WRITTEN QUESTION P-2383/01

by Pat Gallagher (UEN) to the Commission

(3 August 2001)

Subject: European Chemicals Bureau risk assessment report zinc and zinc chemicals

The European Chemicals Bureau has indicated that it wishes to hold the final in-depth discussions on the risk assessment report for zinc and zinc chemicals at Technical Meeting 3 on 17 September next. This is despite the fact that there is currently significant research being carried out in this area which will only be completed by the end of 2002.

Does the Commission agree that this research could significantly alter the conclusions of the RAR, in both the health and environmental areas? Does the Commission agree that it would be reasonable to await the availability of the most up-to-date scientific knowledge, important aspects of which will already be ready for consideration by the end of the first quarter of 2002, before proceeding to complete the RAR report?

Answer given by Mr Busquin on behalf of the Commission

(8 October 2001)

The first draft risk assessment reports (RAR) on zinc and zinc compounds were submitted by the Dutch authorities, acting as Member State Rapporteur to the Community Technical Meeting (TM) in December 1999. Over the last decade, extensive discussions between the Rapporteur and zinc industry have taken place, and the output has been incorporated in the reports. Sufficient time was given to assure a well-balanced scientific consensus. In particular, a special two-day workshop dedicated to metals risk assessment methodologies was organised in London, in January 2001.

In-depth discussions of each section of the risk assessment reports have now taken place over a number of TMs, held in June 2000, in December 2000 and in March 2001. At this last meeting (March 2001), despite industry's objections, all Member States and Norway agreed to the current version of the risk assessment report, implying that they were not convinced that the ongoing research could significantly alter the report's conclusions. However, in addition to the normal process, the European Chemicals Bureau (Work Area on Existing Chemicals), which chairs and manages all TMs, suggested using an additional written procedure for any further comments and holding a final meeting in September 2001 to address the industry concerns. The TM agreed unanimously to this proposal. This procedure should assure an efficient discussion on the remaining points of disagreement between the Dutch rapporteur and industry.

The current efforts of the Zinc Industry to start new scientific studies are much appreciated. However this research programme could in principle have been started much earlier, given that the whole exercise on zinc began in 1995.

It is in fact a standard dilemma faced by any science based regulatory committee that a decision must be taken at a given time, whereas research is permanently producing new results. The decision to complete the discussions on zinc at the next TM is done on the basis of assuring an efficient use of meeting time and resources. Awaiting continuously new developments would delay the discussions of other priority substances. It is not acceptable that belated input from industry postpones the finalisation of the risk assessment.

Furthermore, once the Technical Meeting has finalised its work, the risk assessment reports will be anyhow peer-reviewed by the Scientific Committee for Toxicology, Eco-toxicology and the Environment (CSTEE), before submitting the results to a Regulatory Committee. In any case, should the outcome of the current research modify substantially the Reports conclusions, then the Rapporteur would be able to include them in an addendum to the RAR at a later stage.