WORLD TRADE  
ORGANIZATION  G/TBT/W/272 
17 October 2006 
 (06-5008) 
Committee on Technical Barriers to Trade Original:   English 
  
CHINA'S
 TRANSITIONAL  REVIEW  MECHANISM  
Communication from the European Communities  
  The following communication, dated 16 October 2006, is being circulated at the request of 
the delegation of the European Communities
. 
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I. INTRODUCTION 
1. The European Communities notes with satisfac tion the increased co-operation between China 
and the European Communities on TBT issues. This is demonstrated by the increased frequency of 
bilateral contacts between the EC and China and th e good functioning of a number of formal co-
operation mechanisms in the TBT field. 
2. This document identifies a number of concerns in  the TBT field, which we will continue to 
discuss with the Chinese in a bilate ral context. The EC also considers it is useful to table these 
concerns in a multilateral context in order to inform other Members of the WTO. 
II. CCC SYSTEM 
3. The EC would like to underline that a positiv e co-operation has been established with the 
competent Chinese authorities which has allowed the EC to raise concerns on the CCC system. 
4. Despite the progress in the implementation of  the CCC system, it remains a burdensome, 
expensive and time-consuming conf ormity assessment procedure.  
5. The EC would like to recall what our main outstanding concerns are: 
(a) The CCC scheme, including its product cove rage, is still unclear, non-transparent and 
leaves room for interpretations. The EC is concerned that China is enlarging the list 
of products subject to CCC marking. The EC  would suggest that low-risk products do 
not need to be subject to the CCC and that  simplified procedures, such as suppliers’ 
declaration of conformity, should be explored. 
(b) Spare parts: components and sub-assemb lies are also subject to mandatory 
certification, even when they are intended for incorporation in a finished product and 
the later will be tested and certified in China. The EC would request China to 
examine how CCC requirements could be simplified. 
(c) Confidentiality:  The information required for the purpose of certification procedure 
should be treated as confidential. In orde r to avoid any disclosure of commercially G/TBT/W/272 
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  sensitive information, the EC suggests th at the CCC information requirements should 
be simplified. 
(d) Factory Inspections:  The EC considers that China should exempt the inspection of 
the manufacturing facilities of the companies having been certified to international standards (e.g. ISO 9001). 
(e) The uncertain application of national treatme nt.  In particular the EC is concerned 
that exemption procedures are not transparent. We would urge China to simplify and standardise the customs clearance for exemption. 
(f) The surveillance for imported products is primarily carried out by the custom 
authorities. This means, that importing manufacturers are affected by an intensive 
control which doesn’t exist for Chinese manufacturers.  
6. As an example, as from June 2007 six categor ies of toys will be subject to the CCC 
certification requirement and toys without a CCC mark cannot be sold in China. To obtain the certificate, the toys will have to pass the test of  “National safety technical code for toys” and “the 
safety for electricity powered toys”. The EC would urge China to reconsider this approach and to 
allow the introduction of SDoc and also to impl ement reasonable market surveillance mechanisms 
(instead of compulsory custom controls). 
7. In summary, technical requirements of the CCC system are not always relevant to the level of 
risk the product poses, which imp lies that the CCC system is more trade restrictive than necessary. 
III. STANDARDIZATION 
Cooperation in the field of standardization between Europe and China is effective. The EC especially 
appreciates efforts on the Chinese side to enhance transparency and cooperation in its standard 
development work – as demonstrated in: 
 
(a) China’s commitment to substantially incr ease the adoption rate of international 
standards 
(b) China’s commitment to play a substantial role in international standardization 
organizations and the rela ted technical committees 
(c) Chinese participation and relevant contribu tions in global standard making consortia 
such as 3GPP 
(d) Chinese participation in international mutual  recognition of testing results such as the 
IECEE/CB scheme. 
8. There is, though, considerable concern about the development of so-called “home-grown” 
standards in China, especially in areas where internationally recognized standards already exist.  The 
EC identifies here a contradiction with China’ s commitment to increase ad option of international 
standards.  Especially in the ICT field the European  industry is confronted with entire families of new 
Chinese standards which substantially differ from ex isting international standards serving identical 
purposes.  The EC prefers to see the respective Chinese standardization efforts integrated in 
established international standardization organizations  and consortia.  The EC is committed to support 
all respective activities from Chinese st andard developing  organizations.  G/TBT/W/272 
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  9. As an example the EC would like to refer to  the WAPI security standard for Wireless LAN 
(WLAN).  In the view of the EC this standard w as developed in isolation and without due regard to 
the relevant international standards.  In additio n the EC is concerned that similar developments 
continue in the Chinese ICT sector in other areas, e. g. with the audio visual  coding standards (AVS). 
