Proposal for a Directive of the European Parliament and of the Council on the safety of toys {SEC(2008)38} {SEC(2008)39}
Date: 2008-01-25
Institutions: European Commission
Subjects: European standard, consumer protection, harmonisation of standards, product safety, safety standard, technical standard, toy industry

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.1.2008 
COM(2008) 9 final 

2008/0018 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the safety of toys 

(presented by the Commission) 

{SEC(2008)38} 
{SEC(2008)39} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General context 

The revision of Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the 
Member  States  concerning  the  safety  of  toys1  (TSD)  was  announced  in  the  Communication 
from the Commission to the Council, the European Parliament, the European Economic and 
Social  Committee  and  the  Committee  of  the  Regions  -  Updating  and  simplifying  the 
Community acquis.2 

Directive 88/378/EEC was adopted in the context of the achievement of the Internal Market. 
The proliferation of different safety provisions across the Member States had led to barriers to 
trade  and  marketing.  This  went  hand  in  hand  with  the  recognition  that  a  proliferation  of 
different  national  safety  regimes  across  the  EU  did  not  necessarily  afford  consumers  in  the 
EU,  especially  children,  with  effective  protection  against  hazards  arising  from  toys.  The 
Directive was the first EC Directive applying the New Approach method – introduced in 1985 
– to mass market consumer goods. The key New Approach concept consisted in laying down 
in the legislation the essential safety related requirements, leaving the technical specifications 
of  products  meeting  the  essential  requirements  in  harmonised  standards.  Since  1988,  the 
Directive has been amended only once in respect of the CE marking3. 

Whilst the TSD has in general proven successful in providing safe products and eliminating 
trade barriers between the Member States, a number of deficiencies have been identified over 
time, which have triggered the need to assess the existing legal framework. 

A thorough revision of the TSD seems appropriate, with a view to: 

•  Updating and completing the existing provisions to address safety issues that were 

unknown at the time of the TSD adoption; 

•  Improving  the  implementation  and  enforcement  of  the  TSD  throughout  the 

European Union; 

•  Clarifying the scope and concepts of the Directive; 

•  Ensuring  consistency  with  the  general  measures  that  have  been  tabled  in  the 

general legislative framework for the marketing of goods4. 

Consistency with other policies and objectives of the Union 

The  proposal  is  a  central  element  to  ensure  the  free  movement of  toys  within  the  European 
Union  and  contributes  to  the  protection  of  the  consumer  by  providing  at  the  same  time  a 
uniform level of toy safety across the EU. 

The objectives pursued by the revision are in line with the EU´s strategy for jobs and growth 
and  also  fit  into  the  Community  policy  of  better  regulation  and  simplification.  The  overall 
goal is to improve the quality and efficiency of the toys safety regulations and to simplify the 
current legislation for both economic operators and market surveillance authorities. 

1 
2 
3 
4 

OJ L 187, 16.7.1988, p.1. 
COM/2003/0071 final. 
Council Directive 93/68/EEC of 22 July 1993, OJ L 220, 30.8.1993, p.1. 
Proposal for a Regulation on accreditation and market surveillance; COM(2007)37 final of 14/02/2007. 
Proposal for a Decision on a common framework for the marketing of goods; COM (2007) 53 final of 
14/02/2007. 

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2. 

CONSULATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

The  revision  has  been  under  consideration  since  2003  and  has  been  the  subject  of  a  wide 
ranging  consultation,  namely  in  the  framework  of  the  Expert  Group  on  toys  safety  with  the 
Member States authorities and other stakeholders like industry, consumer- and standardisation 
organisations. 

A public consultation was organised in May 2007 to invite all interested parties to send their 
observations on those questions which have been identified as potential objects for changes in 
the  Expert  Group  discussions.  The  results  of  the  public  consultation  are  published  at 
http://ec.europa.eu/enterprise/toys/public_consultation.htm.  More  than  1500  replies  were 
received: 91 percent responded  as an individual  and 9 percent on  behalf of an  organisation, 
institution or enterprise. 

The  public  consultation  confirmed  the  need  to  revise  the  Directive  and,  in  particular,  to 
improve its enforcement and implementation and to clarify its scope and concepts. There was 
also an agreement to update the essential safety requirements on certain hazards. Although the 
vast  majority  of  reactions  came  from  respondents  qualifying  themselves  as  individuals, 
because  of  the  nature  and  or  the  focus  of  the  comments  it  could  be  assumed  that  a  part  of 
these individual replies originates from individuals who are to various degrees involved in the 
toys business (distributors, retailers, company managers, etc.). 

Collection and use of expertise 

Three  studies  have  been  established  by  independent  consultants  for  the  purposes  of  this 
revision: one general impact assessment study as well one specific impact assessment study 
on the revision of the chemical requirements as well as a specific study on certain chemicals 
used  in  toys  to  provide  elements  for  the  revision  of  the  chemicals  requirements  of  the 
Directive. The studies are available at: http://ec.europa.eu.enterprise/toys/index_en.htm. 

Impact assessment  

Five options for a revision have been identified:  

•  Repealing of Directive 88/378/EEC; 

•  No Commission action, i.e. maintaining the status quo; 

•  Non-regulatory approach; guidance documents; recommendations; 

•  A new Directive based on the “Old Approach”; 

•  A revised Directive to the extent necessary to ensure that safe toys can circulate in the EU 

internal market. 

The  fifth  option  was  identified  as  the  preferred  option  because  it  seems  adequate  and 
proportionate to cope with the identified problems without requiring a fundamental change of 
the system that has proved workable. Option 5 keeps an adequate balance between on the one 
hand new (compliance and administrative) costs for the industry concerned and on the other 
hand benefits for children’s health and safety. 

Within the option to adapt the Directive to the extent necessary, a number of sub-options with 
various degrees of stringency have been identified and assessed in detail: 

•  To enhance safety requirements for toys  

–  New provisions on the chemical requirements; 

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–  More stringent requirements on warnings; 

–  Changes to the requirements concerning the choking risk;  

–  Clarifying the suffocation risk; 

–  Clarifying the criteria of essential safety requirements; 

–  Special requirements for toys in food; 

•  To improve the enforcement and efficiency of the Directive 

–  Changes to the technical file as regards information on chemicals; 

–  Changes to the CE marking and traceability information; 

–  Changes to the conformity assessment procedures. 

The Commission has carried out a detailed impact assessment listed in the Work Programme. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Main elements of the revision 

3.1. 

Enhanced safety requirements 

3.1.1.  Chemical substances used in toys 

The revision focuses on enhanced safety requirements for toys, namely with regard to the use 
of chemicals in toys. The revision also aims at updating requirements on electrical properties 
and in physical and mechanical areas, as chocking risks and suffocation. 

As regards chemicals in toys, the Directive foresees that toys must comply with Community’s 
general chemicals legislation, including Regulation EC No 1907/2006 (REACH). 

Main  novelty  of  the  revision  is  the  introduction  of  specific  rules  on  CMR  (carcinogenic, 
mutagenic, or toxic for reproduction) in toys. The proposal foresees that toys and components 
of  toys  or  micro-structurally  distinct  parts  of  toys  that  are  accessible  to  children  shall  not 
contain CMR of categories 1, 2 and 35. This ban applies to CMR with a concentration above 
0,1%, with the exception of some CMR substances for which a lower concentration is already 
foreseen in existing legislation. The proposal, however, provides for a possibility of granting 
an  exemption  from  this  ban,  if  the  substance  has  been  evaluated  by  the  relevant  Scientific 
Committee  and  found  acceptable  for  use  in  toys,  while  for  CMR  1  and  2  no  suitable 
alternative substances must be available at the same time.  

It  is  in  important  to  note  that  REACH  imposes  a  duty  on  suppliers  of  articles  containing 
substances,  in  particular  CMRs  1  or  2,  to  communicate  sufficient  information  to  allow  safe 
use of the article. These provisions are unaffected by the revision of the toys directive and so 
will continue to apply to toys  

The Directive prohibits the use or requires the labelling of certain allergenic substances and 
certain  fragrances.  This  approach  also  follows  the  regime  of  Directive  76/768/EEC  on 
cosmetic products. 

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Substances CMR substances are categorised into categories 1, 2 and 3 based on the degree of evidence 
of  their  carcinogenic,  mutagenic  or  reprotoxic  properties.  Category  1:  “Substances  known  to  be 
carcinogenic to man”; Category 2: “Substances which should be regarded as if they are carcinogenic to 
man”; Category 3: “Substances which cause concern for man owing to possible carcinogenic effects but 
in respect of which the available information is not adequate for making a satisfactory assessment”. 

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In order to take into account new scientific knowledge, the Directive provides for an update of 
certain  chemical  substances  to  be  used  in  toys  and  raises  the  limit  values  for  these 
substances.  The  proposal  replaces  the  reference  to  bioavailability  (i.e.  the  soluble  extract 
having toxicological significance) with “migration” in line with the Standard EN 71-3. 

3.1.2.  Warnings 

According to the existing Directive toys must be accompanied by clearly legible warnings in 
order  to  reduce  inherent  risks  of  their  use.  The  revision  foresees  to  complement  these 
provisions by requiring that warnings specify, where appropriate for safe use, user limitations 
such as minimum and maximum ages for users or the ability of the user of toys or maximum 
or minimum weight of the users as well as the need to ensure that the toy is used under adult 
supervision.  It  is  furthermore  proposed  to  require  warnings  at  the  point  of  sale  specifying 
minimum  and  maximum  ages  for  users.  The  new  measures  are  meant  to  improve  their 
effectiveness in the prevention of accident. More detailed practical instructions on warnings 
will  be  established  in  a  guidance  document  to  be  drawn  up  together  with  the  various 
stakeholders  and  Member  States  authorities  taking  into  account  developments  of  scientific 
and technical knowledge. 

3.1.3.  Choking and suffocation risks 

The  risk  of  choking,  that  is  the  risk  of  inhalation  of  small  parts,  is  currently  regulated  in 
respect  of  toys  intended  for  children  under  36  months.  The  revised  Directive  foresees  to 
extend  the  provisions  to  those  toys  that  are  intended  to  be  put  in  the  mouth,  such  as  toy 
instruments, even when destined to children above 36 months. 

The  suffocation  risk,  defined  as  an  external  airway  obstruction  of  the  mouth  and  nose,  is 
already covered by the current Directive. The proposed new measures provide for extending 
the  definition  in  question  to  internal  airway  obstruction,  to  deal  with  the  risk  presented  by 
new toys such as those with suction cups. The suffocation risk shall be covered in case of all 
toys and not only for those intended for children under 36 months. 

3.1.4.  Toys in food 

Under the current Directive there are no specific provisions for toys in food. These products 
need to respect the general requirements of the Directive for small parts and for warnings. It is 
appropriate to proceed to an assessment of the hazard inherent in toys in food on the basis of 
the precautionary principle6. The Directive foresees the new requirement that i) toys should be 
marketed  in  a  package  separating  them  from  the  food  items  they  are  attached  to,  ii)  the 
packaging itself should not present any choking hazard (namely that it passes the safety ‘small 
parts cylinder test’) and iii) to ban toys that are firmly coupled with foodstuffs in such a way 
that prior consumption of the food item is necessary to access to the toy itself. 

3.1.5.  Definition of the general safety requirement 

The current safety requirements have created problems of interpretation, in particular because 
the  general  safety  requirement  refers  to  the  obligation  to  cover  “foreseeable”  use  of  a  toy 
taking  into  account  the  “normal  behaviour  of  children”,  which  may  result  in  a  narrow 
consideration of safety issues. 

Clarifying  the  general  safety  requirement  is  essential  because  it  is  the  only  legal  basis  for 
taking dangerous toys out of the market in cases were a new risk is discovered, that is, a risk 
which  has  previously  not  been  known  and  which  is  therefore,  not  covered  by  specific 

6 

Commission Communication COM (2000) 1, 1.2.2000. 

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standards. A recent example of such risk which was previously not known and which is not 
yet covered by standards is the risk presented by certain powerful magnets. 

It is, therefore, foreseen to refer in the general safety requirement to "behaviour" of children 
to  ensure  that  the  often  unpredictable  behaviour  of  children  is  taken  into  account  when 
designing toys with a view to achieve greater safety benefits. 

3.2.  More efficient and coherent enforcement of the Directive 

3.2.1.  Reinforcement of the Member States market surveillance measures 

The  proposal  reinforces  in  Chapter  VI  the  market  surveillance  obligations  of  the  Member 
States  under  the  General  Product  Safety  Directive  2001/95/EC  by  granting  certain  specific 
powers  to  the  market  surveillance  authorities  (right  of  access  to  the  premises  of  economic 
operators, right to request information from Notified bodies, right to give instructions to the 
Notified bodies, right to obtain mutual assistance from other Member States). It also foresees 
an  obligation  for  the  Member  States  to  ensure  a  cooperation  of  their  market  surveillance 
authorities  and  those  of  the  other  Member  States and  between  their  own  authorities and the 
Commission and the relevant Community Agencies. 

3.2.2. 

Information on chemicals in the technical file 

The proposal contains an update of the documentation which toy manufacturers and importers 
have to keep available for inspection by the market surveillance. It has been assessed which 
information besides a detailed description of the design and manufacture of the toy should be 
kept  in  the  technical  documentation.  It  is  proposed  that  the  technical  file  needs  to  contain 
information on components and materials used in toys. 

3.2.3.  CE marking and its affixing 

The Directive takes into account the detailed rules on the CE-marking foreseen in the general 
legislative framework for the marketing of products. 

In  addition,  the  revision  retains  the  provision  of  the  existing  Directive  that  the  CE  marking 
shall  be  marked  either  on  the  toy  or  the  packaging  or  in  case  of  small  toys  on  a  label  or 
accompanying  leaflet.  It  adds  one  novelty:  the  CE  marking  shall  always  be  affixed  on  the 
packaging if the marking on the toy is not visible from outside the packaging. This provision 
which adds more visibility to the CE-marking is foreseen to facilitate market surveillance. 

3.2.4. 

Safety assessment 

A new obligation will be introduced to perform an analysis of the  hazards that the toy may 
present,  and  to  make  it  available  -  as  part  of  the  toy’s  technical  file  -  to  the  market 
surveillance  authorities  for  inspection.  This  new  provision  is  designed  to  provide  a  reliable 
and systematic basis for the analysis of  risk,  which industry already  performs as part of  the 
process involved in the design and marketing of new products, with a view to evaluating their 
soundness and ensuring conformity with the essential safety requirements. 

