EN    EN  COMMISSION OF THE E UROPEAN 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}  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT OF THE PROPOSAL  
General context 
The revision of Directive 88/378/EEC of 3 Ma y 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 Europe an Parliament, the European Economic and 
Social Committee and the Committee of th e Regions - Updating and simplifying the 
Community acquis.2 
Directive 88/378/EEC was adopted in the context of the achieveme nt of the Internal Market. 
The proliferation of different sa fety provisions across the Member States had led to barriers to 
trade and marketing. This went hand in hand with the recogni tion that a proliferation of 
different national safety regimes across the EU did not necessarily afford consumers in the 
EU, especially children, with effective prot ection against hazards arising from toys. The 
Directive was the first EC Directive applyi ng the New Approach method – introduced in 1985 
– to mass market consumer goods. The key New Approach concept cons isted in laying down 
in the legislation the essential safety related re quirements, leaving the technical specifications 
of products meeting the essential requireme nts in harmonised standards. Since 1988, the 
Directive has been amended only on ce 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 num ber of deficiencies ha ve been identified over 
time, which have triggered the need to  assess the existing legal framework. 
A thorough revision of the TSD seem s appropriate, with a view to: 
• Updating and completing the existing provision s 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 elemen t to ensure the free movement of toys within the European 
Union and contributes to the protection of th e 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 bett er regulation and simplification. The overall 
goal is to improve the quality a nd efficiency of the toys safety  regulations and to simplify the 
current legislation for both economic operato rs and market surv eillance authorities. 
                                                 
1 OJ L 187, 16.7.1988, p.1. 
2 COM/2003/0071 final. 
3 Council Directive 93/68/EEC of 22 July 1993,  OJ L 220, 30.8.1993, p.1. 
4 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.  
EN 3   EN 2. CONSULATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT  
Consultation of interested parties 
The revision has been under consideration si nce 2003 and has been th e subject of a wide 
ranging consultation, namely in the framework of  the Expert Group on toys safety with the 
Member States authorities and other stakeholde rs 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 wh ich 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/enterpri se/toys/public_c onsultation.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 responde nts 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 degree s involved in the 
toys business (distributors, reta ilers, company managers, etc.). 
Collection and use of expertise 
Three studies have been established by indepe ndent 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 chemical s 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. ma intaining the status quo; 
• Non-regulatory approach; guidanc e documents; recommendations; 
• A new Directive based on the “Old Approach”; 
• A revised Directive to the extent necessary to en sure that safe toys can circulate in the EU 
internal market. 
The fifth option was identified as the pref erred option because it seems adequate and 
proportionate to cope with the identified probl ems 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 concer ned 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 b een identified and assessed in detail: 
• To enhance safety requirements for toys  
– New provisions on the chemical requirements;  
EN 4   EN – More stringent requir ements 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 imp act 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 fore sees that toys must comply with Community’s 
general chemicals legislation, includi ng Regulation EC No 1907/2006 (REACH). 
Main novelty of the revision is th e 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 cat egories 1, 2 and 3
5. 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, ho wever, provides for a possibility of granting 
an exemption from this ban, if the substance has been evaluated by th e relevant Scientific 
Committee and found acceptable for use in t oys, 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 supp liers of articles containing 
substances, in particular CMRs 1 or 2, to co mmunicate 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 labell ing of certain allergenic substances and 
certain fragrances.  This approach also follows the regime of Directive 76/768/EEC on 
cosmetic products. 
                                                 
5 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”.  
EN 5   EN In order to take into account ne w scientific knowledge, the Directiv e 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 “migra tion” 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, wher e 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 th at the toy is us ed under adult 
supervision. It is furthermore proposed to requ ire warnings at the poin t 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 inst ructions on warnings 
will be established in a guidance document to be drawn up together with the various stakeholders and Member States authorities ta king into account developm ents of scientific 
and technical knowledge. 
3.1.3.  Choking and suffocation risks 
The risk of choking, that is the risk of inhala tion 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 to ys 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. Th e 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 su ction cups. The suffocation risk sh all 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 specifi c 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 principle
6. The Directive foresees the new re quirement 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 h azard (namely that it passes the safety ‘small 
parts cylinder test’) and iii) to ban toys that ar e 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 interp retation, in particular because 
the general safety requirement refers to the obligation to cover “for eseeable” 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 es sential 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 therefor e, not covered by specific 
                                                 
6 Commission Communication COM (2000) 1, 1.2.2000.  
EN 6   EN 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 gene ral safety requirement to "behaviour" of children 
to ensure that the often unpredictable behaviour  of children is take n into account when 
designing toys with a view to ach ieve greater safety benefits. 
3.2. More efficient and coherent en forcement of the Directive 
3.2.1.  Reinforcement of the Member Stat es market surveillance measures 
The proposal reinforces in Chapter VI the ma rket surveillance obligat ions of the Member 
States under the General Product Safety Dir ective 2001/95/EC by granti ng certain specific 
powers to the market surveillanc e authorities (right of access to the premises of economic 
operators, right to request information from Notif ied bodies, right to give instructions to the 
Notified bodies, right to obtain mu tual 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 Stat es 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 docum entation which toy manufacturers and importers 
have to keep available for inspection by the mark et surveillance. It has been assessed which 
information besides a detailed description of the design and manufactur e of the toy should be 
kept in the technical documentation. It is propo sed 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-mar king 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 pack aging or in case of small toys on a label or 
accompanying leaflet. It adds one novelty: the CE marking shal l always be affixed on the 
packaging if the marking on the toy is not visi ble 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 hazar ds 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, wh ich industry already perf orms 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 fr amework on the marketing of products 
On 14 February 2007, the Commission adopted its proposals for a Council and European 
Parliament Regulation and Decisi on for the marketing of goods7. The proposal for Regulation 
sets the requirements for accreditation and mark et 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.  
EN 7   EN According to the Commission proposal, the requ irements of the Regulation for accreditation 
of conformity assessment bodies and the rules on market surveillance w ill apply also to the 
accreditation in the toys sector and to the market surveillance of toys at external frontiers. In 
order to ensure consistency w ith other sectoral product legi slation, the revised Directive 
contains the following horizontal provisions of  the above mentioned Decision: definitions, 
general obligations for economic operators, pr esumption of conformity, formal objection 
against harmonised standards, rules for th e CE marking, requirements for conformity 
assessment bodies and the notific ation 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 procedur es (internal production control and EC type-
examination combined with the conformity to  type procedure) av ailable 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 comp leting 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 defin itions 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, hazar d, risk, harm, suffocation and design speed. 
The proposal also aims at clarifying the re lationship 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 certa inty 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 tota l harmonisation directive adopted on the basis of Article 95 of 
the Treaty with the objective of the establishmen t and functioning of the internal market for 
toys. National legislation cannot impose addition al 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 th eir placing on the market are concerned, within 
the exclusive competence of the Community. The a pplication of the principle of subsidiarity 
within the meaning of Artic le 5, second paragraph, of th e 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 ot herwise. 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, theref ore, only arises with re gard to the other areas 
of the revision, namely with regard to the improvement of effective enforcement of the 
Directive. Experience has shown that cohere nt and effective enforcement and market 
surveillance has not been sufficiently achie ved by Member States acting alone. As a 
consequence, the issue of setting some manda tory common minimum requirements arises. As  
EN 8   EN 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 ope rators, and a similar level of protection for 
the citizens in all the Member States. 
Proportionality  
In accordance with the principle of proportiona lity, 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 a nd undermine the achievements of the single 
market, and very likely lead  to confusion for consumer s and producers alike. The 
consequences could be higher pr ices for consumers, as producer s 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 im pose unnecessary burden and costs on industry, 
especially on small and medium sized enterpri ses, or administrations . A number of options 
concern the improvement of clarity of the ex isting 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 th e most proportionate response to 
the problems identified.  
4. BUDGETARY IMPLICATIONS  
The proposal foresees establishment of a Regul atory committee. Budgetary implications are 
discussed in the legislative financia l statement annexed to this proposal. 
5. ADDITIONAL INFORMATION  
Repeal of existing legislation 
The adoption of the proposal will lead to repe al of Directive 88/378/EEC on the safety of 
toys. 
European Economic Area 
The proposal concerns the EEA and should th erefore extended to the European Economic 
Area.  
EN 9   EN 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 CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission8, 
Having regard to the opinion of the Eu ropean 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) Council Directive 88/378/EEC of  3 May 1988 on the approximation of the laws of the 
Member States concerni ng the safety of toys
12 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. 
(2) 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 ap proach to technical harmonisation and 
standards. Thus, it sets out only the essentia l safety requirements with regard to toys, 
while technical details are adopted by th e European Committee for Standardisation 
(CEN) and the European Committee for Elect rotechnical 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 standa rds and regulations
13. Conformity with harmonised standards so set, 
the reference number of wh ich 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 ba sic principles have worked well in the 
toys sector and should be maintained. 
(3) Technological developments in the toys mark et have, however, raised new issues with 
respect to the safety of toys and have give n rise to increased consumer concerns. In 
                                                 
