WORLD TRADE
ORGANIZATIONG/TBT/W/227
6 October 2003
(03-5246)
Committee on Technical Barriers to Trade Original:  English
TRANSITIONAL REVIEW MECHANISM PURSUANT TO PARAGRAPH 18
OF THE PROTOCOL ON THE ACCESSION OF THE PEOPLE'S
REPUBLIC OF CHINA ("CHINA")
Submission by the European Communities to the TBT Committee
1. The EC is transmitting comments and questi ons well in advance of the TBT Committee
meeting of 7 November 2003 in order for the Chinese authorities to reply and to complete any
information that may be incomplete.
2. Once the information to be provided by China in accordance with paragraph 8 and Annex 1A
of its accession protocol has been received, the EC might come back with additional questions.
3. The EC appreciates that the Chinese authorities have organised seminars open to government
officials and industry to handle questions addr essed by the EC in its submission G/TBT/W/182, in
particular with respect to food labelling, cosmetics and the new certification system (CCC).  However,
there are still issues requiring further clarification.
4. EC’s comments and questions relate to the following items: CCC system, automobile,
cosmetics, food labelling and pharmaceuticals.
I. CCC SYSTEM
5. The China Compulsory Certification system is a step forward compared to the previous
conformity assessment scheme.  At the seminar on the China Compulsory Certification system, which
was held in Beijing in September 2003, the China National Certification Administration (CNCA)
provided several useful explanations.  However, a number of issues are still a matter of concern for
the EC.
• As a general remark, the EC would like to emphasise that National Treatment should be
ensured in the implementation of the new Compulsory Certification system.
6. The list of products subject to mandatory certification (the First Catalogue of Products
Subject to Compulsory Product Certification) includes spare parts and components, unless they are
incorporated in whole machines.  This creates trade difficulties, especially when spare parts aresupplied separately for the purposes of repair or maintenance, or when components are assembled in
China.  In this context, the EC would be grateful if China could:
• grant spare parts and components an exemption, following a procedure as clear and
easy as possible;
• in any event, avoid that end products and their components are subject to separate
certification;
• make it clear with which authority the ultimate decision lies as to whether or not the
mandatory certification is required, in cases of uncertainty.G/TBT/W/227
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7. The scope, the procedure and the related costs of conformity assessment fees are another
matter for concern.  Reportedly, fixed fees (covering the application, licensing and checking of
accompanying English documents) are rather expensive.  Conversely, conformity assessment fees
vary considerably according to the specific product conformity assessment.
• China is requested to clarify whether fees reflect the real cost of certification and do not
discriminate between domestic and imported products.
8. Conformity assessment procedures can include so-called factory inspections, where Chinese
auditors perform on the spot checks at the manufacturer’s premises.  The related costs ($ 3.000, plus
the auditors’ travel expenses) are charged to the importer, i.e. on the EC producer.
The EC would like to ask China to:
• specify if and when these inspections are compulsory;
• ensure that local manufacturer of like produ cts are subject to similar treatments and
conditions.
9. As well as other information, the Chinese authorities require, as part of the procedure,
detailed technical documentation.  Given the potential risks for the intellectual property rights, the
protection of confidential is a matter of concern.
• The EC would like to know which procedures  have been implemented to ensure that
confidentiality of technical information about products is dealt in a manner that
legitimate commercial interests are protected at both national and local levels.
10. Another issue that requires clarification is the recognition of different conformity assessment
procedures.  In this context, the EC would be grateful if China could:
• confirm whether products already certified according to the previous regime
(for instance, CCIB certification) need to undergo the new certification system;
• explain how far foreign conformity assessment will be taken into consideration in the
Chinese procedures, notably in sectors where similar requirements apply.  Theautomotive sector described below is a good example.
II. AUTOMOBILE
11. With regard to automobiles, one of the major problems seems to be that China is not part of
the UN/ECE revised 1958 Agreement on world harmonisation of automobile regulations.
12. As a consequence, China does not accept the UN/ECE approval marks although they are
based mainly on the same international standards applie d by China (for instance tyres, safety belts and
safety glass).  The comparison between the Chinese regulation and the European regulation in those
sectors shows that the texts are almost identical.
• The EC is deeply concerned about the significant hurdles, which are caused by the
repetition of tests for several parts and/or components, and wonders whether China iswilling to accept the results of foreign conformity assessment procedures based on
practically the same standards.
