CE marking & your legal obligations

Transcription

1 CE marking & your legal obligations This presentation is intended to provide a practical approach guide to what you need to know about the CE marking requirements for electrical and electronic equipment placed on the European Market CE marking & Due Diligence Presented by Richard Poate Compliance Services Manager, TÜV Product Service 1

2 Who Am I? Name Title: Employer: Experience: Richard Poate Compliance Services Manager 16 years experience in product compliance Telephone:

3 Contents What is CE marking? What are EU Directives? What is Due diligence? How is CE marking enforced? Declaration of Conformity What is a Technical file? Harmonised Standards Presumption of conformity Placing products on the market

4 What is CE marking? CE marking is a declaration by the manufacturer or responsible body that the product(s) meets the requirements of the applicable European Directive(s).

5 CE marking = Safety and Quality? Consumers and retailers may associate CE marking with safety and quality. Actually it has nothing to do with safety and quality!

6 What is CE marking? CE marking = Guaranteed no hangover Guaranteed to get drunk Guaranteed quality beer Unbreakable glass Confusion everywhere Chinese export

7 What is CE marking? Enables free movement of goods around EU member States (some non EU countries have adopted CE marking procedures) Places responsibility with the manufacturer or importer of goods; whoever places the equipment on the market Relates to EU Directives (European Law) Primarily self certification Not evidence of compliance in itself

8 Penalties for failing to comply 1. Fines 2. Ban on sale of product 3. Product recall 4. Damage to company or brand name reputation 5. Imprisonment

9 What are EU Directives?

10 What are EU Directives? "New Approach" Directives (Community Law) set out the essential requirements Written in general terms and must be met before products may be sold in the European Community European harmonised standards provide detailed technical information enabling essential requirements to be met Directives explain how to demonstrate conformity with the essential requirements Products meeting essential requirements are to display CE marking meaning they can be sold in the Community

11 21 CE marking Directives Directive 2006/95/EC 87/404/EEC 2009/48/EC 89/106/EEC 2004/108/EC 2006/42/EC 89/686/EEC 90/384/EEC 90/385/EEC 90/396/EEC 92/42/EEC 93/15/EEC 93/42/EEC 94/9/EC 94/25/EC 95/16/EC 97/23/EC 98/79/EC 1999/5/EC 2000/9/EC 2004/22/EC Title of directive Low Voltage Simple Pressure Vessels Safety of toys Construction products Electromagnetic compatibility (EMC) Machinery Personal protective equipment (PPE) Non-automatic weighing instruments Active implantable medical devices Appliances burning gaseous fuels Efficiency requirements for new hot-water boilers fired with liquid/gaseous fuels Explosives for civil uses Medical devices Equipment explosive atmospheres (ATEX) Recreational craft Lifts Pressure equipment In vitro diagnostic medical devices Radio Equipment and Telecommunications Terminal Equipment Cableway installations designed to carry persons Measuring instruments

12 Summary of applicable Directives The CE marking Directives below are those that would typically apply to your products. Directive Title of Directive 2006/95/EC Low Voltage Directive (LVD) 2004/108/EC Electromagnetic compatibility (EMC) 1999/5/EC Radio Equipment and Telecommunications Terminal Equipment 2009/48/EC Toys Directive Just because a Directive does not call for CE marking does not mean it doesn t apply. Other typically applicable directives / legislation: Reference Title of Directive 2001/95/EC General Product Safety Directive (GPSD) 2002/96/EC Waste from Electrical and Electronic Equipment (WEEE) 2002/95/EC Restriction of Hazardous Substances (RoHS) 1907/2006 REACh

13 What is Due Diligence?

14 What is Due Diligence? Knowing what is required Declaring that you have met the relevant requirements Demonstrating compliance with applicable Directives Being properly prepared ready to defend yourself in court being able to produce a technical file being confident in your compliance case

15 Due Diligence How do you demonstrate compliance? - Comply with applicable EN standards - Test certificates from a testing laboratory - Test reports from a testing laboratory - Third party certification (e.g. TÜV PS, VDE, SEMKO, UL) - Provide a declaration of conformity (DoC) - Ensure there is a technical file for the product

16 Due Diligence What is type testing? - A one off test on a representative sample of the product - A report or certificate relating to the product - No production control of factory inspections to ensure ongoing compliance and consistency in production - A snapshot based on one sample does not guarantee future product quality / compliance

17 Due Diligence What is Product Certification? - Ongoing partnership between manufacturer/certification Body - Initial testing of product - Regular factory inspections where the product is made - Certification mark permitted to be displayed on the product - Ongoing compliance maintained - Highest level of approval for products

