On Technical Requirements For Toys

Original Language Title: o technických požadavcích na hračky

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=74027&nr=86~2F2011~20Sb.&ft=txt

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.