13. Another trade obstacle comes from the so-called Unit Classification Guidelines issued by the
Chinese authorities, since they deviate from international practices.  For instance, identical products
manufactured in different plants must have different certificates.  Separate applications are requiredG/TBT/W/227
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depending on engine power and displacement, while these two features do not influence safety-related
items.
• The EC strongly recommends that China accede to the 1958 UN/ECE Agreement and
consequently sign up to the majority of the existing Geneva regulations.
14. It would avoid unnecessary trade barriers such as, for example, the recent Chinese notification
(G/TBT/N/CHN/26) on the protection of the occupants of a passenger car, in the event of a frontal
collision, which deviates from the corresponding UN-ECE regulation.
III. PHARMACEUTICALS
15. With regard to pharmaceuticals, the main issues at stake are the hurdles encountered by
EC producers for active pharmaceutical ingredients (API) when exporting to China.
16. Considerable progress has been achieved from a formal-legal point of view, by means of the
repealing of Article 15.5 of the Chinese “Provision Governing Import Drugs”.  However, in practiceChinese authorities still require quality standards on imported products that are higher both compared
to the domestic product standard and compared to international standards.
• The EC would be grateful if China could ensure that the national authorities implement
the newly enacted rules in conformity with the requirements stemming from theWTO – TBT Agreement.
17. Furthermore, according to industry sources, domestic producers only have to meet the
requirements established in the Chinese pharmacopoeia, whilst EC exporters have to meet at least the
same standards of other APIs previously registered.
18. Moreover, when applying for an import drug licence registration (IDL) for a new API, the
exporter does not know the internal specifications required by the State Drug Administration (SDA)for each product.  Those specifications are frequent ly changing (getting stricter) without any external
communication or consultation about the changes.
• China is requested to ensure consistency of standards used for APIs in the
IDL requirements and to respect the transparency obligations set in Article 2.9 of theAgreement.
IV. COSMETICS
19. At the present time, importers have to file an application to the Ministry of Health to obtain a
pre-market registration, which is lengthy (6-9 months), onerous (between $ 1300 and $ 3200) and
requires the disclosure of confidential data (formula or manufacturing process).  On the other hand,
domestic producers simply notify the local authorities two months after the launch of the product.
• The EC asks China to ensure that, in line with its WTO commitments, this
discrimination be ceased forthwith.
20. In addition, the Administration for Quality Supervision and Inspection and Quarantine
(AQSIQ) requires a pre-import registration for impor ted cosmetics.  This procedure is expensive,
takes time and for products marketed outside Beijing it must be repeated at local level.
• The EC would appreciate it, if China could phase out the current double registration
system for imported cosmetics.G/TBT/W/227
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21. Another matter of concern is the labelling.  For the time being, new products are required to
bear a label that gives a literal translation of th e original label.  However, sometimes the Chinese
authorities oppose the assertions and advertising on the label.  With specific reference to the
advertising, there are several provisions sometimes contradicting each other.
• The EC requests China to reconsider its legislation on labelling and advertising in order
to achieve transparency, compliance with global practice and a rule-based system.
22. Finally, as it is known, the EC has already made specific comments in its SPS Committee
with regard to restrictive measures adopted in relation to BSE emergency.
23. In this context, fruitful dialogue between China and the EC has already brought about the
de facto  removal of BSE-related trade impediments.
• The EC asks the Chinese authorities to formally endorse the important achievements in
this field.
V. FOOD LABELLING
24. The EC notes that a very constructive seminar on food labelling was organised in Beijing on
15 July 2003.  The seminar was open to officials and industry representatives.  The meeting allowed
for the clarification of a number of issues.  However, many issues still remain open and require further
clarification, notably as regards registration procedures for labelling.  In this context, the EC wouldask China to:
• ensure that registration procedure for a label be no more time-consuming than
necessary (currently, it takes more than 90 days);
• apply transparent criteria for the approval of labels.  In particular, the best before
indication for wines and spirits should follow international practice;
• allow economic operators to decide how to present the required Chinese-language
information on the product label(s) as long as the objective of consumer information is
met;
• accept that approved labels are attached after the goods enter China, but before the
AQSIQ inspection takes place;
• clarify the labelling requirements for products in ‘large-scale’ or bulk packaging;
• guarantee that only the trademark owner/producer could apply for the label, in order to
protect products against counterfeiting.
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