WRITTEN QUESTION P-3692/00 by John Cushnahan (PPE-DE) to the Commission. The toxic nature of the Shu Gan Wan pill.
Date: 2000-11-23
Institutions: European Parliament, Provisional data
Subjects: competence of the Member States, intra-EU trade, medicinal product, metal pollution

22.5.2001

EN

Official Journal of the European Communities

C 151 E/201

(2001/C 151 E/233)

WRITTEN QUESTION E-3678/00

by Glenys Kinnock (PSE) to the Commission

(29 November 2000)

Subject: WTO waiver

Would the Commission give details of any progress which is being made in consultations to end the
impasse on a WTO waiver for the EU-ACP Cotonou Agreement?

Would the Commission agree that reform of the EU(cid:146)s banana regime and the granting of a WTO waiver
for the Cotonou Agreement are two entirely separate issues, and that ACP countries should not be
penalised by any further delay in dealing with the waiver request?

Answer given by Mr Lamy on behalf of the Commission

(22 December 2000)

The Commission fully agrees with the Honourable Member in that reform of the Community banana
regime and the granting of a World Trade Organisation (WTO) waiver for the Cotonou Agreement are two
entirely separate issues, and that the African, Caribbean and Pacific (ACP) countries should not be
penalised by any further delay in dealing with the waiver request. Indeed, the Commission, representing
the Communities in the WTO council for trade in goods (CTG), has repeatedly stated this very same
argument in its interventions in support of an examination of the request and then the granting of the
waiver.

However, in spite of the concerted efforts of the Community and the representatives of the ACP countries
in the CTG, it has not been possible to break the impasse on a WTO waiver for the Cotonou Agreement.
Some members of the WTO continue to claim all documentation relating to the Agreement has not been
made available since no details are given on the ACP preferential treatment for bananas. These members
have not been convinced by the ACP and Community arguments that the waiver request refers to tariff
preferences for the ACP, which is clearly foreseen in the Agreement, and not to the details of them.

The Commission wishes to underline that this situation has not penalised the ACP since they continue to
fully enjoy their preferential access to the Community without restrictions.

(2001/C 151 E/234)

WRITTEN QUESTION P-3692/00

by John Cushnahan (PPE-DE) to the Commission

(23 November 2000)

Subject: The toxic nature of the Shu Gan Wan pill

Is the Commission aware of the toxic nature of the Shu Gan Wan (or Shu Kan Wan) pill, a traditional
Chinese medicine? The pill is used to treat stomach or liver disorders and contains dangerous levels of
mercury. What action does the Commission intend to take to protect consumers against this health risk?

Answer given by Mr Liikanen on behalf of the Commission

(19 December 2000)

No medicinal product may be marketed in the Community unless it has received a marketing authorisation
and documentation has been submitted to enable its quality, safety and efficacy to be evaluated. Marketing
authorisations are granted either through the centralised procedure for medicinal products from biotech-

C 151 E/202

Official Journal of the European Communities

EN

22.5.2001

nology or for those which are particularly innovative, or through the national procedure. In the former
case, the competent authority is the Commission, and in the latter, it is the authorities in the Member
States.

Though traditional Chinese medicinal products such as Shu Gan Wan or Shu Kan Wan are presented as
medicinal products with therapeutic benefits, they have no marketing authorisation under the (cid:145)centralised(cid:146)
procedure. According to the data available, certain traditional Chinese medicinal products are contami-
nated by heavy metals such as mercury.

Since the Commission is not competent with regard to medicinal products which do not come under the
centralised procedure, the national authorities are responsible for ensuring that only those medicinal
products which have been properly authorised are marketed.

(2001/C 151 E/235)

WRITTEN QUESTION P-3694/00

by Mario Mastella (PPE-DE) to the Commission

(23 November 2000)

Subject: Protection of workers at the work place

Directive 2000/54/EC (1)of the European Parliament and of the Council of 18 September 2000 places
special emphasis on the protection of workers from health and safety risks related to exposure to
biological agents at work.

In this connection, specialists in hygiene and preventive medicine are specifically trained to deal with
health surveillance of workers who are or may be exposed to such agents in their work, especially as
regards adopting all possible preventive measures such as vaccinations.

Once again the question arises, then, of whether specialists in hygiene and preventive medicine can be
employed as medical officers responsible for health and safety at the workplace, thereby taking advantage
of the adoption of the EU directive by all Member States.

Will the Commission therefore say whether it intends to take specific measures to enable specialists in
health and preventive medicine to act as medical officers with responsibility for health and safety at the
work place?

(1) OJ L 262, 17.10.2000, p. 21.

Answer given by Mrs Diamantopoulou on behalf of the Commission

(20 December 2000)

The qualifications required to deal with health surveillance of workers are not referred to in Directive
2000/54/EC of the European Parliament and of the Council on the protection of workers from risks
related to exposure to biological agents at work, which was mentioned specifically by the Honourable
Member, or in any other directive on the safety and health protection of workers, as per Article 16(1) of
the framework Directive 89/391/EEC on the introduction of measures to encourage improvements in the
safety and health of workers at work (1).

In defining the (cid:145)medical officer(cid:146) as the person responsible for the above surveillance, the secondary Italian
legislation determined the qualification required and, as a result, it is within the competence of the Italian
legislature to broaden the range of qualifications, as requested by the Honourable Member.

(1) OJ L 183, 29.6.1989.