European Diagnostic Manufacturers Association
EDMA
EDMA has transferred all its activities, assets and liabilities into the MedTech Europe AiSBL new entity as from 1 January 2017.
ID: 06119144810-12
Lobbying Activity
Response to REACH Regulation - Annex XIV
14 Oct 2016
EDMA, the in vitro diagnostic (IVD) industry association and Eucomed, the European medical technology association, would like to express their grave concerns with the draft proposal to add 4-tert-OPnEO, known as octylphenol ethoxylates (OPEs), including ‘TritonsTM’, to Annex XIV of REACH. The provision of essential diagnostic tests and other medical devices to patients would be substantially endangered as OPEs are used in the manufacturing of many products. The IVD and medical device sectors, with clinical chemistry and laboratory medicine, provide screening, diagnosis, prediction and monitoring of medical conditions including infectious, rare or genetic diseases. IVDs ensure the safety of blood supply in Europe; in medical devices TritonTM is crucial in the manufacture of syringes and of surgical meshes. Evaluation of alternatives and feasibility of substitutes required by the authorisation procedure would result in excessive costs, and require substantial R&D capacity diverting resources from innovation. Costs for substitution are conservatively estimated to be well over €100 million per substance. In an industry made up of 95% SMEs with IVD European market revenues of €10.635 billion (2014), this risks unavailability of products indispensable to the healthcare system. The continued use of OPEs is essential to safeguard uninterrupted supply of these critical medical technologies. More information on the use of OPEs in IVDs and the impact of Authorisation were provided by EDMA to ECHA in 2013. We understand that the decision to list OPEs in Annex XIV was driven by their predominant use in non-healthcare sectors. However, the IVD sector uses negligible amounts of OPEs – only 0.3% (33 tonnes). Additionally, IVD use does not impact the general public but is limited to a professional environment (e.g. clinical labs and hospitals). The prioritisation of OPEs described in the ECHA OPEs background document was based on intrinsic properties, high volumes and wide dispersiveness of uses. The total score for prioritisation was 16-17, warranting high priority for inclusion in Annex XIV. Assuming that the use in the public domain is addressed by other legislative means (e.g. as with the Nonylphenol ethoxylates Annex XVII restriction), the prioritisation score for the remaining professional uses in the healthcare sector would clearly not warrant Authorisation. In highly regulated IVD and medical device industries, substitution (if possible) would necessitate a complete re-design, re-validation, verification and stability testing due to their impact on the core of the test performance (i.e. sensitivity and specificity and stability of the test) and would require conformity assessment by notified bodies. Changes in technology would also generate significant follow-up costs for end-users. Considerable investment would be needed to register each redesigned device in the EU and globally. Considering the high negative impact to the IVD and medical device industries and more importantly on patients and society, and given the following rationale: 1. The evidence to support prioritisation of 4-tert-OPnEO is not based on the substance properties, but on a possible link to their degradation products which are estimated by a possible link to other substances (of significantly different chemical structure) to become a substance of very high concern. Furthermore, these degradation products are inherently degradable and removable under aerobic conditions which are standard procedure in waste water treatment; 2. An environmental quality standard is in effect for these degradation products ensuring regulated threshold limits are not exceeded; 3. The low volume use in the controlled professional healthcare sector does not warrant prioritisation, EDMA and Eucomed urge the Commission not to put OPEs on Annex XIV now, but rather to consider another mitigation measure to proportionately control the risks in wide dispersive use in non-health care sectors.
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