I 
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)  
DIRECTIVES  
DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
of 18 June 2009  
on the safety of toys  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE 
EUROPEAN UNION,  
Having regard to the Treaty establishing the European 
Community, and in particular Article 95 thereof,  
Having regard to the proposal from the Commission,  
Having regard to the opinion of the European Economic and 
Social Committee (  1 ), 
Acting in accordance with the procedure laid down in 
Article 251 of the Treaty (  2 ), 
Whereas:  
(1) Council Directive 88/378/EEC of 3 May 1988 on the 
approximation of the laws of the Member States 
concerning the safety of toys (  3 ) 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 approach to technical harmoni ­
sation and standards (  4 ). Thus, it sets out only the 
essential safety requirements with regard to toys, 
including the particular safety requirements regarding 
physical and mechanical properties, flammability, 
chemical properties, electrical properties, hygiene and 
radioactivity. Technical details are adopted by the 
European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation 
(Cenelec) in accordance with Directive 98/34/EC of the 
European Parliament and of the Council of 22 June 1998 
laying down a procedure for the provision of infor ­
mation in the field of technical standards and regulations 
and of rules on Information Society services (  5 ). 
Conformity with harmonised standards so set, the 
reference number of which is published in the  Official 
Journal of the European Union , provides a presumption 
of conformity with the requirements of Directive 
88/378/EEC. Experience has shown that these basic prin ­
ciples have worked well in the toys sector and should be 
maintained.  
(3) Technological developments in the toys market have, 
however, raised new issues with respect to the safety of 
toys and have given rise to increased consumer concerns. 
In 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 by 
this Directive.  
(4) Toys are also subject to Directive 2001/95/EC of the 
European Parliament and of the Council of 
3 December 2001 on general product safety (  6 ), which 
applies in a complementary manner to specific sectoral 
legislation.  
(5) Regulation (EC) No 765/2008 of the European 
Parliament and of the Council of 9 July 2008 setting 
out the requirements for accreditation and market 
surveillance relating to the marketing of products (  7 ) 
lays down horizontal provisions on the accreditation of 
conformity assessment bodies, on the CE marking and 
on the Community market surveillance framework for, 
and controls of, products entering the Community 
market which also apply to the toys sector.EN 30.6.2009 Official Journal of the European Union L 170/1  
( 1 ) OJ C 77, 31.3.2009, p. 8.  
( 2 ) Opinion of the European Parliament of 18 December 2008 (not yet 
published in the Official Journal) and Council Decision of 11 May 
2009.  
( 3 ) OJ L 187, 16.7.1988, p. 1.  
( 4 ) OJ C 136, 4.6.1985, p. 1.  ( 5 ) OJ L 204, 21.7.1998, p. 37.  
( 6 ) OJ L 11, 15.1.2002, p. 4.  
( 7 ) OJ L 218, 13.8.2008, p. 30.(6) Decision No 768/2008/EC of the European Parliament 
and of the Council of 9 July 2008 on a common 
framework for the marketing of products (  1 ) provides 
common principles and reference provisions for the 
purposes of legislation based on the New Approach prin ­
ciples. In order to ensure consistency with other sectoral 
product legislation, it is appropriate to align certain 
provisions of this Directive to that Decision, in so far 
as sectoral specificities do not require a different solution. 
Therefore, certain definitions, the general obligations of 
economic operators, the presumption of conformity, 
formal objections against harmonised standards, rules 
for the CE marking, requirements for conformity 
assessment bodies and notification procedures and the 
provisions concerning procedures dealing with products 
presenting a risk should be aligned to that Decision.  
(7) In order to facilitate the application of this Directive by 
manufacturers and national authorities, the scope of this 
Directive should be clarified by completing the list of 
products which are not within its scope, in particular 
as regards certain new products, such as videogames 
and peripherals.  
(8) It is appropriate to provide for certain new definitions 
specific to the toys sector in order to facilitate the under ­
standing and uniform application of this Directive.  
(9) Toys that are placed on the Community market should 
comply with the relevant Community legislation, and 
economic operators should be responsible for the 
compliance of toys, in relation to their respective roles 
in the supply chain, so as to ensure a high level of 
protection of public interests, such as health and safety, 
and the protection of consumers and of the environment, 
and to guarantee fair competition on the Community 
market.  
(10) All economic operators are expected to act responsibly 
and in full accordance with the legal requirements 
applicable when placing or making toys available on 
the market.  
(11) All economic operators intervening in the supply and 
distribution chain should take appropriate measures to 
ensure that under normal and reasonably foreseeable 
conditions of use, the toys they place on market do 
not jeopardise the safety and health of children and 
that they make available on the market only toys 
which comply with the relevant Community legislation. 
This Directive provides a clear and proportionate distri ­
bution of obligations which correspond to the role of 
each operator in the supply and distribution process.  
(12) As certain tasks can be executed only by the manu ­
facturer, it is necessary to distinguish clearly between 
the manufacturer and operators further down the distri ­
bution chain. It is also necessary to distinguish clearly between the importer and the distributor, as the importer 
introduces toys from third countries to the Community 
market. The importer has thus to make sure that those 
toys comply with the applicable Community 
requirements.  
(13) The manufacturer, having detailed knowledge of the 
design and production process, is best placed to carry 
out the complete conformity assessment procedure for 
toys. Conformity assessment should therefore remain the 
obligation of the manufacturer alone.  
(14) It is necessary to ensure that toys from third countries 
entering the Community market comply with all 
applicable Community requirements, and in particular 
that appropriate assessment procedures have been 
carried out by manufacturers with regard to those toys. 
Provision should therefore be made for importers to 
make sure that the toys they place on the market 
comply with the applicable requirements and that they 
do not place on the market toys which do not comply 
with such requirements or which present a risk. For the 
same reason, provision should also be made for 
importers to make sure that conformity assessment 
procedures have been carried out and that product 
marking and documentation drawn up by manufacturers 
are available for inspection by the supervisory authorities.  
(15) Where the distributor makes a toy available on the 
market after the toy has been placed on the market by 
the manufacturer or the importer, it should act with due 
care to ensure that its handling of the toy does not 
adversely affect the compliance of the toy. Both 
importers and distributors are expected to act with due 
care in relation to the requirements applicable when 
placing or making toys available on the market.  
(16) When placing a toy on the market, importers should 
indicate on the toy their name and the address at 
which they can be contacted. Exceptions should be 
provided for in cases where the size or nature of the 
toy does not allow for such an indication. This 
includes cases where importers would have to open the 
packaging to put their name and address on the product.  
(17) Any economic operator that either places a toy on the 
market under its own name or trademark or modifies a 
toy in such a way that compliance with applicable 
requirements may be affected should be considered to 
be the manufacturer and should assume the obligations 
of the manufacturer.  
(18) Distributors and importers, being close to the market 
place, should be involved in market surveillance tasks 
carried out by competent national authorities, and 
should be prepared to participate actively, providing 
those authorities with all necessary information relating 
to the toy concerned.EN L 170/2 Official Journal of the European Union 30.6.2009  
( 1 ) OJ L 218, 13.8.2008, p. 82.(19) Ensuring traceability of a toy throughout the whole 
supply chain helps to make market surveillance simpler 
and more efficient. An efficient traceability system facil ­
itates market surveillance authorities' task of tracing 
economic operators who made non-compliant toys 
available on the market.  
(20) Certain essential safety requirements which were laid 
down in Directive 88/378/EEC should be updated to 
take account of technical progress since the adoption 
of that Directive. In particular, in the field of electrical 
properties, technical progress has made it possible to 
allow the limit of 24 volts set in Directive 88/378/EEC 
to be exceeded, while guaranteeing the safe use of the toy 
concerned.  
(21) It is also necessary to adopt new essential safety 
requirements. In order to ensure a high level of 
protection of children against risks caused by chemical 
substances in toys, the use of dangerous substances, in 
particular substances that are classified as carcinogenic, 
mutagenic or toxic for reproduction (CMR), and 
allergenic substances and certain metals, should be 
subject to careful attention. It is therefore in particular 
necessary to complete and update the provisions on 
chemical substances in toys to specify that toys should 
comply with general chemicals legislation, in particular 
Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH) and establishing 
a European Chemicals Agency (  1 ). Those provisions 
should, however, also be adapted to the particular 
needs of children, who are a vulnerable group of 
consumers. Therefore, new restrictions on CMR 
substances, in accordance with applicable Community 
legislation on the classification, labelling and packaging 
of substances and mixtures, and on fragrances in toys 
should be provided for on account of the special risks 
that these substances may entail for human health. Nickel 
in stainless steel has proven to be safe, and consequently 
it is appropriate that it can be used in toys.  
(22) The specific limit values laid down in Directive 
88/378/EEC for certain substances should also be 
updated to take account of the development of scientific 
knowledge. Limit values for arsenic, cadmium, chromium 
VI, lead, mercury and organic tin, which are particularly 
toxic, and which should therefore not be intentionally 
used in those parts of toys that are accessible to 
children, should be set at levels that are half of those considered safe according to the criteria of the relevant 
Scientific Committee, in order to ensure that only traces 
that are compatible with good manufacturing practice 
will be present.  
(23) Toys or their parts and their packaging that can 
reasonably be expected to be brought into contact with 
food should comply with Regulation (EC) No 1935/2004 
of the European Parliament and of the Council of 
27 October 2004 on materials and articles intended to 
come into contact with food (  2 ). 
(24) In order to ensure adequate protection in the case of toys 
involving a high degree of exposure, it should be possible 
to adopt implementing measures establishing specific 
limit values for chemicals used in toys intended for use 
by children under 36 months and in other toys intended 
to be put in the mouth, taking into account the 
requirements of Regulation (EC) No 1935/2004 and 
the differences between toys and materials which come 
into contact with food.  
(25) The general and specific chemical requirements laid 
down by this Directive should aim at protecting the 
health of children from certain substances in toys, 
while the environmental concerns presented by toys are 
addressed by horizontal environmental legislation 
applying to electrical and electronic toys, namely 
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 equipment (  3 ) and Directive 2002/96/EC 
of the European Parliament and of the Council of 
27 January 2003 on waste electrical and electronic 
equipment (  4 ). In addition, environmental issues on 
waste are regulated by Directive 2006/12/EC of the 
European Parliament and of the Council of 5 April 
2006 (  5 ), those on packaging and packaging waste by 
Directive 94/62/EC of the European Parliament and of 
the Council of 20 December 1994 (  6 ) and those on 
batteries and accumulators and waste batteries and accu ­
mulators by Directive 2006/66/EC of the European 
Parliament and of the Council of 6 September 2006 (  7 ). 
(26) The system established by this Directive should also 
encourage, and in certain cases ensure, that dangerous 
substances and materials used in toys are replaced by 
less dangerous substances or technologies, where 
suitable economically and technically viable alternatives 
are available.EN 30.6.2009 Official Journal of the European Union L 170/3  
( 1 ) OJ L 396, 30.12.2006, p. 1.  ( 2 ) OJ L 338, 13.11.2004, p. 4.  
( 3 ) OJ L 37, 13.2.2003, p. 19.  
( 4 ) OJ L 37, 13.2.2003, p. 24.  
( 5 ) OJ L 114, 27.4.2006, p. 9.  
( 6 ) OJ L 365, 31.12.1994, p. 10.  
( 7 ) OJ L 266, 26.9.2006, p. 1.(27) In order to protect children from the risk of impairment 
of hearing caused by sound-emitting toys, more stringent 
and comprehensive standards to limit the maximum 
values for both impulse noise and continuous noise 
emitted by toys should be established. It is therefore 
necessary to lay down a new essential safety requirement 
concerning the sound from such toys.  
(28) In line with the precautionary principle, it is appropriate 
to lay down specific safety requirements to cover the 
potential specific hazard presented by toys in food, 
since the association of a toy and food could be the 
cause of a risk of choking that is distinct from the 
risks presented by the toy alone and which is, 
therefore, not covered by any specific measure at 
Community level.  
