Initial reflections on the recent ‘one substance, one assessment' EU proposals

The Proposals seek to address this problem and claims to allow a more consolidated assessment of the safety of chemicals, resulting in better scientific basis for regulatory decision-making.The Proposals are complex and will have an overarching impact on the generation and handling of scientific data in the EU. They will affect data generated under over 40 pieces of harmonised EU legislation on the manufacturing and importation of chemicals, but also covering their environmental impact and workers safety as well as their placing on the market in different regulated products, such as biocides, pesticides, medicinal products, food and feed.

As a general trend, the Proposals seek to shift the focus towards the hazard assessment of chemicals under the overarching expertise of the European Chemicals Agency (“ECHA”). While the specialization of the different affected EU agencies seems to be respected, and no scientific work is taken away from them, the fact that ECHA will assume tasks that have been carried out so far by the Commission, supported by ad hoc committees or external consultants, could turn to be problematic.

It will be essential indeed that this re-attribution of competences is accompanied with the necessary accountability, confidentiality, transparency and resources, objectives which ECHA has not always been able to meet so far. In particular, the Commission is yet to publish a proposal for a basic regulation of ECHA tackling the reorganization of ECHA and the takeover of the new or expanded competences attributed to it by the present package. This will be a fundamental piece that could hopefully ensure the proper functioning of the new system that the EU is seeking to implement.

More generally, it remains to be seen how much the proposed package will allow meeting this objective and to what extent it will not generate all sorts of other issues, and possibly derail some of the regulated process organised by the underlying EU regulations that will be affected.

We have identified some potential issues in our initial analysis of the Proposals as outlined below. Companies will need to be extremely vigilant to safeguard their legal rights as the Proposals are going through the decision making process and eventually are implemented.

In particular, the proposal to require companies and laboratories to notify ECHA of any studies being conducted for regulatory purposes will need to be fully assessed to ensure it does not lead to unintended detrimental effects on the fundamental rights of companies and laboratories to carry out their business.

Initial comments on the three Proposals

The ("OSOA") Proposals have been adopted in order to “ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of sustainable chemicals, to ensure the proper functioning of the single market for chemicals, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals”².

The OSOA legislative package intends to target these issues via three Proposals:

1.  Proposal for a Regulation on handling chemicals’ data

This Proposal focuses on the information and transparency aspects of the OSOA approach, to ensure that (i) information on chemicals is readily accessible, interoperable, and can be shared and reused by the Commission, the national authorities and the EU agencies; and (ii) safety assessments of chemicals and the underlying scientific data are transparent and available. In essence, it creates a “one-stop-shop” platform bringing together data on chemicals obtained from different sources.

We highlight the potential impact of a few selected provisions in the Proposal:

•   Data generation by ECHA

Importantly, the Proposal introduces a new data generation mechanism whereby ECHA may commission scientific studies, on its own initiative or at the Commission's request, when results cannot be obtained through existing legal provisions or processes under EU acts. EFSA has already a similar mandate to commission scientific studies under EU food law, but here this new mechanism may be used in particular to generate data on chemicals in general requiring additional scrutiny. ECHA could do so for instance as part of a procedure of harmonized classification under the CLP Regulation, in case when there is not enough scientific data to assess the hazard for a certain endpoint. Some limits to the discretion of ECHA are provided for in the Proposal, such as that ECHA cannot commission studies with a predominant research objective, and should avoid duplication of data generated by Member State or Union Research programs. Also ECHA can only commission the studies when the results cannot be obtained through existing legal provisions or processes under EU law related to chemicals. This could mean that ECHA should not, for instance, commission studies that could be requested under dossier evaluation under REACH as the data obtained from this process are information requirements that must be provided by registrants under REACH. It is less clear, however, how this limit would be articulated with the substance evaluation process, which allows ECHA to require data not specifically identified in the Annex XII to X of REACH. It is also not clear how disagreements on commissioned studies could possibly be solved and whether, for example, the business operators (i) will be allowed/ have to cooperate in the conduct of the studies, to prevent unnecessary animal testing, and (ii) will have the possibility to appeal ECHA’s request to conduct studies, e.g., before the Board of Appeal of ECHA or otherwise.

