DG Justice and Consumers 

Former Directorate General for Health and Consumers 

Directorate General for Health and Food Safety 

DG TAXUD 

DG Taxation and Customs Union 

DoC 

EC 

EN 

ESO(s) 

ETSI 

EU 

GPSD 

Declaration of Conformity 

European Commission 

European Standard 

European Standardisation Organisation(s) 

European Telecommunications Standards Institute 

European Union 

General Product Safety Directive 

4 

 
 
IA 

IoT 

JRC 

IDB 

MS 

MSA 

NB 

OJEU 

Impact Assessment 

Internet of Things 

Joint Research Centre 

European Injuries Database 

Member State(s) 

Market Surveillance Authority(ies) 

Notified Body(ies) 

Official Journal of the EU 

PROSAFE 

Product Safety Forum of Europe 

R&TTE 

RAPEX 

REACH 

RoHS 

RPS  

SCCS 

SCHER 

SG 

SME(s) 

TIE 

UK 

US(A) 

Radio and Telecommunications Terminal Equipment 

EU Rapid Exchange System for dangerous non-food products 

Registration, Evaluation, Authorisation and Restriction of Chemicals 

Restriction of Hazardous Substances 

Regulatory Procedure with Scrutiny 

Scientific Committee on Consumer Safety 

Scientific Committee on Health and Environmental Risks 

Secretariat-General 

Small- and Medium-sized Enterprise(s) 

Toy Industries of Europe 

United Kingdom 

United States (of America) 

WTO TBT 

World Trade Organization – Technical Barriers to Trade 

5 

 
1. 

INTRODUCTION 

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on 
the safety of toys,1 commonly known as the Toy Safety Directive, lays down the safety 
and other requirements that toys must meet before they can be marketed in the EU. 

Directive  2009/48/EC  replaced  the  former  Directive  88/378/EEC  in  order  to  adapt  the 
requirements  for toys to  technical and scientific developments and previously unknown 
safety  issues.  The  application  and  enforcement  are  aligned  with  the  so-called  'New 
Legislative Framework’, adopted in July 2008 and laying down a horizontal framework 
of  common  principles  and  reference  provisions  intended  to  apply  across  sectorial 
legislation (such as the Toy Safety Directive). It defined all the necessary elements for an 
effective  conformity  assessment,  accreditation  and  market  surveillance,  including  the 
control of products imported into the European Union.2 

The  new  Directive  had  to  be  transposed  by  the  EU  Member  States  into  their  national 
legislation by 20 January 20113 and was to be applied as of 20 July 2011, except for the 
chemical safety requirements which were to be applied as of 20 July 2013.4 

Member  States  have  to  report  every  five  years  on  the  application  of  the  Toy  Safety 
Directive in  their national  territories. The  first  reporting exercise  covered 2009  – 2013, 
the second 2014 – 2018. 

1.1.  Purpose of this evaluation 

The overarching purpose of this evaluation is to assess the performance of the Toy Safety 
Directive since its entry into force in relation to its two objectives of (1) ensuring a high 
level of safety of toys with a view to ensuring the health and safety of children, and of 
(2) guaranteeing the functioning of the internal market for toys. 

Following  the  2014  Member  States’  reports  on  the  application  of  the  Directive  during 
2009  –  20135  and  an  external  study  by  a  consultant  in  2014  and  2015  (2015  external 

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, p. 1) 
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1403078123201&uri=CELEX:02009L0048-
20181126 

2  The New Legislative Framework relies on: 

a) 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; 
b)  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. 
https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en 

3  Article 54 of the Toy Safety Directive 

4  Article 53 of the Toy Safety Directive 

5 

See  the  Commission  Summary  of  Member  States'  Reports  on  the  Application  of  the  Toy  Safety 
Directive 2009/48/EC at http://ec.europa.eu/growth/sectors/toys/safety/legislation_en 

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study)6  analysing  the  performance  of  the  Directive  with  regard  to  its  effectiveness, 
efficiency,  relevance,  coherence  with  other  legislation  (whether  EU  or  Member  States' 
national legislation) and EU added value, the Commission considered it necessary, about 
five years after the full applicability of the Directive in the Member States, to conduct an 
own  evaluation  of  the  performance  of  the  Directive,  in  order  to  consolidate  the 
information collected so far and to complement it with its own observations. 

This evaluation assesses the extent to which the Toy Safety Directive is fit for purpose, 
hence continues to deliver effectively and efficiently the intended benefits for consumers 
and  business.  It  also  assesses  whether  the  Directive  is  relevant  to  stakeholder  needs, 
coherent  with  other  EU  legislation  (EU  or  Member  States'  national  legislation)  and 
whether it has an EU added value. 

The  evaluation  provides  conclusions  on  current  drawbacks  of  the  Toy  Safety  Directive 
that prevent it from fully achieving its objectives and generating the desired results. 

1.2. 

Scope of the evaluation 

The period evaluated starts from the entry into force of the Toy Safety Directive in 2009, 
bearing  in  mind  that  its  provisions  only  started  applying  on  20  July  2011  (chemicals-
related provisions: 20 July 2013), and covers all the Member States of the EU; and the 
world as a whole, since obligations for toy manufacturers apply to both EU and non-EU 
manufacturers  whose  toys  are  placed  on  the  EU  market.  This  evaluation  covers  the 
27 EU  Member  States  and  the  United  Kingdom  as  during  the  period  covered  by  the 
evaluation  (2009  –  2018)  the  United  Kingdom  was  still  a  Member  of  the  European 
Union7. It should therefore be noted that when the document refers to EU Member States 
in  the  presentation  of  results  these  include  also  the  United  Kingdom.  It  focuses  on  the 
period  from  2009  to  2018,  seeking  to  understand  trends  over  this  period  wherever 
possible. 

2.  BACKGROUND TO THE INTERVENTION 

2.1.  Description of the intervention and its objectives 

2.1.1.  Market evolution 

The EU has the largest single market for goods and services worldwide. Toys valued at 
about € 18 billion were sold in the EU in 2016. Imports into the EU represented half of 
the  sales  (€  9.1  billion).  Most  toy  production  takes  place  in  China.  Online  sales  are 
increasing and reach over 1 in every 4 toys in some countries8. 

6 

2015 Evaluation of directive 2009/48/EC on the safety of toys. 
http://ec.europa.eu/growth/sectors/toys/safety/legislation_en 

7 The United Kingdom withdrew from the European Union and became a third country as of 1 February 

2020. 

8  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  

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Almost 60,000 people are working in the EU toy sector and over 130,000 workers have 
an  indirect  role  to  play.9  The  EU  toy  industry  is  an  international  player:  in  2016,  toys 
worth  €  1.91  billion  were  exported  from  the  EU  to  third  countries.  Moreover,  it  is  a 
dynamic and innovative  industry:  around one third of the toys on the market  each  year 
have been newly developed.10 

The structure of the EU  toy industry is  complex and very heterogeneous, ranging from 
large world-wide operating companies to very small producers of certain specific kinds 
of toys. About 99% of the EU’s 5,900 toy companies are SMEs, most of which have less 
than  10 members  of  staff  and  account  for  90%  of  the  total  number  of  manufacturers. 
Almost half of the EU toy manufacturers are located in four countries: Germany, France, 
Poland  and  the  UK.  It  is  a  dynamic  market  with  900  new  companies  which  joined  the 
sector since 2013. The turnover of the industry in 2016 accounted for € 7.75 billion and 
steadily grew since 2009 by 16%.11  

According to Toy Industries of Europe (TIE), the trade association for the European toy 
industry  providing,  amongst  others,  relevant  information  both  for  and  on  the  EU  toy 
industry, there were 18,680 specialised retailers  in  toys in 2016  compared to  19,083 in 
2011.12  According  to  the  Retail-Index  data,  the  biggest  retailer  in  Europe  was  Amazon 
with € 45 million of turnover.13 

The export from EU countries of toys covered by the Toy Safety Directive amounted to 
€ 10.4  billion  in  2018.  This  corresponds  to  0.2%  of  the  total  EU  exports.  86%  of  the 
export goes to other EU countries (intra EU trade), and the remaining 14% is sold outside 
the  EU.  Intra-EU  export  of  toys  covered  by  the  Toy  Safety  Directive  almost  doubled 
since 2007 (real growth rate of 89%), while export of other toys grew by 12%, and the 
overall intra EU export of all goods grew by 9%.14 

The traditional toys  and  games market  shows moderate  growth rates in  Europe and the 
US  and  strong  growth  rates  in  China  and  especially  in  the  rest  of  the  world.  Growth 
levels for traditional toys and games sales are higher than for the economy as a whole, 
offering a positive outlook for the toy sector with opportunities for expansion, especially 
for  European  toy  producers,  who  are  the  second  most  important  toy  exporters  after 
China.15 

9  The European Toy Industry (TIE), Facts and Figures. 

https://www.toyindustries.eu/resource/facts-figures-brochure/  

10  The European Toy Industry (TIE), Facts and Figures. See footnote above. 

11  Annual detailed enterprise statistics for trade (NACE Rev. 2 G) [sbs_na_dt_r2], Retail sale of games 

and toys in specialised stores. 

12 

 The European Toy Industry (TIE), Facts and Figures. See footnote above. 

13  Retail-Index. To note that the 5th retailer on the list, Toys R Us, declared bankruptcy in 2018. 

https://www.retail-index.com/Sectors/ToysGamesRetailersinEurope.aspx  

14  Source: Eurostat, EU trade since 1988 by CN8 [DS-016890] 

15  ECSIP  Consortium  (2013).  Study  on  the  competitiveness  of  the  toy  industry  –  Final  Report,  p.  19. 
https://ec.europa.eu/DocsRoom/documents/6653/attachments/1/translations/en/renditions/native 

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Figures  from  the  association  of  the  European  toy  industry  suggest  that  500  new 
companies have entered the sector between 2013 and 2017. This gave a total of 5,600 toy 
companies  in  the  EU,  of  which  99%  are  SMEs.16  It  may  appear  therefore  that  the  toy 
sector was attractive enough, in particular for SMEs, so that the number of toy companies 
increased  by  some  10%  within  five  years  This  is  also  confirmed  by  the  Eurostat  data 
according to which in 2011 in EU there were around 5,000 companies “Manufacturers of 
games and toys”. This number increased to around 6,000 in 201717. There were only 33 
large companies (0.6%) in the EU, the rest were SMEs (90.7% micro companies, 7.4% 
small  and  1.3%  medium-sized).  The  majority  of  companies  were  located  in  France, 
Poland,  UK  and  Germany.  The  highest  number  of  large  companies  was  located  in 
Germany. 

Consumers  are  fairly  price  sensitive.  In  combination  with  a  low  concentration  in  the 
market, this means that producers face cost and price competition to a significant extent. 
This competition on costs is reflected in the production strategy of producers, with many 
producers offshoring and outsourcing production to China to reduce production costs. In 
toy  production,  margins  in  the  entire  sector  are  under  pressure  with  long-term  profit 
margins  around  6%  for  the  top  100  firms  in  terms  of  size.  The  margins  are  lower  for 
small  and  medium  sized  (SME)  firms  than  for  large  firms.  Also,  the  profit  margin  for 
retail is lower than for the manufacture of toys.  

The  short  product  life  cycle  of  toys  drives  the  need  for  innovation  and  research  and 
development  (R&D).  Innovation  is  widely  acknowledged  in  the  sector  as  essential  to 
maintaining  a  competitive  position.  In  addition,  it  allows  manufacturers  to  experience 
(temporarily)  reduced  price  competition  for  the  innovative  toys.  Nonetheless,  R&D 
expenditures in the sector may seem modest, with actual R&D expenditure amounting to 
0.6% to 2.6% of total turnover. This range, however, is in line with the R&D intensity of 
the entire manufacturing industry in the EU. Also marketing strategies are very important 
to the toy sector. The key is market research and introduction of novelties. 

2.1.2.  The EU legislative context 

The twofold objective of the Toy Safety Directive is (1) to maintain a high level of safety 
for children and protection against possible health threats from toys, while (2) allowing 
the free circulation of toys in the internal market. 

Definition of ‘toys’ 

The scope of the Toy Safety Directive covers all ‘products designed or intended, whether 
or not exclusively, for use in play by children under 14 years of age’.18  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 

16  Toy Industries of Europe. The European toy industry. Flyer designed in July 2017.   

https://www.toyindustries.eu/wp-content/uploads/2018/01/TIE-EU-Toy-Sector-Facts-and-Figures-
FINAL.pdf  

17  Eurostat Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E) [sbs_na_ind_r2], Last 

update: 21-03-2019 

18  Article 2.1 of the Toy Safety Directive. 

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small plush teddy bear attached to it is considered as a toy, or a toy plastic figurine with a 
pencil sharpener in its foot.19 

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.20 

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.21 
Moreover, Annex I to the Toy Safety Directive enumerates examples of products that are 
not considered as toys but could be confused with toys. Since it would be impossible to 
enumerate all the products that are not considered as toys, the list is not exhaustive. 

Essential safety requirements 

The Toy Safety Directive lays down the safety criteria (‘essential  safety  requirements’) 
that toys must meet before they can be marketed in the EU. Toys must also comply with 
other  EU  legislation  applicable  to  them,  such  as  the  following:  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 December  2006 
concerning  the  registration,  evaluation,  authorisation  and  restriction  of  chemicals 
(REACH),22      Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the 
Council  of  16  December  2008  on  classification,  labelling  and  packaging  of  substances 

19  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/  

20  Paragraph 5 of section 2 of Guidance document No 4. 

21  Article 2.2 of the Toy Safety Directive. 

22  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  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  

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and  mixtures,23  and  Regulation  (EC)  No 1223/2009  of  the  European  Parliament  and  of 
the Council of 30 November 2009 on cosmetic products (recast).24 

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.25  As  a  consequence  there  may  be  several  safety  requirements 
associated to the same product. 

The essential safety requirements in the Toy Safety Directive cover: 

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

parents or supervisors; 

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

and radioactivity risks. 

How the Directive is keeping up with progress 

In order to keep pace with latest technical and scientific developments, the Commission 
can amend certain  parts of  the Toy Safety Directive via the Regulatory Procedure with 
Scrutiny  (RPS).26  Such  procedure  may  be  used  to  amend  specific  provisions.  It  may 
adapt Annex I that lists examples of products that are not toys (but may be confused with 
them), the list of prohibited allergenic fragrances and the list of allergenic fragrances to 
be  labelled  in  Annex  II,  it  may  adapt  the  limit  values  for  heavy  metals  and  other 
hazardous metals I Annex II, and the warnings for toys in Annex V. 

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

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

In  the  period  2012  –  2019,  the  Directive  was  amended  14  times  to  address  newly 
identified chemical risks and to revise limit values for chemicals such as chromium VI, 
lead,  phenol,  bisphenol  A.  The  list  of  the  amendments  so  far  adopted  is  presented  in 
annex 4. 

23  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  

24  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  

25  DG ENTR (2014). 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  

26  Article 46 of the Toy Safety Directive. 

11 

 
                                                           
 
 
 
Toy safety standards 

As described above the Toy Safety Directive establishes the mandatory ‘essential’ health 
and safety requirements  for toys. However it does  not  translate those requirements into 
detailed  specifications  for  testing  toys.  These  are  provided  by  toy  safety  standards  that 
are thus ‘supporting’ the Directive (see annex 6). 

European standards are developed by recognised European Standardisation Organisations 
(ESOs):  CEN,27  CENELEC,28  and  ETSI.29  If  developed  following  a  request  from  the 
European  Commission,  the  resulting  standards  are  called  European  ‘harmonised’ 
standards. 

is  voluntary, 

The  use  of  European  harmonised  standards 
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. 

including  for 

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 Journal30 is in Annex 7. 

Conformity assessment 

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

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

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

standards; 

  or by third party verification through a Notified Body. This procedure applies when 
existing  referenced  harmonised  standards  do  not  cover  all  relevant  safety 

27  European Committee for Standardization. https://www.cen.eu/Pages/default.aspx  

28  European Committee for Electro-technical Standardization. https://www.cenelec.eu/  

29  European Telecommunications Standards Institute. https://www.etsi.org/  

30  Commission Implementing Decision (EU) 2019/1728 of 15 October 2019 on harmonised standards for 
toys drafted in support of Directive 2009/48/EC of the European Parliament and of the Council, in OJ 
https://eur-lex.europa.eu/legal-
L 263, 16.10.2019, p. 32.  
content/FR/TXT/?uri=uriserv:OJ.L_.2019.263.01.0032.01.FRA&toc=OJ:L:2019:263:TOC   

12 

 
                                                           
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,31 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.32 The study concluded 
that  third  party  conformity  assessment  leads  to  a  much  lower  number  of  market 
restriction  measures  on  toys  than  the  EU  self-verification  assessment.  However,  this 
conclusion appears questionable since the study does not take account of the intensity of 
market surveillance in the EU which, according to the study, is higher in the EU than in 
the USA. 

In  this  connection,  it  is  important  to  consider  that  US  attorneys  can  demand  enormous 
sums  on  grounds  of  liability.  This  can  put  companies  out  of  business  if  they  cannot 
satisfy such demand. In contrast to this, the EU legal system is much less liability-prone. 
Therefore, any comparison between the EU and the US has to be considered with utmost 
care. 

Restrictive measures against dangerous toys: EU Safety gate RAPEX 

A EU wide Rapid Information Exchange System for dangerous products (RAPEX)33 was 
established  in  2001  under  Directive  2001/95/EC  on  general  product  safety  (GPSD).34 
Today  the  system  is  called  Safety  gate  RAPEX.35  It  aims  to  ensure  the  exchange  of 
information  between  Member  States  and  the  European  Commission  on  measures  that 
have been taken to prevent or restrict the marketing or use of products posing a (serious) 
risk  to  the  health  and  safety  of  consumers  or  to  other  public  interests.  This  not  only 
applies  to  consumer  products  covered  by  the  GPSD,  but  also  to  any  product  under 
sectorial  legislation,  such  as  toys.  Data  on  those  measures  can  therefore  be  used  as  a 
source  of  information  on  market  surveillance  activities  on  toys  that  present  a  (serious) 
risk and whose marketing has been restricted. 

31  A restriction may change or invalidate certain specification(s) in the standard referenced. 

32  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  

33  With  the  exception  of  food,  pharmaceutical  and  medical  devices,  which  are  covered  by  other 

mechanisms.  

34  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 January 2002, p. 4. 
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0095&from=EN    

35  https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/ 

pages/rapex/index_en.htm 

13 

 
                                                           
 
2.1.3.  The intervention logic 

The twofold objective of Directive 2009/48/EC is (1) to maintain a high level of safety 
for children and protection against possible health threats from toys, (2) while allowing 
toys’ free movement in the internal market. 

In  order  to  ensure  EU  citizens’  (and  particularly  children’s)  safety,  the  Toy  Safety 
Directive lays down safety requirements and regulates the conditions for the manufacture 
and the trade of toys within – and across – Member States. 

How does the Directive require manufacturers to ensure the safety of toys? 

The  Toy  Safety  Directive  imposes  considerable  obligations  on  manufacturers  in  order 
that they ensure the safety of their toys and document that safety unambiguously.36 

When developing a toy,  the manufacturer, whether in the EU or elsewhere, has first  to 
assess whether it will be safe. To this end he analyses the harm that the toy may cause 
when  a  child  is  playing  with  the  toy.  He  analyses  which  mechanical,  physical,  
flammability, chemical, electrical, hygiene or radioactivity hazards the toy may present, 
and  subsequently  how  a  child  may  be  exposed  to  the  hazards  of  the  toy  under  the 
conditions of play. He not only considers the intended way to play with the toy, but also 
the reasonably foreseeable ways of how children may be (mis-) using the toy. 

The manufacturer then has to document the toy’s hazards and the exposure to them in the 
‘safety  assessment’  of  the  toy.  The  safety  assessment  should  show  why  the  toy  can  be 
considered to be safe, despite the hazards that it presents. 

To  substantiate  his  safety  assessment,  the  manufacturer  has  to  demonstrate  that  his  toy 
conforms to the safety requirements that the Toy Safety Directive imposes on a toy with 
the  identified  hazards.  He  has  the  choice  between  two  ‘conformity  assessments’  (see 
above): 

1.  Self-verification. The manufacturer is allowed to verify the toy’s conformity himself if 
all  the  requirements  of  the  Directive,  which  apply  to  the  toy,  are  represented  in  the 
relevant harmonised European toy safety standards the references of which have been 
published in the Official Journal (see above). 

2.  Third party verification. The manufacturer asks a ‘Notified Body’ to examine his toy. 
The  Directive  requires  such  third  party’s  verification  in  particular  when  the  toy 
presents one or more hazards that are not covered by harmonised toy safety standards 
referenced in the Official Journal. 

A notified body is a test laboratory of recognised quality, which has been accredited 
by a Member State (where the test laboratory is located) for carrying out a conformity 
assessment (the ‘EC-type examination’).37 

The Notified Body  examines the toy and, if the toy passes  all the tests  successfully, 
issues  an  ‘EC-type  examination  certificate’  for  the  toy  that  the  manufacturer  had 

36  Steps for manufacturers. https://ec.europa.eu/growth/sectors/toys/placing-on-eu-market_en  

37  See Chapter V of the Toy Safety Directive: ‘Notification of conformity assessment bodies’. 

14 

 
                                                           
submitted  for  examination.  The  toy  submitted  is  thus  the  ‘type’  for  future  routine 
production.38 

The manufacturer then draws up the ‘EC Declaration of Conformity’ for his toy.39 With 
this  he  declares  that  the  toy  conforms  with  all  relevant  requirements  of  the  Toy  Safety 
Directive. The Declaration has to be signed by the manufacturer, he thus takes over the 
responsibility for the conformity of the toy. 

The  manufacturer  also  draws  up  the  ‘Technical  documentation’  for  the  toy.  Among 
others, the Technical  documentation describes  the  toy  and its manufacturing process,  it 
includes  the  safety  assessment  and  a  copy  of  the  EC  Declaration  of  conformity,  and  it 
describes  the  conformity  assessment  used.  In  the  case  of  third-party  conformity 
assessment, the EC-type examination certificate is equally to be included in the Technical 
documentation.40 

During routine production, the manufacturer has to ensure that each toy item produced is 
identical to the toy type that he submitted to the conformity assessment. 

On any toy item produced, the manufacturer affixes the CE mark (either directly on the 
toy,  on  an  affixed  label  or  on  the  packaging)41  and  his  address  as  well  as  an  element 
allowing to trace back the toy (such as a serial number). 

Finally,  the  manufacturer  adds  instructions  and  safety  information  to  the  toy,  and  the 
required warnings. 

How does the Directive require importers and distributors to ensure the safety of toys? 

Importers have fewer obligations than manufacturers.42 An importer has to ensure that the 
manufacturer  has  fulfilled  his  obligations,  such  as  carried  out  a  conformity  assessment 
demonstrating  that  the  toy  is  safe.  The  importer  further  has  to  affix  his  own  name  and 
address on the toy. 

Distributors have even fewer obligations.43 A distributor has to verify that a toy bears the 
CE  mark  and  a  traceability  number,  that  both  the  manufacturer  and  the  importer  have 
indicated their names and addresses (in the case of imported toys), and that instructions 
and safety information, including the required warnings, accompany a toy. 

38  See Article 20 of the Toy Safety Directive ‘EC-type examination’. 

39  See Article 15 and Annex III of the Toy Safety Directive. 

40  See Annex IV of the Toy Safety Directive. 

41  See article 16 and 17 of the Toy Safety Directive. 

42  Steps for importers. https://ec.europa.eu/growth/sectors/toys/placing-on-eu-market_en  

43  Steps for distributors. https://ec.europa.eu/growth/sectors/toys/placing-on-eu-market_en  

15 

 
 
 
                                                           
How  does  the  Directive  ensure  that  its  obligations  are  complied  with  by  the  economic 
operators? 

The  Directive  provides  for  the  obligation  for  Member  States  to  perform  market 
surveillance  and  test  toys  on  the  market  as  well  as  verifying  the  manufacturers’ 
documentation,  in  order  to  take  unsafe  toys  from  the  market  and  to  prosecute  those 
responsible  for  placing  them  on  the  market.44  Traceability  requirements  and  penalties 
support the enforcement.45 

How is the Directive ensuring the free movement of toys? 

The  Directive  requires  Member  States  ‘not  [to]  impede  the  making  available  on  the 
market in their territory of toys which comply with this Directive.’46 Thus, as long as a 
toy complies with the safety and other requirements of the Directive, no Member State is 
allowed to impose any other condition that would hinder the free circulation of the toy in 
the  EU.  The  Toy  Safety  Directive  is  thus  a  ‘maximum  harmonisation’  Directive.  This 
eliminates all barriers for cross-border trade and guarantees the proper functioning of the 
internal market. 

Overview on the intervention logic 

Two  strategic  objectives  were  identified,  namely  the  safety  of  toys  and  the  smooth 
functioning  of  the  internal  market  (see  table  below).  They  correspond  to  the  areas  of 
major concern that emerged from the 2008 Impact  Assessment47  (2008  IA) prepared to 
identify  the  possible  impact  of  the  then  future  Toy  Safety  Directive.  While  the  two 
strategic  objectives  embrace  long-term  processes,  the  four  specific  objectives  derived 
from them break them down into workable pieces. 

In  order  to  achieve  the  objectives,  a  number  of  provisions  (‘input’;  for  details  see 
annex 5) were included in the Toy Safety Directive that address different issues that can 
emerge  along  the  life  cycle  of  a  toy  –  from  manufacture  to  marketing  and  use.  The 
Directive’s  provisions  are  expected  to  lead  to  (short-term)  output,  (medium-term) 
outcome and (long-term) impact, thus eventually reaching the two strategic objectives as 
outlined in the table below. 

44  See Chapter VI of the Toy Safety Directive : ‘Obligations and powers of Member States’. 

45  See Article 51 of the Toy Safety Directive : ‘Penalties’. 

46  Article 12 of the Directive. 

47  Commission  staff  working  document  accompanying  the  proposal  for  a  Directive  of  the  European 
Parliament  and  of  the  Council  amending  Directive  88/378/EEC  on  the  safety  of  toys  –  Impact 
assessment. COM(2008) 9 final, SEC(2008) 38. 25.1.2008. Section 5.2.1 
http://ec.europa.eu/smart-regulation/impact/ia_carried_out/docs/ia_2008/sec_2008_0038_en.pdf  

16 

 
                                                           
 
17 

 
 
 
Baseline and points of comparison  

In  the  context  of  the  internal  market,  the  1988  Toy  Safety  Directive48  was  adopted  in 
order to harmonise the different safety levels across Member States. This was crucial as 
the lack of regulatory and enforcement consistency not only caused obstacles to the free 
movement  of  toys  across  Member  States,  but  also  hampered  an  effective  protection  of 
children against risks that may arise from toys. 

The 1988 Directive was revised in 2009 based on a 2008 Impact Assessment (2008 IA)49 
that identified three main areas for improvement: 

  Firstly,  safety  requirements  were  outdated  and  not  fully  responding  to  newly 
identified  hazards,  in  particular  those  of  chemicals.  The  limits  for  8  ‘elements’ 
(mainly  heavy  metals)  were  expressed  in  terms  of  bioavailability50  in  the  1988 
Directive.  The  2009  Toy  Safety  Directive  added  11 further  chemicals  (mainly 
metals) and expressed the limits in terms of migration.51 

Warning requirements also needed to be refined. The provisions on warnings in the 
1988  Directive  presented  gaps  because  they  did  not,  in  particular,  provide  that  the 
warnings should always indicate appropriate user limitations such as those related to 
age, ability and weight of the user, as well as the need to ensure that the toy be used 
under adult supervision. These warnings, essential to the safe use of the toy, might 
have been lacking in some cases. 

  Secondly, Member States highlighted the need for improving both the  enforcement 
consistency  and  effectiveness  of  market  surveillance  and  of  the  institutional 
framework  concerning  the  implementation  of  the  Directive  and  of  toy-related 
information  and  traceability.  For  example,  a  specific  problem  linked  to  efficient 
market  surveillance  concerned the analysis of the hazards and risks that  a toy may 
present.  The  1988  Directive  did  not  contain  any  explicit  obligation  for  the 
manufacturers to carry out such an analysis. There was no requirement for them to 
document  the  hazard/risk  analysis  and  to  keep  it  available  for  inspection  by  the 
market surveillance authorities (in the technical file). Responsible manufacturers did 
already  carry  out  a  hazard/risk  analysis.  However,  since  the  analysis  was  not 
mandatory,  it  was  difficult  for  market  surveillance  authorities  to  check  whether  an 
analysis had been undertaken. 

48  Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States 

concerning the safety of toys (OJ L 187, 16.7.1988, p. 1.   
https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31988L0378 

49  Commission staff working document ... . See footnote above. 

50  The  1988  Directive  provided  that  the  ‘bioavailability  of  these  substances  means  the  soluble  extract 

having toxicological significance.’. 

51 

‘Migration limit’ is the amount of an element that can be released from a toy material when (ingested 
and) present in the stomach (Matrix Insight (2012). Impact assessment study on the health costs due to 
children’s exposure to lead via toys and on the benefits resulting from reducing such exposure.  Final 
Report).  https://ec.europa.eu/growth/sectors/toys/safety/legislation_en  

18 

 
 
                                                           
  Finally, the scope and concepts of the 1988 Directive turned out to lack clarity. The 
1988 Directive contained ambiguities, long  and  complicated sentences  and internal 
and  external  cross-references.  In  addition,  it  needed  a  clarification  on  its  relation 
with the General Product Safety Directive (GPSD). 

Following the 2008 IA and the Commission proposal for a new Toy Safety Directive that 
it accompanied, the new Directive was adopted  on 18 June 2009. Annex 8 provides an 
outline  of  the  problems  identified  in  the  2008  IA  (on  scope  and  concepts,  on  safety 
requirements and on enforcement) and where they have been addressed in the 2009 Toy 
Safety Directive. 

In  particular,  the  2009  Toy  Safety  Directive  puts  in  place  stricter  requirements  for 
chemicals: 

  Chemicals  that  are  susceptible  to  cause  cancer,  change  genetic  information,  harm 
fertility or  harm an unborn child (‘CMR substances’  52) were no longer allowed in 
toys  beyond  the  concentration  limits  set  in  the  Regulation  on  Classification, 
Labelling  and  Packaging  of  substances  and  mixtures,53 or  unless  they  are 
inaccessible or considered safe following a rigorous scientific evaluation and if they 
are  not  prohibited  in  consumer  articles  under  REACH.  In  addition,  for  CMR 
substances  of  categories  1A  and  1B  which  are  of  most  concern,  no  suitable 
alternatives must exist. (For the ‘less concerning’ CMRs category 2, no analysis of 
alternatives is necessary.) 

  19 'elements' such as mercury or cadmium were not allowed in toy parts accessible 

to children beyond the limits laid down in Toy Safety Directive.54 

  Concerning the 19 'elements' the Directive draws a distinction among three types of 
materials used in toys – dry, brittle, powder-like or pliable; liquid or sticky; scraped-
off – each subject to a different migration limit. 

  55 allergenic fragrances were prohibited because the relevant Scientific Committee 
considered  that  they  must  not  form  part  of  cosmetic  products  due  to  their 
allergenicity in most cases (fragrances 1 to 31 and 36 to 40);55 or they were (photo-) 
allergenic (fragrances 32 to 35);56 or because they were most frequently reported as 

52  Substances that are carcinogenic, mutagenic or toxic for reproduction. 

53  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. 

54  Annex II, part III, point 13 of the Toy Safety Directive. 

55  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 

56  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 

19 

 
                                                           
 
contact  allergens (fragrances 41 to  53);57 or because they contain allergenic species 
(fragrances  54  to  55).58  The  presence  of  traces  of  these  55 fragrances  is  however 
allowed if technically unavoidable under good manufacturing practice and if they do 
not exceed 100 mg/kg. 

  A  further  11 allergenic  fragrances  may  be  used  in  toys  on  condition  that  they  are 
labelled  when  their  concentration  exceeds  100 mg/kg  in  the  toy  or  any  of  its 
components. They were less frequently reported as contact allergens.59 

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

The law-making process that resulted in the 2009 Toy Safety Directive reinforced several 
chemical  safety  requirements  in  the  proposal  for  the  new  Directive,  and  added  further 
requirements: 

  CMR  substances  are  only  allowed  in  toys  beyond  the  concentration  limits  of  the 
Regulation on Classification, Labelling and Packaging of substances and mixtures if 
they are entirely inaccessible to children, including by inhalation. The proposal had 
only  referred  to  the  inaccessibility  of  parts  of  toys  containing  CMR  substances, 
which however does not take account of the inhalation of such chemicals; 

  The limit values for the ‘elements’ ‘arsenic, cadmium, chromium VI, lead, mercury 
and organic tin, which are particularly toxic, … should be set at levels that are half 
of  those  considered  safe  according  to  the  criteria  of  the  relevant  Scientific 
Committee,  in  order  to  ensure  that  only  traces  that  are  compatible  with  good 
manufacturing practice will be present.’60 The proposal had not foreseen an extra role 
for the six afore-mentioned ‘elements’. 

  15 allergenic fragrances proposed for labelling were moved to prohibition to give the 
total of 55. 13  61 of the 15 had been ‘most frequently reported as contact allergens’ 
by the Scientific Committee, 2 62 of the 15 were very strong allergens. 

57  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 

58  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 

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  

59  Scientific Committee ... . SCCNFP/0017/98 final, 8.12.1999, Table 6b, p. 23. See footnote above. 

60  Recital 22 and Article 46(1b) of the Toy Safety Directive, and Directive (EU) 2017/738 amending the 

Toy Safety Directive as regards lead. 

61  Listed as numbers 41 to 53 in the Toy Safety Directive. 

20 

 
                                                           
 
 
 
 
  Specific limit values for any chemical in toys can be set. These limit values apply to 
toys  for  children  under  36 months  (who  take  ‘everything’  into  their  mouth)  and  to 
toys intended to be placed in the mouth, since those toys lead to a high exposure of 
children  to  chemicals.  The  proposal  had  not  foreseen  the  establishment  of  such 
specific limit values;63 

  Limit values for nitrosamines (0,05 mg/kg) and for nitrosatable substances (1 mg/kg) 

were added to the proposal. 

There are no specific or quantified estimates published of the potential impact (i.e., the 
expected costs and benefits) of the 1988 Directive. The 2008 IA which accompanied the 
revision of the Toy Safety Directive provided quantification of costs and benefits related 
to  planned    chemical  provisions  and  three  illustrative  case  studies  with  large  ranges  of 
costs  and  a  number  of  assumptions  for  multinational,  SME  and  medium  size 
manufacturers. The  2008  IA  however  did  not  foresee  any  monitoring  and  evaluation 
arrangements  and  did  not  provide  a  clear  description  of  the  baseline.  Therefore,  the 
baseline  for  this  evaluation  is  the  2009  Directive  and  a  comparison  of  data  before  and 
after  the  adoption  of  the  2009  directive  was  not  possible.  Therefore,  it  is  difficult  to 
identify  clear  points  of  comparison  for  the  purpose  of  this  evaluation,  especially  as 
concerns  the  main  changes  (outdated  safety  requirements  or  scope  and  concept 
clarification).  

In the present evaluation the estimates of costs and benefits have been contrasted with the 
estimates  from  the  2008  IA  where  possible  (see  section  5.2).  The  reproduction  of 
assessment of costs and benefits of chemical provisions for the purpose of this evaluation 
was considered disproportionate.64 In the data gathering, it was decided not to artificially 
separate costs of chemical requirements and other provisions and instead to concentrate 
on one-off adaptation costs and recurring costs related to the Toy Safety Directive. The 
additional difficulty in relation to points of comparison relies in different dates of entry 
into  force  of  different  provisions  (mid-2013  for  chemical  provisions  and  mid-2011  for 
the  remaining  provisions)  and  a  number  of  amendments  to  the  Toy  Safety  Directive 
adapting the chemical requirements between 2012 and 2019. 

In the meantime, other EU initiatives have been adopted that may affect the functioning 
of  the  Toy  Safety  Directive,  such  as  the  EU  Regulation  on  Market  Surveillance  and 
Compliance of Products,65 which aims to improve market surveillance by strengthening 
controls  by  national  authorities  to  ensure  that  products  (including  toys)  are  safe  and 
comply with the rules. This new Regulation takes into account the increasingly complex 
supply  chains,  as  well  as  the  increase  of  products  that  are  offered  online  to  end  users 
within the EU. 

62  Listed as numbers 51 and 55 in the Toy Safety Directive. 

63  Recital 24  and Article 46(2) of the Toy Safety Directive. 

64

  The  2008  IA  provided  Life  Cycle  modelling  of  costs  and  benefits  of  chemical  provisions  based  on 
DALY (Disability Adjusted Life Years). These analyses were outsourced. Moreover, given the number 
of amendments of the Directive, the cost estimates would not be comparable with those from 2008 IA. 

65  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market 
surveillance  and  compliance  of  products  and  amending  Directive  2004/42/EC  and  Regulations  (EC) 
No  765/2008  and  (EU)  No  305/2011,  OJ  L  169,  25.6.2019,  p.  1,  see  https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:32019R1020. 

21 

 
                                                                                                                                                                            
Practical experience of market surveillance has shown that such supply chains sometimes 
involve economic operators whose novel functions and activities do not allow to fit them 
easily into the traditional supply chain operators in the existing legal framework. Such is 
the  case,  in  particular,  with  online  sales  platforms  that  qualify  as  ‘fulfilment  service 
providers’, which perform many of the same functions as importers but which might not 
always  correspond  to  the  traditional  definition  of  importer  in  EU  law  (and  in  the  Toy 
Safety  Directive).  In  order  to  ensure  that  market  surveillance  authorities  can  carry  out 
their  responsibilities  effectively  and  to  avoid  a  gap  in  the  enforcement  system,  these 
fulfilment  service  providers  have  been  included  in  the  recent  Regulation  on  Market 
Surveillance and Compliance of Products. They are part of the list of economic operators 
against  whom  it  is  possible  for  market  surveillance  authorities  to  take  enforcement 
measures.  Market surveillance authorities will be better able to deal with new forms of 
economic activity in order to ensure the safety of consumers and the smooth functioning 
of the internal market, including those cases where the economic operator acts both as an 
importer as regards certain products and as a fulfilment service provider as regards other 
products. 

3. 

IMPLEMENTATION AND STATE OF PLAY 

The 2009 Toy Safety Directive has been transposed by all Member States, although such 
transposition was not notified within the deadline by some of them. Following the failure 
by several Member States to timely notify the Commission about national transposition 
measures  before  the  January  2011  deadline,  the  Commission  opened  15  non-
communication  cases,  but  all  of  them  were  closed  before  the  end  of  2011,  once 
transposition had been completed and notified.66 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 Decision67 that the limit 
values  for  nitrosamines68  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. 

66  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 

67  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  

68 

‘Nitrosamines’ is here understood to mean ‘nitrosamines and nitrosatable substances’. 

22 

 
                                                           
 
 
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.69 

  The Expert Group on Toys Safety70 is the setting for EU Member States, EEA-EFTA 
countries,  Switzerland,  Candidate  Countries,  stakeholders  and  the  Commission.  It 
assists  in  the  consistent  implementation  of  legislation  on  toy  safety  across  the  EU 
and  provides  advice  on  the  preparation  of  new  legislative  proposals  and  policy 
initiatives.  The  Expert  Group  also  develops  guidance  material.  Its  sub-group  on 
Chemicals  is  a  forum  for  discussion  between  representatives  of  Member  States  on 
chemicals  of  concern  and  assists  the  Expert  Group  in  the  preparation  of  amending 
directives setting (stricter) limit values for chemicals. 

  The Administrative Cooperation (AdCo)71 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.72 They are applied by the Notified Bodies on a voluntary basis. 

Another  important  mechanism  supporting  the  implementation  of  the  Toy  Safety 
Directive  is  European  standardisation.  Industry  representatives  active  in  the  European 

69  See Articles 46 and 47 of the Toy Safety Directive. 

70  Register of Commission Expert Groups  and other similar entities.   

http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360 

71  The  Toys-AdCo  is  the  closed  session  of  the  Expert  Group  on  Toys  Safety  (E01360)  and  comprises 

only market surveillance authorities. 

72  Recommendations and Protocols under the Toy Safety Directive are available at 

https://ec.europa.eu/growth/sectors/toys/safety/guidance_en  

23 

 
                                                           
 
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.73 
Harmonised  standards  translate  the  essential  safety  requirements  of  the  Toy  Safety 
Directive into detailed technical specifications for a large range of toys.  

4.  METHOD 

This evaluation of the Toy Safety Directive 2009/48/EC began in 2014 with the work of 
an external consultant and continued until March 2020 with an internal evaluation by the 
Commission services. 

It  used  two  main  sources  of  input:  1.  studies,  reports  and  databases,  2.  stakeholder 
consultations. Output was aimed to be qualitative and, where possible, quantitative. 

The evaluation was monitored by a steering group composed of representatives of several 
European  Commission  services,  namely  of  the  Secretariat-General  and  of  Directorates-
General  Internal  Market,  Industry,  Entrepreneurship  and  SMEs  (GROW),    Justice  and 
Consumers (JUST),  Health and Food Safety (SANTE),  Environment (ENV), Taxation 
and Customs Union (TAXUD). 

Details on the procedure are given in annex 1. 

4.1. 

Supporting studies and reports 

The 2015 external study, prepared by an external consultant in 2014 and 2015, analysed 
existing  evidence  relating  to  the  functioning  of  the  Toy  Safety  Directive,  including 
literature  data  as  well  as  views  and  suggestions  of  Member  States  in  their  five  yearly 
reports 2009 – 2013 on the application of the Toy Safety Directive. Input from industry, a 
European consumer association, standardisation organisations and Notified Bodies were 
collected through interviews. For this evaluation, data from the 2015 external study have 
been updated and complemented as appropriate by the Commission services. 

