Toys [EU]

Toys

There have been EU directives on safety standards for toys since the early days of the EU. Toys are products which are designed or intended, whether or not exclusively, for use by children under fourteen years of age. A list of products which may be used by children but are not considered as toys is available in Annex I of this Directive.

The directives require conformity with essential safety requirements having regard to children’s age, behavior and any use of chemicals. They also provide specific safety provisions relating to physical, mechanical, electrical, chemical properties flammability, radioactivity and hygiene.

Warnings must appear specifying appropriate conditions and limitations of use.

Products must bear the CE conformity mark.

The manufacturer must ensure the products comply with essential and specific safety requirements. The CE mark certifying conformity must be affixed in accordance with approved procedure.

If the manufacturer designate a representative, the mandate must comply with minimum obligations in respect to national authorities. They must be able to provide proof of product conformity and must cooperate in order to eliminate potential risks.

The importer is responsible for ensuring the products which are placed in the market are compliant. In the event of noncompliance, they must inform the manufacturer and market surveillance authority and must if applicable withdraw the product.

The distributor must cverify conformity marking of the product before it is placed on the market. If the toy is not compliant they must take corrective actions or withdraw the product from the market.

States organize market surveillance and designate bodies that are authorized to evaluate product conformity. There is a presumption that products conform if they comply with the harmonized standards published in the Official Journal.

The procedure for assessing confirmative essential requirements is set out in EC decision on conformity marking.

The toy conformity assessment must be carried out either by bodies designated by States or by the manufacturer. Other marks may be affixed, provided there is no risk of confusion with the conformity marking.

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the

Safety of toys

Summary

Toys are subject to safety requirements and rules on their movement in the European Union (EU). Toys are products which are designed or intended, whether or not exclusively, for use by children under fourteen years of age. A list of products which may be used by children but are not considered as toys is available in Annex I of this Directive.

Safety requirements

It must be possible to use toys placed on the market without any danger to health or safety during all of their foreseeable and normal period of use. They are to comply with:

the essential safety requirements regarding age, children’s behaviour and the rules of use of chemicals;
specific safety provisions (listed in Annex II), concerning physical, mechanical, electrical and chemical properties, flammability, hygiene and radioactivity.

Warnings are to appear on products specifying the appropriate conditions and limitations of use.

Products which meet the safety requirements may circulate freely on Community territory. They bear EC conformity marking.

Product conformity

Economic operators have a liability concerning product conformity according to their role in the distribution chain.

The manufacturer ensures that products comply with the essential and specific safety requirements and then establishes an “EC” declaration of conformity as well as evaluating the toys’ safety before they are marketed, in line with Decision 768/2008/EC.

If a manufacturer designates a representative, the mandate shall contain minimum obligations with regard to national authorities. They must be able to provide the proof of product conformity and cooperate in order to eliminate potential risks.

The importer makes sure that the products they are placing on the market are compliant. In the event of non-compliance, they inform the manufacturer and the market surveillance authorities and must, if applicable, recall the products.

The distributor verifies the conformity marking of the product before it is placed on the market. If they find that a toy is not compliant, they are to take corrective measures or withdraw the product from the market.

Member States organise market surveillance and designate notified bodies that are authorised to evaluate product conformity. The measures taken to ensure toys’ compliance with safety take account of the precautionary principle.

Products are subject to a presumption of conformity if they comply with harmonised standards published in the Official Journal of the European Union.

Context

Directive 88/378/EEC is to be repealed as from 20 July 2011. However, Article 2 and part 3 of Annex II of the said Directive are to remain in force until 20 July 2013.

This repeal aims at aligning some provisions with Decision 768/2008 on the marketing of products in the internal market. It allows technical developments that have taken place in the toy market to be taken into account.

The Directive on the general safety of products complements this Directive, and is applicable in the absence of specific provisions governing product safety. Toys are also subject to the provisions of Directive 2001/95/EC setting out the general framework for product safety and Directive 85/374/EEC on liability for defective products.

