WRITTEN QUESTION E-0513/03 by Alexander de Roo (Verts/ALE) to the Commission. Scrap wood and dioxin in meat.
Date: 2003-02-24
Institutions: European Parliament, Provisional data
Subjects: European standard, application of EU law, environmental protection, food contamination, public health, toxic substance, waste incineration, waste management, wood residue

21.11.2003

EN

Official Journal of the European Union

C 280 E/59

Does the Commission believe that it should propose the adoption of corresponding Community legislation
requiring that all pharmaceutical package leaflets be published in three languages, so as to enable citizens
from the remaining EU countries who consume the products concerned to understand what is indicated in
the leaflet and prevent the health risks for consumers which may arise from possible contra-indications?

Answer given by Mr Liikanen on behalf of the Commission

(22 April 2003)

The essential aim of the Community rules governing the production, distribution and use of medicinal
products is to safeguard public health. The information supplied to users has to provide a high degree of
consumer protection, in order that medicinal products may be used correctly on the basis of full and
comprehensible information.

Article 59 of Directive 2001/83/EC (1) requires that the package leaflet shall be drawn up in accordance
with the summary of the product characteristics. For products authorised by the Community, there is a
single product characteristics agreed at Community level that forms part of the Community decision, and
the text of the package leaflet is the same throughout the Union.

In accordance with Article 63(2) of this Directive, the package leaflet must be presented at least in the
official language or languages of the Member State(s) where the product is placed on the market. When
more than one language is used, then all the text must be in each language, and the overall readability of
the label should not be adversely affected. The content of all language versions must be identical.

At the moment, the package leaflet translation into three or more languages is only an option for the
marketing authorisation holder.

The Commission supports any initiative to improve patient information on medicines. Our proposal to
review Directive 2001/83/EC and Regulation 2309/93/EC (2) includes various important suggestions related
to this area. In December 2002, the Commission accepted some Parliament amendments with regard to
increasing the transparency in this field and to make more and better information accessible to patients.
However, no amendment was included by the Parliament regarding the languages of the package leaflet.

(1) Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating

to medicinal products for human use (cid:1) OJ L 311, 28.11.2001.

(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products (cid:1) OJ L 214, 24.8.1993.

(2003/C 280 E/062)

WRITTEN QUESTION E-0513/03

by Alexander de Roo (Verts/ALE) to the Commission

(24 February 2003)

Subject: Scrap wood and dioxin in meat

The incineration of scrap wood in a drying plant in Erfurt (Germany) appears to be the cause of the
presence of dioxin in cattle transport and meat.

A great deal of wood and wood products are treated and impregnated to increase their durability. For this
purpose chlorinated hydrocarbons are often used.

When the treated wood (building waste and scrap wood) is burnt, dioxin is produced.

Is the Commission prepared to curb the incineration of scrap wood and impregnated wood and to permit
this incineration method only in specialised treatment plants, thus prohibiting it from having an effect on
the food chain?

C 280 E/60

Official Journal of the European Union

EN

21.11.2003

Answer given by Mrs Wallström on behalf of the Commission

(3 April 2003)

Incineration of waste, including the incineration of scrap wood is regulated by Council Directive 75/442/
EEC of 15 July 1975 on waste (1), Council Directive 91/689/EEC of 12 December 1991 on hazardous
waste (2), and by Directive 2000/76/EC of the Parliament and of the Council of 4 December 2000 on the
incineration of waste (3).

Directive 75/442/EC lays down in its Article 4 the general principle ‘that Member States shall take the
necessary measures to ensure waste is recovered or disposed of without endangering human health and
without using processes or methods which would harm the environment’. Furthermore, this Directive
provides for establishments or undertakings treating waste to be permitted or under certain conditions to
be subject to general rules adopted by Member States.

Directive 91/689/EEC defines hazardous waste and adds more stringent provisions concerning permitting
of facilities managing hazardous wastes. Commission Decision 2000/532/EC containing the European list
of waste classifies wood containing or contaminated with hazardous substances as hazardous waste.

Additionally, as regards incineration of wood waste which may contain halogenated compounds or heavy
metals as a result of
treatment with wood-preservatives or coating, Directive 2000/76/EC on the
incineration of waste determines stringent operational conditions and emission limit values. This Directive
has entered into force for new facilities in 2002 and will enter into force for existing facilities in 2005.
In the meantime, Council Directive 94/67/EC of 16 December 1994 on the incineration of hazardous
waste (4) is applicable.

Installations who burn more than 10 tonnes hazardous wastes a day are subject to Council Directive 96/
61/EC of 24 September 1996 concerning integrated pollution prevention and control (5). These
installations need to operate in a way that all appropriate preventive measures are taken into account
in particular by applying best available techniques (BAT). BAT means not only the
against pollution,
technology used but as well
It entered into effect for new and
substantially changed installations in October 1999. For the remaining installations it will apply in full in
October 2007.

issues such as proper maintenance.

Furthermore, as regards legislation applying to feed, the introduction of the system of hazard analysis and
critical control points (HACCP) in the feed producing chain which is in the process of being proposed by
the Commission will also reduce the risk of contamination.

The Commission considers that proper implementation of these measures will ensure that incineration of
waste wood takes place without negative impact on human health and the environment.

(1) OJ L 194, 25.7.1975.
(2) OJ L 377, 31.12.1991.
(3) OJ L 332, 28.12.2000.
(4) OJ L 365, 31.12.1994.
(5) OJ L 257, 10.10.1996.

(2003/C 280 E/063)

WRITTEN QUESTION E-0514/03

by Miet Smet (PPE-DE) to the Council

(24 February 2003)

Subject: Women’s rights in Egypt

Cooperation between the European Union and Egypt is based on the Euro-Mediterranean Partnership. This
partnership builds on the Barcelona Declaration, which was signed by the Member States of the EU and
the 12 partner countries from the Mediterranean region. In 2001 the EU and Egypt signed an association
agreement.