José María Ferrer / 20 May 2024

One substance, one assessment: Towards sustainability for chemicals

“Chemicals are ubiquitous in our daily lives and play a crucial role in most of our activities. They are part of virtually all the products we use for our well-being and to protect our health and safety, and of the innovative solutions to address new challenges. With these words, the European Commission launches its reasons and objectives for the Proposal for a Regulation of the European Parliament and of the Council that establishes a common data platform on chemicals and sets out the rules to ensure that the data it contains are easy to find, accessible, interoperable, and reusable, as well as a monitoring framework and outlook for chemicals.”

This is the first of three proposals that have been launched to comply with the Chemicals Sustainability Strategy (European Green Deal). The aim of this package of measures is to improve the efficiency, effectiveness, coherence, and transparency of the safety assessments of chemicals across all European Union legislation. Achieving these objectives is undeniably reliant on the approach of one assessment per substance (“one substance, one assessment”).

The other two proposals focus on how to reallocate scientific and technical tasks among the involved EU Agencies, particularly the role that the European Chemicals Agency should play.

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No. 178/2002, (EC) No. 401/2009, (EU) 2017/745, and (EU) 2019/1021 of the European Parliament and of the Council with regard to the reallocation of scientific and technical tasks and improving cooperation among the Union’s agencies in the field of chemicals.

Proposal for a Directive of the European Parliament and of the Council amending Directive 2011/65/EU of the European Parliament and of the Council concerning the reallocation of scientific and technical tasks to the European Chemicals Agency.

Identified Problems and Solutions

The European Commission recognises the dispersion of data on chemicals across various EU agencies, Commission services, and at the member state level. The solution to this issue involves a holistic, robust, and proactive approach. We are facing a cross-sectoral issue, as the use of chemicals affects most production sectors. The proposals mention medical devices, cosmetics, toys, food, pesticides, and biocides, but it must be considered that chemicals are present in all consumer goods.

One substance, one assessment

The European Commission’s approach with the proposed measures aims for harmonisation and optimisation of resources, both human and technical. With the “one substance, one assessment” concept, time will be saved in the regulatory process from the identification of a potential risk to the implementation of necessary regulatory measures for its mitigation or control. This time-saving will be achieved through the development of faster, more simplified, and transparent processes.

As we have seen, the European Commission will cross-reference information to optimise efforts by all involved entities (European Chemicals Agency + European Food Safety Authority + European Environment Agency + European Medicines Agency = Common Chemicals Data Platform).

Another positive element in this approach is the reduction of activity dispersion among all entities currently involved in chemical-related issues. We will see significant task reallocation among the four aforementioned EU agencies, allowing for more coherent and transparent assessments of the safety of chemicals used across multiple sectors (medical devices, toys, food, pesticides, and biocides, among others).

As a result of the expected outcomes from these legislative proposals, we will have a scenario that better protects human health and the environment. In the coming years, the various agencies will be better equipped to harmonize the establishment of priorities, timelines, processes, and methodologies used for the assessment of chemicals. Additionally, knowledge gained from assessments under one legislative act (for example, on biocides) can be reused for another (for example, in toys).

Scope and Expected Evolution

The measures being proposed are wide-ranging, as their scope of application will affect much of the EU’s legislation on chemicals and the development of new tools and databases.

Regarding the expected evolution, the proposals are currently awaiting review by the European Parliament and the Council, as envisaged in the ordinary legislative procedure. We will continue to monitor the progress of these comprehensive initiatives for all chemicals in the European Union.

José María Ferrer (366 articles)

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José María Ferrer
Responsable de Asuntos Regulatorios Alimentarios

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