Transcript Slide 1

EUROPEAN COMMISSION
TOYS SAFETY DIRECTIVE
2009/48/EC
EXISTING RULES
Directive 88/378/EEC was adopted in 1988
(20 years old)
Allows for free movement of safe toys in all
27 Member States of the EU
Contains essential safety requirements/general
principles
Technical details are adopted in harmonised
standards (EN 71 series and EN 62115)
Reasons for a new Directive
Changes in the toys market (many kinds of new
toys)
Changes in production areas - 80% imports
to EU
New scientific evidence of substances used
in toys
Need to enhance control
inside EU/at external borders
TIME FRAME OF REVISION
Proposal adopted by the European Commission on
25 January 2008
Proposal was under discussion with EU institutions:
- Council (27 EU-Member States)
- European Parliament (700 deputies from 27 EUMember states)
Text adopted by EP on 18 December 2008
Text adopted by Council on 11 May 2009
Directive signed on the 18th June and published in
the OJEU on 30 June 2009
Directive 2009/48/EC: time schedule
OJEU
(1)
(2) (3)
(4)
(1) OJEU + 20 days : entry into force i.e. 20 July 2009
(2) OJEU + 20 days +18 months: time for MS to transpose
i.e. 20 January 2011
(3) OJEU + 20 days + 2 years: application of the Directive
(except chemical requirements) i.e. 20 July 2011
(4) OJEU + 20 days + 4 years: application of the Directive for
chemical requirements i.e. 20July 2013
DIRECTIVE 2009/48/EC
I Clarifying the scope and concepts
II Obligations of economic operators
III Safety assessment and conformity assessment
IV Warnings
V Requirements
DIRECTIVE 2009/48/EC
I Clarifying the scope and concepts
I SCOPE and CONCEPTS
88/378/EEG
2009/48/EC
Definition of “Toys” in
Article 1 (1)
Definition of “Toys” in
Article 2 (1)
“any product or material
designed or clearly
intended for use in play
by children of less than
14 years of age”
“products designed or
intended, whether or not
exclusively, for use in
play by children under
14 years of age”
LIST OF PRODUCTS THAT ARE NOT
REGARDED AS TOYS (ANNEX I)
= products that do not fulfil the definition of toys but
could be confused with them:
- non exhaustive list
LIST OF PRODUCTS THAT ARE NOT
REGARDED AS TOYS (ANNEX I)
Attention!
A contrario interpretation should not be drawn from
the list, that is, if a particular product is not
mentioned in the list, it does not mean that it is
automatically a toy
The definition of toy has to always be the basis for
deciding whether a product is a toy or not
LIST OF PRODUCTS THAT ARE NOT
CONSIDERED AS TOYS (ANNEX I)
1.
2.
3.
4.
Decorative objects for festivities and celebrations
Products for collectors, provided that the product or its packaging bears a
visible and legible indication that it is intended for collectors of 14 years of
age and above. Examples of this category are:
(a) detailed and faithful scale models;
(b) kits for the assembly of detailed scale models;
(c) folk dolls and decorative dolls and other similar articles;
(d) historical replicas of toys; and
(e) reproductions of real fire arms.
Sports equipment, including roller skates, inline skates, and skateboards
intended for children with a body mass of more than 20 kg
Bicycles with a maximum saddle height of more than 435 mm, measured as
the vertical distance from the ground to the top of the seat surface, with the
seat in a horizontal position and with the seat pillar set to the minimum
insertion mark
LIST OF PRODUCTS THAT ARE NOT
CONSIDERED AS TOYS (ANNEX I)
5.
6.
7.
8.
9.
10.
11.
12.
13.
Scooters and other means of transport designed for sport or which are
intended to be used for travel on public roads or public pathways
Electrically driven vehicles which are intended to be used for travel on
public roads, public pathways, or the pavement thereof
Aquatic equipment intended to be used in deep water, and swimming
learning devices for children, such as swim seats and swimming aids
Puzzles with more than 500 pieces
Guns and pistols using compressed gas, with the exception of water guns
and water pistols, and bows for archery over 120 cm long
Fireworks, including percussion caps which are not specifically designed
for toys
Products and games using sharp-pointed missiles, such as sets of darts
with metallic points
Functional educational products, such as electric ovens, irons or other
functional products operated at a nominal voltage exceeding 24 volts
which are sold exclusively for teaching purposes under adult supervision
Products intended for use for educational purposes in schools and other
pedagogical contexts under the surveillance of an adult instructor, such as
science equipment
LIST OF PRODUCTS THAT ARE NOT
CONSIDERED AS TOYS (ANNEX I)
14.
15.
16.
17.
18.
19.
