Safety of Toys  
Implementing Regulation  
 
SECTION I 
Aim, Scope, Basis and Definitions   
Aim 
ARTICLE  1 - (1) The aim of this Implementing Regulation is to lay down the 
procedures and principles on the s afety and free movement of toys.   
Scope  
 ARTICLE  2 - (1) This Implementing Regulation   
a) shall apply to products designed or intended, whether or not exclusively, for use in 
play by children under 14 years of age . The products listed in Annex I shall not be considered 
as toys within the meaning of this  Implemen ting Regulation . 
b) shall not apply to the following toys:  
1) playground equipment intended for public use;  
2) automatic playing machines, whether coin operated or not, intended for public use;  
3) toy vehicles equipped with combustion engines;  
4) toy steam  engines;   
5) slings and catapults . 
Basis  
ARTICLE  3 - (1) This Implementing Regulation is drawn up based on Law of 
Preparation  and Implementation of Technical Legislation for Products numbered 4703 and 
dated 29/6/2001, Decree Law about the Organization  and Assignment of Ministry of Customs 
and Trade numbered 640 and dated 3/6/2011, Implementing Regulation on Market 
Surveillance which enter ed into forc e by the Council of Ministers Decision numbered 
2001/3529 and dated 13/11/2001 and Decision numbered 97/9196  and dated 15/1/1997 on 
Identification of the Bodies That Will Draw Up the Technical Legislation for Increasing the 
Exports of Turkish Products.   
 Definitions  
       ARTICLE  4 - (1) For the purposes of this Implementing Regulation the following 
defin itions  shall apply ; 
a) Accreditation : An attestation by a national accreditation body that a conformity 
assessment body meets the requirements set by harmonised standards and, where applicable, 
any additional requirements set out in relevant sectoral schemes, to  carry out a specific 
conformity assessment activity ; 
b) Activity toy : 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;  
c) EC: European Community;  
ç) Ministry : Ministry of Customs and Trade ; d)“CE” marking : A marking by which  the manufacturer  indicates tha t the toy is in 
conformity with all the relevant rules of the technical legislation, providing for the affixing of 
the “CE marking”;  
e) Distributor : Any natural or legal person in the supply chain, other than the 
manufacturer or the importer, who makes a t oy available on the market;  
f) Functional toy : 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;  
g) Functional pro duct: A product which performs and is used in the same way as a 
product, appliance or installation intended for use by adults  (indicated in item 12 in Annex I), 
and which may be a scale model of such product, appliance or installation ; 
ğ) Withdrawal : Any measu re aimed at preventing a toy in the supply chain from being 
made available on the market ; 
h) Economic  operator : The manufacturer, the authorised representative, the importer 
and the distributor;   
ı) Manufacturer : Any natural or lega l person who manufactures a toy or has a toy 
designed or manufactured, and markets that toy under his name or trademark;  
i) Importer : Any natural or legal person established in Turkey who supplies a toy  from 
abroad on the domestic market ;  
j) Law: Law no.4 703 on Preparation and Implementation of Technical Legislation for 
Products published in the Official Gazette no. 24459 and dated 11/7/2001 ; 
k) Chemical toy:  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 ; 
l) Olfactory board game : A toy the purpose of which is to assist a child to learn to 
recognise different odours or flavours;  
m) Commission : European Commission ; 
n) Cosmetic  kit: 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;  
o) Gustative game : A toy the purpose of which is to al low children to make sweets or 
dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas;   
ö) Toy:  products designed or intended, whether or not exclusively, for use in play by 
children under 14 years of age;  
p) Market su rveillance : The activities carried out  and measures taken by public 
authorities to  ensure that  products comply with the rules in relevant technical regulation  and 
do not endanger  health,  safety or  any  other  aspect  of  public interest protection ; 
r) Making available on the market : Any supply of a to y for distribution, consumption or 
use on the  domestic market in the course of a commercial activity, whether in return for 
payment or free of charge;   
s) Placing on the market : The first making available  of a toy on the domestic market;   ş) Risk: The probable rate of occurrence of a hazard causing harm and the degree of 
severity of the harm;  
t) Aquatic toy : A toy intended for use in shallow water which is capable of carrying or 
supporting a child on the water;  
u) Intended for use by : 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;  
ü) Design speed : Representative potential  operating speed that is dete rmined by the 
design of the toy;  
v) Hazard : A potential source of harm;  
y) Recall : Any measure aimed at achieving the return of a toy that has already been 
made available to the end user ; 
z) Conformity  assessment body : A body established in Turkey, which p erforms 
conformity assessment activities, including calibration, testing, certification and inspection;   
aa) Conformity assessment : The process demonstrating whether specified requirements 
relating to a toy have been fulfilled ; 
bb) Harmonised standard : A standard drawn up  and adopted upon EC’s request by one 
of the European standardization bodies listed in Annex I of the Implementing Regulation on 
the Notification of Technical Legislation and Standards Between Turkey and EU  published in 
the Official Gazette  no. 24714 and dated 03/04/2002;  
cc) Authorised   representative : Any  natural  or   legal person   established  in Turkey  
who  has received a  written  mandate  from  a  manufacturer under this implementing 
regulation to  act on his behalf in relation to  specified tasks;  
dd) Harm : Physical injury  or  any  other  damage  to health, including long -term health 
effects .  
 
