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Volumn , Issue , 2009, Pages 207-242

Product safety, private standardsetting and information networks

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EID: 84891017154     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.4337/9781848447264.00017     Document Type: Chapter
Times cited : (8)

References (156)
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    • This chapter is part of a larger project focusing on a comparative analysis concerning product safety between the EU and US. It was first presented at the Comparative Law and Economics (CLEF) workshop, Florence, February 2008. I thank the participants for comments. Responsibility is my own.
  • 2
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    • the package of measures adopted in August 2008, that includes also the Regulation (EC) n° 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the market of products, OJEU 13.08.2008, L218/03.
  • 3
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    • Council Directive 374/85/EEC of 25 July on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210, 7.8.1985,
    • Council Directive 374/85/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210, 7.8.1985, p. 29.
    • (1985) , pp. 29
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    • Directive 95/2001/EC of the European Parliament and of the Council of 3 December on general product safety, OJ L 11, 15.1.2002,
    • Directive 95/2001/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, OJ L 11, 15.1.2002, p. 4.
    • (2001) , pp. 4
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    • par. 13, the complete text is available at
    • par. 13, the complete text is available at http://wwweuroparl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2008-0211+0+DOC+XML+V0//EN&language=EN.
  • 6
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    • Third report on the application of Council directive on the approximation of laws, regulations and administrative provisions of the Member States concerning liability for defective products, COM, 496 final.
    • Third report on the application of Council directive on the approximation of laws, regulations and administrative provisions of the Member States concerning liability for defective products, COM(2006)496 final.
    • (2006)
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    • Rethinking product liability: A missing element in the European Commission's Third review of the European Product Liability Directive
    • D. Fairgrieve and G. Howells, 'Rethinking product liability: A missing element in the European Commission's Third review of the European Product Liability Directive', in (2007) 70 Modern Law Review, pp. 962 ff.
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    • Fairgrieve, D.1    Howells, G.2
  • 8
    • 84891041592 scopus 로고    scopus 로고
    • some countries, like Germany, administrative discretion in risk assessment and control prevails over technical approaches. On the contrary, in Scandinavian countries a more technical approach prevails.
  • 9
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    • European Product Safety Legislation-A comparative study of legal frame and practice in Germany and Baltic Sea States
    • H.W. Micklitz, T. Roethe, European Product Safety Legislation-A comparative study of legal frame and practice in Germany and Baltic Sea States, pp. 114 ff.
    • Micklitz, H.W.1    Roethe, T.2
  • 10
    • 84891035846 scopus 로고    scopus 로고
    • Keeping European Consumers Safe, Annual Report on the operation of the Rapid Alert System for non-food consumer products
    • Keeping European Consumers Safe, 2007 Annual Report on the operation of the Rapid Alert System for non-food consumer products, available at http://ec. europa.eu/consumers/safety/rapex/docs/rapex_annualreport2008_en.pdf.
    • (2007)
  • 11
    • 84890974621 scopus 로고    scopus 로고
    • But see the Resolution of the European Parliament on consumer policy strategy 2007-2013, above n. 5, where the EP 'Calls for measures to improve dialogue at EU level between consumer organisations and industry, to include all actors in the value chain; takes the view that a good dialogue, including the sharing of best practices, could reduce problems in the internal market'.
  • 12
    • 47549109402 scopus 로고    scopus 로고
    • A coordinated approach to regulation and civil liability: Rethinking institutional complementarities
    • On the complementarity of regulation and liability, F. Cafaggi (ed.), (OUP)
    • On the complementarity of regulation and liability, see F. Cafaggi, 'A coordinated approach to regulation and civil liability: Rethinking institutional complementarities', in F. Cafaggi (ed.), The institutional framework of European private law (OUP, 2006), pp. 191 ff.
    • (2006) The institutional framework of European private law , pp. 191
    • Cafaggi, F.1
  • 13
    • 84891022854 scopus 로고    scopus 로고
    • Interaction between product liability and regulation at the European level
    • Chapter 8 below.
    • also G. Spindler, 'Interaction between product liability and regulation at the European level', Chapter 8 below.
    • Spindler, G.1
  • 14
    • 84890998105 scopus 로고    scopus 로고
    • the Commission staff working document-Instruments for a modernised single market policy-Accompanying document to the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions-Asingle market for 21st century Europe, COM(2007) 724 final, SEC 1518, ff.
    • the Commission staff working document-Instruments for a modernised single market policy-Accompanying document to the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions-Asingle market for 21st century Europe, COM(2007) 724 final, SEC(2007) 1518, pp. 8 ff.
    • (2007) , pp. 8
  • 15
    • 84890987247 scopus 로고    scopus 로고
    • for example in the UK the Principles of Good Regulation drafted by the Better Regulation Task Force
    • for example in the UK the Principles of Good Regulation drafted by the Better Regulation Task Force, available at http://archive.cabinetoffice.gov.uk/brc/ publications/principlesentry.html.
  • 16
    • 84890976676 scopus 로고    scopus 로고
    • also the report on Self-regulation practices in SANCO policy areas, Zoetermeer, February 2008, where the current cases for self-regulation and co-regulation are presented, indicating also their effectiveness in terms of monitoring and compliance
    • also the report on Self-regulation practices in SANCO policy areas, P. Van der Zeijden and R. Van der Horst, Zoetermeer, February 2008, where the current cases for self-regulation and co-regulation are presented, indicating also their effectiveness in terms of monitoring and compliance, pp. 32 ff.
