EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC - Maureen Logghe

EUROPEAN COMMISSION
TOYS SAFETY DIRECTIVE
2009/48/EC

Maureen Logghe

EXISTING RULES

• Directive 88/378/EEC was adopted in 1988
 (20 years old)

• Allows for free movement of safe toys in all
 EU Member States

• Contains essential safety requirements/general
principles

• Technical details are adopted in harmonised
standards (EN 71 series and EN 62115)

DIRECTIVE 2009/48/EC - TIMESCHEDULE

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

  Scope and concepts

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”

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 toys:

- non exhaustive list

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

DIRECTIVE 2009/48/EC
        NEW REQUIREMENTS

• General safety requirement

• Particular Safety requirements
   - Physical and mechanical properties
   - Chemical properties
   - Electrical properties
   - Flammability
   - Hygiene
   - Radioactivity

DIRECTIVE 2009/48/EC

Safety assessment and
conformity assessment

ASSESSMENT
88/378/EEC                                    2009/48/EC
                                              extends with
Choice of the conformity assessment
procedure
                                              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

DIRECTIVE 2009/48/EC

Technical documentation

TECHNICAL
            DOCUMENTATION

• Contains all relevant data of the means used by the
manufacturer to ensure the compliance of the toy

• Shall be drawn up in one of the official EU languages

• Needs to be kept 10 years after the toy is placed on the
market

TECHNICAL DOCUMENTATION

The technical documentation shall contain

• a detailed description of the design and manufacture, including a list of
components and materials used in the toy as well as the safety data sheets on
chemicals used, to be obtained from the chemical suppliers
• the safety assessment
• a description of the conformity assessment procedure followed
• a copy of the EC declaration of conformity
• the addresses of the places of manufacture and storage
• copies of documents that the manufacturer has submitted to a notified body, if
involved
• test reports and description of the means whereby the manufacturer ensured
conformity of production with the harmonised standards (module A)
• a copy of the EC-type examination certificate, a description of the means whereby
the manufacturer ensured conformity of the production with the product type as
described in the EC-type examination certificate (module B+C)

DIRECTIVE 2009/48/EC

Declaration of Conformity

DECLARATION OF CONFORMITY

The EC declaration of conformity shall state that
the fulfilment of the requirements has been
demonstrated

The manufacturer shall assume responsibility for
the compliance of the toy

DoC shall be translated into the language or
languages required by the Member State in whose
market the toy is placed or made available

EC DECLARATION OF CONFORMITY

1. No … (unique identification of the toy(s))
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of
the manufacturer:
4. Object of the declaration (identification of toy allowing traceability). It
shall include a colour image of sufficient clarity to enable the identification of
the toy.
5. The object of the declaration described in point 4 is in conformity with the
relevant Community harmonisation legislation:
6. References to the relevant harmonised standards used, or references to
the specifications in relation to which conformity is declared:
7. Where applicable: the notified body … (name, number) … performed …
(description of intervention) … and issued the certificate:
8. Additional information:
Signed for and on behalf of:
(place and date of issue)
(name, function)(signature)

DIRECTIVE 2009/48/EC

   CE marking

CE-MARKING

• Affixed visibly, legibly and indelibly

• On the toy, affixed label or packaging

• If not visible from the outside, it has to be on the packaging

DIRECTIVE 2009/48/EC

   Warnings

WARNINGS

Marking of the warnings

      The manufacturer shall mark the warnings in a
      clearly visible, easily legible and understandable
      and accurate manner

      In a language(s) easily understood by
      consumers, as determined by the MS on whose
      market the toy is placed

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

Marking of the warnings

Warnings which determine the decision to purchase the
toy, 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

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

DIRECTIVE 2009/48/EC

Obligations of authorities

OBLIGATIONS OF AUTHORITIES -
              Accreditation

Member states shall:
−  Designate one single national
   accreditation body (NAB) per
   Member State (the sole body that performs
     accreditation with authority derived from state)
    • Prevention of competition for NABs
    • Set of requirements for NABs
    • EA (European co-operation for accreditation)
    • Peer evaluation

OBLIGATIONS OF AUTHORITIES

Member states shall:

- Designate one notifying authority
 responsible for setting up and carrying
 out the necessary procedures for the
 assessment and notification of conformity
 assessment bodies
http://ec.europa.eu/enterprise/newa
  pproach/nando/

