PURPOSE: to establish a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: the European Green Deal sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives.

CONTENT: the Commission is presenting this draft Regulation which aims to implement the above-mentioned objectives.

Subject matter and scope

The proposed Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of sustainable chemicals, to ensure the proper functioning of the single market for chemicals, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.

To achieve the objectives, this proposal contains measures to:

- bring together data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;

- keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;

- establish the widest possible scientific base for the implementation and development of Union legislation and policy on chemicals;

- establish an early warning and action system for emerging chemical risks.

Common data platform on chemicals

The proposal aims to establish a common data platform on chemicals to be managed by the European Chemicals Agency (ECHA). The common data platform is a digital infrastructure that brings together data on chemicals and information generated under the EU chemicals acquis and held by EU agencies, namely ECHA, the European Environment Agency (EEA), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA). This includes data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances and current regulatory procedures.

The proposal creates an obligation to ensure that data on chemicals held by these agencies or by the Commission is included in the common data platform. The common data platform will centralise and consolidate data on chemicals at EU level in one centrally accessible IT infrastructure.

The proposed Regulation will also establish dedicated services within the common data platform and lay down rules on the accessibility and usability of the data contained in this platform . It aims to create a common knowledge base on chemicals available to authorities to enable better, comprehensive, consistent and robust scientific assessments of chemicals and their impacts, as well as to ensure the best use of existing information for the implementation and development of EU chemicals legislation.

In addition, the proposed Regulation aims to provide a one-stop-shop on chemicals data and information in the Union accessible to the public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, as well as to strengthen public trust in the robustness of scientific decision-making.