1 EC Directorate-General for Trade, 21 March 2012, available on the Internet at: <http://trade.ec.europa.eu/doclib/docs/2006/september/tradoc_113366.pdf> (last accessed on 31 October 2012), p. 1.

2 EU's largest export market is the USA with a volume of € 260.6 billion in 2011; see: EC Directorate-General for Trade (see n. 1), p. 5.

3 Fundamentally, it has to be emphasized that ensuring product safety in Europe is the responsibility of the EU and not of the PRC. Nevertheless, the PRC's legal system provides – in contradistinction to EU's legal system – an export control mechanism to protect the Chinese export markets. V.i. B.II.2 with further reference.

4 RAPEX is a rapid alert system for the notification of dangerous consumer products (excluding foods and pharmaceutical products). For the latest RAPEX reports see: EC Directorate-General for Health and Consumer Affairs (DG SANCO), available on the Internet at: <http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm> (last accessed on 31 October 2012).

5 DG SANCO, “2011 Annual Report on the operation of the Rapid Alert System for non-food dangerous products”, 2012, available on the Internet at: <http://ec.europa.eu/consumers/safety/rapex/docs/2011_rapex_report_en.pdf> (last accessed on 31 October 2012), p. 20.

6 See with further reference: Holly Hart, undated, “Product Safety Is China's Achilles’ Heel”, Bloomberg Businessweek, 2008, available on the Internet at: <http://www.businessweek.com/debateroom/archives/2008/10/product_safety.html> (last accessed on 31 October 2012).

7 It should be noticed that there is no Free Trade Agreement between the EU and China. In sectors which are not covered by WTO PRC’s administration is in charge to decide who will be granted market access. See: A.II.

8 Example: Goods are produced for the European and the Chinese market and there is no possibility to implement different product safety standards in the process of production and, hence, the higher standards have to be applied.

9 Issued by the State Counsel on 29 June 2005, available on the Internet at: <http://www.fdi.gov.cn/pub/FDI_EN/Laws/GeneralLawsandRegulations/AdministrativeRegulations/P020060620321937963078.pdf> (last accessed on 31 October 2012).

10 Formulated by the competent department of production license for industrial products of the State Council together with the relevant departments of the State Council and published on 2 November 2009, available on the Internet at: <http://www.sczj.gov.cn/english/service/200911/t20091112_104835.html> (last accessed on 31 October 2012).

11 Issued by the Ministry of Commerce and the General Administration of Customs of the PRC on 30, December 2011, available on the Internet at: <http://www.zhaoqing.gov.cn/english/tz/zcfg/201202/t20120222_147377.html> (last accessed on 31 October 2012).

12 Issued by CNCA on 27, February 2003, available on the Internet at: <http://vip.chinalawinfo.com/newlaw2002/slc/slc.asp?db=chl&gid=45520> (last accessed on 31 October 2012).

13 For further reference see: CNCA, undated, available on the Internet at: <http://www.cnca.gov.cn/cnca/cncatest/20040420/column/227.htm> (last accessed on 31 October 2012)

14 Exemptions apply for products such as pharmaceuticals, medical devices, etc.

15 According to the “New Approach” only products fulfilling the relevant “essential requirements” may be placed on the market. Compliance with the “harmonised standards” grants presumption of conformity with the corresponding essential requirements but, however, manufacturers may chose between various conformity assessment procedures contained in the applicable directive that provide compliance with the essential requirements. In addition, the CE marking is based on a self declaration by the person responsible that “the product conforms to all applicable Community provisions, and the appropriate conformity assessment procedures have been completed”. Thus, there currently is no compulsory third party assessment in the EU. See: European Commission (EC), “Leitfaden für die Umsetzung der nach dem neuen Konzept und dem Gesamtkonzept verfaßten Richtlinien”, 2000, available on the Internet at: <http://ec.europa.eu/enterprise/policies/singlemarket-goods/files/blue-guide/guidepublic_de.pdf> (last accessed on 31 October 2012), p. 7, 8 and 44.

16 See: Prosafe, “Best Practice Techniques in Market Surveillance”, undated, available on the Internet at: <http://www.prosafe.org/read_write/file/EMARS_Best_Practice_Book.pdf> (last accessed on 31 October 2012), p. 1.

