1988L0378 — EN — 02.08.1993 — 001.001 — 1
Thisdocumentismeantpurelyasadocumentationtoolandtheinstitutionsdonotassumeanyliabilityforitscontents
►B COUNCIL DIRECTIVE
of 3 May 1988
on the approximation of the laws of the Member States concerning the safety of toys
(88/378/EEC)
(OJ L 187, 16.7.1988, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 93/68/EEC of 22 July 1993 L 220 1 30.8.1993
Corrected by:
►C1Corrigendum, OJ L 281, 14.10.1988, p. 55 (88/378)
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COUNCIL DIRECTIVE
of 3 May 1988
ontheapproximationofthelawsoftheMemberStatesconcerning
the safety of toys
(88/378/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100A thereof,
Having regard to the proposal from the Commission(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas the laws, regulations and administrative provisions in force in
the various Member States relating to the safety characteristics of toysdiffer in scope and content; whereas such disparities are liable to createbarriers to trade and unequal conditions of competition within theinternal market without necessarily affording consumers in the commonmarket, especially children, effective protection against the hazardsarising from the products in question;
Whereas these obstacles to the attainment of an internal market in
which only sufficiently safe products would be sold should be removed;whereas, for this purpose, the marketing and free movement of toysshould be made subject to uniform rules based on the objectivesregarding protection of consumer health and safety as set out in theCouncil resolution of 23 June 1986 concerning the future orientation ofthe policy of the European Economic Community for the protection andpromotion of consumer interests(
4);
Whereas, to facilitate proof of conformity with the essential require-
ments, it is necessary to have harmonized standards at European levelwhich concern, in particular, the design and composition of toys so thatproducts complying with them may be assumed to conform to theessential requirements; whereas these standards harmonized at Europeanlevel are drawn up by private bodies and must remain non-mandatorytexts; whereas for that purpose the European Committee for Standardi-zation (CEN) and the European Committee for Electrotechnical Stan-dardization (CENELEC) are recognized as the competent bodies for theadoption of harmonized standards in accordance with the general guide-lines for cooperation between the Commission and those two bodiessigned on 13 November 1984; whereas, for the purposes of thisDirective, a harmonized standard is a technical specification (Europeanstandard or harmonization document) adopted by one or both of thosebodies upon a remit from the Commission in accordance with theprovisions of Council Directive 83/189/EEC of 28 March 1983 layingdown a procedure for the provision of information in the field oftechnical standards and regulations(
5), as last amended by the Act of
Accession of Spain and Portugal, and on the basis of the generalguidelines;
Whereas, in accordance with the Council resolution of 7 May 1985 on a
new approach to technical harmonization and standards(
6), the harmon-
ization to be achieved should consist in establishing the essential safetyrequirements to be satisfied by all toys if they are to be placed on themarket;
(1) OJ No C 282, 8. 11. 1986, p. 4.
(2) OJ No C 246, 14. 9. 1987, p. 91 and Decision of 9 March 1988 (not yet
published in the Official Journal).
(3) OJ No C 232, 31. 8. 1987, p. 22.
(4) OJ No C 167, 5. 7. 1986, p. 1.
(5) OJ No L 109, 26. 4. 1983, p. 8.
(6) OJ No C 136, 4. 6. 1985, p. 1.
