WORLD TRADE  
ORGANIZATION  G/TBT/W/271 
16 October 2006 
 (06-4963) 
Committee on Technical Barriers to Trade Original:   English 
 
 
TRANSITIONAL REVIEW MECHANISM PURSUANT TO SECTION 18 
 OF THE PROTOCOL ON THE ACCESSION OF THE  
PEOPLE'S REPUBLIC OF CHINA (“CHINA”) 
 
Questions and Comments from th e United States to China  
 
 The following communication, dated 12 October 2006, is being circulated at the request of 
the delegation of the United States . 
_______________ 
  I. TRANSPARENCY 
1. A significant number of technical regulations con tinue to be introduced or amended without 
the advance notification required by the TBT Agreement.   This is particularly the case for regulations 
issued outside the control of the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ).  
2. The vast majority of China’s notifications  are still from AQSIQ and its sub-unit, the 
Standardization Administration of China (SAC).  Few of  the trade-related technical regulations 
promulgated by China’s other ministries (Ministr y of Health (MOH), Ministry of Information 
Industry (MII), State Environmental Protection Administration (SEPA), and the State Food and Drug Administration (SFDA)) are consistently notified to the TBT Committee.  The United States urges 
China to notify the TBT Committee of all draft technical regulations and conformity assessment 
procedures that may affect trade and to provide  a reasonable period for comment and a reasonable 
interval between publication and entry into for ce.  The charts below provide a breakdown of 
notifications by agency.   
   
