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Key actions to simplify and consolidate the legal framework: One substance, one assessment?

The complexity of assessment procedures represents a specific challenge for authorities and stakeholders. It can lead to inconsistencies, slow procedures, inefficient use of resources and unnecessary burdens.

The Commission will strive to make those assessment processes simpler and more transparent, in order to reduce the burden on all stakeholders and to make decision-making faster as well as more consistent and predictable. This process will also support the gradual move away from assessing and regulating chemicals substance-by-substance to regulating them by groups.

Chemical safety assessments are being initiated under various pieces of legislation, by various actors and at different points in time, and they are carried out by various EU agencies, scientific committees, expert groups or Commission departments. Stakeholders and the general public struggle to keep track of regulatory processes and resulting decisions. ‘One substance, one assessment’ will ensure that the initiation and priority setting of the safety assessments are done in a coordinated, transparent and to the extent possible synchronised manner taking into account the specificities of each sector. When an assessment is proposed under one piece of legislation, full account shall be taken of the planning under other pieces of legislation, so that coordinated action is ensured. This could be most efficiently done by building on the success of the ‘Public Activities Coordination Tool’, the existing mechanism in place under REACH and CLP. To avoid duplication of work, early agreement on the problem definition will be key, favouring the assessment by groups of substances with structural or functional similarities. The use of available resources and expertise shall be optimised, through a clear allocation of responsibilities as well as good cooperation among all actors.

COORDINATE AND SIMPLIFY ACTIONS ACROSS EU CHEMICAL LEGISLATION

The Commission will:

  • use a single ‘Public Activities Coordination Tool’ to provide an up-to-date overview of all planned and ongoing initiatives on chemicals by authorities across legislation;
  • establish an expert working group of Member States, Commission services and EU Agencies to discuss initiatives on hazard/risk assessment on chemicals across chemical legislation, taking into account also the specificities of the sector concerned;
  • establish a coordination mechanism within the Commission to agree and synchronise, to the extent possible, actions across chemical legislation as regards hazard identification/classification and risk assessment and oversee the process towards ‘one substance, one assessment’;
  • rationalise the use of expertise and resources by proposing the reattribution of technical and scientific work on chemicals performed under the relevant pieces of legislation to European agencies, including work of the SCHEER and SCCS;
  • make a proposal to strengthen the governance of the European Chemicals Agency  and increase the sustainability of its financing model;
  • reform the REACH authorisation and restriction processes based on key findings from its practical implementation.

In order to achieve consistency of regulatory outcomes, EU chemicals legislation need to use coherent terminology, in particular to define chemicals (e.g. nanomaterials). Policy evaluations also show that interested parties are not always aware of what information is available, and that re-use rights are sometimes too restrictive. They also highlight a number of shortcomings in the interoperability and accessibility of chemical data. In addition, regulatory safety assessments use various methodologies, which may lead to incoherent outcomes, while academic studies are not sufficiently exploited. Different transparency rules are also applied to the initiation and performance of assessments and data use.

The ‘one substance, one assessment’ approach aims to ensure that methodologies are made more coherent and to the extent possible harmonised.  It strives to free the data access of technical or administrative obstacles, according to the principles that data should be easily findable, interoperable, secure, shared and reused by default. Data will be made available in appropriate formats and tools – i.e. IUCLID and IPCHEM - to ensure interoperability. ‘One substance, one assessment’ will also build greater trust in the scientific underpinning of the EU decision-making process for chemicals, building on the important steps taken regarding transparency in the EU food safety sector.

METHODOLOGIES AND DATA

The Commission will:

  • ensure that the CLP Regulation is the central piece for hazard classification and allows the Commission to initiate harmonised classifications;
  • review the definition of nanomaterial and ensure its coherent application across legislation using legally binding mechanisms;
  • develop a common open data platform on chemicals to facilitate the sharing, access and re-use of information on chemicals coming from all sources;
  • promote reuse and harmonisation of human and environmental health-based limit values among EU risk assessors and managers through a centralised and curated EU repository;
  • establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes;
  • enable EU and national authorities to commission testing and monitoring of substances as part of the regulatory framework when further information is considered necessary;
  • remove legislative obstacles for the re-use of data and better streamline the flow of chemical data between EU and national authorities;
  • extend the principle of open data and the relevant transparency principles from the EU food safety sector to other pieces of chemical legislation.

Source: European Commission

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