17 A representative list of various provisions can be found on the offi cial website of AQSIQ at: <http://english.aqsiq.gov.cn/AboutAQSIQ/Mission/> (last accessed on 31 October 2012), (item “Laws and Regulations“), where is also mentioned that there are at least 316 (as of August 2005) additionally “governing documents” (such as Ordinances and Notices) issued by AQSIQ that are also legally binding.

18 For the hierarchy of legal norms in China see: Binding, Jörg and Radjuk, Anna, “Die Rangordnung der Rechtsnormen der VR China”, 11 Recht der Internationalen Wirtschaft (2009), pp. 785 et sqq., at p. 785 – unfortunately in German.Google Scholar

19 V.i.: B.III.

20 “Product” is, unless the context means otherwise, used as a umbrella term for products (v.i.: B.I.2 and B.I.4) and commodities (v.i.: B.I.3).

21 V.i.: B.I.2.

22 V.i.: B.I.3.

23 V.i.: B.I.4.

24 V.i.: C.

25 V.i.: D.

26 V.i.: E.

27 E.g. the “Memorandum of Understanding on Consumer Protection Matters between the State Administration for Industry and Commerce of the PRC and the Federal Trade Commission of the USA”, 12 July 2007, available on the Internet at: <http://www.ftc.gov/os/2007/06/070612chinamou.pdf> (last accessed on 31 October 2012) or the “Joint Statement on Enhancing Consumer Product Safety”, 11 September 2007, available on the Internet at: <http://www.cpsc.gov/cpscpub/prerel/prhtml07/07305.pdf> (last accessed on 31 October 2012).

28 AQSIQ (see n. 17).

29 See: http://www.lawinfochina.com/wto/index.aspx – unfortunately in Chinese (last accessed on 31 October 2012).

30 DG SANCO, “Consumers: European Commission hosts first high level EU-China-US product safety summit”, IP/08/1717, 17 November 2008, available on the Internet at: <http://europa.eu/rapid/press-ReleasesAction.do?reference=IP/08/1717&format=HTML&aged=0&language=EN> (last accessed on 31 October 2012).

31 DG SANCO, “EU and China to strengthen co-operation on product safety”, IP/05/XXXX, 11 November 2005, available on the Internet at: <http://ec.europa.eu/dgs/health_consumer/library/press/press363_en.pdf> (last accessed on 31 October 2012).

32 DG SANCO (see n. 30). From September to December 2007, a nation-wide specifi c rectification campaign has been carried out by AQSIQ, in which all 3540 export toy enterprises were audited in terms of quality and safety control, export quality license of 701were revoked. All have signed guarantee letter of quality control, ECC-NET, “RAPEX Report 2007, 4 April 2008, available on the Internet at: <http://www.europakonsument.at/cs/Satellite?pagename=Europakonsument/Artikel/Detail&cid=1034663> (last accessed on 31 October 2012).

33 During the period between 2006 and 2010, AQSIQ has investigated and adopted measures in relation to 1,386 RAPEX notifications. On average, AQSIQ investigates 92 RAPEX cases over a three-month period, DG SANCO (see n. 5), p. 48.

34 During the period between 2006 and 2010, in 591 cases (43 % of the total) AQSIQ was not able to fi nd the responsible Chinese companies and thus could not adopt appropriate restrictive measures, DG SANCO (see n. 5) p. 48.

35 See: AQSIQ, “ The Seventh High-level Meeting between the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) and the Directorate- General for Health & Consumers of the European Commission held in Beijing – Long-term plan to steadily push forward the China-EU quality inspection cooperation; Mr. ZHI Shuping and Mr. John Darley signed a cooperation agreement and delivered speeches”, 21 March 2012, available on the Internet at: <http://www.aqsiq.gov.cn/zjxw/zjxw/zjftpxw/201203/t20120321_211993.htm> (last accessed on 31 October 2012) – only in Chinese.

