CE Marking A short guide to what you need to know about CE Marking Alastair McLaughlin Product Safety Specialist Slide 1 Who Am I? Name Title: Employer: Alastair McLaughlin Product Safety Specialist Experience: History: Telephone: 01789 731155 20 years experience in Compliance Management and Consumer Product Testing Worked for suppliers to WH Smith and Woolworths, Radica Games, Mattel, E-mail: Alastair.McLaughlin@tuv-sud.co.uk Slide 2 Contents CE marking and your legal obligations What is CE marking? What are EU Directives? Who is responsible for CE marking? What is Due Diligence? How is CE marking enforced? Applying directives How to identify which Directives apply Scope and exemptions EMC, LVD, RoHS, RTTE Slide 3 1
Contents Applying directives, continued Routes to conformity Essential Requirements Harmonised standards Technical documentation required to demonstrate compliance Declaration of Conformity Technical File Contents Technical File Compilation Placing a product on the market Summary Questions and answers Slide 4 What is CE Marking? Slide 5 CE Conformity Marking The CE conformity marking shall consist of the initials CE taking the following form: If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. Slide 6 2
What is CE Marking Designed to enable free trade around European Union (EU) member States (note: 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) designed to ensure quality on the market place Primarily self certification Not evidence of compliance in itself Slide 7 What Are EU Directives? Slide 8 What are EU Directives? "New Approach" Directives set out the essential requirements, written in general terms, which must be met before products may be sold in the European Community. European harmonised standards provide the detailed technical information to meet the essential requirements. The directives also explain how manufacturers are able to demonstrate conformity with the essential requirements. Products which meet the essential requirements must display the CE marking. The CE marking means that the products can be sold anywhere in the Community / European Economic Area (EEA). Slide 9 3
CE Marking Directives There are 20+ Directives that require CE Marking: Active implantable medical devices Appliances burning gaseous fuels Cableway installations designed to carry persons Eco-design of energy related products Electromagnetic compatibility Equipment and protective systems intended for use potentially explosive atmospheres Explosives for civil uses Hot-water boilers In vitro diagnostic medical devices Lifts Low Voltage Devices.. Slide 10 CE Marking Directives Machinery Measuring Instruments Medical devices Noise emission in the environment Non-automatic weighing instruments Personal protective equipment Pressure equipment Pyrotechnics Radio and telecommunications terminal equipment Recreational craft Safety of toys Simple pressure vessels Slide 11 Responsibilities of Legal Operators Slide 12 4
Responsibilities Manufacturer You are the manufacturer if the product is marketed under your brand name, if you have the product made on your behalf, or if you make the product yourself. Responsibilities 1. Identify the applicable directive(s) Check the scope and exemptions of likely directives 2. Consult a Notified Body? Not all CE marking directives require an NB 3. Identify the directives requirements 4. Check conformity to those requirements Harmonised standards provide a presumption of conformity 5. Compile the technical file Issue a Declaration of Conformity 6. Apply the CE marking Slide 13 Responsibilities Importer When goods are produced in third countries and the manufacturer is not represented in the EEA, importers must make sure that the products they place on the market comply with the applicable requirements and do not present a risk to the European public. The importer has to verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available upon request. Request written assurance that a D of C and technical documentation will be made available Ensure the manufacturer is continually contactable Importer as the manufacturer If you market the products under your own name, you take over the manufacturer s responsibilities. Slide 14 Responsibilities Distributor Distributors must act with due care to ensure that their handling of the product does not adversely affect its compliance. Must have sufficient knowledge to determine which products require CE marking and what documentation should accompany such products Must have an affirmation from the manufacturer or importer that the product meets the CE marking directives requirements Must be able to assist authorities in obtaining documentation from the manufacturer or importer Distributor as the manufacturer If you market the products under your own name, you take over the manufacturer s responsibilities. Slide 15 5
How is CE Marking Enforced? Slide 16 Legal Status of Directives Directives are agreed, adopted & accepted by the governments of the member states into national law. The Directives are transposed into UK Law as Statutory Instruments. This gives the Directives the same status as other laws in this country. Directive 2011/65/EU RoHS Directive 2006/95/EC Low Voltage Directive 2004/108/EC EMC Directive 1999/5/EC RTTE Directive UK Law (Recast regulations to be published November 2012) 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) Slide 17 Who Enforces the Law? Enforcement varies by directive: Health and Safety Executive (for machinery, pressure vessels, ATEX, etc) Local trading standards departments within their region (consumer products) MRHA (for medical devices) The Office of Communications (Ofcom) (for protection and management of the radio spectrum) National Measurement Office (RoHS) Slide 18 6
Market Surveillance The enforcement authority can:- Challenge any product on the Market Pull samples from the Market for examination Request a manufacturer, importer or retailer to provide their Technical file Enlist the assistance of 3 rd Party Laboratories to test or check products Respond to public complaint Notify other member states Instigate legal proceedings resulting in potential:- Banning of a product from sale Ordering a product recall Payment of fines Imprisonment of responsible persons Slide 19 What is Due Diligence? Slide 20 What is Due Diligence? Knowing what is required. Demonstrating compliance with relevant applicable Directives. Declaring that you have met the relevant requirements. Being properly prepared. Ready to defend yourself in court. Being able to produce a technical file. Being confident in your safety case. Slide 21 7
