II
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)
DECISIONS
COMMISSION
COMMISSION DECISION
of 21 April 2008
requiring Member States to ensure that magnetic toys placed or made available on the market
display a warning about the health and safety risks they pose
(notified under document number C(2008) 1484)
(Text with EEA relevance)
(2008/329/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Directive 2001/95/EC of the European
Parliament and of the Council of 3 December 2001 ongeneral product safety (
1), and in particular Article 13 thereof,
Having consulted the Member States,
Whereas:
(1) Pursuant to Directive 2001/95/EC and Council Directive
88/378/EEC of 3 May 1988 on the approximation of the
laws of the Member States concerning the safety of
toys (2), as amended by Council Directive 93/68/EEC (3),producers are obliged to place only safe toys on the
market.
(2) Directive 88/378/EEC lays down the essential safetyrequirements that toys must meet to ensure the safetyobjectives of the Directive. In addition, the Directiveprovides that, in order to facilitate the proof ofconformity with the essential safety requirements,European standards concerning the design and compo-sition of toys should be drawn up by the standardisation
bodies. Currently the risk posed by magnets is covered
by the general safety requirement of Directive88/378/EEC, but the Directive does not lay downparticular safety requirements dealing with the riskposed by magnets.
(3) The European Committee for Standardisation (CEN)issued European standard EN 71-1:2005 ‘Safety of toys
—Part I: mechanical and physical properties ’which is a
consolidated version of harmonised standard EN 71-1:1998 and its 11 amendments. Toys complying with
the standard are presumed to be in conformity with
the essential requirements of Directive 88/378/EEC, asfar as the specific requirements covered by the standardare concerned. The standard does not currently containtechnical requirements for magnetic toys. In accordancewith Article 8(2)(a) of Directive 88/378/EEC, producersmust have recourse to EC type-examination when aharmonised standard does not cover all the risks that atoy may present.EN L 114/90 Official Journal of the European Union 26.4.2008
(1) OJ L 11, 15.1.2002, p. 4.
(2) OJ L 187, 16.7.1988, p. 1. Directive as amended by Directive
93/68/EEC (OJ L 220, 30.8.1993, p. 1).
(3) OJ L 220, 30.8.1993, p. 1.(4) In order to address the specific risks of magnetic toys, on
25 May 2007 the Commission gave a mandate toCEN (
1), in accordance with Directive 98/34/EC of the
European Parliament and of the Council of 22 June1998 laying down a procedure for the provision of infor-mation in the field of technical standardsand regulations (
2), to revise the European standard
EN 71-1:2005 within 24 months. Pending the drawing
up and entry into force of the revised standard, it is
necessary to address immediately the risks posed bymagnetic toys in order to minimise further accidents tochildren caused by these toys by improving theknowledge of the risks.
(5) In addition to Directive 88/378/EEC, the safety of toys iscovered by Directive 2001/95/EC which sets out themarket surveillance framework for consumer products.According to Article 13 of Directive 2001/95/EC, if theEuropean Commission becomes aware that certainproducts present a serious risk to the health and safetyof consumers, it may, under certain conditions, adopt adecision requiring Member States to take temporarymeasures intended in particular to restrict or makesubject to specific conditions the placing and makingavailable on the market of such products.
(6) Such a decision may be adopted if (a) Member Statesdiffer significantly on the approach adopted or to beadopted to deal with the risk concerned; (b) the risk
cannot, in view of the nature of the safety issue, be
dealt with in a manner compatible with the degree ofurgency of the case under other procedures laid down bythe specific Community legislation applicable to theproduct concerned; and (c) the risk can be eliminatedeffectively only by adopting appropriate measuresapplicable at Community level, in order to ensure aconsistent and high level of protection of the healthand safety of consumers and the proper functioning ofthe internal market.
(7) A serious risk has recently emerged concerning magnetsin toys. Even though magnets have been used in toys fora long time, in the last few years they have becomeincreasingly powerful and they can become detachedmore easily if attached using the same techniques asthose employed in the past. Moreover, given theirincreased strength, loose magnets or magnetic partsused in toys now pose a higher risk of serious
accidents than in the past.
