EU Toy Safety

Product safety training for buyers and sourcing professionals

Shanghai, Guangzhou and ShundeAugust-September 2014

Katleen HENDRIX

European Commission, Directorate-General Enterprise and Industry

Internal Market and its International Dimension

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DIRECTIVE 2009/48/EC ("Toy Safety Directive")

• Applicable in all EU Member States since 20 July 2011; chemical requirements applicable since 20 July 2013

• Clear definitions and obligations for all economic operators

• Clear requirements on identification, warning labels, technical documentation including EC Declaration of Conformity, safety assessment, conformity assessment procedures, …

• Stricter safety requirements

• Free movement of safe toys in all EU Member States

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What is a toy?

A toy is a product:

-designed or intended -whether or not exclusively -for use in play -by children under 14 years of age

according to the Toy Safety Directive

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What is a toy? (continued)

Some products are not toys Decorative objects for festivities and celebrations Puzzles with more than 500 pieces Fireworks etc. (see Annex I of the Toy Safety Directive, non-exhaustive

list)

Some toys are not covered by the Toy Safety Directive Playground equipment intended for public use Automatic playing machines intended for public use Toy steam engines etc. (see Article 2 of the Toy Safety Directive)

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A toy has to be safe

• The manufacturer placing a toy on the EU market has to ensure that it complies with • General safety requirement

(see Article 10.2 of the Toy Safety Directive)• Particular safety requirements

(see Annex II of the Toy Safety Directive)

• The essential safety requirements (= general + particular safety requirements) are mandatory

=> Standards are not mandatory in the EU!

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A toy has to be safe (continued)

• General safety requirement• Toys must not jeopardise the health and safety of the child

playing, nor of others (parents, child carers, …) when used as intended or in a foreseeable way

• Bear in mind the behaviour of children!

• Particular safety requirements• Physical and chemical properties (incl. small parts, sound)• Flammability• Chemical properties (incl. allergenic fragrances, 19 elements)• Electrical properties• Hygiene (incl. microbiological safety aspects)• Radioactivity

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Physical and mechanical properties (example)

Choking risk= swallowing or inhalation

of small parts

cf the "small parts cylinder"

Small parts are banned:•in toys clearly intended for children under 36 months and •in other toys intended to be put in the mouth (e.g. toy musical instruments) 8

Chemical properties (examples)

• Ban in principle: substances classified as carcinogenic, mutagenic and toxic for reproduction (CMR)

• Ban: 55 named allergenic fragrances• Labelling requirements: 11 named fragrances

susceptible to be allergenic for certain persons• Migration limits for 19 named "heavy elements" like

cadmium, lead and mercury• From end 2015: specific limit values recently laid down

for TCEP, TCPP, TDCP and bisphenol A (and more coming)• in toys intended for children under 36 months and • in other toys intended to be placed in the mouth

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Chemical properties (examples - continued)• EU legislation on chemicals must also be respected!• Especially relevant: REACH restrictions on phthalates

• DEHP, DBP and BBP are banned• in toys (and childcare articles) and • in a concentration greater than 0.1% by weight of the plasticised material

• DINP, DIDP and DNOP are banned • in toys (and childcare articles) which can be placed in the mouth by

children and• in a concentration greater than 0.1% by weight of the plasticised material

Guidance on "which can be placed in the mouth" available http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm

Q&A http://echa.europa.eu/support/qas-support/qas select "Restrictions"

• From end 2015: REACH restriction on PAH • 0.5 mg/kg by weight of rubber or plastic components in direct, prolonged or

repetitive skin or oral cavity contact

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Electrical properties (examples)

• Cables and conductors of electricity must be protected so as to prevent risk of electric shock Wires and conductors must be protected so that they do

not come into contact with burrs that may damage their insulation

• Directly accessible surfaces cannot cause burns when touched Batteries of toys intended for children under 36 months

must have secure battery compartment cover or must be removable only with the aid of a tool

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What type of economic operator am I / is the entity for which I am sourcing?

1 EU Production

2 Developed & Domestic

33rd Party & Domestic (without product

alteration) importer

43rd Party & Domestic (with product

alterations)

5 Direct Import / FOB

6Direct Import/FOB - manufacturer is

an EU entity

73rd Party (Sales Commission) FOB

8Manufacturers Authorised

Representative in EUAuthorised representative

9 Retailer own Brand Product

Developed product (by a Non-EU Operator) sold outside of the EU for Direct Import by an EU Operator.

Developed product (by EU or Non-EU Operator) sold outside of the EU by an EU or Non-EU sales agent, for Direct Import by an

EU Operator.

Product sold by a contracted representative of a Non-EU Operator to hold (but not draw up) Technical File.

Product CycleTypical Business Model

importermanufacturer

manufacturer importer

distributor

distributormanufacturerProduct developed and sold within the EU by an EU Operator, but

produced outside the EU.

Unaltered product developed by a supplier, then sold within the EU by an EU Operator

distributorProduct developed, produced and sold entirely within the EU. manufacturer

manufacturer

distributor

manufacturer distributor

manufacturer

Supplier product specifically modified (see point 3 below) for or by an EU Operator and sold within the EU.