8 OJ C […], […], p. […]. 
9 OJ C […], […], p. […]. 
10 OJ C […], […], p. […]. 
11 OJ C […], […], p. […]. 
12 OJ L 187, 16.7.1988, p. 1. Directive as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1). 
13 OJ L 204, 21,7.1998, p. 37.  
EN 10   EN 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. 
(4) Toys are also subject to Di rective 2001/95/EC of the Eur opean 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. 
(5) Decision […] of the European Parliament  and of the Council of […] on a common 
framework for the marketing of products15 provides common princi ples and reference 
provisions for the purposes of legislation based on the New Approach principles. In 
order to ensure consistency with other sector al product legislation, it  is appropriate to 
align certain provisions of th is 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 st andards, rules for the CE marking, requirements for 
conformity assessment bodies and the notificati on procedures as well  as the provisions 
concerning procedures dealing with products  presenting a risk s hould be aligned to 
that Decision. 
(6) 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 rega rds certain new products, such as videogames 
and peripherals. 
(7) It is appropriate to provide for certain new definitions specific to the toys sector in 
order to facilitate the unde rstanding and uniform applic ation of this Directive. 
(8) All economic operators interv ening in the supply and dist ribution 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. Th is Directive provides a clear 
and proportionate distribution of obligations which correspond to th e respective role of 
each operator in the supply and distribution process. 
(9) As certain tasks can only be executed by the manufacturer, it is necessary to clearly 
distinguish between the manufacturer and th e 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 pr oduction process, is 
best placed to carry out the complete c onformity assessment procedure for toys. 
Importers and distributors perform a trading function and do not ha ve any influence on 
the production process. The conformity assessment should therefore remain the obligation of the manufacturer alone. 
(11) Since importers and distributors are downstr eam operators they cannot in the normal 
course of events be obliged to ensure themselves that th e design and production of the 
                                                
 
14 OJ L 11, 15.1.2002, p. 4. 
15 OJ L […], […], p. […].  
EN 11   EN toy is in compliance with the applicable re quirements. Their obligations in relation to 
the compliance of the toy shoul d be limited to certain cont rol measures to ascertain 
whether the manufacturer has fulfilled his obligations, such as verifying whether the 
toys bears the required conformity marki ng 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 appli cable 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 su ch a way that complia nce 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 carri ed 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 th e whole supply chain contributes to 
rendering market surveillance simpler and more efficient. An efficient traceability system facilitates th e task of market surveillance authorities to trace the economic 
operator responsible for s upplying non-compliant toys. 
(15) Certain essential safety requirements whic h were laid down in Directive 88/378/EEC 
should be updated to take account of tec hnical 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 ag ainst recently discovered risks, it is also 
necessary to adopt new essential safety requir ements. 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), es tablishing a European Chemicals Agency, 
amending Directive 1999/45/EC and repeal ing Council Regulation (EEC) No 793/93 
and Commission Regulation (EC) No 1488/ 94 as well as Council Directive 
76/769/EEC and Commission Directives  91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC
16. 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 th at are classified as carcinoge nic, mutagenic or toxic for 
reproduction (CMR) according to Direct ive 67/548/EEC of 27 June 1967 on the 
approximation of laws, regulations and ad ministrative provisions relating to the 
classification, packaging and labe lling 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 ac count of the development of 
scientific knowledge. 
                                                 
16 OJ L 396, 30.12.2006, p. 1. Regulation as amende d by Council Regulation (EC) No 1354/2007 (OJ L 
304, 22.11.2007, p. 1). 
17 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 12   EN (17) The general and specific chemical require ments in this Dir ective should aim at 
protecting the health of children from dangerous substances in toys, while 
environmental concerns presented by toys are addressed in horiz ontal environmental 
legislation applying also to toys, in partic ular 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 Par liament and of the C ouncil of 27 January 
2003 on waste electrical a nd electronic equipment20, in Directive 94/62/EC of the 
European Parliament and of the Council of 20 December 1994 on packaging and packaging waste
21 and in Directive  2006/66/EC of the European Parliament and of the 
Council of 6 September 2006 on batteries a nd 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 cau se of a risk of choki ng 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 whic h 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 determ ined by reference to th e intended use of the 
product while taking into account the foreseea ble 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 assessm ent in a broad sense. General principles 
governing the use of the CE ma rking, and rules as to its affixing should therefore be 
set in this Directive. 
(22) It is crucial to make clear to both manu facturers 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. 
(23) It is appropriate to lay down rules on th e affixing of CE-marki ng which ensure enough 
visibility for the marking in order to facilitate market surveillance of toys. 
(24) In order to ensure that the essential requirements are complie d with it is necessary to 
lay down  appropriate conformity assessment pr ocedures to be followed by the 
manufacturer. To complete the legal oblig ations 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 Direct ive, and the manufacturers should be obliged 
                                                 