    • Van der Zeijden, P.1    Van der Horst, R.2
  • 19
    • 58149494559 scopus 로고    scopus 로고
    • Tensions in the Regulatory State
    • J. Black, 'Tensions in the Regulatory State' (2007) Public Law, p. 58
    • (2007) Public Law , pp. 58
    • Black, J.1
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    • 63349110003 scopus 로고    scopus 로고
    • Really Responsive Regulation
    • R. Baldwin and J. Black, 'Really Responsive Regulation' (2008) 71 Modern Law Review, p. 59
    • (2008) Modern Law Review , vol.71 , pp. 59
    • Baldwin, R.1    Black, J.2
  • 21
    • 84891011911 scopus 로고    scopus 로고
    • presentation at the European Economic and Social Committee, public hearing on The Current State of European Self- and Co-Regulation, 31 March.
    • F. Cafaggi, presentation at the European Economic and Social Committee, public hearing on The Current State of European Self- and Co-Regulation, 31 March 2008.
    • (2008)
    • Cafaggi, F.1
  • 22
    • 84891013032 scopus 로고    scopus 로고
    • Art. 2 of GPSD, which defines as 'safe product': 'any 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 the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons'.
  • 23
    • 84890972606 scopus 로고    scopus 로고
    • Art. 6 PL directive, that provides: 'A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product the use to which it could reasonably be expected that the product would be put the time when the product was put into circulation.
  • 24
    • 84882031923 scopus 로고    scopus 로고
    • Liability for Products-English law, French law and European Harmonisation
    • For a deep analysis of the interaction between the two aspects, (OUP)
    • For a deep analysis of the interaction between the two aspects see S.Whittaker, Liability for Products-English law, French law and European Harmonisation (OUP, 2005)
    • (2005) , pp. 191
    • Whittaker, S.1
  • 25
    • 84890966811 scopus 로고    scopus 로고
    • A coordinated approach to regulation and civil liability
    • above n. 11, ff.
    • F. Cafaggi, 'A coordinated approach to regulation and civil liability', above n. 11, ff.
    • Cafaggi, F.1
  • 26
    • 84890974735 scopus 로고    scopus 로고
    • Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II), OJ L 199, 31.07.2007,
    • Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II), OJ L 199, 31.07.2007, p. 40.
  • 27
    • 84891042604 scopus 로고    scopus 로고
    • Regulation n° 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, above n. 2.
    • Regulation n° 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, above n. 2.
  • 28
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    • Regulation n° 765/2008, above n. 2.
    • Regulation n° 765/2008, above n. 2.
  • 29
    • 84890990326 scopus 로고    scopus 로고
    • Art. 4 Regulation on Market surveillance, General principles, above n. 2.
    • Art. 4 Regulation on Market surveillance, General principles, above n. 2.
  • 30
    • 84890995713 scopus 로고    scopus 로고
    • Art. 6 Regulation on Market Surveillance, Principle of non competition: '1. National accreditation bodies shall not compete with conformity assessment bodies 2. National accreditation bodies shall not compete with other national accreditation bodies.' 27
  • 31
    • 84891009339 scopus 로고    scopus 로고
    • Regulating Torts
    • J. Braithwaite (ed.)
    • J. Stapleton, 'Regulating Torts', in J. Braithwaite (ed.), Regulating Law, at pp. 122 ff.
    • Regulating Law , pp. 122
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  • 33
    • 84890995281 scopus 로고    scopus 로고
    • On the definition of private regulation see F. Cafaggi (ed.), Reframing selfregulation in European private law (Kluwer)
    • On the definition of private regulation see F. Cafaggi (ed.), Reframing selfregulation in European private law (Kluwer, 2006)
    • (2006)
  • 34
    • 84891009925 scopus 로고    scopus 로고
    • a governance perspective on product standards, see H. Schepel, The constitution of private governance: product standards in the regulation of integrating markets (Hart).
    • a governance perspective on product standards, see H. Schepel, The constitution of private governance: product standards in the regulation of integrating markets (Hart, 2005).
    • (2005)
  • 36
    • 84890993921 scopus 로고    scopus 로고
    • Art. 6 PL directive which provides: '1. A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product
  • 37
    • 84890970628 scopus 로고    scopus 로고
    • A product shall not be considered defective for the sole reason that a better product is subsequently put into circulation.'
  • 39
    • 84890968978 scopus 로고    scopus 로고
    • La responsabilità civile
    • C. Castronovo and S. Mazzamuto (eds.), (Giuffré, Milano, 2007), ff. part. pp. 226 ff.
    • C. Castronovo, 'La responsabilità civile', in C. Castronovo and S. Mazzamuto (eds.), Manuale di diritto privato europeo (Giuffré, Milano, 2007), pp. 213 ff. part. pp. 226 ff.
    • Manuale di diritto privato europeo , pp. 213
    • Castronovo, C.1
  • 40
    • 84891000756 scopus 로고    scopus 로고
    • In the Third report the Commission has drawn attention to different interpretations of defect given by national courts. On these questions see (ed.), Product liability in comparative perspective (Cambridge University Press).
    • In the Third report the Commission has drawn attention to different interpretations of defect given by national courts. On these questions see D. Fairgrieve (ed.), Product liability in comparative perspective (Cambridge University Press, 2005).
    • (2005)
    • Fairgrieve, D.1
  • 41
    • 84890966811 scopus 로고    scopus 로고
    • A coordinated approach to regulation and civil liability
    • above n. 11, ff.
