WRITTEN QUESTION E-0790/04 by Roberto Bigliardo (UEN) to the Commission. Presence of dangerous dioxin in the town of Acerra (Na), Italy.
Date: 2004-03-11
Institutions: European Parliament, Provisional data
Subjects: Campania, environmental protection, food contamination, milk, public health, sheep, toxic substance

8.4.2004

EN

Official Journal of the European Union

C 88 E/223

In the light of the above, the Commission takes the view that the amendments to Regulation (EC) No 753/
2002 are in line with the rules on consumer protection and do not encourage international piracy or
imitation.

(1) Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council
Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine
sector products, OJ L 118, 4.5.2002.

(2) Commission Regulation (EC) No 316/2004 of 20 February 2004, OJ L 55, 24.2.2004.
(3) Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine,

OJ L 179, 14.7.1999.

(2004/C 88 E/0227)

WRITTEN QUESTION E-0790/04

by Roberto Bigliardo (UEN) to the Commission

(11 March 2004)

Subject: Presence of dangerous dioxin in the town of Acerra (Na), Italy

In March 2003, a set of analyses of milk from ewes grazing in roaming pasture in Acerra, a populous
town in the Province of Naples, Italy, which went unpublished until October 2003, made some disturbing
findings, recording a presence of dioxin of 12 pg, compared with the 3 pg limit set by the law.

In the face of such alarming data that demonstrates the existence of serious environmental damage, the
Campania Region, which is responsible for monitoring and the relevant provisions, has remained deaf to
all requests by the Acerra town authorities to carry out the necessary land reclamation.

The relevant local health authority for the area has taken no action.

The situation is currently extremely dangerous for the population (around 50 000 inhabitants) of the town.
The latest analyses carried out by the Mario Negri Institute in Milan have revealed unimaginable levels of
dioxin in milk from the same ewes: 50 pgTe/g.

This is an astonishing and highly serious statistic, unprecedented in the area, showing dioxin traceability in
the area at the level of serious pollutants, which was duly reported to the Public Prosecutor’s Office in Nola
on 31 October 2003 by local political representatives of Alleanza Nazionale.

Given that I have already written to the Chairman of the Committee on Petitions requesting a proper study
of the objective environmental situation in and around Acerra, can the Commission call on the Campania
Region to safeguard the environment and, with it, the life of tens of thousands of people living there?

Answer given by Mrs Wallström on behalf of the Commission

(30 April 2004)

The Commission was informed of this contamination case on 26 March 2003 and the information was
distributed to the competent authorities of the other Member States through the Rapid Alert System for
Feed and Food on 28 March 2003. The contamination was detected by analysing sheep milk samples
taken in application of the monitoring plan provided for in Council Directive 96/23/EC of 29 April 1996
on measures to monitor certain substances and residues thereof in live animals and animal products (1).
The levels found exceeded significantly the maximum levels for dioxins established by Commission
Regulation (EC) No 466/2001 of 8 March 2001 setting maximium levels for certain contaminants in
foodstuffs (2), as amended by Council Regulation (EC) No 2375/2001 of 29 November 2001 (3).

C 88 E/224

Official Journal of the European Union

EN

8.4.2004

In accordance with Commission Recommendation 2002/201/EC of 4 March 2002 on the reduction of the
presence of dioxins, furans and dioxin-like PCBs in feedingstuffs and foodstuffs (4) investigations were
initiated to identify the source of contamination and to take measures to reduce or eliminate the source of
contamination. The investigations revealed that one of the causes of the contamination could be the
uncontrolled burning of materials that have been dumped in the countryside.

Following the information provided by the Italian authorities, the contamination was limited to parts of
the province Caserta and to adjacent municipalities in the northern part of Naples. The affected areas were
demarcated. No commercial animal
feed was found with dioxin levels above the maximum levels
established in Directive 2002/32/EC of the Parliament and of the Council of 7 May 2002 on undesirable
substances in animal feed (5) as amended by Commission Directive 2003/57/EC of 17 June 2003 (6).

The Italian authorities have provided guarantees:

(cid:1) to eliminate/remove the mentioned source and to undertake further investigations to identify possible

other sources and to rehabilitate the areas contaminated,

(cid:1) to eliminate the possible sources of contamination,

(cid:1) to continuously monitor the environment, farms, the feedingstuffs used and the products in the

affected areas,

(cid:1) to withdraw contaminated products from the market and to destroy them under controlled conditions.

Given these guarantees and should all the above-mentioned measures be strictly applied, the Commission
is of the opinion that the measures are sufficient to protect public health and the environment.

(1) OJ L 125, 23.5.1996.
(2) OJ L 77, 16.3.2001.
(3) OJ L 321, 6.12.2001.
(4) OJ L 67, 9.3.2002.
(5) OJ L 140, 30.5.2002.
(6) OJ L 151, 19.6.2003.

(2004/C 88 E/0228)

WRITTEN QUESTION E-0794/04

by Paul Rübig (PPE-DE) to the Commission

(11 March 2004)

Subject: Regulation (EC) No 141/2000 on orphan medicinal products

In connection with Regulation (EC) No 141/2000 (1) on orphan medicinal products, we request
clarification on the following questions:

1. Can a medicinal product continue to be designated as an orphan drug if, after it has been designated
as such but before it has received centralised authorisation, other medicinal products containing partly
the same and partly different active ingredients are granted national authorisation in several Member
States to treat the same condition?

2. Can a medicinal product continue to enjoy orphan drug status if the Committee for Proprietary
Medicinal Products (CPMP) has granted approval for its use as a second-line treatment only and the
first-choice drug is not authorised in all Member States?

3. Does the registration by one sponsor of an active ingredient for use as a second-line treatment prevent
another sponsor from obtaining the designation of the same active ingredient as an orphan drug for
use as a first-line treatment?

4. Can a sponsor apply for an active ingredient

to be designated as an orphan drug if national
authorisation has already been granted to an identical medicinal product manufactured by another
pharmaceutical company?