18 OJ L 114, 27.4.2006, p. 9. 
19 OJ L 37, 13.2.2003, p. 19. 
20 OJ L 37, 13.2..2003, p. 24. 
21 OJ L 365, 31.12.1994, p. 10. 
22 OJ L 266, 26.9.2006, p. 1.  
EN 13   EN to keep this safety assessment in the technical file to allow market surveillance 
authorities to perform effici ently their tasks. Internal production co ntrol based on the 
manufacturer’s own responsibil ity for the conformity asse ssment 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 cas es where such harmonised standards do not 
exist, the toy should be submitted to a thir d 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 pa rt. The manufacturer should submit the toy 
to the EC-type-examination in cases wher e he considers that the nature, design, 
construction or purpose of the toys necessitates third party verification. 
(25) Since it is necessary to ensure thr oughout the Community a uniform level of 
performance of bodies performing conformity  assessment of toys and since all such 
bodies should perform their functions to th e 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 Directiv e. Provision should also be made for the 
provision of adequate information about  such bodies and for their monitoring. 
(26) In order to ensure a cohere nt 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 sa tisfactory level of ma rket surveillance in 
all Member States, the provisions on mark et surveillance measures laid down in 
Directive 2001/95/EC should, however, be enha nced and certain ot her 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 consider s 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 complement ed 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 resp ect of such products. 
(30) In a case in which Member States and the Co mmission agree as to the justification of a 
measure taken by a Member State, no furt her 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 impl ementing 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 14   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 meas ures are of general 
scope and are designed to amend non-essentia l 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 penalt ies 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 minimu m 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 intende d, 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 cons idered toys within the meaning of 
this Directive. 
2. This Directive shall not apply to the following toys: 
(a) playground equipment intended for public use; 
(b) automatic playing machines, whether coin  operated or not, in tended for public 
use; 
(c) toy vehicles equipped wi th combustion engines; 
(d) toy steam engines; 
(e) slings and catapults. 
Article 2 
Definitions 
For the purposes of this Directive the following definitions shall apply:   
EN 15   EN (1) "making available on the market” means any supply of a toy for distribution, 
consumption or use on the Community ma rket in the course of a commercial 
activity, whether in return fo r payment or free of charge; 
(2) “placing on the market” means the firs t making available of a toy on the 
Community market; 
(3) “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; 
(4) “distributor” means any natural or le gal person in the supply chain, who 
makes a toy available on the market; 
(5) “importer” means any natural or legal person established within the 
Community, who places a toy from a third country on the Community 
market; 
(6) “economic operators” means the manufact urer, the importer, the distributor 
and the authorised representative; 
(7) “harmonised standard” means a standa rd adopted by one of the European 
standardisation bodies listed in Anne x I to Directive 98/34/EC of the 
European Parliament and of the Counc il in accordance with Article 6 of 
Directive 98/34/EC; 
(8) “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 products
24; 
(9) “withdrawal” means any measure aimed at preventing the making available 
on the market of a toy in the supply chain; 
(10) “recall” means any measure aimed at achieving the return of a toy that has 
already been made available to the end user; 
(11) "activity toy" means a toy which is inte nded for domestic use and designed to 
bear the weight of one or more childr en, excluding ride-o n vehicles, and is 
intended for children to play on or in, such as swings, slides, carousels, 
climbing frames, trampolines, paddling pool s and non aquatic inflatable toys;  
(12) “suffocation” means the result of airw ay 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 inju ry 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 16   EN CHAPTER II  
OBLIGATIONS OF ECONOMIC OPERATORS 
Article 3 
Obligations of manufacturers 
1. Manufacturers shall ensure that their t oys are designed and manufactured in 
accordance with the essential safety require ments set out in Article 9 and in Annex 
II. 
2. Manufacturers shall draw up technical docum entation in accordance with Article 20 
and carry out or have carried  out the conformity assessmen t procedure applicable in 
accordance with Article 18. 
Where the compliance of the toy with the applicable requirements has been 
demonstrated by such procedure, manufactur ers shall draw up an EC declaration of 
conformity, as referred to in Article 14 a nd affix the conformity marking set out in 
Article 16 (1). 
3. Manufacturers shall keep the technical doc umentation and the EC declaration of 
conformity for a period of 10 years after the toy has been placed on the market. 
4. 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 refe rence to which confor mity of a toy is 
stated shall be adequately taken into account. 
Manufacturers shall, in all cases where a ppropriate, carry out sample testing of 
marketed toys, investigating, and, if necessa ry, keeping a register of complaints, and 
keeping distributors inform ed of such monitoring. 
5. Manufacturers shall ensure that their toys bear a type, batch or serial or model 
number or any other element allowing thei r identification, or, where the size or 
nature of the toy does not allow it, that the required informa tion is provided on the 
packaging or in a document accompanying the toy. 
6. Manufacturers shall indicate their name a nd the address at which they can be 
contacted on the toy or, where the size or na ture of the toy does not allow it, on its 
packaging or in a document accompanying the toy.  
7. 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 de tails, in particular, of the non-compliance 
and of the corrective measures taken. 
8. Manufacturers shall, on request from the competent national authorities, provide 
them with all the information and docum entation 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.   
EN 17   EN Article 4 
Authorised representatives 
1. Manufacturers may appoint, by a written ma ndate, any natural or legal person 
established within the Community, ("the auth orised representative"), to act on their 
behalf for specified tasks w ith regard to the obligations  of manufacturers under this 
Directive.  
2. The obligations under Article 3 (1) and th e drawing up of technical documentation 
may not form part of the author ised representative's mandate. 
3. Where a manufacturer has appointed an author ised representative, the latter shall at 
least do the following: 
(a) keep the EC declaration of  conformity and the tec hnical documentation at the 
disposal of national surveillance au thorities for a period of 10 years; 
(b) on request from the competent national authorities, provide them with all the 
information and documentation necessary to  demonstrate the conformity of the 
toy; 
(c) 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 
1. When placing a toy on the market, importers sh all act with due care in relation to the 
applicable requirements. 
2. Before placing a toy on the market importers shall verify that the appropriate 
conformity assessment procedure has b een 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 ha s 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. 
3. Importers shall indicate their name and the a ddress 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. 
4. Importers shall ensure that, while a toy is  under their responsib ility, storage or 
transport conditions do not jeopa rdise its compliance with the requirements set out in 
Article 9 and in Annex II. 
5. Importers who consider or have reason to be lieve that a toy whic h they have placed 
on the market is not in conformity with the applicable Community legislation shall 
take the necessary corrective measures to br ing 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 de tails, in particular, of the non-compliance 
and of the corrective measures taken.  
EN 18   EN 6. 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 avai lable to those author ities, upon request. 
7. Importers shall, on request from the comp etent national authorities, provide them 
with all the information and documentation necessary to demonstr ate the conformity 
of the toy. They shall cooperate with those au thorities, at the reque st of the latter, on 
any action to avoid the risks posed by t oys which they have placed on the market. 
Article 6 
Obligations of distributors  
1. When making a toy available on the market, distributors shall act with due care in 
relation to the applicable requirements. 
2. 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 a nd the importer have complied with the 
requirements set out in Article 3 (5) a nd (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 ma y make the toy available on 
the market only after it has been brought in to conformity with those requirements. 
The distributor shall inform the manufact urer or the importer to this effect. 
3. A distributor shall ensure that, while a t oy is under his responsib ility, storage or 
transport conditions do not jeopa rdise its compliance with the requirements set out in 
Article 9 and in Annex II. 
4. 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 corre ctive measures to bring that toy in 
conformity or withdraw it from the mark et and recall it from end users, if 
appropriate. They shall immediately inform  the national authorit ies of the Member 
States where they made the toy available to th is effect, giving details, in particular, of 
the non-compliance and of the corrective measures taken. 
5. Distributors shall, on request from the co mpetent national authorities, provide them 
with all the information and documentation necessary to demonstr ate the conformity 
of the toy. They shall cooperate with those au thorities, at the reque st of the latter, on 
any action to avoid the risk s posed by toys which they have made available on the 
market. 
Article 7 
Cases in which obligations of manufac turers apply to impor ters 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 Artic le 3 in respect of these 
modifications.  
EN 19   EN Article 8 
Identification of economic operators 
Economic operators shall be able to identify the following: 
(a) any economic operator who has supplied them with a toy; 
(b) any economic operator to whom they have supplied a toy. 
They shall have in place appropriate systems an d procedures which allow for this information 
to be made available to the market surveilla nce authorities on request, for a period of 10 
years. 
CHAPTER III  
CONFORMITY OF THE TOY 
Article 9 
Essential safety requirements  
1. Member States shall take all measures necessary to ensure that toys may not be 
placed on the market unless they comply w ith the essential safety requirements set 
out, as far as the general safe ty requirement is c oncerned, in paragraph 2, and, as far 
as the particular safety require ments are concerned, in Annex II. 
2. Toys shall not jeopardize the safety or health of users or third parties when they are 
used as intended or in a foreseeable wa y, bearing in mind behaviour of children. 
 The ability of the users and where appropria te their supervisors shall be taken into 
account, in particular, in the case of t oys which, by virtue of their functions, 
dimensions and characteristics, are inte nded for use by children of under 36 months. 
Labels on toys or on thei r packaging and the instructi ons 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.  
3. Toys placed on the market shall comply with  the essential safety requirements during 
their foreseeable and normal period of use. 
Article 10 
Warnings  
1. Where appropriate for safe use, warnings ma de 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. 
2. The manufacturer shall mark the warnings in a visible, clearl y 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 maxi mum ages for users shall be visible, 
legible and conspicuously disp layed at the point of sale.  
EN 20   EN 3. Member States may require warnings and safe ty 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 st andards 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 cove red by those standards or parts thereof, set out 
in Article 9 and in Annex II.  
Article 13 
Formal objection against harmonised standards 
1. When a Member State or the Commission c onsiders 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. 
2. In the light of the Committee’s opinion, th e Commission shall decide to publish, not 
to publish, to publish with restriction, to main tain, to maintain with restriction or to 
withdraw the references to the harm onised standard concerned in the Official Journal 
of the European Union . 
3. 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 
1. The EC declaration of conformity shall stat e that the fulfilment of the requirements 
specified in Article 9 and in A nnex II has been demonstrated. 
2. The EC declaration of conformity shall as  a minimum contain the elements specified 
in Annex III and shall continuously be upda ted. The EC declarat ion of conformity 
shall have the model structure set out in Annex III. 
3. By drawing up the EC declaration of conf ormity, the manufacturer shall assume the 
responsibility for the compliance of the toy. 
Article 15 
General principles of the CE marking 
1. Toys made available on the mark et shall bear the CE marking.  
EN 21   EN 2. The CE marking may only be affixed by the manufacturer or his authorised 
representative. 
By affixing or havi ng affixed the CE marking the manufacturer shall assume the 
responsibility for the conform ity of the toy with the requ irements laid down in this 
Directive.  
3. Member States shall presume that toys bearing the CE marking comply with the 
provisions of this Directive. 
4. The CE marking shall be the only marking wh ich attests conformity of the toy with 
the applicable requirements.  
5. 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 th e provisions of this Directive. 
6. 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 ma y be affixed to the toy pr ovided that the visibility, 
legibility and meaning of the CE marking are not thereby impaired. 
7. Toys not bearing a CE-marking and which do not comply with the provisions of this 
Directive may feature in trade fairs an d 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 fo r sale or for distribu tion free of charge. 
Article 16 
Rules and conditions for the af fixing of the CE marking 
1. The CE marking shall consist of the in itials “CE” taking the following form:  
 
