The latest development in EU - FHKI - Federation of Hong ... · The latest development in EU . 2.55 2.86 1.09 0.78 4.70 4.42 ... right click on the slide ... CLP-on Ps-on cs on s

© 2015 The LEGO Group l © 2015 The LEGO Group l

Hong Kong Toys & Games Fair 2016

Seminar on Toy Safety

Christian Wetterberg

Chair of CEN/TC 52 and ISO/TC 181

The latest development in EU

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• The EU-framework for toy safety

• The Toy Safety Directive

• The EN 71 and EN 62115 standards

• Other directives and regulations

© 2015 The LEGO Group Page 2

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer.

Do not cover the LEGO logo

Do not cover the graphic elements – pick a simple layout instead

The standards and Guidance docs vs the TSD


Toy Safety Directive 2009/48/EC

Mechanic

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Chemical

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Radio

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Mig

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EN 71-1 EN 71-8 EN 71-14

EN 71-3 EN 71-4 EN 71-5 EN 71-7 EN 71-12 EN 71-13

EN 62115

--------

Guidance doc

------- (EN 71-9, -10, -11)

Guidance

doc

EN 71-2

Partic

ula

r safe

ty re

quire

ments

Sta

ndard

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G

uid

ance d

ocs

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Guidance doc

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Standards, guidance docs and the safety assessment


Legislation that can be relevant for toys

Toy S

afe

ty D

irectiv

e

RoH

S-d

irectiv

e

REACH

Packagin

g &

Waste

Food C

onta

ct M

ate

rial

Regula

tion

Batte

ry D

irectiv

e

R&

TTE-d

irectiv

e

EM

C-d

irectiv

e

CLP-re

gula

tion

PO

Ps-re

gula

tion

Cosm

etic

s re

gula

tion

Phth

ala

tes

Nic

kel re

lease

Benzene

Cadm

ium

Azo-d

yes

PAH

s

SVH

C-lis

t

Standards & Guidance documents

Safety Assessment according to Article 18 in TSD (also used to determine necessary testing)

The above is not an exhaustive list of legislation

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. The EU-framework for toy safety


Toy Safety Directive

2009/48/EC

Specific electrical:

(e.g. RoHS, R&TTE and

EMC) Packaging & Waste Directive 94/62/EC

Batteries Directive

2006/66/EC

Cosmetic products

Regulation 1223/2009

Food contact

materials Regulations 1935/2004

and

10/2011

Specific chemical

restrictions (e.g. REACH,

POPs and CLP)

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. The TSD

• Directive 2009/48/EC – certain parts can be amended, e.g:

• Annex II, Section 3, point 13, Migration limits: Sets limits for

the migration of 19 elements

• Appendix A: Lists substances that are classified as Carcinogenic,

Mutagenic or Reprotoxic (CMR) but are exempted from the general

prohibition on CMR-substances

• Appendix C: Includes specific limit values for chemicals used in

toys intended for use by children under 36 months or in other toys

intended to be placed in the mouth. Limits in App C overrule the

general requirements for CMR-substances


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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. Changes to TSD after its publication


Migration limits

Element mg/kg in

dry, brittle, powderlike or pliable toy material

mg/kg in liquid or sticky toy material

mg/kg in scraped-off toy material

Barium Old 4 500 1 125 56 000

New 1 500 375 18 750

Cadmium Old 1,9 0,5 23

New 1,3 0,3 17

These limits were changed prior to July 20, 2013

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. Changes to TSD that are under discussion


Migration limits

It has also been discussed to adapt migration limits for Chromium VI that would correspond to the Limit of Quantification (0,053 mg/kg).

The discussions on migration limits have been on hold due to a published erratum to the report from RIVM. This is the report which estimated the potential daily intake of different toy materials and thus formed the basis for the present TSD migration requirements.

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Changes to TSD after its publication

© 2015 The LEGO Group Page 9 © 2015 The LEGO Group Page 9

Appendix A

• Nickel (classified as Carcinogenic Category 2) is permitted in toy

components which are intended to conduct an electric current. (It is

since before also permitted in toys and toy components made of

stainless steel). The new exemption entered into force July 1st, 2015

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Appendix C: The following restrictions entered into force December 21, 2015

Expl. guidance doc:

TCEP is a phosphate ester used as a flame-retardant plasticiser in polymers. TDCP and TCPP are TCEP's halogenated alternatives.