Electronic equipment, such as personal computers and game consoles,
used to access interactive software and their associated peripherals,
unless the electronic equipment or the associated peripherals are
specifically designed for and targeted at children and have a play value on
their own, such as specially designed personal computers, key boards, joy
sticks or steering wheels
Interactive software, intended for leisure and entertainment, such as
computer games, and their storage media, such as CDs
Babies' soothers
Child-appealing luminaries
Electrical transformers for toys
Fashion accessories for children which are not for use in play
LIST OF PRODUCTS THAT ARE REGARDED
AS TOYS, BUT ARE EXCLUDED
= products that fulfil the definition of toys but
are excluded from the scope:
- exhaustive list
LIST OF PRODUCTS THAT ARE REGARDED
AS TOYS, BUT ARE EXCLUDED
playground equipment intended for public use
automatic playing machines, whether coin operated
or not, intended for public use
toy vehicles equipped with combustion engines
toy steam engines
slings and catapults
DIRECTIVE 2009/48/EC
II Obligations of economic operators
OBLIGATIONS OF ECONOMIC OPERATORS
Economic operators are
responsible for the compliance of
the toy in relation to their role in
the supply and distribution chain
DIRECTIVE 2009/48/EC
Manufacturer
DIRECTIVE 2009/48/EC
manufacturer means any natural or legal
person who manufactures a toy or has a toy
designed or manufactured, and markets
that toy under his name or trademark
manufacturers shall ensure that the toys
have been designed and manufactured in
accordance with the requirements set out
in the Toy Safety Directive
DIRECTIVE 2009/48/EC
Manufacturers shall draw up the
required technical documentation and
carry out or have carried out the
applicable conformity assessment
procedure
Manufacturers shall draw up an EC
declaration of conformity and affix the
CE marking
DIRECTIVE 2009/48/EC
The EC declaration of conformity states that the
fulfilment of the requirements has been
demonstrated
The manufacturer assumes responsibility for the
compliance of the toy
It is translated into the language or languages
required by the Member State in whose market the
toy is placed or made available
DIRECTIVE 2009/48/EC
DIRECTIVE 2009/48/EC
DIRECTIVE 2009/48/EC
Obligation to keep the technical documentation
and the EC declaration of conformity for a period of
10 years after the toy has been placed on the
market
http://ec.europa.eu/enterprise/newapproach/legislat
ion/guide/index.htm
DIRECTIVE 2009/48/EC
Manufacturers ensure that procedures are in place
for series production to remain in conformity
Changes in toy design or characteristics and
changes in the harmonised standards by reference
to which conformity of a toy is declared shall be
adequately taken into account
DIRECTIVE 2009/48/EC
Manufacturers
 carry out sample testing
 investigate complaints, recalls,…
 keep a register of complaints, recalls,…
 keep distributors informed
DIRECTIVE 2009/48/EC
 Unique identification :
A type, batch, serial or model number or other
element allowing their identification
On the toy, on the packaging or in a document
accompanying the toy
 Address:
name, registered trade name or registered trade
mark and the address
On the toy, on the packaging or in a document
accompanying the toy
DIRECTIVE 2009/48/EC
Manufacturers ensure that the toy is accompanied
by instructions and safety information in a
language or languages easily understood by
consumers
DIRECTIVE 2009/48/EC
Manufacturers
 immediately take corrective measures
 immediately inform the competent national authorities
 give details on the non compliance
DIRECTIVE 2009/48/EC
Manufacturers
 provide all the information and documentation
necessary to demonstrate the conformity of the toy
 a language easily understood by the authority
 cooperate
DIRECTIVE 2009/48/EC
Authorized representative
DIRECTIVE 2009/48/EC
authorised representative means any natural or
legal person established within the Community
who has received a written mandate from a
manufacturer to act on his behalf in relation to
specified tasks
The obligations to manufacturer and the drawing
up of technical documentation shall not form part
of the authorised representative's mandate
DIRECTIVE 2009/48/EC
The authorised representative does at least the following:
(a) keep the EC declaration of conformity and the technical
documentation at the disposal of national surveillance authorities
for a period of 10 years after the toy has been placed on the market
(b) further to a reasoned request from a competent national authority,
provide that authority with all the information and documentation
necessary to demonstrate the conformity of a toy
(c) cooperate with the competent national authorities, at their request,
on any action taken to eliminate the risks posed by toys covered by
the mandate.
