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NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials

Several terms in the field of environmental health and safety (EHS) assessment of chemicals and nanomaterials (hereinafter NMs) have been defined or used by the scientific community and different organisations, including international bodies, European authorities, and industry associations. This is also true for multidisciplinary projects such as NANoREG, which aims at supporting regulatory authorities and industry in dealing with EHS issues of manufactured NMs. The objective of the present JRC technical report is to publish the harmonised terminology that has been developed and used within NANoREG. It has been agreed upon and adopted by all project partners in their activities and related documents. The report specifically includes: i) the methodology used to select key terms that form the harmonised terminology and to develop harmonised definitions; ii) the existing literature definitions that have been used as a starting point to develop for each key term a harmonised definition; and iii) the reason(s) behind the choices that have been made in drafting a definition. As far as possible, the harmonised definition is reproducing (an) already existing definition text(s), thus avoiding the creation of new and unwelcome information. The discussion on the key terms to be considered for the harmonised terminology led to the selection of 43 key terms. The list includes terms with international regulatory relevance, such as those defined at OECD level, as well as terms that have a specific meaning and use under REACH. The 'NANoREG Harmonised Terminology' has already proven very useful in the context of the OECD work, as support document to the April 2016 OECD Expert Meeting on 'Grouping and read-across for the hazard assessment of manufactured nanomaterials', and in a regulatory context, as support document to the work recently released by RIVM, ECHA and JRC on using (eco)toxicological data for bridging data gaps between nanoforms of the same substance (March 2016). For quick access, the 'NANoREG Harmonised Terminology' is reported in Section 3.