Sn

1
More detailed division of obligations and
responsibilities for economic operators in
supply chain Kvetoslava Steinlová, SOSMT
CE marking versus RoHS and WEEE UNECE
MARS Bratislava 7.10. 2010
2
REGULATION (EC) No 765/2008 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL setting out the
requirements for accreditation and market
surveillance relating to the marketing of
products and repealing Regulation (EEC) No
339/93 DECISION No 768/2008/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL on a common
framework for the marketing of products, and
repealing Council Decision 93/465/EEC Already
reflected to DIRECTIVE 2009/48/EC OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL on the
safety of toys entering into force 20th June 2011
New legal framework for the CE marking
3
CE marking general principles
Regulation 765/2008 CE marking

• shall be affixed only by the manufacturer or his
  authorized representative
• affixation responsibility for conformity
• the only marking which indicates compliance with
  Community harmonised legislation assuming its
  affixing
• relation with other markings
• responsibility for member states to protect the
  CE marking

4
CE marking and Europe's market is yours! if

• You are a manufacturer or his authorized
  representative
• You have an internal system of quality
• Your goods are in compliance with harmonized
  standards http//ec.europa.eu/enterprise/policies/
  european-standards/documents/harmonised-standards-
  legislation/index_en.htm
• in the whole range of risks, that a product may
  pose
• You issue an EC declaration of conformity and
  affix the CE marking to the product as a
  compliance with Community harmonised legislative

Risk assessment by the manufacturer against the
EHSR
5
CE marking and Europe's market is yours! if

• You are a manufacturer or his authorized
  representative
• Your goods are not in compliance with harmonized
  standards
• http//ec.europa.eu/enterprise/policies/european-
  standards/documents/harmonised-standards-legislati
  on/index_en.htm
• in the whole range of risks, that a product may
  pose
• You turn to the accredited conformity assessment
  body
• You use CAB assessment results when issuing the
  EC declaration of conformity and affix the CE
  marking to the product as a compliance with
  Community harmonised legislative

After the revision of New Approach
directives CE marking Be prepared in time
6
Europe's market is yours! if
After the revision of New Approach
directives Be prepared in time Regulation
764/2008/EC on mutual recognition

• You are an importer, or you're placing a product
  to the market and you're not sure in if the
  product does fall under the Community harmonised
  legislative
• Contact National contact point for goods at
  www.productinfo.sk
• The certificate issued by accredited laboratory
  opens the markets also when the product is not
  covered by Community harmonised legislative
• You can apply the rule of mutual recognition
  (see 764/2008/EC)

7
The protection of CE marking

• Market surveillance authorities shall control
  if the affixing and use of CE marking is correct
  and whether the principles for the next markings
  and signs are respected
• Market surveillance authorities notify to EC
• if they decide to restrict the free movement of
  product because of incorrect affixation of CE
  marking
• to take measures relating to misleading CE
  marking
• The market surveillance authorities are also the
  customs authorities in the case of
  counterfeiting of CE marking they shall be
  entitled to act outside the regime of free
  circulation of goods - after registering CE
  marking as a protective trademark of Community

• CE marking
• Function of market
• surveillance
• authorities

8
EC opinion on the CE marking

• CE marking is a declaration that the product is
  safe for its intended use and meets all relevant
  technical requirements
• Due to the ignorance of real mission of CE
  marking, this marking doesn't often have an
  influence or impact on consumers decision to
  purchase the product

CE marking - opinion of EC (1)
9
EC opinion on the CE marking

• Therefore, the EC intends to eliminate this low
  awareness by broad-based information campaign to
  improve public awareness of real mission of the
  CE marking
• In addition, the EC intends to register CE
  marking as a common communitarian trademark,
  which would lead to greater supervisory powers in
  legal actions against those who misuse the CE
  marking

CE marking - opinion of EC (2)
10
CE marking Graphic guide (1)
11
CE marking Graphic guide (2)
12
The CE marking is not a designation of country of
origin!
CE marking - example of abuse
And in any case, it doesn't mean CHINESE EXPORT
!!!
13

• Directive for which it is already possible to
  enforce the provisions of Regulation 765/2008/EC
  and Decision 768/2008/EC
• New directive on toys (2009/48/EC)
• Additional requirements GPSD,
• General product safety directive 2001/95/EC?
• Risk assessment guidelines Official Journal L
  22 of 26.1.2010
• Explicit obligation to carry out an analysis of
  hazards and detailt it in a comprehensive safety
  assessment to be part of the of the product
  technical file
• See also REACH RoHS recast of the 2002/96/EC
  directive