SECTION II  
Obligations of Economic Operators  
Obligations of manufacturers  
ARTICLE  5 - (1) When placing their toys on the market, m anufactu rers shall ensure 
that the toys have been designed and manufactured in accordance with the requirements set 
out in Article 11 and Annex II . 
(2) Manufacturers shall draw up the required technical documentation in accordance 
with Article 22, to carry out or have carried out the conformity assessment procedure in 
accordance with Article 20, where compliance of a toy has been demonstrated by conformity 
assessment procedure, to draw up an EC declaration o f conformity, as referred to in Article 
16, and to affix t he CE marking on the toy as set out in paragraph 1 of Article 18 .  
 (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 necessary mechanisms are installed 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, investigate, and, if necessary, keep a regi ster 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 identifi cation, 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 a nd the address at which they can be contacted on the toy or, where that is no t possible, 
on its packaging or in a document accompanying the toy. The said address shall indicate a 
single point at which the manufacturer can be contacted . 
(7) Manufacturers sh all draw up  the instructions for use and safety information 
accompanying the toy in Turkish language in a manner  easily understood by consumers . 
 (8) Manufacturers who consider or have reason to bel ieve that a toy which they have 
placed on the market is no t in conformity with the relevant legislation shall immediately take 
the corrective actions  necessary to bring that toy into conformity, to withdraw it or recall it , if 
appropriate . Where the toy made available in the market presents a risk, manufactures s hall 
immediately inform the Ministry on the non -compliance of the toy and of any corrective 
action s taken . 
(9) Manufacturers shall, further to a reasoned request from the Ministry, provide the 
Ministry with all the information and documentation demonstrati ng the conformity of the toy . 
Furthermore manufacturers  shall  cooperate  with the Ministry, at its request, as regards any 
action taken to eliminate the  risks posed by toys which they have placed on the market .  
Obligations of authorised representatives   
ARTICLE  6 - (1) A manufacturer may, by a written mandate, appoint an authorised 
representative .   
(2) The manufacturer’s obligations laid down in paragraph 1 of Article 5 and the 
drawing up of technical documentation shall not form part of the authorised rep resentative’s 
mandate .  
(3) An authorised representative shall perform the tasks  specified in the mandate 
received from the manufacturer. The said 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 the Ministry for a period of 10 years after the toy has been placed on the market ; 
b) Further to a reasoned request from the Ministry, pro vide the Ministry with all the 
information and documen tation necessary to demonstrate the conformity of a toy ; 
c) Cooperate  with the Ministry, at their request, on any action taken to eliminate the 
risks posed by toys covered by the mandate . 
Obligations of importers  ARTICLE  7- (1) Importers shall place on the market only the toys compliant with the 
technical regulation .  
 (2) Before placing a toy on the market, importers shall ensure that the appropriate 
conformity assessment procedure has been carried out  by the manufacturer, that the 
manufacturer has drawn up  the technical documentation of the toy, that the toy bears the CE 
marking and is accompanied by the required documents, and that the manufacturer has 
complied with the requirements set out in paragraphs 5 and 6 of Article 5 .  
Where an importer considers o r has reason to believe that a toy is not in conformity 
with the requirements set out in Article 11 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 impor ter shall inform the manufacturer and the Ministry 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 
pack aging or in a document accompanying the toy . 
 (4) Importers  shall ensure that the manufacturer provides  instructions for use and 
safety information accompanying the toy in Turkish language in a manner  easily understood 
by consumers . 
 (5) Importers shall en sure that, while a toy is under their responsibility, storage or 
transport conditions do not jeopardise its compliance with the requirements set out in Article 
11 and Annex II . 
 (6) When deemed appropriate with regard  to the risks presented by a toy, impor ters 
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 monito ring. 
(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 legislation shall immediately take the 
corrective action s necessary to bring that toy into conformity, to with draw it or recall it , if 
appropriate.  Where the toy made available at the market presents a risk, importers shall 
immediately inform  the Ministry to that effect, giving details, in particular, of the non -
compliance and of any corrective action s taken . 
(8) 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 to be submitted to the Ministry and ensure 
that the technical documentation can be made available to the Ministry , upon re quest.  
(9) Importers shall, further to a reasoned request from the Ministry, provide the 
Ministry with all the information and documentation necessary to demonstrate the conformity 
of the toy in Turkish language. Furthermore, they shall cooperate with the Ministry, at its 
request, on any action taken to eliminate the risks posed by toys which they have placed on 
the market .  
 
Obligations of distributors  
ARTICLE  8- (1) When making a toy available on  the market, distributors shall act   
with due care in relat ion to the applicable requirements . (2) Before making a toy available on the market, distributors shall verify that the toy 
bears the CE marking, that it is accompanied by required documents, instructions  for use  and 
safety information provided that there are in Turkish language, and that the manufacturer and 
the importer have complied with the requirements set out in paragraphs 5 and 6 of Article 5 
and paragraph 3 of Article 7 .  
Where a distributor considers or has reason to believe that a toy is not in co nformity 
with the requirements set out in Article 11 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 distributors shall inform the manufa cturer or the importer, and the 
Ministry, 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 
11 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 legislation shall make sure 
that the corrective action s necessary to bring that toy into conformity, to with draw it or recall 
it, if appropriate , are taken . Furthermore, where the toy made available in the market presents 
a risk, distributors shall inform the Ministry to that effect, giving details, in particular, of the 
non-compliance and of any corrective actions taken .   
(5) Distributors shall, further to a reasoned request from the Ministry, provide the 
Ministry with all the information and documentation necessary to demonstrate the conformity 
of the toy. They shall  cooperate  with  the Ministry,  at  its  r equest,  as  regards  any  action  
taken  to eliminate the risks posed by toys which they have made available on the market . 
Cases in which obligations of manufacturers are undertaken by importers and 
distributors   
ARTICLE  9- (1) An importer or distributor  shall be considered a manufacturer for the 
purposes of this Implementing Regulation and be subject to the obligations of the 
manufacturer under Article 5 where it places a toy on the market under its name or trademark 
or modifies a toy already placed on t he market in such a way that compliance with the 
applicable requirements may be affected . 
Identification of economic operators   
ARTICLE  10- (1) Economic operators shall, on request, identify the following to the 
Ministry ;   
a) any economic operator who has  supplied them with a toy , 
    b) any economic operator to whom they have supplied a toy . 
(2) 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 . 
 
SECTION III   
Conformity of Toys  Essential safety requirements  
ARTICLE  11- (1) Ministry shall take all measures necessary to ensure that toys may 
not be placed on the market unless they comply with the essential safety requirements 
including  the general safety requirement in paragraph 2 and the particular safety requirements  
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 . 
 Labels affixed in accordance with paragraph 2 of Article 12 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 mar ket sha ll comply with the essential safety requirements 
during their foreseeable and normal period of use . 
Warnings  
ARTICLE  12- (1) Where appropriate for safe use, warnings made for the purposes of 
paragraph 2 of Article 11 shall specify appropriate user limitati ons in accordance with Part A 
of Annex V . 
As regards the categories of toy s listed in Part B of Annex V, the warnings set out 
there  shall be used. The warnings set out in points 2 to 10 of Part B of Annex V shall be used 
as worded here . 
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 clea rly 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 appropri ate warnings affixed to them . 
 If a warning is to be used, the words ‘Warning’ or ‘Warnings’ shall be used before the 
warnings . 
Warnings which determine the  decision to  purchase the  toy, such  as  those  
specifying the  minimum  and  maximum ages for us ers 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 paragraph 7  of Article 5, the safety instructions and warnings 
shall be written in Turkish language .  
Free movement  
     ARTICLE  13- (1) The making available on the market of toys which comply with the 
provisions of t his Implementing Regulation  shall not be impeded . Presumption of conformity  
ARTICLE  14- (1) Toys which are manufactured in conformity with harmonised 
standards or their parts  thereof, the references of which have been published in the Official 
Journal of the European Union  shall be presumed to be in confo rmity with the requirements  
covered by those standards or parts thereof set out in Article 11 and Annex II .   
    Formal objection to a harmonised standard  
ARTICLE  15- (1) When the Ministry detects that a harmonised standard does not 
entirely fulfil the r equirements which it aims and which are set out in Article 11 and Annex II, 
it shall communicate its opinions to the Ministry of Economy  for them to be informed  to the 
Commission or to be brought before the technical committee operating under Directive 
98/34/EC.  
EC declaration of conformity   
ARTICLE  16- (1) The  EC  declaration of  conformity  shall  state  that  the fulfilment  
of  the  requirements  set  out  in  Article  11 and Annex II has been demonstrated . 
(2) The EC  declaration of conformity shall a s a minimum contain the elements 
specified in Annex III and the relevant modules set out in Annex III to the Implementing 
Regulation on CE Marking  published in the Official Gazette no. 28213 and dated 23/02/2012 , 
and shall be updated as necessary . The EC d eclaration of conformity shall be drawn up in 
accordance with the sample set out in Annex III. In cases where the EC declaration of 
conformity is not in Turkish language, its Turkish translation shall accompany  the declaration . 
(3) By drawing  up the EC dec laration of conformity,  the manufacturer shall assum e 
responsibility for the  compliance of the toy .  
General procedures and principles of the CE marking   
ARTICLE  17 - (1) Toys made available on the market shall bear the CE marking . 
(2) The CE marking shall  be subject to the provisions  set out in the Implementing 
Regulation on CE Marking, which was published in the Official Gazette no. 28213 and dated 
23/02/2012 .  
(3) It shall be  presumed that the toys bearing the CE  marking comply with this 
Implementing Re gulation . 
(4) Toys not bearing a CE marking or which do not comply with this Implementing 
Regulation 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 w ith thi s 
Implementing Regulation and that they will not be made  available on the market before being 
brought into conformity . 
  Rules and conditions for affixing the CE marking   
ARTICLE  18- (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 accompanying 
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, it shall as a 
minimum be a ffixed 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 .  
 
