86/2011 Sb.
GOVERNMENT REGULATION
of 9 June. March 2011
on technical requirements for toys
Change: 24/Sb.
Change: 151/2015 Sb.
Change: 339/Sb.
Government orders under section 22 of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
Act No. 207/2002 Coll. and Act No. 34/2007 Coll. (hereinafter the "Act") to
implement section 2 (a). (d)), section 11 (1) 1, 2 and 9, section 11a. 2, § 12 and 13
the law:
PART THE FIRST
GENERAL PROVISIONS
§ 1
The subject of the edit
This regulation incorporates the relevant provisions of the European Union ^ 1), at the same time
builds on the directly applicable European Union regulation ^ 4) and modifies the
technical requirements for toys, and the conditions for the placing on the market.
§ 2
Toys
(1) laid down under this regulation are products within the meaning of § 12 para.
1 (b). and toys) of the Act. For the purposes of this regulation, the toy
considers the product designed or intended for use in play by children under 14 years of age,
including product designed or specified next to the gaming and for other purposes.
(2) shall not be considered toys products referred to in annex 1 to this
of the regulation.
(3) this Regulation shall not apply to the following toys:
and equipment for children's playgrounds) intended for the general public,
b) slot machines, including vending machines for coins, intended for the general public,
(c) vehicles and vehicles for children) with internal combustion engines,
d) steam engines for toys and
e) slings and catapults.
§ 3
Basic concepts
(1) for the purposes of this regulation, means a
and) operator, the manufacturer, importer, distributor and the authorised
the representative,
(b)) a functional product the product that is used and is used as well as the
product, apparatus or device designed for adults and may be
a scale model,
c) functional toy toy that can be used and is used as well as the
product, apparatus or device designed for adults and may be
a scale model,
d) toy in the water toy which is intended for use in shallow water and
that is able to bear a child on the water or to keep him afloat,
e) design speed of the typical potential operating speed that
is determined by the design of the toy,
f) toy for physical activity toy for domestic use, the
the structure remains stable during physical activity, and which is intended
to ensure that the child is engaged in any of the following activities: climbing,
jumping, swinging, sliding, rolling, rolling, crawling and creeping,
or any combination of these activities,
g) chemical toy toy intended for direct manipulation of the chemical
substances and mixtures, which is to be used in a manner appropriate to the age and under
adult supervision,
h) stimulating olfactory Board Games game toy, the purpose of which is to help
child learn to recognize the different smells and aromas,
I) cosmetic Kit toy, the purpose of which is to help the child to learn
to produce products such as perfumes, soaps, creams, shampoos, foams
bath salts, lip gloss, lipstick, make-up, toothpaste and shampoo,
j) game gustative toy whose purpose is to allow the
child to produce sweets or dishes with the use of food additives,
such as candies, liquid, powders and flavourings,
to damage health injury) any other damage to health, including
long-term health consequences,
l) the dangers of a potential source of damage to health,
m) the probable rate of occurrence of risk the risk of causing damage to the
health and the severity of the damage,
n) toy intended for designated age group children toy, in which
can a parent or supervision on the basis of their functions, dimensions and characteristics
reasonably assume that it is intended for a child this age group.
(2) a manufacturer is also considered a person who places a toy on the market under
his own name or trademark or modifies a toy that was
already placed on the market in such a way that may affect its compliance with the
the requirements of this regulation.
PART TWO
THE ACTIVITIES OF ECONOMIC OPERATORS
§ 4
The manufacturer of the
(1) the manufacturer before placing a toy on the market, shall draw up technical documentation
in accordance with section 18 and carry out or arrange for the appropriate procedure
conformity assessment in accordance with section 16. In the case of demonstration of conformity of the toy with
the requirements laid down in article 9 and in annex 2 of this regulation by
procedure, manufacturers shall draw up before placing a toy on the market of the EC declaration of
conformity in accordance with section 12 and affix the CE marking in accordance with § 13.
(2) the manufacturer shall keep the technical documentation and the EC declaration of conformity
a period of 10 years after the toy on the market.
(3) the manufacturer shall ensure that the toy, which lists on the market, listed
type, batch, serial number or model number or any other element
enabling the identification, or in cases where the size or
nature of the toy does not allow it, that the required information is provided on
packaging or in a document accompanying the toy.
(4) the manufacturer shall indicate on the toy or, where that is not possible, on its packaging or in
a document accompanying the toy its name or first and last name,
business name, name or trade mark, if it can be
under it to uniquely identify and address a single point,
on which he can be contacted.
(5) in order to protect the health and safety of persons, and having regard to the nature of the
toys and the risks that toy, manufacturer
and the testing of samples of the toys) is placed on the market by
(b)), whether it is saving a toy marketed by him in accordance with the requirements of
laid down in article 9 and in annex 2 to this regulation, and in particular
If you received a complaint about this toy,
c) keeps records of complaints referred to in subparagraph (b)), toys which have been
the investigation referred to in subparagraph (b)) found that are not in accordance with the requirements of
laid down in article 9 and in annex 2 to this regulation, adopted by the
measures aimed at achieving the return of a toy that has already been delivered to the
to the end user,
(d)) shall inform distributors of the procedures laid down in points (a) and (b)).)
(6) the manufacturer, who believes or has reason to believe that a toy,
you stated on the market is not in conformity with the requirements of this regulation, the
immediately take the corrective measures necessary to bring that toy into conformity with
These requirements, or, where appropriate, withdraw it from the market or make arrangements,
aiming at the recovery of the specified product that has already been shipped
to the user. Furthermore, where the toy presents a risk, it shall immediately
shall inform the competent supervisory authority or equivalent authorities of the Member States
The European Union (hereinafter referred to as "Member State"), in which he added to the toy
market, outlining details, in particular about the non-compliance and of any
corrective measures taken.
(7) the manufacturer shall submit to the competent supervisory authority or similar body
the Member State on the basis of its reasoned request, all the information and
documentation necessary to demonstrate the conformity of the toy with the requirements of this
Regulation in the language of the Member State concerned, unless otherwise agreed.
The manufacturer shall cooperate with the institutions referred to in the first sentence, on request
in any activities, the goal is to eliminate the risks posed by
toys which it placed on the market.
§ 5
Authorized representative
(1) the authorized representative shall be entitled to at least
and retention) EC declaration of conformity and the technical documentation for the needs of
the supervisory authorities for 10 years after the toy on the market,
(b) all information and Administration) transmission of all documents that are
necessary to demonstrate the conformity of the toy, the surveillance of the competent authorities on the basis of
reasoned request,
c) cooperation with the relevant supervisory authorities, if they so request, on
activities, the goal is to eliminate the risks posed by toys on
his power of attorney.
(2) the manufacturer cannot appoint an authorised representative by developing
technical documentation and by ensuring that the toys were designed and
manufactured in accordance with the requirements laid down in article 9 and in annex 2 to the
application of this regulation.
§ 6
The importer
(1) the importer may place on the market only a toy for which the manufacturer made the
technical documentation in accordance with section 18, which was carried out by the competent
conformity assessment procedure according to § 16, which is accompanied by the required
papers and that is provided with the CE marking in accordance with § 13 and other
information pursuant to § 4 paragraph 2. 3 and 4. Where an importer considers or has reason to
believe that a toy is not in conformity with the requirements set out in section 9 and in
Annex 2 to this regulation, shall not place the toy on the market, until the
brought into conformity with those requirements. Furthermore, where the toy presents a
risk, it shall inform the manufacturer, as well as the competent supervisory authorities.
(2) the importer shall indicate on the toy or, where that is not possible, on its packaging or in
a document accompanying the toy its name or first and last name,
business name, name or trade mark, if it can be
It uniquely identify, and address of the place at which the
You can contact him.
(3) the importer shall ensure that for the period prior to launch with a toy
treats, its storage or transport conditions do not jeopardise the conformity of toys
with the requirements laid down in article 9 and in annex 2 to this regulation.
(4) the importer for a period of 10 years after the toy on the market keeps a copy of the EC
Declaration of conformity at the disposal of the competent supervisory authorities and ensure that the
the technical documentation will be made available to those authorities, upon request.
