MACRAMÉ Partners publish White Paper on Test Guideline Development

As part of their joint efforts within the NanoHarmony project, the MACRAMÉ Partners BAuA (German Federal Institute for occupational Safety and Health ), RIVM (DutchNational Institute for Public Health and the Environment), BASF (BASF SE), LIST (Luxembourg Institute of Science and Technology), and AIST (AcumenIST), and INIA (National Institute for Agriculture and Food Science and Technology of the Spanish National Research Council (CSIC), member of the MACRAMÉ External Advisory Board), have published a seminal White Paper entitled ‘From Science to Regulation – The NanoHarmony White Paper on Test Guideline Development’.

The White Paper concludes the 42 months research programme of the NanoHarmony project of supporting the development of OECD Test Guidelines and Guidance Documents for eight endpoints, where nanomaterial-adapted test methods have been identified as a regulatory priority.

The White Paper opens by stating that ‘[t]he OECD Mutual Acceptance of Data (MAD) agreement has clearly demonstrated the benefits of such an international approach. For this agreement to remain effective, however, OECD Test Guidelines (TGs) need to remain up to date and fit for purpose for new scientific and/or industrial developments and innovations, and for new and future regulatory needs. The European project NanoHarmony has analysed processes in test method development to identify obstacles and (unnecessary) delaying factors.’

The recommendations outlined in the White Paper are the direct results of the project’s efforts to further streamline the process of OECD TG development, and are based on the feedback that the project collected from stakeholders involved in these processes. The result is a set of recommendations concerning not only nanomaterials, but also addressing some overarching issues pertaining to the development of OECD TGs in general.

In addition, the authors identify a number of hurdles to the efficient development of TGs, including:

  • the need for an effective strategy for prioritising, initiating and coordinating TG developments to ultimately keep up with innovation,
  • the difficulties in engaging the scientific community in TG developments, and
  • the need for extensive validation work, which requires immense human and financial resources.

The White Paper provides recommendations on how to overcome these hurdles, and suggests that ‘[t]he European Commission, Member States and stakeholders should support the Malta Initiative’s European Test Methods Strategy as proposed in its Malta Initiative Position Paper.

Follow this link to read the publication‘From Science to Regulation – The NanoHarmony White Paper on Test Guideline Development’ on the NanoHarmony project website.

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