The Commission’s Joint Research Centre (JRC) conducted a study on costs and benefits 
of the Toy Safety Directive (JRC study) for the  purpose of this evaluation.74 The study 
provided a review of quantitative literature data on the costs and benefits of regulation in 
the toys sector. The study deployed counterfactual impact analysis by looking at imports 
and at product restrictions under the Safety  gate RAPEX data, and company  level data 
from Bureau van Dijk75 were used to analyse the possible cost impact of the Toy Safety 
Directive on manufacturers and distributors. 

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

74 

Joint  Research  Centre,  Competence  Centre  on  Microeconomic  Impact  Evaluation.  Evaluation  of  the 
benefits and the costs generated by the Toy Safety Directive – A supply side analysis (October 2019). 

75  https://www.bvdinfo.com/en-gb/our-products/data  

24 

 
                                                           
In addition, several Fitness Checks (FC) and related studies on chemicals legislation have 
been taken into account for the purpose of the present evaluation to the extent that they 
referred to toys or to the Toy Safety Directive.76 

The present evaluation further takes account of the first five yearly reports 2009 – 2013 
from the Member States on the application of the Toy Safety Directive, as well as of the 
second five yearly reports 2014 – 2018 as far as available. 

4.2. 

Stakeholder consultations 

Both  a  public  and  a  targeted  consultation  of  stakeholders  have  been  carried  out  in  the 
context of this evaluation. The table below gives an overview of the two consultations. 

Table 4.1. Public and targeted online consultations carried out for this evaluation 

Data collection source 
Expected outcome 
Target 

Number of responses 

Public consultation 
Public online survey 
Views of all interested parties 
All stakeholders: 
  general public including consumers; 
authorities in 28 Member States and 
EEA-EFTA countries; 
industry including SMEs: 
manufacturers, importers, distributors; 

 

  consumer associations: ANEC (The 

European consumer voice in 
standardisation), BEUC (The European 
Consumer Organisation); 

  Notified Bodies: NB-Toys Group; 
  European Standardisation 

Organisations: CEN, CENELEC. 

116 responses from: 
  32 companies; 
  12 business associations; 
  7 Notified Bodies; 
  31 public authorities; 
  6 EU and national consumer 

organisations; 

  26 citizens; 
  2 others. 

Targeted consultation 
Targeted online survey 
Industry feedback 
Industry: manufacturers, 
importers, distributors 

32 responses 

the  Commission 

is  doing.  http://ec.europa.eu/growth/sectors/chemicals/ec-support_en  

76  Cumulative Cost Assessment for the EU Chemical Industry - Final Report  
http://ec.europa.eu/DocsRoom/documents/17784/attachments/1/translations/ 
What 
FC-chemicals_FR-3-AnnexVI_Final.pdf. 
http://ec.europa.eu/DocsRoom/documents/22063/attachments/3/translations/ 
Study  on  the  cumulative  health  and  environmental  benefits  of  chemical  legislation.  Final  report  – 
Study. 
https://publications.europa.eu/en/publication-detail/-/publication/b43d720c-9db0-11e7-b92d-
01aa75ed71a1/language-en 
Towards a non-toxic environment strategy 
http://ec.europa.eu/environment/chemicals/non-toxic/index_en.htm 
Study  supporting  the  Fitness  Check  on  the  most  relevant  chemicals  legislation  (‘Fitness  Check  +’). 
Final report – Study. https://publications.europa.eu/en/publication-detail/-/publication/07ad8b92-dbca-
11e7-a506-01aa75ed71a1/language-en/format-PDF 

25 

 
 
 
                                                           
 
 
 
Moreover,  within  the  framework  of  the  2015  external  study,  direct  interviews  with 
economic  operators,  consumer  representatives,  test  laboratories'  representatives  and  the 
relevant European Standardisation Organisations (ESOs) were conducted. 

A synopsis summarising the different consultation activities is given in annex 2. 

4.3.  Limitations of available data 

This evaluation covers the application of the Toy Safety Directive since mid-2011, when 
the Directive's provisions were to be applied in the Member States. The evidence is more 
recent  for  the  chemicals  provisions  that  were  to  be  applied  as  of  mid-2013,  thus  two 
years later. 

Many of the elements assessed under the current evaluation, such as the principle of free 
movement  of  toys  in  the  internal  market,  were  already  present  in  the  1988  Toy  Safety 
Directive.  Therefore,  many  observable  outputs  and  outcomes  cannot  be  attributed 
exclusively to the 2009 Toy Safety Directive. 

It  is  important  to  highlight  the  limited  availability  of  data  and  the  limitations  of  the 
available data for the use in this evaluation. 

4.3.1.  Data on toy-related injuries 

The number of toy-related injuries of children and their possible reduction could provide 
a quantitative analysis of the benefits of the Toy Safety Directive in terms of protection. 
However, already the 2008 IA pointed to the very limited availability of data related to 
such injuries. It was therefore impossible to quantify the benefits of the protective effect 
of the Directive: 

  There were no consistent EU-wide statistics on toy-related accidents; 
  Only three Member States – Denmark, the Netherlands and the United Kingdom77  – 
had  injury  reporting  systems  with  the  potential  to  provide  useful  data.  In  these 
national  systems,  the  exact  cause  of  accidents  was  however  not  available,  and  the 
link with a toy or its manufacturer could not be established; 

  Not all products included in these reporting systems were toys within the meaning of 

the Toy Safety Directive; 

  Accidents  and  incidents  not  involving  hospital  visits  or  consultation  of  a  medical 

doctor were not reported. 

Another  source  that  registers  injuries  with  products  is  the  European  Injury  Database 
(IDB);78  it  is  the  only  ‘EU  wide’  data  base  of  this  kind.  It  was  set  up  by  former 
Directorate  SANCO    (today:  SANTE)  under  the  Injury  Prevention  Programme  since  a 
better  availability  of  injury  and  accident  data  was  considered  important  for  public 
authorities  and  other  stakeholders  to  identify  possible  risks  and  to  spot  what  types  of 
products may pose a threat. 

77  The UK database was discontinued in 2002. 

78  EuroSafe (2016) EU-Injury Database: Operating Manual. 

http://www.eurosafe.eu.com/uploads/inline-files/IDB_operating_manual_Jan%202017.pdf . 

26 

 
                                                           
The IDB however only collected data from around 100 hospital emergency departments 
across 20 EU Member States since the years 1990. Patients were asked about the cause 
of  the  injuries  and  accidents  (activity  when  the  injury  occurred,  area,  unintentional, 
intentional  injuries,  etc.)  and  their  socio-demographic  characteristics  (age,  gender, 
country, etc.). 

For this evaluation of the Toy Safety Directive the information in the IDB was analysed 
by  the  JRC  to  potentially  quantify  the  impact  of  the  Directive  on  the  number  of  toy-
related  injuries.  The  JRC  however  concluded  that  the  IDB  contains  too  little  usable 
information.79 

The  Susy  Safe  registry80  aiming  to  establish  an  international  surveillance  system  for 
suffocation injuries could not be used either, since, according to the JRC,81 these injuries 
are  reported  on  a  voluntary  basis  by  physicians,  otorhinolaryngologists,  pneumologists 
and  general  practitioners  and  will  therefore  not  be  representative  of  all  injuries  that 
occurred. Moreover, as the Susy Safe project is concerned with only a single, particular 
type of injury, an analysis would be too narrow. 

The lack of available data on injuries has also been highlighted in various reports82, 83, 84 
and by several organisations.85 

In 2010, twenty-two Member States signed up for a Joint Action for Injury Monitoring in 
Europe, with the aim of having a common hospital-based injury data collection system in 
place  by  2015.  However,  several  consumer  and  business  associations  pointed  out  that 
most  Member  States  and  the  European  Institutions  have  failed  to  give  political 
commitment to  the continued exchange of injury data after 2014.  In  addition,  the same 
associations found that whilst injury data are available from several sources in Member 
States,  they  are  usually  limited  in  size  and  scope.  Moreover,  data  are  not  comparable 
among  Member  States  and  are  not  exhaustive  enough  to  identify  the  circumstances 
leading to accidents and injuries. Finally, a lack of coordination and funding at EU level 
has been pointed out as the root cause for the absence of consistent accident data. 

79  The  IDB  was  analysed  by  the  Commission’s  Joint  Research  Centre,  Unit  Monitoring,  Indicators  and 

Impact Evaluation. The results were reported in a note to GROW, Unit 0.1, of 2 October 2019. 

80  www.susysafe.org 

81  See footnote on the IDB above. 

82  European  Parliament  (2008).  Study  On  Safety  And  Liability  Issues  Relating  To  Toys,  Policy 

Department Economic and Scientific Policy, (IP/A/IMCO/FWC/2006-058/LOT 4/C1/SC4).   
http://www.civic-consulting.de/reports/toys_study.pdf  

83 

Impact Assessment for the revision of the 1988 Directive. See footnote 35. 

84  RPA (2004). Study on the Impact of the Revision of the Council Directive 88/378/EEC on the Safety 

of Toys, Final Report, DG ENTR. 
http://ec.europa.eu/DocsRoom/documents/1756/attachments/1/translations/en/renditions/native  

85  See for instance the joint call for action by consumer and industry associations. 

http://www.anec.eu/attachments/Joint%20call%20for%20a%20pan-
European%20accident%20&%20injury%20data%20system.pdf 

27 

 
                                                           
 
 
The use of US statistics in the 2015 external study on the Toy Safety Directive is limited 
to the identification of main toy-related issues. Toy-related injuries that occurred in the 
US  may  indeed  contribute  to  provide  a  picture  of  major  risk  categories  related  to  toys. 
However, taking account of the different  contexts  and legal  frameworks in place in  the 
US and in the EU, the relevance of these risk categories may be questioned. 

Finally,  market  developments  may  affect  the  number  of  injuries.  The  market  of  toys 
changes continuously, certain (dangerous) toys may flood the market in a specific year, 
such as fidget spinners in 2017 (with easy-to-open compartments for dangerous electrical 
button cells). The advent of such toy ‘hypes’ may contribute to an increasing number of 
injuries  that  interferes  with  the  effects  of  toy  safety  regulation  and  its  enforcement  by 
market surveillance. 

Thus, in  light  of the above, the possible impact of the Toy Safety Directive on injuries 
have been analysed only qualitatively. 

4.3.2.  Data on marketing restrictions for toys 

Also  the  number  of  toys  banned  or  otherwise  restricted  from  (further)  marketing  could 
provide  a  quantitative  analysis  of  the  benefits  of  the  Toy  Safety  Directive  in  terms  of 
protection. A higher number of dangerous toys that are no longer allowed on the market 
could mean a better protection of children. 

Looking at the number of toys restricted from marketing and notified via the Safety gate 
RAPEX from 2009 to 2018 (see figure below)86 however shows no unambiguous link to 
the application of the Toy Safety Directive. When its provisions (without the provisions 
on  chemicals)  became  applicable  in  mid-2011,  an  expected  rise  in  the  number  of 
notifications did not materialise in that year, and neither in 2012. 

Number of toy notifications in Safety Gate RAPEX 
during 2009 - 2018 

750

700

650

600

550

500

450

400

350

300

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

86  Own analysis on ‘Safety Gate - Search alerts’. 

https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.search&ln
g=en  

28 

 
 
                                                           
 
On the other hand, the number of toy notifications increased steeply in 2013. This might 
have  been  the  result  of  the  application  of  the  many  new  chemical  requirements  in  the 
2009 Toy Safety Directive. However, the number toy notifications with a chemical risk 
went already up in 2012 and decreased in 2013, followed by a further downward trend in 
the following years before going up again in 2018 (see figure below).87 

Toy notifications with chemical risk, in % of all toy 
notifications in Safety Gate RAPEX 
during 2009 - 2018 

50

45

40

35

30

25

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

Thus, it appears that the Safety Gate RAPEX data are not useful to reflect an impact of 
the Toy Safety Directive. 

It  seems  more  likely  that  the  yearly  changing  numbers  of  notifications  may  be  heavily 
influenced by national  market surveillance campaigns that target different types of toys 
in the course of the years, by changes in the number of market surveillance staff and of 
inspectors who actually take the samples, by more or less imports into the EU, by ‘hypes’ 
for  certain  toys  which  are  easier  (or  less  easy)  to  test  for  (non-)  compliance,  by  new 
economic operators entering or leaving the toy market, and others. 

It may also be that a new legal requirement for toys takes time to be applied in practice 
by market surveillance authorities, simply because no laboratories are yet known that are 
able to competently test toys against the new requirement. The impact of a new, stricter 
requirement  may  thus  only  be  phasing  in  over  time  and  therefore  not  be  clearly 
discernible from the volatility effects of the ‘remaining’ market surveillance activities. 

4.3.3.  Data on toy trade 

A further approach to measuring possible benefits of the Toy Safety Directive could be a 
comparison  of  the  trade  in  toys  before  and  after  the  application  of  the  Directive. 
Manufacturing 
the  more  numerous  and  more  demanding 
requirements of the Directive requires adaptation time and causes costs. This might cause 
a drop in toys trade until the adaptation is complete and trade returns to its usual pace. 

toys  compliant  with 

87  Own analysis on ‘Safety Gate - Search alerts’. See footnote above. 

29 

 
 
                                                           
An analysis88 of the evolution of toy imports into the EU was contrasted with the imports 
of similar products. As a result, the introduction of the Toy Safety Directive in 2009 and 
the application of its chemical requirements since 2013 seem to have reduced the imports 
of  toys.  The  effect  was  less  pronounced  between  2010  and  2013.  Overall,  the  analysis 
suggested that the Toy Safety Directive may have reduced the imports of toys. Yet, the 
results  should  be  interpreted  with  caution  due  to  many  confounding  factors  in  the 
marketing of toys as described further above. 

4.3.4.  Data on costs related to toy production 

Costs related to the Toy Safety Directive, in particular to the manufacture of toys, may be 
an  indicator  of  the  strictness  of  the  Directive’s  requirements.  Additional  or  more 
ambitious safety requirements may lead to higher costs. 

The 2015 external study on the Toy Safety Directive mainly relied on data retrieved from 
stakeholders’  qualitative  perceptions  gathered  through  interviews  to  assess  costs  (and 
benefits) of the Toy Safety Directive. 

The lack of data on  costs could  perhaps have been compensated by a large survey, but 
this was not in the scope of the 2015 external study. As a result, the available data made 
it difficult to obtain exhaustive and comprehensive information on costs encountered by 
companies to comply with the Directive’s requirements. 

Furthermore, there are a number of factors that can influence manufacturing costs. Toy 
manufacturers will permanently seek to reduce costs by looking for cheaper sources for 
raw materials and by becoming more efficient in the manufacturing process such as when 
scaling  up  or  automating  more  extensively  the  production  processes,  or  by  shifting 
manufacture to lower-wage countries. Also, a company may decide to develop innovative 
toys  that  are  more  expensive  to  manufacture  but,  if  successful,  allow  higher  profit 
margins.  Taking  manufacturing  costs  as  an  indicator  for  the  impact  of  legislation  may 
therefore  have  intrinsic  limitations.  As  a  consequence,  economic  operators  in  the  2015 
external study were not  always able to distinguish cost increases directly caused by the 
Directive from those induced by exogenous factors. 

Also  on  the  costs  borne  by  Member  States  no  quantification  was  possible  in  the  2015 
external study since no related data were provided in the 2009 – 2013 national reports on 
the application of the Directive. 

For the present evaluation of the Toy Safety Directive, in order to collect at least some 
quantitative information on the costs of the toy industry, a consultation  was  targeted to 
economic  operators.  It  provided  32 responses  (26  from  toy  manufacturers,  5  from  toy 
importers  and  1  from  a  toy  distributor).  Due  to  this  limited  number  of  responses,  the 
analysis of costs presented in this evaluation should of course be considered with caution. 

An effort was made in  this evaluation  to  compare the present  analysis, where possible, 
with the estimates in the 2008 IA. The 2008 IA estimates were however based on only a 
few case studies and a number of assumptions. Different cost categories and timeframes 
were used in  the 2008  IA compared to  the data  collected for this evaluation.  Therefore 
the comparison had to remain limited. 

88  See footnote on the Joint Research Centre supply side analysis (October 2019) above. 

30 

 
                                                           
A counterfactual analysis of cost impacts on distributors and manufacturers89 confirmed a 
possible  cost  impact  of  the  Toy  Safety  Directive  on  economic  operators.  However  the 
methodology  applied  did  not  allow  to  identify  which  elements  of  the  Directive  might 
have been particularly burdensome. 

4.3.5.  Lack  of  representativeness  of 

the  respondents 

in 

the  stakeholder 

consultations 

The  more  than  150  responses  received  through  the  different  consultations90  provided  a 
good  overall  number  of  inputs  for  the  analysis,  taking  into  account  that  some  of  the 
respondents,  such  as  TIE  and  consumer  organisations  (ANEC  and  BEUC)  represented 
the  views  of  all  their  individual  corporate  members  and  national  associations.  It  can 
therefore be trustfully assumed that the input received represents the meaningful views of 
the stakeholders having toy safety as their core business. It should be underlined that the 
consultations reached all types of relevant stakeholders, ranging from industry, consumer 
organisations, public authorities and citizens. 

The replies to the 2018 public consultation were mainly provided by companies/business 
organisations and public authorities, followed by EU citizens. Fewer replies came from 
business associations, Notified Bodies and consumer organisations. 

It  is  evident  that  all  these  responses  cannot  be  seen  as  representative  from  a  statistical 
viewpoint.  They  represent  opinions  of  those  who  decided  to  participate.  Also,  the 
robustness of the consultations that targeted industry and other economic operators may 
be influenced by these stakeholders’ inherent interest to generally favour the status quo, 
because changes in the legislation can lead to additional costs which can hinder business. 

Notwithstanding the above-mentioned limitations, partially compensated by the fact that 
replies came from those stakeholders that are really concerned with toys and whose input 
is  most  significant,  the  overall  availability  and  reliability  of  data  and  the  approach 
followed  are  generally  considered  as  satisfactory.  Care  was  taken  to  accurately  report 
different opinions and findings while also ensuring that the evidence and sources can be 
traced  back.  Wherever  possible  the  data  gathered  were  cross-checked  and  validated 
against several sources in order to ensure reliability and robustness. 

5. 

ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS 

5.1.  Effectiveness of the Toy Safety Directive 

5.1.1.  Effectiveness in relation to the safety of toys 

The safety of toys is one of the two key objectives of the Toy Safety Directive. Safety is 
the focus of the Directive, almost all provisions aim to ensure the safety of toys. The free 
movement of toys in the internal market is covered by a single provision: the Directive 
obliges Member States to not impede the making available on the market in their territory 

89 

Joint Research Centre ... (October 2019) See footnote above. 

90  The  consultation  on  the  Roadmap,  the  2018  public  consultation  and  the  2019  targeted  survey  of 

economic operators. 

31 

 
                                                           
of toys which comply with this Directive.91 Thus, as long as toys are safe in accordance 
with  the  Directive,  they  can  move  freely  in  the  internal  market.  This  means  that  if  the 
internal market provision is correctly implemented and enforced, the required high level 
of safety is ensured across the EU and no Member States is allowed to go beyond what is 
required. 

This evaluation therefore focusses on the safety of toys, and less on the internal market. 

5.1.1.1.Why focus on chemical safety? 

According to the 2008 IA the safety requirements of the 1988 Toy Safety Directive had 
to be improved in particular on chemicals. Indeed, a range of chemical requirements were 
added to the proposal for the 2009 Toy Safety Directive, and they were further reinforced 
during the law-making process. 

Furthermore,  the  ‘subgroup  Chemicals’  was  set  up  under  the  Directive  to  inform  the 
Commission  in  particular  about  new  limit  values  that  were  to  be  set  for  specific 
chemicals. All the 14 amendments of the Toy Safety Directive so far were based on the 
work of the subgroup. 

Finally,  chemicals  deserve  particular  attention  because  knowledge  about  their  toxicity 
may change. Even chemicals with a long-known toxicity may become ‘more toxic’ when 
new knowledge arises.  

As an example, ‘[t]he toxicity of lead has been studied extensively in both animals and 
humans. On numerous occasions these data have been evaluated by expert committees.’92 
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. 93 However, in 2013, 
the European Food Safety Authority (EFSA) issued a scientific opinion on lead providing 
that lead is more toxic than known before.94 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.95 

In  2012  and  2013,  the  limit  values  for  cadmium96  and  barium97  had  to  be  lowered, 
respectively, due to  updated knowledge on their toxicity.  For the same  reason the limit 

91  Article 12 of the Toy Safety Directive. 

92  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, of 2008, p. 182. https://www.rivm.nl/bibliotheek/rapporten/320003001.pdf 

93  National Institute for Public Health and the Environment (RIVM) ... p. 120 – 122. See footnote above. 

94  EFSA  Panel  on  Contaminants  in  the  Food  Chain  (CONTAM),  Scientific  Opinion  on  Lead  in  Food. 

EFSA Journal 2010; 8(4):1570. www.efsa.europa.eu  

95  Directive  (EU)  2017/738  amending,  for  the  purpose  of  adapting  to  technical  progress,  Annex  II  to 
Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards 
lead. OJ L 110, 27.4.2017, p. 6. 
content/EN/TXT/PDF/?uri=CELEX:32017L0738&qid=1575370788272&from=EN  

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

96  Commission Directive 2012/7/EU amending, for the purpose of adaptation to technical progress, part 
III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy 
safety Text with EEA relevance. OJ L 64, 3.3.2012, p. 7. 

32 

 
                                                           
values  for  bisphenol  A98  and  for  aluminium99  had  to  be  lowered,  respectively,  in  2017 
and 2019. 

These  examples  show  that  chemical  risks  deserve  permanent  attention.  For  risks  other 
than chemical, such as physical and mechanical risks, knowledge does not increase in the 
same way, if at all. When children under the age of three years choke on small parts, that 
risk  will  not  change  over  time.  Provisions  addressing  these  risks  therefore  need  less 
updating  once  they  have  been  put  in  place.  Mechanical  and  physical  risks  are  thus 
covered by European toy safety standard EN 71-1.100 Certainly, the standard is improved 
when  new  toys  can  cause  new  risks.  This  was  the  case  in  2013  when  more  extensive 
specifications to limit the noise from toys were included in the standard.101 

5.1.1.2.Is the Directive effective in protecting children from the risk of chemicals?  

Chemicals in general 

The  Toy  Safety  Directive  emphasizes  the  protection  from  chemical  risks  in  its  general 
safety requirement: ‘Toys, including the chemicals they contain, shall not jeopardise the 
safety and health of users …’. 102 The reference to chemicals in toys was added during the 
law-making process, and thus considered as important by the EU co-legislators.  

The Directive further lists a range of ‘particular’ safety requirements on chemicals in its 
Annex  II,  Part  III,  as  described  in  section  ‘Baseline  and  points  of  comparison’  further 
above.  In  addition,  cosmetic  toys  have  to  comply  with  the  compositional  and  labelling 
requirements of the Cosmetics Regulation.103 Finally, toys that are themselves substances 
or mixtures have to comply with the CLP Regulation.104 

97  Commission Regulation (EU) No 681/2013 of 17 July 2013 amending part III of Annex II to Directive 
2009/48/EC  of  the  European  Parliament  and  of  the  Council  on  the  safety  of  toys  Text  with  EEA 
relevance. OJ L 195, 18.7.2013, p. 16. 

98  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. 
content/EN/TXT/PDF/?uri=CELEX:32017L0898&qid=1580139759341&from=EN  

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

99  Commission  Directive  (EU)  2019/1922  of  18  November  2019  amending,  for  the  purposes  of 
adaptation  to  technical  and  scientific  developments,  point  13  of  part  III  of  Annex  II  to  Directive 
2009/48/EC  of  the  European  Parliament  and  of  the  Council  on  the  safety  of  toys,  as  regards 
aluminium. OJ L 298, 19.11.2019, p. 5.  
content/EN/TXT/PDF/?uri=CELEX:32019L1922&qid=1580139868389&from=EN  

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

100  The choking risk from small parts is dealt with in clause 5.1 of EN 71-1. 

101  See EN 71-1:2011+A2:2013, clause 4.20 Acoustics. 

102  Article 10(2) of the Toy Safety Directive. 

103  See footnote on Regulation (EC) No 1223/2009 further above. 

104  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. 

33 

 
                                                                                                                                                                            
The many detailed safety requirements on chemicals in the 2009 Toy Safety Directive are 
based  on  the  recognition  in  the  2008  IA  that  its  predecessor,  the  1988  Toy  Safety 
Directive, needed additional safety requirements especially in the field of chemicals.  In 
addition,  during  the  law-making  process  the  2009  Toy  Safety  Directive  was  given  the 
possibility to include ‘Specific limit values for chemicals used in toys intended for use by 
children  under  36 months  or  in  other  toys  intended  to  be  placed  in  the  mouth  …’.  The 
specific  limit  values  in  the  related  Appendix  C  should  ‘ensure  adequate  protection  [of 
children] in the case of toys involving a high degree of exposure … intended for use by 
children under 36 months and in other toys intended to be put in the mouth …’.105 

Indeed, eight amendments to the Toy Safety Directive have inserted specific limit values 
for a number of CMR substances and highly sensitising substances in Appendix C (see 
annex 4). However, experts in the subgroup Chemicals, but also in the Expert Group on 
Toys Safety,106 repeatedly raised the need that children of 36 months and over be equally 
well  protected  as  those  under  36 months.  Furthermore,  in  the  2018  public  consultation, 
two Member States submitted position papers calling to expand Appendix C in order that 
the  limit  values  also  be  applicable  to  toys  for  children  of  36 months  and  over.  In  their 
2009  –  2013  national  reports  on  the  application  of  the  Toy  Safety  Directive,107  four 
Member States proposed that Appendix C limit values also apply to toys for children of 
36 months  and  over.  These  views  have  been  confirmed  in  the  2014  –  2018  national 
reports, submitted in 2019, where Member States indicated that the limitation to toys for 
children  under  36 months  and  to  toys  intended  to  be  taken  in  the  mouth  is  clearly 
inadequate, in particular for sensitising substances and preservatives, and that such limits 
should  apply  to  all  toys.  In  the  ‘Fitness  check  on  chemicals  legislation  (excluding 
REACH)’,108  the  supporting  case  study  on  toys109  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,110 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. 

105  Recital 24 of the Toy Safety Directive. 

106  See footnote on the Register of Commission Expert Groups further above. 

107  See footnote on the Commission Summary of Member States’ Reports further above. 

108  http://ec.europa.eu/growth/sectors/chemicals/ec-support_en.  Click 

‘Supporting 

studies 

and 

consultations’, click ‘Annex VI’. 

109  http://ec.europa.eu/DocsRoom/documents/22063/attachments/3/translations/  

110  Letter of 25.4.2019, Ares(2019)2833234. 

34 

 
                                                           
The above shows that the Toy Safety Directive is not considered effective enough in the 
eyes  of  Member  States  and  Notified  Bodies.  They  suggest  the  specific  limit  values  for 
chemicals apply to the toys for children of all ages. 

In  the  Commission  services’  view,  the  distinction  between  (1)  toys  for  children  under 
36 months  and  toys  intended  to  be  taken  in  the  mouth,  and  (2)  other  toys,  takes  good 
account  of  the  oral  exposure  to  chemicals.  Indeed,  children  under  36 months  take 
‘everything’  in  their  mouth,  and  toys  such  as  a  toy  flute  or  a  toy  harmonica  are  by 
definition played in contact with the mouth. 

are 

the 

However,  children  may  also  be  exposed  to  chemicals  via  the  skin  or  via  inhalation. 
benzisothiazolinone,111  
Examples 
chloromethylisothiazolinone and methylisothiazolinone112 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. 

preservatives 

sensitising 

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 kg113 when calculating the migration limits for toxic ‘elements’ such 
as  arsenic,  cadmium  or  lead;  for  children  of  36 months  and  over  the  bodyweight  was 
assumed to be 15 kg. This 2-fold difference is only minor from the toxicological point of 
view, a notable difference would be 10-fold. 

Finally,  only  the  limit  values  in  Appendix  C  have  an  age  limit  and  the  limitation  to 
mouthing  toys,  all  other  chemical  limit  values  in  the  Toy  Safety  Directive  apply  to  all 
toys for children of all ages. This puts a general question mark on the Appendix C limit 
values. 

Thus, in light of the above, it appears that the limitation of the scope of the specific limit 
values  in  Appendix  C,  both  in  terms  of  children’s  age  and  types  of  toys,  hampers  the 
effectiveness of the Toy Safety Directive. 

CMR substances in general 

The  Toy  Safety  Directive  prohibits  the  use  of  substances  that  are  classified,  under  the 
CLP  Regulation,  as  carcinogenic,  mutagenic  or  toxic  for  reproduction  (CMR).  CMR 
substances may be identified as substances of very high  concern under REACH.114 The 
hazardous effects  of such substances can only be seen in  the long term  and can  almost 
never be traced back to the chemical of origin,115 and are often irreversible. 

111  See the related amendment in annex 4. 

112  See the related amendment in annex 4. 

113  National Institute for Public Health and the Environment (RIVM) ... pages 120 and 123. See footnote 

above. 

114  See footnote on Regulation (EC) No 1907/2006 further above, Articles 55 and 57. 

115  A prominent exception is asbestos that causes ‘… mesothelioma [that] are very rare malignancies … ‘. 
IARC  monographs,  Volume  100C  (2012)  Asbestos  (Chrysotile,  Amosite,  Crocidolite,  Tremolite, 

35 

 
                                                           
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 carcinogens116 and mutagens117 of categories 1 and 2, respectively, and 0.3% and 
3% for reproductive toxins118 of categories 1 and 2, respectively. 

These ‘relevant  concentrations’ of the CLP Regulation  are hazard-based and have been 
set  for  the  purpose  of  classification  and  labelling  of  mixtures  containing  hazardous 
substances, with the primary aim to ensure that the hazards of such mixtures are properly 
identified  and  communicated.  They  do  not  take  account  of  possible  exposures,  do  not 
entail an assessment of risk related to the uses of a substance, and thus are inadequate for 
establishing a safe level when a substance is present in an article such as a toy. 

To take account of the exposure of children to chemicals in toys the subgroup Chemicals 
was established to recommend limit values for chemicals in toys when those chemicals 
could pose a risk. On the basis of the work of the subgroup the Toy Safety Directive was 
amended  six  times  to  include  (in  its  Appendix  C)  risk-based  limit  values  for  several 
CMRs:  TCPP  and  two  similar  flame  retardants,  bisphenol  A,  formamide,  phenol, 
bisphenol A and formaldehyde.119 

Those risk-based limit values are often migration limits. They cannot be compared with 
the  ‘relevant  concentrations’  taken  from  the  CLP  Regulation,  which  are  content  limits.  
There is no relationship between the concentration of a substance inside a material, i. e., 
its content, and the migration of the substance out of that material. Both therefore cannot 
be converted into one another. Nevertheless, for a few substances the Directive sets risk-
based content limits and comparisons are therefore possible: 

Chemical substance 

‘Relevant concentration’ in 
the CLP Regulation, mg/kg 

TCEP 
Phenol 
Formamide 
Formaldehyde 

3,000 
10,000 
3,000 
1,000 

Content limit 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. 

Actinolite and Anthophyllite), p. 238. 
https://monographs.iarc.fr/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-19/  

116  Table 3.6.2 of the CLP Regulation. 

117  Table 3.5.2 of the CLP Regulation. 

118  Table 3.7.2 of the CLP Regulation. 

119  See the related amendments in annex 4. 

36 

 
 
                                                                                                                                                                            
 
This likely inadequacy of the CMR derogation based on the CLP Regulation was referred 
to by public authorities and by consumer organisations in the 2018 public consultation. 
The  fitness  check  on  chemicals  legislation  (excluding  REACH)120  reported  in  its  case 
study on toys121 about  a consumer association indicating that the thresholds  outlined in 
the CLP Regulation for CMR substances were not originally intended to be used as a safe 
limit  for  consumer  products  and  were  therefore  not  appropriate  for  application  to 
consumer products  (and  in  particular  toys, as  children are vulnerable). Also, a Member 
State authority noted that the CLP Regulation follows a hazard-based approach and the 
generic classification limits of 0.1% for human carcinogens were too high meaning that 
health  risks  to  children  could  not  be  excluded.  Also  the  2015  external  study  reported 
consumer organisations deeming the limits for CMR substances to be too high. 

In light of the above, the CMR provisions in the Toy Safety Directive can be considered 
not to be sufficiently effective to protect children’s health. To note that, according to the 
2008  IA,  these  provisions  had  been  explicitly  inserted  in  the  Directive122  because  the 
1988 Toy Safety Directive had no specific provisions on CMRs.  It is however not clear 
why  the  inadequacy  of  such  a  prohibition,  which  does  not  take  account  of  exposure, 
remained unrecognised before the adoption of the Directive. 

In addition to the above the Toy Safety Directive provides for two further derogations for 
the use of CMRs in general: 

  The second derogation in the Toy Safety Directive allows CMRs in toys that exceed 
the ‘relevant  concentration’ in  the CLP Regulation. Such higher concentrations are 
allowed  if  the  CMRs  are  inaccessible  in  any  form,  including  inhalation,  when 
children  are  playing  with  the  toys.  This  derogation  takes  full  account  of  exposure: 
When there is no exposure to CMRs, there is no risk. This derogation puts children’s 
safety at the highest rank. 

This second derogation was possibly less strict in the Commission’s proposal for the 
Toy Safety Directive, because the proposal allowed CMRs in toy parts ‘that are not 
accessible  to  any  physical  contact  by  children.’  The  proposal  thus  clearly  took 
account  of  oral  and  skin  exposure,  but  it  is  unclear  whether  it  also  covered 
inhalation. 

  The third derogation that allows CMRs in toys is conditioned by an evaluation by the 
relevant Scientific Committee that a CMR is safe in toys, and that REACH does not 
prohibit the CMR in consumer articles. For the ‘stronger’ CMRs (categories 1A and 
1B  under  the  CLP  Regulation),  the  third  condition  is  the  non-availability  of 
alternatives, which is not needed for the ‘weaker’ CMRs (category 2). – So far only a 
single  derogation  of  this  kind  was  allowed,  namely  for  nickel  in  toys  and  toy 
components  made  of  stainless  steel  and  in  toy  components  which  are  intended  to 
conduct an electric current.123  

120  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52019DC0264&from=EN  

121  http://ec.europa.eu/DocsRoom/documents/22063/attachments/3/translations/ , p. 33. 

122  COM(2008) 9 final. 25.1.2008. 

123  Annex II, Appendix A of the Toy Safety Directive. 

37 

 
                                                           
This third derogation in the Toy Safety Directive is the same as in the Commission 
proposal,  however  the  Directive  as  adopted  is  more  explicit,  which  makes  its 
implementation easier. 

From  the  above  it  appears  that  a  generic  approach  to  the  risks  of  a  whole  class  of 
chemicals  could  be missing effectivity if derogations  are set  that ignore  one of the two 
constituents of risk, namely in this case the exposure to a vulnerable group of consumers. 
This calls for utmost attention when applying a generic approach to risk for example to 
newly identified groups of chemicals causing concern, such as endocrine disruptors. On 
the other hand, developing appropriate risk assessments for single chemicals has proven 
to be laborious, if not cumbersome, although ensuring tailor-made protection. 

Specific CMRs: Nitrosamines and nitrosatable substances 

The  Toy  Safety  Directive  sets  migration  limits  for  nitrosamines  and  nitrosatable 
substances in toys intended for use by children under 36 months or in other toys intended 
to  be  placed  in  the  mouth:  0.05 mg/kg  for  nitrosamines,  1 mg/kg  for  nitrosatable 
substances.124  Relevant  nitrosamines  may  be  genotoxic  and  very  strong  carcinogens. 
Nitrosatable substances can be converted into nitrosamines in the human body. 

the 
Limit  values  for  nitrosamines  and  nitrosatable  substances  were  added 
Commission’s proposal for the Directive during the co-decision process. The amendment 
of the European Parliament125 proposed to take over the limit values applicable to teats 
and soothers from the related directive, namely 0.01 mg/kg for nitrosamines, 0.1 mg/kg 
for  nitrosatable  substances.126  That  directive  referred  to  an  opinion  of  the  Scientific 
Committee  for  Food  recommending  ‘to  keep  the  amounts  of  nitrosamines  and 
nitrosatable substances  migrating from such rubber articles below the detection limit of 
agreed appropriate sensitive methods.’  127  Indeed those migration limits were based on 
detection limits and not on toxicological evaluation, because for genotoxic carcinogenic 

to 

124  Annex II, Part III, point 8 of the Toy Safety Directive. 

125  European  Parliament  Report  on  the  proposal  for  a  directive  of  the  European  Parliament  and  of  the 
Council on the safety of toys. (COM(2008)0009 – C6 0039/2008 – 2008/0018(COD)). 12.11.2008. 
  Amendment No 85 of the Opinion of the Committee on the Environment, Public Health and Food 
Safety for the Committee on the Internal Market and Consumer Protection on the proposal for a 
directive of the European Parliament and of the Council on the safety of toys. (COM(2008)0009 – 
C6 0039/2008 – 2008/0018(COD)) 15.10.2008.  

  Amendment No 124 of the Draft European Parliament legislative resolution on the proposal for a 
directive of the European Parliament and of the Council on the safety of toys. (COM(2008)0009 – 
C6 0039/2008 – 2008/0018(COD)). 

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT%20REPORT%20A6-2008-
0441%200%20NOT%20XML%20V0//en 

126  Directive  93/11/EEC  concerning  the  release  of  N-nitrosamines  and  N-nitrosatable  substances  from 

elastomer or 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=1575564486032&from=EN  

127  Commission of the European Communities, Reports of the Scientific Committee for Food (20th series). 
Report EUR 11558 EN, p. 23: Nitrosamines in babies dummies and teats. (Opinion  expressed on 10 
December 1987) 
http://aei.pitt.edu/40829/1/20th_food.pdf  

38 

 
                                                           
 
 
 
substances no safe level  of exposure exists;  a toxicological  evaluation  by  the Scientific 
Committee  on  Consumer  Products  (SCCP)  concluded  however  that  0.05 mg/kg  for 
nitrosamines in balloons was acceptable.128 

The final position of the European Parliament129 adopted the limit values as they are in 
the  Directive  eventually  adopted  in  2009,  namely  0.05 mg/kg  for  nitrosamines  and 
1 mg/kg for nitrosatable substances. 

Germany  however  insisted  on  its  lower  national  limits  of  0.01 mg/kg  for  nitrosamines 
and of 0.1 mg/kg for nitrosatable substances in toys made of natural or synthetic rubber 
designed for children under 36 months and intended or likely to be placed in the mouth. 
The  Commission  allowed  Germany  in  a  Decision  of  March  2012  to  keep  its  lower 
limits,130 acknowledging that ‘the German request is based on a real concern with regard 
to children’s health …’.131 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.132  –  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.133 Standardisation should take account of the latest data on the 
mouthing behaviour of children (which is related to all toys), not only of the mouthing of 
balloons.  With  this,  CEN’s  work  resulted  in  the  adoption  of  standard  EN 71-12:2017, 
made  available  in  January  2017,  that  included  lower  limits  for  nitrosamines  and 
nitrosatable substances in accordance with the Commission’s mandate. 

Thus, the Directive’s effectiveness  with  regard to the protection from nitrosamines and 
nitrosatable  substances  is  compromised.  Also,  referencing  EN  71-12:2017  with  its 
strengthened limits for nitrosamines and nitrosatable substances in the Official Journal is 
not possible since that would lead to a conflict with the limits in the Directive. EN 71-
12:2017 therefore cannot provide the presumption of conformity until the Directive has 
been revised. 

128  Scientific  Committee  on  Consumer  Products  (SCCP)  Opinion  on  the  Presence  and  Release  of 
Nitrosamines  and  Nitrosatable  Compounds  from  Rubber  Balloons.  Adopted  on  18.12.2007,  p.  11, 
p. 23. https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_121.pdf   

129  Position of the European Parliament adopted at first reading on 18 December 2008 with a view to the 
adoption of Directive 2009/.../EC of the European Parliament and of the Council on the safety of toys 
(EP-PE_TC1-COD(2008)0018). 18.12.2008. 

130   See section on Implementation and State of Play above. 

131  Recital 

88 

of 

Commission  Decision 

2012/160/EU. 

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

content/EN/TXT/PDF/?uri=CELEX:32012D0160&qid=1571656440439&from=EN  

132  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  

133  Letter of 29.3.2012. ARES(2012)363020. 

39 

 
                                                           
Finally,  market  surveillance  authorities  in  the  Member  States  continue  to  find  both 
nitrosamines  and  nitrosatable  substances  in  toys  in  excess  of  the  current  limits  in  the 
Directive,  in  particular  in  balloons,  much  less  so  in  finger  paints  or  other  toys. 
Nitrosatable  substances  are  more  often  found  in  toys  than  the  nitrosamines  themselves 
(annex 9). 

In  their  letter  of  April  2019  to  the  Commission,134  11 Member  States  considered  that 
there was an urgent need to lower the limits for nitrosamines and nitrosatable substances. 
In  the  2018  public  consultation,  public  authorities  commented  that  the  limits  for 
nitrosamines and nitrosatable substances should be aligned, according to position papers 
submitted by Denmark, Germany and Sweden, with the limits that the Commission had 
requested  from  CEN  and  available  in  standard  EN  71-12:2017.  Industry  and  Notified 
Bodies considered the existence of lower limits in national legislation as an incoherence 
with  the  Toy  Safety  Directive.  Consumer  organisations  considered  the  limits  for 
nitrosamines  and  nitrosatable  substances  to  be  inadequate  already  in  the  2015  external 
study on the Directive. The 2008 IA mentioned nitrosamines as an example of dangerous 
chemicals requiring regulation. 

In  conclusion,  the  Toy  Safety  Directive  is  less  effective  than  required  to  ensure  a  high 
level  of  protection  from  nitrosamines  and  nitrosatable  substances  in  toys.  At  the  same 
time these carcinogens continue to be found in toys in  excess of the limit values in the 
Directive. 

Allergenic fragrances 

The  Toy  Safety  Directive  prohibits  55  allergenic  fragrances,  with  certain  derogations, 
and  requires  to  label  a  further  11  when  used  in  toys;135  in  addition,  specific  labelling 
provisions apply to olfactory board games, cosmetic kits and gustative games. 

