WORLD TRADE  
ORGANIZATION  G/TBT/W/281 
6 November 2007 
 (07-4812) 
Committee on Technical Barriers to Trade Original:   English 
  
CHINA'S
 TRANSITIONAL  REVIEW  MECHANISM  
Communication from the European Communities  
  The following communication, dated 1 November 2007, is being circulated at the request of 
the delegation of the European Communities
. 
_______________ 
 
 
I. INTRODUCTION 
1. Fruitful cooperation between China and the EC on TBT issues has continued since last year's 
transitional review.  Frequent bilateral contacts between the EC and China and the good functioning 
of a number of formal cooperation mechanisms in the TBT field have allowed for some progress in 
most of the areas covered in the last year's submission (G/TBT/W/272).  
2. This document identifies a number of outstanding  concerns in the TBT field, which the EC 
will continue to discuss with the Chinese authorities in  a bilateral context.  The EC also considers it 
useful to table these concerns in a multilateral cont ext in order to inform other Members of the WTO. 
II. CCC SYSTEM 
3. The EC would like to underline its positive cooperation with the competent Chinese 
authorities, which has allowed the EC to raise co ncerns on the CCC system and discuss in detail 
various issues relating to the practical implementation of the CCC system. 
4. As a general remark, the EC notes that, despite some improvements in a number of areas, the 
CCC system remains one of the main market access hurdles for foreign companies, and in particular 
for small and medium-sized enterprises, due to the complexity, length and costs of the procedure. 
5. The EC considers that the current requirements of the CCC system are not always relevant to 
the level of risk the products pose, which implies that the CCC system is more trade restrictive than 
necessary.  The EC sees a general need for the overall streamlining and simplification of the CCC 
system. 
6. The EC would like to recall its main  requests and outstanding concerns: 
A. CONFORMITY ASSESSMENT PROCEDURES SHOULD BE MORE CLEARLY LINKED TO THE LEVEL 
OF RISK POSED BY THE PRODUCT  
7. In this respect, the EC notes that, during last y ear's transitional review before this Committee, 
China stated that it had been studying the possi bility of adopting different conformity assessment 
procedures, including the Supplier's Declaration of C onformity (SDoC), to reflect the different levels 
of risk posed by the products listed in the CCC Product Catalogue. G/TBT/W/281 
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  8. The EC expresses appreciation for the efforts undertaken by China's National Certification 
and Accreditation Administration (CNCA) in the cour se of 2007, in particular as regards the launch of 
a comprehensive research programme on risk management and risk assessment schemes with a view to identifying categories of low-risk products in respect of which CCC requirements could and should 
be considerably simplified. 
9. The EC also notes the efforts of the Chinese authorities in est ablishing a more efficient post-
market surveillance system as well as an adequate legal framework in support of the possible future 
introduction of SDoC for some products. 
10. The EC encourages China to acc elerate the above process and stands ready to share its 
experiences of managing conformity assessment pro cedures based on the SDoC for low-risk products. 
B. S
PARE PARTS , COMPONENTS AND SUB -ASSEMBLIES  
11. Spare parts, components and sub-assemblies are currently exempted from CCC certification 
when incorporated in final exported products. 
12. However, they are subject to mandatory certifi cation, when they are imported as single units, 
even when they are intended fo r incorporation in CCC certified final products and are not made 
available separately on the Chinese market.  
13. The EC would request China to consider ex empting from the CCC certification requirements 
single spare parts, components and sub-assemblies whic h (i) are solely intended for incorporation into 
a CCC certified final product and (ii) are not sold separately on the Chinese market.  
C. ALLOW FOREIGN -OWNED CERTIFICATION BODIES ESTABLISHED IN CHINA TO BE DESIGNATED 
AS CCC  CERTIFICATION BODIES  
14. China's Regulation on Certification and Accr editation provides for the possibility that 
foreign-owned certification bodies be established a nd engage in product certification activities in 
China.  
15. During last year's transitional review, China confirmed that foreign-owned certification 
bodies established in China could be qualified as  CCC certification bodies by way of official 
authorization by CNCA. 