(8) This serious risk has been established by a number of
accidents that were reported worldwide in the course of2006 and 2007 where children had swallowed magnets
detached from toys or small parts of toys containingmagnets. When more than one magnet is swallowed,the magnets can attract each other and may causeintestinal perforation, infection or blockage, which canbe fatal. Inhalation of those magnets has also causedserious injuries, and aspiration into the lungs requiresimmediate surgery.
(9) Besides one fatal accident reported in the United States,several occurrences of children swallowing at least twomagnets or a magnet and a metal object, and requiringmajor surgery, have been reported worldwide since 2006.These incidents have involved children aged between 10months and 12 years.
(10) In 2006 and 2007, several toy producers launched majorrecalls of magnetic toys. In particular, over 18 millionmagnetic toys were recalled worldwide during thesummer of 2007, and a significant proportion of thesetoys were on the European market. As a result of theaccidents and the recent recalls, many producers haverealised the risk and modified the design of the toys
concerned, encapsulating or collaring the magnets in
the parts containing them.
(11) Some countries have already adopted measures to dealwith the risk. In particular, the United States ConsumerProduct Safety Commission (CPSC) released, on 19 April2007, a warning to parents concerning the health andsafety risks posed by magnetic toys. The CPSC has alsoparticipated in the revision of ASTM F963-2007‘Standard Consumer Safety Specification on Toy Safety ’
created under the auspices of the standardisation body,ASTM International, to deal with magnets in toys. InEurope, both France and Germany have informed theCommission of national measures.
(12) In its resolution of 26 September 2007 on the safety ofproducts and particularly toys (
3), the European
Parliament urged the Commission to use its powers totake restrictive measures, including bans, if consumergoods placed on the Community market are found tobe unsafe.
(13) Consultation of the Member States in the Committee setup by Article 15 of Directive 2001/95/EC has establishedthat Member States differ significantly on the approachto deal with the risk posed by magnetic toys.EN 26.4.2008 Official Journal of the European Union L 114/91
(1) Standardisation mandate to CEN of 25 May 2007 to draw up
standard for magnetic toy (M/410).
(2) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council
Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). (3) Texts Adopted, P6_TA(2007)0412.(14) In the absence of Community rules, some Member States
have adopted or are about to adopt divergent nationalmeasures to manage the risk posed by magnetic toys.The introduction of such national measures willinevitably result in an uneven level of protection andin intra-Community barriers to trade in magnetic toys.Several Member States have called for a Communitymeasure.
(15) There is Community legislation on small parts in toysmeant for small children (
1), but that legislation does not
deal specifically and sufficiently with risks from magnetictoys to children who are over three years of age. In viewof the nature of the hazard, the risk posed by magnetictoys cannot be dealt with effectively under otherprocedures laid down in specific rules of Communitylaw in a manner compatible with the degree ofurgency of the case. It is therefore necessary to haverecourse to a temporary decision under Article 13 ofDirective 2001/95/EC until the revised Europeanstandard EN 71-1:2005 provides a comprehensivesolution to the problem identified. The targetedmeasure introduced by this Decision offers only apartial, temporary, short-term solution. The Commissionhas already clearly recognised the need for constructionalrequirements to deal adequately with the risks posed by
magnetic toys when issuing the standardisation mandate
to CEN to revise EN 71-1:2005.
(16) In view of the serious risk from magnetic toys, and inorder to ensure a consistent and high level of consumerhealth and safety protection throughout the EU as well asto avoid barriers to trade, it is urgent that a temporarydecision pursuant to Article 13 of Directive 2001/95/ECbe adopted. Such a decision should rapidly make theplacing and making available on the market ofmagnetic toys subject to the condition that they aremarked with an adequate warning of the risks linkedto the presence of magnets or magnetic components ofingestible shape and size that are accessible to children.Such a decision should contribute to the prevention offurther deaths and injuries.
(17) In the light of the accident and hazard data and the
pending permanent measure in the form of the
revision of standard EN 71-1:2005, the scope of thisDecision should cover magnetic toys.