(29) Since it is possible that toys which present hazards which 
are not covered by a particular safety requirement laid 
down in this Directive might exist or be developed, it is 
necessary to set a general requirement of safety as the 
legal basis for taking action in respect of such toys. In 
this respect, the safety of toys should be determined by 
reference to the intended use, while taking into account 
the foreseeable use, and bearing in mind the behaviour of 
children, who do not generally show the same degree of 
care as the average adult user. Where a hazard cannot be 
sufficiently minimised by design or safeguards, the 
residual risk could be addressed by product-related infor ­
mation directed at the supervisors, taking into account 
their capacity to cope with the residual risk. According to 
acknowledged methods of risk assessment, it is not 
appropriate for information to supervisors or a lack of 
history of accidents to be used as a substitute for design 
improvements.  
(30) In order to further promote safe conditions of use of 
toys, it is necessary to supplement the provisions on 
warnings which should accompany the toy. In order to 
prevent the misuse of warnings to circumvent the 
applicable safety requirements, which has occurred in 
particular in case of the warning stating that the toy is 
not suitable for children under 36 months, it is necessary 
to provide explicitly that the warnings provided for 
certain categories of toy may not be used if they 
conflict with the intended use of the toy.  
(31) The CE marking, indicating the conformity of a toy, is 
the visible consequence of a whole process comprising 
conformity assessment in a broad sense. General prin ­
ciples governing the CE marking are set out in Regu ­
lation (EC) No 765/2008. Rules governing the affixing 
of the CE marking should be laid down in this Directive.  
(32) It is crucial to make clear to both manufacturers and 
users that by affixing the CE marking to the toy, the 
manufacturer declares that the toy is in conformity with all applicable requirements and that the manu ­
facturer takes full responsibility therefor.  
(33) The CE marking should be the only marking of 
conformity indicating that the toy is in conformity 
with Community harmonisation legislation. However, 
other markings may be used as long as they contribute 
to the improvement of consumer protection and are not 
covered by Community harmonisation legislation.  
(34) It is appropriate to lay down rules on the affixing of CE 
marking which ensure sufficient visibility of the marking 
in order to facilitate market surveillance of toys.  
(35) In order to ensure compliance with the essential safety 
requirements, it is necessary to lay down appropriate 
conformity assessment procedures to be followed by 
the manufacturer. To complete the legal obligations of 
the manufacturer which aim at ensuring the safety of 
toys, an explicit obligation to carry out an analysis of 
the various hazards that the toy may present and an 
assessment of the potential exposure to them, which 
for chemicals includes an assessment of the likelihood 
of the presence in the toy of prohibited or restricted 
substances, should be included in this Directive, and 
manufacturers should be obliged to keep this safety 
assessment in the technical documentation to allow 
market surveillance authorities to perform their tasks 
efficiently. Internal production control based on the 
manufacturer’s own responsibility for the conformity 
assessment has proven adequate in cases where it has 
followed the harmonised standards, the reference 
number of which has been published in the  Official 
Journal of the European Union , covering all the safety 
requirements for the toy. In cases where such 
harmonised standards do not exist, the toy should be 
submitted to third party verification, in this case EC- 
type examination. The same should apply if one or 
more such standards has been published with a 
restriction in the  Official Journal of the European Union , 
or if the manufacturer has not followed such standards 
completely, or only in part. The manufacturer should 
submit the toy to EC-type examination in cases where 
it considers that the nature, design, construction or 
purpose of the toy necessitates third party verification.  
(36) Since it is necessary to ensure a uniformly high level of 
performance of bodies performing conformity 
assessment of toys throughout the Community, and 
since all such bodies should perform their functions to 
the same level and under conditions of fair competition, 
obligatory requirements should be set for conformity 
assessment bodies wishing to be notified in order to 
provide conformity assessment services under this 
Directive.EN L 170/4 Official Journal of the European Union 30.6.2009(37) In order to ensure a consistent level of quality in the 
performance of conformity assessment of toys, it is 
necessary not only to consolidate the requirements that 
conformity assessment bodies wishing to be notified 
must fulfil, but also, in parallel, to set requirements 
that notifying authorities and other bodies involved in 
the assessment, notification and monitoring of notified 
bodies must fulfil.  
(38) Where the available scientific evidence is insufficient to 
allow an accurate risk assessment, Member States, when 
taking measures under this Directive, should apply the 
precautionary principle, which is a principle of 
Community law outlined,  inter alia , in the Communi ­
cation from the Commission of 2 February 2000, 
while taking due consideration of the other rules and 
principles contained in this Directive, such as the free 
movement of goods and the presumption of conformity.  
(39) Regulation (EC) No 765/2008 complements and 
strengthens the existing framework for the market 
surveillance of products covered by Community harmo ­
nisation legislation, including toys. Member States should 
therefore organise and carry out market surveillance of 
toys in accordance with that Regulation. In accordance 
with that Regulation, its application does not prevent the 
market surveillance authorities from taking more specific 
market surveillance measures as are available under 
Directive 2001/95/EC. Furthermore, specific measures 
concerning the possibility for a market surveillance 
authority to request information from a notified body 
and to give instructions to it should be included in this 
Directive in order to strengthen the possibilities for 
action by market surveillance authorities in the case of 
toys covered by an EC-type examination certificate.  
(40) Directive 88/378/EEC already provides for a safeguard 
procedure allowing the Commission to examine the justi ­
fication for a measure taken by a Member States against 
toys it considers to be non-compliant. In order to 
increase transparency and to reduce processing time, it 
is necessary to improve the existing safeguard procedure, 
with the aim of making it more efficient and of drawing 
on expertise available in the Member States.  
(41) The existing system should be complemented by a 
procedure allowing interested parties to be informed of 
measures taken with regard to toys presenting a risk to 
the health and safety of persons or other issues of public 
interest protection. It should also allow market 
surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect 
of such toys.  
(42) Where Member States and the Commission agree as to 
the justification for a measure taken by a Member State, 
no further involvement of the Commission should be 
required.  
(43) The measures necessary for the implementation of this 
Directive should be adopted in accordance with Council 
Decision 1999/468/EC of 28 June 1999 laying down the 
procedures for the exercise of implementing powers 
conferred on the Commission (  1 ). 
(44) In particular, the Commission should be empowered to 
adapt requirements concerning chemical properties in 
certain well-defined cases and to 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 toy. Since those 
measures are of general scope and are designed to 
amend non-essential elements of this Directive,  inter 
alia, by supplementing it with 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.  
(45) Council Directive 85/374/EEC of 25 July 1985 on the 
approximation of the laws, regulations and administrative 
provisions of the Member States concerning liability for 
defective products (  2 ) applies,  inter alia , to toys which are 
not in conformity with Community harmonisation legis ­
lation. Manufacturers and importers who have placed 
non-compliant toys on the Community market are 
liable for damages under that Directive.  
(46) Member States should provide for penalties applicable to 
infringements of this Directive. Those penalties should be 
effective, proportionate and dissuasive.  
(47) In order to allow toy manufacturers and other economic 
operators sufficient time to adapt to the requirements 
laid down by this Directive, it is necessary to provide 
for a transitional period of two years after the entry 
into force of this Directive during which toys which 
comply with Directive 88/378/EEC may be placed on 
the market. In the case of chemical requirements, this 
period should be set at four years so as to allow the 
development of the harmonised standards which are 
necessary for compliance with those requirements.EN 30.6.2009 Official Journal of the European Union L 170/5  
( 1 ) OJ L 184, 17.7.1999, p. 23.  
( 2 ) OJ L 210, 7.8.1985, p. 29.(48) Since the objective of this Directive, namely to ensure a 
high level of safety of toys with a view to ensuring the 
health and safety of children whilst guaranteeing the 
functioning of the internal market by setting harmonised 
safety requirements for toys and minimum requirements 
for market surveillance, cannot be sufficiently achieved 
by the Member States and can therefore, by reason of 
its 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 propor ­
tionality, as set out in that Article, this Directive does not 
go beyond what is necessary in order to achieve that 
objective,  
HAVE ADOPTED THIS DIRECTIVE:  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject-matter  
This Directive lays down rules on the safety of toys and on their 
free movement in the Community.  
Article 2  
Scope  
1. This Directive shall apply to products designed or 
intended, whether or not exclusively, for use in play by 
children under 14 years of age (hereinafter referred to as toys).  
The products listed in Annex I shall not be considered as 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, 
intended for public use;  
(c) toy vehicles equipped with combustion engines;  
(d) toy steam engines; and  
(e) slings and catapults.  
Article 3  
Definitions  
For the purposes of this Directive the following definitions shall 
apply:  
1. ‘making available on the market’ means any supply of a toy 
for distribution, consumption or use on the Community market in the course of a commercial activity, whether in 
return for payment or free of charge;  
2. ‘placing on the market’ means the first making available of 
a toy on the Community market;  
3. ‘manufacturer’ means any natural or legal person who 
manufactures a toy or has a toy designed or manufactured, 
and markets that toy under his name or trademark;  
4. ‘authorised representative’ means any natural or legal 
person established within the Community who has 
received a written mandate from a manufacturer to act 
on his behalf in relation to specified tasks;  
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. ‘distributor’ means any natural or legal person in the supply 
chain, other than the manufacturer or the importer, who 
makes a toy available on the market;  
7. ‘economic operators’ means the manufacturer, the 
authorised representative, the importer and the distributor;  
8. ‘harmonised standard’ means a standard adopted by one of 
the European standardisation bodies listed in Annex I to 
Directive 98/34/EC on the basis of a request made by the 
Commission in accordance with Article 6 of that Directive;  
9. ‘Community harmonisation legislation’ means any 
Community legislation harmonising the conditions for the 
marketing of products;  
10. ‘accreditation’ shall have the meaning assigned to it by 
Regulation (EC) No 765/2008;  
11. ‘conformity assessment’ means the process demonstrating 
whether specified requirements relating to a toy have been 
fulfilled;  
12. ‘conformity assessment body’ means a body that performs 
conformity assessment activities, including calibration, 
testing, certification and inspection;  
13. ‘recall’ means any measure aimed at achieving the return of 
a toy that has already been made available to the end user;  
14. ‘withdrawal’ means any measure aimed at preventing a toy 
in the supply chain from being made available on the 
market;  
15. ‘market surveillance’ means the activities carried out and 
measures taken by public authorities to ensure that toys 
comply with the applicable requirements set out in 
Community harmonisation legislation and do not 
endanger health, safety or any other aspect of public 
interest protection;EN L 170/6 Official Journal of the European Union 30.6.200916. ‘CE marking’ means a marking by which the manufacturer 
indicates that the toy is in conformity with the applicable 
requirements set out in Community harmonisation legis ­
lation providing for its affixing;  
17. ‘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 which may be a scale model 
of such product, appliance or installation;  
18. ‘functional toy’ means a toy which performs and is used in 
the same way as a product, appliance or installation 
intended for use by adults, and which may be a scale 
model of such product, appliance or installation;  
19. ‘aquatic toy’ means a toy intended for use in shallow water 
which is capable of carrying or supporting a child on the 
water;  
20. ‘design speed’ means representative potential operating 
speed that is determined by the design of the toy;  
21. ‘activity toy’ means a toy for domestic use in which the 
support structure remains stationary while the activity is 
taking place and which is intended for the performance 
by a child of any of the following activities: climbing, 
jumping, swinging, sliding, rocking, spinning, crawling 
and creeping, or any combination thereof;  
22. ‘chemical toy’ means a toy intended for the direct handling 
of chemical substances and mixtures and which is used in a 
manner appropriate to a given age-group and under the 
supervision of an adult;  
23. ‘olfactory board game’ means a toy the purpose of which is 
to assist a child to learn to recognise different odours or 
flavours;  
24. ‘cosmetic kit’ means a toy the purpose of which is to assist 
a child to learn to make products such as fragrances, soaps, 
creams, shampoos, bath foams, glosses, lipsticks, other 
make-up, tooth-paste and conditioners;  
25. ‘gustative game’ means a toy the purpose of which is to 
allow children to make sweets or dishes which involve the 
use of food ingredients such as sweets, liquids, powders and 
aromas;  
26. ‘harm’ means physical injury or any other damage to 
health, including long-term health effects;  
27. ‘hazard’ means a potential source of harm;  
28. ‘risk’ means the probable rate of occurrence of a hazard 
causing harm and the degree of severity of the harm;  
29. ‘intended for use by’ means that a parent or supervisor shall 
reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended 
for use by children of the stated age group.  