SECTION IV   
Conformity Assessment  
Safety assessments  
ARTICLE  19- (1) Manufacturers shall, before placing a toy on the market, carry out 
an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and 
radioactivity hazards that the toy may present, and an assessment of the potential exposure to 
such hazards . 
Applicable conformity assessment methods  
ARTICLE  20- (1) Before placing a toy on the market, manufacturers shall use the 
conformity assessment procedures referred to in paragraphs 2 and 3 to demonstrate that the 
toy complies with the requiremen ts set out in Article 11 and Annex II .  
(2) If the manufacturer has applied harmoni sed 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, the man ufacturer shall use the internal production control 
procedure set out in Module A of Annex III to the Implem enting Regulation on CE Marking  
published in the Official Gazette no. 28213 and dated 23/02/2012 .  
 (3) In the following cases, the toy shall be sub mitted to EC -type examination, as 
referred to in Article 2 1, together with the conformity -to-type procedure based on the internal 
control of manufacturing set out in  Module C of Annex III to the Implementing Regulation on 
CE Marking published in  the Offici al Gazette no. 28213 and dated 23/02/2012:  
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 har monised 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 manuf acturer considers that the  nature, design, construction or purpose of 
the toy necessitate third party verification . 
EC-type examination  
ARTICLE  21- (1) An application for EC -type examination, the performance of that 
examination and the issuing  of the EC -type examination certificate shall be carried out in 
accorda nce with the procedures set out  in Module B of Annex III to the Implementing 
Regulation on CE Marking published in  the Official Gazette no. 28213 and dated 23/02/2012 .  
EC-type examination shall be carried out in the  manner specified in the second 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 descrip tion of the toy 
and an indication of the place of manufacture, including the address .  
 (3) When  a  conformity  assessment  body, which is  notified  u nder Article 23 and 
referred to as a notified body, carries out  the  EC -type examination ; it shall evalu ate, 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 19 . 
 (4) The EC -type examination certificate shall include the name of this Implementing 
Regulation  and a reference to the Directive 2009/48/EC of the European Parliament and of the 
Council of 18 June 2009 on the safety of toys, which this Regulation transposes and is 
equivalent to , a colour image of t he toy, a clear description of the toy,  including its 
dimensions, and  a  list of  the  tests performed, together with the name of 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 . 
 The EC -type examination certificate shall be withdrawn if the toy fails to comply with 
the requirements set out in Article 11 and Annex II.  
 Ministry shall take necessary meas ures to ensure that an EC -type examination 
certificate is not granted by national notified bodies 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 
examinat ion procedures shall be drawn up in Turkish language if the notified body is in the 
country , in an official language of the Member State in which the notified body is established 
or in a language acceptable to the notified body . 
Technical documentation  
ART ICLE  22- (1) The technical documentati on referred to  in paragraph 2 of  Article 5 
shall contain all relevant data or details of the means used by the manufacturer to ensure that 
toys compl y with the requirements set out in Article 11 and Annex II. It shall,  in particular, 
contain the documents listed in Annex IV . 
 (2) The technical documentation shall be drawn up in Turkish language or in one of 
the official languages of the EU subject to the requirement set out in paragraph 5 of Article 
21. 
(3) When the tec hnical documentation is not in Turkish language, the manufacturer, as 
per Ministry’s reasoned request, shall provide a Turkish translation of the relevant parts of the 
technical documentation .  
Manufacturer  shall provide the translation of the techn ical do cumentation or parts 
included in the technical documentation, requested by the Ministry, in 30 days at the latest . 
Ministry may fix a shorter deadline by giving the justification of a  serious and immediate risk .   
(4) If the manufacturer does not comply wi th the requirements of paragraphs 1, 2 and 
3, Ministry may require the manufacturer 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 re quirements  
 