3.3. 

Alignment to the general legislative framework on the marketing of products 

On  14  February  2007,  the  Commission  adopted  its  proposals  for  a  Council  and  European 
Parliament Regulation and Decision for the marketing of goods7. The proposal for Regulation 
sets  the  requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of 
products. The proposed Decision on a common framework for the marketing of products sets 
standard Articles to be used in future New Approach Directives. 

7 

See footnote 4. 

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According to the Commission proposal, the requirements of the Regulation for accreditation 
of conformity assessment  bodies and  the rules on market surveillance will apply also to the 
accreditation in the toys sector and to the market surveillance of toys at external frontiers. In 
order  to  ensure  consistency  with  other  sectoral  product  legislation,  the  revised  Directive 
contains  the  following  horizontal  provisions  of  the  above  mentioned  Decision:  definitions, 
general  obligations  for  economic  operators,  presumption  of  conformity,  formal  objection 
against  harmonised  standards,  rules  for  the  CE  marking,  requirements  for  conformity 
assessment  bodies  and  the  notification  procedures  as  well  as  the  provisions  concerning 
procedures  dealing  with  products  presenting  a  risk.  The  conformity  assessment  procedures 
available to the manufacturer are also be set by reference to the proposed horizontal Decision. 
Experience  has  shown  that  the  two  procedures  (internal  production  control  and  EC  type-
examination  combined  with  the  conformity  to  type  procedure)  available  under  Directive 
88/378/EEC  and  the  conditions  of  their  use  are  appropriate  for  the  toy  sector  and  should 
therefore be maintained. 

3.4. 

Clarifying scope and concepts of the Directive  

In order to facilitate the application of the Directive by manufacturers and national authorities 
the scope of the Directive is clarified, by completing the list of products which are not within 
its scope, in particular as regards certain new products, such as videogames and peripherals. 
In  addition  to  adopting  the  harmonised  definitions  laid  down  in  the  proposed  standard 
Articles,  it  is  appropriate  to  foresee  certain  new  definitions  specific  to  the  toys  sector: 
Functional toy, activity toy, trampoline, hazard, risk, harm, suffocation and design speed. 

The  proposal  also  aims  at  clarifying  the  relationship  between  the  Toys  Directive  and  the 
General Product Safety Directive. The General Product Safety Directive applies in accordance 
with  its  Article  1  (2)  to  toys  in  so  far  as  there  are  no  specific  provisions  with  the  same 
objective in the Toys Directive. For the sake of clarity and legal certainty the toys proposal 
enumerates the Articles of the Directive 2001/95/EC that apply to toys. 

Legal basis 

The proposal is based on Article 95 of the EC-Treaty. 

Subsidiarity principle 

Directive 88 /378/EEC is a total harmonisation directive adopted on the basis of Article 95 of 
the Treaty with the objective of the establishment and functioning of the internal market for 
toys.  National  legislation  cannot  impose  additional  provisions  on  the  safety  of  toys  which 
would  require  the  modification  of  the  product  or affect  the conditions for its placing on the 
market. Therefore, the revision of provisions of Directive 88/378/EEC is, as far as the safety 
requirements for toys or the conditions of their placing on the market are concerned, within 
the exclusive competence of the Community. The application of the principle of subsidiarity 
within the meaning of Article 5, second paragraph, of the EC-Treaty does not arise. 

It is important to note that the revision aims at clarifying the scope of products covered by the 
Directive,  but  not  at  extending  or  changing  it  otherwise.  Therefore  the  issue  of  subsidiarity 
within  the  meaning  of  Article  5,  second  paragraph,  of  the  EC-Treaty  does  not  arise  in  this 
respect either. 

The respect of the subsidiarity principle, therefore, only arises with regard to the other areas 
of  the  revision,  namely  with  regard  to  the  improvement  of  effective  enforcement  of  the 
Directive.  Experience  has  shown  that  coherent  and  effective  enforcement  and  market 
surveillance  has  not  been  sufficiently  achieved  by  Member  States  acting  alone.  As  a 
consequence, the issue of setting some mandatory common minimum requirements arises. As 

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a  result  of  the  proposal,  this  activity  would  remain  within  the  authority  of  the  national 
authorities  but  some  general  EU-wide  requirements  would  be  introduced  to  ensure  equal 
treatment, a level playing field for economic operators, and a similar level of protection for 
the citizens in all the Member States. 

Proportionality 

In  accordance  with  the  principle  of  proportionality,  the  proposed  modifications  do  not  go 
beyond what is necessary to achieve the objectives set. In order to protect the benefits of the 
single market in the toys sector, any changes to the existing directive have to be dealt with at 
the Community level. If Member States acted on their own, there would be a proliferation of 
safety  requirements  which  would  hamper  and  undermine  the  achievements  of  the  single 
market,  and  very  likely  lead  to  confusion  for  consumers  and  producers  alike.  The 
consequences  could  be  higher  prices  for  consumers,  as  producers  would  have  to  revert  to 
abiding  by  member  state  specific  requirements,  while  there  would  be  a  lack  of  clarity 
regarding the safety of toys bought in another Member State. 

All modifications of the Directive do not impose unnecessary burden and costs on industry, 
especially  on  small  and  medium  sized  enterprises,  or  administrations.  A  number  of  options 
concern the improvement of clarity of the existing Directive without introducing  significant 
new requirements with cost implication. Where modifications have more significant impacts, 
the analysis of the impacts of the option serves to provide the most proportionate response to 
the problems identified.  

4. 

BUDGETARY IMPLICATIONS 

The proposal foresees  establishment  of a Regulatory  committee. Budgetary implications are 
discussed in the legislative financial statement annexed to this proposal. 

5. 

ADDITIONAL INFORMATION 

Repeal of existing legislation 

The  adoption  of  the  proposal  will  lead  to  repeal  of  Directive  88/378/EEC  on  the  safety  of 
toys. 

European Economic Area 

The  proposal  concerns  the  EEA  and  should  therefore  extended  to  the  European  Economic 
Area. 

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2008/0018 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the safety of toys 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission8, 
Having regard to the opinion of the European Economic and Social Committee9, 
Having regard to the opinion of the Committee of the Regions10, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty11, 

Whereas: 

(1) 

(2) 

Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the 
Member  States  concerning  the  safety  of  toys12  was  adopted  in  the  context  of 
establishing  the  internal  market  in  order  to  harmonise  the  safety  levels  of  toys 
throughout  the  Member  States  and  to  remove  obstacles  to  trade  in  toys  between 
Member States. 

Directive  88/378/EEC  is  based  on  the  New  Approach  principles,  as  set  out  in  the 
Council Resolution of 7 May 1985 on a new approach to technical harmonisation and 
standards. Thus, it sets out only the essential safety requirements with regard to toys, 
while  technical  details  are  adopted  by  the  European  Committee  for  Standardisation 
(CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) 
in accordance with Directive 98/34/EC of the European Parliament and of the Council 
of 22 June 1998 laying down a procedure for the provision of information in the field 
of technical standards and regulations13. Conformity with harmonised standards so set, 
the  reference  number  of  which  is  published  in  the  Official  Journal  of  the  European 
Union,  provides  presumption  of  conformity  to  the  requirements  of  Directive 
88/378/EEC. Experience has shown that these basic principles have worked well in the 
toys sector and should be maintained. 

(3) 

Technological developments in the toys market have, however, raised new issues with 
respect  to  the  safety  of  toys  and  have  given  rise  to  increased  consumer  concerns.  In 

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13 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 187, 16.7.1988, p. 1. Directive as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1). 
OJ L 204, 21,7.1998, p. 37. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

order to take account of those developments and to provide clarification in relation to 
the  framework  within  which  toys  may  be  marketed,  certain  aspects  of  Directive 
88/378/EEC  should  be  revised  and  enhanced  and,  in  the  interests  of  clarity,  that 
Directive should be replaced. 

Toys are also subject to Directive 2001/95/EC of the European Parliament and of the 
Council  of  3  December  2001  on  general  product  safety14,  which  applies  in  a 
complementary manner to specific sectoral legislation, and in particular are subject to 
the Community Rapid Information System (RAPEX) foreseen in that Directive. 

Decision  […]  of  the  European  Parliament  and  of  the  Council  of  […]  on  a  common 
framework for the marketing of products15 provides common principles and reference 
provisions  for  the  purposes  of  legislation  based  on  the  New  Approach  principles.  In 
order to ensure consistency with other sectoral product legislation, it is appropriate to 
align  certain  provisions  of  this  Directive  to  that  Decision,  in  so  far  as  sectoral 
specificities  do  not  require  a  different  solution.  Therefore,  certain  definitions,  the 
general  obligations  for  economic  operators,  presumption  of  conformity,  formal 
objection  against  harmonised  standards,  rules  for  the  CE  marking,  requirements  for 
conformity assessment bodies and the notification procedures as well as the provisions 
concerning  procedures  dealing  with  products  presenting  a  risk  should  be  aligned  to 
that Decision. 

In  order  to  facilitate  the  application  of  this  Directive  by  manufacturers  and  national 
authorities, its scope should be clarified, by completing the list of products which are 
not within its scope, in particular as regards certain new products, such as videogames 
and peripherals. 

It  is  appropriate  to  provide  for  certain  new  definitions  specific  to  the  toys  sector  in 
order to facilitate the understanding and uniform application of this Directive. 

All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
the appropriate measures to ensure that they make available on the market only toys 
which are in conformity with the applicable legislation. This Directive provides a clear 
and proportionate distribution of obligations which correspond to the respective role of 
each operator in the supply and distribution process. 

As  certain  tasks  can  only  be  executed  by  the  manufacturer,  it  is  necessary  to  clearly 
distinguish between the manufacturer and the operators further down the distribution 
chain.  It  is  furthermore  necessary  to  clearly  distinguish  the  importer  and  the 
distributor,  as  the  importer  introduces  toys  from  third  countries  on  the  Community 
market. He has thus to ensure that these toys comply with the applicable Community 
requirements. 

(10)  The manufacturer, having detailed knowledge of the design and production process, is 
best  placed  to  carry  out  the  complete  conformity  assessment  procedure  for  toys. 
Importers and distributors perform a trading function and do not have any influence on 
the  production  process.  The  conformity  assessment  should  therefore  remain  the 
obligation of the manufacturer alone. 

(11)  Since importers and distributors are downstream operators they cannot in the normal 
course of events be obliged to ensure themselves that the design and production of the 

14 
15 

OJ L 11, 15.1.2002, p. 4. 
OJ L […], […], p. […]. 

EN 

10 

   EN 

 
                                                 
toy is in compliance with the applicable requirements. Their obligations in relation to 
the  compliance  of  the  toy  should  be  limited  to  certain  control  measures  to  ascertain 
whether  the  manufacturer  has  fulfilled  his  obligations,  such  as  verifying  whether  the 
toys bears the required conformity marking and whether the required documents have 
been supplied. However,  it  can  be  expected of both importers and distributors  to act 
with  due  care  in  relation  to  the  applicable  requirements  when  placing  or  making 
available products on the market. 

(12)  Where  an  importer  or  a  distributor  either  places  a  toy  on  the  market  under  his  own 
name  or  trademark  or  modifies  a  toy  in  such  a  way  that  compliance  with  applicable 
requirements may be affected, he should be considered to be the manufacturer. 

(13)  Distributors  and  importers,  being  close  to  the  market  place,  should  be  involved  in 
market surveillance tasks carried out by national authorities, and should be prepared to 
participate actively, providing the competent authorities with all necessary information 
relating to the toy concerned. 

(14)  Ensuring  traceability  of  a  toy  throughout  the  whole  supply  chain  contributes  to 
rendering  market  surveillance  simpler  and  more  efficient.  An  efficient  traceability 
system  facilitates  the  task  of  market  surveillance  authorities  to  trace  the  economic 
operator responsible for supplying non-compliant toys. 

(15)  Certain essential safety requirements which were laid down in Directive 88/378/EEC 
should  be  updated  to  take  account  of  technical  progress  since  the  adoption  of  that 
Directive.  In  particular,  in  the  field  of  electrical  properties,  technical  progress  has 
made  it  possible  to  allow  the  limit  of  24  volts  set  in  Directive  88/378/EEC  to  be 
exceeded while guaranteeing the safe use of the toy concerned. 

(16) 

In  order  to  ensure  protection  of  children  against  recently  discovered  risks,  it  is  also 
necessary to adopt new essential safety requirements. In particular, it  is necessary to 
complete  and  update  provisions  on  chemical  substances  in  toys.  These  provisions 
should  specify  that  toys  should  comply  with  the  general  chemicals  legislation,  in 
particular  Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH), 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/EC16.  These  provisions  should,  however,  also  be  adapted  to  the  particular 
needs  of  children,  who  are  a  vulnerable  group  of  consumers.  Therefore,  new 
restrictions  on  substances  that  are  classified  as  carcinogenic,  mutagenic  or  toxic  for 
reproduction  (CMR)  according  to  Directive  67/548/EEC  of  27  June  1967  on  the 
approximation  of  laws,  regulations  and  administrative  provisions  relating  to  the 
classification,  packaging  and  labelling  of  dangerous  substances17  and  fragrances  in 
toys should be provided for on account of the special risks that these substances may 
entail for human health. The specific limit values laid down in Directive 88/378/EEC 
for  certain  substances  should  be  updated  to  take  into  account  of  the  development  of 
scientific knowledge. 

16 

17 

OJ L 396, 30.12.2006, p. 1. Regulation as amended by Council Regulation (EC) No 1354/2007 (OJ L 
304, 22.11.2007, p. 1). 
OJ  196,  16.8.1967,  p.  1.  Directive  as  last  amended  by  Directive  2006/121/EC  of  the  European 
Parliament and of the Council (OJ L 396, 30.12.2006. p. 850). 

EN 

11 

   EN 

 
                                                 
(17)  The  general  and  specific  chemical  requirements  in  this  Directive  should  aim  at 
protecting  the  health  of  children  from  dangerous  substances  in  toys,  while 
environmental  concerns  presented  by  toys  are  addressed  in  horizontal  environmental 
legislation applying also to toys, in particular inDirective 2006/12/EC of the European 
Parliament and of the Council of 5 April 2006 on waste  18, Directive 2002/95/EC of 
the European Parliament and of the Council of 27 January 2003 on the restriction of 
the  use  of  certain  hazardous  substances  in  electrical  and  electronic  equipment19,  in 
Directive  2002/96/EC  of  the  European  Parliament  and  of  the  Council  of  27  January 
2003  on  waste  electrical  and  electronic  equipment20,  in  Directive  94/62/EC  of  the 
European  Parliament  and  of  the  Council  of  20  December  1994  on  packaging  and 
packaging waste21 and in Directive 2006/66/EC of the European Parliament and of the 
Council  of  6  September  2006  on  batteries  and  accumulators  and  waste  batteries  and 
accumulators and repealing Directive 91/157/EEC22. 