(5) in order to protect the health and safety of persons, and having regard to the nature of the
toys and the toy presents a risk, importers,
and the testing of samples of the toys) is placed on the market by
(b)), whether it is saving a toy marketed by him in accordance with the requirements of
laid down in article 9 and in annex 2 to this regulation, and in particular
If you received a complaint about this toy,
c) keeps records of complaints referred to in subparagraph (b)), toys which have been
the investigation referred to in subparagraph (b)) found that are not in accordance with the requirements of
laid down in article 9 and in annex 2 to this regulation, adopted by the
measures aimed at achieving the return of a toy that has already been delivered to the
to the end user,
(d)) shall inform distributors of the procedures laid down in points (a) and (b)).)
(6) the importer considers or has reason to believe that a toy,
you stated on the market is not in conformity with the requirements of this regulation, the
immediately take the corrective measures necessary to bring that toy into conformity with
These requirements, or, where appropriate, withdraw it from the market or make arrangements,
aiming at the recovery of the specified product that has already been shipped
to the user. Furthermore, where the toy presents a risk, it shall immediately
shall inform the competent supervisory authority or similar bodies in the Member States,
in which a toy on the market, he added, outlining details, in particular on the
non-compliance and of any corrective measures taken.
(7) the importer shall submit to the competent supervisory authority or similar body
the Member State on the basis of its reasoned request, all the information and
documentation necessary to demonstrate the conformity of the toy with the requirements of this
Regulation in the language of the Member State concerned, unless otherwise agreed.
Importer cooperates with the authorities referred to in the first sentence, on request
in any activities, the goal is to eliminate the risks posed by
toys which it placed on the market.
§ 7
Distributor
(1) the Distributor before you deliver the toys on the market validates that is equipped with a
the CE marking in accordance with § 13, whether it is accompanied by the required
documents, notices, instructions and safety information in Czech language
and that the manufacturer and importer to meet the requirements set out in section 4, paragraph 4. 3 and 4 and
§ 6 para. 2. where a distributor considers or has reason to believe that
the toy is not in conformity with the requirements laid down in article 9 and in annex 2 to the
This regulation may make the toy available on the market after its entry into
compliance with these requirements. Furthermore, where the toy presents a risk,
distributor shall inform the manufacturer or the importer, as well as the relevant
the supervisory authorities.
(2) the Distributor shall ensure that, for the period before delivery to the market with a toy
treats, its storage or transport conditions do not jeopardise the conformity of toys
with the requirements laid down in article 9 and in annex 2 to this regulation.
(3) a Distributor who believes or has reason to believe that a toy,
He added that the market is not in conformity with the requirements of this regulation,
ensure that the corrective measures necessary to bring that toy
in accordance with these requirements, or, where appropriate, withdraw it from the market or
They shall take measures aimed at achieving the return of a product established
It has already been delivered to the user. Furthermore, where the toy presents a risk,
It shall immediately inform the competent supervisory authority or similar bodies
Member States in which the toy on the market, he added, outlining
details, in particular about the non-compliance and of any corrective measures taken.
(4) the Distributor shall submit to the competent supervisory authority or similar
authority of the Member State on the basis of the substantiated request all
the information and documentation necessary to demonstrate the conformity of the toy with the requirements
of this regulation. The Distributor interacts with the authorities referred to in the sentence
the first, on request, in any activities aimed at
eliminate the risks posed by toys which he added to the market.
§ 8
Identification of economic operators
(1) economic operators on request of the competent supervisory authorities
identify all operators,
and they have supplied a toy to them),
b) whom they have supplied a toy.
(2) manufacturers and importers to provide information referred to in paragraph 1 for a period of 10
years of putting toys on the market and distributors for 10 years after they
the toy was made.
PART THREE
THE CONFORMITY OF TOYS
§ 9
The basic requirements
(1) the Toys may be placed on the market only if they comply with basic
safety requirements referred to in terms of a general requirement on
safety, in paragraph 2, and with regard to specific requirements for the
safety, in annex 2 to this Regulation (hereinafter referred to as ' the basic
requirements ").
(2) Toys, or chemical substances and mixtures contained therein must not compromise the
the safety or health of users or third parties when they are used as intended
in a foreseeable way having regard to normal behaviour
the children, taking into account the capabilities of the user and, where appropriate, its
surveillance, especially in the case of toys intended for children under the age of 36
months or for other well-defined age groups. The toy must be
connected or accompanied by the notification according to § 11 para. 2.
(3) Toys placed on the market must be designed and constructed so that they are in
compliance with the essential requirements for the foreseeable and normal period
the use of.
§ 10
The presumption of conformity of toys
If the toys are in conformity
and) with harmonised standards or parts thereof which have been
references published in the official journal of the European Union,
(b)) with the harmonised Czech technical standards or parts thereof,
transposing the standards referred to in point (a)), or
(c)) with foreign technical standards in the Member State or
parts, which transpose the standards referred to in point (a)),
shall be considered as the essential requirements covered by those standards or parts thereof
concern, have been met.
§ 11
Warnings, instructions and safety information
(1) the manufacturer and the importer shall ensure that the toy, which lists on the market,
the warning accompanied by instructions and safety information in accordance with paragraphs
2 and 3 in the Czech language.
(2) the labels and instructions for use connected or attached to the toy
must notify the user or their sight on the hazards and risks
health damage related to the use of this toy, and arising from its
and ways to avoid these hazards and risks should be avoided. If
It is suitable for the safe use of the toy, shall indicate the appropriate warning
restrictions on user in accordance with part A of annex 5 to this
of the regulation.
(3) in the case of toy categories listed in part B of annex 5 to this
Regulation shall be followed warnings and instructions given in this section.
The warning referred to in paragraphs 2 to 10 of part B of annex 5 to this
the regulation shall apply in the version referred to in those paragraphs. On toys,
do not mention the warnings set out in part B of annex 5 to this regulation,
If they are inconsistent with the intended use of the toy, which is determined on the
the basis of its functions, dimensions and characteristics.
(4) the manufacturer indicates the warning referred to in paragraphs 2 and 3 clearly
visible, easily legible, easily comprehensible and precise manner to
the toy on the label or on the packaging and, where appropriate, in the instructions for
the use of the toy, which is attached. For small toys that are sold without
the package warns connects directly them. Before warnings
shall bear the word "warning".
(5) Notice relevant to a decision to purchase toys, in particular
those specifying the minimum and maximum age limits for
and other appropriate user warnings set out in annex 5 to this
Regulation, shall be placed on the sales packaging or be otherwise
clearly visible to the consumer before the purchase, and even in the case of
purchase through means of distance communication.
§ 12
EC declaration of conformity
EC declaration of conformity shall be drawn up in accordance with the model set out in
Annex 3 to this regulation in any language or in that language
translated and must be continuously updated.
section 13 of the
Terms and conditions for affixing the CE marking
(1) Toy or supplied on the market shall bear the "CE" marking
the graphic design and the use of the guidelines provides for the directly
applicable regulation the European Union ^ 2). The CE marking may be connected
a pictogram or any other mark indicating a special risk or
the use of the.
(2) the CE marking must be affixed visibly, legibly and indelibly
to the toy to the attached label or packaging. In the case of small toys and
Toys consisting of small parts the CE marking may alternatively
connect to a label or an accompanying leaflet. If in the case of toys
offered in a shop in rack storage vessels is not technically
feasible and if the tank was originally used as a wrapper for the
Toys CE marking may be affixed to the connected stack. If
the CE marking is not visible through the packaging, if any, must be connected
at least on the packaging.
§ 14
Conditions for use of toys not complying with the requirements of this regulation
A toy that does not bear the CE mark or does not meet in another respect,
the requirements of this regulation, may be exposed to and used at trade fairs
and the shows, if it is accompanied by the designation, which clearly indicates that
the toy does not meet the requirements of this regulation and will not be placed on the market in
The European Union, until the requirements of this regulation meet.
PART FOUR
CONFORMITY ASSESSMENT
§ 15
Assess the safety
Before placing a toy on the market, the manufacturer performs the analysis of chemical,
physical, mechanical and electrical hazards and risk
flammability, hygiene and radioactivity, which can
Toy pose, and an assessment of potential exposure to such risks.
section 16 of the
The relevant conformity assessment procedures
(1) before placing a toy on the market, the manufacturer shall apply the appropriate procedure
conformity assessment referred to in paragraph 2 or 3, to prove that the toy
complies with the essential requirements.
(2) if the manufacturer has applied the harmonised European standards which have been
references published in the official journal of the European Union and that include
all the relevant essential requirements, it shall proceed in accordance with the procedure
internal production control laid down in part I of annex 6 to this
of the regulation.