10. The EC would like to recall a number of other concerns in the standardisation field: 
(a) Compulsory Standards: 
The Chinese standardization system distinguishes between voluntary and compulsory 
standards. “Compulsory Standards” are a unique feature of the Chinese standardization system and 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 performa nce and interoperability requirements.  
Compulsory standards might create effectiv e trade barriers, especially in cases where 
other international standards favour differ ing technical solutions, or where current 
Chinese standards do not reflect newest technical  developments in this field.  In order 
to reduce the potential of compulsory standards to hinder trade, the EC would urge 
the Chinese side to: 
(i) Create a transparent set of procedures to acknowledge, review and approve 
alternative systems and processes equally  complying with needs of Chinese 
regulators.  
(ii) Restrict compulsory standards to few well defined areas where there is a clear 
public interest for having such standards. 
(b) Participation of European compani es in Chinese Standardisation Work: 
In addition, the EC wants to emphasize that  full industry participation is the key to 
success for any standard development, and ur ges China to increase its efforts in this 
regard. European companies – despite ha ving established operations in China – are 
often excluded from participation in Chin ese Standard Development Organizations 
and their Technical Committees. Contrary to  international practice, Chinese Standard 
Development organizations do not apply the principle of national treatment, by restricting access for “non-Chinese” orga nizations. Exclusion of European 
organizations might also imply that the respective Chinese Standard Development Organizations do not gain access to recent technological developments. 
(c) Standards for Accreditation of Testing Laboratories: 
The EC urges China to fully implement international standards as provided by 
ISO/IEC for the accreditation of China based testing labs.  
(d) Need for greater transparency of devia tions of Chinese standards from corresponding 
international standards: 
Many of the Chinese compulsory standard s are based on ISO/IEC standards, albeit 
often with certain Chinese national devia tions. Another source of difficulty is the 
delay between different versions. Due to  the national standardization process 
(including translation of ISO/IEC standa rds into Chinese), Chinese standards often 
lag 1 or 2 versions behind the ISO/IEC st andards from which they were originally 
derived.  G/TBT/W/272 
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  The EC would request China to consider wa ys to make information regarding those 
national deviations more transparen t and accessible for economic operators. 
IV. ICT PRODUCTS 
11. EU industry reports that the overall approval syst em incurs significant costs and delays due to 
the existence of multiple procedures managed by different authorities. 
12. The Chinese Compulsory Certification (CCC) proce dure is applied to a wide range of the ICT 
and Consumer Electronics Products.  ICT products ar e typically low-risk products that could be 
subject to simplified procedures. 
13. In addition, telecommunications products  (terminal equipment and networking 
interconnecting equipment) and radio communications  equipment have to obtain, respectively, a 
Network Access License and Network Access License plus a Radio Certificate before they can be 
placed on the market. 
14. The EC would like to urge China to consider  simplifying the current system by merging the 
existing separate procedures into a single approval procedure overseen by one authority.  
15. In addition, when a single device contains a combination of features (e.g. GSM and WLAN), 
the current approval process is pending the developm ent of a test procedure for a dual mode product 
although all relevant specifications are available. Th is results in the supplier of the equipment having 
to remove specific functions from the device in order for it to be placed on the Chinese market.  
V. AUTOMOBILES 
16. The EC appreciates that, over the last three y ears, the contacts between our administrations 
have increased in frequency and also in the depth of  detailed discussion.  Nevertheless, the apparent 
broadening and deepening of Chinese regulations remains disappointing.  The EC appreciates the 
increasing possibilities for representatives of the EC a nd of its automotive sector to be involved in 
consultations with the Chinese authorities on issu es of standards, regulations, and conformity 
assessment and fully supports the goals of regulatin g safety, health, and environmental concerns with 
respect to motor vehicles which are shared by both administrations. 
17. 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) and 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 
possibility for non-Chinese firms to perform inspec tions or offer certifications, although there are UN 
and ISO standards for doing so. 
18. 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 from the earliest possible time. 
VI. PHARMACEUTICALS 
19. The EC would like to draw China’s attention to the following issues: 
(a) Active Pharmaceutical Ingredients  G/TBT/W/272 
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  The issue of active pharmaceutical ingredients (APIs) remains of great concern to the 
EC. Specifically the fact that each imported API batch in China remains subject to the 
routine multi-sampling and testing practice carried out by the Port Drug Inspection. Systematically batches are sampled and tested 6-7 times resulting each time in an identical outcome.  
