EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC - PowerPoint PPT Presentation

Loading...

PPT – EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC PowerPoint presentation | free to download - id: 3d8765-ZDA1Y



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC

Description:

european commission toys safety directive 2009/48/ec list of products that are not considered as toys (annex i) list of products that are not considered as toys ... – PowerPoint PPT presentation

Number of Views:32
Avg rating:3.0/5.0
Slides: 77
Provided by: miCamcom
Learn more at: http://www.mi.camcom.it
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC


1
EUROPEAN COMMISSIONTOYS SAFETY DIRECTIVE
2009/48/EC
2
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)
3
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

4
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
    EU-Member 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

5
Directive 2009/48/EC time schedule
OJEU
(1)
(2)
(3)
(4)
  • OJEU 20 days entry into force i.e. 20 July
    2009
  • OJEU 20 days 18 months time for MS to
    transpose i.e. 20 January 2011
  • OJEU 20 days 2 years application of the
    Directive (except chemical requirements) i.e. 20
    July 2011
  • OJEU 20 days 4 years application of the
    Directive for chemical requirements i.e. 20July
    2013

6
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
7
DIRECTIVE 2009/48/EC
I Clarifying the scope and concepts
8
I SCOPE and CONCEPTS
2009/48/EC Definition of Toys in Article 2
(1) products designed or intended, whether or
not exclusively, for use in play by children
under 14 years of age
88/378/EEG Definition of Toys in Article 1
(1) any product or material designed or clearly
intended for use in play by children of less than
14 years of age
9
(No Transcript)
10
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

11
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
12
LIST OF PRODUCTS THAT ARE NOT CONSIDERED AS TOYS
(ANNEX I)
1. Decorative objects for festivities and
celebrations 2. 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. 3. Sports equipment, including roller
skates, inline skates, and skateboards intended
for children with a body mass of more than 20
kg 4. 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
13
LIST OF PRODUCTS THAT ARE NOT CONSIDERED AS TOYS
(ANNEX I)
5. Scooters and other means of transport designed
for sport or which are intended to be used for
travel on public roads or public
pathways 6. Electrically driven vehicles which
are intended to be used for travel on public
roads, public pathways, or the pavement
thereof 7. Aquatic equipment intended to be used
in deep water, and swimming learning devices for
children, such as swim seats and swimming
aids 8. Puzzles with more than 500 pieces 9. Guns
and pistols using compressed gas, with the
exception of water guns and water pistols, and
bows for archery over 120 cm long 10. Fireworks,
including percussion caps which are not
specifically designed for toys 11. Products and
games using sharp-pointed missiles, such as sets
of darts with metallic points 12. 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 13. Products intended for use for
educational purposes in schools and other
pedagogical contexts under the surveillance of an
adult instructor, such as science equipment
14
LIST OF PRODUCTS THAT ARE NOT CONSIDERED AS TOYS
(ANNEX I)
14. 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 15. Interactive
software, intended for leisure and entertainment,
such as computer games, and their storage media,
such as CDs 16. Babies' soothers 17. Child-appeali
ng luminaries 18. Electrical transformers for
toys 19. Fashion accessories for children which
are not for use in play
15
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

16
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
17
DIRECTIVE 2009/48/EC
II Obligations of economic operators
18
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

19
DIRECTIVE 2009/48/EC
Manufacturer
20
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

21
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

22
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
23
DIRECTIVE 2009/48/EC
24
DIRECTIVE 2009/48/EC
25
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/newapproac
h/legislation/guide/index.htm
26
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
27
DIRECTIVE 2009/48/EC
  • Manufacturers
  • carry out sample testing
  • investigate complaints, recalls,
  • keep a register of complaints, recalls,
  • keep distributors informed

28
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

29
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
30
DIRECTIVE 2009/48/EC
  • Manufacturers
  • immediately take corrective measures
  • immediately inform the competent national
    authorities
  • give details on the non compliance

31
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

32
DIRECTIVE 2009/48/EC
Authorized representative
33
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
34
DIRECTIVE 2009/48/EC
  • The authorised representative does at least the
    following
  • 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
  • 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.

35
DIRECTIVE 2009/48/EC
Importer
36
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

37
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

38
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

39
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

40
DIRECTIVE 2009/48/EC
  • Importers
  • carry out sample testing
  • investigate complaints, recalls,..
  • keep a register of complaints , recalls,
  • keep distributors informed

41
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

42
DIRECTIVE 2009/48/EC
Distributors
43
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

44
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

45
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

46
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

47
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

48
OBLIGATIONS OF ECONOMIC OPERATORS

 P1
49
DIRECTIVE 2009/48/EC
III Safety assessment and conformity assessment
50
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
51
EVALUATIONS
52
DIRECTIVE 2009/48/EC
IV Warnings
53
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
54
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
55
WARNINGS
56
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
57
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
58
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
59
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
60
(No Transcript)
61
(No Transcript)
62
DIRECTIVE 2009/48/EC
V REQUIREMENTS
63
DIRECTIVE 2009/48/EC NEW REQUIREMENTS
  • Particular Safety requirements
  • - Physical and mechanical properties
  • - Chemical properties
  • - Electrical properties
  • - Flammability
  • - Hygiene
  • - Radioactivity

64
PHYSICAL AND MECHANICAL PROPERTIES
Choking risk inhalation of small parts
88/378/EEC toys for children under 36 months
2009/48/EC Extended with toys which are intended
to be put in the mouth ( for example toy
instruments)
65
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)
66
PHYSICAL AND MECHANICAL PROPERTIES
Toys in food
  • 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)

88/378/EEC no specific provisions
67
PHYSICAL AND MECHANICAL PROPERTIES
68
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
69
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

70
PROPOSAL EXEMPTIONS FROM THE CMR BAN UNDER
STRICT CONDITIONS
  • This decision may be taken if the following
    conditions are met   
  • the use of the substance or mixture has been
    evaluated by the relevant Scientific Committee
  • the substance or mixture is not prohibited for
    uses in consumer articles under Regulation (EC)
    No 1907/2006 (REACH)
  • there are no suitable alternative substances or
    mixtures available (for 1A and 1B)

71
CHEMICAL SUBSTANCES
nickel in stainles steel is authorized nitrosa
mines 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.
72
ALLERGIC FLAGRANCES
  • Ban for 55 allergenic fragrances
  • 2) Labelling for 11 fragrances that are
    susceptibleto be allergenic for certain persons

73
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

74
HYGIENE
88/378/EEC Toys must meet the requirements of
hygiene and cleanliness in order to avoid any
risk of infection, sickness and contamination
2009/48/EC extends with 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
75
Directive 2009/48/EC
MORE INFORMATION http//ec.europa.eu/enterprise/s
ectors/toys/index_en.htm
76

Questions?
About PowerShow.com