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Whereas, in view of the size and mobility of the toy market and the
diversity of the products concerned, the scope of this Directive shouldbe determined on the basis of a sufficiently broad definition of ‘toys';whereas, nevertheless, it should be made clear that some products arenot to be regarded as toys for the purposes of this Directive eitherbecause they are not in fact intended for children or because they callfor supervision or special conditions of use;
Whereas toys placed on the market should not jeopardize the safety
and/or health either of users or of third parties; whereas the standard ofsafety of toys should be determined in relation to the criterion of the useof the product as intended, but allowance should also be made for anyforeseeable use, bearing in mind the normal behaviour of children whodo not generally show the same degree of care as the average adult user;
Whereas the standard of safety of the toy must be considered when it is
marketed, bearing in mind the need to ensure that this standard ismaintained throughout the foreseeable and normal period of use of thetoy;
Whereas compliance with the essential requirements is likely to guar-
antee consumer health and safety; whereas all toys placed on the marketmust comply with these requirements and, if they do, no obstacle mustbe put in the way of their free movement;
Whereas toys may be presumed to comply with these essential require-
ments where they are in conformity with the harmonized standards,reference numbers of which have been published in the Official Journal
of the European Communities ;
Whereas toys that conform to a model approved by an approved body
may also be regarded as complying with the essential requirements;whereas such conformity must be certified by the affixing of a Euro-pean mark;
Whereas certification procedures must be established to define the way
in which national approved bodies have to approve models of toys notin conformity with standards and issue type-examination certificates forthem and for toys in conformity with standards, a model of which issubmitted to them for approval;
Whereas adequate information for the Member States, the Commission
and all the approved bodies must be provided for at the various stagesof the certification and inspection procedures;
Whereas Member States must appoint bodies, called ‘approved bodies',
for the purposes of applying the system introduced for toys; whereasadequate information on these bodies must be provided and they mustall comply with minimum criteria for their approval;
Whereas cases might arise where a toy does not satisfy the essential
safety requirements; whereas, in such cases, the Member State whichascertains this fact must take all appropriate measures to withdraw theproducts from the market or to prohibit their being placed on themarket; whereas a reason must be given for this decision and, where thereason is a shortcoming in the harmonized standards, these, or a partthereof, must be withdrawn from the list published by the Commission;
Whereas the Commission is to ensure that the harmonized European
standards in all the areas covered by the essential requirements listed inAnnex II are drawn up in sufficient time to enable Member States toadopt and publish the necessary provisions by 1 July 1989; whereas thenational provisions adopted on the basis of this Directive should conse-quently become effective on 1 January 1990;
Whereas provision must be made for suitable action to be taken against
anyone wrongfully affixing a mark of conformity;
Whereas checks on the safety of toys already on the market must be
carried out by the competent authorities of the Member States;
Whereas, for some categories of toys that are particularly dangerous or
intended for very young children, warnings or details of precautions tobe taken must also be given;
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Whereas the Commission must receive regular information on activities
carried out under this Directive by the approved bodies;
Whereas those to whom any decision taken under this Directive is
addressed must know the reason for that decision and the remedies opento them;
Whereas the opinion of the Scientific Advisory Committee for the
evaluation of the toxicity and ecotoxicity of chemical compounds hasbeen taken into account with respect to the health-based limits ofbioavailability of metallic compounds in toys to children,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive shall apply to toys. A ‘toy'shall mean any product
or material designed or clearly intended for use in play by children ofless than 14 years of age.
2. The products listed in Annex I shall not be regarded as toys for the
purposes of this Directive.
Article 2
1. Toys may be placed on the market only if they do not jeopardize
the safety and/or health of users or third parties when they are used asintended or in a foreseeable way, bearing in mind the normal behaviourof children.
2. In the condition in which it is placed on the market, taking
account of the period of foreseeable and normal use, a toy must meetthe safety and health conditions laid down in this Directive.
3. For the purposes of this Directive, the expression ‘placed on the
market' shall cover both sale and distribution free of charge.
Article 3
Member States shall take all steps necessary to ensure that toys cannot
be placed on the market unless they meet the essential safety require-ments set out in Annex II.
Article 4
Member States shall not impede the placing on the market on their
territory of toys which satisfy the provisions of this Directive.
Article 5
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1. Member States shall presume that toys bearing the CE markinglaid down in Article 11 comply with all the provisions of this Directive,including the conformity assessment procedures referred to in Articles8, 9 and 10.
Conformity of toys with the national standards which transpose the
harmonized standards the reference numbers of which have beenpublished in the Official Journal of the European Communities shall
result in a presumption of conformity to the essential safety require-ments referred to in Article 3. Member States shall publish the referencenumbers of such national standards.