CHAPTER II  
OBLIGATIONS OF ECONOMIC OPERATORS  
Article 4  
Obligations of manufacturers  
1. When placing their toys on the market, manufacturers 
shall ensure that they have been designed and manufactured 
in accordance with the requirements set out in Article 10 and 
Annex II.  
2. Manufacturers shall draw up the required technical docu ­
mentation in accordance with Article 21 and carry out or have 
carried out the applicable conformity assessment procedure in 
accordance with Article 19.  
Where compliance of a toy with the applicable requirements 
has been demonstrated by that procedure, manufacturers shall 
draw up an EC declaration of conformity, as referred to in 
Article 15, and affix the CE marking, as set out in Article 17(1).  
3. Manufacturers shall keep the technical documentation and 
the EC declaration of conformity for a period of 10 years after 
the toy has been placed on the market.  
4. Manufacturers shall ensure that procedures are in place for 
series production to remain in conformity. Changes in toy 
design or characteristics and changes in the harmonised 
standards by reference to which conformity of a toy is 
declared shall be adequately taken into account.  
When deemed appropriate with regard to the risks presented by 
a toy, manufacturers shall, to protect the health and safety of 
consumers, carry out sample testing of marketed toys, inves ­
tigate, and, if necessary, keep a register of complaints, of non- 
conforming toys and toy recalls, and shall keep distributors 
informed of any such monitoring.  
5. Manufacturers shall ensure that their toys bear a type, 
batch, serial or model number or other element allowing their 
identification, or, where the size or nature of the toy does not 
allow it, that the required information is provided on the 
packaging or in a document accompanying the toy.  
6. Manufacturers shall indicate their name, registered trade 
name or registered trade mark and the address at which they 
can be contacted on the toy or, where that is not possible, on 
its packaging or in a document accompanying the toy. The 
address shall indicate a single point at which the manufacturer 
can be contacted.EN 30.6.2009 Official Journal of the European Union L 170/77. Manufacturers shall ensure that the toy is accompanied by 
instructions and safety information in a language or languages 
easily understood by consumers, as determined by the Member 
State concerned.  
8. Manufacturers who consider or have reason to believe that 
a toy which they have placed on the market is not in 
conformity with the relevant Community harmonisation legis ­
lation shall immediately take the corrective measures necessary 
to bring that toy into conformity, to withdraw it or recall it, if 
appropriate. Furthermore, where the toy presents a risk, manu ­
factures shall immediately inform the competent national 
authorities of the Member States in which they made the toy 
available to that effect, giving details, in particular, of the non- 
compliance and of any corrective measures taken.  
9. Manufacturers shall, further to a reasoned request from a 
competent national authority, provide that authority with all the 
information and documentation necessary to demonstrate the 
conformity of the toy, in a language easily understood by that 
authority. They shall cooperate with that authority, at its 
request, as regards any action taken to eliminate the risks 
posed by toys which they have placed on the market.  
Article 5  
Authorised representatives  
1. A manufacturer may, by a written mandate, appoint an 
authorised representative.  
2. The obligations laid down in Article 4(1) and the drawing 
up of technical documentation shall not form part of the 
authorised representative’s mandate.  
3. An authorised representative shall perform the tasks 
specified in the mandate received from the manufacturer. The 
mandate shall allow the authorised representative to do at least 
the following:  
(a) keep the EC declaration of conformity and the technical 
documentation at the disposal of national surveillance 
authorities for a period of 10 years after the toy has been 
placed on the market;  
(b) further to a reasoned request from a competent national 
authority, provide that authority with all the information 
and documentation necessary to demonstrate the 
conformity of a toy;  
(c) cooperate with the competent national authorities, at their 
request, on any action taken to eliminate the risks posed by 
toys covered by the mandate.  Article 6  
Obligations of importers  
1. Importers shall place only compliant toys on the 
Community market.  
2. Before placing a toy on the market, importers shall ensure 
that the appropriate conformity assessment procedure has been 
carried out by the manufacturer.  
They shall ensure that the manufacturer has drawn up the 
technical documentation, that the toy bears the required 
conformity marking and is accompanied by the required 
documents, and that the manufacturer has complied with the 
requirements set out in Article 4(5) and (6).  
Where an importer considers or has reason to believe that a toy 
is not in conformity with the requirements set out in Article 10 
and Annex II, it shall not place the toy on the market until the 
toy has been brought into conformity. Furthermore, where the 
toy presents a risk, the importer shall inform the manufacturer 
and the market surveillance authorities to that effect.  
3. Importers shall indicate their name, registered trade name 
or registered trade mark and the address at which they can be 
contacted on the toy or, where that is not possible, on its 
packaging or in a document accompanying the toy.  
4. Importers shall ensure that the toy is accompanied by 
instructions and safety information in a language or languages 
easily understood by consumers, as determined by the Member 
State concerned.  
5. Importers shall ensure that, while a toy is under their 
responsibility, storage or transport conditions do not jeopardise 
its compliance with the requirements set out in Article 10 and 
Annex II.  
6. When deemed appropriate with regard to the risks 
presented by a toy, importers shall, to protect the health and 
safety of consumers, carry out sample testing of marketed toys, 
investigate, and, if necessary, keep a register of complaints, of 
non-conforming toys and toy recalls, and shall keep distributors 
informed of such monitoring.  
7. Importers who consider or have reason to believe that a 
toy which they have placed on the market is not in conformity 
with the relevant Community harmonisation legislation shall 
immediately take the corrective measures necessary to bring 
that toy into conformity, to withdraw it or recall it, if appro ­
priate. Furthermore, where the toy presents a risk, importers 
shall immediately inform the competent national authorities 
of the Member States in which they made the toy available to 
that effect, giving details, in particular, of the non-compliance 
and of any corrective measures taken.EN L 170/8 Official Journal of the European Union 30.6.20098. Importers shall, for a period of 10 years after the toy has 
been placed on the market, keep a copy of the EC declaration of 
conformity at the disposal of the market surveillance authorities 
and ensure that the technical documentation can be made 
available to those authorities, upon request.  
9. Importers shall, further to a reasoned request from a 
competent national authority, provide that authority with all 
the information and documentation necessary to demonstrate 
the conformity of the toy in a language easily understood by 
that authority. They shall cooperate with that authority, at its 
request, on any action taken to eliminate the risks posed by 
toys which they have placed on the market.  
Article 7  
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, 
that it is accompanied by the required documents and by 
instructions and safety information in a language or languages 
easily understood by consumers in the Member State in which 
the toy is to be made available on the market, and that the 
manufacturer and the importer have complied with the 
requirements set out in Article 4(5) and (6) and Article 6(3).  
Where a distributor considers or has reason to believe that a toy 
is not in conformity with the requirements set out in Article 10 
and Annex II, it shall not make the toy available on the market 
until the toy has been brought into conformity. Furthermore, 
where the toy presents a risk, the distributor shall inform the 
manufacturer or the importer, as well as the market surveillance 
authorities, to that effect.  
3. Distributors shall ensure that, while a toy is under their 
responsibility, storage or transport conditions do not jeopardise 
its compliance with the requirements set out in Article 10 and 
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 relevant Community harmonisation legis ­
lation shall make sure that the corrective measures necessary to 
bring that toy into conformity, to withdraw it or recall it, if 
appropriate, are taken. Furthermore, where the toy presents a 
risk, distributors shall immediately inform the competent 
national authorities of the Member States in which they made 
the toy available to that effect, giving details, in particular, of 
the non-compliance and of any corrective measures taken.  
5. Distributors shall, further to a reasoned request from a 
competent national authority, provide that authority with all 
the information and documentation necessary to demonstrate the conformity of the toy. They shall cooperate with that 
authority, at its request, as regards any action taken to 
eliminate the risks posed by toys which they have made 
available on the market.  
Article 8  
Cases in which obligations of manufacturers apply to 
importers and distributors  
An importer or distributor shall be considered a manufacturer 
for the purposes of this Directive and be subject to the obli ­
gations of the manufacturer under Article 4 where it places a 
toy on the market under its name or trademark or modifies a 
toy already placed on the market in such a way that compliance 
with the applicable requirements may be affected.  
Article 9  
Identification of economic operators  
Economic operators shall, on request, identify the following to 
the market surveillance authorities:  
(a) any economic operator who has supplied them with a toy;  
(b) any economic operator to whom they have supplied a toy.  
Economic operators shall be able to present the information 
referred to in the first paragraph for a period of 10 years 
after the toy has been placed on the market, in the case of 
the manufacturer, and for a period of 10 years after they 
have been supplied with the toy, in the case of other 
economic operators.  
CHAPTER III  
CONFORMITY OF TOYS  
Article 10  
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 
with the essential safety requirements set out, as far as the 
general safety requirement is concerned, in paragraph 2, and, 
as far as the particular safety requirements are concerned, in 
Annex II.  
2. Toys, including the chemicals they contain, shall not 
jeopardise the safety or health of users or third parties when 
they are used as intended or in a foreseeable way, bearing in 
mind the behaviour of children.  
The ability of the users and, where appropriate, their supervisors 
shall be taken into account, in particular, in the case of toys 
which are intended for use by children under 36 months or by 
other specified age groups.EN 30.6.2009 Official Journal of the European Union L 170/9Labels affixed in accordance with Article 11(2) and instructions 
for use which accompany toys shall draw the attention of users 
or their supervisors to the inherent hazards and risks of harm 
involved in using the toys, and to the ways of avoiding such 
hazards and risks.  
3. Toys placed on the market shall comply with the essential 
safety requirements during their foreseeable and normal period 
of use.  
Article 11  
Warnings  
1. Where appropriate for safe use, warnings made for the 
purposes of Article 10(2) shall specify appropriate user 
limitations in accordance with Part A of Annex V.  
As regards the categories of toy listed in Part B of Annex V, the 
warnings set out therein shall be used. The warnings set out in 
points 2 to 10 of Part B of Annex V shall be used as worded 
therein.  
Toys shall not bear one or more of the specific warnings set out 
in Part B of Annex V where that warning conflicts with the 
intended use of the toy, as determined by virtue of its function, 
dimension and characteristics.  
2. The manufacturer shall mark the warnings in a clearly 
visible, easily legible and understandable and accurate manner 
on the toy, on an affixed label or on the packaging and, if 
appropriate, on the instructions for use which accompany the 
toy. Small toys which are sold without packaging shall have 
appropriate warnings affixed to them.  
The warnings shall be preceded by the words ‘Warning’ or 
‘Warnings’, as the case may be.  
Warnings which determine the decision to purchase the toy, 
such as those specifying the minimum and maximum ages 
for users and the other applicable warnings set out in Annex 
V, shall appear on the consumer packaging or be otherwise 
clearly visible to the consumer before the purchase, including 
in cases where the purchase is made on-line.  
3. In accordance with Article 4(7), a Member State may, 
within its territory, stipulate that those warnings and the 
safety instructions shall be written in a language or languages 
easily understood by consumers, as determined by that Member 
State.  
Article 12  
Free movement  
Members States shall not impede the making available on the 
market in their territory of toys which comply with this 
Directive.  Article 13  
Presumption of conformity  
Toys which are in conformity with harmonised standards or 
parts thereof, the references of which have been published in 
the Official Journal of the European Union , shall be presumed to 
be in conformity with the requirements covered by those 
standards or parts thereof set out in Article 10 and Annex II.  
Article 14  
Formal objection to a harmonised standard  
1. When a Member State or the Commission considers that a 
harmonised standard does not entirely satisfy the requirements 
which it covers and which are set out in Article 10 and 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, giving its arguments. The Committee 
shall, having consulted the relevant European standardisation 
bodies, deliver its opinion without delay.  
2. In the light of the Committee's opinion, the Commission 
shall decide to publish, not to publish, to publish with 
restriction, to maintain, to maintain with restriction or to 
withdraw the references to the harmonised standard 
concerned in or from the  Official Journal of the European Union . 
3. The Commission shall inform the European standardi ­
sation body concerned and, if necessary, request the revision 
of the harmonised standards concerned.  
Article 15  
EC declaration of conformity  
1. The EC declaration of conformity shall state that the 
fulfilment of the requirements set out in Article 10 and 
Annex II has been demonstrated.  