(18) 

It is appropriate to lay down specific safety requirements to cover the potential specific 
hazard presented by toys inside food in line with the precautionary principle, since the 
association  of  a  toy  and  food  could  be  the  cause  of  a  risk  of  choking  that  is  distinct 
from the risks presented by the toy alone and which is, therefore, not covered by any 
specific measures at Community level. 

(19)  Since toys may exist or be developed which present hazards which are not covered by 
a  particular  safety  requirement  laid  down  in  this  Directive,  it  is  necessary  to  set  a 
general requirement of safety as the legal base for taking action against such toys. In 
this respect safety of toys should be determined by reference to the intended use of the 
product  while  taking  into  account  the  foreseeable  use,  bearing  in  mind  behaviour  of 
children, who do not generally show the same degree of care as the average adult user. 

(20) 

In  order  to  further  promote  safe  conditions  for  use  of  toys,  there  is  a  need  to 
supplement the provisions on warnings which should accompany the toy. 

(21)  The  CE  marking,  materialising  conformity  of  a  toy,  is  the  visible  consequence  of  a 
whole process comprising conformity assessment in a broad sense. General principles 
governing the use of the CE marking, and rules as to its affixing should therefore be 
set in this Directive. 

(22) 

(23) 

(24) 

It  is  crucial  to  make  clear  to  both  manufacturers  and  users  that  by  affixing  the  CE 
marking to the toy the manufacturer declares that the product is in conformity with all 
applicable requirements and that he takes full responsibility thereof. 

It is appropriate to lay down rules on the affixing of CE-marking which ensure enough 
visibility for the marking in order to facilitate market surveillance of toys. 

In order to ensure that the essential requirements are complied with it is necessary to 
lay  down  appropriate  conformity  assessment  procedures  to  be  followed  by  the 
manufacturer.  To  complete  the  legal  obligations  of  the  manufacturer  which  aim  at 
ensuring  the  safety  of  toys,  an  explicit  obligation  to  carry  out  an  assessment  of  the 
various hazards that the toy may present and an assessment of the potential exposure 
to them should be included in this Directive, and the manufacturers should be obliged 

18 
19 
20 
21 
22 

OJ L 114, 27.4.2006, p. 9. 
OJ L 37, 13.2.2003, p. 19. 
OJ L 37, 13.2..2003, p. 24. 
OJ L 365, 31.12.1994, p. 10. 
OJ L 266, 26.9.2006, p. 1. 

EN 

12 

   EN 

 
                                                 
to  keep  this  safety  assessment  in  the  technical  file  to  allow  market  surveillance 
authorities to perform efficiently their tasks. Internal production control based on the 
manufacturer’s own responsibility for the conformity assessment has proven adequate 
in  cases  where  he  has  followed  the  harmonised  standards,  the  reference  number  of 
which has been published in the Official Journal of the European Union, covering all 
the safety requirements for the toy. In cases where such harmonised standards do not 
exist, the toy should be submitted to a third party verification (EC type examination). 
The  same  should  apply  if  such  standards  or  one  of  them  has  been  published  with  a 
restriction in the Official Journal of the European Union, or the manufacturer has not 
followed such standards completely or in part. The manufacturer should submit the toy 
to  the  EC-type-examination  in  cases  where  he  considers  that  the  nature,  design, 
construction or purpose of the toys necessitates third party verification. 

(25)  Since  it  is  necessary  to  ensure  throughout  the  Community  a  uniform  level  of 
performance  of  bodies  performing  conformity  assessment  of  toys  and  since  all  such 
bodies  should  perform  their  functions  to  the  same  level  and  under  conditions  of  fair 
competition, requirements should be set for conformity assessment bodies seeking to 
be  notified  for  the  purposes  of  this  Directive.  Provision  should  also  be  made  for  the 
provision of adequate information about such bodies and for their monitoring. 

(26) 

In  order  to  ensure  a  coherent  level  of  quality  in  the  performance  of  conformity 
assessment of toys, it is also necessary to make provision about the requirements to be 
fulfilled by the authorities  responsible for notifying  conformity assessment  bodies to 
the Commission and the other Member States. 

(27)  Market  surveillance  of  toys  in  the  Member  States  is  subject  to  the  provisions  of 
Directive 2001/95/EC. In order to ensure a satisfactory level of market surveillance in 
all  Member  States,  the  provisions  on  market  surveillance  measures  laid  down  in 
Directive 2001/95/EC should, however, be enhanced and certain other obligations and 
powers should be added to those already existing. 

(28)  Directive  88/378/EEC  already  provides  for  a  safeguard  procedure  allowing  the 
Commission  to  examine  the  justification  of  a  measure  taken  by  a  Member  States 
against toys it considers to be non-compliant. In order to increase transparency and to 
reduce  processing  time,  it  is  necessary  to  improve  the  existing  safeguard  clause 
procedure,  with  the  aim  of  making  it  more  efficient  and  of  drawing  on  expertise 
available in Member States. 

(29)  The  existing  system  should  be  complemented  by  a  procedure  allowing  interested 
parties to be informed of measures intended with regard to toys presenting a risk for 
the health and safety of persons or for other issues of public interest protection. It also 
allows  market  surveillance  authorities,  in  cooperation  with  the  relevant  economic 
operators, to act at an earlier stage in respect of such products. 

(30) 

In a case in which Member States and the Commission agree as to the justification of a 
measure taken by a Member State, no further involvement of the Commission should 
be required. 

(31)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission23. 

23 

OJ L184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L200, 22/7/2006, p.11). 

EN 

13 

   EN 

 
                                                 
(32) 

In  particular  power  should  be  conferred  on  the  Commission  in  order  to  adapt  the 
chemical  requirements  in  certain  well  defined  cases  and  grant  exemptions  from  the 
prohibition of CMR substances in certain cases as well as to adapt the wording of the 
specific  warnings  for  certain  categories  of  toys.  Since  those  measures  are  of  general 
scope  and  are  designed  to  amend  non-essential  elements  of  this  Directive  and/  or  to 
supplement this Directive by the addition of new non-essential elements, they must be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC. 

(33)  Member  States  should  provide  for  penalties  applicable  to  infringements  of  the 
provisions  of  this  Directive.  Those  penalties  should  be  effective,  proportionate  and 
dissuasive. 

(34)  Since the objectives of the proposed action, namely to ensure a high level of safety of 
toys whilst guaranteeing the functioning of the internal market by setting harmonised 
safety  requirements  for  toys  and  minimum  requirements  for  market  surveillance, 
cannot be sufficiently achieved by the Member States and can therefore, by reason of 
scale and effects, be better achieved at Community level, the Community may adopt 
measures,  in  accordance  with  the  principle  of  subsidiarity  set  out  in  Article  5  of  the 
Treaty. In accordance with the principle of proportionality, as set out  in  this Article, 
this  Directive  does  not  go  beyond  what  is  necessary  in  order  to  achieve  those 
objectives, 

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I 
GENERAL PROVISIONS 

Article 1 
Subject-matter and scope 

1. 

This  Directive  lays  down  rules  on  the  safety,  and  the  free  movement  in  the 
Community, of products designed or intended, whether or not exclusively, for use in 
play by children under 14 years of age, hereinafter "toys". 

The  products  listed  in  Annex  I  shall  not  be  considered  toys  within  the  meaning  of 
this Directive. 

2. 

This Directive shall not apply to the following toys: 

(a) 

(b) 

(c) 

(d) 

(e) 

playground equipment intended for public use; 

automatic playing machines, whether coin operated or not, intended for public 
use; 

toy vehicles equipped with combustion engines; 

toy steam engines; 

slings and catapults. 

Article 2 
Definitions 

For the purposes of this Directive the following definitions shall apply:  

EN 

14 

   EN 

 
(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

"making available on the market” means any supply of a toy for distribution, 
consumption or use on the Community market in the course of a commercial 
activity, whether in return for payment or free of charge; 

“placing  on  the  market”  means  the  first  making  available  of  a  toy  on  the 
Community market; 

“manufacturer”  means  any  natural  or  legal  person  who  designs  and 
manufactures  a  toy  or  who  has  such  a  toy  designed  or  manufactured,  under 
his name or trademark; 

“distributor”  means  any  natural  or  legal  person  in  the  supply  chain,  who 
makes a toy available on the market; 

“importer”  means  any  natural  or  legal  person  established  within  the 
Community,  who  places  a  toy  from  a  third  country  on  the  Community 
market; 

“economic  operators”  means  the  manufacturer,  the  importer,  the  distributor 
and the authorised representative; 

“harmonised  standard”  means  a  standard  adopted  by  one  of  the  European 
standardisation  bodies  listed  in  Annex I  to  Directive  98/34/EC  of  the 
European  Parliament  and  of  the  Council  in  accordance  with  Article  6  of 
Directive 98/34/EC; 

“accreditation” has the meaning assigned to it by Regulation (EC) No […] of 
the  European  Parliament  and  of  the  Council  of  […]  setting  out  the 
requirements  for  accreditation  and  market  surveillance  relating  to  the 
marketing of products24; 

“withdrawal”  means  any  measure  aimed  at  preventing  the  making  available 
on the market of a toy in the supply chain; 

“recall”  means  any  measure  aimed  at  achieving  the  return  of  a  toy  that  has 
already been made available to the end user; 

"activity toy" means a toy which is intended for domestic use and designed to 
bear  the  weight  of  one  or  more  children,  excluding  ride-on  vehicles,  and  is 
intended  for  children  to  play  on  or  in,  such  as  swings,  slides,  carousels, 
climbing frames, trampolines, paddling pools and non aquatic inflatable toys;  

“suffocation”  means  the  result  of  airway  obstruction  external  to  the  mouth 
and nose or internal airway obstruction by closing off the flow of air from the 
mouth and nose by objects wedged in the mouth or pharynx or lodged over 
the entrance to the lower airways. 

(13) 

“harm” means the physical injury or damage to health; 

(14) 

“hazard” means a potential source of harm; 

(15) 

“risk”  means  the  probable  rate  of  occurrence  of  a  hazard  causing  harm  and 
the degree of severity of the harm. 

24 

OJ L […], […], p. […]. 

EN 

15 

   EN 

 
                                                 
CHAPTER II 
OBLIGATIONS OF ECONOMIC OPERATORS 

Article 3 
Obligations of manufacturers 

Manufacturers  shall  ensure  that  their  toys  are  designed  and  manufactured  in 
accordance with the essential safety requirements set out in Article 9 and in Annex 
II. 

Manufacturers shall draw up technical documentation in accordance with Article 20 
and carry out or have carried out the conformity assessment procedure applicable in 
accordance with Article 18. 

Where  the  compliance  of  the  toy  with  the  applicable  requirements  has  been 
demonstrated by such procedure, manufacturers shall draw up an EC declaration of 
conformity, as referred to in Article 14 and affix the conformity marking set out in 
Article 16 (1). 

Manufacturers  shall  keep  the  technical  documentation  and  the  EC  declaration  of 
conformity for a period of 10 years after the toy has been placed on the market. 

Manufacturers  shall  ensure  that  procedures  are  in  place  to  ensure  the  continued 
conformity of series production. Changes in the product design or characteristics and 
changes  in  the  harmonised  standards  by  reference  to  which  conformity  of  a  toy  is 
stated shall be adequately taken into account. 

Manufacturers  shall,  in  all  cases  where  appropriate,  carry  out  sample  testing  of 
marketed toys, investigating, and, if necessary, keeping a register of complaints, and 
keeping distributors informed of such monitoring. 

Manufacturers  shall  ensure  that  their  toys  bear  a  type,  batch  or  serial  or  model 
number  or  any  other  element  allowing  their  identification,  or,  where  the  size  or 
nature of the toy does not allow it, that the required information is provided on the 
packaging or in a document accompanying the toy. 

Manufacturers  shall  indicate  their  name  and  the  address  at  which  they  can  be 
contacted on the toy or, where the size or nature of the toy does not allow it, on its 
packaging or in a document accompanying the toy. 

Manufacturers  who  consider  or  have  reason  to  believe  that  a  toy  which  they  have 
placed on the market is not in conformity with the applicable Community legislation 
shall  take  the  necessary  corrective  measures  to  bring  that  toy  into  conformity  or 
withdraw it from the market and recall it from end users, if appropriate. They shall 
immediately inform the national authorities of the Member States where they made 
the  toy  available  to  this  effect,  giving  details,  in  particular,  of  the  non-compliance 
and of the corrective measures taken. 

Manufacturers  shall,  on  request  from  the  competent  national  authorities,  provide 
them  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the toy. They shall cooperate with those authorities, at the request of 
the latter, on any action to avoid the risks posed by toys which they have placed on 
the market.  

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

EN 

16 

   EN 

 
1. 

2. 

3. 

1. 

2. 

3. 

4. 

5. 

Article 4 
Authorised representatives 

Manufacturers  may  appoint,  by  a  written  mandate,  any  natural  or  legal  person 
established within the Community, ("the authorised representative"), to act on their 
behalf for specified tasks with regard to the obligations of manufacturers under this 
Directive. 

The obligations under Article 3 (1) and the  drawing  up  of  technical  documentation 
may not form part of the authorised representative's mandate. 

Where a manufacturer has appointed an authorised representative, the latter shall at 
least do the following: 

(a) 

(b) 

(c) 

keep the EC declaration of conformity and the technical documentation at the 
disposal of national surveillance authorities for a period of 10 years; 

on  request  from  the  competent  national  authorities,  provide  them  with  all  the 
information and documentation necessary to demonstrate the conformity of the 
toy; 

cooperate  with  the  competent  authorities,  at  the  request  of  the  latter,  on  any 
action to avoid the risks posed by toys covered by their mandate. 

Article 5 
Obligations of Importers 

When placing a toy on the market, importers shall act with due care in relation to the 
applicable requirements. 

Before  placing  a  toy  on  the  market  importers  shall  verify  that  the  appropriate 
conformity assessment procedure has been carried out by the manufacturer.  