36 See: <http://ec.europa.eu/consumers/cons_safe/prod_safe/safe_toys.pdf> (last accessed on 31 October 2012).

37 DG SANCO, 2007, available on the Internet at: <http://ec.europa.eu/consumers/cons_safe/prod_safe/intl_coop_en.htm> (last accessed on 31 October 2012). DG SANCO, “By 2010, AQSIQ has submitted 15 quarterly reports to DG SANCO on enforcement actions carried out in response to RAPEX notifi cations exchanged via the system.”, (see n. 5) p. 47.

38 First version issued on 22 February 1993, entered into force on 1 September 1993, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=1834&lib=law> (last accessed on 31 October 2012).

39 It should be noted, however, that the PQL, just like the majority of the civil laws of the PRC, is not applicable on the territory of Hong Kong and Macau due to their special status as Special Administrative Regions.

40 Exemptions are made to certain extend for construction projects (Art. 2 para. 3 PQL) and military products like arms, ammunition and other military related products (Art. 73 PQL). For details concerning the defi nition see: Binding, Jörg, “VR China”, in Kullmann, Hans Josef and Pfister, Bernhard (eds), Produzentenhaftung (Berlin: ESV, dely. 2/12), pp. 15 et sqq., at p. 15 – unfortunately in German.Google Scholar

41 Esp. Art. 2, 3 and 8 PQL.

42 V.i.: B.II.1.

43 Chapter three especially regulates the responsibilities of producers (Art. 26 to 32 PQL) and sellers (Art. 33 to 39 PQL) including certain label requirements (Art. 27 PQL). Chapter four contains, among other things, provisions on contractual (Art. 40 PQL) and tort (Art. 41 to 44 PQL) product liability . Certain “Supplementary Provisions” can be found in chapter six.

44 Entered into force on 1 August 1989, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=2307&lib=law> (last accessed on 31 October 2012), the latest implementation regulation (IECIL-IR) was issued on 31 August 2005, available at the Internet at: <http://www.lawinfochina.com/display.aspx?id=4742&lib=law> (last accessed on 31 October 2012).

45 Marx, Karl, “A Contribution to the Critique of Political Economy” in: Marx, Karl and Engels, Friedrich (ed.), Collected Works of KarlMarx and Frederick Engels: Volume 29 (International Publishers: New York, 1987), pp. 269 et sqq., at p. 269.Google Scholar

46 It came into effect on April 1, 1989, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=1197&lib=law> (last accessed on 31 October 2012). Additionally the State Council issued the “Regulation for the Implementation of the SL of the PRC (SL-IR)”, 6 April 1990, available on the Internet at: <http://www. lawinfochina.com/display.aspx?id=1309&lib=law> (last accessed on 31 October 2012).

47 Esp. Art. 4 and 5 SL.

48 Chapter two provides detailed regulations on the “formulation of standards” and chapter five (“Supplementary Provisions”) especially contains the competency for formulating the standards (Art. 25 SL).

49 E.g.: Art. 15 PQL and 19 IECIL.

50 E.g.: Art. 11 sent. 2 and Art. 26 IECIL.

51 E.g.: Art. 26 IECIL.

52 E.g.: Art. 5, 27, 31 PQL.

53 E.g.: Art. 4, 5, 6 and 7 IECIL.

54 For dealing with consumer complaints, Art. 10, 22 and 23 PQL contain detailed provisions.

55 Also see: Art. 4 PQL.

56 According to Art. 3 PQL the producers are obliged to establish such quality management systems.

57 Junhui, Huang, Product Quality Law of the People's Republic ofChina and Relevant Regulations (Beijing: Law Press 2009), at p. 15 – only in Chinese.Google Scholar

58 The “Administrative Measures for Product Quality Spot Inspections (SIR)”, issued by AQSIQ on 29 December 2010, contains more detailed provisions regarding different types of sampling in Chapter III Section I (Sampling), available on the Internet at: <http://www.lawinfochina.com/display.aspx?lib=law&id=9039> (last accessed on 31 October 2012).

59 Huang Junhui, (see n. 57), p. 15.

60 See: available on the Internet at: <http://cpzljds.aqsiq.gov.cn/zcfg/jsgf/201007/t20100720_150200.htm> (last accessed on 29 May 2012), 2011 Version, issued for 101 product categories by AQSIQ on 10 February 2011, available on the Internet at: <http://cpzljds. aqsiq.gov.cn/zcfg/jsgf/201102/t20110215_177407.htm> (last accessed on 31 October 2012) – only in Chinese. More norms are expected to come up.