    • F. Cafaggi, 'A coordinated approach to regulation and civil liability', above n. 11, pp. 191 ff.
    • Cafaggi, F.1
  • 42
    • 84891015533 scopus 로고    scopus 로고
    • Arts. 4, 8, 11, 12, 13 of GPSD.
    • Arts. 4, 8, 11, 12, 13 of GPSD.
  • 43
    • 84891022854 scopus 로고    scopus 로고
    • Interaction between product liability and regulation at the European level
    • Chapter 8 below.
    • G. Spindler, 'Interaction between product liability and regulation at the European level', Chapter 8 below.
    • Spindler, G.1
  • 44
    • 84891026574 scopus 로고    scopus 로고
    • Impact of the mutual recognition principle on the law applicable to products
    • Chapter 9 below.
    • M. Audit, 'Impact of the mutual recognition principle on the law applicable to products', Chapter 9 below.
    • Audit, M.1
  • 45
    • 84891039629 scopus 로고    scopus 로고
    • In general regulatory compliance is seen more as an enforcement than as a coordination device, concentrating on the question of whether compliance with administrative regulation is sufficient to exclude liability.
  • 46
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    • While here I am focusing on the definition of defect, in particular design defect, the potential impact of private regulation is much broader. for the UK, General Product Safety Regulations 2005 (SI 2005/1803)
  • 47
    • 84891036424 scopus 로고    scopus 로고
    • General product safety-a revolution through reform?
    • D. Fairgrieve and G. Howells, 'General product safety-a revolution through reform?', 69 Modern Law Review, p. 59
    • Modern Law Review , vol.69 , pp. 59
    • Fairgrieve, D.1    Howells, G.2
  • 48
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    • The regulation of product safety
    • G. Howells (ed), (Lexis-Nexis)
    • P. Cartwright, 'The regulation of product safety', in G. Howells (ed), The law of product liability (Lexis-Nexis, 2007), pp. 695 ff
    • (2007) The law of product liability , pp. 695
    • Cartwright, P.1
  • 49
    • 84890975721 scopus 로고    scopus 로고
    • France, see Art. 1386-10 of the French Civil Code, 'A producer may be liable for a defect although the product was manufactured in accordance with the rules of the trade or of existing standards or although it was the subject of an administrative authorization'
  • 50
    • 84890988503 scopus 로고    scopus 로고
    • La responsabilité du fait des produits (Dunod),
    • B. Cazeneuve, La responsabilité du fait des produits (Dunod, 2005), p. 78
    • (2005) , pp. 78
    • Cazeneuve, B.1
  • 51
    • 84891007936 scopus 로고    scopus 로고
    • Contrats et responsabilité. La responsabilité des fournisseurs du fait du défaut de sécurité de leurs produits' Revue des contrats,
    • J.S. Borghetti, 'Contrats et responsabilité. La responsabilité des fournisseurs du fait du défaut de sécurité de leurs produits' (2006) Revue des contrats, p. 835
    • (2006) , pp. 835
    • Borghetti, J.S.1
  • 52
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    • La responsabilità del produttore (Cedam)
    • F. Cafaggi, La responsabilità del produttore (Cedam, 2003), p. 995
    • (2003) , pp. 995
    • Cafaggi, F.1
  • 53
    • 84890987795 scopus 로고    scopus 로고
    • the case law concerning drugs see Cass. N. 8069, 20 luglio 1993, and Cass. n. 1138, 1 February 1995: 'le imprese farmaceutiche le quali intervengono nel ciclo produttivo di gammaglobuline umane, sono responsabili per colpa grave dei danni derivati in caso di contagio conseguite all'uso del farmaco ove, pur avendo ottemperato alle disposizioni normative vigenti non dimostrino di avere impiegato ogni cautela idonea ad impedire l'evento'
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    • 84891005441 scopus 로고    scopus 로고
    • the US see Third Restatement on Products Liability § 402 (a).
    • the US see Third Restatement on Products Liability § 402 (a).
  • 55
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    • European regulation of consumer product safety (OUP)
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    • (2005) , pp. 21
    • Hodges, C.1
  • 56
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    • Pharmaceutical products: the relationship between regulatory approval and the existence of a defect
    • pharmaceutical products
    • pharmaceutical products, M. Mildred, 'Pharmaceutical products: the relationship between regulatory approval and the existence of a defect' (2007) European Business Law Review, pp. 1267 ff.
    • (2007) European Business Law Review , pp. 1267
    • Mildred, M.1
  • 57
    • 84890998287 scopus 로고    scopus 로고
    • In Europe see the third report, COM (2006) 496 final, 14.09.2006, In the US the Supreme Court has recently issued a judgment, Riegel v. Medtronic INC, 06/179, WL 440744, 20 February 2008, reviewing the relationship between administrative regulation and tort law;
    • In Europe see the third report, COM (2006) 496 final, 14.09.2006, p. 11. In the US the Supreme Court has recently issued a judgment, Riegel v. Medtronic INC, 06/179, WL 440744, 20 February 2008, reviewing the relationship between administrative regulation and tort law;
  • 58
    • 44149128709 scopus 로고    scopus 로고
    • Products liability pre-emption: an institutional approach
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    • Sharkey, C.1
  • 59
  • 60
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    • Reassessing regulatory compliance
    • earlier significant contributions to the regulatory compliance debate
    • earlier significant contributions to the regulatory compliance debate see R. Rabin, 'Reassessing regulatory compliance' (2000) 88 Geo LJ p. 2049
    • (2000) Geo LJ , vol.88 , pp. 2049
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    • Regulatory compliance preclusion of tort liability: Limiting the dual track system
    • R. Stewart, 'Regulatory compliance preclusion of tort liability: Limiting the dual track system' (2000) 88 Geo LJ, p. 2167.