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2. Member States shall presume that toys in respect of which themanufacturer has not applied the standards referred to in paragraph 1, orhas applied them only in part, or for which no such standards exist,satisfy the essential requirements referred to in Article 3 where, afterreceipt of an EC type-examination certificate, their conformity with theapproved model has been certified by the affixation of the ►
M1CE
marking ◄.
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3. (a) Where the toys are subject to other Directives covering other
aspects and which also provide for the affixing of the CEmarking, the latter shall indicate that the toys in question are alsopresumed to conform to the provisions of those other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicate conformityonly to the Directives applied by the manufacturer. In this case,particulars of the Directives applied, as published in the Official
Journal of the European Communities , must be given in the
documents, notices or instructions required by the Directives andaccompanying such toys or, failing that, on their packaging.
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Article 6
1. Where a Member State or the Commission considers that the
harmonized standards referred to in Article 5 (1) do not entirely satisfythe essential requirements referred to in Article 3, the Commission orthe Member State shall refer the matter to the Standing Committee setup under Directive 83/189/EEC, hereinafter referred to as ‘the commit-tee',setting out its reasons. The committee shall issue an opinion as amatter of urgency.
After receiving the committee’s opinion, the Commission shall notify
the Member States whether or not the standards concerned or a partthereof have to be withdrawn from the publications referred to inArticle 5 (1).
2. The Commission shall inform the European standardization body
concerned and, if necessary, issue a new standardization brief.
Article 7
1. Where a Member State ascertains that toys bearing the ►
M1CE
marking ◄which are used as intended or in accordance with Article 2
are likely to jeopardize the safety and/or health of consumers and/orthird parties, it shall take all appropriate measures to withdraw theproducts from the market, or to prohibit or restrict their placing on themarket. The Member State shall inform the Commission immediately ofthis measure and indicate the reasons for its decision, stating in partic-ular whether the non-compliance results from:
(a) failure to meet the essential requirements referred to in Article 3, if
the toy does not meet the standards referred to in Article 5 (1);
(b) incorrect application of the standards referred to in Article 5 (1);
(c) shortcomings in the standards referred to in Article 5 (1).
2. The Commission shall enter into consultation with the parties
concerned as soon as possible. Where, after such consultation, theCommission finds that any measure as referred to in paragraph 1 isjustified, it shall forthwith so inform the Member State that took theaction and the other Member States. Where the decision referred to inparagraph 1 is attributed to shortcomings in the standards, the Commis-sion, after consulting the parties concerned, shall bring the matter beforethe Committee within two months if the Member State which has takenthe measures intends to maintain them and shall initiate the proceduresreferred to in Article 6.
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3. Where the toy which does not comply with the requirements bears
the►M1CE marking ◄, the competent Member State shall take
appropriate measures and inform the Commission, which shall informthe other Member States.
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Article 8
1. (a) Before being placed on the market, toys manufactured in accord-
ance with the harmonized standards referred to in Article 5 (1)must have affixed to them the ►
M1CE marking ◄by which
the manufacturer or his authorized representative establishedwithin the Community confirms that the toys comply with thosestandards;
(b) The manufacturer or his authorized representative established
within the Community shall keep the following informationavailable for inspection:
— a description of the means (such as the use of a test report or
technical file) whereby the manufacturer ensures conformityof production with the standards referred to in Article 5 (1)and, as appropriate: an EC type-certificate drawn up by anapproved body; copies of the documents the manufacturerhas submitted to the approved body; a description of themeans whereby the manufacturer ensures conformity withthe approved model,
— the addresses of the places of manufacture and storage,— detailed information concerning the design and manufacture.
Where neither the manufacturer nor his authorized representative
are established within the Community, the above obligation tokeep a dossier available shall be the responsibility of the personwho places the toy on the Community market.
