The EU Training Programme for Turkish Chamber Executives Free Movement of Goods Product legislation in the EU

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The EU Training Programmefor Turkish Chamber
Executives Free Movement of GoodsProduct
legislation in the EU
Mr Henk de Pauw, Eurochambres expert
henk.depauw_at_certif.be Ankara, 18 June
2009 Istanbul, 19 June 2009
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Harmonisation and standardisation for SMEs

• Purpose of product regulations
• Barriers to trade
• Removal of non-tariff barriers to trade The EU
  way
• New approach directives Principles of
  harmonisation and standardisation

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Purpose of product regulations

• Protection of men, animals, plants, other
  products, environment in general
• Securing the functionality of a product
• Barrier against competitive products from abroad

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Barriers to trade

• Tariff barriers
• Direct tariff barriers Duties, quotas,
  licences, import bans
• Indirect tariff barriers By local regulations
• Non-tariff barriers
• Technical barriers (TBTs) Technical product
  regulations
• Administrative barriers Rules for certification
  and marking

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Decline of tariff barriers
Weighted average of duties in in industrial
countries since 1947 (Source WTO 1997)
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Rise of non-tariff barriers

• Rising product complexity
• Ever keener competition
• Increased awareness of quality and safety
• User demands for proof of conformity

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Effect of non-tariff barriers

• Higher costs for manufacturer
• Slower introduction to the market of new products
  
• Smaller choice for consumers
• Higher prices for consumers

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Removal of non-tariff barriers The EU way

• Mutual recognition Principle
• Cassis de Dijon-principle
• Exception public policy
• Exception Public security
• Exeption public morality
• Case 121/85, Conegate Ltd v Customs and Excise
  Commissioners
• Exception Protection of the health and life of
  humans, animals and plants

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Product legislation in the EU

• Non-Harmonised
• Ex. Furniture
• (-)Need to find the legislation of all Member
  States
• Harmonised
• Old Approach
• Ex. chemicals, medicinal products, foodstuffs
• SCAD database
• () Technical details in directive
• (-) Directives underwent several changes
• (ex. http//europa.eu.int/scadplus/leg/en/lvb/l212
  76.htm
• New Approach
• 20 directives
• Roughly 20 of trade

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Principles of the New Approach

• New Approach principles
• Legislative harmonization - only essential
  requirements to be met
• (c) Toys must be so designed and constructed as
  to minimize the risk of physical injury which
  could be caused by the movement of their parts.
• Technical specifications are to be found in
  harmonized standards
• EN 71-1 Safety of toys-Part 1 Mechanical and
  physical properties
• - Application of standards, including harmonized
  standards is voluntary
• - Essential requirements are presumed to be met
  if product is manufactured in compliance with
  harmonized standards

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Where CE
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Where CE

• - EU (not mandatory in UK, Ireland and Sweden)
• EEA (EULichtenstein, Norway and Iceland)
• Switserland
• Turkey
• Croatia
• Soon Kosovo, Morocco, Albania
• - Future MEDA and ENP countries

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Principles of the Global Approach

• Global Approach principles
• - Modules for various phases of conformity
  assessment procedures
• - CE-marking
• - Quality assurance (EN/ISO 9000 series
  standards)
• - Conformity Assessment bodies (EN 45000 series
  standards)
• - Setting up accreditation systems
• - Mutual recognition agreements for testing and
  certification in the non-regulatory sectors
• - Programs to reduce differences in the quality
  of testing inspection, certification,
  accreditation

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Questions

1. Who is responsible?
2. Is my product covered by the directive(s)?
3. Does my product meet the Essential Requirements?
4. Do I apply Standards?
5. Do I need a Notified Body?

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Actions

1. Draft a Technical Construction File
2. Gather Information
3. Draft a Manual
4. Draft a Declaration of Conformity
5. Apply the CE-mark
6. Adaptations and New Developments

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Who is responsible

• Compare with Product Liability
• 1. The manufacturer
• the person who is responsible for designing and
  manufacturing a product with a view of placing it
  on the Community market on his own behalf.
• In practice under his own name
• 2. Authorised Representative
• If manufacturer is not established in the EU,
  though not mandatory
• 3. Importer
• 4. Distributor
• 5. Assembler and Installer
• 6. User (Employer)

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The Manufacturer

• Not always clear
• The manufacturer is any natural or legal person
  who is responsible for designing and
  manufacturing a product with a view of placing it
  on the Community market under his own name.
• Whoever is on the label
• Whoever retains the overall control

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The Authorised Representative

• The manufacturer may appoint any natural or legal
  person to act on his behalf as an authorised
  representative.
• Authorised Representative must be established
  inside the Community.

