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EDC Targeted Consultation

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Introducing Standard Information Requirements for Endocrine Disruption

REACH Registration requires manufacturers and importers of substances in quantities greater than 1 tonne per year to collect and share information on the properties and uses of such substances. Registrants must assess the intrinsic properties of their substance and whether the substance may cause an adverse effect on human health or the environment. This information is communicated to ECHA in their Registration dossier, and for substances manufactured or imported in quantities greater than 10 tonnes per year, the chemical safety report. Standard information requirements are the minimum required to meet REACH Registration obligations and are dependent on the tonnage that is manufactured or imported into the EU/EEA.

The European Commission has been investigating the regulation of endocrine disruptors for a number of years. In 1999, the EU Commission adopted the Community Strategy for endocrine disruptors, which has led to action in the fields of regulation, research, and international cooperation. Despite significant improvements in our understanding and regulation of endocrine disruptors, there remains a need to update the EU approach in order to ensure that it continues to build on existing knowledge and coherently address these substances throughout the chemical legislative framework.

The Commission Communication ‘Towards a comprehensive European Union framework on endocrine disruptors’[1] confirmed the commitment of the Commission to update data requirements in the different legislative frameworks to improve identification of endocrine disruptors. The 2020 Fitness Check on Endocrine Disruptors noted that questions had been raised by stakeholders on the overall coherence of the EU legal framework in relation to EDCs. Building on this, the Chemicals Strategy for Sustainability seeks to “ensure that sufficient and appropriate information is made available to authorities [on the intrinsic properties of a substance] to allow the identification of endocrine disruptors [which may cause adverse effects on human health and the environment] by reviewing and strengthening the information requirements across legislation” [2]. To do this, the European Commission shall “update information requirements to allow the identification of endocrine disruptors in relevant legislation, particularly under REACH”.

In order to meet the ambition of Chemicals Strategy for Sustainability to ensure sufficient and appropriate information for identification of endocrine disruptors, the Commission proposes to update:
  • Annex I - General provisions for assessing substances and preparing chemical safety reports
  • Annex VII - Standard information requirements for substances manufactured or imported in quantities of one tonne or more
  • Annex VIII - Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more
  • Annex IX - Standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more.
  • Annex X - Standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more.[3]

Options for introducing standard information requirements for endocrine disruptors at each tonnage level were presented at the 3rd meeting of the CASG-ED in October 2020. Following the advice of the subgroup of the Competent Authorities for REACH and CLP on endocrine disruptors (CASG-ED) experts, the Commission has developed two different options for adaptations of the Annexes, which will include new standard tests providing information on endocrine disrupting properties. Before the potential revision of the REACH Annexes, the Commission following its guidelines on Better Regulation conducts an Impact Assessment of the relevant regulatory options. The purpose of this consultation is to gather the views of key stakeholders on the costs and benefits of including in REACH standard information requirements for endocrine disruption.

[1] COM(2018) 734
[2] COM(2020) 667
[3] Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).