PRODUCT SAFETY

1. PRODUCT SAFETY Marko Baretić Faculty of Law University of Zagreb

2. BASIC CONCEPTS • Why to regulate safety? • How much safety? • What to regulate? • Who should regulate? • How to regulate? • How to control? • Who should control?

3. WHY TO REGULATE SAFETY? • Consumer safety - first objective of consumer protection policy • Perils to consumers • New and sophisticated products • Competitive markets • Mass-production • Preventive function of the safety regulation

4. HOW MUCH SAFETY? • Absolute safety or optimal safety? • No risk or acceptable risk? • Optimal safety – acceptable risk system • Elements of product regulation: • Safety, performance, efficiency,quality, price • Risk-utility test • Acceptability of the product assessed against its utility

5. WHAT TO REGULATE? • (Producers) • Design of the product • Manufacturing/performance process • Instructions, warnings and information

6. WHO SHOULD REGULATE? • Private regulation • Individual manufacturer • Manufacturers’ associations • Private regulators • Public regulation • Government (politicians) • Regulatory agencies (technocrats, experts)

7. HOW TO REGULATE? • Compulsory regulation • laws, regulations, administrative provisions • Voluntary regulation • standards • Mixed regulation • compulsory laws supplemented by voluntary standards

8. HOW TO CONTROL? • Pre-market control • Imposition of safety requirements • Approval to market the product • Post-market control • Conformity assessment after the product is put on the market

9. WHO SHOULD CONTROL? • Conformity assessment • self-declaration by the manufacturer • quality assessment procedures supervised and controlled by a third party • third party certification

10. EUROPEAN MODEL • “Old approach” • 1969 – General Programme for the elimination of technical barriers to trade that result from disparities between the provisions laid down by law, regulation or administrative action in Member States • “New approach” • 1985 – Council resolution on the New Approach to Technical Harmonisation and Standards

11. OLD APPROACH • Overambitious • Sought to set out in details all the performance objectives and design and manufacture specifications for the products covered • Long-lasting and expensive • In 18 months only 1 measure instead of 124 envisaged • Detailed regulation to inflexible • Flaws in style and content of the resulting legislation

12. NEW APPROACH • Distinction is drawn between: • Essential safety requirements • Imposed by harmonising legislation (regulations and directives) • Design/Manufacturing specifications • Set out by voluntary standards • Safety is achieved through the synergy of mandatory legislation and voluntary standards

13. ESSENTIAL SAFETY REQUIREMENTS • They are safety objectives which must be met • A directive should contain a description of the safety which products covered by it must satisfy • It should be worded precisely enough • Sometimes vague objectives: • to minimise risks • to reduce risks as far as possible • to insure temperatures do not cause burning

14. STANDARDS • Technical specification approved by a recognised standardisation body for repeated and continuous application with which compliance is not compuslory and which is adopted by an international, regional or national standardisation body and made available to the public

15. STANDARDS • Detailed technical (design and manufacturing) specifications • Define how to reach the level of safety envisaged by essential safety requirements in a manner acceptable to industry • Voluntary in nature • Produced by professional public and independent standardisation bodies

16. STANDARDS • International • ISO • International Organisation for Standards • Regional (European) • EN • European Committee for Standardisation (CEN) • European Committee for Electrotechnical Standardisation (CENELEC) • European Telecommunication Standards Institute (ETSI) • National • HRN • Hrvatski zavod za norme (HZN)

17. ESSENTIAL SAFETY REQUIREMENTS generally defined created by the politicians set out in the regulations or directives mandatory TECHNICAL SPECIFICATIONS very detailed created by technocrats (experts) set out in standards voluntary DISTINCTION

18. SYNERGY OF REGULATION AND STANDARDS • Regulation determines what level of safety must be achieved • Standards define how to achieve required level of safety • Products conforming to the harmonised standards are presumed to conform to the essential requirements

19. CONFORMITY ASSESSMENT • Council Resolution on a Global Approach to Conformity Assessment of 1989 • Conformity Assessment and CE Marking Decision of 1993 • establishment of European Organisation for Testing and Certification (EOTC) in 1990

20. CONFORMITY ASSESSMENT • Three basic categories: • Self-declaration • Quality assessment procedures supervised and controlled by a third party • Third party certification

21. SELF DECLARATION • Voluntary conformity assessment • Dominant conformity assessment mechanism • The manufacturer must: • establish technical documentation that covers conformity assessment of the design, manufacture and operation of the product • affix the CE marking to each product and draw up a written declaration of conformity • CE (Conformité Européene) • The mark signifies that the product confirms to new approach directives • The mark DOES NOT signify that the product has been tested or previously approved by third party

