ONE SUBSTANCE, ONE ASSESSMENT (1S1A): a new approach

Legislative background

In view of a substantial increase in global chemicals production expected by 2030, making the implementation of EU’s chemical legislation more important than ever, the European Commission (EC) published a Chemicals Strategy for Sustainability in the context of EU Green Deal with the aim to better protect citizens and the environment and boost innovation for safe and sustainable chemicals in the road leading to key commitment of the abovementioned Green Deal: the EU’s zero pollution ambition.

 

What is “ONE SUBSTANCE, ONE ASSESSMENT” (1S1A)?

“One substance, one assessment” is a Commission reform included in “Chemicals Strategy for Sustainability” aimed at improving the efficiency, effectiveness, coherence and transparency of safety assessments of chemicals used in several product categories across EU legislation. This proposal is outlined by three main topics.

The first one consists in the strengthen of the cooperation and improve the coordination of the safety assessments of substances tasks across EC, EU Agencies and Member states (MSs) experts, while making best use of all available resources and expertise. This would result in harmonisation of processes and methodologies, data format standardisation towards IUCLID one, mutual involvement in opinion forming and data exchange under the support of a new ad hoc legislation.

The second topic concern data and is outlined by a horizontal legislative proposal to strengthen the knowledge base on chemicals through an EU Common Data Platform on chemicals which would be established, allowing the availability of a single and harmonised data package together with a mutual accessibility for authorities to necessary data. This Common Data Platform will subsume already existing platforms, such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU chemicals legislation finder (EUCLEF), but also new tools and databases complementing them. Another important point is a modification of data generation mechanisms, allowing authorities to generate new data, when needed and when this responsibility cannot be put on specific companies, as well as the consideration of a possible introduction and use of academic data. Moreover, also the notification of studies will play a key role in this process, to both avoid unnecessary duplication and to ensure transparency of scientific studies on chemicals. Therefore, with these improvements, data will be more readily available, accessible, secure, shared and re-used, and processes for identifying and evaluating common substances across regulations will be speeded up.

The last one, but not less important, consists in setting up monitoring activities and ensure early detection and action on emerging chemical risks through a revision of CLP regulation and a more central role of Harmonised Classification, together with a systematic collection of human and environmental biomonitoring data generated in the EU, and a repository of reference values. All this will enable fast regulatory responses and ensure better exposure correction and prevention activities through improved chemicals data management.

 

What does 1S1A means for biocides?

Biocides are really at the forefront of 1S1A since many biocidal active substances are regulated also under other legislations (e.g. pesticides). 1S1A approach will ensure an enhanced collaboration between EU Agencies (e.g. ECHA, EFSA, EMA etc.) on evaluation of common substances, seeking alignment of outcomes whenever it is possible; an enhanced interrelation with REACH, especially in the context of non-active substances or co-formulants evaluation and regulation, as well as enhanced role of Harmonised Classification (also for new hazard classes like ED,PBT and PMT) enabling ECHA Risk Assessment Committee (RAC) to take a final decision which will serve both biocides and pesticides legislations, and hopefully in the future also other ones. On the same line, also a progressive alignment of guidances for substance properties evaluation will be implemented, as already done in the context of ED properties determination, for instance.

Moreover, in the context of EU Common Data Platform also biocides data will be included, and biocides as well, will be subjected to prior notification of studies to be performed under BPR, as it happens already for pesticides.

 

Who will benefit from this new approach?

Citizens, companies, and authorities will benefit from simplified and transparent access to chemicals information, from more harmonised and predictable processes across legislation and from strengthened certainty of the assessments. The new measures will shorten the gap between the identification of a possible risk and the necessary regulatory action. Moreover, knowledge gained from assessments under one type of legislation can be re-used for another one. Therefore, these measures will lead to better estimate of the level of exposure of EU citizens to chemicals and to a quicker prevention and protection of people’s health and the environment.

 

What is already ongoing?

Despite the difficulties in existing differences between regulations and the presence of different expert bodies taking decisions, an effort of alignment has been already initiated, with for example joint authorities’ guidance redaction (e.g. Guidance on impact of active substances residual on drinking water treatment, ED guidance) or aligned risk assessment methodology approaches development (e.g. risk assessment for bees and arthropods).

 

What will be the next steps?

The next steps will include the examination of these proposals by the European Parliament and the Council under the ordinary legislative procedure.