They  shall  verify  that  the  manufacturer  has  drawn  up  the  technical  documentation, 
that the toy bears the required conformity marking(s), is accompanied by the required 
documents  and  that  the  manufacturer  has  respected  the  requirements  set  out  in 
Article 3 (5) and (6). 

Where  an  importer  discovers  that  the  toy  is  not  in  conformity  with  the  essential 
safety requirements set out in Article 9 and in Annex II, he may place the toy on the 
market only after it has been brought into conformity with those requirements. 

Importers shall indicate their name and the address at which they can be contacted on 
the toy or, where the size or nature of the toy does not allow it, on its packaging or in 
a document accompanying the toy. 

Importers  shall  ensure  that,  while  a  toy  is  under  their  responsibility,  storage  or 
transport conditions do not jeopardise its compliance with the requirements set out in 
Article 9 and in Annex II. 

Importers who consider or have reason to believe that a toy which they have placed 
on the market is not in conformity with the applicable Community legislation shall 
take the necessary corrective measures to bring that toy into conformity or withdraw 
it  from  the  market  and  recall  it  from  end  users,  if  appropriate.  They  shall 
immediately inform the national authorities of the Member States where they made 
the  toy  available  to  this  effect,  giving  details,  in  particular,  of  the  non-compliance 
and of the corrective measures taken. 

EN 

17 

   EN 

 
 
6. 

7. 

1. 

2. 

3. 

4. 

5. 

Importers  shall,  for  a  period  of  10  years,  keep  a  copy  of  the  EC  declaration  of 
conformity at the disposal of the market surveillance authorities and ensure that the 
technical documentation can be made available to those authorities, upon request. 

Importers  shall,  on  request  from  the  competent  national  authorities,  provide  them 
with all the information and documentation necessary to demonstrate the conformity 
of the toy. They shall cooperate with those authorities, at the request of the latter, on 
any action to avoid the risks posed by toys which they have placed on the market. 

Article 6 
Obligations of distributors 

When  making  a  toy  available  on  the  market,  distributors  shall  act  with  due  care  in 
relation to the applicable requirements. 

Before  making  a  toy  available  on  the  market  distributors  shall  verify  that  the  toy 
bears  the  required  conformity  marking(s)  and  is  accompanied  by  the  required 
documents  and  that  the  manufacturer  and  the  importer  have  complied  with  the 
requirements set out in Article 3 (5) and (6) and Article 5 (3) respectively. 

Where a distributor discovers that a toy is not in conformity with the essential safety 
requirements set out in Article 9 and in Annex II, he may make the toy available on 
the  market  only  after  it  has  been  brought  into  conformity  with  those  requirements. 
The distributor shall inform the manufacturer or the importer to this effect. 

A  distributor  shall  ensure  that,  while  a  toy  is  under  his  responsibility,  storage  or 
transport conditions do not jeopardise its compliance with the requirements set out in 
Article 9 and in Annex II. 

Distributors who consider or have reason to believe that a toy which they have made 
available  on  the  market  is  not  in  conformity  with  the  applicable  Community 
legislation  shall  take  the  necessary  corrective  measures  to  bring  that  toy  in 
conformity  or  withdraw  it  from  the  market  and  recall  it  from  end  users,  if 
appropriate.  They  shall  immediately  inform  the  national  authorities  of  the  Member 
States where they made the toy available to this effect, giving details, in particular, of 
the non-compliance and of the corrective measures taken. 

Distributors shall, on request from the competent national authorities, provide them 
with all the information and documentation necessary to demonstrate the conformity 
of the toy. They shall cooperate with those authorities, at the request of the latter, on 
any action to avoid the risks posed by toys which they  have made available on the 
market. 

Article 7 
Cases in which obligations of manufacturers apply to importers and distributors 

An importer or distributor who places a toy on the market under his name or trademark shall 
be subject to the obligations of the manufacturer under Article 3. 

An  importer  or  a  distributor,  who  modifies  a  toy  in  such  a  way  that  compliance  with  the 
essential  safety  requirements  set  out  in  Article  9  and  in  Annex  II  may  be  affected,  shall  be 
subject  to  the  obligations  of  the  manufacturer  under  Article  3  in  respect  of  these 
modifications. 

EN 

18 

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Article 8 
Identification of economic operators 

Economic operators shall be able to identify the following: 

(a) 

(b) 

any economic operator who has supplied them with a toy; 

any economic operator to whom they have supplied a toy. 

They shall have in place appropriate systems and procedures which allow for this information 
to  be  made  available  to  the  market  surveillance  authorities  on  request,  for  a  period  of  10 
years. 

CHAPTER III 
CONFORMITY OF THE TOY 

Article 9 
Essential safety requirements  

1. 

2. 

3. 

1. 

2. 

Member  States  shall  take  all  measures  necessary  to  ensure  that  toys  may  not  be 
placed  on  the  market  unless  they  comply  with  the  essential  safety  requirements  set 
out, as far as the general safety requirement is concerned, in paragraph 2, and, as far 
as the particular safety requirements are concerned, in Annex II. 

Toys shall not jeopardize the safety or health of users or third parties when they are 
used  as  intended  or  in  a  foreseeable  way,  bearing  in  mind  behaviour  of  children. 

The  ability  of  the  users  and  where  appropriate  their  supervisors  shall  be  taken  into 
account,  in  particular,  in  the  case  of  toys  which,  by  virtue  of  their  functions, 
dimensions and characteristics, are intended for use by children of under 36 months. 

Labels on toys or on their packaging and the instructions for use which accompany 
them shall draw the attention of users or their supervisors to the inherent hazards and 
risks of harms involved in using the toys and to the ways of avoiding them.  

Toys placed on the market shall comply with the essential safety requirements during 
their foreseeable and normal period of use. 

Article 10 
Warnings  

Where appropriate for safe use, warnings made for the purposes of Article 9 (2) shall 
specify appropriate user limitations, in accordance with Part A of Annex V.  

As regards the categories of toys listed in Part B of Annex V, the warnings set out 
therein shall be used. 

The manufacturer shall mark the warnings in  a  visible,  clearly legible and accurate 
manner on the toy, on an affixed label or on the packaging and, if appropriate, on the 
instructions  for  use  which  accompany  the  toy.  Small  toys  that  are  sold  without 
packaging shall have appropriate warnings affixed to them. 

Warnings  specifying  the  minimum  and  maximum  ages  for  users  shall  be  visible, 
legible and conspicuously displayed at the point of sale. 

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3. 

Member States may require warnings and safety instructions, or some of them, to be 
presented in their own official language or languages when the toys are placed on the 
market in their territory. 

Article 11 
Free movement  

Members States shall not impede the making available on the market in their territory of toys 
which comply with the provisions of this Directive. 

Article 12 
Presumption of conformity  

Toys  which  are  in  conformity  with  harmonised  standards  or  parts  thereof,  the  references  of 
which have been published in the Official Journal of the European Union, shall be presumed 
to be in conformity with the requirements covered by those standards or parts thereof, set out 
in Article 9 and in Annex II.  

Article 13 
Formal objection against harmonised standards 

When a Member State or the Commission considers that a harmonised standard does 
not entirely satisfy the requirements which it covers and which are set out in Article 
9 and in Annex II, the Commission or the  Member State concerned shall bring the 
matter before the Committee set up by Article 5 of Directive 98/34/EC, hereinafter 
the  "Committee",  giving  its  arguments.  The  Committee  shall  deliver  its  opinion 
without delay. 

In the light of the Committee’s opinion, the Commission shall decide to publish, not 
to publish, to publish with restriction, to maintain, to maintain with restriction or to 
withdraw the references to the harmonised standard concerned in the Official Journal 
of the European Union. 

The Commission shall  inform the European standardisation body concerned and, if 
necessary, request the revision of the harmonised standards concerned. 

Article 14 
EC declaration of conformity 

The EC declaration of conformity shall state that the fulfilment of the requirements 
specified in Article 9 and in Annex II has been demonstrated. 

The EC declaration of conformity shall as a minimum contain the elements specified 
in  Annex  III  and  shall  continuously  be  updated.  The  EC  declaration  of  conformity 
shall have the model structure set out in Annex III. 

By drawing up the EC declaration of conformity, the manufacturer shall assume the 
responsibility for the compliance of the toy. 

1. 

2. 

3. 

1. 

2. 

3. 

Article 15 
General principles of the CE marking 

1. 

Toys made available on the market shall bear the CE marking. 

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2. 

3. 

4. 

5. 

6. 

7. 

The  CE  marking  may  only  be  affixed  by  the  manufacturer  or  his  authorised 
representative. 

By  affixing  or  having  affixed  the  CE  marking  the  manufacturer  shall  assume  the 
responsibility for the conformity of the toy with the requirements laid down in this 
Directive.  

Member  States  shall  presume  that  toys  bearing  the  CE  marking  comply  with  the 
provisions of this Directive. 

The CE marking shall be the only marking which attests conformity of the toy with 
the applicable requirements.  

Member States shall refrain from introducing into their national regulations, or shall 
withdraw  any  reference  to,  a  conformity  marking  other  than  the  CE  marking  in 
connection with conformity to the provisions of this Directive. 

The affixing on a toy of markings, signs and inscriptions which are likely to mislead 
third  parties  as  to  the  meaning  or  form  of  the  CE  marking,  or  both,  shall  be 
prohibited. Any other marking may be affixed to the toy provided that the visibility, 
legibility and meaning of the CE marking are not thereby impaired. 

Toys not bearing a CE-marking and which do not comply with the provisions of this 
Directive  may  feature  in  trade  fairs  and  exhibitions,  provided  that  they  are 
accompanied by a sign which clearly indicates that the toys do not comply with the 
requirements of this Directive and are not for sale or for distribution free of charge. 

Article 16 
Rules and conditions for the affixing of the CE marking 

1. 

The CE marking shall consist of the initials “CE” taking the following form:  

2. 

3. 

4. 

If  the  CE  marking  is  reduced  or  enlarged  the  proportions  given  in  the  graduated 
drawing in paragraph 1 must be respected. 

Where  specific  legislation  does  not  impose  specific  dimensions,  the  CE  marking 
shall have a height of at least 5 mm. 

The CE marking shall be marked visibly, legibly and indelibly either on the toy, on 
an affixed label, or on the packaging. 

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5. 

6. 

7. 

In  the  case  of  small  toys  and  toys  consisting  of  small  parts  the  CE-marking  may 
alternatively  be  affixed  on  a  label  or  an  accompanying  leaflet.  If  that  is  not 
technically possible in the case of toys sold in counter displays, the information shall 
be affixed to the counter display. 

If the CE-marking is not visible from outside the packaging, if any, it shall at least be 
affixed on the packaging. 

The CE marking shall  be  affixed before the toy is placed on the market. It may be 
followed by a pictogram or any other mark indicating a special risk or use. 

CHAPTER IV 
CONFORMITY ASSESSMENT 

Article 17 
Safety assessments  

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 and an assessment of the potential exposure to them. 

Article 18 
The applicable conformity assessment procedures 

1. 

2. 

3. 

Before  placing  the  toys  on  the  market,  manufacturers  shall  use  the  conformity 
assessment procedures identified in paragraphs 2 and 3 to demonstrate that the toys 
comply with the essential safety requirements set out in Article 9 and Annex II. 

If  the  manufacturer  has  applied  the  harmonised  standards  the  reference  number  of 
which has been published in the Official Journal of the European Union covering all 
the relevant safety requirements for the toy, the manufacturer shall use the procedure 
of internal production control as set out in Module A of Annex I to Decision […]. 

The  toy  shall  be  submitted  for  EC-type-examination  as  referred  to  in  Article  19 
combined with the conformity to type procedure set out in Module C of Annex I to 
Decision […] in the following cases: 

(a) 

(b) 

(c) 

(d) 

when harmonised standards, the reference number of which has been 
published in the Official Journal of the European Union, covering all 
relevant safety requirements for the toy, do not exist; 

when  standards  as  referred  to  in  point  (a)  exist  but  the  manufacturer 
has not applied them or has applied them only in part; 

when  standards  as  referred  to  in  point  (a)  or  any  of  them  have  been 
published with a restriction.; 

when the manufacturer considers that the nature, design, construction 
or purpose of the toy necessitate third party verification. 

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1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

Article 19 
EC type-examination 

Application for EC type-examination, performance of that examination and issue of 
the  EC  type-examination  certificate  shall  be  carried  out  in  accordance  with  the 
procedures set out in Module B laid down in Annex I to Decision […].  

The EC type-examination shall be carried out in the manner specified in paragraph 2, 
second indent, of Module B (combination of production type and design type).   
In addition to  those provisions, the requirements laid down  in paragraphs 2  to  5 of 
this Article shall apply. 

The application for an EC type-examination shall include a description of the toy and 
an indication of the place of manufacture, including the address.  

When a conformity assessment body notified under Article 21, hereinafter "notified 
body",  carries  out  the  EC  type-examination,  it  shall  evaluate,  if  necessary,  jointly 
with  the  manufacturer,  the  analysis  performed  by  the  manufacturer  in  accordance 
with Article 17 of the hazards that the toy may present. 

The  EC  type-examination  certificate  shall  include  a  reference  to  this  Directive,  a 
colour image and a clear description of the toy including dimensions, and a list of the 
tests performed with a reference to the relevant test report. 

The certificate shall be reviewed at any time where necessary, in particular in case of 
a modification in the manufacturing process, in the raw materials or the components 
of the toy and, in any case, every 5 years.  

It shall be withdrawn if the toy fails to comply with the essential safety requirements 
set out in Article 9 and Annex II. 
Member  States  shall  ensure  that  their  notified  bodies  do  not  grant  an  EC  type-
examination certificate for toys in respect of which a certificate has been refused or 
withdrawn. 

The file and correspondence relating to the EC type-examination procedures shall be 
drawn up in an official language of the Member State in which the notified body is 
established or in a language acceptable to the body. 

Article 20 
Technical documentation 

The technical documentation referred to in Article 3 (2) shall contain all relevant data 
or details of the means used by the manufacturer to ensure that toys comply with the 
relevant essential requirements set out in Article 9 and in Annex II and, in particular, 
it shall contain the documents listed in Annex IV. 

The technical documentation shall be drafted in one of the official languages of the 
Community, subject to the requirement laid down in Article 19 (5).  

Following  a  reasoned  request  from  the  market  surveillance  authority  of  a  Member 
State,  the  manufacturer  shall  provide  a  translation  of  the  relevant  parts  of  the 
technical documentation into the language of that Member State. 