Product developed exclusively for EU retailer and bought outside the EU.

Developed product (by EU Operator) sold outside of the EU for Direct Import by an EU Operator. *5

distributormanufacturer

manufacturer

TSD explanatory guidance document Rev 1.7 at http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm , p. 137

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Obligations of economic operators

Each economic operator has different obligations, according to hisrole in the supply and distribution chain

Manufacturer (EU or non EU)Design and manufacture in accordance with the requirementsImporter (only EU)Place only compliant toys on the EU market DistributorAct with due care in relation to the applicable requirements Authorised representative An importer or distributor is considered to be a manufacturer if:

• he places the toy on the EU market under his name or trademark• he modifies a toy already placed on the market in such way that

compliance with the requirements may be affected

level of responsibility

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Manufacturer: Design and prototyping

• The manufacturer has to perform a safety assessment for the toy:• An analysis of the hazards (chemical, physical, mechanical,

electrical, flammability, hygiene and radioactivity) that the toy may present

• An assessment of the potential exposure to such hazards

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Manufacturer: Design and prototyping (continued)• The manufacturer has to submit the toy to a

conformity assessment• There are 2 possible conformity assessment

procedures:1. by the manufacturer himself2. by a Third Party ("Notified Body" = "Conformity Assessment

Body")

• In both cases the manufacturer assumes responsibility for compliance and affixes the CE mark

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Manufacturer: Design and prototyping (continued)

1. Conformity assessment by the manufacturer himself ("self-certification")• If he applies harmonised standards, whose references have

been published in the Official Journal of the EU, and all the relevant safety requirements for the toy are covered by those harmonised standards

=> For properties other than electrical properties: EN 71

=> For electrical properties: EN 62115

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Manufacturer: Design and prototyping (continued)

Latest publication of references of harmonised standards: OJ C 181, 13.6.2014, p. 1 http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/toys/index_en.htm

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Manufacturer: Design and prototyping (continued)

2. Conformity assessment by a Third Party ("Notified Body")

• If the relevant safety requirements for the toy are not entirely covered by harmonised standards whose references have been published in the Official Journal of the EU

• If the manufacturer has applied the harmonised standards only in part or not at all

• If the harmonised standards have been published with a restriction (currently not the case)

• If the manufacturer considers that the toy needs to be assessed by a Third Party

"EC-type examination" => "EC-type examination certificate"

List of Notified Bodies: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=140521

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Manufacturer: Design and prototyping (continued)

If the conformity assessment procedure shows that:• the toy is compliant, then the manufacturer

• must draw up the technical documentation • must draw up the EC Declaration of Conformity• must ensure conformity of production at all times• must affix the CE mark

• the toy is not compliant, then the manufacturer• must not place the toy on the market• may improve the toy in order to become compliant

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Manufacturer: Design and prototyping (cont'd) Draw up the EC Declaration of Conformity:

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Manufacturer: Design and prototyping (cont'd) Draw up the technical documentation:

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Manufacturer: placing the toy on the market

The manufacturer must •make the toy identifiable/traceable: type, batch, serial or model number on the toy•make himself identifiable: his name, registered trade name/trademark and address on the toy, the packaging or an accompanying document•add instructions and safety information, including warnings, on the toy, an affixed label or the packaging

• Some warnings are mandatory! See Annex V ofthe Toy Safety Directive

• Member States impose language requirements!

•keep technical documentation and ECDeclaration of Conformity for 10 years

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Manufacturer: once the toy is on the market

The manufacturer must:•take samples of marketed toys and test them•investigate complaints on non-conforming toys•take action if he believes or has reason to believe that the toy is not in conformity, including:

• bring the toy into conformity• withdraw/recall the toy if appropriate• if risk: immediately inform the competent Member State authorities

•cooperate with the Member State authorities, including:• provide documents proving conformity of the toy• cooperate on authorities' actions to eliminate risks from toys

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Importer

The importer must:•place only compliant toys on the EU market•therefore, ensure that the manufacturer has done his job!

• ensure that appropriate conformity assessment was done• ensure that all the required documents are there• ensure that the CE marking and the instructions, safety

information and warnings are affixed• ensure that the toy is identifiable/traceable• ensure that the manufacturer's name etc. appear

•affix his own name, registered trade name/trademark and address•monitor and take action if he considers or has reason to believe that the toy is not in conformity•cooperate with the Member State authorities

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More informationEU toy safety homepage•http://ec.europa.eu/enterprise/sectors/toys/index_en.htm Text of the Toy Safety Directive (including Chinese version!)•http://ec.europa.eu/enterprise/sectors/toys/documents/directives/index_en.htm Guidance (including some Chinese versions!)•http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htmAmendments of the Toy Safety Directive•http://ec.europa.eu/enterprise/sectors/toys/documents/index_en.htm#h2-2 Reference documents•http://ec.europa.eu/enterprise/sectors/toys/documents/index_en.htm

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Thank you for your attention!

Any Questions?

For questions in the future:ENTR-TOYS@ec.europa.eu

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