(3) in the event that the
and) there are no harmonised European standards, the references of which have been
published in the official journal of the European Union, and that include all
the relevant essential requirements,
b) harmonised European standards referred to in point (a)), but there are
the manufacturer has not applied, or has applied only in part,
c) harmonised European standards referred to in point (a)) or any of the
they have been published with a restriction, or
(d)) the manufacturer considers that the nature, design, construction or purpose of the toy
requires third party verification, the manufacturer shall submit the toy to EC type-examination
type according to section 17 and shall proceed in accordance with the conformity to type
laid down in part II of annex 6 to this regulation.
§ 17
EC type-examination
(1) the application for EC type-examination, the implementation of this examination and release
EC type-examination certificate shall be governed by the procedures laid down in the annex
# 7 to this regulation.
(2) if the notified body carries out the EC type-examination, it shall evaluate, in
If necessary, together with the manufacturer, the analysis of the risk in accordance with § 15.
(3) If a notified body finds that a toy does not meet the basic
requirements, it shall request the manufacturer to take appropriate corrective measures, and
shall not issue the EC type-examination certificate.
(4) the EC type-examination Certificate must be reviewed, in particular in the
event of a change in the manufacturing process, in the raw materials or the components of toys
and at least every 5 years. Notified body shall not issue a certificate of EC
type-examination to the toys, which have been the issue of the certificate
rejected, or to toys, to which the certificate has been revoked. Authority
supervision, has a reasonable doubt, that the toy does not meet the basic
requirements, can be notified to a person an incentive to EC type-examination certificate
the type of review.
(5) the technical documentation for the purposes of the EC type-examination, and other
the document relating to the EC type-examination procedures must be
drawn up in the English language or in another language that was designed
certification.
section 18
The technical documentation
(1) the technical documentation must contain all relevant information about
means by which the manufacturer ensure that the toy complies with the essential
requirements. The elements of the technical documentation laid down in annex 4 to
application of this regulation.
(2) the technical documentation to be drawn up in one of the official languages of the
The European Union, with the exception of the requirement set out in § 17 paragraph 2. 5.
(3) on the basis of a reasoned request from the competent supervisory authority or
similar to the authority of the Member State shall ensure that the manufacturer of the translation of the relevant
parts of the technical documentation into the language of the Member State concerned.
If the supervisory authority requests the technical documentation or the manufacturer of the
translation of the relevant parts, may set a time limit for the delivery of
documentation or translation, the length of which is 30 days, if it is not needed
a shorter period because of serious and immediate risk.
(4) if the manufacturer does not comply with the requirements referred to in paragraphs 1 to 3 may, from
the competent supervisory authority to require him to let test
certification at its own expense and in due time to verify the
line toys with the essential requirements.
PART FIVE
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
§ 19
Effects of the notification
Certification under this regulation, a person authorized by the
§ 11 (1) 2 of the Act becoming the expiry of two weeks after the notification, if it is
used as the basis for the notification of the accreditation certificate, or of the period 2
months of the notification, if this certificate does not apply, and only for
provided, that the European Commission or the other Member States in the
the time limits have not raised objections to this notification.
section 20
Requirements for authorized persons
(1) an authorized person under this Regulation may only be legal
person established under the law of the United States.
(2) the application for authorization for the purposes of notification according to § 7 (2). 7
(a). (b)) of the Act is a description of the conformity assessment activities, the procedure or procedures
conformity assessment.
(3) the authorized person must be independent of the entity, whose toy
assessed, and the toy itself. An authorized person may also be
legal person belonging to a business association or Professional Federation
business owners involved in the design, manufacture, supply,
installation, use or maintenance of toys that the authorized person
be assessed, if it proves its independence and the absence of any
a conflict of interest.
(4) the authorized person, the persons who conduct the business of an authorized person, and
persons responsible for carrying out the conformity assessment tasks shall not be the
persons, the designer, manufacturer, supplier, Installer, purchaser,
custom or maintainer of the toys which they assess, nor the
the authorised representative of any of these people. This does not preclude the use of
assessed toys that are necessary for the operation of the authorized
the person, or the use of such toys for personal purposes. Authorized
person, persons who conduct the business of an authorized person, and the persons responsible
for the implementation of the conformity assessment tasks shall not be directly involved in the
designing or manufacturing, marketing, installation, use or
maintenance of those toys, or represent the entities, these activities
dealing with. Shall not engage in any activity that could harm the
their independence of judgement and impartiality in relation to the activities of the assessment,
to which they are notified. This is especially true for
consultancy services. The notified body shall ensure that the activities of its
affiliates or subcontractors do not threaten the confidentiality, objectivity or
impartiality of its conformity assessment activities.
(5) the authorized person and the persons conducting or responsible for
the implementation of activities related to conformity assessment carried out by these
the activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and must not succumb to any
inducements, influencing and nátlakům, particularly financial, which might
influence their judgement or the results of their conformity assessment, especially
from persons or groups of persons that have the results of those
activities of interest.
(6) the authorized person must be able to perform all the obligations of the
connected with conformity assessment, it under the section 17 of, and for which the
notified, whether those tasks itself, the notified body or
are carried out on its behalf and under its responsibility. Authorized person
must be always available for each conformity assessment procedure and to
each type or category of toys for which it is notified,
and) persons with expertise and experience needed to
carrying out the tasks related to conformity assessment,
(b)), according to which procedures for conformity assessment is carried out and which
ensure transparency and reproducibility of these procedures; must apply
appropriate policies and procedures to distinguish between tasks, which carries out
as a notified body and other activities,
(c) the procedures for the implementation of the actions), which duly take into account the size and
the structure of the undertaking, the sector in which they operate, the degree of complexity of
technology of the toys and the mass or serial nature of the production
process.
(7) the authorized person must have the means necessary for the proper
the technical and administrative tasks connected with the assessment
compliance and must have access to all necessary equipment or facilities.
(8) persons responsible for carrying out conformity assessment activities
must
and) have adequate technical and vocational training covering all
the conformity assessment activities for which it was authorized
person notified
(b) have a satisfactory knowledge of the requirements) related to the assessment, which
they carry out and adequate authority to carry out this assessment,
(c)) have appropriate knowledge of the essential requirements, the competent
harmonised European standards and of the relevant provisions of the
harmonisation of European Union legislation and its implementing regulations and
to understand them,
(d)) to be able to draw up the certificates, records and reports to demonstrate
that was the assessment made.
(9) the authorized person after his announcement in accordance with § 19 involved in
relevant standardisation activities and the activities of the coordination
a group of people set up by the European Commission notified or ensure that
were the staff informed of those activities, and is used as a
General decisions and documents that are the result of work
of this group.
(10) the authorized person, the persons who conduct the business of an authorized person,
and persons carrying out conformity assessment shall be in the performance of its activities
impartial. The remuneration of the persons who conduct the business of an authorized person, and
persons engaged in or responsible for carrying out the assessment of conformity shall not
be dependent on the number of assessments carried out or the results thereof.
section 21
Presumption of conformity
When a conformity assessment body demonstrates that it complies with the criteria laid down
and the relevant harmonized European standards) or parts thereof,
the links which have been published in the official journal of the European Union,
b) harmonised Czech technical standards or parts thereof,
transposing the standards referred to in point (a)), or
c) foreign technical standards or parts thereof, which in
Member State to transpose the standards referred to in point (a)),
consider the requirements set out in section 20, in which the said
the standards cover those requirements, have been met.
section 22
Affiliates and subcontractors of the notified persons
(1) a notified body may specify specific tasks relating to the
conformity assessment subcontractors only or branch office that meets the requirements
set out in section 20. To enter these tasks shall inform the Office.
(2) the notified body shall bear full responsibility for the tasks performed by
by subcontractors or subsidiaries, regardless of where they are established.
(3) the activities of conformity assessment subcontractors or branch can be specified
only with the consent of the customer.
(4) the notified body shall keep at the disposal of the Office the relevant documents
concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work
made by the subcontractor or the subsidiary under section 17.
Article 23 of the
Obligations relating to the activities of the notified persons
(1) the conformity assessment shall be carried out in such a way as to prevent
excessive burden on economic operators. Notified when
perform their activities taking due account of the size and structure of the
undertaking, the sector in which it operates, the degree of complexity of the technology
toys and the mass or serial nature of the production process. Must be
However, compliance with the degree of rigour and the level of protection required,
that toy in conformity with this regulation.
(2) If, after the issue of the EC type-examination certificate (hereinafter referred to as
the "certificate") notified body finds that a toy no longer complies with
the essential requirements, it shall request the manufacturer to take appropriate corrective
measures, and, if necessary, the validity of the certificate is suspended or
This certificate cancels.