Notwithstanding the prohibition of the 55 allergenic fragrances, the presence of traces of 
these  fragrances  is  allowed  if  technically  unavoidable  under  Good  Manufacturing 
Practice and if they do not exceed 100 mg/kg.136 

This  tolerance  of  100 mg/kg,  corresponding  to  0.01%,  does  not  appear  to  compromise 
toy safety. The Scientific Committee on Consumer Safety (SCCS) noted, when assessing 
fragrance  allergens  in  cosmetic  products,  that  ‘The  studies  available,  however,  indicate 
that a general level of exposure of up to 0.8 μg/cm² (0.01% in cosmetic products) may be 
tolerated by most consumers, including those with contact allergy to fragrance allergens. 
The  SCCS  is  of  the  opinion  that  this  level  of  exposure  (up  to  0.01%)  would  suffice  to 
prevent elicitation for the majority of allergic individuals, unless there is experimental or 
clinical substance-specific data allowing the derivation of individual thresholds.’137 Since 

134  See letter of 25.4.2019 … above. 

135  See section on Baseline and points of comparison above. 

136  Annex II, Part III, point 11 of the Toy Safety Directive. 

137  Scientific Committee on Consumer Safety (SCCS) Fragrance allergens in cosmetic products. Opinion 

adopted on 26 – 27 June 2012, p. 8.  
https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf  

40 

 
                                                           
 
cosmetic products such as face creams or hand creams will stay 12 hours or more per day 
on the skin, exposure to allergenic fragrances from such products will normally be more 
pronounced than from toys. The 100 mg/kg tolerance in the Toy Safety Directive, legally 
acceptable only if unavoidable under Good Manufacturing Practice conditions, therefore 
appears to go hand in hand with a high level of protection. 

The only caveat to this could be the presence of allergenic fragrances in toys for children 
under  36  months  of  age,  because  those  children  take  ‘everything’  into  their  mouth  by 
bringing their lips and their mouth’s mucous membranes in contact with a toy material. 

On the other hand, allergies from the fragrances in question are caused by contact with 
the external skin, but not the (oral) mucosa, and exposure of the latter may therefore be 
tolerated.  An  example  for  this  is  the  maximum  limit  of  1%  for  hydroxy-citronellal  in 
cosmetics  in  general  combined  with  a  labelling  requirement  as  of  0.001%  in  leave-on 
cosmetics  and  as  of  0.01%  in  rinse-off  cosmetics,138  however  no  limit  applies  to  oral 
cosmetics.139  An  analogous  example  is  isoeugenol:  maximum  limit  of  0.02%  for 
cosmetics  in  general  (plus  the  same  labelling  requirements),  but  unlimited  use  in  oral 
cosmetics.140 

The  further  11 allergenic  fragrances  that  may  be  used  in  toys  if  labelled  above  a 
concentration  of  100 mg/kg  in  the  toy  or  any  of  its  components  were  less  frequently 
reported  as  contact  allergens.141  In  cosmetics  they  have  to  be  labelled  as  of  0.001%  (= 
10 mg/kg) in leave-on products, and as of 0.01% (= 100 mg/kg) in rinse-off products. In 
this light the Toy Safety Directive appears to be sufficiently protective, since most toys 
will  lead  to  a  lower  exposure  than  leave-on  cosmetics,  with  a  possible  exception  for 
finger  paints,  which  may  stay  for  several  hours  on  children’s  skin,  and  thus  rather 
resemble a leave-on cosmetic. This will require further expert consideration. 

An exception amongst the 11 allergenic fragrances is methyl heptine carbonate that has a 
maximum limit of 0.01% in cosmetics in general,142 but can be used without limit in oral 
cosmetics.143 The maximum limit being based on a Scientific Committee opinion144 and 

138  Scientific  Committee  on Non-Food Products (SCCNFP) An initial list of perfumery  materials  which 
must  not  form part of cosmetic products except subject to tge restrictions and conditions laid down. 
SCCNFP/392/00 final, 25.9.2001, p. 8.  
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf  

139  Entry 72 of Annex III to Regulation (EC) No 1223/2009 on cosmetic products. 

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-
20190813&qid=1570630231024&from=EN  

140  Entry 73 of Annex III to Regulation (EC) No 1223/2009 on cosmetic products. See footnote 121. 

141  Scientific  Committee  on  Non-Food  Products  (SCCNFP)  Fragrance  allergy  in  consumers.  Opinion 

SCCNFP/0017/98 final, 8.12.1999. Table 6b, p. 23. 
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out98_en.pdf 

142  0.08% when used in combination with methyl octine carbonate. 

143  Entry 89 of Annex III to Regulation (EC) No 1223/2009 on cosmetic products. See footnote 121. 

144  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, p. 8.  
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf 

41 

 
                                                           
 
 
corresponding  to  a  prohibition  under  the  Toy  Safety  Directive,  the  transfer  of  methyl 
heptine  carbonate  to  the  group  of  55 prohibited  allergenic  fragrances  in  the  Toy  Safety 
Directive is under preparation. 

Finally,  for  amending  the  specific  labelling  provisions  for  olfactory  board  games, 
cosmetic kits and gustative games in the Toy Safety Directive145 Council and Parliament 
have  to  decide  in  an  ordinary  legislative  procedure.  This  is  time  consuming  and  seems 
disproportionate  given  that  amending  the  list  of  allergenic  fragrances  follows  the 
regulatory procedure with scrutiny which requires much less time. This appears to be an 
in-built design defect of the Toy Safety Directive which could reduce its effectiveness.  

Setting limit values for chemicals 

Under  the  Toy  Safety  Directive,  limit  values  for  the  (mostly  heavy  metal)  ‘elements’ 
have been set at 10% of the toxicological reference value, as recommended by Scientific 
Committee opinions.146, 147 This takes satisfactory account of the intake of elements from 
other sources, in particular from food, reported to be generally between 20% and 70%.148 

The  10%  have  to  be  reduced  to  half  (i.e.,  5%)  when  such  an  element  is  ‘particularly 
toxic’, as provided for in the Directive149 and applied to the adaptation of the limit values 
for lead.150 

The 10% allocation has also been used in the case of bisphenol A.151 In other cases, such 
as  on  highly  allergenic  preservatives,152  the  limit  values  were  set  so  low  that  even 
sensitised  individuals  would  not  suffer  if  exposed  to  a  toy  complying  with  the  limit 
values.  At  the  same  time  these  preservatives  would  have  no  preserving  effect  in  a  toy. 
The limit values thus effectively prohibit the use of those chemicals while allowing legal 
certainty when testing for compliance. 

145  Annex II, Part III, point 12 of the Toy Safety Directive. 

146  Scientific  Committee  on  Toxicity,  Ecotoxicity  and  the  Environment  (SCTEE)  Assessment  of  the 

bioavailability of certain elements in toys. Opinon of 22.6.2004. 
https://ec.europa.eu/health/ph_risk/committees/sct/documents/out235_en.pdf  

147  Scientific Committee on Health and Environmental Risks (SCHER) Evaluation of the migration limits 

for chemical elements in toys. Opinion of 1.7.2010.  
https://ec.europa.eu/health/sites/health/files/scientific_committees/environmental_risks/docs/scher_o_
126.pdf  

148  See footnote on National Institute for Public Health above. 

149  Recital 22 of the Toy Safety Directive. 

150  See the related amendment in annex 4. 

151  See the related amendment by Commission Directive (EU) 2017/898 in annex 4. 

152  See the related amendment by Commission Directive (EU) 2015/2117 in annex 4. 

42 

 
                                                           
 
 
On  the  other  hand,  in  the  case  of  chromium-VI  the  toxicological  assessment  would 
require  limit  values153  that  are  so  low  that  they  cannot  be  tested  for  compliance.  The 
chromium-VI  limit  value  for  scraped-off  toy  material  in  the  Toy  Safety  Directive  has 
thus been adapted to a level that can reliably be tested with the most recent standard test 
method154 referenced in the Official Journal.155 

In  conclusion,  limit  values  in  the  Toy  Safety  Directive  are  normally  set  at  levels  that 
leave a sufficient reserve against the background exposure from sources other than toys. 
Where  this  is  not  possible  due  to  modern  test  methods  not  being  sufficiently  sensitive, 
they are set at a level that allows compliance testing and unambiguous enforcement. 

Identifying chemicals for limit setting 

Chemicals  to  be  considered  for  setting  specific  limit  values  in  the  Directive  have 
regularly been identified by the dedicated subgroup Chemicals. Its chemical experts from 
several Member States, the toy industry and a consumer organisation have identified (and 
have been working on) chemicals that are particularly hazardous, such as CMRs or very 
strong sensitisers,  or on  chemicals  recognised to  be more toxic than previously known, 
such  as  aluminium.  Suggestions  (and  work)  of  the  subgroup  have  also  concerned 
chemicals  newly  identified  in  toys,  such  as  volatile  chemicals  in  squeezing  toys  made 
from foam materials. Furthermore, opinions of the Commission’s independent Scientific 
Committees,  such  as  the  Scientific  Committee  on  Consumer  Safety  (SCCS),  that  is 
primarily working on cosmetics, or of the European Food Safety Authority (EFSA) have 
constituted a source of advice, normally via the subgroup. Finally, the subgroup has been 
discussing  ‘Anything  to  signal  on  risks  from  chemicals  in  toys?’  at  its  meetings,  this 
being  an  opportunity  to  bring  up  any  relevant  aspect  on  chemical  risks  in  toys.  – 
Chemical  issues  are  also  discussed  in  the  Expert  Group  on  Toys  Safety,  which  has 
equally  been  suggesting  chemicals  for  limitation,  such  as  for  certain  allergenic 
fragrances. 

Thus  the  identification  of  chemicals  for  potential  limit-setting  in  toys  has  so  far  been 
based  on  expert  advice  regarding  existing  or  new  concerns,  and  the  opportunity  for 
experts to raise any concern they may have. So far there has been no oversight of a risk 
from chemicals in toys, and the absence of an explicit, more systematic link to activities 
elsewhere in the EU or worldwide has shown to be sufficient. 

5.1.1.3.Is  the  Directive  effective  in  protecting  children  from  risks  other  than 

chemical? 

The safety requirements in the Toy Safety Directive for hazards other than chemical have 
not  led  to  any  major  discussion  with  Member  States  or  stakeholders  about  their 
effectiveness, it seems that they can be applied in practice without further ado. 

153  Scientific  Committee  Health  and  Environmental  Risks  (SCHER)  Chromium  VI  in  toys.  Opinion  of 

22.1.2015. 
https://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_167.pdf  

154  EN 71-3:2019 Migration of certain elements. 

155  See footnote on Commission Implementing Decision (EU) 2019/1728 above.  

43 

 
                                                           
 
The  only  safety  requirement  triggering  almost  permanent  discussion  is  the  ‘small  parts 
requirement’: ‘Toys, which are clearly intended for use by children under 36 months, and 
their component parts and any of their detachable parts must be of such dimensions as to 
prevent  their  being  swallowed  or  inhaled.  This  also  applies  to  other  toys  which  are 
intended to be put in the mouth, and to their component parts and any of their detachable 
parts.’ 156 

This requirement is based on the fact that children under 36 months put ‘everything’ in 
their  mouth  to  explore  the  world.  They  therefore  run  the  highest  risk  of  choking  on  a 
small  part  that  they  have  swallowed.  This  mouthing  behaviour  fades  out  with  the 
completion of their 36 months. Nevertheless, toys or their components that are intended 
to or may be put in the mouth continue to present the ‘small parts risk’: for those toys the 
safety requirement applies regardless of the age of children. An example for the latter are 
suction  cups  at  the  tip  of  a  toy  arrow  that  children  may  wet  in  their  mouth  (so  that  it 
sticks better when shot onto a surface). 

Manufacturing toys that comply with the small parts requirement is a challenge, because 
the toys have to be particularly resistant to mechanical stress. 

The  demanding  specifications  are  circumvented  by  some  manufacturers  who  disregard 
the rules and who, although their toys are apparently for children under 36 months, claim 
that  they  would  be  for  children  of  36 months  and  over.  Such  cases  have  led  to 
discussions  amongst  Member  States’  authorities  in  the  AdCo  about  the  sometimes  fine 
line between toys for children under 36 months and toys for older children. A toy mouse 
with a wind-up mechanism to be activated by simply pushing the mouse over the ground 
was  thus  considered  to  be  for  children  under  36 months,  whereas  a  pony  with  a 
mechanism to  be winded up with the fingers was seen by some as too  complex for the 
dexterity of such children, and thus categorised for children of 36 months and over. 

A guidance document on the classification of toys intended for children under 36 months 
of  age  has  been  developed  by  Member  State  authorities  and  eventually  adopted  by  the 
Expert Group (which also includes the stakeholders) in 2009.157 Nevertheless, discussions 
are  taken  up  when  necessary,  and  a  once-for-all  remedy  for  this  less-than-optimal 
effectiveness  of  the  Toy  Safety  Directive  does  not  appear  to  exist:  new  toys  with  new 
features  are  continuously  being  placed  on  the  market,  which  requires  a  case-by-case 
approach. 

5.1.1.4.Are standards effectively supporting the safety of toys? 

The  specifications  in  the  harmonised  toy  safety  standards  referenced  in  the  Official 
Journal cover a wide range of requirements of the Toy Safety Directive.158 Only hygiene 
specifications  are  limited  to  ‘Material  cleanliness’  in  clause  4.1  of  EN 71-1,  without 
further  details.  Details  on  the  maximum  presence  of  specific  microorganisms  can 
however be taken from Protocol no 2 on the microbial safety of toys, drafted and adopted 

156  See Annex II, Part I, point (d). 

157  Guidance  document  No  11  on  the  classification  of  toys  intended  for  children  under  3  years  of  age. 

http://ec.europa.eu/growth/sectors/toys/safety/guidance_en  

158  See annex 7. 

44 

 
                                                           
by the Notified Bodies under the Directive.159 The radioactivity requirement in the Toy 
Safety Directive refers to the Treaty establishing the European Atomic Community. 

So  far  the  harmonised  standards  referenced  in  the  Official  Journal  appear  to  have 
effectively supported the Directive and thus the safety of toys. There have been no major 
incidents with toys complying with such standards. 

Also,  on  only  very  rare  occasions  did  Member  States  object  to  a  standard  for  being 
insufficient160. For example, a formal objection in 2016 from a Member State regarding 
EN 71-1 (mechanical and physical properties) considered that specifications for balance 
bikes were missing, and another formal objection from a Member State regarding EN 71-
2  (flammability)  in  2012  considered  not  to  cover  the  easily  flammable  plastic  puffer 
balls. 

Furthermore, toy safety standards delivered by CEN are normally of a quality that allows 
the Commission to reference them without further ado in the Official Journal. Only the 
2018 publication of the references to toy safety standards161 had to be completed by the 
Commission  with  a  note  on  the  maximum  concentration  of  a  preservative  in  finger 
paints. The note limited the preservative to the maximum concentration recommended by 
the  Scientific  Committee  on  Consumer  Safety  (SCCS)  for  leave-on  cosmetics  (such  as 
hand  creams).  CEN  was  not  able  to  amend  the  standard  on  time  because  the  SCCS 
opinion was published only shortly before the standard publication by CEN. 

Harmonised referenced standards play a major role in the conformity assessment of toys 
(see  ‘Conformity  assessment’  in  section  2.1.2).  They  appear  to  help  manufacturers  to 
bring  their  toys  more  swiftly  to  the  market,  by  avoiding  the  extra  effort  in  time  and 
money that an EC-type examination requires in comparison to self-certification. 

5.1.1.5.Is the Directive effective in defining its scope?  

The Toy Safety Directive defines toys as ‘… products designed or intended, whether or 
not exclusively, for use in play by children …’. Thus, products may be considered as toys 
subject  to  the  Directive  when  they  have  a  play  value  for  children,  although  children’s 
play may not be the main intended use (‘not exclusively’). 

Due to this wide definition some 15 guidance documents on the related Commission web 
site162  are  dealing  with  the  distinction  between  toys  and  other  products,  such  as  dolls 
(dolls for play by children or for adult collectors; the latter are not toys), toys used in and 
on the water (such  as inflatable plastic animals  or inflatable life-saving  rings;  the latter 
are not  toys), pools, books, musical  instruments, and so on. These guidance documents 
have been primarily developed by the AdCo and eventually agreed by the majority of all 

159  Protocol No 2 : Microbiological safety of toys (Rev 3). 

https://ec.europa.eu/growth/sectors/toys/safety/guidance_en  

160  Notifications 

from  Member  States  on 

formal  objections 

to  standards  are  published  at  

https://ec.europa.eu/growth/single-market/european-standards/notification-system/ 

161  Commission communication in the framework of the implementation of Directive 2009/48/EC on the 

safety of toys. OJ C 282, 10.8.2018, p. 3. 

162  http://ec.europa.eu/growth/sectors/toys/safety/guidance_en  

45 

 
                                                           
 
stakeholders  in  the  Expert  Group  on  Toys  Safety,  they  thus  indicate  the  view  that  has 
been  generally  adopted  in  the  EU.  Nevertheless  these  guidance  documents  are  not 
binding and do not relieve national authorities from their obligation to determine for any 
individual  product,  on  a  case-by-case  basis,  whether  it  falls  within  the  scope  of 
application  of  the  Toy  Safety  Directive  or  within  the  scope  of  application  of  other 
sectorial legislation. 

The  guidance  documents  are  valued  by  all:  Member  States,  the  toy  industry,  notified 
bodies, and others. Updates of existing guidance documents is a recurrent task, such as 
on pools or on musical instruments, and new guidance documents are being drafted, such 
as on puffer balls and similar toys, or soother holders. 

Still, the classification of products as toys (or not) is a permanent, almost daily task for 
market surveillance authorities, which they are discussing via email exchanges amongst 
themselves,  with  the  Commission  taking  the  role  of  an  observer  to  ensure  that  the 
provisions of the Directive are not infringed. 

Experience with  the AdCo exchanges shows that  products,  which previously had never 
been  classified  as  toys,  are  suddenly  given  a  child-attractive  design  by  manufacturers.  
This may give them a play value for children and thus may make them subject to the Toy 
Safety Directive. Those ‘grey zone products’ lead to hesitations, inquiries and exchanges 
between the authorities.  

These hesitations have been confirmed by the 2014  – 2018 national reports of Member 
States,163 where many countries referred to difficulties on how to interpret the provisions 
of the Toy Safety Directive, in particular as concerns the concept of play value and the 
foreseeable use of a toy. Also the classification of products as toys or not was raised as 
an issue, as was the classification of toys as being for children under 36 months of age 
and/or toys for children of 36 months of age and above. The 2014 – 2018 national reports 
called for more guidance and for more targeted guidance documents in this regard. The 
quest  for  related  meetings  with  the  Commission  and  the  other  countries  to  find  agreed 
views was less pronounced, but still well noticeable. 

Despite these discussions, triggered by new market developments, there has been no call 
to  amend  the  definition  of  ‘toy’,  and  thus  the  scope  of  the  Directive.  The  need  to 
comprehensively  protect  children  has  been  recognised  by  everyone  in  the  stakeholder 
consultations.  

Also under the predecessor Directive the main difficulty was the concept of ‘use in play’ 
or  ‘play  value’.164  This  has  not  changed  but  is  being  monitored  via  the  continued 
exchange of views between the Member State authorities and with the Commission. 

5.1.2.  Effectiveness related to the free movement of toys in the EU 

The free movement of toys placed on the market in the EU is the second key objective of 
the Toy Safety Directive. The Directive is a maximum harmonisation directive: toys that 

163  The  Commission  is  to  provide  a  summary  of  the  2014  –  2018  national  reports  in  accordance  with 

Article 48 of the Toy Safety Directive. 

164  Section 4.2.3 of the 2008 IA. 

46 

 
                                                           
comply with  all applicable requirements of the Directive can move freely and be made 
available  throughout  the  EU.165  There  is  therefore  no  need  for  other  provisions  on  the 
free movement. 

The effectiveness of the Directive related to the free movement of toys could be analysed 
by looking at the intra-EU trade of toys and its evolution over the years. 

Export  of  toys  covered  by  the  Toy  Safety  Directive166  from  EU  countries  amounted  to 
€10.4bn in 2018. This corresponds to 0.2% of total EU exports. 86% of the export goes 
to  other  EU  countries  (intra-EU  trade),  and  the  remaining  14%  is  sold  outside  the  EU 
(Fig. 5.1.). 

Fig. 5.1. Evolution of intra EU export of toys since 2000 

)
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t

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(

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30.000

25.000

20.000

15.000

10.000

5.000

0

4.000.000

3.500.000

3.000.000

2.500.000

2.000.000

1.500.000

1.000.000

500.000

0

0
0
0
2

1
0
0
2

2
0
0
2

3
0
0
2

4
0
0
2

5
0
0
2

6
0
0
2

7
0
0
2

8
0
0
2

9
0
0
2

0
1
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2

1
1
0
2

2
1
0
2

3
1
0
2

4
1
0
2

5
1
0
2

6
1
0
2

7
1
0
2

8
1
0
2

intra EU export of toys coverd by TSD (lhs)
intra EU export of toys not covered by TSD (lhs)
Total Intra EU export (rhs)

)
s
d
o
o
g

l
l

a
f
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o
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x
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(

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n
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Note: Toys covered by the TSD are classified under CN9503, toys not covered include categories CN9504, 9505 and 
9506. Values presented in 2018 prices. 
Source: Eurostat, EU trade since 1988 by CN8 [DS-016890]  

The intra-EU export of toys  covered by the Toy  Safety Directive increased slightly but 
steadily since the  year 2000. A steep increase started however in  2012/2013 (Fig. 5.1). 
Since the Toy Safety Directive started to apply fully in mid-2013, namely including all 
its new chemical requirements, this increase suggests that the Directive does not appear 
to have been a hindrance to intra-EU export. 

The intra-EU export of toys covered by the TSD almost doubled since 2007 (real growth 
rate of 89%), while export of other toys grew by 12 % and the overall intra-EU export of 
all goods grew by 9% (Fig. 5.2). In particular, the intra-EU export of toys covered by the 
Toy Safety Directive saw a remarkable increase since 2012/2013. This again supports the 

165  See Article 12 of the Toy Safety Directive. 

166  Toys  classified  under  category  CN9503  of  trade  statistics.  Products  under  this  category  include 
“tricycles,  scooters,  pedal  cars  and  similar  wheeled  toys;  dolls'  carriages;  dolls;  other  toys;  reduced-
size ('scale') models and similar recreational models, working or not; puzzles of all kinds”. Source: EU 
trade since 1988 by CN8 [DS-016890]. 

47 

 
 
                                                           
 
 
 
 
 
 
 
 
 
 
 
above suggestion that the application of the Directive with all its requirements since mid-
2013 did apparently not hamper the increase of intra-EU toy exports. 

Seen from a different angle, the steep increase of intra-EU toy exports from 2012 – 2016 
(Fig.  5.2)  could  make  it  plausible  that  economic  operators  increasingly  seized  the 
business  opportunities  offered  by  toys  during  that  time  period  that  started  with  the  full 
applicability of the Toy Safety Directive’s provisions. 

Fig. 5.2. Real growth of intra EU export of toys since 2007 

intra EU toys export covered by TSD

intra EU toys export not covered by TSD

total intra EU export

)
1
=
7
0
0
2
(
h
t
w
o
r
g

t
r
o
p
x
e

2

1,8

1,6

1,4

1,2

1

0,8

0,6

0,4

7
0
0
2

8
0
0
2

9
0
0
2

0
1
0
2

1
1
0
2

2
1
0
2

3
1
0
2

4
1
0
2

5
1
0
2

6
1
0
2

7
1
0
2

8
1
0
2

Note: Toys covered by the TSD are classified under CN9503, toys not covered include categories CN9504, 9505 and 
9506 
Source: Eurostat, EU trade since 1988 by CN8 [DS-016890]  

During the slight decrease of toy imports into the EU between 2010 and 2013,167 possibly 
related to the application of the Toy Safety Directive, intra-EU toy exports increased by 
some  20%.  This  might  suggest  a  potentially  higher  competitiveness  of  EU  toy 
manufacturers during the first years of application of the Directive, presumably through 
their  better  access  to  first-hand  information  and  their  subsequent  quicker  adaptation  to 
the requirements of the new Directive. 

Stakeholders  in  the  public  consultation  also  highly  rated  the  effectiveness  of  the 
Directive in relation to the free movement of toys in the internal market. The majority of 
consumer organisations all agreed that the Toy Safety Directive definitely has helped to 
ensure  the  free  movement  of  toys  throughout  the  EU  by  harmonising  rules  and 
procedures for placing toys on the market. Half of the business associations agreed that 
the  Toy  Safety  Directive  has  helped  to  ensure  the  free  movement  of  toys  in  the  EU, 
however, differences in interpretation and national deviations are still to be solved. Two 
thirds  of  the  responding  companies/business  organisations  considered  that  the  Toy 
Safety Directive has helped to improve the placing on the market of toys and their free 
movement throughout the EU to a large or moderate extent. 

An effective internal  market  for toys  also  requires a strong level  of  enforcement of the 
Directive by competent authorities (both market surveillance and customs) in all Member 

167  See footnote on the Joint Research Centre supply side analysis (October 2019) above. 

48 

 
 
 
                                                           
 
 
 
 
States.  Where  a  toy  does  not  comply  with  the  requirements  of  the  Directive,  its 
movement in the internal market is to be restricted. 

In this light it is not  relevant in which country of the world a toy for the EU market is 
manufactured. Whereas a large majority of the toys in the EU are said to originate from 
far  east,  all  toys  have  to  comply  with  all  applicable  requirements,  whether  in  the  Toy 
Safety  Directive  or  in  other  pieces  of  legislation,  in  the  same  way  as  any  toy 
manufactured in the EU. 

From the same perspective it is of no relevance whether toy designers or the actual toy 
manufacturers have the largest influence on toy safety.  When placed on the market the 
toy has to  fulfil all requirements for toys, regardless of the efforts that many may have 
invested into it beforehand. 

As a consequence, compliant toys can move freely and be made available throughout the 
EU. There is no need for other provisions on the free movement: the current provisions 
have proven to be effective in ensuring the smooth functioning of the internal market for 
toys  which  is  further  confirmed  by  the  intra-EU  trade  data  and  stakeholder  perception 
presented above, 

5.1.3.  Is the Directive effective with regard to market surveillance?  

Market  surveillance  is  the  exclusive  competence  of  Member  States:  they  determine  the 
resources that they put into market surveillance and how these resources are employed; 
they  set  the  priorities  about  the  types  of  toys  they  inspect;  they  decide  against  which 
requirements  they  test  the  toys,  and  they  decide  about  the  action  they  take  on  non-
compliant toys in accordance with their national laws, including with regard to fines and 
penalties.  

The Toy Safety Directive only obliges Member States generally to organise and perform 
market  surveillance  of  toys  placed  on  the  market168  in  accordance  with  the  relevant 
provisions  in  Regulation  (EC)  No  765/2008.  The  Directive  further  limits  itself  to  ‘the 
usual’ general rules on penalties (‘effective, proportionate and dissuasive’) and sanctions. 
Also,  the  Directive  obliges  market  surveillance  authorities  to  report  measures  only  on 
toys that pose a risk beyond their national  territory. No reporting is  necessary for risks 
limited to the national territory, and none is necessary either on toys that have been found 
compliant. All this considerably limits the Commission’s knowledge about the reality of 
market  surveillance,  and  this  consequently  hinders  the  assessment  of  the  Directive’s 
effectiveness with regard to market surveillance. 

Nevertheless,  under  their  obligation  to  report  on  the  application  of  the  Directive,169 
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 population170) provided for the first time data on marketing restrictions of 

168  Article 40 of the Toy Safety Directive. 

169  Article 48 of the Toy Safety Directive. 

170  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.  

49 

 
                                                           
 
toys that could be consistently evaluated. The data reported by the other Member States 
were too complex to be included in this evaluation. 

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. 

Although these numbers would approximately increase by half if all 28 Member States 
could be included, they only represent a very tiny amount of the toys placed on the EU 
market. With the ‘Sales of traditional games and toys’ projected to between € 18 billion 
and  € 20 billion  per  year  between  2014  and  2016,171  it  can  easily  be  assumed  that  the 
number  of  toys  placed  on  the  EU  market  every  year  may  be  counted  in  billions. 
Compared  to  the  figures  in  the  2014  –  2018  reports  above,  market  surveillance  could 
appear to be ineffective. 

On the other hand, 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. 172 

By  comparison,  four  joint  market  surveillance  actions  on  toys,173  supported  by  the 
Consumer Programme of the European Commission,174 showed non-compliance rates for 

https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32018D2076&qid=1571646130303&from=EN  

171  ECSIP Consortium study …, p. 29. See footnote further above. 

172  Good practice for market surveillance. Guidance document developed by market surveillance experts 
who  are  members  or  Chairpersons  of  various  Administrative  Cooperation  (AdCo)  groups.  P.  7. 
https://ec.europa.eu/docsroom/documents/23041/attachments/1/translations/en/renditions/pdf  

173  Chemical risks in plasticised toys 

http://prosafe.org/images/Documents/JA2015/Reports/PROSAFE_Final_Technical_Report%20_TOY
S-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  

174  Consumer Programme 2014-2020. http://ec.europa.eu/chafea/consumers/programme/index_en.htm  

50 

 
                                                                                                                                                                            
 
 
 
 
 
 
the tested toys between 10% and 96%, with an average of 43%. This is somewhat higher 
than  the  33%  reported  by  Member  States  for  2014  –  2018,  but  can  be  considered 
comparably  good  since  the  chance  of  identifying  non-compliant  toys  at  first  sight  can 
vary considerably. A higher effectiveness in this regard would rather suggest that market 
surveillance  would  just  focus  on  toys  that  are  apparently  non-compliant,  without 
protecting from the risks that can only be identified following testing, such as those from 
intrinsic material defects or from chemicals. 

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  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 present evaluation.  

Overall and on a large scale, however, and in particular in light of the assumed billions of 
toys  on  the  EU  market,  the  effectiveness  of  market  surveillance  can  be  considered  as 
limited.175  This  was  confirmed  in  the  2018  public  consultation:  both  public  authorities 
and  consumer  organisations  deplored  that  market  surveillance  is  understaffed;  they 
suggested  more  staff  for  authorities,  including  customs.  Already  in  the  2015  external 
study,  a  lack  of  adequate  financial  resources  and  competences  available  to  market 
surveillance was highlighted. 

Many of the 2014 – 2018 national reports on the application of the Toy Safety Directive 
highlighted that the EC Declaration of conformity is difficult to obtain and equally often 
incorrect or of questionable quality and/or only drafted when requested by authorities. A 
similar  situation  was  reported  regarding  the  safety  assessment  and  the  technical 
documentation,  which  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. With all this, 
the  replies  provided  in  the  reports  confirmed  the  unfortunate  situation  reported  in  the 
replies of market surveillance authorities’ in the 2018 public consultation. 

In  that  consultation,  companies  and  business  associations  claimed  that  market 
surveillance authorities work differently in different Member States. Similarly, consumer 
organisations  thought  that  authorities  do  not  work  sufficiently  together.  However  both 
are difficult to verify since no details were given. 

175  See  Communication  from  the  Commission  of  28  October  2015  ‘Upgrading  the  single  market:  more 

opportunities for people and business’.COM(2015)550 final, page 19.  
https://ec.europa.eu/transparency/regdoc/rep/1/2015/EN/1-2015-550-EN-F1-1.PDF  

51 

 
                                                           
 
In  any  case,  to  counteract  the  above  the  Commission  has,  under  the  Consumer 
Programme,176 made funding available for Member State authorities to jointly carry out 
market  surveillance  projects,177  including  on  toys.178  These  projects  foster  the 
cooperation  between  Member  States’  market  surveillance  authorities  who  generally 
appreciate the collaboration with colleagues from other Member States.179 

In  addition,  Regulation  (EU)  2019/1020  on  market  surveillance  and  compliance  of 
products  provides  for  binding  and  detailed  EU  wide  rules  on  how  to  carry  out  market 
surveillance  and  make  it  function  effectively,  including  through  cooperation  of  market 
surveillance  authorities.  The Regulation  covers a wide range of products  subject  to  EU 
harmonisation  legislation,  including  toys,  and  it  also  provides  rules  for  the  effective 
surveillance  of  online  sales.  Once  applied  as  of  16  July  2021,  it  can  be  expected  to 
harmonise and improve the effectiveness of market surveillance further. 

Interestingly,  companies  and  business  associations  in  the  2018  public  consultation 
claimed  that  market  surveillance  would  not  always  target  the  ‘bad  guys’,  namely  those 
economic operators that may not be complying with the rule of law. Already in the 2015 
external study, it was noted that ‘several Market Surveillance Authorities seem to focus 
their  checks  on  large,  reputable  companies  who  are  more  keen  to  provide  technical 
documentation and pay due fines … .’ 

This appears to be contrary to market surveillance authorities efforts to use their limited 
resources  most  effectively.  Guidance  developed  at  EU  level  and  building  on  best 
practices  suggests  that  ‘When  targeting  Economic  Operators  in  a  given  sector,  priority 
should  be  given  to  those  that  are  most  likely  to  break  the  rules,  that  do  not  follow  the 
rules, or that have a history of non-compliance rather than targeting Economic Operators 
based on random selection … .’ 180 

In conclusion, the effectiveness of surveillance under the Toy Safety Directive appears to 
be  less  than  optimal.  The  Commission  has  engaged  in  improving  the  effectiveness  of 
market  surveillance  throughout  the  years  (also  with  regard  to  other  product  legislation) 
and  continues  to  do  so.  On  the  legislative  side,  the  recent  Regulation  on  Market 
Surveillance and Compliance of Products can be expected to improve the effectiveness of 
surveillance and harmonise surveillance further through its binding and detailed EU wide 
rules on how to carry out market surveillance. 

176  Consumer Programme 2014-2020. See footnote above. 

177  PROSAFE (Product Safety Forum of Europe): 

http://www.prosafe.org/index.php?option=com_content&view=article&idcontent&view=article&id=3
3&Itemid=128 http://prosafe.org/  

178  http://prosafe.org/index.php/toys-gpsd-actions-by-product  

179  In the 2018 public consultation, 29 of 31 responding public authorities answered that ‘Meeting market 

surveillance colleagues from other Member States is useful for my own work.’ 

180  Good practice for market surveillance … , p. 49. See the footnote above. 

52 

 
 
 
                                                           
 
5.1.4.  Does the legal form – Directive or Regulation – impact the effectiveness? 

In order to be fully effective, the Toy Safety Directive as well as all its amendments have 
to  be transposed into national legislation by the required deadline(s). Only  then  can  all 
provisions be concurrently enforced in all Member States. Delays in the transposition in 
one  or  several  Member  States  would  in  particular  be  detrimental  to  the  protection  of  
children in those States. 

Delays in the transposition could also affect the free movement of certain toys, namely 
those using permitted substances. For example, the CMR substance nickel was permitted 
for use ‘[i]n toy components which are intended to conduct an electric current’,181 such as 
toy railway rails. Such toy components could not be placed on a national market if that 
permitted use was missing in the national legislation. 

Thus, the Member States’ obligation to transpose the Directive and its amendments have 
to be closely monitored and, where necessary, enforced by the Commission services.182 
This requires resources in staff and time, which are both scarce however. Investing those 
resources  in  the  management  of  the  Directive,  such  as  the  organisation  of  joint  market 
surveillance  projects,  the  exchange  of  best  practices  or  the  development  of  guidance 
documents,  could  in  practice  be  more  beneficial  for  children’s  safety  and  for  the  free 
movement of toys. 

As concerns the legal form of the toy safety rules  (directive or regulation), it has to be 
considered that the Toy Safety Directive is a maximum harmonisation directive: Member 
States  are  not  allowed  to  adopt  any  different  requirements  than  those  provided  in  the 
Directive. There is therefore no room for any national specificity. 

This  is  not  different  from  a  Regulation  on  toy  safety  that  is  directly  applicable  in  the 
Member States and does not need any transposition nor any related checks. 

As  reported  in  the  2015  external  study,  national  transpositions  of  amendments  to  the 
Directive often turn out to be excessively burdensome and time-consuming (finding 31). 
According  to  a  few  Member  States  and  stakeholders,  this  would  not  occur  with  a 
regulation,  as  amendments  would  then  be  directly  applicable  at  national  level.183  The 
preference  for  a  regulation  is  motivated  by  the  desire  to  avoid  delays  by  national 
transpositions  and  to  ensure  consistency  in  all  Member  States,  thus  preventing 
differences in the application of provisions on the safety of toys (finding 16, finding 17). 

Some other stakeholders and Member States believed that a directive grants much more 
flexibility  without  regulating  into  detail,  leaving  technical  specifications  to  harmonised 
standards, and the transposition of amendments  into  national  laws constitutes a benefit, 
since it provides all interested parties with enough time to become aware of - and monitor 
- the legislative process. 

181  See the related amendment in annex 4. 

182  See section on Implementation and State of Play further above. 

183  Whereas  directives  require  EU  countries  to  achieve  a  certain  result  and  set  out  general  rules  to  be 
transferred into national law by each country as they deem appropriate,  regulations are legal acts that 
apply automatically and uniformly to all EU countries as soon as they enter into force, without needing 
to be transposed into national law, see http://ec.europa.eu/legislation/index_en.htm   

53 

 
                                                           
In  the  2018  public  consultation,  a  majority  of  public  authorities,  Notified  Bodies  and 
consumer  organisations  were  in  favour  of  converting  the  Toy  Safety  Directive  into  a 
Regulation. They commented that a regulation would be more effective and be applicable 
at  the  same  time  in  all  Member  States;  it  would  also  create  clearer  conditions  for  all 
Member States and avoid a cumbersome transposition into national law. 

Companies and business associations were less in favour of a regulation; they considered 
that  the  Directive  was  actually  working  effectively  and  sufficiently  well,  and  that  an 
improvement of the current rules would be more efficient. 

Although the 2015 external study had not raised any major need to change the legal form 
of  the  Toy  Safety  Directive,  clear  majority  views  in  favour  of  a  Regulation  were 
expressed  in the 2018 public consultation by public authorities, consumer organisations 
and business associations. 

To note that the Toy Safety Directive and its amendments (in the form of directives) have 
always been applicable  at  the same date in  all  Member States and have always created 
the same effective conditions for all Member States. The difference with a possible Toy 
Safety  Regulation  would  be  the  Regulation’s  direct  applicability  in  all  the  Member 
States, thus avoiding the transposition into national law. 

All the above suggests that it may be appropriate, in particular considering the delays in 
the  transposition  of  the  Directive  that  have  led  to  the  opening  of  infringement 
proceedings  (see  section  3),  that  the  effectiveness  of  the  Toy  Safety  Directive  could 
benefit  from  a  conversion  into  a  Regulation,  by  freeing  up  resources  that  are  currently 
bound  by  the  transposition  in  the  Member  States  and  by  the  ensuing  checks  of  the 
Commission services required in dealing with infringements. Such a choice of the legal 
form would be even more justified by the considerations above that, given the maximum 
harmonisation  underpinning  the  Toy  Safety  Directive,  any  national  specificities  would 
not need to be taken into account. 

5.1.5.  Has  the  law-making  process  affected  the  effectiveness  of  the  Toy  Safety 

Directive? 

The  European  Parliament  inserted  several  provisions  in  the  Commission’s  proposal  for 
the 2009 Toy Safety Directive. These provisions were the only changes to the proposal in 
the law-making process. 

The  provisions  inserted  by  the  European  Parliament  can  be  considered  to  increase  the 
effectiveness  of  the  proposal.  To  quite  an  extent  these  are  linked  to  the  protection  of 
children from chemical risks: 

  The  key  safety  requirement,  namely  that  toys  shall  not  jeopardize  the  health  and 
safety of users, was completed with a specific reference to  chemicals. The adopted 
Directive  provides  that  ‘Toys,  including  the  chemicals  they  contain,  shall  not 
jeopardize … .’184 The European Parliament thus attached a particular importance to 
the protection from chemicals; 

184  Article 10(2), first paragraph of the Toy Safety Directive. 

54 

 
                                                           
  The possibility to add specific limit values for any chemical in toys involving a high 
degree of exposure, namely those for children under 3 years of age and those that are 
placed in  the mouth (such as  a toy flute), has equally been added by the European 
Parliament.185 Indeed, up to the time of writing this provision has been used in eight 
cases to add specific limit values to the Directive;186  

  Also the limit values for nitrosamines and nitrosatable substances187 have been added 

by the European Parliament during the law-making process; 

  From  the  allergenic  fragrances  proposed  to  be  labelled  on  toys,  the  European 
Parliament  shifted 15 to the list  of allergenic fragrances prohibited in  toys, namely 
fragrances  number  41  –  55  of  the  adopted  Directive.  Also  the  ‘tolerance  level’  of 
100 mg/kg  for  prohibited  allergenic  fragrances  was  inserted  by  the  European 
Parliament, this adds more clarity to the practical implementation of the prohibition. 
– The detailed labelling rules for allergenic fragrances in toys, including in olfactory 
board  games,  cosmetic  kits  and  gustative  games,  equally  inserted  by  the  European 
Parliament, also clarify the implementation of the rules on prohibited fragrances and 
on the fragrances to be labelled. 

The  European  Parliament  also  added  provisions  on  warnings  that  are  to  be  placed  on 
toys.  They  can  equally  be  considered  to  increase  the  effectiveness  since  they  draw 
attention to dangers that may not always be evident: 

  specific warnings for imitations of protective masks and helmets (since these do not 
provide  protection),188  toys  intended  to  be  strung  across  a  cradle  (since  the  related 
cord  could  lead  to  entanglement),189  and  the  packaging  for  fragrances  in  olfactory 
board  games,  cosmetic  kits  and  gustative  games  (since  the  fragrances  may  cause 
allergies);190 

  a  provision  that  aims  to  prevent  the  misuse  of  warnings.191  A  commonly  known 
misuse concerns the warning that a toy is not to be used by children under 3 years of 
age,192 because small parts may come off the toy and could be swallowed by a child 
under 3 years and lead to choking. This warning has been repeatedly found on soft-
filled toys such as plush animals. Since plush animals, or plush toys in general, are 
without  doubt  intended  for  children  under  3 years,  the  warning  is  not  appropriate. 
The truth may be that the manufacturer wants to circumvent his obligation that, for 
example, the tip of the nose of a plush dog does not detach, and thus be exempted 
from his liability for using detachable small-parts in toys intended for children under 
3 years. 

