EN Official Journal of the European Union CE 70/249

(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.

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 — which include those mentioned by the American researcher Frederick vom Saal — the Commission requested the SCF to review its previous opinion. In its opinion of 17 April 2002, the SCF lowered the TDI to 0,01 mg/kg body weight and required that 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.

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 to Directive 2002/72/EC (2) regulating plastics for 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.

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/ foodcontact/indexen.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.