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

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  EN 

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

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative? 

This initiative has the same legal basis as Directive 2009/48/EC of the European Parliament and of the 
Council on the safety of toys: Article 114 of the Treaty on the functioning of the European Union on 
the  approximation  of  national  rules  for  the  establishment  and  well-functioning  of  the  internal 
market. 

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in 
nature? 

In the case of internal market, the Union competence is shared according to Article 4(2) of the Treaty 
on the functioning of the European Union.  

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 21: 

-  Has there been a wide consultation before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative indicators 
allowing an appraisal of whether the action can best be achieved at Union level? 

For  the  preparation  of  this  proposal,  the  Commission  has  consulted  national  authorities,  industry 
associations,  companies  (including  SMEs),  consumer  associations  and  civil  society.  It  has  also 
consulted  the  Expert  Group  on  Toy  Safety.  The  proposal  is  based  on  a  comparative  impact 
assessment  of  a  number  of  policy  options,  and  reflects  the  option  that  scored  best  in  terms  of 
economic,  social,  environmental  and  health  impacts,  effectiveness,  efficiency  and  coherence.  The 
proposal  will  replace  Directive  2009/48/EC  on  the  safety  of  toys.  The  Evaluation  of  this  Directive2 
concluded  on  the  added  value  of  the  Directive  in  terms  of  toy  safety  and  the  creation  of  a  large 
internal market for safe toys, the EU added value of the Toy Safety Directive. In particular, without 
the Directive, Member States could set diverging limit values for chemicals, which would be to the 
detriment of the internal market. The Evaluation also concluded that all categories of stakeholders 
welcomed  the  existence  of  harmonised  safety  requirements  across  the  EU,  and  companies  valued 
the creation of a large market for toys and the simplification of trade as major achievements. This is 
why  the  Regulation  is  considered  to  maintain  the  EU  added-value  of  the  current  Directive.  The 
explanatory memorandum and the impact assessment (chapter 3) contain a section on the principle 
of subsidiarity. For more details, see question 2.2 below.   

2.2 Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the conformity with the 
principle of subsidiarity? 

Yes, those documents contain such a justification.  

Both the Impact Assessment and the Explanatory Memorandum recall that regulating at EU level the 
safety  of  toys  is  considered  to  have  added  value  for  all  stakeholders,  to  ensure  a  high  level  of 
protection  of  children  and  the  free  movement  of  toys  within  the  EU.  There  was  widespread 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  
2  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1852-Evaluation-of-the-Toy-
Safety-Directive 

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consensus  among  all  interested  stakeholders  during  the  consultation  process  that  the  issues 
addressed by the Directive continue to require action at the EU level. In order to ensure the internal 
market of toys and a high level of protection of children, the safety of toys  cannot be addressed at 
national level.  Further, since the Directive fully harmonises the matters it explicitly covers, Member 
States are not allowed to make changes to the scope, concepts and definitions or other requirements 
of the Directive: these must therefore be made at EU level. In the absence of a uniform set of rules 
applicable to toys, manufacturers would be faced with 27 different sets of rules, leading to different 
levels of protection for consumers and professional users, market barriers and distorted competition 
among market operators from different Member States.   

2.3 Based on the answers to the questions below, can the objectives of the proposed action be 

achieved sufficiently by the Member States acting alone (necessity for EU action)? 

The objectives of the proposed action cannot be achieved sufficiently by the Member States acting 
alone. The problems identified in the impact assessment are widespread across the EU and cannot be 
solved  individually  by  the  Member  States.  The  absence  of  EU  level  action  would  conflict  with  the 
objectives of the Treaty. Member States cannot deviate from the provisions of  the proposal, as the 
requirements  for making toys available are common across all Member States. Member States are 
not  overstretched  in  achieving  the  objectives  of  the  planned  measure  and  are  therefore  largely 
supportive for the adoption.  

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

Yes.  The  current  Directive  aims  at  ensuring  the  free  movement  of  toys  by  setting  common 
requirements  for  the  safety of  toys  at  EU  level. The problems  identified  in the  Evaluation with the 
functioning  of the  current  Directive  must  be  necessarily  addressed  at  EU  level by  a  revision  of the 
Directive.  In  particular,  the  Evaluation  found  that  the  Directive  did  not  sufficiently  protect  children 
when playing with toys from the risks of the most harmful chemicals. In addition, a high number of 
non-compliant  and  unsafe  toys  can  be  found  in  the  internal  market.  Those  problems  and  their 
impacts were quantified and, where not possible, a qualitative analysis was carried out.   