SECTION V   
Notification of Conformity Assessment  Bodies  
Notification  
ARTICLE  23- (1) Ministry shall notify  the Commission thr ough the Ministry of 
Economy of the bodies authorised to carry out  third -party conformity assessment tasks under 
Articl e 21.  
Principles relating to the competent bodies that assign notified bodies  
ARTICLE  24- (1) Ministry shall assign notified bodies and carry out their 
surveillance and inspection . Ministry shall  take necessary measures and make arrangements to 
ensure that  
a) Its managers and personnel do not have a relationship based on self -interest with the 
notified body  candidates ; 
b) The relevant units are organised and operated so as to safeguard their independence 
and objectivity ; 
c) Each decision related to assignin g notified bodies is taken by competent personnel  
and that the personnel is  different from those who made  the competency review on the 
notified body ; 
ç) The managers and personnel of any unit performing competency reviews or making 
decisions related to the  notified bodies do not offer or provide any activities performed by 
conformity assessment bodies on a commercial or competitive basis , particularly consultancy 
services ,; 
d) The managers and the relevant personnel safeguard the confidentiality of the 
information they obtain ; and 
e) The managers and the relevant personnel have the competency, quality and quantity 
for the proper performance of surveillance of the notified bodies for which they are assigned.  
Information obligation of the competent body that a ssigns notified bodies  
  ARTICLE  25- (1) Ministry of Economy shall inform the Commission of Ministry’s  
principles  for the assessment of competency of the conformity assessment bodies,  which are 
notified body candidates,  the assignment of those bodies as no tified bodies, the notification 
and inspection  of them , and the changes that occurred in those principles . 
Qualifications required from  notified bodies   
ARTICLE  26- (1) A conformity assessment body, which will be assigned as a 
notified body under this Impl ementing Regulation,  shall meet the following qualifications : 
a) A conformity assessment body shall be established under national law and shall 
have legal personality . 
b) A conformity assessment body  shall be an independent third -party body which has 
no co nnections whatsoever with the toy it assesses or the organisation for which  it provides 
conformity assessment service .  A  body  belonging to  a  chamber of industry, chamber of commerce, professional 
chamber, union, business association or  profess ional f ederation representing  organizations  
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 co nsidered a third -party body . 
c) A conformity assessment body  
1) itself , its managers  and its personnel  shall not be the designer, manufacturer, 
supplier, installer, purchaser, owner, user (without prejudice to the use of assessed toys that 
are necessary fo r the operations of the conformity assessment body or the use of such toys for 
personal purposes), configurer or maintainer of the toy which is assessed , nor the authorised 
representative of any of those parties .  
2) itself, its managers and its per sonnel shall not  be directly involved in the  design or 
manufacture, marketing, insta llation, u se or maintenance of the  toy, or represent  the  parties  
engaged  in  those activities and sh all  not  engage  in  any  activity that may negatively affect 
the independ ence of judgements for conformity as sessment activities which it carries  out as 
the notified body, and  the duly performance of professional requirements . This shall in 
particular apply to consultancy services.  
3) shall take necessary measures to ensure th at the activities of its branch offices , 
agencies or contractors  do not affect the  confidentiality, objectivity or impartiality of its 
conformity assessment activities . 
ç) 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 re sults of  
their conformity assessment activities , especially as regards persons or  groups of persons with 
an interest in the results of those activities . 
d) A conformity assessment body shall be capable of carrying out all the conformity 
assessment tasks a ssigned to it in accordance with Article 21 of this Implementing Regulation 
whether those tasks are carried out by the conformity assessment body itself or on its behalf 
and under its responsibility. At all times and for each conformity assessment procedur e and 
each kind or category of toy in relation to which it has been assigned as a notified body, a 
conformity assessment body shall have the following ; 
1) Personnel with technical knowledge and sufficient and appropriate experience to 
perform the conformit y assessment tasks ;   
2) Records to ensure the transparency of methods used in conformity assessment 
procedures and ability of reproduction of those procedures ; 
3) Appropriate policies and procedures that ensure the separation of its tasks as a 
notified bo dy and its other tasks ;  
4) Procedures for the performance of activities which take due account of the size of 
the operations that has applied for conformity assessment , the sector in which it operates, its 
structure, the degree of complexity of the techno logy used for the toy in question and the mass 
or serial nature of the production process .  e) A conformity assessment body shall have the means necessary to perform  the 
technical and administrative tasks connected with the conformity assessment activities  it is 
assigned with and shall have access to all necessary equipment or facilities . 
f) The personnel of a conformity assessment body, responsible for carrying out the 
conformity assessment activities , shall have ; 
1) Sound technical and vocational training  covering all the conformity assessment 
activities which the conformity assessment body has been assigned to perform as a notified 
body ; 
2) Satisfac tory knowledge of the requi rements of the assessment they carry out and 
adequate authority  to carry out thos e assessments;   
3) Appropriate knowledge and understanding of the essential requirements and 
provisions of the Implementing Regulation and of the applicable harmonized standards ; and 
4) The ability  to draw up certificates, records and reports demonstrating  the 
assessments they have carried out . 
g) Notified bodies shall tak e out  professional liability insurance  that covers the 
activities they carry out  unless liability is assumed by the  public in accordance with the 
legislation, and the insurance coverage i s determined by the Ministry by considering such 
measures as the inherent risks of the toy subject to conformity assessment activity, the risks 
they toy may pose within its normal period of use , the nature of the conformity assessment 
activity and user as well as the consumers, and the size of the sector .  
ğ) A conformity assessment body  shall ensure the impartiality of itself, its managers 
and its personnel that will carry out the  assessment . The remuneration of the managers and 
assessment personnel of a c onformity assessment body shall not depend on the number of 
assessments carried out or on the results of those assessments .  
h) The personnel of a conformity assessment body  shall protect the  secrecy of 
information t hey obtained while carrying out  their ta sks under Article 21 of the Implementing 
Regulation and  information under intellectual property rights except the obligation to provide 
information and documents to the Ministry as per legisla tion. Proprietary rights shall be 
protected.  
ı) Conformity assessmen t bodies shall participate in, or ensure that their assessment 
personnel are informed of, the relevant standardisation activities and the activities of  the 
group established under Article 36 for the coordination of the notified bodie s and shall apply 
as general guidance the administrative decisions and documents produced as a result of the 
activities of the group established for the coordination of the notified bodies . 
 