16. However, the EC understands that, due to certa in general limitations in Chinese law on the 
activities of foreign-owned entities, only Chinese-owne d certification bodies are in practice eligible 
for designation under the CCC System.  
17. On the other hand, the EC understands that  acceptance of test results from local-based 
foreign-owned certification bodies is possible on th e basis of either prior approval from CNCA 
followed by a contractual arrangement betw een such bodies and a CCC designated Chinese 
certification body, or on the basis of an internationa l voluntary scheme that Ch ina adheres to (e.g. the 
IECEE CB Scheme). 
18. The EC would appreciate it if China could cl arify the situation regarding the effective 
possibility for foreign-owned certification bodies estab lished in China to be designated and perform 
activities under the CCC System without discrimination compared to Chinese-owned certification 
bodies.  G/TBT/W/281 
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  D. FACILITATE AND EXPAND THE SCOPE OF REC OGNITION OF TEST RESULTS FROM FOREIGN 
CERTIFICATION BODIES  
19. In the field of electrical safety, recognition of  test results from foreign certification bodies is 
greatly facilitated by China's participation in the IECEE CB Scheme.  
20. The EC would like to request China to consider  making full use of all the options provided for 
under this scheme, by accepting in particular th e results of tests performed in qualifying 
manufacturers' laboratories in accordance with the Supervised Manufacturer's Testing and Recognised 
Manufacturer's Testing procedures. 
21. The EC further encourages China to continuall y increase the scope of the products and of the 
IEC standards it adheres to in the IECEE CB Scheme. 
22. The EC understands that, outside internati onal voluntary schemes such as the IECEE CB 
Scheme, foreign-based certification bodies may be accep ted to undertake testing work on behalf of 
Chinese certification bodies, on the basis of bilateral agreements with CNCA and the relevant Chinese 
certification bodies. 
23. The EC asks China to continue to encourage such agreements, which have great potential for 
facilitating compliance with the CCC requirements as well as for reducing associated costs, in 
particular for small and medium-sized enterprises who often do not have representation in China. 
E. FACTORY INSPECTIONS  
24. The EC takes note of China's position, as stated in the context of last year's transitional 
review, that the factory inspection in the CCC Sy stem contains not only requirements related to 
general quality management systems, as specified in the ISO9001 series, but also requirements on 
process control and product conformity assessment.  China is therefore of the view that ISO9001 
cannot fully replace the factory inspection requirement in the CCC system. 
25. The EC would like to request assurance from Ch ina that the requirements already covered by 
the ISO9001 certificate are not verified again in th e context of the factory inspection under the CCC 
system.  
26. Given the significant costs associated with the factory inspections (mostly related to travel 
and subsistence costs of the Chinese auditors), which place a very heavy burden especially on small 
and medium-sized enterprises, the EC urges China to consider allowing foreign-based certification 
bodies to carry out the initial factory inspection, on the basis of agreements si milar to those currently 
in place between CNCA and designated Chinese certif ication bodies, on one hand, and a number of 
foreign-based certification bodies, on the other ha nd, in connection with the follow-up factory 
inspections. 
III. STANDARDIZATION - GENERAL 
27. Cooperation in the field of standardization betw een Europe and China is effective.  Real 
progress was made on some of the issues raised last year's transitional review although there remain 
some areas of concern, as outlined below. G/TBT/W/281 
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  A. P
ARTICIPATION OF FOREIGN -OWNED COMPANIES ESTABLISHED IN CHINA IN DOMESTIC 
STANDARDISATION WORK  
28. The EC was pleased to hear from the Chin ese delegation on the occasion of the last 
transitional review that the Standardisation Administration of China (SAC) had promulgated 
Document No. 40 of 2005 on Opinions on Participation of Foreign Enterprises in China in Domestic 
Standardisation , which provides the legal framework fo r the participation of foreign-owned 
enterprises established in China in the domestic standardisation making process. 
29. The EC is also pleased to report that, at a recen t bilateral meetings with the EC in October 
2007, China confirmed that the “national treatment” pr inciple would be systematically applied in all 
standard development activities, especially in Technical Committees.  
30. The EC very much welcomes these developments  and would like to stress the importance of 
ensuring an effective participation of foreign-owne d enterprises established in China in the domestic 
standardisation-making process on the same conditions as Chinese-owned enterprises.  
