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NEW APPROACH DIRECTIVES

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Title: SAFETY OF TOYS Author: David Steadman Last modified by: Nazipa Created Date: 3/15/2006 2:20:41 PM Document presentation format: On-screen Show – PowerPoint PPT presentation

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Title: NEW APPROACH DIRECTIVES


1
NEW APPROACH DIRECTIVES
  • Trade

2
TRADE
  • Free Movement of Goods
  • Previous system Old Approach
  • Difficulty in updating of regulations, they
    contained too much detail
  • Trade Barriers between EU members
  • Rigid assessment - no options
  • Little recognition of overseas testing
    organisations

3
TRADE
  • Free movement of goods
  • Article 30 of Treaty of Rome established the
    principle that any product produced in one state
    must be admitted to any other (Cassis de Dijon
    1979)
  • Mutual Recognition was restated in the EC White
    Paper of 1985 which also established a New
    Approach to technical harmonisation and
    standardization

4
TRADE
  • Free movement of goods
  • New Approach contains
  • New type of mandatory Directives
  • New voluntary Technical Standards
  • Large product groups - Machines, Toys, Electrical
    Equipment, etc.

5
TRADE
  • Free movement of goods
  • New Approach also covers-
  • Horizontal risks - EMC, Efficiency
  • Removing existing barriers to trade
  • Mutual recognition of conformity assessment
    organisations
  • All Directives are adopted by all Member States

6
TRADE
  • Free movement of goods
  • Directives have similar format
  • Scope - What products are included
  • Exclusions - What products are not!
  • Conformity procedures - What to do
  • Use of Harmonized Standards
  • Enforcement, dates, CE marking
  • Essential Requirements

7
TRADE
  • Free movement of goods
  • Essential Requirements
  • Listed in each Directive
  • Mandatory product features
  • Describe general characteristics of the product,
    i.e. it should be safe
  • Do not describe what the product should look like

8
TRADE
  • Free movement of goods
  • CE Directives covers all products? - No
  • Either a Specific CE marking Directive
  • Machinery, Toys, Lifts, etc.
  • or other existing Directives
  • Motor Vehicles, Packaging, etc
  • or general provisions
  • Product Liability 85/374/EEC
  • General Product Safety 2001/95/EC

9
TRADE
  • Free movement of goods
  • Enforcement
  • Surveillance by Members States
  • Safeguard Clause
  • Use of Standards
  • Reporting non-compliance

10
TRADE
  • Free movement of goods
  • Summary
  • The Directive is law
  • New Approach Directives are different from Old
    ones (which still exist!)
  • Products maybe subject to more than one Directive
  • Essential Requirements must be met
  • Product must be CE marked

11
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12
SAFETY OF TOYS
  • Harmonised Standards

13
STANDARDS
  • Harmonised standards
  • Technical specifications
  • Voluntary use only
  • Product design guides
  • Produced by Standards Bodies (independent of
    Government)
  • Consensus document, drafted by industry - which
    reflect the relevant Essential Requirements of a
    Directive

14
STANDARDS
  • Harmonised standards
  • Important Differences!
  • Directives
  • Essential Requirements Mandatory list of product
    features
  • CE marking
  • Harmonized Standards
  • Voluntary guidance for manufacturers
  • presumption of compliance with Essential
    Requirements of Directive(s)

15
STANDARDS
  • Harmonised standards

Directives
Machinery standards
Toy standards
EMC standards
CE marking
16
STANDARDS
  • Harmonised standards
  • Developed by industry and national members of
    CEN, CENELEC, ETSI
  • Listed by European Commission with respect to a
    Directive in Official Journal

17
STANDARDS
  • Harmonised standards
  • European Standards has close links with
    international standards bodies

18
STANDARDS
  • Harmonised standards
  • Must be adopted by the National Standards Body of
    each Member State
  • In UK by BSI (BS EN 1234)
  • Provides presumption of conformity with the
    Essential Requirements (Directive)
  • Simplifies conformity assessment

19
STANDARDS
  • Harmonised standards
  • Summary
  • Directives and Standards are different
  • Standards are developed by industry
  • Standards provide guidance in meeting the
    Essential Requirements
  • Standards are the same throughout the Member
    States

20
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21
SAFETY OF TOYS
  • Compliance

22
COMPLIANCE
  • How do I comply?
  • 1. Identify all appropriate Directive(s)
  • 2. Identify product Standards
  • 3. Understand options for conformity
  • 4. Identify Notified Body (if applicable)
  • 5. Determine the important dates
  • 6. CE marking
  • 7. Prepare Declaration
  • 8. Maintain technical records - 10 years!

23
COMPLIANCE
  • 1. Identify the directive(s), for example
  • Toys - CE Directives
  • Safety of Toys
  • Electrical Equipment
  • Electromagnetic Compatibility
  • Cosmetics
  • Dangerous substances

24
COMPLIANCE
  • Read the Directive, each new approach Directive
    contains
  • Scope - What products are included
  • Exclusions - What products are not!
  • Conformity procedures - What to do
  • Enforcement, Dates, CE marking
  • Essential Requirements and quality control
    procedures, etc.