REFERENCES

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive2009/48/EC[COD 2008/0018]	20.7.2009	20.1.2011	OJ L 170 of 30.6.2009

RELATED ACTS

Directive2005/84/ECof the European Parliament and of the Council of 14 December 2005 amending for the 22nd time Council Directive 76/769/EEC on the approximation of laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles).
The use of phthalates and the placing in circulation of toys and childcare articles containing such substances is prohibited in the European Union. These bans are to be reassessed in 2010.

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the registration, evaluation and authorisation of chemicals, and the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.

Regulation (EC) No 1272/2008of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

Toy safety

The safety of toys is harmonised at European level so that the essential requirements can be met at the manufacturing stage. The standards laid down by the European standardisation bodies provide evidence of compliance with the essential requirements. Toys that meet these requirements bear the CE conformity marking.

ACT

Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys .

Summary

This Directive applies to toys, i.e. any product or material designed or clearly intended for use in play by children under 14 years of age.

It lays down the safety criteria or “essential requirements” which toys must meet during manufacture and before being placed on the market.

Harmonised European standards are drawn up on the basis of the essential requirements by the European standardisation bodies. These non-mandatory standards are notified to the Official Journal of the European Union (EU).

Any toy manufactured in conformity with the harmonised standards is presumed to comply with the essential requirements.

The procedures for assessing the conformity of toys with the essential requirements are based on the modular approach set out in the Council Decision on CE conformity marking. The toy conformity assessment must be carried out:

either by bodies designated by the Member States on the basis of common evaluation criteria, and notified to the Commission and the other Member States;
or by the manufacturers themselves.

Before being placed on the market, toys must be given a CE conformity marking which:

symbolises their conformity with the provisions of these Directives;
consists of a unique acronym, namely the CE acronym;
is affixed by the manufacturer or its authorised representative established in the Community.

When a toy falls within the purview of other Directives that stipulate the CE marking, the marking must also indicate that the toy conforms with the requirements of those Directives.

Any other mark may be affixed to the toy, provided there is no risk of confusion with the conformity marking.

Penalties may be adopted by the Member States if they ascertain that the CE marking has been improperly used.

The new Directive 2009/48/EC on toy safety repeals Directive 88/378/EEC from 20 July 2011.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 88/378/EEC	6.5.1988	30.6.1989	OJ L 187 of 16.7.1988

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 93/68/EEC	2.8.1993	1.7.1994	OJ L 220 of 30.8.1993

RELATED ACTS

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on toy safety (Text with EEA relevance).

ASSESSMENT OF CONFORMITY

Commission Decision 2007/224/EC of 4 April 2007 concerning the publication of the reference of the standard EN 71-1:2005 ‘Safety of Toys — Part 1: mechanical and physical properties’ regarding the technical requirements on projectiles with suction cups as an impact area in accordance with Council Directive 88/378/EEC on the safety of toys [notified under document number C(2007) 1460] (Text with EEA relevance).

Commission Decision of 23 March 2007 concerning the publication of the reference of the standard EN 71-1:2005 ‘Safety of Toys — Part 1: mechanical and physical properties’ regarding the technical requirements on hemispheric toys in accordance with Council Directive 88/378/EEC on the safety of toys [notified under document number C(2007) 1256] (Text with EEA relevance).

Partial non-conformity of standard EN 71-1:1998 “Safety of Toys – Part 1: mechanical and physical properties”: Commission Decision2005/195/EC [Official Journal L 63 of 10 March 2005].
This Decision partially withdraws the presumption of conformity of the standard on toys made of expanding materials. Until the standard has been amended accordingly, toys containing expanding material must have received an EC type-examination certificate.

Commission Decision2001/579/EC [Official Journal L 205 of 31 July 2001].
This Decision concerns toys that use percussion caps and stipulates that the maximum sound pressure level of 140 dB would remain in force until 31 July 2001, after which it would be reduced to 125 dB.