61 Available on the Internet at: <http://cpzljds.aqsiq.gov.cn/zcfg/jsgf/201007/t20100720_150200.htm> (last accessed on 31 October 2012) – only in Chinese.

62 Available on the Internet at: <http://cpzljds.aqsiq.gov.cn/zcfg/jsgf/201102/t20110215_177407.htm> (last accessed on 31 October 2012) – only in Chinese. More norms are expected to come up.

63 The rule is formulated rather wide, it covers also older more general provisions and is not limited to “different provisions” as lex specialis.

64 In addition, Art. 15 para. 1 sent. 6 and 7 PQL clarify the relationship between controls of authorities at different levels of governmental hierarchy.

65 This is not to be confused with the provision in Art. 24 PQL that obliges the authorities to “publicize regularly the quality situation of the products that they have tested on the random basis”.

66 The English version of the law available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=1834&lib=law> (last accessed on 31 October 2012) is not translated correctly and, thus, does not indicate that the reexamination is conducted after the publication.

67 Since the English translation available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=1834&lib=law> (last accessed on 31 October 2012) is not correct, it does not point out that Art. 17 PQL contains two time limits – one in Art. 17 para. 1 sent. 1 PQL and one in Art. 17 para. 1 sent. 2 half sent. 2 PQL.

68 Art. 50 sent. 1 SIR sets this time limit to 30 days.

69 This is a so called “sanction reference”. Thus, the legal prerequisites of the Art. 49 et seq. PQL do not need to be fulfilled.

70 The control of export commodities is a special Chinese feature.

71 Given that the volume of China's foreign trade and constraint of inspector capacity, in practice the supervision administrations identify and focus on the selected product groups when they set up and implement inspection plans.

72 Some measures determined to increase the efficiency of the authorities are contained in Art. 30 para. 2 IECIL.

73 Art. 30 para. 3 IECIL specifies the requirements for functionaries.

74 The “other laws” are not further specified and, thus, not limited to provisions as lex specialis, see n. 63.

75 Art. 5 para. 3 IECIL provides an exemption from the compulsory inspection under certain circumstances.

76 E.g.: Art. 11 sent. 1 IECIL establishes reporting requirements for consignees or their agents, Art. 12 sent. 1 IECIL the scope of obligatory tolerance for the inspection and Art. 12 sent. 2 IECIL makes specifications concerning the accomplishment of the inspection.

77 Art. 16 IECIL governs the further procedure for export commodities after the inspection. Art. 17 and 18 IECIL contain provisions concerning packaging and transport vessels in certain cases.

78 Issued by AQSIQ on 9 March 1993, available on the Internet at: <http://law.e-to-china.com/index_content-id-6207c470ae3f5f78d-03bd3c905587a691.html> (last accessed on 31 October 2012).

79 “Not less than 5 % but not more than 20 % of the value of the commodities”.

80 See: Art. 28 IECIL.

81 See: Art. 29 IECIL.

82 See for this term: Art. 24 sent. 1 SL-IR.

83 See also: Art. 23 sent. 2 SL-IR.

84 Issued by AQSIQ on 23 July 1990, available on the Internet at: <http://vip.chinalawinfo.com/newlaw2002/slc/slc.asp?db=chl&gid=45109> (last accessed on 29 May 2012).

85 When export products, are sold at domestic market, they – obviously – must meet the requirements of the Chinese compulsory standards, see Art. 16 SL, Art. 25 SL-IR.

86 V.i.: C.II.1.

87 V.i.: C.II.2.

88 “Interpretation of Standardization Law”, issued by the State Administration of Quality and Technical Supervision on 23 July 1990, available on the Internet at: <http://www.law-lib.com/fzdt/newshtml/21/20050711223254.htm> (last accessed on 31 October 2012).

89 Art. 5, 6 no 6, 7 no 6, 8 no 6, 9 no 5, 28, 29 and 30 SL-IR for example, presume respective supervisory instruments and inspections, too.