2. If the CE marking is reduced or enlarg ed the proportions given in the graduated 
drawing in paragraph 1 must be respected. 
3. Where specific legislation does not impos e specific dimensions, the CE marking 
shall have a height of at least 5 mm. 
4. The CE marking shall be marked visibly, le gibly and indelibly either on the toy, on 
an affixed label, or on the packaging.  
EN 22   EN 5. In the case of small toys and toys cons isting 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.  
6. If the CE-marking is not visibl e from outside the packaging, if any, it shall at least be 
affixed on the packaging. 
7. 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 placi ng a toy on the market, carry out an analysis of the chemical, 
physical, mechanical, electrical, flammability, hygi ene 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. Before placing the toys on the market, manufacturers shall use the conformity 
assessment procedures identified in paragra phs 2 and 3 to demonstrate that the toys 
comply with the essential safety requirem ents set out in Article 9 and Annex II. 
2. If the manufacturer has applied the harm onised 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 t oy, the manufacturer shall use the procedure 
of internal production control as set out in  Module A of Annex I to Decision […]. 
3. The toy shall be submitted for EC-type-e xamination as referred to in Article 19 
combined with the conformity to type pr ocedure set out in Module C of Annex I to 
Decision […] in the following cases: 
(a) when harmonised standards, the re ference number of which has been 
published in the Official Journal of the European Union , covering all 
relevant safety requiremen ts for the toy, do not exist; 
(b) when standards as referred to in poi nt (a) exist but the manufacturer 
has not applied them or has applied them only in part; 
(c) when standards as referred to in point (a) or any  of them have been 
published with a restriction.; 
(d) when the manufacturer considers that  the nature, desi gn, construction 
or purpose of the toy necessita te third party verification.  
EN 23   EN Article 19 
EC type-examination 
1. Application for EC type-exa mination, 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 a nd design type).  
In addition to those provisi ons, the requirements laid down in paragraphs 2 to 5 of 
this Article shall apply. 
2. The application for an EC type-examination shall include a descri ption of the toy and 
an indication of the place of manuf acture, including the address.  
3. When a conformity assessment body notified under Article 21, here inafter "notified 
body", carries out the EC type-examination, it shall evaluate, if necessary, jointly 
with the manufacturer, the analysis perfor med by the manufacturer in accordance 
with Article 17 of the hazards  that the toy may present. 
4. The EC type-examination certificate shall in clude a reference to this Directive, a 
colour image and a clear description of th e 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 co mply 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. 
5. The file and correspondence re lating to the EC type-exami nation 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 
1. The technical documentation referred to in Ar ticle 3 (2) shall contain all relevant data 
or details of the means used by the manufactur er to ensure that toys comply with the 
relevant essential requirements set out in Ar ticle 9 and in Annex II  and, in particular, 
it shall contain the documents listed in Annex IV. 
2. 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).  
3. Following a reasoned request from the mark et surveillance authority of a Member 
State, the manufacturer shall provide a tr anslation of the rele vant parts of the 
technical documentation into the la nguage of that Member State. 
When a market surveillan ce authority requests the te chnical 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.  
EN 24   EN 4. If the manufacturer does not observe the ob ligations foreseen in paragraphs 1, 2 and 
3, the market surveillance au thority 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 standard s and essential safety requirements. 
CHAPTER V 
NOTIFICATION OF CONFORMI TY ASSESSMENT BODIES 
Article 21 
Notification  
Member States shall notify the Commission and th e 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. Member States shall designa te 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 purpo ses of this Directive and 
for the monitoring of notified bodies, incl uding compliance with the provisions of 
Article 27. 
2. Member States may decide that the a ssessment and monitoring referred to in 
paragraph 1 shall be carried out by thei r national accreditation bodies within the 
meaning of and in accordance w ith Regulation (EC) No […]. 
3. Where the notifying authority delegates, subcontracts or othe rwise entrusts the 
assessment, notification or monitoring referr ed to in paragraph 1 to a body which is 
not a governmental entity, the delegated, su b-contracted or othe rwise entrusted body 
shall be a legal entity and sh all have arrangements to cove r liabilities arising from its 
activities. 
Article 23 
Requirements relating to notifying authorities 
(1) The notifying authority shall meet the re quirements set out in paragraphs 2 to 7 
(2) The notifying authority shall be established in such a way that no conflicts of interest 
with conformity assessment bodies occur 
(3) The notifying authority shall be organise d and operated so as to safeguard the 
objectivity and impartiality of its activities 
(4) 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; 
(5) The notifying authority shall not offer or provide any activitie s that conformity 
assessment bodies perform, or consultancy.  
EN 25   EN (6) The notifying authority shall have ade quate arrangements to safeguard the 
confidentiality of the information obtained. 
(7) The notifying authority shall have a suffici ent number of competent personnel at its 
disposal for the proper performance of its tasks. 
Article 24 
Information obligation fo r 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  
1. For the purposes of notification under this Directive, a conformity assessment body 
shall meet the requirements se t out in paragraphs 2 to 11. 
2. The conformity assessment body shall be established under national law and have 
legal personality. 
3. The conformity assessment body shall be a third-party body independent from the 
organisation or the product it assesses. 
4. The conformity assessment body, its t op level management and the personnel 
responsible for carrying out the conform ity assessment tasks shall not be the 
designer, manufacturer, supplier, installer, pu rchaser, 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, us e or maintenance of those products, nor 
represent the parties enga ged 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 th e possibility of exchanges of technical 
information between the manufacturer a nd 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 confidentia lity, objectivity and impartiality of its 
conformity assessment activities. 
5. The conformity assessment body and its pe rsonnel 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, whic h might influence their judgement or the 
results of their conformity a ssessment activities, especially from persons or groups of 
persons with an interest in the results of those activities. 
6. The conformity assessment body shall be cap able of carrying out all the conformity 
assessment tasks assigned to such a body by the provisions of Article 19 and for  
EN 26   EN which it has been notified, whether those tasks are carried out by the conformity 
assessment body itself or on its beha lf and under its responsibility.  
At all times and for each conformity a ssessment procedure and for each kind or 
category of products for whic h it is notified, the confor mity assessment body shall 
have at its disposal the necessary personnel with tech nical knowledge and sufficient 
and appropriate experience to perform the c onformity 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 assessm ent activities shall 
have the following: 
(a) sound technical and vocational trai ning covering all the conformity 
assessment activities of the relevant scope for which the conformity assessment body has been notified; 
(b) satisfactory knowledge of the requir ements of the assessments they 
carry out and adequate authorit y to carry out such operations; 
(c) appropriate knowledge and unde rstanding 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 a ssessment body, its top level management and 
assessment personnel shall be guaranteed. 
The remuneration of the conformity a ssessment 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. 
9. The conformity assessment body shall take ou t liability insurance unless liability is 
assumed by the State in accordance with nati onal law, or the Member State itself is 
directly responsible for th e conformity assessment. 
10. The personnel of the conformity a ssessment body shall be bound to observe 
professional secrecy with regard to all in formation gained in carrying out its tasks 
under Article 19 or any provision of national law givi ng effect to  it, except in  relation 
to the competent administrative authorities of the Member State in which its activities are carried out. Proprieta ry rights shall be protected. 
11. The conformity assessment body shall particip ate in, or ensure that its assessment 
personnel is informed of, the relevant sta ndardisation activities and the activities of 
the notified body co-ordination group esta blished under Article 36 and apply as 
general guidance the administrative decisi ons and documents produced as a work 
result of that group. 
Article 26 
Presumption of conformity 
Where a conformity assessment body can demonstrat e its conformity with the criteria laid 
down in the harmonised standard s, the references of which have been published in the 
Official  
EN 27   EN Journal of the European Union , it shall be presumed to comply with the requirements set out 
in Article 25 
Article 27 
Subsidiaries and subcontracting of notified bodies 
1. Where the conformity assessment body subcon tracts specific tasks connected with 
the assessment of conformity or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets th e requirements set out in Article 25. 
2. The conformity assessment body shall take full responsibility for the tasks performed 
by subcontractors or subsidiaries, wherever these are established.  
3. Activities may be subcontracted or carr ied out by a subsid iary only with the 
agreement of the client. 
4. The conformity assessment body shall keep at  the disposal of th e national authorities 
the relevant documents concerning the assessment of the s ubcontractor’s or 
subsidiary’s qualifications and the work carried out by the subcontractor or the 
subsidiary under Article 19. 
Article 28 
Application for notification 
1. 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. 
2. The application shall be accompanied by a de scription of the conformity assessment 
activities, the confor mity 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 a ccreditation body with in the meaning of 
Regulation (EC) No […], a ttesting that the conformity assessment body meets the 
requirements laid down in Arti cle 25 of this Directive. 
3. Where the conformity assessment body c oncerned 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 
1. Notifying authorities may notify only conf ormity assessment bodies which have 
satisfied the requirements laid down in Article 25. 
2. They shall notify the Commission and the othe r Member States us ing the electronic 
notification tool developed and managed by the Commission. 
3. The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules  and product or produ cts concerned and 
the relevant attestation of competence. 
4. Where a notification is not based on an accred itation certificate referred to in Article 
28 (2), the notifying authority shall provi de the Commission and the other Member 
States with all documentary evidence necessa ry for the verification of the conformity 
assessment body's competence.  
EN 28   EN 5. The body concerned may perform the activ ities of a notified body only where no 
objections have been raised by the Commi ssion 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. 
6. The Commission and the other Member States shall be no tified of any subsequent 
relevant changes to the notification. 
Article 30 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an identi fication number to a notified body. 
It shall assign a single such  number even where the body is notified under several 
Community acts. 
2. The Commission shall make publicly availa ble 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 
1. Where a notifying authority has ascertained or  has been informed that a notified body 
no longer meets the requirements set out in Ar ticle 25, or that it is failing to fulfil its 
obligations, the notifying authority shal l restrict, suspend or withdraw the 
notification as appropriate. It shall immediately inform the Commission and the other 
Member States thereof. 
2. 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 f iles are either processed by another notified 
body or kept available for the responsib le notifying and market surveillance 
authorities on request. 
Article 32 
Challenge of the competence of notified bodies 
1. The Commission shall investigate all cases where it doubts or doubt  is brought to its 
attention as to the competence of a notif ied body or the continued fulfilment by a 
notified body of the requirements and responsibilities placed on it.  
2. 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. 
3. The Commission shall ensure that all information obtained in the course of its 
investigations is treated confidentially.  
4. Where the Commission ascertains that a notified body does not meet, or no longer 
meets, the requirements for its notificati on, it shall inform the notifying Member  
EN 29   EN State thereof and request it to take the necessary corrective measures, including de-
notification, if necessary. 
Article 33 
Operational obligations for notified bodies 
1. Notified bodies shall carry out conform ity assessments in accordance with the 
conformity assessment procedur e provided for in Article 19. 
2. 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 comp lexity of the technology used by the toys. 
3. Where a notified body finds that the require ments 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) . 
4. Where, in the course of the monitoring of conformity following the delivery of 
certificate, a notified body finds that a t oy no longer complies, it shall require the 
manufacturer to take appropriate correctiv e measures and shall suspend or withdraw 
the certificate if necessary. 
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, su spend or withdraw any cer tificates, as appropriate. 
Article 34 
Information obligation for notified bodies 
1. Notified bodies shall inform the notifying authority of the following: 
(a) any refusal, restriction, suspension or withdrawal of EC type-examination 
certificates; 
(b) any circumstances affecting the scope of and conditions for notification; 
(c) any request for information which they ha ve received from market surveillance 
authorities; 
(d) on request, conformity assessment activit ies performed within the scope of 
their notification and, a ny other activity performe d, including, cross-border 
activities and subcontracting. 
2. Notified bodies shall provide  the other bodies notified under this Directive carrying 
out similar conformity assessment activit ies 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 re sponsible for policy on notification.  
EN 30   EN Article 36 
Coordination of notified bodies 
The Commission shall ensure that appropriate  coordination and coope ration between bodies 
notified under this Directive is put into place an d properly operated in the form of a sectoral 
group of notified bodies. 
Member States shall ensure that the bodies notif ied 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. 
Article 38 
Powers of market surveillance authorities 
1. The market surveillance authorities ma y require from the economic operators 
concerned any information considered necessa ry for the purposes of effective market 
surveillance, including the technical documentation referred to in Article 20. 
2. The market surveillance authorities may as k a notified body to provide information 
relating to any EC type-examination cer tificate 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.  
3. The market surveillance auth orities shall be entitled to enter the premises of the 
economic operators concerne d where it appears necessa ry for the purposes of 
carrying out the surveillance of toys in accordance with Article 37. 
Article 39 
Instructions to the notified body 
1. If the market surveillance authority finds th at 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. 
2. Where necessary, and in particular in cases  specified in the second subparagraph of 
Article 19 (4), the market surveillance au thority shall instruct the notified body to 
review the EC type-e xamination certificate. 
Article 40 
Co-operation for market surveillance 
1. Member States shall ensure efficient co-operation and exchange of information on all 
issues relating to toys presenting a risk be tween their market surveillance authorities 
and those of the other Member States a nd between their own authorities and the 
Commission and the relevant Community Agencies.  
EN 31   EN 2. 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 a ppropriate measure or by participating in 
investigations initiated in other Member States. 
CHAPTER VII 
SAFEGUARD PROCEDURES 
Article 41 
Safeguard clause 
Procedure to deal with toys pr esenting a risk at national level 
1. Where the market surveillance authorities of one Member Stat e 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 Di rective presents a risk for the health or 
safety of persons they shall, together w ith the relevant econo mic operators, perform 
an evaluation in relation to the toy con cerned covering all the requirements laid down 
by this Directive. 
Where, in the course of th at evaluation, the market surv eillance 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 re quirements or to withdraw the toy from 
the market or recall it within such reas onable period, commensurate with the nature 
of the risk, as they may prescribe. 
2. 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 th e actions which they have 
required the economic operator to take. 
3. The economic operator shall ensure that any corrective actions are taken in respect of 
all the toys concerned which he has ma de available on the market throughout the 
Community. 
4. Where the relevant economic operator, with in the period referred to in the second 
subparagraph of paragraph 1, does not take adequate corr ective actions, the market 
surveillance authorities shall take all appr opriate provisional measures to prohibit or 
restrict the making available of the toy on th e 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. 
5. The information referred to in paragraph 4 shall provide all av ailable details, in 
particular as regards the necessary data for the identification of the non-compliant 
toy, the origin of the toy, th e nature of the risk involve d, the nature and duration of 
national measures taken. In particular, th e 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;  
EN 32   EN (b) shortcomings in the harmonised standard s referred to in Article 12 (1) as 
conferring presumption of conformity. 
6. Member States other than the Member St ate which initiated the procedure shall 
without delay inform the Commission and th e other Member States of any measures 
adopted and of any additional information relating to the non-co mpliance of the toy 
concerned at their disposal, and, in the event of disagreement with the notified 
national measure, of their objections. 
7. 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 
1. 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 wh ere the Commission 
considers the national measure to be c ontrary 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 eval uation, the Commission sh all take a decision, 
indicating whether the measur e is justified or not. 
The Commission shall address its decisi on to all Member States and shall 
immediately communicate it to them and to the relevant economic operator(s). 
2. 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 unjus tified, the Member State concerned shall 
withdraw the measure. 
3. Where the national measure is considered to  be justified and the non-compliance of 
the toy is attributed to shortcomings in the harmonised standard s as referred to in 
Article 41(5)(b), the Commission or the Memb er State shall bring the matter before 
the Standing Committee set up under Ar ticle 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 ne cessary to make a sepa rate notification under 
Article 41(4) of this Directive, provide d that the following conditions are met:  
(a) the RAPEX notification indicates that the notification of the measure is also 
required by this Directive; 
(b) the supporting evidence referred to in Article 41 (5) is enclosed with the 
RAPEX notification.  
EN 33   EN Article 44 
Formal non-compliance  
1. Without prejudice to Article 41, where a Me mber State makes one of the following 
findings, it shall require the relevant ec onomic operator to put an end to the non-
compliance concerned: 
(a) the conformity marking has been affixed in violation of Article 15 or Article 
16, 
(b) the conformity marking has not been affixed; 
(c) the EC declaration of confor mity has not been drawn up; 
(d) 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 rest rict or prohibit the ma king available on the 
market of the toy or ensure that it is  recalled or withdraw n from the market. 
CHAPTER VIII 
COMMITTEE PROCEDURES 
Article 45 
Amendments and implementing measures 
1. The Commission may, for the purposes of ad apting them to technical and scientific 
developments, amend the following: 
(a) Points 7 and 8 in Part III of Annex II; 
(b) Annex V. 
Those measures, designed to amend non-esse ntial elements of this Regulation, shall 
be adopted in accordance with the regulator y 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-e ssential elements of  this Directive by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 46 (2). 
Article 46 
Committee 
1. The Commission shall be assisted by a committee. 
2. Where reference is made to this paragra ph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having re gard to the provisions of Article 8 
thereof.  
EN 34   EN 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 year s thereafter, Member States shall send the 
Commission a report on the application of this Directive.  
This report shall contain an evaluation of the si tuation concerning the safe ty 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 lim its applying to such remedies. 
Article 50 
Penalties 
Member States shall lay down the rules on pena lties, which may include criminal sanctions 
for serious infringements, applicable to in fringements 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 Commi ssion 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 Directiv es 85/374/EEC and 2001/95/EC 
1. This Directive is without prejudice to the application of Directive 85/374/EEC.  
EN 35   EN 2. Directive 2001/95/EC shall apply to toys in  accordance with Article 1(2) thereof. The 
applicable Articles of Dir ective 2001/95/EC are those mentioned in Articles 37, 43 
and 48 of this Directive as well as Ar ticles 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 wh ich 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 afte r this Directive entered into force.  
Article 53 
Transposition 
Member States shall bring into force the la ws, regulations and ad ministrative provisions 
necessary to comply with this Directive by at  the latest. They shall forthwith inform the 
Commission thereof. 
They shall apply those provisi ons with effect from […] 
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the o ccasion of their official publication. Member 
States shall determine how such  reference is to be made. 
Member States shall communicate to the Comm ission the provisions of  national law which 
they adopt in the field c overed by this Directive. 
Article 54 
Repeal 
Directive 88/378/EEC is repealed  from the date set out in th e 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 tw entieth 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 For the Council  
The President The President  
EN 36   EN ANNEX I  
LIST OF PRODUCTS THAT, IN PARTIC ULAR, ARE NOT CONSIDERED AS TOYS 
WITHIN THE MEANING OF THIS  DIRECTIVE (ARTICLE 2 (1))  
1. Decorative objects for festivities and celebrations; 
2. Products for adult collectors,  provided that the product or its packaging bears a 
visible and legible indication that it is inte nded for collectors of 14 years of age and 
above. Examples of this category are: 
(a) detailed and faithful scale models, 
(b) kits for the assembly of  detailed scale models, 
(c) folk dolls and decorative dolls and other similar articles, 
(d) historical replicas of toys, 
(e) reproductions of real fire arms; 
3. Sports equipment, including roller skates, inline skates, and skateboards intended for 
children with a body mass of more than 20 kg; 
4. Bicycles, scooters and other means of tran sport designed for sport or which are 
intended to be used for travel on public roads or public pathways; 
5. Electrically driven vehicles which are intende d to be used for travel on public roads, 
public pathways, or on the pavement of these. 
6. Aquatic equipment intended to be used in deep water and swimming learning devices 
for children, such as swim seats and swimming aids; 
7. Puzzles with more than 500 pieces; 
8. Guns and pistols using compressed gas, with the exception of water guns, and bows 
for archery over 120 cm long; 
9. Fireworks, including percussion caps which ar e not specifically designed for toys; 
10. Products and games using sharp-pointed missiles, such as sets of darts with metallic 
points; 
11. Functional educational products , such as electric ovens, irons or other functional 
products operated at a nominal voltage ex ceeding 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, a ppliance or installation. 
12. Products intended for use for educatio nal purposes in schools and in other 
pedagogical framework under the surveillance of  an adult instructor, such as science 
equipment; 
13. Electronic equipment, such as personal computers and game consoles, used to access 
interactive software and their associated peripherals, unless th e electronic equipment 
or the associated peripherals are specifica lly designed for and ta rgeted at children 
and have a play value on their own, such as specially designed personal computers, 
key boards, joy sticks or steering wheels;   
EN 37   EN 14. Interactive software, intended for leisure and entertainment, such as computer games, 
and their storage media, such as CD; 
15. Babies' soothers; 
16. Child-appealing luminaires; 
17. Electrical transformers for toys. 
ANNEX II  
PARTICULAR SAFETY REQUIREMENTS  
I. PHYSICAL  AND  MECHANICAL  PROPERTIES 
1. Toys and their parts and, in the case of fi xed toys, their anchorages, must have the 
requisite mechanical strength and, where appropriate, stability to withstand the stresses to which they are subjected dur ing use without breaki ng or becoming liable 
to distortion at the risk of causing physical injury. 
2. Accessible edges, protrusions, cords, cable s and fastenings on toys must be so 
designed and constructed that the risks of phys ical injury from contact with them are 
reduced as far as possible. 
3. 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. 
4. Toys and their parts must not present risk  of asphyxiation cause d, 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 us e by children under 36 months, and their 
component parts and any of thei r detachable parts must be of such dimensions as to 
prevent their being swallowed and/or inhale d. 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-mingl ed with a food must have their own 
packaging. This packaging, in its supplied c ondition, must be of such dimensions as 
to prevent it being sw allowed 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 ge t direct access to the toy, 
shall be prohibited. 
5. Toys intended for use in shallow water wh ich 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 recommende d use of the toy, any risk of loss of 
buoyancy of the toy and loss of support afforded to the child. 
6. 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. 
7. 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 38   EN developed by it. Such a system must be eas y for the user to operate without risk of 
ejection or physical injury for th e user of for third parties.  
 The maximum design speed of electrically dr iven 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 ener gy 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: 
(a) the maximum and minimum temperature of any accessible surfaces does not 
cause injury when touched; 
(b) 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. 
10. Toys which are designed to emit a sound shoul d be so designed and constructed so 
that the sound from them is not ab le to impair children’s hearing. 
11. Activity toys shall be constructed so as to reduce the risk of crus hing or trapping of 
body parts or trapping of clothing and the ri sk of falls, impacts and drowning as far 
as possible. 
II. FLAMMABILITY 
1. Toys must not constitute a dangerous flammable element in the child's environment. 
They must therefore be composed of ma terials which fulfil one or more of the 
following conditions: 
(a) they do not burn if directly exposed to a flame or spark or other potential seat 
of fire;  
(b) they are not readily flammable (the flame goes out as soon as the fire cause 
disappears);  
(c) if they do ignite, they burn slowly and present a low rate of spread of the 
flame;  
(d) irrespective of the toy's ch emical composition, they are treated mechanically so 
as to delay the combustion process 
(e) Such combustible materials must not c onstitute a risk of ignition for other 
materials used in the toy.  
2. Toys which, for reasons essential to thei r functioning, contain dangerous substances 
or preparations as defined in Council Di rective 67/548/EEC, in particular materials 
and equipment for chemistry experiments,  model assembly, plastic or ceramic 
moulding, enamelling, photography or simila r activities, must not contain, as such,  
EN 39   EN substances or preparations which may become flammable due to the loss of non-
flammable volatile components. 
3. 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). 
4. Toys and, in particular, chemical game s and toys, must not contain as such 
substances or preparations: 
(a) which, when mixed, may explode:- th rough chemical reaction, or through 
heating,- when mixed with oxidizing substances; 
(b) which contain volatile components which are flammable in air and liable to 
form flammable or explos ive vapour/air mixture. 
III. CHEMICAL  PROPERTIES 
1. Toys shall be so designed and constructed th at there are no risks of adverse effects on 
human health due to exposure to the chemi cal substances or preparations of which 
the toys are composed or which they contai n, when the toys are used as specified in 
the first subparagraph of Article 9 (2). 
2. Toys shall comply with relevant Community  legislation relating to certain categories 
of products or to the prohibition of us e of certain danger ous substances and 
preparations.  Toys that are themselves substances or  preparations must comply also with 
Directives 67/548/EEC and 1999/45/EC
25 relating to the classification, packaging 
and labelling of dangerous substances and dangerous preparations. 
3. Without prejudice to the app lication 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 preparati ons 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 distin ct parts of toys that are 
not accessible to any physical contact by children.  
4. 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: 
4.1. 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; 
4.2. there are no suitable alternative substances av ailable, as documented in an analysis of 
alternatives, 
4.3. they are not prohibited for uses in cons umer articles under Regulation (EC) No 
1907/2006 (REACH). 
                                                 