31. Full industry participation is the key to succes s for any standard development. Failure to 
involve foreign companies might result in the respective Chinese Standard Development 
Organizations not gaining access to recent technologi cal developments, to the ultimate detriment of 
the Chinese society.  
B. IMPLEMENTATION OF INTERNATIONAL STANDARDS – NATIONAL DEVIATIONS  
32. The EC notes with appreciation China’s achieveme nts with regard to the adoption rate of 
international standards and its commitments to th e continuous alignment of  its domestic technical 
regulations and standards with  international standards.  
33. The EC also wishes to positively highlight China’ s commitment to play a substantial role in 
international standardization organizations  and the related technical committees.  
34. At the same time, some concerns remain as to the availability of information regarding 
deviations of Chinese standards from correspondi ng international standards.  The EC would 
appreciate if China could provide an update of any measures taken to make information on those 
national deviations more transparen t and accessible for economic operators. 
C. COMPULSORY VERSUS VOLUNTARY STANDARDS  
35. The Chinese standardization system distinguishes be tween four different levels of standards, 
namely National Standards, Sector Standards (als o known as Industrial Standards), Local Standards, 
and Enterprise Standards. National Standards, Sect or Standards and Local Standards can be further 
subdivided into voluntary or compulsory. 
36.  "Compulsory Standards" are a unique feature of the Chinese standardization system and, as 
far as the EC understands, focus mainly on fields of specific public interest such as health and safety, 
environmental protection, data protection, etc.; however, they often include unrelated topics such as performance and interoperability requirements.  Co mpulsory standards might create effective trade 
barriers, especially in cases where other internationa l standards favour differing technical solutions, or 
where current Chinese standards do not reflect late st technical developments in this field. 
37. European industry has reported that in some  instances standards initially developed as 
"Voluntary Standards" have in fact later been ma de mandatory without any prior warning being given  G/TBT/W/281 
 Page 5 
 
 
  to the participants in the standard-making process a bout this policy change.  By the same token, no 
notification in accordance with the provis ions of the TBT Agreement was given. 
38. As an example, the EC refers to the standard on a Unified Charger for Mobile 
Telecommunications Terminal Equipment  (YD/T 1591-2006), which had been developed and initially 
adopted in December 2006 as a “Voluntary Industria l Standard” but was later rendered mandatory (as 
of 14 June 2007) on all mobile phones and chargers  manufactured in China in the framework of the 
Network Access License procedure operated by the Ministry of Information Industry (MII). 
39. The EC would appreciate it if China could clarify the effective differences between 
Compulsory Standards and Voluntary Standards in China’s domestic standardisation system, 
including the different suffixes of the standard cod es used to differentiate between the two categories 
of standards. 
IV. STANDARDISATION - ICT  
40. The EC would like to draw China's attention to the following issues: 
A. HOME-GROWN STANDARDS  
41. There continues to be considerable concern a bout the development of a "home-grown" body 
of national standards featuring unique Chinese technologies to the exclusion of leading technologies 
of foreign origin, especially in areas where intern ationally recognized standards serving identical 
purposes already exist or are being developed. 
42. When relevant international standards are tr anslated into Chinese standards, additional 
requirements are sometimes placed on top of the sp ecifications of the international standards. 
43. This requires re-designing products specifically  for the Chinese market, thus delaying time-
to-market, which is crucial in such a fast evolvi ng sector, and also leads to potential inter-operability 
problems.  Ultimately, the need to find local variati ons to existing solutions th at are applied anywhere 
else in the world hampers the development of i nnovative products and applications in the Chinese 
market.  This means that Chinese consumers are being denied access to the latest mobile-phone 
technology. 
44. As examples, the EC would like to refer to  the TD-SCDMA (Time Division-Synchronous 
Code Division Multiple Access) for the third gene ration mobile telecommunications standard, the 
China Multimedia Mobile Broadcasting (CMMB) standard, the WLAN Autentication and Privacy 
Infrastructure (WAPI) standard and the Audio Video Coding Standards (AVS).  