The EC urges China to clarify the rational for carrying out the multi-sampling and 
testing practice on batches that are intrin sically homogeneous and of consistent 
quality throughout?  It should also be stated that the homogeneous quality is already guaranteed by the applied manufacturing method (ICH/Q7A Guideline on cGMP for API manufacture) which is one of the criteria for receiving a Chinese import 
registration licence from the SFDA in the first place.  
In our opinion the practice is not in line with Article 5.1.2 of the WTO/TBT 
agreement which calls for assessment procedures not to create an unnecessary 
obstacle to trade and of Article 5.2.6 which specifies that the selection of samples are not such as to cause unnecessary inconvenience to applicants  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 has 
already in some cases acted de facto as an import ban of valuable drugs precursors for Chinese consumers. 
(b) Non Tariff Barriers 
Some trade impediments originate in a variety of unnecessary, burdensome or costly 
registrations, licensing, certification and reimbursement procedures:  
(a) Imported active pharmaceutical ingredient s as well as finished medicinal products 
face stricter testing requirements compared to local manufactured products. 
(b) It typically takes 6 to 12 months to obtain clinical trial approval in China, as clinical 
trial approval can usually be obtained with in 3 months in other major markets. 
(c) Medicinal products registration timelines ar e extremely long and requirements are not 
always clear. 
(d) One problem relates to the National Reimbursement Drug List (NRDL). As the lists 
are not updated annually the most innovative products are not included. 
In this regard, the EC would be grateful if China could: (a) Ensure imported and locally manufac tured products are treated equally. 
(b) Ensure the regular, systematic updates to reimbursement lists are made for newly 
registered drugs  
VII. COSMETICS 
20. The EC would like to draw China’s attention to the following issues: 
(a) The approval procedures for imported non-special use cosmetics still differ from that 
of domestic non-special use cosmetics. Fo r imported products, a multiple approval G/TBT/W/272 
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  procedure is still compulsory, leading to  extensive workload, misallocation of 
personnel and financial resources and delays  in product introduction to the market. 
This measure is likely to invalidate some  of China’s WTO commitments (national 
treatment obligation). 
In this regard, the EC would be grateful if China could unify the notification system 
currently in force for imported non-special use and domestic non-special use 
cosmetics. 
(b) EC notes with interest that there has been  an important change in authorisation 
procedure in China. It is understood that the approval of the labels of imported cosmetic products has been delegated to local AQSIQ-offices. 
The EC welcomes this decision as one step towards reducing the multiple registration 
requirements for the import of cosmetic products.  
21. However, the EC would like to outline two things: 
(a) First, there is a risk that the decentra lisation of authorisation procedure means 
different practices and interpretations of the applicable rules. Therefore, the EC urges 
China to ensure a uniform application of the existing rules by the different local 
AQSIQ offices and requests explanation how to  ensure such a uniform interpretation. 
(b) Secondly, the EC considers that this should be  only a first step towards a lift of all ex-
ante approvals for imported cosmetics – no matter on which level (central or 
regional). They are impediments to free trade and a disproportionate hurdle for market access for European products. 
VIII.  MEDICAL DEVICES 
22. The EC would like to draw China’s attention to the following issues: 
(a) Double certification 
The Chinese authorities have been requiring doubl e certificates, from third party conformity 
assessment bodies, regarding medical devices. AQSIQ informed the EC  that the Chinese 
authorities were considering enacting legislation requiring a single certification. The EC 
would welcome official confirmation when the impl ementation of that legislation will start, as 
well as the official text where such provisi ons are laid down. We would also welcome 
clarification concerning a single test procedure. 
 
(b) Reprocessing and reprocessed medical devices 
The EC urges the Chinese authorities to treat ne w or fully refurbished medical devices in the 
same way. The EC believe that the ban on refu rbished products is not justified In Europe 
refurbished medical devices  are subject to the same requirements as new medical devices and therefore are safe once they bear the CE mark. The EC would urge China to take a similar 
approach.   G/TBT/W/272 
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  IX. TEXTILES 
(a) Raw Silk Quality Compulsory Certificate 
CIQ (regional branches of AQSIQ) carry out export quality tests of raw silk and thrown yarns 
and provide a compulsory certificate of silk qua lity which is required before the raw silk can 
be exported from China. According to the Eur opean Silk industry, domestic buyers of raw 
silk are not obliged to have or pay for this cer tificate whilst international buyers have to pay 
for the test/certificate (up to 2% of the value) . EU industry claims that this quality control 
does not provide any real quality insurance as th e testing methods are not in line with modern 
industrial requirements for silk use. China benefits from a virtual monopoly in the silk 
market, so the European industry has no real alternative sources of supply.  