18 How is CE marking enforced?

19 Legal status of Directives Directives are agreed, adopted & accepted by the governments of the member states into their own national law. Transposed into UK Law as Statutory Instruments. Gives Directives the same status as other laws in this country. Directive UK Law 2006/95/EC Low Voltage Directive 2004/108/EC EMC Directive 1999/5/EC RTTE Directive The Electrical Equipment (Safety) Regulations 1994 (SI 1994/3260) EMC Regulations 2006 (SI 2006/3418) The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (SI 2000 No.730)

20 Who enforces the Law? In Great Britain by: Local Trading Standards District Councils (Northern Ireland) The Office of Communications (Ofcom) where responsibility where enforcement relates to the protection and management of the radio spectrum

21 Enforcement authorities can: Challenge products on the market Pull samples from the market for examination & contract 3 rd party testing Request manufacturers, importers or retailers to provide Technical Files Respond to public complaints Notify other member states (e.g. RAPEX) Instigate criminal proceedings resulting in potential: Banning of products from sale Ordering product recalls Payment of fines Imprisonment of responsible persons

22 Enforcement examples Both the examples shown below were notified to ALL Member States using Safeguard Clauses of the relevant Directives. Electric police car (toy) "Biltema Electric police car" (battery operated) Type/model: Country of origin: China/Hong Kong. Risk of injury. When released on a tilted surface (10 degrees tilt, 50N applied to the brake pedal)), the toy should not move more than 5cm, however, when tested the toy did not stop at all. The toy does not comply with the Toys Directive and the European Standards. Voluntary withdrawal of the product from the market and consumers by importer. AC-DC electrical adapter "CELLY" Type/model: CBR8310. Country of origin: China. Risk of electric shock. Risk of electric shock because of insufficient insulation in transformer T1 between the primary and the secondary circuit. This product does not comply with the LVD Directive and the European Standards. Recall from consumers ordered by authority.

23 Declaration of Conformity (DoC)

24 What is a DoC? 1. A formal statement that products comply with: Relevant Directives Applicable standards 2. Signed by responsible person within the organisation (e.g. company director) 3. It is not evidence of compliance in itself 4. Minimum legal requirement

25 Example Declaration of Conformity (DoC) EU DECLARATION OF CONFORMITY Date of Issue: Reference Number: Directive: Conforming Apparatus: Date of DoC Serial Number for this DoC Relevant Directive's Equipment Title, Part Number (and Serial Numbers as applicable) Manufacturer: Authorised Representative: Harmonised Standards Referenced or Applied: Specifications with which Conformity is Declared: Relevant standards, amendments and dates of issues If Harmonised Standards are not used then insert standards used and reference number of Notified Body Certificate. xxxxltd hereby declare that the equipment named has been designed (alternative:) tested and found to comply with the relevant sections of the above referenced specifications. The unit complies with all essential requirements of the Directives. Signed: Name: Position:

26 Technical Files

27 Technical Files Technical files are your documented evidence to show that products properly comply with the requirements of the directives which apply to it.

28 Technical Files Technical files must enable enforcement authorities to assess the conformity of products to the relevant requirements They can be the same document as your design file for the products Most importantly, they forms the basis of your compliance case!

29 Harmonised Standards

30 Harmonised Standards: Support one or more Directives Have been produced by CEN or CENELEC Have been published in the Official Journal of the EC (OJ) Have been published by at least one national standards body Provide presumption of conformity with Essential Requirements These standards provide the technical measures to meet the Essential Requirements

31 What are Harmonised Standards? Directives state the legal objectives to be met and Harmonised Standards identify the technical means (requirements) to meet these legal objectives. Harmonised Standards are one way of meeting Essential Requirements and are never intended to be mandatory. However compliance with them does give a presumption of conformity

32 Presumption of conformity Products are presumed to conform to the objectives of Directives where the equipment has been tested in accordance with harmonized standards Alternatively, the manufacturer may construct the product in conformity with the essential requirements of the Directives, without applying harmonised, international or national standards In such cases products will not benefit from presumption of conformity The technical documentation must include a description of the solutions adopted to satisfy the requirements of the Directives

33 Placing products on the market

34 Identification of applicable Directives Review the scope of the Directives Seek the assistance of Notified Bodies (if applicable) Refer to official guidance on-line (see useful links) Manufacturer must compile technical documentation which makes it possible to assess product compliance with relevant Directives Manufacturer or authorised representative must draw up the DoC and affix the CE marking

35 CE marking or not...? If one or more CE marking Directives apply then you must apply CE marking! But, if there is no relevant Directive(s) then CE marking MUST NOT be applied!

36 Useful Links European Union Official website of the European Union; The official source of information relating to European Directives UK BIS Department for Business Innovation & Skills website Provides a range of on line and downloadable guidance to the directives written in plain English

37 Thanks for Listening Any Questions? Richard Poate Compliance Services Manager, TÜV Product Service Tel: +44(0)