Presumption of conformity  
ARTICLE  27- (1) Where a conformity asse ssment 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 re quirements set out in Article 26 insofar as the 
applicable harmonised standards cover those requirements.    
Formal objection to a harmonised standard  ARTICLE  28- Where the M inistry has a formal objection to the  harmonised  standards   
referred to in Article  27, the provisions of Article 15 shall apply.  
Branch offices, agencies and contractors   
 ARTICLE  29- (1) Where a notified body assigned by the Ministry subcontracts some 
tasks connected with conformity assessment or uses a branch office or agency to carry  out 
those tasks , this notified body shall take responsibility  for ensuring that these branch offices, 
agencies or contractors meets the requirements set out in Article 26,  and for informing the 
Ministry to that effect .  
(2) Notified bodies shall take full  responsibility for the tasks performed by all branch 
offices and agencies, including the ones established abroad, or their subcontractors .  
(3) Conformity assessment activities may be subcontracted or carried out by a branch 
office or agency only with the  agreement of the client . 
(4) A notified body assigned by the Ministry shall maintain the documents concerning 
the assessment of the competency of the branch office, agencies or contractors and the work 
carried out by them under Article 21, so that they ca n be submitted to the Ministry upon its 
request.  
Application for notification  
ARTICLE  30- (1) When conformity assessment bodies established in Turkey apply to 
the Ministry to become notified bodies, their application document shall be accompanied 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 and by an  
accreditation certificate, where one exists, issued as indicated in the Implementing Regu lation 
on Conformity Assessment Bodies and Notified Bodies  published in the Official Gazette 
no.283123 and dated 23/02/2012, attesting that the conformity assessment  body fulfils the 
requirements laid down in Article 26 .  
(2) When conformity assessment bo dies, which  do not have the accreditation 
certificate mentioned in paragraph 1 , apply to become notified bodies, they shall provide the 
Ministry with the evidence and documents that will allow for the verification, recognition and 
regular monitoring of the ir compliance with the requirements for notified bodies laid down in 
Article 26 of the Implementing Regulation.  
Notification process and assignment   
ARTICLE  31-  (1) In cases required by this Implementing Regulation, the Ministry  
shall assign  notified bodi es within the framework of Article 26 of this Implementing 
Regulation, the procedures and principles, if any, which are referred to  in the regulatory 
procedure  published by the Ministry in respect of the assignment, and the Implementing 
Regulation on Confo rmity Assessment Bodies and Notified Bodies published in the Official 
Gazette no.283123 and dated 23/02/2012, by selecting an appropriate number of  conformity 
assessment bodies from amongst the ones that are established in Turkey and that apply to the 
Mini stry. 
(2) Necessary records and documents in respect of the notified body candidate shall be 
communicated  to the Commission and the EU Member States through the Ministry of 
Economy . The communication  shall include full details of the relevant conformity as sessment activities, module or modules , toy or toys subjected to conformity assessment and the 
competency of this body .   
3) Where an assignment is not based on  an accreditation certificate as referred to  in   
paragra ph 1 of Article 30, Ministry  shall prov ide the Ministry of Economy with evidence and 
documents that will allow for the verification, recognition and regular monitoring of the 
notified body’s compliance with the requirements laid down in Article 26 , to be sent to the 
European Commission and the EU Member States .     
(4) Commission and the EU Member States can request additional information or raise 
an objection about the competency of the notified body candidate for which information was 
provided , as of the date when information was provided to t he Commission , within two weeks 
where an accreditation certificate is used and within two months where accreditation is not 
used for assessing the notified body candidate .  
(5) The Commission shall allocate  an identification number to the conformity 
assess ment body for which information was provided , and after that  Ministry shall assign  this 
body as a notified body . Assignment decision shall be  published in the Official Gazette by the 
Ministry within the shortest time .  
  (6) Any changes in the notified bod ies’ activities and features subject to information 
shall be informed to the Commission and the EU Member States through the Ministry of 
Economy .  
Sanctions to be applied to the notified bodies that fail to meet the requirements  
ARTICLE  32- (1) Ministry shall monitor  and inspect , when it deems necessary , 
whether the notified bodies it has assigned continues meet the requirements laid down in 
Article 26 of this Implementing Regulation, the Implementing Regulation on Conformity 
Assessment Bodies and Notified Bodies  published in the Official Gazette no.283123 and 
dated 23/02/2012 , and the regulatory procedure  published by the Ministry in respect of the 
assignment , whether it fulfils its obligations , and whether it carries on with its activities in 
compliance wi th this legislation .  
(2) If the result of this monitoring  and inspection is negative , Ministry shall restrict or 
suspend the activities carried out by those bodies as notified bodies .  
(3) If the identified non -conformities cannot be corrected in a time -period to be 
determined by the Ministry not to be less than 20 workdays and not to be more than 60 
workdays by considering such measures  as  
a) severity of the risks likely to be posed by the assessed product ,  
b) urgency of the h azard , 
c) qualifications of  the users and consumers , 
Ministry shall withdraw the notified body status of those bodies under this 
Implementing Regulation . 
(4) Decisions regarding the restriction and suspension of notified body activities or the 
withdrawal of notified body status shal l be published in the Official Gazette by the Ministry . 
Those decisions shall be  informed to the Commission and the EU Member States through the 
Ministry of Economy .  (5) A notified body, whose activities are restricted or suspended or whose notified 
body status is withdrawn by the Ministry or who willingly terminates its activities, shall 
submit the documents and records regarding the conformity assessment procedures it carried 
out in its activity period to the Ministry to be transferred, when necessary, t o another notified 
body operating in the same field . However, the responsibilities of this notified body for the 
said documents and records shall continue for 10 years as of the date when those documents 
and records are drawn up . Ministry shall take necess ary measures to ensure that the notified 
body fulfils those responsibilities .  
Evaluating the objection to the competence of notified bodies  
ARTICLE 33- (1) When the Commission or one of the EU Member States requests 
that the technical competence and  confo rmity with the relevant legislation of a notified body 
assigned by the Ministry is investigated , the procedure referred to  in Article 4 of Decision 
no.1/2006 of the  Turkey  - EU Association  Council shall be  followed . Ministry shall deliver 
the necessary inf ormation and documents to the Ministry of Economy , establish the necessary 
collaboration with relevant parties and take the necessary measures . 
Obligations of notified bodies  
ARTICLE 34- (1) The notified bodies assigned by the Ministry ; 
 a) shall carry out  conformity assessment in accordance with the conformity assessment 
procedure provided for in Article 21 ; 
b) shall carry out conformity assessment in compliance with this Implementing 
Regulation, in a transparent, independent, impartial manner , without dis criminating or 
creating unnecessary burdens for their clients, and perform their activities by taking due 
account of the size of the operations that has applied for conformity assessment, the sector in 
which it operates, its structure, the degree of comple xity of the technology used for the toy in 
question and the mass or serial nature of the production process ; 
c) shall  require the m anufacturer  to take the necessary corrective action s when they 
identify that the manufacturer does not comply with  the requir ements of Article 11  and  
Annex II  or relevant harmonized standard s  and shall not issue the  EC-type examination 
certificate ;  
ç) shall, in  the  course of  the  monitoring  of  conformity following the  issue  of  a  
EC-type examination  certificate, req uire the  manufacturer to  take necessary  corrective 
action s, and shall suspend or withdraw the certificate if necessary where  they identify a toy’s 
non-compliance ,  
d) shall restrict the scope or duration of the certificate, suspend it or withdraw it 
proportionate to the non -compliance where  the m anufacturer  does not take the necessary 
corrective action s or such action s do not bring about the intended effect .  
Information obligation of notified bodies  
ARTICLE 35- (1) The notified bodies assigned by the Mi nistry shall inform the 
Ministry of  any refusal, restriction, suspension or withdrawal of an EC -type examination 
certificate, any changes affecting the scope of and conditions for the assignment of a notified 
body, any request for information which they ha ve received from authorities carrying out 
market surveillance regarding conformity  assessment activities and on request,  conformity  assessment  activities  they  performed as notified bodies, and any other activity performed,  
including their activities outside  Turkey and subcontracting relations .  
(2)- The notified bodies assigned by the Ministry , shall provide the other notified 
bodies , which carry out similar conformity assessment activities for the toys that fall under 
this Implementing Regulation with information on conformity assessment procedures  ending 
up with  negative results and, on request, conformity assessment procedures ending up with 
positive results.  
Coordination of notified bodies  
ARTICLE 36 - (1) Ministry  shall ensure the partic ipation of the notified bodies which 
it has assigned  or their representatives to the sectoral group/groups established by the EU 
Commission, in order to provide  coordination and cooperation among notified bodies which 
are assigned to function within the scope of toys directive.  
 
