MedTech Europe views on the ‘One Substance, One Assessment’ European Commission package of legislative proposals

MedTech Europe published its views and recommendations on the ‘One Substance, One Assessment’ (OSOA) package of legislative proposals published on 7 December 2023.

The concept behind the OSOA package to streamline the assessment of chemicals across EU legislation is welcomed as a means to bring efficiency and a harmonised approach to chemical assessments and processes. Some potential benefits include reduced animal testing and the prevention of duplicate testing and regulatory activities.

Furthermore, ECHA’s involvement in RoHS could lead to more transparency, predictability, and legal certainty in the exemption process for businesses.

The medical technology industry finds it important to have opportunities in the long-term to continue shaping the OSOA approach and the three legislative proposals that implement it. We consider that several clarifications are needed to optimise the legislative proposals in the OSOA package, including the following:

• Ensuring ECHA has the necessary expertise at hand to handle the new responsibilities envisaged in the targeted amendments to RoHS and the Medical Devices Regulation (MDR), i.e. in specific technologies (electronics, medical devices and IVDs) and their respective legislation (medical devices and IVDs in the scope of RoHS are regulated by sectoral legislation MDR and IVDR).
• Ensuring that a formal Impact Assessment is carried out, considering the additional resources and budget needed for ECHA to deliver on its new tasks.
• Providing ECHA with the necessary funding via the ECHA Founding Regulation, to ensure it is empowered to complete its (new) tasks. The reallocation of tasks to an already overburdened ECHA and its Committees raises concerns about resource efficiency, effectiveness and accuracy of evaluation outcomes.
• Using the OSOA package and specifically the common data platform as an opportunity to streamline existing databases and regulatory requirements for business operators and remove any such duplication of existing information requirements.
• Clarifying the interface between REACH and RoHS, considering the new role of ECHA, e.g. preventing regulatory overlaps.
• A common data platform seems to be an improvement in principle; however, more details need to be provided as to what information will be made available in the public domain and how confidential business information will be protected.

Read the full position paper below