NEW APPROACH DIRECTIVES

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NEW APPROACH DIRECTIVES

• Trade

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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

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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

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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.

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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

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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

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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

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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

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TRADE

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

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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

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SAFETY OF TOYS

• Harmonised Standards

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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

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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)

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STANDARDS

• Harmonised standards

Directives
Machinery standards
Toy standards
EMC standards
CE marking
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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

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STANDARDS

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

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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

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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

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SAFETY OF TOYS

• Compliance

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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!

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COMPLIANCE

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

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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.

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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

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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

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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

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COMPLIANCE
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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

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COMPLIANCE

• Simplified Flow Chart

Harmonised standards
CE marking
Production
Notified body
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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

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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
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COMPLIANCE

• 6. CE marking

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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!

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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)

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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)

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COMPLIANCE

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

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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!

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SAFETY OF TOYS

• Role of standards

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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

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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

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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

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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

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ROLE OF STANDARDS
Trade Associations
Consumer Bodies
Professional Institutions
Certification Bodies
Standards Users
Standard
Research Organizations
Government Departments
Public Sector
Education Bodies
Enforcement Bodies
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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

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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

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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

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ROLE OF STANDARDS

• Summary
• Standardisation
• a tool for globalisation, innovation and
  deregulation

Standardization a tool for globalization,
innovation and deregulation