45. The EC identifies here a contradiction with  China’s commitment to increase adoption of 
international standards and reiterates its call for the respective Chinese standardization efforts being 
integrated in established international standardiza tion organizations and consortia.  The EC remains 
committed to supporting all respective activities fro m Chinese standard developing organizations. 
B. STANDARDS FOR MOBILE PHONES  
46. The EC notes a growing trend in Chinese sta ndardisation for mobile phones to regulate in 
detail aspects related to design and quality. 
47. The EC urges China to limit the scope of com pulsory standards to aspects related to the 
protection of public interests such as human health and safety, property, or the environment, and to G/TBT/W/281 
Page 6  
 
  avoid covering aspects that are merely or mostly rela ted to user satisfaction in compulsory standards, 
thereby allowing market forces to dictate the quality of the products.  
48. The EC would like to point out that excessive regulation in the absence of a compelling 
public interest to be protected may not only cons titute a market access barrier but also slow down 
innovation and restrict the choice of innova tive products for Chinese consumers.   
49. The EC is aware that a number of standards are currently being developed by MII in the field 
of mobile telephony on topics such as the size of lithium batteries of mobile phones ( "Specification 
for General lithium batteries of Mobile Telecommunication Terminal Equipment" , YD/T xxxx-xxxx), 
peripheral interface with mobile phones, headset  interface, data exchange format, hearing aid 
compatibility, and so on.   
50. The EC would be grateful if China could explain the purpose of the above standardisation 
programme for mobile phones and whether the standards under development are based on any 
international standard. 
51. The EC would also ask China to confirm that  demonstrating compliance with any of the 
above standards will not become mandatory for m obile phone manufacturers to obtain the relevant 
CCC certificate or Network Access License before placing their products on the Chinese market. 
52. If any of those standards will be a mandatory requirement, the EC expects China to notify 
them before they come into e ffect in accordance with the provisi ons of the WTO TBT Agreement so 
as to provide an opportunity for interested parties to comment. 
V. ICT PRODUCTS 
53. The EC would like to draw China's attention to the following issues: 
A. M
ULTIPLE AND PARTIALLY OVERLA PPING CERTIFICATION PROCEDURES  
54. The EC would like to recall its concerns about the costly and lengthy multiple, and in some 
respect duplicative certification procedures (e.g. on electromagnetic compatibility aspects) managed 
by different authorities, namely the CCC (managed by CNCA) plus the Radio Certificate or Type 
Approval and the Network Access License (both managed by MII).  
55. As far as the EC understands, while the three pro cedures continue to remain separate from an 
administrative point of view, unified testing has been developed in practice by Chinese laboratories 
for the purposes of both the CCC and the Network Acce ss License.  However, separate testing in a 
different laboratory is still required unde r the Radio Certificate procedure. 
56. The EC would like to again urge China to cons ider simplifying the current system by merging 
the existing separate procedures into a single a pproval procedure managed by one authority.  
57. At the least, concrete steps should be take n towards developing unified testing procedures 
under the responsibility of a single body in order to a void any duplication of testing, to reduce costs 
and administrative burdens a nd shorten time-to-market.  
58. The EC understands that the simplification of the certification procedures for ICT equipment 
is being addressed in China's draft new Telecommuni cations Law, which is currently pending before 
the State Council.  The EC would appreciate it if China could provide additional information in this 
regard, including on the possibility for foreign stakehol ders to provide their views into the legislative 
process.   G/TBT/W/281 
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  B. MULTIMODE PRODUCTS  
59. The EC understands that, due to the current leve l of regulation and restrictions on the use of 
certain technologies, the placing on the market of  innovative products havi ng multimode capabilities 
(multimedia, multiradio, etc.) is often impeded as some of the new features are not accepted by the 
Chinese authorities.  
60. This results in the supplier of the equipmen t having to remove specific functions from the 
device (e.g. the WLAN function) in order for it to be placed on the Chinese market. 
61. The EC would urge China to lift the current r estrictions and allow multimode products on the 
market. 
