Enhanced Scope of Responsibilities in EU Supply Chain Regulation

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 COUNCILon 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 themanufacturer or his authorized representative • affixation =responsibility for conformity • the only markingwhich indicatescompliance with Community harmonised legislation assuming its affixing • relation withother markings • responsibility for member statesto 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 standardshttp://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/index_en.htm in the whole range of risks, that a productmay pose • You issue an EC declaration of conformityandaffix theCE 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-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 whenissuing the EC declaration of conformityandaffix 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 authoritiesnotify 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 thecustoms 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 aprotective 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-basedinformation campaignto improve public awareness of real mission of the CE marking • In addition, the EC intendsto 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 applicableCommunity harmonisation legislationshall • 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 • cooperateswith 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 harmonisationlegislation, 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 surveillanceauthorities 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 withCommunity harmonisationlegislation, 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 exportselectrical 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 exportselectrical 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 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. 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 • 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

31. 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 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/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

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/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

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/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

34. Thank you for your attention Contact: Kvetoslava Steinlová E-mail: kvetoslava.steinlova@normoff.gov.sk : 02/52493521