Bisphenol A residual monomer is normally found at trace levels only in polycarbonate and epoxy resins. It can also be present as an additive (polymerisation aid) in certain PVC materials;

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Appendix C

• The following restriction for BIT will enter into force May 27, 2017

Note that the restriction applies to aqueous toy materials (e.g. finger paints,

window/glass paints, glues and soap bubbles)

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Appendix C

• The following restrictions for CMI+MI, CMI and MI will enter into force

Nov 27, 2017

Note that the restriction applies to aqueous toy materials (e.g. finger paints,

window/glass paints, glues and soap bubbles)

General recommendation - preservatives

It is expected that the guidance document on Technical Documentation will be

updated with a recommendation to proceed with a Toxicological Risk Assessment

(in addition to considering limit values e.g. in the TSD and standards)

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Appendix C

• The following restriction for Formamide will enter into force May 27, 2017

Expl. guidance doc:

Will clarify that the restriction targets EVA, PE and PU foam materials larger

than 0,45 m2 and for indoor use. Examples with pictures will be given (e.g.

puzzle mats).

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. Changes to TSD that are under discussion


Appendix C

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The EN 71 and EN 62115-standards


EN 71-1 Mechanical and physical properties

EN 71-2 Flammability

EN 71-3 Migration of certain elements

EN 71-4 Experimental sets for chemistry and related activities

EN 71-5 Chemical toys (sets) other than experimental sets

EN 71-7 Finger paints

EN 71-8 Activity toys for domestic use

EN 71-9 Organic chemical compounds – Requirements

EN 71-10 Organic chemical compounds – Sample preparation

EN 71-11 Organic chemical compounds - Methods of analysis

EN 71-12 N-Nitrosamines and N-nitrosatable substances

EN 71-13 Olfactory board games, cosmetic kits and gustative games

EN 71-14 Trampolines for domestic use

EN 62115 Electrical toys

Blue = Reference not published in the Official Journal of the EU

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EN 71-1 MECHANICAL & PHYSICAL PROPERTIES • Until 29 February 2016, both EN 71-1:2011+A3:2014 and EN 71-

1:2014 give presumption of conformity to TSD.

• EN 71-1:2011+A3:2014 includes:

• A1: ”Legibility of warnings”

• A2: “Acoustics”

• A3 “Toy books” (paper and paperboard)

• EN 71-1:2014 was published November 26th 2014 and is an editorially

revised version of EN 71-1:2011+A3:2014. Toys that comply with EN 71-

1:2011+A3:2014 do not need to be retested to EN 71-1:2014

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EN 71-1 MECHANICAL & PHYSICAL PROPERTIES

Ongoing work affecting EN 71-1

• Amendment prA1 to EN 71-1:2014 regarding ”Cords and drawstrings in toys

and packaging” is under elaboration. A 3-month public Enquiry is expected to

be launched in April 2016.

• Amendment prA2 regards ”Projectiles, rotors, propellers and flying toys”.

The ambition is to launch the 3-month public enquiry first half of 2016.

• Amendment prA3 is named ”Various” and the 3-month CEN Enquiry closed 9

October 2015. If possible it will be aligned (timewise) and merged with A1 and

A2 in order to reduce the number of amendments.

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EN 71-series continued

• EN 71-2:2011 Flammability

• No important changes have been made since the

publication. Amd 1 includes only minor corrections

• EN 71-3:2013 Migration of certain elements

• Amd 1 was published in October, 2014 and regards

pH control/adjustment during testing of certain toy

materials. The previous version of the standard can be

used until Feb 29, 2016.

• Major revision with financial support from the European

Commission will start 2016. Publication of the revised

standard is expected for 2019. The project includes

round robin tests with new reference materials

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• EN 71-4:2013 Chemical Experimental Sets

• No changes have been made since the publication.

• EN 71-5 Chemical toys

• EN 71-5:2013 – published June 2013

• EN 71-5:2015 - published September 2015 (this version

aligns the standard with the requirements for mixtures

in the CLP regulation 1272/2008)

• EN 71-5:2013 can be used until May 31, 2016

• EN 71-7:2014 Finger paints

• An amendment is planned in order to delete CMI/MI

from the list of permitted preservatives (due to the

published App C restriction)

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• EN 71-8:2011 Activity toys for domestic use

• No changes have been made since the publication

• A revision of EN 71-8 is however ongoing and a public

enquiry is expected to be launched autumn 2016

• EN 71-9, -10 and -11 Organic Chemical Compounds

• Initial discussions have been held about the need to

publish methods that support Appendix C restrictions

• EN 71-12:2013 Nitrosamines and Nitrosatable substances

• Includes an “A-deviation” for National German limits

• The final vote for a revised version of EN 71-12 will be

launched April 2016. It includes the national German limit

values for certain toys (with the ambition to delete the A-

deviation).