Commission Decision2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment [Official Journal L 66 of 4 March 2004].
This Decision sets up three Scientific Committees; one of them – the Scientific Committee on Consumer Products – will be competent for the safety of toys placed on the market. It will provide the Commission with scientific opinions on this subject.

Directive 2005/84/EC of the European Parliament and of the Council of 14 December 2005 amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles). [Official Journal L 344 of 27 December 2005].

The Commission is extending the ban on the marketing of six types of phthalates and their use for this particular purpose. As a precaution, other toys and childcare articles of soft PVC intended for children under the age of three and which could be put in the mouth, even if this is not the purpose intended by the manufacturer, shall display a warning if they contain phthalates in order to ensure safe use under all circumstances.

These measures will be reassessed no later than 2010.

Notified bodies

The notified bodies and the third countries responsible for performing the conformity evaluation procedures referred to in the “New Approach” Directives can be found in the NANDO-IS base. The list of titles and references of harmonised standardsis available on the website of the Directorate-General for Enterprise and Industry.

IMPLEMENTATION OF THE DIRECTIVE

Commission Communications:

Commission communication in the framework of the implementation of the Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys (Text with EEA relevance) (Publication of titles and references of harmonised standards under the directive) [Official Journal C 99 of 30.4.2009].

[Official Journal C 237 of 16.9.2008];
[Official Journal C 201 of 29.8.2007];
[Official Journal C 127 of 8.6.2007];
[Official Journal C 258 of 26.10.2006];
[Official Journal C 157 of 6.7.2006];
[Official Journal C 127 of 31.5.2006];
[Official Journal C 56 of 8.3.2006];
[Official Journal C 188 of 2.8.2005];
[Official Journal L 63 of 10.3.2005];
[Official Journal C 79 of 30.3.2004];
[Official Journal C 297 of 9.12.2003].

Commission impact study of 8 October 2004 on revising Council Directive 88/378/EEC (EN) [Not published in the Official Journal].
This study examines the fields in which the rules in force could be improved and the relationship between the costs and benefits to the toys industry of the various amendments proposed.

Toys intended to be placed in the mouth by children under three years of age and containing phthalates are prohibited throughout the European Union; importing these products is also prohibited. Phthalates are toxic substances that may be found in soft PVC, a type of plastic which is also used in the manufacturing of toys.

ACT

Summary

This Directive prohibits the use of certain categories of phthalates in the manufacture of toys and childcare articles [*] intended for children.

It applies to the following chemical substances: di (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and butylbenzyl phthalate (BBP).

A second group of phthalates may be potentially dangerous to health; it consists of: di-iso nonyl phthalate (DINP), di-iso-decyl phthalate (DIDP) and di-n-octyl phthalate (DNOP). However, in the absence of adequate scientific information, the prohibition on these substances is limited to toys and childcare articles which can be placed in the mouth by children.

The Commission regularly reviews the prohibition measures to bring them into line with developments in scientific knowledge. The next review is scheduled for 2010 at the latest.

Background

The first warning against the use of phthalates in toys was the Recommendation adopted by the Commission on 1 July 1998 concerning toys and childcare articles intended to be placed in the mouth by children under three years of age, made of soft PVC and containing phthalates.

The Commission consulted the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) at the time, which had confirmed toxicity hazards. Decision 1999/815/EC made it possible to prohibit the use of certain phthalates on the basis of the legislation on general product safety. In particular, this legislation makes it possible to restrict the marketing of a product or to withdraw it quickly if it presents a serious health risk, thanks to the Community rapid information system (RAPEX).

Since 1999, Decision 1999/815/EC was extended more than 20 times in the name of the precautionary principle until the adoption of Directive 2005/84/EC.

Key terms used in the act

· Childcare article: any product intended to facilitate sleep, relaxation, hygiene, the feeding of children, or sucking on the part of children.

REFERENCES

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2005/84/EC	16.1.2006	–	OJ L 344 of 27.12.2005; with corrigendum [OJ L 033 of 04.02.2006]; addendum [OJ L 068 of 08.03.2006]

Last updated: 31.10.2008

Toys [EU]

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