 
    China TBT Notifications:  2002 - present 
24
84 1 2 1162
21
020406080100120140160180
SAC AQSIQ CNCA MOH MII SFDA SEPA Other China TBT Notifications:  2006 Year-to-Date
5
03
035
1 2 2
0510152025303540
SAC
AQSIQ
MOH
CNCA
SFDAMII
SEPA
OtherG/TBT/W/271 
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  3. The problems relating to transparency, moreover,  are not limited to availability of information 
on new regulations.  Even when information is av ailable on new regulations or regulatory proposals, 
the opportunity for foreign stakeholders to comment  is either limited or does not exist at all. 
4. A recent example illustrat es the United States’ concern about China’s notification practices.  
In both the March 2006 and June 200 6 meetings of the TBT Committe e, several Members including 
the United States expressed concern about new requirements on toxic chemicals in China that had 
entered into force on 1 January 2006, five days  after the measure was announced.  Specifically, 
Members asked China to notify the regulations to  the WTO TBT Committee, provide opportunity for 
comment, and allow a reasonable period of time to comply.  Despite these repeated requests in the Committee and through bilateral channels, China notified the measure on 12 June 2006, with no 
opportunity for comment and no transition period.   
5. The United States continues to urge China to notify the TBT Committee of all draft technical 
regulations and conformity assessment requirements that  may affect trade, and to provide a reasonable 
opportunity for comment and compliance.  
II. INTERNATIONAL STANDARDS 
6. The United States appreciates the information provide d by China last year on the results of its 
review of its existing national standards to ascerta in their relevance to current market requirements 
and alignment with international standards.  We note that implementation documents associated with 
China’s Law on Standards limit its definition of “int ernational standards” to standards issued by the 
International Organization for Standardization (ISO), International Electrotechnical Commission 
(IEC), International Telecommunication Union (IT U) and other international organizations 
recognized and publicized by ISO.  China will recall that in response to questions raised at previous 
TBT Committee meetings, the ISO indicated it did not have in place procedures or criteria to evaluate 
the bodies it had identified in its publication of inte rnational standards bodies.  As noted in previous 
reviews, we remain concerned that China may be unnecessarily restricting itself to the use of 
standards from certain identified bodies.  We appreci ate the explanations that have already been 
provided.  Nevertheless, we recall that the TBT Committee has agreed upon a Decision containing 
principles for international standards (G/TBT/1 /Rev.8, IX) to assist Members in implementing 
relevant obligations in the TBT Agreement.  In  considering future amendments to its Law on 
Standards and/or implementing measures, we en courage China to take these principles into 
consideration.  That being said, we welcome the ser ious efforts that China has made to contribute to 
the development of standards from a broader range of bodies, and we welcome China’s utilization of 
these standards in its domestic regulatory system.  We  encourage China to continue to consider the 
use of these standards from a broader range of bodi es when appropriate for domestic purposes, while 
continuing to take into consideration the principles of G/TBT/1/Rev.8, IX. 
III. CONFORMITY ASSESSMENT PROCEDURES 
7. U.S. suppliers continue to express concerns with the operation of the China Compulsory 
Certification (CCC) system and associated costs.  The United States welcomed the statement by China 
during last year’s transitional review that it was gi ving serious consideration to the concerns Members 
had raised.  China noted that while ensuring th at the goal of safety protection was met, it was 
exploring the possibility of adopting different c onformity assessment procedures, including supplier’s 
declaration of conformity.  Can China provide an upd ate of its review and whether any concrete steps 
have been taken to make adjustments in the light of concerns raised? 
8. The United States understands from information pr ovided at the last review that China’s, 
“Regulations on Certification a nd Accreditation” limit its ability to recognize foreign bodies to 
undertake compulsory certification work to a frame work of mutual recognition agreements (MRAs)  G/TBT/W/271 
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  signed between China's certification and accreditation authorities or authorized bodies under the State 
Council and the foreign counterparts.  In addition,  the Committee was informed that China had signed 
cooperation agreements with more than 20 countries or regions.  Have any of China’s MRAs provided 
for the acceptance of testing or certification pe rformed by competent bodies located in other 
countries?  Has China notified any of these MRAs pur suant to Article 10.7?  Has China considered 
providing alternative approaches to facilitate the acceptance of conformity assessment results from 
bodies located in other countries?   
9. Recently, the United States sought clarificati on from Chinese authorities as to why revisions 
to the “Administrative Measures for Compulsory Pr oduct Certification” issued by the Certification 
and Accreditation Administration (CNCA) had not  been notified to WTO members for comment. 
China’s response was that the revision is a draf t for comment.  This response is troubling as the 
purpose of the WTO notifications is to make othe rs aware of proposed changes and to afford an 
opportunity for comment on them before a final deci sion is taken.  The response creates doubt as to 
whether China will consider comments it receives if  and when it does make a notification to the 
WTO.  Could China please clarify the status of the proposed amendments which have been made 
public but which have not yet been notified pursuant to the TBT Agreement? 
IV. MEDICAL DEVICES   
10. The United States recognizes China’s efforts to e liminate duplication in certification of eight 
categories of medical devices, as stated in Notice Number 70 issued on 30 April 2006 by SFDA and AQSIQ.  However, the United States remains se riously concerned that a number of duplicative 
requirements remain, specifically, two application processes, two application fees, and two on-site 
factory inspections and audits.  At the June 2006 TBT Committee Meeting, China noted that it would 
provide a reply to this concern at the next mee ting of the TBT Committee.  Can China provide an 
update on its plans to eliminate remaining testi ng and certification redundancies for medical devices? 
V. ADMINISTRATION ON THE CONTROL OF POLLUTION CAUSED BY 
ELECTRONIC INFORMATION PRODUCTS (G/TBT/N/CHN/140)  
11. The United States continues to have serious concerns about China’s “Management Measures 
for Controlling Pollution Caused by Electronic Inform ation Products,” scheduled to go into effect on 
1 March 2007.  With less than five months be fore the 1 March 2007 implementation date, no 
measures except a general framework for the propo sal frequently referred to as “China RoHS” regime 
(given its similarity to the Eur opean Union’s regulation) have been notified to the WTO.  It seems 
unlikely that China can implement such a regulatory framework on 1 March 2007 requiring labelling, 
as well as testing and certification of a catalogue of products.  Further, it seems unlikely that a less-
than-five month period provides domestic and foreig n companies, especially those producing products 
not subject to EU RoHS, with sufficient time to research and prepare a detailed hazardous substance 
table to ensure that all products are properly labe lled.  Also, currently there are no details on the 
testing and certification protocols for the catalogue of products. Companies need sufficient time to 
adapt their products or methods of production to the requirements of China.  
(a) The United States is aware of two draft docum ents related to China RoHS that were 
issued by the Ministry of Information Industry but have not been notified to the WTO: (a) “Requirements for Concentration Limits for Certain Hazardous Substances 
in Electronic Information Products”; and, (b) “Marking for Control of Pollution Caused by Electronic Information Products.”  What is their status?  Are they 
available for comment, and if so, why h as China not notified the measures to the 
WTO?  Was notice of their availability p ublished and, if so, when and in which 
publication?  Does China intend to notify th ese two measures to the WTO, provide an G/TBT/W/271 
Page 4  
 