2. (a) Toys which do not conform in whole or in part to the standards
referred to in Article 5 (1) must have affixed to them, beforebeing placed on the market, the ►
M1CE marking ◄by which
the manufacturer or his authorized representative establishedwithin the Community confirms that the toy concerned conformsto the model examined in accordance with the procedures laiddown in Article 10 which an approved body has stated complieswith the essential requirements referred to in Article 3;
(b) the manufacturer or his authorized representive established
within the Community shall keep the following informationavailable for inspection:
— a detailed description of manufacture,— a description of the means (such as the use of a test report or
technical file) whereby the manufacturer ensures conformitywith the approved model
— the addresses of the places of manufacture and storage,— copies of the documents the manufacturer has submitted to
an approved body in accordance with Article 10 (2),
— the test certificate for the sample or a certified copy thereof.
Where neither the manufacturer nor his authorized representative
is established within the Community, the above obligation tokeep a dossier available shall be the responsibility of the personwho places the toy on the market in the Community.
3. In the event of non-observance of the obligations laid down in
paragraphs 1 (b) and 2 (b), the competent Member State shall takeappropriate measures to ensure that those obligations are observed.
Where non-observance of the obligations is obvious, it may in particular
require the manufacturer or his authorized representative establishedwithin the Community to have a test performed at his own expensewithin a specified period by an approved body in order to verify
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compliance with the harmonized standards and essential safety require-
ments.
Article 9
1. The minimum criteria which Member States must meet in order to
appoint the approved bodies referred to in this Directive are containedin Annex III.
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2. Member States shall notify the Commission and the other MemberStates of the bodies which they have appointed to carry out the ECtype-examination referred to in Article 8 (2) and Article 10 togetherwith the specific tasks which these bodies have been appointed to carryout and the identification numbers assigned to them beforehand by theCommission.
The Commission shall publish in the Official Journal of the European
Communities a list of the notified bodies with their identication number
and the tasks for which they have been notified. The Commission shallensure that this list is kept up to date.
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3. A Member State which has approved a body shall withdrawapproval if it finds that the body no longer meets the criteria listed inAnnex III. It shall forthwith inform the Commission thereof.
Article 10
1. EC type-examination is the procedure by which an approved body
ascertains and certifies that a model of a toy satisfies the essentialrequirements referred to in Article 3.
2. The application for EC type-examination shall be lodged with an
approved body by the manufacturer or by his authorized representativeestablished within the Community.
The application shall include:
— a description of the toy,— the name and address of the manufacturer or of his authorized
representative or representatives, and the place of manufacture ofthe toy,
— comprehensive manufacturing and design data; and shall be accom-
panied by a model of the toy to be manufactured.
3. The approved body shall carry out the EC type-examination in the
manner described below:
— it shall examine the documents supplied by the applicant and estab-
lish whether they are in order,
— it shall check that the toy would not jeopardize safety and/or health,
as provided for in Article 2,
— it shall carry out the appropriate examinations and tests — using as
far as possible the harmonized standards referred to in Article 5 (1)— in order to check whether the model meets the essential require-ments referred to in Article 3,
— it may ask for further examples of the model.
4. If the model complies with the essential requirements referred to
in Article 3, the approved body shall draw up an EC type-examinationcertificate which shall be notified to the applicant. This certificate shallstate the conclusions of the examination, indicate any conditionsattaching to it and be accompanied by the descriptions and drawings ofthe approved toy.
The Commission, the other approved bodies and the other Member
States may obtain on request a copy of the certificate and, on reasonedrequest, a copy of the design and manufacturing schedule and thereports on the examinations and tests carried out.
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5. An approved body which refuses to issue an EC type-examinationcertificate shall so inform the Member State which approved it and theCommission, giving the reasons for refusal.
Article 11
1. The ►
M1CE marking ◄referred to in Articles 5, 7 and 8 and
the name and/or trade name and/or mark and address of the manufac-turer or his authorized representative or the importer into theCommunity shall as a rule be affixed either to the toy or on thepackaging in a visible, easily legible and indelible form. In the case ofsmall toys and toys consisting of small parts these particulars may beaffixed in the same way to the packaging, to a label or to a leaflet.Where the said particulars are not affixed to the toy, the consumer’sattention must be drawn to the advisability of keeping them.
