Council agrees on mandate for the "One substance, one assessment" reform package.

Mid-June this year, the Council of the European Union (EU) agreed its mandate for the interinstitutional negotiations with the European Parliament on the "One substance, one assessment" reform package. The package includes proposals for two regulations and a directive aimed at harmonising the assessment of chemical substances in all relevant EU legislation, strengthening the knowledge base for chemical substances and ensuring the early identification of newly occurring chemical risks and corresponding measures.

Promoting cooperation and resources

Many of the new tasks, such as the technical and scientific work on assessments of substances are to be transferred to the European Chemicals Agency (ECHA). ECHA's committees dealing with the assessment of risks to human health and the environment as well as socio-economic impacts do not have sufficient capacity to fully implement the new tasks. Consequently, Member States have argued in favour of an adjustment of resources which should also be taken into account in future legislation on the financing of ECHA. The DSV also highlighted this in its opinion on the reform package and also calls for the expansion of ECHA's expertise in the field of electrical and electronic equipment.

The new rules 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 establishment of a procedure to resolve any disagreements between ECHA, EFSA, EEA and EMA was welcomed by the Member States. The DSV also recognises this and points out that a comprehensive scientific and technical exchange on the contentious points must be ensured.

Free access to data in the platform

The establishment of a new data platform, as proposed by the European Commission, enables the collection of all information on chemicals at EU level using centrally accessible IT infrastructure. This makes the data findable, accessible, interoperable and reusable for interested parties. In its proposal, the European Commission nevertheless limits access to all data. The Member States criticise this approach and demand free access to all data that is not classified as confidential. This would strengthen public confidence in the EU's scientific decisions.

In its statement, the DSV points out that not only authorities, but also scientific bodies and the social insurance agencies should have access to all data that they need for their work or to fulfil their statutory duties. The Member States are also considering extending the database and supporting the inclusion of medical data on active ingredients and environmental risk assessments as well as other medical data six years after the Regulation comes into force.

Interinstitutional negotiations

The negotiations usually take place as a trialogue between the Council, the European Parliament and the European Commission. The European Parliament must determine its position prior to this trialogue. The Committee on the Environment, Public Health and Food Safety (ENVI) was found to be responsible for these negotiations. However, the role of rapporteur must be reassigned as the designated rapporteur was not re-elected. It therefore remains to be seen when the ENVI Committee will deal with the reform package.