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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

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slide2
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)

slide3
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
slide4
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
slide5
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
slide6
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

slide7
DIRECTIVE 2009/48/EC

I Clarifying the scope and concepts

slide8
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”

slide10
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
slide11
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
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

list of products that are not considered as toys annex i1
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

list of products that are not considered as toys annex i2
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-appealing luminaries

18. Electrical transformers for toys

19. Fashion accessories for children which are not for use in play

slide15
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
slide16
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

slide17
DIRECTIVE 2009/48/EC

II Obligations of economic operators

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
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 ec1
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

slide22
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

slide25
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/legislation/guide/index.htm

slide26
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

slide27
DIRECTIVE 2009/48/EC
  • Manufacturers
  • carry out sample testing
  • investigatecomplaints, recalls,…
  • keep a register of complaints, recalls,…
  • keep distributors informed
slide28
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
slide29
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

slide30
DIRECTIVE 2009/48/EC
  • Manufacturers
  • immediately take corrective measures
  • immediately inform the competent national authorities
  • give detailson the non compliance
slide31
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
slide32
DIRECTIVE 2009/48/EC

Authorized representative

slide33
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

slide34
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.
directive 2009 48 ec2
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 ec3
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 ec4
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 ec5
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 ec6
DIRECTIVE 2009/48/EC

Importers

  • carry out sample testing
  • investigatecomplaints, recalls,..
  • keep a register of complaints , recalls,…
  • keep distributors informed
directive 2009 48 ec7
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 ec8
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 ec9
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 ec10
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 understoodby consumers
directive 2009 48 ec11
DIRECTIVE 2009/48/EC
  • inform the manufacturer or the importer, as well as the market surveillance authoritiesof non compliant toys
  • not make a non compliant toy available on the market
directive 2009 48 ec12
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
slide49
DIRECTIVE 2009/48/EC

III Safety assessment and conformity assessment

slide50
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

slide51
Design phase

Production phase

Module A

Module A1

Module A2

Module C

CON

F

O

R

M

I

T

Y

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

EVALUATIONS

slide53
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

slide54
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

slide56
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

slide57
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

slide58
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

slide59
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

slide62
DIRECTIVE 2009/48/EC

V REQUIREMENTS

slide63
DIRECTIVE 2009/48/EC NEW REQUIREMENTS
  • Particular Safety requirements
    • - Physical and mechanical properties
    • - Chemical properties
    • - Electrical properties
    • - Flammability
    • - Hygiene
    • - Radioactivity
slide64
PHYSICAL AND MECHANICAL PROPERTIES

Choking risk

= inhalation of small parts

2009/48/EC

Extended with toys which are intended to be put in the mouth ( for example toy instruments)

88/378/EEC

toys for children under 36 months

slide65
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)

slide66
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

slide68
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

slide69
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
slide70
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)
slide71
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.

slide72
ALLERGIC FLAGRANCES
  • Ban for 55 allergenic fragrances
  • 2) Labelling for 11 fragrances that are susceptibleto be allergenic for certain persons
slide73
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
slide74
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

slide75
Directive 2009/48/EC

MORE INFORMATION

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

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