92000E1234

WRITTEN QUESTION P-1234/00

by Karin Scheele (PSE) to the Commission

(10 April 2000)

Subject: The softener diethylhexyladepate in PVC

In the retail food trade in Austria, food items available for self-service, such as cheese in portions are generally wrapped in cling-film (which may be made from PVC) to keep them fresh. These PVC films

contain the softener diethylhexyladepate, which is suspected of being dangerous to health. In some cases this softener is added to foodstuffs, particularly those with a high fat content.

Commission Directive 89/109/EEC of 21 December 1989(1) (as amended by Dir. 95/3/EEC(2)), relating to materials and articles intended to come into contact with foodstuffs, sets a general limit value of 60 mg/kg. A study carried out by the Salzburg (Austria) food research institute showed, however, that this value was exceeded in 73 % of cases, sometimes by up to four times the acceptable daily intake.

1. Has the Commission recently carried out or ordered any studies on possible health risks of diethylhexyladepate, or has it any plans to do so in the near future? If studies already exist, what were the results of these studies?

2. Has the Commission considered the possibilities of banning PVC films (particularly those containing the softener diethylhexyladepate) as food packagings?

3. Is the Commission planning to prescribe a particular limit value for diethylhexyladepate? If so, what limit value does it propose?

(1) OJ L 40, 11.2.1989, p. 38.

(2) OJ L 41, 23.2.1995, p. 44.

Answer given by Mr Byrne on behalf of the Commission

(10 May 2000)

1. The Commission is aware of the problem of migration of plasticisers into fatty foodstuffs, and has therefore requested the advice of the scientific committee on food (SCF) on the toxicity of diethylhexyladipate (DEHA). The SCF is the scientific committee which deals with all issues related to food contact materials. The SCF, in its session of 16 December 1994, established a tolerable daily intake (TDI) for this substance of 0,3 milligrammes per kilogramme body weight (mg/kg b.w). This means that a 60 kg person can tolerate daily during his lifetime a dietary exposure of 18 mg DEHA. Two studies were carried out by the Ministry of agriculture, food and fisheries (MAFF) of the United Kingdom to estimate the real exposure of the consumer, by taking into account the level of DEHA in the daily diet in the United Kingdom. Both surveys indicated that the estimated exposure of the consumer was lower (and in the second survey, substantially lower) than the tolerable value established by the SCF.

2. No. A ban on polyvinyl chloride (PVC) films (particularly those containing the softener diethylhexyladipate), does not appear justified on the basis of the available scientific evidence at present. However, the Commission will continue to monitor developments in this area.

3. Yes. The Commission is preparing a new amendment of Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs(1) to regulate the specific migration of DEHA. It is premature at this stage to indicate the future value of the specific migration limit. In fact, the consultation of the interested parties (Member States, enforcement laboratories, etc.) is not yet finished, and other statistical data are expected which may affect the estimation of the real exposure and the Commission position on this issue.

(1) OJ L 75, 21.3.1990.