When  a  market  surveillance  authority  requests  the  technical  documentation  or  a 
translation  of  parts  of  it  from  a  manufacturer,  it  may  fix  a  deadline  for  doing  so 
which shall be 30 days unless a shorter deadline is justified because there is a serious 
and immediate risk. 

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4. 

If the manufacturer does not observe the obligations foreseen in paragraphs 1, 2 and 
3, the market surveillance authority may require him to have a test performed by a 
notified  body  at  his  own  expense  within  a  specified  period  in  order  to  verify 
compliance with the harmonised standards and essential safety requirements. 

CHAPTER V 
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES 

Article 21 
Notification  

Member States shall notify the Commission and the other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive. 

Bodies which were notified according to Directive 88/378/EEC shall be presumed notified for 
the purposes of this Directive. 

Article 22 
Notifying authorities 

1. 

2. 

3. 

(1) 

(2) 

(3) 

(4) 

(5) 

Member  States  shall  designate  a  notifying  authority  that  shall  be  responsible  for 
setting  up  and  carrying  out  the  necessary  procedures  for  the  assessment  and 
notification  of  conformity  assessment  bodies  for  the  purposes  of  this  Directive  and 
for  the  monitoring  of  notified  bodies,  including  compliance  with  the  provisions  of 
Article 27. 

Member  States  may  decide  that  the  assessment  and  monitoring  referred  to  in 
paragraph  1  shall  be  carried  out  by  their  national  accreditation  bodies  within  the 
meaning of and in accordance with Regulation (EC) No […]. 

Where  the  notifying  authority  delegates,  subcontracts  or  otherwise  entrusts  the 
assessment, notification or monitoring referred to in paragraph 1 to a body which is 
not a governmental entity, the delegated, sub-contracted or otherwise entrusted body 
shall be a legal entity and shall have arrangements to cover liabilities arising from its 
activities. 

Article 23 
Requirements relating to notifying authorities 

The notifying authority shall meet the requirements set out in paragraphs 2 to 7 

The notifying authority shall be established in such a way that no conflicts of interest 
with conformity assessment bodies occur 

The  notifying  authority  shall  be  organised  and  operated  so  as  to  safeguard  the 
objectivity and impartiality of its activities 

The notifying authority shall be organised in such a way that each decision relating to 
notification of the conformity assessment body is taken by competent persons different 
from those who carried out the assessment; 

The  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity 
assessment bodies perform, or consultancy. 

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(6) 

(7) 

The  notifying  authority  shall  have  adequate  arrangements 
confidentiality of the information obtained. 

to  safeguard 

the 

The  notifying  authority  shall  have  a  sufficient  number  of  competent  personnel  at  its 
disposal for the proper performance of its tasks. 

Article 24 
Information obligation for the notifying authorities 

Member  States  shall  inform  the  Commission  and  the  other  Member  States  of  their  national 
procedures  for  the  assessment  and  notification  of  conformity  assessment  bodies  and  the 
monitoring of notified bodies, and of any changes to that information.  

The Commission shall make that information publicly available. 

Article 25 
Requirements for notified bodies  

For the purposes of notification under this Directive, a conformity assessment body 
shall meet the requirements set out in paragraphs 2 to 11. 

The  conformity  assessment  body  shall  be  established  under  national  law  and  have 
legal personality. 

The  conformity  assessment  body  shall  be  a  third-party  body  independent  from  the 
organisation or the product it assesses. 

The  conformity  assessment  body,  its  top  level  management  and  the  personnel 
responsible  for  carrying  out  the  conformity  assessment  tasks  shall  not  be  the 
designer,  manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of 
the  products  which  they  assess,  nor  the  authorised  representative  of  any  of  those 
parties.  Nor  shall  they  become  directly  involved  in  the  design,  manufacture  or 
construction,  the  marketing,  installation,  use  or  maintenance  of  those  products,  nor 
represent the parties engaged in those activities. 

They shall not provide consultancy related to the conformity assessment activities for 
which  they  are  notified  and  relating  to  products  intended  to  be  placed  on  the 
Community market. This shall not preclude the possibility of exchanges of technical 
information between the manufacturer and the conformity assessment body and the 
use  of  assessed  products  that  are  necessary  for  the  operations  of  the  conformity 
assessment body. 

The  conformity  assessment  body  shall  ensure  that  activities  of  its  subsidiaries  or 
subcontractors  do  not  affect  the  confidentiality,  objectivity  and  impartiality  of  its 
conformity assessment activities. 

The  conformity  assessment  body  and  its  personnel  shall  carry  out  the  conformity 
assessment  activities  with  the  highest  degree  of  professional  integrity  and  requisite 
technical  competence  in  the  specific  field  and  must  be  free  from  all  pressures  and 
inducements,  particularly  financial,  which  might  influence  their  judgement  or  the 
results of their conformity assessment activities, especially from persons or groups of 
persons with an interest in the results of those activities. 

The conformity assessment body shall be capable of carrying out all the conformity 
assessment  tasks  assigned  to  such  a  body  by  the  provisions  of  Article  19  and  for 

1. 

2. 

3. 

4. 

5. 

6. 

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which  it  has  been  notified,  whether  those  tasks  are  carried  out  by  the  conformity 
assessment body itself or on its behalf and under its responsibility. 

At  all  times  and  for  each  conformity  assessment  procedure  and  for  each  kind  or 
category  of  products  for  which  it  is  notified,  the  conformity  assessment  body  shall 
have at its disposal the necessary personnel with technical knowledge and sufficient 
and appropriate experience to perform the conformity assessment tasks. It  shall  have 
the means necessary to perform the technical and administrative tasks connected with 
the conformity assessment activities in an appropriate manner and shall have access 
to all necessary equipment or facilities. 

7. 

The personnel responsible for carrying out the conformity assessment activities shall 
have the following: 

(a) 

(b) 

(c) 

sound  technical  and  vocational  training  covering  all  the  conformity 
assessment  activities  of  the  relevant  scope  for  which  the  conformity 
assessment body has been notified; 

satisfactory  knowledge  of  the  requirements  of  the  assessments  they 
carry out and adequate authority to carry out such operations; 

appropriate  knowledge  and  understanding  of 
the  essential 
requirements,  of  the  applicable  harmonised  standards  and  of  the 
relevant provisions of the relevant Community legislation and relevant 
implementing regulations 

(d) 

the ability required to draw up the certificates, records and reports to 
demonstrate that the assessments have been carried out. 

8. 

The  impartiality  of  the  conformity  assessment  body,  its  top  level  management  and 
assessment personnel shall be guaranteed. 

9. 

10. 

11. 

The  remuneration  of  the  conformity  assessment  body’s  top  level  management  and 
assessment personnel shall not depend on the number of assessments carried out or 
on the results of such assessments. 

The conformity assessment body shall take out liability insurance unless liability is 
assumed by the State in accordance with national law, or the Member State itself is 
directly responsible for the conformity assessment. 

The  personnel  of  the  conformity  assessment  body  shall  be  bound  to  observe 
professional  secrecy  with  regard  to  all  information  gained  in  carrying  out  its  tasks 
under Article 19 or any provision of national law giving effect to it, except in relation 
to  the  competent  administrative  authorities  of  the  Member  State  in  which  its 
activities are carried out. Proprietary rights shall be protected. 

The  conformity  assessment  body  shall  participate  in,  or  ensure  that  its  assessment 
personnel is informed of, the relevant standardisation activities and the activities of 
the  notified  body  co-ordination  group  established  under  Article  36  and  apply  as 
general  guidance  the  administrative  decisions  and  documents  produced  as  a  work 
result of that group. 

Article 26 
Presumption of conformity 

Where  a  conformity  assessment  body  can  demonstrate  its  conformity  with  the  criteria  laid 
down in the harmonised standards, the references of which have been published in the Official 

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Journal of the European Union, it shall be presumed to comply with the requirements set out 
in Article 25 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

1. 

2. 

3. 

4. 

Article 27 
Subsidiaries and subcontracting of notified bodies 

Where  the  conformity  assessment  body  subcontracts  specific  tasks  connected  with 
the assessment of conformity or has recourse to a subsidiary, it shall ensure that the 
subcontractor or the subsidiary meets the requirements set out in Article 25. 

The conformity assessment body shall take full responsibility for the tasks performed 
by subcontractors or subsidiaries, wherever these are established.  

Activities  may  be  subcontracted  or  carried  out  by  a  subsidiary  only  with  the 
agreement of the client. 

The conformity assessment body shall keep at the disposal of the national authorities 
the  relevant  documents  concerning  the  assessment  of  the  subcontractor’s  or 
subsidiary’s  qualifications  and  the  work  carried  out  by  the  subcontractor  or  the 
subsidiary under Article 19. 

Article 28 
Application for notification 

A conformity assessment body shall submit an application for notification under this 
Directive to the notifying authority of the Member State in which it is established. 

The application shall be accompanied by a description of the conformity assessment 
activities, the conformity assessment module or modules and the product or products 
for which the body claims to be competent, as well as by an accreditation certificate, 
where  it  exists,  delivered  by  a  national  accreditation  body  within  the  meaning  of 
Regulation  (EC)  No  […],  attesting  that  the  conformity  assessment  body  meets  the 
requirements laid down in Article 25 of this Directive. 

Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate,  it  shall  provide  the  notifying  authority  with  all  documentary  evidence 
necessary for the verification, recognition and regular monitoring of its compliance 
with the requirements laid down in Article 25. 

Article 29 
Notification procedure 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 
satisfied the requirements laid down in Article 25. 

They shall notify the Commission and the other Member States using the electronic 
notification tool developed and managed by the Commission. 

The notification shall include full details of the conformity assessment activities, the 
conformity  assessment  module  or  modules  and  product  or  products  concerned  and 
the relevant attestation of competence. 

Where a notification is not based on an accreditation certificate referred to in Article 
28 (2), the notifying authority shall provide the Commission and the other Member 
States with all documentary evidence necessary for the verification of the conformity 
assessment body's competence. 

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5. 

6. 

1. 

2. 

1. 

2. 

1. 

2. 

3. 

4. 

The  body  concerned  may  perform  the  activities  of  a  notified  body  only  where  no 
objections have been raised by the Commission and the other Member States within 
two months following that notification. 
Only  such  a  body  shall  be  considered  as  a  notified  body  for  the  purpose  of  this 
Directive. 

The  Commission  and  the  other  Member  States  shall  be  notified  of  any  subsequent 
relevant changes to the notification. 

Article 30 
Identification numbers and lists of notified bodies 

The  Commission  shall  assign  an  identification  number  to  a  notified  body. 
It  shall  assign  a  single  such  number  even  where  the  body  is  notified  under  several 
Community acts. 

The Commission shall make publicly available the list of the bodies notified under 
this Directive, including the identification numbers that have been assigned to them 
and the activities for which they have been notified. 

The Commission shall ensure that this list is kept up to date. 

Article 31 
Changes to the notification 

Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements set out in Article 25, or that it is failing to fulfil its 
obligations,  the  notifying  authority  shall  restrict,  suspend  or  withdraw  the 
notification as appropriate. It shall immediately inform the Commission and the other 
Member States thereof. 

In  the  case  of  withdrawal,  restriction  or  suspension  of  notification  or  where  the 
notified  body  has  ceased  activity,  the  notifying  Member  State  concerned  shall  take 
the appropriate steps to ensure that the files are either processed by another notified 
body  or  kept  available  for  the  responsible  notifying  and  market  surveillance 
authorities on request. 

Article 32 
Challenge of the competence of notified bodies 

The Commission shall investigate all cases where it doubts or doubt is brought to its 
attention  as  to  the  competence  of  a  notified  body  or  the  continued  fulfilment  by  a 
notified body of the requirements and responsibilities placed on it.  

The  notifying  Member  State  shall  provide  the  Commission,  on  request,  with  all 
information related to the basis for notification or the maintenance of the competence 
of the body concerned. 

The  Commission  shall  ensure  that  all  information  obtained  in  the  course  of  its 
investigations is treated confidentially.  

Where  the  Commission  ascertains  that  a  notified  body  does  not  meet,  or  no  longer 
meets,  the  requirements  for  its  notification,  it  shall  inform  the  notifying  Member 

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State thereof and request it to take the necessary corrective measures, including de-
notification, if necessary. 

Article 33 
Operational obligations for notified bodies 

1. 

2. 

3. 

4. 

5. 

Notified  bodies  shall  carry  out  conformity  assessments  in  accordance  with  the 
conformity assessment procedure provided for in Article 19. 

Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary  burden  for  economic  operators,  in  particular  taking  into  consideration 
the size of companies and the relative complexity of the technology used by the toys. 

Where  a  notified  body  finds  that  the  requirements  laid  down  in  Article  9  and  in 
Annex II have not been met by the manufacturer, it shall require the manufacturer to 
take appropriate corrective measures and it shall not deliver the EC type-examination 
certificate as referred to in Article 19(4). 

Where,  in  the  course  of  the  monitoring  of  conformity  following  the  delivery  of 
certificate,  a  notified  body  finds  that  a  toy  no  longer  complies,  it  shall  require  the 
manufacturer to take appropriate corrective measures and shall suspend or withdraw 
the certificate if necessary. 

Where  corrective  measures  are  not  taken  or  do  not  have  the  required  effect,  the 
notified body shall restrict, suspend or withdraw any certificates, as appropriate. 

Article 34 
Information obligation for notified bodies 

1. 

Notified bodies shall inform the notifying authority of the following: 

(a) 

(b) 

(c) 

(d) 

any  refusal,  restriction,  suspension  or  withdrawal  of  EC  type-examination 
certificates; 

any circumstances affecting the scope of and conditions for notification; 

any request for information which they have received from market surveillance 
authorities; 

on  request,  conformity  assessment  activities  performed  within  the  scope  of 
their  notification  and,  any  other  activity  performed,  including,  cross-border 
activities and subcontracting. 

2. 

Notified bodies shall provide the other bodies notified under this Directive carrying 
out  similar  conformity  assessment  activities  and  covering  the  same  products  with 
relevant  information  on  issues  relating  to  negative  and,  on  request,  positive 
conformity assessment results. 

Article 35 
Exchange of experience 

The  Commission  shall  provide  for  the  organisation  of  exchange  of  experience  between  the 
Member States’ national authorities responsible for policy on notification. 

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Article 36 
Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified under this Directive is put into place and properly operated in the form of a sectoral 
group of notified bodies. 