    • (2000) Geo LJ , vol.88 , pp. 2167
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  • 62
    • 84891003081 scopus 로고    scopus 로고
    • on state liability for defective products mainly in relation to health related injuries such as blood infection, S. Whittaker, Liability for Products, above n. 21 pp.
    • on state liability for defective products mainly in relation to health related injuries such as blood infection, S. Whittaker, Liability for Products, above n. 21 pp.
  • 63
    • 84891028829 scopus 로고    scopus 로고
    • In Italy see Cass. n. 11609, 31 May 2005 on which N. Coggiola, The Italian Ministry of Health held liable for the damages arising out of contaminated blood and blood products, ERPL, ff.
    • In Italy see Cass. n. 11609, 31 May 2005 on which N. Coggiola, The Italian Ministry of Health held liable for the damages arising out of contaminated blood and blood products, ERPL, 2007,451 ff.
    • (2007) , pp. 451
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    • Liability for Products, above n. 21 ff.
    • For a detailed examination of England and France, see S. Whittaker, Liability for Products, above n. 21 pp. 305 ff.
    • Whittaker, S.1
  • 65
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    • for example in UK, Balding v. Law Ways Ltd (1995) QBLR 314 where the judge held that compliance with technical standards does not amount to due diligence under Consumer Protection Act 1987.
    • for example in UK, Balding v. Law Ways Ltd (1995) QBLR 314 where the judge held that compliance with technical standards does not amount to due diligence under Consumer Protection Act 1987.
  • 67
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    • Rethinking self-regulation in European private law
    • n. 11.
    • F. Cafaggi, 'Rethinking self-regulation in European private law', n. 11.
    • Cafaggi, F.1
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    • Art. 3.2 GPSD. On the interpretation
    • Art. 3.2 GPSD. On the interpretation
  • 69
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    • Interaction between product liability and regulation at European level
    • Chapter 8 below.
    • G. Spindler, 'Interaction between product liability and regulation at European level', Chapter 8 below.
    • Spindler, G.1
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    • Interaction between product liability and regulation at European level
    • Chapter 8 below.
    • G. Spindler, 'Interaction between product liability and regulation at European level', Chapter 8 below.
    • Spindler, G.1
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    • US, Spearman v. Georgia Building Authority 482 SE 2d 465 (GAApp. 1997); for UK, Ward v. Ritz Hotel
    • US, Spearman v. Georgia Building Authority 482 SE 2d 465 (GAApp. 1997); for UK, Ward v. Ritz Hotel [1992] PIQR 315.
    • (1992) PIQR , pp. 315
  • 72
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    • Case C-300/95, Commission v. UK [1997] ECR I-2649.
    • Case C-300/95, Commission v. UK [1997] ECR I-2649.
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    • Products Liability in the United Kingdom: The Myths of Reform
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    • (1999) Tex Int LJ , vol.34 , pp. 50
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    • Legal aspects of standardisation in the Member States of the EC and EFTA, Volume 1 Comparative Report
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    • a comparative analysis H. Schepel and J. Falke, Legal aspects of standardisation in the Member States of the EC and EFTA, Volume 1 Comparative Report (Luxembourg, 2000), pp. 233 ff.
    • (2000) , pp. 233
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    • the area of technical standards see the agreement between CEN and CENELEC and the Commission 2003 (General Guidelines for the cooperation between CEN, CENELEC and ETSI and the European Commission and the European Free Trade Association, 28 March , (2003/C 91/04)).
    • the area of technical standards see the agreement between CEN and CENELEC and the Commission 2003 (General Guidelines for the cooperation between CEN, CENELEC and ETSI and the European Commission and the European Free Trade Association, 28 March 2003, (2003/C 91/04)).
    • (2003)
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    • Constitution of private governance, above n. 30
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    • Consumer law and policy, 2nd edn. (Hart, Oxford)
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    • (2007) , pp. 711
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    • below text and footnotes
    • below text and footnotes pp. 229 ff.
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    • The question of consumer representation in technical standard-setting has been one of the main preoccupations of the European Commission.
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    • the results of the Consultation on the review and extension of the new approach
    • the results of the Consultation on the review and extension of the new approach, available at http://ec.europa.eu/enterprise/newapproach/review_en.htm.
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    • For this distinction see F. Cafaggi, 'Le rôle des acteurs privés dans le processus de régulation: participation, autorégulation et régulation privée', in La Régulation, Nouveaux modes? Nouveaux territoires? 109 Revue française d'administration publique,
    • For this distinction see F. Cafaggi, 'Le rôle des acteurs privés dans le processus de régulation: participation, autorégulation et régulation privée', in La Régulation, Nouveaux modes? Nouveaux territoires? (2004) 109 Revue française d'administration publique, p. 23
    • (2004) , pp. 23
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    • Gouvernance et responsabilité des régulateurs privés' Revue Internationale de Droit Economique, 111.
    • 'Gouvernance et responsabilité des régulateurs privés' (2005) Revue Internationale de Droit Economique, 111.