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• EN 71-13:2013 Olfactory Board Games and Gustative

Games

• No changes have been made since the publication

• EN 71-14:2014 TRAMPOLINES FOR DOMESTIC USE

• EN 71-14:2014 was published in December 2014

• A proposal for amendment has been launched to change

the safety factor from 2,5 to 5 for calculation of the load in

the mat deflection test

• Discussions regarding a revision of 71-14 are ongoing.

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CEN TECHNICAL REPORTS

• CEN Technical Report 15071 “National translations of warnings and instructions for use in EN 71-standards“. The revised 2015-version was made available in August, 2015.

• CEN Technical report 15371-1 “Replies to requests for interpretation of EN 71-1, EN 71-2 and EN 71-8”. CEN TR 15371:2014 published May 7, 2014. CEN TR 15371-1:2015 was published in October 2015

• CEN Technical report 15371-2 “Replies to requests for interpretation of the EN 71 Chemical standards”. CEN TR 15371-2:2015 was published in October 2015

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CEN TECHNICAL REPORTS

• New CEN Technical report 8124-8:2016 “Age determination guidelines” The TR was approved in parallel in ISO and CEN and is a slightly revised version of ISO TR 8124-8:2014. Publication is expected early 2016

• New CEN Technical report 16918 “Children´s mouthing behaviour in contact with toys”. CEN TR 16918:2015 was published December 23, 2015.

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EN 62115

• The current referenced standard is EN 62115:2005 plus

amendments A2:2011, A11:2012, and A12:2015

• A12 was published early 2015 and contains the

requirements on the electro-magnetic fields generated by

toys, drawing on the requirements of the horizontal

standard EN 62233:2008

• The previous version of EN 62115 (without A12) can be

used until 3 June, 2017

• The standard is presently undergoing a revision which

includes an update of the LED Annex.

• The final vote for the revised version standard is expected

to be launched in the autumn of 2016 (parallel voting in

IEC and CENELEC)

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Other Directives and Regulations

REACH Regulation 1907/2006

Phthalate content

restriction

Nickel release

restriction

Azodyes (aromatic amines content)

Cadmium content

restriction

Benzene content

restriction (toy specific)

PAH Content restriction

REACH: A new restriction at 0,5 mg/kg for 8 PAHs in rubber or plastic

components of toys that come into direct as well as prolonged or short-term

repetitive contact with the human skin or the oral cavity, under normal or

reasonably foreseeable conditions of use. Applies from 27 December, 2015.

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Other Directives and Regulations

REACH:

ECHA has published a definition of “prolonged contact with the skin”

for the Nickel release restriction:

• Prolonged contact with the skin is defined as contact with the skin of

nickel of potentially more than

• 10 minutes on three or more occasions within two weeks, or

• 30 minutes on one or more occasions within two weeks

The European Court of Justice (ECJ) has said the 0,1 % threshold for

notifying Substances of Very High Concern in articles, applies to “each of

the articles incorporated as a component of a complex product”

rather than to the entire article.

ECHA published a quick update of its guidance document on substances and

articles in December 2015. A more comprehensive update will come in 2016

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. Other Directives and Regulations


• Textiles - The European Commission has launched a public

consultation on a possible restriction of approx. 300 hazardous

substances (CMR 1A and 1B) in textile articles and clothing for

consumer use (including toys) at 50 ppm under REACH.

• R&TTE - Directive 1999/5/EC on radio equipment and tele-

communications terminal equipment (R&TTE) will be repealed 13

June 2016 and replaced by Directive 2014/53/EU on Radio

Equipment (RE)

• EMC - Directive 2004/108/EC on Electromagnetic Compatibility

(EMC) will be repealed 20 April 2016 and replaced by Directive

2014/30/EU on EMC

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TIP: You can change the layout of the slide. Choose the slide in the slide overview, in the left panel, right click on the slide – go to ‘Layouts’ and pick the design you prefer. Other Directives and Regulations


• RoHS – Four phthalates (DEHP, BBP, DBP och DIBP) will be

restricted to 0,1 % under the RoHS Directive from 22 July 2019.

DEHP, BBP and DBP are already restricted in toys through

REACH. DIBP (Diisobutyl phthalate) is however not restricted in

toys but it is listed as an SVHC.

• POPs – Regulation (EC) No 850/2004 on persistent organic

pollutants (POPs) has been amended to include a threshold for

Short-Chained Chlorinated Paraffines (SCCPs) at 1 500 ppm (it

was previously covered by a total ban)

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That’s all for today


Documents

The latest development in EU - FHKI - Federation of Hong ... · The latest development in EU . 2.55 2.86 1.09 0.78 4.70 4.42 ... right click on the slide ... CLP-on Ps-on cs on s