Member  States  shall  ensure  that  the  bodies  notified  by  them  participate  in  the  work  of  that 
group. 

CHAPTER VI 
MARKET SURVEILLANCE 

Article 37 
General obligation to organise market surveillance 

Member States shall organise and perform surveillance in accordance with Articles 6, 8 and 9 
of  Directive  2001/95/EC  of  toys  placed  on  the  market.  In  addition  to  those  provisions, 
Articles 38, 39 and 40 of this Directive shall apply. 

1. 

2. 

3. 

1. 

2. 

1. 

Article 38 
Powers of market surveillance authorities 

The  market  surveillance  authorities  may  require  from  the  economic  operators 
concerned any information considered necessary for the purposes of effective market 
surveillance, including the technical documentation referred to in Article 20. 

The market surveillance authorities may ask a notified body to provide information 
relating  to  any  EC  type-examination  certificate  which  that  body  has  issued  or 
withdrawn,  or  which  relates  to  any  refusal  to  issue  such  a  certificate,  including  the 
test reports and technical documentation.  

The  market  surveillance  authorities  shall  be  entitled  to  enter  the  premises  of  the 
economic  operators  concerned  where  it  appears  necessary  for  the  purposes  of 
carrying out the surveillance of toys in accordance with Article 37. 

Article 39 
Instructions to the notified body 

If  the  market  surveillance  authority  finds  that  a  particular  toy  is  not  in  conformity 
with  the  essential  safety  requirements  set  out  in  Article  9  and  Annex  II,  it  shall, 
where  appropriate,  instruct  the  notified  body  to  withdraw  the  EC  type-examination 
certificate in respect of such products. 

Where necessary, and in particular in cases specified in the second subparagraph of 
Article  19  (4),  the  market  surveillance  authority  shall  instruct  the  notified  body  to 
review the EC type-examination certificate. 

Article 40 
Co-operation for market surveillance 

Member States shall ensure efficient co-operation and exchange of information on all 
issues relating to toys presenting a risk between their market surveillance authorities 
and  those  of  the  other  Member  States  and  between  their  own  authorities  and  the 
Commission and the relevant Community Agencies. 

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2. 

1. 

2. 

3. 

4. 

5. 

For the purposes of paragraph 1, the market surveillance authorities of one Member 
State shall provide, on request, assistance to market surveillance authorities of other 
Member  States  by  supplying  information  or  documentation,  by  carrying  out 
appropriate  investigations  or  any  other  appropriate  measure  or  by  participating  in 
investigations initiated in other Member States. 

CHAPTER VII 
SAFEGUARD PROCEDURES 

Article 41 
Safeguard clause 
Procedure to deal with toys presenting a risk at national level 

Where  the  market  surveillance  authorities  of  one  Member  State  have  taken  action 
referred  to  in  Article  12  of  Directive  2001/95/EC  or  where  they  have  sufficient 
reason to believe that a toy covered by this Directive presents a risk for the health or 
safety of persons they shall, together with the relevant economic operators, perform 
an evaluation in relation to the toy concerned covering all the requirements laid down 
by this Directive. 

Where, in the course of that evaluation, the market surveillance authorities find that 
the toy does not comply with the requirements laid down by this Directive, they shall 
require  the  relevant  economic  operator  to  take  all  appropriate  corrective  actions  to 
bring the toy into compliance with those requirements or to withdraw the toy from 
the market or recall it within such reasonable period, commensurate with the nature 
of the risk, as they may prescribe. 

Where  the  market  surveillance  authorities  consider  that  the  non-compliance  is  not 
limited  to  the  national  territory,  they  shall  inform  the  Commission  and  the  other 
Member  States  of  the  results  of  the  evaluation  and  of  the  actions  which  they  have 
required the economic operator to take. 

The economic operator shall ensure that any corrective actions are taken in respect of 
all  the  toys  concerned  which  he  has  made  available  on  the  market  throughout  the 
Community. 

Where  the  relevant  economic  operator,  within  the  period  referred  to  in  the  second 
subparagraph  of  paragraph  1,  does  not  take  adequate  corrective  actions,  the  market 
surveillance authorities shall take all appropriate provisional measures to prohibit or 
restrict the making available of the toy on the national market or to withdraw the toy 
from that market or to recall it. 

They  shall  inform  the  Commission  and  the  other  Member  States,  without  delay,  of 
such measures. 

The  information  referred  to  in  paragraph  4  shall  provide  all  available  details,  in 
particular  as  regards  the  necessary  data  for  the  identification  of  the  non-compliant 
toy, the origin of the toy, the nature of the risk involved, the nature and duration of 
national  measures  taken.  In  particular,  the  market  surveillance  authorities  shall 
indicate whether the non compliance is due to either of the following: 

(a) 

failure  of  the  toy  to  meet  the  requirements  related  to  the  health  or  safety  of 
persons; 

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31 

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6. 

7. 

1. 

2. 

3. 

(b) 

shortcomings  in  the  harmonised  standards  referred  to  in  Article  12  (1)  as 
conferring presumption of conformity. 

Member  States  other  than  the  Member  State  which  initiated  the  procedure  shall 
without delay inform the Commission and the other Member States of any measures 
adopted and of any additional information relating to the non-compliance of the toy 
concerned  at  their  disposal,  and,  in  the  event  of  disagreement  with  the  notified 
national measure, of their objections. 

Where, within three months of receipt of the information referred to in paragraph 4, 
no objection has been raised by either a Member State or the Commission in respect 
of a provisional measure taken by a Member State in relation to the toy concerned, 
the measure shall be deemed justified. 

Article 42 

Community safeguard procedure 

Where, on completion of the procedure set out in Article 41 (3) and (4), objections 
are  raised  against  a  national  measure  of a  Member  State  or  where  the  Commission 
considers  the  national  measure  to  be  contrary  to  Community  legislation  the 
Commission shall without delay enter into consultation with the Member States and 
the relevant economic operator(s) and shall proceed to the evaluation of the national 
measure. 

On the basis of the results of that evaluation, the Commission shall take a decision, 
indicating whether the measure is justified or not. 

The  Commission  shall  address  its  decision  to  all  Member  States  and  shall 
immediately communicate it to them and to the relevant economic operator(s). 

If  the  national  measure  is  considered  justified,  all  Member  States  shall  take  the 
necessary  measures  to  ensure  that  the  non-compliant  toy  is  withdrawn  from  their 
markets. Member States shall inform the Commission thereof. 

If the national measure is considered unjustified, the Member State concerned shall 
withdraw the measure. 

Where the national measure is considered to be justified and the non-compliance of 
the  toy  is  attributed  to  shortcomings  in  the  harmonised  standards  as  referred  to  in 
Article 41(5)(b), the Commission or the Member State shall bring the matter before 
the Standing Committee set up under Article 5 of Directive 98/34/EC. 

Article 43 
RAPEX notifications  

If a measure referred to in Article 41 (4) is a type of measure which is required under Article 
12  of  Directive  2001/95/EC  to  be  notified  through  the  Community  Rapid  Information 
Exchange  System  (RAPEX),  it  shall  not  be  necessary  to  make  a  separate  notification  under 
Article 41(4) of this Directive, provided that the following conditions are met:  

(a) 

(b) 

the  RAPEX  notification  indicates  that  the  notification  of  the  measure  is  also 
required by this Directive; 

the  supporting  evidence  referred  to  in  Article  41  (5)  is  enclosed  with  the 
RAPEX notification. 

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Article 44 
Formal non-compliance 

1. 

Without prejudice to Article 41, where a Member State makes one of the following 
findings,  it  shall  require  the  relevant  economic  operator  to  put  an  end  to  the  non-
compliance concerned: 

(a) 

(b) 

(c) 

(d) 

the  conformity  marking  has  been  affixed  in  violation  of  Article  15  or  Article 
16, 

the conformity marking has not been affixed; 

the EC declaration of conformity has not been drawn up; 

the EC declaration of conformity has not been drawn up correctly. 

2. 

Where  the  non-compliance  referred  to  in  paragraph  1  continues,  the  Member  State 
shall take all appropriate measures to restrict or prohibit the making available on the 
market of the toy or ensure that it is recalled or withdrawn from the market. 

CHAPTER VIII 
COMMITTEE PROCEDURES 

Article 45 
Amendments and implementing measures 

1. 

The Commission may, for the purposes of adapting them to technical and scientific 
developments, amend the following: 

(a) 

(b) 

Points 7 and 8 in Part III of Annex II; 

Annex V. 

Those measures, designed to amend non-essential elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 46 (2).  

2. 

The  Commission  may  decide  upon  the  use  in  toys  of  substances  or  preparations 
classified as carcinogenic, mutagenic or toxic for reproduction, of category 1, 2 and 
3, under Annex I to Directive 67/548/EEC. 

Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 46 (2). 

Article 46 
Committee 

1. 

2. 

The Commission shall be assisted by a committee. 

Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4),  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

EN 

33 

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CHAPTER IX 
SPECIFIC ADMINISTRATIVE PROVISIONS 

Article 47 
Reporting 

Three  years  following  the  date  of  application  of  this  Directive  referred  to  in  the  second 
paragraph  of  Article  53  and  every  five  years  thereafter,  Member  States  shall  send  the 
Commission a report on the application of this Directive.  

This report shall contain an evaluation of the situation concerning the safety of toys and of the 
effectiveness  of  this  Directive  as  well  as  a  presentation  of  the  market  surveillance  activities 
performed by the Member State.  

The Commission shall draw up and publish a summary of those national reports. 

Article 48 
Transparency and confidentiality 

When  the  authorities  of  the  Member  States  and  the  Commission  adopt  measures  under  this 
Directive, the requirements of transparency and confidentiality provided for in Article 16 of 
Directive 2001/95/EC shall apply. 

Article 49 
Motivation of measures 

Any measure taken pursuant to this Directive to prohibit or restrict the placing on the market 
of a toy, or to withdraw or recall a toy from the market, shall state the exact grounds on which 
it is based.  

Such measures shall be notified without delay to the party concerned, who shall at the same 
time be informed of the remedies available to him under the laws in force in the Member State 
in question and of the time limits applying to such remedies. 

Article 50 
Penalties 

Member  States shall  lay down the rules  on penalties,  which  may  include  criminal  sanctions 
for  serious  infringements,  applicable  to  infringements  to  the  national  provisions  adopted 
pursuant  to  this  Directive  and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented. The penalties provided for shall be effective, proportionate and dissuasive.  

The Member States shall notify those provisions to the Commission by the date specified in 
Article  53  at  the  latest  and  shall  notify  it  without  delay  of  any  subsequent  amendment 
affecting them. 

CHAPTER X 
FINAL AND TRANSITIONAL PROVISIONS 

Article 51 
Application of Directives 85/374/EEC and 2001/95/EC 

1. 

This Directive is without prejudice to the application of Directive 85/374/EEC. 

EN 

34 

   EN 

 
2. 

Directive 2001/95/EC shall apply to toys in accordance with Article 1(2) thereof. The 
applicable Articles of Directive 2001/95/EC are those mentioned in Articles 37,  43 
and 48 of this Directive as well as Articles 10,11 and 13 of Directive 2001/95/EC . 

Article 52 
Transitional period 

Member  States  shall  not  impede  the  placing  on the  market  of  toys  which  are  in  accordance 
with Directive 88/378/EEC and which were placed on the market before this Directive entered 
into force or at the latest 2 years after this Directive entered into force.  

Article 53 
Transposition 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive  by  at  the  latest.  They  shall  forthwith  inform  the 
Commission thereof. 

They shall apply those provisions with effect from […] 

When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made. 

Member  States  shall  communicate  to  the  Commission  the  provisions  of  national  law  which 
they adopt in the field covered by this Directive. 

Article 54 
Repeal 

Directive 88/378/EEC is repealed from the date set out in the second paragraph of Article 53. 

References to the repealed Directive shall be construed as references to this Directive. 

Article 55 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 56 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

35 

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LIST OF PRODUCTS THAT, IN PARTICULAR, ARE NOT CONSIDERED AS TOYS 
WITHIN THE MEANING OF THIS DIRECTIVE (ARTICLE 2 (1)) 

ANNEX I 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

Decorative objects for festivities and celebrations; 

Products  for  adult  collectors,  provided  that  the  product  or  its  packaging  bears  a 
visible and legible indication that it is intended for collectors of 14 years of age and 
above. Examples of this category are: 

(a) 

(b) 

(c) 

(d) 

(e) 

detailed and faithful scale models, 

kits for the assembly of detailed scale models, 

folk dolls and decorative dolls and other similar articles, 

historical replicas of toys, 

reproductions of real fire arms; 

Sports equipment, including roller skates, inline skates, and skateboards intended for 
children with a body mass of more than 20 kg; 

Bicycles,  scooters  and  other  means  of  transport  designed  for  sport  or  which  are 
intended to be used for travel on public roads or public pathways; 

Electrically driven vehicles which are intended to be used for travel on public roads, 
public pathways, or on the pavement of these. 

Aquatic equipment intended to be used in deep water and swimming learning devices 
for children, such as swim seats and swimming aids; 

Puzzles with more than 500 pieces; 

Guns and pistols using compressed gas, with the exception of water guns, and bows 
for archery over 120 cm long; 

Fireworks, including percussion caps which are not specifically designed for toys; 

Products and games using sharp-pointed missiles, such as sets of darts with metallic 
points; 

Functional  educational  products,  such  as  electric  ovens,  irons  or  other  functional 
products operated at a nominal voltage exceeding 24 volts which are sold exclusively 
for teaching purposes under adult supervision;  

“Functional product" means a product which performs and is used in the same way 
as a product, appliance or installation intended for use by adults, and may be a scale 
model of such a product, appliance or installation. 

Products  intended  for  use  for  educational  purposes  in  schools  and  in  other 
pedagogical framework under the surveillance of an adult instructor, such as science 
equipment; 

Electronic equipment, such as personal computers and game consoles, used to access 
interactive software and their associated peripherals, unless the electronic equipment 
or  the  associated  peripherals  are  specifically  designed  for  and  targeted  at  children 
and have a play value on their own, such as specially designed personal computers, 
key boards, joy sticks or steering wheels;  

EN 

36 

   EN 

 
14. 

15. 

16. 

17. 

I. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Interactive software, intended for leisure and entertainment, such as computer games, 
and their storage media, such as CD; 

Babies' soothers; 

Child-appealing luminaires; 

Electrical transformers for toys. 