Applying Directives Slide 22 Scope & Exemptions - EMC Electromagnetic Compatibility Scope: Applies to all electrical and electronic apparatus which are liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance. Exemptions: Equipment covered by Directive 1999/5/EC on Radio and telecommunications terminal equipment (R&TTE) Aeronautical products as referred to in Regulation (EC) No1592/2002 Radio equipment used by radio amateurs Benign equipment Slide 23 Essential requirements - EMC Equipment shall be designed and manufactured to ensure that: The electromagnetic disturbance it generates does not exceed a level above which radio and telecommunications equipment or other equipment cannot operate as intended; It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use. Slide 24 8
Scope & Exemptions - LVD Low Voltage Directive Scope: Applies to all electrical equipment designed for use with a voltage rating of between 50-1000Vac and 75-1500 Vdc. Exemptions: Electrical equipment for use in a potentially explosive atmosphere Electrical equipment for radiology and medical purposes Electrical parts for lifts Electricity meters Products which are covered by other Community directives Plugs and socket outlets for domestic use Electric fence controllers Specialised electrical equipment, for use on ships, aircraft or railways provided it complies with the safety provisions drawn up by international bodies in which the Member States participate - which so far are not covered by any Community directive and therefore must not be CE marked for LVD Slide 25 Essential requirements - LVD Products must: be marked with their rated characteristics. be clearly marked with the brand name or the trade mark. where that is not possible, on the packaging. be made in such a way as to ensure that it can be safely and properly assembled and connected. protect against hazards arising from the electrical equipment to ensure:- that persons and domestic animals are adequately protected against the danger of physical injury or other harm which might be caused by direct or indirect contact; that temperatures, arcs or radiation which would cause a danger, are not produced; that the insulation must be suitable for foreseeable conditions. Slide 26 Essential requirements - LVD Products must: Protect against hazards which may be caused by external influences on the electrical equipment to ensure: that the electrical equipment meets the expected mechanical requirements in such a way that persons, domestic animals and property are not endangered; that the electrical equipment shall be resistant to non-mechanical influences in expected environmental conditions, in such a way that persons, domestic animals and property are not endangered; that the electrical equipment shall not endanger persons, domestic animals and property in foreseeable conditions of overload. Slide 27 9
Scope & Exemptions - RoHS Restrictions of Hazardous Substances (Re-cast) Scope: Applies to all electrical equipment falling within the categories of Annex I of the Directive. Exemptions: Military equipment Equipment designed to be sent into space Equipment designed and installed as part of another type of equipment not within scope Large-scale stationary industrial tools Large-scale fixed installations The means of transport Non-road mobile machinery for professional use Active implantable medical devices Photovoltaic panels R&D equipment only available on B to B basis Slide 28 Scope & Exemptions - RoHS RoHS - Specific technical exemptions Some restricted substances in certain applications cannot be replaced by alternate materials these have specific exemptions. There are too many technical application exemptions to list in this short presentation. They re listed in Annex III together with the date from which they cease to be valid, if any. Slide 29 Essential requirements - RoHS The restricted substances must not be present in any homogeneous material of the equipment in concentrations above the specified limits Restricted substances: Lead, Pb (0.1%) Mercury, Hg (0.1%) Cadmium, Cd (0.01%) Hexavalent Chromium, Cr (VI) (0.1%) Polybrominated Biphenyls, PBB (0.1%) Polybrominated Diphenyl Ethers, PBDE (0.1%) NOTE: the restricted substances are to be reviewed by July 2014 Slide 30 10
Scope & Exemptions R&TTE Radio and Telecommunications Terminal Equipment Scope: Applies to all radio and telecommunication terminal equipment (with certain exclusions) as defined in the Directive. Exemptions: Amateur radio equipment not commercially available Radios used exclusively by the State for security purposes (see Note 1) Equipment within the scope of the Marine Equipment Directive (MED) Radios on display at trade exhibitions Broadcast sound and television receivers (excluding any line termination equipment such as set-top boxes) Cabling and wiring Note 1: The R&TTE-D specifically excludes military equipments, but this does not exempt those equipments from the requirements of CE marking where the EMC and Low Voltage Directives still apply. Slide 31 Essential requirements R&TTE Health & Safety (as required by 2006/95/EC (LVD) (includes any RF exposure requirements) EMC (as required by 2004/108/EC (EMC-D)) Efficient use of the spectrum Radio equipment shall be so constructed that it uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference. Slide 32 Proof of compliance How do you show compliance? Can be through: - testing - design Must explain HOW the measures show compliance - Harmonised standards (more later) give presumption of conformity - Other standards should be accompanied by rationale to show how those tests meet the directive requirements - Design (use of 3 rd -party approved components, layout and materials designed to meet directive requirements) will often need to be backed up by tests; for example: heating tests, fault tests Slide 33 11