185  Recital 24 and Article 46(2) of the Toy Safety Directive. 

186 

 See Annex 4. 

187  Annex II, Part III, point 8 of the Toy Safety Directive. 

188  Annex V, Part B, No 8 of the Toy Safety Directive. 

189  Annex V, Part B, No 9 of the Toy Safety Directive. 

190  Annex V, Part B, No 10 of the Toy Safety Directive. 

191  Article 11(1), 3rd paragraph of the Toy Safety Directive. 

192  Annex V, Part B, No 1 of the Toy Safety Directive. 

55 

 
                                                           
The  European  Parliament  further  required  manufacturers  to  ensure  that  the  instructions 
and  safety  information  for  toys  are  written  in  a  language  (or  languages)  ‘easily 
understood  by  consumers,  as  determined  by  the  Member  State  concerned.’193  These 
language obligation certainly contribute to  make the Toy Safety Directive more effective 
in the various Member States. 

In  conclusion,  a  number  of  provisions  have  been  added  in  the  Toy  Safety  Directive 
during the law-making process on initiative of the European Parliament, thus increasing 
the effectiveness of the Directive. 

5.2.  Efficiency of the Toy Safety Directive 

The  2009  Toy  Safety  Directive  assigns  clear  roles  and  responsibilities  to  toy 
manufacturers,  their  authorised  representatives,  importers  and  distributors.  These 
responsibilities  not  only 
toy 
manufactured,  imported  or  distributed,  but  also  obligations  to  prevent  potentially  non-
compliant  toys  from  accessing  the  market  and  obligations  to  follow-up  on  non-
conformity. 

include  documentary  obligations 

regarding 

the 

This section will shed some light on the costs, but also on the benefits of manufacturing 
toys and placing them on the market under the 2009 Toy Safety Directive. 

5.2.1.  Costs related to the Toy Safety Directive 

5.2.1.1.  One-off costs for adapting to the Toy Safety Directive 

With the adoption of the 2009 Toy Safety Directive with its increased number of detailed 
safety  requirements  for  toys,  in  particular  on  chemicals,  companies  had  to  invest  in 
technical and human resources to adapt to the new requirements. These additional costs 
had already been reported in the 2015 external study. 

In  the  2018  public  consultation,  29  (out  of  32)  company  respondents  agreed  to  this,  or 
even  agreed  entirely.  Based  on  the  replies  to  a  targeted  survey  of  economic  operators, 
this  one-off  adaptation  cost  was  on  average  about  2%  of  the  annual  turnover  (1.7%  in 
case of large companies, and 2.4% in case of SMEs).194 The median cost was around 1% 
for all and for large companies, and 3% for SMEs. 

The 2008 IA accompanying the Toy Safety Directive did not indicate clearly any one-off 
adaptation  costs  and  only  concentrated  on  production  costs.  The  only  references  in  the 
2008 IA to costs that could be considered as one-off costs are costs related to the need of 
altering 90% of moulds in the range of € 500 to € 1,000 per mould and changing the text 
on the packaging of € 0.05 per product.195 

In  monetary  terms  the  median  value  of  this  one-off  cost  amounted  to  an  average  of 
€ 17 million per large firm in the survey, and € 110,000 per SME. Relating to the number 

193  Article 4(7) of the Toy Safety Directive. 

194  Averages, based on 12 responses, exclude two extreme values of 30,000% and 30%. 

195  See 2008 IA, p. 80. 

56 

 
                                                           
of  toy  types  produced  this  meant  an  average  of  € 150,000  per  toy  type  produced  by  a 
large firm and € 12,000 per toy type produced by a SME196 (Table 5.1). This one-off cost 
was on average recovered over 2 years and 10 months (3 years in case of SMEs).197 

Table 5.1. One-off cost of adapting to the requirements of the 2009 Toy Safety Directive 

% of turnover (average*) 
% of turnover (median) 
Euro per company 
Euro per company per toy type 

All manufacturers 
2% 
1% 

Large companies 
1.7% 
1% 
€ 17 million 
€ 150,000 

SMEs 
2.4% 
3% 
€ 110,000 
€ 12,000 

Note: Average values based on 12 replies for all, 3 for large companies and 9 for SMEs 
* excludes two extreme values of 30,000% and 30% 
Source: Own analysis based on targeted survey 

Using Eurostat data on turnover and number of companies, the one-off cost for the whole 
toy  manufacturing  industry  amounted  to  between  € 140 million  and  € 200 million  (see 
annex 3). 

Technical  resources  such  as  software  to  measure  chemical  substances  or  an  IT  system 
were the most costly investments that companies had to make to comply with Toy Safety 
Directive,  followed  by  updates  of  internal  procedures  and  guides  and  training  of  staff. 
Among other investments, companies mentioned training of foreign suppliers and review 
of  raw  materials  and  product  portfolio  (Table  5.2).  Large  companies  considered  these 
investments as more costly than SMEs. 

Table 5.2. Response to the question: Prior to / With the full applicability of the Toy Safety Directive 
in July 2013, my company had to invest in the following areas: 5 = very costly, 1 = not costly 
Investment 
Technical resources (such as software to measure chemical substances, or 
an IT system). 
Update of internal procedures and guides. 
Training for staff. 
*Weighted average, number of replies per investment  between 20 and 24 
Source: Own analysis based on targeted survey 

Average reply* 
3.9 

3.7 
3.6 

More  than  half  of  manufacturers  reported  having  to  hire  new  staff  to  comply  with  the 
requirements  of  Toy  Safety  Directive.  Almost  all  large  companies  did  so,  while  the 
majority of SMEs did not (Table 5.3). 

Table 5.3. Response to the question: Did you hire  new staff to comply with the requirements of the 
Toy Safety Directive? 

Yes 
No 
No. of replies 
Source: Own analysis based on targeted survey 

All manufacturers 
58% 
42% 
26 

Large 
90% 
10% 
10 

SMEs 
38% 
63% 
16 

196  Calculated average value based on responses to the question on percentage of turnover (excludes two 
extreme  values  of  30,000%  and  30%)  and  reported  turnover  in  2017,  based  on  9  responses  (3  from 
large firms and 6 from SMEs). 

197  Respondents were asked to choose one of the following time ranges: 1 year, 2  – 3 years, 4 – 5 years, 
more than 5 years. In order to calculate the average time the middle of range was used, there were two 
responses in the last open range to which value of 5,5 years was arbitrarily assigned. 

57 

 
 
 
 
 
                                                           
Respondents  mentioned  engineers,  chemists,  technicians,  administrative  personnel  and 
lawyers as the hired personnel. 

Around two thirds of the respondents used outsourcing to comply with the requirements 
of  the  Toy  Safety  Directive.  It  was  more  often  used  by  large  companies  than  SMEs 
(Table  5.4).  Activities  such  as  testing  and  risk/safety  assessment  were  most  often 
outsourced. 

Table  5.4.  Response  to  the  question:  Did  you  have  to  outsource  any  activities  due  to  the  new 
requirements of the Toy Safety Directive? 

Yes 
No 
No. of replies 
Source: Own analysis based on targeted survey 

All manufacturers 
65% 
35% 
26 

Large 
80% 
20% 
10 

SMEs 
56% 
44% 
16 

5.2.1.2.  Recurring costs for manufacturers 

The  Toy  Safety  Directive  with  its  increased  number  of  detailed  safety  requirements,  in 
particular  on  chemicals,  is  causing  higher  costs  than  the  predecessor  Directive. 
Companies’ replies in the 2015 external study had reported major costs related to the Toy 
Safety Directive’s chemical requirements.198 

More  specifically,  in  the  2019  survey  targeted  to  economic  operators,  almost  all 
manufacturers  (91%)  stated  that  their  production  costs  had  increased  since  July  2013, 
while the remaining (9%) said the costs had not changed.199 

New requirements of the Toy Safety Directive were quoted as the most significant reason 
for  production  cost  increases.  These  were  followed  by  an  increase  in  the  cost  of 
materials, fixed costs, salaries, energy and transport cost. Two respondents stated that the 
cost of testing has increased substantially (Table 5.5). 

Table 5.5. Reasons for production costs increases since 2011. 
 5 = most significant, 1 = least significant 
Reason for cost increase 
New requirements of the Toy Safety Directive (in addition to the former 
Toy Safety Directive). 
Increase in cost of materials. 
Fixed cost increase. 
Wages / salary increase. 
Energy cost increase. 
Transport cost increase. 
*Weighted average. The number of replies per reason was between 10 and 12 
Source: Own analysis based on targeted survey to economic operators 

Average reply* 
4.4 

3.6 
3.0 
2.9 
2.6 
2.3 

198  See the 2015 external study. Table 7, p. 79; section 6.3.1.2, p. 86. 

199  21 answers and 2 answers, respectively. 

58 

 
 
                                                           
The reported average cost increase due to Toy Safety Directive was around 6.8% for all 
manufacturers,  and  7.4%  for  those  who  reported  cost  increases.  Large  companies 
(7 replies) reported a cost increase of 5.8%, SMEs (16 replies) one of 7.4%. 

The  JRC  study200  confirmed  the  increase  of  materials  costs  for  manufacturers  in  the 
period 2009 to 2013 and after 2013.  In both time intervals results show an increase in 
cost  of  materials  of  13%  and  14%  due  to  Toy  Safety  Directive  in  small  and  medium 
firms, however leaving large and micro firm unaffected.  An absence of effects on large 
firms, as identified by the study, could be explained by market power considerations and 
by  the  ability  to  accommodate  cost  increases.  The  cost  effect  of  the  Directive  is 
statistically significant from 2011 onwards. This could reflect an anticipation of the effect 
of  the  considerably  increased  chemical  requirements  of  the  Toy  Safety  Directive  that 
were to be applied as of July 2013. 

These estimates are broadly consistent with the 2008 IA which estimated the increase of 
costs due to chemical provisions for multinationals of 4.8% and 7.6% for SMEs and the 
cost  of  other  provisions  for  multinationals  in  the  range  of  0.56%    11.4%  and  2.3%   
12.5% for SMEs.201 

5.2.1.3.Costs related to different provisions of the Toy Safety Directive 

When developing toys, manufacturers have to generate a safety assessment for each toy. 
This requires to consider all the hazards that a toy presents and that could lead to a risk 
when  a  child  is  exposed  to  a  hazard  during  play.  Taking  account  of  all  safety 
requirements  causes  significant  costs:  24  (out  of  32)  respondents  indicated  this  in  the 
2018  public  consultation,  and  also  the  safety  assessment  thus  causes  significant  costs 
(18 out of 32 respondents). − On the other hand the safety assessment is also beneficial 
since it allows to limit toy testing to the necessary minimum when demonstrating that the 
toy is safe (see the benefits section further below). 

Manufacturers had to  spend on average around 485 man-hours to  comply with  all the 
requirements of the Toy Safety Directive when developing a toy. It took more time for 
SMEs – around 520 man-hours – than for large firms with 440 man-hours. This included 
both  internal  staff  time  and  time  of  external  contractors  (Table  5.6).  For  instance,  one 
very large international company reported employing 30 full time persons in its product 
safety and compliance department. 

Table 5.6. Cost of developing a toy in percentage of man-hours per toy type 

Activity 

Safety aspects 
Identifying all applicable safety requirements. 
Generating the safety assessment. 
Applying a chemical amendment of the Toy Safety Directive or a 
new specification in a standard. 
Identifying the necessary tests. 
Getting supply chain information. 

Total Safety aspects: 

% of man-hours 

All  

Large 

SMEs 

8 
6 

7 
5 
6 
33 

8 
6 

9 
4 
8 
34 

8 
7 

7 
5 
5 
32 

200  JRC study ... (October 2019). See footnote further above. 

201  See 2008 IA, p. 64 and p. 66. 

59 

 
 
 
 
                                                           
Testing and documentation 
Testing the quality and compliance of the raw materials for the toy. 
Testing the toy. 
Generating the conformity assessment. 
Obtaining an EC-type examination certificate. 
Generating the EC declaration of conformity. 
Generating the technical documentation. 

Total Testing and documentation: 

Labelling 
Identifying how to apply the CE mark on the toy and affixing it 
(Article 17 of the Toy Safety Directive). 
Identifying the applicable warnings and marking the warnings. 
Identifying the traceability elements and marking the toy. 

Total Labelling: 

Packaging 
Designing the packaging. 
Selecting the packaging material. 
Testing that the packaging is fit for purpose. 

Other 
Other man-hours (e.g. filing documents) 

Total Packaging: 

Total Other: 

7 
9 
6 
5 
5 
12 
43 

2 
3 
2 
7 

6 
3 
3 
12 

8 
10 
4 
7 
4 
15 
48 

1 
2 
1 
5 

4 
3 
3 
10 

7 
8 
7 
4 
5 
10 
40 

3 
3 
2 
9 

6 
4 
4 
13 

4 
4 
100 
485 

3 
3 
100 
438 

6 
6 
100 
516 

Total all activities 
Total man-hours for all activities for developing a toy type 
Note: average number of man-hours (both internal staff and external consultants) per year devoted to each activity 
per toy type. Distribution per activity based on weighted average of ranges selected by respondents (available ranges 
0-4  man  hours,  5-10,  11-20,  21-35,  >35).  Middle  of  range  used.  Open  range  value  selected  to  keep  the  sum  of 
activity  equal  to  average  reported  man-hour  for  a  given  activity  group  (extreme  values  were  eliminated  from  the 
average).  
Source: Own analysis based on targeted survey 

Also the technical documentation causes significant costs to companies, as confirmed by 
24  (out  of  32)  respondents  in  the  2018  public  consultation.  It  includes  the  safety 
assessment, conformity assessment documents and supply chain information, and has to 
be  kept  up-to-date.  If  not  all  of  a  toy’s  risks  are  covered  by  harmonised  standards  the 
references of which have been published in the Official Journal, an EC-type examination 
by a Notified Body is necessary to carry out the conformity assessment of the toy. Also 
EC-type  examination  was  considered  to  be  costly  by  24  (out  of  32)  respondents  in  the 
2018 public consultation. 

There are 10 toy safety standards in the EN 71 series that provide detailed specifications 
on the safety requirements that toys have to fulfil and which are referenced in the Official 
Journal.  Adding  up  to  this  is  standard  EN  62115  on  electrical  toy  safety,  equally 
referenced.  All  standards,  which  to  a  large  extent  describe  the  technical  details  of  test 
methods,  have  been  repeatedly  amended  to  adapt  them  to  technical  and  scientific 
developments  and  to  take  account  of  the  hazards  of  novel  toys  placed  on  the  market. 
Standards are available for purchase from the national standardisation organisations.202  

In  the  2018  public  consultation,  respondents  considered  standards  to  cause  significant 
costs. This was noted by companies (20 out of 32 respondents), public authorities (20 out 
of  31  respondents),  but  also  consumer  organisations  in  light  of  their  testing  activities 

202  http://standards.cen.eu/dyn/www/f?p=CENWEB:5  

60 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
(4 out  of  6 respondents).  Also  the  2015  external  study  on  the  Toy  Safety  Directive 
reported that standards were claimed to be expensive.203  

On  the  other  hand,  comparing  the  prices  of  standards  with  other  costs  may  lead  to  a 
different  conclusion.  A  set  of  all  non-electrical  toy  safety  standards,  the  references  of 
which have been published in the Official Journal,204 is available for less than € 180 from 
a  ‘low-price  standards  organisation’  in  a  certain  EU  Member  State,  and  for  around 
€ 1,300 from ‘high-price standards organisations’ in other EU Member States. The cost 
for the electrical toy safety standard EN 62115 is difficult to estimate due to the complex 
system of updates actually valid, but can be estimated to be no more than € 300 from a 
‘high-cost standards organisation’. 

In  addition,  the  permanent  updates  of  standards  may  require  to  purchase  those  updated 
standards.  Assuming  that  the  three  most  expensive  standards  would  be  updated  once 
every year this could lead to yearly costs of € 70 (‘low-price standards organisation’) to 
€ 600 (‘high-price standards organisations’). 

In  comparison,  staff-costs  (in  man-hours)  for  developing  a  new  toy  amount  to 
approximately  € 11,000  (Table  5.7  further  below).  This  is  remarkably  higher  than  the 
above  cost  estimates  for  standards,  even  more  so  as  a  new  toy  may  only  require  the 
application  of  a  few  standards,  because  the  majority  of  standards  are  targeting  specific 
toys. Also, knowing that the toy industry is innovative, with around one third of the toys 
on the market each year being newly developed,205 the estimated yearly costs for updated 
standards  appears  in  a  different  light,  in  particular  if  a  company  develops  several  new 
toys every year. 

On  the  other  hand,  missing  standards,  respectively  standardised  test  methods,  equally 
cause  significant  costs.  Without  standardised  test  methods,  EC-type  examination  is 
necessary  if  a  certain  hazard  in  a  toy  cannot  be  tested  with  a  method  included  in  a 
harmonised standard referenced in the Official Journal. Companies replying to the 2018 
public  consultation  confirmed 
(16 out  of 
32 respondents), and the results of the 2019 survey of economic operators confirmed that 
view. More specifically all respondents to the survey agreed that a lack of standards or 
standards  that  are  not  referenced  on  time  is  causing  additional  cost  because  EC-type 
examination becomes necessary. 

these  costs  of  missing  standards 

Testing  of  toys,  as  of  any  other  product,  entails  considerable  laboratory  costs.  This 
includes  the  operation  and  maintenance  of  the  laboratory  and  its  equipment  as  well  as 
costs  for  hiring  the  appropriate  staff.  Tests  need  normally  sophisticated,  specialised 
equipment  and  machines  and,  in  the  case  of  chemical  tests,  a  permanent  input  of 
chemicals, some of which can be very expensive. 

An EC-type examination by a Notified Body is more expensive than testing by a ‘simple’ 
test laboratory, because at least the costs for the review of the Technical documentation 
have  to  be  added.  Those  are  typically  in  the  order  of  €  500.-  .  If  test  methods  or  test 

203  2015 external study, Table 7, p. 79; p. 95. See footnote further above. 

204  EN 71-1, EN 71-2, EN 71-3, EN 71-4, EN 71-5, EN 71-7, EN 71-8, EN 71-12, EN 71-13, EN 71-14. 

205  The European Toy Industry (TIE), Facts and Figures. See footnote further above. 

61 

 
                                                           
protocols have to be developed, such as for innovative features in toys, costs will further 
increase. There is however no general estimation of such costs. 206 

The higher testing costs  are however not the most  important  issue. Toys  requiring EC-
type examination are often innovations and a manufacturer may already have invested a 
lot  into  its  development.  The  biggest  problem  is  the  time  to  the  market.  The  market  is 
used  to  getting  quick  results,  but  EC-type  examination  is  often  considered  too  long  a 
process  for  manufacturers.  The  main  issue  is  to  collect  and  complete  the  Technical 
documentation, which can cause delays.207 On the other hand, collecting the documents 
necessary for the Technical documentation is also required when a manufacturer is self-
certifying his toys. 

The  responses  to  the  2018  public  consultation  noted  that  testing  costs  under  the  Toy 
Safety  Directive  have  considerably  increased  compared  to  the  predecessor  Directive 
(7 out of 7 responses from Notified Bodies). This is certainly due to the increased safety 
requirements, in particular on chemicals, under the Toy Safety Directive. 

The  Toy  Safety  Directive  requires  a  range  of  documents  accompanying  a  toy  to  be 
translated in a language that is well understood in the Member State(s) in which the toy is 
placed on the market. This includes instructions and safety information on the toy,208, 209 
information  and  documentation  on  the  conformity  of  the  toy,210,  211  warnings  and  the 
safety  instructions,212  the  EC  declaration  of  conformity,213  the  technical  documentation 
and correspondence relating to the EC-type examination,214 and finally relevant parts of 
the technical documentation.215 

Nevertheless,  translation  costs  were  not  signalled  as  a  major  cost  in  the  2018  public 
consultation.  Only  the  costs  for  affixing  warnings  in  different  languages  were 
commented  as  costly  by  companies  who  indicated  that  warnings  should  therefore  be 
replaced by pictograms. 

An attempt was made to quantify the costs related to different requirements of the Toy 
Safety Directive. According to the results of the 2019 targeted consultation of economic 
operators  (37 respondents  in  total,  but  only  32  replies  could  be  taken  into  account), 

206  Information from the NB-Toys group. 

207  Information from the NB-Toys group. 

208  Article 4(7) of the Toy Safety Directive. 

209  Article 6(4) of the Toy Safety Directive. 

210  Article 4(9) of the Toy Safety Directive. 

211  Article 6(9) of the Toy Safety Directive. 

212  Article 11(3) of the Toy Safety Directive. 

213  Article 15(2) of the Toy Safety Directive. 

214  Article 20(5) of the Toy Safety Directive. 

215  Article 21(3) of the Toy Safety Directive. 

62 

 
                                                           
testing  and  documentation  activities  require  on  average  around  43%  of  the  total  man-
hours.  These  activities  include:  testing  the  quality  and  compliance  of  the  raw  materials 
for the toy; testing the toy; generating the conformity assessment, obtaining an EC-type 
examination certificate, generating the EC declaration of conformity and generating the 
technical documentation. 

Around  one  third  of  the  time  is  devoted  to  safety  aspects  such  as  identifying  all 
applicable  safety  requirements,  generating  the  safety  assessment,  applying  chemical 
amendments of the Toy Safety Directive or new specifications in standards, identifying 
the necessary tests and obtaining supply chain information. 

Activities connected to packaging take around 12% of the time (designing the packaging, 
selecting  the  packaging  material  and  testing  whether  the  packaging  is  fit  for  purpose). 
Labelling takes 7% of the time. This includes identifying how to apply the CE mark on 
the  toy  and  how  to  affix  it  (Article  17  of  the  Toy  Safety  Directive);  identifying  the 
applicable  warnings  and  the  marking  of  the  warnings;  and  identifying  the  traceability 
elements and marking them on the toy. Other activities include the filing of documents. 

% of man-hours  Cost in Euro 

Table 5.7. Cost of developing a toy in percentage of man-hours per toy type 
Activity 
Safety aspects 
Identifying all applicable safety requirements. 
Generating the safety assessment 
Applying a chemical amendment of the Toy Safety Directive or a 
new specification in a standard. 
Identifying the necessary tests. 
Getting supply chain information. 
Total Safety aspects:  

7 
5 
6 
33 

8 
6 

Testing and documentation 
Testing the quality and compliance of the raw materials for the 
toy. 
Testing the toy. 
Generating the conformity assessment. 
Obtaining an EC-type examination certificate. 
Generating the EC declaration of conformity. 
Generating the technical documentation. 
Total Testing and documentation : 

Labelling 
Identifying how to apply the CE mark on the toy and affixing it 
(Article 17 of the Toy Safety Directive). 
Identifying the applicable warnings and marking the warnings. 
Identifying the traceability elements and marking the toy. 
Total Labelling:  

Packaging 
Designing the packaging. 
Selecting the packaging material. 
Testing that the packaging is fit for purpose. 
Total Packaging:  

Other 
Other man-hours 
Total Other: 

63 

7 
9 
6 
5 
5 
12 
43 

2 
3 
2 
7 

6 
3 
3 
12 

4 
4 

900 
700 

800 
500 
700 
3,600 

800 
900 
700 
500 
500 
1,300 
4,700 

200 
300 
200 
700 

600 
400 
400 
1,400 

500 
500 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total all activities 
Total man-hours for all activities for developing a toy type 
The average number of man-hours per activity per imported/distributed toy type is assumed to be the 
same for all EU countries, multiplied by an adjusted average hourly wage  (adjusted by price change to 
2017 levels, non-labour costs and 25% overhead) of Technicians and associate professionals ISCO 3; 
for Croatia wage data of Slovenia is used. 

100 
485 

10,900 

Source: Own analysis based on targeted survey 

The  2008  IA  provided  some  illustrative  estimations  of  cost  impacts  for  different 
economic operators  and  identified a number of factors that  can determine the  extent of 
the costs faced, including: 

  product  type:  a  large  disparity  was  found  in  the  costs  of  CE  marking  between 
companies  producing  plush  or  wooden  toys  and  toys  that  are  manufactured  from 
plastic or metal; 

  volume  produced:  the  higher  the  turnover  and  the  higher  the  volume  a  company 
produces,  the  lower  the  cost  impacts  will  be,  due  to  economies  of  scale  in 
production; and 

  number  of  product  lines:  the  larger  the  number  of  different  products  produced,  the 
higher the costs, as risk and conformity assessment procedures have to be carried out 
for each product separately. 

The  2019  targeted  consultation  of  economic  operators  confirmed  some  of  these 
assumptions. Manufacturers confirmed that costs increase with stricter requirements and 
with the number of different toys they produced. To a lesser extent producers agreed that 
compliance  cost  diminishes  with  higher  production  volume  or  turnover.  There  was 
general  agreement  that  SMEs  have  difficulties  dealing  with  costs  imposed  by  the  Toy 
Safety Directive. (Table 5.8) 

Table 5.8. Costs caused by the Toy Safety Directive in general 

All answers 
% agree*  % disagree* 

100 

SMEs have difficulties dealing with the costs induced by the Toy Safety 
Directive. 
The constant changes to the Toy Safety Directive cause continuous costs 
to a company. 
The stricter the requirements, the larger the costs. 
The larger the number of a company’s product lines, the larger the costs. 
The larger a company’s production volume, the smaller the costs. 
The larger a company’s turnover, the smaller the costs. 
*Agree combines ‘agree entirely’ and ‘agree’ answers, Disagree combines ‘disagree entirely’ and 
‘disagree’ answers, ‘Neither agree nor disagree’ and ‘no opinion’ answers ignored; number of replies 
per reason was between 18 and 24. 

5 
10 
25 
43 

95 
90 
75 
57 

96 

4 

0 

Source: Own analysis based on targeted survey 

Importers spent on average 110 man-hours per toy type to comply with the Toy Safety 
Directive  requirements  which  cost  them  about  € 2,500.  This  time  is  evenly  spent  on 
ensuring that: appropriate conformity assessment procedures have been carried out by the 
manufacturers; that the manufacturer has drawn up the technical documentation; that the 
toy bears the required conformity marking; that the toy is accompanied by the required 
documents;  and  that  the  manufacturer  has  complied  with  the  traceability  requirements 
(identification of the toys, manufacturer’s name and address). 

64 

 
 
 
 
 
 
 
The one distributor who replied spent 86 man-hours per toy type (i.e., the cost estimated 
at about € 1,950) to verify that: toys bear the required conformity marking; that toys are 
accompanied by the required documents and by instructions and safety information in a 
language or languages easily understood by consumers in the Member State in which the 
toy  is  going  to  be  sold;  that  the  manufacturer  and  the  importer  had  complied  with  the 
traceability  requirements  (identification  of  the  toys,  manufacturer’s  name  and  address, 
importer’s  name  and  address)  (table  5.9).  This  estimate  cannot  be  compared  with  the 
2008 IA where the increase of costs for chemical provisions for importers was estimated 
at 6%. 

Table 5.9. Cost of developing a toy in percentage of man-hours per toy type 

Activity 

Importers 
Ensuring appropriate conformity assessment procedures have been carried out 
by the manufacturers. 
Ensuring that the manufacturer has drawn up the technical documentation. 
Ensuring that the toy bears the required conformity marking. 
Ensuring that the toy is accompanied by the required documents. 
Ensuring that the manufacturer has complied with the traceability requirements 
(identification of the toys, manufacturer’s name and address). 

% of 
cost 

21% 

21% 
17% 
22% 
21% 

Cost, € 

516 

516 
418 
548 
516 

Total man-hours and cost for importers: 

110 

2,514 

Distributors 
Verifying that toys bear the required conformity marking. 
Verifying that toys are accompanied by the required documents and by 
instructions and safety information in a language or languages easily understood 
by consumers in the Member State in which the toy is to be made available on 
the market. 
Verifying that the manufacturer and the importer have complied with the 
traceability requirements (identification of the toys, manufacturer’s name and 
address, importer’s name and address). 

33% 
33% 

651 
651 

33% 

651 

Total man-hours and cost for distributors: 

86 

1,953 

Note: average number of man-hours (both internal staff and external consultants) per year devoted to 
each activity per toy type. Distribution per activity based on weighted average of ranges selected by 
respondents  (available  ranges  0-4  man  hours,  5-10,  11-20,  21-35,  >35).  Middle  of  range  used,  no 
replies in the open range.  

Source: Own analysis based on targeted survey 

The average number of man-hours per activity per imported/distributed toy type is assumed to be the same for all EU 
countries, multiplied by an adjusted average hourly wage (adjusted by price change to 2017 levels, non-labour costs 
and 25% overhead) of Technicians and associate professionals ISCO 3; for Croatia wage data of Slovenia is used. 

Values  for  importers  are  based  on  responses  of  only  five  firms  (all  SMEs),  and  values  for  distributers  are  based  on 
replies of only one micro firm. 

Source: Own analysis based on targeted survey and Eurostat Structure of Earnings Survey 2014 

For  distributors  the  Toy  Safety  Directive  has  produced  a  significant  increase  in  costs 
according to the JRC study. This increase was observed both in the period 2009 − 2013 
(about 14%) and from 2013 onwards (about 10%). The increase in costs is significant in 
2011  –  2012,  and  a  strong  impact  was  detected  for  the  group  of  small  and  micro 
distributors  (about  15%)  in  both  2009  and  2013.  This  suggests  that  the  increased  costs 
incurred by the manufacturers has been passed on to distributors / importers in the form 
of an increased price of the final product. 

Public authorities are burdened with getting the documentation that has to accompany a 
toy  from  the  economic  operators.  In  the  2018  public  consultation  with  31  responding 

65 

 
 
 
 
 
 
 
 
 
 
public  authorities,  16  considered  it  costly  or  very  costly  to  get  the  safety  assessment, 
14 to get the technical documentation, 13 to get the EC-type certificate and 11 to get the 
EC declaration of conformity. These results were confirmed by the 2014 – 2018 national 
reports  of  the  Member  States,  most  of  which  observed  that  economic  operator  (and 
specifically  the  SMEs)  have  difficulties  in  identifying  their  obligations  under  the  Toy 
Safety Directive. 

It appears therefore that in the above cases, economic operators save on the costs for the 
required Technical documentation, thus increasing their competitiveness, unless they are 
caught  by  market  surveillance  authorities.  On  the  other  hand,  authorities  have  to  bear 
costs that would be unnecessary if all economic operators would play by the rules. 

Finally,  enforcing  the  Toy  Safety  Directive  in  online  sales  causes  significant  costs,  as 
signalled by 16 (out of 31) responding public authorities in the 2018 public consultation. 
These  costs  result  among  others  from  the  extended  time  needed  to  get  hold  of  online 
providers  who  place  non-compliant  products  on  the  market,  sometimes  in  vain.  Online 
toy  surveillance  was  also  identified  as  a  concern  by  different  Member  States  in  the 
national  reports  they  submitted  for  2014  –  2018.  However,  a  comparison  with  results 
from the previous reporting period (2009 – 2013) was not possible, since data on online 
sales were not reported in that period. 

Market  surveillance  authorities  do  not  have  available  the  necessary  tools  for  checking 
online sales as they have them for traditional sales. An improvement of the situation can 
be expected from the Regulation on market surveillance and compliance of products that 
will  be  applicable  from  2021,  because  it  includes  binding  obligations  for  economic 
operators in  order to  support authorities in  their work. According to  Article 7(2) of the 
Regulation,  ‘[i]nformation  society  service  providers  shall  cooperate  with  market 
surveillance authorities … to facilitate any action to eliminate … the risks presented by a 
product … offered for sale online …’.  

5.2.1.4.Costs related to amendments of the Toy Safety Directive 

In the period of 2012 − 2018 there have been 12 amendments of the Toy Safety Directive 
(see  annex  4),  which  have  been  primarily  strengthening  the  limit  values  for  CMR 
substances. In the 2018 public consultation, all stakeholders, in particular companies and 
business associations, signalled that amendments of the Toy Safety Directive are costly 
(Table 5.10). 

Stakeholders responding** 

Table 5.10. It is costly to adapt to amendments of the Toy Safety Directive (% of respondents*) 
No 
opinion  
10 
30 
0 
10 
20 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

Disagree/ 
Entirely disagree 
0 
0 
0 
10 
0 

Neither agree 
nor disagree 
10 
0 
0 
30 
20 

Agree entirely/ 
Agree 

80 
80 
100 
50 
70 

* Rounded to the nearest 10%, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

This  was  also  confirmed  by  the  results  of  the  2019  targeted  consultation  of  economic 
operators.  The  reported  average  annual  cost  caused  by  amendments  to  the  Toy  Safety 

66 

 
 
Directive (such as the introduction of new restrictions on chemicals that can be used) was 
on  average  1.4%  of  the  annual  turnover216.  It  amounted  to  1.7%  in  case  of  SMEs  and 
0.6%  in  case  of  large  companies.  The  median  value  was  lower  and  stood  at  1%  of  the 
turnover for all companies and for SMEs, and at 0.4% for large companies. 

In monetary terms this cost amounted to € 3.3 million per large firm in the consultation, 
and  € 207,000  per  SME.  Or  taking  into  account  the  number  of  toy  types  produced  by 
companies:  € 6,500  per  toy  type  produced  by  large  firm  and  € 7,700  per  toy  type 
produced by SMEs217 (Table 5.11). 

Table 5.11. Cost of implementation of amendments to Toy Safety Directive  

% of turnover (average*) 
% of turnover (median) 
Euro per company 
Euro per company per toy type 

All manufacturers 
1.4% 
1% 

Large 
0.6% 
0.4% 
€ 3.3 million 
€ 6,500 

SMEs 
1.7% 
1% 
€ 207,000  
€ 7,700 

Note: Average values based on 16 replies for all, 2 for large companies and 11 for SMEs 
* Excludes two extreme values of 10% and 15% reported by SMEs. 
Source: Own analysis based on targeted survey 

5.2.2.  Costs for SMEs 

From  the  different  sources  of  information  used  for  this  Evaluation,  it  appears  that  in 
general SMEs have difficulties dealing with costs imposed by the Toy Safety Directive. 
SMEs'  low  production  volume  fails  to  reap  economies  of  scale  benefits  and  to 
compensate  initial  investments.  The  costs  in  terms  of  turnover  thus  might  affect  SMEs 
disproportionately. 

Also SMEs themselves denounced the high costs caused by the Directive. This concerned 
the  one-off  adaptation  costs  to  the  2009  Toy  Safety  Directive  as  well  as  a  higher  cost 
increase due to the Directive (compared to the predecessor Directive), in particular due to 
the safety requirements and the safety assessments as such. Also the amendments to the 
Toy Safety Directive (such as the introduction of new restrictions on chemicals that can 
be used) costed more to SMEs in terms of annual turnover than to large companies. 

The increase of costs due to the Directive could have had an impact on the profits of the 
firms  which  in  2009  dropped    even  deeper  than  for  the  whole  industry  (Fig.  5.3).218 
However,  from 2010 to 2015 the profits of the toy industry were systematically higher 
than for the manufacturing sector as a whole, suggesting that the full applicability of the 
Toy Safety Directive since mid-2013 did not hinder the cost competitiveness of the toy 
industry. 

216  Based on 16 observations. Excludes two extreme values of 10% and 15% reported by SMEs. 

217  Calculated  average  value  based  on  response  to  question  on  percentage  of  turnover  (excludes  two 
extreme  values  of  10%  and  15%  reported  by  SMEs)  and  reported  turnover  in  2017,  based  on  13 
responses  2 large and 11 SMEs. 

218  Please note that there may be many other factors explaining that difference. 

67 

 
 
 
 
                                                           
Fig. 5.3. Development of profit per firm since 2008 for toy producers and 
manufacturing sector  

e
g
n
a
h
c

l

s
u
p
r
u
s
g
n
i
t
a
r
e
p
o
s
s
o
r
g
f
o
%

)
1
=
8
0
0
2
(

130%

120%

110%

100%

90%

80%

70%

60%

Manufacturing sector

Toy producers

2008

2009

2010

2011

2012

2013

2014

2015

2016

Note: Gross operating surplus219 per firm in NACE C324 “Manufacture of games and toys” and NACE C 
“Manufacturing”, 2018 prices.   
Source: Eurostat, [sbs_na_ind_r2], [prc_hicp_aind] 

SMEs were reported to  have limited staff, lacking specific skills  such as those of legal 
experts  or  chemists.  Therefore,  identifying  their  obligations  under  the  Toy  Safety 
Directive  is  difficult  and,  when  faced  with  new  legislative  requirements,  SMEs  turn  to 
external  consultants,  significantly  increasing  overall  costs.  Also,  due  to  the  limited 
capacity  of  their  laboratories  –  as  regards  both  economic  resources  and  competences  – 
SMEs  have  to  recur  to  external  testing  laboratories  or  Notified  Bodies  to  ensure 
compliance with the Directive. This again increases the costs. 

However, there is no evidence on a possible reduction of these costs by means of national 
legislation – instead of an EU Directive – on the safety of toys, nor do SMEs point to any 
benefit stemming from national rather than EU rules. National rules were not considered 
to be more beneficial. 

Finally, figures from the association of the European toy industry220 suggest that 500 new 
companies  have  entered  the  sector  between  2013  and  2017.  This  resulted  in  a  total  of 
5,600 toy companies in the EU, of which 99% are SMEs. It may appear therefore that, 
despite the high(er) costs for SMEs, the toy sector was attractive enough in particular for 
SMEs, so that the number of toy companies increased by some 10% within five years. 

219  Gross  operating  surplus  or  profits  is  defined,  in  the  context  of  structural  business  statistics,  as  value 

added minus personnel costs.   
 https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:Gross_operating_surplus_-
_SBS  

220  The increase in number of SMEs in the sector is also confirmed by the Eurostat data. See section 2.1.1. 

68 

 
 
 
                                                           
 
 
 
 
 
 
 
 
 
5.2.3.  Are there any costs of consumers 

Almost all manufacturers (91%) responded in the 2019 targeted consultation of economic 
operators that their production costs had increased since July 2013. It may thus be argued 
that  prices  for  toys  could  consequently  increase.  However,  only  ¼  of  the  economic 
operators reported a significant price change in general; more than one third considered 
that prices had remained approximately unchanged, and some more gave no answer. 

On average, the respondents to the consultation reported a 2.9% toy price increase since 
2013. According to Eurostat between 2013 and 2018 all prices rose by 5% while prices 
of ‘games, toys and hobbies’ declined by 2%.221 To note that the reported cost increase 
was  higher  and  amounted  to  6.8%.  This  suggests  that  not  all  costs  were  transmitted  to 
consumers, and companies internalised 2 – 4 percentage points of the cost increase (see 
also annex 3). 

No clear indications were given as to the reasons for any price increase: 75 – 80% did not 
express themselves on any potential reason suggested: Higher demand for toys; toys are 
more  complex/advanced;  toys  are  generally  of  better  quality;  increased  transport  costs; 
new  requirements  of  the  Toy  Safety  Directive  (namely  those  in  addition  to  the  former 
Toy  Safety  Directive);  external  factors  (crisis);  lower  demand  for  toys.  The  option  to 
report any ‘other’ reason for a price increase remained unanswered by all.  - Analogous 
questions relating to a potential price decrease remained without any answer. 

Thus,  it  seems  that  the  Toy  Safety  Directive  has  not  lead  to  a  major  price  increase  of 
toys, but certainly not to a price decrease. The increased costs appear to have been partly 
internalised by companies. 

5.2.4.  Benefits of the Toy Safety Directive 

The  benefits  of  the  Toy  Safety  Directive  in  terms  of  safety  could  in  principle  be 
confirmed  by  a  lower  number  of  toy-related  accidents  and  injuries.  They  could  also  be 
indicated by a higher number of toys restricted from the market and by a reduced trade in 
toys,  at  least  for  a  certain  period  after  the  introduction  of  the  Directive  and  until  toy 
manufacturers have adapted to the Directive. 

However, as explained further above,222 these figures are either not existing, incomplete 
or may be confounded by many other factors. As a result, it appears impossible to draw 
unambiguous  quantitative  conclusions  on  the  benefits  of  the  Toy  Safety  Directive. 
Nevertheless it can more generally be noted that the overall proportion of child-product 
related  injuries  with  children  younger  than  14  years  in  the  IDB  ranged  from  0.01%  to 
0.04% of the total. This can be considered to be comparably low. 

Already  the  2008  IA223  tried  to  estimate  the  (future)  benefits  of  Directive,  naming  for 
example  the  reduction  of  the  number  of  toy-related  accidents  and  ‘significant  health 
benefits in medium and long term’. However the statistics on accidents available then did 

221 Eurostat HICP, prc_hicp_aind, last update: 17-04-2019 

222  See section on Limitations of available data further above and annex 3 for a detailed explanation. 

223  See 2008 IA, section 8.2. 

69 

 
                                                           
not allow to quantify the benefits. The new chemical requirements were estimated, on the 
basis of questionnaires to stakeholders such as manufacturers or environmental groups, to 
provide  financial benefits of almost € 13 billion. However the 2008 IA also noted that 
figures on the basis of questionnaires ‘may not be fully reliable because of the inherent 
stakeholder’s interest in the assessment.’ 

The  2008  IA  noted,  as  direct  benefits  to  industry,  a  reduced  legal  uncertainty  as  to  the 
definitions  and  roles  of  economic  operators  and  the  definitions  of  toys,  as  well  as  the 
clarification of the responsibilities of the Member States’ surveillance authorities, thereby 
protecting legitimate manufacturers, suppliers and distributors from counterfeit products 
and questionable imports. The 2008 IA however also noted that ‘[t]hese benefits cannot 
be quantified based on the available data.’ 

