In the absence of a proposal to revise the REACH regulation on the authorisation and restriction of chemical substances, on Thursday 7 December the European Commission adopted three legislative proposals that should streamline the assessment of risks to human health and the environment from chemical substances across existing EU chemicals legislation and increase the transparency of information.
There are two proposals for regulations and one proposal for a directive, all three of which stem from the EU’s 2020 ‘Chemicals Strategy for Sustainability’, which foresees the phasing out of the most harmful substances in everyday consumer products and assessment by categories of substances presenting the same risks, rather than substance by substance (see EUROPE 12581/6).
A common data platform. The Commission is proposing a regulation establishing a common data platform for chemicals, laying down rules to ensure that the data it contains is findable, accessible, interoperable and reusable, and establishing a monitoring and outlook framework for chemicals.
This platform will provide a single point of access to data held by EU agencies and the Commission, gathered from EU legislation. This includes data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances and current regulatory processes.
The proposed regulation will take over from and extend the scope of existing platforms under various specific legislations to almost all Community legislation on chemicals, and complement them with new tools and databases, such as a repository of reference values based on human and environmental data.
The Commission proposes to set up a systematic collection of human biomonitoring data generated in the EU in order to inform policy makers about the levels of chemical substances found in people (for example in blood or breast milk).
It also proposes setting up a monitoring and outlook framework to enable the early detection of chemical risks, such as those generated by forever chemical pollutants PFAS.
The European Chemicals Agency (ECHA) will be able to generate data if required.
This framework will also make it possible to provide a rapid regulatory response and to monitor the impact of regulatory measures taken in relation to chemical substances.
It will also ensure the transparency of scientific studies on chemicals, including those commissioned by companies, according to the Commission.
Better cooperation between EU agencies. The Commission is proposing a regulation on the reallocation of the technical tasks of EU agencies to strengthen their cooperation and consolidate their work through a targeted amendment of the regulations on persistent organic pollutants (2019/1021), on medical devices (2017/745) as well as the regulations that established the European Environment Agency (401/2009) and the European Food Safety Authority (178/2002).
This will involve harmonising priorities and timelines, developing methodologies, exchanging data and reconciling differences in scientific findings.
In addition, the knowledge acquired during assessments carried out for one piece of legislation (e.g. on biocides) can be re-used for another (e.g. on toys).
A proposal for a targeted amendment to a directive. In addition, the Commission is proposing a targeted amendment to directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment to entrust scientific and technical tasks to ECHA.
The proposal for a common data platform: https://aeur.eu/f/a0l
The proposal on the reallocation of technical tasks to EU agencies: https://aeur.eu/f/a0r
The proposal for a directive on the reallocation of scientific and technical tasks to ECHA: https://aeur.eu/f/a0s (Original version in French by Aminata Niang)