DIRECTIVE 2009/48/EC
Importer
DIRECTIVE 2009/48/EC
importer means any natural or legal
person established within the
Community who places a toy from a
third country on the Community
market
Notice: an importer is considered a manufacturer
where it places a toy on the market under its name or
trademark or modifies a toy already placed on the
market in such a way that compliance with the
applicable requirements may be affected
DIRECTIVE 2009/48/EC
 Importers shall identify any economic operator
who has supplied them with a toy and any
economic operator to whom they have supplied a
toy
 Importers shall be able to present the information
for a period of 10 years after they have been
supplied with the toy
DIRECTIVE 2009/48/EC
Importers place only compliant toys on
the Community market
Importers ensure that
 the manufacturer carried out the conformity
assessment
 the manufacturer drew up the technical
documentation
 the toy bears the CE marking
 the toy is accompanied by the required documents
 the toy bears an indentification and the
manufacturers address
DIRECTIVE 2009/48/EC
Importers
 indicate their name, registered trade name or
registered trade mark and the address
 ensure that the toy is accompanied by
instructions and safety information
 ensure that storage or transport conditions do
not jeopardise the compliance
DIRECTIVE 2009/48/EC
Importers
carry out sample testing
investigate complaints, recalls,..
keep a register of complaints , recalls,…
keep distributors informed
DIRECTIVE 2009/48/EC
Importers
 immediately take the corrective measures
 immediately inform the competent national
authorities
 keep a copy of the EC declaration of
conformity
 ensure that the technical documentation can
be made available
 cooperate
DIRECTIVE 2009/48/EC
Distributors
DIRECTIVE 2009/48/EC
distributor means any natural or legal
person in the supply chain, other than
the manufacturer or the importer, who
makes a toy available on the market
Notice: a distributor is considered a manufacturer
where it places a toy on the market under its name or
trademark or modifies a toy already placed on the
market in such a way that compliance with the
applicable requirements may be affected
DIRECTIVE 2009/48/EC
 Distributors shall identify any economic
operator who has supplied them with a toy
and any economic operator to whom they
have supplied a toy
 Distributors shall be able to present the
information for a period of 10 years after
they have been supplied with the toy
DIRECTIVE 2009/48/EC
act with due care
verify that the toy bears the CE marking
verify that the toy is accompanied by the
required documents
verify if the instructions are in a
language or languages easily
understood by consumers
DIRECTIVE 2009/48/EC
inform the manufacturer or the importer,
as well as the market surveillance
authorities of non compliant toys
not make a non compliant toy available
on the market
DIRECTIVE 2009/48/EC
 ensure that storage or transport conditions do
not jeopardise its compliance
 make sure that the corrective measures
necessary are taken
 provide the authority with all the information
and documentation necessary to demonstrate
the conformity of the toy
OBLIGATIONS OF ECONOMIC OPERATORS
Manufacturer
Draw up
Technical doc
X
Keep
Technical
Doc
10 y after placing on the
market
Authorised rep
Importer
distributor
10 y after placing on the
market
Upon reasoned request
10 y after placing on the
market
Upon reasoned request
10 y after placing on the
market
Make
available
Technical doc
Draw up DoC
X
X
Keep DoC
10 y after placing on the
market
10 y after placing on the
market
Address
X
Identification
X
Affix CE
X
X
DIRECTIVE 2009/48/EC
III Safety assessment and conformity assessment
ASSESSMENT
88/378/EEC
Choice of the conformity assessment
procedure
1) Self verification if
- harmonised standard covering all safety
aspects are complied with
2) Third party verification (EC type
examination) if
- harmonised standards do not exist
- harmonised standards are not applied or
only in part
- harmonised standards are published with a
restriction
2009/48/EC
extends with
Explicit obligation to carry out an
analysis of hazards
- manufacturers considers that
toy necessitates 3rd party
verification
EVALUATIONS
Design phase
Production phase
Module A
Module A1
Module A2
Module C
Manufacturer
Module C1
Module B
Module C2
Module D
Module E
Module F
Module D1
Module E1
Module F1
Module G
Module H
Module H1
C
O
N
F
O
R
M
I
T
Y
DIRECTIVE 2009/48/EC
IV Warnings
WARNINGS
Marking of the warnings
The manufacturer shall mark the warnings in a
clearly visible, easily legible and understandable
and accurate manner
a Member State may stipulate that those warnings
and the safety instructions shall be written in a
language(s) easily understood by consumers
WARNINGS
Marking of the warnings
The warnings shall be preceded by the words
"Warning" or "Warnings"
The manufacturer shall mark the warnings on the
toy, on an affixed label or on the packaging and, if
