REACH Annexes to be updated

Background

The European Commission has proposed an update of REACH Annexes for inclusion of data requirements on endocrine disruption, following the 30th CARACAL (Competent Authorities for REACH and CLP) meeting on 1 and 2 July 2019. This action is part of the Commission’s activities “Towards a comprehensive European Union framework on endocrine disruptors” including the development of a horizontal approach for the identification of endocrine disruptors across EU legislations, building on the criteria developed for pesticides and biocides.

In general, REACH standard information requirements have limited capacity for providing data on endocrine disrupting properties. Some of them, e.g. reproductive toxicity, repeated dose studies or to some extent long-term toxicity testing on fish are able to provide some information on endocrine disrupting properties. However, they do not in all cases provide enough information for the identification of endocrine disruptors for human health or the environment. Hence, it is suggested that an integration of the latest developments on ED related test methods and screening strategies is needed to better identify endocrine disrupting properties.

The majority of the information and tests described in the Conceptual framework (CF) of the OECD GD 150 (2012, updated 2017) for evaluating chemicals for endocrine disruption within a tiered approach, are not part of the REACH Annexes on standard data requirements.

What has been proposed?

It is proposed that several Annexes should now be updated in order to better enable the identification of EDs under REACH, within a step-wise procedure: some changes could be proposed as soon as possible (by the end of 2019), while more comprehensive changes should be addressed on a mid/long-term basis (i.e. Action 1 or Action 2 changes). The Commission aims to start working on Action 1 changes already during 2019.

Action 1

• Annex I on “General provisions for assessing substances and preparing chemical safety reports” should be updated to integrate ED assessment in human health hazard assessment (section 1) and environmental hazard assessment (section 3). Further, a new section on ED should be added, in accordance to the section regarding the PBT and vPvB assessment (section 0.6 and 4). The CSR format (section 7) should also be updated accordingly.
• In Annexes VII to X, the information requirements for human health as well as environmental assessment are listed in a tiered procedure, depending on use volumes and substance properties. A tiered approach should therefore also be developed for explicit information and specific tests on ED to be conform to the REACH principles. It could either set default requirements for each tier or use clear triggers to decide when data is required or may be waived.
• Importantly, to avoid unnecessary further animal testing, an improved use of existing information (e.g. also by means of databases), in silico and in vitro approaches and an improved mutual reference to available test results from respectively human health and environmental hazard assessment and vice versa to decide on specification or need for further testing is desired.
• It is emphasized that possible solutions should be found for registration dossiers at different tonnage levels to provide information on endocrine disruption while considering issues such as proportionality and animal welfare. Therefore it will be important to gather the required information e.g. on costs, laboratory capacity and animal welfare, as soon as possible.
• Based on the input of the CARACAL-subgroups to be set up working on these tasks, the Commission will then further develop the proposals with different options for adaptations of these Annexes, which will be used to carry out an impact assessment in line with the Commission Better Regulation guidelines.
• Finally, the Commission will prepare a draft amendment of Annex VII to X to include new standard tests (in silico, in vitro and in vivo) for evaluating ED properties.

Action 2

• Following the modifications of the Annexes (Action 1), an update of relevant ECHA guidance documents should be launched to include the available approaches (e.g. OECD GD 150) and new standard tests (in silico, in vitro and in vivo) for evaluating ED properties in existing guidances. If necessary, the entry into force of the amended Annexes, and in particular Annex I, could be adjusted to the availability of the updated guidances.

Both these actions will be monitored and assessed, and if required, amended to take into account the conclusions of the Fitness Check on Endocrine Disruptors, which was announced in the Commission Communication on Endocrine Disruptors and recently launched with the public consultation of the Roadmap.