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EU Toy Safety Product safety training for buyers and sourcing professionals Shanghai, Guangzhou and Shunde August-September 2014. Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry Internal Market and its International Dimension.

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Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry

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Katleen hendrix european commission directorate general enterprise and industry

EU Toy SafetyProduct safety training for buyers and sourcing professionalsShanghai, Guangzhou and ShundeAugust-September 2014

Katleen HENDRIX

European Commission, Directorate-General Enterprise and Industry

Internal Market and its International Dimension


Directive 2009 48 ec toy safety directive

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


Katleen hendrix european commission directorate general enterprise and industry

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


What is a toy continued

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)


A toy has to be safe

A toy has to be safe

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

    • General safetyrequirement

      • (see Article 10.2 of the ToySafety Directive)

    • Particularsafetyrequirements

      • (seeAnnex II of the ToySafety Directive)

    • The essential safetyrequirements (= general + particularsafetyrequirements) are mandatory

      => Standards are notmandatory in the EU!


A toy has to be safe continued

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


Physical and mechanical properties example

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)


Chemical properties examples

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


Chemical properties examples continued

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 greaterthan 0.1% by weight of the plasticisedmaterial

    • DINP, DIDP and DNOP are banned

      • in toys (and childcare articles) whichcanbeplaced in the mouth by children and

      • in a concentration greaterthan 0.1% by weight of the plasticisedmaterial

        Guidance on "whichcanbeplaced in the mouth" availablehttp://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


Electrical properties examples

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 burnswhentouched

    • 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


What type of economic operator am i is the entity for which i am sourcing

Typical Business Model

Product Cycle

Product developed, produced and sold entirely within the EU.

EU Production

manufacturer

distributor

1

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

Developed & Domestic

manufacturer

distributor

2

produced outside the EU.

Unaltered product developed by a supplier, then sold within the

3rd Party & Domestic (

without

product

manufacturer

distributor

importer

3

EU by an EU Operator

alteration)

Supplier product specifically modified (see point 3 below) for or by

3rd Party & Domestic (

with

product

manufacturer

distributor

4

an EU Operator and sold within the EU.

alterations)

Developed product (by a Non-EU Operator) sold outside of the

Direct Import / FOB

manufacturer

importer

5

EU for Direct Import by an EU Operator.

Developed product (by EU Operator) sold outside of

Direct Import/FOB - manufacturer is

manufacturer

distributor

6

the EU for Direct Import by an EU Operator. *5

an EU entity

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

3rd Party (Sales Commission) FOB

manufacturer

importer

7

EU Operator.

Product sold by a contracted representative of a Non-EU

Manufacturers Authorised

Authorised representative

manufacturer

distributor

8

Operator to hold (but not draw up) Technical File.

Representative in EU

Product developed exclusively for EU retailer and bought outside

Retailer own Brand Product

manufacturer

9

the EU.

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

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


Obligations of economic operators

Obligations of economic operators

Each economic operator has different obligations, according to his

role in the supply and distribution chain

Manufacturer (EU or non EU)

Design and manufacture in accordance with therequirements

Importer (only EU)

Place only compliant toys on the EU market

Distributor

Act 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


Manufacturer design and prototyping

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


Manufacturer design and prototyping continued

Manufacturer: Design and prototyping (continued)

  • The manufacturer has to submit the toy to a conformity assessment

  • There are 2 possible conformity assessment procedures:

    • by the manufacturer himself

    • by a Third Party ("Notified Body" = "Conformity Assessment Body")

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


Manufacturer design and prototyping continued1

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 propertiesotherthanelectricalproperties: EN 71

    • => For electricalproperties: EN 62115


Katleen hendrix european commission directorate general enterprise and industry

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


Manufacturer design and prototyping continued2

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-typeexamination" => "EC-typeexaminationcertificate"

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


Manufacturer design and prototyping continued3

Manufacturer: Design and prototyping (continued)

If the conformityassessmentprocedure shows that:

  • the toyiscompliant, then the manufacturer

    • must draw up the technical documentation

    • must draw up the EC Declaration of Conformity

    • must ensureconformity of production at all times

    • must affix the CE mark

  • the toyis not compliant, then the manufacturer

    • must not place the toy on the market

    • mayimprove the toy in order to becomecompliant


Manufacturer design and prototyping cont d

Manufacturer: Design and prototyping (cont'd)

Draw up the EC Declaration of Conformity:


Manufacturer design and prototyping cont d1

Manufacturer: Design and prototyping (cont'd)

Draw up the technical documentation:


Manufacturer placing the toy on the market

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 of

      the Toy Safety Directive

    • Member States impose languagerequirements!

  • keep technical documentation and EC

    Declaration of Conformity for 10 years


Manufacturer once the toy is on the market

Manufacturer: once the toy is on the market

The manufacturer must:

  • takesamples of marketedtoys and test them

  • investigate complaints on non-conformingtoys

  • take action if hebelieves or has reason to believethat the toyis not in conformity, including:

    • bring the toyintoconformity

    • withdraw/recall the toy if appropriate

    • if risk: immediatelyinform the competentMember State authorities

  • cooperatewith the Member State authorities, including:

    • provide documents provingconformity of the toy

    • cooperate on authorities' actions to eliminaterisksfromtoys


Importer

Importer

The importer must:

  • place onlycomplianttoys on the EU market

  • therefore, ensurethat the manufacturer has donehis job!

    • ensurethatappropriateconformityassessmentwasdone

    • ensurethat all the required documents are there

    • ensurethat the CE marking and the instructions, safety information and warnings are affixed

    • ensurethat the toyis identifiable/traceable

    • ensurethat the manufacturer'sname etc. appear

  • affixhisownname, registeredtradename/trademark and address

  • monitor and take action if heconsiders or has reason to believethatthe toyis not in conformity

  • cooperatewith the Member State authorities


More information

More information

EU toy safety homepage

  • http://ec.europa.eu/enterprise/sectors/toys/index_en.htm

    Text of the ToySafety Directive (includingChineseversion!)

  • 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.htm

    Amendments 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


Katleen hendrix european commission directorate general enterprise and industry

Thank you for your attention!

Any Questions?

For questions in the future:

[email protected]


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