More detailed division of obligation s and responsibilities for economic operators

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

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/index_en.htm



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


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)

http://www.productinfo.sk/

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.


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


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



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.



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.



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.



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.



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


- 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


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)



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)



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)



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



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 purposesalso the subject of the mandates

given to the


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.


Example

of theMandate - 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


Economic operators

under the


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

mailto:[email protected]

Documents

More detailed division of obligation s and responsibilities for economic operators