25
COMPLIANCE
  • 2. Identify Harmonized Standards
  • Find out which ones apply to the directive (or
    product)
  • Read the standards - they will help in the design
    the products
  • Look at the list on the EU web site
  • http//www.newapproach/Directives/DirectivesList.a
    sp
  • Get advice from the National Standards Body

26
COMPLIANCE
  • 3. Which Conformity Modules?
  • Modules A-H
  • Conformity requirements in each directive may be
    different!
  • Options for the manufacturer
  • Self-certification
  • Notified Body intervention

27
COMPLIANCE
  • Modules A-H
  • A Internal control of production
  • B EC type-examination
  • C Conformity to type
  • D Production quality assurance
  • E Product quality assurance
  • F Product verification
  • G Unit verification
  • H Full quality assurance

28
COMPLIANCE
29
COMPLIANCE
  • 4. Notified Bodies - independent evaluation of
    the product
  • Accredited by Member States against criteria in
    Directive
  • Have equipment and experience to evaluate
    products
  • Listed on the EU web site
  • http//europa.eu.int/comm/enterprise/newapproach/l
    egislation/nb/notified_bodies.htm
  • Any Notified Body can be used

30
COMPLIANCE
  • Simplified Flow Chart

Harmonised standards
CE marking
Production
Notified body
31
COMPLIANCE
  • Set Compliance control procedures
  • Any system can be used (i.e. ISO 9001, SPC, AQAP,
    etc)
  • Testing results will support your claim of
    compliance (keep results safe)
  • Notified Body testing may help reduce product
    design costs

32
COMPLIANCE
  • Each directive had different dates for coming
    into force

A
B
C
CE marking only
Existing national regulations
Optional CE Marking
Compulsory
Transitional period
33
COMPLIANCE
  • 6. CE marking

34
COMPLIANCE
  • CE Marking
  • Means the product complies with ALL the
    applicable directives
  • Size Scaleable (5mm minimum)
  • Notified Body ID number, if necessary
  • On the product if possible, if not then on
    packaging
  • CE is not a mark of quality!

35
COMPLIANCE
  • 7. Declaration by manufacturer
  • Name and address
  • List of directive(s) that have been applied
  • List harmonised standards used
  • Signed by a responsible person within the company
  • Keep a copy in the Technical File
  • (each Directive has specific requirement)

36
COMPLIANCE
  • 8. Technical File and records
  • Papers relevant to the product design
  • Drawings
  • Design calculations
  • Test results
  • This is the evidence in a future investigation /
    court case it must be kept safe
  • (each Directive has specific requirement)

37
COMPLIANCE
  • CE marking misuse is a criminal offence
  • Prohibition / disposal of goods
  • Fine
  • Imprisonment!
  • Manufacturer, Importer or Representative within
    EU is responsible for compliance

38
COMPLIANCE
  • Summary
  • 1. Identify all appropriate Directive(s)
  • 2. Identify product Standards
  • 3. Understand options for conformity
  • 4. Identify Notified Body (if applicable)
  • 5. Determine the important dates
  • 6. CE marking
  • 7. Prepare Declaration
  • 8. Maintain technical records - 10 years!

39
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40
SAFETY OF TOYS
  • Role of standards

41
ROLE OF STANDARDS
  • Benefits of Standards
  • Assisting innovation
  • Enabling ideas to become accepted internationally
  • Balancing producer and user interests
  • Assisting de-regulation
  • Reduce unnecessary variety
  • Efficient use of materials

42
ROLE OF STANDARDS
  • Standards support economic growth
  • Critical to enable economic development - allows
    concentration on areas of competitive advantage
  • Enables the move from local (State) to national
    to international, as industry is globalized
  • Covers technical specifications, product
    assessment and system assessment

43
ROLE OF STANDARDS
  • Assisting Innovation
  • Sharing best practice, so designers can focus on
    real product enhancement
  • Setting benchmarks for performance, quality
    safety
  • Establishing parameters for inter-operability
  • Making clear technical requirements to gain
    global market acceptance

44
ROLE OF STANDARDS
  • New Standards Development
  • National Standards Bodies are key to new regional
    and international standards
  • Experts and Representatives share a role in
    developing new standards
  • Participation raises the profile of industry and
    commerce in overseas markets

45
ROLE OF STANDARDS
Trade Associations
Consumer Bodies
Professional Institutions
Certification Bodies
Standards Users
Standard
Research Organizations
Government Departments
Public Sector
Education Bodies
Enforcement Bodies
46
ROLE OF STANDARDS
  • Balancing producer user interests
  • Standards are market led
  • reflect interests of manufacturers, consumers and
    the environment
  • promote fair competition to counteract unhealthy
    concentrations of economic power
  • reduce development, production and transaction
    costs for all businesses
  • increase the diversity and quality of suppliers
    for both producers and consumers

47
ROLE OF STANDARDS
  • Assisting Deregulation
  • Regulations set general principles but Standards
  • reflect the input of people who have to use them
  • practical not legalistic
  • easier to amend as circumstances change
  • voluntary and indicative, not mandatory and
    prescriptive
  • permit different routes to compliance and so do
    not stifle innovation

48
ROLE OF STANDARDS
  • Trends in Standards Harmonization
  • WTO encourages use of international standards
    i.e. BS EN ISO 9001
  • International cooperation
  • Vienna Agreement
  • Dresden Agreement
  • Increasing adoption of EN standards outside
    Europe

49
ROLE OF STANDARDS
  • Summary
  • Standardisation
  • a tool for globalisation, innovation and
    deregulation

Standardization a tool for globalization,
innovation and deregulation
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