European Commission Releases "One Substance, One Assessment" Chemicals Legislation Package

The European Commission has presented today, December 7, 2023, its "one substance, one assessment" legislative package. Announced in the Chemicals Strategy for Sustainability in October 2020, the "one substance, one assessment" initiative seeks to streamline chemical assessments in the EU by consolidating scientific and technical work on chemicals in the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA).

The Package is made out of a set of three legislative proposals:

1. Proposal for a Regulation establishing a common data platform on chemicals,
2. Proposal for a Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals, and
3. Proposal for a Directive on the re-attribution of scientific and technical tasks to the European Chemicals Agency English.

1. 1. 1. Proposal for a Regulation establishing a common data platform on chemicals

The Proposal for a Regulation establishing a common data platform on chemicals aims to create an integrated framework for data management, including setting up a Common Data Platform. The platform is designed to centralize and consolidate chemical data at the EU level within a single, easily accessible IT infrastructure.

The Proposal sets out the rules for ECHA to establish and manage the Common Data Platform. Information covered will encompass, among others, physico-chemical properties, hazards, exposure safety, risk, occurrence, emissions, manufacturing processes, environmental sustainability, legal obligations, academic studies, and reference values. Information relating to emergency health response (Article 45 of the CLP Regulation) and information related to cosmetic products (Article 13 of the Cosmetics Regulation) will be excluded. The Proposal will require the Commission and EU agencies to specify formats and controlled vocabularies, ensuring that chemicals-related information is easily discoverable, interoperable, and accessible on the Common Data Platform.

A fundamental concern with this initiative is the protection of commercially sensitive data. Yet, the Proposal barely touches upon this key issue. For example, it contains no mechanism for data owners to be consulted prior to disclosure of their data or to challenge disclosure, beyond what would be provided under existing rules. Given the wide scope of information intended to be made available on the Common Data Platform, it is tantamount that rigorous confidentiality safeguards are included in the Proposal.

This is particularly true considering that the Proposal obliges operators to notify information on new studies. The aim is to keep authorities informed when a study is planned in the context of a regulatory process under the chemicals regulatory framework. The information to be notified includes the title, scope, laboratory, or testing facility carrying out the study and the intended starting and planned completion dates. Laboratories would also be subject to a notification duty, including those located in third countries. This raises multiple, significant concerns from a legal perspective and should be closely analysed.

Finally, another novelty introduced by the Proposal is the possibility for authorities to generate data on chemicals. The new provisions will allow ECHA to commission studies to support the implementation and evaluation of EU’s chemicals legislation, of its own motion or at the request of the Commission. The Proposal is silent about the use which shall be made of the results, and about possible remedies.

2. Proposal for a Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

The Proposal for a Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals aims to ensure that ECHA, as the Agency most equipped with expertise in the field of chemicals, is involved in more tasks matching its capabilities. It will do so by reattributing certain existing scientific and technical tasks to ECHA, as well as the attribution of new tasks. The Proposal will amend relevant parts of existing Regulations:

• Article 1 of the Proposal will amend Regulation (EC) No 178/2002 (Food Requirements Regulation), introducing provisions to enhance cooperation and coordination between EFSA and other agencies such as ECHA, EMA, and EEA.
• Article 2 will amend Regulation (EC) No 401/2009 (European Environment Regulation), seeking to enhance the role of EEA in coordinating the development of chemicals assessment methodologies in the fields falling within its mission and cooperation with the other Agencies.
• Article 3 modifies Annex I of Regulation (EU) 2017/745 (Medical Devices Regulation), granting the Commission the possibility of requesting ECHA to update guidelines for risk-benefit assessments of phthalates in medical devices. Additionally, ECHA may be tasked with developing guidelines for substances classified as carcinogenic, mutagenic, toxic to reproduction (CMR) category 1A or 1B, or those with endocrine-disrupting properties.
• Article 4 of the Proposal will amend Regulation (EU) No 2019/1021 (Persistent Organic Pollutants Regulation), providing the Commission with the authority to request ECHA to analyze the impact of concentration limit values specified in Annexes IV and V to Regulation (EU) No 2019/1021 (POPs Regulation). This analysis, including the input from the ECHA Committee for Socio-Economic Analysis, will support the Commission in proposing changes to these limits. The provision also redirects data flows on persistent organic pollutants to the EEA.

3. Proposal for a Directive on the re-attribution of scientific and technical tasks to the European Chemicals Agency English

The Proposal for a Directive on the re-attribution of scientific and technical tasks to the European Chemicals Agency English will allocate scientific and technical tasks to ECHA currently executed by the European Commission under the Directive 2011/65/EU (RoHS Directive).

The Proposal consists of only one article, which will be amending Articles 5 and 6 of RoHS. As RoHS is a Directive, it could only be amended by another Directive (whereas the proposal described above is a Regulation).

The amendment allocates to ECHA and its scientific committees responsibilities in the procedures related to substance restrictions and the evaluation of exemption requests associated with these restrictions under RoHS. Applications for granting, renewing, or revoking an exemption will be filed with ECHA, which will issue opinions relying on its Committees for Risk Assessment and Socio-economic Analysis.

A report on the review of the RoHS Directive, published together with the three proposals, concluded that entrusting this role to ECHA would help address issues of transparency and efficiency with the current system (where the Commission is supported by external consultants) and ensure overall coherence with the processes under REACH.

Next steps

The three proposals of the "one substance, one assessment" package will now undergo the ordinary legislative procedure, where the European Parliament and the Council need to jointly agree on the text before the final adoption. It is unclear whether this ambitious package can be adopted before the May 2024 elections.

In any event, given the potential for massive impacts on current and future processes, including on commercially sensitive information and data sharing, this file should require urgent attention.