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2. The CE conformity marking shall consist of the initials ‘CE'takingthe form of the specimen given in Annex V.
3. The affixing of markings on the toys which are likely to deceive
third parties as to the meaning and form of the CE marking shall beprohibited. Any other marking may be affixed to the toys, their pack-aging or a label provided that the visibility and legibility of the ECmarking is not thereby reduced.
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4. The particulars referred to in paragraph 1 may be abbreviatedprovided that the abbreviation enables the manufacturer, his authorizedrepresentative or the importer into the Community to be identified.
5. Annex IV sets out the warnings and indications of precautions to
be taken during use that have to be given for certain toys. MemberStates may require that these warnings and precautions, or some ofthem, together with the information specified in paragraph 4, be givenin their own national language or languages when the toys are placed onthe market.
Article 12
1. Member States shall take the necessary measures to ensure that
sample checks are carried out on toys which are on their market, so asto verify their conformity with this Directive.
The authority responsible for inspection:
— shall obtain access, on request, to the place of manufacture or
storage and to the information referred to in Article 8 (1) (b) and (2)(b),
— may ask the manufacturer, his authorized representative or the
person responsible for marketing the toy established within theCommunity to supply the information as provided for in Article 8(1) (b) and (2) (b) within a period specified by the Member State,
— may select a sample and take it away for examination and testing.
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1a. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representativeestablished within the Community shall be obliged to make theproduct conform as regards the provisions concerning the CEmarking and to end the infringement under the conditions imposedby the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is withdrawnfrom the market in accordance with the procedures laid down inArticle 7.
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2. Every three years, Member States shall send the Commission areport on the application of this Directive.
3. The Member States and the Commission shall take the necessary
measures to guarantee confidentiality with regard to the forwarding ofthe copies relating to the EC type-examination referred to in Article 10(4).
Article 13
Member States shall regularly inform the Commission of the activities
carried out in pursuance of this Directive by the bodies they haveapproved so that the Commission may ensure that the inspectionprocedures are implemented correctly and without discrimination.
Article 14
Any decision taken pursuant to this Directive and involving restrictions
on the placing of the toy on the market shall state the exact grounds onwhich it is based. It shall be notified at the earliest opportunity to theparty concerned, who shall at the same time be informed of theremedies available to him under the laws in force in the Member Statein question and of the time limits applying to such remedies.
Article 15
1. Member States shall adopt and publish by 30 June 1989 the
provisions necessary to comply with this Directive. They shall forthwithinform the Commission thereof.
They shall apply these provisions from 1 January 1990.2. Member States shall communicate to the Commission the texts of
the provisions of national law which they adopt in the field covered bythis Directive.
Article 16
This Directive is addressed to the Member States.
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ANNEXI
PRODUCTSNOTREGARDEDASTOYSFORTHEPURPOSEOFTHIS
DIRECTIVE
(Article 1 (1))
1. Christmas decorations
2. Detailed scale models for adult collectors3. Equipment intended to be used collectively in playgrounds4. Sports equipment5. Aquatic equipment intended to be used in deep water6. Folk dolls and decorative dolls and other similar articles for adult collectors7. ‘Professional'toys installed in public places (shopping centres, stations, etc.)8. Puzzles with more than 500 pieces or without picture, intended for special-
ists
9. Air guns and air pistols
10. Fireworks, including percussion caps (
1)
11. Slings and catapults12. Sets of darts with metallic points13. Electric ovens, irons or other functional products operated at a nominal
voltage exceeding 24 volts
14. Products containing heating elements intended for use under the supervision
of an adult in a teaching context
15. Vehicles with combustion engines16. Toy steam engines17. Bicycles designed for sport or for travel on the public highway18. Video toys that can be connected to a video screen, operated at a nominal
voltage exceeding 24 volts
19. Babies’ dummies20. Faithful reproductions of real fire arms21. Fashion jewellery for children
(1) With the exception of percussion caps specifically designed for use in toys without
prejudice to more stringent provisions already existing in certain Member States.