SECTION VI  
Market Surveillance  
Precautionary principle  
ARTICLE 37 - (1) When  the Ministry takes measures as provided for in  this 
Implementing Regulation  and in particular those referred to in Article 38, it shall take due 
account of the precau tionary principle . 
Conducting market surveillance  
ARTICLE 38 - (1) Ministry shall perform surveillance of toys placed on the market in 
accordance with Articles 40 to 45 of this Implementing Regulation and the Implementing 
Regulation on Market Surveillance  published in the Official Gazette no. 24643 and dated 
17/01/2002. In addition to those articles, Article 39 of this Implementing Regulation shall also 
apply.  
Instructions to the notified bodies   
ARTICLE 39- (1) Ministry may request a notified body it has assigned to provide 
information relat ing to any EC -type examination certificate which that body has issued or 
withdrawn, or whi ch relates to any refusal to issue such a  certificate, including the test reports 
and technical documentation . 
 (2) If the Minist ry finds t hat a toy is not in conformity with the requirements set out in  
Article 11 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 p articular in the cases specified in paragraph 4 of Article 
21, the Ministry shall instruct the notified body  to review the EC -type examination certificate . 
Information sharing  
ARTICLE 40- (1) Ministry shall establish an adequate mechanism in order to ; 
a) follow up complaints and reports on the risks relating to toys ; 
b) monitor accidents and health hazards which are caused or suspected to have been 
caused by toys ; 
c) verify that corrective action s have been taken ; and  
d) follow up scientific and technical knowledge concerning safety .   Measures taken  
ARTICLE 41- (1) While carrying out the checks included in Article 9 of the 
Implementing Regulation on Market Surveillance published in the Official Gazette no. 24643 
and dated 17/01/2002 , Ministry shall take co unt of the existing risk assessment criteria, 
complaints and other information . Ministry may require economic operators  to submit all 
kinds of information required for market surveillance activities and where it is necessary and 
justified, enter the manufa cturing plants  of economic operators and  take the necessary 
samples of product . It may destroy or render inoperable products presenting a serious risk 
when necessary . Ministry shall take due account of the test reports or doc uments attesting the 
conformity  of the products of the economic operator and received from an accredited 
conformity assessment body . 
Products with severe risk  
ARTICLE 42 - (1) Ministry shall ensure that products which present a serious risk 
requiring rapid intervention, including a seri ous risk the effects of which are not immediate, 
are recalled, withdrawn or that their being made available on their market is prohibited and 
shall inform the Ministry of Economy on the matter for the information to be communicated 
to the Commission .  
(2) The decision whether or not a product represents a serious risk shall be based on an 
appropriate risk assessment which takes account of the nature of the hazard and the likelihood 
of its occurrence. Obtaining higher levels of safety or the availability of products p osing less 
risk shall not mean  that a product presents a serious .  
Restrictive measures  
ARTICLE 43- (1) Ministry , shall ensure that any measure taken, pursuant to this 
Implementing Regulation, to prohibit or restrict the product's being made avai lable on the 
market, to withdraw it from the market or to recall it, is proportionate and states the exact 
grounds on which it is based in its decision .  
(2) Ministry shall communicate to the economic operator the measures referred to  in 
paragraph 1 , the l egal remedies that can be followed against those measures, the ways of 
objection and the time limits applicable to them .  
(3) Except for the  health or safety requirements or other emergencies required by 
public interests foreseen in this Implementing Regul ation and  prior to the adoption of a 
measure referred to in paragraph 1, the Ministry shall give the economic operator a time 
period of not less than 10 days for submitting its opinions . If action has been taken without 
getting the opinion of the economic operator, the economic operator shall be given this 
opportunity as soon as possible and the action taken shall be reviewed promptly thereafter .  
 (4) Ministry shall promptly withdraw or amend any measure referred to in paragraph 
1 upon the economic operato r's demonstrating that he has taken effective action .  
           Inspection of the toys imported from non -EU states  
ARTICLE 44- (1) The import stage inspection of toys imported from the non -EU 
states shall be  carried out within the framework of the proced ures and principles referred to in 
the Decision on Technical Regulations and Standardization Regime in Foreign Trade and its 
sub-regulations . Measures to be taken for risky toys  
ARTICLE 45- (1) Where the Ministry have taken action pursuant  to  Article 42,    or  
where it has sufficient reason to believe that a toy covered by this Implementing Regulation 
presents a risk to the  health  or  safety  of  persons, Ministry shall  carry  out   an evaluation 
in  relation to  the  toy  concerned covering all the re quirements   laid   down   in   this   
Implementing Regulation . The   relevant economic operators shall cooperate  as necessary  
with the Ministry . Where, in the course of that evaluation, Ministry finds that the toy does not 
comply with the requirements lai d down  in  this  Implementing Regulation, it  shall without 
delay require the  relevant economic operator  to  take appropriate corrective action to bring 
the toy into compliance with those requirements, to withdraw the toy from the market, or to 
recall i t  within a  reasonable period, commensurate with  the nature of the risk . Ministry shall 
inform the relevant notified body accordingly . Article 43 shall apply to the assessment 
process for taking actions . 
(2) Where Ministry considers that non -compliance  is  not  restricted  to  Turkey only, 
it  shall  inform  the  Commission  and  EU  Member States  through the Ministry of Economy 
of  the  results  of  the  evaluation  and  of  the  actions which it has required the  relevant 
economic operator  to take . 
(3) The relevant economic operator shall take the necessary corrective action in 
respect of toys which it has made available on the market .  
(4) Where  the  relevant  economic  operator  does  not  take adequate corrective 
actions within the period referred  to in paragraph 1, Ministry shall take appropriate 
provisional measures to prohibit  or  restrict  the  toy  being  made  available on  its national 
market, to withdraw the toy from that market or to recall it . Ministry shall inform  the 
Commission and EU Member States through the Ministry of Economy, 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, Ministry shall indicate whether the no n-compliance is due to either : 
 a) failure of the toy to meet requirements relating to the health or safety of persons; or  
b) short -comings in  the harmonised standards referred to in Article 14 conferring a 
presumption of conformity .  
Formal non -compliance  
ARTICLE 46- (1) Without prejudice to  Article 45, where the Ministry makes one of 
the following findings, Ministry 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 17 or 18 , 
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 ei ther not available or not complete . (2) Where the non -compliance referred to in paragraph 1 persists , Ministry shall take 
necessary measures to restrict or prohibit the toy being made available on the market, or shall 
ensure that it is recalled or withdraw n from the market . 
 
SECTION VII   
Miscellaneous   
Reporting  
ARTICLE 47- (1) Ministry, in every 5 years , shall send its report on the application 
of this Implementing Regulation to the Ministry of Economy to be sent to the Commission . 
First report will be sub mitted to the Commission by 20/7/2019.  That report shall contain an 
evaluation of the situation concerning the safety of toys and of the effectiveness of this 
Implementing Regulation, as well as a presentation of the market surveillance activities 
performe d by the Ministry .  
Confidentiality  
      ARTICLE 48- (1) Ministry shall take the necessary measures to protect the 
confidentiality of the information that it obtained while applying this Implementing 
Regulation  and which are trade secret or which relate t o individual or industrial property 
rights . However , the disclosure made when required by other laws and human health and 
safety does not fall under this scope  
Implementation of  measures  
ARTICLE 49- (1) The grounds of any measure taken by the Ministry pur suant to this 
Implementing Regulation 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 be stated clearly in the decision . 
Decision for such a measure shall be notified without delay to the  party concerned by stating 
the legal remedies and the ways of objection and the time limits applicable to them . 
Penalties  
ARTICLE 50- (1) The provisions of Law no.4703, Turkish Penal Code no. 765 and 
other relevant legislation according to the nature a nd severity of the act shall apply to those 
who act or operate against the provisions of this Implementing Regulation . 
 
SECTION VIII  
Final and Transitional  Provisions   
 
Relevant provisions  
ARTICLE 51- (1) The provisions of the Law and other relevant legisl ation shall 
apply.  
Harmonized EU Directive  
ARTICLE  52- (1) This Implementing Regulation  is drawn up in parallel with the 
Directive 2009/48/EC of the European Parliament and of the Council of 18/7/2009 on the 
Safety of Toys . Transitional  Article 1- (1) Economic operators, which are still active and which are 
covered by this Implementing Regulation  shall  ensure compliance with the provisions of 
Implementing Regulation in the process from the publication of this Implementing Regulation 
until its effective dat e. 
 (2) The making available on the market of toys, which have been placed on the market  
in  accordance with  the Implementing Regulation on Toys published in the Official Gazette 
no. 28807 and dated 31/10/2013 before the effective date of this Implementin g Regulation,  
are shall not be impeded . 
Repealed  provisions  
ARTICLE 53- (1) The Implementing Regulation on Toys which entered into force on 
31/10/2013 by being published in the Official Gazette no. 28807  shall be  repealed on the 
effective date of this Impl ementing Regulation . 
Entry into force  
ARTICLE 54- (1) This Implementing Regulation  shall enter into force six months  
following upon its publication in the Official Gazette of Turkey.  
Execution  
ARTICLE 55 - (1) The provisions of t his Implementing Regulation  shall be  executed 
by the Minister of Customs and Trade . 
  