appropriate, on the instructions for use which
accompany the toy
Small toys which are sold without packaging shall
have appropriate warnings affixed to them
WARNINGS
WARNINGS
Marking of the warnings
Warnings which determine the decision to
purchase the toy, such as those specifying the
minimum and maximum ages for users and the
other applicable warnings set out in Annex V,
shall appear on the consumer packaging or be
otherwise clearly visible to the consumer before
the purchase, including in cases where the
purchase is made on-line
WARNINGS
User limitations
The user limitations shall include at least the
minimum or maximum age of the user and, where
appropriate, the abilities of the user, the
maximum or minimum weight of the user and the
need to ensure that the toy is used only under
adult supervision
WARNINGS
Specific warnings
The warnings shall be used as worded, except for
the toys not intended for children under 36
months
The economic operator can choose between
"Not suitable for children under 36 months" or
"Not suitable for children under three years" or a
warning in the form of the following graphic
WARNINGS
Specific warnings
Toys shall not bear one or more of the specific
warnings where that warning conflicts with the
intended use of the toy, as determined by virtue
of its function, dimension and characteristics
Identificati
on
Toy
Identificati
on (where
the size or
the nature
does not
allow it)
X
Address
Address
(if not
possible)
X
packaging
X
X
Document
(instructio
ns/leaflet/l
abel)
X
X
Affixed
label
X
X
Counter
display
CE mark
CE mark
(small toy)
CE mark
(counter
display)
Warning
Warning
(small toy
without
packaging
)
X
X
X
X
X
X
X
X
X
X
X
X (if
appropriat
e)
X
X
X
X
X (if used
as
packaging
)
X
DIRECTIVE 2009/48/EC
V REQUIREMENTS
DIRECTIVE 2009/48/EC NEW
REQUIREMENTS
•Particular Safety requirements
- Physical and mechanical properties
- Chemical properties
- Electrical properties
- Flammability
- Hygiene
- Radioactivity
PHYSICAL AND MECHANICAL
PROPERTIES
Choking risk
= inhalation of small parts
88/378/EEC
2009/48/EC
toys for children under
36 months
Extended with toys which
are intended to be put in the
mouth ( for example toy
instruments)
PHYSICAL AND MECHANICAL
PROPERTIES
Suffocation risk
88/378/EEC
external airway
obstruction of
mouth and nose
2009/48/EC
extended with
internal airway
obstruction
(Example: suction
cups)
PHYSICAL AND MECHANICAL
PROPERTIES
Toys in food
88/378/EEC
no specific provisions
2009/48/EC
Separate packaging
Packaging: no choking
hazard
Warning: “Toy inside;
Adult supervision
recommended ”
Ban of toys firmly
attached to a food product
(example : some lollypops)
PHYSICAL AND MECHANICAL
PROPERTIES
BAN OF CMRs CATEGORY 1A, 1B AND 2
Substances that are classified as carcinogenic,
mutagenic or toxic for reproduction (CMR), category
1A, 1B or 2 shall not be used in toys, in components
of toys or in micro-structurally distinct parts of toys
EXEMPTIONS FROM THE CMR BAN UNDER
STRICT CONDITIONS
- these substances and mixtures are
contained in individual concentrations equal
to or smaller than the relevant
concentrations established in the
Community legal acts
-or these substances and mixtures are
inaccessible to children in any form,
-or a decision has been taken
PROPOSAL: EXEMPTIONS FROM THE CMR
BAN UNDER STRICT CONDITIONS
This decision may be taken if the following
conditions are met :
i) the use of the substance or mixture has
been evaluated by the relevant Scientific
Committee
ii) the substance or mixture is not prohibited
for uses in consumer articles under
Regulation (EC) No 1907/2006 (REACH)
iii) there are no suitable alternative
substances or mixtures available (for 1A
and 1B)
CHEMICAL SUBSTANCES
nickel in stainles steel is authorized
nitrosamines and nitrosatable substances shall
be prohibited for use in toys intended for use by
children under 36 months or in other toys
intended to be placed in the mouth if the
migration of the substances is equal to or higher
than 0,05 mg/kg for nitrosamines and 1 mg/kg for
nitrosatable substances.
ALLERGIC FLAGRANCES
1) Ban for 55 allergenic fragrances
2) Labelling for 11 fragrances that are susceptible
to be allergenic for certain persons
LIMIT VALUES FOR CERTAIN DANGEROUS
SUBSTANCES
- List of elements of Directive 88/378/EEC enlarged
to those relevant for toys
- New strict migration limits for elements in toys
- “Bioavailability” limits replaced by migration limits
Distinction of limits as regard toy material
HYGIENE
88/378/EEC
2009/48/EC extends with
Toys must meet the
requirements of hygiene
and cleanliness in order
to avoid any risk of
infection, sickness and
contamination
A toy intended for children under
36 months must be designed and
manufactured in such a way that it
can be cleaned.
A textile toy shall be washable,
except if it contains a mechanism
that may be damaged if soak
washed
Directive 2009/48/EC
MORE INFORMATION
http://ec.europa.eu/enterprise/sectors/toys/index_en.htm
Questions?