The 2008 IA further noted that Member States’ authorities expected significant benefits 
from  the  many  changes  proposed  for  the  Toy  Safety  Directive,  including  from  the 
modified  definitions  of  toys  and  of  economic  operators.  The  latter  could  be  ‘reducing 
legal costs if a consumer or the relevant body takes an economic operator to court.’ 

When  asked  about  possible  benefits  of  the  Toy  Safety  Directive  in  the  2018  public 
consultation,  companies,  business  associations  and  public  authorities  acknowledged 
widely (60 – 80%) that the detailed provisions of the Toy Safety Directive ensure legal 
certainty and a level playing field (annex 8). Notified Bodies and consumer organisations 
however were less enthusiastic about it (30 – 40%) or preferred to be neutral (30 – 70%). 

Moreover,  as  indicated  by  companies  and  business  associations/organisations  in  the 
context  of  the  public  consultation  (see  annex  2),  among  the  benefits  of  the  Toy  Safety 
Directive  is  the  fact  that  the  CE  mark  is  considered  as  helpful  when  selling  toys  to 
customers and outside the EU, which can be seen as evidence that the CE mark brings an 
added value to the companies in terms of reputation.   

Also,  stakeholders  appreciated  that  the  safety  assessment  is  a  good  tool  to  ensure  the 
safety  of  toys  (70  –  90%),  only  consumer  organisations  were  less  convinced  (70%) 
(annex 8). Economic operators reported in the 2019 targeted consultation that the safety 
assessment allows companies to focus on the relevant safety aspects of a toy (60%), and 
thus helps to reduce (testing) costs (50%) (annex 8). 

5.2.5.  Balance of benefits and costs 

Whereas it does not appear possible to quantify the benefits of the Directive (see above), 
costs  related  to  the  Toy  Safety  Directive  have  been  quantified  to  a  certain  extent  (see 
further above). As a result, however, it is not possible to provide a quantitative balance of 
benefits  and  costs.  Even  qualitatively  it  does  not  appear  possible,  for  example,  to 
counterweigh ‘reduced legal uncertainty’ or ‘added value in terms of reputation’ against 
increased  monetary  costs  due  to  more  stringent  safety  requirements,  which  in  turn 
provide a benefit due to the higher level of protection for children. 

Nevertheless,  in  the  2018  public  consultation,  half  of  the  companies  and  business 
associations considered that the benefits of the Toy Safety Directive outweigh the costs, 
sometimes even by far (Table 5.12). A further 20% of the companies considered the costs 
proportionate to the benefits, and some 30% of the companies and business associations 

70 

 
noted  that  the  costs  would  (by  far)  outweigh  the  costs.  –  The  other  stakeholders 
highlighted even more that the benefits of the Toy Safety Directive outweigh the costs. 

Table 5.12. How do the benefits of the Toy Safety Directive compare to its costs? (% of respondents*) 

Stakeholders responding** 

The benefits 
/by far/ 
outweigh the 
costs 

The costs are 
proportionate 
to the benefits 

The costs /by far/ 
outweigh the 
benefits 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

50 
50 
60 
60 
80 

20 
0 
40 
20 
0 

30 
30 
0 
0 
0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

No 
opinion / 
Don’t 
know 
0 
30 
0 
20 
20 

Considering  the  benefits  as  outweighing  the  costs  may  be  due  to  the  fact  that  the 
protection  of  children  is  highly  valued  in  society  and  that,  therefore,  ‘any  cost’  is 
justified. Reputable toy manufacturers may therefore prefer to acknowledge this societal 
attitude and rather tend declare that the benefits (by far) outweigh the costs. 

Importantly,  however,  the  reportedly  increased  costs  resulting  from  the  Toy  Safety 
Directive (in comparison with its predecessor Directive) did not prevent new companies 
to join the toy sector. Figures from the association of the European toy industry suggest 
that  500  new  companies  have  entered  the  sector  between  2013  and  2017.  This  gave  a 
total  of  5,600 toy  companies  in  the  EU,  of  which  99%  are  SMEs.224  It  may  appear 
therefore  that  the  toy  sector  was  attractive  enough,  in  particular  for  SMEs,  so  that  the 
number of toy companies increased by some 10% within five years, and this despite the 
full  applicability  of  the  increased  number  of  requirements  of  the  new  Toy  Safety 
Directive, including chemical, as of mid-2013, and the related costs. 

On the other hand, in the eyes of the association, there are many other external factors to 
take  into  consideration,  such  as  the  impact  of  the  economic  crisis  in  the period  2008  – 
2013.  There  might  have  been  a  return  to  the  ‘normal’  level  as  of  2013,  and  lately  e-
Commerce and considerable changes in the retail channels (such as the Toys ‘r’ Us going 
out of business) have been of influence. It is therefore difficult to make assumptions on a 
direct  impact  of  the  Toy  Safety  Directive  on  the  number  of  companies  in  the  sector, 
especially as there are no data available on the impact of the economic crisis on the toy 
sector. 

5.2.6.  Is there scope for simplification? 

Obligations of economic operators 

The  Toy  Safety  Directive  appears  to  be  quite  complex  due  to  its  many  obligations 
imposed  in  particular  on  the  manufacturers  of  toys.  Manufacturers  not  only  have  to 
ensure that their toys comply with the (safety) requirements, but also have to document 

224  Toy Industries of Europe. The European toy industry. Flyer designed in July 2017.   

https://www.toyindustries.eu/wp-content/uploads/2018/01/TIE-EU-Toy-Sector-Facts-and-Figures-
FINAL.pdf  

71 

 
 
                                                           
this unambiguously and keep the documentation for 10 years. Even after having placed 
the  toy  on  the  market,  they  have  to  monitor  it  and  take  action  if  they  consider  or  have 
reason  to  believe  that  the  toy  is  not  compliant,  even  at  the  price  of  recalling  it  from 
consumers. 

Importers have less obligations than manufacturers, and distributors  even less, but  both 
have to ensure that only compliant (and thus safe) toys are available on the market. 

In  practice,  economic  operators  may  not  know  their  obligations.  Even  the  most  basic 
document,  the  EC  Declaration  of  Conformity  of  the  manufacturer,  may  be  difficult  to 
obtain or might be incorrect. This was reported by 15 - 16 of the 27 Member States’ 2014 
– 2018 national reports, available at the time of writing. According to these reports, also 
the Technical documentation is difficult to obtain or incorrect, and the safety assessment, 
which  is  part  of  the  Technical  documentation,  is  no  better,  as  reported  by  5  –  9  of  the 
27 Member States. 

On the other hand the Directive leaves far-reaching freedom to economic operators, and 
in  particular to  manufacturers:  they  can decide when to  start  the development of a toy, 
how to design it, how, where, when and by whom to have it tested for safety, where to 
have it manufactured at what price, and when and where to place it on the market. Except 
in  particular  circumstances  where  the  intervention  of  a  third  party  is  required    (namely 
for EC-type examination), there is no intervention of, or fee to be paid to, any third party 
in  the  entire  process  that  could  delay  or  block  the  entry  of  a  toy  on  the  market. 
Manufacturers  are  free  to  decide  on  their  way  of  action,  in  cooperation  with  importers 
and distributors as appropriate. 

Also,  there  is  a  good  body  of  tips225  and  guidance226  available  for  manufacturers, 
importers,  distributors  and  any  other  stakeholders,  including  on  the  applicable 
legislation227  and  including  flow-charts,  suggested  templates  for  checklists  and  actual 
examples in particular in the ‘Technical documentation guidance document’. Most of the 
guidance is available in all EU languages and in Chinese. 

Of course all this assistance cannot provide immediate answers to very specific questions 
on toys (and non-toys) manufactured under specific circumstances, however its existence 
has  been  appreciated  by  stakeholders  when  they  contacted  the  Commission  services  to 
inquire about specific details.  

Weighing the obligations and the freedom for economic operators including the available 
tips and guidance against the need to protect children therefore suggests that the balance 
is  about  right,  and  a  simplification  entailing  fewer  obligations  would  run  the  risk  of 
losing protection for children. 

225  Steps for manufacturers; Steps for importers; Steps for distributors. 
https://ec.europa.eu/growth/sectors/toys/placing-on-eu-market_en  

226  Guidance on Toy Safety. 

https://ec.europa.eu/growth/sectors/toys/safety/guidance_en  

227  Legislation.  https://ec.europa.eu/growth/sectors/toys/safety/legislation_en  

72 

 
 
 
                                                           
 
Third-party approval 

For a toy manufacturer the self-certification conformity assessment can be burdensome, 
among others due to the need to identify the appropriate test methods for his toy. On the 
other hand, a conformity assessment via an EC-type examination leaves the testing to a 
third party, the Notified Body. 

However,  in  both  cases  the  Technical  documentation  has  to  be  put  together,  which  is 
time-consuming,  and  it  can  even  cause  delays.228  Getting  a  third  party  approval  thus 
appears to add a further delay to the marketing of a toy, and additional costs.  

In  addition,  if  all  toys  were  to  be  subject  to  an  EC-type  conformity  assessment,  this 
would require a considerable increase in the number of notified bodies, since only around 
3% of the toys in the EU market have so far been subject to third-party testing.229 Linked 
to this would be considerable more efforts, and costs, to control laboratories’ quality.  

To note that, in the 2018 public consultation, an association of Notified Bodies suggested 
that toys for children under 3 years of age be required to pass an EC-type examination as 
carried out by Notified Bodies. 

Placing all limit values for chemicals in a single piece of legislation 

Limit values for chemicals in toys can not only be found in the Toy Safety Directive but 
also  in  other  pieces  of  EU  legislation  such  as  REACH,  CLP  or  the  RoHS  Directive. 
Identifying the limit values applicable to a toy can therefore be cumbersome. Placing all 
limit values in a single piece of legislation could relieve from this burden. 

Considering the Toy Safety Directive to be this single piece of legislation – a ‘one-stop-
shop’  –  would  have  several  benefits.  All  economic  operators,  Member  States’  market 
surveillance  authorities  and  any  other  stakeholder  would  find  all  information  in  the 
Directive they are acquainted with, the limit values could be specifically targeted to the 
needs of the Toy Safety Directive since the necessary expert knowledge in particular on 
the  exposure  from  toys  would  be  readily  available,  any  double  testing  to  fulfil  the 
requirements  in  different  pieces of legislation could  be avoided, and there would be no 
confusion or risk of overlapping since only the limit values in the Toy Safety Directive 
would have to be taken into account. All this could foreseeably simplify the application 
of the Directive and thus offer benefits for all. 

Ensuring consistency with other pieces of legislation 

In  the  2018  public  consultation  stakeholders  reported  complexities  and  overlaps  of  the 
Toy Safety Directive with other pieces of legislation as regards inconsistent requirements 
and  chemical  limit  values  (see  section  5.4  Coherence).  None  of  these  perceptions  was 
however substantiated with clear, specific evidence or at least illustrative examples. 

The latter appears to confirm the experience of the Commission services that there are no 
two chemical limit values for toys that would contradict each other (apart from the limit 
values  for  nitrosamines  and  nitrosatable  substances  (see  section  on  ‘Effectiveness’)). 

228  Information from the NB-Toys group. 

229  Information from the NB-Toys group. 

73 

 
                                                           
Stakeholders  may  however  have  understood  the  question  ‘Are  you  are  aware  of  any 
different limit values for chemicals in other EU or national legislation?’ in a wider sense, 
and indeed there are migration limit values for certain metal elements in the Toy Safety 
Directive,  but  content  limit  values  for  some  of  those  elements  in  REACH  and  in  the 
RoHS  directive  (see  section  5.4  Coherence).  Also,  when  two  limit  values  of  the  same 
kind  apply  to  the  same  (toy)  material,  the  stricter  limit  value  applies  because  the  less 
strict  value  is  then  also  complied  with.  Thus,  although  the  applicable  limit  value  can 
always  be  identified  unambiguously,  there  can  be  confusion  and  a  more  or  less 
considerable effort to identify the applicable limit value, which lowers the efficiency of 
the Directive. 

5.3.  Relevance 

5.3.1.  Is  the  Toy  Safety  Directive’s  requirement  that  toys  have  to  be  safe  still 

relevant? 

In light of the many unsafe toys on the market, as shown by the weekly notifications on 
the EU Safety gate RAPEX, the safety requirements of the Toy Safety Directive still play 
a  crucial  role.  These  requirements,  supported  by  standards  providing  the  technical 
specifications and test methods to check compliance with the requirements, give market 
surveillance authorities the means to restrict dangerous toys from the market before they 
can affect the health of children. The Toy Safety Directive is, therefore, a relevant policy 
measure for the safety of toys, in  that it requires that all toys  placed on the EU market 
comply with its safety provisions that are specific for the different risks possibly inherent 
to toys. 

The requirement that toys be safe has undoubtedly been confirmed to be relevant by at 
least  a  very  large  majority,  if  not  all,  stakeholders  (Table  5.13)  in  the  2018  public 
consultation. 

Table 5.13. The Toy Safety Directive requires toys to be safe. Is this objective (still) relevant? (% of 
respondents*) 

Stakeholders responding** 

To a large 
extent 

To a moderate 
extent 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

80 
100 
90 
90 
100 

10 
0 
10 
10 
0 

To some extent / 
To a small extent 
/ Not at all 
0 
0 
0 
0 
0 

Don’t 
know 

0 
0 
0 
0 
0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

The  many  detailed  safety  requirements  in  the  Toy  Safety  Directive  were  considered  as 
helpful by a 70% majority of companies and of business associations (Table 5.14) in the 
2018 public consultation. Those details were rated definitely higher by Notified Bodies, 
public authorities and consumer organisations. 

74 

 
 
 
Table 5.14. The Toy Safety Directive provides for many detailed requirements on toys’ physical and 
mechanical  properties,  flammability,  chemical  properties,  electrical  properties,  hygiene  and 
radioactivity.  Is  it  helpful  that  the  Toy  Safety  Directive  includes  that  many  details?  (%  of 
respondents*) 

Stakeholders responding** 

To a large 
extent 

To a moderate 
extent 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

70 
70 
100 
80 
100 

10 
10 
0 
10 
0 

To some extent / 
To a small extent 
/ Not at all 
20 
20 
0 
0 
0 

Don’t 
know 

0 
10 
0 
0 
0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

The 12 adaptations of the Toy Safety Directive to technical and scientific developments 
between 2012 and 2018 (see annex 4) have primarily been adding stricter limit values for 
chemicals in toys. In the eyes of stakeholders they however do not appropriately reflect 
the  developments  that  have  been  taking  place  (Table  5.15).  While  about  half  of  the 
companies and business associations concede that the Directive is up-to-date to a large or 
moderate  extent,  Notified  Bodies,  public  authorities  and  consumer  organisations  rather 
see the Directive as being moderately up-to-date, or less. 

Table  5.15.  Do  changes  to  the  Toy  Safety  Directive  appropriately  reflect  all  the  latest  technical, 
scientific and social developments? (% of respondents*) 

Stakeholders responding** 

To a large 
extent 

To a moderate 
extent 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

30 
30 
0 
10 
0 

20 
30 
40 
40 
30 

To some extent / 
To a small extent 
/ Not at all 
40 
40 
60 
30 
70 

Don’t 
know 

10 
10 
0 
20 
0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

In their comments, 
  Companies and business associations noted that changes to the Toy Safety Directive 
were made through a ‘political’ approach: Limit values would only be made stricter, 
but  if  scientific  evidence  indicated  the  contrary,  limits  would  not  be  released 
accordingly.  Companies  mainly  referred  to  the  application  of  recital  22  of  the 
Directive230  in  connection  with  the  strengthening  of  the  limit  value  for  lead,  since 

230  Recital 22: ‘The specific limit values laid down in Directive 88/378/EEC for certain substances should 
also be updated to take account of the development of scientific knowledge. Limit values for arsenic, 
cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic, and which should 
therefore not be intentionally used in those parts of toys that are accessible to children, should be set at 
levels  that  are  half  of  those  considered  safe  according  to  the  criteria  of  the  relevant  Scientific 
Committee, in order to ensure that only traces that are  compatible  with good  manufacturing practice 
will be present.’ 

75 

 
 
                                                           
recital 22  requires  setting  the  limit  value  for  lead  (and  five  other  hazardous  metal 
compounds)  at  half  of  what  science  commands,  due  to  lead  (and  the  five  other 
compounds)  being  ‘particularly  toxic’.  Similar  concerns  for  ‘political’  limit  setting 
had  been  raised  in  the  2015  external  study.  Points  anecdotally  referred  to  in  the 
comments  were  nano  particles,  the  absence  of  risks  from  books,  the  treatment  of 
personal data and the respect for human rights in toy manufacture. 

In reply to these comments it has to be said that a limit value for a chemical is set on 
the  basis  of  a  risk  assessment  of  that  chemical,  which  is  a  scientific  exercise. 
Deriving  then  a  limit  value  from  the  risk  assessment  is  linked  to  the  question  how 
much  risk  a  society  is  ready  to  accept.  For  example,  in  the  limit-setting  for 
carcinogens: is it acceptable that 1 person in 100,000 may get cancer, or should it be 
1 in  a  million?  No  science  can  provide  an  answer  to  this,  it  is  thus  a  political 
decision, a decision in light of the societal background. 

Against this background it is difficult to make a limit value less strict, even if science 
suggests that the risk would not increase beyond what society tolerates. On the other 
hand, science evolves  and may well provide new evidence that a chemical  is  more 
toxic than established previously. A prominent example of this is the toxicity of lead 
which,  although  well-known  for  decades,  was  recognised  to  harm  children’s 
intelligence in even smallest amounts. The limit value for lead in toys therefore had 
to be made 7-fold stricter  (see above). 

  Notified Bodies considered that the Toy Safety Directive missed out the recent risks 
linked  to  data  and  privacy  protection.  In  the  2015  external  study  of  the  Directive, 
Notified  Bodies  were  only  concerned  about  the  inclusion  (or  not)  of  slings  and 
catapult in the Directive. 

As  a  reply  it  has  to  be  said  that  the  Toy  Safety  Directive  does  indeed  not  cover 
privacy,  this  would  require  a  new  Directive.  The  same  goes  for  toy  slings  and 
catapults which, although being toys in light of the Directive, are excluded from its 
scope.231 

  Public authorities equally commented most often about the missing coverage of data 
and  privacy  protection,  but  also  referred  to  the  inadequacies  of  the  Toy  Safety 
Directive  concerning  CMRs,  nitrosamines,  the  ‘rapidly  evolving  market’  and  the 
slow  adaptation  process  in  general.  This  is  different  from  the  2015  external  study 
where  authorities  had  generally  confirmed  the  relevance  of  the  adaptation 
mechanisms. 

In reply it can be said that a new Directive would be necessary to take account of the 
comments on privacy (see above), CMRs and nitrosamines (see further above). The 
claimed slowing down of the adaptation process since 2015 was probably due to the 
need  to  collect  sufficient  technical  and  scientific  evidence  to  ensure  that  the 
amending directives  could  resist  any potential legal  challenge, including  before the 
WTO. 

  Consumer  organisations  called  for  broadening  the  scope  for  changes  of  the  Toy 
Safety  Directive,  Article  46  would  be  too  limited.  Market  changes  and  new  risks 

231  Article 2(2) of the Toy Safety Directive. 

76 

 
                                                           
could require to change the Directive’s scope, to identify toys that needed third party 
testing, to ban certain toys or set chemical limit values for any kind of toy (not only 
for toys intended for the under 3 and for toys intended to be placed in the mouth).  
Similar concerns had been voiced in the 2015 external study. 

These  comments,  which  had  also  been  raised  by  the  other  stakeholders  above,  
effectively call for a new Toy Safety Directive adopted by the EU co-legislators. 

5.3.2.  Is  the  Directive  still  relevant  in  view  of  new  type  of  risks  such  as 

cybersecurity? 

Consumers  are  increasingly  using  connected  devices  in  their  daily  lives.  While  the 
number of connected products is rising, many of these products are manufactured without 
even basic security features in their system. This lack of security increases the risk that 
consumers become victims of malicious cyberattacks. 

Internet-connected  toys  were  not  relevant  for  the  Toy  Safety  Directive  when  adopted, 
since  such  toys  did  not  exist  at  that  time.  There  are  therefore  no  specific  rules  in  the 
Directive to address the risks that internet-connected toys can present. In the meantime, 
more and more toys which can connect to the internet have come to the market. 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. 

In  the  present  evaluation  the  issue  of  security  of  internet-connected  toys  came  out  as  a 
relevant  concern.  Already  in  their  reply  to  the  Roadmap  of  the  present  evaluation  (see 
annex 2, section III) 4 stakeholders232 expressed their concerns about internet-connected 
toys and related security and data privacy threats. They requested that the scope of the 
Toy  Safety  Directive  be  extended  to  include  new  safety  requirements  on  information 
security  which  cannot  be  addressed  by  the  Directive  in  its  current  version.233  This  is 
because the safety requirements covered by the Toy Safety Directive are limited to health 
and safety (see the particular safety requirements in Annex II: physical and mechanical 
properties, 
electrical  properties,  hygiene, 
radioactivity234)  and  do  not  cover  information  security.  The  Toy  Safety  Directive 
therefore  cannot  address  the  security  threats  that  new  technologies  pose.  As  the  Toy 
Safety  Directive  does  not  have  specific  requirements  for  internet-connected  toys,  they 
would be covered horizontally by the General Product Safety Directive, as long as they 
might  have  an  impact  on  the  safety  of  consumers.  For  example,  one  notification  in  the 
Safety Gate RAPEX clearly refers to the vulnerability of a smart watch which could lead 
to localisation of children by intruders. 

chemical  properties, 

flammability, 

232  2 consumer organisations, a federation and a Notified Body. 

233  Feedback on the Roadmap is available at: 

https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-3667279_en  

234  See section 2.1.2 above. 

77 

 
                                                           
 
According  to  respondents,  the  concept  of  ‘safety’  in  the  Toy  Safety  Directive  is  too 
narrow and fails to protect children from the security flaws of connected devices thereby 
jeopardising their safety. A 2016 report by the Norwegian Consumer Council235 exposed 
security  flaws  in  a  number  of  Bluetooth-connected  toys  that  left  their  users’  data 
vulnerable to cyberattacks. Two campaigns, run by the national consumer organisation in 
2016  (#ToyFail236)  and  2017  (#WatchOut237),  have  echoed  the  inadequate  security 
mechanisms  of  popular  consumer  connected  products  intended  for  children  and  sold 
across the EU. 

A recent investigation from another national consumer organisation revealed that four out 
of seven connected toys tested could easily be hacked and enable anybody to use the toy 
to  communicate  with  a  child.238  Another  campaign  run  by  the  consumer  organisations 
from Belgium, Germany and Spain found similar security flaws and revealed that anyone 
could connect to the Bluetooth network of the toys without being required to provide a 
password or any other type of authentication. 

On these grounds, the consumer organisations requested that the General Product Safety 
Directive as well as product specific safety legislation including the Toy Safety Directive 
be updated to ensure that they are in line with the new ‘security for safety’ concept of the 
framework.239  These  concerns  were  confirmed 
general 
respondents’ 
contributions to the 2018 public consultation.240 

legal 

in 

On the other hand, it is also to be noted that the described risks of internet-connected toys 
are due to criminal misuse of connected toys by third parties. 

Further  to  consumer  organisations,  also  politicians  (members  of  the  European 
Parliament241) have been vocal in calling for an update of the safety concept in the EU 
regulatory framework, in order to cover these risks. 

On  12 March 2019, 
the EU  Cybersecurity 
the  European  Parliament  adopted 
Regulation.242  This  Regulation  will  establish  a  voluntary  cybersecurity  certification 

235 See https://www.forbrukerradet.no/siste-nytt/connected-toys-violate-consumer-laws/ 

236  #ToyFail: https://fil.forbrukerradet.no/wp-content/uploads/2016/12/toyfail-report-desember2016.pdf  

237  #WatchOut:https://fil.forbrukerradet.no/wp-content/uploads/2017/10/watchout-rapport-october-

2017.pdf 

238  http://press.which.co.uk/whichpressreleases/which-issues-child-safety-warning-on-connected-toys/  

239  See BEUC position paper ‘CYBERSECURITY FOR CONNECTED PRODUCTS’ at 

 http://www.anec.eu/images/Publications/position-papers/Digital/ANEC-DIGITAL-2018-G-
001final.pdf 

240  See  the  position  papers  available  at  https://ec.europa.eu/info/law/better-regulation/initiatives/ares-

2018-3667279/public-consultation_en   

241  Ref. : http://www.europarl.europa.eu/doceo/document/E-8-2019-001470-ASW_EN.html 

242 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 (Cybersecurity Act) (Text with 
EEA relevance). OJ L 151, 7.6.2019, p. 15. 

78 

 
                                                           
 
framework for information and communication technology (ICT) products, services and 
processes in the European Union. The regulation recognises that increased digitalisation 
and connectivity can jeopardise cybersecurity, and that in this respect children represent 
particularly vulnerable consumers.  

There  have  been  calls  on  the  European  Union  to  adopt  legislation  which  guarantees 
proper protection against the misappropriation and exploitation of data.  

Connected toys usually involve processing of personal data. The General Data Protection 
Regulation (GDPR)243, to be applied as of May 2018, regulates such processing, setting 
out, among others, rules on transparency, information security and parental consent. The 
GDPR  includes  a  household  exemption  in  Article  2(2),  which  can  exempt  certain  on-
device processing244. While the GDPR focuses on organisations processing personal data 
(‘controllers’),  its  recital  78  also  encourages  producers  of  products  who  are  not 
themselves controllers to take into account the right to data protection when developing 
and designing such products, with reference to the principles of data protection by design 
and  by  default245,  so  that  their  products  enable  processing  that  is  in  line  with  the 
principles of the GDPR. 

Since  the  Toy  Safety  Directive  does  not  at  all  touch  upon  cybersecurity  issues,  those 
issues  could  be  addressed  horizontally  because  they  are  not  only  relevant  for  toys  but 
also other Internet of Things (IoT) devices for many daily-use products. Covering certain 
aspects of security and privacy risks separately for toys could lead to a fragmentation of 
privacy and cyber security rules and thus undermine the internal market. 

As  all  internet-connected  wireless  devices  fall  under  the  Radio  Equipment  Directive 
(RED)246,  the  Commission  has  recently  adopted  a  decision  to  explore  whether  a 
delegated  act  under  that  Directive  can  increase  the  security  of  internet-connected 
products whilst ensuring a level playing field for businesses. This initiative on ‘Internet-
connected radio  equipment and wearable radio equipment’ includes connected toys and 
seems to be supported by the toy industry247. 

243    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  (General  Data  Protection  Regulation),  OJ  L  119, 
4.5.2016, p. 1–88, available at:  
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0679-20160504  

244   See by analogy  for connected vehicles: EDPB Guidelines  1/2020 on processing personal data  in the 
context  of  connected  vehicles  and  mobility  related  applications  (version  for  public  consultation), 
paragraphs 70 to 75, available at: 
https://edpb.europa.eu/sites/edpb/files/consultation/edpb_guidelines_202001_connectedvehicles.pdf  

245   EDPB  Guidelines  4/2019  on  Article  25  Data  Protection  by  Design  and  by  Default,  paragraph  1, 

available at:   
https://edpb.europa.eu/sites/edpb/files/consultation/edpb_guidelines_201904_dataprotection_by_desig
n_and_by_default.pdf  

246  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  

247  See TIE position at https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-6426936_en 

79 

 
                                                           
 
The initiative aims to assess whether a delegated act under the RED can further enhance 
protection by requesting manufacturers to demonstrate, as a market access condition, that 
their products can (1) protect the personal data and privacy (in line with the principles of 
GDPR),  (2)  protect  from  fraud  and  (3)  do  not  harm  the  network  to  which  they  are 
connected. The Impact Assessment study has been published on the related Commission 
website.248 

Delegated  acts  under  the  RED249  could  require  manufacturers  to  demonstrate  that 
personal data and privacy are protected before an internet-connected wireless device can 
be  placed  on  the  market.  This  would  entail  that,  if  Member  States  identify  a  radio-
connected product presenting a serious risk related to personal data, privacy or fraud, a 
notification should be submitted through the EU Safety gate RAPEX. In contrast to this, 
Member  States  can  currently  only  rely  on  national  acts,  if  they  exist,  to  withdraw 
products from the market that negatively impact data protection and privacy. 

If adopted, a delegated act under the RED250 would entail that, if Member States identify 
a  radio-connected  product  presenting  a  serious  risk  related  to  personal  data,  privacy  or 
fraud, a notification should be submitted through the EU Safety gate RAPEX. In contrast 
to this, Member States can currently only rely on national acts, if they exist, to withdraw 
products from the market that negatively impact data protection and privacy. 

In conclusion, the above initiatives are expected to strengthen the security by design of 
internet-connected products, including toys. 

5.3.3.  Is the requirement on the free movement of goods in the Toy Safety Directive 

still relevant? 

The  key  objective  of  the  Toy  Safety  Directive  to  ensure  the  free  movement  of  toys  is 
directly related to the size and prominence of the toy sector, which justify the need for a 
common  legislation  easing  the  smooth  functioning  of  the  internal  market.  The 
considerable  number  of  toys  crossing  the  borders  require  legislative  certainty  on  the 
applicable rules for placing toys on the internal market and their free movement therein. 
The  harmonisation  of  national  requirements  is  therefore  crucial.  The  Directive  indeed 
requires that all toys placed on the EU market comply with the same safety requirements 
thus  eliminating  possible  barriers  that  would  stem  from  different  regulatory  systems  in 
the Member States. 

248  https://ec.europa.eu/docsroom/documents/40763  

249  Article  3(3)  provides  the  basis  for  further  delegated  regulation  governing  additional  aspects, 
empowering the Commission to adopt delegated acts in order to specify which categories or classes of 
radio  equipment  are  concerned  by  each  of  the  requirements  set  out  in  its  points  (a)  to  (i).  The 
requirements  referred  to  in  points  (a)  to  (i)  relate  to  interoperability,  emergency  services,  software, 
fraud, accessibility, privacy, personal data and misuse. 

250  Article  3(3)  provides  the  basis  for  further  delegated  regulation  governing  additional  aspects, 
empowering the Commission to adopt delegated acts in order to specify which categories or classes of 
radio  equipment  are  concerned  by  each  of  the  requirements  set  out  in  its  points  (a)  to  (i).  The 
requirements  referred  to  in  points  (a)  to  (i)  relate  to  interoperability,  emergency  services,  software, 
fraud, accessibility, privacy, personal data and misuse. 

80 

 
                                                           
The free movement of toys in the EU market has been confirmed as highly relevant by 
(almost)  all  stakeholders,  with  some  lesser  enthusiasm  from  public  authorities  (Table 
5.16) in the 2018 public consultation. 

Table 5.16. The Toy Safety Directive allows safe toys to be marketed throughout the EU. Is this 
objective (still) relevant? (% of respondents*) 
To a large 
extent 

To a moderate 
extent 

Stakeholders responding** 

Don’t 
know 

To some extent / 
To a small extent 
/ Not at all 
0 
0 
0 
0 
0 

0 
0 
10 
10 
0 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

90 
100 
90 
70 
100 

10 
0 
0 
20 
0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

5.3.4.  Is the current monitoring and evaluation system fit for purpose? 

As explained further above, available data cannot be used to clearly identify effects of the 
Toy Safety  Directive, since those data are often  incomplete, not  representative or there 
are  too  many  confounding  factors.  This  concerns  data  on  toy-related  injuries,  on 
marketing restrictions for toys, on toy trade, on costs related to toy production, and on the 
feedback collected through stakeholder consultations. Any trend in such data could only 
vaguely be linked, if at all, to the requirements  of the Toy Safety Directive, with some 
exception  perhaps  for  the  cost  data  reported  by  the  toy  industry.  For  example,  the  data 
from Orbitz which were used for the purpose of the present evaluation are representative 
but they are limited to the costs of materials, therefore the database does not allow to get 
the level of granularity expected for the evaluation, i. e., which provisions are driving the 
costs.  The  targeted  consultation  of  economic  operators  will  need  to  remain  the  main 
source of data for the assessment of the costs of the Directive. 

Isolating the effects of the Toy Safety Directive from the many confounding factors thus 
appears to be very difficult. Perhaps techniques of multifactorial analyses could provide 
some  further  insight,  but  mathematical-statistical  tools  usually  reflect  correlations  and 
cannot  demonstrate cause-effect  relationships. Effects  of the Directive may however be 
masked by unforeseeable decisions of economic operators.  

As  concerns  the  IDB,  although  it  is  currently  the  largest  and  best  available  source  of 
information  on  accidents  and  injuries  in  Europe,  this  database  has  however  never  been 
used  for  research  purposes  in  general,  nor  for  the  evaluation  of  product  safety  or 
European health related programmes in particular. One possible explanation could be that 
the  collection  of  data  at  the  EU  Member  States’  level,  in  particular  the  selection  of 
representative reference hospitals, needs substantial improvements. 

Two levels of datasets are available: 

(1) 

IDB-MDS  (minimum  data  set)  that  is  used  to  compute  European  Core 
Health  Indicators  (ECHI),  specifically  ECHI  indicator  29b  “Home,  leisure, 
school injuries: registered based incidence”;  

81 

 
(2) 

IDB-FDS (full data set) that collects more detailed information in particular 
regarding the product category leading to the injury (EuroSafe 2013). 

The  MDS  version  has  proven  to  be  useful  to  create  European  Core  Indicators  (ECHI). 
The  FDS  collects  valuable  and  detailed  information,  in  particular  on  product  category 
related injuries. The harmonised classification of product and injuries makes comparison 
of  cases  possible  across  recording  hospitals  and  Member  States.  However,  the  sample 
feeding the FDS version would need to be improved substantially in order to be valuable 
in quantitative studies at the European level, in particular in the consistency of the sample 
over  time  and  the  representativeness  of  selected  hospitals.  To  correct  estimates  and 
improve the sample, a number of methods can be implemented, as it is done already in 
the  MDS  version  (extrapolation  methods  and  corrected  weighted  estimates)  or  taking 
insights  for instance from  the system used in  the US  with  the NEISS standardised data 
abstraction (EuroSafe 2016) 

The FDS shows the limits of the current European system in the collection of harmonised 
data:  enforcement  of  data  collection  and  sustainable  source  of  funding.  More  than  30 
years of data have been collected so far but these can and have been unfortunately only 
be used in a very limited way, in qualitative study or case specific studies based on one 
hospital and one year.  

Safety gate RAPEX 

The impact of the Toy Safety Directive on the number of toys removed from the market 
in  EU  countries  has  been  assessed  in  the  JRC  study  based  on  information  collected  by 
Safety  gate RAPEX,  from  which three product  categories  were used as control groups, 
and three  geographic areas  were  considered. The usefulness of the Safety gate RAPEX 
data  is  that  they  reflect  the  activities  of  the  market  surveillance  authorities  on  the 
dangerous  toys  that  they  have  identified  on  the  market  during  their  targeted  activities. 
However,  to  improve  the  usefulness  of  Safety  gate  RAPEX  further,  it  would  be 
interesting  to  have  in  addition  the  number  of  compliant  toys  that  market  surveillance 
authorities have inspected. This could give a more complete picture of specific categories 
of  compliant  toys  and  could  help  orientating  market  surveillance  activities,  where 
needed, away from (largely) compliant toy categories to those that are (largely) missing 
any record of compliance. 

Nevertheless, it appears possible to identify effects of the Directive in the short-term and 
for  single  toys,  once  a  new  requirement  triggers  changes  in  the  design,  in  the  raw 
materials  or  in  the  production  process  of  a  toy.  Manufacturers  would  probably  be  best 
placed  to  demonstrate  those  effects,  but  may  however  not  provide  any  related  data,  in 
particular in quantitative terms, due to the sensitiveness of such data for their business. 

On the other hand, effects of the Directive can relatively easily be seen in any activity of 
market surveillance and customs, in particular when restricting the marketing of specific 
toys.  The  related  data  are  being  reported  publicly,  and  they  reflect  the  effects  of  the 
Directive,  although  only  in  the  non-representative  way  in  which  market  surveillance 
authorities (and customs) are acting. 

Future data collection could present better harmonised data on toys. The Member States’ 
5-yearly reports on the application of the Toy Safety Directive have shown inconsistent 
reporting of market surveillance’s activities across the different Member States. The Toy 
Safety Directive only provides for a general reporting obligation for Member States, but 

82 

 
does  not  set  any  specific  requirements  for  such  reporting,  thus  leaving  room  for 
manoeuvre to Member States as concerns the data collection at national level. While each 
individual report highlights interesting aspects of the data presented, it could be useful to 
identify the indicators and the related data needs for future monitoring and evaluation, so 
that the Member States would know in advance what kind of data they will be asked to 
provide for the next evaluation period. This could ensure that indeed comparable data are 
collected,  for  example  concerning  the  number  of  non-compliant  toys  vis-à-vis  the  total 
number of inspections carried out and the total numbers of toys traded in each Member 
State. 

In  addition,  Member  States  could  be  requested  to  report  on  their  measures  relating  to 
specific (categories of) toys, on novel toys ‘flooding’ the market, on the blockage of toys 
at the EU borders, and similar. This could provide a realistic picture on the ad-hoc effects 
of the Directive, and perhaps suggest where further improvements are needed. 

5.4.  Coherence 

5.4.1.  Is  the  Toy  Safety  Directive  coherent  with  other  EU  or  Member  State 

legislation? 

In  the  2018  public  consultation,  stakeholders  mostly  reported  about  perceived 
incoherencies  in  the  area  of  chemicals,  in  particular  on  restrictions  of  hazardous 
chemicals  and  the  related  limit  values.  Companies,  business  associations,  Notified 
Bodies and consumer organisations often referred to other chemicals legislation such as 
REACH  or  the  CLP  Regulation.  Also  the  Biocidal  Products  Regulation251  was  named. 
Public  authorities  further  referred  to  the  Food  Imitating  Products  Directive252  and  a 
possible overlap with the Toy Safety Directive. They also saw different requirements for 
affixing the CE mark under the Toy Safety Directive, the Radio Equipment Directive253 
and the RoHS Directive.254 Consumer organisations noted an inconsistent approach of the 
Toy  Safety  Directive  and  the  Directive  on  General  Product  Safety  regarding  childcare 
articles, deploring that protection from chemicals in childcare articles was less than from 
toys, although exposure of children to such chemicals would be similar. 

251  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, p. 1. 
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0528-
20140425&qid=1571659897414&from=EN  

252  Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States 
concerning  products  which,  appearing  to  be  other  than  they  are,  endanger  the  health  or  safety  of 
consumers. OJ L 192, 11.7.1987, p. 49.  
content/EN/TXT/PDF/?uri=CELEX:31987L0357&qid=1571659964745&from=EN  

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

253  Directive 1999/5/EC on radio equipment and telecommunications terminal equipment and the mutual 

recognition of their conformity. OJ L 91, 7.4.1999, p. 10.  
content/EN/TXT/PDF/?uri=CELEX:31999L0005&qid=1571660072469&from=EN  

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

254  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. OJ L 174, 1.7.2011, 
p. 88.  
20190722&qid=1571660168647&from=EN  

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02011L0065-

83 

 
                                                           
However, in all cases of perceived inconsistencies above, little or no details were given 
to  substantiate  them,  nor  examples  to  illustrate  them.  It  was  therefore  not  possible  to 
verify what actually caused the concerns. 

For the particular case of childcare articles, it is well understandable that the high level of 
protection  acknowledged  for  chemicals  under  the  Toy  Safety  Directive  should  equally 
apply  to  childcare  articles  and  children  in  their  first  months  and  years.  Consideration 
however has to be given to the exposure from each product group: 

  Whereas  exposure  to  chemicals  in  toys  is  always  linked  to  play,  exposure  from 
childcare  articles  is  linked  to  a  quite  different  range  of  activities,  namely  ‘sleep, 
relaxation, hygiene, the feeding of children or sucking on the part of children’ which 
childcare articles are supposed to facilitate according to the definition of ‘childcare 
articles’ for the prohibition of phthalates (in toys and childcare articles);255 

  Also the age span of children is different: Under 14 years for toys, but perhaps up to 

6 years for childcare articles. 

Each  product  group  thus  requires  its  own  expertise  to  ensure  tailor-made  safety  for 
children; merging both under the same umbrella for the sake of ‘consistency’ would bear 
the risk of failure. 

To conclude: From managing the Toy Safety  Directive the only apparent inconsistency 
with other EU or Member State legislation appeared to be Germany’s stricter limit values 
for nitrosamines and nitrosatable substances. 

5.4.2.  Is  the  Toy  Safety  Directive  coherent  with  the  risk  assessment  and  risk 

management approaches under other pieces of EU legislation?  