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ANNEXII
ESSENTIAL SAFETY REQUIREMENTS FOR TOYS
I. GENERAL PRINCIPLES
1. In compliance with the requirements of Article 2 of the Directive, the users of
toys as well as third parties must be protected against health hazards and riskof physical injury when toys are used as intended or in a forseeable way,bearing in mind the normal behaviour of children. Such risks are those:
(a) which are connected with the design, construction or composition of the
toy;
(b) which are inherent in the use of the toy and cannot be completely
eliminated by modifying the toy’s construction and composition withoutaltering its function or depriving it of its essential properties.
2.(a) The degree of risk present in the use of a toy must be commensurate with
the ability of the users, and where appropriate their supervisors, to copewith it. This applies in particular to toys which, by virtue of theirfunctions, dimensions and characteristics, are intended for use by chil-dren of under 36 months.
(b) To observe this principle, a minimum age for users of toys and/or the
need to ensure that they are used only under adult supervision must bespecified where appropriate.
3. Labels on toys and/or their packaging and the instructions for use which
accompany them must draw the attention of users or their supervisors fullyand effectively to the risks involved in using them and to the ways ofavoiding such risks.
II. PARTICULAR RISKS
1.Physical and mechanical properties
(a) Toys and their parts and, in the case of fixed toys, their anchorages, must
have the requisite mechanical strength and, where appropriate, stability towithstand the stresses to which they are subjected during use withoutbreaking or becoming liable to distortion at the risk of causing physicalinjury.
(b) Accessible edges, protrusions, cords, cables and fastenings on toys must
be so designed and constructed that the risks of physical injury fromcontact with them are reduced as far as possible.
(c) Toys must be so designed and constructed as to minimize the risk of
physical injury which could be caused by the movement of their parts.
(d) Toys, and their component parts, and any detachable parts of toys which
are clearly intended for use by children under 36 months must be of suchdimensions as to prevent their being swallowed and/or inhaled.
(e) Toys, and their parts and the packaging in which they are contained for
retail sale must not present risk of strangulation or suffocation.
(f) Toys intended for use in shallow water which are capable of carrying or
supporting a child on the water must be designed and constructed so as toreduce as far as possible, taking into account the recommended use of thetoy, any risk of loss of buoyancy of the toy and loss of support affordedto the child.
(g) Toys which it is possible to get inside and which thereby constitute an
enclosed space for occupants must have a means of exit which the lattercan open easily from the inside.
(h) Toys conferring mobility on their users must, as far as possible, incor-
porate a braking system which is suited to the type of toy and iscommensurate with the kinetic energy developed by it. Such a systemmust be easy for the user to operate without risk of ejection or physicalinjury for the user or for third parties.
(i) The form and composition of projectiles and the kinetic energy they may
develop when fired from a toy designed for that purpose must be suchthat, taking into account the nature of the toy, there is no unreasonablerisk of physical injury to the user or to third parties.
(j) Toys containing heating elements must be so constructed as to ensure
that:
— the maximum temperature of any accessible surfaces does not cause
burns when touched,
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— liquids and gases contained within toys do not reach temperatures or
pressures which are such that their escape from a toy, other than forreasons essential to the proper functioning of the toy, might causeburns, scalds or other physical injury.
2.Flammability
(a) Toys must not constitute a dangerous flammable element in the child’s
environment. They must therefore be composed of materials which:
1. do not burn if directly exposed to a flame or spark or other potential
seat of fire; or
2. are not readily flammable (the flame goes out as soon as the fire cause
disappears); or
3. if they do ignite, burn slowly and present a low rate of spread of the
flame; or
4. irrespective of the toy’s chemical composition, are treated so as to
delay the combustion process.
Such combustible materials must not constitute a risk of ignition for other
materials used in the toy.
