ec by liuhongmei


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

Technical details are adopted in harmonised
standards (EN 71 series and EN 62115)
Changes in the toys market (many kinds of new

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
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
                                   "#! $% &
                                   !                   ' ()*

   (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
                            $           "#! $

I Clarifying the scope and concepts

II Traceability

III Declaration of Conformity

IV Safety assessment and conformity assessment

V warnings
              $               "#! $

I Clarifying the scope and concepts
                  $ +      ($   $ +
       88/378/EEG                 2009/48/EC

Definition of “Toys” in    Definition of “Toys” in
Article 1 (1)              Article 2 (1)

“any product or material   “products designed or
designed or clearly        intended, whether or not
intended for use in play   exclusively, for use in
by children of less than   play by children under
14 years of age”           14 years of age”
                   +        $        ,
                                 -       .       /

= products that do not fulfil the definition of toys but
  could be confused with them:

- non exhaustive list
                  +        $        ,
                                -       .      /


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
                        +            $         ,
          $                                    - .                    /

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
                        +           $         ,
           $                                  - .                   /
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.   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-appealing luminaires
18.   Electrical transformers for toys
19.   Fashion accessories for children which are not for use in play
              +        $      ,
                    - 01              $

= products that fulfil the definition of toys but
  are excluded from the scope:

- exhaustive list
            +      $      ,
                - 01              $

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
   $              "#! $

II Traceability
                                   $                    "#! $

Unique Identification:
a type, batch, serial or model number or other element allowing their

On the toy, on the packaging or in a document accompanying the toy

name, registered trade name or registered trade mark and the address

On the toy, packaging or in a document accompanying the toy

Note: unique identification is equal to one on EC DoC
                $               "#! $

Manufacturers shall identify any economic
operator who has supplied them with a toy and
any economic operator to whom they have
supplied a toy

Manufacturers shall be able to present the
information for a period of 10 years after they
placed the toy on the market
                $               "#! $

Importers/distributors shall identify any economic
operator who has supplied them with a toy and
any economic operator to whom they have
supplied a toy

Importers/distributors shall be able to present the
information for a period of 10 years after they
have been supplied with the toy
           $               "#! $

III Declaration of Conformity
                        $             "#! $
Manufacturers shall draw up the required technical
documentation and the EC Declaration of

Manufacturers shall 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
$   "#! $
$   "#! $
                    $             "#! $

IV Safety assessment and conformity assessment
88/378/EEC                                    2009/48/EC
                                              extends with
Choice of the conformity assessment
                                              Explicit obligation to carry out an
1) Self verification if                       analysis of hazards
- 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                                  - manufacturers considers that
- harmonised standards are published with a   toy necessitates 3rd party
restriction                                   verification
  $          "#! $

V 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

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

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

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

Specific warnings

      The warnings shall be used as worded, except for
      the toys not intended for children under 36
      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

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   Identificati   Address   Address       CE mark    CE mark      CE mark      Warning      Warning
               on             on (where                (where                  (small toy)   (counter                  (small toy
                              the size or              that is not                           display)                  without
                              the nature               possible)                                                       packaging
                              does not                                                                                 )
                              allow it)
Toy            X                             X                       X         X             X            X            X

packaging                     X                        X             X         X             X            X

Document                      X                        X                       X             X            X (if
(instructio                                                                                               appropriat
ns/leaflet/l                                                                                              e)

Affixed                       X                        X             X         X             X            X            X

Counter                                                                                      X (if used
display                                                                                      as
                $            "#! $
                             !            2

•Particular Safety requirements

   - Physical and mechanical properties
   - Chemical properties
   - Electrical properties
   - Flammability
   - Hygiene
   - Radioactivity
             +,-   $               $,      $
                       +       +
 Choking risk

 = inhalation of small parts

88/378/EEC                 2009/48/EC

toys for children under    Extended with toys which
36 months                  are intended to be put in the
                           mouth ( for example toy
          +,-      $               $,     $
                       +   +

Suffocation risk

88/378/EEC                     2009/48/EC
                               extended with
external airway
obstruction of                 internal airway
mouth and nose                 obstruction
                               (Example: suction
               +,-   $                $,     $
                         +     +
Toys in food
                               Separate packaging
                               Packaging: no choking
no specific provisions
                               Warning: “Toy inside;
                             Adult supervision
                             recommended ”
                               Ban of toys firmly
                             attached to a food product
                             (example : some lollypops)
      1         $      $           - 4 041

    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
     +                  ,   $    1
                $   $

- 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
         $,       $        1       $

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.
                          $            $

1) Ban for 55 allergenic fragrances

2) Labelling for 11 fragrances that are susceptible
   to be allergenic for certain persons
                   1       $

- 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

88/378/EEC                  2009/48/EC extends with

Toys must meet the          A toy intended for children under
requirements of hygiene     36 months must be designed and
                            manufactured in such a way that it
and cleanliness in order    can be cleaned.
to avoid any risk of        A textile toy shall be washable,
infection, sickness and     except if it contains a mechanism
contamination               that may be damaged if soak
                 1                                            $                      $         +
                 Manufacturer                Authorised rep              Importer                    distributor

Draw up          X
Technical doc

Keep             10 y after placing on the   10 y after placing on the
Technical        market                      market
Make                                                                     10 y after placing on the   Upon reasoned request
available                                                                market
Technical doc
Draw up DoC      X                           X

Keep DoC         10 y after placing on the   10 y after placing on the   10 y after placing on the   Upon reasoned request
                 market                      market                      market
Address          X                                                       X

Identification   X

Affix CE         X
                                 "#! $


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