New obligations of manufacturers, authorized
representatives and importers regarding CE marking

14

• Obligations of manufacturers
• When deemed appropriate with regard to the risks
  presented by a product, manufacturers shall, to
  protect the health and safety of consumers, carry
  out sample testing of marketed products,
  investigate, and, if necessary, keep a register
  of complaints, of non-conforming products and
  product recalls, and shall keep distributors
  informed of any such monitoring.
• Manufacturers shall indicate their name,
  registered trade name or registered trade mark
  and the address at which they can be contacted on
  the product or, where that is not possible, on
  its packaging or in a document accompanying the
  product. The address must indicate a single point
  at which the manufacturer can be contacted.

New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

15

• Obligations of manufacturers
• manufacturers who consider or have reason to
  believe that a product which they have placed on
  the market is not in conformity with the
  applicable Community harmonisation legislation
  shall
• immediately take the necessary corrective
  measures to bring that product into conformity,
  to withdraw it or
• recall it from the market or from the end users,
  if appropriate
• manufacturers, where the product presents a risk
  shall
• immediately inform the competent
• national authorities of the Member States in
  which they made the product available to that
  effect, giving details, in particular, of the
  noncompliance and of any corrective measures taken

New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

16
Obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

• Authorized representatives
• performs the tasks specified in the mandate
  received from manufacturer
• mandate cant include taking over obligations of
  manufacturer to ensure
• that the products are designed and manufactured
  in accordance with the requirements of
  harmonizing legal acts
• drawing up of technical documentation
• cooperates with the competent national
  authorities, at their request, on any action
  taken to eliminate the risks posed by products
• covered by their mandate

17

• Obligations of importers
• Importers shall ensure that
• before placing a product on the market that the
  appropriate conformity assessment procedure has
  been carried out by the manufacturer
• the manufacturer has drawn up the technical
  documentation
• the product bears the required conformity
  marking or other markings
• the product is accompanied by the required
  documents
• the manufacturer has complied with the
  requirements set out in relevant legislation
• Where an importer considers or has reason to
  believe that a product is not in conformity with
  Community harmonisation legislation, he shall not
  place the product on the market until it has been
  brought into conformity. Furthermore, where the
  product presents a risk, the importer shall
  inform the manufacturer and the market
  surveillance authorities to that effect.

New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

18
New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

• Obligations of importers
• shall indicate their name, registered trade name
  or registered trade mark and the address at which
  they can be contacted on the product or, where
  that is not possible, on its packaging or in a
  document accompanying the product
• when deemed appropriate with regard to the risks
  presented by a product to consumer, importers
  shall carry out sample testing of marketed
  products
• investigate, and, if necessary, keep a register
  of complaints, of non-conforming products and
  product recalls, and shall keep distributors
  informed of such monitoring
• where the product presents a risk, the importer
  shall inform the manufacturer and the market
  surveillance authorities to that effect.

19

• Obligations of distributors
• Before making a product available on the market
  distribution distributors shall verify that
• the product bears the required conformity
  marking or other markings
• it is accompanied by the required documents and
  by instructions and safety information in a
  language which can be easily understood by
  consumers and other end-users in the Member State
  in which the product is to be made available on
  the market
• the manufacturer and the importer have complied
  with appropriate requirements
• where a distributor considers or has reason to
  believe that a product is not in conformity with
  Community harmonisation legislation, he shall not
  make the product available on the market until it
  has been brought into conformity.
• furthermore, where the product presents a risk,
  the distributor shall inform the manufacturer or
  the importer to that effect as well as the market
  surveillance authorities.

New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

20

• Obligations of distributors
• Distributors who consider or have reason to
  believe that a product which they have made
  available on the market is not in conformity with
  applicable Community harmonisation legislation
  shall
• make sure that the corrective measures necessary
  to bring that product into conformity, if
  appropriate, are taken, or
• withdraw it or recall it
• Furthermore, where the product presents a risk,
  distributors shall immediately inform the
  competent national authorities of the Member
  States in which they made the product available
  to that effect, giving details, in particular, of
  the non-compliance and of any corrective measures
  taken.