25 OJ No L 200, 30.7. 1999, p. 1-68  
EN 40   EN 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 deci sion in accordance with Article 45 (2) was 
taken. 
5. 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 refe rred to in Article 45 (2) and provided that they are 
not prohibited for uses in consumer ar ticles under Regulation (EC) No 1907/2006 
(REACH). 
6. Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional 
and labelling requirements provided for in Directive 76/768/EEC. 
7. Toys shall not contain the following allergenic fragrances:  
(1) Alanroot (Inula helenium) 
(2) Allylisothiocyanate 
(3) Benzyl cyanide 
(4) 4 tert-Butylphenol 
(5) Chenopodium oil 
(6) Cyclamen alcohol 
(7) Diethyl maleate 
(8) Dihydrocoumarin 
(9) 2,4-Dihydroxy-3-methylbenzaldehyde 
(10) 3,7-Dimethyl-2-octen-1-o l (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-deca hydronaphthalenol 
(24) 7-Methoxycoumarin 
(25) 4-Methoxyphenol  
EN 41   EN (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 substa nces shall be allowed provided that such 
presence is technically unavoida ble in good manufacturing practice. 
In addition the following allergen ic fragrances shall be listed if added to toys, as such, at 
concentrations exceeding 0,01 % by weight: 
(1) Amyl cinnamal 
(2) Amylcinnamyl alcohol 
(3) Anisyl alcohol 
(4) Benzyl alcohol 
(5) Benzyl benzoate 
(6) Benzyl cinnamate 
(7) Benzyl salicylate 
(8) Cinnamal 
(9) Cinnamyl alcohol 
(10) Citral 
(11) Citronellol 
(12) Coumarin 
(13) Eugenol 
(14) Farnesol 
(15) Geraniol 
(16) Hexyl cinnamaldehyde 
(17) Hydroxy-citronellal 
(18) Hydroxy-methylpentylcycl ohexenecarboxaldehyde 
(19) Isoeugenol  
EN 42   EN (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-cyc lohexen-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 fi rst subparagraph of Article 9 (2), shall not 
be exceeded:  
Element mg/kg in dry, brittle, 
powder-like or 
pliable toy material mg/kg 
in liquid or sticky 
toy material  
Aluminium 5625 1406 
Antimony 45 11.3 
Arsenic 7.5 1.9 
Barium 4500 1125 
Boron 1200 300 
Cadmium 3.8 0.9 
Chromium (III) 37.5 9.4 
Chromium (VI) 0.04 0.01 
Cobalt 10.5 2.6 
Copper 622.5 156 
Lead 27 6.8 
Manganese 1200 300 
Mercury 15 3.8 
Nickel 75 18.8 
Selenium 37.5 9.4 
Strontium 4500 1125 
Tin 15000 3750  
EN 43   EN Organic tin 1.9 0.5 
Zinc 3750 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. ELECTRICAL  PROPERTIES 
1. Toys shall not be powered by electricity exceeding 24 volts and th eir 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. 
2. Parts of toys which are connected to, or liabl e to come into contact with a source of 
electricity capable of caus ing electric shock, together  with the cables or other 
conductors through which electricity is conve yed to such parts, must be properly 
insulated and mechanically protected so as to prevent the risk of such shock. 
3. Electric toys must be so designed and c onstructed as to ensure that the maximum 
temperatures reached by all directly acces sible surfaces are not such as to cause 
burns when touched. 
4. Under foreseeable fault conditions, toys mu st provide protection against electrical 
hazards arising from an electrical power source. 
5. Electric toys must provide adequate  protection against fire hazards. 
6. Electric toys must be designed and manuf actured in such a way that electric, 
magnetic, and electromagnetic fields and othe r 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. 
7. 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. 
8. Toys must be so designed and constructed th at they do not presen t any health hazards 
or risk of injury to eyes or skin fro m lasers, light-emitting diodes (LEDs) or any 
other type of radiation. 
9. The electrical transformer for toys sh all not be integral part of the toy. 
V. HYGIENE 
1. 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. 
2. Textile toys for children under 36 months sha ll be washable and shall fulfil the safety 
requirements also after washing.  
EN 44   EN VI. RADIOACTIVITY 
Toys shall comply with all relevant disposit ions adopted under Chapte r III of the Treaty 
establishing the European Atomic Community. 
ANNEX III  
EC DECLARATION OF CONFORMITY  
1. No xxxxxx (unique identification of the toy(s)) 
2. Name and address of (authorised repr esentative of the) manufacturer:  
3. This declaration of conformity is issu ed under the sole re sponsibility of the 
manufacturer:  
4. Object of the declarat ion (identification of toy allowing traceability): 
5. The object of the declaration described a bove is in conformity  with the relevant 
Community harmonisation legislation………  
6. References to the relevant harmonised standards used, or references to the 
specifications in relation to which conformity is declared: 
7. The notified body ... (name, number)… perf ormed … (description of intervention)… 
and issued the certificate: …. 
8. 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 Articl e 20 shall contain, in particular, so far as 
relevant for assessment: 
a) a detailed description of the desi gn and manufacture, including a list of 
components and materials used in toys as we ll 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 conform ity 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 harmoni sed standards if the manufacturer has 
followed the internal production control referred to in Article 18 (2). 
h) a copy of the EC type-examination certifi cate, a description of  the means whereby 
the manufacturer ensures conformity of the production with the product-type as 
described in the EC type-examination certifica te and copies of th e documents that the  
EN 45   EN manufacturer has submitted to the notifie d body, if the manufacturer has followed the 
EC type-examination and type conformity –d eclaration 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 appropri ate, 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 IN DICATIONS 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 child ren 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 specifi c hazard calling fo r 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, trapez es, 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 dr awing attention to the need to carry out 
checks and maintenance of the main parts (s uspensions, fixings, an chorages, 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 co rrect assembly of the toy, indicating those 
parts which can present dangers if it is incorrectly assembled. Specific information 
regarding suitable surf ace 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 intende d for use by adults, and may be a scale 
model of such a product, a ppliance or installation. 
Functional toys or their packaging shall be ar the marking 'Warning: to be used under 
the direct supervis ion of an adult'. 
In addition, these toys shall be acco mpanied by directions giving working 
instructions as well as the precautions to be  taken by the user, with the warning that  
EN 46   EN failure to take these precautions would e xpose the user to the hazards - to be 
specified - normally associated with the a ppliance 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 a pplication of the provisions  laid down in Community 
directives on the classification, packaging a nd labelling of dangerous substances or 
preparations, the instructi ons for use of toys contai ning inherently dangerous 
substances or preparations shall bear a warning of the danger ous nature of these 
substances or preparations and an indication of the pre cautions to be taken by the 
user in order to avoid hazards associat ed with them, which shall be specified 
concisely according to the type of toy. The fi rst 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 fo r in the previous subparagraph, chemical 
toys shall bear the following marking on their packaging:  
‘Warning: Not suitable for children under (¹ ) years. For use unde r 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 re action or similar substance alteration during 
use. 
5. Skates, roller skates, online skates, skat eboards, scooters and toy bicycles for 
children 
If these toys are offered fo r 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 cont ain 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. So me 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 wh ich 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 47   EN LEGISLATIVE FINANCIAL STATEMENT  
1. NAME  OF THE  PROPOSAL: 
Proposal for a Directive of the European Parl iament and of the C ouncil 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. BUDGET
 LINES 
3.1. Budget lines (operational lines and related technical and administrative 
assistance lines (ex- B.A lines) including headings: 
3.2. Duration of the action a nd 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 YES/  NO YES /NO YES/NO  No […] 
 Comp/  
Non-comp  Diff/  
Non-diff  YES/  NO YES /NO YES/NO  No […] 
                                                 
