WRITTEN QUESTION E-2034/01 by Cristiana Muscardini (UEN) to the Commission. Inappropriate use of botulin.
Date: 2001-07-13
Institutions: European Parliament, Provisional data
Subjects: consumer protection, dangerous substance, market approval, medicinal product, public health, therapeutics

C 40 E/168

Official Journal of the European Communities

EN

14.2.2002

Furthermore, because they imply a guarantee that the item was produced free of exploitation and abuse,
which cannot be verified by testing the product itself, ethical or social labels would require permanent
verification of the workplace which is complex and problematical to implement.

In its Green Paper on Corporate Social Responsibility (1), the Commission has raised these issues and
opened a consultation on the best means to develop, evaluate and ensure the effectiveness and reliability of
corporate social responsibility instruments such as ethical or social labels. A Communication (2) adopted
the same day focuses on promoting core labour standards and improving social governance in the context
of globalisation.

(1) COM(2001) 366 final.
(2) COM(2001) 416 final.

(2002/C 40 E/180)

WRITTEN QUESTION E-2034/01

by Cristiana Muscardini (UEN) to the Commission

(13 July 2001)

Subject: Inappropriate use of botulin

It is apparently becoming increasingly common to treat wrinkles by injecting botulin into the skin. This
substance is known to be highly toxic and can cause irreversible injury to facial muscles. It is banned in
some Member States and other countries for precisely these reasons.

1.

Is the Commission aware of the above practice?

2. What steps, if any, will it take to protect the health of citizens as consumers against such methods,
which damage health as well as impairing physical appearance?

Answer given by Mr Bolkestein on behalf of the Commission

(24 September 2001)

The Commission is aware of the fact that botulin is a potentially dangerous substance.

This substance is defined as a medicinal product. No medicinal product can be put on the market without
having obtained a marketing authorisation. To obtain this, the applicant is required to carry out tests
which demonstrate the quality, safety and effectiveness of the medicinal product. Once the competent
authorities have conducted the evaluation, the marketing authorisation can be granted if the risk/benefit
ratio is favourable. Marketing authorisations are thus granted by the Member States for serious therapeutic
purposes such as the treatment of blepharospasms, facial hemispasms or spasmodic torticollis. These
medicinal products must be medically prescribed and should be used in specialist units.

Given that the substance mentioned by the Honourable Member (cid:129) botulin (cid:129) is a medicinal product, it is
subject to Community regulations concerning the marketing, use, testing and advertising of such products,
particularly Directive 65/65/EC (1).

The Commission is aware of the fact that this substance is used for non-therapeutic purposes, such as the
treatment of wrinkles.

The Commission does not have detailed information on the specific position adopted by each of the
Member States regarding this use of botulin.

14.2.2002

EN

Official Journal of the European Communities

C 40 E/169

In view of the above remarks, the Commission would, however, like to stress that whenever a doctor
prescribes and uses a medicinal product for purposes other than those approved under the marketing
authorisation procedure, the said doctor assumes full responsibility for the prudent use of the substance
and for providing information to the patient.

(1) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation

or administrative action relating to proprietary medicinal products (OJ B 22, 9.2.1965).

(2002/C 40 E/181)

WRITTEN QUESTION E-2035/01

by Hanja Maij-Weggen (PPE-DE) to the Commission

(13 July 2001)

Subject: Human rights situation in Vietnam

Is the Commission aware that the Vietnamese Government is still holding the 83-year-old patriarch of the
United Buddhist Church of Vietnam, Thich Huyen Quang, in prison?

Is the Commission aware that, moreover, the Secretary-General of the churches, Thich Quang Do, was
placed under house arrest for two years on 31 May and that three Buddhist monks, Thich Tam An, Thich
Khong Tahn and Thich Quang Hue, have been arrested?

Is the Commission aware that hundreds of pagodas in Central Vietnam are being blockaded by the
Vietnamese army?

Will the Commission request clarification of the fate of the above people and urge the Vietnamese
Government to respect freedom of religion as a fundamental right of its citizens?

Answer given by Mr Patten on behalf of the Commission

(4 September 2001)

It is understood that the Most Venerable Thich Huyen Quang is not in prison, but remains under house
arrest at a Buddhist pagoda in the Province of Quang Ngai. The Venerable Thich Quang Do is reported to
have been placed under administrative detention for two years from 1 June 2001 by the People(cid:146)s
Committee of Ho Chi Minh, following his public statement of his intention to lead a convoy to Quang
Ngai Province in order to remove Thich Huyen Quang from house arrest and escort him to Ho Chi Minh
City for medical treatment. It is reported that Thich Tam An, Thich Khong Tanh and Thich Quang Hue are
under arrest due to their support for the action announced by Thich Quang Do. It is also reported that, at
the beginning of June, (coinciding with the detention of Thich Quang Do), access to a number of pagodas
was blocked by the local Vietnamese authorities.

The Delegation of the Commission in Hanoi, together with the diplomatic missions to Vietnam of the
Member States, follows closely matters of concern in the field of human rights and participates in all
actions to convey the Union(cid:146)s concern to the Vietnamese authorities. The Commission will continue to
raise particular issues and individual cases of concern in the course of these contacts.

Attention is drawn to the remarks of the member of the Commission responsible for External Relations in
the Parliament debate on religious freedom in Vietnam on 5 July 2001 (1).

(1) H/se asia/Vietnam/2001/EP Replies.