EN Official Journal of the European Union CE 84/513

(2004/C 84 E/0591)

WRITTEN QUESTION E-3964/03

by Hiltrud Breyer (Verts/ALE) to the Commission

(5 January 2004)

Subject: Endocrine disrupters in drinking water — reaction to the Commission's answer to Written Question E-2565/03

In a number of Länder of the Federal Republic of Germany, research has been carried out into endocrine-disrupting compounds (EDCs). The Commission, too, has had similar studies drawn up. It is, therefore, widely known that phthalic acid esters (plasticisers) are passed into drinking water from the pipe system. Deep-well readings confirm the ubiquitous presence of plasticisers. Various plasticisers are not classified as genetically harmful, but they do damage testes, kidneys and liver. In animal experiments, they have been shown to damage reproductive capacity and interfere in genital development. A new study carried out by the University of Erlangen shows that the absorption of DEHP (a plasticiser) is significantly higher than had been assumed hitherto. The Federal German Risk-Assessment Institute has drawn the findings of that study to the attention of the European Chemicals Bureau.

1. How is the Commission intending to protect European consumers, both male and female, in application of the precautionary principle?

2. Is the Commission planning to introduce limit values?

Answer given by Mrs Wallström on behalf of the Commission

(8 March 2004)

The need to regulate endocrine disraptors in drinking water was discussed in the Seminar on Drinking Water organised by the Commission on 27/28 October 2003, with participation by Member States, the scientific community and non-governmental organisations (NGOs). The seminar concluded that it is not possible to set limit values for individual EDCs in the Drinking Water Directive (1) at this point, as knowledge needed to evaluate the potential human health risk is insufficient. Sufficient and reliable data on the occurrence of EDCs in both raw water and drinking water are not yet available and validated bioassays for screening the total potential effects of EDCs are lacking. More data are needed to evaluate the risk of human consumption of drinking water, especially at places with high risk factors for pollution.

There is evidence of the release of EDCs from materials to drinking water/bottled water. Such products and materials used for storage and distribution of water intended for human consumption that are permanently incorporated in construction works are regulated and fall within the scope of the Construction Products Directive (CPD) (2) and are referred to in the Drinking Water Directive (DWD). The issue is currently addressed within the work done for the establishment of a ‘European Acceptance Scheme’ (EAS) under the CPD Directive. The EAS is intended to be a single system of regulatory framework and of supporting test methods covering the acceptance of construction products used in contact with water intended for human consumption.

However, as far as the possibility that phthalates are passed into drinking water from the pipe system is concerned, the Commission does not have evidence to this effect. Water pipes made from PVC consist of hard PVC, which is normally not plasticized by the addition of plasticisers.

Regarding phthalates (plasticizers), a series of five risk assessments has been initiated by the Commission under the Existing Substances Regulation (3). Three risk assessments have in the meantime been finalised and are available on the web site of the European Chemicals Bureau (4). The Commission is now in the process of developing risk reduction strategies. Possible restrictions need to be based on the outcome of the risk assessment and must be scientifically defendable, while taking into account the precautionary principle.

For two phthalates, DEHP and BBP, the risk assessments have not yet been finalised. In the case of DEHP, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) has recently published an opinion on the results of the draft risk assessment (5). The draft risk assessment will now be revised by the rapporteur in the light of this opinion. The revision is also likely to affect the risk characterisation for man exposed indirectly via the environment, which will allow the Commission to draw a conclusion if, and under which circumstances, there is a risk from DEHP as an endocrine disrupter.

Future limit values for the total potential endocrine effects can only be proposed once validated analytical tools are available. A safe level for the total of EDCs should be based on toxicological data and bioassay values for total EDC potency.

(1) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, OJ L 330, 5.12.1998.

(2) Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the member States relating to construction products, OJ L 40, 11.2.1989.

(3) Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances, OJ L 84, 5.4.1993.

(4) http://ecb.jrc.it/existing-chemicals/

(5) Adopted by the CSTEE during its 41th plenary meeting on 8 January 2004; http://europa.eu.int/comm/health/ph_risk/committees/set/documents/out214_en.pdf