  opportunity for comment, and allow a reasonable period of time to comply?  If not, 
why not? 
(b) Please explain the necessity for China’s requirement for mandatory labelling on all 
products on a lengthy list of electronic in formation products that will apparently go 
beyond the scope of the actual product catal ogue which will require a testing and 
certification process. 
(c) Please provide a list of all laboratories that are currently accredited to perform 
hazardous substance testing for China.  How many more laboratories does China anticipate accrediting? 
(d) Will China accredit for RoHS certification la boratories physically located in China 
that are wholly-foreign owned facilities or majority-foreign owned facilities?  If not, 
why not? 
(e) Will China accredit for RoHS certification bodies located in other countries or 
recognize bodies in other countries which have been accredited by other accreditation bodies?  If not, why not? 
(f) Please provide an update on when the produc t catalogue for products requiring RoHS 
certification will be issued.  
(g) Please reconfirm that the product catalogue will be notified to the WTO and that 
China will allow a reasonable interval be tween the publication of the final product 
catalogue and its entry into force.  
(h) Please provide information on the status of th e testing standards that will be used for 
RoHS certification.  
(i) Will China use relevant internati onal standards for RoHS testing? 
(j) Will China institute a system for Supplier’ s Declaration of Conformity for RoHS 
compliance? 
VI. DISTILLED SPIRITS  
12. In past transitional reviews (e.g., G/TBT/W/ 257), the United States has raised questions 
concerning China’s regulation of distilled spirits.  On 28 August 2006, Chin a notified to the WTO, 
under G/SPS/N/CHN/99, a draft revision on Hygienic  Standard for Distilled Spirits and Swizzle 
(GB2757-1981) for public comment.  We are pleased  that China updated this notification on  
20 September 2006.  The revision “deletes the tole rance for higher alcohol.”  Would China please 
confirm our understanding that this updated notifi cation, would eliminate the requirement for 
tolerance levels of superior alcohols or “fusel oil”?  As stated in the notifi cation, the comment period 
will end “60 days after circulation by WTO Secret ariat”.  By our calculation, comments are now due 
on 15  November 2006 and the standard will be adopte d 30 days thereafter  The final standard will be 
published six months after adoption.  The United States notes China’s statement at last year’s 
transitional Review that it was conducting a stu dy assessing the human health effects of superior 
alcohols.  It appears that scientif ic data gathered in the last y ear has guided China to eliminate 
tolerance levels for superior alcohol s in line with international practice, including the guidelines of the 
Joint UN FAO/WHO Expert Comm ittee on Food Additives, and China has notified its revised 
standard in line with its WTO obligations for publ ic comment and transparency.  The United States 
looks forward to evaluating the final standard th at will be issued after the comment period is  G/TBT/W/271 
 Page 5 
 
 
  complete, and the United States hopes that China’s fina lized standard reflects the intent of the notified 
draft regulation which recognizes that superior al cohols pose no risk for human consumption.  The 
United States appreciates China’s responsive ness to Member concerns on this issue. 
VII. TOXIC CHEMICALS 
13. The United States has continuing concerns a bout China’s issuance of Circular 65 on the 
“Highly Restricted Import/Export Toxic Chemicals List” issued on 27 December 2005 and effective  
1 January 2006.  In addition to th e concerns expressed about notifica tion of the measure in paragraph 
3 above, the United States has several substantive con cerns and related questions  about the measure.   
Many of these concerns were also expressed in U. S. industry comments submitted in response to the 
notification, despite the lack of comment period.  
(a) The required $10,000 registration fee per product, per contract appears to be 
inconsistent with international practice and the fee’s rationale is not explained in the 
Circular.  What is the purpose of the fee and on what basis is it calculated?  Do analogous fees and requirements apply to domestic chemical products?  If not, why 
not?   
(b) China’s Customs is the primary enforcement agency for exporters and importers.  If 
this measure is applied domestically, who is  the enforcement authority for domestic 
producers marketing within China? 
(c) For domestic producers of trichloroethyl ene (HS:  290322000) who sell domestically 
in China, what fees for registration apply?  
(d) The regulation appears to apply to “pure” substances as opposed to mixtures. 
However, there is a concern that mixtures could be captured by this measure if a 
listed substance is identified (by CAS number)  on the mixture’s material safety data 
sheet. Could China confirm that this measure  is not intended to address mixtures?   
(e) The Circular is supposed to implement the obligations of the Prior Informed Consent 
(PIC) and Persistent Organic Pollutants Agreements but seems to go beyond the 
chemicals listed in those agreements to incl ude chemicals widely used in commerce.  
Could China explain the reasoning behind these additional listings and the criteria 
used for including them in the Circular? 
 
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