(b)  Would national action or the absence of the EU level action conflict with core objectives of 

the Treaty3 or significantly damage the interests of other Member States? 

Yes, this would be the case, as possible upcoming divergences of measures taken by Member States 
would disrupt the functioning of the internal market and would lead to different levels of protection 
of  health  and  safety  of  children.  Different  national  rules  would  lead  to  obstacles  to  the  free 
movement of toys in the Single Market.  

(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

The  Treaty  establishes  the  obligation  that  Member  States  shall  exercise  their  competence  to  the 
extent  that  the  Union  has  not  exercised  its  competence  (Article  2(2)  TFEU);  by  adopting  the  Toy 
Safety Directive 2009/48/EU the Union has exercised its competence in the field.  
In this framework, the current Directive or the proposal for a Regulation does not make it possible 
for Member States to deviate from its provisions. On the other hand, the proposal continues to rely 
on Member States for the enforcement of the Regulation. 

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

3 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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across the national, regional and local levels of the EU? 

The  problems  identified  exist  everywhere  in  the  EU.  The  need  to  better  protect  children  against 
harmful  chemicals  should  apply  equally  across  the  EU,  and  the  lack  of  adequate  provisions  in  the 
Directive  is  common  for  all  EU  Member  States.  Similarly,  the  high  number  of  non-compliant  toys 
affects all Member States, as toys enjoy free movement within the EU. 

(e)  Is the problem widespread across the EU or limited to a few Member States? 

The problem is widespread across the EU. It concerns toys which move freely in the internal market. 
It is therefore relevant for all Member States.   

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

No. Member States are largely supportive for the adoption of this legislative proposal. 

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

Public authorities are of the uniform view that further action is needed and an agreement exists to a 
large extent about the direction of the proposed measures. 

2.4 Based on the answer to the questions below, can the objectives of the proposed action be 

better achieved at Union level by reason of scale or effects of that action (EU added value)? 

Yes.  The  Evaluation  concluded  that  the  added  value  of  having  harmonised  rules  for  the 
making available and placing on the market of toys was uncontested. 

(a)  Are there clear benefits from EU level action?  

Yes.  Regulatory  action  at  EU  level  ensures  the  free  movement  of  toys  across  the  single 
market  while  providing  a  high  and  uniform  level  of  protection  of  the  health  and  safety  of 
children. 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level (larger 

benefits per unit cost)? Will the functioning of the internal market be improved? 

By maintaining common requirements under the wider EU regulatory framework applicable 
to toys, and by strengthening the digital requirements for placing toys on the Union market, 
the proposal will reduce the regulatory burden on economic operators. Economic operators 
will be able to make available their toys complying with common requirements across all the 
Single Market. 

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

The  issues  related  to  toys,  in  terms  of  protection  of  human  health  and  ensuring  free 
movement,  have  already  been  harmonised  at  EU  level.  A  homogeneous  policy  approach 
exists. This is why strengthening the requirements on chemical substances and improving the 
compliance of toys should also be addressed at EU level.  Therefore, these elements cannot 
be addressed at national level in order to ensure the well-functioning of the internal market 
and an equal level of human health protection across the EU. 

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member States 

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and the local and regional authorities (beyond the costs and benefits of acting at national, 
regional and local levels)? 

In the absence of a uniform set of rules at EU level applicable to toys, manufacturers would 
be faced with 27 different sets of rules, leading to different levels of protection for children, 
market barriers and distorted competition among market operators from different Member 
States.   

Finally,  the  strengthening  of  the  requirements  set out  in  Directive  2009/48/EC  can  only  be 
achieved  through  a  legal  instrument  at  EU  level.  Furthermore,  to  ensure  consistent 
application  of  the  toy  safety  rules  as  well  as  of  its  possible  subsequent  amendments,  the 
Directive should be converted into a Regulation. 

(e)  Will there be improved legal clarity for those having to implement the legislation? 

The  proposed  Regulation  aims  at  streamlining  the  requirements  for  toys  concerning  the 
presence of chemical substances and in that respect it aims at improving legal clarity. 