    • (2005)
  • 86
    • 84890974794 scopus 로고    scopus 로고
    • It is important to differentiate between standards that are purely private and binding only on those who consented to them and standards that are enacted in the context of co-regulation, delegated private regulation and ex post recognized self-regulation.
  • 87
    • 84890969250 scopus 로고    scopus 로고
    • Contractualizing standard-setting in civil liability, on file with the author.
    • F. Cafaggi, Contractualizing standard-setting in civil liability, on file with the author.
    • Cafaggi, F.1
  • 88
    • 84881757247 scopus 로고    scopus 로고
    • Product Liability A History of Harmonization
    • A. Hartkamp, M. Hesselink, and E. Hondius et al., (Kluwer Law International)
    • G. Howell, 'Product Liability A History of Harmonization', in A. Hartkamp, M. Hesselink, and E. Hondius et al., Towards a European Civil Code (Kluwer Law International, 2004), at 645
    • (2004) Towards a European Civil Code , pp. 645
    • Howell, G.1
  • 89
    • 84891042985 scopus 로고    scopus 로고
    • Liability for Products, above n. 21.
    • S. Whittaker, Liability for Products, above n. 21.
    • Whittaker, S.1
  • 90
    • 84891009339 scopus 로고    scopus 로고
    • Regulating Torts
    • C. Parker et al., above n. 28 at 122.
    • J. Stapleton, 'Regulating Torts', in C. Parker et al., Regulating Law, above n. 28 at 122.
    • Regulating Law
    • Stapleton, J.1
  • 91
    • 84891022854 scopus 로고    scopus 로고
    • Interaction between product liability and regulation at the European level
    • For the definition of private regulatory standards as minimum standards, Chapter 8 below
    • For the definition of private regulatory standards as minimum standards, see G. Spindler, 'Interaction between product liability and regulation at the European level', Chapter 8 below.
    • Spindler, G.1
  • 92
    • 84891034172 scopus 로고    scopus 로고
    • The role of civil liability and judicial review should be very important for the content of regulatory activity and standard supervision.
  • 93
    • 78149424108 scopus 로고    scopus 로고
    • Self-regulation in European contract law
    • For a detailed analysis concerning contract law
    • For a detailed analysis concerning contract law, see F. Cafaggi, 'Self-regulation in European contract law' (2007) European Journal of Legal Studies, 1, available at www.ejls.eu.
    • (2007) European Journal of Legal Studies , vol.1
    • Cafaggi, F.1
  • 95
    • 84890966811 scopus 로고    scopus 로고
    • A coordinated approach to regulation and civil liability
    • above n. 11.
    • F. Cafaggi, 'A coordinated approach to regulation and civil liability', above n. 11 p. 191.
    • Cafaggi, F.1
  • 96
    • 84891011158 scopus 로고    scopus 로고
    • I have addressed this issue in 'La responsabilité des régulateurs privés', cit.,
    • I have addressed this issue in 'La responsabilité des régulateurs privés', cit., p. 111
  • 97
    • 84890993875 scopus 로고    scopus 로고
    • La responsabilità dei regolatori privati
    • Mercato Concorrenza e Regole
    • 'La responsabilità dei regolatori privati' (2006) Mercato Concorrenza e Regole, pp. 1 ff.
    • (2006) , pp. 1
  • 98
    • 84882031923 scopus 로고    scopus 로고
    • For a detailed analysis of these aspects, see above n. 21
    • For a detailed analysis of these aspects, see S. Whittaker, Liability for Products, above n. 21 pp. 305 ff.
    • Liability for Products , pp. 305
    • Whittaker, S.1
  • 100
    • 84890996371 scopus 로고    scopus 로고
    • Rethinking institutional complementarities
    • above n.
    • F. Cafaggi, 'Rethinking institutional complementarities', above n. 11 p.
    • Cafaggi, F.1
  • 101
    • 84891021545 scopus 로고    scopus 로고
    • in Italy, Corte di cassazione, n. 6007, 15.03.2007, which states: 'Senonchè, l'art. 5 della legge definisce difettoso non ogni prodotto insicuro ma quel prodotto che non offra la sicurezza che ci si può legittimamente attendere in relazione al modo in cui il prodotto è stato messo in circolazione, alla sua presentazione, alle sue caratteristiche palesi alle istruzioni o alle avvertenze fornite, all'uso per il quale il prodotto può essere ragionevolmente destinato, ed ai comportamenti che, in relazione ad esso, si possono ragionevolmente prevedere, al tempo in cui il prodotto è stato messo in circolazione. Il difetto del prodotto non si identifica, dunque, con la mancanza di una assoluta certezza o di una oggettiva condizione di innocuità dello stesso, ma con la mancanza dei requisiti di sicurezza generalmente richiesti dall'utenza in relazione alle circostanze specificamente indicate dall'art. 5 o ad altri elementi in concreto valutabili e concretamente valutati dal giudice di merito, nell'ambito dei quali, ovviamente, possono e debbono farsi rientrare gli standards di sicurezza eventualmente imposti dalle norme in materia.' 75 Study on property law and non contractual liability as they relate to contract law. Submitted to the EC Health and Consumer Protection directorate general, Sanco B5-1000/02/000574 by C. Von Bar and U. Drobnig (hereinafter the Study on non contractual liability), available at http://ec.europa.eu/consumers/cons_int/safe_shop/ fair_bus_pract/cont_law/study.pdf.
