Transcript www.icphso.org

EU Directive on the Safety of
Toys
Mark Dewar
ICPHSO
Seoul
1st November 2011
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Is a toy not a toy when inflated by an under 8 balloonist?
Questioning your existence – but only in this room. What am I doing here?
Follow the instructions: Open and blow.

What is a toy?

What am I?

Does it matter?

What is the TSDR (‘ToySDirRe’)?

How does it dovetail with other legislation/regulation eg ASTM, ISO

Why should I care?
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Statistics (2010)
Greece 159
(8%)
Cyprus 178
(8%)
Others 294
(15%)
Others 1039
(54%)
Unknown 201
(10%)
Hungary 191
(10%)
Bulgaria 192
(10%)
China
including Hong
Kong 1,134
(58%)
EU & EEA 338
(17%)
Germany 204
(10%)
Notifying Countries
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Countries of Origin
Statistics (2010)
600
550
500
439
Injuries
Electrical
appliances 158
(8%)
Motor Vehicles
175 (9%)
Childcare
articles and
children's
equipment 72
(4%)
Clothing,
textiles and
fashion items
625 (32%)
400
356
Chemical
330
Strangulation
300
197
200
Electric Shock
100
Others 432
(22%)
Toys 488 (25%)
0
Product Categories
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Choking
Types of Risks (Top
five categories)
Welcome to ToySDirRe
 Changes replaces and builds on 20 year old directive
 New Approach Directive
–
Principles – essential safety requirements – Article 10 and Annex II
–
Underpinned by harmonised standards that stipulate technical requirements
–
Part of interlocking EU regulatory regime
 Approximation of laws of member states concerning safety of toys becomes
safety of toys.
 What is toy? Definition refined by amendment to exclusion ( Annex 1)
–
Products designed or intended, whether or not exclusively, for use in
play by children of less than 14 years of age
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Welcome to ToySDirRe
Context/Reminder: Key changes introduced by TSD
Depends on your perspective. Testing lab may say:
 EC declaration on conformity –drawn up by manufacturer
 Safety assessment/risk assessment
–
Carried out by manufacturer – id hazards
–
Keep in technical documentation
 Product control – more specific internal, self verification and monitoring
 New Chemical requirements 20 July 2013
 New mechanical requirments for toys with food.
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Welcome to ToySDirRe
Context/Reminder: Key changes introduced by TSD
To improve the enforcement and
efficiency of the Directive

Economic Operator Responsibilities

Changes to technical file contents
To improve safety requirement of toys

Clarifying criteria of essential safety
requriements

Enhanced warning requirements

Choking risk

Suffocation risk

Special requirements for toys in food

New Chemical Requirements
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Implementation
 20th July 2011 – Implement but not Chemicals
– Develop revised harmonised standards
 20th July 2013 – implement chemical requriements
– Develop revised chemical standards
 20th July 2017 -Develop special requirements for food grade materials
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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EN 71-1:
Standard for
mechanical
and physical
properties
EN 71-2
Flammability
New Approach
Directive
2013 EN for
ToySDirRe
Chemicals
EN 62115
Electrical
Toys
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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EN 71-8
Active Toys
for domestic
use
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To improve the enforcement and efficiency of the Directive
Technical Documentation – manufacturers
need to know what in materials and
substances in toy
Conformity Assessment Procedures

Based on criteria on directive – purchase,
design, brand and stage in cycle

Design and manufacture- components -,safety
data sheet on chemicals from chemical
suppliers

May not be what expected

May be different for same company depending
on role

Safety/risk assessment before toy placed on
market

Different obligations depending on role.
Upstream ( manufacturer more onerous than
importer)

Conformity assessment procedure

EC declaration of conformity signed by senior
officer of company

Economic Operators – refinement to place on
market
–
Manufacturers
–
Importers
–
Distributors
–
Authorised Representatives (Manuf only)
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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To improve the enforcement and efficiency of the Directive
Traceability
Surveillance authorities to trace toys through supply chain by
 Include colour image of sufficient clarity to enable identification of the Toy in
Declaration of Conformity or Tech Doc
 Ensure traceability throughout supply chain
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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To improve safety requirement of Toys

Clarify Essential Safety Requirements – update to reflect technical change
– Stronger limits on noise – impulse and prolionged
– Permit exceed 24v and maintain safety level.

Chemical Requirements
– Extend migration limits for heavy elements from 8 to 19 (2013)
– Chemical requirements update to cover allergenic and CMRs – take a/c of REACH
and other legislation
– Fragrances
– 55 banned subject to trace of up to 100ppm where unavoidable in GMP
– More than cosmetics requirements – sourcing issue
– 11 allergenic substances permitted but label needed if >0.01% weight
– Exemptions apply for certain games and cosmetic kits
– Nitrosamines and nitrosable substances are banned in toys for <3yrs and all
mouthable toys if migration .05mg/kg for nitrosamines and 1mg for nitrosable
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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Warnings and marking
Primarily manufacture duty but importer has to show name and address on the product. Other
Economic Operators have to show has been done.


NB
–
CE marking fixed visibly, legibly and indelibly to the toy or an affixed label – small
toys to label/leaflet or counter
–
If not visible from outside packaging then on packaging
ToySDirRe more explicit re warnings:
–
EN 71-1 comprehensive list of prescriptive warnings
–
‘Warning’ needs to precede statement
–
At point of sale if determine decision to purchase
–
In food, own label: ‘Contains a toy, adult supervision recommended’ – cannot be a
small part choking hazard
–
Must be in one or more languages easily understood by consumers as required by
Member State
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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 Choking and suffocation risk – changes
–
Toys and detachable parts mustn’t present risk asphyxiation by blocking
mouth and nose, nor block off airways if wedged in mouth
–
Toys for < 36 months, or placed in mouth – must not be small part that can
be swallowed or inhaled
–
Retail packaging must not present a risk of strangulation or asphyxiation by
blockage to mouth and nose – esp egg shaped, spherical
 Special requirements for toys with food
–
Prior toys coupled with foodstuffs in a way that prior consumption of food
item is necessary to access toy-
–
Toys in food or mingled with food must have own packaging
–
Packaging should not present choking hazard
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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The answer:


No : since 1998 balloons made of latex carry a
warning that recommends adult supervision. It
does not prevent children under the age of 8
from blowing up balloons
What is says: “Warning! Children under eight
years can choke or suffocate on uninflated or
broken balloons. Adult supervision required. Keep
uniflated balloons from children. Discard broken
balloons at once.’
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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The Telegraph 9th October 2011
‘EU toy safety directive states that balloons must
not be blown up by unsupervised children under
the age of 8 in case they accidentally choke’
Daily Mail 10th October 2011
‘Under the rules children under the age of 8 are
no longer allowed to blow up balloons, if they are
unsupervised’
Westender Brisbane Australia
‘EU have passed new toy safety
laws….according to new directives, children
under the age of 8 will no longer be able to blow
up balloons’
What next?
 More harmonised standards, increasing specificity
 Greater co-ordination the length and breadth of supply chain
 Market surveillance enhanced under EU 765/2008 – fewer places for noncompliants to hide
 Increased cost of regulatory compliance – even EN 71-1 cost £261
 Multijurisdictional issues – ISO, ASTM ToySDiRe
 Multilingual issues – even EU needs warnings for same product in possibly 23
languages
 Greater barriers to new market entrants – will the big players share their know
how with those less able to afford it?
© Simmons & Simmons LLP 2011. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
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simmons-simmons.com
elexica.com
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