more detailed division of obligations and responsibilities for economic operators in supply chain...
TRANSCRIPT
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
REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILsetting 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 COUNCILon 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 toysentering into force 20th June 2011
New legal framework for the CE marking
Regulation 765/2008 CE marking
CE marking – general principles:
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
Risk assessment by the manufactureragainst the EHSR
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
After the revision of New Approach directives
CE marking
Be prepared in time
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-legislation/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
Be prepared in time
Regulation 764/2008/EC on mutual recognition
Europe's market is yours! – if
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)
CE marking
- Function of market surveillance authorities
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 -opinion of EC (1)
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
EC opinion on the CE marking
CE marking -opinion of EC (2)
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
EC opinion on the CE marking
CE markingGraphic guide (1)
CE markingGraphic guide (2)
CE marking -example of abuse
The CE marking is not a designation of country of origin!
And in any case, it doesn't mean CHINESE EXPORT !!!
1. 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
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
New obligations of manufacturers, authorized representatives and importers regarding CE marking
Decision 768/2008/EC
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 competentnational 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
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 productscovered by their mandate
New obligations of manufacturers, authorized representatives and importers regarding CE marking
Decision 768/2008/EC
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
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.
New obligations of manufacturers, authorized representatives and importers regarding CE marking
Decision 768/2008/EC
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
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
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
a) any economic operator who delivered the product to them;
b) any economic operator to whom the product has been delivered
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
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
Categories of products
1. Large household appliances2. Small household appliances3. IT and telecommunications equipment4. Consumer equipment5. Lighting equipment6. Electrical and electronic tools (with the
exception of large-scale stationary industrial tools)
7. Toys, leisure and sports equipment8. Medical devices.9. Monitoring and control instruments
including industrial monitoring and control instruments
10. Automatic dispensers11. 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
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 waste3) 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)
producer any person who, irrespective of theselling technique used, including by means ofdistance communication, who
1) manufactures and sells electrical andelectronic 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)
producer any person who, irrespective of theselling technique used, including by means ofdistance communication, who
1) manufactures and sells electrical andelectronic 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)
Manufacturer - natural or legal person1) 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.
2) 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
3) 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
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
Categories of products (given by the implementing Regulations):
1) glandless standalone circulators including glandless circulators integrated in products
2) electrical motors 3) household refrigerating appliances 4) televisions5) external power supplies (non load
condition)6) ultraviolet radiation of non-directional
household lamps7) Lighting products in the domestic and
tertiary sectors 8) Simple set-top boxes 9) Standby and off mode electric power
consumption of household and office equipment
10) Others
http://ec.europa.eu/energy/efficiency/ecodesign/legislation_en.htm
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
M/470 : Motors, including variable speed drives;• AC induction motors, as specified in relevant
standards, such as in EN 60034-30:2009-03 and in EN 60034-2-1:2007-11;Ref. Ares(2010)367759 - 25/06/2010• All other types of motors, such as single phase
induction motors and permanentmagnet 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 cageinduction motor, as defined in the draft Commission
Regulation, such as motorsdesign for converter operation;• Other electric motors which operate in the same
fields of application as AC inductionmotors.
http://ec.europa.eu/energy/efficiency/ecodesign/legislation_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
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/legislation_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
Categories of operators 1) Supplier - manufacturer or its authorised
representative in the Union or the importer who places or puts into service the product on the Union market.
2) 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/legislation_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
Thank you for your attention
Contact: Kvetoslava SteinlováE-mail: [email protected]: 02/52493521