3.  Proportionality: How the EU should act 

3.1  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the proportionality of the 
proposal and a statement allowing appraisal of the compliance of the proposal with the 
principle of proportionality? 

The explanatory memorandum mentions that the  proportionality of this proposal has been 
evaluated. The proposal is in the form of a Regulation to replace Directive 2009/48/EC. Given 
that  this  Directive  is  a  total  harmonisation  Directive,  Member  States  no  longer  have  the 
possibility  to  add  additional  requirements  for  toys.  Nevertheless,  Member  States  are 
required to transpose the regular amendments of the Directive, which in the past has lead to 
regulatory amendments applying inconsistently across the EU. The regular adaptations of the 
Directive have proven to be ressource intensive for Member States. This is why a Regulation 
will  allow  for  a  more  rapid  and  coherent  application  of  the  legislation  adopted  at  EU  level 
and will establish a clearer regulatory environment for economic operators.  

3.2 Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memorandum or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

This proposal is an appropriate way to achieve the intended objectives given that they can be 
better  achieved  at  Union  rather  than  at  national  level.  The  proposal  is  based  on  a 
comparative assessment of a number of policy options, and reflects the option that scored 
best in terms of economic, social, environmental and health impacts, effectiveness, efficiency 
and coherence.   

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on 

their own, and where the Union can do better? 

Yes,  the  intended  objectives  can  be  better  achieved  at  Union  level.  The  proposed 
harmonised criteria for  toy safety will ensure  a high level of protection of children and the 
free  movement  of  toys  within  the  Union.  They  will  also  avoid  the  emergence  of  diverging 
national criteria on the EU’s single market. The Regulation will set essential requirements for 

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which the technical specifications will be determined by harmonised standards. 

(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 

coherent with the satisfactory achievement of, and ensuring compliance with the objectives 
pursued (e.g. choice between regulation, (framework) directive, recommendation, or 
alternative regulatory methods such as co-legislation, etc.)? 

The  proposal  takes  the  form  of  a  Regulation.  The  proposed  change  from  a  Directive  to  a 
Regulation takes into account the Commission’s general objective to simplify the regulatory 
environment and the need to ensure a uniform implementation throughout the Union of the 
proposed  legislation.  In  addition,  the  Toy  Safety  Directive  is  a  already  total  harmonisation 
directive,  which  means  that  it  establishes  a  high  level  of  safety,  and  does  not  allow  the 
Member  States  to  impose  different  obligations  but  however  requires  Member  States  to 
transpose  the  Directive  as  well  as  the  subsequent  regular  amendments  into  national 
legislation. A Regulation will ensure the consistent application of the toy safety rules as well 
as  any  futur  amendment  to  it,  and  will  lead  to  simplification  for  businesses  and  Member 
States. 

(c)  Does the Union action leave as much scope for national decision as possible while achieving 
satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum 
standards or use a less stringent policy instrument og approach?) 

The  proposed  Union  action  does  not  exceed  what  it  is  needed  to  achieve  the  objectives 
followed. In order to ensure harmonisation with an equivalent level of protection of health 
and safety of children when playing with toys, as well as the free movement of toys in the 
Union, it is necessary to set common requirements for toys at EU level. Regulatory action at 
EU  level  should  lay  down  EU-wide  requirements  for  ensuring  the  health  and  safety  of 
children when playing with toys, and allowing market enforcement at the national level. 

(d)  Does the initiative create financial or administrative cost for the Union, national 

governments, regional or local authorities, economic operators or citizens? Are these costs 
commensurate with the objective to be achieved? 

There will not be significant impacts on national budgets and administrations caused by this 
Regulation, although Member States will face some adaptation costs to the product passport 
which  is  already  foreseen  in  the  Commission  proposal  for  a  Regulation  on  Ecodesign  for 
Sustainable Products4. Similarly, adapting to the product passport will imply certain costs for 
businesses,  in  particular  in  the  beginning,  but  it  will  also  lead  to  savings  in  administrative 
burden, in particular when dealing with enforcement authorities.    

(e)  While respecting the Union law, have special circumstances applying in individual Member 

States been taken into account? 

Not relevant. 

4 Sustainable products initiative (europa.eu). Proposal for a Regulation of the European Parliament and of the 
Council establishing a framework for setting ecodesign requirements for sustainable products and repealing 
Directive 2009/125/EC of 30 March 2022, COM(2022) 142 final. 

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