(3) if the manufacturer has not taken corrective measures referred to in paragraph 2, or
If these measures do not have the required effect, the notified changes
or suspend the validity of the relevant certificate or, where appropriate, this
the certificate cancels.
section 24
Information obligation on notified persons
(1) a notified body to provide the other notified persons
carrying out similar conformity assessment activities and covering the same
toys, relevant information about restrictions, cancellations and refusals
issue the certificate and, on request, about certificates issued.
(2) the notified body shall inform the Office of the
and restrictions) of any suspension or cancellation of certificates and the
any refusals to issue the certificate,
(b)) of any request of the supervisory authorities concerning assessment activities
conformity,
c) on request, conformity assessment activities performed within the
the scope of the authorization and any other
the activities, including cross-border activities and subcontracting.
(3) a notified body to provide information at the request of the supervisory authorities
for certificates that are issued by the notified body, have refused to
issued or cancelled.
PART SIX
TRANSITIONAL AND FINAL PROVISIONS
§ 25
Transitional period
(1) toys which comply with the requirements laid down by regulation of the Government No.
19/2003 Coll., in the version in force until the date of entry into force of this regulation,
that have been placed on the market before the date of entry into force of this regulation,
can be supplied on the market even after the date of entry into force of this regulation.
(2) toys which comply with the requirements of this regulation, with the exception of
the requirements set out in part III of annex 2 to this regulation,
that meet the requirements of part II, point 3 of annex 2 of Decree-Law No.
19/2003 Coll., in the version in force until the date of entry into force of this regulation,
may be placed on the market before 20. July 2013 and made available on the market, even after the
This date.
section 26
Regulation (EEC)
Shall be repealed:
1. Government Regulation No. 19/2003 Coll., laying down technical requirements
on toys.
2. Government Regulation No 340/2008 Coll., amending Decree-Law No.
19/2003 Coll., laying down technical requirements for toys.
3. Government Regulation No. 1/2010 Coll., amending Decree-Law No.
19/2003 Coll., laying down technical requirements for toys, as amended by
Government Regulation No 340/2008 Sb.
section 27 of the
The effectiveness of the
This Regulation shall enter into force on 20 March 2004. July 2011.
Prime Minister:
RNDr. Nečas in r.
Minister of industry and trade:
Ing. Sri k v r.
Annex 1
PRODUCTS WHICH ARE NOT CONSIDERED AS TOYS
1. decorative objects for festivities and celebrations,
2. products for collectors, if the product or its packaging bears the
in a visible and legible indication that it is intended for collectors of 14 years of age;
examples of this category include:
and faithful to the original models of the products) in reduced scale,
b) Kit for folding models in reduced scale,
c) folklore and decorative dolls and other similar articles,
(d)) toys and replicas of historical
e) reproductions of real firearms,
3. sports equipment, including roller skates, in-line skates and
skateboards intended for children with a body weight of more than 20 kg,
4. bicycles with a maximum saddle height of more than 435 mm, measured as
the vertical distance between the top of the saddle from the ground, while seat is in
horizontal position and seat post is at the lowest level,
5. the scooters and other means of transport designed for sport or intended
for riding on the road,
6. electric vehicles and vehicles that are designed for cyclists
on roads or sidewalks,
7. water sports equipment to be used in deep water and equipment for
teaching swimming to children, such as floats and swimming AIDS,
8. Jigsaw (puzzle) consisting of more than 500 parts,
9. guns and pistols using compressed gas, with the exception of water guns
and guns, and bows for archery more than 120 cm,
10. pyrotechnic products including capsules, which are not specifically designed
for toys,
11. products, and games, in which missiles are used with sharp spikes,
as are sets of darts with metallic points,
12. functional educational products, such as electric ovens, irons, and
other functional products operated at a nominal voltage exceeding 24 volts
which are sold exclusively for teaching purposes under adult supervision
of the person,
13. products intended for use in schools and in other educational
context for didactic purposes, under the supervision of an adult instructor,
such as scientific instruments,
14. electronic devices such as personal computers and game consoles
used to access interactive software and their respective
peripheral device if this electronic devices and the appropriate
peripheral devices are especially designed for kids and children
and they do not own the game value such as. specially designed personal
computer, keyboard, joysticks (joysticks), and steering wheels,
15. interactive software, intended for leisure and entertainment, such as
computer games, and their storage media, such as CD,
16. babies ' soothers,
17. lighting fixtures attractive to children,
18. electrical transformers for toys,
19. fashion accessories for kids, not intended for game.
Annex 2
SPECIAL SECURITY REQUIREMENTS
I. physical and mechanical properties
1. Toys and their parts and, in fixed toys, their anchorages
must have the requisite mechanical strength and, where appropriate,
stability to withstand the stresses, and when you use after possible breakage or
distortion could cause injury.
2. Accessible edges, corners, cords, cables and fastenings on toys must be
to have such a shape and must be manufactured in such a way that, when in contact with
them was the risk of injury as possible.
3. Toys must be so designed and constructed as to avoid any
the risk associated with their use, which could arise due to
certain parts of the movement, or, if the risk cannot be completely excluded that the
It was this risk as possible.
4.
and toys and their parts) must not present a risk of strangulation.
(b)) Toys and their parts must not present a risk of suffocation and restriction
air access due to the external blocking of the mouth and nose.
(c)) toys and their parts must be of such dimensions to avoid
risk of suffocation and restriction of access of air because of
internal blockage of the airway objects wedged in
the mouth or pharynx or got stuck at the entrance to the lower respiratory tract.
(d)) Toys clearly intended for children under 36 months, their components, and
all detachable parts must be of such dimensions as to
prevent their being swallowed and/or inhaled. This also applies to other toys,
which are intended to be placed in the mouth, and their components and all
detachable parts of toys.
e) Packaging in which toys are packaged for retail sale,
must not present risk of strangulation or suffocation and restriction of access
the air as a result of the external blocking of the mouth and nose.
f) Toys contained within food or co-mingled in
the food must have their own packaging. This container must be supplied in the
the status of such dimensions, which prevents it from swallowing or inhalation.
(g)) if the packaging of toys by the letters e) and (f)) or one of its
detachable spherical, ovoid or ellipsoid shape or the shape of war
with rounded end, must be of such dimensions, which prevents the
caused avoidance of air as a result of his wedge in the oral
cavity or pharynx or jam at the entrance to the lower respiratory tract.
h) Toys firmly attached with food at the moment of consumption, in such a
in a way, it is necessary to consume the food first, that was
directly accessible, are prohibited. Parts of toys which are directly linked
with food in a different way, must comply with the requirements laid down in
(c)), and (d)).
5. Aquatic toys must be designed and manufactured in such a way that the risk of loss
ability to float and to provide child support was at the recommended
How to use as possible.
6. Toys which it is possible to access to, and where then arises for
entering the inner enclosure must have East, which may
specified by the user without problems from the inside open.
7. toys conferring mobility on their users must be in accordance with
options to incorporate a braking system adapted to the type of toy and
appropriate kinetic energy, which is developing a toy. This device must
be such as to allow it to user to operate freely and without the risk of falling or
the risk of injury to the user or other third party.
The maximum design speed of electrically operated toys on which
must be limited so as to reduce the risk of injury to the
minimum.
8. The shape and composition of projectiles and the kinetic energy they may
a shot of the toy must be such that, having regard to the type of
Toy, there is a risk of injury to the user or third parties.
9. Toys must be so constructed as to
and the highest and lowest temperature), which are all accessible exterior
desktop, does not cause injury when touched and
b) liquids, vapours and gases in the toy below these temperatures or
pressures, when the leak, which is not for the proper functioning of the toy
inevitable, could lead to Burns and scalds, or raise the risk of
another injury.
10. Toys which are designed to emit a sound should be
designed and manufactured as to the maximum values for impulse noise and
continuous noise, so that the sound which is issued, could damage the
children's hearing.
11. Activity toys shall be constructed so as to what
most reduce the risk of crushing or imprisonment of the parts of the body or
the capture of clothing and the risk of falls, impacts and drowning. In particular, must be
any surfaces of such toys, which has in-game access to one
or more children, designed to support their weight.