(b) Toys which, for reasons essential to their functioning, contain dangerous
substances or preparations as defined in Council Directive 67/548/EEC (
1), in particular materials and equipment for chemistry experi-
ments, model assembly, plastic or ceramic moulding, enamelling, photog-raphy or similar activities, must not contain, as such, substances orpreparations which may become flammable due to the loss of non-flam-mable volatile components.
(c) Toys must not be explosive or contain elements or substances likely to
explode when used as specified in Article 2 (1) of the Directive. Thisprovision does not apply to toy percussion caps, for which referenceshould be made to point 10 of Annex I and the related footnote.
(d) Toys and, in particular, chemical games and toys, must not contain as
such substances or preparations:
— which, when mixed, may explode:
— through chemical reaction, or through heating,— when mixed with oxidizing substances,
— which contain volatile components which are flammable in air and
liable to form flammable or explosive vapour/air mixture.
3.Chemical properties
1. Toys must be so designed and constructed that, when used as specified in
Article 2 (1) of the Directive, they do not present health hazards or risksof physical injury by ingestion, inhalation or contact with the skin,mucous tissues or eyes.
They must in all cases comply with the relevant Community legislation
relating to certain categories of products or to the prohibition, restrictionof use or labelling of certain dangerous substances and preparations.
2. In particular, for the protection of children’s health, bioavailability
resulting from the use of toys must not, as an objective, exceed thefollowing levels per day:
0,2µg for antimony,
0,1µg for arsenic,
25,0 µg for barium,
0,6µg for cadmium,
0,3µg for chromium,
0,7µg for lead,
0,5µg for mercury,
5,0µg for selenium,
or such other values as may be laid down for these or other substances in
Community legislation based on scientific evidence.
The bioavailability of these substances means the soluble extract having
toxicological significance.
(1) OJ No 196, 16. 8. 1967, p. 1/67.
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3. Toys must not contain dangerous substances or preparations within the
meaning of Directives 67/548/EEC and 88/379/EEC (1) in amounts which
may harm the health of children using them. At all events it is strictlyforbidden to include, in a toy, dangerous substances or preparations ifthey are intended to be used as such while the toy is being used.
However, where a limited number of substances or preparations are
essential to the functioning of certain toys, in particular materials andequipment for chemistry experiments, model assembly, plastic or ceramicmoulding, enamelling, photography or similar activities, they arepermitted up to a maximum concentration level to be defined for eachsubstance or preparation by mandate to the European Committee forStandardization (CEN) according to the procedure of the committee set upby Directive 83/189/EEC, provided the permitted substances and prepara-tions comply with the Community classification rules in respect of label-ling, without prejudice to point 4 of Annex IV.
4.Electrical properties
(a) Electric toys must not be powered by electricity of a nominal voltage
exceeding 24 volts and no part of the toy may exceed 24 volts.
(b) Parts of toys which are connected to, or liable to come into contact with a
source of electricity capable of causing electric shock, together with thecables or other conductors through which electricity is conveyed to suchparts, must be properly insulated and mechanically protected so as toprevent the risk of such shock.
(c) Electric toys must be so designed and constructed as to ensure that the
maximum temperatures reached by all directly accessible surfaces are notsuch as to cause burns when touched.
5.Hygiene
Toys must be so designed and manufactured as to meet the requirements of
hygiene and cleanliness in order to avoid any risk of infection, sickness andcontamination.
6.Radioactivity
Toys must not contain radioactive elements or substances in forms or propor-
tions likely to be detrimental to a child’s health. Council Directive 80/836/Euratom shall apply (
2).
(1) OJ No L 187, 16. 7. 1988, p. 14.
(2) OJ No L 246, 17. 9. 1980, p. 1.
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ANNEXIII
CONDITIONS TO BE FULFILLED BY THE APPROVED BODIES
(Article 9 (1))
The bodies designated by the Member States must fulfil the following minimum
conditions:
1. availability of personnel and of the necessary means and equipment;2. technical competence and professional integrity of personnel;3. independence, in carrying out the tests, preparing the reports, issuing the
certificates and performing the surveillance provided for in this Directive, ofstaff and technical personnel in relation to all circles, groups or personsdirectly or indirectly concerned with toys;
4. maintenance of professional secrecy by personnel;5. subscription of a civil liability insurance unless that liability is covered by the
state under national law.