26 Differentiated appropriations 
27 Non-differentiated appropriations hereafter referred to as NDA  
EN 48   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.   
Year 
n  
n + 1  
n + 2  
n + 3  
n + 4 n + 5  
and 
later  
Total 
Operational expenditure28         
Commitment Appropriations 
(CA) 8.1. a        
Payment Appropriations 
(PA)  b        
Administrative expenditure within reference amount29     
Technical & administrative 
assistance (NDA) 8.2.4. c        
TOTAL REFERENCE AMOUNT        
Commitment 
Appropriations  a+c        
Payment Appropriations  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 resources and 
associated expenditure 
(NDA) 8.2.5. d        
Administrative costs, other 
than human resources and 
associated costs, not 
included in reference amount (NDA) 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 49   EN TOTAL PA including cost 
of Human Resources  b+c
+d+
e 0,120 0,120 0,120 0,120 0,120 0,120 0,120 
Co-financing details 
If the proposal involves co-financing by Member States, or other bodies (please 
specify which), an estimate of the level of  this co-financing s hould be indicated in 
the table below (additional lines may be adde d if different bodies are foreseen for the 
provision of the co-financing):  
No co-financing is envisage d within the scope of the revision of this existing 
legislation. 
EUR million (to 3 decimal places) 
Co-financing body 
  