Ii. Flammability
1. Toys must not constitute a dangerous flammable in the surroundings of the child element.
They must therefore be composed of materials which fulfil one or more of the
the following conditions:
and) if directly exposed to flame or spark or other potential sources of
the fire did not ignite;
(b)) are not readily flammable (the flame goes out as soon as the fire cause
zooms out);
c) after ignition, burn slowly and only allow slow flame spread;
d) irrespective of the toy's chemical composition are designed so that
mechanically delay the combustion process.
Such combustible materials must not give rise to a risk of ignition for other materials
used in the toy.
2. Toys which, given the characteristics of an indispensable for its
Use contain substances or mixtures that meet the classification criteria
provided for in section 1 of Appendix B, in particular materials and equipment for the
Chemistry, modeling, modeling of plastic or ceramic,
enamelling, photography or similar work, must not contain any
substances or mixtures which may become combustible after leak
non-flammable ingredients.
3. Toys other than toy capsules for use shall be in accordance with § 9
paragraph. 2 the first sentence of the explosive and shall not contain elements or substances with
danger of explosion.
4. Toys, in particular, chemical games and toys, must not contain as such
the substance or mixture,
and after mixing) which can explode due to chemical reactions or
warm up,
(b)) which may explode when mixed with oxidizing substances, or
c) which contain volatile components which occurs in the air to ignite
and that can form flammable or explosive vapour/air mixture.
III. Chemical properties
1. Toys must be so designed and constructed that, when used according to § 9
paragraph. 2 the first sentence there is no risk of adverse effects on human
health due to exposure to chemicals or mixtures from which
the toys are composed or which they contain.
Toys must be in accordance with the relevant legislation of the European Union
relating to certain categories of products or to restrictions applicable to
certain substances and mixtures.
2. Toys which are themselves the substance or mixture must also be in
accordance with the legislation governing chemical substances and mixtures in ^ 3) and with
European Parliament and Council Regulation (EC) no 1272/2008 of 16 June.
December 2008 on classification, labelling and packaging of substances and mixtures, which are
related to the classification, packaging and labelling of certain substances and mixtures.
3. without prejudice to the restrictions referred to in paragraph 1, second subparagraph,
must not be substances classified as carcinogenic, mutagenic or
toxic for reproduction (CMR) category 1A, 1B or 2 under regulation
(EC) no 1272/2008 used in toys, in components of toys or in
micro-structurally distinct parts of toys from the point of view of the microstructure.
4. By way of derogation from point 3, substances or mixtures classified as
carcinogenic, mutagenic or toxic for reproduction categories listed
in section 3 of Appendix B may be used in toys, in components of toys
or micro-structurally distinct parts of toys in terms of microstructure, if
is one or more of the following conditions is true:
and) these substances and mixtures are contained in individual concentrations
of the same or lower than the relevant concentrations established by
legal acts of the European Union for the classification of mixtures containing such
substances pursuant to section 2 of Appendix B;
(b) children to these substances) and mixtures do not have any access, even
through inhalation, if the toy is used in accordance with § 9 para. 2 first
the phrase;
(c)), the European Commission decided on the authorisation of the substance or mixture and its
the use of a substance or mixture and approved ways of its use are
listed in Appendix A.
5. By way of derogation from point 3, substances or mixtures classified as
carcinogenic, mutagenic or toxic for reproduction categories listed
in section 4 of Appendix B may be used in toys, in components of toys
or micro-structurally distinct parts of toys in terms of microstructure, if
It is one of the following conditions are met:
and) these substances and mixtures are contained in individual concentrations
of the same or lower than the relevant concentrations established by
legal acts of the European Union for the classification of mixtures containing such
substances pursuant to section 2 of Appendix B;
(b) children to these substances) and mixtures do not have any access, even in the
the case of inhalation, if the toy is used in accordance with § 9 para. 2
the first sentence; or
(c)), the European Commission decided on the authorisation of the substance or mixture and its
the use of a substance or mixture and approved ways of its use are
listed in Appendix A.
6. Paragraphs 3, 4 and 5 shall not apply to nickel in stainless steel.
7. Paragraphs 3, 4 and 5 shall not apply to materials that meet specific
the exposure limit values referred to in Appendix C, or until they are established
such provisions, but within a maximum of 20. July 2017, on the materials, on the
subject to the provisions of the materials intended to come into contact with
food contained in Regulation (EC) No 1935/2004 and the related
specific measures for particular materials and with these
the provisions of and the measures adopted in accordance.
8. without prejudice to the application of points 3 and 4, it is prohibited to use
nitrosamines and nitrosatable substances in toys intended for use
children under 36 months or in other toys intended to be placed in
the mouth, if the migration is equal or higher 0.05 mg/kg for nitrosamines and 1
mg/kg in nitrosatable substances.
9. Cosmetic toys, such as cosmetics for dolls, shall be in
accordance with the requirements on composition and labelling laid down in the Decree
The Ministry of health no. 448/2009 Coll., on the determination of the sanitary
requirements for cosmetic products.
10. Toys shall not contain the following allergenic fragrances:
-----------------------------------------------------------------
The name of the fragrance allergens number CAS number
-----------------------------------------------------------------
(1) the right of Oman oil (Inula helenium) 97676-35-2
(2) any 57-06-7
(3) fenylacetonitril (benzylkyanid) 140-29-4
(4) 4-tert-butylfenol 98-54-4
(5) chenopodium oil 8006-99-3
(6) cyklamenalkohol 4756-19-8
(7) diethylmaleinát 141-05-9
(8) dihydrokumarin 119-84-6
(9) 2.4-dihydroxy-3-methylbenzaldehyd 6248 switch-20-0
(10) 3.7-dimethylokt-2-en-1-ol (6.7-40607-48-5
dihydrogeraniol)
(11) 4.6-dimethyl-8-tert-butylchromen-2-on 17874-34-9
(12) 2-isopropylmaleinát 617-54-9
(13) 7.11-3,6,10-trimethyl-3,5,9-undecatrien-2-one-4, 6.10-trien-3-one 26651-96-7
(14) 6.10-dimethylundeka-3-5.9-trien-2-on 141-10-6
(15) diphenylamine 122-39-4
(16) ethyl acrylate 140-88-5
(17) fig leaf (fresh and preparations) 68916-52-9
(6) (E)-hept-2-enal 18829-55-5
(19) (E)-hex-2-enal-diethylacetal 67746-30-9
(20) (E)-hex-2-enal-dimethylacetal 18259-83-7
(21) 7-isopropyl-1, 4a-i‑13393-93-6
dimethyltetradekahydrodekahydrofenant
hren-1-methanol (hydroabietylalkohol)
(22) 4-ethoxyfenol 622-62-8
(23) 6-isopropyldekahydro-2-naphthol 34131-99-2
(24) 7-methoxychromen-2 (7-531-59-9
methoxykumarin)
(25) 4-methoxyphenol 150-76-5
(26) 4-(4-methoxyphenyl)-3-en-2-on 943-88-4
(27) 1-(4-methoxyphenyl) pent-1-en-3-104-27-8
(28) methyl (E)-TRANS-2-butenoate 623-43-8
(29) 6-methylcoumarin 92-48-8
(30) 7-methylcoumarin 2445-83-2
(31) the 5-methyl-2.3-hexanedione 13706-86-0
(32) the oil from the root of chrpovníku (Saussurea 8023-88-9
lappa Clarke)
(33) 7-ethoxy-4-methylcoumarin 87-05-8
(34) hexahydrokumarin 700-82-3
(35) Peru balsam, crude exudation (8007-00-9
Myroxylon balzámového, vododřevu
pereirae (Royle) Klotzsch)
(36) 2-pentylidencyklohexan-1-on 25677-40-1
(37), 3, 6, 10-3, 3,6,10-trimethyl-3,5,9-undecatrien-2-one 5.9-trien-2-on 1117-41-5
(38) the oil of lemon verbena (Lippia 8024-12-2
citriodora Kunth)
(39) 1-tercbutyl-2-methoxy-4-methyl-3.5-83-66-9
Dinitrobenzene
(40) the 4-phenyl-3-butene-2-on 122-57-6
(41) amylcinnamal 122-40-7
(42) 3-phenyl-2-pentylprop-2-en-1-ol-101-85-9
(43) benzyl alcohol 100-51-6
(44) benzyl salicylate-118-58-1
(45) 3-fenylprop-2-en-1-ol-104-54-1
(46) cinnamal 104-55-2
(47) the citral 5392-40-5
(48) coumarin 91-64-5
(49) eugenol 97-53-0
(50) the geraniol 106-24-1
(51) hydroxycitronellal 107-75-5
(52) 4-(4-hydroxy-4-methylpentyl) of cyclohex-22926-04-4
3-en-1-karbaldehyd
(53) isoeugenol 97-54-1
(54), extracts of větvičníku slívového 90028-68-5
(55) extracts from terčovky otrubičnaté 90028-67-4
-----------------------------------------------------------------
The presence of traces of these fragrances, however, is permitted under the
provided that such presence is technically in good manufacturing practice
inevitable and does not exceed 100 mg/kg.