2. The EC declaration of conformity shall as a minimum 
contain the elements specified in Annex III to this Directive 
and the relevant modules set out in Annex II to Decision No 
768/2008/EC and shall be continuously updated. It shall have 
the model structure set out in Annex III to this Directive. It shall 
be translated into the language or languages required by the 
Member State in whose market the toy is placed or made 
available.  
3. By drawing up the EC declaration of conformity, the 
manufacturer shall assume responsibility for the compliance 
of the toy.  
Article 16  
General principles of the CE marking  
1. Toys made available on the market shall bear the CE 
marking.  
2. The CE marking shall be subject to the general principles 
set out in Article 30 of Regulation (EC) No 765/2008.EN L 170/10 Official Journal of the European Union 30.6.20093. Member States shall presume that toys bearing the CE 
marking comply with this Directive.  
4. Toys not bearing a CE marking or which do not otherwise 
comply with this Directive may be shown and used at trade 
fairs and exhibitions, provided that they are accompanied by a 
sign which clearly indicates that they do not comply with this 
Directive and that they will not be made available in the 
Community before being brought into conformity.  
Article 17  
Rules and conditions for affixing the CE marking  
1. The CE marking shall be affixed visibly, legibly and 
indelibly to the toy, to an affixed label or to the packaging. 
In the case of small toys and toys consisting of small parts, the 
CE marking may alternatively be affixed to a label or an accom ­
panying leaflet. Where, in the case of toys sold in counter 
displays, that is not technically possible, and on condition 
that the counter display was originally used as packaging for 
the toy, the CE marking may be affixed to the counter display.  
Where the CE marking is not visible from outside the 
packaging, if any, it shall as a minimum be affixed to the 
packaging.  
2. 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 18  
Safety assessments  
Manufacturers shall, before placing a toy on the market, carry 
out an analysis of the chemical, physical, mechanical, electrical, 
flammability, hygiene and radioactivity hazards that the toy may 
present, as well as an assessment of the potential exposure to 
such hazards.  
Article 19  
Applicable conformity assessment procedures  
1. Before placing a toy on the market, manufacturers shall 
use the conformity assessment procedures referred to in para ­
graphs 2 and 3 to demonstrate that the toy complies with the 
requirements set out in Article 10 and Annex II.  
2. If the manufacturer has applied harmonised standards, the 
reference number of which has been published in the  Official 
Journal of the European Union , covering all relevant safety 
requirements for the toy, it shall use the internal production 
control procedure set out in Module A of Annex II to Decision 
No 768/2008/EC.  3. In the following cases, the toy shall be submitted to EC- 
type examination, as referred to in Article 20, together with the 
conformity to type procedure set out in Module C of Annex II 
to Decision No 768/2008/EC:  
(a) where harmonised standards, the reference number of which 
has been published in the  Official Journal of the European 
Union , covering all relevant safety requirements for the 
toy, do not exist;  
(b) where the harmonised standards referred to in point (a) exist 
but the manufacturer has not applied them or has applied 
them only in part;  
(c) where one or more of the harmonised standards referred to 
in point (a) has been published with a restriction;  
(d) when the manufacturer considers that the nature, design, 
construction or purpose of the toy necessitate third party 
verification.  
Article 20  
EC-type examination  
1. An application for EC-type examination, performance of 
that examination and issue of the EC-type examination certifi ­
cate shall be carried out in accordance with the procedures set 
out in Module B of Annex II to Decision No 768/2008/EC.  
EC-type examination shall be carried out in the manner 
specified in the second indent of point 2 of that Module.  
In addition to those provisions, 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 
description of the toy and an indication of the place of manu ­
facture, including the address.  
3. When a conformity assessment body notified under 
Article 22 (hereinafter referred to as a ‘notified body’) carries 
out the EC-type examination, it shall evaluate, if necessary 
together with the manufacturer, the analysis of the hazards 
that the toy may present carried out by the manufacturer in 
accordance with Article 18.  
4. The EC-type examination certificate shall include a 
reference to this Directive, a colour image, a clear description 
of the toy, including its dimensions, and a list of the tests 
performed, together with a reference to the relevant test report.  
The EC-type examination certificate shall be reviewed whenever 
necessary, in particular in case of a change to the manufacturing 
process, the raw materials or the components of the toy, and, in 
any case, every five years.EN 30.6.2009 Official Journal of the European Union L 170/11The EC-type examination certificate shall be withdrawn if the 
toy fails to comply with the requirements set out in Article 10 
and Annex II.  
Member States shall ensure that their notified bodies do not 
grant an EC-type examination certificate for a toy in respect 
of which a certificate has been refused or withdrawn.  
5. The technical documentation and correspondence relating 
to the EC-type examination procedures shall be drawn up in an 
official language of the Member State in which the notified 
body is established or in a language acceptable to that body.  
Article 21  
Technical documentation  
1. The technical documentation referred to in Article 4(2) 
shall contain all relevant data or details of the means used by 
the manufacturer to ensure that toys comply with the 
requirements set out in Article 10 and Annex II. It shall, in 
particular, contain the documents listed in Annex IV.  
2. The technical documentation shall be drawn up in one of 
the official languages of the Community, subject to the 
requirement set out in Article 20(5).  
3. Following a reasoned request from the market surveillance 
authority of a Member State, the manufacturer shall provide a 
translation of the relevant parts of the technical documentation 
into the language of that Member State.  
When a market surveillance authority requests the technical 
documentation or a translation of parts thereof from a manu ­
facturer, it may fix a deadline for receipt of such file or trans ­
lation, which shall be 30 days, unless a shorter deadline is 
justified in the case of serious and immediate risk.  
4. If the manufacturer does not comply with the 
requirements of paragraphs 1, 2 and 3, the market surveillance 
authority may require it to have a test performed by a notified 
body at its own expense within a specified period in order to 
verify compliance with the harmonised standards and essential 
safety requirements.  
CHAPTER V  
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES  
Article 22  
Notification  
Member States shall notify the Commission and the other 
Member States of bodies authorised to carry out third-party 
conformity assessment tasks under Article 20.  Article 23  
Notifying authorities  
1. Member States shall designate a notifying authority that 
shall be responsible for setting up and carrying out the 
necessary procedures for the assessment and notification of 
conformity assessment bodies for the purposes of this 
Directive, and for the monitoring of notified bodies, including 
compliance with Article 29.  
2. Member States may decide that the assessment and moni ­
toring referred to in paragraph 1 shall be carried out by a 
national accreditation body within the meaning of and in 
accordance with Regulation (EC) No 765/2008.  
3. Where the notifying authority delegates or otherwise 
entrusts the assessment, notification or monitoring referred to 
in paragraph 1 to a body which is not a governmental entity, 
that body shall be a legal entity and shall comply mutatis 
mutandis with the requirements laid down in Article 24(1) to 
(5). In addition, that body shall have arrangements to cover 
liabilities arising out of its activities.  
4. The notifying authority shall take full responsibility for the 
tasks performed by the body referred to in paragraph 3.  
Article 24  
Requirements relating to notifying authorities  
1. Notifying authorities shall be established in such a way 
that no conflict of interest with a conformity assessment body 
occurs.  
2. Notifying authorities shall be organised and operated so as 
to safeguard the objectivity and impartiality of their activities.  
3. Notifying authorities shall be organised in such a way that 
each decision relating to notification of a conformity assessment 
body is taken by competent persons different from those who 
carried out the assessment.  
4. Notifying authorities shall not offer or provide any 
activities that conformity assessment bodies perform, nor shall 
they offer or provide consultancy services on a commercial or 
competitive basis.  
5. Notifying authorities shall safeguard the confidentiality of 
the information they obtain.  
6. Notifying authorities shall have a sufficient number of 
competent personnel at their disposal for the proper 
performance of their tasks.EN L 170/12 Official Journal of the European Union 30.6.2009Article 25  
Information obligation of notifying authorities  
Member States shall inform the Commission of their procedures 
for the assessment and notification of conformity assessment 
bodies and the monitoring of notified bodies, and of any 
changes thereto.  
The Commission shall make that information publicly available.  
Article 26  
Requirements relating to notified bodies  
1. For the purposes of notification under this Directive, a 
conformity assessment body shall meet the requirements laid 
down in paragraphs 2 to 11.  
2. Conformity assessment bodies shall be established under 
national law and shall have legal personality.  
3. A conformity assessment body shall be a third-party body 
independent of the organisation or the toy it assesses.  
A body belonging to a business association or professional 
federation representing undertakings involved in the design, 
manufacturing, provision, assembly, use or maintenance of 
toys which it assesses, may, on condition that its independence 
and the absence of any conflict of interest are demonstrated, be 
considered such a body.  
4. A conformity assessment body, its top level management 
and the personnel responsible for carrying out the conformity 
assessment tasks shall not be the designer, manufacturer, 
supplier, installer, purchaser, owner, user or maintainer of the 
toys which they assess, nor the authorised representative of any 
of those parties. This shall not preclude the use of assessed toys 
that are necessary for the operations of the conformity 
assessment body or the use of such toys for personal purposes.  
A conformity assessment body, its top level management and 
the personnel responsible for carrying out the conformity 
assessment tasks shall not be directly involved in the design 
or manufacture, the marketing, installation, use or maintenance 
of those toys, or represent the parties engaged in those 
activities. They shall not engage in any activity that may 
conflict with their independence of judgement or integrity in 
relation to conformity assessment activities for which they are 
notified. This shall in particular apply to consultancy services.  
Conformity assessment bodies shall ensure that the activities of 
their subsidiaries or subcontractors do not affect the confiden ­
tiality, objectivity or impartiality of their conformity assessment 
activities.  5. Conformity assessment bodies and their personnel shall 
carry out the conformity assessment activities with the highest 
degree of professional integrity and the requisite technical 
competence in the specific field and shall be free from all 
pressures and inducements, particularly financial, which might 
influence their judgement or the results of their conformity 
assessment activities, especially as regards persons or groups 
of persons with an interest in the results of those activities.  
6. Conformity assessment bodies shall be capable of carrying 
out the conformity assessment tasks assigned to them by the 
provisions of Article 20 and in relation to which they have been 
notified, whether those tasks are carried out by the conformity 
assessment body itself or on its behalf and under its responsi ­
bility.  
At all times and for each conformity assessment procedure and 
each kind or category of toy in relation to which it has been 
notified, a conformity assessment body shall have at its disposal 
the necessary:  
(a) personnel with technical knowledge and sufficient and 
appropriate experience to perform the conformity 
assessment tasks;  
(b) descriptions of procedures in accordance with which 
conformity assessment is carried out ensuring the trans ­
parency and ability of reproduction of those procedures. It 
shall have appropriate policies and procedures in place that 
distinguish between tasks it carries out as a notified body 
and other activities;  
(c) procedures for the performance of activities which take due 
account of the size of an undertaking, the sector in which it 
operates, its structure, the degree of complexity of the tech ­
nology of the toy in question and the mass or serial nature 
of the production process.  
A conformity assessment body shall have the means necessary 
to perform the technical and administrative tasks connected 
with the conformity assessment activities in an appropriate 
manner and shall have access to all necessary equipment or 
facilities.  
7. The personnel responsible for carrying out the conformity 
assessment activities shall have:  
(a) sound technical and vocational training covering all the 
conformity assessment activities in relation to which the 
conformity assessment body has been notified;  
(b) satisfactory knowledge of the requirements of the 
assessments they carry out and adequate authority to 
carry out those assessments;EN 30.6.2009 Official Journal of the European Union L 170/13(c) appropriate knowledge and understanding of the essential 
requirements, of the applicable harmonised standards and of 
the relevant Community harmonisation legislation and of its 
implementing regulations;  
(d) the ability to draw up certificates, records and reports 
demonstrating that assessments have been carried out.  
8. The impartiality of conformity assessment bodies, their 
top level management and assessment personnel shall be 
ensured.  
The remuneration of the top level management and assessment 
personnel of a conformity assessment body shall not depend on 
the number of assessments carried out or on the results of those 
assessments.  
9. Conformity assessment bodies shall take out liability 
insurance unless liability is assumed by the Member State in 
accordance with its national law, or the Member State itself is 
directly responsible for the conformity assessment.  