Harmonised Standards Slide 34 What are Harmonised Standards? A "Harmonised Standard" is a standard that: Supports one or more Directives Has been produced by CEN or CENELEC Has been published in the Official Journal of the EC (OJ) At least one national standards body has published it Provides a presumption of conformity with the Essential Requirements These standards, produced under a mandate from Member States through the Commission, provide the technical measures to meet the Essential Requirements. Slide 35 What are Harmonised Standards? Directives state the legal objectives (Essential Requirements) to be met (*1) Harmonised Standards identify the technical means to meet these legal objectives. Harmonised Standards are one way of meeting the Essential Requirements, and are never intended to be mandatory however, Compliance with harmonised standards gives a presumption of conformity *1 The EHSRs of the Machinery Directive do contain technical requirements. Slide 36 12
What are Technical Files? Slide 37 Technical Files Your technical file is your documented evidence to show that the product properly complies with the requirements of the directives which apply to it. Slide 38 Technical Files Technical documentation must be such as to enable enforcement authorities to assess the conformity of the product to the requirements of the directives. It must cover the design, manufacture and operation of equipment. It can be the same document as your design file for the equipment. Most importantly, it forms the basis of your compliance case! Slide 39 13
Technical File Contents A general description of the equipment This requirement can normally be met by the description (including model number etc.) found in the equipment manual. Conceptual design This can be met by a general assembly drawing and / or photographs plus a block diagram. The drawings should relate to a particular model number and year of manufacture. Circuit diagrams are also required. Slide 40 Technical File Contents Technical File Contents Descriptions and explanations necessary for the understanding of the drawings and schemes referred to previously and the operation of the electrical equipment. Your equipment manual may meet this requirement - but it may be necessary to include a schematic operation description. A list of the standards applied in full (or in part), and descriptions of the solutions adopted to satisfy the safety requirements of the Regulations / Directive where standards have not been applied. If no standards have been applied references should be made as to how the safety requirements have been satisfied. List of Components. complete listing of all components, materials and parts used in the product (i.e.: complete bill of materials) Safety approval information on critical components and materials Slide 41 Technical File Contents Results of design calculations made, examinations carried out, etc. In many cases test reports will meet this requirement if they can demonstrate that the design calculations have been made correctly. Test reports. This could include test reports drawn up by the manufacturer, a notified body or any other person the manufacturer considers to be competent. These reports will demonstrate how the product complies with the relevant directives. Typically this will be by the application of harmonised standards. A copy of the EC Declaration of Conformity. Slide 42 14
Format of Technical File Must contain all the required information. Can be a traditional paper file Information may be stored electronically Hyperlinks can be used to link documents Needs to be backed up Be easy to produce all documentation on short notice Be easy to maintain and keep up to date You can t just do it then forget about it! Slide 43 Declaration of Conformity (DoC) Slide 44 What is a Declaration of Conformity (DoC)? 1. A formal statement that the product complies with: Applicable 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 Slide 45 15
The DoC must include The name and address of the manufacturer or their authorised representative A description of the product including type, model and any other information that clearly relates the equipment to the Declaration. A reference to the standards applied harmonised standards that have been applied and when harmonised standards have not been applied, references to International or National standard(s) with which conformity is declared. If standards have not been applied, reference should be made to other specifications adopted or to the safety objectives that have been applied and satisfied. Identification of the signatory must be someone empowered to enter into commitments on behalf of the manufacturer (or their authorised representative). The last two digits of the year in which CE marking was affixed. Slide 46 Placing on the Market & Putting Into Service Slide 47 Placing on the Market / into Service A product must comply with the applicable CE marking directives when it is placed on the market for the first time and put into service Placing on the market is the initial action of making a product available for the first time on the Community market, with a view to distribution or use in the Community. Making available can be either for payment or free of charge Without need for further processing (packaging, labelling, etc) Putting into service takes place at the moment of first use within the Community by the end user. However, market surveillance is only carried out on products: Which can only be used after assembly or installation Which could be negatively influenced by transport and storage Which are not first placed on the market prior to putting into service (e.g. manufactured for own use) Slide 48 16
Placing on the Market / into Service Before a product is placed on the market / into service, the following must happen: The manufacturer must put together technical documentation which makes it possible to assess whether the product complies with the relevant Directives The manufacturer or the authorised representative must draw up a declaration of conformity. The manufacturer or the authorised representative must affix the CE marking Summary What is CE Marking? EU Directives Scope and Exemptions Essential Requirements Harmonised standards Technical files Declaration of Conformity (DoC) Placing products on the market Thanks for Listening. Any Questions? 17