Transcript Standardization & Certification requirements

The EU Training Programme
for Turkish Chamber Executives
Free Movement of Goods
Product legislation in the EU
Mr Henk de Pauw, Eurochambres expert
[email protected]
Ankara, 18 June 2009
Istanbul, 19 June 2009
www.eurochambres.eu
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
Decline of tariff barriers
40
40
Annecy
1949
35
30
Gründung des
Gatt Genf 1947
30
Genf 1956
25
25
23
20
Torquai
1950/51
15
15
10
Dilion-Runde
1960 - 62
5
Kennedy-Runde
1964 - 67
10
Uruguay-Runde
1986 - 93
6,4
4
Tokio-Runde
1973 - 79
0
1947
1949
1951
1956
1962
1967
1979
1993
Weighted average of duties in % in industrial countries
since 1947 (Source: WTO 1997)
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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/l21276.htm
– New Approach
• 20 directives
• Roughly 20% of trade
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
Where CE
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
Where CE
- EU (not mandatory in UK, Ireland and
Sweden)
- EEA (EU+Lichtenstein, Norway and
Iceland)
- Switserland
- Turkey
- Croatia
- Soon: Kosovo, Morocco, Albania
- Future: MEDA and ENP countries
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
The importer
• Is considered as the representative of
the manufacturer if there is no
Authorised Representative
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
The court
• The ultimate decision: no more
grey areas
• No technical expert
• Very few cases
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
Paperwork under the NA
• Technical Construction File
• Manual
• Declaration of Conformity
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
The Technical Construction File
• Part A & B
• Part A should be at hand at all times
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
The Manual
• From start to finish
• Essential for limiting product liability
• Language!
• Ingredients in each directive
www.eurochambres.eu
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
The Declaration of Conformity
• Need a model: PPE
• Ingredients in each
directive
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
Labelling
• The most visible part of CE-marking.
• Name & Adress.
• N° of notified body.
• Others, specified per directive.
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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/in
dex.htm
– DG ENTR site on the NA, source for guides, such as the “Blue
Guide”
• http://europa.eu.int/comm/enterprise/sectors_en.htm
– 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
www.eurochambres.eu
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
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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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
Thank you…
Please feel free to contact us
[email protected]
Free Movement of Goods
With the support of the European Commission
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Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • Belgium
Tel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]