WRITTEN QUESTION E-0616/98 by Ursula Schleicher (PPE) to the Commission (9 March 1998)

Subject: Implementation of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances

In several Member States complaints have been made about the long delays in the implementation of Regulation (EEC) No 793/93 ((OJ L 84, 5.4.1993, p. 1. )) on the evaluation and control of the risks of existing substances, particularly over the last two years.

1. How can the Commission explain these delays in implementation?

2. Does the European office for chemical substances have sufficient resources to implement the Regulation?

3. Could the delays be partly due to the fact that the relevant procedures are excessively bureaucratic and the Regulation is not sufficiently binding?

4. What practical measures does the Commission intend to take to solve these problems?

Answer given by Mrs Bjerregaard on behalf of the Commission (8 April 1998)

The Commission is aware and concerned about the difficulties encountered in the implementation of Council Regulation (EEC) No 793/93.

The implementation of this Community legislation requires high level scientific and technical expertise, in particular in the Member States, since they act as 'rapporteur' for each priority substance. One of the reasons for the slow pace of the implementation is the structure of the Regulation itself, which entails long and complex stages and procedures without precise deadlines or rules. It should be noted that a number of Community legislative measures based on a similar structure face the same difficulties.

Furthermore, the risk evaluation process is much more complicated, time consuming and costly than initially foreseen, both for industry and the national authorities. It has been necessary to determine in a specific Regulation the modalities of the risk assessment for health and the environment.

Industry's delays in delivering the information needed on prioritised substances have contributed to the delays in the implementation of the Regulation. The initial phase of the Regulation relies entirely on the obligatory submission of data from manufacturers or importers.

In addition, the inability of some Member States, responsible for the evaluation of a great number of substances in the first list, to deliver any of the planned risk assessments has hindered the operation of this Community measure. However, it should be noted that important progress has been achieved recently.

The finalization in the coming weeks of an initial batch of four risk assessments together with risk reduction measures for some of the substances, represents a crucial stage in the operation of the Regulation and should give rise in the next months to a substantial improvement in terms of output of finalized risk assessment reports. Once the first four substances are completed, the Commission intends to proceed with a general stocktaking exercise on the efficiency and effectiveness of the Regulation. This exercise will focus on the weaknesses and difficulties encountered so far, with a view to suggesting specific measures to improve the operation of the Regulation.

In this context it should be noted that the European chemicals bureau provides extremely valuable scientific and technical assistance in the implementation of the Regulation. In particular its 'Existing chemicals' work area is responsible for data collection, priority setting and risk assessment activities. As far as the resources are concerned, the building up of the European chemicals bureau is still in progress.