22. QUALITY ASSESSMENT PROCEDURE • Manufacturer ensures and declares that the products are in conformity with technical documentation and essential safety requirements • Manufacturer affixes CE marking and draws up a written declaration • The manufacturer must operate an approved quality system for production, final product inspection and testing which is subject to monitoring • The quality system must be under surveillance of a notified body

23. THIRD PARTY CERTIFICATION • Manufacturer establishes technical documentation to enable conformity assessment concerning the design, manufacture and operation of the product • Manufacturer lodges an application with a notified body • If the “type” or actual product is in conformity with technical documentation and essential safety requirements, notified body issues a certificate

24. PRODUCT SAFETY SYSTEM • General product safety • Directive 2001/95/EC on general product safety • Specific product safety • Toys (Directive 2009/48, Directive 2005/84/EC) • Pyrotechnic articles (Directive 2007/23/EC) • Machinery (Directive 2006/42/EC) • Cableway installations (2000/9/EC) • Medicinal products (Directive 93/42/EEC, Directive 2002/98/EC, Directive 2004/33/EC, Directive 2005/62/EC, Directive 2004/23/EC, Directive 2006/17/EC, Directive 2005/62/EC, Directive 2001/83/EC, Directive 2004/27/EC, Regulation 1394/2007, Regulation 726/2004, Regulation 1901/2006) • Pressure equipment (Directive 97/23/EC, Directive 2009/105/EC) • Appliances burning gaseous fuels (Directive 2009/142/EC) • Electrical equipment (Directive 2006/95/EC) • Telecommunications equipment (Directive 1999/5/EC) • Passenger ships (Directive 98/18/EC) • Airplanes (Regulation 1592/2002, Regulation 1702/2003)

25. GENERAL PRODUCT SAFETY • The system applies if no specific provisions on product safety exist • If specific product safety system does exist, the general system applies to the aspects and risks or categories of risks not covered by specific system

26. CONCEPT OF SAFE PRODUCT • A product which • under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, • does not present any risk or only minimum risks compatible and consistent with a high level of protection for the safety and health of persons

27. CONCEPT OF SAFE PRODUCT • When determining whether the product is safe, following shall be taken into account: • the characteristics of the product, including its composition, packaging, instructions for assembly andfor installation and maintenance • the effect on other products, where it is reasonably foreseeable that it will be use with other products • the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product • the categories of consumers at risk when using the product, in particular children and elderly

28. CONCEPT OF SAFE PRODUCT • The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be “dangerous”

29. ASSESSMENT OF SAFETY • It is presumed that the product is safe when it conforms to: • voluntary national standards transposing European standards • If there are no such standards, the safety shall be assessed by taking into account • standards drawn up in the MS • Commission recommendations setting guidelines on product safety assessment • product safety codes of good practice in force in the sector concerned • the state of the art and technology • reasonable consumer expectations concerning safety

30. RESPOSIBLE PERSONS • Producer • manufacturer and anyone presenting himself as the manufacturer by putting his name, trade mark or other distinctive mark on the product • manufacturer’s representative, when the manufacturer is not established within EU • importer if there is no representative established in the EU • other professionals in the supply chain, insofar as their activities may affect the safety of the product

31. OBLIGATIONS OF THE PRODUCER • To place only safe products on the market • To inform consumers and other users on risks which the products might pose • To take appropriate action including, if necessary to avoid the risks, withdrawal from the market, adequately and effectively warning consumers or recall from consumers • Recall shall be taken as a last resort, where other measures would not suffice to prevent the risks

32. OBLIGATIONS OF THE MS • To insure that producers and distributors comply with their safety obligations • To nominate authorities competent to monitor the compliance of products with safety requirements • To define tasks, powers, organisation and cooperation arrangements of the competent authorities

33. ETITLEMENTS OF COMPETENT AUTORITIES • For any product: • to organise appropriate checks, even after product being placed on the market • to require all necessary information • to take samples of products and subject them to safety checks • For any product which could pose the risk: • to require that product be marketed with suitable warnings • to make its marketing subject to prior conditions • For any product that could be dangerous: • to temporarily ban the supply, for the period needed for safety evaluations, checks and controls • For any dangerous product: • to ban marketing • to order and organise withdrawal from the market • to order recall from consumers and the destruction of the product

34. EXCHANGE OF INFORMATION AND RAPID INTERVENTION • When a MS takes measures restricting placing on the market of the products it shall notify other MS • RAPEX (Rapid alert system for dangerous consumer products) http://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm?event=main.listNotifications