CE marking of technical products – bridge to the European market Center for Testing and European Certification CE marking of technical products – bridge to the European market CTEC – general overview www.ctec-sz.com 1

MARKING Principles of the New Approach and the related regulations of the European Union facilitate the free movement of goods within the European market and ensure protection of life and health of people, domestic animals, consumer protection and protection of the environment and property. Any product that is covered by one or more New Approach Directives, must conform to their applicable requirements. Proof of this is the affixation of the CE marking to the product and/ or its packaging. 2

WHAT IS MARKING? The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA) and in Turkey. This also applies to products made in other countries which are sold in the EEA and Turkey. However, not all products must bear the CE marking, only product categories mentioned in specific EU directives on the CE marking. There are more than 20 New Approach Directives. 3

NEW APPROACH DIRECTIVES 89/686/EEC Personal protective equipment 90/385/EEC Active implantable medical devices 92/42/EEC Hot-water boilers 93/15/EEC Explosives for civil uses 93/42/EEC Medical devices 94/25/EC Recreational craft 94/9/EC Equipment and protective systems intended for use in potentially explosive atmospheres 95/16/EC Lifts 97/23/EC Pressure equipment 98/79/EC In vitro diagnostic medical devices 99/5/EC Radio and telecommunications terminal equipment 2000/9/EC Cableway installations designed to carry persons 2004/108/EC Electromagnetic compatibility 2004/22/EC Measuring Instruments Directive 2006/42/EC Machinery 2006/95/EC Low voltage directive 2009/105/EC (ex-87/404/EEC) Simple pressure vessels 2009/48/EC Safety of toys 2009/23/EC (ex-90/384/EEC) Non-automatic weighing instruments 2009/142/EC (ex-90/396/EEC) Appliances burning gaseous fuels Regulation (EU) No 305/2011 Construction products 4

MARKING IN ACCORDANCE WITH REGULATION No 765/2008 MAIN PRINCIPLES OF THE MARKING IN ACCORDANCE WITH REGULATION No 765/2008 СE marking is the only marking which attests conformity of the product with the applicable requirements of the relevant legislation of the European Community. Member States shall ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. 5

AFFIXATION OF THE MARKING TO YOUR PRODUCT The CE marking must be affixed by the manufacturer after completion of the requirements of the relevant directive/s. CE marking must be affixed according to its legal format visibly, legibly and indelibly. If a Notified Body was involved in the production control phase, its identification number must also be displayed. 6

MARKING - DIRECTIVE 93/68/EEC 7

EC DECLARATION OF CONFORMITY It is the manufacturer’s responsibility to draw up and sign an “EC declaration of conformity” proving that the product meets the requirements. After that your CE-marked product is ready for the market. Declaration of performance under Regulation (EU) 305/2011 on Constriction products 8

RESPONSIBILITIES OF THE ECONOMIC OPERATORS It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the EC declaration of conformity and to affix CE marking on a product. MANUFACTURER: Distributors must verify the presence of both the CE marking and the necessary supporting documentation. DISTRIBUTOR: If the product is being imported from a third country, the importer has to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. IMPORTER:

NOTIFIED BODIES Notified bodies are nominated by governments and approved by the European Commission. The manufacturer may apply to any notified body approved for the relevant Directive within the European Economic Area. The notified body must be selected according to its impartiality, competence and authority. Each notified body obtains an identification number by the European Commission. NANDO (Information System) – official journal or the European commission where the notified bodies are listed. New Approach Notified and Designated Organizations 10

CTEC IN BRIEF Private organization founded in 2002 in the town of Stara Zagora as a body for conformity assessment of technical products Recognized company on the Bulgarian market in the field of laboratory testing and certification of construction products, machinery and electrical equipment Increasing market share of the foreign market (Serbia, Turkey, Greece, UK, Russia, China, South Korea, etc.) Notified body under 4 European Directives with identification number NB 1871 Two on-site testing laboratories accredited according to EN ISO/IEC 17025 Notified laboratory for reaction to fire testing of construction products 50 people permanent staff more than half of them engineers and 15 external auditors

CTEC LOCATION Great location in the central part of Bulgaria, at an equal distance to all Balkan neighbors.

MEMBERSHIP CTEC is a member of: Association of Notified Bodies for Construction Products; Forum of Notified Bodies; 25 technical committees for standardization as an active member; Bulgarian Industrial Capital Association; Bulgarian Association of Electrical Engineering and Electronics (BASSEL). Bulgarian Branch Chamber of Machines Building Bulgarian Chamber of Commerce and Industry Manager of the CTEC is: Board member of the Bulgarian Institute for Standardization Chairwoman of the Forum of Notified Bodies in Bulgaria Member of the National Council of Metrology

NOTIFIED BODY NB 1871

OUR SERVICES As a Notified Body with accredited laboratories CTEC performs: 1. Conformity assessment / certification of: Construction products – Regulation (EU) 305/2011 Machinery – Directive 2006/42/EC Low voltage equipment - Directive 2006/95/EC Noise emission in the environment by equipment for use outdoors - Directive 2000/14/EC 2. Voluntary certification 3. Testing of construction products 4. Testing of machinery, electrical equipment and devices

OUR SERVICES CTEC is accredited by Bulgarian Accreditation Service according to EN ISO/IEC 17021 to perform: 5. Management systems certification ISO 9001:2008 - quality management system ISO 14001:2004 – environmental management BS OHSAS 18001:2007 - occupational health and safety management system Certificates issued by CTEC are valid in all countries members of the EU. 6. Professional education, specialized seminars and trainings in European technical legislation, Product certification, CE marking, Quality management, etc.

The CTEC office and laboratory equipment

THANK YOU FOR YOUR ATTENTION! eng. Blagovesta Shineva – Мanaging Director Center for Testing and European Certification Ltd. Stara Zagora 6006, 2, Industrialna Str. tel..: +359 42 620 368, mob. +359 887 598 697 e-mail: ctec@ctec-sz.com , website: www.ctec-sz.com 18