  • 102
    • 84891000834 scopus 로고    scopus 로고
    • the Study on non contractual liability, above n. 75 pp. 164 ff. In relation to the English and French system, see S. Whittaker, Liability for products, above n. 21 pp. 93 ff. and pp. 260 ff.
    • the Study on non contractual liability, above n. 75 pp. 164 ff. In relation to the English and French system, see S. Whittaker, Liability for products, above n. 21 pp. 93 ff. and pp. 260 ff.
  • 103
    • 84890979196 scopus 로고    scopus 로고
    • Member states' legal regimes differ quite significantly, but they all allow some possibility.
  • 104
    • 84891019893 scopus 로고    scopus 로고
    • the Study on non contractual liability, above n. 75 pp. 164 ff
    • the Study on non contractual liability, above n. 75 pp. 164 ff
  • 107
    • 84891029874 scopus 로고    scopus 로고
    • Research Group on the Existing EC Private Law (Acquis Group), Principles of the Existing EC Contract Law (Acquis Principles)-Pre-contractual Obligations, Conclusion of Contract, Unfair Terms Contract I (2007) European Law Publisher.
  • 108
    • 84891042972 scopus 로고    scopus 로고
    • Art. 12 Dir. 374/85 EC.
    • Art. 12 Dir. 374/85 EC.
  • 109
    • 84890986232 scopus 로고    scopus 로고
    • Principles, Definitions and model Rules of European private law, Draft Common Frame of Reference. In particular
    • Principles, Definitions and model Rules of European private law, Draft Common Frame of Reference, available at http://webh01.ua.ac.be/storme/ DCFRInterim.pdf. In particular
  • 110
    • 84891014792 scopus 로고    scopus 로고
    • see book VI Art. 5:401, 'Contractual exclusion and restriction of liability': 'Liability for causing legally relevant damage intentionally cannot be excluded or restricted (1) Liability for causing legally relevant damage as a result of profound failure to take such care as is manifestly required in the circumstances cannot be excluded or restricted: (a) in respect of personal injury (including fatal injury), or (b) if the exclusion or restriction is otherwise illegal or contrary to good faith and fair dealing.' 81 This can be inferred from the last part of the article where it is stated that 'Other liability under this Book can be excluded or restricted unless statute provides otherwise', DCFR VI-5:401(4).
  • 111
    • 58149494559 scopus 로고    scopus 로고
    • Tensions in the Regulatory State
    • J. Black
    • J. Black, 'Tensions in the Regulatory State' (2007) Public Law, p. 58
    • (2007) Public Law , pp. 58
  • 112
    • 63349110003 scopus 로고    scopus 로고
    • Really Responsive Regulation
    • R. Baldwin and J. Black
    • R. Baldwin and J. Black, 'Really Responsive Regulation' (2008) 71 Modern Law Review, p. 59.
    • (2008) Modern Law Review , vol.71 , pp. 59
  • 113
    • 84881940412 scopus 로고    scopus 로고
    • The public-private law divide: Une entente assez cordiale?
    • (Oxford, Hart)
    • J. B. Auby and M. Freedland (eds.), The public-private law divide: Une entente assez cordiale? (Oxford, Hart, 2006).
    • (2006)
    • Auby, J.B.1    Freedland, M.2
  • 114
    • 84890981393 scopus 로고    scopus 로고
    • Delegation occurs when a public body transfers its law making power to private bodies or when it shares it.
  • 116
    • 77955564714 scopus 로고    scopus 로고
    • Rethinking Private Regulation in the European Regulatory Space
    • F. Cafaggi (ed.), (Kluwer)
    • F. Cafaggi, 'Rethinking Private Regulation in the European Regulatory Space', in F. Cafaggi (ed.), Reframing self-regulation in European private law (Kluwer, 2006), p. 3.
    • (2006) Reframing self-regulation in European private law , pp. 3
    • Cafaggi, F.1
  • 117
    • 84890980883 scopus 로고    scopus 로고
    • Guidelines on horizontal cooperation 2001, in particular Art. 6 on standard agreements: 'Standardisation agreements have as their primary objective the definition of technical or quality requirements with which current or future products, production processes or methods may comply. Standardisation agreements can cover various issues, such as standardisation of different grades or sizes of a particular product or technical specifications in markets where compatibility and interoperability with other products or systems is essential. The terms of access to a particular quality mark or for approval by a regulatory body can also be regarded as a standard'.
  • 118
    • 77955564714 scopus 로고    scopus 로고
    • Rethinking Private Regulation in the European Regulatory Space
    • above n. 84
    • For an overview, see F. Cafaggi, 'Rethinking Private Regulation in the European Regulatory Space', above n. 84, p. 16.
    • Cafaggi, F.1
  • 119
    • 84891002287 scopus 로고    scopus 로고
    • on the distinction between private normative and technical standardsetting
    • on the distinction between private normative and technical standardsetting, pp. 229 ff.
  • 120
    • 84891026465 scopus 로고    scopus 로고
    • On the role of self-regulation in civil liability and in particular in standardsetting, above n. 62.
    • On the role of self-regulation in civil liability and in particular in standardsetting, see F. Cafaggi, Contractualizing standard-setting in civil liability, above n. 62.
    • Contractualizing standard-setting in civil liability
    • Cafaggi, F.1
  • 122
    • 84891011300 scopus 로고    scopus 로고
    • above, n 68. Agreements among firms that perform standard-setting functions are generally scrutinized under antitrust rules.