10. The personnel of a conformity assessment body shall 
observe professional secrecy with regard to all information 
obtained in carrying out their tasks under Article 20 or any 
provision of national law giving effect to that Article, except in 
relation to the competent authorities of the Member State in 
which its activities are carried out. Proprietary rights shall be 
protected.  
11. Conformity assessment bodies shall participate in, or 
ensure that their assessment personnel are informed of, the 
relevant standardisation activities and the activities of the 
notified body coordination group established under 
Article 38, and shall apply as general guidance the administra ­
tive decisions and documents produced as a result of the work 
of that group.  
Article 27  
Presumption of conformity  
Where a conformity assessment body demonstrates its 
conformity with the criteria laid down in the relevant 
harmonised standards or parts thereof, the references of 
which have been published in the  Official Journal of the 
European Union , it shall be presumed to comply with the 
requirements set out in Article 26 insofar as the applicable 
harmonised standards cover those requirements.  
Article 28  
Formal objection to a harmonised standard  
Where a Member State or the Commission has a formal 
objection to the harmonised standards referred to in 
Article 27, Article 14 shall apply.  Article 29  
Subsidiaries of and subcontracting by notified bodies  
1. Where a notified body subcontracts specific tasks 
connected with conformity assessment or has recourse to a 
subsidiary, it shall ensure that the subcontractor or the 
subsidiary meets the requirements set out in Article 26, and 
shall inform the notifying authority accordingly.  
2. Notified bodies shall take full responsibility for the tasks 
performed by subcontractors or subsidiaries, wherever these are 
established.  
3. Activities may be subcontracted or carried out by a 
subsidiary only with the agreement of the client.  
4. Notified bodies shall keep at the disposal of the notifying 
authority the relevant documents concerning the assessment of 
the qualifications of the subcontractor or the subsidiary and the 
work carried out by them under Article 20.  
Article 30  
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 referred to in paragraph 1 shall be accom ­
panied by a description of the conformity assessment activities, 
the conformity assessment module or modules and the toy or 
toys for which that body claims to be competent, as well as by 
an accreditation certificate, where one exists, issued by a 
national accreditation body attesting that the conformity 
assessment body fulfils the requirements laid down in 
Article 26.  
3. Where the conformity assessment body concerned cannot 
provide an accreditation certificate, it shall provide the notifying 
authority with the documentary evidence necessary for the veri ­
fication, recognition and regular monitoring of its compliance 
with the requirements laid down in Article 26.  
Article 31  
Notification procedure  
1. Notifying authorities may only notify conformity 
assessment bodies which have satisfied the requirements laid 
down in Article 26.  
2. Notifying authorities shall notify conformity assessment 
bodies to the Commission and the other Member States using 
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, toy or toys concerned and the relevant attestation of 
competence.EN L 170/14 Official Journal of the European Union 30.6.20094. Where a notification is not based on an accreditation 
certificate as referred to in Article 30(2), the notifying 
authority shall provide the Commission and the other 
Member States with documentary evidence which attests to 
the conformity assessment body’s competence and the 
arrangements in place to ensure that that body will be 
monitored regularly and will continue to satisfy the 
requirements laid down in Article 26.  
5. The body concerned may perform the activities of a 
notified body only where no objections are raised by the 
Commission or the other Member States within two weeks of 
a notification where an accreditation certificate is used or within 
two months of a notification where accreditation is not used.  
Only such a body shall be considered a notified body for the 
purposes of this Directive.  
6. The Commission and the other Member States shall be 
notified of any subsequent relevant changes to the notification.  
Article 32  
Identification numbers and lists of notified bodies  
1. The Commission shall assign an identification number to 
each notified body.  
It shall assign a single identification number even where the 
same body is notified under several Community acts.  
2. The Commission shall make publicly available a list of 
bodies notified under this Directive, including the identification 
numbers that have been allocated to them and the activities for 
which they have been notified.  
The Commission shall ensure that the list is kept up to date.  
Article 33  
Changes to notifications  
1. Where a notifying authority has ascertained or has been 
informed that a notified body no longer meets the requirements 
laid down in Article 26, or that it is failing to fulfil its obli ­
gations, the notifying authority shall restrict, suspend or 
withdraw notification as appropriate, depending on the 
seriousness of the failure to meet those requirements or fulfil 
those obligations. It shall immediately inform the Commission 
and the other Member States accordingly.  
2. In the event of restriction, suspension or withdrawal of 
notification, or where the notified body has ceased its activity, 
the notifying Member State shall take appropriate steps to 
ensure that the files of that body are either processed by 
another notified body or kept available to the responsible 
notifying and market surveillance authorities, at their request.  Article 34  
Challenge to the competence of notified bodies  
1. The Commission shall investigate all cases where it 
doubts, or doubt is brought to its attention regarding, the 
competence of a notified body or the continued fulfilment by 
a notified body of the requirements and responsibilities to 
which it is subject.  
2. The notifying Member State shall provide the 
Commission, on request, with all information relating to the 
basis for the notification or the maintenance of the competence 
of the body concerned.  
3. The Commission shall ensure that all sensitive information 
obtained in the course of its investigations is treated confiden ­
tially.  
4. Where the Commission ascertains that a notified body 
does not meet or no longer meets the requirements for notifi ­
cation, it shall inform the notifying Member State accordingly 
and request it to take the necessary corrective measures, 
including de-notification if necessary.  
Article 35  
Operational obligations of notified bodies  
1. Notified bodies shall carry out conformity assessments in 
accordance with the conformity assessment procedure provided 
for in Article 20.  
2. Conformity assessments shall be carried out in a propor ­
tionate manner, avoiding unnecessary burdens for economic 
operators. Conformity assessment bodies shall perform their 
activities taking due account of the size of an undertaking, 
the sector in which it operates, its structure, the degree of 
complexity of the technology of the toy in question and the 
mass or serial nature of the production process.  
In so doing, they shall nevertheless respect the degree of rigour 
and the level of protection required for the compliance of the 
toy with this Directive.  
3. Where a notified body finds that the requirements set out 
in Article 10 and Annex II or in corresponding harmonised 
standards have not been met by a manufacturer, it shall 
require that manufacturer to take appropriate corrective 
measures and shall not issue the EC-type examination certificate 
as referred to in Article 20(4).  
4. Where, in the course of the monitoring of conformity 
following the issue of a EC-type examination certificate, a 
notified body finds that a toy is no longer in compliance, it 
shall require the manufacturer to take appropriate corrective 
measures, and shall suspend or withdraw the EC-type examina ­
tion certificate if necessary.EN 30.6.2009 Official Journal of the European Union L 170/155. Where corrective measures are not taken or do not have 
the required effect, the notified body shall restrict, suspend or 
withdraw any EC-type examination certificates, as appropriate.  
Article 36  
Information obligation of notified bodies  
1. Notified bodies shall inform the notifying authority of the 
following:  
(a) any refusal, restriction, suspension or withdrawal of an EC- 
type examination certificate;  
(b) any circumstances affecting the scope of and conditions for 
notification;  
(c) any request for information which they have received from 
market surveillance authorities regarding conformity 
assessment activities;  
(d) on request, conformity assessment activities performed 
within the scope of their notification, and any other 
activity performed, including cross-border activities and 
subcontracting.  
2. Notified bodies shall provide the other bodies notified 
under this Directive which carry out similar conformity 
assessment activities covering the same toys with relevant infor ­
mation on issues relating to negative and, on request, positive 
conformity assessment results.  
Article 37  
Exchange of experience  
The Commission shall provide for the organisation of exchange 
of experience between the Member States' national authorities 
responsible for notification policy.  
Article 38  
Coordination of notified bodies  
The Commission shall ensure that appropriate coordination and 
cooperation between bodies notified under this Directive are put 
in place and properly operated in the form of a sectoral group 
or groups of notified bodies.  
Member States shall ensure that the bodies notified by them 
participate in the work of that group or groups, directly or by 
means of designated representatives.  CHAPTER VI  
OBLIGATIONS AND POWERS OF MEMBER STATES  
Article 39  
Precautionary principle  
When competent authorities of the Member States take 
measures as provided for in this Directive, and in particular 
those referred to in Article 40, they shall take due account of 
the precautionary principle.  
Article 40  
General obligation to organise market surveillance  
Member States shall organise and perform surveillance of toys 
placed on the market in accordance with Articles 15 to 29 of 
Regulation (EC) No 765/2008. In addition to those Articles, 
Article 41 of this Directive shall apply.  
Article 41  
Instructions to the notified body  
1. Market surveillance authorities may request a notified 
body to provide information relating to any EC-type examina ­
tion certificate which that body has issued or withdrawn, or 
which relates to any refusal to issue such a certificate, 
including the test reports and technical documentation.  
2. If a market surveillance authority finds that a toy is not in 
conformity with the requirements set out in Article 10 and 
Annex II, it shall, where appropriate, instruct the notified 
body to withdraw the EC-type examination certificate in 
respect of that toy.  
3. Where necessary, and in particular in the cases specified in 
the second subparagraph of Article 20(4), the market 
surveillance authority shall instruct the notified body to 
review the EC-type examination certificate.  
Article 42  
Procedure for dealing with toys presenting a risk at 
national level  
1. Where the market surveillance authorities of one Member 
State have taken action pursuant to Article 20 of Regulation 
(EC) No 765/2008, or where they have sufficient reason to 
believe that a toy covered by this Directive presents a risk to 
the health or safety of persons, they shall carry out an 
evaluation in relation to the toy concerned covering all the 
requirements laid down in this Directive. The relevant 
economic operators shall cooperate as necessary with the 
market surveillance authorities.EN L 170/16 Official Journal of the European Union 30.6.2009Where, in the course of that evaluation, the market surveillance 
authorities find that the toy does not comply with the 
requirements laid down in this Directive, they shall without 
delay require the relevant economic operator to take appro ­
priate corrective action to bring the toy into compliance with 
those requirements, to withdraw the toy from the market, or to 
recall it within a reasonable period, commensurate with the 
nature of the risk, as they may prescribe.  
The market surveillance authorities shall inform the relevant 
notified body accordingly.  
Article 21 of Regulation (EC) No 765/2008 shall apply to the 
measures referred in the second subparagraph of this paragraph.  
2. Where the market surveillance authorities consider that 
non-compliance is not restricted to their national territory, 
they shall inform the Commission and the other Member 
States of the results of the evaluation and of the actions 
which they have required the relevant economic operator to 
take.  
3. The relevant economic operator shall ensure that appro ­
priate corrective action is taken in respect of toys which that 
operator has made available on the Community market.  
4. Where the relevant economic operator does not take 
adequate corrective action within the period referred to in the 
second subparagraph of paragraph 1, the market surveillance 
authorities shall take appropriate provisional measures to 
prohibit or restrict the toy being made available on their 
national market, to withdraw the toy from that market or to 
recall it.  
They shall inform the Commission and the other Member 
States, without delay, of those measures.  
5. The information referred to in paragraph 4 shall include 
all available details, in particular the data necessary for the 
identification of the non-compliant toy, the origin of the toy, 
the nature of the alleged non-compliance and the risk involved, 
the nature and duration of the national measures taken and the 
arguments put forward by the relevant economic operator. In 
particular, the market surveillance authorities shall indicate 
whether the non-compliance is due to either:  
(a) failure of the toy to meet requirements relating to the health 
or safety of persons; or  
(b) shortcomings in the harmonised standards referred to in 
Article 13 conferring a presumption of conformity.  
6. Member States other than the Member State initiating the 
procedure shall without delay inform the Commission and the 
other Member States of any measures adopted and of any ad ­
ditional information at their disposal relating to the non- 
compliance of the toy concerned, 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 provi ­
sional measure taken by a Member State, that measure shall be 
deemed to be justified.  
8. Member States shall ensure that appropriate restrictive 
measures are taken in respect of the toy concerned, such as 
withdrawal of the toy from their market, without delay.  
Article 43  
Community safeguard procedure  
1. Where, on completion of the procedure set out in 
Article 42(3) and (4), objections are raised against a measure 
taken by a Member State, or where the Commission considers a 
national measure to be contrary to Community legislation, the 
Commission shall without delay enter into consultation with 
the Member States and the relevant economic operator or 
operators and shall evaluate the national measure.  
On the basis of the results of that evaluation, the Commission 
shall decide whether the national measure is justified or not.  