Year 
n  
n + 1  
n + 2  
n + 3  
n + 4 n + 5  
and 
later  
Total 
…………………… f        
TOTAL CA including co-
financing a+c
+d+
e+f        
4.1.2. Compatibility with Financial Programming 
X Proposal is compatible with existing financial programming. 
 Proposal will entail reprogramming of the relevant heading in the financial 
perspective. 
 Proposal may require application of th e provisions of th e Interinstitutional 
Agreement31 (i.e. flexibility instrument or re vision of the financial perspective). 
4.1.3. Financial impact on Revenue 
X Proposal has no financial implications on revenue 
 Proposal has financial impact – th e effect on revenue is as follows: 
NB: All details and observations relating to the method of calc ulating the effect on revenue 
should be shown in a separate annex. 
EUR million (to one decimal place)  
  Situation following action 
Budget line Revenue Prior to
action 
[Year n-
1] [Year 
n] [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 50   EN (Please specify each revenue budget line involve d, 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’ committ ee is introduced by the proposal, to meet 
the need to revise the legislati on in a timely and convenient manner. 
5.2. Value-added of Community involvement and coherence of the proposal with 
other financial instrume nts 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) 
 Centralised Management 
X directly by the Commission 
 indirectly by delegation to: 
 executive Agencies 
 bodies set up by the Communities as  referred to in art. 185 of the 
Financial Regulation 
 national public-sector bodies/bodies with public-service mission 
 Shared or decentralised management 
 with Member states 
 with Third countries 
 Joint management with internationa l organisations (please specify) 
Relevant comments: None  
EN 51   EN 6. MONITORING  AND  EVALUATION 
6.1. Monitoring system 
The monitoring will be managed through th e expert group on t oy safety (already 
existing prior to the revision that is the object of the pr oposal), and the feedback 
provided by the national authorities, consis tently 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 b een 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/e x-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. A NTI-FRAUD MEASURES    
EN 52   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 financia l incidence of the proposal). 
Commitment appropriations in 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 (Headings of 
Objectives, actions and 
outputs should be 
provided) Type of output Av. 
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 No. 
outputs Total 
cost 
OPERATIONAL OBJECTIVE No.1 
33………                 
Action 1……………….                 
-  O u t p u t  1                  
-  O u t p u t  2                  
Action 2……………….                  
-  O u t p u t  1                  
Sub-total 
Objective 1                 
OPERATIONAL 
OBJECTIVE No.2 
1………                 
Action                 
                                                 