Additionally, you must be on the toy on the attached label, the packaging or on the
the accompanying flyer listed the names of these allergenic fragrances,
If added to toys, as such, in concentrations higher than
100 mg/kg in the toy or one of its components:
-----------------------------------------------------------------
The name of the fragrance allergens number CAS number
-----------------------------------------------------------------
(1) 4-methoxybenzylalkohol 105-13-5
(2) benzylbenzoát 120-51-4
(3) benzylcinnamát 103-41-3
(4) citronelloi 106-22-9
(5) the farnesol 4602-84-0
(6) 2-benzylidenoktanal 101-86-0
(7) lilial 80-54-6
(8) d-limonene 5989-27-5
(9) the linalol 78-70-6
(10) methyl-okt-2-ynoát 111-12-6
(11) the 3-methyl-4-(2, 6, 6-trimethylcyklohex-2-127-51-5
en-1-yl)-3-en-2-on
-----------------------------------------------------------------
11. use of odoriferous substances listed under numbers 41 to 55, in paragraph 10 of the first
paragraph and odoriferous substances listed under numbers 1 to 11 in the third paragraph
the same point is enabled in the olfactory sensations
cosmetic sets and games encourage the taste sensations under the
the condition that the
and) these fragrances are clearly marked on the packaging and the package contains
the warnings set out in part B, point 10 of Annex No. 5
(b)) in the case of cosmetic kits meet the resulting products created
the child according to the requirements of the Decree of the Ministry of health manuals, no.
448/2009 Coll., laying down health requirements for cosmetic
resources and
(c)), these fragrances, where applicable, comply with the appropriate provisions relating to the
food.
Games that encourage olfactory board games, cosmetic kits and games that encourage
taste sensations may not be used by children under 36 months and must be
in accordance with section B, point 1 of annex 5.
12. without prejudice to paragraphs 3, 4 and 5, may not be for toys or part of
Toys exceeded these limits:
-----------------------------------------------------------------------------
Element mg/kg mg/kg mg/kg
in dry, liquid or in seškrábnutém
drobivém, the viscous material toys
práškovitém or material toys
poddajném
the material toys
-----------------------------------------------------------------------------
Aluminum 5 625 1 406 70 000
Antimony 11.3 45 560
Arsenic 3.8 0.9 47
Barium 1 500 375 18 750
BOR 1 200 300 15 000
Cadmium, 1.3 0.3 5
Chromium (III) 37.5 9.4 460
Chrome (VI) 0.02 0.005 0.2
Cobalt 10.5 2.6 130
Copper 622.5 156 7 700
Lead 13.5 3.4 160
Manganese 1 200 300 15 000
Mercury 7.5 1.9 94
Nickel 75 18.8 930
Selenium 37.5 9.4 460
Strontium 4 500 1 125 56 000
Tin 15 000 3 750 180 000
Organic Tin 0.9 0.2 12
Zinc 3 750 938 46 000
-----------------------------------------------------------------------------
These limits do not apply to toys or components of toys that are
due to their accessibility, function, volume or mass in the
use in accordance with § 9 para. 2 the first sentence clearly ruled out any risk of
as a result of sucking, licking, swallowing or prolonged contact with
the skin.
IV. Electrical properties
1. Toys must not be powered by electricity of a nominal DC
voltage exceeding 24 volts or AC, and accordingly no
their accessible part shall not exceed 24 volts DC or
the corresponding value of alternating current.
Internal voltages shall not exceed 24 volts DC or
the corresponding value of the alternating current, it is not a guarantee that the resulting
the combination of current and voltage does not throw any risk and will not cause injury
electric shock, even in the case of broken toys.
2. Parts of toys that are or may be in contact with the source of
electric current, which can cause an electric shock,
including electrical cords and other conductors, which to these components.
the current fed, must be properly insulated and mechanically protected so that
to avoid this danger.
3. Electric toys must be designed and manufactured so as to achieve the
the maximum temperature of any accessible surfaces are not such as to when
touch to cause burns.
4. Toys must under foreseeable fault conditions to provide protection
against the dangers arising from the use of power.
5. Electric toys must provide adequate protection against the risk of
the fire.
6. Electric toys must be designed and manufactured in a way that electric,
magnetic and electromagnetic fields and other radiations generated by the
accessories to be limited to the extent necessary for the operation of the toys, and
must work safely, in accordance with the generally recognized when
consideration of the specific measures of the European Union.
7. Toys which have an electronic control system must be designed and
manufactured to function safely even in toy case
the electronic system starts malfunctioning or fails due to a malfunctioning
the system itself or as a result of external factors.
8. Toys must be so designed and constructed as to avoid any
health hazards or risk of injury to eyes or skin from lasers, light
emitting diode (LED) or other types of radiation.
9. The electrical transformer for toys shall not be an integral part of the toy.
V. Hygiene
1. Toys must be so designed and constructed as to fulfil the requirements for
hygiene and cleanliness in order to avoid the risk of infection, sickness or
of the disease.
2. A toy intended for use by children under 36 months must be designed
and constructed in such a way that it can be cleaned. Textile toy
must be washable, except when it contains a mechanism,
that could be damaged as a result of soaking. Toy, even after
purge in accordance with this point and with the manufacturer's instructions, meet the requirements
on safety.
Vi. Radioactivity
Toys shall comply with all the relevant provisions adopted by
in accordance with Chapter III of the Treaty establishing the European Community for
Atomic Energy.
Appendix A
The list of substances classified as carcinogenic, mutagenic or toxic
for reproduction and approved ways of their use in accordance with part
(III) paragraphs 4, 5 and 6
------------------------------------------------------
Substance Classification approved by way of using
------------------------------------------------------
Nickel CMR 2 in toys and parts of toys
made of stainless
steel.
In parts of toys that are
lead electrical current.
------------------------------------------------------
Appendix B
CLASSIFICATION OF SUBSTANCES AND MIXTURES
As a result of the timesheet for the application of Regulation (EC) no 1272/2008
There are equivalent ways to link to a given classification, which should
be used in different periods.
1. the criteria for the classification of substances and mixtures for the purposes of part II, point 2
A. criteria that apply from 20. July 2011 to 31. may
2015:
The substance
The substance meets the criteria for some of these classes or categories of
the hazards referred to in annex I to Regulation (EC) no 1272/2008:
a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9,
2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to
(F),
b) hazard classes 3.1 to 3.6, 3.7 adverse effects on
sexual function and fertility or on development, 3.8 effects other than
narcotic effects, 3.9 and 3.10;
c) hazard class 4.1, or
(d) hazard class 5.1).
The mixture
The mixture has one or more of the hazardous properties in terms of another
law ^ 3).
B. Criteria that apply from 1. June 2015:
A substance or mixture meets the criteria for some of these classes or categories of
the hazards referred to in annex I to Regulation (EC) no 1272/2008:
a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9,
2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to
(F),
b) hazard classes 3.1 to 3.6, 3.7 adverse effects on
sexual function and fertility or on development, 3.8 effects other than
narcotic effects, 3.9 and 3.10;
c) hazard class 4.1, or
(d) hazard class 5.1).
2. the legal acts of the European Union relating to the use of certain substances for
the purpose of part III, point 4 (b). and point 5 (b)). and)
From 20. July 2011 to 31. may 2015 as the concentration
for the classification of mixtures containing substances concentration laid down shall apply
in accordance with other legislation ^ 3).
From the 1. June 2015, as the relevant concentrations for the classification of mixtures
containing substances concentration laid down shall apply in accordance with regulation
(EC) no 1272/2008.
3. the categories of substances and mixtures that are classified as carcinogenic, mutagenic
or toxic to reproduction for the purposes of part III, point 4
The substance
Point 4 of part III concerns substances classified as carcinogenic,
mutagenic or toxic for reproduction category 1A and 1B under regulation
(EC) no 1272/2008.
The mixture
From 20. July 2011 to 31. may 2015, point 4 of part III concerns mixtures
classified as carcinogenic, mutagenic or toxic for
reproduction category 1 and 2 under another law ^ 3).