The Commission shall address its decision to all Member States 
and shall immediately communicate it to them and the relevant 
economic operator or operators.  
2. If the national measure is considered justified, all Member 
States shall take the measures necessary to ensure that the non- 
compliant toy is withdrawn from their market, and shall inform 
the Commission accordingly.  
If the national measure is considered unjustified, the Member 
State concerned shall withdraw it.  
3. Where the national measure is considered to be justified 
and the non-compliance of the toy is attributed to shortcomings 
in the harmonised standards referred to in Article 42(5)(b), the 
Commission shall inform the relevant European standardisation 
body or bodies and shall bring the matter before the Committee 
set up by Article 5 of Directive 98/34/EC. That Committee shall 
consult the relevant European standardisation body or bodies 
and deliver its opinion without delay.  
Article 44  
Exchange of information — Community Rapid Information 
Exchange System  
If a measure referred to in Article 42(4) is a type of measure 
which is required under Article 22 of Regulation (EC) No 
765/2008 to be notified through the Community Rapid Infor ­
mation Exchange System, it shall not be necessary to make a 
separate notification under Article 42(4) of this Directive, 
provided that the following conditions are met:EN 30.6.2009 Official Journal of the European Union L 170/17(a) the Community Rapid Information Exchange notification 
indicates that the notification of the measure is also 
required by this Directive;  
(b) the supporting evidence referred to in Article 42(5) is 
enclosed with the Community Rapid Information 
Exchange notification.  
Article 45  
Formal non-compliance  
1. Without prejudice to Article 42, where a Member State 
makes one of the following findings, it shall require the relevant 
economic operator to put an end to the non-compliance 
concerned:  
(a) that the CE marking has been affixed in violation of 
Article 16 or 17;  
(b) that the CE marking has not been affixed;  
(c) that the EC declaration of conformity has not been drawn 
up; 
(d) that the EC declaration of conformity has not been drawn 
up correctly;  
(e) that technical documentation is either not available or not 
complete.  
2. Where the non-compliance referred to in paragraph 1 
persists, the Member State concerned shall take appropriate 
measures to restrict or prohibit the toy being made available 
on the market, or shall ensure that it is recalled or withdrawn 
from the market.  
CHAPTER VII  
COMMITTEE PROCEDURES  
Article 46  
Amendments and implementing measures  
1. The Commission may, for the purposes of adapting them 
to technical and scientific developments, amend the following:  
(a) Annex I;  
(b) points 11 and 13 of Part III of Annex II;  
(c) Annex V.  
Those measures, designed to amend non-essential elements of 
this Directive, shall be adopted in accordance with the regu ­
latory procedure with scrutiny referred to in Article 47(2).  
2. The Commission may adopt specific limit values for 
chemicals used in toys intended for use by children under 36 
months or in other toys intended to be placed in the mouth, 
taking into account the packaging requirements for food as laid down in Regulation (EC) No 1935/2004 and the related specific 
measures for particular materials, as well as the differences 
between toys and materials which come into contact with 
food. The Commission shall amend Appendix C to Annex II 
to this Directive accordingly. Those measures, designed to 
amend non-essential elements of this Directive by supple ­
menting it, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 47(2) of this 
Directive.  
3. The Commission may decide upon the use in toys of 
substances or mixtures that are classified as carcinogenic, 
mutagenic or toxic for reproduction of the categories laid 
down in Section 5 of Appendix B to Annex II and have been 
evaluated by the relevant Scientific Committee, and may amend 
Appendix A to Annex II accordingly. Those measures, designed 
to amend non-essential elements of this Directive by supple ­
menting it, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 47(2).  
Article 47  
Committee procedure  
1. The Commission shall be assisted by a committee.  
2. Where reference is made to this paragraph, Article 5a(1) 
to (4) and Article 7 of Decision 1999/468/EC shall apply, 
having regard to the provisions of Article 8 thereof.  
CHAPTER VIII  
SPECIFIC ADMINISTRATIVE PROVISIONS  
Article 48  
Reporting  
By 20 July 2014 and every five years thereafter, Member States 
shall send the Commission a report on the application of this 
Directive.  
That report shall contain an evaluation of the situation 
concerning the safety of toys and of the effectiveness of this 
Directive, as well as a presentation of the market surveillance 
activities performed by that Member State.  
The Commission shall draw up and publish a summary of the 
national reports.  
Article 49  
Transparency and confidentiality  
When the competent 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.EN L 170/18 Official Journal of the European Union 30.6.2009Article 50  
Motivation of measures  
Any measure taken pursuant to this Directive to prohibit or 
restrict the placing on the market of a toy, to withdraw a toy 
or to recall a toy from the market shall state the exact grounds 
on which it is based.  
Such a measure shall be notified without delay to the party 
concerned, which shall at the same time be informed of the 
remedies available to it under the laws in force in the Member 
State in question and of the time limits applicable to them.  
Article 51  
Penalties  
Member States shall lay down rules on penalties for economic 
operators, which may include criminal sanctions for serious 
infringements, applicable to infringements of 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 and may be increased if the relevant economic 
operator has previously committed a similar infringement of 
this Directive.  
The Member States shall notify the Commission of those rules 
by 20 July 2011, and shall notify it without delay of any 
subsequent amendment to them.  
CHAPTER IX  
FINAL AND TRANSITIONAL PROVISIONS  
Article 52  
Application of Directives 85/374/EEC and 2001/95/EC  
1. This Directive is without prejudice to Directive 
85/374/EEC.  
2. Directive 2001/95/EC shall apply to toys in accordance 
with Article 1(2) thereof.  
Article 53  
Transitional periods  
1. Member States shall not impede the making available on 
the market of toys which are in accordance with Directive 
88/378/EEC and which were placed on the market before 
20 July 2011.  
2. In addition to the requirement of paragraph 1, Member 
States shall not impede the making available on the market of 
toys which are in accordance with the requirements of this 
Directive, except those set out in Part III of Annex II, 
provided that such toys meet the requirements set out in Part 3 of Annex II to Directive 88/378/EEC and were placed on the 
market before 20 July 2013.  
Article 54  
Transposition  
Member States shall bring into force the laws, regulations and 
administrative provisions necessary to comply with this 
Directive by 20 January 2011. They shall forthwith inform 
the Commission thereof.  
They shall apply those measures with effect from 20 July 2011.  
When Member States adopt those measures, they shall contain a 
reference to this Directive or shall be accompanied by such a 
reference on the occasion of their official publication. The 
methods of making such reference shall be laid down by 
Member States.  
Member States shall communicate to the Commission the 
provisions of national law which they adopt in the field 
covered by this Directive.  
Article 55  
Repeal  
Directive 88/378/EEC, except Article 2(1) and Part 3 of Annex 
II, is repealed with effect from 20 July 2011. Article 2(1) thereof 
and Part 3 of Annex II thereto are repealed with effect from 
20 July 2013.  
References to the repealed Directive shall be construed as 
references to this Directive.  
Article 56  
Entry into force  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
Article 57  
Addressees  
This Directive is addressed to the Member States.  
Done at Brussels, 18 June 2009.  
For the European Parliament 
The President  
H.-G. PÖTTERING  For the Council 
The President  
Š. FÜLEEN 30.6.2009 Official Journal of the European Union L 170/19ANNEX I  
List of products that, in particular, are not considered as toys within the meaning of this Directive  
(as referred to in Article 2(1))  
1. Decorative objects for festivities and celebrations  
2. Products for collectors, provided that the product or its packaging bears a visible and legible indication that it is 
intended for collectors of 14 years of age and above. Examples of this category are:  
(a) 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; and  
(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 with a maximum saddle height of more than 435 mm, measured as the vertical distance from the ground to 
the top of the seat surface, with the seat in a horizontal position and with the seat pillar set to the minimum 
insertion mark  
5. Scooters and other means of transport designed for sport or which are intended to be used for travel on public roads 
or public pathways  
6. Electrically driven vehicles which are intended to be used for travel on public roads, public pathways, or the 
pavement thereof  
7. Aquatic equipment intended to be used in deep water, and swimming learning devices for children, such as swim 
seats and swimming aids  
8. Puzzles with more than 500 pieces  
9. Guns and pistols using compressed gas, with the exception of water guns and water pistols, and bows for archery 
over 120 cm long  
10. Fireworks, including percussion caps which are not specifically designed for toys  
11. Products and games using sharp-pointed missiles, such as sets of darts with metallic points  
12. Functional educational products, such as electric ovens, irons or other functional products operated at a nominal 
voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision  
13. Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance 
of an adult instructor, such as science equipment  
14. Electronic equipment, such as personal computers and game consoles, used to access interactive software and their 
associated peripherals, unless the electronic equipment or the associated peripherals are specifically designed for and 
targeted at children and have a play value on their own, such as specially designed personal computers, key boards, 
joy sticks or steering wheels  
15. Interactive software, intended for leisure and entertainment, such as computer games, and their storage media, such 
as CDs  
16. Babies’ soothers  
17. Child-appealing luminaires  
18. Electrical transformers for toys  
19. Fashion accessories for children which are not for use in playEN L 170/20 Official Journal of the European Union 30.6.2009ANNEX II  
PARTICULAR SAFETY REQUIREMENTS  
I. Physical and Mechanical Properties  
1. Toys and their parts and, in the case of fixed toys, their anchorages, must have the requisite mechanical strength 
and, where appropriate, stability to withstand the stresses to which they are subjected during use without 
breaking or becoming liable to distortion at the risk of causing physical injury.  
2. Accessible edges, protrusions, cords, cables and fastenings on toys must be designed and manufactured in such a 
way that the risks of physical injury from contact with them are reduced as far as possible.  
3. Toys must be designed and manufactured in such a way as not to present any risk or only the minimum risk 
inherent to their use which could be caused by the movement of their parts.  
4. (a) Toys and their parts must not present a risk of strangulation.  
(b) Toys and their parts must not present a risk of asphyxiation by closing off the flow of air as a result of 
airway obstruction external to the mouth and nose.  
(c) Toys and their parts must be of such dimensions as to not present a risk of asphyxiation by closing off the 
flow of air as a result of internal airway obstruction by objects wedged in the mouth or pharynx or lodged 
over the entrance to the lower airways.  
(d) Toys, which are clearly intended for use by children under 36 months, and their component parts and any of 
their detachable parts must be of such dimensions as to prevent their being swallowed or inhaled. This also 
applies to other toys which are intended to be put in the mouth, and to their component parts and any of 
their detachable parts.  
(e) The packaging in which toys are contained for retail sale must not present a risk of strangulation or 
asphyxiation caused by airway obstruction external to the mouth and nose.  
(f) Toys contained within food or co-mingled with food must have their own packaging. This packaging, as it is 
supplied, must be of such dimensions as to prevent its being swallowed and/or inhaled.  
(g) Toy packaging, as referred to in points (e) and (f), which is spherical, egg-shaped or ellipsoidal, and any 
detachable parts of this or of cylindrical toy packaging with rounded ends, must be of such dimensions as to 
prevent it from causing airway obstruction by being wedged in the mouth or pharynx or lodged over the 
entrance to the lower airways.  
(h) Toys firmly attached to a food product at the moment of consumption, in such a way that the food product 
needs to be consumed in order to get direct access to the toy, shall be prohibited. Parts of toys otherwise 
directly attached to a food product shall fulfil the requirements set out in points (c) and (d).  
5. Aquatic toys must be designed and manufactured so as to reduce as far as possible, taking into account the 
recommended use of the toy, any risk of loss of buoyancy of the toy and loss of support afforded to the child.  
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 generated by it. Such a system must be easy for the 
user to operate without risk of ejection or physical injury for the user or for third parties.  
The maximum design speed of electrically driven ride-on toys must be limited so as to minimise the risk of 
injury.EN 30.6.2009 Official Journal of the European Union L 170/218. The form and composition of projectiles and the kinetic energy they may generate 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 manufactured so as to ensure that:  
(a) the maximum and minimum temperature of any accessible surfaces does not cause injury when touched; and  
(b) liquids and gases contained within the toy do not reach temperatures or pressures which are such that their 
escape from the 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 shall be designed and manufactured in such a way in terms of the 
maximum values for impulse noise and continuous noise that the sound from them is not able to impair 
children’s hearing.  