OBLIGATIONS OF AUTHORITIES

 Member States shall
- Organize and carry out market
  surveillance
- Inform Commission and public
- Send in national programmes

OBLIGATIONS OF AUTHORITIES

Market surveillance authorities:
- Shall take proportionate
  measures
- Notify serious risk (art 22 REG)
  based on appropriate risk
  assessment (Rapex platform)
- Notify non-serious risk (art 23
  REG) (ICSMS-CIRCA)

DIRECTIVE 2009/48/EC

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

Manufacturer

• Any legal or natural person who
  manufacturers or has the toy designed
  and manufactured and places the toy on
  the European market

Authorised representative

• The manufacturer located outside the
  EU can have an authorised
  representative established in the EU
• The AR will act on the behalf of the
  manufacturer in relation to specific
  tasks, on the basis of a written mandate

Importer

• Established in the EU, brings the toy
  from outside the EU on the EU market
   If he places the toy on the market under his
    own name/trademark, he is the
    manufacturer
   If he modifies the toy is such way that the
    compliance is affected, he is the
    manufacturer

Distributor

• Other than the manufacturer or
  importer, he makes the toy available on
  the market
   If he places the toy on the market under his
    own name/trademark, he is the
    manufacturer
   If he modifies the toy is such way that the
    compliance is affected, he is the
    manufacturer

Each economic operator has
different obligations, according to
his own role in the supply and
distribution chain

Draw up the technical documentation

• It’s exclusively an obligation for the
  manufacturer only

Carry out safety and conformity
assessments

• It’s exclusively an obligation for the
  manufacturer only
• The authorised representative may
  carry out parts of the conformity
  assessment procedure

Keep the technical documentation

• Manufacturer
   10 years after the toy has been placed on
    the market (same for the AR)
• Importer
   No obligation
• Distributor
   No obligation

Make available the technical
documentation upon request

• Manufacturer (and his AR)
  Importer
  Distributor
   Upon reasoned request, 10 years after the
    toy has been placed on the market

Draw up the declaration of conformity

• Manufacturer
   Has an obligation
• Authorised representative
   If specified in the written mandate
• Importer
   No obligation
• Distributor
   No obligation

Keep the DoC and make it available

• Manufacturer (and his AR)
  Importer
   10 years after the toy has been placed on
    the market
• Distributor
   Upon reasoned request

Affix CE mark and identification
elements

• Manufacturer (and his AR)
   Has an obligation
• Importer
   Ensures it’s done
• Distributor
   Verify it’s done

Ensure conformity of series
production

• Only an obligation for the manufacturer

Affix name and address

• Manufacturer
   Has an obligation
• Authorised representative
   Only his address if the manufacturer is outside the
    EU
• Importer
   Has an obligation
• Distributor
   Verify it’s done

Ensure the required documents accompany
the toy, in the correct language(s)

• Manufacturer
   Has an obligation
• Authorised representative
   If specified in the written mandate
• Importer
  Distributor
     • Has an obligation

Take all appropriate measures in relation to
non compliant toys and cooperate with
market surveillance authorities
• Manufacturer
  Importer
  Distributor
   Has an obligation
• Authorised representative
   If specified in the written mandate

Sample test marketed toys

• Manufacturer
  Importer
   Obligation, if appropriate in relation to the risks of
    the toys
• Distributor
   No obligation
• Authorised representative
   If specified in the written mandate

Keep register of complaints, non-
conforming toys and recalls. Inform

• Manufacturer
  Importer
   Yes, if necessary
• Distributor
   No obligation, but recommended
• Authorised representation
   If specified in the written mandate

Don’t jeopardise compliance during
storage or transport

• Manufacturer
   No obligation
• Importer
  Distributor
   Have an obligation

Identify the other Economic Operators

• Each economic operator shall identify
  any other economic operator to whom
  he supplied a toy or who supplied him
  with a toy
• 10 years after the toy has been supplied
  to him

Directive 2009/48/EC

MORE INFORMATION

http://ec.europa.eu/enterprise/sectors/toys/index_en.htm

EXPLANATORY GUIDE

http://ec.europa.eu/enterprise/sectors/toys/files/tsd_expla
natory_guidance_document_en.pdf

Questions?