The Council held a policy debate on the draft Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and establishing a European Chemicals Agency. The debate took place on the basis of a Presidency Report which reflected discussions so far in the ad hoc Working Party on Chemicals, established in November 2003.
At the end of the debate, the Presidency stated that a number of key issues have been discussed during the policy debate, the purpose of which was to give political guidance for work under the subsequent Presidencies.
The Council took note of the Presidency's report on the basis of which it held a policy debate addressing a set of key issues, notably: conclusions and recommendations from the REACH Impact Assessment Workshop; mandatory sharing of nonanimal data, including agreements on core data sets and cost sharing; and information requirements for low volume substances.
As to the Workshop on REACH Impact Assessment held in The Hague on 25-27 October 2004, the Council welcomed the conclusions and recommendations and instructed its preparatory bodies in cooperation with the Commission to take account of them in the future work.
Concerning the issue of joint submission of data including cost sharing, the Council stressed the importance of avoiding unnecessary testing on animals and underlined the need to improve the protection of the human health and the environment while ensuring the competitiveness of the European chemicals industry, in particular of SMEs. In this context, the Council discussed a suggestion implying mandatory sharing of all data, including legally-binding rules on cost sharing, as a possible means to achieve these objectives. While there was support, the Council called for further examination of this issue, taking into account the Opinion of the Council Legal Service.
The Council discussed the question of a possible extension of the data requirements for low volume substances (1-10 tonnes per year). Member States acknowledged the importance of having sufficient data to enable appropriate classification and labelling and to ensure the protection of human health and the environment, especially as to the identification of substances of high concern, such as PBTs and vPvBs. Member States stressed the importance of achieving the right balance between costs of additional data (specifically for SMEs) and benefits. The importance of taking into account the competitiveness aspects of such a possible extension of data requirements was also emphasized by Member States and the Commission.
The Council instructed its preparatory bodies to examine in greater detail these issues while, besides considerations of human health and environment, taking into account the impact of REACH on competitiveness, in particular of SMEs, as well as a simplification of the administrative processes and an efficient use of scarce resources.