From the 1. June 2015, point 4 of part III concerns mixtures classified as
carcinogenic, mutagenic or toxic for reproduction category 1A and 1B
pursuant to Regulation (EC) no 1272/2008.
4. Categories of substances and mixtures classified as carcinogenic, mutagenic
or toxic to reproduction for the purposes of part III, point 5
The substance
Point 5 of part III concerns substances classified as carcinogenic,
mutagenic or toxic to reproduction in category 2 in accordance with Regulation (EC)
No 1272/2008.
The mixture
From 20. July 2011 to 31. may 2015, point 5 of part III concerns mixtures
classified as carcinogenic, mutagenic or toxic for
reproduction category 3 under another law ^ 3).
From the 1. June 2015, point 5 of part III concerns mixtures classified as
carcinogenic, mutagenic or toxic to reproduction category 2 according to
Regulation (EC) no 1272/2008.
5. Categories of substances and mixtures classified as carcinogenic, mutagenic
or toxic to reproduction for the purposes of the decisions of the European Commission
the use of substances or mixtures
The substance
Decision of the European Commission relate to substances classified as
carcinogenic, mutagenic or toxic for reproduction category 1A, 1B and
2 under Regulation (EC) no 1272/2008.
The mixture
From 20. July 2011 to 31. may 2015, the decision of the European Commission
concerns mixtures classified as carcinogenic, mutagenic or toxic
for reproduction categories 1, 2 and 3 under another law ^ 3).
From the 1. from 1 June 2015, the decision of the European Commission refers to substances
classified as carcinogenic, mutagenic or toxic for
reproduction category 1A, 1B and 2 under Regulation (EC) no 1272/2008.
Appendix C
Specific limit values for chemicals used in toys intended
for use by children under 36 months or in other toys intended to be
placed in the mouth by a decision adopted by the European Commission on the application
substances or mixtures in toys.
Annex 3
EC DECLARATION OF CONFORMITY
1. No.: (unique identification of the toys/toys)
2. Identification of the manufacturer or his authorised representative:
(first and last name or business name and registered place of business, if
is a natural person, or the name or business name and registered place of
If it is a legal person)
3. this Declaration of conformity is issued under the sole responsibility of the manufacturer:
4. Object of the Declaration (identification of toy allowing: feedback
traceability, including enough clear color images
the toy can be identified)
5. Object of the Declaration described in point 4, is in conformity with the following
Community harmonisation legislation of the European Union:
6. References to the relevant harmonised European standards that were
used, or to other documents containing the specifications on the
conformity is declared:
7. (if applicable) Notified body (name, number) conducted
(description of activities) and issued the certificate:
8. other information:
Signed for and on behalf of the
(place and date of issue)
(name, function) (signature)
Annex 4
THE TECHNICAL DOCUMENTATION
The technical documentation referred to in § 18 shall to the extent necessary for the assessment of
include in particular:
and a detailed description of the toy), its design and manufacture, including a list
components and materials used in the toy, descriptions and explanations necessary
to understand the design, manufacture and operation of the toys and safety
leaves used chemicals obtained from chemical suppliers
substances,
(b) the safety assessment carried out) in accordance with § 15,
(c)) used a conformity assessment procedure
(d)) a copy of the EC declaration of conformity,
e) addresses production and storage sites,
(f) where applicable, copies of documents) that the manufacturer has submitted to the notified
person,
g) test reports and description of the means whereby the manufacturer ensure conformity
production with technical standards under section 10, if the manufacturer has applied the procedure
internal control of production according to § 16 para. 2 and
h) a copy of the EC type-examination certificate, a description of the ways in which the manufacturer
ensure conformity of production toys with the type described in the EC
type-examination, and copies of the documents the manufacturer has submitted the notified
person, if the manufacturer has submitted to the toy to EC-type examination and used
conformity to type procedure set out in § 16 para. 3.
Annex 5
WARNING
PART AND
GENERAL WARNINGS
Restrictions on a user referred to in section 11 (1) 2 and 3 shall indicate the
at least the minimum or maximum age limits for users and
where appropriate, the ability of the user, the maximum or minimum weight of the
the user and the need to ensure that the toy was used
only under adult supervision.
PART (B)
SPECIAL WARNINGS AND SAFETY RULES WHEN USING SOME
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, for example: ' not suitable for children under 36
months ' or ' not suitable for children under three years ' or warning in the form of
tags for this video:
These warnings shall be accompanied by a brief information, which can be
listed in the instructions for use, of the nature of the danger that this warning
requires.
This section does not apply to toys which, for their function, dimensions,
characteristics or properties, or for other compelling reasons clearly
not suitable for children under 36 months.
2. Activity toys
Activity toys shall bear the following warning:
"Just for home use."
To physical activity toys attached to a Crossbeam as well as
where appropriate, to other toys for physical activity, must be connected
operating instructions drawing attention to the need for regular inspection and maintenance
the major parts, namely hinges, fasteners and anchor, and with
warning that the toy may cause a fall or overturn, if these
checks are not carried out.
Instructions must also contain the instructions for proper Assembly toys with
calling attention to the parts that have the wrong Assembly may pose
danger. Specific information must be provided on the appropriate
the surface to which you want to be a toy.
3. Functional toys
Functional toys shall bear the following warning:
"Use only under adult supervision."
In addition, these toys shall be accompanied by instructions containing instructions on how to
use and safety rules that the user has to comply with, with
warning that failure to comply with these rules will expose the user specifically
to the hazards, which is normally associated with the appliance
or product of which the toy is a scale model or an imitation.
It must also be noted that the toy should be kept out of reach of children
under a certain age, which shall be specified by the manufacturer.
4. Chemical toys
Without prejudice to the application of the provisions of the laws of the European
Union concerning the classification, packaging and labelling of certain substances or
the mixture must be in the instructions for use of toys containing dangerous
the substance or mixture briefly and in a form adapted to the type of toy listed
warning on their dangerous character and safety rules,
that the user must adhere to in order to avoid risks with them
associated. Must also be recommended first aid, which needs to be
to provide in the event of serious injury that may when using toys
occur. It must also be indicated that the toy must be kept out of the reach of
children under a certain age, which is specified by the manufacturer.
In addition to the guidelines laid down in the previous paragraph must be chemical packaging
Toys shall bear the following warning:
' Not suitable for children under (*) years. Use only under the supervision of an adult
the person ".
(*) Age shall be specified by the manufacturer.
Shall be regarded as chemical toys: chemistry sets, in particular sets for
watering into plastics, miniature workshops for ceramics, enamelling or
photography and similar toys, which occurs during use
a chemical reaction or a similar change in the substance.
5. Ice skates, roller skates, in-line skates, skateboards, scooters and
bikes as toys for children
If these toys are offered for sale as toys, must be
bear the following warning:
"It is necessary to use protective equipment. Do not use in road
operation. "
In addition, the instructions for use shall contain a reminder that the toy
It requires great skill, and therefore must be used with caution, so as to
to avoid falls or collisions causing injury to the user or third
persons. Must also be provided information about the recommended protective
resources (in particular helmets, gloves, knee pads, Shin guards
elbow room).
6. Toys in the water
Aquatic toys shall bear the following warning:
"Use only in water depth, where the child is, and only under the
adult supervision. "
7. Toys in food
Toys contained within food or mixed with
food, must be accompanied by the following warning:
"Inside the toy. It is recommended that adult supervision. "
8. Imitations of protective masks and helmets
Imitations of protective masks and helmets shall bear the following
Warning:
"This toy does not guarantee protection."
9. Toys intended to be strung across the crib, cot or a children's
the stroller using the ropes, ropes, elastics or straps
Toys intended to be strung across the crib, cot or a children's
the stroller using the ropes, ropes, elastics or straps shall carry on the packaging
This warning, which is also permanently stamped on the toy:
"Remove this toy when the child begins to attempt to raise the hands and
knees in a crawling position, so that the movement's injury by her
entangled. "
10. Packaging for fragrances that are part of the table games
olfactory board games, cosmetic kits and gustative games
Packaging for fragrances that are part of the olfactory games
games, cosmetic kits and gustative games that
they contain aromatic substances listed under numbers 41 to 55, in part III, paragraph 11
the first paragraph of annex 2 and of the fragrances set out in points 1 to 11 in
the third paragraph of the same section, must bear the following warning:
"This product contains perfumes that may cause allergies."
