WRITTEN QUESTION E-2475/97 by Hiltrud Breyer (V) to the Commission (16 July 1997)

Subject: Endocrine-disrupting chemicals

1. What action does the Commission intend to take, in conjunction with the toy industry, following the withdrawal from the market of PVC plastic baby toys in Denmark, Italy and Spain after evidence from the Danish Environmental Protection Agency of dangers to babies from the leaking of plastics into their mouths when sucking on these products?

2. Will the Commission participate in the international working group set up by the toy industry to investigate this problem and will it ensure it is informed of the results of their investigations?

3. Has the Commission already discussed with industry the options for working towards the substitution of known endocrine-disrupting chemicals in their products with benign substances? If not, when will it do so and would it make Community funds available for this?

4. Does the Commission agree that industry should take responsible care for its products and respond promptly to concerns over potential dangers for end-users?

5. Does the Commission condone the categorical statements by certain industry associations that plasticisers such as phthalate and bisphenol A are not hormone-disrupting chemicals, despite growing scientific evidence that these products do have hormone-disrupting effects?

6. The chemical industry has responded to independent scientific concerns over hormone-disrupting chemicals by commissioning its own research into the suspected products. Does the Commission see all the results of research undertaken by industry into suspected endocrine-disrupting chemicals and will it make these available to MEPs?

7. Is the Commission concerned by the possible withholding of research, funded by industry, which produces results contrary to industry's interests?

Joint answer to Written Questions E-2474/97 and E-2475/97 given by Mr Bangemann on behalf of the Commission (5 November 1997)

The Commission is well aware of the issue referred to as endocrine disruption (see answers to oral questions H-114/97 by Mr Spencer during question time at Parliament's March 1997 part-session ((Debates of the Parliament (March 1997). )), and H-423/97 by Mr Pimenta during question time at Parliament's June 1997 part-session ((Debates of the Parliament (June 1997). ))). Last January, the Commission mandated the European committee for standardisation (CEN) to create a working group under technical committee 52 (toys) dealing specifically with organic chemical compounds in toys, including a detailed assessment of the consequences of the use of polyvinyl chloride (PVC) in toys, in compliance with Article 2.1 and Annex III, point II.3 of Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys ((OJ L 187, 16.7.1988. )). The findings of the working party will be included in the European toy safety standard EN 71. Both the Commission and the toy industry, along with European consumer organisations and national standardisation bodies, will be involved in the working group.

The Commission works in close contact with the toy industry and will be informed of all the results of the investigations of the International council of toy industries (ICTI) working group on this subject.

The Commission supports several projects on screening tests for the detection of substances with endocrine disrupting properties. A number of shared-cost action research projects on endocrine-disrupting chemicals are supported by the Commission in the Environment and Climate and in the Biomed II research programmes. These programmes were selected following open calls for proposals and independent scientific evaluation. Where there is industrial participation the Commission supports up to 50% of the costs of the research. Wide dissemination of the results of the research is considered to be an important aspect of the projects.

Of course the Commission agrees that industry should take responsible care for its products and respond promptly to concerns over potential dangers for end-users. This is the reason why the Commission has taken an active role in developing research in this field and why the toy industry itself has established a working group on this subject.

Moreover, in the framework of Council Regulation No 793/93 on evaluation and control of the risks of existing substances ((OJ L 84, 5.4.1993. )), a large group of about 100 chemicals has been selected by the Commission in consultation with the Member States and included in the three lists of priority substances requiring an in-depth risk assessment because of their potential effects on man or the environment. The health risk assessment comprises a reproductivity test which can cover endocrine disrupting activities. Other more specific test methods for the detection of endocrine disrupting effects are under evaluation.

Following this selection each of these priority substances has been assigned to a rapporteur in one of the authorities of the Member States who will evaluate the data available provided by industry for that substance and draft a risk assessment report for consideration by the Member States. On the basis of the risk evaluation the rapporteur may suggest, if appropriate, a strategy for limiting the risks of that substance to man and environment. The results of the risk evaluation and the recommended strategy are adopted at Community level and published by the Commission. The Commission may then decide to propose Community measures within the framework of relevant legislation.

Three phtalates (Di-n-butymphtalate (DBP), Bis (2-ethylhexyl)phthalate (DEHP) and Benzylbutylphtalate (BBP)) implicated as potential endocrine disrupters, are among the priority substances identified by Regulation 793/93. Their current status is as follows:

- Di-n-bytylphtalate (DBP) has been identified as a priority substance in the first priority list annexed to Commission Regulation (EC) No 1179/94 ((OJ L 131, 26.5.1994. )). For this substance the Netherlands have been designated as the Member State rapporteur. A risk assessment report is expected for December 1997;

- Bis (2-ethylhexyl)phthalate (DEHP) has been identified as a priority substance in the second priority list annexed to Commission Regulation (EC) No 2268/95 ((OJ L 231, 28.9.1995. )). For this substance Sweden has been designated as the Member State rapporteur. A risk assessment report is expected for the second semester of 1998;

- Benzylbutylphtalate (BBP) has been identified as a priority substance in the third priority list annexed to Commission Regulation (EC) No 143/97 ((OJ L 25, 28.1.1994. )). For this substance Norway has been designated as rapporteur.

Furthermore, as far as Biphenol A is concerned, it is a substance candidate for inclusion in a next (fourth) priority list annexed to a future Commission regulation, which will be presumably adopted in the course of 1998.

The Commission is following the research on endocrine disrupters and is not aware of any refusals of the chemical industry to co-operate in this field. Whilst there is no obligation for industry to communicate all data to the Commission there are formal obligations under Community law (e.g. Regulation 793/93) for industry to provide information on chemicals. Information from the existing substances programme is made publicly available on CD-ROM.