90 Specifications are made in the fifth chapter of the SL-IR.

91 Art. 33 para. 2 SL-IR contains a correlating provision for sellers.

92 In rare cases the authorities are named expressly, e.g.: Art. 3 SIR or Art. 2 para. 1 IECIL-IR.

93 In addition, for a variety of special products ranges special supervisory authorities are set up. V.i. e.g.: C.IV and Binding, Jörg and Eisenberg, Claudius, “Produkthaftung in der VR China”, 1 Recht der Internationalen Wirtschaft (2010), pp. 1 et sqq., at p. 3– in German.Google Scholar

94 Issued by the General Office of the State Council on 11 July 2008.

95 Issued on 10 July 2008, available on the Internet at: <http://www. lawinfochina.com/display.aspx?lib=law&id=7135> (last accessed on 29 May 2012).

96 There are in total 15 direct affiliates of AQSIQ, which offer technical support for AQSIQ decision-making and implementing , AQSIQ (see n. 17).

97 The SIR contains a lot more detailed provisions concerning the competencies in the area of sampling.

98 Additionally, AQSIQ is also in charge of the voluntary certification system for quality control systems of enterprises (Art. 14 para. 1 sent. 2 PQL).

99 See: Art. 2 para. 2 PMF-AQSIQ.

100 See: Art. 2 para. 5 PMF-AQSIQ, Art. 4, IECIL.

101 See: Art. 2 para. 7 PMF-AQSIQ.

102 Also: Art. 2 para. 1 IECIL-IR.

103 V.s.: B.II.2 and additionally: Art. 3 IECIL-IR.

104 Also: Art. 2 para. 2 IECIL-IR.

105 Issued on 11 July 2008, available on the Internet at: <http://vip.chinalawinfo.com/newlaw2002/slc/slc.asp?db=chl&gid=107034> (last accessed on 31 October 2012) – only in Chinese.

106 The basic structure of SAIC's administration organization is available on the Internet at: http://www.saic.gov.cn/zzjg/jgsz/ – in Chinese.

107 Issued by General Office of State Council on 10 October 2011, available on the internet at: <http://www.foods-info.com/Article- Show.asp?ArticleID=53429> (last accessed on 31 October 2012) – only in Chinese.

108 For details on the consumer protection law of the PRC see: Jörg Binding, “Das Verbraucherschutzrecht der VR China”, Verbraucherund Recht (2012) – forthcoming – in German and Jörg Binding “Protecting the Consumers”, 12, 1 China Law and Practice (2011, 2012), pp. 8.

109 For details see: Jörg Binding (see n. 108).

110 This result is also derived from a teleological interpretation of Art. 8 para. 1 sent. 2 PQL.

111 V.i.: for further details: B.III.2.c).

112 Art. 18 para. 2 PQL.

113 V.s.: B.III.2.a).

114 Art. 22 PQL.

115 Art. 40 para. 3. PQL.

116 For details v.s. B.II.1.d).

117 The AICs are entitled to revoke the business license according to Art. 70 PQL.

118 Issued on 7 August 2001, available on the Internet at: <http://vip.chinalawinfo.com/newlaw2002/slc/slc.asp?db=chl&gid=38892> (last accessed on 31 October 2012) – only in Chinese.

119 Example: SAIC detects a defective product on the market and assumes that the defectiveness is due to flaws in the production process. In this case AQSIQ will be contacted by SAIC. Then AQSIQ will test the product. If the defectiveness is actually due to a fl aw in the production process, the producer will be made responsible. If the producer is not able to remedy the fl aws in the production process the production will be suspended by AQSIQ. In the worst case SAIC will revoke the business license of the producer (Art. 70 PQL and Art. 50 SIR).

120 V.s.: A.II

121 Adopted on 29 April 2006 and entered into force on 1 November 2006, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=5142&lib=law> (last accessed on 31 October 2012).

122 Adopted on 27 August 2007 and entered into force on 1 September 2008, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=6384&lib=law> (last accessed on 31 October 2012).

123 Adopted on 11 March 2003 and entered into force 1 June 2003, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=2641&lib=law> (last accessed on 31 October 2012).