Annex 6
THE CONFORMITY ASSESSMENT PROCEDURES
Part I (module A)
Internal production control
1. Internal production control is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3 and 4 and on their own responsibility
ensures and declares that the toys comply with the requirements of this regulation,
that apply to them.
2. Technical documentation
The manufacturer shall draw up before placing a toy on the market for technical documentation.
This documentation must enable the conformity of the toy with the essential
requirements and adequate analysis and risk assessment. Technical
documentation specifying the applicable requirements, and to the extent necessary for the assessment of
applies to the design, manufacture and operation of the toys. Technical
the documentation shall contain at least the elements set out in annex 4 to
application of this regulation.
3. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured toys with the technical documentation
referred to in point 2 and with the requirements of this regulation which apply to them.
The manufacturer shall take into account the due to changes in design or characteristics
toys and changes in the technical standards referred to in article 10, on the basis of
declares the conformity of the toy.
4. the conformity marking and Declaration of conformity
4.1 the manufacturer must affix the CE marking in accordance with section 13 of this regulation for each
a single toy, which is in accordance with the relevant requirements of this
of the regulation.
4.2. the manufacturer must draw up the model toys written declaration of conformity.
Part II (module C)
Conformity to type based on internal production control
1. conformity to type based on internal production control is the part of the procedure
conformity assessment, whereby the manufacturer fulfils the obligations laid down in points 2 and
3, and ensures and declares that the toys are in conformity with the type
as described in the EC type-examination certificate and satisfy the requirements of this
the regulation, which applies to them.
2. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured toys with the approved type
as described in the EC type-examination certificate and with the requirements of this
the regulation, which applies to them. The manufacturer shall take due account
changes in design or characteristics and changes in the technical standards toys under section
10 on the basis of declaring the conformity of the toy.
3. the conformity marking and Declaration of conformity
3.1 the manufacturer must affix the CE marking in accordance with section 13 of this regulation for each
a single toy, which is in conformity with the type as described in the EC
type-examination certificate and satisfies the applicable requirements of this regulation.
3.2. the manufacturer shall draw up for that model toys written declaration of conformity.
Annex 7
EC TYPE-EXAMINATION
1. Ec type-examination is the part of a conformity assessment procedure during which
notified body shall review the design of the toy and verifies and attests that the design of
Toys meets the requirements of this regulation.
2. the EC type-examination shall be carried out the way of assessing the suitability of the proposal
Toys through a review of the technical documentation and support
the evidence referred to in point 3 and the examination of samples of one or more of the essential
part of the representative of the production envisaged (combination of production type
and design type).
3. the manufacturer must lodge with the notified body, which only his choice, the request for
EC-type examination. The application must include:
and) first and last name or business name and registered place of business, if
This is a natural person, or the name or business name and
the seat, if it is a legal entity (hereinafter referred to as "identification
data ") the manufacturer; If the application is lodged by the authorized representative, his
identification data,
(b)) a written declaration that the same application has not been lodged with any other
the notified body,
c) description of the toy,
(d) the address of the place of production), toys,
e) technical documentation; the technical documentation must enable the
assessment of the conformity of the toy with the applicable requirements of this regulation and
contains an adequate analysis and assessment of the risk. The technical documentation
Specifies the applicable requirements, and to the extent necessary for the assessment by
on the design, manufacture and operation of the toys. The technical dossier contains
at least the elements set out in annex 4 to this regulation with
other than its (d)), and (h)).
(f)) for the planned production of representative samples; notified body
may request further samples if the test programme so requires,
g) supporting evidence for the adequacy of the design solution. This supporting
the evidence shall mention any relevant documents that have been
used, in particular where the relevant harmonised European standards or
the technical specifications have not been applied in its entirety. The supporting evidence
where necessary, the results of the tests carried out by the appropriate
Laboratory of the manufacturer, or by another testing laboratory on his behalf and under his
liability.
4. the notified body
Notified body for the toys to examine the technical documentation and
the supporting evidence to assess the adequacy of the design of toys.
For samples of the notified body:
a) verifies that the samples were made in accordance with the technical documentation,
and identify the elements which have been designed in accordance with the applicable provisions of
relevant harmonised European standards or technical
specifications, as well as parts of which have been designed without applying the
the relevant provisions of these standards,
(b)) carries out or causes perform the appropriate examinations and tests in order to
determine whether, where the manufacturer has chosen the solution in accordance with relevant
harmonised European standards or technical specifications have been
These standards and specifications used correctly,
(c)) carries out or causes perform the appropriate examinations and tests in order to
Verify that in the case where the solution has been applied according to the relevant
harmonised European standards or technical specifications comply with the
the solution that the manufacturer, the corresponding requirements of this regulation,
d) agree with the manufacturer, at which point the examinations and tests
performed.
5. the notified body shall draw up an evaluation report that records the
the activities undertaken in accordance with paragraph 4 and their outcomes.
Without prejudice to the obligations of the notified body to the authority,
notified body shall release the content of this report, as a whole or its
in part, only with the consent of the manufacturer.
6. where the type meets the requirements of this regulation, the notified body shall issue the
EC type-examination certificate to the manufacturer. The certificate shall contain
the manufacturer's identification data, a reference to the regulation of the European
Union ^ 1), colour image and a clear description of the toy, including its
the dimensions, the list of tests performed with a reference to the Protocol on the
test, conclusions of the examination, conditions for its validity, and more
the necessary data for identification of the approved type. The certificate may be
one or more annexes attached.
The certificate and its annexes shall contain all relevant information
to allow evaluation of whether the toy in conformity with the type of subordinated
the examination, and perform a check in operation.
If the type does not satisfy the relevant requirements of this regulation,
notified body refuses to issue the EC type-examination certificate and
It shall inform the applicant and the failure to adequately justify.
7. the notified body shall ensure that she knew about all the changes in General
acknowledged State, which indicate that the approved type may no longer be in the
accordance with the relevant requirements of this regulation, and shall determine whether such
changes require a deeper investigation. If the investigation so require, it shall inform the
manufacturer.
The manufacturer shall inform the certification body the person who keeps the technical
the documentation concerning the EC type-examination certificate of all
modifications to the approved type that may affect the conformity of the toy with
the requirements of this regulation or the conditions for validity of the certificate. These
modifications require additional approval in the form of a supplement to the original of the certificate
EC-type examination.
8. each notified body shall inform the Office about certificates EC
type-examination or additions thereto which it has issued or odejmula, and
shall, periodically or upon request, make available to the Office a list of certificates or
additions thereto which it has refused to issue, suspend, or otherwise limit.
Each notified body shall inform the other notified body of
EC-type examination certificates and/or any additions thereto which it has refused
issue, cancelled, suspended or otherwise restricted, and, upon request, also
about certificates and/or any additions thereto which it has issued.
The Commission, Member States and the other notified body on the basis of
the application may receive a copy of the EC type-examination certificate, or
additions. The Commission and the Member States may, on application, receive a copy of
the technical documentation and the results of the examination carried out by the notified body
person. Notified body's certificate expires, the
keep a copy of the EC type-examination certificate, its annexes and additions,
as well as the technical file including the documentation submitted by the
by the manufacturer.
9. The manufacturer shall keep a copy of the EC type-examination certificate, including the
annexes and additions and technical documentation, so that they are available for
the competent supervisory authorities for 10 years after the toy on the market.
10. the manufacturer's authorised representative may lodge the application referred to in point 3 and
to fulfil the obligations laid down in points 7 and 9, if they are determined in full
power.
1) European Parliament and Council Directive 2009/48/EC of 18 June 2003. June
2009 toy safety.
Commission directive 2012/7/EU of 2. March 2012, which, for the purposes
adapting to technical progress Annex II of part III of the directive
The European Parliament and of the Council 2009/48/EC on the safety of toys.
Commission Directive 84/2014/EU of 30. June 2014, amending
Appendix A to annex II to the directive of the European Parliament and Council directive 2009/48/EC on the
the safety of toys, in terms of nickel.
2) European Parliament and Council Regulation (EC) no 765/2008 of 9 July.
July 2008 setting out the requirements for accreditation and supervision of
market related to the marketing of products and repealing Regulation
(EEC) No 339/93.
3) Act No. 356/2003 SB., on chemical substances and chemical preparations
and amending certain laws, as amended.
4) of Commission Regulation (EU) no 681/2013 of 17 May. July 2013
amended part III of the annex II to the directive of the European Parliament and of the Council
2009/48/EC on the safety of toys.