C. TRANSPARENCY AND PREDICTABILITY IN THE DEVELOPMENT AND ENFORCEMENT OF 
TECHNICAL REGULATIONS AND STANDARDS  
62. European industry reports a practice of ve rbal communications between the Chinese 
regulators and the bodies entrusted with the certificat ion and type approval procedures in the ICT field 
regarding crucial issues such as the date of mandato ry application of a standard or changes in the 
technical requirements of the procedures.  This can  give rise to a situation of legal uncertainty and 
actually complicate the regulator's own efforts in ensuring full compliance with the new requirements. 
63. The EC expresses its appreciation for the fact that e.g. in the recent unified charger case 
written notice was given to vendors of the date of mandatory application of the relevant standard. 
64. Building on this positive development, the EC would like to request China to undertake to 
systematically: 
- give public written notice of any regulatory change  in accordance with Article 2.10 of the TBT 
Agreement, and  
 - provide for a reasonable interval between the publication of technical regulations and their 
entry into force in order for economic operators to adapt in accordance with Article 2.11 of the 
TBT Agreement. 
VI. AUTOMOBILES 
65. The EC notes with satisfaction the increased c ooperation with Chinese authorities, which has 
improved both in terms of frequenc y and depth of discussions.   
66. Nevertheless, the EC needs to reiterate its disappointment at the apparent continuous 
broadening and deepening of Chinese regulations.  The EC appreciates the increasing possibilities for 
representatives of the EC and of its automotive sector to be involved in consul tations with the Chinese 
authorities on issues of standards, regulations, and conformity assessment and fully supports the goals 
of regulating safety, health, and environmental conc erns with respect to motor vehicles, which are 
shared by both administrations. 
67. The EC believes that these goals could be well achieved through harmonisation under the 
United Nations 1958 Agreement on Motor Vehicles  (under the Economic Commission for Europe, 
UNECE).  Thus, the EC continues to urge China to  become a Contracting Party to this Agreement, 
and also to work to eliminate the duplicative, costly and burdensome inspections and testing of 
China’s unique ‘CCC’ certification and marking syst em, which seems at present to offer very little G/TBT/W/281 
Page 8  
 
  possibility for non-Chinese firms to perform inspec tions or offer certifications, although there are UN 
and ISO standards for doing so. 
68. In light of the fact that many of China’s regulations in this sector are very similar to UN 
Regulations under the 1958 Agreement, the EC woul d like to pursue full consultation with the 
Chinese authorities at the earliest possible time. 
VII. PHARMACEUTICALS 
69. The EC regrets that no significant progress has been made on the issues raised in the context 
of last year's transitional review.  
70. The EC would therefore like to draw again China’s attention to the following issues: 
A. A
CTIVE PHARMACEUTICAL INGREDIENTS  
71. The issue of active pharmaceutical ingredients (API s) remains of great concern to the EC, in 
particular the fact that each imported API batch in China is subject to routine multi-sampling and 
testing practice carried out by the Port Drug Inspecti on. Systematically batches are sampled and tested 
6-7 times resulting each time in an identical outcome.  
72. The EC urges China to clarify the rationale  for carrying out multi-sampling and testing 
practice on batches that are intrinsically homogeneous  and of consistent quality  throughout.  It should 
also be stated that the homogeneous quality is already guaranteed by the applied manufacturing 
method (ICH (International Conference on Harmonisati on of Technical Requirements for Registration 
of Pharmaceuticals for Human Use)/Q7A Guideline on cGMP for API manufacture) which is one of 
the criteria for receiving a Chinese import registration licence from the State Food and Drug Administration (SFDA) in the first place.  
73. The EC is of the opinion that the practice is not in line with Article 5.1.2 of the TBT 
agreement, which calls for conformity assessment procedures not to create an unnecessary obstacle to 
trade, and with Article 5.2.6, which specifies that  the selection of samples should not be such as to 
cause unnecessary inconvenience to appli cants or their agents.  As the substantial testing costs (from 
20% to 100% of the market value) are to be carried by the products, this practice unnecessarily results 
in increased cost of APIs and h as already, in some cases, acted de facto  as an import ban of valuable 
drugs precursors for Chinese consumers.  In this re gard the EC has a concern that the fee structure 
must not give imported goods less advantageous cond itions of competition than those applicable to 
domestic goods. 