11. Activity toys shall be manufactured so as to reduce the risk of crushing or trapping of body parts or trapping of 
clothing and of falls, impacts and drowning as far as possible. In particular, any surface of such a toy accessible 
for one or more children to play on shall be designed to bear their load.  
II. Flammability  
1. Toys must not constitute a dangerous flammable element in the child’s environment. They must therefore be 
composed of materials which fulfil one or more of the following conditions:  
(a) they do not burn if directly exposed to a flame or spark or other potential source 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 chemical composition, they are designed so as to mechanically delay the combustion 
process.  
Such combustible materials must not constitute a risk of ignition for other materials used in the toy.  
2. Toys which, for reasons essential to their functioning, contain substances or mixtures that meet the classification 
criteria laid down in Section 1 of Appendix B, in particular materials and equipment for chemistry experiments, 
model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, must not contain, as 
such, substances or mixtures 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 10(2).  
4. Toys and, in particular, chemical games and toys, must not contain as such substances or mixtures:  
(a) which, when mixed together, may explode through chemical reaction or through heating;  
(b) which may explode when mixed with oxidizing substances; or  
(c) which contain volatile components which are flammable in air and liable to form a flammable or explosive 
vapour/air mixture.EN L 170/22 Official Journal of the European Union 30.6.2009III. Chemical Properties  
1. Toys shall be designed and manufactured in such a way that there are no risks of adverse effects on human 
health due to exposure to the chemical substances or mixtures of which the toys are composed or which they 
contain when the toys are used as specified in the first subparagraph of Article 10(2).  
Toys shall comply with the relevant Community legislation relating to certain categories of products or to 
restrictions for certain substances and mixtures.  
2. Toys that are themselves substances or mixtures must comply also with Council Directive 67/548/EEC of 27 June 
1967 on the approximation of laws, regulations and administrative provisions relating to the classification, 
packaging and labelling of dangerous substances (  1 ), Directive 1999/45/EC of the European Parliament and of 
the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions 
of the Member States relating to the classification, packaging and labelling of dangerous preparations (  2 ) and 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures (  3 ), as applicable, relating to the classification, 
packaging and labelling of certain substances and mixtures.  
3. Without prejudice to the restrictions referred to in the second paragraph of point 1, substances that are classified 
as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A, 1B or 2 under Regulation (EC) No 
1272/2008 shall not be used in toys, in components of toys or in micro-structurally distinct parts of toys.  
4. By way of derogation from point 3, substances or mixtures classified as CMR of the categories laid down in 
Section 3 of Appendix B may be used in toys, in components of toys or micro-structurally distinct parts of toys 
provided that one or more of the following conditions is met:  
(a) these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant 
concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the 
classification of mixtures containing these substances;  
(b) these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is 
used as specified in the first subparagraph of Article 10(2);  
(c) a decision in accordance with Article 46(3) has been taken to permit the substance or mixture and its use, 
and the substance or mixture and its permitted uses have been listed in Appendix A.  
That decision may be taken if the following conditions are met:  
(i) the use of the substance or mixture has been evaluated by the relevant Scientific Committee and found to 
be safe, in particular in view of exposure;  
(ii) there are no suitable alternative substances or mixtures available, as documented in an analysis of 
alternatives; and  
(iii) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 
1907/2006.  
The Commission shall mandate the relevant Scientific Committee to re-evaluate those substances or mixtures as 
soon as safety concerns arise and at the latest every five years from the date that a decision in accordance with 
Article 46(3) was taken.  
5. By way of derogation from point 3, substances or mixtures classified as CMR of the categories laid down in 
Section 4 of Appendix B may be used in toys, in components of toys or micro-structurally distinct parts of toys 
provided that one of the following conditions is met:  
(a) these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant 
concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the 
classification of mixtures containing these substances;  
(b) these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is 
used as specified in the first subparagraph of Article 10(2); orEN 30.6.2009 Official Journal of the European Union L 170/23  
( 1 ) OJ 196, 16.8.1967, p. 1.  
( 2 ) OJ L 200, 30.7.1999, p. 1.  
( 3 ) OJ L 353, 31.12.2008, p. 1.(c) a decision in accordance with Article 46(3) has been taken to permit the substance or mixture and its use, 
and the substance or mixture and its permitted uses have been listed in Appendix A.  
That decision may be taken if the following conditions are met:  
(i) the use of the substance or mixture has been evaluated by the relevant Scientific Committee and found to 
be safe, in particular in view of exposure; and  
(ii) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 
1907/2006.  
The Commission shall mandate the relevant Scientific Committee to re-evaluate those substances or mixtures as 
soon as safety concerns arise and at the latest every five years from the date that a decision in accordance with 
Article 46(3) was taken.  
6. Points 3, 4 and 5 shall not apply to nickel in stainless steel.  
7. Points 3, 4 and 5 shall not apply to materials that comply with the specific limit values set out in Appendix C, 
or, until such provisions have been laid down, but not later than 20 July 2017, to materials covered by and 
complying with the provisions for food contact materials set out in Regulation (EC) No 1935/2004 and the 
related specific measures for particular materials.  
8. Without prejudice to the application of points 3 and 4, nitrosamines and nitrosable substances shall be 
prohibited for use in toys intended for use by children under 36 months or in other toys intended to be 
placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines 
and 1 mg/kg for nitrosable substances.  
9. The Commission shall systematically and regularly evaluate the occurrence of hazardous substances of materials 
in toys. These evaluations shall take into account reports of market surveillance bodies and concerns expressed by 
Member States and stakeholders.  
10. Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional and labelling requirements 
laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member 
States relating to cosmetic products (  1 ). 
11. Toys shall not contain the following allergenic fragrances:  
No Name of the allergenic fragrance  CAS number  
(1) Alanroot oil (Inula helenium)  97676-35-2  
(2) Allylisothiocyanate  57-06-7  
(3) Benzyl cyanide  140-29-4  
(4) 4 tert-Butylphenol  98-54-4  
(5) Chenopodium oil  8006-99-3  
(6) Cyclamen alcohol  4756-19-8  
(7) Diethyl maleate  141-05-9  
(8) Dihydrocoumarin  119-84-6  
(9) 2,4-Dihydroxy-3-methylbenzaldehyde  6248-20-0EN L 170/24 Official Journal of the European Union 30.6.2009  
( 1 ) OJ L 262, 27.9.1976, p. 169.No Name of the allergenic fragrance  CAS number  
(10)  3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)  40607-48-5  
(11)  4,6-Dimethyl-8-tert-butylcoumarin  17874-34-9  
(12)  Dimethyl citraconate  617-54-9  
(13)  7,11-Dimethyl-4.6,10-dodecatrien-3-one  26651-96-7  
(14)  6,10-Dimethyl-3.5,9-undecatrien-2-one  141-10-6  
(15)  Diphenylamine  122-39-4  
(16)  Ethyl acrylate  140-88-5  
(17)  Fig leaf, fresh and preparations  68916-52-9  
(18)  trans-2-Heptenal  18829-55-5  
(19)  trans-2-Hexenal diethyl acetal  67746-30-9  
(20)  trans-2-Hexenal dimethyl acetal  18318-83-7  
(21)  Hydroabietyl alcohol  13393-93-6  
(22)  4-Ethoxy-phenol  622-62-8  
(23)  6-lsopropyl-2-decahydronaphthalenol  34131-99-2  
(24)  7-Methoxycoumarin  531-59-9  
(25)  4-Methoxyphenol  150-76-5  
(26)  4-(p-Methoxyphenyl)-3-butene-2-one  943-88-4  
(27)  1-(p-Methoxyphenyl)-1-penten-3-one  104-27-8  
(28)  Methyl trans-2-butenoate  623-43-8  
(29)  6-Methylcoumarin  92-48-8  
(30)  7-Methylcoumarin  2445-83-2  
(31)  5-Methyl-2,3-hexanedione  13706-86-0  
(32)  Costus root oil (Saussurea lappa Clarke)  8023-88-9  
(33)  7-Ethoxy-4-methylcoumarin  87-05-8  
(34)  Hexahydrocoumarin  700-82-3  
(35)  Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) 
Klotzsch)  8007-00-9  
(36)  2-Pentylidene-cyclohexanone  25677-40-1  
(37)  3.6,10-Trimethyl-3.5,9-undecatrien-2-one  1117-41-5  
(38)  Verbena oil (Lippia citriodora Kunth)  8024-12-2  
(39)  Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene)  83-66-9  
(40)  4-Phenyl-3-buten-2-one  122-57-6EN 30.6.2009 Official Journal of the European Union L 170/25No Name of the allergenic fragrance  CAS number  
(41)  Amyl cinnamal  122-40-7  
(42)  Amylcinnamyl alcohol  101-85-9  
(43)  Benzyl alcohol  100-51-6  
(44)  Benzyl salicylate  118-58-1  
(45)  Cinnamyl alcohol  104-54-1  
(46)  Cinnamal  104-55-2  
(47)  Citral  5392-40-5  
(48)  Coumarin  91-64-5  
(49)  Eugenol  97-53-0  
(50)  Geraniol  106-24-1  
(51)  Hydroxy-citronellal  107-75-5  
(52)  Hydroxy-methylpentylcyclohexenecarboxaldehyde  31906-04-4  
(53)  Isoeugenol  97-54-1  
(54)  Oakmoss extracts  90028-68-5  
(55)  Treemoss extracts  90028-67-4  
However, the presence of traces of these fragrances shall be allowed provided that such presence is technically 
unavoidable under good manufacturing practice and does not exceed 100 mg/kg.  
In addition, the names of the following allergenic fragrances shall be listed on the toy, on an affixed label, on the 
packaging or in an accompanying leaflet, if added to a toy, as such, at concentrations exceeding 100 mg/kg in 
the toy or components thereof:  
No Name of the allergenic fragrance  CAS number  
(1) Anisyl alcohol  105-13-5  
(2) Benzyl benzoate  120-51-4  
(3) Benzyl cinnamate  103-41-3  
(4) Citronellol  106-22-9  
(5) Farnesol  4602-84-0  
(6) Hexyl cinnamaldehyde  101-86-0  
(7) Lilial  80-54-6  
(8) d-Limonene  5989-27-5  
(9) Linalool  78-70-6  
(10)  Methyl heptine carbonate  111-12-6  
(11)  3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one  127-51-5EN L 170/26 Official Journal of the European Union 30.6.200912. The use of the fragrances set out in points 41 to 55 of the list set out in the first paragraph of point 11 and of 
the fragrances set out in points 1 to 11 of the list set out in the third paragraph of that point shall be allowed in 
olfactory board games, cosmetic kits and gustative games, provided that:  
(i) those fragrances are clearly labelled on the packaging, and the packaging contains the warning set out in 
point 10 of Part B of Annex V;  
(ii) if applicable, the resulting products made by the child in accordance with the instructions comply with the 
requirements of Directive 76/768/EEC; and  
(iii) if applicable, those fragrances comply with the relevant legislation on food.  
Such olfactory board games, cosmetic kits and gustative games shall not be used by children under 36 months 
and shall comply with point 1 of Part B of Annex V.  
13. Without prejudice to points 3, 4 and 5, the following migration limits, from toys or components of toys, shall 
not be exceeded:  
Element  mg/kg 
in dry, brittle, powder-like or 
pliable toy material  mg/kg 
in liquid or sticky toy material  mg/kg 
in scraped-off toy material  
Aluminium  5 625  1 406  70 000  
Antimony  45  11,3  560  
Arsenic  3,8  0,9  47  
Barium  4 500  1 125  56 000  
Boron  1 200  300  15 000  
Cadmium  1,9  0,5  23  
Chromium (III)  37,5  9,4  460  
Chromium (VI)  0,02  0,005  0,2  
Cobalt  10,5  2,6  130  
Copper  622,5  156  7 700  
Lead  13,5  3,4  160  
Manganese  1 200  300  15 000  
Mercury  7,5  1,9  94  
Nickel  75  18,8  930  
Selenium  37,5  9,4  460  
Strontium  4 500  1 125  56 000  
Tin 15 000  3 750  180 000  
Organic tin  0,9  0,2  12  
Zinc  3 750  938  46 000EN 30.6.2009 Official Journal of the European Union L 170/27These limit values shall not apply to toys or components of toys which, due to their accessibility, function, 
volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin 
when used as specified in the first subparagraph of Article 10(2).  
