[en] Current Technical Guidance Documents for preparing risk assessments, like the guidance for the implementation of REACH, have limited focus on chemical substances in the particulate form and generally do not focus on substances in the nanoform. Within the ENRHES project a comprehensive and critical scientific review of publicly available health and safety information on four types of nanoparticles was performed. Based on the identified exposure and hazard data, basic human health risk assessment appraisals were carried out for fullerenes, carbon nanotubes, nano-silver and nano-titanium dioxide. These risk assessment appraisals followed the structure of a regulatory risk assessment and if possible and relevant, it was attempted to derive indicative human no-effect levels from key studies by applying assessment factors as suggested in the technical guidance document for REACH. These assessment factors address differences and uncertainty related to exposure features between test animals and humans (time, respiratory volume), other interspecies and intraspecies differences and factors for extrapolation to chronic duration. If required, the severity of effects and the quality of the database can be addressed by additional factors. Recently other procedures for deriving human no-effect levels have been published and these are compared to the ENRHES basic risk assessment appraisals. The main differences were observed in relation to evaluating the differences in animal and human exposure situations and interspecies differences, and in applying assessment factors for intraspecies differences for local effects. The applicability of the REACH guidance for nanomaterials is currently being investigated for possible adaptations, considering the specific behaviour and mode of action of nanomaterials.

[en] By 1 December 2010 substances manufactured or imported in the EU ≥ 1000 t (as well as certain other substances) had to be registered under the REACH Regulation 1907/2006. The Joint Research Centre (JRC) in close cooperation with the European Chemicals Agency (ECHA) carried out an analysis and assessment of what type of information on nanomaterials was provided in the received registrations. The aim of the assessment was to develop options for an adaptation of the REACH regulation to ensure proper information generation and reporting and an appropriate risk/safety assessment of nanomaterials (Nano Support project). It should be noted that this analysis and assessment was not a compliance check of the dossiers. From 26000 submitted registration dossiers covering 4700 substances finally 25 dossiers (19 substances) were identified to cover nanomaterials or nanoforms of a substance. It is possible that other dossiers are considered to cover nanomaterials or nanoforms by the registrants, however such dossiers could not be identified to address nanoforms given the information contained in those dossiers. The identified 25 dossiers were subject to a detailed analysis and assessment of information provided for all endpoints including substance identity, physico-chemical properties, human health, environmental fate and behaviour, ecotoxicity, PBT⁶ assessment, Classification and Labelling as well as the attached Chemical Safety Report documenting the Chemical Risk/Safety Assessment. In order to evaluate how the safety of workers and consumers was ensured, it was appropriate to check how the 'Derived No (Minimum) Effect Levels' (DN(M)ELs) were established for substances, covering nanomaterials or nanoforms. DNELs were established mainly for long term inhalation exposure of workers. Half of the assessed dossiers included an oral long term DNEL for the general population. DNELs were usually not specific for nanosized forms and, in the few cases where they were calculated for nanosized materials, they were not derived from hazard data for the nanoform. Different methods for deriving the DNELs were applied and few dossiers derived DNELs by applying the default assessment factors in the REACH guidance. Several DNELs were based on available Occupational Exposure Limits (OELs) for inhalable and respirable dust or the nuisance dust levels, which have not been established for nanosized materials. In general lower (i.e. less strict) assessment factors were applied with different types of justification. All DNELs were expressed in the mass metrics. It is important to note that submission, identification and selection of the dossiers addressed in this study was done before the adoption of the EC recommendation (2011/696/EU) on a definition of nanomaterial and before the publication of the revised ECHA guidance documents that include recommendations for nanomaterials.

[en] Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry. (paper)