EU Parlia­ment sets out its posi­tion on the 'One substance, one assess­ment' reform package.

On 1st April, the European Parliament adopted its position on the 'One substance, one assessment' reform package. In the process, several changes were made to the European Commission's proposals. The package aims to increase the efficiency and transparency of chemicals assessment in the EU. This will be achieved through the development of a data platform for chemicals and the better distribution of tasks between the responsible agencies. Three legislative proposals presented by the Commission in December 2023 form the core components of the package, which is not linked to the pending REACH reform.

Urgent need to strengthen the ECHA commit­tees

In their reform package, the European Commission propose transferring many of the newly arising tasks, such as the technical and scientific work on substance assessments, to the European Chemicals Agency (ECHA). The European Parliament approves of this proposal. However, MEPs also added that ECHA does not have sufficient capacity to fulfil the new tasks in full. As a result, the work of the agencies needs to be reorganised in order to cope with the increased workload. Existing committees must also be strengthened. It is not possible to assess whether the proposed resources are sufficient until clarification of the future structure of the Agency's scientific committees.

Euro­pean Parlia­ment calls for exten­sion of the tran­si­tion period

A transitional period longer than the 12 months previously specified is proposed to give ECHA sufficient time to make adjustments to implement new tasks from the reform package. The European Parliament is in favour of a basic regulation for the ECHA to improve the Agency's human and financial resources. The ECHA should be fit for the future in order to best realise the EU's objectives in the areas of chemical safety, health and environmental protection and the promotion of competitiveness. The German Social Insurance (DSV) had also spoken out in favour of extending the implementation deadline in advance. The Member States agree with this.

Solu­tion in the event of discord among the agen­cies

The new provisions of the second proposal for a regulation are intended to strengthen ECHA's cooperation with other agencies such as the European Food Safety Authority (EFSA), the European Environment Agency (EEA) and the European Medicines Agency (EMA). The European Parliament welcomes the proposed harmonisation, subject to the proviso that each of the agencies concerned will only act within the scope of their respective mandate. Full cooperation is not possible until the regulations are standardised. Furthermore, the cooperation should not lead to all tasks being primarily centralised at one agency. The risk assessment of chemicals, for instance, should continue to be carried out by the respective agencies that already have experience in this area. This is also in the interests of the DSV.

According to Parliament, in the event of significant divergences on scientific issues, all bodies involved should co-operate or draw up a joint paper to clarify the issues in dispute. A proposal that can also be found in DSV’s statement.

Estab­lish­ment of a joint data plat­form promotes trans­parency

The European Parliament also welcomes the European Commission's third proposal to establish a common data platform to harmonise data management and promote transparency in the chemical industry. In addition, MEPs stated that the definitions are too broad, which is why clear guidelines on the data to be reported by companies should be provided. The European Parliament did not accept the DSV's proposal of scientific bodies and institutions with obligations and rights under social security systems having the same access to the data platform as public authorities.

Tria­logue proce­dure initi­ated

The Council adopted a common position as early as June 2024 under the Belgian Council Presidency. Now that the European Parliament has also adopted their position, the trialogue negotiations can begin.