    • F. Cafaggi, 'Self-regulation in European Contract law', above, n 68. Agreements among firms that perform standard-setting functions are generally scrutinized under antitrust rules.
    • Self-regulation in European Contract law
    • Cafaggi, F.1
  • 123
    • 84890992293 scopus 로고    scopus 로고
    • Commission notice of 6 January 2001, Guidelines on the applicability of Article 81 of the EC Treaty to horizontal cooperation agreements, OJ C 3 06.01.2001, p. 167. 'The existence of a restriction of competition in standardisation agreements depends upon the extent to which the parties remain free to develop alternative standards or products that do not comply with the agreed standard. Standardisation agreements may restrict competition where they prevent the parties from either developing alternative standards or commercialising products that do not comply with the standard. Agreements that entrust certain bodies with the exclusive right to test compliance with the standard go beyond the primary objective of defining the standard and may also restrict competition. Agreements that impose restrictions on marking conformity with standards unless imposed by regulatory standards may also restrict competition.' also General Guidelines for the cooperation between CEN, CENELEC and ETSI and the European Commission and the European Trade Association, above n. 57, 'With regard to possible restrictions to competition caused by horizontal cooperation agreements between companies operating on the same market level(s) the Commission published a notice on the applicability of Article 81 of the EC Treaty. In this notice standardisation agreements are considered to be a type of horizontal cooperation agreement, either concluded between private undertakings or determined under the aegis of public bodies or bodies entrusted with the operation of services of general economic interests, such as the standard organisations recognised under directive 98/34/EC. The notice also states that in principle standardisation agreements do not restrict competition if the standards are adopted by recognised standard organisations, based on non discriminatory open and transparent procedures.' On the relationship between standard-setting by private organizations and competition rules, see F. Cafaggi, Contractualizing standard-setting, above n. 62.
  • 124
    • 84891016994 scopus 로고    scopus 로고
    • This part summarizes the results of a broader project which I am currently working on: 'Creating safety networks. Moving away from hierarchy in product safety and liability'.
  • 125
    • 84890975030 scopus 로고    scopus 로고
    • The divergences between real industrial organisational forms and regulatory strategies concerning product safety. When theory departs from reality in institutional design. Unpublished manuscript.
    • F. Cafaggi, The divergences between real industrial organisational forms and regulatory strategies concerning product safety. When theory departs from reality in institutional design. Unpublished manuscript.
    • Cafaggi, F.1
  • 126
    • 84891033222 scopus 로고    scopus 로고
    • The issue becomes even more difficult in relation to liability for defective drugs where information has to be conveyed to doctors who prescribe the drugs as well as to potential users. The matter is regulated at EU level by directive 2001/83/EC and subsequent amendments. Under the directive the holder of market authorization has to conduct pharmacovigilance of the products and to report adverse reactions to the competent authority.
  • 128
    • 80455123705 scopus 로고    scopus 로고
    • Product safety, buybacks and the post-sale duty to warn
    • For a recent analysis related to the US system
    • For a recent analysis related to the US system, see K. Spier, 'Product safety, buybacks and the post-sale duty to warn', Harvard Law and Economics Discussion Paper No. 597, available at http://ssrn.com/abstract=1023125
    • Harvard Law and Economics Discussion Paper No. 597
    • Spier, K.1
  • 129
  • 130
    • 54649084609 scopus 로고    scopus 로고
    • Information based principles for rethinking consumer protection policy
    • an earlier influential contribution on these matters, see G. Hadfield, R. Howse, M. Trebilcock, 'Information based principles for rethinking consumer protection policy' (1998) 21 Journal of Consumer Policy, 131.
    • (1998) Journal of Consumer Policy , vol.21 , pp. 131
    • Hadfield, G.1    Howse, R.2    Trebilcock, M.3
  • 131
    • 84890971986 scopus 로고    scopus 로고
    • The food regime imposes on the food business operator the responsibility to ensure that requirements of food law are met within the food business under their control (see Art. 3(3) Regulation 178/2002).
  • 132
    • 84891023633 scopus 로고    scopus 로고
    • Art. 5.3 of GPSD.
    • Art. 5.3 of GPSD.
  • 133
    • 84890968392 scopus 로고    scopus 로고
    • Art. 5.2 of GPSD.
    • Art. 5.2 of GPSD.
  • 134
    • 84891025991 scopus 로고    scopus 로고
    • To solve this contradiction a review of the Directive is needed to rephrase the definition of distributor. Before then a functional approach should qualify as producers those who are generally considered distributors from an economic perspective whenever they are in the position to monitor products' safety.
