EN Official Journal of the European Union CE 84/855

(2004/C 84 E/0947)

WRITTEN QUESTION P-0713/04

by Catherine Stihler (PSE) to the Commission

(4 March 2004)

Subject: Management of the risk assessment process on zinc

In 2002 I raised concerns about the management of the risk assessment of zinc and its possible premature closing-off without taking into account all relevant and new research. Carried out under the existing chemicals legislation, this first risk assessment of a bio-essential metal is a precedent for future risk assessments. It is also becoming a case study of mismanagement of a process which should be based on best-available science.

My concerns have recently been renewed by the release of the final draft risk assessment report on zinc, which simply misinterprets or ignores the outcome of 18 months of research funded by industry and what is considered to be the best available science. The preparation of this report also raises fundamental questions of over-conservatism, fairness and transparency regarding the very selective approach to available science that has been used to justify and maintain initial draft conclusions drawn two years ago.

In a parallel development, a recent CSTEE opinion on complaint 1999/5056/NL criticises a similar risk assessment for not having used a transparent method of selecting data and for not having provided sufficient scientific justification to show the presence of environmental risks.

In this context, can the Commission explain:

1. What steps have been taken or are being considered to ensure that the issues raised in the CSTEE opinion are avoided in the risk assessment for zinc, for which the same rapporteur has responsibility?

2. How will the Commission ensure that research and scientific developments are not systematically ignored in an attempt by a rapporteur to validate its initial conclusions and that the risk assessment for zinc is brought to a level of quality sufficient for decisions on risk to be taken?

Answer given by Mr Busquin on behalf of the Commission

(13 April 2004)

The drafting of the risk assessment report on zinc has now been in process for almost 10 years. It is a good example of very detailed discussions between all stakeholders in the technical meetings. The Commission shares the Honourable Member's opinion that the assessment of a chemical substance like zinc has to be sound by including all relevant research.

The Honourable Member refers to the comments of the CSTEE about the lack of clarity in the data selection process in the assessment of the use of copper containing anti-foulings and the lack of sufficient scientific information. In the case of zinc, a large amount of data has been presented in an extensive document, very detailed discussions took place in the Technical Meetings on risk assessments carried out under Council Regulation (EEC) No 793/93 (1) and Member States experts have reached consensus on the criteria for data selection and the way the data should be used.

The industry was given the opportunity and the time to carry out an additional research program, based on the expectation that additional scientific information would improve the quality of the report. Meanwhile, the results are available and give a better understanding of the behaviour of zinc in the environment, and will be incorporated in the draft risk assessment report by the rapporteur.

On 8 and 9 March 2004, the draft report was discussed again in a Technical Meeting with all stakeholders. The meeting was chaired by the European Chemical Bureau. An agreement was reached on the conclusions regarding the risks for the compartments ‘water’ and ‘soil’. Further discussion is still needed for the risk assessment for ‘agricultural soil’.

We expect that agreement can be reached on the open issues in the coming months. In line with the normal procedure for risk assessments carried out under Council Regulation (EEC) No 793/93, the final report will subsequently be sent to the CSTEE for their opinion on the scientific basis of the conclusions. A summary of these conclusions will subsequently be published in the Official Journal of the European Union as a Commission recommendation.

(1) 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.