IV. Electrical Properties  
1. Toys shall not be powered by electricity of a nominal voltage exceeding 24 volts direct current (DC) or the 
equivalent alternating current (AC) voltage, and their accessible parts shall not exceed 24 volts DC or the 
equivalent AC voltage.  
Internal voltages shall not exceed 24 volts DC or the equivalent AC voltage 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 liable to come into contact with, a source of electricity capable of causing 
electric shock, together with the cables or other conductors through which electricity is conveyed to such parts, 
must be properly insulated and mechanically protected so as to prevent the risk of such shock.  
3. Electric toys must be designed and manufactured in such a way as to ensure that the maximum temperatures 
reached by all directly accessible surfaces are not such as to cause burns when touched.  
4. Under foreseeable fault conditions, toys must 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 manufactured in such a way that electric, magnetic and electromagnetic fields 
and other radiations generated by the equipment are limited to the extent necessary for the operation of the toy, 
and must 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 must be designed and manufactured in such a way that the toy 
operates safely even when the electronic system starts malfunctioning or fails due to failure of the system itself or 
an outside factor.  
8. Toys must be designed and manufactured in such a way that they do not present any health hazards or risk of 
injury to eyes or skin from lasers, light-emitting diodes (LEDs) or any other type of radiation.  
9. The electrical transformer of a toy shall not be an integral part of the toy.  
V. Hygiene  
1. Toys must be designed and manufactured in such a way as to meet hygiene and cleanliness requirements in order 
to avoid any risk of infection, sickness or contamination.  
2. A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can 
be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if 
soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this 
point and the manufacturer’s instructions.  
VI. Radioactivity  
Toys shall comply with all relevant measures adopted under Chapter III of the Treaty establishing the European 
Atomic Community.EN L 170/28 Official Journal of the European Union 30.6.2009Appendix A  
List of CMR substances and their permitted uses in accordance with points 4, 5 and 6 of Part III  
Substance  Classification  Permitted use  
Nickel  CMR 2  In stainless steelEN 30.6.2009 Official Journal of the European Union L 170/29Appendix B  
CLASSIFICATION OF SUBSTANCES AND MIXTURES  
As a result of the timing of the application of Regulation (EC) No 1272/2008, there are equivalent ways of referring to a 
given classification that should be used at different points in time.  
1. Criteria for classifying substances and mixtures for the purposes of point 2 of Part II  
A. Criteria to be applied from 20 July 2011 until 31 May 2015:  
Substances  
The substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to 
Regulation (EC) No 1272/2008:  
(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 
categories 1 and 2, 2.15 types A to F;  
(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects 
other than narcotic effects, 3.9 and 3.10;  
(c) hazard class 4.1;  
(d) hazard class 5.1.  
Mixtures  
The mixture is dangerous within the meaning of Directive 67/548/EEC.  
B. Criteria to be applied from 1 June 2015:  
The substance or mixture fulfils the criteria for any of the following hazard classes or categories set out in Annex I 
to Regulation (EC) No 1272/2008:  
(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 
categories 1 and 2, 2.15 types A to F;  
(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects 
other than narcotic effects, 3.9 and 3.10;  
(c) hazard class 4.1;  
(d) hazard class 5.1.  
2. Community legal acts governing the use of certain substances for the purposes of points 4(a) and 5(a) of Part 
III 
From 20 July 2011 until 31 May 2015, the relevant concentrations for the classification of mixtures containing the 
substances shall be those established in accordance with Directive 1999/45/EC.  
From 1 June 2015, the relevant concentrations for the classification of mixtures containing the substances shall be 
those established in accordance with Regulation (EC) No 1272/2008.  
3. Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) 
for the purposes of point 4 of Part III  
Substances  
Point 4 of Part III concerns substances classified as CMR category 1A and 1B under Regulation (EC) No 1272/2008.EN L 170/30 Official Journal of the European Union 30.6.2009Mixtures  
From 20 July 2011 until 31 May 2015, point 4 of Part III concerns mixtures classified as CMR category 1 and 2 
under Directive 1999/45/EC and Directive 67/548/EEC as applicable.  
From 1 June 2015, point 4 of Part III concerns mixtures classified as CMR category 1A and 1B under Regulation (EC) 
No 1272/2008.  
4. Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) 
for the purposes of point 5 of Part III  
Substances  
Point 5 of Part III concerns substances classified as CMR category 2 under Regulation (EC) No 1272/2008.  
Mixtures  
From 20 July 2011 until 31 May 2015, point 5 of Part III concerns mixtures classified as CMR category 3 under 
Directive 1999/45/EC and Directive 67/548/EEC as applicable.  
From 1 June 2015, point 5 of Part III concerns mixtures classified as CMR category 2 under Regulation (EC) No 
1272/2008.  
5. Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) 
for the purposes of Article 46(3)  
Substances  
Article 46(3) concerns substances classified as CMR category 1A, 1B and 2 under Regulation (EC) No 1272/2008.  
Mixtures  
From 20 July 2011 until 31 May 2015, Article 46(3) concerns mixtures classified as CMR category 1, 21999 and 3 
under Directive 1999/45/EC and Directive 67/548/EEC as applicable.  
From 1 June 2015, Article 46(3) concerns mixtures classified as CMR category 1A, 1B and 2 under Regulation (EC) 
No 1272/2008.EN 30.6.2009 Official Journal of the European Union L 170/31Appendix C  
Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys 
intended to be placed in the mouth adopted in accordance with Article 46(2)EN L 170/32 Official Journal of the European Union 30.6.2009ANNEX III  
EC DECLARATION OF CONFORMITY  
1. No … (unique identification of the toy(s))  
2. Name and address of the manufacturer or his authorised representative:  
3. This declaration of conformity is issued under the sole responsibility of the manufacturer:  
4. Object of the declaration (identification of toy allowing traceability). It shall include a colour image of sufficient clari ty 
to enable the identification of the toy.  
5. The object of the declaration described in point 4 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. Where applicable: the notified body … (name, number) … performed … (description of intervention) … and issued 
the certificate:  
8. Additional information:  
Signed for and on behalf of:  
(place and date of issue)  
(name, function)(signature)EN 30.6.2009 Official Journal of the European Union L 170/33ANNEX IV  
TECHNICAL DOCUMENTATION  
The technical documentation referred to in Article 21 shall contain, in particular, so far as relevant for assessment:  
(a) a detailed description of the design and manufacture, including a list of components and materials used in the toy as 
well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers;  
(b) the safety assessment(s) carried out in accordance with Article 18;  
(c) a description of the conformity assessment procedure followed;  
(d) a copy of the EC declaration of conformity;  
(e) the addresses of the places of manufacture and storage;  
(f) copies of documents that the manufacturer has submitted to a notified body, if involved;  
(g) test reports and description of the means whereby the manufacturer ensured conformity of production with the 
harmonised standards, if the manufacturer followed the internal production control procedure referred to in 
Article 19(2); and  
(h) a copy of the EC-type examination certificate, a description of the means whereby the manufacturer ensured 
conformity of the production with the product type as described in the EC-type examination certificate, and 
copies of the documents that the manufacturer submitted to the notified body, if the manufacturer submitted the 
toy to EC-type examination and followed the conformity to type procedure referred to in Article 19(3).EN L 170/34 Official Journal of the European Union 30.6.2009ANNEX V  
WARNINGS  
(as referred to in Article 11)  
PART A  
GENERAL WARNINGS  
The user limitations referred to in Article 11(1) shall include at least the minimum or maximum age of the user and, 
where appropriate, the abilities of the user, the maximum or minimum weight of the user and the need to ensure that the 
toy is used only under adult supervision.  
PART B  
SPECIFIC WARNINGS AND INDICATIONS OF PRECAUTIONS TO BE TAKEN WHEN USING CERTAIN 
CATEGORIES OF TOYS  
1. Toys not intended for use by children under 36 months  
Toys which might be dangerous for children under 36 months of age shall bear a warning such as ‘Not suitable for 
children under 36 months’ or ‘Not suitable for children under three years’ or a warning in the form of the following 
graphic:
  
These warnings shall be accompanied by a brief indication, which may appear in the instructions for use, of the 
specific hazard calling for this precaution.  
This point shall not apply to toys which, on account of their function, dimensions, characteristics or properties, or 
on other cogent grounds, are manifestly unsuitable for children under 36 months.  
2. Activity toys  
Activity toys shall bear the following warning:  
‘Only for domestic use’.  
Activity toys attached to a crossbeam as well as other activity toys, where appropriate, shall be accompanied by 
instructions drawing attention to the need to carry out checks and maintenance of the main parts (suspensions, 
fixings, anchorages, etc.) at intervals, and pointing out that, if these checks are not carried out, the toy may cause a 
fall or overturn.  
Instructions must also be given as to the correct assembly of the toy, indicating those parts which can present a 
danger if incorrectly assembled. Specific information regarding a suitable surface on which to place the toy shall be 
given.  
3. Functional toys  
Functional toys shall bear the following warning:  
‘To be used under the direct supervision of an adult’.  
In addition, these toys shall be accompanied by directions giving working instructions as well as the precautions to 
be taken by the user, with the warning that failure to take these precautions will expose the user to the hazards – to 
be specified – normally associated with the appliance or product of which the toy is a scale model or imitation. It 
shall also be indicated that the toy must be kept out of the reach of children under a certain age, which shall be 
specified by the manufacturer.EN 30.6.2009 Official Journal of the European Union L 170/354. Chemical toys  
Without prejudice to the application of the provisions laid down in applicable Community legislation on the 
classification, packaging and labelling of certain substances or mixtures, the instructions for use of toys containing 
inherently dangerous substances or mixtures shall bear a warning of the dangerous nature of these substances or 
mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, 
which shall be specified concisely according to the type of toy. The first aid to be given in the event of serious 
accidents resulting from the use of this type of toy shall also be mentioned. It shall also be stated that the toy must 
be kept out of reach of children under a certain age, which shall be specified by the manufacturer.  
In addition to the instructions provided for in the first subparagraph, chemical toys shall bear the following warning 
on their packaging:  
‘Not suitable for children under (*) years. For use under adult supervision’.  
In particular, the following are regarded as chemical toys: chemistry sets, plastic embedding sets, miniature 
workshops for ceramics, enamelling or photography and similar toys which lead to a chemical reaction or similar 
substance alteration during use.  
5. Skates, roller skates, online skates, skateboards, scooters and toy bicycles for children  
Where these toys are offered for sale as toys, they shall bear the following warning:  
‘Protective equipment should be worn. Not to be used in traffic’.  
Moreover, the instructions for use shall contain a reminder that the toy must be used with caution, since it requires 
great skill, so as to avoid falls or collisions causing injury to the user or third parties. Some indication shall also be 
given as to recommended protective equipment (helmets, gloves, knee-pads, elbow-pads, etc.).  
6. Aquatic toys  
Aquatic toys shall bear the following warning:  
‘Only to be used in water in which the child is within its depth and under adult supervision’.  
7. Toys in food  
Toys contained in food or co-mingled with food shall bear the following warning:  
‘Toy inside. Adult supervision recommended’.  
8. Imitations of protective masks and helmets  
Imitations of protective masks and helmets shall bear the following warning:  
‘This toy does not provide protection’.  
9. Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps  
Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps shall 
carry the following warning on the packaging, which shall also be permanently marked on the toy:  
‘To prevent possible injury by entanglement, remove this toy when the child starts trying to get up on its hands and 
knees in a crawling position’.EN L 170/36 Official Journal of the European Union 30.6.2009  
(*) Age to be specified by the manufacturer.10. Packaging for fragrances in olfactory board games, cosmetic kits and gustative games  
Packaging for fragrances in olfactory board games, cosmetic kits and gustative games that contain the fragrances set 
out in points 41 to 55 of the list set out in the first paragraph of point 11 of Part III of Annex II and of the 
fragrances set out in points 1 to 11 of the list set out in third paragraph of that point shall contain the following 
warning:  
‘Contains fragrances that may cause allergies’.EN 30.6.2009 Official Journal of the European Union L 170/37