WRITTEN QUESTION E-3964/03 by Hiltrud Breyer (Verts/ALE) to the Commission. Endocrine disruptors in drinking water — reaction to the Commission's answer to Written Question E-2565/03.
Date: 2004-01-05
Institutions: European Parliament, Provisional data
Subjects: chemical product, drinking water, environmental standard, food safety, health legislation, hormone, precautionary principle, public health, toxic substance, toxicology, water analysis

3.4.2004

EN

Official Journal of the European Union

C 84 E/513

repealing Council Directive 90/313/EEC are addressed to the Member States and that requests for access to
environmental information are handled according to the applicable national laws. These two Directives
allow the Member States to apply some restrictions to the right of access to information. However, the
Commission is of the opinion that their purpose is to give free access to information on the environment
that is held by public authorities and that, therefore, any exception must be interpreted narrowly.

Both Article 3(3) of Directive 90/313/EEC (1) and Article 4(1)(e) of Directive 2003/4/EC (2), provide that
requests for information may be refused if these concern internal communications. The Commission is of
the opinion that internal communications are indeed the processes by which data and factual information
are exchanged within public authorities.
Internal communications prepare an administrative decision;
it must be possible for an administration to lay down in writing the different arguments in favour of or
against a decision on a specific problem, without these internal deliberations being made public. The
essential element is, after all, the administrative decision and its possible justification, not the way in which
this decision was reached. However, this does not mean that Article 4(1)(e) of Directive 2003/4/EC allows
or even obliges access to be refused to every internal communication. Indeed, Article 4(1)(e) of Directive
2003/4/EC explicitly states that access to internal communications may only be refused taking into
account the public interest served by disclosure.

The interpretation of both Directives lies, in the last resort, with the Court of Justice.

(1) Article 3(3): A request for information may be refused where it would involve the supply of unfinished documents
or data or internal communications, or where the request is manifestly unreasonable or formulated in too general a
manner.

(2) Article 4(1)(e): Member States may provide for a request for environmental information to be refused if the request

concerns internal communications, taking into account the public interest served by disclosure.

(2004/C 84 E/0591)

WRITTEN QUESTION E-3964/03

by Hiltrud Breyer (Verts/ALE) to the Commission

(5 January 2004)

Subject: Endocrine disruptors in drinking water (cid:1) 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.

How is the Commission intending to protect European consumers, both male and female,

1.
application of the precautionary principle?

in

2.

Is the Commission planning to introduce limit values?

C 84 E/514

Official Journal of the European Union

EN

3.4.2004

Answer given by Mrs Wallström on behalf of the Commission

(8 March 2004)

The need to regulate endocrine disruptors 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
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.

limit values for individual EDCs in the Drinking Water Directive (1) at

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