1. Kvetoslava Steinlová, SOSMT
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

2. New legal framework for the CE marking
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
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
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
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. CE marking - example of abuse
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
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. Determination of economic operators
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 covered by CE marking
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 covered by CE marking
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 covered by WEEE and RoHS
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. Economic operators under WEEE and ROHS
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. Directive 2002/96/EC of the EP and of the Council
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. Directive 2002/96/EC of the EP and of the Council
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. Economic operators under
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 manufacturer’s own name or trademark or for the manufacturer’s 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. Economic operators under
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. for Market surveillance purposes
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. Example of the Mandate - see
Motors, including variable speed drives;
• AC induction motors, as specified in relevant standards, such as in EN
30: and in EN : ;
Ref. Ares(2010) /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 ;
• 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.
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 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;
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. Directive 2010/30/EC of the EP and of the Council
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
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
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