(18) This Decision is without prejudice to Articles 3(4) and 6to 8 of Directive 2001/95/EC, and thus does not barMember States from taking appropriate measures wherethere is evidence that a magnetic toy is dangerous,regardless of the conformity with the requirements in
this Decision and other criteria designed to ensure thegeneral safety requirement. Member States must carry outmarket surveillance and enforcement activities to preventrisks posed by unsafe products to the health and safety ofconsumers.
(19) On the basis of the progress made with the revision ofthe European standard EN 71-1:2005 and with regard tothe completeness of the revised standard and its adequacy
to address fully the risks posed by magnetic toys, the
Commission will decide whether to extend the validityof this Decision for additional periods and whether theDecision should be amended. In particular, theCommission will decide whether to introduce construc-tional requirements to supplement the warning requiredin this Decision.
(20) A short transition period is necessary in the interests ofboth the Member States who must ensure that theDecision will be applied efficiently and also of theproducers and distributors of magnetic toys who aresubject to the obligation to place or make available onthe market only magnetic toys that bear the appropriatewarning. In this case, the shortest possible transitionperiod should be laid down, consistent with the needto prevent further accidents and to ensure propor-tionality, taking into account that the measure consists
of a marking only and does not require changes to the
product design itself. Therefore, the requirement for awarning to be affixed to magnetic toys should applyshortly after the adoption of this Decision by theCommission.
(21) The measures provided for in this Decision are inaccordance with the opinion of the Committee estab-lished by Article 15 of Directive 2001/95/EC,
HAS ADOPTED THIS DECISION:
Article 1
Definitions
For the purposes of this Decision the following definitions shall
apply:
—‘magnetic toy ’means a toy that contains or consists of one
or more magnets or one or more magnetic components thatare of ingestible shape and size and are accessible tochildren,EN L 114/92 Official Journal of the European Union 26.4.2008
(1) In accordance with Directive 88/378/EEC, 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 such dimensions as to
prevent their being swallowed and/or inhaled. This means that toysintended for children under 36 months must not contain anyelement liable to be swallowed or inhaled, whether magnets or not.—‘toy’means any product or material designed or clearly
intended for use in play by children of less than 14 yearsof age,
—‘of ingestible shape and size ’means fitting entirely into the
small-parts cylinder defined in the standard EN 71-1:2005,
—‘accessible to children ’means loose or able of becoming
detached from the toy under normal or reasonably fore-seeable conditions of use by children, even if originallycontained, encapsulated, recessed or collared in the toy,
—‘making available on the market ’means any supply of a
magnetic toy for distribution, consumption or use on the
Community market in the course of a commercial activity,whether in return for payment or free of charge,
—‘placing on the market ’means the first making available of a
magnetic toy on the Community market,
—‘withdrawal ’means any measure aimed at preventing the
distribution, display and offer.
Article 2
Warning
1. Member States shall ensure that magnetic toys which are
placed or made available on the Community market display awarning:
(a) with the following wording: ‘Warning! This toy contains
magnets or magnetic components. Magnets stickingtogether or becoming attached to a metallic object insidethe human body can cause serious or fatal injury. Seekimmediate medical help if magnets are swallowed orinhaled. ’;
(b) or with an equivalent easily understandable wording that
clearly conveys the same content.
2. The warning shall appear in a clearly visible and legible
manner, conspicuously displayed on the packaging or otherwiseattached to the magnetic toy in such a way as to be visible tothe consumer at the point of purchase.3. The warning shall appear in the official languages of the
Member State in which the product is placed or made availableon the market.
Article 3
Implementation
1. As of 21 July 2008, Member States shall ensure that
magnetic toys which do not display the required warning areprohibited from being placed or made available on the market.
2. As of 21 July 2008, Member States shall ensure that
magnetic toys which do not display the required warning andare placed or made available on the market are withdrawn fromthe market, and that consumers are adequately informed of therisk.
3. Member States shall inform the Commission without
delay of the measures taken under this Article in accordancewith Article 12 of Directive 2001/95/EC.
Article 4
Information
Member States shall take the necessary measures to comply
with this Decision, publish those measures and forthwithinform the Commission thereof.
Article 5
Period of application
This Decision shall be applicable until 21 April 2009.
Article 6
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 21 April 2008.
For the Commission
Meglena KUNEVA
Member of the CommissionEN 26.4.2008 Official Journal of the European Union L 114/93