Fulfilment of the conditions under 1 and 2 shall be verified at intervals by the
competent authorities of the Member States.
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ANNEXIV
WARNINGS AND INDICATIONS OF PRECAUTIONS TO BE TAKEN
WHEN USING TOYS
(Article 11 (5))
Toys must be accompanied by appropriate clearly legible warnings in order to
reduce inherent risks in their use as described in the essential requirements, andspecifically:
1.Toys not intended for 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'together with a brief indication,which may also appear in the instructions for use, of the specific risks callingfor this restriction.
This provision does not apply to toys which, on account of their function,
dimensions, characteristics, properties or other cogent grounds, are manifestlyunsuitable for children under 36 months.
2.Slides, suspended swings and rings, trapezes, ropes and similar toys
attached to a crossbeam
Such toys shall be accompanied by instructions drawing attention to the need
to carry out checks and maintenance of the main parts (suspensions, fixings,anchorages, etc.) at intervals, and pointing out that, if these checks are notcarried out, the toy may cause a fall or overturn.
Instructions must also be given as to correct assembly of the toy, indicating
those parts which can present dangers if it is incorrectly assembled.
3.Functional toys
Functional toys or their packaging shall bear the marking ‘Warning: to be
used under the direct supervision of an adult'.
In addition, these toys shall be accompanied by directions giving working
instructions as well as the precautions to be taken by the user, with thewarning that failure to take these precautions would expose the user to thehazards — to be specified — normally associated with the appliance orproduct of which the toy is a scale model or an imitation. It will also beindicated that the toy must be kept out of the reach of very young children.
‘Functional toys'means toys which are used in the same way as, and are often
scale models of, appliances or installations intended for adults.
4.Toyscontaininginherentlydangeroussubstancesorpreparations.Chem-
ical toys
(a) Without prejudice to the application of the provisions laid down in
Community directives on the classification, packaging and labelling ofdangerous substances or preparations, the instructions for use of toyscontaining inherently dangerous substances or preparations shall bear awarning of the dangerous nature of these substances or preparations andan indication of the precautions to be taken by the user in order to avoidhazards associated with them, which shall be specified conciselyaccording to the type of toy. The first aid to be given in the event ofserious accidents resulting from the use of this type of toy shall also bementioned. It shall also be stated that the toys must be kept out of reachof very young children.
(b) In addition to the instructions provided for in (a), chemical toys shall bear
the following marking on their packaging:
‘Warning: for children over (
1) years of age only. For use under adult
supervision'.
In particular, the following are regarded as chemical toys: chemistry sets,
plastic embedding sets, miniature workshops for ceramics, enamelling orphotography and similar toys.
(1) Age to be decided by the manufacturer.
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5.Skates and skateboards for children
If these products are offered for sale as toys they shall bear the marking:‘Warning: protective equipment should be worn'.Moreover, the instructions for use shall contain a reminder that the toy must
be used with caution, since it requires great skill, so as to avoid falls orcollisions causing injury to the user and third parties. Some indication shallalso be given as to recommended protective equipment (helmets, gloves,knee-pads, elbow-pads, etc.).
6.Toys intended for use in water
The toys intended for use in water defined in Section II. 1 (f) of Annex II
shall contain the warning in accordance with CEN’s brief to adapt standardEN/71, parts 1 and 2:
‘Warning! Only to be used in water in which the child is within its depth and
under supervision'.
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ANNEXV
CE CONFORMITY MARKING
— The CE conformity marking shall consist of the initials ‘CE' taking the
following form:
— If the CE marking is reduced or enlarged the proportions given in the above
graduated drawing must be respected.
— The various components of the CE marking must have substantially the same
vertical dimension, which may not be less that 5 mm.