• The authorised representative is the contact
  point in the EU for the Marker Authorities
• The manufacturer remains generally responsible
  for actions carried out by an authorised
  representative on his behalf.

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The importer

• Is considered as the representative of the
  manufacturer if there is no Authorised
  Representative

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Others

• Installer
• Has to follow the guidelines laid out by the
  manufacturer
• Repair/Service
• Can be held responsible for re-marking the
  product, if he implements major changes
  (increased risk)

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Market Surveillance Authorities

• For a large part under the jurisdiction of the
  Member States
• Cannot exercise any pre-market inspections
• Must be entitled to obtain access to places of
  manufacture or storage, to receive information,
  and to select a sample and take it away for
  examination and testing
• Requests need to be motivated and specific

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Custom officials

• have the right to stop products coming in the
  Community from third countries, if they find
  products that display certain characteristics
  which would give rise to a serious doubt as to
  the existence of a serious and immediate risk to
  health and safety, or
• if they find products which are not accompanied
  by a document or marked in accordance with
  applicable rules on product safety.
• especially concerned with toys as in most other
  cases in the New Approach products, the customer
  is not a consumer, but a rather more informed
  client.

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The court

• The ultimate decision no more grey areas
• No technical expert
• Very few cases

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Which products

• - Low voltage equipment
• - Simple pressure vessels
• - Toys
• - Construction products
• - Machinery
• - Personal protective equipment
• - Weighing instruments
• - Active implantable medical devices
• - Gas appliances

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Which products (cont.)

• - Hot water boilers
• - Civil explosives
• - Medical devices
• - Products for potentially explosive atmospheres
• - Recreational craft
• - Lifts
• - Refrigeration appliances
• - Pressure equipment

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Which products (cont.)

• - Telecommunications terminal Equipment
• - Electromagnetic compatibility
• - Noise emissions
• - Cableway installations
• - Marine equipment
• - High speed rail systems
• - Packaging and packaging waste
• and the list will be continued...

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Paperwork under the NA

• Technical Construction File
• Manual
• Declaration of Conformity

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The Technical Construction File

• Part A B
• Part A should be at hand at all times

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The Technical Construction File part A

• First aid kit
• Name(s) and adress of mft.
• ID of product
• Description (prospectus)
• Manual
• Declaration of conformity
• List of standards directives
• Content of part B

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The Technical Construction File part B

• Start with the Essential Requirement at top of
  page
• Identify the hazards
• Proof of remedy
• Application of standard
• Drawings
• Testresults

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The Manual

• From start to finish
• Essential for limiting product liability
• Language!
• Ingredients in each directive

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The Declaration of Conformity

• Need a model PPE
• Ingredients in each directive

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Labelling

• The most visible part of CE-marking.
• Name Adress.
• N of notified body.
• Others, specified per directive.

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Mutual Recognition Agreements (MRA)

• Mutual recognition agreements between the EU and
  third countries
• conformity assessment can be performed by bodies
  of the partner countries, eliminating double
  testing and certification
• mutual acceptance of conformity assessment
  results (testing, inspection, certification)
• Partners Australia, New Zealand, Switzerland,
  United States, Canada, Israel, Japan, partly not
  yet concluded

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Sources of information

• www.newapproach.org
• CEN site, source for standards, text of
  directives and link to standard bodies
• http//www.eotc.be/newapproach/cdrom/index.htm
• Introduction to the New Approach
• http//europa.eu.int/comm/enterprise/newapproach/i
  ndex.htm
• DG ENTR site on the NA, source for guides, such
  as the Blue Guide
• http//europa.eu.int/comm/enterprise/sectors_en.ht
  m
• DG ENTR site on different industry sectors, if
  you want to know more about the product-specific
  directives.
• http//ec.europa.eu/enterprise/newapproach/nando
• DG ENTR database on notified bodies

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Sources of information

• www.icsms.org
• Communication tool for market surveillance
  authorities on products to be taken off the
  market
• http//www.emars.eu/
• Sharing of experience on market surveillance

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Free Movement of Goods
Thank you Please feel free to contact
us eurochambres_at_eurochambres.eu
With the support of the European Commission
www.eurochambres.eu
Eurochambres Chamber House 19 A/D Avenue des
Arts B-1000 Brussels BelgiumTel 32 (0)2
282 08 50 Fax [phone] Email
eurochambres_at_eurochambres.eu