•   Notification of studies to ECHA

The Proposal also introduces a very broad obligation for 'business operators' – defined in the Proposal as duty holders, which are private or public undertakings – to notify ECHA of certain information on studies commissioned to support an application, notification or regulatory dossier notified or submitted to the Commission, EU agencies, or Member States Competent authorities, or when those are undertaken as part of a risk or safety assessment under EU chemical related legislation. This obligation has already been introduced by the so-called Transparency Regulation (EU) 2019/1381³ for the food chain, strengthening EFSA’s ability to carry out its risk assessment functions in accordance with the highest transparency standards, which creates a lot of red-tape. The current Proposal expands it to all study results that are relevant to a regulatory process. Accordingly, the duty holders will be required to notify ECHA with the title, scope, laboratory/testing facility carrying out the study, intended start-date, planned completion dates, and if relevant whether the study was required by dossier/substance evaluations under REACH. Moreover, the Commission contemplates to require laboratory and testing facilities to separately notify ECHA of any study commissioned by business operators to support a regulatory dossier on which an EU agency is required to provide a scientific output. This will be applicable from 2 years after the entry into force of this Regulation, and Member States will be required to adopt penalties in case business operators or laboratories do not comply with these obligations. It is unclear whether the studies themselves are required to be disclosed to the authorities. This seems not to be the case as the list of information to be communicated by business operators does not include the content and/or result of the studies. This proposal will need to be fully assessed to ensure it does not lead to unnecessary red tape and unintended detrimental effects on the fundamental rights of companies and laboratories to carry out their business.

•   Common data platform

This data platform, to be managed by ECHA, will integrate chemicals’ data and information held by EU agencies or the Commission (e.g., physico-chemical properties, hazard, use, exposure, risk, occurrence, emissions, etc.). This would cover mainly data (a) generated or submitted as part of the implementation of EU chemical laws (e.g., in regulatory dossiers or applications submitted by business operators, but also in reports on occurrence of chemicals submitted by Member States); or (b) generated as part of EU, national or international programmes or research activities in the sphere of chemicals. The data platform is also aimed to feature dedicated services with information on reference values, study notifications, regulatory processes under EU acts, environmental sustainability-related information, etc.

We highlight, that, importantly, due to sensitivity of information, the data platform will not include: (i) information on the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects; (ii) information on final cosmetic products notified to the Cosmetic Product Notification Portal; and (iii) documents with chemicals data relating to the authorities' internal work or decision-making.

•   Access to and use of the data in the platform

The access to the data platform will be tailored to differentiated access rights: authorities will have full access to the chemicals data in the common data platform, whereas business operators and the public shall have restricted access and will not be able to access information marked as confidential. Also, the data platform shall be designed in a way that accesses to confidential data can be audited.

Regarding use of the data, authorities reusing data shall be bound by the confidentiality regime of the originating legislation under which the data was first submitted, and they shall not disclose the data to the public without the originator authority's consent. Also, data reuse shall not allow the authorities to fill data gaps in regulatory files.

Notwithstanding these safeguards, the provisions on confidentiality are only vaguely defined enough and industry can have legitimate concerns about the sufficiency of these provisions.

•   Information on regulatory processes

A database  within the common data platform will contain information on regulatory processes on chemicals that are planned, ongoing or completed by the Commission, national authorities in the EU Member States and EU agencies. The information will relate inter alia to the substance identity, the regulatory process, and the status and outcome of this process, and it will be made publicly available as soon as the process or activity has formally started. This database is mostly designed as a “transparency” tool. However, the Commission has not delivered on its commitment set out in the CSS to establish a coordination mechanism to initiate assessments in a coordinated and to the extent possible synchronised manner across EU chemicals legislation.

•   Monitoring and outlook framework on chemicals.

The Proposal also introduces a monitoring and outlook framework on chemicals to shorten the reaction time between early signals of risks and the adoption of regulatory risk reduction measures. Under this framework:

• EEA") shall (i) develop and maintain, jointly with other authorities, a framework of indicators in the form of a dashboard to monitor the impacts of exposure to chemicals and to measure the effectiveness of chemicals legislation in protecting human health and the environment; and (ii) compile and report information on 'early warning signals'. This information shall be presented to the Commission, relevant EU agencies and national authorities for consideration of the need for regulatory actions, and made publicly available through the common data platform. The EEA already has within its mandate the collection, processing and analysis of environmental information, including data on chemical substances which are hazardous for the environment. Now the Proposal will task the EEA with additional monitoring in the field of chemicals, including the above-mentioned monitoring of early warning signals, but also the hosting and maintenance of 'human biomonitoring data' (i.e., data on concentrations of chemicals in human matrices such as blood or urine) and of chemical occurrence data.
• In addition, ECHA shall operate an observatory for selected chemicals requiring additional scrutiny which will build on the current EU Observatory for Nanomaterials. The observatory shall include information on properties, safety aspects, uses and market presence for a selection of chemicals. The Commission shall select these chemicals on account of their potential contribution to emerging chemical risks because of their novelty or the high uncertainty around them. The information in the observatory shall be made publicly available through the common data platform or other communication channels. However, while the inclusion of chemicals in the observatory could somehow result in risk management actions, the extent of this link has not been specified in the proposed text. It is not clear whether stakeholders can comment on or contest the listing of substances in the observatory. It is also not clear how this observatory fits with other existing informal mechanisms such as the assessment of regulatory needs (ARN).

Notably, while the Proposal intends to create the conditions to encourage the sharing and reusing of chemicals data, it does not clarify how authorities are expected to reuse these data in their own assessments of those chemicals, especially where the data were generated or submitted under a different regulatory framework. The chemicals’ data will be supported with contextual data and will be shared in standard formats and controlled vocabularies where available, which should ease reuse by other authorities. However, some clarity on this is still necessary and should be provided in the common data platform's governance scheme to be prepared by the Commission alongside a platform steering committee.

2.  Proposal for an Omnibus Regulation amending various EU regulations

This Proposal aims to ensure good cooperation among the EU agencies while conferring increasing powers to ECHA, in some of the following ways:

• The procedure to resolve a potential divergence between scientific opinions issued by EFSA and other bodies or agencies, set in the General Food Law Regulation⁴, is reinforced. In case of an potential divergence between the scientific opinions of the EFSA and those of another body, as it was for instance the case in April 2023, following the publication of the grossly diverging opinions of EFSA and EMA on the recommended temporary daily intake (“TDI”) for bisphenol A (BPA), EFSA and the dissenting body shall cooperate to resolve the divergence. Only when they are not able to resolve the divergence, should they refer to the Commission. A similar provision has been proposed in the revision of the EU pharmaceutical legislation, according to the Proposal, as regards divergences between the EMA and other scientific bodies. Where the divergence is on the fulfilment of the criteria for hazard classification, the Commission may request ECHA to prepare a proposal for harmonised classification and labelling, to which EFSA and the other body will have to contribute.
• Further, the EEA shall cooperate with other scientific EU bodies on the exchange of data and information on chemicals, and on the development of scientific methodologies for the assessment of chemicals. This is consistent with some of EEA's current tasks, which include the provision of EU-wide uniform assessment criteria for environmental data.
• Further amendments are proposed to the POPs Regulation⁵, inter alia to provide that ECHA will – upon request – assist the Commission with possible amendments of Annexes IV and V on POPs waste management by drawing up a report on the human heath, environmental and socio-economic impacts of introducing or modifying POPs concentration limit values in waste and to task the EEA with hosting the flow of POPs monitoring data that is currently hosted by the Commission. These relatively “surgical” amendments all aim to broaden ECHA’s oversight in regulated areas of chemicals other than REACH and would require further scrutiny when applied.
• Further, the Proposal aims to amend the Medical Devices Regulation⁶ inter alia to task ECHA with updating the guidelines on the benefit-risk assessment of the presence of phthalates classified as CMR or having endocrine-disrupting properties; this approach is proposed to be broadened for preparing guidelines on other CMR and endocrine-disrupting substances.

3. Proposal for a Directive amending the RoHS Directive

Finally, the OSOA package includes a Proposal for a targeted revision of the RoHS Directive⁷, whereby again ECHA would be tasked with the scientific and technical work in the substance restriction and exemption procedures under the RoHS Directive, utilizing the information and expertise obtained in the context of assessments for chemical restrictions and authorizations under REACH. These tasks are currently executed by the Commission through external experts.

We highlight the following two elements of the Proposal regarding amendments to the RoHS Directive:

• A non-confidential version of the applications for exemptions from the substance restrictions (and not only a summary thereof) will be made available to the public on ECHA's website.
• In the procedure for the review and amendment of the list of restricted substances in Annex II to the RoHS Directive, ECHA or the Member State submitting the restriction dossier shall take into account any relevant risk assessment submitted for purposes of other EU legislation covering the life cycle of the substance used in EEE, in particular the waste phase.