SUWANNAR KAWILAChemical data
Parliament and Council agree on more efficient evaluation of chemical data.
SK – 07/2025
On 12 June,
the European Parliament and the Council of the European Union
(EU) reached an agreement on the
"One Substance, One Assessment" reform package. The EU is thus taking an important step towards improving chemical safety and
strengthening cooperation between the relevant EU agencies. At the centre of
the reform is the establishment
of a shared digital platform for the centralised collection and provision
of chemical data.
Central platform for chemical data
The new
platform, operated by the European Chemicals Agency (ECHA), will aggregate
information from about 70 EU regulations. It aims to broaden and simplify
access to chemical information. For the first time, information on safe
alternatives for substances of very high concern will be included.
A newly
introduced monitoring framework will help identify potential risks earlier and
enable quicker responses. Data from human biomonitoring will also be
systematically collected and analysed. An EU-wide study to better understand
the population's exposure to chemicals is planned four years after the
regulation comes into force.
Transparent access and gradual expansion
Significant
updates are also planned in the field of pharmaceuticals. The platform will
gradually include selected chemical data from the European Medicines Agency
(EMA), with a stepwise integration of existing datasets. In line with EU
transparency regulations, the data will be publicly accessible, a move
supported by the DSV in its opinion.
Strengthened cooperation between EU agencies
The reform
package also promotes closer
cooperation among the EU agencies working scientifically and technically
with chemicals — particularly ECHA, EMA, the European Food Safety Authority
(EFSA), and the European Environment Agency (EEA).
ECHA will
become the central scientific assessment body for chemicals. EMA and EEA will
gain expanded roles, especially in developing data formats and coordinating
methodological approaches. ECHA will also handle applications concerning hazardous
substances in electrical and electronic equipment.
Next steps
The Council
and the European Parliament must formally adopt the package. Publication in the
EU’s Official Journal is expected no earlier than autumn 2025, since Parliament
will vote in October. Concerns regarding ECHA’s financial and staffing
resources were not addressed in this package but will be considered during
negotiations on the separate basic regulation proposal launched on July 8.