B. N
ON-TARIFF BARRIERS  
74. Some trade impediments originate in a variety of unnecessary, burdensome or costly 
registrations, licensing, certification and reimbursement procedures.  
75. Imported active pharmaceutical ingredients as well as finished medicinal products face 
stricter testing requirements compared to locally manufactured products. 
- It typically takes 6 to 12 months to obtain clinical  trial approval in China, whereas clinical trial 
approval can usually be obtained within  3 months in other major markets; 
 
- medicinal products registration timelines are extremely long and requirements are not always 
clear; 
  G/TBT/W/281 
 Page 9 
 
 
  - one problem relates to the National Reimburseme nt Drug List (NRDL). As the lists are not 
updated annually the most innovati ve products are not included. 
76. In this regard, the EC would be grateful if China could: 
- ensure that imported and locally manuf actured products are treated equally; 
 
- ensure the r egular, systematic updates to reimbursement  lists are made for newly registered 
drugs. 
 
VIII.  COSMETICS 
77. The EC would like to draw China’s attention to the following issues:  
A. PRE-MARKET APPROVAL PROCEDURE FOR NON -SPECIAL USE IMPORTED COSMETICS  
78. Currently, the pre-market approval procedures for non-special use imported cosmetics still 
differ from that of domestic non-special use cosmetic s.  All non-special use imported cosmetics must 
be registered with the Ministry of Health (MoH) prior to importation and sale.  Each shipment of 
imported cosmetics must be inspected at the por t of entry by local Entry-Exist Inspection and 
Quarantine (CIQ) offices. 
79. The MoH pre-market notification procedure and local CIQ inspection procedures delay 
imported non-special use cosmetics into China by 4-6 months, when compared to domestic non-
special use cosmetics.  This measure appears to be  incompatible with China’s obligation pursuant to 
Article 2.1 of the TBT Agreement to accord to pr oducts imported from the territory of any Member 
treatment no less favourable than that accord ed to like products of national origin. 
80. In this regard, the EC would be grateful if China could u nify the notification system currently 
in force for imported and domest ic non-special use cosmetics.  The EC considers that the 
simplification of procedures should be only a first step towards lifting all ex-ante approvals for 
imported cosmetics – regardless of the level (central or regional).  
B. COSMETICS LABELLING SUPERVISION REGULATION  
81. In China, there are currently several regulations and standards related to cosmetic labelling. In 
addition to the National Standard for Cosmetic  Labelling (GB 5296.4-1998), recently the MoH and 
the Administration on Quality Supervision, Inspec tion and Quarantine (AQSIQ) drafted two different 
versions of the Cosmetics La belling Supervision Regulation. 
82. Some sections of the two regulations overlap  and are not consistent with the existing 
regulations and standards for cosmetic labelling whic h are still valid. It will be extremely difficult and 
confusing to comply with two different require ments from two different government bodies at the 
same time.  This will cause huge regulatory di fficulties for both international and domestic 
companies. 
83. The EC urges the Chinese authorities to unify  the multiple cosmetic s labelling supervision 
and standards to facilitate th e manufacturers’ compliance. 
 G/TBT/W/281 
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  C. C
OSMETICS STANDARDS  
84. Presently, MoH and AQSIQ are mandating two different cosmetic standards.  
- MoH is enforcing the Hygiene Standard for Cosmetics 2007. 
 - AQSIQ is using another Hygiene Standard fo r Cosmetics (GB 7916-1987) issued in 1987. 
85. Comparing the two standards, there are many different requirements in terms of cosmetic 
definition, such as a prohibited and restricted ingr edient list. As a result, cosmetic products cannot 
comply with the different requirements. 
86. The EC would welcome a unification of the two di fferent compulsory cosmetic standards that 
are currently mandated by MoH and AQSIQ. 
IX. MEDICAL DEVICES 
87. The EC would like to draw China’s attention to the following issues: 
A. R
EGISTRATION AND RE -REGISTRATION PROCEDURES  
88. Two types of mandatory registration with the same scope of requirements are required from 
SFDA and AQSIQ offering no additional safety benef it for patients and users.  After four years 
manufacturers have to repeat registration not only with SFDA but also with AQSIQ after five years. 