Annex  I 
 
PRODUCTS THAT ARE NOT CONSIDERED AS TOYS ACCORDING TO THIS 
IMPLEMENTING REGULATION  
   
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 products ; 
 d) historical reproductions of toys ,  
 e) reproductions of real fire arms . 
3- Sports equipment, including roller skates,  in-line skates  and skateboards intended for 
children with a body mass of m ore 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 mar k  
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 on t heir pavements  
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 wate r 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- Functi onal 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 pu rposes 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 per ipherals, 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 luminaries  
18- Electrical transformers for toys  
19- Fashion accessories for children which  are not for use in play  Annex  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, stabili ty 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 man ufactured 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 b e 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 externa l 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 entr ance 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 whic h 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 packagi ng, 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 be ing 
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 directly attached to a food product in such a way that the food 
product does not need to be consumed in order to get direct access to the parts of toy shall 
fulfil the requirements set out in points (c) and (d) .  
5-Aquati c 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 a nd 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 driv en ride -on toys must be limited so as to 
minimise the risk of injury . 
           8-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  
b) liquids and g ases 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 manufac tured 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. 
Therefore they must be composed of materials which fulfil one or more of the following 
conditions : 
a) They do not burn if d irectly 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 es sential 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, enamellin g, 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 el ements or 
substances likely to explode when used as specified in paragraph 2 of Article 11 .  
4- Toys and, in particular, chemical games and toys, must not contain the following 
substances or mixtures : 
a) which, when mixed together, may explode through chem ical reaction or through 
heating  or   
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 .  
III. 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 spec ified in 
paragraph 2 of Article 11 . 
 Toys shall comply with the relevant legislation relating to certain categories of 
products or certain substances and mixtures .  
2- Toys that are themselves substances or mixtures must comply also with  the 
Implementing R egulation on the Classification, Packaging and Labelling of Hazardous 
Substances and Preparations, which was published in the Official Gazette no. 27092 and dated 
26/12/2008  and Implementing Regulation on the Classification, Packaging and Labelling of 
Subs tances and Mixtures, which was published in the Official Gazette no. 28848 and dated 
11/12/2013, as applicable, relating to the classification, packaging and labelling of certain 
substances and mixtures.  
3- Without prejudice to the restrictions referred to  in paragraph 2 of Point 1, substances 
that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of categor y 
1A, 1B or 2 pursuant to the Implementing Regulation on the Classification, Packaging and 
Labelling of Substances and Mixtures which was published in the Official Gazette no. 28848 
and dated 11/12/2013  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 relevant legislation referred to in 
Section  2 of Appendix B for the classification of mixtures containing these substances . 
   b) These substances and mix tures are inaccessible to children in any form, including 
inhalation, when the toy is used as specified in paragraph 2 of Article 11 . 
 c) a decision made by the European Commission to permit the substance or mixture 
and its use and the substance or mixture  and its permitted uses  must be listed in Appendix A .   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 legislation 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 paragraph 2 of Artic le 11 . 
 c) The decision made by the European Commission to permit the substance or 
mixture and its use and the substance or mixture and its permitted uses must be listed in 
Appendix A.  
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 fall under the scope of the 
Implementing Regulation on Substances and Materials That Came Into Contact With Food 
published in the Official Gazette no. 28157 and dated 29/12/2011 or that comply with the 
provisions for food contact materials specified under this Implementing Regulation and 
special measures for relevant materials , but not later than 20/07/2017 and until specific limit 
values are laid down   for chemicals used in the toys intended for use by ch ildren under 36 
months or intended to be placed in the mouth .  
 8- Without  prejudice to  the  provisions 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- Cosmetic toys, such as play cosmetics for dolls, shall comply with the co mpositional 
and labelling requirements laid down in the Implementing Regulation on Cosmetics published 
in the Official Gazette no. 25823 and dated 23/05/2005.  
 10- Toys shall not contain the following allergenic fragrances : 
 
No Name of the allergenic fragr ance 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 -20-0 
(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 -dodec atrien -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 o il (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 122-57-6 
(41) Amyl cinnamal  122-40-7 
(42) Amylcinnamyl a lcohol  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 . 
 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 adde d to a toy, as such, at 
concentrations exceeding 100 mg/kg in the toy or components of the toys . 
 
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)  Citronell ol 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 127-51-5  
 
11- The use of the fragrances set out in items 41 to 55 of the list set out in paragraph 1 
of point 10 and of the fragrances set out in items 1 to 11 of the list set out in paragraph 3 of 
that point shall be allowed in olfactory board games, cosmeti c kits and gustative games, 
provided that ;  
 a) 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,  
 b) the products made by the child in accordance with the instructions  comply with the 
requirements of the Implementing Regulation on Cosmetics published in the Official Gazette 
no. 25823 and dated 23/05/2005 , 
 c) those fragrances comply with the relevant legislation on food.  
 Such olfactory board games, cosmetic kits and gu stative games shall not be used by 
children under 36 months and shall comply with point 1 of Part B  of Annex V . 12-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  1500  375 18750  
Boron 1 200  300 15 000  
Cadmi yum 1,3 0,3 17 
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 
Seleni um 37,5 9,4 460 
Stron tium 4 500  1 125  56 000 
Tin 15 000  3 750  180 000  
Organic tin  0,9 0,2 12 
Zinc 3 750  938 46 000  
 
 These 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 
paragraph 2 of Article 11 . 
IV. Electrical Properties  
1-Toys shall not be powered by electricity of a nominal voltage exceeding 24 volts 
direct current (DC) o r 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, t ogether 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 wa y 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 technical methods and latest technologic 
developments . 
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 pr esent any 
health hazards or risk of injury to eyes or skin from lasers, light -emitting diodes (LEDs) or 
any other type of non -ionizing radiation . 
9- The electrical transformer of a toy shall not be an integral part of the toy . 
V. Hygiene  
1- Toys must be de signed 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 t hat it can be cleaned. A textile toy shall 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 i nstructions . 
VI. Radioactivity  
 Toys shall comply with the Implementing Regulation on Radiation published in the 
Official Gazette no.23999 and dated  24/03/ 2000 .  
  
APPENDIX -A 
 
CMR substances and their permitted uses in accordance with points 4, 5 and 6 of  Part III -
Chemical Properties   
 
 
Substance   
Classification   
Permitted use  
 
Nickel  
CMR 2  
In stainless steel  
 APPENDIX  -B 
 
 
As a result of the timing of the application of Implementing Regulation on the 
Classification, Packaging and Labelling of Substa nces and Mixtures which was published in 
the Official Gazette no. 28848 and dated 11/12/ 2013 , 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 mix tures  for the purposes of  Point  2 of Part II 
- Flammability.  
 