New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

21
New obligations of manufacturers, authorized
representatives and importers regarding CE
marking Decision 768/2008/EC

• Determination of economic operators
• Economic operators, at the request of market
  surveillance authorities for ... Period shall be
  determined in proportion to the product's life
  cycle and the level of risk determine
• any economic operator who delivered the product
  to them
• b) any economic operator to whom the product has
  been delivered

22

• Categories of products
• Construction products
• Machinery
• Lifts
• Noise emission in the environment by equipment
  for use outdoors
• Electrical equipment designed for use within
  certain voltage limits (LVD)
• Electromagnetic compatibility (EMC)
• Appliances burning gaseous fuels
• Pressure equipment
• Simple pressure vessels
• Efficiency requirements for new hot-water boilers
  fired with liquid or gaseous fuels
• Ecodesign of products
• Energy efficiency fluorescent lamps
• Pyrotechnic articles

Categories of products covered by CE marking

23

• Categories of products
• Energy efficiency
• Safety of toys
• Personal protective equipment
• Non-automatic weighing instruments
• Equipment and protective systems intended for use
  in potentially explosive atmospheres (ATEX)
• Placing on the market and supervision of
  explosives for civil uses
• Recreational craft
• Cableway installations designed to carry persons
• Interoperability of the trans-European
  conventional and high-speed rail systems
• Radio equipment and telecommunications terminal
  equipment
• Medical devices, including in vitro diagnostic
  medical devices
• Measuring instruments

Categories of products covered by CE marking

24

• Categories of products
• 1. Large household appliances
• 2. Small household appliances
• 3. IT and telecommunications equipment
• 4. Consumer equipment
• 5. Lighting equipment
• 6. Electrical and electronic tools (with the
  exception of large-scale stationary industrial
  tools)
• 7. Toys, leisure and sports equipment
• 8. Medical devices.
• 9. Monitoring and control instruments including
  industrial monitoring and control instruments
• 10. Automatic dispensers
• 11. Other electrical and electronic equipment not
  covered by any of the categories above.

Categories of products covered by WEEE and
RoHS on the restriction of the use of certain
hazardous substances in electrical and electronic
equipment 2002/95/EC 2002/96/EC

25

• Objectives
• 1) prevention of waste electrical and electronic
  equipment (WEEE),
• 2) reuse, recycling and other forms of recovery
  of such wastes so as to reduce the disposal of
  waste
• 3) improvement of the environmental performance
  of all operators involved in the life cycle of
  electrical and electronic equipment, e.g.
  producers, distributors and consumers and
  operators directly involved in the treatment of
  waste electrical and electronic equipment

Economic operators under WEEE and
ROHS Directive 2002/96/EC of the EP and of the
Council on waste electrical and electronic
equipment (WEEE)

26

• producer any person who, irrespective of the
• selling technique used, including by means of
• distance communication, who
• 1) manufactures and sells electrical and
• electronic equipment under his own brand,
• 2) resells under his own brand equipment
  produced by other suppliers, a reseller not being
  regarded as the "producer" if the brand of the
  producer appears on the equipment, as provided
  for in subpoint, or
• 3) imports or exports electrical and electronic
  equipment on a professional basis into a Member
  State.
• distributor person who provides electrical or
  electronic equipment on a commercial basis to the
  party who is going to use it

Producer (WEEE) Directive 2002/96/EC of the EP
and of the Council on waste electrical and
electronic equipment (WEEE)

27

• producer any person who, irrespective of the
• selling technique used, including by means of
• distance communication, who
• 1) manufactures and sells electrical and
• electronic equipment under his own brand,
• 2) resells under his own brand equipment
  produced by other suppliers, a reseller not being
  regarded as the "producer" if the brand of the
  producer appears on the equipment, as provided
  for in subpoint (i), or
• 3) imports or exports electrical and electronic
  equipment on a professional basis into a Member
  State.
• distributor person who provides electrical or
  electronic equipment on a commercial basis to the
  party who is going to use it

Producer (WEEE) Directive 2002/96/EC of the EP
and of the Council on waste electrical and
electronic equipment (WEEE)

28

• Manufacturer - natural or legal person
• Who manufactures products covered by this
  Directive and is responsible for their conformity
  with this Directive in view of their being placed
  on the market and/or put into service under the
  manufacturers own name or trademark or for the
  manufacturers own use.
• any natural or legal person who places on the
  market and/or puts into service products covered
  by this Directive shall be considered a
  manufacturer in the absence of a manufacturer as
  defined above
• an importer reselling under his own brand
  equipment produced by other suppliers (a reseller
  not being regarded as the "producer" if the brand
  of the producer appears on the equipment)