89. In the context of a bilateral meeting with  the European Commission in October 2007 SFDA 
emphasised its willingness to align its provisions with the AQSIQ legislation by prolonging the 
validity of registration from 4 to 5 years, as outlin ed in the draft revision of Decree 276.  The EC 
welcomes this alignment; however, the EC would pref er if unlimited regist ration were supported by 
China. 
90. As a general principle, the EC would sugg est to the Chinese authorities to follow the 
guidelines developed by the Global Harmonisation Task Force (GHTF) for medical devices.  For the ongoing revision of Decree 276 as well as the subseque nt more specific regulation SFDA is urged to 
follow GHTF guidelines as much as possible.  In this  context, the EC also recommends to SFDA to 
adopt the GHTF classification of four categories of medical devices into the new legislation. 
B. S
UPERVISION OF IMPORTED MEDICAL DEVICES  
91. On 29 June 2007, AQSIQ issued Order No. 95 on “The Administrative  Measures on 
Examination and Supervision of Imported Medical Devices” .  Pursuant to this Order, from 1 
December 2007 imported medical devices will be subject to controls and examinations in addition to 
the CCC marking and SFDA approval based on the impor ter’s rating and device risk qualification.  
This new regulation might create unnecessary obstacles to trade resulting from stricter and more time-
consuming procedures for imports (only) than are necessary to assess that a product complies with the 
domestic laws.  
92. In the context of a bilateral meeting with the European Commission in October 2007 AQSIQ 
explained that the aim of Order No. 95 was to sta ndardise inspections and quarantine controls carried 
out by local CIQ offices on Import & Export compan ies dealing with medical devices and to speed up 
customs clearance and strengthen the controls over high risk products. Furthermore, AQSIQ admitted 
that with regard to the current situation of ma jor concerns and misunderstanding of the rules by  G/TBT/W/281 
 Page 11 
 
 
  various stakeholders, some adjustment in its practical implementation (guidelines and product 
catalogue) might be further considered. Howeve r, no formal decision has been made yet. 
93. The EC urges China to announce in an official way the postponement of the effective date of 
the new rules in order to allow sufficient time for feed back and further considerations of details of the 
practicality of all the implementation procedures. 
C. REPROCESSING AND REPROCE SSED MEDICAL DEVICES  
94. The EC urges the Chinese authorities to treat ne w or fully refurbished medical devices in the 
same way.  The EC believes that the ban on refurb ished products is not ju stified.  In Europe, 
refurbished medical devices are subject to the same requirements as new medical devices.  The EC 
urges China to take a similar approach.  
95. In the context of a bilateral meeting with the European Commission in October 2007 AQSIQ 
presented its intention to establish a regulatory framework for refurbished medical devices which 
would allow placing them on the Chinese market  under the same conditions required for new 
products.  The EC welcomes this initiative; however, it is understood that an approval by the Ministry 
of Commerce (MOFCOM) is necessary to change the legal framework for refurbished products.  The 
EC would kindly request the Chinese authoriti es to accelerate this approval procedure.  
X. TEXTILES 
96. The EC would like to draw China’s attention to the following issues: 
A. RAW SILK QUALITY COMPULSORY CERTIFICATE  
97. Raw silk and thrown yarns are subject to qua lity screening and to a compulsory export quality 
certificate before being exported from China.  The te sting costs (up to 2 per cent of value) are borne 
by international buyers whilst in the domestic Chinese market raw silk can be bough freely without 
any quality certificate.  This discriminatory practice and limitation to the export of a raw material has 
been highlighted in the context of last year's tr ansitional review, but no action has been taken by the 
Chinese authorities so far.  The issu e was also raised several times in  meetings between the European 
Commission and the National Development and Re form Commission of China (NDRC), AQSIQ and 
MOFCOM. 
98. In this context, the EC urges China to allow market forces to  operate in its trade in raw 
materials in general and in particular to abolis h the compulsory nature of raw silk testing and 
terminate discriminatory treatment of foreign buyers. 