A. Criteria to be applied until 31/5/ 2016:  
    
Substances  
The substance fulfils the criteria for any of the following hazard classes or 
categories set out in Annex I to Implementing Regulati on on the Classification, 
Packaging and Labelling of Substances and Mixtures  which was published in the 
Official Gazette no. 28848 and dated 11/12/2013 :  
 
(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 Implementing Regulation on the 
Classification, Packaging and Labelling of Hazardous Substances and Preparations, 
which was published in the Official Gazette no. 27092 and dated 26/12/2008.  
 
B. Criteri a to be applied from 1/6/ 2016:  
 
The substance or mixture fulfils the criteria for any of the following hazard classes or 
categories set out in Annex I to Implementing Regulation on the Classification, 
Packaging and Labelling of Substances and Mixtures, wh ich was published in the 
Official Gazette no. 28848 and dated 11/12/2013 :  
(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- Legislation governing the use of certain substances for the purposes of  points 
4(a) and 5(a) of Part III -Chemical Properties:  
 Until 31/5/ 2016, the relevant concentrations for the classification of mixtures containing the 
substances shall be those established in accordance with Implementing Regulation on the 
Classification, Packaging and Labelling of Hazardous Substances and Preparations which 
was published in the Official Gazette no. 27092 and dated 26/12/2008.  
From 1/6/ 2016, the relevant concentrations for the classification of mixtures containing the 
substances shall be those establ ished in accordance with Implementing Regulation on the 
Classification, Packaging and Labelling of Substances and Mixtures which was published in 
the Official Gazette no. 28848 and dated 11/12/2013 . 
 
3- Categories of substances and mixtures classified as c arcinogenic, mutagenic or 
toxic for reproduction (CMR) for the purposes of  point 4 of III- Chemical Properties:  
 
Substances  
Point 4 of Part III  - Chemical Properties  concerns substances classified as CMR 
category 1A and 1B under Implementing Regulation on  the Classification, Packaging and 
Labelling of Substances and Mixtures which was published in the Official Gazette no. 
28848 and dated 11/12/2013 . 
 
Mixtures  
Until 31 /5/2016, point 4 of Part III - Chemical Properties  concerns mixtures classified 
as CMR ca tegory 1 and 2 under Implementing Regulation on the Classification, Packaging 
and Labelling of Hazardous Substances and Preparations which was published in the 
Official Gazette no. 27092 and dated 26/12/2008.  
From 1 June 201 6, point 4 of Part III - Chemica l Properties  concerns mixtures 
classified as CMR category 1A and 1B under Implementing Regulation on the 
Classification, Packaging and Labelling of Substances and Mixtures which was published in 
the Official Gazette no. 28848 and dated 11/12/2013 . 
 
4- Cate gories of substances and mixtures classified as carcinogenic, mutagenic or 
toxic for reproduction (CMR) for the purposes of point 5 of Part III - Chemical 
Properties:  
Substances  
Point 5 of Part III - Chemical Properties concerns substances classified as CMR  
category 2 under Implementing Regulation on the Classification, Packaging and Labelling 
of Substances and Mixtures which was published in the Official Gazette no. 28848 and 
dated 11/12/2013 . 
 
 Mixtures  
Until 31 /5/2016, point 5 of Part III  - Chemical Prope rties concerns mixtures classified 
as CMR category 3 under Implementing Regulation on the Classification, Packaging and 
Labelling of Hazardous Substances and Preparations which was published in the Official 
Gazette no. 27092 and dated 26/12/2008.  
From 1 /6/2016, point 5 of Part III  - Chemical Properties  concerns mixtures classified 
as CMR category 2 under Implementing Regulation on the Classification, Packaging and 
Labelling of Substances and Mixtures, which was published in the Official Gazette no. 
28848 an d dated 11/12/2013.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ANNEX  III 
 
EC DECLARATION OF CONFORMITY   
 
 
1- No ………….( the number that identifies the toy by separating it from the others ): 
 
2- Name and address of the manufacturer or his authorised representative : 
 
3- This dec laration of conformity is issued under the sole responsibility of the 
manufacturer (Name of the manufacturer ): 
 
4- Object of the declaration (identify the toy so as to allow traceability ) and a colour 
image of sufficient clarity to enable the identification o f the toy . 
 
5- The object of the declaration described above is in conformity with the following 
legislation . (Name of the legislation ) 
 
6- References to  the  relevant harmonised standards used, or  references to  the  technical 
specifications in  relation to  which conformity is declared : 
 
7- Name and identification number of the notified body which is involved (describing the 
type of conformity assessment activity ) and which issued the ……………. certificate   
 
8- Additional information : 
 
Signed for and on behalf of: ...........................................  
(Place and date of issue ) 
(Name , task/title) (signature ) 
  
ANNEX  IV 
 
 
TECHNICAL DOCUMENTATION  
 
The technical documentation referred to in Article 22 shall contain , in particular,  the 
following documents so far as re levant 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 suppl iers, 
b) the safety ass essments carried out in accordance with Article 19 , 
  c) a description of the conformity assessment procedure followed , 
ç) a copy of the EC declaration of conformity , 
 d) the addresses of the places of manufacture and storage,  
  e) copies of documents that  the manufacturer has submitted to a notified body, if the 
services of such are used , 
f) 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 paragraph 2 of Article 20 , 
g) 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  
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 t ype procedure referred t o in paragraph 3 of 
Article 20 . 
 
 ANNEX  V 
 
WARNINGS  
(as referred to in Article 12) 
 
PART  A 
GENERAL WARNINGS  
 
The user limitations referred to in paragraph 1 of Article 12 shall specify at least the 
minimum or maximum age of the u ser 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 explanation of the specific hazard 
calling for this precaution, which may appear in the instructions for use . 
This point shall not apply to toys which, on account of th eir 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 regular 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 informatio n 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 
and 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 prod uct of which the toy is a sca le 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 . 
4) Chemical toys  
Without  prejudice to the provisions laid down in applicable legisla tion 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 
accide nts 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 (1) years . For use under adult supervision ”. 
In particular , chemistry sets, plastic or ceramic mould s, enamelling or photography 
and similar toys that lead to a chemical reaction or similar substance alterat ion during use are 
regarded as chemical toys . 
5) Skates , roller  skates, on-line skates, skateboards, scooters and toy bicycles for 
children  
These toys shall bear the following warning : 
“Protective equipmen t 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 an d under adult 
supervision’ . 
                                                 
1 Age to  be specified by the manufacturer . 7) Toys in food  
Toys contained in food or co -mingled with food shall bear the following warning : 
“Toy is inside. Adult supervision is 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 designed/ intended to be strung across a cradle, cot or perambulator by 
means of strings, cords, elastics or straps  
Toys intended to b e 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 to y when the child starts 
trying to get up on its hands and knees in a crawling position ”. 
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 4 1 to 55 of the list set out in the first paragraph of 
point 10 of III -Chemical Properties of Annex II  and of the fragrances set out in points 1 to 11 
of the list set out in third paragraph of that po int shall contain the following warning : 
“Contains fragrances that may cause allergies ”.