Raw silk testing seems to be a discriminatory pr actice, a way to limit raw material export and 
to distort its price as it constitutes a de facto export tax. 
The EC would encourage China to allow market fo rces to operate in its trade in raw materials 
in general and in particular to abolish the com pulsory nature of raw s ilk testing and terminate 
discriminatory treatment of foreign buyers. 
(b) Conformity assessment procedures and market  surveillance mechanisms for textiles and 
footwear 
All imported textile and footwear products ar e subject to the compulsory Chinese National 
General Safety Technical Code for textiles (G B 18401-2003) and several other standards for 
footwear products. The compliance of products with Chinese standards is verified at the 
borders. Additional checks are carried out by Market Surveillance Authorities. 
In this context would like to recall its request s related to textiles, clothing and footwear: 
(i) The EC would urge China to progressively replace customs controls at the 
border controls since double checking for imported goods is discriminatory. 
(ii) To accept ISO standards and take the necessary steps for mutual recognition 
of test reports issued by international recognised laboratories.  
(c) Labelling requirements 
China informed the EC that they have compul sory specifications for clothing marking (GB 
52964/1998) and that all garment products sold in  the market have to have information on: 
name of the product, size, composition, washi ng instructions, life span, quality control n°, 
name and address of manufacturer, etc. However, according to the MAIA study, China does not have particular requirements for la belling of leather and footwear products. 
In this context, and considering that excessive  labelling requirements can hinder trade, the EC 
would like to urge the Chinese authorities to si mplify labelling requirements at international 
level for textiles and footwear products. Idea lly this would mean no requirements for any 
form of prior approval or registration of la bels as a condition for allowing the textile and 
footwear goods to be placed on the market, a nd for the reduction of the information required 
in permanent labels.  
 G/TBT/W/272 
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  X. TOXIC CHEMICALS 
23. With regard to the Chinese “Regulations for Environmental Management on the First Import 
of Chemicals and the Import and Export of To xic Chemicals” of 1 March 1994, the Chinese 
authorities amended, on 27 December 2005, the relevant  annexes: list of severely restrictive toxic 
chemicals (SEPA announcement 65/2005) repl acing SEPA announcement 83/1993 and 29/2005. In 
addition, the Chinese authorities submitted on 31 December 2005 a list of toxic chemicals banned in 
the PRCR (Chinese Customs Announcement 116/2005). Both new lists entered into force on 1 
January 2006 and contain an extended list of chemicals. 
24. So far, China has notified only SEPA announ cement 65/2005 under the TBT Agreement, 
while a notification as regards the Chinese Cust oms Announcement 116/2005 is still expected. As 
both lists have entered into force, one only four da ys after being published, tr ading partners could not 
properly respond and adapt to the new situation. As a result, shipments that have been sent to China in 
good faith have been blocked at the Chinese border. 
25. For these reasons the EC would like to raise the following issue:  
(a) The EC would request more information concerning the rational for the list of 
chemicals covered, which goes beyond those chemicals subject to the Rotterdam PIC 
Convention and the Stockholm Convention on Persistent Organic Pollutants. The EC 
would like the Chinese authorities to clarif y how the relevant risks have been 
assessed. The EC would be pleased to receive a copy of the available technical and scientific information used as the basis of this assessment; 
(b) A clarification of the legislative and ope rational requirements especially as regards 
the rules on mixtures and articles containing strictly restricted would be also 
appreciated; The EC would suggest that China publish guidance material on the internet in this context. 
XI. MEASURES ON THE ENVIRONMENTA L MANAGEMENT OF NEW CHEMICAL 
SUBSTANCES  
26. 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 EU exporters. 
27. Article 8 determines the data requirements fo r newly produced or imported chemicals in 
China. However, there is no detailed specification regarding these data requirements. The EC would 
therefore like to ask which data requirements are ac tually applicable. Additionally, the same data 
requirements are applied for chemicals in any qua ntity. As a consequence, the data testing 
requirements for low volume samples could be very  significant, including the requirement to conduct 
some of the environmental studies in China.  
28. The EC would like to ask China whether ther e are reduced testing schemes for low volume 
chemicals. This would aim to develop a notificati on scheme that continues to protect the health and 
environment but also allow business to introduce new technology through in novative substances.  
29. The EC also would like to know whether the da ta requirements are comp arable to the OECD 
Minimum Pre-marketing set of data.  G/TBT/W/272 
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  XII. FOOD LABELLING 
30. The EC notes that some improvement has been  made on food labelling. However, some 
issues still remain open and require further clarificat ion, notably as regards registration procedures for 
labelling. The EC is concerned that there shoul d be a homogenous application of registration 
procedures throughout China. 
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