Economic operators under Directive 2009/125/EC of
the EP and of the Council establishing a
framework for the setting of ecodesign
requirements for energy-related products

29

• Authorised representative
• any natural or legal person established in the
  Community who has received a written mandate from
  the manufacturer to perform on his behalf all or
  part of the obligations and formalities connected
  with this Directive
• Importer
• any natural or legal person established in the
  Community who places a product from a third
  country on the Community market in the course of
  his business
• Product design means the set of processes that
  transform legal, technical, safety, functional,
  market or other requirements to be met by a
  product into the technical specification for that
  product

Economic operators under Directive 2009/125/EC of
the EP and of the Council establishing a
framework for the setting of ecodesign
requirements for energy-related products

30

• Categories of products (given by the implementing
  Regulations)
• glandless standalone circulators including
  glandless circulators integrated in products
• electrical motors
• household refrigerating appliances
• televisions
• external power supplies (non load condition)
• ultraviolet radiation of non-directional
  household lamps
• Lighting products in the domestic and tertiary
  sectors
• Simple set-top boxes
• Standby and off mode electric power consumption
  of household and office equipment
• Others

Verification for Market surveillance
purposes also the subject of the mandates given
to the Directive 2009/125/EC of the EP and of
the Council Replacing the directive 2005/32/EC

31

• M/470
• Motors, including variable speed drives
• AC induction motors, as specified in relevant
  standards, such as in EN 60034-
• 302009-03 and in EN 60034-2-12007-11
• Ref. Ares(2010)367759 - 25/06/2010
• All other types of motors, such as single phase
  induction motors and permanent
• magnet synchronous and reluctance motors, as e.g.
  in draft EN TS 60034-31
• Any other electric single speed, three-phase 50
  Hz or 50/60 Hz, squirrel cage
• induction motor, as defined in the draft
  Commission Regulation, such as motors
• design for converter operation
• Other electric motors which operate in the same
  fields of application as AC induction
• motors.
• http//ec.europa.eu/energy/efficiency/ecodesign/le
  gislation_en.htm

Example of the Mandate - see Commission
Regulation (EC) No 640/2009 of 22 July 2009
implementing Directive 2005/32/EC of the European
Parliament and of the Council with regard to
ecodesign requirements for electric motors

32

• not applicable to
• (a) motors designed to operate wholly immersed in
  liquid
• (b) motors completely integrated into a product
  (for example gear, pump, fan or compressor) of
  which the energy performance cannot be tested
  independently from the product
• (c) motors specifically designed to operate
• (i) at altitudes exceeding 1 000 metres above
  sea-level
• (ii) where ambient air temperatures exceed 40 C
  
• (iii) in maximum operating temperature above 400
  C
• (iv) where ambient air temperatures are less than
  15 C for any motor or less than 0 C for a
  motor with air cooling
• (v) where the water coolant temperature at the
  inlet to a product is less than 5 C or exceeding
  25 C
• (vi) in potentially explosive atmospheres as
  defined in Directive 94/9/EC of the European
  Parliament and of the Council ( 3 )
• (d) brake motors
• http//ec.europa.eu/energy/efficiency/ecodesign/le
  gislation_en.htm

Commission Regulation (EC) No 640/2009 of 22
July 2009 implementing Directive 2005/32/EC of
the European Parliament and of the Council with
regard to ecodesign requirements for electric
motors

33

• Categories of operators
• Supplier - manufacturer or its authorised
  representative in the Union or the importer who
  places or puts into service the product on the
  Union market.
• Any natural or legal person who places the
  products on the market or puts into service shall
  be considered a supplier in the absence of
  supplier as defined at 1)
• Product covered
• any good having an impact on energy consumption
  during use, which is placed on the market and/or
  put into service in the Union, including parts
  intended to be incorporated into energy-related
  products covered by this Directive which are
  placed on the market and/or put into service as
  individual parts for end-users and of which the
  environmental performance can be assessed
  independently
• http//ec.europa.eu/energy/efficiency/ecodesign/le
  gislation_en.htm

Economic operators under the Directive
2010/30/EC of the EP and of the Council on the
indication by labelling and standard product
information of the consumption of energy and
other resources by energy-related products

34
Thank you for your attention
Contact Kvetoslava Steinlová E-mail
kvetoslava.steinlova_at_normoff.gov.sk ?
02/52493521