ANNEX II 
PARTICULAR SAFETY REQUIREMENTS 

PHYSICAL AND MECHANICAL PROPERTIES 

Toys and their parts and, in the case of fixed toys, their anchorages, must have the 
requisite  mechanical  strength  and,  where  appropriate,  stability  to  withstand  the 
stresses to which they are subjected during use without breaking or becoming liable 
to distortion at the risk of causing physical injury. 

Accessible  edges,  protrusions,  cords,  cables  and  fastenings  on  toys  must  be  so 
designed and constructed that the risks of physical injury from contact with them are 
reduced as far as possible. 

Toys must be so designed and constructed as to minimize the risk of physical injury 
which could be caused by the movement of their parts. 

Toys  and  their  parts  must  not  present  risk  of  asphyxiation  caused,  in  particular,  by 
strangulation or suffocation. 

The  packaging  in  which  toys  are  contained  for  retail  sale  must  not  present  risk  of 
strangulation or asphyxiation caused by airway obstruction external to the mouth and 
nose. 

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 and/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. 

Toys  contained  within  food  or  co-mingled  with  a  food  must  have  their  own 
packaging. This packaging, in its supplied condition, must be of such dimensions as 
to prevent it being swallowed and/or inhaled. 

Toys firmly attached to a food product at the moment of consumption, in such a way 
that the food product needs to be consumed in order to get direct access to the toy, 
shall be prohibited. 

Toys intended for use in shallow water which are capable of carrying or supporting a 
child  on  the  water  must  be  designed  and  constructed  so  as  to  reduce  as  far  as 
possible,  taking  into  account  the  recommended  use  of  the  toy,  any  risk  of  loss  of 
buoyancy of the toy and loss of support afforded to the child. 

Toys  which  it  is  possible  to  get  inside  and  which  thereby  constitute  an  enclosed 
space  for  occupants  must  have  a  means  of  exit  which  the  intended  user  can  open 
easily from the inside. 

Toys conferring mobility on their users must, as far as possible, incorporate a braking 
system which is suited to the type of toy and is commensurate with the kinetic energy 

EN 

37 

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developed by it. Such a system must be easy for the user to operate without risk of 
ejection or physical injury for the user of for third parties. 

The maximum design speed of electrically driven ride-on toys must be limited so as 
to minimise the risk of injury. 

"Design speed" means representative potential operating speed that is determined by 
the design and correlation of the physical features. 

8. 

The  form  and  composition  of  projectiles  and  the  kinetic  energy  they  may  develop 
when  fired  from  a  toy  designed  for  that  purpose  must  be  such  that,  taking  into 
account the nature of the toy, there is no risk of physical injury to the user or to third 
parties. 

9. 

Toys must be so constructed as to ensure that: 

10. 

11. 

II. 

1. 

(a) 

(b) 

the  maximum  and  minimum  temperature  of  any  accessible  surfaces  does  not 
cause injury when touched; 

liquids and gases contained within toys do not reach temperatures or pressures 
which are such that their escape from a toy, other than for reasons essential to 
the proper functioning of the toy, might  cause burns, scalds or other physical 
injury. 

Toys which are designed to emit a sound should be so designed and constructed so 
that the sound from them is not able to impair children’s hearing. 

Activity toys shall be constructed so as to reduce the risk of crushing or trapping of 
body parts or trapping of clothing and the risk of falls, impacts and drowning as far 
as possible. 

FLAMMABILITY 

Toys must not constitute a dangerous flammable element in the child's environment. 
They  must  therefore  be  composed  of  materials  which  fulfil  one  or  more  of  the 
following conditions: 

(a) 

(b) 

(c) 

(d) 

(e) 

they do not burn if directly exposed to a flame or spark or other potential seat 
of fire;  

they  are  not  readily  flammable  (the  flame  goes  out  as  soon  as  the  fire  cause 
disappears);  

if  they  do  ignite,  they  burn  slowly  and  present  a  low  rate  of  spread  of  the 
flame;  

irrespective of the toy's chemical composition, they are treated mechanically so 
as to delay the combustion process 

Such  combustible  materials  must  not  constitute  a  risk  of  ignition  for  other 
materials used in the toy.  

2. 

Toys which, for reasons essential to their functioning, contain dangerous substances 
or preparations as  defined in Council Directive 67/548/EEC, in particular materials 
and  equipment  for  chemistry  experiments,  model  assembly,  plastic  or  ceramic 
moulding,  enamelling,  photography  or  similar  activities,  must  not  contain,  as  such, 

EN 

38 

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substances  or  preparations  which  may  become  flammable  due  to  the  loss  of  non-
flammable volatile components. 

Toys  other  than  toy  percussion  caps  must  not  be  explosive  or  contain  elements  or 
substances  likely  to  explode  when  used  as  specified  in  the  first  subparagraph  of 
Article 9(2). 

Toys  and,  in  particular,  chemical  games  and  toys,  must  not  contain  as  such 
substances or preparations: 

(a) 

(b) 

which,  when  mixed,  may  explode:-  through  chemical  reaction,  or  through 
heating,- when mixed with oxidizing substances; 

which  contain  volatile  components  which  are  flammable  in  air  and  liable  to 
form flammable or explosive vapour/air mixture. 

CHEMICAL PROPERTIES 

Toys shall be so designed and constructed that there are no risks of adverse effects on 
human  health  due  to  exposure  to  the  chemical  substances  or  preparations  of  which 
the toys are composed or which they contain, when the toys are used as specified in 
the first subparagraph of Article 9 (2). 

Toys shall comply with relevant Community legislation relating to certain categories 
of  products  or  to  the  prohibition  of  use  of  certain  dangerous  substances  and 
preparations.  
Toys  that  are  themselves  substances  or  preparations  must  comply  also  with 
Directives  67/548/EEC  and  1999/45/EC25  relating  to  the  classification,  packaging 
and labelling of dangerous substances and dangerous preparations. 

Without  prejudice  to  the  application  of  the  restrictions  under  the  first  sentence  of 
point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or 
toxic  for  reproduction  (CMR)  according  to  Directive  67/548/EEC  in  individual 
concentrations equal to or greater than the relevant concentrations established for the 
classification  of  preparations  containing  the  substances  in  accordance  with  the 
provisions of Directive 1999/45/EC shall be prohibited, except if the substances are 
contained in components of toys or micro-structurally distinct parts of toys that are 
not accessible to any physical contact by children.  

Substances  or  preparations  classified  as  CMR  category  1  and  2  according  to 
Directive 67/548/EEC may be used in toys provided that the following conditions are 
met: 

use  of  the  substance  has  been  evaluated  by  the  relevant  Scientific  Committee  and 
found to be safe, in particular in view of exposure, and a Decision as referred to in 
Article 45 (2) has been taken; 

there are no suitable alternative substances available, as documented in an analysis of 
alternatives, 

they  are  not  prohibited  for  uses  in  consumer  articles  under  Regulation  (EC)  No 
1907/2006 (REACH). 

3. 

4. 

III. 

1. 

2. 

3. 

4. 

4.1. 

4.2. 

4.3. 

25 

OJ No L 200, 30.7. 1999, p. 1-68 

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39 

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The  Commission  shall  mandate  the  relevant  Scientific  Committee  to  re-evaluate 
those  substances  or  preparations  as  soon  as  safety  concerns  arise  and  at  the  latest 
every  5  years  from  the  date  that  a  decision  in  accordance  with  Article  45  (2)  was 
taken. 

Substances  or  preparations  classified  as  CMR  category  3  according  to  Directive 
67/548/EEC may be used in toys if use of the substance has been evaluated by  the 
relevant Scientific Committee and found to be safe, in particular in view of exposure, 
and following a Decision as referred to in Article 45 (2) and provided that they are 
not  prohibited  for  uses  in  consumer  articles  under  Regulation  (EC)  No  1907/2006 
(REACH). 

Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional 
and labelling requirements provided for in Directive 76/768/EEC. 

Toys shall not contain the following allergenic fragrances:  

5. 

6. 

7. 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Alanroot (Inula helenium) 

Allylisothiocyanate 

Benzyl cyanide 

4 tert-Butylphenol 

Chenopodium oil 

Cyclamen alcohol 

Diethyl maleate 

Dihydrocoumarin 

2,4-Dihydroxy-3-methylbenzaldehyde 

(10) 

3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) 

(11) 

4,6-Dimethyl-8-tert-butylcoumarin 

(12)  Dimethyl citraconate 

(13) 

7,11-Dimethyl-4,6,10-dodecatrien-3-one 

(14) 

6,10-Dimethyl-3,5,9-undecatrien-2-one 

(15)  Diphenylamine 

(16)  Ethyl acrylate 

(17)  Fig leaf, fresh and preparations 

(18) 

trans-2-Heptenal 

(19) 

trans-2-Hexenal diethyl acetal 

(20) 

trans-2-Hexenal dimethyl acetal 

(21)  Hydroabietyl alcohol 

(22) 

4-Ethoxy-phenol 

(23) 

6-lsopropyl-2-decahydronaphthalenol 

(24) 

7-Methoxycoumarin 

(25) 

4-Methoxyphenol 

EN 

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(26) 

4-(p-Methoxyphenyl)-3-butene-2-one 

(27) 

1-(p-Methoxyphenyl)-1-penten-3-one 

(28)  Methyl trans-2-butenoate 

(29) 

6-Methylcoumarin 

(30) 

7-Methylcoumarin 

(31) 

5-Methyl-2,3-hexanedione 

(32)  Costus root oil (Saussurea lappa Clarke) 

(33) 

7-Ethoxy-4-methylcoumarin 

(34)  Hexahydrocoumarin 

(35)  Peru balsam (Myroxylonpereirae Klotzsch) 

(36) 

2-Pentylidene-cyclohexanone 

(37) 

3,6,10-Trimethyl-3,5,9-undecatrien-2-one 

(38)  Verbana oil (Lippia citriodora Kunth). 

However, the presence of traces of these substances shall be allowed provided that such 
presence is technically unavoidable in good manufacturing practice. 

In  addition  the  following  allergenic  fragrances  shall  be  listed  if  added  to  toys,  as  such,  at 
concentrations exceeding 0,01 % by weight: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Amyl cinnamal 

Amylcinnamyl alcohol 

Anisyl alcohol 

Benzyl alcohol 

Benzyl benzoate 

Benzyl cinnamate 

Benzyl salicylate 

Cinnamal 

Cinnamyl alcohol 

(10)  Citral 

(11)  Citronellol 

(12)  Coumarin 

(13)  Eugenol 

(14)  Farnesol 

(15)  Geraniol 

(16)  Hexyl cinnamaldehyde 

(17)  Hydroxy-citronellal 

(18)  Hydroxy-methylpentylcyclohexenecarboxaldehyde 

(19) 

Isoeugenol 

EN 

41 

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(20)  Lilial  (referred  to  in  the  Cosmetics  Directive  in  entry  83  as:  2-(4-tert-

Butylbenzyl) propionaldehyde 

(21) 

d-Limonene 

(22)  Linalool 

(23)  Methyl heptine carbonate 

(24) 

3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one 

(25)  Oakmoss extracts 

(26)  Treemoss extracts 

8. 

The following migration limits, from toys or components of toys that are accessible 
to children during use as specified in the first subparagraph of Article 9 (2), shall not 
be exceeded: 

Element 

Aluminium 

Antimony 

Arsenic 

Barium 

Boron 

Cadmium 

Chromium (III) 

Chromium (VI) 

Cobalt 

Copper 

Lead 

Manganese 

Mercury 

Nickel 

Selenium 

Strontium 

Tin 

mg/kg in dry, brittle, 
powder-like or 
pliable toy material 

mg/kg 

in liquid or sticky 
toy material 

5625 

45 

7.5 

4500 

1200 

3.8 

37.5 

0.04 

10.5 

622.5 

27 

1200 

15 

75 

37.5 

4500 

15000 

1406 

11.3 

1.9 

1125 

300 

0.9 

9.4 

0.01 

2.6 

156 

6.8 

300 

3.8 

18.8 

9.4 

1125 

3750 

EN 

42 

   EN 

 
Organic tin 

Zinc 

1.9 

3750 

0.5 

938 

These  limit  values  do  not  apply  to  toys  which  due  to  their  accessibility,  function,  volume  or  mass 
clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when 
used as specified in the first subparagraph of Article 9 (2). 

IV. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

V. 

1. 

2. 

ELECTRICAL PROPERTIES 

Toys shall not be powered by electricity exceeding 24 volts and their accessible parts 
shall not exceed 24 volts. 

Internal voltages shall not exceed 24 volts unless it is ensured that the voltage and the 
current combination generated do not lead to any risk or harmful electric shock, even 
when the toy is broken. 

Parts of toys which are connected to, or liable to come into contact with a source of 
electricity  capable  of  causing  electric  shock,  together  with  the  cables  or  other 
conductors  through  which  electricity  is  conveyed  to  such  parts,  must  be  properly 
insulated and mechanically protected so as to prevent the risk of such shock. 

Electric  toys  must  be  so  designed  and  constructed  as  to  ensure  that  the  maximum 
temperatures  reached  by  all  directly  accessible  surfaces  are  not  such  as  to  cause 
burns when touched. 

Under  foreseeable  fault  conditions,  toys  must  provide  protection  against  electrical 
hazards arising from an electrical power source. 

Electric toys must provide adequate protection against fire hazards. 

Electric  toys  must  be  designed  and  manufactured  in  such  a  way  that  electric, 
magnetic, and electromagnetic fields and other radiations generated by the equipment 
are  limited  to  the  extent  necessary  for  its  operation,  and  operate  at  a  safe  level  in 
compliance  with  the  generally  acknowledged  state  of  the  art,  taking  account  of 
specific Community measures. 

Toys which have an electronic control system shall be designed and manufactured in 
such  a  way  that  the  toy  operates  safely  even  when  the  electronic  system  starts 
malfunctioning  or  fails  due  to  the  failure  in  the  system  itself  or  due  to  an  outside 
factor. 

Toys must be so designed and constructed that they do not present any health hazards 
or  risk  of  injury  to  eyes  or  skin  from  lasers,  light-emitting  diodes  (LEDs)  or  any 
other type of radiation. 

The electrical transformer for toys shall not be integral part of the toy. 

HYGIENE 

Toys must be so designed and manufactured as to meet the requirements of hygiene 
and cleanliness in order to avoid any risk of infection, sickness and contamination. 

