WRITTEN QUESTION E-3271/03 by Marianne Thyssen (PPE-DE) to the Commission. The carcinogenic substance bisphenol A in babies' plastic feeding bottles.
Date: 2003-11-05
Institutions: European Parliament, Provisional data
Subjects: analytical chemistry, baby food, chemical product, consumer protection, food safety, health risk, plastics, public health

20.3.2004

EN

Official Journal of the European Union

C 70 E/249

Pending examination of these plans and consultations with the Member States concerned it is premature to
indicate the precise structural measures that may be required. However, such measures may be carried out
within the current financial framework for the financial instrument for fisheries guidance (IFOP).

The Commission is studying various options permitting the Community NAFO fleet to re-organise its
activities, including alternative fishing opportunities. The possibilities needed in this regard will, however,
depend on the content of the fishing plans.

(2004/C 70 E/268)

WRITTEN QUESTION E-3269/03

by Christopher Huhne (ELDR) to the Commission

(4 November 2003)

Subject: Repeal of legislation

How many pieces of legislation (directives, regulations, decisions) have been repealed in each year for the
last five years?

Answer given by Mr Prodi on behalf of the Commission

(20 November 2003)

The number of legislative instruments which are repealed or expire each year are listed in the General
Report on the Activities of the European Union:

(cid:1) 2002 General Report, Point 1095, (http://europa.eu.int/abc/doc/off/rg/en/2002/pt1095.htm);

(cid:1) 2001 General Report, Point 1212, (http://europa.eu.int/abc/doc/off/rg/en/2001/pt1212.htm);

(cid:1) 2000 General Report, Point 1154, (http://europa.eu.int/abc/doc/off/rg/en/2000/pt1154.htm);

(cid:1) 1999 General Report, Point 1036, (http://europa.eu.int/abc/doc/off/rg/en/1999/pt1036.htm);

(cid:1) 1998 General Report, Point 1090, (http://europa.eu.int/abc/doc/off/rg/en/1998/pt0028.htm);

The data are extracted mid-January from the interinstitutional automated documentation system for
Community law, CELEX, and do not include instruments not published in the Official Journal of the
European Union or published in light type (routine management instruments valid for a limited period).

The data are summarised in the table which has been sent direct to the Honourable Member and
Parliament’s Secretariat.

(2004/C 70 E/269)

WRITTEN QUESTION E-3271/03

by Marianne Thyssen (PPE-DE) to the Commission

(5 November 2003)

Subject: The carcinogenic substance bisphenol A in babies’ plastic feeding bottles

On 26 September 2003 an international conference was held in Antwerp, Belgium, on the subject of
fertility. The American scientist and hormone specialist Frederick vom Saal reported, inter alia, on the
results of his research into the health effects of bisphenol A, a chemical which is used, among other things,
in the manufacture of plastic babies’ bottles.

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Official Journal of the European Union

EN

20.3.2004

The research indicated that bisphenol A is more dangerous than was at first thought. It is believed that in
the long term the substance may be implicated in a number of health problems: prostate cancer, fertility
problems in men, and mental conditions such as Parkinson’s disease and ADHD. Breast cancer and
premature puberty in girls are also thought to be possible effects of ingesting this substance, inter alia via
babies’ feeding bottles.

Is the Commission aware of the possible dangers of bisphenol A? If scientific research confirms that the
substance is indeed dangerous, does the Commission not consider that it would be an urgent necessity to
prohibit its use by manufacturers in the making of their product? Does the Commission not take the view
that, failing this, it should make information available to the general public?

Answer given by Mr Byrne on behalf of the Commission

(1 December 2003)

The Commission is aware of the toxicological properties of Bisphenol A. In 1986, at the request of the
Commission, the Scientific Committee on Food (SCF) evaluated this substance. The SCF at that time
established a tolerable daily intake (TDI) of 0,05 mg/kg body weight. On the basis of this opinion,
Directive 90/128/EEC (1) on plastics established a specific limit of migration (SML) of 3 mg/kg of food.
As soon as the Commission became aware that new studies had been carried out on this substance (cid:1)
which include those mentioned by the American researcher Frederick vom Saal (cid:1) the Commission
requested the SCF to review its previous opinion. In its opinion of 17 April 2002, the SCF lowered the
TDI
further data should be provided by industry.
Recognising that further research is currently under development, the SCF recommended the TDI to be
reviewed when new data are available. The SCF also noted that the estimates of consumer exposure are
well below the TDI (0,48 - 1,6 µg/kg bw/day). The Commission intends to ask the European Food Safety
Authority to re-evaluate the substance as soon as these new data become available.

to 0,01 mg/kg body weight and required that

The Commission does not believe that it is necessary to suspend the use of Bisphenol A as the SCF has
established a TDI for this substance. However, on the basis of the SCF opinion of April 2002, the
Commission is proposing an amendment
food
applications in order to lower the SML to 0,6 mg/kg. This proposed amendment will be presented for
opinion to Standing Committee on the Food Chain and Animal Health (Scofcah) in December 2003. If the
proposal receives a favourable opinion by the Committee the new Directive is likely to be published at the
beginning of 2004.

to Directive 2002/72/EC (2)

regulating plastics for

The Commission ensures that all information related to food safety is made available to the public on the
website of the Directorate General of Health and Consumer Protection. In addition, a specific website on
food contact materials has been set up at the following address: (http://europa.eu.int/comm/food/fs/sfp/
food_contact/index_en.html). This site gives access in particular to all the relevant scientific opinions
related to the substances used in the manufacture of plastics for food applications.

Numerous research projects have recently finished (Fourth framework programme projects) or are ongoing
(Fifth framework programme projects), sponsored by the Commission, in which Bisphenol A is one of the
substances, the effects of which have been investigated on wild-life, farm animals and human beings.
The latter includes studies on early life exposure and long term effects. Data from risk assessment will be
made accessible to regulators and should be available in future. More details about these projects can be
found on following website address: (http://europa.eu.int/comm/research/endocrine/index_en.html).

(1) Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come

into contact with foodstuffs, OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990.

(2) Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into

contact with foodstuffs, OJ L 220, 15.8.2002, as rectified by OJ L 39, 13.2.2003.