Concerning the risk assessments provided to the Commission by different agencies  and  
scientific    committees  under  different  pieces  of  EU  legislation,  ‘there  are  areas  of 
potential overlap (e.g. toys, detergents or other consumer  goods,  nanomaterials).  This  
means  that  the  same  substance  can  be  assessed  by ECHA  or  by  one  of  the  EU  
scientific  committees,  depending  on  which  legislation  applies, and possibly  lead  to  
diverging    opinions.‘256  The    Commission    ‘has    already    started    to    work    on 
streamlining   the   hazard/risk   assessment   by   ECHA   and   EFSA   to   better   ensure   
the convergence  of  conclusions.  There  are  additional  opportunities  for  simplifying  
the  current set-up  and  streamlining  the  risk  assessment  processes  among all  relevant  
EU  assessment bodies.  This  could  make  the  functioning  of  the chemicals  legislation  
more    efficient    (e.g.  avoiding    duplication    of    efforts)    and    more    predictable    (e.g.  
reducing the  risk  of  potentially diverging outcomes of hazard/risk assessments at EU 
level).’257 On the positive side, however, the ‘good  and  effective  cooperation  between  
the  SCCS  and  the  SCHEER  is ensured via the establishment of the Inter-committee 

255  Entries 51 and 52 of Annex XVII of REACH. 

256  Report  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  and 
Social  Committee  and  the  Committee  of  the  Regions.  Findings  of  the  Fitness  Check  of  the  most 
relevant  chemicals  legislation  (excluding  REACH)  and  identified  challenges,  gaps  and  weaknesses 
COM(2019) 264 final, SWD(2019) 199 final, p. 8. 
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52019DC0264&from=EN 

257  Report from the Commission … , p. 8. See footnote above. 

84 

 
                                                           
 
Coordination  Group  (ICCG)  which  deals  with    (amongst    others)    matters    relating    to  
harmonisation  of  risk  assessment  and  diverging scientific  opinions.’258 

In  risk  management  there  are  inconsistencies  reported  regarding  the  protection  of 
vulnerable groups of the population such as children.259 Civil society groups and NGOs 
highlighted  a  ‘lack  of  an  overarching  approach  to  the  protection  of  vulnerable  groups’ 
which ‘could lead to different levels of protection between different pieces of legislation 
for  the  same  vulnerable  group  (e.g.  children)’.  The  analysis  of  risk  management  for 
vulnerable groups260 showed ‘that  not  all  pieces  of  legislation  within  the  scope  of  
this  FC [Fitness Check] take into account  risks  to  vulnerable  groups.  Where  such  
risks  are  taken  into  consideration,  the definition  of  vulnerable  populations  covered  
varies    as    there    is    no    horizontally    applicable  definition  of  'vulnerable  group'.  This 
means  that  risks  for  such  groups  are  addressed  on  case-by-case      basis      through   
product/risk/sector      specific      legislation      taking      into      consideration  circumstances,  
products  or  environments  of  chemical  exposure  that  could  lead  to  different level of 
protection across the legislation.’ On the other hand, ‘the  assessment … did not come to 
a conclusion on the extent of the issue and if, in practice, risks to vulnerable populations 
are  not  sufficiently  well  addressed  and  managed  because  of  these  legislative  gaps  and 
inconsistencies.’261 

5.4.3.  Are  there  different  limit  values  for  chemicals  in  other  EU  or  national 

legislation?  

Limit  values  for  chemical  substances  in  toys  are  not  only  provided  by  the  Toy  Safety 
Directive but also by other pieces of EU legislation. For example, the limit value for the 
CMR DEHP 262 under the Toy Safety Directive is the ‘relevant concentration’ in the CLP 
Regulation,  according  to  Annex  II,  Part  III,  point  4(a)  of  the  Directive.  That  ‘relevant 
concentration’  is  the  generic  concentration  limit  for  reprotoxic  substances  in  the  CLP 
Regulation  and  is  0,3%.263  On  the  other  hand,  REACH  limits  DEHP  in  toys  (and 
childcare articles) to 0,1%.264  

258  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. 
Accompanying the document Report from the Commission … (see footnote 220), p. 77. 
https://eur-lex.europa.eu/resource.html?uri=cellar:e7eb0a70-9757-11e9-9369-
01aa75ed71a1.0001.02/DOC_1&format=PDF 

259  Report from the Commission …, p. 9. See footnote above. 

260  Commission Staff Working Document …, p. 90. See footnote above. 

261  Commission Staff Working Document …, p. 92. See footnote above. 

262  Di-(2-ethylhexyl)  phthalate (CAS No 117-81-7). Classified as reprotoxic category 1B in Regulation 
(EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending 
and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. 
OJ L 353, 31.12.2008, p. 1. 

263  Table 3.7.2 of the CLP Regulation. 

264  Annex XVII, entry 51 of REACH. 

85 

 
                                                           
 
Indeed these are different limit values for DEHP, and it may be cumbersome in practice 
to  have  to  identify  the  strictest  limit  value  before  testing  a  toy.  Nevertheless,  to  help 
finding  the  pieces  of  legislation  applying  to  toys,  a  list  of  applicable  EU  legislation  is 
available on the relevant Commission website.265 

Also  the  RoHS  Directive  applies  to  toys.  From  the  point  of  view  of  environmental 
protection, electrical and electronic equipment should not contain more than 0,1% lead in 
homogeneous materials.266 This provision has been used in particular in 2019 in a range 
of  EU  Safety  gate  RAPEX  notifications267  concerning  toys  including  electric  or 
electronic parts where the lead exceeded the limit value in the solders. 

Since solders are normally enclosed inside a toy, such levels of lead are not covered by 
the limit values for lead in the Toy Safety Directive,268 as those do not apply ‘to toys or 
components of toys which, due to  their accessibility, function, volume or mass,  clearly 
exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin’. 

Thus,  different  limit  values  may  come  from  different  protection  purposes:  health 
protection  from  the  Toy  Safety  Directive,  environmental  protection  from  the  RoHS 
Directive.  Expert  knowledge  is  thus  required  to  deal  with  the  many  aspects  of  EU 
legislation. 

Although the existence of complementary limit values for chemicals  in  different  pieces 
of  EU  legislation,  as  illustrated  above,  is  unfortunate  for  non-experts,  a  further  kind  of 
different  limit  values  is  of  some  more  concern.  An  example  is  the  limit  value  for 
cadmium in the Toy Safety Directive and in REACH. 

The Toy Safety Directive requires that no more than 17 mg/kg cadmium may migrate out 
of  the  paint  on  a  toy,269  whereas  REACH  requires  a  paint  to  contain  less  than  0,1% 
(1000 mg/kg)  cadmium.270  Since  migration  and  content  limits  cannot  be  converted  (by 
calculation) into each other, the paint on a toy has to be tested twice. This appears to be 
an unnecessary burden, since the Toy Safety Directive is already specifically designed to 
provide  for  a  safe  cadmium  limit,  and  the  REACH  cadmium  limit  therefore  cannot  be 
‘safer’. – To note that a migration limit can be as easily tested as a content limit, as long 
as a reliable test method is available, such as the test method for cadmium (and 18 further 
‘elements’) in toy safety standard EN 71-3. 

265  http://ec.europa.eu/growth/sectors/toys/safety/legislation_en  

266  Article 4(1) and Annex II of the RoHS Directive. 

267 

https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.search&ln
g=en. Search for ‘solder’ as a ‘Free text’. 

268  Limit values for lead in three kinds of toy materials; in Annex II, Part III, point 13 of the Toy Safety 

Directive. 

269  Annex II, Part III, Point 13 of the Toy Safety Directive. Column ‘mg/kg in scraped-off toy material’ in 

the table. 

270  Annex XVII, entry 23 of REACH. 

86 

 
                                                           
 
Similarly, toy jewellery such as bracelets, necklaces or rings is subject to the related lead 
migration limit value (23 mg/kg) in the Toy Safety Directive271 and to the content limit 
value (0,05% = 500 mg/kg) in  REACH.272 As explained above, toy jewellery has to  be 
tested twice although the lead limit provided in the Toy Safety Directive is considered to 
provide safety to children already. 

Furthermore,  the  REACH  restriction  for  CMRs  in  textiles273  overlaps  with  the  Toy 
Safety  Directive274  regarding  the  limits  for  the  following  metal  elements  and  their 
compounds:  arsenic,  cadmium,  chromium  VI  and  lead.  Whereas  the  REACH  content 
limit is 1 mg/kg in all cases, the Directive’s migration limits for these four elements are 
70,000 mg/kg, 17 mg/kg, 0.2 mg/kg respectively 0.053 mg/kg as of 18 November 2019, 
and 23 mg/kg, respectively. Since both sets of limits require an acidic extraction,275, 276 a 
comparison  is  approximately  possible,  and  the  stricter  limits  apply.  Nevertheless,  since 
the tests are not identical, they would both have to be carried out if legal certainty were to 
be achieved. 

Avoiding the above concerns could  be achieved  by exempting toys from  restrictions in 
other  pieces  of  legislation  when  chemicals  are  already  regulated  by  the  Toy  Safety 
Directive. An example of this is the limit value for lead in articles supplied to the general 
public in REACH,277 which is 0.05%, but which does not apply to toys.278 For this limit 
the concerned Commission services considered already in the drafting phase that lead in 
toys was sufficiently addressed under the Toy Safety Directive and that the REACH limit 
should not apply to toys. 

On  the  other  hand,  where  two  tests  have  to  be  carried  out,  it  may  be  sufficient  for  a 
manufacturer to ‘double-test’ his toy a few times to gain experience which limit value is 
more  difficult  to  comply  with  by  his  toy.  He  could  then  test  the  toys  from  series 
production only against that limit value and would be to a large extent sure that the toys 
would also comply with the other limit value. 

An incoherence that, as mentioned further above, also limits the Toy Safety Directive’s 
effectiveness are the limit values for nitrosamines and nitrosatable substances, on which 
German  legislation  is  stricter  than  the  Toy  Safety  Directive.  The  Commission  did 

271  Annex II, Part III, Point 13 of the Toy Safety Directive. Column ‘mg/kg in scraped-off toy material’ in 

the table. 

272  Annex XVII, entry 63, No 1 of REACH. 

273  Annex XVII, entry 72 of REACH.  Commission Regulation (EU) 2018/1513. OJ L 256, 12.10.2018., 

p. 1. 

274  Annex II, Part III, point 13 of the Toy Safety Directive. Column for ‘scraped-off toy material’. 

275  Explanatory guide on the restriction on CMRs 1A and 1B in textiles and clothing. 3. List of available 

analytical methods for substances covered by this restriction. 
https://ec.europa.eu/docsroom/documents/32006.  

276  EN 71-3:2019. 

277  Annex XVII, entry 63, No 7 of  REACH. 

278  Annex XVII, entry 63, No 8(k)(iii) of REACH. 

87 

 
                                                           
 
acknowledge that the stricter limits are justified on grounds of major need of protection 
of human health when allowing Germany to keep its lower national limits.279 Also, at the 
Commission’s  request,  the  lower  limits  have  been  included  in  the  related  toy  safety 
standard.280  Lowering  the  limits  in  the  Directive  would  require  an  ordinary  legislative 
procedure  since,  according  to  the  Toy  Safety  Directive,  the  Commission  is  not 
empowered to change the limits in a Comitology procedure. 

This incoherence was the most noted one with regard to chemical limit values in the 2018 
public  consultation.  To  a  lesser  extent  were  the  other  incoherencies  described  above 
equally  referred  to,  although  not  in  that  detail.  The  quantitative  evaluation  of  the 
responses  showed  that  large  parts  of  all  stakeholders,  with  the  exception  of  public 
authorities, reported to be aware of inconsistencies (table 5.17). 

Table  5.17.  Are  you  are  aware  of  any  different  limit  values  for  chemicals  in  other  EU  or  national 
legislation? (% of respondents*) 

Stakeholders responding** 

Yes 

No 

Don't know 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

60 
80 
60 
10 
70 

10 
0 
0 
30 
30 

10 
20 
0 
20 
0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

No 
opinion 
20 
0 
40 
40 
0 

To  remedy  the  noted  inconsistencies,  prior  consultation  when  establishing  new 
legislation was repeatedly recommended by stakeholders in the 2018 public consultation, 
as  well  as  the  exemption  of  toys  from  other  legislation,  in  particular  if  the  limit  in  the 
Toy Safety Directive was considered to provide safety indeed. 

Already in the 2015 external study, inconsistencies with regard to chemical limit values 
were reported.281 Finding the applicable legislation outside the Toy Safety Directive was 
considered  to  be  cumbersome,  however  the  legal  framework  should  be  maintained  in 
order to ensure the safety of the vulnerable population group that children are. 

In  the  2015  external  study282  stakeholders  suggested  a  horizontal  framework  or  the 
alignment of limit values for toys to those of food or cosmetics. They also indicated that 
chemicals in materials should be regulated, regardless of whether the materials were used 
in toys or elsewhere. 

279  Recital 78 of Commission Decision 2012/160/EU. 

280  EN 71-12:2017 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances. 

281  2015 external study, p. 96 ff. See footnote further above. 

282  2015 external study, p. 98 f. See footnote further above. 

88 

 
                                                           
5.5.  EU added value 

The Toy Safety Directive is a ‘maximum harmonisation directive’, adopted on the basis 
of  Article  95  of  the  Treaty  establishing  the  European  Community283  to  establish  an 
internal  market  for toys, both  with  regard to  the safety of toys and their  placing on the 
market. National legislation therefore cannot impose provisions that would go beyond the 
safety  requirements  for  toys  or  affect  their  placing  on  the  market.  Also  the  1988 Toy 
Safety Directive was a ‘maximum harmonisation directive’. 

The added value of the Toy Safety Directive, in comparison to individual Member State 
legislation, thus relates to the 

  same high level of protection of children’s health across the EU: consumers can trust 
that the toys they purchase have to comply with the same high safety requirements in 
any EU country; 

  economic  benefits  coming  from  a  large  harmonised  market  with  about  72 million 
children under 14 years of age.284 Manufacturers have to follow only a single set of 
requirements (a ‘one-stop shop’) when making toys for the entire EU, and importers 
and distributors equally just need to follow a single set of rules when marketing toys 
in the EU. 

Without the Toy Safety Directive, Member States would most likely establish diverging 
national rules on the safety of toys, to the detriment of internal market: 

  During the expert discussions to limit phenol in toys, two Member States insisted to 
have only a single limit value instead of the two that were eventually established: (1) 
a  limit  value  for  phenol  in  polymeric  materials,  (2)  a  limit  value  for  phenol  as  a 
preservative in aqueous toy materials;285 

  Guidance document No 18 on puffer balls and similar toys286 took several  years to 
be  adopted  by  the  AdCo.  Repeatedly,  Member  States  expressed  diverging  views 
until a compromise was found that appeared acceptable to all; 

  The  discussions  at  AdCo  meetings  and  the  almost  daily  email  exchanges  within 
AdCo  members  on  the  classification  of  products  as  toys  (or  not)  or  as  toys  for 
children under 36 months (or older) help to find common views across all Member 
States. 

These examples show that the Toy Safety Directive forces Member States to take account 
of the other Member States’ views when establishing rules under the Directive or when 
implementing  it.  Without  the  Directive,  Member  States  would  not  hesitate  to  go  their 
own  way,  leading  to  divergent  levels  of  safety  and  to  separate  national  markets.  The 
Directive thus clearly provides an EU added value through its harmonising effect. 

283 Treaty establishing the European Community (Consolidated version 2002), in OJ C 325, 24.12.2002, p. 
33–184, at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12002E%2FTXT  

284  Eurostat data of 2011. 

https://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=cens_11ag_r3&lang=en  

285  See the related amendment of the Toy Safety Directive in annex 4. 

286  https://ec.europa.eu/docsroom/documents/37141 

89 

 
                                                           
The  only  issue  hindering  the  complete  harmonisation  is  the  derogation  for  Germany 
allowing  it  to  maintain  its  national  limit  values  for  nitrosamines  and  nitrosatable 
substances;  these  limit  values  are  stricter  than  those  in  the  Toy  Safety  Directive  (see 
further above). However, the toy industry has consistently confirmed that this was not an 
issue for it. It appears therefore that in practice the derogation is not a hindrance to the 
free movement of toys throughout the EU. 

When  asked  about  the  added  value  of  the  Toy  Safety  Directive  in  the  2018  public 
consultation, all stakeholders expressed overwhelming support (100% in almost all cases; 
see annex 11, table 1).  

Inquiring  in  some  more  detail  into  the  Toy  Safety  Directive’s  added  value  for  the 
different stakeholder groups, the majority of companies agreed (or agreed even entirely) 
with  the  creation  of  a  large  market  for  toys,  the  simplification  of  trade  and  the 
harmonisation of testing methodologies and standards (80%; see annex 11, table 2). They 
were however much less convinced that the costs for the development and manufacture 
of toys would be lowered by the Directive (30%). 

Business associations’ views were similar to companies’, however their agreements were 
less pronounced (60 – 70%; see annex 11, table 3). 

Notified  Bodies  thought  that  the  Toy  Safety  Directive  has  indeed  helped  to  harmonise 
testing and standards (100%), but were less convinced that it has increased opportunities 
for conformity assessment in the EU (60%; see Annex 11, table 4). 

Public  authorities  strongly  believed  that  the  Toy  Safety  Directive  helps  harmonising 
testing methodologies and standards (90%), and they highly appreciated its added value 
for their work with other Member States (90%; see annex 11, table 5). 

Consumer organisations were quite neutral on the Toy Safety Directive’s added value for 
harmonising  tests  and  standards  (30%),  in  contrast  to  all  other  stakeholders  above  (see 
annex  11,  table  6).  They  were  also  rather  neutral  regarding  an  added  value  for  market 
surveillance (30%), as opposed to public authorities above. However they were entirely 
enthusiastic about the re-use of test reports from other consumer organisations in the EU 
(100%). 

Thus,  all  stakeholders  were  enthusiastic  about  the  EU  added  value  of  the  Toy  Safety 
Directive  in  general  (see  annex  11,  table  1),  they  linked  this  to  matters  of  their  own 
interest: 

  companies  and  business  associations  to  the  large  market  and  the  simplification  of 
trade (and to quite a majority also to the harmonisation of testing methodologies and 
standards); 

  Notified  Bodies  completely  to  the  harmonisation  of  testing  and  standards  (and  to 
quite  an  extent  also  to  the  opportunities  for  conformity  assessment  throughout  the 
EU); 

  public authorities very largely to  the harmonisation  of testing and standards and to 

their working together with authorities from other Member States, and 

  consumer organisations to the re-use of test reports from their counter parts in other 

EU countries. 

90 

 
Already in the 2015 external study, stakeholders recognised the added value of the Toy 
Safety Directive in facilitating trade and reducing trading costs in the internal market.287 
Stakeholders also  generally agreed that the Directive contributes to streamlining testing 
and standards.288 Although SMEs denounced the very high costs caused by the Directive, 
in particular due to the safety requirements, national rules were not considered to be more 
beneficial.289 

6.  CONCLUSIONS 

6.1.  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) 
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 

287  2015 external study, p. 99. See footnote further above. 

288  2015 external study, p. 100. See footnote further above. 

289  2015 external study, p. 100. See footnote further above. 

91 

 
                                                           
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. 290 

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 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 
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’.  

infringements.  Moreover,  since 

290  See footnote on 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. 

92 

 
                                                           
6.2.  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. 

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. 

6.3.  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. 

93 

 
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.  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. 

94 

 
6.4.  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. 

6.5.  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. 

95 

 
Annex 1 : Procedural information 

1.  LEAD DG, DeCIDE PLANNING/CWP REFERENCES 

Lead DG: Directorate-General for Growth - Internal Market, Industry, Entrepreneurship 
and SMEs (DG GROW); Unit D3: Biotechnology and Food Supply Chain.  

Agenda planning/work programme reference: PLAN/2018/3078 

2.  ORGANISATION AND TIMING 

Organisation  and  timing:  the  inter-service  Steering  Group  consisted  of  SG,  DG  JUST, 
DG ENV, DG TAXUD and DG SANTE. After the kick-off meeting on 18 July 2018, it 
met on 16 May 2019, 3 July 2019, 3 October 2019 and 15 October 2019. 

3.  EXCEPTIONS TO THE BETTER REGULATION GUIDELINES 

Not applicable. 

4.  CONSULTATION OF THE RSB (IF APPLICABLE) 

The  upstream  meeting  with  the  Regulatory  Scrutiny  Board  (RSB)  took  place  on  18 
October 2018 and the final meeting with the RSB after the submission of the draft Staff 
Working Document (SWD) on 20 November 2019. 

Evaluation of the Toy Safety Directive: Overview on how the comments 
and suggestions of the RSB on the draft Staff Working Document have 
been addressed in the version submitted in March 2020 

Summary of the findings 
(1) The report does not sufficiently support 
its conclusions. It does not explain well 
which evidence points to shortcomings 
in the Directive, or how benefits 
outweigh the costs. 

(2) The report notes a lack of data to 
measure the impact on children’s 
health, but does not draw lessons for 
future data collection, monitoring and 
evaluation arrangements. 

(3) The evaluation does not make clear 

why its focus is on protecting children 
from chemical risks in particular, and 
does not sufficiently explain the link to 

How the comments have been addressed 
A number of new sections were added and the existing 
sections revised in order to better support the conclusions 
and the shortcomings of the Directive. Sections ‘Benefits 
of the Toy Safety Directive’ (5.2.4) and ‘Balance of 
benefits and costs’ (5.2.5) have been revised. The 
conclusions on efficiency have been nuanced accordingly. 
Extensive considerations were added in the new section ‘Is 
the current monitoring and evaluation system fit for 
purpose?’ (5.3.4) to better identify  the limitations of the 
IDB injury database in the assessment of the impact of the 
Directive on children’s health and injuries and the 
limitations of the Safety gate RAPEX system to assess the 
impact of the Toy Safety Directive on the number of toys 
removed from the market. This section also provides ideas 
on how the IDB and the Safety gate Rapex could be 
improved. 
The focus on the protection from chemicals is now 
explained in detail in the section ‘Why focus on chemical 
safety?’ (5.1.1.1). 
The link to the internal market has been addressed in 

96 

 
 
 
the internal market. 

What to improve 
(1) The report should substantiate better its 
conclusions or make clear that some are 
tentative. The evaluation identifies a 
number of deficiencies of the Directive 
based only on the opinions of some 
Member States (e.g. regarding the age 
limit of 36 months for chemical 
exposure, the allowed concentrations of 
CMR substances, and the limits for 
nitrosamines and nitrosatable 
substances). The report should explain 
the motivation behind these opinions 
and present evidence to support these 
findings. This could be for instance new 
scientific knowledge showing that the 
provisions of the Directive are no 
longer appropriate. 

(2) The report should justify better the 

conclusion that the benefits outweigh 
the costs.  

 

‘Effectiveness related to the free movement of toys in the 
EU’ (5.1.2) where an explanation on why the two 
objectives (safety and internal market) are linked as well as 
an analysis of the internal market has been provided, 
including data on the intra-EU trade. 
The table on the intervention logic in the section ‘The 
intervention logic’ (2.1.3) has been revised to highlight 
that the differentiation between the two strategic objectives 
(safety and internal market) cannot be seen to be strict, 
since some elements are relevant for both. Moreover, it 
now includes also external factors (internet-connected 
toys, on-line sales, the 2008 economic crisis). 
How the suggestions have been addressed 
The conclusions are now more modulated in line with the 
weight of the evidence presented. 
The deficiencies identified are now motivated as follows: 
 
age limit of 36 months for chemical exposure 
Section 5.1.1.2 Is the Directive effective in protecting 
children from the risk of chemicals?, sub-section 
Chemicals in general includes ‘In the Commission 
services’ view …’ a technical-scientific 
substantiation why the 36 months limit is inadequate. 
allowed concentrations of CMR substances 
Section 5.1.1.2 Is the Directive effective in protecting 
children from the risk of chemicals?, sub-section 
CMR substances in general includes the explanation 
that the allowed concentrations aim to properly 
identify and communicate the hazards of chemical 
mixtures, but do not take account of possible 
exposures which is necessary to assess the risk; and a 
comparison table why the allowed concentrations are 
too high for child protection purposes. 
limits for nitrosamines and nitrosatable substances 
Section 5.1.1.2 Is the Directive effective in protecting 
children from the risk of chemicals?, sub-section 
Specific CMRs: Nitrosamines and nitrosatable 
substances explains that the limit for nitrosamines 
was based on a Scientific Committee opinion on 
nitrosamines in balloons (but not all toys), and that 
CEN 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. 
Section  5.2.5  ‘Balance  of  benefits  and  costs’  reports  that 
‘half  of  the  companies  and  business  associations  in  the 
2018 public consultation considered that the benefits of the 
Toy  Safety  Directive  outweigh  the  costs,  sometimes  even 
by far.’ A new paragraph has been inserted in this section 
to identify as a plausible justification to this statement the  
companies’  inner  interests  to  protect  their  reputation.  A 
paragraph has been inserted in the same section explaining 
that  it  is  not  possible  to  provide  a  quantitative  nor 
qualitative  balance  of  benefits  and  costs.  The  conclusions 
have therefore been nuanced. 

 

There is evidence that the legislation is 
costly for enterprises, in particular 
SMEs. The analysis should also discuss 
the benefits of the Directive for 
industry, considering also effects on 
reputation.  

Additional information has been added in section ‘Market 
evolution’ (2.1.1) which refers to innovation and to a low 
concentration in the toy market as well as to the fact that 
toy producers face cost and price competition to a 
significant extent. This section also indicates that the toy 
sector was attractive enough, in particular for SMEs. 

97 

 
 
 
 
 
 
 
 
 
 
 
It could also analyse whether the high 
costs had an impact on the sector, for 
instance in terms of innovation and 
concentration. 

(3) The report should draw conclusions for 
future data collection and monitoring 
and evaluation arrangements. The data 
used do not allow an assessment of the 
impact of the Directive on children’s 
health and injuries. Stakeholders and 
several earlier reports had already 
highlighted this. The report should also 
assess the quality and usefulness of the 
Member States’ reports. The evaluation 
could make more use of the available 
data on surveillance and enforcement, 
including the rapid alert system for 
products that pose a risk to health. 

(4) The evaluation should better justify its 
focus on protecting children from 
chemical risks. It should explain new 
developments and demands in this area. 
It should also consider that there are 
links between the objective to protect 
children’s health and the functioning of 
the internal market for toys. It could 
develop the analysis of market 
surveillance and assess the 
standardisation system. 

Section ‘Balance of benefits and costs’ (5.2.5) was also 
revised. It reports now that almost 10% of new companies 
have joined the toy sector during the five years from 2013 
– 2017, despite the costs linked to the application of the 
Toy Safety Directive, reported to be higher than under the 
predecessor Directive. 

A paragraph has been added in section ‘Benefits of the toy 
safety directive’ (5.2.4): as indicated by companies and 
business associations/organisations in the context of the 
public consultation (see Annex 2), among the benefits of 
the Toy Safety Directive is the fact that the CE mark is 
considered as helpful when selling toys to customers and 
outside the EU, which can be seen as evidence that the CE 
marking brings an added value to the companies in terms 
of reputation. 
A new section ‘Is the current monitoring and evaluation 
system fit for purpose?’ (5.3.4) was added. It provides 
some ideas on why the current monitoring does not work. 
This new section has also assessed the data quality of the 
Member States’ 5-yearly reports, showing that data 
reporting is insufficient. 

Section ‘Is the Directive effective with regard to 
surveillance?’ (5.1.3) explains the sometimes limited 
usefulness of Member States’ reports, but also uses them 
to calculate market surveillance’s effectiveness when 
checking dangerous toys and to highlight what hampers 
the effectiveness of the Directive in the practice of market 
surveillance. 

Limitations of the Safety gate RAPEX data to detect an 
impact of the Toy Safety Directive have now been 
described in the revised section ‘Data on marketing 
restrictions for toys’ (4.3.2): No impact detectable as of 
mid-2011 (application of the Directive’s new requirements 
except the chemical requirements) and as of mid-2013 
(application of the Directive’s new requirements on 
chemicals). 
New section ‘Why focus on chemical safety?’ (5.1.1.1) 
added to the Effectiveness assessment. 

Link between the maximum harmonisation of safety 
requirements and the free movement in the internal market 
explained in ‘Effectiveness related to the free movement of 
toys in the EU’ (5.1.2) where an explanation on why the 
two objectives (safety and internal market) are linked has 
been provided. 
New Regulation on Market Surveillance and Product 
Compliance and its link to market surveillance of toys 
addressed in 
 

‘The intervention logic’ (2.1.3), sub-section 
‘Baseline and points of comparison’; 
‘Is the Directive effective with regard to 
surveillance?’(5.1.3) 
‘Costs related to different provisions of the Toy 
Safety Directive’ (5.2.1.3). 

 

 

Standardisation system: 

98 

 
 
 
 
 
 
 
  Effectiveness of toy safety standards addressed in 
‘Are standards effectively supporting the safety of 
toys?’ (5.1.1.4) 

  Costs of toy safety standards addressed in ‘Costs 
related to different provisions of the Toy Safety 
Directive’ (5.2.1.3). 

The SWD explains in ‘The intervention logic’ (2.1.3), sub-
section  ‘Baseline  and  points  of  comparison’,  the  baseline 
and clarifies the difficulties related to the identification of 
points  of  comparison  for  some  new  requirements  of  the 
Toy Safety Directive. 

The  SWD  now  includes  changes  to  the  Commission 
proposal  for  the  2009  Toy  Safety  Directive  in  ‘The 
intervention  logic’  (2.1.3),  sub-section  ‘Baseline  and 
points  of  comparison’,  as  regards  several  provisions  on 
chemicals.  Also  the  sub-section  ‘CMR  substances  in 
general’  refers  to  new  elements  inserted  in  the  proposals 
during  the  law-making  process,  as  well  as  sub-section 
nitrosatable 
‘Specific  CMRs:  Nitrosamines 
substances’. The new section ‘Has the law-making process 
affected  the  effectiveness  of  the  Toy  Safety  Directive?’ 
(5.1.5)  refers  in  addition  to  provisions  on  warnings  and 
instructions  and  safety  information  added  during  the  law-
making process. 
Non-expert language used as much as possible, with 
concrete examples for illustrative purposes. 

and 

(5) The report could discuss to what extent 
using the 2008 impact assessment as a 
benchmark for the analysis is adequate. 

The report should assess whether the 
changes introduced to the 2009 
Commission proposal during the 
legislative process affect the Directive’s 
relevance and effectiveness. 

(6) The report should aim for a convincing 
narrative with a non-expert audience in 
mind. 

On  27  April  2020  the  RSB  delivered  a  positive  opinion  on  the  resubmitted  evaluation  staff 
working document (SWD) which included recommendations on how the SWD can still be further 
improved and invited the evaluation team to consider these recommendations in the final version 
of the SWD. 

Evaluation of the Toy Safety Directive: Overview on how the 
recommendations of the RSB on the draft Staff Working Document 
have been addressed in the revised version (June 2020) 

Summary of the findings 
The conclusions are not comprehensive and do 
not fully reflect the analysis. They do not 
sufficiently draw out policy lessons for the 
future. The report does not present conclusions 
on the effectiveness in protecting children 
from risks other than chemicals, on enhancing 
the internal market for toys, or related to the 
standardisation system. The conclusions do 
not reflect the findings related to data 
collection, monitoring and evaluation 
arrangements. 

The report does not present a clear conclusion 
on the impact of the Directive on trade 

How the comments have been addressed 
The conclusions have been extended so as to cover all the 
main points raised in the analysis.  

The specific findings raised by the RSB on the 
effectiveness in protecting children from risks other than 
chemicals, on enhancing the internal market for toys, on 
the standardisation system and on data collection, 
monitoring and evaluation arrangements have been 
integrated in the conclusions of the revised SWD. 

Policy lessons for the future where have been drawn out 
where relevant (for example, regarding the protection 
from chemicals in toys where urgent action is deemed 
essential, see 6.1). 
Section ‘Effectiveness related to the free movement of 
toys in the EU’ (5.1.2) includes conclusions on the 

99 

 
 
 
 
 
What to improve 
(1)  The report should integrate the findings 

of its improved analysis in the 
conclusions, in particular on the 
effectiveness in protecting children from 
risks other than chemicals, on the 
internal market for toys, and on the 
standardisation system. The conclusions 
should also reflect the findings related to 
data collection, monitoring and 
evaluation arrangements. 

(2)  The report should be cautious in using 
figures on new companies to justify the 
conclusions on efficiency. The report 
uses figures from a flyer of the toy 
industry to argue that the Directive has 
not prevented companies from entering 
the toy market. Figures from such non-
authoritative sources should be 
interpreted with caution, unless they can 
be further substantiated. 

(3)  The report should present clear 

conclusions on the impact of the 
Directive on trade. 
The report presents an analysis 
suggesting that the Directive may have 
reduced imports of toys, although the 
results should be interpreted with 
caution. On the other hand, the report 
also suggests that the Directive has not 
hindered intra-EU export of toys covered 
by the Directive. It could expand how 
this has helped the competitiveness of the 
EU industry. The report should discuss 
these findings and reflect them in the 
conclusions. 

(4)  The evaluation could further analyse the 
stakeholders’ views about perceived 
incoherencies in the area of chemicals, as 
expressed in the 2018 public 
consultation. The report now concludes 
that the Directive is coherent, because 
stakeholders did not substantiate their 
claims. 

(5)  Finally, the conclusions should more 

clearly draw out the main lessons learnt 
that require policy-makers’ attention. 

Directive’s effects on trade. 
How the suggestions have been addressed 
Specific findings on the effectiveness in protecting 
children from risks other than chemicals, on enhancing 
the internal market for toys, on the standardisation system 
and on data collection, monitoring and evaluation 
arrangements have been integrated in the conclusions of 
the revised SWD (see 6.1 and 6.3). 

 A new paragraph has been introduced in the analysis 
(see  2.1.1) as well as in the conclusions (see 6.2) 
referring to the fact that an increase of economic activity 
on toys could also be seen in the steep increase of intra-
EU toy exports from 2012 – 2016, hinting to a certain 
increase of competitiveness of EU economic operators. 
This finding is based on figures coming from an 
authoritative source such as Eurostat (see figure E2), 
which supports the data provided by the toy industry. 
Data on number of manufacturers of toys and games from 
Eurostat was added to further substantiate the findings. 
Additional analysis on firm profits were added in the 
efficiency section. 
A new paragraph has been inserted in section 4.3.3 
indicating that during the slight decrease of toy imports 
into the EU between 2010 and 2013, possibly related to 
the application of the Toy Safety Directive, intra-EU toy 
exports increased by some 20% (figure E.2 ). This might 
suggest a potentially higher competitiveness of EU toy 
manufacturers during the first years of application of the 
Directive, presumably through their better access to first-
hand information and their subsequent quicker adaptation 
to the requirements of the new Directive. 

A paragraph has been added in both in the analysis and in 
the conclusions (see 5.2.6 and 6.4) to explain that there 
are no two chemical limit values for toys that would 
contradict each other (apart from the limit values for 
nitrosamines and nitrosatable substances) and that 
stakeholders may however have understood the question 
in a wider sense. 

Where  relevant,  the  main  lessons  learnt  that  require 
policy-makers’  attention  have  been  drawn  out  in  the 
conclusions,  for  example  regarding  the  protection  from 
chemicals in toys where urgent action is deemed essential 
(see 6.1). 

5.  EVIDENCE, SOURCES AND QUALITY 

The  evaluation  was  based  on  a  variety  of  sources,  ranging  from  a  public  consultation 
targeting  different  stakeholders  (EU  citizens,  consumer  organizations,  business 
authorities,  Notified 
associations, 

companies/business  organizations,  national 

100 

 
Bodies/others),  previous  studies  and  impact  assessment,  an  external  study  as  well  as 
literature, open on-line sources and publicly available reports, including national reports 
by Member States. The main source of information were the stakeholder consultations. 

The two main studies used for the purpose of the present evaluation are the following: 
-  Evaluation  of  the  benefits  and  the  costs  generated  by  the  Toy  Safety  Directive:  a 
supply side analysis  (JRC study) by the Joint Research Centre, Competence Centre 
on Microeconomic Impact Evaluation (October 2019); 

-  Evaluation of directive 2009/48/EC on the safety of toys – Final Report (2015 study) 

by Technopolis (December 2015). 

General  market  information  was  collected  from  the  European  industry  associations' 
publications and from Eurostat. More detailed cost related information was collected via 
a specific survey of economic operators.  

The robustness of the consultations:  

  During  the  preparatory  phase,  the  evaluation  team  used  existing  studies/impact 
assessment, reports by Member States and meeting documents of the Expert Group 
on  Toy  Safety  to  prepare  the  next  steps  in  the  evaluation.  The  work  resulted  in 
questionnaires for the targeted survey and the public consultation.  

  The  evaluation  team  (1.5  persons)  was  assisted  by  a  steering  group  (7  people) 
composed  of  representatives  of  different  Commission  directorates-generals  who 
participated  in  the  5  meetings  organised  by  the  evaluation  team  and  monitored  the 
development  of  the  Roadmap,  the  consultation  strategy,  the  questionnaires  for  the 
public consultation and were regularly consulted on the different versions of the staff 
working document.  

  The evaluation team received the scientific support from the Competence Centre on 
Microeconomic  Evaluation  (CC-ME)  of  Unit  JRC.I.1  that  produced  a  study  on  the 
quantification  of  costs  and  benefits  of  the  Toy  Safety  Directive.  The  data  were 
primarily taken from the Bureau Van Dijk Orbis database. 

  The  public  consultation  was  widely  publicised  not  only  via  institutional  channels 
(such as via the Expert Group on Toy safety) but also via indirect channels (such as 
promotional campaign on social media) to unlock the potential of stakeholders who 
initially had not engaged in the evaluation process.  

  Contributions  by  industry  appear  to  be  coherent  and  representative  for  the  sector, 
whereas the information collected via the questionnaires is not representative of the 
majority  of  them.  The  open  consultation  resulted  in  112  replies  and  confirmed  the 
information already obtained from economic operators and national authorities.  

  By  triangulating  data  from  the  targeted  survey,  the  JRC  study  and  the  open  public 
consultation, it has been possible to identify divergences between the data collected 
through the different tools.  

101 

 
 
 
 
 
  Compliance costs appear to be limited: however, information related to market size 
and  compliance  costs  need  to  be  interpreted  with  care  and  should  be  seen  as 
indications of an order of magnitude rather than as precise estimates. 

102 

 
 
Annex 2: Stakeholder consultation 

Synopsis report on the stakeholder consultations for the evaluation of 
the Toy Safety Directive 

I.  Introduction 

The stakeholder consultations for the evaluation of the Toy Safety Directive 2009/48/EC 
began in 2014 with the work of an external contractor and continued until March 2019291 
under an internal evaluation by the Commission services.  The evaluation exercise was to 
assess  the  performance  of  the  Toy  Safety  Directive  in  relation  to  its  objectives  of  a) 
ensuring a high level of safety of toys with a view to ensuring the health and safety of 
children, and b) of guaranteeing the functioning of the internal market for toys. 
As highlighted in the Roadmap,292 the consultation involved collecting input from a wide 
range  of  stakeholders:  general  public  including  consumers;  authorities  in  28  Member 
States  and  in  the  EEA-EFTA  countries;  industry  including  SMEs:  manufacturers, 
importers, distributors; consumer associations: ANEC (The European consumer voice in 
standardisation),  BEUC  (The  European  Consumer  Organisation).  Notified  Bodies:  NB-
Toys Group; European Standardisation organisations: CEN, CENELEC. 

Both public and targeted consultations were undertaken: 

  A Roadmap describing the context,  purpose and scope of the evaluation  as well as 
the stakeholders involved and the data collection and methodology to be used, was 
published in July 2018 and was open for feedback during 4 weeks;  

  A public consultation was launched in September 2018 on the Commission’s central 
consultation  web page ‘Have  your say’293  for 12 weeks in  23 EU languages.  It  was 
promoted  by  widely  informing  Member  States  and  other  stakeholders  concerned 
with toy safety. 

  A targeted consultation with economic operators to collect detailed data on costs and 
benefits related to the Directive was launched in early February 2019 and was open 
during 6 weeks. 

  Within the external study started in 2014, direct interviews with economic operators, 
the  relevant 

consumer  representatives, 
European Standardisation Organizations (ESOs) were conducted. 

laboratories'  representatives  and 

test 

This  Synopsis  Report  summarises  and  analyses  the  contributions  received  in  the 
consultations  mentioned  above.  These  analyses  were  used  to  assess  the  effectiveness, 

291  The cut-off date was 29 March 2019. Stakeholder contributions received by the Commission after that 

date could not be taken into account in preparing this document. 

292  See https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-3667279_en . 

293  https://ec.europa.eu/info/law/better-regulation/have-your-say  

103 

 
 
                                                           
efficiency,  coherence  with  other  legislation  (whether  EU  or  Member  States'  national 
legislation), relevance and EU added value of the Toy Safety Directive. 

In  the  consultation  process,  stakeholders  put  forward  a  number  of  proposals  to  modify 
and extend the scope of the Toy Safety Directive, to include products such as childcare 
articles. These were outside of the scope of the current evaluation/consultation and might 
be  taken  into  consideration  in  the  future.  All  other  messages,  however,  have  been 
summarised in the relevant sections below. 

II. Stakeholder consultation in the external 2015 evaluation 

An external study of the Toy Safety Directive, requested by the Commission, was carried 
out  by  an  external  contractor  in  2014  and  2015.  It  was  to  assess  the  Toy  Safety 
Directive’s  relevance  in  addressing  current  needs,  its  effectiveness  and  efficiency  in 
meeting its objectives, its coherence with the EU legislative framework relevant for toys 
and its EU added value. 

A total of 47 face-to-face and skype interviews were carried out in 2015 by the external 
contractor  with  relevant  stakeholders  of  which:  14 
industry  associations;  20 
manufacturers  (both  large  and  SMEs);  5  distributors;  3  consumers’  associations;  2 
Notified Bodies; 2 standardisation organisations; 1 expert on toy safety 

The evaluation has shown that the Toy Safety Directive is relevant and effective for the 
safety  and  the  economic  sector  of  toys:  it  sets  EU  wide  requirements  for  all  economic 
operators  concerned  with  toys  and  provides  specific  provisions  addressing  at  least  all 
major risks related to toys. Moreover, the Toy Safety Directive does not seem to hinder 
the  import  of  toys  into  the  EU  market.  Only  few  contributions  suggested  that  costly 
safety requirements would hinder toy innovation.  

While economic operators and the majority of Member States are generally satisfied with 
the Toy Safety Directive’s performance, consumer associations and a few Member States 
are  more  sceptical  about  the  Toy  Safety  Directive’s  capacity  to  properly  deal  with  all 
aspects  of  toy  safety.  In  particular,  they  deem  limit  values  for  chemicals  as  either 
inadequate or missing.  

The  ‘grey  area’  between  toys  and  ‘not-toys’,  the  existence  of  different  testing 
methodologies and the lack of adequate resources at the disposal of national Competent 
Authorities emerged as the main issues hindering a consistent implementation of the Toy 
Safety Directive by the Member States. Whilst the costs related to chemical requirements 
are  deemed  proportionate  by  stakeholders  who  consider  them  as  justified  for  achieving 
children’s  safety,  major  inefficiencies  stem  from  shortcomings  in  the  Toy  Safety 
Directive enforcement, which induce implementation bottlenecks and useless delays.  