33 As described under Section 5.3  
EN 53   EN 1……………….  
-  O u t p u t  1                  
Sub-total 
Objective 2                 
OPERATIONAL 
OBJECTIVE No.n 
1                 
Sub-total Objective n                 
TOTAL COST                  
EN 54   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 t hat 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 
A*/AD       Officials or 
temporary 
staff34 (XX 01 
01) 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 Posts currently allocated to the manage ment 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 existi ng resources within the managing service 
(internal redeployment) 
 Posts required for year n although not fo reseen 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 55   EN 8.2.4. Other Administrative expenditure  included in reference amount (XX 01 04/05 – 
Expenditure on administrative management): 
Not relevant 
EUR million (to 3 decimal places) 
Budget line 
(number and heading) Year 
n Year 
n+1 Year 
n+2 Year 
n+3 Year 
n+4 Year 
n+5  
and 
later TOTAL 
1 Technical and administrative 
assistance (including related staff costs)        
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)       
Total cost of Human 
Resources and associated 
costs (NOT in reference amount)       
 
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 legislativ e financial statement for the Executive Agency(ies) 
concerned.  
EN 56   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 of an 
administrative nature (specify 
including reference to budget line)         
Total Administrative expenditure, 
other than human resources and associated costs (NOT included in 
reference amount)       
 
 
Calculation - Other administrative expenditure not  included in reference amount  
None 
                                                 
38 Specify the type of committee and the group to which it belongs.