  • 135
    • 84890987248 scopus 로고    scopus 로고
    • in General Product Safety Regulations 2005 (SI 2005/1803) reg. 13(1): 'Where an enforcement authority has reasonable grounds for believing that a product is a dangerous product in that it could pose risks for certain persons, the authority may serve a notice ("a requirement to warn") requiring the person on whom the notice is served at his own expense to undertake one or more of the following as specified in the notice: (a) where and to the extent it is practicable to do so, to ensure that any person who could be subject to such risks and who has been supplied with the product be given warning of the risks in good time and in a form specified in the notice, (b) to publish a warning of the risks in such a form and manner as is likely to bring those risks to the attention of any such person, (c) to ensure that the product carries a warning of the risks in a form specified by the notice.' 99
  • 136
    • 84890980343 scopus 로고    scopus 로고
    • The regulation of product safety
    • G. Howells, (Lexis-Nexis)
    • P. Cartwright, 'The regulation of product safety', in G. Howells, The law of product liability (Lexis-Nexis, 2007), pp. 734 ff
    • (2007) The law of product liability , pp. 734
    • Cartwright, P.1
  • 137
    • 84890996371 scopus 로고    scopus 로고
    • Rethinking institutional complementarities
    • above n. 11
    • F. Cafaggi, 'Rethinking institutional complementarities', above n. 11, p. 214
    • Cafaggi, F.1
  • 139
    • 84891004246 scopus 로고    scopus 로고
    • In relation to producers Art. 5.1 of GPSD correlates information duties and consumers' risk assessment and deterrence: 'Within the limits of their respective activities producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings and to take precautions against those risks.' In relation to distributors Art. 5.2 of GPSD states 'Moreover, within the limits of their respective activities, they shall participate in monitoring the safety of products place on the market, especially by passing on information on product risks, keeping and providing documentation necessary for tracing the origin of products, and cooperating in the actions taken by producers and competent authorities to avoid the risks.' 101 Art. 5.2 of GPSD: 'Within the limits of their respective activities they shall take measures enabling them to cooperate efficiently.'
  • 140
    • 84890977517 scopus 로고    scopus 로고
    • GPSD Art. 5.1 for producers and 5.2 for distributors.
    • GPSD Art. 5.1 for producers and 5.2 for distributors.
  • 141
    • 84891025857 scopus 로고    scopus 로고
    • Art. 8 of GPSD.
    • Art. 8 of GPSD.
  • 142
    • 84891029960 scopus 로고    scopus 로고
    • Art. 5.3 of GPSD.
    • Art. 5.3 of GPSD.
  • 143
    • 84891012732 scopus 로고    scopus 로고
    • above n. 43, 191 ff., describing the different criteria for evaluating post-marketing obligations of producers and distributors.
    • C. Hodges, European regulation of consumer product safety, above n. 43 pp. 132 ff and 191 ff., describing the different criteria for evaluating post-marketing obligations of producers and distributors.
    • European regulation of consumer product safety , pp. 132
    • Hodges, C.1
  • 144
    • 84905605718 scopus 로고    scopus 로고
    • (Routledge)
    • for an introduction, E. Todeva, Business networks (Routledge, 2006), part. pp. 85 ff.
    • (2006) Business networks , Issue.PART , pp. 85
    • Todeva, E.1
  • 146
    • 67649524100 scopus 로고    scopus 로고
    • Industrial districts and regional clusters
    • J. Zeitlin, (OUP)
    • a more general framework see J. Zeitlin, 'Industrial districts and regional clusters', in J. Zeitlin, Handbook of business history (OUP, 2007)
    • (2007) Handbook of business history
    • Zeitlin, J.1
  • 147
    • 57049151346 scopus 로고    scopus 로고
    • Coase revisited: business groups in the modern economy
    • G. Dosi, D. Teece, J. Chytry, (Oxford)
    • M. Granovetter, 'Coase revisited: business groups in the modern economy', in G. Dosi, D. Teece, J. Chytry, Technology, organization and competitiveness (Oxford, 1998), pp. 67 ff.
    • (1998) Technology, organization and competitiveness , pp. 67
    • Granovetter, M.1
  • 148
    • 84900909876 scopus 로고    scopus 로고
    • Contractual networks and the Small Business Act: towards European principles?
    • On the definition of contractual networks
    • On the definition of contractual networks, see F. Cafaggi, 'Contractual networks and the Small Business Act: towards European principles?', EUI working paper 2008/15.
    • EUI working paper 2008/15.
    • Cafaggi, F.1
  • 150
    • 84891029240 scopus 로고    scopus 로고
    • a broad analysis of business networks, above n. 111 passim.
    • a broad analysis of business networks, E. Todeva, Business networks, above n. 111 passim.
    • Business networks
    • Todeva, E.1
  • 151
    • 84891030907 scopus 로고    scopus 로고
    • The divergences between real industrial organisational forms and regulatory strategies concerning product safety
    • When theory departs from reality in institutional design, unpublished manuscript.
    • F. Cafaggi, The divergences between real industrial organisational forms and regulatory strategies concerning product safety. When theory departs from reality in institutional design, unpublished manuscript.
    • Cafaggi, F.1
  • 152
    • 84891027985 scopus 로고    scopus 로고
    • In the UK these differences have been acknowledged by DTI Guidance suggesting agreements along the chain on who should make the notification.
  • 153
    • 84890983199 scopus 로고    scopus 로고
    • DTI Guidance for businesses, consumers and enforcement authorities, above n. 104 p. 6.6.
    • DTI Guidance for businesses, consumers and enforcement authorities, above n. 104 p. 6.6.
  • 155
    • 84891029240 scopus 로고    scopus 로고
    • above n. 111
    • For a summary concerning different network configurations, see E. Todeva, Business networks, above n. 111 pp. 130 ff.
    • Business networks , pp. 130
    • Todeva, E.1
  • 156
    • 38749085304 scopus 로고    scopus 로고
    • A real time revolution in routines
    • C. Heckscher and P. Adler, (OUP)
    • C. Sabel, 'A real time revolution in routines', in C. Heckscher and P. Adler, The Firm as a Collaborative Community (OUP, 2006), p. 106.
    • (2006) The Firm as a Collaborative Community , pp. 106
    • Sabel, C.1


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