Policy recommendations of the 2015 external study concern soft regulatory measures to 
maximise  the  Toy  Safety  Directive’s  performance.  They  include:  an  effective 
communication  system  between  all  stakeholders  concerned  with  the  Toy  Safety 
Directive,  including  an  ‘ad  hoc  queries  system’  empowering  stakeholders  who  face  a 
specific issue to ask how other actors have managed it in the past or in other contexts; a 
common  market  surveillance  framework,  including  minimum  standards  on  market 
controls;  a  common  procedural  framework  for  conformity  assessment,  including 
minimum standards to be referred to when assessing the conformity of toys by means of 
the  EC-type  examination;  measures  aiming  to  improve  the  Toy  Safety  Directive’s 

104 

 
provisions, such as  the assessment  of both  the need for stricter chemical  limits and the 
feasibility of using new technologies such as QR codes for warnings; measures aiming at 
improving  the  Toy  Safety  Directive’s  working  mechanisms,  including  the  balanced 
involvement  of  all  stakeholder  categories  concerned  with  the  Toy  Safety  Directive  and 
the systematic monitoring of injuries and accidents due to toys;  incentives to economic 
operators to better comply with the Toy Safety Directive, such as subsidies for research 
activities aiming to stimulate innovation that may be currently hindered by the high costs 
needed for performing both safety and conformity assessments of toys.  

Finally, the evaluation suggests to proceed with the international alignment of toy safety 
beyond  Europe.  This  would  ease  both  the  stakeholders’  understanding  of  the 
requirements they are subject to and the trade of toys, since safety parameters would be 
equal irrespective of the place where toys are produced. 

III. Consultation on the Roadmap (July-August 2018) 

The  Roadmap  for  the  commission  internal  evaluation  was  published  in  July  2018  and 
was open for  feedback on the Commission’s central  consultation  web page ‘Have  your 
say’ for 4 weeks. A total of 9 responses were received (from 2 consumers’ associations, 
3 industry associations, 2 Notified Bodies, 1 citizen and 1 Member State).  

-  3 stakeholders called for compulsory third party testing for toys rather  than relying 
on  post-market  surveillance,  especially  in  areas  of  higher  risk  associated  with  toys 
for  the  most  vulnerable  children  under  36  months  of  age.  To  this  purpose  they 
suggested that the evaluation also look at the conformity assessment procedure since 
the  high  non-compliance  levels  are  directly  linked  to  the  existing  provisions  on 
conformity assessment;  

-  3  stakeholders  advocated  a  strengthening  of  chemical  requirements  for  toys,  in 
particular  CMRs  and  endocrine  disruptors,  as  well  as  a  broadening  of  the 
Comitology in order to set limits also for toys for children above 36 months of age 
(other than those intended to be placed in the mouth);  

-  2 stakeholders highlighted the need of better market surveillance on toys to step up 
the  number  of  controls  before  toys  are  placed  on  the  market,  improve  traceability 
and accountability along the supply chain - including toys that are sold online - and 
systematically collect information about accidents with toys through a Pan-European 
Accident and Injury Database; 

-  4 stakeholders were concerned that the current legal framework and its definition for 
a  ‘safe’  toy  does  not  unequivocally  cover  Internet-connected  toys  and  related 
security  threats:  they  requested  that  the  scope  of  the  Toy  Safety  Directive  be 
extended to include new safety requirements on information security; 

-  Further  proposals  put  forward  by  one  stakeholder  include  the  need  to  refer  to  the 
current Cosmetics Regulation (instead of the old Cosmetics Directive), a clarification 
of  Annex  B  ‘Classification  of  substances  and  mixtures’,  an  alignment  of  the  Toy 
Safety  Directive  to  the  new  standard  EN  71-1:2014+A1:2018:  all  of  these  would 
need a revision of the Toy Safety Directive via the Ordinary  Legislative Procedure 
(OLP); 

105 

 
-  Further  requests  from  stakeholders  relate  to  the  introduction  of  limits  to  impulse 
noise  levels  in  toys  and  of  specific  requirements  for  visibility  and  legibility  of 
warnings on toys  (e.g. a minimum  letter size) in  order to  enable Member States to 
enforce these requirements in a uniform way. 

IV. Open public consultation (September – December 2018) 

1.  Origin of the replies 

to 

the  Open  Public  Consultation  were  mainly  provided  by 
The  116  replies 
companies/business  organisations  and  public  authorities  (28%  and  27%,  respectively), 
followed  by  EU  citizens  (22%).  Fewer  replies  came  from  business  associations  (10%), 
Notified Bodies (7%) and consumer organisations (5%). 

By  country  of  origin,  the  largest  number  of  replies  came  from  Spain  (with  29 
contributors), Germany (17), Belgium (10), Italy (10) and the Netherlands (6).  

2.  Feedback from the contributors (except individual consumers) 

Effectiveness  

The majority of consumer organisations considered that to some extent, the Toy Safety 
Directive certainly brought improvements to toy safety in the EU, but they all agreed that 
the  Toy  Safety  Directive  definitely  has  helped  to  ensure  the  free  movement  of  toys 
throughout the EU by harmonising rules and procedures for placing toys on the market. 
Most  of  them  were  aware  of  problems  implementing  or  enforcing  the  Toy  Safety 
Directive  in  the  Member  States.  Regarding  the  possible  solutions  to  overcome  the 
problems,  consumer  organisations  considered  as  most  helpful  to  ensure  better 
collaboration  between  market  surveillance  authorities,  including  customs,  in  different 
Member  States.  To  make  the  Toy  Safety  Directive  more  effective  all  consumer 
organisations  considered  a  list  of  chemicals  permitted  in  toys  (‘positive  list’)  as  the 
highest  priority.  The  second  highest  priority  was  to  improve  communication  and 
collaboration  amongst  stakeholders  and  with  the  European  Commission.  Almost  all 
consumer organisations were of the opinion that an EU Regulation on toy safety would 
be more effective than the current  EU Directive to  ensure a high level  of protection of 
children and the marketing of toys throughout the EU. 

The  majority  of  business  associations  considered  that  the  Toy  Safety  Directive  has 
helped to improve the safety of toys placed on the market to a large or moderate extent. 
Half  of  the  business  associations  agreed  that  the  Toy  Safety  Directive  has  helped  to 
ensure  the  free  movement  of  toys  in  the  EU,  however,  interpretational  differences  and 
national  deviations  are  still  to  be  solved.  A  large  majority  reported  problems  with  the 
implementation and enforcement of the Toy Safety Directive in the Member States, the 
most  significant  problem  being  market  surveillance  authorities  acting  differently  in 
different  Member  States.  To  overcome  these  problems  they  indicated  that  it  would  be 
most  helpful  to  establish  rules  to  better  control  internet  shops  and  to  ensure  better 
collaboration  between  authorities  in  different  EU  countries.  To  make  the  Toy  Safety 
Directive more effective they suggested an improvement of the guidance documents on 
the  Toy  Safety  Directive  as  well  as  better  communication  and  collaboration  amongst 
stakeholders and with the European Commission. 

106 

 
Two thirds of the responding companies/business organisations considered that the Toy 
Safety Directive has helped to improve the placing on the market of toys and their free 
movement  throughout  the  EU  to  a  large  or  moderate  extent.  Less  than  half  of  them 
acknowledged the existence of problems  in  the implementation and enforcement of the 
Toy  Safety  Directive,  the  most  relevant  problems  being  that  market  surveillance  is  not 
always targeting the ‘bad guys’ and that Internet toy shops are not effectively controlled. 
The  proposed  solutions  to  those  problems  were  in  line  with  the  problems’  own  nature: 
market  surveillance  should  focus  more  on  the  ‘bad  guys’,  better  surveillance  rules  for 
internet shops should be established and better collaboration between market surveillance 
authorities  in  different  EU  countries  should  be  ensured.  Priorities  to  enhance  the  Toy 
Safety  Directive’s  effectiveness  were  identified  in  the  following  improvement  of 
guidance documents on  the Toy Safety Directive and communication and collaboration 
amongst stakeholders and with the European Commission. 

Public  authorities,  by  a  large  majority,  considered  the  Toy  Safety  Directive  to  have 
helped  improving  the  safety  of  toys  placed  on  the  market  and  ensuring  the  free 
movement  of toys throughout  the EU. However, two-thirds of them signalled problems 
of implementation or enforcement of the Toy Safety Directive. The two most outstanding 
problems mentioned were the understaffing of the authorities, including customs, and the 
fact  that  under  the  Toy  Safety  Directive  Internet  toy  shops  cannot  be  effectively 
controlled.  Predominant  solutions  suggested  by  respondents  were  the  following 
establishing  rules  to  better  control  internet  shops  and  providing  more  staff  for  market 
surveillance authorities, including customs. To boost the effectiveness of the Toy Safety 
Directive,  public  authorities  clearly  preferred  two  actions,  consisting  in  improving  the 
guidance  documents  on  the  Toy  Safety  Directive  and  the  communication  and 
collaboration amongst stakeholders and with the European Commission. 

The majority of Notified Bodies considered that to some extent, the Toy Safety Directive 
certainly brought improvements to toy safety in the EU, and to a moderate extent that the 
Toy  Safety  Directive  has  definitely  helped  to  ensure  the  free  movement  of  toys 
throughout the EU by harmonising rules and procedures for placing toys on the market. 
Most of them encountered problems in  the implementation  of the Toy Safety Directive 
arising from the conformity assessment of toys. They identified two significant problems: 
1) manufacturers apply for an EC-type examination when their toys do not comply with a 
referenced harmonised standard; 2) there are issues arising from the guidance documents 
for  the  harmonised  application  of  the  Toy  Safety  Directive.  Among  the  solutions  to 
overcome  those  problems,  they  suggested  to  issue  guidance  documents  at  EU  level  for 
Notified  Bodies  and  a  better  exchange  of  information  between  Notified  Bodies  about 
conformity assessments carried out. 

Efficiency  

Concerning the possible benefits of the Toy Safety Directive, consumer organisations 
agree that the warnings  are now more visible than those under the preceding Directive. 
They also consider the safety assessment to be a good tool to ensure the safety of toys, 
that standards and testing methodologies have improved since the date of application of 
the Toy Safety Directive, and also that the detailed provisions in the Toy Safety Directive 
guarantee a level  playing field  as well as  legal  certainty.  As concerns possible  costs of 
the  Toy  Safety  Directive,  consumer  organisations  considered  that  purchasing  the 
necessary standards and adapting toys to amendments of the Toy Safety Directive is very 
costly. They also stated that standards with test methods become available too late after 

107 

 
the  Toy  Safety  Directive  is  amended.  Nonetheless,  5  out  of  6  consumer  organisations 
declared that the benefits of the Directive outweigh the costs.  

The  most  costly  issues  identified  were  the  following:  getting  information  on  a  toy’s 
supply  chain,  checking  compliance  with  the  Toy  Safety  Directive  requirements  and 
enforcing  the  Toy  Safety  Directive  in  online  sales.  The  majority  of  consumer 
organisations  considered  that  the  Toy  Safety  Directive’s  requirements  are  adequate  to 
ensure the safety of toys and their free movement throughout the EU. 

Business  associations  considered  the  following  to  be  the  highest  benefits  of  the  Toy 
Safety  Directive:  the  detailed  provisions  in  the  Toy  Safety  Directive  guarantee  a  level 
playing field and ensure legal certainty, the safety assessment is a good tool to ensure the 
safety of toys and the CE mark is helpful when selling toys to consumers. 

With regard to possible costs of the Toy Safety Directive, business associations reported 
that  manufacturers  had  to  invest  in  technical  and  human  resources  to  adapt  to  the  new 
requirements  of  the  Toy  Safety  Directive,  and  that  the  technical  documentation  causes 
significant costs. In addition, they highlighted the costs for adapting to the amendments 
of  the  Toy  Safety  Directive.  Among  the  most  costly  issues,  business  associations 
identified  the  following:  taking  account  of  all  safety  requirements  and  generating  the 
technical documentation and the EC-type examination certificate. 

The  majority  of  company/business  organisations  agreed  predominantly  with  the 
following  benefits  of  the  Toy  Safety  Directive:  the  safety  assessment  is  a  good  tool  to 
ensure the safety of toys, the CE mark is helpful when selling toys to consumers and the 
detailed  provisions  in  the  Toy  Safety  Directive  ensure  legal  certainty.  On  the  possible 
costs of the Toy Safety Directive, the majority of company/business organisations agreed 
to the largest extent that the technical documentation causes significant costs and that it is 
costly  to  adapt  to  amendments  of  the  Toy  Safety  Directive,  that  the  costs  of 
manufacturing toys have increased compared to those under the preceding Directive and 
that  manufacturers  had  to  invest  in  technical  and  human  resources  to  adapt  to  the  new 
requirements  of  the  Toy  Safety  Directive.  Contributors  identified  as  most  costly  issues 
the  following  ones:  getting  supply  chain  information;  generating  the  technical 
documentation;  generating  an  EC-type  examination  certificate;  taking  account  of  all 
safety requirements. 

Public authorities valued the following statements highest with regard to the benefits of 
the Toy Safety Directive: the safety assessment is a good tool to ensure the safety of toys, 
the  CE  mark  on  toy  helps  authorities  in  their  market  surveillance  activities  and  the 
detailed  provisions  in  the  Toy  Safety  Directive  ensure  legal  certainty.  Standards  and 
testing methodologies have improved compared to those under the preceding Directive. 

With regard to possible costs of the Toy Safety Directive, responding public authorities 
expressed that purchasing the necessary standards is  expensive for market  surveillance. 
In addition, they stressed that it is also costly to adapt to amendments of the Toy Safety 
Directive. 

Among the most costly issues, public authorities identified the following: enforcing the 
Toy  Safety  Directive  in  online  sales,  getting  the  safety  assessment  and  the  technical 
documentation  from  the  economic  operator,  missing  standard  test  methods.  Finally,  a 
clear majority of public authorities considered, to a large or a moderate extent, that the 

108 

 
Toy  Safety  Directive’s  requirements  ensure  both  the  safety  and  the  free  movement  of 
toys throughout the EU.  

The  majority  of  the  responding  Notified  Bodies  agreed  mainly  with  the  following 
statements  concerning possible benefits  of the Toy Safety Directive:  warnings  are now 
better visible than those  under the preceding  Directive, the safety assessment  is  a good 
tool  to  ensure  the  safety  of  toys,  standards  and  testing  methodologies  have  improved 
compared to those under the preceding Directive and the safety requirements of the Toy 
Safety Directive are aligned with the latest technical and scientific developments. 

The  majority  of  the  Notified  Bodies  agreed  with  the  following  statements  concerning 
possible costs of the Toy Safety Directive: testing costs have increased compared to the 
preceding Directive, standards with test methods become available too late after the Toy 
Safety  Directive  is  amended  and  Notified  Bodies  had  to  invest  in  technical  and  human 
resources to adapt to the new requirements of the Toy Safety Directive. Notified Bodies 
identified  the  most  costly  issues  in  this  order:  developing  a  new  test,  adapting  to  new 
requirements of the Toy Safety Directive and to a new harmonised standard. 

Relevance 

All  responding  consumer  organisations  considered  the  Toy  Safety  Directive’s 
requirement  that  toys  be  safe  to  be  relevant  to  a  large  extent  and  recognised  the  high 
relevance of the Toy Safety Directive to include detailed requirements on toys. Most of 
them  indicated  that  the  changes  to  the  Toy  Safety  Directive  do  not  at  all  appropriately 
reflect all the latest technical, scientific and social developments and that the Toy Safety 
Directive has no simple and easy possibility for changes. 

All  responding  business  associations  considered  that  the  Toy  Safety  Directive’s 
requirement  for  toys  to  be  safe  is  relevant  to  a  large  extent  but  only  a  majority 
acknowledged  the  high  relevance  of  the  Toy  Safety  Directive  to  include  detailed 
requirements  on  toys.  A  majority  of  associations  believed  that  the  changes  to  the  Toy 
Safety  Directive  appropriately  reflect  all  the  latest  technical,  scientific  and  social 
developments.  

A  majority  of  company/Business  organisations  confirmed  the  high  relevance  of  the 
requirement  of  toys  to  be  safe  and  underlined  the  high  relevance  that  the  Toy  Safety 
Directive include detailed requirements for toys.  However, only some of them believe to 
a  large  extent  that  the  changes  to  the  Toy  Safety  Directive  appropriately  reflect  all  the 
latest technical, scientific and social developments.  

The  overwhelming  majority  of  public  authorities  considered  that  the  Toy  Safety 
Directive’s  requirement  of  toys  to  be  safe  is  relevant  to  a  large  extent  and  a  large 
majority  underlined  the  high  relevance  of  the  Toy  Safety  Directive  to  provide  detailed 
requirements on toys. However, not all public authorities believed that the changes to the 
Toy Safety Directive reflect all the latest technical, scientific and social developments.  

Almost  all  Notified  Bodies  considered  that  the  Toy  Safety  Directive’s  requirement  of 
toys  to  be  safe  is  relevant  to  a  large  extent.  They  commented  that  the  safety  objective 
should be the priority in setting  all the other requirements. However, they  also thought 
that Third Part testing would be beneficial for toy safety, as the US example would show. 
All of them supported the high relevance of the Toy Safety Directive to include detailed 
requirements on the safety of toys, but only some of them believed that the changes to the 

109 

 
Toy  Safety  Directive  reflect  all  the  latest  technical,  scientific  and  social  developments. 
They  commented  that  as  the  design  of  toys  is  continuously  changing  (in  particular 
concerning  digitalisation)  and  different  products  increase  exponentially,  it  should  be 
made easier to update certain parts of the Toy Safety Directive.  

Coherence  

Most  of  the  responding  Consumer  organisations  stated  that  they  are  aware  of 
contradictions/overlaps/inconsistencies/missing  links  between  the  Toy  Safety  Directive 
and  other  legislation  in  the  EU  or  in  the  Member  States.  For  example,  the  majority  of 
them reported being aware of different limit values for chemicals in other EU or national 
legislation.  

of 

business 

large  majority 

of 
A 
contradictions/overlaps/inconsistencies/missing  links  and  expressed  their  awareness  of 
different limit values for chemicals in other EU or national legislation. To bring the Toy 
Safety  Directive  more  in  line  with  other  EU  or  national  legislation,  respondents 
suggested the adoption of a EU Regulation instead of a Directive 

associations 

aware 

stated 

being 

Only a slight majority of company/business organisations stated that they are aware of 
contradictions/overlaps/inconsistencies/missing  links  between  the  Toy  Safety  Directive 
and other legislation in the EU or in the Member States. A majority of them expressed 
awareness of different limit values for chemicals in other EU or national legislation.  

Less  than  one  third  of  the  responding  public  authorities  stated  that  they  are  aware  of 
contradictions/overlaps/inconsistencies/missing  links  between  the  Toy  Safety  Directive 
and other legislation in the EU or in the Member States. Only a few of them expressed 
their awareness of different limit values for chemicals in other EU or national legislation.  

of 

half 

the  Notified  Bodies 

Over 
of 
contradictions/overlaps/inconsistencies/missing  links  between  the  Toy  Safety  Directive 
and  other  legislation  in  the  EU  or  in  the  Member  States  and  reported  different  limit 
values for chemicals in other EU or national legislation, such as on bisphenol A (BPA), 
plasticisers and nitrosamines.  

awareness 

expressed 

their 

EU added value  

All consumer organisations agreed that it is better for toy safety and the marketing of 
toys  in  the  EU  to  have  the  Toy  Safety  Directive  than  having  individual  Member  State 
laws,  but  they  were  rather  neutral  on  the  harmonisation  effects  of  the  Toy  Safety 
Directive  on  testing  methodologies  and  standards  and  the  facilitation  of  market 
surveillance across Member States. 

Also  all  responding  business  associations  preferred  the  Toy  Safety  Directive  over 
individual Member State legislation with regard to toy safety and the marketing of toys in 
the EU. They  considered a EU Directive to  give legal  certainty for intra-EU trade,  and 
individual  Member  State  legislation  impractical.  The  majority  of  them  agreed  that  the 
Toy Safety Directive creates a large market for the same toy, simplifies the trade of toys 
in the EU and helps harmonising testing methodologies and standards. 

Almost all company/business organisations considered the Toy Safety Directive to be 
better for toy safety and the marketing of toys in the EU than having individual Member 

110 

 
State legislation. However, not all of them agreed that the Toy Safety Directive creates a 
large  market  for  the  same  toy,  simplifies  the  trade  of  toys  in  the  EU  and  helps 
harmonising  testing  methodologies  and  standards.  They  also  commented  that  the  Toy 
Safety  Directive has been taken as  a model for  many  countries for their own standards 
and that it is a world-class legislation adopted or imitated by several third countries; that 
it facilitates trade with non-EU countries since the high level of toy safety is well-known 
in those countries. 

Almost all public authorities declared that it is better for toy safety and the marketing of 
toys in the EU to have the Toy Safety Directive, which is applicable throughout the EU, 
than having individual Member State legislation. Concerning the EU added value of the 
Toy Safety Directive, the clear majority of public authorities agreed that the Toy Safety 
Directive  helps  to  harmonise  testing  methodologies  and  standards  and  that  exchanges 
between  market  surveillance  authorities  from  other  Member  States  are  useful  for  their 
own work, as well as joint projects with them. 

Notified Bodies unanimously declared that it is better for toy safety and the marketing of 
toys  in  the  EU  to  have  the  Toy  Safety  Directive,  than  having  individual  Member  State 
legislation. The majority of them agreed that the largest  added value of  the Toy Safety 
Directive is to help harmonising testing methodologies and standards. They commented 
that the Toy Safety Directive is not about opportunities but about legal compliance and 
protection and improving the safety of citizens, and that EC-type examination could be 
an added value when enforced by the authorities for high risk products or new products. 

3.  Feedback from Consumers 

Consumers were asked to answer questions particularly adapted to their situation, which 
is different from that of the other stakeholders consulted. 

A  clear  majority  of  consumer  respondents  considered  that  the  toys  sold  in  the  EU  are 
safe  to  a  large  or  a  moderate  extent.  Consumers generally  expressed  concern  about  the 
safety  of  toys  imported  in  the  EU,  including  when  purchased  online.  Only  half  of  the 
respondents recognised that the Toy Safety Directive has helped to reduce the number of 
toy-related injuries, at least to some extent.  

A  clear  majority  reported  reading  all  the  information  on  a  toy  packaging  carefully,  the 
‘3 years  age  warning  symbol’  was  correctly  recognised  by  all  consumers  as  being 
required for toys not intended for children under 3 that might however be dangerous for 
those children.  

A large majority reported that they correctly recognised the meaning of the symbol ‘CE’ 
on  toy  packaging.  The  majority  of  consumers  expressed  not  having  encountered  any 
problems with unsafe toys. Small parts from toys were reported to cause problems. 

Half of the consumers indicated that they contacted the supplier or retail shop in case of 
an unsafe toy, and only few of them contacted a consumer association. A large majority 
had never encountered a recall of a toy.  

Most respondents declared buying toys online, considering that these toys sold online are 
safe  to  a  large,  moderate  or  some  extent. Some  reported  buying  toys  only  from  known 
brands and dealers. 

111 

 
A  slight  majority  of  consumers  considered  that  the  Toy  Safety  Directive  ensures  that 
children across the EU have an equal level of protection.  

V. Targeted stakeholder consultation (February-March 2019) 

The  survey  targeted  toy  manufacturers,  importers  and  distributors  and  was  run  on  the 
EUSurvey Platform. Responses arrived between 14 February 2019 and 29 March 2019. 
The participation in the survey was voluntary, therefore its results are an indication and 
are not representative in statistical sense. The questionnaires, once finalised, were sent to 
TIE  and  uploaded  in  CIRCA  asking  TIE  and  the  members  of  the  Expert  Group  to 
disseminate them. 

The  Commission  received  32  replies:  26  from  toy  manufacturers  (81%),  5  from  toy 
importers  (16%)  and  1  from  a  toy  distributor.  Five  additional  replies  did  not  provide 
answers to any of the questions and thus were not taken into account.  Most replies came 
from  Spain  and  the  Netherlands  (22%  or  7  replies  each).  All  respondents  in  the 
importers’ and distributors’ group and 60% in the manufacturers’ group were SMEs. All 
respondents stated that their company was established before 2011 – meaning that they 
had experience with the current Toy Safety Directive. 

In response to the question ‘Have you experienced any significant change in the price of 
toys in general since the Toy Safety Directive became fully applicable in July 2013?’ half 
of  respondents  reported  price  increases  while  the  other  half  saw  no  significant  price 
changes294. The requirements of Toy Safety Directive were chosen as the most significant 
reason  for  price  increases,  followed  by  increased  complexity  of  toys,  higher  quality, 
impact  of  external  factors  (such  as  crisis),  and  higher  transport  cost.  The  Toy  Safety 
Directive  requirements  were  chosen  as  the  most  significant  reason  by  all  the  analysed 
groups: manufacturers, importers/distributers, large companies and SMEs 

Manufacturers agreed that constant changes to the Toy Safety Directive requirements are 
a cause of continuous new costs. They also agreed that their costs increase with stricter 
requirements  and  the  number  of  different  toys  they  produced.  There  was  general 
agreement that SMEs have difficulties dealing with the costs imposed by the Toy Safety 
Directive. More specifically all respondents agreed that the lack of standards or the fact 
that standards are not referenced on time are causing additional costs, due to the fact that 
EC-type examination becomes necessary. Almost all stated that restrictions on the use of 
certain  chemicals  induce  additional  costs.  Nearly  all  stated  that  distributors  in  the  EU 
request  test reports even if they are not  necessary, however it seems  that in  most cases 
test from laboratories outside EU are accepted.  

On the other hand, concerning the benefits of Toy Safety Directive, almost all agreed that 
performing  a  safety  assessment  of  a  toy  allows  them  to  focus  on  the  relevant  safety 
aspects of the toy. And 70% agreed that safety assessments help them to reduce costs. 

Almost  all  manufacturers  (91%)  stated  that  their  production  costs  had  increased  since 
July  2013,  while  the  remaining  9%  said  the  costs  had  not  changed.295  The  new 

294  52% of respondents (15 answers) reported price increase and 48% (14 answers) price decrease. 

295  21 answers and 2 answers, respectively. 

112 

 
                                                           
requirements of the Toy Safety Directive were quoted as the most significant reason for 
production cost increases. 

One  off  costs  of  adapting  to  the  new  Toy  Safety  Directive  requirements  (such  as  e.g. 
hiring new staff or investment in technical resources) were reported on average as about 
2%  of  annual  turnover.  Technical  resources,  such  as  software  to  measure  chemical 
substances or an IT system, were among the most costly investments that companies had 
to carry out in order to comply with Toy Safety Directive 

VI. National reports on the application of the Toy Safety Directive. 

Reporting on the application of the Toy Safety Directive is an obligation under Article 48 
of the Toy Safety Directive. The first five-yearly reports (2009-2014) were submitted by 
all  Member  States  in  2014.  The  second  reporting  period  for  the  years  2014-2018  ran 
between 28 May 2019 – when the questionnaires were sent to the Member States – until 
the  deadline  of  20  July  2019.  However,  some  contributions  were  received  after  the 
deadline. 

The questionnaire included questions concerning the national legislation transposing the 
Toy  Safety  Directive  as  well  as  its  amendments  (notably,  the  difficulties  encountered 
institutional  and 
when  transposing  the  Directive  into  national  legislation),  the 
administrative  arrangements  at  national  level,  the  evaluation  of  the  national  situation 
concerning  the  safety  of  toys  and  the  effectiveness  of  the  Directive  (definition  of  toy,  
safety  requirements,    warnings,  EC  declaration  of  conformity,  safety  assessment,  CE 
marking,    conformity  assessment,  technical  documentation,  procedure  for  dealing  with 
toys presenting a risk and EU safeguard procedure, the exchange of information between 
member  States  and  the  Committee  Procedure).  Questions  on  market  surveillance 
activities  were  also  covered  by  the  questionnaires  for  Member  States,  notably  on 
enforcement,    co-ordination,  co-operation  and  exchange  of  information  within  the 
Member  State,  statistics  on  the  market  surveillance  activities  carried  out  for  the  period 
2014 – 2018, RAPEX data and cooperation with Third Countries. 

The Member States’ reports will feed into the summary that the Commission is to draw 
up and publish according to the above mentioned Article 48 of the Toy Safety Directive. 

113 

 
 
Annex 3: Methods and analytical models 

1. Process/Methodology 

1.1. Desk research 

The  desk  research  relied  on  existing  documents  at  the  international,  EU  and  national 
level  provided  by  the  European  Commission  and  identified  by  means  of  due  diligence 
work and internet search. These documents included relevant literature on toy safety and 
the sector, the policy context and the legal framework of reference. 

1.1.1. Literature on toy industry and safety issues 

Sources 

As regards the toy industry, the main source of information has been the ECSIP Report 
(2013), as it specifically focuses on the toy industry. 

The  source  of  data  used  for  the  market  analysis  in  the  2015  Final  Report  on  the 
Evaluation of Directive 2009/48/EC on the Safety of Toys is the Amadeus – Bureau Van 
Dijk  database.  Specifically,  the  analysis  in  the  context  of  that  evaluation  was  based  on 
the  following  sample  groups:  162  companies  classified  as  ‘Manufacture  of  games  and 
toys’  (NACE  32.4);  25,845  manufacturing  companies  located  in  the  28  Member  States 
(with the exclusion of toy-manufacturing companies) and 785 manufacturing companies 
located outside the EU.  

Evidence on toy safety issues was collected starting from RAPEX notifications filtered 
by ‘risk category’. The filtering process allowed for aggregation and ranking of the main 
risk  categories.  The  research  has  then  been  oriented  towards  the  existing  relevant 
literature on the main risk categories as resulting from the RAPEX notification analysis. 

As for the emerging issues related to toys, the initial input on their relevance was found 
in the 2008 Impact Assessment and in the ECSIP Report, eventually finding confirmation 
in the literature review. The literature ranged from articles, scientific papers and reports, 
studies  -  press  releases,  data  and  alerts  for  dangerous  products  (e.g.  RAPEX  weekly 
reports296)  elaborated  by  relevant  organisations  at  EU  level  -  such  as  PROSAFE, 
EuroSafe, Toy Industries of Europe (TIE) among others. 

Use 

The relevant  literature fed the initial  framing of the current  safety risks, of the toy free 
movement and of the emerging issues related to toys.  

Amadeus has been used to conduct the market analysis, as presented in section 6.3.1.3 of 
the 2015 evaluation  report of the Toy Safety Directive. The aim of the market  analysis 

296 

https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.listNotific
ations&lng=en  

114 

 
 
                                                           
was  to  triangulate  the  stakeholders’  perceptions  on  the  costs  entailed  by  the  Directive 
with statistical data in order to find out any correlation between the increase of costs and 
the  entry  into  force  of  the  Toy  Safety  Directive.  In  other  words,  the  objective  was  to 
understand whether costs have increased because of the Directive or due to other external 
variables.  The  comparison  of  costs  entailed  by  the  Toy  Safety  Directive  with  the 
reasonability of these costs as perceived by stakeholders enhanced the overall evaluation 
of the Directive’s efficiency. 

1.1.2. Policy framework 

Sources 

Insights  on  the  policy  context  have  been  gathered  through  relevant  information 
concerning infringement procedures and the ongoing work of the European Commission 
and  of  Member  States  on  toy  safety,  NB-Toys  protocols  and  recommendations,  the 
requests for standardisation and the amendments to the Toy Safety Directive. 

Another  information  source  to  understand  the  current  policy  context  consisted  in  the 
national reports drafted by national competent authorities, which constitute an obligation 
under the Toy Safety Directive 

Use 

Infringement  procedures  and  court  cases  have  been  used  to  understand  the  level  of 
harmonisation  achieved  across  Member  States.  This  has  also  helped  to  understand  the 
stances of many economic operators on possible limitations to the free movement of toys. 
The ongoing work of the European Commission on toy safety and related documents has 
been  crucial  to  identify  the  Directive’s  adaptation  mechanisms  and  to  understand  the 
extent to which they relate to the evolving context. As a source for the desk research, the 
2014  national  reports  are  used  in  the  analysis  of  toy  free  movement.  Moreover,  the 
national reports provide findings on the Directive’s implementation and enforcement as 
presented in  section 3, expressing the perspective of public authorities dealing with  the 
Directive. The national reports submitted in 2019 have also been used for the purpose of 
the current evaluation. 

1.1.3. Legal framework 

Sources 

The  legal  framework  included  the  legislation  relevant  for  toys,  as  provided  in  DG 
GROW website and listed in the box below. 

115 

 
Box 3 - EU legislation relevant for the toy industry 

  Directive 94/62/EC on packaging and packaging waste;  
  Directive 2004/108/EC on the approximation of the laws of the Member States relating 

to electromagnetic compatibility and repealing Directive 89/336/EEC (EMC);  

  Directive  2006/66/EC  on  batteries  and  accumulators  and  waste  batteries  and 

accumulators and repealing Directive 91/157/EEC;  

  Directive  2006/95/EC  on  the  harmonisation  of  the  laws  of  MS  relating  to  electrical 

equipment designed for use within certain voltage limits;  

  Directive 2008/98/EC on waste and repealing certain Directives;  
  Directive 2011/65/EU, on the restriction  of the use of certain  hazardous substances in 

electrical and electronic equipment (RoHS);  

  Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) (recast);  
  Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to 

electromagnetic compatibility (recast);  

  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 (R&TTE);  

  Regulation (EC) No 850/2004 on persistent organic pollutants and amending Directive 

79/117/EEC;  

  Regulation (EC) No 1935/2004 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 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 1907/2006;  
  Regulation No 1223/2009 on cosmetic products;  
  Regulation  (EU)  No  10/2011  on  plastic  materials  and  articles  intended  to  come  into 

contact with food.  

Use 

The  legal  framework  was  of  crucial  importance  to  analyse  possible  overlapping  and/or 
duplications between the Toy Safety Directive and other EU or Member State legislative 
acts. More in general, the analysis of the legal framework helped understand the overall 
EU approach to the safety and the sector of toys. 

1.2. Stakeholder consultations 

Sources 

The  stakeholders’  consultations  relied  both  on  a  public  consultation  and  on  a  targeted 
survey of relevant economic operators, aimed at collecting data on the costs entailed by 
the Toy Safety Directive. 

116 

 
 
Moreover,  within  the  framework  of  the  2015  external  study,  direct  interviews  with 
economic  operators,  consumer  representatives,  test  laboratories'  representatives  and  the 
relevant European Standardisation Organizations (ESOs) were conducted. 

A  Synopsis  Report  summarising  the  results  of  different  consultations  activities  is 
included in Annex 2. 

Further  information  on  key  stakeholders  to  be  involved  has  been  collected  in  the  desk 
research.  

In  the  open  public  consultation,  questionnaires  have  been  tailored  to  different 
stakeholders’  roles  and  stakes.  This  has  further  facilitated  the  triangulation  of  data  and 
information with the aim of ensuring as much transparency and reliability as possible to 
the evaluation.   

Use  

Based  on  the  in-depth  literature  review,  the  relevant  issues  for  the  evaluation  process 
have been identified. The questionnaires served the purpose of confirming, investigating 
and better understanding the main topics that emerged from the desk research. Firstly, the 
replies  to  the  stakeholders’  consultations  provided  the  stakeholders’  perspective  on  the 
Toy Safety Directive, including suggestions, difficulties and requests on the main issues 
considered during the evaluation process. Furthermore, they allowed for triangulation of 
information among different categories of actors.  

To conclude, it is worth underlining that the relatively low number of responses received 
has  not  represented  a  significant  research  constraint.  While  some  divergences  emerged 
among  the  opinions  expressed  by  different  stakeholder  categories,  a  high  homogeneity 
has  been  observed  within  each  category.  Stakeholders  belonging  to  the  same  category 
largely  agreed  on  the  main  topics  addressed  in  the  questionnaires  and  no  major 
contradiction  has  been  raised.  Therefore,  a  larger  number  of  respondents  would  only 
have been of limited added value.  

2. Limitations – robustness of findings  

As  specified  in  section  1.2,  the  evidence  collected  in  this  report  is  based  on  the 
application of the Toy Safety Directive since mid-2011, when the Directive's provisions 
entered  into  application297.  The  evidence  is  even  more  recent  for  chemicals  provisions 
that  were  to  be  applied  only  as  of  mid-2013.  However,  many  of  the  elements  assessed 
under  the  current  evaluation,  such  as  the  principle  of  free  movement  of  toys  in  the 
internal  market,  were  already  present  in  the  previous  Directive.  Therefore,  many 
observable  outputs  and  outcomes  cannot  be  attributed  exclusively  to  the  application  of 
the new Toy Safety Directive because a direct link could be established with provisions 
already in force when the new Toy Safety Directive started to apply. 

2.1. Lack of statistics on toy-related injuries  

The  IDB  is  currently  the  largest  and  best  available  source  of  information  on  accidents 
and injuries in Europe. 

297  With reference to the market analysis mainly grounded on ECSIP (2013), data are previous to 2011. 

117 

 
                                                           
The  IDB  contains  data  on  accidents  and  injuries  from  selected  emergency  departments 
(ED)  of  hospitals  in  EU  Member  States  from  1996.  Patients  are  surveyed  to  gather 
information  on  the  cause  of  the  injury  and  accident  (activity  when  the  injury  occurred, 
area, unintentional, intentional injuries, etc.) and their socio-demographic characteristics 
(age, gender, country, etc.). 

The  IDB is  hosted by the European Commission  (EC), and was set  up by  DG SANTE 
under  the  injury  prevention  programme,  in  order  to  provide  central  access  to  the  data 
collected by the MS under the European home and leisure accident surveillance system 
(EHLASS) programme. (EuroSafe 2016). 

The  IDB started in  1996 for the first  countries participating  and is  currently the largest 
and more detailed database on injuries in Europe covering all types of injuries. 

Collection  of  data  is  managed  at  the  Member  State  level.  In  particular,  Member  States 
participate on a voluntary basis and are free to select the hospitals (ED units) from which 
the data is collected but need to ensure the representativeness of the event recorded.  

2.1.1  Evaluation strategy 

To measure the causal impact of the Toy Safety Directive on the reduction of toy-related 
accidents, one would need a detailed database tracing the toy from its country of origin 
(manufacture) and entrance into the internal market until its use by the child and observe 
the potential occurrence of injury or accident due to this specific toy. 

One also  needs  to  take into  account  that the impact  of the Toy Safety Directive on toy 
related injury might be measurable from one to several years after the introduction of the 
Toy Safety Directive i.e. the time elapsed between the introduction of the safe toy on the 
market, the use of the child, and the expected occurrence of an accident.  

2.1.3  Information needed and collected in the IDB 

The  evaluation  of  the  effectiveness  of  the  Toy  Safety  Directive  on  toy-related  injuries 
could,  in  principle, benefit  from  the data collected by the  IDB-FDS  because any injury 
event  is  linked  to  the  external  circumstances  that  led  to  the  injury  and  to  the  involved 
products.  

Data  collected  on  toy-related  or  child-product  related  injuries  need  to  be  representative 
and comparable over time and across countries. The available information should allow 
to observe and quantify the Toy Safety Directive impact (if existent) in at least over a 5 
year-window around the introduction date of the Toy Safety Directive in 2011. In other 
words, one would need a longitudinal dataset of injury-records by MS and for each year 
from at least 2005 to 2016. 

2.1.4  Limitations of the IDB in the evaluation of Toy Safety Directive 

The  IDB-FDS  collects  harmonised and detailed information  about  the product  category 
involved  in  the  injury.  However,  the  product  (brand,  identifier)  is  not  identified  in  a 
systematic  and  homogeneous  way.  This  information  is  only  available  for  some  limited 
cases  through  additional  details  recorded  in  narratives  (free  text  fields).  As  a 
consequence,  the  distinction  between  safe  and  unsafe  toys  leading  to  injuries  is  not 
possible.  

118 

 
A bigger concern is the quality, the consistency and the representativeness of the sample 
over time and across country of the IDB-FDS. Data collected are very heterogeneous: the 
number of hospitals participating varies across time and countries, and are from different 
types (children hospitals, general hospitals etc.). In consequence, not all types of injuries 
are  recorded  across  time.  In  addition,  data  for  some  countries  is  only  recorded  for  a 
couple of years; some Member States dropped out of the EU-IDB despite continuing to 
collect similar data for national use. 

However,  the  records  of  unintentional  injuries,  home  and  leisure  injuries  or  injuries 
affecting  children  only  are  of  better  quality  and  availability  than  the  other  types  of 
injuries.  Therefore,  for  the  purpose  of  the  Toy  Safety  Directive  evaluation  focusing  on 
toy- and children-related injuries, the IDB data is potentially appropriate. 

The  information  on  hospitals  (hospital  identifier)  started  to  be  recorded  in  2009  at  the 
earliest; in most cases it is only available since 2012. The evaluation of the Toy Safety 
Directive  would  require  information  on  hospitals  in  the  years  before  and  after  the 
introduction of the Toy Safety Directive (hospital identifier, type of hospital). 

The quality of the data and the amount of records is also increasing over time; however, 
even  in  recent  years,  the  number  of  hospitals  participating  in  the  IDB  is  small  and 
national FDS samples are often not representative at the national level (EuroSafe 2017a, 
EuroSafe  2017b).  This  is  a  big  impediment  to  the  use  of  this  data  for  evaluation 
purposes. 

2.1.5  Results of the detailed investigation298 

Given  the  limitations  of  the  IDB  described  in  the  preceding  section,  one  alternative 
strategy could be to select those countries with the best level of information. This would 
limit  the  data  to  two  or  three  countries  out  of  26.  For  these  countries,  counterfactual 
impact  evaluation  methods  (such  as  a  difference-in-difference  strategy)  could  be 
attempted  to  measure  the  impact  of  the  Toy  Safety  Directive  on  toy-related  injuries  a 
reasonable degree of confidence. 

In the remaining of this subsection, the results of a more detailed feasibility investigation 
are presented and aim at  replying to  the following questions: (1) are there a number of 
Member States with a representative sample of injury records? (2), and is the time period 
covered for those Member States long enough? (5 years window around the introduction 
of the Toy Safety Directive)  

Sample selection 

In the  analysis, only records related to  unintentional  injuries, due to  child products  and 
for  individuals  under  14  years  old  were  selected.  This  sample  represents  4.11%  of  the 
recorded injuries involving children under 14 years of age. 