B. CONFORMITY ASSESSMENT PROCEDURES AND MARKET SURVEILLANCE MECHANISMS FOR 
TEXTILES AND FOOTWEAR  
99. The compliance of textiles, clothing and foot wear products with Chinese standards and 
legislation is verified at the ports and distribution centres.  Additional checks are carried out by Market Surveillance Authorities. Compulsory insp ections are considered by EC operators as 
burdensome.  
100. In this context, the EC would like to recall its requests related to textiles, clothing and 
footwear: 
- Considering that textile, clothing and footwear  products do not constitute a danger to public 
health, the EC would urge China to progr essively replace systematic import commodities G/TBT/W/281 
Page 12  
 
  inspections with random import commodities inspec tions.  Furthermore, whenever appropriate, 
China is urged to accept suppliers’ declarations of conformity as assurance of conformity with 
applicable requirements. 
- To accept ISO standards and take the necessary st eps for mutual recognition of test reports 
issued by international recognised laboratories. 
C. L
ABELLING REQUIREMENTS  
101. Considering that excessive labelling requirements can hinder trade, the EC would like to urge 
the Chinese authorities to simplify labelling requireme nts for textiles and footwear products.  This 
would mean no requirements for any form of prior a pproval registration or certification of labels as a 
condition for allowing the textile a nd footwear goods to be placed on the market.  Furthermore, the 
amount of compulsory information required on labels should be reduced to the minimum necessary.   
XI. TOXIC CHEMICALS 
102. On 1 January 2006, the "Regulations for Environmental Management on the First Import of 
Chemicals and the Import and Export of Toxic Chemicals”  came into force in China.  The severe 
problems that this legislation creates for European  exporters of chemicals to China have been 
discussed several times in different forums since th en.  However, so far no significant improvement 
has been made.  Therefore, the EC has contin uing concerns with regard to this issue.  
103. For these reasons the EC would like to raise the following issues:  
(a) the EC would request more information c oncerning the rational for the list of 
chemicals covered, which goes beyond those chemicals subject to the Rotterdam 
Convention on the Prior Informed Con sent Procedure for Certain Hazardous 
Chemicals and Pesticides in International Trade  and the Stockholm Convention on 
Persistent Organic Pollutants .  The EC would like the Chinese authorities to clarify 
how the relevant risks have been assessed.  The EC would be pleased to receive a copy of the available technical and scientif ic information used as the basis of this 
assessment; 
(b) a clarification of the legislative and operational requirements especially as regards the 
rules on mixtures and articles containing strictly restricted would be also appreciated.  The EC would suggest that China publish gui dance material on the internet in this 
context; 
(c) under the new legislation, the cost of regist ration is 10,000 $.  This registration is 
limited to one supplier and one chemical a nd is valid for only 2 years.  This high 
registration cost is a significant non-tariff barrier.  Since local manufactures of the 
same substances are not affected by these re quirements the EC is concerned about the 
consistency of this legislati on with the TBT Agreement.   
XII. MEASURES ON THE ENVIRONMENTA L MANAGEMENT OF NEW CHEMICAL 
SUBSTANCES  
104. New measures on the Environmental Management of  New Chemical Substances entered into 
force on 15 October 2003. While sharing China’s objectiv e to protect the environment, the EC is also 
concerned about the impact of th is legislation on EC exporters.  G/TBT/W/281 
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  105. The Chinese legislation regarding new chemi cal substances does not provide for reduced 
notification requirements for low volumes (e.g. less than 1 ton) as most other jurisdictions.  As a result, the data requirements for low volume chemicals are very restrictive. 
106. Therefore, the EC would like to ask China wh ether it is considering changing its current 
legislation so that low volume chemicals (e.g. l ess than 1 ton) can benefit from reduced testing 
schemes.  Such a notification scheme would continue to protect health and the environment but also 
allow business to introduce new technol ogy through innovative substances.  
107. The EC also would like to know whether the da ta requirements are comp arable to the OECD 
Minimum Pre-marketing set of data. 
XIII.  FOOD LABELLING. 
108. The EC notes further improvements in food labe lling regulations in China.  However, some 
issues still remain open and require further clarificat ion, notably as regards registration procedures for 
labelling.  The EC continued to be concerned th at there should be a homogenous application of 
registration procedures throughout China. 
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