WRITTEN QUESTION E-3386/03 by Concepció Ferrer (PPE-DE) to the Commission. Chinese type-approval system — non-tariff barrier.
Date: 2003-11-17
Institutions: European Parliament, Provisional data
Subjects: China, EU relations, approval, bilateral relations, industrial product, market access, safety standard, trade restriction

20.3.2004

EN

Official Journal of the European Union

C 70 E/261

(2004/C 70 E/281)

WRITTEN QUESTION E-3374/03

by John Bowis (PPE-DE) to the Commission

(14 November 2003)

Subject: Reclassification of hip, knee and shoulder joint replacements

Has the Commission assessed the scientific justification for its possible forthcoming proposal to reclassify
hip, knee and shoulder replacement devices as Class III medical devices under Directive 93/42/EEC (1) (total
joint replacements are currently classified as Class II b under this Directive), and, in particular, evidence
that might link accidents with such replacement devices with their design? Has the Commission considered
all available studies and the effects of a reclassification on costs, availability and innovation, and what
conclusions has it drawn? In particular, is it aware of the three independent studies commissioned by
Eucomed and completed in October?

(1) OJ L 169, 12.7.1993, p. 1.

Answer given by Mr Liikanen on behalf of the Commission

(18 December 2003)

The Commission,
in cooperation with national authorities, has carefully examined the three studies
forwarded by Eucomed. These are, as stated by Eucomed, independent studies that reflect the views of their
authors, and not Eucomed itself.

In discussions with national authorities, an overwhelming majority emphasised that, in their experience,
clinical data for total joint replacement was often lacking and that changes in design were frequently not
sufficiently verified with regards to their long term effects. In their view, risks associated with recovery
surgery should be minimised as much as possible.

As ever increasingly younger patients receive joint replacements, and in the view of National Authorities,
only the strictest conformity assessment procedures should be followed.

Documents presented in the course of discussions do not suggest that stricter conformity assessment
procedures have a negative impact for patients with respect to cost, availability or innovation.

(2004/C 70 E/282)

WRITTEN QUESTION E-3386/03

by Concepció Ferrer (PPE-DE) to the Commission

(17 November 2003)

Subject: Chinese type-approval system (cid:1) non-tariff barrier

A new Chinese product type-approval system for electrical apparatus and components, electromechanical
products, agricultural machinery, tyres and latex products (which affect human life and health, animals,
is
plants, environmental protection and national security, and which currently affects 132 products,
causing alarm within European industry.

The European Chamber of Commerce in China has uncovered 10 or 12 instances of blocked containers,
long-drawn-out procedures and allegations of problems of intellectual property linked with the new
system.

Did the Commission discuss this issue at its last bilateral summit meeting with China? If not, what does the
Commission intend to do to remove this type of non-tariff barrier and guarantee access to the Chinese
market under fair conditions?

C 70 E/262

Official Journal of the European Union

EN

20.3.2004

Answer given by Mr Liikanen on behalf of the Commission

(16 December 2003)

The Commission is aware of the problems posed by the application of the new Chinese product type-
approval system for European imports.

Up until 2002, two product safety certification systems existed side by side in China.

In fulfilling its World Trade Organisation (WTO) commitments, China unified the existing schemes in
2002 by introducing a single product safety certification system, the China Compulsory Certificate (CCC),
which is applicable as of 1 August 2003 to all products intended for the Chinese market.

The CCC system has, however, been widely criticised by foreign companies.

Aware of the confusion caused by the new system even before it was implemented, the Commission had
brought this matter to the attention of the Chinese authorities on a number of occasions. As a result of
these approaches, the Chinese authorities decided to put back the entry into force of the new compulsory
certification scheme, which was initially scheduled for 1 May 2003, to 1 August 2003.

One month after the introduction of the system, the Commission organised a seminar on the CCC
certification scheme in Beijing,
the European industry
federations concerned (automobiles, machines, electronics) and certifying bodies from the Member States.
This seminar presented an opportunity to draw the attention of the Chinese authorities to the difficulties
encountered by European enterprises in the market and sketched out a number of approaches to remedy
the situation.

in partnership with the Chinese authorities,

These approaches will be analysed by the ad hoc working group set up by the European and Chinese
authorities as part of the EU-China bilateral dialogue on the regulation of industrial products. Its task is to
make it easier to prove that products comply with the safety rules in force in China, and it should bring
together Chinese and European experts, including industry representatives, several times during the course
of this year.

Also, in a recent submission (1) of 7 November 2003 to the WTO Committee on Technical Barriers to
Trade relating to the annual mechanism to review the commitments agreed upon by China on joining the
WTO, the Community asked the Chinese authorities for more details regarding European concerns relating
to CCC certification.

The Commission would like to assure the Honourable Member that it will always keep a close eye on the
conditions governing access to the Chinese market in general, and the application of the CCC certification
system to European enterprises in particular.

(1) Document G/TBT/W/227 of 6 October 2003.

(2004/C 70 E/283)

WRITTEN QUESTION E-3394/03

by Astrid Thors (ELDR) to the Commission

(17 November 2003)

Subject: Cruelty to animals in applicant countries

The history of dancing bears is an old and savage one. In Bulgaria, several dozens bears have been poached
or purchased on the black market and subjected to a harsh training regime. Dancing bears are still
commonplace in Romania as well. The standard method of training involves forcing a thick iron ring
through their nose, which causes considerable pain when yanked. The bears dance in an attempt to avoid
the pain. Alternatively, music is played whilst the bears stands on hot plates, where it will dance to stop
being burnt. It will then dance whenever it hears music. When not performing, the bears are chained up
with little shelter, no exercise and limited food and water. Misguided tourists perpetuate the tradition by
giving money.