Total number of observations 
Drop intentional injuries 
Keep location of injuries: home, school, recreational areas 
Keep injuries with activity when injured is: education, sports and 
exercise during leisure time, leisure or play 

7,717,897 
7,562,195 
3,620,658 
1,484,293 

298  For confidentiality reason, the name of the Member States has been anonymised. 

119 

 
                                                           
Injuries of individuals under 14 years old 
Keep injuries related to child products 

904,221 
37,152 
(4.11%) 

Table 1 further below displays the time period for which data is available by country and 
whether  information  on  the  hospital  identifier  is  recorded.  Countries  for  which 
information  was  available  only  before  (Country  2,  Country  3,  Country  7,  Country  8, 
Country  9,  Country  10,  Country  12,  Country  13,  and  Country  19)  or  only  after  the 
implementation of the Toy Safety Directive in 2011 (Country 4, Country 11, Country 14, 
Country  18,  Country  20,  Country  22,  Country  5,  Country  15,  and  Country  16)  were 
excluded  from  the  sample.  When  information  on  hospital  identifier  was  missing,  the 
information  gathered  in  (EuroSafe,  2017a)  was  used  to  check  whether  the  hospitals 
present in the database remained constant over the time period.  

The above criteria selected data from four countries: Country 1, Country 6, the Country 
17, and Country 21. 

Descriptive statistics on selected countries 

Similar to the strategy followed in (Dumangane et al, 2019; Guthmuller & Elia, 2018) the 
number of injury events before and after the introduction of the Toy Safety Directive in 
2011 due to different child product categories were compared, namely: 

(1) 
(2) 
(3) 
(4) 

toys as defined in the Directive; 
public playground equipment; 
child equipment (or baby and child article) and  
other  type  of  specified  child  products  (as  defined  in  the  IDB,  EuroSafe  (2013) 
code 06.98). 

Figure  1  reports  the  proportion  of  events  by  child-product  categories  among  the  total 
number of events involving children younger than 14 years of age for each year. 

For  Country  1,  the  Country  17,  and  Country  6,  the  time  series  starts  in  2008/2009, 
whereas  for  Country  21  it  starts  in  2002.  The  number  of  child  product  related  injuries 
seems  to  remain  constant  in  the  longest  time  series  available  (Country  21).  The  data 
exhibits no peaks/or decreases around the year 2011 and/or 2013, or thereafter until 2017. 
The proportion of injuries follows a decreasing trend over the entire period. This pattern 
is similar in Country 1 and in the Country 17.  

In  the  Country  17,  there  seems  to  be  a  decrease  in  injury  events  involving  public 
playground  in  2013-2014.  However,  this  decrease  is  not  present  in  Country  1  and  in 
Country  21.  The  shorter  time  period  covered  by  the  data  in  Country  6  does  not  allow 
drawing any conclusion related to child-product related injuries. If the number of child-
product recorded injury event differs (Country 1 with approx. 15 events on average per 
year,  the  Country  17,  Country  6,  and  Country  21  approx.  100  in  average  per  year,  see 
Figure  A  in  Appendix),  the  proportion  of  child-product  related  injury  event  ranges 
between 0.01% and 0.04% amongst the total of injury events involving children younger 
than 14 years of age. 

In  total,  and  with  regard  to  the  two  objectives  of  this  investigation,  the  overall  data 
quality  (heterogeneity  in  the  type  of  injury  event  collected  by  each  Member  State)  and 
the insufficient number of time periods of data collected in most of the Member States in 

120 

 
 
the IDB does not permit a robust quantification of the impact of the Toy Safety Directive 
on toy-related injuries. 

Table 1: Countries and timeline of data collection 
Time period of data availability 
Country 
1996 – 2016 
Country 1 
1996 – 1999 
Country 2 
2006 – 2009 
Country 3 
2009 – 2013 
Country 4 
2006 – 2016 
Country 5 
1996 – 2014 
Country 6 
1996 – 2001 
Country 7 
1996 – 1998 
Country 8 
1996 – 2007 
Country 9 
1996 – 2001 
Country 10 
2013 
Country 11 
1996 – 2002 
Country 12 
1996 -1998, 2002, 05, 14 
Country 13 
2013- 2016 
Country 14 
2005 – 2016 
Country 15 
2006 – 2015 
Country 16 
1996 – 2016 
Country 17 
2013 
Country 18 
1996 – 1998 (2006) 
Country 19 
2012- 2013 
Country 20 
1996 – 2017 
Country 21 
2003 – 2016 
Country 22 

Information on hospital identifier 
2009 – 2016 
No information 
2009 and 2013 
No information 
2009 – 2016 
2009 – 2014 
No information 
No information 
No information 
No information 
No information 
No information 
2014 
2013 – 2016 
2010 – 2016 
2009 – 2015 
2009 – 2012 
2013 
No information 
No information 
2009 – 2017 
2009 – 2016 

Country 1 

Country 6 

Country 17 

Country 21 

Figure 1: Proportion of injuries event related to infant and child product by subtypes 
Note: Toy (code 06.02), Playground equipment (code 06.03), children equipment (bay 
baby and child article, code 06.01), other specified infant and child product (code 
06.98) 

121 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
2.2.  Lack of statistics on costs caused by the Toy Safety Directive 

The  2015  evaluation  of  costs  and  burdens  caused  by  the  2009  Toy  Safety  Directive  is 
mainly qualitative. A more quantitative approach was indeed not feasible in the context 
of that evaluation, mainly because of the lack of data on costs induced by the Directive. 
The lack of statistics could have been compensated by a large survey to collect data, but 
this was not in the scope of the evaluation. As a result, the available information made it 
difficult to obtain exhaustive and comprehensive information on costs supported by firms 
to comply with the Directive’s requirements. Furthermore, this kind of information was 
not provided in the national reports, thus preventing the quantification of costs borne by 
Member  States.  Finally,  there  are  a  number  of  factors  (e.g.  new  technical  or  scientific 
developments, changes in the price of raw materials) that can influence production costs. 
As a consequence, economic operators were not always able to distinguish cost increases 
directly caused by the Directive from those induced by exogenous factors. 

The  2015  study  missed  a  serious  quantification  of  cost/benefits  (data  was  based  on  50 
interviews) and this is particularly important given the fact that the IA supporting the Toy 
Safety Directive provided quite a lot of data, for example,:  

  Cost and benefits related to chemical requirements; 
  Costs and benefits related technical file requirements; 
  Costs  related  to  labelling  (three  scenarios:  low,  medium,  high  estimates  for  each 

company size: small, medium, multinational); 

  Costs  related  to  choking  risk  requirements(three  scenarios:  low,  medium,  high 

estimates for different company size: small and multinational); 

  Costs related to affixing CE- marking; 
  Costs related to conformity assessment procedures; 
  3  case  studies  (small,  medium  and  multinational  company)  concerning  costs  of 

proposed modifications. 

The cost quantifications in the 2008 IA were based on two support studies, the first one 
being Europe Economics 2007 (chemical requirements costs), where the calculations are 
based  on  stakeholder  consultation  (experts  and  survey).  The  other  study  (RPA.  2004) 
provided 3 case studies (copied to IA) and an estimate of costs related to non- chemical 
requirements  (calculations are based on three hypothetical case studies and stakeholder 
survey) 

The 2015 external study had therefore to be supplemented by a quantitative analysis.  A 
study was therefore commissioned to the Commission’s Joint Research Center (JRC) on 
the cost-benefits quantification in the framework of the evaluation of Toys Directive in 
order to: 

  check the existing literature  
  verify the costs and benefit methodology used in IA (ad replicate of feasible);  
  check to what extent the estimated impacts have been materialised.  

Further  information  could  also  be  found  in  other  sectorial  evaluations  produced  by 
GROW/ENV, such as the Fitness check on chemicals legislation (excluding REACH)299 

299 http://ec.europa.eu/growth/sectors/chemicals/ec-support_en  

122 

 
                                                           
–  which  also  includes  a  case-study  on  toys  –  and  the  ECHA  Forum  joint  market 
surveillance action.300 

In order to fill in this data gap, a targeted survey for economic operators was undertaken 
which  provided  32  responses  (26  from  toy  manufacturers,  5  from  toy  importers  and  1 
from a toy distributor). See following section 3 below for further details. 

3.  Analysis of impact of the Toy Safety Directive on costs and prices 

Analysis  are  based  on  the  results  of  targeted  survey  (see  also  annex  2)  and  data  from 
Eurostat.  It  must  be  noted  that  results  of  the  targeted  survey  are  not  representative  in 
statistical sense and are based on a very small number of replies. Therefore, although the 
evaluation team tried to  extrapolate these numbers, the results must be treated as a ball 
park  estimate,  an  indication  of  the  magnitude  of  cost  rather  than  an  actual  statistical 
figure. 

3.1. Demographics of manufacturers 

According  to  Eurostat,  in  2011  in  the  EU  there  were  around  5,000  companies  in  the 
NACE  code  C324  ‘Manufacture  of  games  and  toys’  this  number  increased  to  around 
6,000 in 2017.301  

In that NACE  code in  2016 there  were only 33  large  companies  (0.6%)  in  the EU, the 
rest  were  SMEs  (90.7%  micro  companies,  7.4%  small  and  1.3%  medium-sized).  The 
majority  of  companies  were  located  in  France,  Poland,  UK  and  Germany.  The  highest 
number of large companies was located in Germany. (Fig. 2)/ 

Fig. 2. Number of manufacturers of games and toys by country and size in 2016 

Note: Data for NACE C324 ‘Manufacture of games and toys’. Large companies employ more than 250 employees, 
medium-sized between 50 and 249, small between 10 and 49 and micro below 10. 
Source: Eurostat, Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E) 
[sbs_na_ind_r2],[sbs_sc_ind_r2]  

300  https://echa.europa.eu/-/inspectors-find-phthalates-in-toys-and-asbestos-in-second-hand-products 

301  Eurostat Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E) [sbs_na_ind_r2], Last 

update: 21-03-2019 

123 

78773259857955441737935922421119811995927471676047454240312920000100200300400500600700800900FrancePolandUnited KingdomGermanyCzechiaNetherlandsSpainItalySwedenSlovakiaHungaryRomaniaDenmarkAustriaGreeceLatviaPortugalLithuaniaCroatiaBulgariaBelgiumSloveniaFinlandEstoniaLuxembourgCyprusIrelandMaltaNo. of companiesmicro, 90.7%small, 7.4%medium-sized, 1.3%large, 0.6% 
 
                                                           
3.2. Description of respondents to the targeted survey 

The  Commission  received  32  replies:302  26  from  toy  manufacturers  (81%),  5  from  toy 
importers  (16%)  and  1  from  a  toy  distributor.  Most  replies  came  from  Spain  and  the 
Netherlands (22% or 7 replies from each). All respondents in importers and distributers 
group  and  60%  in  manufacturers  group  were  SMEs  (Fig.  X.1).  All  respondents  stated 
that their company was established before 2011 – meaning that they had experience with 
the current Toy Safety Directive. 

In case of manufacturers large companies who replied produced on average 240 toy types 
(median of 100) requiring a safety assessment, and on average around 33 million toys a 
year. SMEs produced on average 78 toy types303 (median of 30), with an average annual 
production of 3.6m. The combined EU turnover for 2017 of those toy manufacturers who 
replied  amounted  to  € 11.3billion.304  The  majority  of  that  turnover  was  generated  from 
toy sales in the EU (average 70%, median 90%) with SMEs selling more in the EU than 
the  large  firms  did.  Three  manufacturers  were  producing  toys  only  in  the  EU,  others 
produced in many EU and non-EU countries (e.g., 80% had manufacturing in China and 
20% in Vietnam). All firms were selling their toys in more than one EU country, 60% in 
the  entire  EU,  80%  in  the  US,  more  than  40%  in  Brazil,  China,  Gulf  States,  India, 
Mexico, Russia, South Africa and Turkey. 

Among the six toy importers, all were SMEs. The number of toy types requiring safety 
assessments ranged from 12 to 1,000, they import on average 3.3m toys. The combined 
EU  turnover  of  those  who  provided  it  amounted  to  € 30m.  All  were  importing  from 
China, other countries of origin included Hong Kong, Vietnam, Malaysia, USA, Mexico 
and Brazil. One importer was selling only in its country, the rest were covering two to six 
EU countries. 

The one toy distributor was a micro firm, with four toy types requiring safety assessment. 
It was selling mainly via the internet into two EU countries. 

3.3. One-off costs of adapting to the requirements of the Toy Safety Directive 

Between  2010  and  2013,  according  to  the  Eurostat  there  were  around  5,000  firms 
producing  toys  in  the  EU,  with  between  10  and  30  large  firms305  and  the  rest  SMEs. 
Large  companies  were  responsible  for  around  two  thirds  of  the  turnover  of  the  toy 
industry. 

302  Five  additional replies did not provide  answers to any of the questions and thus  were  not taken  into 

account. 

303  This average excludes one outlier who reported production of 4m toy types. 

304  Dominated by three large multinational companies who accounted for €10.6 billion 

305  Between 2010 and 2016 the number of large companies reported by Eurostat is between 10 and 30. 
The number reported for 2011 till 2013 is around 10, however for 2010 and 2015-2016 it is 30. While 
there may be different reasons for that fluctuation (e.g. it is possible that around 20 firms were on the 
threshold  and  thus  flipping  between  large  and  SMEs  category,  or  smaller  firms  could  merge,  or  big 
multinationals  could  enter  the  market)  for  the  calculations  throughout  this  period  we  assumed  that 
there were around 30 large firms. 

124 

 
                                                           
As  reported  in  section  5.2,  one-off  costs  of  large  companies  amounted  to  between  1% 
(median) and 1.7% (average) of annual  turnover, while for SMEs it  was between 2.4% 
(average) and 3% (median). 

Using Eurostat data on turnover and number of companies, we can calculate that average 
annual cost of implementing Toy Safety Directive was between € 2.1 and 3.5m per large 
firm and between € 16,000  20,000 per SME. 

In terms of the whole toy manufacturing industry the one-off cost amounted to between 
€ 140m and 200m. (table 2). 

Table 2. One-off cost of implementing Toy Safety Directive for toy manufacturers 

SME 
16,300 – 20,600 
Cost per company (€) 
Cost per toy industry (€ million) 
82 – 103  
Note: 2018 prices, average number of firms and turnover between 2010 and 2013 used, average number of large 
firms 29. Ranges based on median and average percentage of cost as reported in the targeted survey. 
Source: Own analysis based on targeted survey and Eurostat [sbs_sc_ind_r2], [prc_hicp_aind] 

Large 
2.1 – 3.5 million 
59 – 100 

All sizes 
32,300 – 36,100 
141 – 203 

3.4. Impact on prices 

According  to  Eurostat  between  2013  and  2018  all  prices  rose  by  5%  while  prices  of 
‘games,  toys  and  hobbies’  declined  by  2%.306  However  a  more  detailed  price  inflation 
index for ‘toys and celebration articles’ shows price increase from 2015 to 2018 of 4%.307 

This  is  broadly  in  line  with  the  2.9%  toy  price  increase  since  2013  reported  by 
respondents to the targeted survey. 

Price increased 
Price remained unchanged 
Price decreased 

All 
replies* 

Manu-
facturers 

Importers and 
distributors 

Large 

SMEs 

52% 
48% 

43% 
57% 

83% 
17% 

57% 
43% 

50% 
50% 

Weighted average of those who said it 
increased 
Weighted average for all 

5.6% 
2.9% 

No. of replies 
Source: Own analysis based on targeted survey 

29 

5.8% 
2.5% 

23 

5.4% 
4.5% 

6.8% 
3.9% 

5.3% 
2.7% 

6 

7 

22 

It is interesting to note that the reported cost increase was higher and amounted to 6.8%. 
This suggests that not all cost were transmitted to consumers, and companies internalised 
from  2pp  to  4pp  of  the  increased  cost.  This  can  at  least  partially  be  supported  by  an 
analysis of firm profits which dropped between 2010 and 2011 while the whole industry 
was  growing,  also  reduction  between  2012  and  2013  was  deeper  than  for  the  whole 
industry308 (Fig. Y.2).  

306  Eurostat HICP, prc_hicp_aind, last update: 17-04-2019. 
307  Eurostat HICP, prc_hicp_aind, last update: 17-04-2019, data for 2013-2015 not available. 
308  Please note that there may be many other factors explaining that difference. 

125 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
Fig. 3. Development of profit per firm since 2008 for toy producers and 
manufacturing sector  

e
g
n
a
h
c

l

s
u
p
r
u
s
g
n
i
t
a
r
e
p
o
s
s
o
r
g
f
o
%

130%

120%

110%

100%

)
1
=
8
0
0
2
(

90%

80%

70%

60%

Manufacturing sector

Toy producers

2008 2009 2010 2011 2012 2013 2014 2015 2016
Note: Gross operating surplus309 per firm in NACE C324 ‘Manufacture of games and toys’ and NACE C 
‘Manufacturing’, 2018 prices.  Source: Eurostat, [sbs_na_ind_r2], [prc_hicp_aind] 

309  Gross  operating  surplus  or  profits  is  defined,  in  the  context  of  structural  business  statistics,  as  value 

added minus personnel costs.   
 https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:Gross_operating_surplus_-
_SBS  

126 

 
 
 
 
 
                                                           
 
 
 
 
 
 
 
 
 
Annex 4: 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: 

  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)  

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

Directive (EU) 2019/1922) 

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

Directive (EU) 2018/725) 

  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)  

  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)  

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

2017/738)  

  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 

  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)  
  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 

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

Directive 2014/84/EU)  

  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)  

  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)  

  July  2013:  Revision  of  the  migration  limits  for  barium  (Commission  Regulation 

(EU) No 681/2013)  

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

2012/7/EU) 

127 

 
 
 
 
 
Annex 5: Main provisions of the Toy Safety Directive 

a. Safety requirements  
The essential safety requirements for toys are outlined in article 10(1) of the Toy Safety 
Directive. They include general safety requirements (in paragraph 2) and particular safety 
requirements (in Annex II). 
As for the general safety requirements, the Directive envisages firstly that toys have to be 
safe both for users - namely for the children playing with the toy - and for third parties 
such  as  parents,  supervisors,  other  children  or  even  complete  outsiders.  Secondly,  toys 
are required to be safe when used as intended by the manufacturer but also when used in 
other  foreseeable  ways,  bearing  in  mind  children’s  behaviour.  Thirdly,  when  designing 
and  manufacturing  a  toy,  the  ability  of  children  -  and,  where  appropriate,  of  their 
supervisors - to use it shall be taken into account, in order to properly ensure a safe use of 
the toy. 
The  particular  safety  requirements  concern  physical  and  mechanical  properties, 
flammability,  chemical  properties,  electrical  properties,  hygiene  and  radioactivity  (see 
section 2.1.2 above). 

b. Safety assessment 
Article 18 states that 'Manufacturers shall, before placing a toy on the market, carry out 
an analysis of the  chemical,  physical,  mechanical,  electrical,  flammability, hygiene and 
radioactivity hazards that the toy may present, as well as an assessment of the potential 
exposure to such hazards.’ Safety assessments are often carried out before submitting the 
toy to the conformity assessment, but may be completed at a later stage as well; in any 
case, at the latest before placing the toy on the market.  

c. Conformity assessment  
According  to  article  19,  the  conformity  assessment  aims  at  demonstrating  whether 
specified requirements relating to a toy have been fulfilled. When there are harmonised 
standards  covering  all  the  safety  requirements  relevant  for  the  toy,  and  when  the 
reference of the harmonised standards has been published in the Official Journal of the 
EU, the manufacturer can carry out  the conformity  assessment himself.  Otherwise,  and 
any time the manufacturer deems it necessary, an external conformity assessment body or 
Notified Body must be involved. When carried out by the Notified Body, the conformity 
assessment  is  called  EC-type  examination  and  it  is  accompanied  by  an  EC-type 
examination  certificate  delivered  by  the  Notified  Body  –  as  far  as  the  examination 
demonstrates  conformity  of  the  toy  with  all  relevant  requirements  (see  section  2.1.2 
above). 

d. EC declaration of conformity and CE marking  
The provisions of the Toy Safety Directive require manufacturers to sign a Declaration of 
Conformity  (DoC),  which  is  the  manufacturer's  declaration  that  the  toy  satisfies  all  the 
essential safety requirements. 
As proof it must contain the statements ‘This declaration of conformity is issued under 
the  sole  responsibility  of  the  manufacturer’  and  ‘The  object  of  the  declaration  is  in 
conformity with the relevant Community harmonisation legislation.’ The EC declaration 
of  conformity,  whose  structure  and  content  are  outlined  in  Annex  III  to  the  Directive, 
shall  be  translated  into  the  language(s)  required  by  the  Member  State  where  the  toy  is 
placed or made available on the market. 
In addition to the EC declaration of conformity, all toys made available on the EU market 
shall bear the CE marking (article 16(1)), which is to be affixed only by the manufacturer 

128 

 
or  by  his  authorised  representative.  According  to  article  17(1)  of  the  Directive  the  CE 
marking must be affixed ‘visibly, legibly and indelibly to the toy, to an affixed label, or 
to the packaging.’ Member States shall rely on it to presume that the toy is in conformity 
with the relevant safety requirements (article 16(3)).  
Article  4(3)  of  the  Directive  requires  manufacturers  to  keep  the  EC  declaration  of 
conformity for a period of 10 years after the toy has been placed on the market. Article 
6(8) requires importers to keep a copy of the EC declaration of conformity at the disposal 
of  the  market  surveillance  authorities  for  a  period  of  10  years  after  the  toy  has  been 
placed on the market. 

e. Warnings  
Article  11(1)  lays  down  the  general  rules  for  warnings  applying  to  all  toys.  Warnings 
have  to  be  used  only  where  appropriate  for  a  safe  use  and  have  to  specify  proper  use 
limitations.  Part  B  of  Annex  V  provides  specific  warnings  for  certain  categories  of 
toys.310 In particular, toys that are not suitable for children under 36 months of age shall 
bear a warning such as ‘Not suitable for children under 36 months’, or ‘Not suitable for 
children under three  years’, or a warning in the form of a pictogram. The pictogram or 
warning  text  must  be  accompanied  by  the  description  of  the  hazard  and  the  potential 
harm that makes the product unsuitable. 
As for the location of the warnings, article 11(2) states that ‘the manufacturer shall mark 
the warnings in a clearly visible, easily legible and understandable and accurate manner 
on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions 
for use which accompany the toy’.  

f. Traceability  
Traceability,  which  is  ‘the  ability  to  trace  the  history  of  the  product’,  enables  the 
effective  control  of  the  production  process  and  supply  chain.  Traceability  is  ensured 
through  requiring  manufacturers  and  (for  imported  products)  importers  to  indicate 
directly on the toy, on its packaging or in a document accompanying the toy, their name, 
registered  trade  name  or  registered  trade  mark  and  the  address  at  which  they  can  be 
contacted (article 4(6) and 6(3)). 
Furthermore,  manufacturers  are  obliged  to  provide  the  toy  with  a  type,  batch,  serial  or 
model number or other elements allowing its identification, thus further ensuring product 
traceability. 

g. Technical documentation  
The  provisions  of  the  Toy  Safety  Directive  require  manufacturers  to  put  together  a 
technical  documentation  file.  In  particular,  Article  4(3)  requires  manufacturers  to  keep 

310  Particular toy categories are: 

1. Toys not intended for use by children under 36 months;  
2. Activity toys;  
3. Functional toys;  
4. Chemical toys;  
5. Skates, roller skates, online skates, skateboards, scooters and toy bicycles for children;  
6. Aquatic toys;  
7. Toys in food;  
8. Imitations of protective masks and helmets;  
9. Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics 
or straps;  
10. Packaging for fragrances in olfactory board games, cosmetic kits and gustative games. 

129 

 
                                                           
 
 
 
 
 
 
 
 
 
 
the technical documentation for a period of 10 years after the toy has been placed on the 
market.311 

h. Identification of economic operators in the supply chain  
Economic operators shall, on request, identify any economic operator who has supplied 
them with a toy and/or to whom they have supplied a toy (article 9). They have to be able 
to keep this information at the disposal of national surveillance authorities for a period of 
10 years after the toy has been placed on the market, in the case of the manufacturer, and 
for a period of 10 years after they have been supplied with the toy, in the case of other 
economic operators. 

i. Amendments  
Article 46 empowers the Commission to amend the Directive’s provisions concerning  
 

the  list  of  products  that  are  not  considered  as  toys  within  the  meaning  of  the 
Directive (Annex I); 
the  list  of  allergenic  fragrances  and  the  migration  limit  values  of  elements  used  in 
toys (Points 11 and 13 of Part III of Annex II); 
the warnings (Annex V); 
the permitted use of CMR substances (Appendix A) as well as 
the  specific  limit  values  for  chemicals  in  toys  intended  for  use  by  children  under 
36 months of age or intended to be placed in the mouth (Appendix C). 

 

 
 
 

In addition, Article 47 establishes the Directive’s Committee and its procedure, and rules 
how amendments shall be carried out. 

j. Penalties  
Concerning penalties, article 51 establishes that ‘Member States shall lay down rules on 
penalties  for  economic  operators  -  that  may  include  criminal  sanctions  -  applicable  to 
infringements of the national provisions adopted pursuant to the Directive, and shall take 
all measures necessary to ensure that they are implemented.’ Penalties are required to be 
effective,  proportionate  and  dissuasive  and  may  be  increased  if  the  relevant  economic 
operator has previously committed a similar infringement. 

311 The content of the technical documentation is detailed in Annex IV, where the following documentation 
is required to be included:  
  A  detailed  description  of  the  design  and  manufacture,  including  a  list  of  components  and  materials 
used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical 
suppliers;  

  The safety assessment(s);  
  Description of the conformity assessment procedure;  
  A copy of the EC declaration of conformity;  
  The addresses of the places of manufacture and storage;  
  Copies of documents that the manufacturer has submitted to a Notified Body, if involved;  
  Test reports and description of the means whereby the manufacturer ensured conformity of production 
with  the  harmonised  standards,  if  the  manufacturer  followed  the  internal  production  control 
procedure; and  

  A copy of the EC-type examination certificate, a description of the means whereby the manufacturer 
ensured conformity of the production with the product type as described in the EC-type examination 
certificate, and copies of the documents that the  manufacturer submitted to the notified body, if the 
manufacturer  submitted  the  toy  to  EC-type  examination  and  followed  the  conformity  to  type 
procedure referred to in Article 19(3).  

130 

 
 
 
                                                           
 
Annex  6:  How  a  toy  safety  standard  supports  the  Toy  Safety 
Directive 

The Toy Safety Directive sets the safety requirements that toys have to fulfil in order that 
children can play safely with those toys. 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.’312  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’,313 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. 314 The 
standard  thus  sets  the  detailed  specifications  for  testing  a  toy  against  the  Directive’s 
requirements. 

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

312  Annex II, Part I, point 4 (d) of the Toy Safety Directive 2009/48/EC. 

313  Standard EN 71-1:2014+A1:2018, clause 5.1 a). 

314  Standard EN 71-1:2014+A1:2018, clause 5.1 b). 

315  Latest  as  Commission  Implementing  Decision  (EU)  2019/1728  on  harmonised  standards  for  toys 
drafted in support of Directive 2009/48/EC of the European Parliament and of the Council. OJ L 263, 
16.10.2019, p. 32. 

131 

 
                                                           
Annex  7:  Toy  safety  standards,  the  references  of  which  have 
been published in the Official Journal 

No 

Reference of standards published in the Official Journal 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

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

  EN 71-2:2011+A1:2014 Safety of toys – Part 2: Flammability 

  EN 71-3:2019 Safety of toys – Part 3: Migration of certain elements 

  EN 71-4:2013 Safety of toys – Part 4: Experimental sets for chemistry and related activities 

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

  EN 71-7:2014+A2:2018 Safety of toys – Part 7: Finger paints – Requirements and test methods 

  EN 71-8:2018 Safety of toys – Part 8: Activity toys for domestic use 

  EN 71-12:2013 Safety of toys – Part 12: N-Nitrosamines and N-nitrosatable substances 

  EN 71-13:2014 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.    Electrical safety requirements 

EN 62115:2005/A11:2012/AC:2013  
EN 62115:2005/A11:2012 
EN 62115:2005/A12:2015 
EN 62115:2005/A2:2011/AC:2011 
EN 62115:2005/A2:2011 
IEC 62115:2003/A2:2010 (Modified) 

132 

 
 
 
 
Annex 8: Problems identified in the 2008 IA and addressed in 
the 2009 Toy Safety Directive 

2008 IA: Problems identified 

Scope 
and 
concepts 

The toy definition 
lacked clarity. 

The ‘use in play’ and ‘play 
value’ concepts are not clear. 

The 1988 Toy 
Safety Directive 
does not comply 
with the 
European 
Commission’s 
standards for 
Smart Regulation 
and good 
legislative 
practices 

Clarification on 
the relationship 
between the Toy 
Safety Directive 
and the GPSD 

Need to avoid ambiguities 
and complicated sentences, to 
provide individual articles 
with proper titles and to 
group them under section-
headings 

The GPSD applies to toys in 
cases not always clearly 
defined. 

Safety 
require-
ments 

Outdated safety 
requirements 

Physical and mechanical 
requirements 

Response in the 2009 Toy Safety 
Directive 
Article 2: 
scope of the Toy Safety Directive (the 
definition of toy refers to ‘products 
designed or intended, whether or not 
exclusively, for use in play’) 
Annex I: 
list of products not considered as toys 
within the meaning of the Toy Safety 
Directive 
The 2009 Directive has been drafted 
according to this point. 

Article 52(2): 
GPSD does not apply to toys: 
Recital 4: 
toys also subject to GPSD which applies 
in a complementary manner to specific 
sectorial legislation 
Annex II, Part I: 
physical and mechanical properties 

Lack of safety 
requirements for 
recently 
identified 
hazards 

Electrical properties 

Annex II, Part IV: 
electrical properties 

Safety requirements for 
chemicals should be revised 

Annex II, Part III: 
chemical properties 

Lack of safety requirements 
for noise 

Annex II, Part I, point 10:  
safety requirements for noise 

Lack of safety requirements 
for lasers 

Annex II, Part IV, point 8:  
safety requirements for lasers 

Lack of safety requirements 
for electrically powered ride-
on toys and for activity toys 

Lack of specific safety 
requirements for toys in food 

Annex II, Part IV: 
electrical properties 
Annex II, Part I, point 7: 
requirement for maximum design speed 
of electrically driven ride-on toys 
Annex II, Part I, point 4(f): 
requirements for toys contained within 
food or co-mingled with food 
Annex V, Part B, point 7: 
warning for toys contained within food 
or co-mingled with food 

133 

 
Lack of clarity in 
the general 
safety 
requirement 

The statement ‘Normal 
behaviour of children’ 
created interpretation 
problems. 

Lack of complete 
warning 
requirements 

User limitations should be 
included  

Adult supervision should be 
ensured 

Requirement for 
manufacturers to perform 
hazard/risk analysis is not 
mandatory 

Lack of any specific 
requirement for 
manufacturers to keep 
hazard/risk analysis in the 
technical file 

Need to enhance the 
effectiveness and timeliness 
of implementing the 
Directive 

Lack of clarity of the rules 
concerning the CE marking 

Enforce-
ment 

Market 
surveillance 

Lack of 
appropriate 
institutional 
framework for 
Member States 
and the 
European 
Commission  

Non-satisfactory 
toy-related 
information and 
traceability 

Article 10(2): 
general safety requirement (referring to 
the behaviour of children) 

Annex V, Part A: 
general warnings (referring to user 
limitations) 
Annex V, Part A: 
general warnings (referring to adult 
supervision) 
Article 18: 
requirement for manufacturers to 
perform hazard/risk analysis 

Article 21 and Annex IV: 
requirement for manufacturers to keep 
hazard/risk analysis in the technical file 

Chapter VII:  
Committee procedures providing for the 
Regulatory Procedure with Scrutiny 
(RPS) to amend non-essential elements 
of the Toy Safety Directive for the 
purpose of adapting them to technical 
and scientific developments 

Article 16: 
general principles of the CE marking 
Article 17: 
rules and conditions for affixing the CE 
marking 

134 

 
 
 
 
Annex  9:  Occurrence  of  nitrosamines  and  nitrosatable 
substances in toys – Market surveillance data 

The Commission’s EU Safety gate data show 33 notifications from Member States from 
2012 to 2019,316 mostly balloons, but also one finger paint, with nitrosamines exceeding 
the limit in 25 cases, nitrosatable substances in 16 cases, and the combined occurrence of 
nitrosamines and nitrosatable substances in 8 cases. 

Additional data on nitrosamines in toys provided by Member States showed that: 
  A  campaign  in  Denmark  in  2014  found  no  nitrosamines  in  finger  paint  sets  (up  to 
6 colours per set), with the exception of one yellow paint that largely exceeded the 
limit; 

  Tests on balloons in Germany from 2013 to 2017 showed that of 230 balloons tested 
for nitrosamines, 11 exceeded the limit, 161 others released nitrosamines below the 
limit.  The  634 balloons  tested  for  nitrosatable  substances  exceeded  the  limit  in 
46 cases,  and  they  released  nitrosatable  substances  in  395  cases.  –  In  2015  no 
nitrosamines were detected in 8 finger paints; 

  Tests  for  nitrosamines  and  nitrosatable  substances  in  France  from  2011  to  2017 
showed  that  2  out  of  5    balloons  exceeded  the  limits  for  nitrosamines  and 
nitrosatable substances. Further 11 toys, such as soft plastic toys or finger paints, did 
not release nitrosamines or nitrosatable substances; 

  A  Dutch  report  from  2018  showed  that  of  58  balloons  tested,  16 released 
nitrosamines  and  nitrosatable  substances  above  the  Directive’s  limits.  A  further 
30 balloons  released  nitrosamines  or  nitrosatable  substances,  however  below  the 
limit; 
In  Austria,  4  balloon  samples  in  2016  and  5  in  2017  did  not  exceed  the  limits  for 
nitrosamines  and  nitrosatable  substances.  In  the  same  way,  3 balloon  samples  in 
2015  in  Sweden  did  not  exceed  the  limits.  In  Bulgaria,  no  nitrosamines  or 
nitrosatable substances were found in 10 balloon samples in 2015; 

 

  Data  from  Norway  from  2014,  2016  and  2018  reported  45  balloons  tested: 
13 released  nitrosamines  above  the  limit,  3 further  were  below  the  limit.  Of  other 
toys,  such  as  finger  paints  or  rubber  ducks,  one  finger  paint  showed  nitrosamines 
above  the  limit.  Nitrosatable  substances  exceeded  the  limit  in  22 balloons,  1 finger 
paint  and  1 penguin  rubber  toy;  in  addition,  14 balloons  released  nitrosatable 
substances, but less than the limit. 

The above illustrates that nitrosamines and nitrosatable substances continue to exceed the 
current limits in the Toy Safety Directive, in particular in balloons, much less so in finger 
paints  or  other  toys.  Nitrosatable  substances  are  more  often  found  in  toys  than  the 
nitrosamines themselves. 

316  Up to 27.5.2019. 

135 

 
 
 
                                                           
Annex 10: Possible benefits of the Toy Safety Directive 

Selected results from the 2018 public consultation 

Table  1.  The  detailed  provisions  in  the  Toy  Safety  Directive  ensure  legal  certainty  (%  of 
respondents*) 

Stakeholders responding** 

Agree entirely/ 
Agree 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

80 
60 
30 
80 
30 

Neither agree 
nor disagree 
10 
20 
60 
10 
70 

Disagree/ 
Entirely disagree 
10 
30 
10 
0 
0 

No 
opinion  
0 
0 
0 
10 
0 

* Rounded to the nearest 10%, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

Table  2.  The  detailed  provisions  in  the  Toy  Safety  Directive  guarantee  a  level  playing  field.  (%  of 
respondents*) 

Stakeholders responding** 

Agree entirely/ 
Agree 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

80 
80 
40 
70 
30 

Neither agree 
nor disagree 
10 
0 
30 
20 
70 

Disagree/ 
Entirely disagree 
10 
30 
30 
0 
0 

No 
opinion  
10 
0 
0 
10 
0 

* Rounded to the nearest 10%, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

Table 3. The safety assessment is a good tool to ensure the safety of toys (% of respondents*) 

Stakeholders responding** 

Agree entirely/ 
Agree 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 

90 
80 
70 
80 
30 

Neither agree 
nor disagree 
0 
10 
10 
10 
70 

Disagree/ 
Entirely disagree 
0 
0 
10 
10 
0 

No 
opinion  
0 
20 
0 
10 
0 

* Rounded to the nearest 10%, to avoid the impression of over-precision 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

Table 4. Considerations of economic operators on the safety assessment (% of the 37 respondents*) 
No opinion / 
No answer 

Agree entirely/ 
Agree 

Neither agree 
nor disagree 

Statements 

Disagree/ 
Entirely 
disagree 
10 

20 

30 

30 

The safety assessment of a toy 
allows my company to focus on the 
relevant safety aspects of the toy 
The safety assessment of a toy to be 
manufactured helps to reduce costs. 

60 

50 

10 

0 

* Rounded to the nearest 10%, to avoid the impression of over-precision. 
Source: Own analysis based on public consultation 

136 

 
 
 
 
Annex 11: EU added value 

Selected results from the 2018 public consultation 

Table  1.  Is  it  better  for  toy  safety  and  the  marketing  of  toys  in  the  EU  to  have  the  Toy  Safety 
Directive which is applicable throughout the EU, or to have individual Member State legislation? (% 
of respondents*) 
Stakeholders responding** 

Agree 
(entirely) 

(Entirely) 
disagree 

Companies (32) 
Business associations (12) 
Notified bodies (7) 
Public authorities (31) 
Consumer organisations (6) 
* Rounded to the nearest single significant number, to avoid the impression of over-precision. Figures may 
therefore not add up to 100%. 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

100 
100 
100 
90 
100 

0 
0 
0 
0 
0 

Neither agree 
nor disagree 
0 
0 
0 
0 
0 

No 
opinion  
0 
0 
0 
0 
0 

Table 2. To what extent do you agree with the following statements concerning the EU added value 
of the Toy Safety Directive? (% of respondents*) 

Companies responding (32)** 

The Toy Safety Directive creates a large 
market for the same toy. 
The Toy Safety Directive simplifies the 
trade of toys in the EU. 
The Toy Safety Directive significantly 
lowers product development costs. 
The Toy Safety Directive significantly 
lowers manufacturing costs. 
The Toy Safety Directive helps harmonise 
testing methodologies and standards. 

Agree 
(entirely) 
80 

Neither agree 
nor disagree 
10 

(Entirely) 
disagree 
10 

No 
opinion  
10 

80 

30 

30 

70 

10 

30 

30 

20 

10 

30 

40 

0 

10 

10 

10 

10 

* Rounded to the nearest single significant number, to avoid the impression of over-precision. Figures may 
therefore not add up to 100%. 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

Table 3. To what extent do you agree with the following statements concerning the EU added value 
of the Toy Safety Directive? (% of respondents*) 

Business associations responding (12)** 

The Toy Safety Directive creates a large 
market for the same toy.        
The Toy Safety Directive simplifies the 
trade of toys in the EU.        
The Toy Safety Directive significantly 
lowers product development costs.        
The Toy Safety Directive significantly 
lowers manufacturing costs.        
The Toy Safety Directive helps harmonise 
testing methodologies and standards.        

Agree 
(entirely) 
60 

70 

30 

30 

50 

Neither agree 
nor disagree 

20 

0 

10 

10 

30 

(Entirely) 
disagree 
20 

No 
opinion  
10 

30 

30 

30 

10 

10 

30 

30 

20 

* Rounded to the nearest single significant number, to avoid the impression of over-precision. Figures may 
therefore not add up to 100%. 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

137 

 
Table 4. To what extent do you agree with the following statements concerning the EU added value 
of the Toy Safety Directive? (% of respondents*) 

Notified bodies (7)** 

The Toy Safety Directive helps harmonise testing 
methodologies and standards.        
The Toy Safety Directive helps increase 
opportunities for conformity assessment throughout 
the EU.        

Agree 
(entirely) 

100 

60 

Neither 
agree nor 
disagree 
0 

0 

(Entirely) 
disagree 

No 
opinion  

0 

40 

0 

0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision. Figures may 
therefore not add up to 100%. 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

Table 5. To what extent do you agree with the following statements concerning the EU added value 
of the Toy Safety Directive? (% of respondents*) 

Public authorities responding (31)** 

The Toy Safety Directive helps harmonise 
testing methodologies and standards.  
The Toy Safety Directive facilitates market 
surveillance across Member States.  
Joint projects with market surveillance 
colleagues from other Member States provide 
important insights.  
Meeting market surveillance colleagues from 
other Member States is useful for my own 
work. 

Agree 
(entirely) 
90 

Neither agree 
nor disagree 
10 

(Entirely) 
disagree 
0 

No 
opinion  
0 

90 

90 

90 

10 

10 

0 

0 

0 

0 

10 

0 

10 

* Rounded to the nearest single significant number, to avoid the impression of over-precision. Figures may 
therefore not add up to 100%. 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

Table 6. To what extent do you agree with the following statements concerning the EU added value 
of the Toy Safety Directive? (% of respondents*) 

Consumer organisations responding (6)** 

The Toy Safety Directive helps harmonise 
testing methodologies and standards. 
The Toy Safety Directive facilitates market 
surveillance across Member States. 
The Toy Safety Directive is applicable 
throughout the EU, so test reports from 
consumer organisations in other EU countries 
can be interesting for our own organisation. 

Agree 
(entirely) 

30 

30 

100 

Neither agree 
nor disagree 
70 

(Entirely) 
disagree 
0 

70 

0 

0 

0 

No 
opinion  

0 

0 

0 

* Rounded to the nearest single significant number, to avoid the impression of over-precision. Figures may 
therefore not add up to 100%. 
** Number of respondents in brackets 
Source: Own analysis based on public consultation 

138