Textile toys for children under 36 months shall be washable and shall fulfil the safety 
requirements also after washing. 

EN 

43 

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VI. 

RADIOACTIVITY 

Toys  shall  comply  with  all  relevant  dispositions  adopted  under  Chapter  III  of  the  Treaty 
establishing the European Atomic Community. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

ANNEX III 
EC DECLARATION OF CONFORMITY 

No xxxxxx (unique identification of the toy(s)) 

Name and address of (authorised representative of the) manufacturer:  

This  declaration  of  conformity  is  issued  under  the  sole  responsibility  of  the 
manufacturer:  

Object of the declaration (identification of toy allowing traceability): 

The  object  of  the  declaration  described  above  is  in  conformity  with  the  relevant 
Community harmonisation legislation………  

References  to  the  relevant  harmonised  standards  used,  or  references  to  the 
specifications in relation to which conformity is declared: 

The notified body ... (name, number)… performed … (description of intervention)… 
and issued the certificate: …. 

Additional information: 

Signed for and on behalf of:…………………………. 

(place and date of issue) 

(name, function)(signature) 

ANNEX IV 
TECHNICAL DOCUMENTATION 

The technical documentation referred to in Article 20 shall contain, in particular, so far as 
relevant for assessment: 

a)  a  detailed  description  of  the  design  and  manufacture,  including  a  list  of 
components and materials used in toys as well as the safety data sheets on chemicals 
used to be obtained from chemical suppliers; 

b) the safety assessment(s) carried out in accordance with Article 17; 

c) a description of the conformity assessment procedure followed; 

d) a copy of the EC declaration of conformity; 

e) the addresses of the places of manufacture and storage; 

f)  copies  of  documents  that  the  manufacturer  has  submitted  to  a  notified  body  if 
involved; 

g)  test  reports  and  description  of  the  means  whereby  the  manufacturer  ensures 
conformity  of  production  with  the  harmonised  standards  if  the  manufacturer  has 
followed the internal production control referred to in Article 18 (2). 

h) a copy of the EC type-examination certificate, a description of the means whereby 
the  manufacturer  ensures  conformity  of  the  production  with  the  product-type  as 
described in the EC type-examination certificate and copies of the documents that the 

EN 

44 

   EN 

 
manufacturer has submitted to the notified body, if the manufacturer has followed the 
EC type-examination and type conformity –declaration referred to in Articles18 (3). 

i) Colour image of the toy. 

ANNEX V 
WARNINGS  
(Article 10) 

PART A – GENERAL WARNINGS 

The  user  limitations  referred  to  in  Article  10  (1)  shall  include  at  least  the  minimum  or 
maximum  age  of  the  user  and,  where  appropriate,  the  ability  of  the  users  of  toys,  the 
maximum or minimum  weight of  the  users  and  the need to  ensure that  the toy  is  used only 
under adult supervision.  

PART B – SPECIFIC WARNINGS AND INDICATIONS OF PRECAUTIONS TO BE 
TAKEN WHEN USING CERTAIN CATEGORIES OF TOYS 

1. 

Toys not intended for children under 36 months 

Toys  which  might  be  dangerous  for  children  under  36  months  of  age  shall  bear  a 
warning,  for  example:  'Warning:  Not  suitable  for  children  under  36  months'  or 
'Warning:  Not  suitable  for  children  under  three  years'  or  the  word  “Warning” 
together with the following graphic: 

[Pictogram] 

These warnings shall be accompanied with a brief indication, which may appear in 
the instructions for use, of the specific hazard calling for this restriction. 

This  provision  does  not  apply  to  toys  which,  on  account  of  their  function, 
dimensions,  characteristics,  properties  or  other  cogent  grounds,  are  manifestly 
unsuitable for children under 36 months. 

2. 

Slides, suspended swings and rings, trapezes, ropes and similar toys attached to 
a crossbeam 

Such toys shall bear a marking “Warning: only for domestic use”. 

They shall be accompanied by instructions drawing attention to the need to carry out 
checks and maintenance of the main parts (suspensions, fixings, anchorages, etc.) at 
intervals, and pointing out that, if these checks are not carried out, the toy may cause 
a fall or overturn. 

Instructions  must  also  be  given  as  to  correct  assembly  of  the  toy,  indicating  those 
parts  which  can  present  dangers  if  it  is  incorrectly  assembled.  Specific  information 
regarding suitable surface shall be given. 

3. 

Functional toys 

“Functional  toy”  means  a  toy  which  performs  and  is  used  in  the  same  way  as  a 
product,  appliance  or  installation  intended  for  use  by  adults,  and  may  be  a  scale 
model of such a product, appliance or installation. 

Functional toys or their packaging shall bear the marking 'Warning: to be used under 
the direct supervision of an adult'. 

In  addition,  these  toys  shall  be  accompanied  by  directions  giving  working 
instructions as well as the precautions to be taken by the user, with the warning that 

EN 

45 

   EN 

 
failure  to  take  these  precautions  would  expose  the  user  to  the  hazards  -  to  be 
specified  -  normally  associated  with  the  appliance  or  product  of  which  the  toy  is  a 
scale model or an imitation. It shall also be indicated that the toy must be kept out of 
the reach of very young children. 

4. 

Toys  containing  inherently  dangerous  substances  or  preparations.  Chemical 
toys 

Without  prejudice  to  the  application  of  the  provisions  laid  down  in  Community 
directives on the classification,  packaging and  labelling  of  dangerous  substances or 
preparations,  the  instructions  for  use  of  toys  containing  inherently  dangerous 
substances  or  preparations  shall  bear  a  warning  of  the  dangerous  nature  of  these 
substances  or  preparations  and  an  indication  of  the  precautions  to  be  taken  by  the 
user  in  order  to  avoid  hazards  associated  with  them,  which  shall  be  specified 
concisely according to the type of toy. The first aid to be given in the event of serious 
accidents resulting from the use of this type of toy shall also be mentioned. It shall 
also be stated that the toys must be kept out of reach of very young children. 

In  addition  to  the  instructions  provided  for  in  the  previous  subparagraph,  chemical 
toys shall bear the following marking on their packaging:  
‘Warning: Not suitable for children under (¹) years. For use under adult supervision'. 

In  particular,  the  following  are  regarded  as  chemical  toys:  chemistry  sets,  plastic 
embedding  sets,  miniature  workshops  for ceramics, enamelling  or photography and 
similar toys which lead to a chemical reaction or similar substance alteration during 
use. 

5. 

Skates,  roller  skates,  online  skates,  skateboards,  scooters  and  toy  bicycles  for 
children 

If these toys are offered for sale as toys they shall bear the following markings: 

'Warning: protective equipment should be worn. Not to be used in traffic'. 

Moreover, the instructions for use shall contain a reminder that the toy must be used 
with  caution,  since  it  requires  great  skill,  so  as  to  avoid  falls  or  collisions  causing 
injury  to  the  user  and  third  parties.  Some  indication  shall  also  be  given  as  to 
recommended protective equipment (helmets, gloves, knee-pads, elbow-pads, etc.). 

6. 

Toys intended for use in water 

The toys intended for use in water defined in Section 1 (5) of Annex II shall contain 
the warning: 

'Warning! Only to be used in water in which the child is within its depth and under 
adult supervision'. 

(¹) Age to be decided by the manufacturer. 

7. 

Toys in food 

Toys contained in food or co-mingled with food shall contain the warning: 

“Adult supervision recommended”. 

EN 

46 

   EN 

 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal for a Directive of the European Parliament and of the Council on the safety 
of toys 

2. 

ABM / ABB FRAMEWORK 

Policy  Area(s)  concerned  and  associated  Activity/Activities:  Simplification  of 
existing legislation. 

Policy area 02 “Enterprise” 

Activity: “ Administrative expenditure of Enterprise Policy area” 

3. 

3.1. 

BUDGET LINES 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B.A lines) including headings: 

3.2. 

Duration of the action and of the financial impact: 

2009-2013 

3.3. 

Budgetary characteristics (add rows if necessary):  

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Diff/ 
Non-diff 

Diff26/ 
Non-
diff27 

Comp/ 
Non-comp 

Diff/ 
Non-diff 

YES/ NO 

YES/NO 

YES/NO 

No […] 

YES/ NO 

YES/NO 

YES/NO 

No […] 

26 Differentiated appropriations 
27 Non-differentiated appropriations hereafter referred to as NDA 

EN 

47 

   EN 

 
 
 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Not applicable 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

n + 5 
and 
later 

Total 

Operational expenditure28 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

Administrative expenditure within reference amount29 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

Payment Appropriations 

a+c 

b+c 

Administrative  expenditure  not  included  in  reference  amount30:  no  new 
expenditure for HR is contemplated as a result of the proposal  
Not applicable 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

8.2.5. 

d 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
included 
reference 
in 
amount (NDA) 

costs, 

8.2.6. 

e 

0,120  0,120 

0,120 

0,120 

0,120 

0,120 

0,600 

Total indicative financial cost of intervention 
Not applicable 

TOTAL CA including cost 
of Human Resources 

a+c
+d+
e 

0,120  0,120 

0,120 

0,120 

0,120 

0,120 

0,600 

28 Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
29 Expenditure within article xx 01 04 of Title xx. 
30 Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

48 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
TOTAL  PA  including  cost 
of Human Resources 

b+c
+d+
e 

Co-financing details 

0,120  0,120 

0,120 

0,120 

0,120 

0,120 

0,120 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 
No  co-financing  is  envisaged  within  the  scope  of  the  revision  of  this  existing 
legislation. 

EUR million (to 3 decimal places) 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

n  +  5 
and 
later 

Total 

Co-financing body 

…………………… 

TOTAL  CA  including  co-
financing 

f 

a+c
+d+
e+f 

4.1.2.  Compatibility with Financial Programming 

X 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement31 (i.e. flexibility instrument or revision of the financial perspective). 

4.1.3.  Financial impact on Revenue 

X 

(cid:133) 

Proposal has no financial implications on revenue 

Proposal has financial impact – the effect on revenue is as follows: 

NB: All details and observations relating to the method of calculating the effect on revenue 
should be shown in a separate annex. 

Budget line 

Revenue 

EUR million (to one decimal place) 

Prior to
action 
[Year n-
1] 

[Year 
n] 

Situation following action 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

[n+5]32

a) Revenue in absolute terms 

b) Change in revenue 

 Δ 

31 See points 19 and 24 of the Interinstitutional agreement. 
32 Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years 

EN 

49 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(Please specify each revenue budget line involved, adding the appropriate number of rows to 
the table if there is an effect on more than one budget line.) 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1.  

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total  number  of  human 
resources 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

Only the creation of a ‘comitology’ committee is introduced by the proposal, to meet 
the need to revise the legislation in a timely and convenient manner. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

Not relevant 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

? 

5.4.  Method of Implementation (indicative) 

(cid:133)  Centralised Management 

X 

(cid:133) 

directly by the Commission 

indirectly by delegation to: 

(cid:133) 

(cid:133) 

executive Agencies 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

(cid:133) 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: None 

EN 

50 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The  monitoring  will  be  managed  through  the  expert  group  on  toy  safety  (already 
existing  prior  to  the  revision  that  is  the  object  of  the  proposal),  and  the  feedback 
provided by the national authorities, consistently with the arrangements in place for 
the legislation in force. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

A thorough evaluation of the proposal has been done on the basis of several studies 
and a comprehensive Impact Assessment that is annexed to the proposal. 

6.2.2.  Measures taken  following  an  intermediate/ex-post evaluation (lessons learned from 

similar experiences in the past) 

Not relevant 

6.2.3.  Terms and frequency of future evaluation 

Five years after entering into force. 

7. 

ANTI-FRAUD MEASURES 

EN 

51 

   EN 

 
 
8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost: 

Not relevant (please refer to the information above on the limited scope of the financial incidence of the proposal). 

Commitment appropriations in EUR million (to 3 decimal places) 

Type of output 

Av. 
cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

of 

(Headings 
Objectives, 
actions 
and 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
33……… 

Action 
1………………. 

- Output 1 

- Output 2 

Action 
2………………. 

- Output 1 

Sub-total 
Objective 1 

OPERATIONAL 
OBJECTIVE  No.2 
1……… 

Action 

33 As described under Section 5.3 

EN 

52 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
1………………. 

- Output 1 

Sub-total 
Objective 2 

OPERATIONAL 
OBJECTIVE  No.n 
1 

Sub-total 
Objective n 

TOTAL COST 

EN 

53 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Administrative Expenditure 

8.2.1.  Number  and  type  of  human  resources:  no  immediate  change  to  the  current  HR 
staffing  is  envisaged;  the  possibility  of  adding  new  staff  will  be  assessed  once  the 
proposal will have been adopted, on the basis of the provisions that will have been 
finally introduced as a result of the legislative process. 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4  Year n+5 

Officials or 
temporary 
staff34 (XX 01 
01) 

A*/AD 

B*, 
C*/AST 

Staff  financed35  by  art. 
XX 01 02 

Other  staff36  financed by 
art. XX 01 04/05 

TOTAL 

8.2.2.  Description of tasks deriving from the action 

See explanatory memorandum. 

8.2.3. 

Sources of human resources (statutory):  

X 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts currently allocated to the management of the programme to be replaced 
or extended: 1 administrator  

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

Posts required for year n although not foreseen in the APS/PDB exercise of the 
year in question 

34 Cost of which is NOT covered by the reference amount 
35 Cost of which is NOT covered by the reference amount 
36 Cost of which is included within the reference amount 

EN 

54 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management): 

Not relevant 

Budget line 

(number and heading) 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5  

and 
later 

TOTAL 

Technical 

1 
and 
assistance (including related staff costs) 

administrative 

Executive agencies37 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

Total  Technical  and  administrative 
assistance 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount: EUR million (to 3 decimal places) 

Type of human resources 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4 

Year n+5 

and later 

Officials  and  temporary  staff 
(XX 01 01) 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

Calculation– Officials and Temporary agents 

See above, 8.2.1. 

Calculation– Staff financed under art. XX 01 02 

37  Reference  should  be  made  to  the  specific  legislative  financial  statement  for  the  Executive  Agency(ies) 

concerned. 

EN 

55 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees38  

0 

0,120 

0,120 

0,120 

0,120 

0,120 

0,600 

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2 

Total 

Other  Management 

Expenditure (XX 01 02 11) 

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

Calculation - Other administrative expenditure not included in reference amount 

None 

38 Specify the type of committee and the group to which it belongs. 

EN 

56 

   EN