124 E.g. the “Administrative Regulation on the Slaughtering of Pigs” issued by the State Council on 25 May 2008, available on the Internet at: <http://vip.chinalawinfo.com/newlaw2002/slc/slc.asp?db=chl&gid=105516> (last accessed on 31 October 2012) – in Chinese or the administrative regulations issued by the Minstery of Health on, e.g., soy sauce, rice or unpacked food. The provincial governments or city governments adopted a series of rules as well. The most relevant regulation concerning the PAL is the “Regulations for the Implementation of Pharmaceutical Administration Law of the PRC” issued by the State Council on 4 August 2002.

125 Available on the Internet at: <http://www.lawinfochina.com/Display.aspx?Lib=law&Id=7344&keyword=> (last accessed on 31 October 2012).

126 Available on the Internet at: <http://www.lawinfochina.com/Display.aspx?Lib=law&Id=116&keyword=> (last accessed on 31 October 2012).

127 An implementation regulation was issued on 20 July 2009, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=7589&lib=law> (last accessed on 31 October 2012).

128 Adopted on 28 February 2001 and entered into force on 1 December 2001, available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=1832&lib=law> (last accessed on 31 October 2012).

129 As defi ned in Art. 102 para. 3 PAL.

130 As defi ned in Art. 102 para. 4 PAL.

131 The PAL, however, does not provide any compensation claims.

132 V.s.: B.I.1.a).

133 DG SANCO (see n. 30).

134 Art. 31 FSL.

135 See: Sabine Muscat and Mure Dickie, “China verschärft Lebensmittel- Kontrollen”, Financial Times Deutschland, 7 June 2007, available on the Internet at: <http://www.ftd.de/politik/international/209922.html?nv=cd-topnews> (last accessed on 31 October 2012) – in German.

136 Available on the Internet at: <http://www.lawinfochina.com/display.aspx?lib=law&id=3739> (last accessed on 31 October 2012).

137 The FSL only specifies that MOH is responsible for overall coordination but not for the enforcement.

138 This includes responsibility “for investigating and dealing with the serious food safety accidents concerning domestic food production and processing”, AQSIQ (see n. 17).

139 Issued by General Office of State Council on 10 July 2008, available on the internet at: <http://vip.chinalawinfo.com/newlaw2002/slc/slc.asp?db=chl&gid=108148> (last accessed on 31 October 2012) – only in Chinese.

140 See for UN: UN in China, “Advancing Food Safety in China”, March 2008, available on the Internet at: <http://www.un.org.cn/public/resource/2aebcd033e334d961fefb1588b70f2ab.pdf> (last accessed on 31 October 2012), p. 11, for WHO: Henk Bekedam, WHO Representative China , “UNCT meeting”, 24 July 2007, p. 17.

141 Art. 2.5, ISO/IEC 17000:2004 Conformity Assessment – Vocabulary and General Principles.

142 ISO/IEC 17000:2004 says Accreditation Body (AB) is not a conformity assessment body.

143 See: PMF-SIQCASA.

144 CNCA para.1,PMF-SIQCASA, Art. 4 Measures for the Administration of Certification Institutions, issued by AQSIQ on 20 July 2011. It should be noticed, however, that CNCA is not a national accreditation body – that would be the “ China National Accreditation Service for Conformity Assessment” (CNAS).

145 CNCA Art. 2 para. 1,5,6,7 PMF- SIQCASA.

146 Issued by the State Council on 3 September 2003 , available on the Internet at: <http://www.lawinfochina.com/display.aspx?id=3128&lib=law. (last accessed on 31 October 2012). In this sense, AB could also be regarded as CABs.

147 There are various certifi cation systems in the PRC's legal system: e.g. Art. 24 to 27 IECIL.

148 Currently, China is constructing a cooperative governance network of food and drug safety supervision.

149 See: EU-China Trade Project (II), available on the Internet at: <http://www.euctp.org/> (last accessed on 31 October 2012).

150 See: Sino-German Consumer Protection and Product Safety Programme, available on the Internet at: <http://www.consumerprotection-productsafety.org> (last accessed on 31 October 2012).